Medical Malpractice and Compensation in Global Perspective 9783110270235, 9783110269970

Table of contents :
Medical Malpractice and Compensation in Global Perspective: Introduction
I. Issues Addressed
A. Overall Scheme
B. Details of the Applicable Liability and Compensation Systems
C. Empirical Data
D. Attitudes, Concerns, and Prospects
II. Aims
Medical Malpractice in Austria
Introduction
I. The Insurance Framework
A. Social Insurance in Austria
B. The Role of Private Insurance
1. First-Party Insurance
2. Liability Insurance
II. The Regulatory Framework
A. Professional Law
B. Criminal Law
C. Contract Law
D. Tortious and Contractual Liability
1. Tortious and Contractual Liability Not Mutually Exclusive
2. Tort Law in General
3. Damage
4. Causation
5. Wrongfulness and Fault
6. Multiple Persons Involved
7. Informed Consent
8. Remedies
III. Compensation claims in practice
A. General Remarks
B. Patient Advocacies
C. Conciliation Bodies
D. Compensation Funds
E. Outlook
A Bridge over troubled Waters: The Development of Medical Malpractice Litigation in Brazil
Introduction
I. The Brazilian Legal System
II. The Structure of the Brazilian Legal System
III. The influence of the Consumer’s Defense Code
A. Informed Consent, the Duty to Inform, and Informed Choice
B. Moral Damages and the Inversion of the Burden of Proof As Patient’s Basic Rights
IV. The Changes Brought by the New Civil Code
Conclusion
Canadian Medical Malpractice Law in 2011: Missing the Mark on Patient Safety
Introduction
I. The Canadian Malpractice Context
rvice Delivery, Regulation and Liability Insurance
II. State and Quality of the Canadian Health Care System
A. Medical Malpractice in the Domain of Privately Financed Care
III. Redressing Adverse Events through the Courts
A. Canadian Medical Malpractice Liability in Context
B. Empirical Trends on Medical Liability Claims
C. Black Letter of Canadian Tort Law
1. Battery by Physicians
2. Negligence by Physicians
3. Hospital Liability
4. Government Liability
5. Damages
6. Ongoing Issues and Avenues of Reform
IV. Preventing Adverse Events: Professional and System Reform
A. Reforms at the Level of the Professions
1. Alternative Complaint Mechanisms
2. Revalidation/Recertification
3. Apology Legislation
B. Systemic Reforms
1. Accreditation of Facilities
2. Canadian Patient Safety Institute
3. Improved Information Gathering and Dissemination
Conclusion
Yangge Dance: the Rhythm of Liability for Medical Malpractice in the People’s Republic of China
Introduction
I. The Wider Healthcare Context
II. The Early P.R. China: Medical Services as Social Welfare (1949–1987)
III. The Administrative Liability Regime
A. The Medical Accident Rules 1987
1. Context
2. Main Features of the Administrative Liability Regime, 1987–2002
B. The Medical Accident Regulations 2002
1. Context
2. Main Features of the Administrative Liability Regime, 2002 onwards
IV. The Tort Liability Regime
A. Recourse to the General Principles of Civil Liability
B. Elements of the Tort Liability Regime
1. Cause of Action
2. Burden of Proof
3. The Identification Process
4. Assessment of Damages
C. Effect on the Administrative Liability Regime
V. Reform of Medical Liability under the Tort Liability Law of 2009
A. Antecedents
1. Increasing Disputes between Doctors and Patients
2. Concerns about Defensive Medical Treatments
3. The Chaos Resulting from the Dual Dystem of Medical Liability
B. Legislative History
C. Four Dimensions of the TLL
1. Basis of the Cause of Action
2. Burden of Proof
3. The Identification Procedure
4. Assessment of Damages
VI. Another Step Backwards on Its Way?
Conclusion
Medical Malpractice and Compensation in France
Part I: The French Rules of Medical Liability since the Patients’ Rights Law of March 4, 2002
Introduction
I. General Conditions of Medical Liability
A. Facts Likely to Justify the Physician’s Responsibility
1. Liability Based on Fault
2. Strict Liability
B. The Causal Link
1. Causation Criterion
2. Causation Proof
C. The Victim’s Harm
II. Administration and Adjudication of claims based on liability rules
A. Adjudication Through Conciliation Commissions
B. Adjudication Through Courts
Part II: Compensation Based on National Solidarity
Introduction
I. Typology of Cases Covered by National Solidarity
A. Medical Hazards
B. Hospital-Acquired Infections
C. Blood Transfusions Infections
1. HIV Infection
2. Hepatitis C Infection
3. Additional Grounds
II. Administration and Adjudication of Claims Based on National Solidarity
A. Administrated Claims
B. Procedural Routes to ONIAM
C. Adjudication Proceedings in Front of ONIAM
D. Regulatory Principles Applying to Rights of Recourse
III. Awarded Compensation
Medical Malpractice and Compensation in Germany
Introduction
I. The Potential Legal Consequences of Medical Injury
A. Criminal Law
B. Professional and Disciplinary Sanctions
C. Fault-Based Compensation in Private Law
D. Strict Liability and No-Fault Compensation for Medical Product Injury
E. Social Security, Insurance, and Subrogation Issues
II. The System of Private Law Compensation
A. Treatment Malpractice Claims
1. Faulty Treatment
2. Causation
3. Proof Issues
B. Disclosure Malpractice Claims
1. Background
2. Standard of Disclosure
3. Causation
C. Damages and Liability Insurance Issues
D. The Medical Arbitration Boards
III. Assessment of the Current Situation
A. Empirical Data
B. Evaluation of the Private Law Redress Rules
C. Patient Safety Initiatives
Conclusion
Addendum
Medical Malpractice: The Italian Experience
Introduction
I. The Problematic Nature of Medical Liability
II. The Assignment of the Burden of Proof Between Parties
A. Proving Fault
B. Proving Causation-In-Fact
C. Proving Causation Under the Criminal Law and Under the Civil Law
D. The Role of Informed Consent
Conclusion
The Law of Medical Misadventure in Japan
Introduction
I. Prosecutions and Their Consequences
A. Prosecutions in Medical Cases
B. Response by the Health Ministry and the Medical Profession
C. One Prosecution Too Many: The Medical Professionals’ Counterattack and the String of Acquittals
II. Civil Liability
A. Substantive Law of Medical Malpractice
1. Theories of Recovery
2. Standard of Care
3. Level of Proof
4. Informed Consent and Related Actions
5. Damages
B. Key Aspects of Procedural Law and Practice
1. In General
2. Discovery of Peer Review Findings
3. Judicial Administration Reforms
4. Settlement Practices, Overall Claiming Levels, and Malpractice Insurance Premiums
5. Plaintiffs’ Attorney Fees and Court Filing Fees
III. The No-Fault Compensation System for Obstetrical Injury
Conclusion
Addendum
Treatment Injury in New Zealand
Introduction
I. The New Zealand Accident Compensation Scheme
A. The Woodhouse Report
B. Implementation
C. Developments to 2010
D. Relationship with the Common Law
E. Cover
1. Categories of Cover
2. Personal Injury
3. Residual Actions for Damages
F. Claimants
G. Benefits
H. Claims Process
I. Funding
J. Administration
II. Medical Injuries
A. Cover
B. Treatment Injury
1. Proof of Cause
a. Atkinson and Ambros
b. Modification of Ordinary Rules?
2. Nature of Treatment Injury
3. Treatment Injury in Operation
4. Costs
C. Professional Accountability
1. Reporting of Medical Risks
2. Complaints
3. Actions for Damages
a. Clinical Trials
b. Stillbirths
c. Pregnancy and Unwanted Births
d. Informed Consent Cases
e. Mental Injury
f. Miscellaneous
g. Exemplary Damages
Conclusion
A. Adequate Compensation?
B. Defensible Boundaries?
C. Administratively Efficient?
D. Disincentive to Safety-Conscious Behavior?
E. Overview
Medical Malpractice and Compensation in Poland
Introduction
I. Grounds for Civil Liability
II. Liability Based on Fault
III. Burden of Proof and Causation
IV. Compensation
V. Professional Liability of Doctors
Conclusion
Addendum
Malpractice in Scandinavia
Introduction
I. The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events
A. Regulatory Methods in the Nordic Health Care Systems
B. Compensation Systems
C. Liability Systems
D. The Relationship Between the Systems
II. The Details of the Applicable Liability and Compensation Systems
A. Patient Injury Compensation Systems
1. Introduction
2. Basis for Compensation
a. The Experienced Specialist Standard
b. The Failure of Apparatus
c. The Alternative Treatment Rule
d. The Reasonableness Rule
e. “Accidents”
f. Wrong Diagnosis
g. Infection
3. Causation
a. The Concept of Causation in Scandinavian Law
b. The Problems of Causation in Malpractice Law
c. Relaxation of Evidence
d. Assessment of Damages
III. Available Empirical Data
Conclusion
Medical Malpractice and Compensation in South Africa
I. The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events, Including Regulation, Criminal and Civil Liability, and Social and Private Insurance, and the Relationships Among These Various Systems
A. Regulatory Methods
1. Government Licensing Authorities for Doctors and Hospitals
2. Medico-Ethical Codes of Conduct
3. Reporting of Medical Errors and Adverse Events to the Health Profession Council of South Africa
B. Liability Systems
1. Contract
2. Delict (Tort)
3. Criminal Law
4. Relationship Between the Liability Systems
C. Compensation Systems
1. Sufficient Insurance Cover To Be Required for Private Health Establishments
2. Private Indemnity (Medical Protection Society)
D. Relationships Among the Compensation Systems, the Liability Systems, and the Regulatory Systems
II. The Details of the Applicable Liability and Compensation Systems
A. Criteria Defining Qualification for Compensation
1. Liability Based on Fault
2. The Role of the South African Constitution, 1996
3. Nature of Damages and Compensation
B. Causation and “Loss of Chance”
1. General Rules on Causation
2. “Loss of a Chance”
C. Liability for Failure to Obtain Informed Consent
D. Matters of Proof and Gathering of Evidence
1. Matters of Proof
a. General
b. Gathering of Evidence
III. Available Empirical Data on Medical Errors and Adverse Events, the Operation of the Systems Designed to Prevent and/or Redress such Errors and Events, and the Prevalence and Impact of Measures Designed to Reduce Medical Errors and Adverse Events, Improve System Performance, or Reduce System Costs
IV. Attitudes and Concerns About the Liability and Compensation Systems
Medical Malpractice and Compensation in the UK
Introduction
I. The Context of Medical Malpractice Liability
II. Recent Empirical Evidence on the Numbers and Funding of Claims
A. England
B. Scotland
C. Summary
III. NHS Redress Act 2006
IV. Patients’ Rights Bill in Scotland: The No-Fault Compensation Review Group Report (McLean Report)
V. Basis of Liability for Medical Injury
A. Contract, Tort, and Delict
B. The Requirements of Negligence
C. Duty of Care
D. Standard of Care
E. Causation
1. Difficulties in Proving Causation in Clinical Negligence Cases
2. The Burden of Proof
3. The “But For” Test
4. Cumulative Causation
5. Material Increase in Risk
6. Alternative Causation
7. Reinstating McGhee: Fairchild
8. The Scope of Fairchild and Clinical Negligence Cases
9. Loss of a Chance
VI. Reforming the Costs of Civil Litigation in England and Wales: Implications of the Jackson Report for the Costs of Clinical Negligence and the Ministry of Justice Reform of Legal Aid
A. Jackson Report
B. Reform of Legal Aid in England and Wales
Conclusion
Medical Malpractice and Compensation in Global Perspective: How Does the U.S. Do It?
Introduction
I. Details of the Applicable Regulatory and Liability/Compensation Systems
A. Regulating the Delivery of Medical Care
B. Liability/Compensation Systems
1. Fault-Based (Negligence)
2. No-Fault Liability (Strict Liability)
C. Limitations on Liability/Contracting out of Liability
D. Immunity from Liability
II. Empirical Data on Medical Errors/Adverse Events and Malpractice Litigation
A. How Common Are Medical Errors and Adverse Events?
B. Malpractice Litigation
1. Claiming Frequency (relative to rate of medical error/adverse events)
2. Compensation Patterns and Time Trends
3. Impact of Caps on Non-Economic Damages
4. Accuracy of the Liability System
5. Frivolous Lawsuits
6. Cost of Medical Errors/Adverse Events
7. Cost of the Liability System
III. Attitudes and Concerns About the Liability and Compensation Systems
IV. Why Do Things Look the Way They Do?
V. What Have We Learned by Studying Texas?
A. Who Decides Malpractice Cases?
B. Does it Matter How Much the Jury Awards in a Malpractice Case?
C. How Much Coverage Do Physicians Have?
D. Do Changes in the Tort System (i.e., increases in the number of claims, or payouts per claim) Help Explain the Malpractice Crises that Hit the United States in 2000–2003?
E. Impact of Tort Reforms on Claim Frequency and Payouts
Conclusion
Medical Malpractice and Compensation: Comparative Observations
Introduction
I. Making Sense of Diversity
A. A Diversity of Legal Mechanisms
1. Liability systems
2. Alternative compensation systems
3. Other regulatory and complaints mechanisms
B. The Wider Context
1. The substantive legal context
2. The wider litigation process
3. The health care context
C. Comparative Functional Analysis
II. Assessment of Liability-Based Approaches
A. Compensation
1. Mechanisms for dealing with organizational complexity
2. Adaptation of the Requirements of Causation and Proof
3. Patients’ Rights and Disclosure Duties
B. Prevention
1. The deterrent effect of liability rules
2. Pushing prevention too far? Defensive medicine and related issues
C. Accountability
D. Weighing the Evidence
1. Public controversy and narratives of crisis
2. Empirical evidence
III. Assessment of No-Fault Alternatives
A. Introduction
B. New Zealand: an exclusive no-fault regime
C. The Nordic Patient Insurance Schemes
D. France: Compensation on the Basis of National Solidarity
E. Comparison and Evaluation
Conclusion
Publications

Citation preview

Ken Oliphant Richard W. Wright (eds.)

Medical Malpractice and Compensation in Global Perspective

Tort and Insurance Law TIL 32

Tort and Insurance Law Vol 32 Edited by the Institute for European Tort Law of the Austrian Academy of Sciences and the University of Graz together with the

European Centre of Tort and Insurance Law and the Chicago-Kent Law Review

De Gruyter

Ken Oliphant Richard W. Wright (eds.)

Medical Malpractice and Compensation in Global Perspective With Contributions by Kinga Ba˛czyk-Rozwadowska Pieter Carstens Loutjie Coetzee Eduardo Dantas Claudia di Marzo Colleen M. Flood Richard Golderg Florence G'Sell-Macrez Mette Hartlev Genevieve Helleringer David A. Hyman

Bernhard A. Koch Robert B Leflar Ken Oliphant Richard W. Wright Mårten Schultz Charles M. Silver Marc S. Stauch Bryan Thomas Stephan Todd Vibe Ulfbeck Zhu Wang

De Gruyter

Institute for European Tort Law Reichsratsstraße 17/2 A-1010 Vienna Tel.: +43 1 4277 29651 Fax: +43 1 4277 29670 E-Mail: [email protected] European Centre of Tort and Insurance Law Reichsratsstraße 17/2 A-1010 Vienna Tel.: +43 1 4277 29650 Fax: +43 1 4277 29670 E-Mail: [email protected] Chicago-Kent Law Review Chicago-Kent College of Law 565 West Adams Street Chicago, Illinois 60661-3691 Tel: 312-906-5190 Fax: 312-906-5189 E-Mail: [email protected]

ISBN 978-3-11-026997-0 e-ISBN 978-3-11-027023-5 ISSN 1616-8623

Bibliografische Information der Deutschen Nationalbibliothek Die Deutsche Nationalbibliothek verzeichnet diese Publikation in der Deutschen Nationalbibliografie; detaillierte bibliografische Daten sind im Internet über http://dnb.d-nb.de abrufbar. © 2013 Walter de Gruyter GmbH, Berlin/Boston Druck: Hubert & Co. GmbH & Co. KG, Göttingen Gedruckt auf säurefreiem Papier Printed in Germany www.degruyter.de

Preface

This publication collects together papers delivered at a symposium held in Vienna in December 2010 under the joint organization of the ChicagoKent Law Review and the Institute for European Tort Law of the Austrian Academy of Sciences, in collaboration with the European Centre of Tort and Insurance Law. With the exception of the final chapter, the papers previously appeared in two special symposium issues of the Chicago-Kent Law Review (vol. 86:3 and vol. 87:1). Apart from the correction of the occasional typographical error, they are presented in the form in which they were first published. For the present book, contributors were given the opportunity to add an update at the end of their original text if they so wished, and it was thus possible to make brief reference to new legislative provisions introduced in Germany and Poland. The text of the New Zealand chapter was also updated to reflect a Supreme Court decision of 2012 (Allenby v H). Other chapters reflect the law at the time of their submission (mid-2011). The new final chapter, written by Ken Oliphant, provides concluding reflections from a comparative perspective on the main issues addressed by the book. The Editors would like to express their thanks to the editorial team at the Chicago-Kent Law Review, led by Brian Langs and Margaret Master as successive Editors-in-Chief of the Review, for their painstaking work on the symposium issues. In Vienna, Colm McGrath provided sterling assistance in organizing the symposium and in coordinating the present publication in book-form, and the Editors are very grateful indeed for his efforts. Ken Oliphant adds his particular thanks to Colm for helping with the research that underpins the new final chapter. Ken Oliphant Vienna Richard W. Wright Chicago

V

Table of Contents Ken Oliphant and Richard W. Wright Medical Malpractice and Compensation in Global Perspective: Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1

I. Issues Addressed . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Overall Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Details of the Applicable Liability and Compensation Systems C. Empirical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Attitudes, Concerns, and Prospects . . . . . . . . . . . . . . . . II. Aims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 2 3 4 4 4

Bernhard A. Koch Medical Malpractice in Austria

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Insurance Framework . . . . . . . . . . . . . . . . . . . . . . A. Social Insurance in Austria . . . . . . . . . . . . . . . . . . . . B. The Role of Private Insurance . . . . . . . . . . . . . . . . . . . 1. First-Party Insurance . . . . . . . . . . . . . . . . . . . . . 2. Liability Insurance . . . . . . . . . . . . . . . . . . . . . . II. The Regulatory Framework . . . . . . . . . . . . . . . . . . . . . . A. Professional Law . . . . . . . . . . . . . . . . . . . . . . . . . . B. Criminal Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Contract Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Tortious and Contractual Liability . . . . . . . . . . . . . . . . 1. Tortious and Contractual Liability Not Mutually Exclusive 2. Tort Law in General . . . . . . . . . . . . . . . . . . . . . . 3. Damage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Causation . . . . . . . . . . . . . . . . . . . . . . . . . . . 5. Wrongfulness and Fault . . . . . . . . . . . . . . . . . . . 6. Multiple Persons Involved . . . . . . . . . . . . . . . . . . 7. Informed Consent . . . . . . . . . . . . . . . . . . . . . . . 8. Remedies . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. Compensation claims in practice . . . . . . . . . . . . . . . . . . . A. General Remarks . . . . . . . . . . . . . . . . . . . . . . . . . B. Patient Advocacies . . . . . . . . . . . . . . . . . . . . . . . . . C. Conciliation Bodies . . . . . . . . . . . . . . . . . . . . . . . .

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7 7 8 8 9 9 10 10 10 11 12 13 13 14 14 14 17 18 21 24 28 28 29 30

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D. Compensation Funds . . . . . . . . . . . . . . . . . . . . . . . . . E. Outlook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Eduardo Dantas A Bridge over troubled Waters: The Development of Medical Malpractice Litigation in Brazil . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Brazilian Legal System . . . . . . . . . . . . . . . . . . . . . II. The Structure of the Brazilian Legal System . . . . . . . . . . . . III. The influence of the Consumer’s Defense Code . . . . . . . . . . A. Informed Consent, the Duty to Inform, and Informed Choice B. Moral Damages and the Inversion of the Burden of Proof As Patient’s Basic Rights . . . . . . . . . . . . . . . . . . . . . . IV. The Changes Brought by the New Civil Code . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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35 39 40 43 45

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49 50 52

Colleen M. Flood and Bryan Thomas Canadian Medical Malpractice Law in 2011: Missing the Mark on Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

55

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Canadian Malpractice Context . . . . . . . . . . . . . . . . . . A. Service Delivery, Regulation and Liability Insurance . . . . . . II. State and Quality of the Canadian Health Care System . . . . . . . A. Medical Malpractice in the Domain of Privately Financed Care III. Redressing Adverse Events through the Courts . . . . . . . . . . . A. Canadian Medical Malpractice Liability in Context . . . . . . . B. Empirical Trends on Medical Liability Claims . . . . . . . . . C. Black Letter of Canadian Tort Law . . . . . . . . . . . . . . . . 1. Battery by Physicians . . . . . . . . . . . . . . . . . . . . . 2. Negligence by Physicians . . . . . . . . . . . . . . . . . . . 3. Hospital Liability . . . . . . . . . . . . . . . . . . . . . . . 4. Government Liability . . . . . . . . . . . . . . . . . . . . . 5. Damages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Ongoing Issues and Avenues of Reform . . . . . . . . . . . IV. Preventing Adverse Events: Professional and System Reform . . . A. Reforms at the Level of the Professions . . . . . . . . . . . . . 1. Alternative Complaint Mechanisms . . . . . . . . . . . . . 2. Revalidation/Recertification . . . . . . . . . . . . . . . . . 3. Apology Legislation . . . . . . . . . . . . . . . . . . . . . . B. Systemic Reforms . . . . . . . . . . . . . . . . . . . . . . . . . 1. Accreditation of Facilities . . . . . . . . . . . . . . . . . . 2. Canadian Patient Safety Institute . . . . . . . . . . . . . . 3. Improved Information Gathering and Dissemination . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

55 57 59 60 66 67 69 70 72 73 73 81 83 84 86 87 88 88 89 90 91 91 92 92 94

VIII

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31 32

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Zhu Wang and Ken Oliphant Yangge Dance: the Rhythm of Liability for Medical Malpractice in the People’s Republic of China . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Wider Healthcare Context . . . . . . . . . . . . . . . . . . . . . . II. The Early P.R. China: Medical Services as Social Welfare (1949–1987) III. The Administrative Liability Regime . . . . . . . . . . . . . . . . . . . A. The Medical Accident Rules 1987 . . . . . . . . . . . . . . . . . . 1. Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Main Features of the Administrative Liability Regime, 1987–2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. The Medical Accident Regulations 2002 . . . . . . . . . . . . . . . 1. Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Main Features of the Administrative Liability Regime, 2002 onwards . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. The Tort Liability Regime . . . . . . . . . . . . . . . . . . . . . . . . . A. Recourse to the General Principles of Civil Liability . . . . . . . . B. Elements of the Tort Liability Regime . . . . . . . . . . . . . . . . 1. Cause of Action . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Burden of Proof . . . . . . . . . . . . . . . . . . . . . . . . . . 3. The Identification Process . . . . . . . . . . . . . . . . . . . . 4. Assessment of Damages . . . . . . . . . . . . . . . . . . . . . . C. Effect on the Administrative Liability Regime . . . . . . . . . . . V. Reform of Medical Liability under the Tort Liability Law of 2009 . . . A. Antecedents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Increasing Disputes between Doctors and Patients . . . . . . . 2. Concerns about Defensive Medical Treatments . . . . . . . . . 3. The Chaos Resulting from the Dual Dystem of Medical Liability . . . . . . . . . . . . . . . . . . . . . . . . . B. Legislative History . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Four Dimensions of the TLL . . . . . . . . . . . . . . . . . . . . . 1. Basis of the Cause of Action . . . . . . . . . . . . . . . . . . . 2. Burden of Proof . . . . . . . . . . . . . . . . . . . . . . . . . . 3. The Identification Procedure . . . . . . . . . . . . . . . . . . . 4. Assessment of Damages . . . . . . . . . . . . . . . . . . . . . . VI. Another Step Backwards on Its Way? . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

97 97 99 102 105 105 105 106 108 108 108 111 111 113 113 113 114 115 116 117 117 117 118 119 120 121 121 124 126 126 127 130

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Medical Malpractice and Compensation in France . . . . . . . . . . . 131 Florence G’sell-Macrez Part I: The French Rules of Medical Liability since the Patients’ Rights Law of March 4, 2002 . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. General Conditions of Medical Liability . . . . . . . . . . . . . . . A. Facts Likely to Justify the Physician’s Responsibility . . . . . . 1. Liability Based on Fault . . . . . . . . . . . . . . . . . . . . 2. Strict Liability . . . . . . . . . . . . . . . . . . . . . . . . . B. The Causal Link . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Causation Criterion . . . . . . . . . . . . . . . . . . . . . . 2. Causation Proof . . . . . . . . . . . . . . . . . . . . . . . . C. The Victim’s Harm . . . . . . . . . . . . . . . . . . . . . . . . II. Administration and Adjudication of claims based on liability rules A. Adjudication Through Conciliation Commissions . . . . . . . B. Adjudication Through Courts . . . . . . . . . . . . . . . . . .

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131 131 134 135 136 143 148 148 149 154 156 157 159

Geneviève Helleringer Part II: Compensation Based on National Solidarity . . . . . . . . . . 163 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. Typology of Cases Covered by National Solidarity . . . . . . . A. Medical Hazards . . . . . . . . . . . . . . . . . . . . . . . . B. Hospital-Acquired Infections . . . . . . . . . . . . . . . . . C. Blood Transfusions Infections . . . . . . . . . . . . . . . . 1. HIV Infection . . . . . . . . . . . . . . . . . . . . . . . 2. Hepatitis C Infection . . . . . . . . . . . . . . . . . . . 3. Additional Grounds . . . . . . . . . . . . . . . . . . . . II. Administration and Adjudication of Claims Based on National Solidarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Administrated Claims . . . . . . . . . . . . . . . . . . . . . B. Procedural Routes to ONIAM . . . . . . . . . . . . . . . . . C. Adjudication Proceedings in Front of ONIAM . . . . . . . D. Regulatory Principles Applying to Rights of Recourse . . . III. Awarded Compensation . . . . . . . . . . . . . . . . . . . . . .

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163 164 164 166 167 167 168 168

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169 169 171 173 174 175

Marc S. Stauch Medical Malpractice and Compensation in Germany . . . . . . . . . . 179 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Potential Legal Consequences of Medical Injury A. Criminal Law . . . . . . . . . . . . . . . . . . . . B. Professional and Disciplinary Sanctions . . . . . C. Fault-Based Compensation in Private Law . . .

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D. Strict Liability and No-Fault Compensation for Medical Product Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. Social Security, Insurance, and Subrogation Issues . . . . . . . . II. The System of Private Law Compensation . . . . . . . . . . . . . . . A. Treatment Malpractice Claims . . . . . . . . . . . . . . . . . . . 1. Faulty Treatment . . . . . . . . . . . . . . . . . . . . . . . . 2. Causation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Proof Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Disclosure Malpractice Claims . . . . . . . . . . . . . . . . . . . 1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Standard of Disclosure . . . . . . . . . . . . . . . . . . . . . 3. Causation . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Damages and Liability Insurance Issues . . . . . . . . . . . . . . D. The Medical Arbitration Boards . . . . . . . . . . . . . . . . . . III. Assessment of the Current Situation . . . . . . . . . . . . . . . . . . A. Empirical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Evaluation of the Private Law Redress Rules . . . . . . . . . . . C. Patient Safety Initiatives . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Addendum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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186 187 189 189 189 192 193 196 196 197 198 199 201 202 202 205 207 208 209

Claudia Di Marzo Medical Malpractice: The Italian Experience . . . . . . . . . . . . . . . 211 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Problematic Nature of Medical Liability . . . . . . . . II. The Assignment of the Burden of Proof Between Parties . . A. Proving Fault . . . . . . . . . . . . . . . . . . . . . . . B. Proving Causation-In-Fact . . . . . . . . . . . . . . . . C. Proving Causation Under the Criminal Law and Under the Civil Law . . . . . . . . . . . . . . . . . . . . . . . D. The Role of Informed Consent . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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211 213 221 221 226

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Robert B Leflar The Law of Medical Misadventure in Japan . . . . . . . . . . . . . . . . 239 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. Prosecutions and Their Consequences . . . . . . . . . . . . . . . A. Prosecutions in Medical Cases . . . . . . . . . . . . . . . . . B. Response by the Health Ministry and the Medical Profession C. One Prosecution Too Many: The Medical Professionals’ Counterattack and the String of Acquittals . . . . . . . . . . II. Civil Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Substantive Law of Medical Malpractice . . . . . . . . . . . . 1. Theories of Recovery . . . . . . . . . . . . . . . . . . . .

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2. Standard of Care . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Level of Proof . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Informed Consent and Related Actions . . . . . . . . . . . . . 5. Damages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Key Aspects of Procedural Law and Practice . . . . . . . . . . . . . 1. In General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Discovery of Peer Review Findings . . . . . . . . . . . . . . . 3. Judicial Administration Reforms . . . . . . . . . . . . . . . . 4. Settlement Practices, Overall Claiming Levels, and Malpractice Insurance Premiums . . . . . . . . . . . . . . . . . . . . . . . 5. Plaintiffs’ Attorney Fees and Court Filing Fees . . . . . . . . . III. The No-Fault Compensation System for Obstetrical Injury . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Addendum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

253 254 257 258 260 260 261 262 263 267 268 271 273

Stephen Todd Treatment Injury in New Zealand . . . . . . . . . . . . . . . . . . . . . . 275 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . I. The New Zealand Accident Compensation Scheme A. The Woodhouse Report . . . . . . . . . . . . . B. Implementation . . . . . . . . . . . . . . . . . C. Developments to 2010 . . . . . . . . . . . . . D. Relationship with the Common Law . . . . . . E. Cover . . . . . . . . . . . . . . . . . . . . . . . 1. Categories of Cover . . . . . . . . . . . . . 2. Personal Injury . . . . . . . . . . . . . . . 3. Residual Actions for Damages . . . . . . . F. Claimants . . . . . . . . . . . . . . . . . . . . . G. Benefits . . . . . . . . . . . . . . . . . . . . . . H. Claims Process . . . . . . . . . . . . . . . . . . I. Funding . . . . . . . . . . . . . . . . . . . . . J. Administration . . . . . . . . . . . . . . . . . II. Medical Injuries . . . . . . . . . . . . . . . . . . . A. Cover . . . . . . . . . . . . . . . . . . . . . . . B. Treatment Injury . . . . . . . . . . . . . . . . 1. Proof of Cause . . . . . . . . . . . . . . . . a. Atkinson and Ambros . . . . . . . . . . . b. Modification of Ordinary Rules? . . . . 2. Nature of Treatment Injury . . . . . . . . 3. Treatment Injury in Operation . . . . . . . 4. Costs . . . . . . . . . . . . . . . . . . . . . C. Professional Accountability . . . . . . . . . . . 1. Reporting of Medical Risks . . . . . . . . . 2. Complaints . . . . . . . . . . . . . . . . .

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275 276 276 278 279 283 285 285 286 287 288 288 290 291 292 292 295 296 296 297 301 304 307 310 311 312 313

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3. Actions for Damages . . . . . . . . . . a. Clinical Trials . . . . . . . . . . . . b. Stillbirths . . . . . . . . . . . . . . c. Pregnancy and Unwanted Births . d. Informed Consent Cases . . . . . . e. Mental Injury . . . . . . . . . . . . f. Miscellaneous . . . . . . . . . . . . g. Exemplary Damages . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . A. Adequate Compensation? . . . . . . . . . . B. Defensible Boundaries? . . . . . . . . . . . C. Administratively Efficient? . . . . . . . . . D. Disincentive to Safety-Conscious Behavior? E. Overview . . . . . . . . . . . . . . . . . . .

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314 314 315 316 317 318 318 318 319 319 319 321 322 324

Kinga Ba˛czyk-Rozwadowska Medical Malpractice and Compensation in Poland . . . . . . . . . . . 327 Introduction . . . . . . . . . . . . . . . I. Grounds for Civil Liability . . . II. Liability Based on Fault . . . . . III. Burden of Proof and Causation . IV. Compensation . . . . . . . . . . V. Professional Liability of Doctors Conclusion . . . . . . . . . . . . . . . . Addendum . . . . . . . . . . . . . . . .

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327 331 344 351 356 370 372 373

Vibe Ulfbeck, Mette Hartlev and Mårten Schultz Malpractice in Scandinavia . . . . . . . . . . . . . . . . . . . . . . . . . . 377 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Regulatory Methods in the Nordic Health Care Systems . . . . . . B. Compensation Systems . . . . . . . . . . . . . . . . . . . . . . . . C. Liability Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. The Relationship Between the Systems . . . . . . . . . . . . . . . II. The Details of the Applicable Liability and Compensation Systems . . A. Patient Injury Compensation Systems . . . . . . . . . . . . . . . . 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Basis for Compensation . . . . . . . . . . . . . . . . . . . . . . a. The Experienced Specialist Standard . . . . . . . . . . . . b. The Failure of Apparatus . . . . . . . . . . . . . . . . . . . c. The Alternative Treatment Rule . . . . . . . . . . . . . . . d. The Reasonableness Rule . . . . . . . . . . . . . . . . . . . e. “Accidents” . . . . . . . . . . . . . . . . . . . . . . . . . .

377 379 379 380 381 382 383 383 383 383 383 385 386 386 387

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f. Wrong Diagnosis . . . . . . . . . . . . . . . . . g. Infection . . . . . . . . . . . . . . . . . . . . . . 3. Causation . . . . . . . . . . . . . . . . . . . . . . . a. The Concept of Causation in Scandinavian Law b. The Problems of Causation in Malpractice Law c. Relaxation of Evidence . . . . . . . . . . . . . . d. Assessment of Damages . . . . . . . . . . . . . III. Available Empirical Data . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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388 388 388 388 392 392 393 394 395

L.C. Coetzee and Pieter Carstens Medical Malpractice and Compensation in South Africa . . . . . . . . 397 I. The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events, Including Regulation, Criminal and Civil Liability, and Social and Private Insurance, and the Relationships Among These Various Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Regulatory Methods . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Government Licensing Authorities for Doctors and Hospitals 2. Medico-Ethical Codes of Conduct . . . . . . . . . . . . . . . . 3. Reporting of Medical Errors and Adverse Events to the Health Profession Council of South Africa . . . . . . . . . . . . . . . B. Liability Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Contract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Delict (Tort) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Criminal Law . . . . . . . . . . . . . . . . . . . . . . . . . . . 4. Relationship Between the Liability Systems . . . . . . . . . . C. Compensation Systems . . . . . . . . . . . . . . . . . . . . . . . . 1. Sufficient Insurance Cover To Be Required for Private Health Establishments . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Private Indemnity (Medical Protection Society) . . . . . . . . . D. Relationships Among the Compensation Systems, the Liability Systems, and the Regulatory Systems . . . . . . . . . . . . . . . . II. The Details of the Applicable Liability and Compensation Systems . . A. Criteria Defining Qualification for Compensation . . . . . . . . . 1. Liability Based on Fault . . . . . . . . . . . . . . . . . . . . . . 2. The Role of the South African Constitution, 1996 . . . . . . . 3. Nature of Damages and Compensation . . . . . . . . . . . . . B. Causation and “Loss of Chance” . . . . . . . . . . . . . . . . . . . 1. General Rules on Causation . . . . . . . . . . . . . . . . . . . 2. “Loss of a Chance” . . . . . . . . . . . . . . . . . . . . . . . . C. Liability for Failure to Obtain Informed Consent . . . . . . . . . . D. Matters of Proof and Gathering of Evidence . . . . . . . . . . . . 1. Matters of Proof . . . . . . . . . . . . . . . . . . . . . . . . . . a. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . b. Gathering of Evidence . . . . . . . . . . . . . . . . . . . .

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III. Available Empirical Data on Medical Errors and Adverse Events, the Operation of the Systems Designed to Prevent and/or Redress such Errors and Events, and the Prevalence and Impact of Measures Designed to Reduce Medical Errors and Adverse Events, Improve System Performance, or Reduce System Costs . . . . . . . . . . . . . . 432 IV. Attitudes and Concerns About the Liability and Compensation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435 Richard Goldberg Medical Malpractice and Compensation in the UK . . . . . . . . . . . 439 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. The Context of Medical Malpractice Liability . . . . . . . . . . . . . . II. Recent Empirical Evidence on the Numbers and Funding of Claims. . A. England . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Scotland . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III. NHS Redress Act 2006 . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Patients’ Rights Bill in Scotland: The No-Fault Compensation Review Group Report (McLean Report) . . . . . . . . . . . . . . . . . . . . . . V. Basis of Liability for Medical Injury . . . . . . . . . . . . . . . . . . . A. Contract, Tort, and Delict . . . . . . . . . . . . . . . . . . . . . . . B. The Requirements of Negligence . . . . . . . . . . . . . . . . . . . C. Duty of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Standard of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. Causation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Difficulties in Proving Causation in Clinical Negligence Cases 2. The Burden of Proof . . . . . . . . . . . . . . . . . . . . . . . 3. The “But For” Test . . . . . . . . . . . . . . . . . . . . . . . . 4. Cumulative Causation . . . . . . . . . . . . . . . . . . . . . . 5. Material Increase in Risk . . . . . . . . . . . . . . . . . . . . . 6. Alternative Causation . . . . . . . . . . . . . . . . . . . . . . . 7. Reinstating McGhee: Fairchild . . . . . . . . . . . . . . . . . . . 8. The Scope of Fairchild and Clinical Negligence Cases . . . . . . 9. Loss of a Chance . . . . . . . . . . . . . . . . . . . . . . . . . . VI. Reforming the Costs of Civil Litigation in England and Wales: Implications of the Jackson Report for the Costs of Clinical Negligence and the Ministry of Justice Reform of Legal Aid . . . . . . . . . . . . . A. Jackson Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. Reform of Legal Aid in England and Wales . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

439 440 442 442 445 446 446 448 451 451 451 452 452 454 455 456 456 457 457 457 458 459 462

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David A. Hyman and Charles M. Silver Medical Malpractice and Compensation in Global Perspective: How Does the U.S. Do It? . . . . . . . . . . . . . . . . . . . . . . . . . . . 473 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I. Details of the Applicable Regulatory and Liability/Compensation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. Regulating the Delivery of Medical Care . . . . . . . . . . . . . . B. Liability/Compensation Systems . . . . . . . . . . . . . . . . . . . 1. Fault-Based (Negligence) . . . . . . . . . . . . . . . . . . . . . 2. No-Fault Liability (Strict Liability) . . . . . . . . . . . . . . . . C. Limitations on Liability/Contracting out of Liability . . . . . . . . D. Immunity from Liability . . . . . . . . . . . . . . . . . . . . . . . II. Empirical Data on Medical Errors/Adverse Events and Malpractice Litigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A. How Common Are Medical Errors and Adverse Events? . . . . . . B. Malpractice Litigation . . . . . . . . . . . . . . . . . . . . . . . . . 1. Claiming Frequency (relative to rate of medical error/adverse events) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Compensation Patterns and Time Trends . . . . . . . . . . . . 3. Impact of Caps on Non-Economic Damages . . . . . . . . . . 4. Accuracy of the Liability System . . . . . . . . . . . . . . . . . 5. Frivolous Lawsuits . . . . . . . . . . . . . . . . . . . . . . . . 6. Cost of Medical Errors/Adverse Events . . . . . . . . . . . . . 7. Cost of the Liability System . . . . . . . . . . . . . . . . . . . III. Attitudes and Concerns About the Liability and Compensation Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV. Why Do Things Look the Way They Do? . . . . . . . . . . . . . . . . . V. What Have We Learned by Studying Texas? . . . . . . . . . . . . . . . A. Who Decides Malpractice Cases? . . . . . . . . . . . . . . . . . . . B. Does it Matter How Much the Jury Awards in a Malpractice Case? C. How Much Coverage Do Physicians Have? . . . . . . . . . . . . . D. Do Changes in the Tort System (i.e., increases in the number of claims, or payouts per claim) Help Explain the Malpractice Crises that Hit the United States in 2000–2003? . . . . . . . . . . . . . . E. Impact of Tort Reforms on Claim Frequency and Payouts . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

473 476 476 477 477 483 483 485 486 486 487 488 489 496 499 501 502 503 505 506 507 507 508 508

509 510 510

Ken Oliphant Medical Malpractice and Compensation: Comparative Observations . . . . . . . . . . . . . . . . . . . . . . . . . . 513 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 513 I. Making Sense of Diversity . . . . . . . . . . . . . . . . . . . . . . . . . 516 A. A Diversity of Legal Mechanisms . . . . . . . . . . . . . . . . . . . 516

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Table of Contents

1. Liability systems . . . . . . . . . . . . . . . . . . . . . . . . . 2. Alternative compensation systems . . . . . . . . . . . . . . . 3. Other regulatory and complaints mechanisms . . . . . . . . B. The Wider Context . . . . . . . . . . . . . . . . . . . . . . . . . 1. The substantive legal context . . . . . . . . . . . . . . . . . 2. The wider litigation process . . . . . . . . . . . . . . . . . . 3. The health care context . . . . . . . . . . . . . . . . . . . . . C. Comparative Functional Analysis . . . . . . . . . . . . . . . . . II. Assessment of Liability-Based Approaches . . . . . . . . . . . . . . . A. Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. Mechanisms for dealing with organizational complexity . . 2. Adaptation of the Requirements of Causation and Proof . . 3. Patients’ Rights and Disclosure Duties . . . . . . . . . . . . B. Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1. The deterrent effect of liability rules . . . . . . . . . . . . . 2. Pushing prevention too far? Defensive medicine and related issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . D. Weighing the Evidence . . . . . . . . . . . . . . . . . . . . . . . 1. Public controversy and narratives of crisis . . . . . . . . . . 2. Empirical evidence . . . . . . . . . . . . . . . . . . . . . . . III. Assessment of No-Fault Alternatives . . . . . . . . . . . . . . . . . . A. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B. New Zealand: an exclusive no-fault regime . . . . . . . . . . . . C. The Nordic Patient Insurance Schemes . . . . . . . . . . . . . . D. France: Compensation on the Basis of National Solidarity . . . . E. Comparison and Evaluation . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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XVII

Medical Malpractice and Compensation in Global Perspective: Introduction Ken Oliphant* and Richard W. Wright**

Medical malpractice and compensation for medical injuries are highly visible, controversial, and publicly debated topics that regularly create tension and innovation in legal systems around the world, but the analysis and debate in each country is often limited to national audiences with an assumption that the issues are unique to that location. These chapters address this subject matter in a uniquely global context that demonstrates the universal nature of the issues and the diversity of approaches currently taken around the world and reveal key areas of tension and the likely direction of future developments. Wherever possible, the analysis is supported by reference to the available empirical data, though in many countries this is unfortunately very limited. The chapters in this collection are drawn from a symposium held in Vienna in December 2010 under the joint organization of the ChicagoKent Law Review and the Institute for European Tort Law of the Austrian Academy of Sciences, in collaboration with the European Centre of Tort and Insurance Law. The conference brought together expert commentators from fourteen national or regional legal systems, spread across six continents: Austria, Brazil, Canada, China, France, Germany, Italy, Japan, New Zealand, Poland, Scandinavia, South Africa, the United Kingdom and the United States. The aim was to ensure a good mix of common law and civil law systems, advanced and emerging economies, primarily private and primarily public healthcare systems, and representatives of the major legal families (common law, Germanic, Romanic, Nordic, communist, and post-communist). The countries selected include those that rely primarily on traditional civil liability (whether tortious or contrac-

* **

Director, Institute for European Tort Law, Vienna; Professor of Tort Law, University of Bristol. Distinguished Professor of Law, Chicago-Kent College of Law, Illinois Institute of Technology.

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Ken Oliphant and Richard W. Wright

tual) and those (in particular, France, New Zealand and the Nordic countries) where no-fault approaches have emerged. The chapters in this collection were also published as two special issues of the Chicago-Kent Law Review (vols 86:3 and 87:1). The extended comparative conclusions in this collection have not been previously published which allowed time for reflection on the overall patterns and themes that emerged from the individual reports.

I.

Issues Addressed

The issues that we asked the contributors to cover included (but were not limited to) the following.

A.

Overall Scheme

We asked contributors to give a general account of the overall scheme that exists in each legal system for preventing, redressing, and otherwise providing appropriate accountability for medical errors and adverse events, including regulation, criminal and civil liability, and social and private insurance, and the relationships between these various systems. As a matter of definition, we took “regulation” to include government licensing authorities for doctors and hospitals, voluntary medical guidelines by hospitals and other medical groups, mandatory and/or voluntary reporting of medical errors and adverse events to these or other entities, and the availability of such information to other parts of the overall schemes, including the public. “Liability systems” referred, to the extent applicable, to liability under criminal law, tort law, contract law, and any other liability system. We asked contributors not just to describe each liability and compensation system but also to describe the relationships, if any, between the different systems. As regards civil liability, an initial question within each system was whether the liability for medical malpractice is grounded in tort or contract or both. Lastly, we took “compensation systems” to include (in addition to the liability systems mentioned above) social and private insurance, as well as statutory compensation schemes for criminally-caused injuries. As regards the relationships between the various systems and their effects on prevention, compensation, and accountability, we asked the contributors to consider a number of issues. One very important issue, especially in many civil law countries, is the extent to which the patient’s compensa2

Introduction

tion claim can (theoretically and in practice) be resolved in conjunction with a criminal prosecution initiated by a public prosecutor or by the patient, and the advantages that this may have (e.g., speed of resolution, costs borne by the prosecuting agency rather than the claimant) over a claim brought in the civil courts, as well as the dangers that this may create in blurring the distinction between the purposes of and criteria for criminal and civil liability. Another important issue is the extent to which social or (mandatory or voluntary) private insurance displaces civil liability for medical malpractice or limits the recovery of damages to injuries and/ or losses not covered by the social or private insurance systems. We also asked whether information on medical errors and adverse events that is provided to social or private insurers is available for use in the regulatory and liability systems and to the general public, and whether social and/or private insurers are able, through subrogation or otherwise, to claim reimbursement from the source of the medical error or adverse event (by a damage claim or by any other mechanism) for payments made to compensate for the expenses and losses caused by the error or adverse event. We were particularly interested to find out, in systems where this is theoretically possible, the extent to which it actually occurs in practice.

B.

Details of the Applicable Liability and Compensation Systems

Here we posed a variety of questions to the project participants. What criteria define qualification for compensation? Under each relevant system, is compensation based on conduct generating legal liability (e.g., negligence), medical error, an adverse event, causation, or some other criterion or criteria? How are these criteria defined and how are they actually applied in practice? Is there liability for “loss of a chance” and, if so, is the liability proportional to the lost chance or for the entire injury (assuming the lost chance reaches a given threshold)? Is there liability for failure to obtain informed consent, construed as a dignitary or autonomy injury, regardless of any adverse physical consequence? Who has the burden of proof on these and other issues, what is the burden of persuasion (e.g., “virtual certainty”, “beyond a reasonable doubt”, “preponderance of the evidence”, “balance of probabilities”), and how are these requirements actually applied in practice? If, as in some countries, a claim for compensation can be attached to and determined in a criminal action, are the burdens of persuasion different for criminal and civil proceedings and, if so, how is this handled when both criminal sanctions and the liability to compensate are litigated in the same action?

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Ken Oliphant and Richard W. Wright

We also asked contributors to address issues relating to the wider claims process, including costs. Specifically: Who pays the costs of litigation, including attorney, expert, and court fees? Does “loser pays” apply, or does each side bear its own costs? And are there contingent or conditional fees? Lastly, we asked how easy or difficult it is to obtain evidence in the hands of the opposing party or held by a third party.

C.

Empirical Data

We asked contributors to provide information about available empirical data on medical errors and adverse events, the operation of the systems designed to prevent, redress, or otherwise provide appropriate accountability for such errors and events, and the prevalence and impact of measures designed to reduce medical errors and adverse events, improve system performance, or reduce system costs (including so-called “tort reform”). As mentioned above, this was at the heart of what we wanted to discover, though we were aware in advance that empirical data may not be generally available in a number of the legal systems covered.

D.

Attitudes, Concerns, and Prospects

A final set of issues related to attitudes to and concerns expressed about the existing legal systems for preventing, redressing and otherwise providing appropriate accountability for medical errors and adverse events and prospects for the future. In many countries, the existing systems are a subject of considerable controversy. Minor and major reforms are proposed and often enacted based on public perceptions that have little or no empirical support and with little or no analysis of the potential intra- and inter-system effects. We wanted contributors to give an indication of how well or poorly each country’s set of systems is perceived to operate (as a whole, as well as in its constituent parts), to critically evaluate any reforms that have been undertaken or proposed, and to assess the general prospects in the future.

II.

Aims

It is our hope that these chapters, which discuss the various schemes employed in different countries around the world to prevent, redress, and otherwise provide appropriate accountability for medical errors and 4

Introduction

adverse events, will provide a broader and sounder foundation for consideration of the difficult issues involved and the pros and cons of the many alternative schemes available for addressing them. We hope not only to provide a better understanding of the various options by taking a global approach that transcends national boundaries, but also to contribute thereby to future policy formulation and legal development in this difficult but crucial area.

5

Medical Malpractice in Austria Bernhard A. Koch*

Introduction Austria is a federal republic. While the judiciary is an exclusive federal power without the competence to create law like in a common law jurisdiction, the legislative and executive powers are shared between the federation and the nine provinces (Länder), though with a strong emphasis on the former. Public health, for example, is within the exclusive legislative and executive competence of the federation, whereas only principles of the laws governing hospitals and other healthcare institutions are a federal power, with implementing legislation and execution remaining the business of the Länder. In 2007, Austria spent 10.3 % of its GDP on health (as compared to 15.7 % in the US).1 Of this, 76.4 % was public spending (compared to 45.5 % in the US).2 Per 1,000 inhabitants, Austria had 4.53 practicing physicians (2.43 in the US) and 7.8 hospital beds (3.1 in the US).3 There were 6.8 doctor consultations per capita (4.0 in the US).4 While there are both public and private healthcare institutions in Austria, the distinction is not easy to make because it depends upon a combination of factors such as ownership and status. There are, for example, privately owned hospitals with public law status as well as provincial or municipal hospitals without. For purposes of this article, the distinction does not

*

1

2 3 4

Professor of Law, University of Innsbruck, Austria. This paper is based upon a contribution to Medical Liability in Europe. A Comparison of Selected Jurisdictions (Bernhard A. Koch ed., 2011). All periodicals cited below are from Austria unless indicated otherwise. Organisation for Economic Co-operation and Development (OECD), OECD Health Data 2010 – Frequently Requested Data, Institut de recherché et documentation en économie de la santé (Oct. 2010), http://www.irdes.fr/EcoSante/DownLoad/OECDHealthData_FrequentlyRequestedData.xls. Id. Id. Id.

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matter, however, as both public and private providers are subject to the same rules on medical liability.

I.

The Insurance Framework

A.

Social Insurance in Austria

Ninety-nine percent of all Austrians are currently covered by social health insurance.5 While offered by several providers, the insured cannot choose among them, but are assigned to one or more of them by law according to their professional status and other characteristics. The system is financed by contributions from the insured and, if applicable, their employers (totaling around eighty percent of the social insurance system’s income) but also by the state via general tax monies (thirteen percent in 2009).6 Social health insurance provides coverage for most medical needs, including primary health care services, specialized in-patient and outpatient care, emergency care, maternity services, psychotherapy, physiotherapy and other curative therapies, dental services, prescription medicines, medical devices, ambulance services, etc.7 Most of this coverage is paid for directly by the social insurance carrier by way of a contract with the respective healthcare provider, so the patients primarily receive benefits in kind. They are free to choose their doctors, including specialists without prior consultation of a general practitioner, so they may also select a doctor or hospital who is not a party to an agreement with the social insurance carrier. In the latter case, however, will patients pay the healthcare provider directly, but they are still eligible for at least partial reimbursement from their social insurance carrier. Social health insurance benefits are granted irrespective of the cause triggering the need for treatment, and therefore, include cases of bodily harm tortiously inflicted by a third person such as a medical professional.

5 Die österreichische Sozialversicherung in Zahlen [The Austrian Social Insurance by the Numbers] 9, 13 (Hauptverband der österreichischen Sozialversicherungsträger ed., 25th ed. 2010), http://www.hauptverband.at/mediaDB/703989_Sozialversicherung_in_ Zahlen_25_Ausgabe_August_2010.pdf. 6 Id. On the Austrian social security system, see Wolfgang Holzer, The Interaction of Tort Law and Social Security under Austrian Law, in Tort Law and Social Law 7 (Ulrich Magnus ed., 2003). 7 See The Austrian Health Care System, Bundesministerium Für Gesundheit [Federal Ministry for Health], 10 (June 2010), http://www.bmg.gv.at/home/EN/Topics/The_Austrian_ Health_Care_System.

8

Austria

In such cases, the victim’s tort law claims are assigned by law to the competent social insurance provider, which thereby acquires a right of recourse. Unfortunately, the extent to which such rights are actually being pursued is not published; however, it seems that the frequency is on the rise. In a medical malpractice scenario, the injured patient will therefore receive treatment as well as other support from her social health insurance provider, which in most cases will already have covered the initial treatment when something went wrong.

B.

The Role of Private Insurance

1.

First-Party Insurance

While social health insurance already covers all costs of primary and secondary treatment, around thirty-three percent of all Austrians still decide to buy some form of private health insurance.8 Depending upon the type and scope of policy, the added benefits of private insurance can include, for example, more pleasant conditions during a hospital stay, such as a single or double room. Private health insurance may also cover, for example, the excess costs of a doctor who is not contractually linked with a social insurance provider and who charges more than what the latter would refund to its insured.9 To the extent that a private insurer has paid compensation to a beneficiary, the latter’s liability claims against third parties are subrogated by law to the insurer, which shifts the role of the active party, including medical malpractice cases, from the immediate victim to her insurer.

8 Jahresbericht 2008 [Annual Report 2008], Versicherungsverband Österreich [Insurance Association of Austria], 133 (2009), http://www.vvo.at/jahresbericht-zahlen-und-daten/257. html. 9 Typical policies would therefore cover either singularly or in combination such items as temporary disability, additional hospital expenses, hospital daily benefits, outpatient and dental treatment expenses beyond those covered by social insurance. Cf. Types of Health Insurance Contract, Versicherungsverband Österreich, http://www.vvo.at/index.php?op tion=com_content&task=view&id=277&Itemid=275&lang=en (last visited Apr. 25, 2011).

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2.

Liability Insurance

Since 2010, all practicing doctors are required to take out liability insurance with a minimum coverage of E 2 million.10 Some doctors have already in the past entered into framework contracts with a commercial insurer, as have some professional organizations of specialists. Most insurers offer policies with such coverage, with premiums calculated according to the area of expertise (with plastic surgeons, gynecologists, radiologists, and anesthetists in the most expensive group) and professional status (trainee, general practitioner, specialist).11

II.

The Regulatory Framework

A.

Professional Law

All doctors are mandatory members of a so-called medical chamber in their respective province (Landesärztekammer). These provincial institutions jointly constitute the Austrian Medical Chamber (Österreichische Ärztekammer). Dentists are united in the Austrian Dentists Chamber (Österreichische Zahnärztekammer). These chambers are established under public law by statute and represent the interests of their members. They are, inter alia, in charge of organizing their training and of disciplinary matters. Austrian doctors are not only answerable to courts of law, but also to their competent local disciplinary commission, which acts under the supervision of the disciplinary council of the Austrian Medical Chamber. However, section 136 of the Austrian Ärztegesetz (ÄrzteG) [Act on the Medical Profession] only rather vaguely defines disciplinary offences as any conduct which may adversely affect the reputation of Austrian doctors, or any violation of professional duties.12 Details have to be identified by the disciplinary commissions themselves. Apart from temporary injunctions, they can issue anything from written reprimands to permanent bans on 10 11

12

10

Hospital staff are typically (but not necessarily) covered by their institution’s insurance policy. See Ärzte-Haftpflichtversicherungen, News4Docs, at 14, 14–16 (Feb. 2008), http://www. mein-doktor.at/pdf/MD0208n4d_net.pdf (market overview for 2008); see also ÄrzteHaftpflichtversicherung Verein Ärzte Service, http://www.aerzteservice.com/downloadcenter/ (find section Anträge zur Ärzte-Haftpflichtversicherung then select pdf Ärzte-Haftpflichtversicherung Verein Ärzte Service) (last visited Apr. 25, 2011) (current application form quoting an annual premium of E 448 for gynecologists and other high risk doctors with an insured amount of E 4 million). Ärztegesetz [Act on the Medical Profession] Bundesgesetzblatt [BGBl] I No. 169/1998, as amended, § 136.

Austria

practicing medicine.13 Decisions of the disciplinary commissions remain confidential, so their impact on liability issues cannot be properly assessed. While requiring doctors to pursue continuing professional training, section 49 of the ÄrzteG refers to professional standards in a rather broad and unspecific way, pointing to medical science and experience in general as well as “existing rules and specialist quality standards.”14 A 2005 federal statute (Act on the Quality of Health Services) foresees, among other measures, the development of national quality standards for specific areas.15 These standards can either be mere guidelines or mandatory by way of federal regulations, violations of which can be sanctioned with administrative fines. So far, however, no such standards seem to have been adopted. Due to recent amendments to the laws governing the medical professions, quality control mechanisms are now mandatory for medical doctors and dentists. There is no compulsory certification procedure, but the market for voluntary certification of doctors and other healthcare providers seems to be expanding. In November 2009, a nationwide CIRS pilot project was started, initiated by the Austrian Medical Chamber and the Federal Ministry of Health.

B.

Criminal Law

Criminal law obviously draws the outer lines of appropriate conduct by medical professionals and deals with the more extreme deviations from acceptable behavior. The classic list of crimes against bodily integrity also applies to the medical profession, including involuntary manslaughter16 and negligent bodily injury.17 The latter will not be punished, though, if 13 14 15 16

17

Id. at § 139. Id. at § 49. Gesundheitsreformgesetz [Health Care Reform Act] BGBl I No. 179/2004. Strafgesetzbuch [StGB] [Penal Code] BGBl No. 60/1974, as amended, § 80 foresees a maximum sanction of one year imprisonment for involuntary manslaughter, unless it was committed under particularly dangerous circumstances, in which case the maximum is raised to three years imprisonment. Id. at § 81. The maximum penalty for negligent bodily injury is three months of imprisonment or a fine of 180 Tagessätzen [daily rates]. A daily rate is calculated on the basis of the personal and economic circumstances of the convict and is capped at E 5,000. These sanctions are doubled if the victim was harmed under particularly dangerous conditions, or if her injuries were particularly serious. If those two latter conditions coincide, the sanction can be imprisonment of up to two years even. StGB, § 88.

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committed by a member of the medical profession and if its harmful effects lasted for less than two weeks.18 A special provision of the Austrian Criminal Code deals with unauthorized medical treatment, which is only prosecuted upon the express request of the patient.19 This provision is of particular relevance regarding informed consent.20

C.

Contract Law

All patients are deemed to be treated on the basis of a contract with a doctor or a hospital. This is not only true for patients who pay out of their own pocket, but also for the vast majority of patients whose treatment is paid for directly by their social health insurance provider.21 A contractual relationship between a patient and a hospital can fall under a broad range of varieties, from an ‘all-inclusive’ contract covering all services connected with the patient’s stay at the hospital (including medical treatment) to ‘lodging’ contracts where the patient merely rents the room and the medical facilities, which are then used by one or more internal or external medical professionals that the patient hires separately. Accordingly, the hospital’s contractual duties do not necessarily include all aspects of the patient’s treatment. In particular, it will generally not be held responsible for malpractice of an out-house surgeon that the patient has contracted with individually. The protective scope of a treatment contract, whether concluded with a doctor or a hospital, not only covers the immediate contracting parties themselves, but extends to all persons affected by the treatment. This includes in particular (at first) unborn children, who are also clearly at the focus of a gynecologist’s or obstetrician’s (or other doctor’s) contractual duties primarily owed to the mother. However, the father may also be protected, as well as visitors of patients in a hospital. As a consequence,

18 19 20

21

12

Id. at § 88, ¶ 2. Id. at § 110. Section 110 of the StGB foresees criminal sanctions of up to six months of imprisonment or a fine not exceeding 360 daily rates. Id; see also supra note 17. In case of emergency treatment, the sanction only applies if the urgency of the situation was negligently misjudged by the accused and in fact missing. Sabine Völkl-Torggler, Die Rechtsnatur des ärztlichen Behandlungsvertrages in Österreich [The Legal Nature of the Medical Treatment Contract in Austria], 106 Juristische Blätter [JBl]72 (1984); Daniela Engljähringer, Ärztlicher Behandlungsvertrag [The Medical Treatment Contract], 48 Österreichische Juristen-Zeitung [ÖJZ] 488 (1993).

Austria

such third parties can themselves raise direct claims for breach of contractual duties even though these were promised to another.

D.

Tortious and Contractual Liability

1.

Tortious and Contractual Liability Not Mutually Exclusive

The tort law section of the Austrian Civil Code applies equally to contractual liability, as the concept of liability encompasses both bases of a claim for compensation, which is also expressed by the core rule of tort law: Everyone is entitled to claim compensation for a loss from the person whose fault has caused it; the loss may have been caused by the breach of a contractual obligation or irrespective of any contract.22 Someone injured by another in the course of their contractual relationship may therefore typically sue the latter under both a contract theory as well as a tort law theory, even though the duty breached by the defendant will differ in the two alternatives. In the former variety, the duty is owed to the claimant and arises out of their contract, whereas in the latter variety, the duty of care is owed to everyone, at least in theory. Contractual liability nevertheless holds some (at least strategic) advantages for the claimant, which is why she will most often prefer to pursue her claims on that basis primarily, even though in practice she will also rest her case on a delict possibly committed by the defendant when breaching the contract. In personal injury cases, the contractual duties at stake will typically be socalled protective duties, which are not the core obligations arising out of the contract, but still bind both parties to protect, inter alia, the bodily integrity of the respective other. In a medical malpractice scenario, the prime duties of the treatment contract may also be relevant as these immediately affect the health and well-being of the patient. In the following, tort and contract liability will therefore be presented jointly, even though the specialties in a contract relationship will be highlighted where applicable.

22

Allgemeines Bürgerliches Gesetzbuch [ABGB] [Civil Code] Justizgesetzsammlung [JGS] No. 946/1816, as amended, § 1295 ¶ 1. Cf. Helmut Koziol, Characteristic Features of Austrian Tort Law, in Developments in Austrian and Israeli Private Law 159, 159–60 (Herbert Hausmaninger et al. eds., 1999) (emphasizing that “there is no clear dividing line between the core of tort and the core of breach of contract”).

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2.

Tort Law in General

Austrian tort law is traditionally based on liability for wrongful and faulty conduct.23 Unlike common law, there is only one basis for a tort law claim in the ABGB [civil code] as opposed to multiple torts, and it is probably most closely related to the tort of negligence.24 However, it also applies if harm is caused intentionally, which is just one (though the most serious) variety of fault in Austrian tort law theory. While there are certain instances of strict liability introduced by special legislation in Austrian law, none of these is of particular relevance to the field of medical malpractice.25

3.

Damage

In order to succeed, a victim must prove that she has incurred some damage which is deemed compensable. The latter is not universally true for pure economic loss, which outside a contractual relationship tends to be indemnified only if caused intentionally. Not only does the victim have to prove a loss, she also needs to quantify it in monetary terms. However, a provision of the Act on Civil Procedure comes to her rescue, allowing the judge to assess the loss according to her discretion if it cannot be proved in every detail or if such proof were unreasonably difficult.

4.

Causation

As a rule, the patient needs to convince the court that the deterioration of her condition was caused by someone attributable to the defendant.26 Prima facie proof will suffice, so if she can prove certain facts which are

23 24

25

26

14

ABGB, §§ 1293–1341. There are, however, certain special cases of fault liability also recognized by the ABGB itself such as liability for animals or for certain constructions where specific rules apply, e.g. on the burden of proof. Only two statutory regimes may come into play at all, including the Act on Products Liability, which inter alia also applies to defective pharmaceuticals or medical equipment or devices, and the Act on Nuclear Liability, which amongst other scenarios also applies to radionuclides used for medical therapy. See, e.g., Oberster Gerichtshof [OGH] [Supreme Court] Mar. 16, 1989, docket No. 8 Ob 525/88, 62 Entscheidungen des Obersten Gerichtshofes in Zivil-und Justizverwaltungssachen [SZ] No. 53.

Austria

typically linked, even without being able to establish this link as such, the connection will be deemed proven even if the probability thereof is not significantly high (which is the common standard of proof)27 but at least “clearly outweighs” the opposite.28 Courts shift the burden of proving causation if it is evident that something was objectively wrong within the sphere of the defendant that increased the likelihood of adverse effects upon the patient more than just insignificantly. While the latter still has to be established by the claimant,29 it is up to the defendant to rebut this by proving “with highest probability” that her misconduct did not in fact cause the patient’s loss.30 If the claimant can establish that the loss must have been caused by one of two or more external sources, but it remains unclear which one of them, joint and several liability for all these alternative causes will apply, irrespective of whether they intervened jointly or independently.31 This is also true if two causes concur, and each alone would have triggered the full loss (cumulative causation).32 In cases where not only the defendant may have caused the claimant’s injuries, but where another possible cause for the (full) same damage lies in the claimant’s own sphere, such as a precondition or an illness which brought the patient to the doctor in the first place, the Austrian scholar Franz Bydlinski33 proposed to split the loss between the two causes, arguing that the aforementioned rule on alternative causation should be read together with the statutory provision on comparative negligence.34 Since he deemed it unfair in such cases of causal uncertainty to leave the risk entirely with one side, Bydlinski proposed to spread it according to the ratio of the respective probabilities,35 but only if it is proven that the 27

28 29 30 31 32 33

34 35

The previous standard of “probability close to certainty” is no longer valid.OGH Dec. 12, 2007, 4 Zivilrecht aktuell [Zak] No. 212 (2008). However, it is still not just a mere preponderance of the evidence. OGH May 31, 1990, 63 SZ No. 90; OGH Dec. 12, 2007, 4 Zak No. 212 (2008). OGH Aug. 4, 2009, 65 Evidenzblatt der Rechtsmittelentscheidungen [EvBl] No. 9 (2010). E.g. OGH Jan. 29, 2008, 4 Zak No. 244 (2008); Thomas Juen, Arzthaftungsrecht [Medical Liability Law] 241 (2d ed. 2005). See Helmut Koziol, Causation under Austrian Law, in Unification of Tort Law: Causation 11, 13–15 (Jaap Spier ed., 2000). Id. Franz Bydlinski, Probleme der Schadensverursachung nach deutschem und österreichischem Recht [Problems of Damage Causation in German and Austrian Law] 86–90 (1964); see also Koziol, supra note 22, at 177, 180–84. Bydlinski, supra note 33, at 86–90. See also Koziol, supra note 22, at 177, 180–81. Bernhard A. Koch & Helmut Koziol, Austrian report, in Cases on Medical Malpractice in a Comparative Perspective 57, 78–80 (Michael Faure & Helmut Koziol eds., 2001).

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defendant violated a duty of care and behaved highly dangerously under the circumstances.36 Therefore, in the medical liability scenario, if a patient suffers injuries in the course of some treatment and it remains unclear whether this happened due to some precondition of the patient herself or whether these injuries were alternatively caused by the (undisputedly) negligent behavior of the physician, both sides will have to share this uncertainty, and therefore, the loss.37 Austrian courts have meanwhile adopted this theory of proportional liability.38 If it is certain, however, that a precondition of the patient would have led to the same harmful result as the faulty conduct of the doctor, but only at a later point in time, the doctor only has to account for the fact that such damage has occurred earlier than anticipated under the now hypothetical course of events.39 If, for example, a wrongful and faulty treatment brings about the same symptoms that would have arisen anyway due to the patient’s predisposition, liability accrues only for the harm incurred during the time period starting from the actual occurrence until the predicted moment when the natural cause would have manifested itself anyway or, if the tortious act has aggravated a precondition, such deterioration.40 All this has to be proved by the defendants, who have to meet high standards of proof as imposed by the Austrian courts for such defense.41

36 37

38

39

40 41

16

Id. Bydlinski, supra note 33, at 89. The theory of a loss of a chance therefore never gained any importance in Austria as this alternative route towards proportional liability already takes care of the problem. See Bernhard A. Koch, Der Verlust einer Heilungschance in Österreich [Loss of a Chance of Healing in Austria], 16 European Rev. of Private L. 1051, 1057–59 (2008). OGH Nov. 9, 1989, docket No. 7 Ob 648/89, 112 JBl 1990, 524 (1990) critical note Holzer; cf. also OGH Nov. 7, 1995, docket No. 4 Ob 554/95, 68 SZ No. 207 (only distribution of the damage ensures “a solution to the problem which is in accordance with principles of justice”). Rudolf Reischauer, in II Kommentar zum Allgemeinen bürgerlichen Gesetzbuch [Commentary on the ABGB] § 1302 no. 14–15 (Peter Rummel ed., 3d ed. 2007); Friedrich Harrer, in VI ABGBP Raxiskommentar [Practice Commentary on the ABGB] (Michael Schwimann ed., 3d ed. 2006) §§ 1301–1302 no. 35–43; I Helmut Koziol, Österreichisches Haftpflichtrecht [Austrian Tort Law] (3d ed. 1997) No. 3/58–3/81 (arguing at no. 3/78 that Bydlinski’s theory discussed supra note 35 should be applied). OGH Sept. 3, 1996, docket No. 10 Ob 2350/96b, 69 SZNo. 199; OGH May 5, 1998, docket No. 4 Ob 23/98f, 121 JBl246 (1999) note Bumberger; cf. Juen, supra note 30, at 44. It is therefore not sufficient if the parties to the patient’s contract can only prove a “preponderant probability” of the intervening predisposition as to the injuries at issue. Instead, such probability must almost amount to certainty (insofar as possible). OGH Sept. 3, 1996, docket No. 10 Ob 2350/96b, 69 SZ No. 199.

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5.

Wrongfulness and Fault

While section 1294 of the ABGB requires ‘unlawful’ conduct by the tortfeasor and thereby looks at the objective deviation from conduct that would be expected under the circumstances (a duty of care in common law terminology),42 the fault requirement adds a subjective component and assesses whether the defendant herself could have behaved properly under the circumstances.43 In theory, therefore, the personal abilities of the tortfeasor still seem to be decisive.44 However, at least in medical malpractice cases where the conduct of professionals is at stake who are deemed experts within their trade or occupation, an objective standard of due care applies, enshrined in section 1299 of the ABGB.45 Medical and other professionals are expected to possess the training, expertise and abilities of their peers even if they in fact do not, and they have to account for any behaviour deviating from such standard.46 As the Austrian Supreme Court has expressed: [a] doctor has violated his duties of care owed to his patient if he failed to act in accordance with medical science and experience or if he neglected to exercise the usual prudence of a conscientious average doctor in the actual situation. He is not at fault, however, if the method of treatment that he chose is in accordance with the practice of wellrespected doctors who are familiar with this method, even if other experts may have chosen a different technique. In such case, the doctor

42

43 44 45

46

“Damage is either caused by some unlawful action or omission of another, or by chance. The unlawful infliction of harm is done either voluntarily or involuntarily. The voluntary infliction of harm is either based upon evil intent, if damage is caused with knowledge and will; or upon neglect, if caused with culpable lack of knowledge, or with lack of due attention or of due diligence. Both is called fault.” ABGB, § 1294; see generally Helmut Koziol, Wrongfulness under Austrian Law, in Unification of Tort Law: Wrongfulness 11 (Helmut Koziol ed., 1998). See generally Helmut Koziol, Fault under Austrian Law, in Unification of Tort Law: Fault 11 (Pierre Widmer ed., 2005). See, e.g., Helmut Koziol, Liability Based on Fault: Subjective or Objective Yardstick? 5 Maastricht J. European Comparative L. 111 (1998) (Neth.). This provision reads: “Whoever professes some office, art, business or trade, or who without need takes upon a task whose exercise requires special knowledge or extraordinary diligence thereby indicates that he is confident to have such required diligence and necessary extraordinary knowledge; he therefore had to account for any lack thereof. However, a person who entrusted him with such task knew of the latter’s inexperience or should have known with due attention also is to be charged with such oversight.” See Koziol, supra note 22, at 173–74. Cf. Koch & Koziol, supra note 35, at 72–74.

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has to take the safest measures according to the state of medical science in order to prevent known risks of such treatment.47 The burden of proving fault is reversed according to section 1298 of the ABGB48 if the conduct complained of constitutes a breach of duty arising out of some pre-existing special relationship between the parties, particularly in cases of breach of contract. However, this reversal only applies for plain negligence, whereas gross negligence and intent still have to be proved by the claimant.49 The latter is of no practical relevance for the medical malpractice scenario, however, as the degree of fault has no impact on damages for personal injury.

6.

Multiple Persons Involved

a. No Delegation of Treatment as a General Rule. As a rule, a doctor must obtain her patient’s consent before delegating her duties to a colleague, otherwise she will be held responsible for all negative consequences which would not have materialized had she performed her obligations herself.50 If the patient agrees to substitution or if it becomes unavoidable, the doctor will only have to account for fault in selecting the substitute (culpa in eligendo).51

b. Vicarious Liability in General. Notwithstanding liability for personal fault in selecting an auxiliary (culpa in eligendo), (true) vicarious liability for tortious acts committed by employees and other staff outside of special 47 48

49 50

51

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OGH Jan. 25, 1994, docket No. 1 Ob 532/94, 67 SZ No. 9; cf. OGH Mar. 16, 1989, docket No. 8 Ob 525/88, 62 SZ No. 53. ‘He who claims that he was prevented from fulfilling his contractual or statutory obligation without his fault has to prove it. If he is only liable for grave negligence according to a contractual agreement, he also has to prove that this requirement is missing.’ ABGB, § 1298. In case of a contractual exclusion of liability but for gross negligence of the party in breach, the latter has to prove the absence of such qualified fault. Doctors have to exercise their profession “personally ..., at most in cooperation with other doctors.” Ärztegesetz § 49 ¶ 2. A doctor can, however, employ helpers who have to act under his exact orders and permanent supervision. Ärztegesetz § 49 ¶ 3 allows doctors “in individual cases” to delegate certain duties vis-à-vis their patients to other health service professionals or to trainee doctors, but the delegator bears full responsibility for such delegation. See generally Peter Steiner & Gerald Fleisch, Ärztliche Substitutionsbefugnis [Doctors’ Entitlement to Appoint a Substitute], 59 Anwaltsblatt [AnwBl] 702 (1997). Patients may also implicitly consent to being treated by another doctor, the longer the treatment or consultation is meant to last, the more likely this is (and vice versa); cf. Reischauer, supra note 39, at § 1299 no. 30. Reischauer, supra note 39, at § 1299 no. 30.

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(in particular, contractual) relationships is very limited in Austrian tort law. According to section 1315 of the ABGB, a principal only has to account for the misbehavior of a helper if the latter is either dangerous or unfit.52 In the dangerous variety, the victim needs to establish that the principal had known about the dangerousness, which is not required in the unfit variety.53 If the auxiliary was charged with the fulfillment of contractual duties of her principal, however, the principal will be held vicariously liable for her auxiliary’s behavior irrespective of the qualifications required in tort law as just mentioned.54 Furthermore, a special relationship of social or economic dependency between the principal and her auxiliary is not of the essence, so that the latter may also be a mere independent contractor.

c. Liability for Other Doctors and Other Medical Professionals. A hospital may be vicariously liable for its staff (including doctors, nurses etc.) to the extent that these acts fall within the scope of their employment in order to fulfill the hospital’s obligations vis-à-vis its patients and third parties to whom the duties are extended. If the hospital entrusts a junior doctor or even an intern with tasks that should be assigned to an experienced specialist, or if a specialist in a different field would be required, as far as the hospital’s vicarious liability is concerned, the conduct of the employee actually performing the task will be assessed according to the standard of care to be expected from the expert required.55 If a doctor operates in a hospital without being employed there and merely rents the space and equipment and contracts for temporary support services of hospital staff (as a so-called Belegarzt), she may be liable if the staff assisted her in fulfilling her own obligations towards her pa-

52

53 54

55

The provision reads: “On the whole, he who avails himself of an unfit or knowingly of a dangerous person for taking care of his affairs is liable for any harm this person causes to another because of such qualities.” ABGB § 1315. See also II Helmut Koziol, Österreichisches Haftpflichtrecht [Austrian Tort Law] 352–65 (2d ed. 1984). Id. at 358. Section 1313a of the ABGB reads: “He who owes a duty to another is liable to the latter for any fault of his statutory representative or any person of whom he avails himself for the fulfillment.” ABGB § 1313a. On vicarious liability in general, see Koziol, supra note 52, at 163–4. For the area of healthcare, see I Kurt Stellamor & Johannes Steiner, Handbuch des österreichischen Arztrechts [Manual of Austrian Medical Practitioners’ Law] 149–55 (2d ed. 1999); Christian Markl & Raimund Pittl, Ausgewählte Fragen der Erfüllungsgehilfenhaftung beim ärztlichen Behandlungsvertrag [Selected Aspects of Vicarious Liability in the Context of a Medical Treatment Contract], 52 ÖJZ 774 (1997). Reischauer, supra note 39, at § 1313a no. 12; OGH Jan. 25, 1994, docket No. 1 Ob 532/94, 67 SZ No. 9.

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tient.56 In addition, the Austrian Supreme Court also held such a Belegarzt liable for the negligence of a fellow specialist (in the case at hand an anesthetist), even though the latter was also not employed by the hospital but hired directly by the defendant.57 In that case, the court held that the anesthetist had acted under the defendant surgeon’s (at least general) direction and control, which was particularly disputed because both were independent specialists acting exclusively within the scope of their expertise.58

d. Liability of the Auxiliaries Themselves. While the patient may of course not recover the same damage twice, the fact that a hospital or practitioner is vicariously liable for the behavior of its or her staff does not exclude the possibility that these auxiliaries can also be held (jointly and severally) responsible for their own personal acts and omissions. Since auxiliaries themselves are not personally bound by the contractual or other obligations of their employer,59 they can only be held liable for duties of care that they themselves have to fulfill, which, apart from the general duty to protect a person’s bodily integrity, includes, inter alia, the duty to skillfully complete a task undertaken insofar as necessary to avoid further harm. In a labor law relationship, the Austrian Dienstnehmerhaftpflichtgesetz [DHG] [Act on the Liability of Employees] foresees certain limits to direct liability of the employee in cases of minor degrees of negligence.60

e. Recourse. If a hospital has been ordered to pay compensation based on vicarious liability for the behavior of its staff, it has a right of recourse based on section 1313 of the ABGB61 to the extent that the employees have

56

57 58

59 60 61

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OGH Oct. 27, 1999, docket No. 1 Ob 267/99t, 7 Recht der Medizin [RdM] No. 7 (2000) note Pitzl & Huber. In addition, the hospital may be jointly and severally liable for the same misconduct of its staff if the duties owed to the patient by the Belegarzt and the hospital overlap.OGH Sept. 29, 2009, docket No. 8 Ob 103/09v. OGH Nov. 23, 1999, docket No. 1 Ob 269/99m, 7 RdMNo. 8 (2000) note Kopetzki. See the comment by Christian Kopetzki, supra note 57, and the critical remarks by Hans Bruck & Hans Pfersmann, Wie weit reicht die Haftung des operierenden Chirurgen? [How Far Does the Liability of the Operating Surgeon Go?] 123 JBl 64 (2001). On the general notion of who should count as an assistant in the meaning of section 1313a of the ABGB, see Reischauer, supra note 39, at § 1313a No. 9 (on independent contractors); Koziol, supra note 52, at 340–42. Reischauer, supra note 39, at § 1299 no. 24. The contribution claim of the employer may be reduced or even inapplicable according to section 4 of the DHG. “Generally, nobody is responsible for the unlawful action of another in which he did not participate. Even in cases where the law provides otherwise, he still has a right of recourse against the person at fault.” ABGB § 1325.

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violated personal obligations vis-à-vis the hospital (in particular those arising from their employment contracts).62 Depending on the degree of the employee’s fault, the hospital’s contribution claim can be reduced or even denied.63 If, for example, the nurse’s or doctor’s behavior attributed to the hospital was hardly negligent at all, the hospital will not recover any damages paid to the patient. In other cases of negligence, the judge may mitigate the hospital’s claim in light of certain equitable aspects.64 If a doctor in a direct tort law action has to pay damages to a patient of the hospital that she is working for (the reverse scenario), she might have a contribution claim against the hospital according to analogous principles if she merely has to account for some minor degree of negligence.

7.

Informed Consent65

The doctrine of informed consent is of utmost importance for medical malpractice claims in Austria, as it traditionally seems to have served as a buffer for those cases filed against healthcare providers where the deviation from medical standards cannot be established for whatever reason, but where one is still left with the feeling that something went wrong during treatment. Shifting the blame to an entirely different aspect of the relationship may lead to the same result: if the patient can prove that she was not properly informed before or in the course of her treatment, the healthcare provider may be held liable for all adverse consequences thereof irrespective of whether it is to blame for them. Oddly enough, this is not only advantageous for the patients, but one is left with the impression that even doctors deem this a much less bitter pill to swallow than being accused of having failed as a medical professional.

62 63

64

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Koziol, supra note 52, at 350. The right of recourse mentioned in section 1313 of the ABGB is already founded in the employment contract. Helmut Koziol & Klaus Vogel, Vicarious Liability under Austrian Law, in Unification of Tort Law: Liability for Damage Caused by Others No. 58–59 (Jaap Spier ed., 2003); Wolfgang Brodil, Arzthaftung und Dienstnehmerhaftpflichtgesetz [Medical liability and the Act on the Liability of Employees], 1 RdM 50 (1994); Stellamor & Steiner, supra note 54, at 153. The judge has to take into account: the skill of the employee; the degree of responsibility which the work implied; the dangerousness of the work and the question of whether the employee was paid (extra) for it; finally, also the degree of blameworthiness of the employee’s behavior. Cf. Wolfgang Brodil, Mäßigung der Haftung nach art. 2 DHG im ärztlichen Bereich [Reduction of Liability Sccording to Section 2 DHG in the Medical Context], 2 RdM 34 (1995). See generally Karin Prutsch, Die ärztliche Aufklärung [Informed Consent] (2d ed. 2004).

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The contract for medical treatment requires doctors or hospitals to inform the patient not only about the diagnosis66 and the recommended therapy,67 but also about all possible risks of the treatment68 and to offer her adequate and proper medical care. If she subsequently rests her claim solely upon the breach of the doctor’s or hospital’s duty to inform, she must not only prove that such breach did indeed occur, but also that it led to the damage which she has suffered because she would have abstained from going on with the treatment had she been properly informed. Instead, she might follow another line of reasoning which helps to avoid potential difficulties that such a burden of proof could produce. She can alternatively sue on the grounds that she was physically injured through the acts of the practitioner, hospital, or its staff. Such effect by itself indicates wrongful behavior on their part because it implies that they have acted in violation of the claimant’s interest in her own bodily integrity. This interest is not only protected under general principles of delict, but further specified by contractual duties. The doctor or hospital could still justify such acts by claiming that the patient had validly consented to the treatment beforehand, but in this case, they would have to prove that fact since this argument now would serve as defense.69 Consequently, the hospital would further have to establish that the patient previously had received sufficient information about the upcoming treatment and the risks involved therewith, which is a prerequisite to her informed choice. Without such consent, the doctor or hospital is liable for the claimant’s damage, even if caused accidentally in the course of proper and careful treatment.70

66 67 68

69

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E.g. OGH Jan. 29, 2001, docket No. 3 Ob 87/00s, 8 RdMNo. 21 (2001). See Juen, supra note 30, at 118. E.g. OGH Aug. 4, 2009, docket No. 9 Ob 64/08i, 65 EvBlNo. 9 (2010). On the issue of whether this is a primary or collateral duty of the contract, see Daniela Engljähringer, Ärztliche Aufklärungspflicht vor medizinischen Eingriffen [Doctors’ Duty to Inform Before Medical Treatment] 59–60 (1996). E.g. OGH Mar. 20, 1997, docket No. 6 Ob 2391/96b, 4 RdM No.29 (1997); see also Georg Gaisbauer, Zur Beweislast für Einwilligung des Patienten und Erfüllung der ärztlichen Aufklärungspflicht [On the Burden of Proving the Patient’s Consent and the Fulfillment of the Doctor’s Duty to Inform], 116 JBl 352 (1994). Cf. OGH Aug. 7, 2007, docket No. 4 Ob 137/07m, 2007 SZ No. 122 (no reversal of the burden of proof if the risk not disclosed concerns the chance of a relapse or the failure of the treatment, since doctors do not owe the success of the treatment). E.g. OGH Nov. 11, 1997, docket No. 7 Ob 355/97z, 120 JBl 443 (1998) note Bernat.

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Information must be given early enough so that the patient can thoroughly consider the pros and cons of the treatment71, which enables her to decide on the basis of ample background knowledge whether she wants to go ahead with the planned treatment or not. A mere standard form letter or leaflet including printed information is not enough: the patient must have the option of asking questions.72 While there are no generally applicable criteria for determining what complications need to be disclosed, the Austrian Supreme Court (OGH) has developed a few guidelines on how to observe the patient’s right of self-determination while still respecting the superior goal of her wellbeing.73 The more urgent the treatment is for the patient’s health, the less extensively she has to be informed, especially if an overly anxious patient might opt against the treatment, which in turn would constitute a much higher risk to her health.74 On the other hand, if treatment is not imperative (such as purely diagnostic measures)75, information has to be given as extensively as possible.76 Typical risks always have to be disclosed, even if chances of such complications are remote.77 Statistical probabilities thereby play a role, but are just one factor amongst others:78 The para-

71

72 73

74 75 76

77 78

If there is no imminent danger, a rule of thumb might say that the higher the risks involved, the more time the patient will need. Engljähringer, supra note 68, at 166; Albert Heidinger,Die ärztliche Aufklärungspflicht in der Rechtsprechung des Obersten Gerichtshofes [The Doctor’ Duty to Inform in the Jurisprudence of the Supreme Court], in Ärztliche Verantwortung und Aufklärung 17, 37–38 (Friedrich Harrer & Anton Graf eds., 1999). See also OGH June 23, 1994, docket No. 6 Ob 555/94, 2 RdMNo. 1 (1995) note Kopetzki (information given on the eve of the operation still timely). See, e.g., OGH Jan. 30, 1996, docket No. 4 Ob 505/96, 3 RdM No. 24 (1996). Cf. Heidinger, supra note 71, at 39–41. See in particular the landmark case of OGH June 23, 1982, docket No. 3 Ob 545/82, 105 JBl 373 (1983) note Holzer. Cf. the overview given by Kurt Hofmann, Die Aufklärungspflicht des Arztes im Lichte der Rechtsprechung des Obersten Gerichtshofes [The Doctor’ Duty to Inform in Light of the Jurisprudence of the Supreme Court], 76 Österreichische Richterzeitung [ÖRZ] 1998, 80; see also Koch & Koziol, supra note 35, at 61–65. Engljähringer, supra note 68, at 215. OGH Sept. 16, 2009 docket No. 1 Ob 80/08h, 16 RdM No.62 (2009) note Leischner. See, e.g., OGH Sept. 3, 1996, docket No. 10 Ob 2350/96b, 69 SZ No. 199; OGH July 10, 1997, docket No. 2 Ob 197/97b, 5 RdM No.(1998) 18; see furtherGeorg Gaisbauer, Ärztliche Aufklärungspflicht bei kosmetischen Eingriffen [Doctor’s Duty to Inform in Case of Cosmetic Surgery], 48 ÖJZ 25 (1993). E.g. OGH Jan. 17, 2001, docket No. 6 Ob 318/00h, 8 RdM No. (2001) 16; Engljähringer, supra note 68, at 189. This does not mean that rare risks never have to be disclosed.OGH Sept. 7, 1993, docket No. 10 Ob 503/93, 1 RdMNo. 1 (1994) note Kopetzki. Even if the risk of infection is close to one in a thousand, the patient still has to be informed if the doctor realizes that the patient would otherwise believe that the treatment is without any danger at all.

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mount test is whether the patient might be specifically interested in the particular risk at stake79 and to what extent knowledge thereof might influence her decision.80 Even if the patient was not sufficiently informed and could not therefore give any valid consent to her treatment, she will nevertheless have to bear her own loss if the defendant can prove that the patient would still have gone ahead with the treatment had she known all possible complications thereof.81

8.

Remedies

a. Pecuniary Losses. Austrian law bears no surprises when it comes to the list of compensable heads of damage.82 Apart from expenses for medical treatment,83 medication, medical aids, nursing, rehabilitation and the like, even the costs relatives incurred while visiting the victim and other comparable extras can be recovered.84 The same is true for increased expenses such as adaptations of the house and loss of income.85 If the victim can count on relatives to take care of her voluntarily and for

79 80 81

82

83

84

85

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OGH Jan. 29, 1997, docket No. 7 Ob 12/97h, 4 RdM No.18 (1997). OGH Oct. 24, 1996, docket No. 6 Ob 2211/96g, 4 RdM No.28 (1997). OGH Jan. 31, 1995, docket No. 4 Ob 509/95, 117 JBl 453 (1995) note Steiner. But see Koziol, supra note 39, at no. 8/72, who does not grant the doctor such a possibility to justify his acts if “the practitioner has substantially violated his duties’, for example if he ‘completely failed to disclose risks”. In contrast to Germany, Austrian courts do not require patients to substantiate a decisional conflict whether they would have gone ahead with the treatment had they been fully informed.OGH Oct. 14, 2008, docket No. 4 Ob 155/08k, 20 ecolex No. 77 (2009). Cf. Bernhard A. Koch & Helmut Koziol, Comparative Analysis, in Compensation for Personal Injury in a Comparative Perspective 407, 419–20 (Bernhard A. Koch & Helmut Koziol eds., 2002). This may include the additional costs for treatment by a private doctor who is under no contract with a social insurance provider and/or a stay in a more expensive hospital room (so-called Sonderklasse), if appropriate to the patient’s situation, or if it is otherwise adequate under the circumstances of the case (e.g. if treatment by a specialist working for a private hospital is required by the patient’s medical condition). OGH Apr. 24, 2003, docket No. 2 Ob 284/01f, 49 ZVR No. 38 (2004). In the medical malpractice scenario, this is obviously the case if the deterioration of the patient’s condition happens while staying in the Sonderklasse, but also otherwise if the more expensive treatment is expected to lead to a more satisfactory result.OGH June 28, 2005, docket No. 10 Ob 24/05k, 12 RdM No. (2005) 106. This may even include tips for the nursing staff of a hospital or flowers and other small presents. Karl-Heinz Danzl, in Kurzkommentar zum ABGB [Concise Commentary on the ABGB] 1539, § 1325, no. 7 (Helmut Koziol et al. eds., 3d ed. 2010). Id. at § 1325, no. 10–12.

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free, she can still recover the (fictitious) expenses of a professional nurse because the gratuitous services are not meant to benefit the tortfeasor.86 Apart from the reduction of previous income, loss of earning capacity is also compensable due to the objective approach to calculating the damage. Therefore, even if the victim suffers no actual loss of earnings, her reduced ability to theoretically generate income according to her educational background and other circumstances determining that ability has to be indemnified by the tortfeasor.87 The costs of housekeeping and childcare have to be compensated as well according to labor market value to the extent that the injuries prevent the victim from rendering such services herself.88 A so-called abstrakte Rente [abstract annuity] has to be paid for any likely diminution of future income89 due to the victim’s lasting handicap, or if her physical or mental efforts to maintain the previous level of income have to be increased, both criteria in light of her deteriorated standing when competing with others on the labor market.90 The so-called Verunstaltungsentschädigung [compensation for disfigurement] foreseen by section 1326 of the ABGB91 is meant to indemnify reduced chances of future income and other pecuniary consequences, including weaker prospects of finding a marital partner,92 whereas the emotional effects of disfigurement may (additionally or instead) be claimed as non-pecuniary loss. A mere slight possibility of an impact upon the advancement of the victim suffices to give her a claim under section 1326 of the ABGB; such impact also need not be permanent.93 The highest award under section 1326 so far amounted to E 30,000.94

86 87 88 89

90 91

92 93 94

Id. at § 1325, no. 8. Helmut Koziol, Damages under Austrian Law, in Unification of Tort Law: Damages, 7, no. 47 (Ulrich Magnus ed., 2001); Danzl, supra note 84, at 1541, no. 12. Danzl, supra note 84, at 1546, § 1325 no. 24. It cannot be claimed for additional efforts made in the past. e.g. OGH Apr., 29, 2009, docket No. 2 Ob 234/08p, 20 ecolex 1057 (2009) (with detailed analysis of further aspects). Danzl, supra note 84, at 1544–45, § 1325 no. 22. “If the injured person was disfigured by the maltreatment, this has to be considered particularly if it was a female person whose advancement may be hindered.” ABGB § 1326. Despite its wording, the provision is nowadays applied in a gender-neutral way, of course. Not the emotional bonds are at focus here, but the fact that a spouse at least contributes to the family income and assumes maintenance duties. OGH May 7, 2003, docket No. 7 Ob 36/03z, 49 ZVR no. 39 (2004). Id. Like non-pecuniary loss, it is typically compensated by way of a lump sum payment, except it may also be in the form of an annuity. Danzl, supra note 84, at 1553, § 1326 no. 9.

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If medical malpractice causes the death of the patient, section 1327 of the ABGB95 is the statutory basis for claiming not only funeral expenses and other costs relating to the death as such (including unsuccessful efforts to save the life), but also for maintenance claims of surviving relatives if recognized by law.96 The latter are calculated on the basis of the deceased’s income after taxes.97 The tortfeasor also has to indemnify the loss of services that the deceased would have provided in fulfillment of her maintenance duties (e.g. childcare or household activities).98

b. Non-Pecuniary Loss. Irrespective of whether the claim is based on contractual liability or on tort law, persons suffering personal injuries are entitled not only to compensation for their pecuniary losses, but also for pain and suffering “as adequate under the circumstances”.99 Even if it does not amount to a medical condition in itself (such as a shock, trauma or depression), significant mental suffering is included in the notion of ‘personal injury’, either as a consequence of actual bodily harm or due to a massive threat to the physical integrity.100 This is why, for example, under certain circumstances the fear of dying can also constitute a compensable material loss.101 Damages for non-pecuniary loss are calculated on the basis of the duration and intensity of the actual suffering. Since the latter can hardly be measured, the assessment in practice primarily focuses on more objective criteria like the type and seriousness of the injury.102 While one could imagine further including subjective elements like sensitivity of the injured person (to the extent objectively assessable), most courts decline to do so.103 Neither do they take into account the degree of the defendant’s 95

96

97 98 99 100

101 102 103

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“If bodily injury results in death, not only all costs must be compensated, but also the dependants whose maintenance had to be paid by the deceased under the law shall be indemnified for all they thereby lost.” ABGB § 1327 Danzl, supra note 84, at 1555, § 1327no. 5. This excludes, inter alia, fiancé(e)s or lifetime companions, and also those whom the deceased had contractually promised to provide support. Id. Danzl, supra note 84, at 1557–59, § 1327 no. 11–18. ABGB § 1295. Danzl, supra note 84, at 1547, § 1327 no. 28; Ernst Karner, Der Ersatz ideeller Schäden bei Körperverletzung [Compensation for Non-Pecuniary Loss Resulting from Bodily Injury] 106 (1999). OGH Jan. 14, 2010, docket No. 6 Ob 248/09b, 6 Zak No. 197 (2010). Koziol, supra note 39, at no. 11/19. Reischauer, supra note 39, at § 1325 no. 45; Karner, supra note 100, at 123. Only more recent cases award damages despite lack of sensitiveness. OGH Jan. 14, 1993, docket No. 2 Ob 66/92, 38 ZVR No. 150 (1993); Karl-Heinz Danzl, in Das Schmerzengeld in

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fault when calculating non-pecuniary loss.104 Personal (in particular economic) circumstances of the victim are generally not considered either105; this is subject to substantial criticism.106 Damages are typically awarded in the form of a lump sum for all pain and suffering sustained.107 Nevertheless, in practice, courts consider statistical data, which is published regularly on the basis of prior awards.108 Such tables list average ‘rates’ determined according to the severity of pain (‘agonizing’, ‘severe’, ‘medium’, and ‘slight’) as well as its duration (given in days).109 While such rates are certainly not used as mathematical constants, they at least regularly serve as guidelines for the assessment of damages for pain and suffering.110 The maximum compensation currently attributable for non-pecuniary loss probably is around E 250,000.111 Apart from the immediate victim, Austrian courts have meanwhile acknowledged that close relatives and loved ones112 can claim damages for

104 105

106 107

108

109 110

111 112

medizinischer und juristischer Sicht [Damages for Pain and Suffering from a Medical and Legal Perspective] 144 (Karl-Heinz Danzl et al. eds., 9th ed. 2009). E.g. OGH Apr. 11, 1956, docket No. 3 Ob 162/56, 2 ZVR No. 6 (1957); see also Danzl, supra note 103, at 105–07. OGH Nov. 15, 1989, docket No. 1 Ob 43/89, 62 SZNo. 176; OGH Dec. 19, 1990, docket No. 1 Ob 27/90, 63 SZ no. 223; contra OGH May 9, 1985, docket No. 7 Ob 566/85, 58 SZNo. 80. Koziol, supra note 39, at no. 11/21. Reischauer, supra note 39, at § 1325 no. 49. Exceptionally, annuity payments are also possible in case of severe bodily injuries with particularly grave and lasting painful consequences: OGH Nov. 21, 1968, docket No. 2 Ob 330/68, 41 SZNo. 159; OGH Aug. 8, 2002, docket No. 2 Ob 145/02s, 47 ZVR No. 95 (2002). On the practice of compensation of future pain, see, for example, Christian Huber, Globalbemessung, Teilbemessung und Teilglobalbemessung bei zukünftigen Schmerzen [Global Assessment, Partial Assessment and Partial Global Assessment of Future Pain and Suffering], 63 ÖJZ 83 (2008). Robert Fucik & Franz Hartl, Schmerzengeld für seelische Schmerzen [Damages for Emotional Suffering], 72 ÖRZ 148, 151 (1994); cf. the latest list in Franz Hartl, Schmerzengeldsätze in Österreich [Rates of Damages for Pain and Suffering in Austria], 7 Zak 47 (2011) (with E 100– 120 per day of light pain, E 200–250 per day of medium pain, and E 300–360 per day of severe pain). Hartl, supra note 108. Karl-Heinz Danzl, Schmerzengeldsätze in Österreich? [Rates of Damages for Pain and Suffering in Austria?] 35 ZVR 295 (1990); Juen, supra note 30, at 16–17; Karner, supra note 100, at 91. The highest published award so far was around E 218,000 in 2002.OGH Apr. 18, 2002, docket No. 2 Ob 237/01v, 2002 SZ No. 50. So far, courts have recognized parents, children, siblings, and life-time companions as eligible for such claims. Amounts awarded are, for example, E 20,000 for each parent and up to E 15,000 to siblings; cf. OGH June 26, 2008, docket No. 2 Ob 55/08i, 19 ecolex 907 (2008).

27

Bernhard A. Koch

bereavement in wrongful death cases.113 However, so far courts insist on qualified fault on the side of the tortfeasor, therefore claims based upon merely slight negligence or strict liability are not granted to such third parties. Furthermore, until recently, only damages for bereavement, i.e. in fatal cases, were granted. However, the Supreme Court has already indicated obiter that it may look more favorably upon cases in the future where the immediate victim has survived but suffered severe and lasting injuries, though still only if caused by qualified fault.114

III. Compensation claims in practice A.

General Remarks

Before addressing special ways to pursue claims based upon medical malpractice in Austria, it seems important to highlight just some of the most fundamental differences between Austrian and U.S. civil procedure. To begin with, there are no juries in civil procedure, so in first instance, it is always a single judge alone who hears the case and decides both about liability and remedies. Furthermore, experts are typically appointed by the court, even though the parties may bring in further expert evidence. There is nothing equivalent to discovery in Austrian civil procedure.115 Finally, Austria follows the loser-pays principle, which means that whatever side wins the case is eligible to claim costs from the opponent in proportion to the percentage of success. This includes lawyers’ fees, even though these are limited by statutory amounts linked to the value in dispute. So if the patient loses her case, she has to pay not only her own dues, but also court fees and the doctor’s and/or hospital’s attorneys’ fees.

113 Danzl, supra note 84, at 1547–49, no. 29. This has to be differentiated from cases where the relatives have suffered a shock when learning about the (fatal) injuries of one of the family, which leads to a medical condition and therefore personal injury of themselves. On both types, see Ernst Karner & Helmut Koziol, Der Ersatz ideellen Schadens im österreichischen Recht und seine Reform [Compensation for Non-pecuniary Damage Under Austrian Law and its Reform], in II/1 Verhandlungen des 15. Österreichischen Juristentags Innsbruck 2003 at 74 (2003). 114 E.g. OGH June 14, 2007, docket No. 2 Ob 163/06v, 2007 SZ No. 96. 115 On the taking of evidence in Austrian civil procedure, see Taking of Evidence and Mode of Proof – Austria, European Judicial Network, http://ec.europa.eu/civiljustice/evidence/ evidence_aus_en.htm (last visited Apr. 14, 2011).

28

Austria

If she succeeds only in half, the corresponding success of the defendant(s) effectively offsets the respective claims for reimbursement of costs.116

B.

Patient Advocacies

As required by federal law,117 all provinces have installed so-called Patientenanwaltschaften [patient advocacies]118, which offer, inter alia, free advice and support to patients who believe they have been wronged in the course of medical treatment at a hospital.119 These independent bodies, which are part of the executive branch and staffed by the provincial government, are not competent to represent patients before courts, but their services may prevent cases from going there inasmuch as they offer guidance to patients about their options, negotiate on their behalf with liability insurers, appoint experts to assess the facts, and so on. The patient advocacies serve an important buffer function, filtering out unsubstantiated cases, while at the same time, at least offering an official place to be heard to these complainants.120

116 On the costs of litigation in Austria, see generally Benedikt Spiegelfeld, Country Report Austria, in Study on the Transparency of Costs of Civil Judicial Proceedings in the European Union (Jean Albert ed., 2007), available at https://e-justice.europa.eu/attach ments/cost_study_austria_en.pdf. 117 Bundesgesetz über Krankenanstalten und Kuranstalten [KAKuG] [Federal Act on Hospitals and Sanatoriums] BGBl I No. 69/2005, § 11(e) provides: “Provincial law has to foresee that independent patient representations (patient spokespersons, ombudsinstitutions or other such representative bodies) are made available to assess possible complaints and to ensure patient interests upon request.” 118 Though misleading in light of the missing right of representation before courts, this German term is used in five provinces (Burgenland, Carinthia, Lower Austria, Vienna, Vorarlberg), whereas others speak of “Patientenvertretung” (Salzburg, Tyrol, Upper Austria) or “Patientinnen- und Pflegeombudsschaft” (Styria). On the history, see Belinda Jahn, Außergerichtliche Konfliktlösung im Gesundheitswesen [Out-of-court Settlement of Disputes in the Health Care Sector] (2009). See generally Gerald Bachinger, Patienten helfen – The System of the Patient Advocacies in Austria, NÖ Patienten- und Plfegeanwaltschaft (Lower Austrian Patient Advocacy] (Nov. 2005), http://www.pa tientenanwalt.com/fileadmin/dokumente/09_english_documents/legal_information/ 0510legalinfo_patient_advocacies_DrBachinger.pdf. 119 In Burgenland, Carinthia, Lower Austria, Styria, Vienna, and Vorarlberg, the patient advocacy is also competent to handle claims concerning individual doctors. Patientenanwaltschaften [Patient Advocacy], Public Health Portal of Austria, available at https:// www.gesundheit.gv.at/Portal.Node/ghp/public/content/Patientenanwaltschaften_LN. html (last updated Jan. 3, 2011). 120 In 2008, of all 673 complaints filed with the Lower Austrian patient advocacy, for example, 563 (eighty-four percent) upfront turned out to be unsubstantiated from a liability perspective. However, of the remaining 110 cases, 98 led to compensation payments, either through direct talks with the insurers (seventy-five cases) or after consulting the Medical Chamber’s conciliation panel (twenty-three cases). See Tätigkeitsbericht [Activity Report] 2008, NÖ Patienten- und Plfegeanwaltschaft, 27(f) (2008),

29

Bernhard A. Koch

C.

Conciliation Bodies

All provinces with the exception of Salzburg121 have established so-called Schiedsstellen or Schlichtungsstellen (conciliation panels122) in order to provide a forum for both patients and doctors to resolve disputes arising from or in the course of the treatment. They can therefore not only be called upon by patients, but also by doctors.123 These panels are typically organized at the seat of the respective medical chamber.124 The number of members varies and typically includes at least one doctor and one judge each. The proceedings are entirely voluntary for both sides125 and can be initiated by an informal request. The panel tries to resolve the matters in dispute by offering a forum for discussion. In some cases, it will request a formal independent expert opinion.126 The decisions of the panel are mere non-binding recommendations, so that the patient can still file suit before a regular court of law. The decisions (if in the patient’s favor) primarily recommend lump-sum payments. Doctors or dentists who participate in the fact-finding process of the conciliation procedure are not deemed to thereby violate an obligation under their liability insurance policy, which otherwise might lead to a release from the obligation to cover the incident.127

121 122

123

124

125

126 127

30

http://www.patientenanwalt.com/fileadmin/dokumente/04_publikationen/taetigkeitsberichte/noe_ppa/T%C3 %A4tigkeitsbericht_2008.pdf. While the number of patient complaints has doubled over the past ten years in Vorarlberg, only eight cases on average go to court each year. Patienten klagen seltener wegen Kunstfehlern, ORF (Feb. 9, 2010), http://vorarlberg.orf.at/stories/422006/. In Salzburg, the Patientenvertretung (patient advocacy) is entrusted with similar functions. See Jahn, supra note 118, at 74–75. The literal translation would be “arbitration panel”. Despite their name, however, they do not offer arbitration in the formal sense since their decisions are not binding: Jahn, supra note 118, at 67. On details see Maria Leitner, Schiedsstelle in Arzthaftpflichtfragen [Conciliation Panels in Medical Liability Cases], 5 RdM 7 (1998); Marianne Roth & Johann Sperl, Außergerichtliche Konfliktlösung in Medizinischen Schadensfällen [Out-of-Court Dispute Resolution in Medical Loss Cases], 62 AnwBl 387 (2000). This is true for Burgenland, Lower Austria, Styria, Tyrol, Upper Austria and Vienna. In Carinthia and Vorarlberg, they are seated at the offices of the patient advocacy. The same is true for Salzburg with respect to hospitals, whereas the competent body for self-employed doctors is at the seat of the Salzburg Medical Chamber. In some provinces, hospitals have filed general ex ante-submissions so that it is entirely up to their patients whether they want to have their cases heard before the competent conciliation panel or go straight to court. Cf. Juen, supra note 30, at 294. In Tyrol, this is true for about half of all cases handled. Juen, supra note 30, at 296. Ärztegesetz§ 58(a) ¶ 2; Zahnärztegesetz [Dental Act]BGBlI No. 126/2005, as amended, § 48 ¶ 2.

Austria

D.

Compensation Funds

A federal law introduced in 2001128 initiated the creation of compensation funds (Patientenentschädigungsfonds) for hospitals.129 As this falls under the jurisdiction of the provinces themselves, the federal legislator only laid down the principles for its provincial counterparts; thus there are some differences in the models ultimately adopted by the various Länder.130 The fund is financed by contributions from the patients (i.e. the potential victims!) themselves, who must pay an extra E 0.73 per day spent in hospital.131 The fund was created for patients who have suffered material or immaterial harm in the course of medical treatment (or the omission thereof) at a hospital.132 It is not meant to replace liability regimes, in fact, it is quite the contrary. The primary focus of the fund is cases of hardship, where liability cannot be clearly established (particularly due to problems involved in proving causation or fault),133 or if a rare but severe (‘catastrophic’) complication has occurred, even if the patient had been warned of its possibility before. Patients may still try to pursue their claims in court, even if already (partially) indemnified by the fund, but they have to

128 KAKuG § 27(a) ¶¶ 5, 6. To some extent, this was modeled after the Viennese fund created earlier. See Jahn, supra note 118, at 133. The Freiwillige Wiener Härtefonds [Ex gratia Viennese Hardship Fund] continues to exist alongside the general fund and offers payments up to E 50,000 for people domiciled in Vienna who have suffered damage in the course of a treatment in a Viennese hospital; see Freiwilliger Wiener Härtefonds, Vienna City Administration, http://www.wien.gv.at/gesundheit/wppa/haer tefonds.html (last visited Apr. 25, 2011). 129 Practitioners outside hospitals are not covered by this fund. 130 Wolfgang Kossak, Der Entschädigungsfonds gem § 27a Abs 5 und Abs 6 Krankenanstaltengesetz [The Compensation Fund According to section 27a, paragraph 5 and 6 Hospitals Act], 9 RdM 111 (2002); Eckhard Pitzl & Gerhard Huber, Verschuldensunabhängige Patientenentschädigung [No-Fault Compensation for Patients], 10 RdM 100 (2003). 131 The fund’s means vary from province to province: In 2003, the funds in Vienna and Lower Austria stood at almost E 1 million each (with payments totalling about E 400,000 in the latter province during that year). In comparison, the monies collected in the same period in the Burgenland amounted to only one tenth. See Patientenentschädigungsfonds- Tatigkeits Bericht, NÖ Patienten- und Plfegeanwaltschaft, 18 http://www. patientenanwalt.com/pdf/Patientenentschaedigungsfonds_Taetigkeitsbericht_2003. pdf (last visited Apr. 11, 2011). 132 On details of this causation requirement, see Pitzl & Huber, supra note 130, at 103. 133 As expressly stated in the guidelines of the Viennese fund, for example, payments out of the fund are excluded if the facts are clear (whether in the patient’s favour or not). See Richtlinien des Patientenentschädigungsfonds, Vienna City Administration (2009) (hereinafter Richtlininen), http://www.wien.gv.at/gesundheit/wppa/patientenfonds-richt.html.

31

Bernhard A. Koch

return payments in case of success.134 The application process is suspended, on the other hand, while a court trial is pending, or as long as the parties try to find an out-of-court settlement. As cases typically do not reach the commission before the Patientenanwalt has decided on the tort law merits of the cases in the negative, the success rate of these filings is rather high.135 Payments out of the fund are capped, but the threshold amounts vary from province to province.136 The Austrian Medical Chamber has also installed a Solidarfonds [solidarity fund] as required by the Federal Act regulating their profession. It is meant to absorb losses that are not recoverable despite a valid claim, particularly due to the lack of liability insurance coverage. Eligible claimants are patients who have been harmed by wrongful and faulty medical treatment provided by doctors in private practice.

E.

Outlook

Medical malpractice became a hot topic for legal scholars and judges in the last quarter of the past century, even though there had been court cases long before, of course. At least in part, this may have been the logical consequence of changes in society. A significant growth in the number of doctors coupled with a decline of the one-stop-shop concept of medical treatment offered by general practitioners who were being replaced by more and more diverse specialists, the local family doctor in the commu134 This works either way, so if a patient is awarded E 10,000 by the fund and subsequently obtains judgment in the amount of E 5,000, she only has to pay back the latter amount, whereas if the court award in her favour exceeds E 10,000, this is the maximum she has to repay. Repayment may be waived in cases of social hardship. See Richtlinien, supra note 133. 135 The 2008 statistics show that 94 percent of applications were successful in Vienna. Bericht über das Jahr [Annual Report] 2008, Vienna City Administration, 57 (2009), available at http://www.wien.gv.at/gesundheit/wppa/pdf/bericht-2008.pdf. Seventy-six percent succeeded in Lower Austria. NÖ Patienten-Entschädigungsfonds, Tätigkeitsbericht 2008, NÖ Patienten- und Plfegeanwaltschaft, 5 (2009), http://www.patientenanwalt.com/filead min/dokumente/04_publikationen/taetigkeitsberichte/noe_patienten_entschaedigungs fonds/Patienten_Entschaedigungsfonds_Taetigkeitsbericht_2008_Publikationen_ Taetigkeitsberichte.pdf. 136 While the maximum in Vienna currently stands at E 100,000 (exceptions possible, see Richtlinien, supra note 133), awards in Lower Austria generally must not exceed E 21,801.85 (in cases of extraordinary hardship E 36,336.417, but in special cases of permanent harm of extraordinary dimensions, the exceptional ultimate maximum is E 150,000. See Geschäftsordnung der Entschädigungskommission, NÖ Patienten- und Pflegeanwaltschaft, 4 (2007), available at http://www.patientenanwalt.com/fileadmin/do kumente/02_ihre_rechte/Geschaeftsordnung_08_NOE_Patienten-Entschaedigungs fonds.pdf.

32

Austria

nity was superseded by some anonymous service providers, whose quality of service was being more and more questioned. Awareness of and belief in the progress of science at the same time raised patients’ expectations with regard to the outcome of a treatment, however unrealistic those expectations might have been.137 The media has certainly also had its share in the growing alertness of patients that not all adverse outcomes of their treatment may be fateful. The introduction of ombudsmen and conciliation panels, both very active in cultivating public relations, not only attracted a growing number of complaints (at least initially) but at the same time served as a buffer to keep unfounded claims out of the court system.138 While further reform of medical malpractice law has been discussed repeatedly over the past decades, including a shift towards the Scandinavian models, there is no reform plan in sight at present that has any chance of immediate legislation. This lack of reform also seems to indicate that political pressure to proceed is low, and therefore, dissatisfaction with the system as it stands is rather low as well.

137 See Bernhard A. Koch, The Development of Medical Liability in Austria, in The Development of Medical Liability 108, 108–09 (Ewoud Hondius ed., 2010), in particular the statement by a doctor that “95 fatalities among 100 cancer patients were considered an inevitable matter of fate in the old days when a doctor was praised for the five survivor. With today’s knowledge and technology, 50 % may be healed, while already five patients with constant or deteriorating condition are nowadays often presumed to be a clear-cut indication of the doctor’s failure.” Id. at 109 n.5. 138 See supra note 120; Koch, supra note 137, at 129–31.

33

A Bridge over troubled Waters: The Development of Medical Malpractice Litigation in Brazil Eduardo Dantas*

Introduction Medicine has been evolving in leaps, and the practical consequence for that is changing of social behavior, the creation of new practices, and the need to deal with dilemmas once only a product of science fiction. In vitro fertilization, cloning techniques, the manipulation of stem cells, genetic engineering, nanotechnology, and the deciphering of the human genome are just part of an almost endless list of medical advances that have generated controversy and have created issues that must be dealt with by ethical and legal regulations. Law and medicine – two of the most ancient sciences known to mankind – have had a historically troubled coexistence, with conflicting views and concepts for the same issues. And these differences have grown even stronger in the last six decades as a result of a technological revolution in the field of medicine. And the law can only change when required, or perhaps provoked, by these social movements, to define new limits, limitations, and rules. In other words, it must provide a solution to newly created conflicts. But it takes time. Between these two points of the journey, there is uncertainty, legal breaches, and conflict. *

Lawyer, specialist in Consumer Law; University of Castilla-La Mancha, Spain; LL.M. in Medical Law from the University of Glasgow, Scotland; Ph.D. student at the University of Coimbra, Portugal; Vice-President of the World Association for Medical Law; Vice-President of the Asociación Latinoamericana de Derecho Médico; President of the Brazilian Association for Health Law. Author of several articles published in Brazil, Portugal, and France; Author of Direito Médico (Editora GZ 2009) and Comentários ao Código de Ética Médica (Editora GZ 2010). E-mail: [email protected]. All translations of original Brazilian texts are the author’s, unless otherwise indicated.

35

Eduardo Dantas

Not only Brazil, but the whole world is suffering from the effects of these troubled times, where law and medicine struggle to define the new shape of the legal rules regulating healthcare.1 That is exactly why bioethics and medical law have become so prominent in the last few years. In Brazil, we are talking about a potential market comprised of over 300,000 active physicians (not counting dentists, nurses, other health professionals, and of course, hospitals and clinics). Below, the statistics provided by the Federal Council of Medicine,2 divided by state: UF

Registered

Active

AC

1115

564

AL

5208

3525

AM

5572

3250

AP

915

565

BA

20064

14582

CE

11011

7915

DF

15698

8768

ES

9372

6337

GO

13185

8492

MA

5245

3709

MG

47325

33936

MS

5667

3410

MT

4966

3283

PA

9127

5615

PB

6636

4320

PE

17045

11501

PI

3776

2532

PR

25130

16865

1 Mariano Alonso Pérez, La relación médico-enfermo, presupuesto de responsabilidad civil (En torno a la “lex artis”) [The doctor-patient relationship, allocating civil liability (around the “lex artis”)], in Perfiles de la Responsabilidad Civil en el Nuevo Milenio [Profiles of Liability in the New Millenium] 13, 13 (Juan Antonio Moreno Martínez ed., 2000) (Sp.). 2 Conselho Federal de Medicina [Federal Council of Medicine], available at www.cfm.org.br.

36

Brazil

UF

Registered

RJ

88034

53195

RN

5713

3739

RO

2610

1309

RR

1084

477

RS

32200

23076

SC

14586

10191

SE

3381

2428

SP

130235

96099

TO

2214

1458

487114

331141

Total

Active

Source: Federal Council of Medicine, supra note 2. Total Registered and Active Doctors in Brazil (Divided by State)

Before we continue, there are two important data to provide, also from the Federal Council of Medicine. Although the number of administrative (ethical) claims has risen, the number of doctors considered at fault has fallen. These kinds of claims (although without economic value), have the power to harm the reputation of doctors, and in some cases, deter them from practicing medicine. Consequently, it is also important that defensive medicine becomes more and more a part of the product. Gynecology, Obstetrics, and plastic surgery are the specialties most likely to face judicial claims. The graphics below show the percentages:

37

Eduardo Dantas

Justiça de Branco O nūmero de processos por erro médico no Conselho Federal de Medicina subiu, enquanto o de médicos culpados caiu 100 Processos (Total 356)

93

Médicos Culpados (Total 128)

71

78

60

40

32

20

11

25

15

21

19

14

10

34

30

26

5

0 1991

1992

1993

1994

1995

1996

1997

0

Fonte: Conselho Federal de Medicina

80

1998

Onde o problema é maior 50

Veja quais sāo as especialidades médicas que mais sofrem processos

41 %

40

20

Fonte: Conselho Federal de Medicina

30

20 %

10 %

10

9%

8% 6%

6%

Ortopedia

Pediatria

0 Ginecologia & obstetrica

Cirurgia Plastica

Oftalmologia

Cirurgia Geral

Outros

Source: Federal Council of Medicine, supra note 2.3

3 The graph titled Justiça de Branco (White Justice) represents the evolution of the number of Administrative Claims against physicians, tried before the Federal Council of Medicine, during a period of eight years. The red line, in a rising curve, shows the number of claims. The blue one, on the other hand, represents the number of cases where they were actually found guilty of an ethical fault. It can be interpreted in different ways: 1) The obvious conclusion is that since 1991, the number of cases has skyrocketed; 2) A small percentage of guilty physicians can either show that a) the Federal Council is being over protective; or b) Although the intolerance in the physician-patient relationship has risen, the majority of cases have no strong basis. The graph titled Onde o problema é maior (Where the problem is bigger) shows that, following the general statistics about the most dangerous specialties in medicine (from the legal

38

Brazil

I.

The Brazilian Legal System

The legal systems of the world are so different and complex it is nearly impossible to explore the laws of each country individually. However, these systems share common legal problems in certain areas, like medicine, for instance. Four common heritages (Common, Code, Islamic Law, and Socialist Law) form the basis for the majority of legal systems throughout the world. The differences are more than theoretically important because due process of law varies considerably among and within these legal systems. Code law, the system used in Brazil, is based on a comprehensive system of written rules, or codes, of law. It is divided into commercial, civil, and criminal codes, and is highly influenced by the French, German, and Portuguese systems. It is helpful, then, to stress the basic differences of common law and code law, as we see it. The common law, which developed in Great Britain after the Norman Conquest,4 was based on the decisions of judges in the royal courts. It evolved into a system of rules based on “precedent.” Whenever a judge makes a decision that is to be legally enforced, this decision becomes a precedent: a rule that will guide judges in making subsequent decisions in similar cases. The common law is unique because it cannot be found in any code or body of legislation, but exists only in past decisions. At the same time, common law is flexible and adaptable to changing circumstances. The tradition of code law is quite different. It is based on Roman law, which had been scattered about in many places – in books, in statutes, and in proclamations – until the Emperor Justinian ordered his legal experts to consolidate all the laws into a single book to avoid confusion. Ever since, code law has been associated with a “civil code.” All civil codes, such as the Code Napoleon in France, contain a comprehensive statement of rules, many of which are framed as broad, general principles designed to deal with any dispute that may arise. Unlike common law courts, courts in a

point of view), gynecology and obstetrics answer for 20 percent of the lawsuits, while plastic surgery represents 10 percent of the cases. Ophthalmology, general surgery, orthopedics, and pediatrics follow the list. It’s not by chance that those specialties all work with positive expectations. Every single unexpected result (or even those which are normal, but weren’t informed to the patient) is a potential risk of lawsuit. That strengthens even more the need for appropriate information to be disclosed to the patient, in order to prevent legal risks. 4 See R.B. Seaberg, The Norman Conquest and the Common Law: The Levellers and the Argument From Continuity, 24 Hist. J. 791, 794–95 (1981).

39

Eduardo Dantas

code law system first look to their Code, and then refer to previous decisions for consistency. The term “civil law” is used to mean two quite different things, which can be a little confusing at first for people trying to understand this type of justice system. Sometimes the term is used in contrast to “common law” to refer to the legal system that is based on a civil code, such as the Justinian Code or the Civil Code of Brazil. In its other sense, civil law refers to matters of private law as opposed to public law, particularly criminal law, which is concerned with harm to society at large and is present in both code law and common law systems. In common law legal practice, judges are largely passive with respect to the production of case-specific information. Litigants are responsible for obtaining evidence, interviewing witnesses, researching the law, developing legal reasoning about the application of the law to the evidence and then conveying this to the judge. The incentives for litigants to make these investments are based on the legal rules governing judicial practice and the exercise of judicial power. Judges are generally prohibited, for example, from having ex parte independent contacts with witnesses or reviewing documents that are not obtained from the parties according to the rules of evidence. Common law judges may dismiss a lawsuit or enter a default judgment against a party if that party has failed to present the evidence necessary to support the application of a legal rule. In code law systems, in contrast, judges play a more active role in obtaining evidence and, though less often, legal principles. Although litigants may provide documents in their possession and suggest potential witnesses, Brazilian judges, for example, take on significant responsibilities, such as obtaining additional documents and testimony, shaping the development of evidence, questioning witnesses and determining the order in which issues will be investigated. These are, in short, the basic and most important differences needed to be stressed here, in order to keep in mind what kind of legal struggles we may face in litigating medical malpractice claims.

II.

The Structure of the Brazilian Legal System

In order to comprehend the judicial process in Brazil, it is important to understand its structure, especially to stress the differences when compared to the common law system used in England and the U.S. The Brazilian system is based upon a hierarchy of norms, in which the 40

Brazil

Brazilian Federal Constitution of 1988 occupies the top space in a pyramid of authority. Dating back to the colonial period, Brazil’s legal system has been formed in part by Portuguese influence, Roman canonical law, and the German system. It differs from England and the U.S. in one fundamental way. Whereas in the common law systems, a body of law is built from the application of law by the courts, in Brazil the law is applied concretely to each specific case and judicial decisions are not completely based upon a body of jurisprudence. Questions confronted and decided in other cases do not have the force of law in current cases being decided in Brazil; they are applicable only as a point of reflection by the Brazilian judge. In essence, English and U.S. law is decided according to judicial precedents and not by the legislation in force, as it is in Brazil. The proliferation of legislation and legal doctrine in Brazil creates what is often viewed as a complicated and bureaucratic litigation process. Measures have been undertaken to simplify and speed up the processing of civil law in Brazil. Small claims civil and criminal courts and rules allowing parties to settle claims through arbitration have been established.5 The Brazilian Federal Constitution of 1988 was promulgated following the end of military rule in the country. It consecrates the Democratic State of Law and guarantees fundamental rights of Brazilian citizens and alien residents in the country in its most ample form as well as set within defined limits. The rights guaranteed in the Brazilian Constitution, specifically in Articles 5 and 7, which govern individual rights, are viewed as true principles of law, which inform all Brazilian legislation as well as judgments that occur in the country.6 As opposed to others, the Brazilian Congress was extremely detailed in writing the Brazilian Constitution, bringing forth general rules and obligations to be observed in diverse fields of law. In this varied range, highlights include the organization and structure of Brazilian states and the powers, rights, and obligations of public entities. It grants to the judiciary, comprised of courts and judges, the authority to resolve disputes between private parties through the application of law.

5 In Brazil, mediation is regulated by Federal Law 9.306/1996, with original text available at http://www.planalto.gov.br/ccivil_03/leis/L9307.htm. 6 Constituição Federal [C.F.] [Constitution] arts. 5, 7 (Braz.).

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Contrary to the common law practiced in England and the U.S., Brazilian law is based on the classical positivist school.7 In other words, the law is imperative, and as such, it is imperious in its observation and application. The criteria for judging a defendant before judges or courts are governed by legislation. The Brazilian judge must apply the text of the law to the concrete case. In cases where the law does not cover the issue, the judge may use social rules for the common good to guide his judgment and sentences. In this manner, objectivity and impartiality are, in theory, preserved. It is inevitable, however, that the vast array of laws and norms published in the country frequently end up generating inconsistencies, often allowing the reader to reach various conflicting interpretations. For this reason, there is a strong trend today toward standardizing the interpretation of laws and norms currently in force in order to arrive at a uniform application of the law. In these cases, the interpretation of a law handed down by the Federal Supreme Court, the highest court in the land, prevails. Notwithstanding the vast array of Brazilian legislation and the positivist approach to law, the principle of the judge’s right to be freely convinced and to freely appreciate the evidence brought in the process in accordance with facts and circumstances therein prevails. The judge, operating within this principle, is obliged to explain the motives for his conclusion at the end of the process.8 It is worth emphasizing at this juncture that the Brazilian judicial process is extremely formal. Judgments may only be reached in accordance with the information brought forward during the process, according to the principle of formal truth.9

7 See Josef L. Kunz, Contemporary Latin-American Philosophy of Law: A Survey, 3 Am. J. Comp. L. 212, 212–13 (1954). 8 For further details about the obligation to present solid arguments in judicial ruling, we recommend reading Jasson Hibner Amaral’s Considerações acerca do dever de fundamentação das decisões, available at http://jus.com.br/revista/texto/8248/consideracoes-acerca-do-de ver-de-fundamentacao-das-decisoes; Sílvio Luís Saíki’s A norma juridical da motivação das decisões judiciais, available at http://www.planalto.gov.br/ccivil_03/revista/Rev_88/Artigos/ PDF/SilvioSaiki_Rev88.pdf; and Eid Badr’s Princípio da motivação das decisões judiciais como garantia constitucional, available at http://jus.com.br/revista/texto/14333/principio-da-motivacao-das-decisoes-judiciais-como-garantia-constitucional. 9 For further details about the principle of formal truth in the Brazilian legal system, we recommend reading Euler Paulo de Moura Jansen’s A verdade real e a formal têm relacionamento harmônico, available at http://www.conjur.com.br/2008-jun-05/verdade_formal_ real_relacionamento_harmonico, and Regina Lúcia Teixeira Mendes’ Princípio da verdade real no processo judicial brasileiro, available at http://www4.jfrj.jus.br/seer/index.php/revis ta_sjrj/article/viewFile/209/202.

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This principle is only set aside in criminal cases, where the principle of real truth based upon the evidence guides the judge. In this, the judge is empowered to determine the production of evidence necessary to form his opinion. In both the civil and criminal processes, the parties to the case have a right to understand the judge’s motives for reaching the final decision. If this justification is not given, the final verdict is nullified. In addition, a judicial decision only becomes definitive after the appeals process has been exhausted. In general, a single magistrate first judges the case. If the parties are not satisfied with this outcome, they may appeal to the court. Following this, an appeal to the superior court is permitted. The Federal Supreme Court is the last word in all cases, and decisions proffered by this body are definitive. As such, they may not be appealed. A lawsuit in Brazil may take some time to reach a resolution. Depending on a number of factors (e.g., venue, judge assigned to decide, complexity of issues, and proof searching, etc.), it may take between two and ten years for the average case to conclude.

III. The influence of the Consumer’s Defense Code Were it possible to determine when the discussion of medical law started to gain importance in the Brazilian legal system, the probable date would be the year 1992, when the Consumer’s Defense Code (CDC)10 was enacted and put into effect. Still today, medicine is a profession that resents from the existence of a proper federal law, defining its rights and obligations, its boundaries and frontiers. The Federal Constitution enacted in 1988 transformed the defense of consumers into a constitutional right.11 Article 5, XXXII, expressly states, “The Brazilian State will promote, in the terms of the law, the defense of the consumer.”12 The law that the Constitution refers to is the CDC of

10 11 12

Lei No. 8.078, 11.09.1990, Diário Oficial Da Uniâo [D.O.U.], 12.09.1990. Caio Mário da Silva Pereira, Responsabilidade Civil De Acordo Com A Constituição de 1988 [Liability Under the Constitution of 1988] (5th ed. 1994) (Braz.). C.F. art. 5; see also José Afonso da Silva, Curso de Direito Constitucional Positivo [Positive Constitutional Law Course] (8th ed. 1992) (Sp.).

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1992, which was the first important piece of legislation to recognize the vulnerability of common citizens in consumer transactions.13 As a result, higher courts started using the concepts of a consumer and a service provider as defined in the CDC to resolve conflicts between patients and physicians.14 This application creates an almost tangible tension between the courts and the medical associations, with the latter rejecting the possibility of having the medical profession considered as a consumer-oriented relationship. The first issue that arises is whether the practice of medicine – or in other words, the physician-patient relationship – can be viewed as a consumer/ commercial relationship under the CDC.15 To answer that, it is necessary to analyze the legal definitions under Brazilian law of “consumer,” “provider,” and “services.” Article 2 of the CDC defines a consumer as “any person, individual or collective, who acquires or uses products or services as the final recipient.”16 A provider is defined by Article 3 as “any person, individual or collective, public or private, national or alien, who develops activities of production, assembly, creation, construction, transformation, import, export, distribution or selling of products or services.”17 With an exercise of interpretation of the spirit of the law, and the literal concepts included therein, it is easy to conclude that the patient, a user of medical services, is the consumer for which a service is provided (a medical procedure in general, a consultation, an intervention, or any other type of procedure), and that the healthcare professional is the provider who develops his professional activity, and is paid for it, in situations listed in the aforementioned Article 3.

13

14

15

16 17

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Marcos Almeida Magalhães Andade Jr., Marcadores atuais da relação médico-paciente – O palco atual onde transcorre o trabalho médico, Determinantes da deflagração dos processos judiciais pacientes × médicos [Current markers of the doctor-patient relationship – The current setting where medical care takes place: Determining of the triggers of medical malpractice litigation], in Direito & Medicina – Aspectos Jurídicos da Medicina 21 (Arnaldo Oliveira ed., 2000) (Braz.). Gerson Luiz Carlos Branco, Responsabilidade Civil por Erro Médico: Aspectos [Liability for Medical Error: Aspects], 4 Revista Síntese de Direito Civil e Processual Civil [Synthesis of Civil Law and Civil Procedure Magazine], 128–151, (2000) (Braz.). Sérgio Cavalieri Filho, O direito do consumidor no limiar do século XXI [The Right of the Consumer Approaching the 21st Century], 2 Revista Trimestral de Direito Civil 123, 125–26 (abr./jun. 2000) (Braz.). Lei No. 8.078, 11.09.1990, Diário Oficial Da Uniâo [D.O.U.], 12.09.1990. Id.

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The general consensus is that the patient is considered a consumer of services, regardless of whether it is a simple consultation or a complex surgical procedure, under the terms and for the purposes of the CDC. The physician offers his knowledge and services, not merely as a healthcare provider, but as a service provider, plain and simple. And that happens because there is not a specific legal definition of what constitutes a medical act or a medical service. Treated as a general rule, all regulation of healthcare falls under the CDC. The recently enacted Medical Ethics Code (a resolution, not a law, issued by the Federal Council of Medicine) expressly excludes the possibility of considering the practice of medicine as an activity regulated by the CDC.18 On the other hand, courtroom decisions apply the CDC in the rulings.19 Under the CDC, the physician-patient relationship gains new colors.20 It is not just a private relationship anymore. Instead, it is heavily regulated by the law, with new rules for marketing, billing, disclosure of information,21 burden of proof, and patient consent. Apart from that, empowering the patient with very favorable legal tools has boosted the number of lawsuits in the past ten years.

A.

Informed Consent, the Duty to Inform, and Informed Choice

There are several legal issues regarding consent, and litigation is increasing in relation to consent issues. Several aspects need to be taken into consideration when determining whether consent was valid, such as when consent was obtained and whether the risks have been explained; moreover, whether these risks were understood by the patient (sometimes, cultural issues or language barriers can be a complication); whether the patient is a minor (and if so, whether mature enough or not to decide alone); whether an adult patient has legal capacity to decide (and also, if having legal capacity to decide, whether clinical capacity is absent); and

18 19

20

21

Resoluçao No. 1.931, 17.09.2009, Diário Oficial Da Uniâo [D.O.U.], 24.09.2009. See, e.g., S.T.J.J., REsp No. 1.180.815, Relator: Min. Nancy Andrighi, 19.08.2010, 641, Diário do Judiciário Eletrônico [D.J.e.], 26.08.2010; S.T.J.J., REsp No. 467.878, Relator: Min. Ruy Rosado de Aguiar, 05.12.2002, Diário da Justiça [D.J.], 10.02.2003, 222. Genival Veloso de França, O Código do Consumidor e o exercício da medicina [The Consumer Code and the Practice of Medicine], Busca Legis, available at http://www.egov.ufsc.br/portal/ sites/default/files/anexos/24742-24744-1-PB.pdf (Braz.). See Adalbertos Pasqualotto, Os Efeitos Obrigaciones da Publicidade no Código de Defesa do Consumidor [The Effects of Advertising on the Consumer Defense Code] (1997) (Braz.).

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whether an oral consent constitutes enough evidence that information has been given and understood. But, above all, the most important issue is whether the patient has been given sufficient, adequate, complete information, so that they can actually decide, and not simply acquiesce to a physician’s suggestion. Very often, though, physicians and healthcare providers misunderstand the concept of so-called informed consent.22 Informed consent is the authorization given by the patient to undergo treatment, based on the knowledge of the nature of a medical procedure, and to be exposed to risks, side effects, possible complications, benefits and alternatives to the proposed treatment.23 In other words, it is the acceptance of the services to be delivered by a healthcare professional after understanding what is being consented to. It is necessary to understand that the process of consenting constitutes, simultaneously, a patient’s right and a physician’s duty.24 Yet this notion is not well understood among Brazilian physicians. It is yet to be understood by a vast majority of them that the patient must be informed in a clear and comprehensible way, according to his cognitive capabilities, about his diagnosis, risks, prognosis, and existing treatment alternatives, including those the doctor does not think are appropriate for the patient. It is also important to point out that the mere act of reading and signing a consent form is not enough to release the physician from his duties, from

22

23 24

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Ruth Fadin & Tom L. Beauchamp, A History and Theory of Informed Consent 237 (1986) (“It is always an open question whether an autonomous person with the capacity to give an informed consent actually has, in any specific instance, given an informed consent, in the sense of making an autonomous choice to authorize or refuse an intervention.”). See Eduardo Dantas, Direito Médico 71–105 (Editora GZ 2009). See, e.g., Resolucão No. 1.931, 17.09.2009, Diário Oficial Da Uniâo [D.O.U.], 24.09.2009, art. 22 (Braz.) (“[The physician shall not] fail to obtain consent from the patient or the patient’s legal representative after a full disclosure of any procedure to be performed, except in the case of imminent risk of death.”); id. at art. 24 (“[The physician shall not] prevent the patient from exercising the right to decide freely on his own personal wellbeing as well as exercise his authority to limit it.“); id. at art. 26 (“[The physician shall not] fail to respect the will of any person, capable physically and mentally, on hunger strike, or forcibly feed him, providing him with information about possible complications of prolonged fasting, and in the assumption of risk of imminent death, treating it.“); id. at art. 31 (“[The physician shall not] disregard the right of the patient or the patient’s legal representative to decide freely on the performance of diagnostic or therapeutic practices, except in case of imminent risk of death.“); id. at art. 34 (“[The physician shall not] fail to inform the patient about the diagnosis or prognosis, or the risks and goals of treatment, except when direct communication may cause the patient damage, in which case, the communication shall be delivered to the patient’s legal representative.“).

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his obligation to inform accordingly (even if this written form is an important piece of evidence of due diligence). The right to be informed has little or nothing to do with the true exercise of the patient’s autonomy. The act of consenting to some treatment, research, experiment, or surgical procedure is just a part of a bigger process, where the patient can exercise autonomy. Someone can consent based on his trust in the doctor, based on indifference, fear, or even because he did not receive all the information necessary to meaningfully choose among possible options. Informed consent is often confused with informed choice, the latter being essential to achieve the fulfillment of the right to be informed (and the physician’s duty to inform). The patient needs not only to receive, but also to understand the information that is being conveyed. Information without comprehension is legally void, because it could be proven that the patient consented (or signed a consent form), but did not exercise his right to free and informed choice. His autonomy would be jeopardized. And what is appropriate information? That is a difficult question, since the answer may differ, given the specific situation. But mostly, the communication between the physician and his patient must include the existing treatment options (not only the main options) with their purposes and details, their benefits and risks (commonly occurring risks and those unlikely to occur), possible side effects, success rates, the reasons why a specific option is being recommended, the prognosis, and the risks of not getting treatment.25 That being said, the act of obtaining consent without allowing proper choice does not represent an automatic release from professional duties regarding information, if it was withheld, distorted, tampered with, or incomplete. The physician would still be held liable for informational negligence.26

25 26

See Eduardo Dantas, Direito Médico 71–105 (Editora GZ 2009). See S.T.J.J., REsp No. 1.071.969, Relator: Min. Luis Felipe Salomão, 02.02.2010, 527, Diário do Judiciário Eletrônico [D.J.e.], 01.03.2010 (Braz.) (The Superior Court of Justice decided in favor of the plaintiff, holding a blood bank liable for lack of proper communication of test results.); S.T.J.J., AgRg No. 818.144, Relator: Min. Ari Pargendler, 09.10.2007, 23, Diário do Judiciário Eletrônico [D.J.e.], 05.11.2007 (Braz.) (“The physician who does not inform his patient about the risks of surgery is negligent, being liable for all damages resulting from the intervention.”); but see S.T.J.J., REsp No. 1.051.674, Relator: Min. Massami Uyeda, 23.04.2003, 349, Diário do Judiciário Eletrônico [D.J.e.], 24.04.2009 (Braz.) (exempting the doctor from being considered responsible for an unexpected result, because he proved the fulfillment of the duty to inform). All three rulings available at www.stj.jus.br.

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The examples of legal documents could go on and on, in Brazil,27 Portugal,28 Spain29, France30 and Israel,31 and all over the world, showing that there is a new way of dealing with old dilemmas, and that healthcare providers must modify their practices to conform to emerging standards. The world has evolved, and that requires adaptation. It is a mistake to think that obtaining informed consent – as it happens today in most cases – is enough to exempt the physician from liability, absolving legal responsibility in the event an undesired outcome occurs during the treatment or procedure. A treatment or procedure can be considered successful from a clinical point of view, but later be seen as inappropriate when compared to other possible outcomes that could be expected if a different therapeutic method had been explained to and chosen by the patient. This lack of information does not necessarily constitute negligence. It may represent the expression of the physician’s beliefs, based in his own experience or in the medical literature, that the course of treatment taken was the most appropriate for the situation faced at that moment. The problem is that this behavior goes against ethical principles and legal commands that make mandatory the disclosure of all information available. Withholding information about alternatives may be considered, in a lawsuit or in a disciplinary investigation, an undue interference in treat-

27

28 29

30

31

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See, e.g., Lei No. 10.741, 1.10.2003, Diário Oficial Da Uniâo [D.O.U.], 3.10.2003 (Braz.) (The Elderly Protection Act ensures the right to choose the most favorable health treatment.); Lei No. 9.434, 4.02.1997, Diário Oficial Da Uniâo [D.O.U.], 5.02.1997 (Braz.) (The Organ and Tissues Transplantation Law requires consent for every procedure.); Lei No. 8.080, 19.09.1990, Diário Oficial Da Uniâo [D.O.U.], 20.09.1990 (Braz.) (The Health Organization Law article 7, section V, reinforces to the patient the right to information about his/her health conditions.). State law also regulates patients’ rights. See, e.g., Lei No 16.279, 20.07.2006, Diário da Minas Gerais [D.O.E.M.G.], 21.07.2006 (Braz.); Lei No 14.254, 4.12.2003, Diário Oficial da Paranà [D.O.E.P.], 23.12.2003 (Braz.); Lei No 10.204, 7.01.1999, Diário Oficial da Sao Paolo [D.O.E.S.P], 8.01.1999 (Braz.). Regulamento 14/2009, D.R. II. Série 8, 13 Jan. 2009, 1355–1369, art. 44–51 (Port.). Básica Reguladora de la Autonomía del Paciente y de Derechos y Obligaciones en Nateria de Información y Documentación Clínica [Basic Law on Patient Autonomy and Rights to Information and Clinical Documentation] (B.O.E. 2002, 22188) (Sp.). Loi 2002-303 du 4 mars 2002 de relative aux droits des maladies et à la qualité du systéme de santé [Law 2002-303 of March 4, 2002 on Patients’ Rights and the Quality of the Health System], Journal Officiel de la République Française [J.O.] [Official Gazette of France], Mar. 5, 2002, p. 4118 (Fr.); see also Loi 2005-370 du 22 avril 2005 relative aux droits des malades et à la fin de vie [Law 2005-370 of 22 April, 2005 on Patients’ Rights and End of Life], J.O., Apr. 23, 2005, p. 7089 (Fr.). Patients’ Rights Law, 5756-1996, SH No. 327 (Isr.).

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ment and a breach of confidence that is contrary to the principles promoting good-faith and patient autonomy.32

B.

Moral Damages and the Inversion of the Burden of Proof As Patient’s Basic Rights

The CDC offers, in its Article 6, a list of what is considered the “consumer’s basic rights,” and among them “the effective prevention and reparation of material and moral damages” (item VI) and “easy access to the defense of consumers’ rights, including the reversal of the burden of proof, in civil procedures, if the judge finds it reasonable, according to the ordinary rules of experience.” (item VIII).33 The Brazilian Constitution also provides grounds for the compensation for moral damages34 in Article 5, X.35 Contrary to the general rule established in the procedural law, the burden of proof can also be shifted to fall upon the defendant’s shoulders. If a judge finds it reasonable to determine that the plaintiff does not have the means (either financially or technically) to prove his allegations, this burden can be transferred to the physician, who must prove that no harm was done, or that the adverse event was not caused by negligence, imprudence, or lack of expertise.36 It is the no-fault system taken to the extreme, contributing to an increase of groundless litigation.37 As a result of all these “rights,” the system is overloaded with cases that take long to analyze, and will be dismissed in the end.

32 33 34 35

36 37

See Eduardo Dantas, Direito Médico 71–105 (Editora GZ 2009). Lei No. 8.078, 11.09.1990, Diário Oficial Da Uniâo [D.O.U.], 12.09.1990. Danielle Machado Soares, O Médico e sua Responsabilidade [The Doctor and His Responsibility], 1 Revista de Responsabilidade Civil, 15–34 (2000) (Braz.). C.F. art. 5 (“Intimacy, private life, honor, and image of persons are inviolable and the right to compensation for property or moral damages resulting from the violation thereof shall be ensured.”). Luiz Antonio Rizzatto Nunes, Comentários ao Código de Defesa do Consumidor [Comments to the Code of Consumer Protection], (1st ed. 2000) (Braz.). Jane Courtes Lutzky, El Código de Defensa del Consumidor y la responsabilidad personal del médico en la República Federativa del Brasil [The Consumer Code and the Personal Responsibility of the Physician in the Federative Republic of Brazil], in, Cuadernos de Bioética [Journal of Bioethics], 101–09 (1997) (Braz.).

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IV. The Changes Brought by the New Civil Code In January 2003, a new Civil Code was enacted in Brazil, represented by the Federal Law 10.406/2002,38 replacing the eighty-seven-year-old Civil Code of 1916.39 Almost nine decades separating these two documents could lead to great expectations for change and innovation. At least in tort law, they did not come true. In general, there has been merely a semantic recycling, with different words for identical commands. As an example, Article 927 replaced the 1916’s Article 159: Article 927 (2002). Who, by an unlawful act (articles 186 and 187) harm others, is obliged to repair it. Sole Paragraph. There will be an obligation to repair the damage, regardless of fault, in the cases specified by law, or when the activity normally carried out by the perpetrator imply, by its nature, risk to the rights of others. Article 159 (1916). Who, by voluntary act or omission, negligence, or recklessness, violate the rights, or cause injury to others, is obliged to repair the damage. In principle, one could imagine that the new code is concerned only with the harm caused by wrongful acts, and that the old definitions, encompassing voluntary acts or omissions, negligence or recklessness, would be more complete. However, one must look at the code as an integrated system, so that hermeneutic interpretation is made according to a set, whether or not cohesive. In this light, it is necessary to consider Articles 949 to 951 of the new law, which relate directly to possible problems caused by malpractice in the practice of medicine and certainly present in many lawsuits. The only addition that can be considered timely innovation is the inclusion of what was already being applied by the Superior Courts, as is the case of the sole paragraph of Article 950, transcribed below: Article 949 (2002). In case of injury to health or other offense, the offender shall indemnify the offended for the cost of treatment, for the profits not earned until the end of convalescence, and some other injury that the victim proves to have suffered.

38 39

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Lei No. 10.406, 10.01.2002, Diário Oficial Da Uniâo [D.O.U.], 11.01.2002. Federal Law 3.071/1916.

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Article 1.538 (1916). In the case of injury to health or other offense, the offender shall indemnify the offended for the cost of treatment or for the profits not earned until the end of convalescence, and to pay a fine in the importance of the average degree felony accordingly. Article 950 (2002). If the offense results in an injury that prevents the injured person from conducting such person’s business or profession, or reduces the ability of the injured person to perform job duties, compensation, plus the cost of treatment and lost earnings until the end of convalescence, will include a pension corresponding to the nature of the work that the injured person is prevented from doing. Sole Paragraph. The injured person may require that compensation be arbitrated and paid in one installment. Article 1.539 (1916). If the offense results in an injury that prevents the injured person from conducting such person’s business or profession, or reduces the ability to work, compensation, plus the cost of treatment and lost earnings until the end of convalescence, will include a pension corresponding to the nature of the work that the injured person is prevented from doing. This hypothesis conforms to situations where, because of medical malpractice the patient loses, for example, major motor functions, disabling him from working. The Article does not mention the complete inability to work (leaving this issue for the subsequent Article). Rather it deals only with the situation when the injured person is unable to exercise his profession, or when the quantity or quality of his performance is significantly reduced. Thus, factors such as evidence backed by technical expert reports, average market values for the services provided by the victim, degree of specialization of the victim, average salary, financial capacity, and economic potential of the offender are relevant in determining a fair measure of damages – all this without prejudice to any criminal or disciplinary sanctions, to be discussed in the appropriate forum. Article 951 (2002). The provisions of Articles 948, 949, and 950 also apply in the case of compensation payable by a person, in the exercise of professional activity, whose negligence, imprudence or inexperience, causes the death of the patient, aggravate the harm, cause him injury, or disqualify him for employment.

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Article 1.545 (1916). Physicians, surgeons, pharmacists, midwives and dentists are liable for damage which, when due to recklessness, negligence or malpractice in professional acts, results in death, inability to serve, or injury. There was the intention of expanding the scope of the Article so as to make it a reference to professional liability in general, not just to medical activity. However, the use of the term “patient” restricts the Article’s application to doctors, surgeons, pharmacists, dentists, nurses, anesthesiologists, and all other healthcare professionals. The new Article, even though paradoxically more general, gains in precision, expanding its applicability. The new Article, when examined in practice, brings no change, since the chances of application remain the same, and the other job categories not mentioned in the old Article had already been treated this way by national courts.

Conclusion The defense of the consumer has developed considerably in recent decades to become an autonomous branch of law.40 At the same time, there has been an evolution in the concepts that guide the physician-patient relationship, on account of the progress in the medical sciences, which have become too specific on one hand, and extremely popular on the other. There has been a depersonalization of services, and the demystification of the medical profession. These two movements combined have laid the groundwork for the formation of a new understanding, a new view on the legal nature of medical activity, with direct consequences on the rules established to guide the relationships arising from there. In Brazil, the legislative amendment of concepts occurred rapidly, and received extensive support from the courts, thereby driving the improvement of the rules themselves. In principle, the aversion to change in some sectors is understandable. There is no denying, however, that it is positive for the people that matter:

40

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Ada Pellegrini Grinover et al., Código Brasileiro de Defesa do Consumidor comentado pelos autores do anteprojeto [The Drafters’ Comments to the Brazilian Code of Consumer Defense] (6th ed. 1999) (Braz.).

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the patients, the consumers of medical services. Most importantly, the changes help to clarify the rules of procedure between the parties. There are only benefits to good people, those concerned about treating their patients effectively, and those who embrace their profession. The arguments explained above are not intended to be immutable ideas. They are, however, contribution to the debate, critical thinking that seeks to illuminate some points still considered controversial by some. For Brazil, it is undeniable the complete and perfect applicability of the CDC to the medical activity, improving the existing rules, especially those inserted into the Code of Medical Ethics. The tendency towards this subject proves irreversible, and the obligation of doctors, lawyers, and other actors is to identify ways to improve rules using their everyday experience to bring security (legal and procedural) to healthcare providers and their patients.

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Canadian Medical Malpractice Law in 2011: Missing the Mark on Patient Safety Colleen M. Flood* and Bryan Thomas**

Introduction Canadian tort law, as it applies to medical malpractice, appears relatively settled from a systems perspective; there is no “burning platform” driving major tort reform in this area of the law. There are at least six factors which have contained the volume and cost of malpractice litigation in Canada, summarized here and discussed further below. First, as distinct from the U.S., non-pecuniary damages for personal injury were capped by the Supreme Court of Canada in a trilogy of cases handed down in the late 1970s.1 Second, there is no pressure to reform from physicians, because the dominant insurance scheme, overseen by the Canadian Medical Protective Association (CMPA), effectively insulates physicians from the impact of tort liability; a finding of medical malpractice does not drive up an individual’s insurance premiums. The provinces contribute significantly to this cushioning effect, by reimbursing a significant portion of CMPA fees. Third, the CMPA has used its deep pockets to pursue what one Ontario judge recently described as a “scorched earth” policy in responding to medical malpractice claims, which has discouraged litigation.2

*

Canada Research Chair in Health Law and Policy and Associate Professor of Law at the University of Toronto, cross- appointed into the Department of Health Policy, Management and Evaluation and the School of Public Policy. The authors would like to thank Alanna Courtright, Patrick Dyke, and Insiya Essajee for their superb research assistance. ** Research Associate/Research Manager, Faculty of Law, University of Toronto. 1 Andrews v. Grand & Toy Alberta Ltd., [1978] 2 S.C.R. 229 (Can.); Arnold v. Teno, [1978] 2 S.C.R. 287 (Can.); Thornton v. School Dist. No. 57 (Prince George) et al., [1978] 2 S.C.R. 267 (Can.). While medical malpractice liability is more costly in the U.S., its importance as a factor in the overall cost of health care is frequently overstated. The direct cost of medical malpractice liability is less than two percent of overall healthcare costs. Timothy Stoltzfus Jost, Our Broken Health Care System and How to Fix It: An Essay on Health Law and Policy, 41 Wake Forest L. Rev. 537, 548 (2006). 2 Frazer v. Haukioja (2008), 62 C.C.L.T.3d 280, para. 2 (O.S.C.J.). At issue in this case was a nearly $1 million claim for costs submitted by the plaintiff, in connection with a

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Fourth, Canada’s rules for awarding costs contribute to this problem, by making it risky for plaintiffs to pursue uncertain claims. Fifth, the inherent difficulties in establishing causation in medical malpractice cases combined with the broad defenses available for physicians further exacerbate the uphill battle facing the plaintiff patient. Finally, the tort law system treats physicians as “independent warriors,” shielding hospitals from vicarious liability for their malpractice. This is arguably problematic, because, as argued below, the deterrent effects of tort need to be targeted at the right level within the health care system. Though there is no urgent call to reform medical malpractice tort law, one should not take this as a sign that all is well in Canada, as matters of patient safety and quality of care still remain a concern. Though Canada compares relatively well with other countries in terms of its rates of adverse events,3 over the last decade, various provinces have encountered grave systemic problems: a breast cancer diagnosis crisis in Newfoundland; concerns about the competence of Ontario’s pathologists; a pediatric care crisis in Manitoba. We argue that tort law, as it stands today, misses the mark in addressing the hidden epidemic in patient safety; although we admit the paucity of robust empirical evidence makes it difficult to know whether rates of iatrogenic injury are worsening, stable or improving. There is, however, rising concern regarding the quality of care and safety of patients in privately financed and informal health care settings, e. g. in private clinics, in long-term care homes and in home care. This suggests that what we do know about the rates of adverse events in the hospital setting may be merely the tip of the iceberg. As we describe further below, Canada has attempted to address issues of safety and quality outside the courts, through regulation and the employment of preventative levers for addressing adverse events, including: quality councils, physician recertification, patient safety initiatives, and hospital accreditation. These appear to be positive trends, but they are rather piecemeal, and there is little evidence being collected (or planned to be collected) to assess the impact of these reforms. Proponents of patient safety are ardently opposed to a role for tort law – it is frequently identified as linked to patient safety problems – and yet as tort law

successful malpractice suit. The court explained that these high costs were the result of the defendant’s decision – with CMPA backing – to pursue a “scorched earth policy of putting the plaintiffs to the test of establishing virtually all of their claims on all issues of damages and liability.” Id. 3 G. Ross Baker et al., The Canadian Adverse Events Study: The Incidence of Adverse Events Among Hospital Patients in Canada, 170 CMAJ 1678 (2004), available at http://www.cmaj.ca/cgi/ reprint/170/11/1678 (last visited Apr. 20, 2011).

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presently functions it is hard to see what adverse impact it could possibly have on physician or hospital behavior, given the very low rates of litigation and the enormous hurdles that patient-plaintiffs face. Consequently, we still are left with the possibility that there is a role for reform of medical malpractice law and that such reform would contribute to better addressing patient safety issues.

I.

The Canadian Malpractice Context

The current state of medical malpractice law must be understood within the broader context of the Canadian healthcare system. To begin, the landscape of Canadian healthcare is shaped by the division of powers between the federal and provincial governments, as laid out in the Constitution Act of 1867.4 According to the Act, which sets out the responsibilities assigned to each level of government, health care does not fall solely under one jurisdiction. Instead, as the Supreme Court of Canada states in Schneider v. The Queen: ‘[H]ealth’ is not a matter which is subject to specific constitutional assignment but instead is an amorphous topic which can be addressed by valid federal or provincial legislation, depending in the circumstances of each case on the nature or scope of the health problem in question.5 Throughout the twentieth century, as responsibility for health care was absorbed by the public sector, it was necessary to mark out the roles of each level of government more carefully. While the federal government has jurisdiction over areas like quarantine, criminal law, patent regulation and spending power, the “lion’s share of responsibility for health care” is provincial.6 Most notably, provincial and territorial governments are charged with regulating health care insurance and the supply of hospital and physician services.7 Thus, publicly funded healthcare in Canada is best understood as “an interlocking set of ten provincial and three territorial health 4 Constitution Act, 1867, 30 & 31 Vict., c.3 (U.K), reprinted in R.S.C. 1985, app. II, no. 5 (Can.). 5 Schneider v. The Queen, [1982] 2 S.C.R. 112, 142 (Can.). 6 Joan M. Gilmour, Patient Safety, Medical Error and Tort Law: An International Comparison, Final Report, Health Policy Research Program, Health Canada 56 (2006), available at http://osgoode.yorku.ca/osgmedia.nsf/0/094676DE3FAD06A5852572330059253C/ $FILE/FinalReport_Full.pdf. 7 Reference re The Employment and Social Insurance Act, [1936] S.C.R. 427, 451 (Can.).

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insurance plans” that provide coverage for most hospital and physician services.8 As each of these plans is distinct, they form a patchwork of coverage and regulation across the country. While the provinces may have the lion’s share of responsibility over healthcare, the federal government exerts influence over the provincial management of healthcare through its spending power. In order to secure health care funding from the federal government, provinces are required to adhere to five criteria set out in the Canada Health Act (comprehensiveness, universality, portability, accessibility and public administration) and effectively to ensure first-dollar public funding for all “medically necessary” hospital and “medically required” physician services.9 The dynamics between these two levels of government are constantly at issue. One major concern is increased health care spending, resulting in part from high pharmaceutical costs. Between 1975 and 2006, while inflation-adjusted per capita spending on physician services increased 98 % and spending on hospital services increased 51 %, pharmaceutical expenditures increased by 338 %.10 Despite references to Canada’s “singlepayer” system, in reality a significant portion (approximately 30 %) of health care is privately financed11 and the proportion increases dramatically in specific sectors excluded from the CHA. For example, there is no requirement in the CHA for public coverage of prescription drugs consumed outside of hospital walls, nor are provinces required to provide home care or long-term care. Provincial governments voluntarily provide some coverage for certain groups, e.g. low-income and senior residents.12 Nonetheless, the majority of Canadians must pay out of pocket, or seek private insurance, in order to have access to drugs prescribed outside of hospitals, ambulance services, hearing, vision and dental care.13 All of this is to say that health care financing is an issue at the forefront of public concern, and an ongoing source of tension between the two levels of government.

8 Health Canada, H.C. Pub.: 5912, Canada’s Health Care System1 (2005), available at http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2005-hcs-sss/2005-hcssss-eng.pdf. 9 Canada Health Act, R.S.C. 1985, c. C-6 (Can.). 10 Mark Stabile & Jacqueline Greenblatt, Institute for Research on Public Policy, IRPP Study No. 2, Providing Pharmacare for an Aging Population: Is Prefunding the Solution?, 9 (2010), available at http://www.irpp.org/pubs/IRPPstudy/IRPP_Study_no2.pdf. 11 Canadian Institute for Health Information, National Health Expenditure Trends, 1975 to 2010, at xi (2010), available at http://publications.gc.ca/collections/collection_2010/iciscihi/H118-2-2010-eng.pdf. 12 Health Canada, supra note 8, at 7. 13 Id.

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Along with the majority of healthcare responsibilities, the administration of justice also falls under provincial jurisdiction;14 consequently, areas like tort reform are predominantly provincial matters, meaning that there is no singular “Canadian” approach to medical malpractice reform.

A.

Service Delivery, Regulation and Liability Insurance

As mentioned above, the delivery of physician and hospital services falls under the purview of the provincial governments. In general, the provinces supply publicly funded health services by contracting with physicians – who are private, for-profit contractors – through provincial medical associations. The dominant method of payment for these private physicians has been a fee-for-service system, although this is slowly changing.15 In Canada, physicians are granted a significant degree of authority for self-regulation, and each province has a College of Physicians and Surgeons that acts as a governing body for medical doctors. The various colleges monitor and maintain standards of training and practice, investigate complaints about doctors, conduct disciplinary hearings, etc.16 Unlike physicians, hospitals are much more carefully managed and regulated by the provincial governments. Though they receive public funding, hospitals are usually non-profit private institutions, operating under provincial or territorial legislation. In addition, unlike the fee-for-service system used for physicians, hospitals are funded through annual lump sums comprised of a complex mix of historical spending, population needs and cases treated.17 Each province has its own Hospital Act and accompanying regulations that lay out the organization and operation of

14 15

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Constitution Act, 1867, 30 & 31 Vict., c.3 (U.K.), reprinted in R.S.C. 1985, app. II, no. 5. s. 92 (Can.). Brian Hutchinson, Julia Abelson, & John Lavis, Primary Care In Canada: So Much Innovation, So Little Change, 20 Health Affairs 3, 118 (2001), available at http://content.health affairs.org/cgi/content/full/20/3/116#R8. See generally Tracey Epps, Regulation of Health Care Professionals, in Canadian Health Law and Policy 69 (Jocelyn Downie, Timothy Caulfield, & Colleen Flood, eds., 2007); The College of Physicians & Surgeons of Ontario, About the College: Self Regulation and the Practice of Medicine, available at http://www.cpso.on.ca/aboutus/ (last visited Mar. 29, 2011). For a succinct overview of funding models and decision-making processes for prioritysetting within Ontario hospitals, see L. Kapiriri, O. Frithjof Norheim & D. K. Martin, Priority setting at the micro-, meso- and macro-levels in Canada, Norway and Uganda, 82 Health Policy 78 (2007).

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these publicly funded institutions and provide for extensive public control when necessary.18 This public control power was recently exercised at the Hôtel-Dieu Hospital in Windsor, Ontario following a number of serious errors in pathology and surgery. Pursuant to § 9.(1) of the Hospital Act, the Lieutenant Governor in Council of Windsor appointed an external hospital supervisor to run the hospital and take over all functions of the board.19 The structure of Canada’s health service delivery has shaped key features of the Canadian medical malpractice system. First, the fact that physicians are not salaried employees means that they are viewed by the law as independent professionals, with the effect that hospitals are generally not held responsible for physician negligence.20 By contrast, hospitals can be held vicariously liable for negligence of nurses under their employ. As is discussed in more detail below, this differential recognition of liability is problematic given the mounting evidence of the need for an overall “systems” approach to preventing errors and improving safety.21

II.

State and Quality of the Canadian Health Care System

Although Canada’s medical malpractice law has been relatively static in recent history, there have nevertheless been serious concerns regarding patient safety and quality of care. First, it is important to note that where there is data gathered, it is mostly with respect to adverse events within hospitals. In this regard, Canada’s rates of adverse events in hospitals compares relatively well with other countries,22 though there is nonetheless significant room for improvement.23 In addition to hospital care, there has been growing concern about adverse events in private facilities, such as long-

18 19 20 21 22 23

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See e.g., Public Hospitals Act, R.S.O. 1990, c.P.40 (Can.), available at http://www.e-laws. gov.on.ca/html/statutes/english/elaws_statutes_90p40_e.htm. Province Takes Control of Hotel Dieu Hospital, CBC News, Dec. 13, 2010, available at http:// www.cbc.ca/canada/windsor/story/2010/12/13/wdr-hotel-dieu-province-steps-in.html. Yepremian v. Scarborough General Hospital (1980), 28 O.R. 2d 494, 496 (Can. Ont.C.A.). Gilmour, supra note 6, at 60–61. Baker et al., supra note 3, at 1685. A recent initiative aimed at reducing preventable adverse events and deaths in Canadian hospitals has found significant improvements in participating hospitals during the first three years of its implementation. See Safer Healthcare Now!, Frequently Asked Questions, available at http://www.saferhealthcarenow.ca/EN/about/faqs/Pages/default.aspx (last visited Nov. 14, 2010).

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term care facilities24 and cosmetic surgery clinics.25 This section first presents some background data on the frequency of adverse events in Canadian hospitals and long-term care facilities, and then recounts several major incidents in the Canadian health care system over the past two decades. The first Canadian adverse events study, conducted by Ross Baker and his colleagues, reached a conservative estimate that adverse events occurred in 7.5 % of all hospital admissions.26 Adverse events are defined as unintended injuries or complications caused by health care management, rather than by the patient’s underlying disease, that lead to death, disability or prolonged hospital stays.27 To be clear, not all adverse events, nor even all preventable adverse events, qualify as instances of legal negligence. As explained below, there are standards of fault that must be met in determining whether negligence has occurred. Although most of the identified adverse events resulted in no physical impairment or disability, approximately 20 % were estimated to have caused the death of the patient (representing around 40,000 deaths in Canadian hospitals per year).28 While it must be acknowledged that adverse events are an inevitable byproduct of health care, over a third of the events identified in the study were deemed “highly preventable” – including an estimated 16,500 preventable deaths as a result of adverse events.29 One especially common type of adverse event is nosocomial infection, which has drawn considerable media and scholarly scrutiny.30 Nosocomial infections are infections acquired during hospital care that are not present or incubating at admission.31 There are approximately 235,000 nosocomial infections in Canadian hospitals each year, resulting in approximately 10,000 deaths per year, making this the fourth leading cause of death in Canada.32

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25 26 27 28 29 30 31 32

Keir G. Johnson, Adverse Events among Winnipeg Home Care Clients, 9 (Sp) HEALTHCARE QUARTERLY 127 (2006); Dale Brazao & Moira Welsh, Seniors at Risk in Retirement Home, Investigation Reveals, Toronto Star, Oct. 1, 2010, available at http://www.thestar.com/ news/investigations/article/869045–seniors-at-risk-in-retirement-home-investigationreveals (last visited Apr. 20, 2011); Dale Brazao, Reporter’s Diary Reveals Substandard Conditions at Retirement Home, Toronto Star, Oct. 1, 2010, available at http://www. thestar.com/news/gta/article/869047 (last visited Nov. 20, 2011). Colleen M. Flood et al., Cosmetic Surgery Regulation and Regulation Enforcement in Ontario, 36 Queen’s L.J. 31, 33 (2011). Baker et al., supra note 3, at 1685. Id. at 1678. Id. at 1681–1682. Id. at 1681. Lara Khoury & Mikhail Iokheles, Factual Causation and Healthcare-Associated Infections, 17 HEALTH L.J. 195, 195 (2009). Id. at 196. Id. at 198.

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Existing research suggests that adverse events are a serious problem within hospitals, yet their true incidence is likely much greater due to underreporting. Experts agree that the Canadian Adverse Events Study – which involved a retrospective review of randomly selected hospital charts – captures only twenty-five to thirty-three percent of the total incidence of adverse events for a variety of reasons, most notably: some adverse events are simply not recorded in hospital charts; some of the randomly selected charts were not available for review, and these “missing charts” have an increased likelihood of adverse events; in the first level of review, the researchers looked for certain “triggers” before passing a chart on for second review, though there would have been some cases where adverse events occurred without these “triggers.”33 The figures reported also do not include adverse events that occur outside of hospitals, such as in private offices, local clinics, and long-term care facilities. It is hard to judge whether things are getting better or worse, as the lack of consistent, nationwide data collection on the occurrence of adverse events in Canada makes it impossible to assess longitudinal trends with any confidence. A study of adverse events among hospital admissions and day surgeries in Ontario, from 1992 to 1997, found “a troubling increase in the trend in hospital complication rates.”34 Other studies undertaken over the years have provided snapshots of adverse event rates in specific areas: one study gathered data on when, during treatment, adverse events were most likely to occur at one Ottawa hospital;35 another looked at complication rates after discharge from hospital;36 etc. The 2004 Baker and Norton study was the first and to date last major study on adverse event rates nationwide. In the wake of Baker and Norton’s study, the Canadian Institute for Patient Safety launched a safety campaign – called Safer Healthcare Now! – whereby ninety-five healthcare institutions nationwide committed to a strategy seeking to lower adverse events by six percentage points. Data have been collected showing safety improvements through

33 34 35

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Interview with Peter Norton, Professor Emeritus in the Department of Family Medicine, University of Calgary (Feb. 20, 2011). Dunan Hunter & Namrata Bains, Rates of Adverse Events Among Hospital Admissions and Day Surgeries in Ontario from 1992 to 1997, 160(11) Can. Med. Ass’n J. 1585, 1585 (1999). Alan J. Forster, Tim R. Asmis, Heather D. Clark, et al., Ottawa Hospital Patient Safety Study: Incidence and timing of Adverse Events in Patients Admitted to a Canadian Teaching Hospital, 170 Can. Med. Ass’n J. 1235, 1235 (2004). Alan J. Forster, Heather D. Clark, A. Menard, N. Dupuis, R. Chernish, N. Chandok et al., Adverse Events Among Medical Patients After Discharge from Hospital, 170 Can. Med. Ass’n J. 345, 345 (2004).

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this initiative, but again, this provides only a fragmentary picture of improvements at the institutions enrolled.37 Apart from empirical evidence that exists regarding hospital error, there is more anecdotal evidence of system-wide concerns with quality and safety both in the public and private health care sectors. Among the most tragic health care incidents of the past two decades were twelve pediatric cardiac surgery deaths at the Winnipeg Health Sciences Centre (HSC) in 1994.38 That year the HSC pediatric cardiac program introduced the provision of surgical services, which was accompanied by a considerable personnel overhaul: a new director of pediatric cardiology and a new cardiac surgeon were hired, while three cardiologists left the program without replacement.39 Within the first four months of the introduction of pediatric surgical services, five children died.40 Mounting protests, particularly on the part of the program’s nurses and anesthesiologists, resulted in the formation of an internal review committee.41 While the four-month review was underway, the program was limited to a reduced number of procedures, yet two more children died.42 The review recommended that the surgical program be fully reinstated in September of that year, butin the next three months five more children died, following which the program was suspended pending an external review.43 As a result of this review the HSC suspended the program for six more months and issued a press release alerting the public, in particular the parents of the deceased children, to the problem.44 Several parents demanded a public inquiry into the events, which led the province to establish the Sinclair Inquest to investigate the circumstances surrounding the deaths.45 It was determined that at least five of the twelve deaths were preventable, and that some of

37

38

39 40 41 42 43 44 45

Safer Health Care Now!, Accomplishment Report, 2009, available at http://www.saferhealthcarenow.ca/EN/about/Overview/Documents/2009%20Safer%20Healthcare%20Now!% 20Accomplishment%20Report.pdf (last visited Apr. 20, 2011). The report does not track adverse events overall, but rather tracks achievements directly related to specific strategic initiatives, e.g. preventing adverse drug events, improving care for acute myocardial, etc. Murray Sinclair, The Report of the Manitoba Pediatric Cardiac Surgery Inquest: An Inquiry Into Twelve Deaths at the Winnipeg Health Sciences Centre in 1994,at v (2000), available at http:// www.pediatriccardiacinquest.mb.ca/pdf/index.html (last visited Nov. 14, 2010). Id. at vii. Id. at 127. Id. at 5. Id. Id. at 4. Id. Id.

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the others may have been preventable.46 Additionally, the evidence suggested that in most cases the parents were not provided with sufficient information to allow fully informed consent.47 The Sinclair Inquest ultimately found that substandard care was partly a product of individual failures, but primarily a result of systemic issues relating to the structure of the HSC, particularly the hospital policies and procedures governing staffing, leadership, and teamwork.48 The Report deemed the failure to replace the three cardiologists who had left the program a serious erosion in the ability of the program to operate, and identified serious flaws in the recruitment process used in the hiring of Dr. Odim, the surgeon involved in each of the cases.49 Flashing forward ten years, from 1997–2005, another crisis has centered on breast cancer screening test errors in Newfoundland and Labrador.50 Hormone receptor tests are critical in determining the appropriate course of treatment for breast cancer patients; if the patient’s hormones stimulate the tumor, they are considered ER/PR-positive, and are treated with a hormone-blocking drug.51 This treatment is not provided to patients who test ER/PR-negative. In 2002, the retesting of one patient – at the insistence of an oncologist consulted out of province – uncovered an epidemic of errors in hormone testing across Newfoundland and Labrador.52 This led officials at Eastern Health – the health authority for eastern Newfoundland – to retest more than a thousand breast cancer patients who were diagnosed ER/PR-negative between 1997 and 2005. Of the 1,013 retested patients, 383 had been wrongly diagnosed.53 In response, the provincial government established a Commission of Inquiry to investigate the failures.54 The Commission determined that the quality control 46 47 48 49

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Id. at 501. Id. at vi. Id. at 465. In particular, though Dr. Odim’s credentials were outstanding, he was hired without anyone from the HSC actually seeing him perform a surgical procedure or even speaking with anyone who had seen him perform a surgical procedure. Id. at 467–468, 5. Vik Adhopia, Misdiagnosed: Anatomy of Newfoundland’s Cancer-testing Scandal, CBC News (2008), available at http://www.cbc.ca/news/background/cancer/misdiagnosed.html (last visited Nov. 14, 2010); Margaret Cameron, Commission of Inquiry on Hormone Receptor Testing, Volume 1: Investigation and Findings, (2009), available at http://www.releases.gov.nl.ca/ releases/2009/health/Volume1_Investigation_and_Findings.pdf (last visited Nov. 14, 2010). Adhopia, supra note 50. Peggy Deane became known as the “index case.” Once it was discovered that she was in fact ER/PR positive she was switched onto a hormone-blocking drug, but she died four months later. Id. Over 100 of the wrongly-tested patients are now dead. Id. Cameron, supra note 50, at vii.

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and quality assurance within the ER/PR testing laboratory, especially with respect to the handling and processing of tissue samples, was so minimal and haphazard as to be non-existent.55 Had proper quality assurance and control policies been in place, and had they been followed, the testing problem would have been discovered much earlier.56 While no death or harm to patients can be conclusively linked to the testing failures, misdiagnosed patients were denied the opportunity to access the best possible treatment for their cancer.57 There is ongoing uncertainty as to whether all misdiagnosed patients have been informed of their flawed tests.58 In 2009, in response to concerns about similar testing problems in Quebec, the province’s pathology association sent a small number of samples to be retested at a reliable lab, which revealed that 15–20 % of the hormone receptor tests sampled had false results.59 Following those results, nearly 3,000 samples taken from 2007–2009 were sent for retesting, of which eighty-seven yielded different results than the original tests.60 Similar problems have recently surfaced in Ontario, after it was discovered that a pathologist had botched cancer-screening tests, leading a surgeon at the Hôtel-Dieu hospital in Windsor to perform unnecessary mastectomies on two women who were cancer-free.61 The province undertook a review of all the hospitals that employed the pathology lab in question, finding a systemic lack of communication and cooperation between pathologists and surgeons.62 Investigators found, for example, that some patients had two diagnoses on file for the same ailment, and that surgeons in some cases proceeded with operations before receiving test results.63 In their report, investigators urged the Ontario Ministry of Health and Long-term

55 56 57 58

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Id. at 146, 451. Id. at 452. Id. Tara Brautigam, Newfoundland Health Board Apologizes in Breast Cancer Scandal, The Globe and Mail, March 5, 2009, available at http://www.theglobeandmail.com/news/national/ article975202.ece (last visited Nov. 14, 2010). 1 in 5 Breast Cancer Hormone Tests Wrong, Quebec Pathologists Fear, CBC News, May 27, 2009, available at http://www.cbc.ca/canada/montreal/story/2009/05/27/breast-cancer-quebechormone-tests.html (last visited Nov. 14, 2010). Special Report: The Controversy About Breast Cancer, Canadian Cancer Society,Dec. 19, 2009,available at http://www.cancer.ca/Quebec/About%20us/Media%20centre/Qc_nou velle_diagnostics.aspx?sc_lang=en (last visited Nov. 14, 2010). Karen Howlett & CaroineAlphonso, Error-prone Hospital Plagued by a Culture of Mistrust, The Globe and Mail, Aug.4, 2010, available at http://www.theglobeandmail.com/news/ national/ontario/error-prone-hospital-plagued-by-a-culture-of-mistrust-report/ article1661451/ (last visited Apr. 20, 2011). Id. Id.

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Care to implement province-wide standards and guidelines for pathology by the spring of 2011.64

A.

Medical Malpractice in the Domain of Privately Financed Care

Adverse events are not confined to the hospital setting. Indeed, significant problems in recent years have arisen outside of the publicly funded system, in private retirement homes, and private cosmetic surgery clinics. On the whole, governments have taken a comparatively “hands-off” approach to the regulation of privately financed care. In principle, patient safety standards should be equivalent across institutional settings.65 In reality, however, the government and regulators appear to be primarily concerned with preventing adverse events within the Medicare system proper. Moves to regulate the private facilities have come very slowly, and only in response to crises. One area of major concern in recent years has been the quality of care provided outside of hospitals, through home care, or in long-term care facilities and retirement homes. A recent study of home care in Winnipeg found preventable or ameliorable adverse events in 4 % of the sample study.66 Extrapolating their findings to the Winnipeg regional home care population as a whole – a population of approximately 15,000 – the authors estimated a range of between 304 to 866 preventable or ameliorable adverse events annually.67 A recent undercover report on the treatment of residents and the quality of conditions at a Toronto private retirement home also raised concerns.68 The Toronto Star reporter, who posed as a new resident at the retirement home, observed appallingly poor sanitary conditions and in some cases profound neglect – residents left for hours in diapers, or left stranded on the floor after a fall.69 There have also been ongoing concerns about preventable adverse events in private, for-profit clinics across Canada, particularly in the domain of cosmetic surgery. The issue made headlines in the fall of 2007, when a thirty-two year old woman died in the recovery room following a liposuc64 65 66 67 68 69

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Id. Flood et al., supra note 25. Johnson, supra note 24, at 131. Id. at 132. At least half of the retirement home’s residents need medical care that they can only get at a licensed nursing home. Brazao & Welsh, supra note 24; Brazao, supra note 24. Id.

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tion procedure at a Toronto clinic.70 Multiple concerns came to light following this event: cosmetic surgery clinics in the province were not subject to any regime of licensing or regular inspection; GPs in Ontario were portraying themselves as “cosmetic surgeons,” despite having no formal credentials or hospital privileges in surgery; and some individual physicians had been carrying on with cosmetic surgery practices despite repeated warning signs of inadequate care. Indeed, concerns had been raised about the lax regulation of cosmetic surgery since the early 1990s, and yet it was only in 2010 that the Ontario College of Physicians took steps to seriously verify the credentials of cosmetic surgeons and inspect facilities.71 Following the 2008 death of a twenty-five year old septorhinoplasty patient, the College of Physicians of Quebec rushed to recommend reforms to the practice and regulation of cosmetic surgery in 2010, which are to be implemented within the year.72

III. Redressing Adverse Events through the Courts Under Canadian law, adverse events may in principle be redressed through criminal, contract, and tort law remedies. However, the criminal law plays a very minor role in addressing medical malpractice, primarily because of the higher substantive and procedural standards required to impose criminal liability compared to civil liability. The Canadian Criminal Code defines criminal negligence as involving “wanton or reckless disregard for the lives or safety of other persons,” which the Crown must prove beyond a reasonable doubt.73 Between 1900 and 2007, only fifteen physicians were prosecuted for alleged criminal negligence or manslaughter in Canada, and only one has been convicted.74 In addition to being infrequently used, the criminal law is poorly equipped to deal with medical misconduct because health professionals often work collaboratively, making it difficult to assign sole responsibility and blame.75 Canadian patients pursuing civil remedies have the option of suing in contract as well as in tort law. Claims in contract may try to allege that an 70 71 72

73 74 75

Flood et al., supra note 25, at 34. Id. CBC News, Quebec Doctors Clamp Down on Cosmetic Surgery, June 15, 2010,available at http://www.cbc.ca/health/story/2010/06/15/mtl-college-of-physicians-cosmeticsurgery.html (last visited Feb. 9, 2010). Criminal Code, R.S.C. 1985, c. C-46, s.220 (Can.). Fiona MacDonald, The Criminalization of Medical Mistakes in Canada: A Review, 16 Health L. J. 1, 12 (2008). Id.

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implied contractual term to exercise reasonable care was breached.76 Bringing a claim under contract law as well as tort law often makes little difference to the outcome of the case, because the standard of medical care in contract and tort is understood to be the same.77 In some circumstances, however, there may be a benefit to suing in contract. For example, where a physician has guaranteed a specific outcome and it has not been realized, such as an aesthetically pleasing nose following rhinoplasty, damages have been awarded for breach of the contractual term in addition to those in negligence.78 It should be noted, however, that contract law plays a somewhat more important role in Quebec, which is unique among Canada’s provinces in that it has a civil law system, wherein it is established that an intuiti personae contract exists between patient and physician.79 For the most part the resulting contract obligations are identical to the obligations established in tort law, with one exception: under their contractual obligations, physicians are expected to personally provide services, which can give rise to breach of contract where physicians delegate tasks without patient consent. In Currie v. Blundell,80 for example, a surgeon allowed a surgical resident to perform heart surgery, under his direct supervision, but did not first obtain the patient’s consent. The decision to delegate without the patient’s consent was criticized by the court, as a violation of the patient/physician contract.81 While adverse medical events may sometimes engage criminal or contract law concerns, the vast majority of malpractice cases proceed as tort cases – hence this will be the major focus of this section.82

76 77 78 79

80 81 82

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Ellen I. Picard and Gerald B. Robertson, Legal Liability of Doctors and Hospitals in Canada 432 (4th ed., 2007). Worth v. Royal Jubilee Hospital (1980), 4. L. Med.Q. 59, 67 (B.C.C.A., Can.). LaFleur v. Cornelis (1979), 28 N.B.R.2d 569 (Q.B., Can.). Robert P. Kouri & Suzanne Philips-Nootens, Civil Liability of Physicians under Quebec Law, in Canadian Health L. & Pol’y 135–87 (Jocelyn Downie, Timothy Caulfield and Colleen M. Flood eds., 3rd ed., 2007). [1992], 10 C.C.L.T.2d 288 (Que. S.C., Can.) Id. The legal characterization of the relationship between doctor and patients has changed over the past six centuries from a duty based on the doctor’s status as a member of a professional calling to implied contract and finally to negligence. With the rise of the tort of negligence, the liability of doctors came to be judged by its principles. See Picard & Robertson, supra note 76, 1–2.

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A.

Canadian Medical Malpractice Liability in Context

Canadian doctors working in hospitals or in private practice are required to carry medical malpractice liability insurance.83 The Canadian Medical Protective Association (CMPA) offers professional liability protection to approximately 95 % of physicians in Canada. However, CMPA is not an “insurer” in the strict technical sense but rather a mutual defense organization that will cover a physicians’ costs if found negligent and provides advice, legal assistance, and risk management education.84 Physicians’ premiums are not affected by their history of adverse events, which are determined solely by the type of medicine practiced and regional location.85 In addition to CMPA premiums not being tied to physician performance, provincial governments largely cover the cost of the CMPA membership dues, in some cases up to 83 %.86 Coverage of these dues is meant to compensate for the fact that, under Canada’s single-payer system, physicians cannot pass on the cost of the insurance to patients in increased fees.87 Yet a downside of the current scheme, arguably, is that it effectively insulates physicians from the “disincentive to risk-taking behaviour” that a tort liability regime is meant to impose.88 The conduct of physicians is still moderated, however, by the threat of disciplinary action by the provincial self-regulating professional colleges. 83

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85 86 87 88

Stephen F. Clarke, Law Library of Congress, Medical Malpractice Liability: Canada, Aug. 30, 2010, available at http://www.loc.gov/law/help/medical-malpractice-liability/canada. php (last visited Apr. 20, 2011). Canadian Medical Protective Association (“CMPA”), CMPA Annual Report 2009, at 2, available at http://www.cmpa-acpm.ca/cmpapd04/docs/about_cmpa/annual_report/ 2009/com_ar_about_the_cmpa-e.cfm. The CMPA was founded in 1901 at the annual meeting of the Canadian Medical Association (CMA) and became a formal affiliate of the CMA in 1924. The annual general meeting of the CMPA is held in conjunction with that of the CMA. See CMPA, A History of the Canadian Medical Protective Association 1901–2001, available at http://www.cmpa-acpm.ca/cmpapd04/docs/about_cmpa/com_history-e.cfm (last visited Apr. 20, 2011). From the beginning, the aim of the association was to protect physicians’ reputations and ward off frivolous lawsuits through a display of sheer legal might. Quoting a 1919 report by the CMPA’s founder, Dr. R.H.W. Powell stated, “our organization does not consist in the fights we have put up or in the open success we have had but rather in the silent influence we have swayed against litigants who for a money gain have sought to blast the reputation of conscientious, painstaking and reputable practitioners knowing or suspecting that they have an easy mark and that to avoid publicity a medical man will often submit to what amounts to blackmail ... These litigants have found out that our Counsel stands ready to accept service of the writ and your Executive stands ready with a bank account to furnish the sinews of war .... Dozens and dozens of cases have thus been strangled at their inception and have disappeared like dew off the grass.” Id. (emphasis added). Clarke, supra note 83. Gilmour, supra note 6, at 55. Id. Of course it is possible that faced with increased insurance premiums, medical associations would seek to increase fees earned at the next bargaining round. Stewart v. Pettie, [1995] 1 S.C.R. 131, para. 50.

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It should also be noted that while the CMPA is a national organization, tort law reform is generally within the purview of the provinces, owing to the constitutional division of powers between the federal and provincial governments, explained in section 1 of this paper. Hospitals and healthcare institutions also carry liability insurance, with many participating in the Health Insurance Reciprocal of Canada (HIROC), a member-owned non-profit insurance organization. Founded in 1987 in response to a report by the Ontario Hospitals Association calling for alternative liability arrangements, HIROC now insures over 600 institutions across Canada.89 The premiums paid by health care institutions are to some extent loss sensitive, unlike physician premiums, which are unaffected by experience or negative history.90

B.

Empirical Trends on Medical Liability Claims

From the late 1960s to late 1980s, the frequency of tort claims quadrupled in Canada. Thus in the late 1980s, scholars were at work trying to explain the “medical malpractice explosion” in Canada.91 Yet the rate of claims has stabilized since then, ranging from 1.7 to 2.5 claims per 100 physicians annually.92 Indeed, the CMPA reported in 2009 that over the past ten years there has been a marked decline in the number of legal actions against CMPA members. The CMPA claims several factors are at play in this decline, including “better medical care resulting in fewer adverse events, increased awareness and understanding of patient safety, enhanced risk management procedures, more effective and timely disclosure to patients, and tort reform initiatives.”93 A less sanguine explanation for the low frequency and success of tort claims is that the CMPA pursues a “scorched earth” policy in countering

89 90 91

92 93

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Healthcare Insurance Reciprocal of Canada, Our History, available athttp://www.hiroc. com/ourhistory.asp (last visited Feb. 15, 2011). Gilmour, supra note 6, at 56. For an attempt to explain the rising trend throughout this period, see M. Trebilcock, D. Dewees& D. Duff, The Medical Malpractice Explosion: An Empirical Assessment of Trends, Determinants, and Impacts, 17 Melbourn U.L. Rev. 539 (1990). Doctrinal developments through this period can be found in J. Robert S. Prichard, Liability and Compensation in Health Care (A Report to the Conference of Deputy Ministers of Health of the Federal/Provincial/ Territorial Review on Liability and Compensation Issues in Health Care) (1990) [hereinafter The Prichard Report]. Canada Institute for Health Information, Health Care in Canada 2004, available at http:// secure.cihi.ca/cihiweb/products/hcic2004_e.pdf (last visited Apr. 20, 2011). CMPA, Annual Report 2009, supra note 84.

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allegations of medical misconduct, taking all measures to robustly defend claims.94 Of the 101 civil actions against CMPA members that went to trial in 2009, plaintiffs succeeded in only nineteen, or 11 %, of cases.95 The vast majority of cases, however, never reached trial and were discontinued/ dismissed/abandoned (522, or 55 %) or settled (319, or 34 %).96 The CMPA’s high rate of success in defending actions is part of a consistent pattern; since 1996 their success rate has never been below 70 %.97 The CMPA is envied around the world for having contained the cost of negligence suits, but commentators such as Picard and Roberston raise concerns about the fact that so very few injured patients manage to secure compensation.98 Apart from the robustness of the CMPA’s defense of claims, patient tort actions may be further chilled by the fact that under Canadian law a losing plaintiff may be ordered to pay up to two thirds of a defendant’s costs, making it risky to challenge an opponent as well-financed as the CMPA.99 Successful litigants in Canada (plaintiffs or defendants) have a reasonable expectation of receiving an award of costs, subject to the court’s discretion and any governing rules or legislation.100 Costs are generally awarded on one of two scales: partial indemnity costs (traditionally 50 %) or substantial indemnity costs (traditionally 75 %).101 The Canadian Supreme Court has held that the traditional approach to costs can be understood as advancing fairness and efficiency in the justice system by acting as a disincentive to bringing meritless claims and by making the legal system more accessible to litigants who seek to vindicate a legally sound position.102 In a recent Ontario case the presiding trial judge recognized the potential chilling effect of imposing costs awards against unsuccessful plaintiffs in medical negligence cases: I believe that a cost award to the defendant in a lawsuit of this nature would send the wrong signal to plaintiffs who suffer injuries when undergoing treatment by physicians. This was a lawsuit that was Frazer v. Haukioja (2009), 62 C.C.L.T.3d 280, para 2 (O.S.C.J., Can.); see also Law Library of Congress, Medical Malpractice Liability: Canada, Aug. 30, 2010, available at http://www. loc.gov/law/help/medical-malpractice-liability/canada.php (last visited Apr. 20, 2011). 95 CMPA, Annual Report 2009, supra note 84. 96 Id. 97 Picard & Robertson, supra note 76, 528–29. 98 Id. at 532. 99 Law Library of Congress, supra note 94. 100 Id. 101 Janet Walker & Lorne Sossin, Civil Litigation 33–36 (2010). 102 British Columbia (Minster of Forests) v. Okanogan Indian Band, [2003] 3 S.C.R 371, para.26 (Can.). 94

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supported by two eminent physicians. Proving negligence in medical malpractice lawsuits is extremely difficult. Failure to prove negligence should not always result in cost penalties. The plaintiff in this case clearly deserves the sympathy of the court. I am not prepared to award costs against him.103 At least one author claims, however, that Canadian courts are generally hesitant to make costs orders against unsuccessful plaintiffs in medical malpractice cases absent egregious or vexatious behavior by the plaintiff.104 Similarly, it is claimed that defendants often do not seek costs in cases that were brought in good faith, based on solid opinions, and well argued at trial.105 While the total number of claims against physicians has been decreasing, there has been an increase in one particular type of claim: class actions.106 This may help explain why although the number of cases against physicians has declined, the total amount of compensation being paid by the CMPA has been increasing. For example, in a recent class action against a hospital and physician for performing an unnecessary metroplasty surgery, the court approved a $9.9 million settlement for a class of approximately 200 women.107 If class actions continue to be settled for such large sums, alarm bells may be sounded about damages and legal expenses in the system.108

C.

Black Letter of Canadian Tort Law

Medical liability in Canada has been characterized by “continuity and stability.”109 There has been little major change and recent medical malpractice cases still primarily rely on legal principles developed over fifty years ago.110 However, as we argue above and further below, although the

103 Khoshmashrab v. Bent, [2004] O.J. No. 2831, para. 204 (Can.). 104 D. Embury, Preparing the Plaintiff for the Medical Negligence Trial, at 4, June 7, 2006, available at http://www.torkinmanes.com/lawyers/default.asp?load=d_embury at 4 (last visited Apr. 20, 2011). 105 Id. at 6. 106 CMPA General Counsel, Class Actions: On the Increase?, April, 2008, available at http:// www.cmpa-acpm.ca/cmpapd04/docs/resource_files/infosheets/2006/com_is0660-e. cfm (last visited Apr. 20, 2011). 107 Bellaire v. Daya (2007), O.J. No. 4819 (Can.). 108 Gerald. B. Robertson, A View of the Future: Emerging Developments in Health Care Liability, 1 Special Ed. Health L.J. 1, 12 (2008). 109 Id. at 1. 110 Id.

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law in this domain may be stable it is insufficient to address the hidden epidemic of patient safety concerns.

1.

Battery by Physicians

Historically, physician liability has fallen under the torts of battery or negligence. The tort of battery arises where a physician fails to obtain the patient’s consent to treatment, or obtains it though coercion, fraud or deceit, and there are no extenuating circumstances.111 Battery is actionable without proof of damage and liability is not confined to foreseeable consequences.112 However, the Supreme Court of Canada circumscribed the scope of battery in Reibl v. Hughes, characterizing the nature of many battery claims as more properly claims in negligence.113 Specifically, the court held that the failure of a physician to disclose material risks of a procedure does not vitiate the consent freely given by the patient.114 The patient in that case had consented to an internal carotid endartectomy, but had not been warned of the 10 % risk of stroke associated with the procedure. The patient suffered a serious stroke. Although on the face of it this might be characterized as a lack-of-consent case, the court held that the proper remedy for failure to disclose risks – however serious – would lie in negligence rather than battery.115 Since Reibl, medical malpractice plaintiffs have rarely succeeded in battery claims because rarely are the deficiencies in the disclosure provided so serious as to totally vitiate consent.116 However, empirical data demonstrates that disclosure to patients has increased in clinical practice since the Reibl decision.117 This may be due to increased focus on informed consent in the negligence case law, along with a shift in medical culture towards greater recognition of patient autonomy.

2.

Negligence by Physicians

Negligence is the primary category of claims against doctors and hospitals in Canada. To succeed in a negligence action, the plaintiff must demon111 112 113 114 115 116 117

See Norberg v. Wynrib, [1992] 2 S.C.R. 226 (Can.). Id. at para. 54. Reibl v. Hughes, [1980] 2 S.C.R. 880 (Can.). Id. Id. Picard & Robertson, supra note 76, at 191. Gerald B. Robertson, Informed Consent 20 Years Later, Health L.J. 153, 155 (2003).

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strate a legal duty of care, a breach of a legal standard of care, injury or loss to plaintiff that was caused by the breach, and damage not too remote to be recoverable in law.118 The plaintiff bears the burden of proof and must establish his or her claim on the balance of probabilities.119 It is generally uncontested that physicians owe a duty of care to their patients. The foundational statement outlining the standard of care owed by physicians to patients comes from the Supreme Court decision in Crits v. Sylvester: Every medical practitioner must bring to his task a reasonable degree of skill and knowledge, and must exercise a reasonable degree of care. He is bound to exercise that degree of care and skill which could reasonably be expected of a normal prudent practitioner of the same experience and standing and if he holds himself as a specialist, a higher degree of skill is required of him, than of one who does not profess to be so qualified by special training and experience.120 Physicians also owe duties to third parties in circumstances where it is reasonably foreseeable that their negligence will affect such persons. For example, doctors have been held liable to third parties injured in a car accident for a failure to report a patient’s incapacity to drive to the licensing authority.121 Another foreseeable class of persons is the born– alive children of pregnant patients, whose claims in negligence become actionable upon birth. Physicians may be liable in negligence for failing to disclose risks and alternative treatments; failing to diagnose properly; negligence in performing services; failing to disclose errors; and breaches of confidentiality.122 In making determinations about whether the relevant standard of care has been breached, reference to clinical guidelines, patient safety policies, and codes of conduct can be influential, in addition to expert evidence. Although these guidelines are not determinative, failure to comply is seen as suggestive of substandard care. The content of the obligation to disclose varies depending on the type of procedure. There is a trend towards finding a higher obligation of disclosure for risks relating to cosmetic and elective procedures than for

118 119 120 121 122

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Reibl, 2 S.C.R. at 880. Crits v. Sylvester (1956), 1 D.L.R. 2d 502, 508 (Ont. C.A.), aff’d [1956] S.C.R. 991 (Can.). Id. Toms v. Foster (1994), 7 M.V.R. 3d 34 (Ont. C.A.). Gerald B. Robertson, When Things Go Wrong: The Duty to Disclose Medical Error, 28 Queen’s L.J. 353, 359–60 (2002).

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required therapeutic treatments.123 Physicians are also obligated to inform patients of alternative treatments,124 but it is not clear whether the obligation extends to informing patients of treatments not available due to cost containment in their home province, but available in another region or country.125 The legal duty of disclosure is not confined to possible risks or alternative treatments, but also requires physicians to disclose any mistakes – including their own – that a reasonable person in the patient’s position would want to be informed of.126 However, as Gibson writes, courts are much more likely to find a duty in situations where further injury is caused as a result of the mistake.127 In addition to proving a duty and a breach of the standard of care, a plaintiff must prove causation between the act or omission (the breach) and the injury in question. The traditional test for causation in negligence is whether the injury would not have occurred “but for” the conduct of the defendant. In Snell v. Farell, the Supreme Court criticized lower courts for applying a rigid conception of causation and endorsed a “robust and pragmatic approach” to determining causation in medical negligence cases.128 The Court held that causation “need not be determined by scientific precision” and encouraged lower courts to be more willing to infer causation in the absence of contrary evidence adduced by the defendant.129 In that case a patient suffered damage to her optic nerve following her doctor’s negligent decision to continue with an operation after retrobulbar bleeding had been observed in the eye. Following the surgery, blood filled a chamber in the plaintiff’s eye, remaining for nine months; at some point bleeding within the eye caused damage to the optic nerve, rendering that eye blind. Expert witnesses could not say whether the atrophied optic nerve occurred naturally or was caused by the surgery, but at any rate the defendant’s negligence had made it impossible to detect the problem in time to address it. The Court found that it would be proper to infer causation on such facts.130

123 Picard & Robertson, supra note 76, at 145. 124 Videto et. al v. Kennedy, [1981] 33 O.R.2d, 497 (Can.) 125 Timothy Caulfield & Kerry Siminoski, Physicians Liability and Drug Formulary Restrictions, 166 CMAJ 458, 459 (2002). 126 Stamos v. Davies (1985), 52 O.R.2d 10, para. 25 (Can.). 127 Elaine Gibson, Memorandum on Duty of Disclosure in Canadian Law – Commissioned by Eastern Health for Submission to Part II of the Newfoundland and Labrador Hormone Receptor Commission of Inquiry, [unpublished report, on file with authors], May 14, 2008. 128 Snell v. Farrell(1990), 2 S.C.R. 311, para 34 (Can.). 129 Id. at paras. 29–33. 130 Id. at para. 43.

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A patient’s own exercise of autonomy is an important link in establishing this chain of causation. A failure to disclose risks may not be a “but for” factor, if it can established that a patient would have proceeded with a treatment even if the risks were adequately disclosed. As Reibl established, the question is framed by asking what a reasonable patient in the plaintiff’s position would have chosen.131 On its face this seems to involve an objective question of fact, answered for example with testimony from other physicians, as to what their average patient would opt to do in situations comparable to the plaintiff’s. Robertson has noted however that the courts have slowly shifted to consider subjective factors, very often to decide against the plaintiff: “For example, it is very common to find cases where the court describes the patient as ‘assertive’ or ‘independent minded’, and then uses this to support the conclusion that the patient had already made up their mind in favour of the treatment and hence would not have been dissuaded by disclosure of risks.”132 In circumstances where the “but for” test is unworkable, the Court has held that causation may be established using the “material contribution” test. Causation is made out using this test if the negligence of the defendant created a risk and the patient suffered an injury that was within the ambit of the risk created. In such cases the conduct of the defendant can be said to have materially contributed to the injury.133 In the recent decision of Resurfice Corp. v. Hanke, the Supreme Court discussed in obiter the requirements for employing the “material contribution” test.134 The “material contribution” may be employed in place of the presumptive “but for” test in exceptional circumstances where it is impossible to apply the “but for” test due to limited scientific knowledge.135 Klar argues that, notwithstanding this attempt at clarification on the part of the Supreme Court, it remains unclear in what circumstances the material contribution test will be applied, and in cases decided since Hanke the courts have not embraced its application.136 A restrictive application of the “material contribution” test will likely disadvantage plaintiff patients. For example, Khoury suggests that by limiting the availability of the “material contribution” test to situations of scientific uncertainty, claims arising from

131 132 133 134 135 136

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Reibl, 2 S.C.R. at para. 11. Robertson, supra note 117, at 158. Athey v. Leonati (1996), 3 S.C.R. 458, para. 3 (Can.). Hanke v. Resurfice Corp (2007), 1 S.C.R. 333, para. 4 (Can.). Id. at para. 25. Lewis N. Klar, Tort Law 449 (4th ed., 2008).

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health-care acquired infections may be less likely to succeed since their numerous potential causes are often scientifically understood.137 There will be no finding of causation, however, if the physician’s error only caused the plaintiff to lose a (mere) chance to avoid his or her damages. It is insufficient for a patient to show that, had a proper diagnosis been made or proper treatment given, the unfavorable outcome might not have occurred. A patient must prove that, had the proper treatment or diagnosis been made, it would be “more likely than not” that the unfavorable outcome would have been avoided.138 For example, a cancer patient who lost a 45 % chance of recovery due to misdiagnosis and delayed treatment would likely be unable to demonstrate causation. Picard and Roberston have described this as an area where “form triumphs over substance.”139 Remoteness involves an inquiry into the reasonableness of holding a defendant liable and is motivated by policy concerns that a defendant should only be held liable for what would be foreseeable to a reasonable person in the defendant’s position. A determination that an injury is unforeseeable or too remote serves to limit legal liability regardless of the factual cause of the injury. In Martin v. Inglis, a physician was found not to be negligent in his performance of gastroplasty surgery that resulted in a gastric leak.140 The trial judge held that even if the physician had been negligent, liability would not have been imposed due to the unforeseeable nature of the injury. Patients undergoing gastroplasty who survive the critical period immediately following the operation are very unlikely to suffer complications and die. The plaintiff’s death fourteen and a half months after the initial operation was therefore unforeseeable.141 An exception to the usual limits imposed by foreseeability occurs in the case of “thin skulled” victims of negligence, where injuries are unexpect137 Khoury, supra note 30, at 211–213. 138 Cottrelle v. Gerard (2003), 67 O.R.3d 737, para. 25 (Ont. Can.) 139 Ellen I. Picard and Gerald B. Robertson, Legal Liability of Doctors and Hospitals in Canada, 4th ed., (Toronto: Thomson Carswell, 2007) at 288; see also J. Gilmour, The Multiple Meanings of Causation in the Supreme Court of Canada’s Medical Malpractice Jurisprudence: Past, Present and Future, in Health Law at the Supreme Court of Canada (J. Downie & E. Gibson eds., 2007). For more on trends in causation, see Vaughan Black, The Transformation of Causation in the Supreme Court: Dilution and “Policyization,” in Annual Review of Civil Litigation 2002 (Todd Archibald & Michael Cochrane eds., 2003) and Colleen M. Flood, Conundrums in Causation and Informed Medical Consent, 23 Advoc. Q. 217(2000). 140 Martin v. Inglis (2002), 218 Sask. R. 1, paras.115–16 (Sask. Can.). 141 Id.at paras. 133–137. The Supreme Court has recently opined at greater length on remoteness in Mustapha v. Culligan of Canada Ltd. (2008), 2 S.C.R. 114 (finding that a purified water company was not liable for the unforeseeable psychological damage done to the plaintiff when a fly was found in his bottled water).

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edly severe owing to a preexisting condition. Defendants are liable for thin skulls, but not for “crumbling skulls” – cases where the preexisting condition made the injuries inevitable.142 Furthermore, as Justice Linden’s text on tort law states, “If the negligence of the defendants renders the skull of the plaintiff thin, making the plaintiff more susceptible to additional injury of sickness, the defendant is responsible for the further complications.”143 This statement of the “thin skull rule” was applied by the Manitoba Court of Appeal to hold a physician liable not only for negligent post-operative hip surgery care, but also for the fractured femur the plaintiff sustained in a subsequent operation to address the consequence of his substandard care.144 The most common defenses against claims of physician negligence are as follows: the physician followed approved practice; the physician only committed an excusable error of judgment; the patient was contributorily negligent; the action is statutorily barred. Each will be addressed in turn. The Supreme Court clarified in terNuzen v. Korn that doctors acting in accordance with a recognized and respectable practice of the profession would generally not be found to be negligent.145 In reaching that decision, the court emphasized its lack of expertise and inability to second-guess the appropriateness of clinical decisions. However, when the standard is “fraught with obvious risks” such that a reasonable person without clinical skill would find it negligent, the court may find the approved practice to be negligent.146 The Court cited Anderson v. Chasney as an example of this exception to the general rule.147 After removing a child’s tonsils, the surgeon was told by the anesthetist that not all the sponges had been removed. The surgeon found no sponges, but the child later asphyxiated on one. The surgeon was held liable even though it was not the practice of the hospital at the time to count sponges, or employ ones with strings.148 A failure to comply with approved practice does not necessarily mean the standard of care was breached. However, if a physician acts in accordance with a respectable body of opinion, even if not the opinion of the majority, he or she will normally avoid liability.149

142 143 144 145 146 147 148 149

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Athey, 3 S.C.R. at para. 35. A.M. Linden, Canadian Tort Law 350 (7th ed., 2001). Powell v. Guttman (1978), 89 D.L.R.3d 180, para.38 (Man., Can.). terNeuzen v. Korn (1995), 34 S.C.R. 674, para. 38 (Can.). Id. at para. 39. Id. at para. 45. Anderson v. Chasney (1949), 4 D.L.R 71 (Man., Can.), aff’d (1950) 4 D.L.R 223 (SCC). Picard and Robertson, supra note 76, at 362; see e.g., Lapointe v. Hopital le Gardeur (1992), 90 D.L.R. 4th 7 at para. 23 (S.C.C).

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In Wilson v. Swanson, the leading case on the defense of “error of judgment,” the Supreme Court held that “an error of judgment has long been distinguished from an act of unskillfulness or carelessness or due to lack of knowledge.”150 Reasonableness, not perfection, is expected of doctors, and even reasonable doctors make mistakes.151 The defense of error of judgment is most often raised in respect of a failure to correctly diagnose a patient’s condition.152 While an initial misdiagnosis may be only an error in judgment, courts have found the failure to reconsider a diagnosis as negligent where the patient did not respond to treatment and her condition worsened.153 The defense of contributory negligence is essentially a claim that the patient was wholly or partially the author of his or her own misfortune. In arguing that damages should be reduced, defendants will often allege an unreasonable delay on the part of a patient in seeking medical attention. Picard & Robertson contend that claims of contributory negligence rarely succeed in Canadian medical malpractice law, possibly because courts have been loathe to find patients at fault given the seemingly unequal positions of the parties.154 As patients take more agency with respect to their medical care, however, it is possible that findings of contributory negligence will become more common.155 All Canadian jurisdictions have legislation requiring plaintiffs to commence a civil action within a certain limitation period. Thus one of the most common defenses to a claim of medical negligence is that that action is statutorily barred because the limitation period has elapsed. Most provinces and territories have a two-year limitation period, running from when the plaintiff knew or ought to have known of the tort, for actions against physicians and other health professionals, consistent with the limitation for other claims in negligence. In the past, limitation periods for medical malpractice actions were much shorter in many jurisdictions. Apparently the preferential treatment originated in Ontario in the late nineteenth century when the Ontario legislature shortened the limitation period from the regular six years to one year for physicians. This special

150 151 152 153 154 155

Wilson v. Swason (1956), 5 D.L.R. 2d 113, para. 23 (SCC). Felix v. Red Deer Regional Hospital Centre (2001), 2001 ABQB 545, para. 80 (Q.B.). Picard and Robertson, supra note 76, at 366. Bergen v. Sturgeon General Hospital (1984), 52 A.R. 161, para. 24 (Q.B.). Picard & Robertson, supra note 76, at 369. Id.

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rule, providing additional protection to the medical profession, then spread across Canada.156 Historically, the “locality” doctrine borrowed from American law provided a partial defense to claims in negligence by holding physicians in rural and/or remote communities to a lower standard of care. The doctrine is occasionally still referenced in Canadian case law, but appears now to have little to no impact on how cases are decided. This is especially so since there is no requirement in Canada that expert testimony comes from a physician within the same (or comparable) community as the defendant physician.157 Although physicians may be under pressure to contain costs, Law Estate v. Simice suggests that limited resources cannot be a defense for physician negligence.158 The case involved a patient who died after the treating physician – responding to pressures to limit the use of expensive tests – declined to order a diagnostic CT scan that would have revealed the patient’s aneurism. The court stressed in obiter that cost considerations should not affect a physician’s decision making; a physician’s duty is to his or her patient, not the financial health of the Medicare system overall.159 Where resources are simply not available to a physician, due for example to the remote location of their practice, this may be a defense,160 though in some cases courts have found a responsibility to refer patients to a more well-equipped treatment facility.161 As resource constraints increase it is possible that this question of a defense of limited resources will need to be revisited. Motivated by a desire to reduce litigation rates and improve system quality, “apology” legislation has recently been introduced in many provinces and territories to address concerns regarding the legal consequences of apologizing. For example, the Ontario legislation provides that an apology is not admissible in any civil, administrative, or arbitration proceeding as evidence of fault or liability.162 Even if a physician’s apology includes an explicit admission of fault, the broad definition of apology in the legislation seems to preclude the use of such an admission in a 156 Picard & Robertson, supra note 76, at 377. 157 Id. at 248–251; see also Ellen I. Picard and Gerald B. Robertson, Legal Liability of Doctors and Hospitals in Canada 191–92 (3d ed., 1996). 158 Law Estate v. Simice (1994), 21 C.C.L.T.2d 228, para. 24 (B.C.S.C.), aff’d (1996) 4 W.W.R. 672 (C.A.). 159 Id. at paras. 21, 34–35. 160 Rodych v. Krasey (1971), 4 WWR 358 (Can.). 161 Dillon v. Leroux (1994), 89 B.C.L.R. 2d 376 (B.C., Can.). 162 Apology Act, 2009, S.O. 2009, c. 3, s. 2.(3) (Ont., Can.).

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negligence action. Legislation in British Columbia, Alberta, Saskatchewan, Nova Scotia and Manitoba is similarly drafted.163 As this legislation has only been recently enacted, there has been little or no case law to date testing its impact on negligence law.

3.

Hospital Liability

Hospitals may be both directly and vicariously liable for harm caused to patients. A hospital may be directly liable for a variety of shortcomings, including: inadequate equipment; inadequate record-keeping; improper performance or supervision of staff/treatment; poor supervision of postop care; failure to protect patients from infection; improper supervision of emergency departments; failure to establish systems necessary for safe functioning; failure to have a written protocol or internal regulations with respect to the treatment of a particular injury, or failure to follow written protocol; failure to prevent a patient from injuring themselves or other patients.164 Hospitals are vicariously liable for the torts of their employees, such as nurses. Hospital vicarious liability for nurses working as part of a health care team raises interesting issues, given that nurses are health professionals with independent skills, knowledge, and judgment, but have a duty to follow the orders of physicians.165 In a recent obstetrics malpractice case a rural hospital was found vicariously liable for the death of an infant.166 The court determined that the nurse assisting with the delivery was negligent in failing to summon qualified help (including emergency resuscitation) in the circumstances. The treating physician displayed signs of emotional distress and panic in attempting to deal with complications that arose during the birth and did not request appropriate assistance from other medical staff.167 Hospitals may, in principle, face vicarious liability for the negligence of a doctor practicing at a hospital depending on the relationship between the

163 Letter from John E. Gray, Exec. Dir., Can. Med. Protective Agency, to Lorenzo Berardinetti, Chair, Standing Comm. on Justice Policy, “Re: Bill 108: Apology Act, 2008” (Jan. 5, 2009), available at http://www.cmpa-acpm.ca/cmpapd04/docs/submis sions_papers/com_bill_108_apology_act-e.cfm (last visited Apr. 16, 2011). 164 Moe Litman, Fiduciary Law in the Hospital Context: The Prescriptive Duty of Protective Intervention, 25 Health L. J. 295 (2007); Picard & Robertson, supra note 76, at 460–473. 165 Id. at 491. 166 Skeels Estate v. Iwashkiw (2006), 2006 Alta. L.R.4th 26, para. 258 (Alta. Can.). 167 Id. at para. 87.

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doctor, the hospital, and the patient.168 Hospitals are vicariously liable for physicians employed as house staff who are under the control of the hospital, such as medical residents and interns.169 However, most physicians practicing in Canadian hospitals have hospital privileges, but are paid through provincial health insurance schemes and considered to be independent contractors. These physicians are directly liable to their patients and hospitals are not vicariously liable for their negligence. Whether hospitals are liable for physicians other than interns and residents requires a close examination on the facts of a case. For example, some courts have held hospitals vicariously liable for the negligence of anesthesiologists,170 while others have rejected such claims.171 Key considerations in determining whether to impose vicarious liability include whether the patient chose the physician; whether the physician is salaried by the hospital; whether the physician is integral to rather than accessory to the hospital’s operation.172 The Supreme Court has recently expanded the application of vicarious liability, but these decisions have not involved hospitals.173 Hospitals have recourse to many of the same defenses as physicians: they followed an approved standard of practice, the patient was contributorily negligent, the limitation period has expired, or the injury was not foreseeable. Hospitals can also defend actions by characterizing the nature of the physician’s relationship with the hospital as one of independent contractor rather than as an agent of the hospital, thereby defeating the rationale for imposing liability. A unique defense open to hospitals is that the care provided was sufficient based on the reasonable expectation of the community it serves. In Bateman v. Dorian, a hospital in Moncton, New Brunswick was found not to be negligent for staffing its emergency room with part-time general practitioners rather than specialists in emergency medicine.174 The court held that “the non-availability of trained and experienced personnel, to say nothing of the problems of collateral resource allocation, simply makes this standard unrealistic, albeit desirable.”175 As mentioned earlier it is perhaps only a matter of time until a similar defense is open to physicians.

168 Yepremian v. Scarborough General Hospital (1980), 28 O.R. 2d 494, para. 179 (Can. Ont., C.A.); leave to appeal allowed (1980), 120 D.L.R. 3d 337 (Can. Ont. C.A.). 169 Id. at para. 49. 170 Martel v. Hôtel-Dieu St. Vallier (1969), 14 D.L.R 3d 445 (S.C.C.). 171 Toronto General Hospital v. Matthews et al. (1972), 1972 S.C.R. 435 (Can.). 172 Picard and Robertson, supra note 76, at 481. 173 Gilmour, supra note 6, at 59. 174 Bateman v. Doiron (1991), 118 N.B.R.ed 20, para.3–4 (N.B., Can). 175 Id. at para. 43.

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4.

Government Liability

Governments may conceivably be subject to tort liability.176 Despite the possibility of bringing claims against governments, Gilmour explains that in practice “they have generally been immune from liability for negligence in their decision-making about the organization and funding of the health care system, on the basis that such decisions did not give rise to a private law duty of care, and were not amenable to a finding of negligence because they were policy and not operational decisions.”177 This type of reasoning is illustrated by the Divisional Court’s decision in Mitchell Estate v. Ontario, a case involving allegations that hospital restructuring and health care spending decisions made by the Ontario government caused the death of a patient in an over-crowed emergency department.178 In striking out the motion the Court held that “there should be no private law duty of care arising with respect to decisions affecting health care funding and hospital restructuring.”179 Many of the actions against governments involve allegations by private citizens that governments failed to maintain safe systems – for instance, in response to outbreaks of Severe Acute Respiratory Syndrome (SARS) in the greater Toronto area and West Nile virus across Ontario. The Ontario Court of Appeal has struck down actions against the Ontario government emerging from injuries suffered due to infection by West Nile virus180 and SARS181. In Eliopoulos v. Ontario the Court held that while the government did owe a public law duty to promote health and protect against the spread of the West Nile virus, there was no relationship of proximity between the plaintiff and Ontario capable of giving rise to a private law duty of care.182 In Williams v. Ontario, a proposed SARS class action, the Court held that it was “plain and obvious on the facts pleaded in the claim that Ontario did not owe a private law duty of care to the plaintiff.”183 Even if the plaintiffs had been able to demonstrate a relationship of sufficient proximity, the court would have declined to find a duty for

176 Lorian Hardcastle, Governmental and Institutional Tort Liability for Quality of Care in Canada, 15 Health L.J. 401, 431–34 (2007). 177 Gilmour, supra note 6, at 62. 178 Mitchell Estate v. Ontario (2004), 2004 O.J. No. 3084, paras.2–3 (Ont., Can.). 179 Id. at para. 33. 180 Eliopoulos v. Ontario (Minister of Health & Long-Term Care) (2006), 217 O.A.C. 69, para. 3 (Ont., Can.). 181 Williams v. Ontario (2009), 95 O.R.3d 401, paras. 30–34 (Ont. Can.). 182 Eliopoulos, 217 O.A.C. at para. 17. 183 Williams, 95 O.R.3d at para. 40.

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policy reasons, explaining that “[p]ublic health authorities should be left to decide where to focus their attention and resources without threat of lawsuits.”184 Case law is not yet well developed regarding the lines between policy and operational decisions and the boundaries of private law duties of care that governments owe members of the public with respect to health care and public health.185 Claimants may have greater success in making claims against local health authorities than the government due to more proximate relationship, greater managerial role, and more limited duties towards the public.186

5.

Damages

A major focus tort law reform in the United States has been a perceived need to control costs, but allegedly excessive damages awards have not been a significant issue in Canada. The Canadian Supreme Court capped damages for general non-pecuniary injuries, such as for pain and suffering, in a trilogy of cases released in 1978.187 The capped amount has been adjusted for inflation over the years, and now stands around $CAD 300,000.188 To be clear, a plaintiff patient may still claim pecuniary damages, such as loss of income and health care costs not covered under the public system (as discussed below, patients are required to claim damages, in subrogation, for expenses incurred by the public insurer as a result of medical malpractice). Nonetheless, this cap on non-pecuniary losses is a major disincentive for patients to commence a malpractice action and for lawyers to specialize in or seek out malpractice cases.189 A further disincentive is that the availability of punitive damages has been greatly limited by the Supreme Court. Punitive damages are only awarded in exceptional circumstances in negligence claims where there has been “high-handed, malicious, arbitrary or highly reprehensible misconduct” that departs to a marked degree from ordinary standards of decent behavior.190

184 Id. at para. 35. 185 Gilmour, supra note 6, at 59. 186 Lorian Hardcastle, Systemic Accountability through Tort Claims Against Health Regions, 18:2 Health L.R 40 (2010). 187 See e.g., Andrews v. Grand & Toy Alberta Ltd., [1978] 2 S.C.R. 229 (Can.). 188 Stephen F. Clark, Medical Malpractice Liability: Canada, Law Library of Congress (Aug. 30, 2010), available at http://www.loc.gov/law/help/medical-malpractice-liability/canada. php. 189 Id. 190 Whiten v. Pilot Insurance Co., [2002) 1 S.C.R. 595, para. 94 (Can.)

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One may also wonder about the impact of subrogation on damages awards. All provinces and territories in Canada now have legislation requiring patients to inform the ministry of a potential claim and/or to bring a claim on behalf of the government as part of a medical malpractice action commenced by the patient.191 For example, Ontario’s Health Insurance Act (OHIP) requires plaintiffs to pursue a subrogated claim on behalf of OHIP for the extraordinary cost of past and, in some case, expected future health care services incurred as a result of the alleged negligence. Section 31(1) of the Act states as follows: Any person who commences an action to recover for loss or damages arising out of the negligence or other wrongful act of a third party, to which the injury or disability in respect of which insured services have been provided is related shall, unless otherwise advised in writing by the General Manager, include a claim on behalf of the Plan for the cost of the insured services.192 In Ontario, the Ministry of Health and Long-term Care routinely recovers the cost of publicly insured health services associated with medical malpractice, automobile accidents, and a range of other situations such as assaults, slip and falls, and manufacturing defects.193 While recent CMPA annual reports do not provide specific information regarding the cost of subrogation, a report on tort law reform prepared by the CMA and CMPA in 2000 indicated that subrogated claims represented 4.2 % of the value of total awards and settlements made by CMPA in the previous two years.194 The report advocated for the elimination of subrogation respecting medical malpractice actions, claiming it was a “logical absurdity” since “virtually every dollar paid to OHIP in medical malpractice litigation originates in the Ministry of Health.”195 Similar sentiments were echoed in the 2008 CMPA Annual Report, in which the CMPA argued that the elimination of subrogation would create overall savings by reducing unnecessary transaction costs.196

191 See, e.g.Health Insurance Act, R.S.O., c. H.6, s. 30–36 (1990) (Ontario); Hospitals Act, R. S.A., c. H-12, Part 5 (2000) (Alberta); Health Care Costs Recovery Act, S.B.C., C. 27 (2008) (British Columbia). 192 Health Insurance Act, R.S.O., c. H.6, s. 31(1) (1990) (Ontario). 193 “Personal Injury Accidents: Recovering Health Care Costs” Ministry of Health and Long-Term Care, available at http://www.health.gov.on.ca/english/public/pub/ohip/ injury.html (last visited Apr. 8, 2011). 194 Canadian Medical Association & Canadian Medical Protective Association, CMPA Tort Reform 2000; Structures and Subrogation available at http://www.cmpa-acpm.ca/cmpapd04/ docs/submissions_papers/com_tort_backgrounder_2000-e.cfm. 195 Id. 196 CMPA 2008 Annual Report, available at http://www.cmpa-acpm.ca/cmpapd04/docs/ about_cmpa/annual_report/2008/com_leadership-e.cfm.

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6.

Ongoing Issues and Avenues of Reform

One of the main purposes of tort law is to deter risk-taking through the imposition of potential liability.197 A key challenge when using tort liability as a lever to promote patient safety is to ensure that responsibility is targeted at the appropriate level within the system. Hospitals (and arguably regional health authorities that have managerial responsibility for hospitals) are able to improve patient safety by providing better working conditions for physicians, nurses, pharmacists and other health professionals and instituting policies and procedures that will reduce error. The nature of the delivery of modern health care in hospitals is such that the present sharp distinction in Canadian law between hospital responsibility and physician responsibility is artificial. Tort law for the most part shields “blunt end” actors such as hospitals and government, and assigns liability to “sharp end” actors such as physicians practicing in hospitals.198 Increasing awareness generated by the patient safety movement regarding the role of systemic factors in causing patient injury provides strong support for the expansion of hospital vicarious liability to include nonemployed physicians in the future.199 Another main goal of tort law is to ensure those harmed by wrongdoing are compensated for their injuries. Most tort reform initiatives in Canada over the last decade have focused on streamlining the process for resolution, and introducing structured settlements whereby damages are paid out according to a pre-determined timeline.200 These initiatives were encouraged in the 1990 Prichard Report to the Conference of Deputy Minister of Health, entitled Liability and Compensation in Health Care.201 Progress towards achieving these goals has proceeded at a pace described as “excruciatingly slow.”202 A far more ambitious recommendation con-

197 There is disagreement as to whether tort law does, and ought to, serve an instrument of deterrence. For a defense of deterrence, see Michael J.Trebilcock, Incentive Issues in the Design of No-Fault Compensation Systems, 39 U. TORONTO L.J. 19, 19–20 (1989); but see Terence Ison, The Forensic Lottery: A Critique of Tort Liability as a System of Personal Injury Compensation (London, Staples, 1967). 198 Even so, the structure of the current liability system provides little in the way of effective deterrence for the “sharp end” actors, as previously discussed above. 199 Gilmour, supra note 6, at 60–61. 200 Canada Unlikely to Follow U.S. Malpractice Reform, MEDICAL POST (8 Feb. 2005). 201 J.R.S. Prichard, LIABILITY AND COMPENSATION IN HEALTH CARE: A REPORT TO THE CONFERENCE OF DEPUTY MINISTERS OF HEALTH OF THE FEDERAL/ PROVINCIAL/TERRITORIAL REVIEW ON LIABILITY AND COMPENSATION ISSUES IN HEALTH CARE, (Toronto: University of Toronto Press, 1990). 202 Recent Rumblings May Move Mountain of Malpractice Reform: Nine Years Have Passed With No Changes, MEDICAL POST vol. 34, no. 39, pp. 1 (1998).

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sidered in the Prichard Report was that Canada introduce a no-fault compensation scheme for medial injuries to supplement the existing tort regime.203 While no-fault compensation is a subject of perennial interest to Canadian legal scholars,204 there does not appear to be any real political momentum in this direction.205 Any impetus for significant change is also unlikely to come from the CMPA, given its findings in a recent report on medical liability practices that “the Canadian model appears fundamentally sound” and “may be the best available solution.”206

IV. Preventing Adverse Events: Professional and System Reform A recurring theme in the literature on Canadian tort law is the slow pace and modest nature of reforms.207 The lack of momentum on this front should not be taken as a sign that all is rosy in Canadian health care: as explained in Part II, there have been a number of grave systemic problems in recent years, resulting in widespread calls for improvements to patient safety standards. The federal government, provincial governments, and non-governmental regulatory bodies, have pursued various strategies with a view to reducing the incidence of adverse events. What follows is a brief survey of these strategies.

203 While there is no current compensation scheme for medical injuries, provincially funded disability benefits are available to qualifying individuals. For example, the Ontario Disability Support Program (ODSP) provides very basic income support to persons with a substantial disability that impairs their ability to work or care for themselves, but only those with minimal financial resources are eligible. The federally operated Canada Pension Plan (CPP) also provides a disability benefit for those under 65 who have recently contributed to the CPP through mandatory deductions from their income but are currently unable to work due to disability. The CPP disability benefit provides a very basic level of support (the maximum benefit is $CA 1,105.99 per month). See Ontario Disability Support Program: Income Support, Ministry of Community and Social Services, http://www.accesson.ca/en/mcss/programs/social/odsp/in come_support/index.aspx; see also CPP Disability – I want to apply, Service Canada, http://www.servicecanada.gc.ca/eng/isp/cpp/applicant.shtml. 204 See e.g. R. Elgie, T. Caulfield et al., Medical Injuries and Malpractice: Is It Time For No-Fault?, 1 HEALTH L.J. 97, 99 (1993); Colleen M. Flood, New Zealand’s No-Fault Accident Compensation Scheme: Paradise or Panacea? 8 HEALTH L.REV. 3, 3 (1999/2000). 205 No fault insurance was later considered, and rejected, by the commission formed after Canada’s tainted blood scandal – a public health crisis wherein more than 2000 individuals were infected with AIDS and hepatitis C through blood transfusions. See H. Krever, FINAL REPORT: COMMISSION OF INQUIRY ON THE BLOOD SYSTEM IN CANADA (Ottawa: The Commission, 1997). 206 Canadian Medical Protective Association, Medical Liability Practices in Canada: Towards the Right Balance, 5–7 (2005), available at http://www.cmpa-acpm.ca/cmpapd04/docs/sub missions_papers/piaa/com_home-e.cfm. 207 Gilmour, supra note 6, at 19–26.

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A.

Reforms at the Level of the Professions

1.

Alternative Complaint Mechanisms

Instead of (or in addition to) bringing a claim in negligence, patients who believe they were injured or improperly treated may make a formal complaint regarding a health care provider to the appropriate self-regulating health college. In Ontario, for example, each college has a Complaints Committee, which conducts initial investigations and may refer specific allegations to the Discipline Committee for a hearing.208 While physicians in Canada are self regulating, decisions of the discipline committees of many provincial colleges of physicians are subject to public oversight through the courts, or through provincial ombudsman offices, for instance in Alberta.209 Some of Canada’s more populous provinces have devised additional public channels for patients seeking redress for inadequate care. Under reforms introduced in 1991, the province of Quebec enacted a Patients’ Bill of Rights, with complaints being heard by local health commissioners and, if unresolved at that level, escalated to the provincial Health and Social Services Ombudsman.210 It is unclear whether Quebec’s Ombudsman addresses many complaints concerning medical malpractice per se. In 2009, the Ombudsman primarily addressed individual and group complaints about systemic problems, relating for example to denial and delays of care, delays in the certification of long term care facilities, and ineffective triage within emergency wards.211 Ontario has not enacted a bill of patient rights, but there is nevertheless a provincial Ombudsman, whose remit encompasses decisions of the Ministry of Health and Long-Term Care – though not individual hospitals or physicians.212 Every year, the

208 Decisions by the Ontario Complaints Committees are subject to review by the Health Professions Appeal and Review Board. 209 See Alberta Ombudsman, How We Help (2010), http://www.ombudsman.ab.ca/what wedo.php (last visited Apr. 8, 2011). 210 An Act Respecting Health and Social Services, R.S.Q., ch. 4.2 (1991) (Quebec). 211 Quebec, Le Protecteur du Citoyen, 2009–2010 Annual Report, available at http://www. protecteurducitoyen.qc.ca/en/major-cases-and-documentation/annual-reports/index. html#haut. Controversy has surrounded these changes, as a leaked government document revealed that these patient rights provisions are meant to build public confidence in the system in the lead up to increased privatization. See Karen Kleiss, Health-care Privatization Alleged by Alberta Opposition, Edmonton Journal, Nov. 30, 2010. 212 Ontario’s Ombudsman did however gain jurisdiction to investigate Hôtel-Dieu Grace Hospital when it was put under direct control of the Ministry of Health and LongTerm Care, after systemic problems were discovered in pathology services. See Windsor Hospital Taken Over by Province, Toronto Star, Jan. 5, 2011.

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Ombudsman hears between 500–1000 complaints about wait times, access to care, and quality of care and other systemic issues relating to the Ministry’s work.213 The Alberta legislature has very recently passed the Alberta Health Act, which will see the enactment in that province of a Health Charter, to be overseen by a government appointed Health Advocate, similar to Quebec’s Ombudsman.214

2.

Revalidation/Recertification

The Code of Ethics of the Canadian Medical Association requires, among other things, that physicians “engage in lifelong learning to maintain and improve their professional knowledge, skills, and attitudes.”215 There has recently been a push, led by the Federation of Medical Regulatory Authorities of Canada (FMRAC), to require that Canadian physicians “recertify” their qualifications on an ongoing basis, through a rigorous and standardized revalidation process.216 Although some provincial regulators have tried to introduce new approaches to practice assessment, physician organizations are often resistant to any system seen as too burdensome or time consuming.217 One might expect that such concerns would resonate with the public, given the general sense that the health care system is overtaxed – yet polls indicate that 87 % of patients support the idea of regular, ongoing exams for physicians.218 Some provinces, but not all, have mandated that physicians participate in an educational program – typically through the Royal College of Physicians and Surgeons’ Maintenance of Certification program or the College of Family Physicians’ Maintenance of Proficiency program – as a condition of maintaining licensure. Critics have argued that these efforts have, to date, lacked rigor – pointing out, for example, that they rely on self-reporting, and involve no external review.219 Canadian physicians are often able to 213 Ombudsman’s Annual Reports, http://www.ombudsman.on.ca/en/publications-resources/annual-reports.aspx (last visited Apr. 11, 2011). 214 Bill 17: Alberta Health Act(Dec. 2, 2010), available at http://www.assembly.ab.ca/net/ index.aspx?p=bills_status&selectbill=017. 215 Canadian Medical Association, CMA Code of Ethics (Ottawa, 2004), available at http:// policybase.cma.ca/PolicyPDF/PD04-06.pdf. 216 Kirstyn Shaw et al., Shared Medical Regulation in a Time of Increasing Calls for Accountability and Transparency, 302 JAMA 18 (2009). 217 Id. 218 Troyen A. Brennan, et al., The Role of Physician Specialty Board Certification Status in the Quality Movement, 292 JAMA 1038 (2004). 219 Wendy Levinson, Revalidation of Physicians in Canada: Are We Passing the Test? 179:10 Can. Med. Ass’n J. 979 (2008).

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satisfy their Maintenance of Certification requirements simply by attending medical education activities, and reporting their attendance to their college, without ever being tested on what they have learned.220 It is said that Canada has not been as rigorous as other jurisdictions (e.g., the UK and the US) in the implementation of revalidation schemes.221 The FMRAC has complained specifically that the provincial Colleges are not gathering sufficient evidence linking physicians’ ongoing training with their scope of practice.222 The above-mentioned regulatory failings in the area of cosmetic surgery have been traced partly to this problem; over the years, many general practitioners expanded their scope of practice to include cosmetic surgeries, without reporting the change to their college, or undergoing any testing to verify their competence. The province of Ontario is taking steps to address this problem, but faces the challenge of assessing the qualifications of physicians who have been performing cosmetic surgeries for years, without any surgical designation.223 Cases of general practitioners undertaking cosmetic surgical practices plainly lie at the extreme. It is unclear whether there will be a push by the colleges to better correlate physicians’ scope of practice with their credentials across the board. It has taken decades to respond to the problem of under-qualified cosmetic “surgeons” in Ontario – despite patient deaths and considerable public outrage – which suggests that the FMRAC’s concerns about self-regulation may be well founded.

3.

Apology Legislation

The earlier discussion of tort liability briefly described the move to enact apology legislation in several Canadian provinces. One rationale for such legislation is to break the code of silence around medical errors, allowing physicians to be honest and apologetic with patients. Receiving an apology may help the healing process for patients, but the open disclosure of errors is also argued to be important to improving patient safety overall. It is through gathering data on the occurrence of errors and near

220 Id. 221 Shaw et al., supra note 216. 222 FMRAC Revalidation Working Group, Physician Revalidation: Maintaining Competence and Performance, Federation of Medical Regulatory Authorities of Canada (2007), available at http://www.fmrac.ca/policy/revalidation_eng.html. 223 Flood et al., supra note 25.

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misses that systemic problems are detected and corrected.224 At the moment, only six Canadian provinces have enacted apology legislation, though there have been calls to enact similar legislation in the remaining provinces. In the meantime, the CMPA has been criticized for continuing to give “apology-chilling advice” to physicians in provinces without such legislation.225

B.

Systemic Reforms

1.

Accreditation of Facilities

As indicated above, each province has its own Hospital Act, which allows for the ongoing inspection and accreditation of hospitals by provincial ministries of health. Yet there has been a lack of equivalent regulation for smaller clinics that offer privately financed care; privately financed care represents a growing portion of the overall health system, owing to “passive privatization” of Canadian health care.226 For example, in Ontario there is a massive backlog of elderly patients who require full-time nursing care and who are on wait lists for spots in government-regulated and subsidized long-term care homes. In the meantime, many take up residence in private retirement homes, which are not regulated by government – conditions in these homes are in some cases appalling.227 In the spring of 2009, the Ontario legislature passed the Retirement Homes Act, which creates a regime of licensure and inspection for these facilities.228 While seniors in the province have welcomed the change, it is worrying that the proposed regime will be one of self-regulation, overseen by “people with a background in the retirement-home business.”229 A very similar story can be told of the regulation of private clinics delivering non-essential care, such as elective cosmetic surgery. After years of inaction, the province of Ontario has taken steps to ensure that private clinics are subject to inspection, and that the credentials of staff are

224 Gerald B. Robertson, When Things Go Wrong: The Duty to Disclose Medical Error, 28 Queen’s L. J. 353 (2002). 225 Noni MacDonald & Amir Attaran, Medical Errors, Apologies and Apology Laws, 180(1) Can. Med. Ass’n J. 11 (2009). 226 Dale Brazao, Seniors at Risk in Retirement Homes, Investigation Reveals, Toronto Star (October 1, 2010) 227 Brazao, Seven Sad Days, supra note 24. 228 Retirement Homes Act, S.O. 2010, Chapter 11 (2010) (Ontario). 229 Quoted in Retirement Homes: Seniors need more protections TORONTO STAR (October 3, 2010).

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vetted.230 But again, this has been achieved through a regime of selfregulation, overseen by the College of Physicians and Surgeons of Ontario.231 Thus there remains a disparity: hospitals delivering medically necessary care within the province are subject to direct oversight by the province’s Ministry of Health, while private clinics are subject only to selfregulation.

2.

Canadian Patient Safety Institute

Over the past decade, there has been recognition of the need for a comprehensive and coordinated strategy to improve patient safety. The Royal College of Physicians and Surgeons of Canada held a one-day forum on patient safety in 2001, which spawned a National Steering Committee on Patient Safety. The Committee in turn recommended the creation of the Canadian Patient Safety Institute (CPSI), tasked with promoting innovation and collaboration among governments and stakeholders, with a view to enhancing patient safety. The CPSI has been in operation since December of 2003, and has funded research, developed patient safety guidelines, and led campaigns in various targeted areas – from hand hygiene to suicide prevention.232 To be clear, the CPSI plays only an advisory and facilitative role; it does not have the power to enforce patient safety standards on the provinces, or the power to license facilities or discipline physicians.

3.

Improved Information Gathering and Dissemination

Timely information gathering and dissemination will be essential to detecting and preventing patient safety crises of the sort described above – e.g., the breast cancer screening test crisis in Newfoundland and Labrador. Regrettably, Canada has lagged behind other developed nations in its adoption of IT systems for healthcare.233 There have, however, been some steps taken to remedy this situation. Canada Health Infoway is a non-profit

230 CPSO, Out-of-Hospital Premises Inspection Program, http://www.cpso.on.ca/members/de fault.aspx?id=3756 (last visited Apr. 11, 2011). 231 Id. 232 Canadian Patient Safety Institute, http://www.patientsafetyinstitute.ca/ (last visited Apr. 11, 2011). 233 Cathy Schoen, et al., A Survey of Primary Care Physicians in Eleven Countries, 2009: Perspectives on Care, Costs, and Experiences, 28 Health Affairs 6 (Web Exclusives): w1171w1183 at w1175 (2009).

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organization created by Canada’s First Ministers in 2001, and funded by the federal government, which is tasked with creating a national, interoperable system of Electronic Health Records (EHRs). The country’s patchwork of regulations and privacy laws is partly to blame for the long delays in designing and implementing a system of EHRs.234 There are significant concerns that the EHR system under development by Infoway is not being built with a view to facilitate secondary research.235 Thus it remains unclear, at this stage, to what extent this project will furnish data that can be used in improving patient safety at a systemic level. A variety of smaller projects have been initiated in recent years. The National System for Incident Reporting (NSIR) is a free web-based application used by Canadian hospitals to securely and anonymously share, analyze and discuss medication/IV fluid incidents. Health Canada’s program, MedEffect Canada, provides consumers, patients, and health professionals with easy access to report adverse events and obtain latest safety information on drugs and health products. Another Health Canada initiative, the Canada Vigilance Adverse Reaction Online Database, stores information reported about suspected adverse reactions to health products, such as prescription and non-prescription medication, natural health products, and radiopharmaceuticals. Lastly, the Health Council of Canada was established following the February 2003 First Ministers’ Accord on Healthcare Renewal.236 The Council is to provide monitoring, public reporting and informed discussion about the performance of provincial health systems, partly with a view to improving patient safety. The majority of provinces have, in the past decade, created their own Health Quality Councils, to the same end.237 While very little information is available to the public, there is increasing interest and recognition of the importance of providing information on health quality and safety indicators to healthcare consumers. For instance,

234 Canada, Standing Senate Committee on Social Affairs, Science and Technology, The Health of Canadians – The Federal Role, 6 Ottawa: Standing Senate Committee on Social Affairs, Science and Technology 10.4 (2002). 235 Patricia Kosseim & Megan Brady, Policy by Procrastination, 2 Mcgill J.L. & Health 5, 6–9 (2008); see also Kimberly McGrail & Paul C. Hebert, No More Dithering on E-health: Let’s Keep Patients Safe Instead, 182 Can. Med. Ass’n J. 535 (2010). 236 Health Counsel of Canada, http://www.healthcouncilcanada.ca/en/ (last visited Apr. 11, 2011). 237 See, e.g., The BC Patient Safety and Quality Council, http://www.bcpsqc.ca/; The Health Quality Council of Alberta, http://www.hqca.ca/; The Saskatchewan Health Quality Council,http://www.hqc.sk.ca/; The Manitoba Institute for Patient Safety, http://www. mbips.ca/; The Ontario Health Quality Council, http://www.ohqc.ca/;The Health Quality Council of Quebec, http://www.indicateurs.ca/ (all last visited Apr. 11, 2011).

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the Manitoba Physician Profile Regulation requires that the history of all licensed physicians, including medical training and disciplinary history, be available to the public.238 This initiative arose out of recommendations made by a committee reviewing the results of the Manitoba Pediatric Cardiac Surgery Inquest, as is discussed above.239 While this physician profile information is easily accessible online, it is based on self-report and is not verified by the Manitoba College of Physicians and Surgeons, limiting its usefulness.240

Conclusion Plainly there are real and well-founded concerns about patient safety in Canada, within hospitals and within facilities that deliver privately financed care (e.g., retirement homes and cosmetic surgery clinics). What’s more, the full extent of these problems is as yet partly unknown, due to the lack of ongoing data collection on adverse events across the health care system. There is no single, prevailing explanation for the system’s failings to date; one can only list a variety of contributing factors and speculate as to their relative importance. From a risk reduction perspective, physicians are individually shielded from the deterrent effects of potential medical malpractice liability, thanks to the CMPA’s rules for setting insurance premiums and significant subsidization of those premiums by provinces. From the plaintiff patient’s perspective, there are enormous challenges to successfully litigating medical error for a number of reasons: Patients are discouraged from pursuing claims in the first place by both the CMPA’s reputation for aggressive litigation of claims and Canadian rules for the awarding of costs. The inherent difficulties in establishing causation in medical malpractice cases combined with broad defenses for physicians of “accepted practice” and “excusable error of judgment” make imposing liability challenging. Finally, caps on non-pecuniary damage awards limit the possible recovery of litigants who do succeed at trial. It is worrisome that, after cases are effectively pre-screened by these harsh disincentives, such a small proportion of claims succeed at trial. Certainly a proportion of cases are settled, thus negating the need to pursue litigation, but one still has still to question whether such a small proportion of Canadian patients have had rightful claims to damages for medical mal238 Manitoba Physician Profile Regulation, Reg. 104/2005 (2005). 239 Gilmour, supra note 6, at 68. 240 See Physician Profile, College of Physicians and Surgeons of Manitoba,http://www. cpsm.mb.ca/3_1_search.php (last visited Apr. 11, 2011).

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practice. Or have short limitation periods, unequal bargaining power, prohibitive rules on the awarding of costs, and caps on non-pecuniary damages conspired to create an access to justice problem? A systematic review of the case law would be required in order to ascertain whether the burden of proof set out in black letter law tilts the scales against claimants in medical malpractice cases. We noted however that, for example, patients cannot recover for missed diagnoses unless they would have had a better than 50 % chance of avoiding their injuries, given an accurate diagnosis. On the face of it, these do not seem very forgiving odds for plaintiffs. Governments at both the federal and provincial levels have been more focused on strategies for the prevention of medical malpractice, but efforts have at times been slow, scattershot, and ineffectual. For example, patient safety issues have occurred repeatedly in the delivery of privately financed care, and yet provincial governments and regulatory colleges have taken more than a decade to tighten regulations, typically opting for regimes of self-regulation, which may not provide optimal protection. Within this approach, steps are being taken in some provinces to ensure that physicians have adequate and up-to-date training for their scope of practice. Yet it appears that revalidation of credentials, in many cases, is nothing more than an exercise in self-reporting. The provinces and territories, along with the federal government, seem most enthusiastic about improved information gathering and dissemination of best practice standards as a means for preventing adverse events – hence the rapid proliferation of Health Quality Councils across Canada, over the past five to ten years. This is laudable, but it is the easiest piece of the puzzle, politically. And little is being done to evaluate whether any of these reforms will result in meaningful improvements in patient safety. Governments should also be asking harder questions, concerning access to justice for victims of medical malpractice, and the expanding role of selfregulation that has accompanied the “passive privatization” of Canadian health care. Greater consideration also needs to be given to what changes in medical malpractice law would ensure that it better meets the mark of improving patient safety, for example, consideration of whether a more systems-like approach to safety would result if hospitals or regional authorities were more frequently held vicariously liable for the actions of the physicians who operate therein.

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Yangge Dance: the Rhythm of Liability for Medical Malpractice in the People’s Republic of China Zhu Wang and Ken Oliphant*

Introduction Yangge Dance is a popular folk dance in rural China. Its basic pattern is three paces forwards, followed by two paces back; then a step to the right, followed by a step to the left. In our view, Yangge Dance is an apt simile for the process of legal development relating to liability for medical malpractice in the People’s Republic of China (P.R. China).1 The three paces forward refer to successive reforms furthering the interests of patients, following an initial period – dating from the foundation of P.R. China in 1949 until 1987 – during which medical malpractice was handled by an administrative system without formal liability rules. The first of these advances came in 1987, when the existing administrative system was

*

Zhu Wang, LLD., Associate Professor of Law, Law School of Sichuan University, Deputy Director of Institute for Chinese Tort Law of Research Center for Civil and Commercial Jurisprudence of Renmin University of China ([email protected]). Ken Oliphant is Director of the Institute for European Tort Law, Vienna, Austria, Professor of Tort Law, University of Bristol, England, and Honorary Professor, Yantai University, Shandong Province, China. Zhu Wang’s research is supported by the Fundamental Research Funds for the Central Universities, and the Research Funds of Sichuan University of China. In this article, Chinese names are rendered with the given name preceding the family name except in Chinese-language citations, where the order is reversed. Unless otherwise indicated, all translations are by Zhu Wang, and were revised with the assistance of Ken Oliphant. 1 The account presented below relies primarily on Chinese-language materials. For discussion of compensation for medical injuries in P.R. China in English, see Chunyan Ding, Medical Negligence Law in Transitional China: A patient in need of a cure (July 2009) (unpublished PhD thesis, University of Hong Kong) (on file with the authors); Liming Liu, Medical Professional Liability in the Chinese Tort Law Reform Act 2010, 26 PN 224 (2010); Chao Xi & Lixin Yang, Medical Liability Laws in China: The Tale of Two Regimes, 19 Tort L. Rev. 65 (2011).

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formalized by an administrative regulation,2 the Rules on the Handling of Medical Accidents,3 which provided not only for administrative sanctions in the event of malpractice but also for a (limited) liability to pay compensation for resultant injury. A further advance came in 2002 with the amendment of this system of administrative liability by the Regulations on the Handling of Medical Accidents.4 The third and final advance, consolidated by rulings of the Supreme People’s Court (SPC)5 in 2002– 2003, was to recognize that liability could be established – independently of the administrative system – under the ordinary rules of tort6 liability, then embodied in the General Principles of the Civil Law of the People’s Republic of China (GPCL).7 Conversely, the enactment of the new Tort 2 Administrative regulations issued by the State Council have effect as legislation under the Legislation Law of 2000. Zhong hua ren min gong he guo li fa fa [Legislation Law of the People’s Republic of China] (promulgated by the Standing Comm. Nat’l People’s Cong., Mar. 15, 2000, effective Sept. 1, 2000), available at gov.cn (last visited Oct. 23, 2011). They are subordinate to the legislation enacted by the National People’s Congress (NPC), the supreme legislative organ of P.R. China, and by its Standing Committee, but have priority over departmental rules issued by central government ministries and agencies, and over local regulations issued by provincial and municipal people’s congresses and their standing committees. 3 Rules on the Handling of Medical Accidents, (promulgated by the State Council, June 29, 1987) [hereinafter Medical Accident Rules 1987]. 4 Dui chuli yiliao shigu de guiding [Regulations on Handling Medical Accidents] (promulgated by the St. Council, Apr. 4, 2002, effective Sept. 1, 2002), available at gov.cn (last visited Oct. 23, 2011) [hereinafter Medical Accident Regulations 2002]. 5 The SPC is P.R. China’s highest court. In addition to its role as P.R. China’s final court of appeal, the SPC also has the power to issue quasi-legislative “judicial interpretations” on specific issues concerning the application of law in the adjudicative work of the people’s courts. Depending on the circumstances, judicial interpretations are issued as an “interpretation,” “provision,” “reply,” or “decision.” See Zui gao ren min fa yuan guan yu si fa jie shi gong zuo de gui ding [Provisions of the Supreme People’s Court on its Work Relating to Judicial Interpretations] art. 6 (promulgated Mar. 23, 2007, effective Apr. 1, 2007), available at http://www.eastlaw.net/chineselaws/judicial/JudicialInterpretation2007.htm (last visited Oct. 26, 2011). Such rulings have played a vital role in the area of compensation for medical injuries (and indeed in compensation for personal injury generally). See infra Part III. P.R. China’s lower courts include people’s courts at various local levels: basic people’s courts, intermediate people’s courts, and higher people’s courts. See. Zhong hua ren min gong he guo ren min fa yuan zu zhi fa [Organization Law of the People’s Courts of the People’s Republic of China] (adopted by the Nat’l People’s Cong., Jul. 1, 1979, revised Sept. 2, 1983, Dec. 2, 1986, and Oct. 31, 2006), available at http://www.china.org.cn/china/ LegislationsForm2001-2010/2011-02/12/content_21907420.htm (last visited Oct. 26, 2011). 6 An aggrieved party is entitled to proceed in tort even where the conduct complained of is both a tort and a breach of contract. Zhong hua ren min gong he guo he tong fa [Contract Law of the People’s Republic of China] art. 122 (adopted by the Nat’l People’s Cong., Mar. 15, 1999, effective Oct. 1, 1999), available at http://en.chinacourt.org/public/detail.php?id=97 (last visited Oct. 24, 2011). In practice, claims for medical injuries under general civil law are normally brought on the basis of tort rather than contractual liability. 7 Xing tian ren zhong hua ren min gong he guo de min shi fa lu de yi ban yuan ze [General Principles of the Civil Law of the People’s Republic of China] (adopted by the Nat’l People’s Cong.,

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Liability Law (TLL) in 2009, taking effect on July 1, 2010, arguably marks a step backwards, subordinating the interests of patients in favor of the interests of the medical community. A second backwards step, through the prospective enactment of additional rules relating to liability for medical malpractice that further advantage healthcare providers, may also be anticipated in the future. The sideways steps of Yangge Dance – first to the right, then to the left – may be taken to refer to the constant interplay (at least since 1992) between the two concurrent systems of liability for medical malpractice – one administrative, broadly favoring the interests of the medical community, and the other tortious, broadly favoring the interests of patients. To compare the two liability regimes (administrative and tortious), and to show their development over time, the analysis below addresses four common dimensions of the parallel systems, namely, the basis of the cause of action, the burden of proof, the process of (technical or judicial) “identification”8 used to establish that a compensable medical injury has been suffered, and the assessment of damages.

I.

The Wider Healthcare Context9

P.R. China was founded in 1949. In the early years of the Communist regime, healthcare – and social welfare provision in general – was organized on a commune or workplace basis, with free basic healthcare for all. All medical facilities were publicly owned and operated; doctors were

Apr. 12, 1986, effective Jan. 1, 1987), available at http://en.chinacourt.org/public/detail. php?id=2696 (last visited Oct. 24, 2011) [hereinafter GPCL]. The GPCL was the first legislation in P.R. China to deal comprehensively with general civil law, including the law of tort (which was addressed in Section 3 of Chapter 6). For an English translation, see Whitmore Grey & Henry Ruiheng Zheng, General Principles of Civil Law of the People’s Republic of China, 34 Am. J. Comp. L. 715 (1986). For analysis in English of its tort law provisions, see Lin Ye, The Tort System in China, 52 L. & Contemp. Probs. 143 (Xiaoming Li & Henry Pitney, trans. 1989); Kui-Hua Wang & Danuta Mendelson, An Overview of Liability and Compensation for Personal Injury in China under the General Principles of Civil Law, 4 Torts L.J. 137 (1996) (Austl.). 8 Also translated as “authentication” by some authors. See, e.g., Ding, supra note 1, passim; Xi & Yang, supra note 1, passim. 9 For general accounts in English, see David Blumenthal & William Hsiao, Privatization and Its Discontents – The Evolving Chinese Health Care System, 353 New Eng. J. Med. 1165 (2005); Sarah L Barber & Lan Yao, Health Insurance Systems in China: A briefing note, World Health Report (2010), Background Paper No. 37 (2010), available at http://www.who.int/ healthsystems/topics/financing/healthreport/37ChinaB_YFINAL.pdf (last visited Oct. 3, 2011); R.E. Ling et al., Emerging Issues in Public Health: A Perspective on China’s Healthcare System, 125 Pub. Health 9 (2011).

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employees of the State; there was no private medicine. The system achieved significant success against a range of health indicators (e.g., life expectancy, infant mortality), with its performance matching or exceeding that of many countries with superior economic resources.10 With the reform and opening-up policy adopted in 1978,11 the commune system was dismantled as private enterprise was encouraged. Many stateowned enterprises closed. The social safety net the communes and publicsector employment provided was abruptly swept away. The proportion of the population covered by health insurance declined sharply. Though some doctors (especially doctors in rural areas and practitioners of traditional Chinese medicine) began to practice privately, most healthcare facilities remained under state ownership. But user fees were introduced even for public healthcare and providers were generally encouraged to operate as businesses.12 Substantial disparities arose in the quality of care provided, reflecting widely divergent levels of investment. The resultant problems were particularly acute in rural areas.13 Since 1997, China has striven to address inequalities in healthcare provision with successive reform programs supported by significant investment.14 The voluntary medical insurance schemes previously applying to urban workers and rural residents have been replaced, and contributions are now subsidized to a significant degree by central and local government. A medical assistance program (Medicare) has been introduced for the poor. A network of community health centers, dependent on State financing rather than user fees, has been created. Efforts have been made to address skill shortages – in particular, in remote areas and in primary care – through education and training. New initiatives have sought to secure the maintenance of appropriate quality standards, with an empha-

10 11

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Blumenthal & Hsiao, supra note 9, at 1166. On the reform and opening-up, and in particular their impact on the role of law in P.R. China, see Stanley B. Lubman, Bird in a Cage: Legal Reform in China After Mao ch. 5 (1999). Qingyue Meng and Shenglan Tang, Universal Coverage of Health Care in China: Challenges and Opportunities, World Health Report (2010), Background Paper No. 7 para. 3.2 (2010), available at http://www.who.int/healthsystems/topics/financing/healthreport/7ChinaM_T.pdf (last visited Oct. 3, 2011). See Adam Wagstaff et al., The Int’l Bank for Reconstruction & Dev./The World Bank, Reforming China’s Rural Health System (2009), available at http://siteresources.worldbank.org/CHINAEXTN/Resources/318949-1248160372290/rural_health_full_report_en.pdf (last visited Oct. 3, 2011). For general accounts in English, see Shenglan Tang et al., Tackling the Challenges to Health Equity in China, 372 Lancet 1493 (2008); Shanlian Hu et al., Reform of How Health Care is Paid for in China: Challenges and Opportunities, 372 Lancet 1846 (2008).

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sis on better record keeping and the reporting of adverse events15 to supplement the traditional forms of government oversight (licensing and accreditation of practitioners and facilities, approval of drugs, etc.). The “Health China” initiative adopted in 2009 aspires to universal basic healthcare coverage by 2020.16 Problems remain, however. China’s health system performs unevenly, doing well on some indicators and poorly on others.17 Three underlying problems in particular have proved hard to solve, notwithstanding the increased investment: (1) high levels of out-ofpocket expenditure on medicines and medical services, including a high proportion of catastrophic expenditure (i.e., more than 30 percent of income), with potentially devastating effects on those affected;18 (2) a geographical imbalance in healthcare spending, with greater expenditure on urban as compared with rural areas; and (3) the commercialization of healthcare without adequate attention to cost control, which has led to escalation of prices and decreased efficiency.19 According to World Health Organization statistics, China’s total expenditure on health as a percentage of gross domestic product was 4.3 % in 2007 (as compared with a global average of 9.7 %, and 15.7 % and 8.8 % for the United States and European Region respectively).20 Of the total, 44.7 %

15

16

17 18

19 20

The Medical Accident Regulations 2002 impose a reporting obligation on medical workers who, in the course of their medical activities, cause or discover a medical accident, or medical fault that might result in a medical accident; such reports are investigated internally and entail an obligation to inform and provide an appropriate explanation to the patient concerned. Yi liao shi gu chu li tiao li [Regulations on Handling Medical Accidents] art. 13 (promulgated by the St. Council, Feb. 20, 2002, effective Sept. 1, 2002), available at http://www.gov.cn/english/laws/2005-07/25/content_16885.htm (last visited Oct. 25, 2011). Where a medical accident actually occurs, the medical institution is also obliged to report it to the health administration. Id. at art. 14. By Article 10, item 9 of the Government Information Publicity Regulations, the government has an obligation to make such information available to the public. Zheng fu xin xi gong kai tiao li [Regulation on Open Government Information] (promulgated by the St. Council, Apr. 24, 2007, effective May 1, 2008), available at http://www.law.yale.edu/ documents/pdf/Intellectual_Life/Ch_OGI_Regualtions_Eng_Final_051607.pdf (last visited Oct. 25, 2011). Communist Party of China Central Committee and State Council, Opinions of the CPC Central Committee and State Council on Deepening the Health Care System Reform (Mar. 17, 2009), available at http://www.china.org.cn/government/scio-press-conferences/200904/09/content_17575378.htm (last visited Oct. 3, 2011). Yuanli Liu et al., China’s Health System Performance, 372 Lancet 1914 (2008). As exemplified by the “Harbin scandal” of 2005, in which the family of an elderly patient hospitalized in an intensive care unit for over two months were required to pay in excess of RMB 6 million (approx. US$ 660,000). See Edwin C. Hui, The Contemporary Healthcare Crisis in China and the Role of Medical Professionalism, 35 J. Med. Philos. 477, 479– 80 (2010). Ling et al., supra note 9. World Health Organization, World Health Statistics 2010 127–39 tbl. 7 (2010), available at http://www.who.int/whosis/whostat/EN_WHS10_Full.pdf.

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was general government expenditure and 55.3 % private expenditure. General government expenditure on health was 9.9 % of total government expenditure.21 Reflecting the high levels of direct (out-of-pocket) payment for medicines and medical services, noted above, only 7.1 % of private expenditure on health was on private prepaid plans.22 Per capita total expenditure on health was equivalent to just USD $ 43, far below not just Europe and the United States (USD $ 2,035 and USD $ 7,285 respectively) but also the global average of USD $ 802. Just to give these figures is to make clear the nature of the challenge facing Chinese healthcare in the coming years.

II.

The Early P.R. China: Medical Services as Social Welfare (1949–1987)

As detailed above, medical services were treated as a matter of social welfare in the early years of P.R. China after its foundation in 1949. There was no legislation on liability or compensation for medical malpractice,23 and disputes were normally settled on an informal basis within the administrative framework. As early as 1953, the central government investigated and reported improper acts on the part of medical institutions and person-

21 22

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Id. at 130. Global average: 15.4 %; United States: 19.5 %; Europe Region: 15.3 %. Id. at 136, 138. Id. at 131. Global average: 45.0 %; United States: 63.5 %; Europe Region: 24.3 %. Id. at 137, 139. In considering the interaction between health insurance and the liability system, it is material to note that an insurer who pays insurance moneys to an injured insured has no right to recover those sums from the third party who caused the injury, though the latter’s liability to the insured is unaffected. Zhong hua ren min gong he guo bao xian fa [Insurance Law of the People’s Republic of China] art. 46 (promulgated by the Standing Comm. Nat’l People’s Cong., Jun. 30, 1995, amended Oct. 28, 2002 and Feb. 28, 2009), available at http://www.china.org.cn/english/DAT/214788.htm (last visited Oct. 25, 2011). All laws dating from before 1949 were repealed on the foundation of P.R. China. Although there were periodic attempts thereafter to legislate a civil code, none has yet been successful, though a first concrete step was taken in that direction with the enactment of the GPCL in 1986. See GPCL, supra note 7. The enactment of a Tort Liability Law in 2009, following the Contract Law of 1999 and Property Law of 2007, can be seen as a further step towards a complete civil code. See Qin quan ze ren fa di zhong guo ren min gong huo guo, [Tort Law of the People’s Republic of China] (promulgated by the Standing Comm. Nat’l People’s Cong., Dec. 26, 2009, effective Jul. 1, 2010); Zhong hua ren min gong he guo he tong fa [Contract Law of the People’s Republic of China] (promulgated by the Standing Comm. Nat’l People’s Cong., Mar. 15, 1999, effective October 1, 1999), available at http://en.chinacourt.org/public/detail.php?id=97 (last visited Oct. 25, 2011); Zhong hua ren min gong he guo wu quan fa [Property Law of the People’s Republic of China] (promulgated by the Standing Comm. Nat’l People’s Cong., Mar. 13, 2007, effective Oct. 1, 2007) available at http://www.china.org.cn/china/LegislationsForm2001-2010/201102/11/content_21897791.htm (last visited Oct. 25, 2011).

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nel; these acts included serious accidents that caused death or deterioration of patients’ conditions as a result of negligence on the part of hospitals and major fault in nursing.24 At that time, judges believed dispute settlement through mediation served judicial policy better than litigation, and declined to impose civil liability.25 A Reply by the Supreme People’s Court, dated January 18, 1964, states: In dealing with medical accidents, the court should not award economic compensation, but may seek other types of remedy for patients who suffer death or disability or loss of income as a result of medical accidents. Therefore, you may advise the department of public health of your province to seek remedies through joint efforts with labor, personnel and civil administration departments, and execute them.26 Few claims of medical malpractice were litigated at this time, and little attention was given to compensation for harm caused by medical treatment. In 1978, the Central Committee of the Communist Party of China (CPC) adopted a policy of reform and opening-up, and China began a transformation from a planned to a market economy. As Chinese society underwent a remarkable change, the foundations of the established medical system began to shake (as detailed above). With the progress of medical reform, more medical disputes arose, requiring the improvement of relevant legal mechanisms. But, generally speaking, most workers still enjoyed free medical services at this time, and medical institutions remained part of the social welfare system, funded by government, and it seems from the very few civil cases discussed in the secondary literature at this time (in contrast with the number of criminal cases discussed there) that few disputes actually went to court. In practice, the main focus as

24

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Zhong Yang Ren Min Zheng Fu Zheng Wu Yuan Guan Yu Zheng Wu Yuan Ren Min Jian Cha Wei Yuan Hui Guan Yu Chu Li Ruo Gan Yuan Zhong De Yi Liao Shi Gu He Yi Wu Ren Yuan Bu Liang Zuo Feng An Jian De Tong Bao, Shan Xi Zheng Bao 1954 nian di 10 qi, di 70–72 ye. (《中央人民政 府政务院关于政务院人民监察委员会关于处理若干院中的医疗事故和医务人员不良作风 案件的通报》，《山西政报》1954 年第 10 期，第 70－72页。) [A Circular on Dealing with Medical Accidents in Hospitals and Improper Acts of Medical Personnel by the Supervisory Commission of Government Administration Council of the Central People’s Government, 10 Shanxi Pol. J. 70, 70–72 (1954)]. Xie Guisheng (谢桂生), Cong Yi Jian Yi Liao Shi Gu An Jian de Chu Li Kan Shen Pan Si Xiang ， Fa Xue 1985 nian di 9 qi, di 26–28 ye.(《从一件医疗事故案件的处理看审判思想》) (法学》 1958 年第 9 期，第 26－28 页。) [A Study on Trial Thoughts Through the Judgment of A Medical Accident, 9 Legal Sci. 26, 26–28 (1958)]. Zui Gao Ren Min Fa Yuan Guan Yu Chu Li Yi Liao Shi Gu An Jian Bu Ying Pan Gei Jing Ji Bu Chang Wen Ti De Pi Fu, 1964 nian 1 yue 18 ri. (《最高人民法院关于处理医疗事故案件不应判 给经济补偿问题的批复》（1964 年 1 月 18 日）) [Reply by the Sup. People’s Ct. as to Not Granting Economic Compensation in Medical Accidents (Sup. People’s Ct. 1964)].

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regards medical malpractice was on criminal liability, even though the then-effective Criminal Law, promulgated by the National People’s Congress in 1979, did not criminalize medical malpractice as such.27 Doctors were charged with various crimes of general application, such as negligent killing, negligently causing a serious accident, or neglect of duty, or sometimes with crimes specifically relating to medical malpractice (e.g., negligently causing a serious medical accident or criminal medical fault) without any express basis in the legislative text.28 Shortly after the enactment of the 1979 Criminal Law,29 scholars began to suggest that medical malpractice should itself be recognized as a crime.30 This controversial issue was finally settled in 1997 when Article 335 of the newly amended Criminal Law established a crime of serious medical malpractice resulting in death or serious harm: “[m]edical personnel whose serious failure to carry out their responsibility causes the death of a patient or serious harm to a patient’s health shall be sentenced to not more than three years of fixed-term imprisonment or criminal detention.”31 It should be noted that Chinese law allows a person injured by a criminal act to recover compensation through the criminal courts. Under the Criminal Procedure Law,32 if a victim has suffered material losses as a result of the defendant’s criminal act, he has the right to file an “incidental civil action” during the course of the criminal proceeding.33 The incidental civil action is generally heard together with the criminal trial, but may

27 28

29 30

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Criminal Law of the People’s Republic of China (promulgated by the Second Session of the Fifth Nat’l People’s Cong, July 1, 1979) [hereinafter 1979 Criminal Law]. Chan Zhang, (张赞宁), Yi Liao Shi Gu Xing Shi An Jian Liu Shi Si Li Fa Li Pou Xi, Fa Lv Yu Yi Xue Za Zhi 1994 nian di 2 qi, di 74 ye. (《医疗事故刑事案件 64 例法理剖析》，《法律与医 学杂志》 1994年第 2 期，第 74 页。) [An Analysis of 64 Criminal Cases of Medical Accidents, 2 L. & Med. 74 (1994)]. 1979 Criminal Law, supra note 27. Wu Shimin, (吴仕民), Zhong Da Yi Liao Shi Gu Ru He Ding Zui, Xian Dai Fa Xue 1982 nian di 1 qi, di 30–31 ye. (,《重大医疗事故如何定罪?》，《现代法学》1982 年第 1 期，第30－31 页。) [How to Establish Criminal Liability for Serious Medical Accidents, 1 Mod. Sci. of L. 30, 30– 31 (1982)]; Wang Xiaojuan & Chen Haibo, (王晓娟、陈海波), Guan Yu Ren Ding Yi Liao Shi Gu Fan Zui de Ji Ge Wen Ti, Fa Zhi Cong Lun 1992 nian di yi qi, di 42–46 ye. (《关于认定医疗事 故犯罪的几个问题》，《法治论丛》 1992 年第 1 期，第42－46页。) [Several Problems Concerning the Establishment of Medical Accidents, 1 Collection of Papers on Rule of Law 42, 42– 46 (1992)]; Hou Guoyun(侯国云), You Guan Yi Liao Shi Gu Zui de Ji Ge Wen Ti，Zhong Guo Wei Sheng Fa Zhi 1995 nian di 2 qi, di 7–10 ye.（《有关医疗事故罪的几个问题》，《中国卫 生法制》 1995 年第 2 期，第 7－10 页。) [Guoyun Hou, Several Questions on Convictions in Respect of Medical Accidents, 2 Rule of Law in China’s Pub. Health, 7–10 (1995)]. Criminal Law of the People’s Republic of China (promulgated by the Nat’l People’s Cong., Mar. 14, 1997) [hereinafter 1997 Criminal Law]. Criminal Procedure Law of the People’s Republic of China (promulgated by the Nat’l People’s Cong., July 1, 1979, amended Mar. 17, 1996). Id. at art. 77 para. 1.

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be continued after the criminal trial has ended if necessary to prevent it being excessively delayed.34 So far as can be ascertained, however, criminal prosecutions of doctors are rare.

III. The Administrative Liability Regime A national regime of administrative liability for medical accidents was established by the Medical Accident Rules of 1987,35 and reformed by the Medical Accident Regulations of 2002. Both enactments were administrative regulations drafted by the Ministry of Health and promulgated by the central government (State Council), and were applicable to both public and private healthcare.

A.

The Medical Accident Rules 1987

1.

Context

The Medical Accident Rules 1987 were enacted when the provision of free medical services, including medical treatment by a healthcare institution, was part of social welfare policy. Most hospitals were still state-owned at the time. As a result, it was thought desirable to place a strict limit on the liability of medical institutions that did harm to their patients when performing medical treatment. The 1987 Rules created a formal system of administrative liability in cases of medical accident in which claims for compensation were submitted in the first instance to the health administration (for adjudication or mediation), with the option of a new hearing before a court if either party was unsatisfied with the outcome.36 In hearing such a claim, the court would apply the 1987 Rules rather than the ordinary principles of tortious liability. The enactment of the Rules immediately after the GPCL strongly suggests that their intention was to exclude the GPCL’s application to medical accidents so as to limit the circumstances giving rise to liability and the amount of compensation to be paid when liability was established.

34 35 36

Id. at art. 78. The 1987 Rules were preceded by local administrative regulations adopted in Shanghai and Shanxi Province in 1985. See Ding, supra note 1, at 70–71, 78–80. Rules on the Handling of Medical Accidents art. 11 (promulgated by the St. Council, June 29, 1987) [hereinafter Medical Accidents Rules 1987].

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2.

Main Features of the Administrative Liability Regime, 1987–2002

a. Basis of the Cause of Action. Under the Rules, the basic component of the cause of action was a dispute about compensation for harm caused by a medical accident.37 The term “medical accident” referred to a situation where the patient suffered death, disability, or organ damage resulting in dysfunction, as a direct result of fault in diagnosis, medical treatment, or nursing on the part of medical personnel.38 Medical accidents included “malpractice accidents” and “technical accidents.” A medical malpractice accident was an accident caused by medical personnel due to a breach of duty as a result of the violation of rules or regulations, or of procedures for diagnosis, cure or nursing. A technical medical accident was an accident caused by medical personnel due to negligent treatment not involving the violation of any such rule or procedure. Accidents involving malpractice were regarded as more serious than those involving mere negligence in treatment,39 with administrative sanctions (e.g., dismissal, demotion or warning) attaching to the responsible personnel, while such sanctions applied to technical accidents only where a seriousness threshold was crossed, and even then the sanctions applied were less severe.40

b. Burden of Proof. Under the Rules of 1987, the burden of proof lay on the patient. The Rules required that, when a medical accident (or an incident which might later be recognized as a medical accident) occurred, the medical institution should assign a specific person to properly keep such original materials as were relevant.41 In reality, however, it was possible for the medical institution to alter, forge, conceal, or even destroy the original materials. Consequently, it seems to have been difficult for patients – who were further disadvantaged by their own lack of medical knowledge – to satisfy the burden of proof lying on them. So they had to apply for “technical identification” (see below), which itself tended to favor the hospital.42

37 38 39 40 41 42

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As affirmed by the Regulation on Causes of Action for Civil Cases (for Trial Implementation) (promulgated by the SPC, effective Jan. 1, 2001). Medical Accident Rules 1987, supra note 36, at art. 2. Id. at art. 5. Id. at arts. 20, 21. Id. at art. 8. Yang Lixin (杨立新), Yi Liao Qin Quan Yu Fa Lv Shi Yong, Fa Lv Chu Ban She 2008 nian ban, di 4 ye. (《医疗侵权法律与适用》，法律出版社2008年版，第4页。) [The Law and Its Application for Medical Torts 4 (2008)].

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c. The Identification Process. A central feature of the administrative liability regime established by the 1987 Rules was the process of “technical identification.” This was the procedure by which a committee of medical experts, selected by the health administration (i.e., the responsible provincial, regional or municipal department of health),43 would investigate the circumstances giving rise to a claim and report their conclusions to the appropriate tribunal. A decision of a local committee could be appealed to a higher level (e.g., a provincial committee) but the outcome of the process was in practice binding on the tribunal (whether the health administration or a court), except to the extent that the court could remit the case to be reviewed either by the original committee or a higher-level committee. Technical identification could be carried out at the level of the province, city, county or municipal district;44 there was no nationwide organization undertaking the process. Since most hospitals were still state-owned at the time, technical identification organized by the local health administration was just a case of (in the common parlance) “making the father the judge of the son.” Hospitals were favored with the excuse that medical malpractice did not amount to a “medical accident” but merely a “medical error” giving rise to no liability to pay compensation. d. Assessment of Damages. Where an occurrence was identified as a medical accident, the patient was to be awarded a lump sum payment of compensation according to the accident’s grade of severity on a scale of 1–3 (see below), its circumstances and the patient’s pre-existing condition. The Rules provided that the level of compensation should be formulated by the provincial, regional or municipal government in whose area the accident occurred.45 The sums awarded were small, and reflected the grade of the accident rather than the loss actually suffered by the patient. As an example, we may consider the levels of compensation prescribed in Tianjin, a municipality directly under the central government near Beijing:46 Grade I medical accidents (causing death): compensation in the range of RMB 3,000 to 4,000;47 compensation for infants under the age of three was RMB 1,000; compensation for neonates was RMB 700. 43 44 45 46 47

Medical Accident Rules 1987, supra note 36, at art. 11. Id. at art. 12. Id. at art. 18. Detailed Rules on the Implementation of the Regulations on Handling Medical Accidents in Tianjin art. 19 (1988). In 1988, the exchange rate for the US dollar: Chinese Renminbi (or yuan) was USD 1: RMB 3.712. U.S. Dep’t Treasury, Fin. Mgmt. Serv.,Treasury Reporting Rates of Exchange (1988–1991) 3 (1991).

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Grade II medical accidents (causing serious disability or severe dysfunction): RMB 3,000 to 5,000. Grade III medical accidents (causing disability or dysfunction): RMB 2,000 to 3,000; compensation for infants under the age of three was RMB 700; compensation for neonates was RMB 500. These compensation levels were actually very low even when they were introduced (1988), and they did not change in the fourteen years until the enactment of a new set of Regulations in 2002.

B.

The Medical Accident Regulations 200248

1.

Context

A new set of administrative regulations replaced the previously enacted rules in 2002, though they maintained the basic features of the previous regime, at least in broad outline. The Medical Accident Regulations 2002 were intended to respond to widespread criticism of the strict limits on liability in the previous regime and they may thus be considered to have made some progress towards the better protection of patients’ interests. However, there was still a big gap between the medical and legal community’s estimations of the proper extent of liability.

2.

Main Features of the Administrative Liability Regime, 2002 onwards

a. Basis of the Cause of Action. The 2002 Regulations defined “medical accident” as an accident caused by a medical institution or its medical personnel resulting in personal injuries to a patient due to negligence in medical activities as a result of the violation of laws, administrative regulations or departmental rules on medical and health administration, or of standards or procedures for diagnosis, cure and nursing.49 Compared with the Rules of 1987, the new Regulations expanded the scope of medical accident in two aspects. First, harm was no longer limited to

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For analysis in English, see Dean M. Harris & Chien-Chang Wu, Medical Malpractice in the People’s Republic of China: The 2002 Regulation on the Handling of Medical Accidents, 33 J.L. Med. & Ethics 456 (2005). Regulations on Handling of Medical Accidents art. 2 (promulgated by the St. Council, Apr. 4, 2002, effective Sept. 1, 2002) [hereinafter Medical Accident Regulations 2002].

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death, disability or functional dysfunction: any physical injury caused by negligent medical treatment was covered. Four grades of accident were now recognized (instead of the previous three): death and serious disability (Grade I); moderate disability (Grade II); mild disability (Grade III); and other obvious injury (Grade IV).50 Second, causality was no longer limited to direct causation: indirect causation was also included.

b. Burden of Proof. Though the burden of proof was still on the patient, the 2002 Regulations imposed a more onerous recordkeeping obligation on medical institutions, who were to compile and properly preserve medical records as required by the health administration department of the State Council. In the case of emergency treatment to save the patient’s life, where timely record keeping might not be possible, the medical person concerned had an obligation to update the record within six hours of the treatment being given.51 Alteration, forgery, concealment, destruction, and seizure of medical records were strictly forbidden,52 on penalty of administrative or disciplinary sanction or, in prescribed circumstances, criminal punishment.53 Patients were entitled to a copy of their record on request.54

c. Technical Identification. There were two significant changes as regards the process of technical identification.55 First, the responsibility for organizing the process was shifted from the health administration to the medical associations (i.e., the professional bodies representing healthcare practitioners). In the 1987 Rules, the technical identification was organized by the health administration itself, which was also the administrative authority of the hospital that was being sued, and this created a very obvious conflict of interests. To address this unsatisfactory situation, the 50 51 52 53 54 55

Id. at art. 4. Id. at art. 8. Id. at art. 9. Id. at arts 58–59. Id. at art. 10. In departmental rules issued shortly after the Medical Accident Regulations 2002, the aim of technical identification was described as being to reach a conclusion as to the following issues (amongst others): (1) whether the medical treatment violated a law, administrative regulation or departmental rule or the applicable standards and procedures for diagnosis, cure or nursing; (2) the causal relationship between the medical fault (if any) and the personal injury; (3) the extent of responsibility to be attributed to the medical fault for causing injury in the medical accident; and (4) the grade of severity of the medical accident. See Temporary Rules on Technical Identification of Medical Accidents (coming into force on Sept. 1, 2002), at item 4–7, para. 1, arts. 35–36.

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2002 Regulations required the health administration department concerned to forward any report of serious medical fault from a medical institution, and every application to settle a medical accident dispute from a party to it, to the responsible medical association for the purposes of organizing the necessary technical identification.56 Second, technical identification at a national level became available. In addition to the technical identifications organized by local medical associations, the 2002 Regulations provided for the Chinese Medical Association57 to organize technical identification of difficult and complicated medical accident disputes having significant national importance.58 In spite of these major changes, the new system attracted criticism because the medical associations had such close links with the health administration. Though formally independent, in reality the medical associations perform a semi-official role and are closely linked with and dependent upon government at all levels, with leading positions in them being taken by leaders of health administration departments. Consequently, the new identification system was perceived to involve medical institutions “shielding” one another, and still tended to protect hospitals from liability.59

d. Assessment of Damages. In contrast with the 1987 Rules, which left the amount of compensation payable for each grade of medical accident to be determined by provincial, regional or municipal administrative rules, the 2002 Regulations treated the loss suffered by the patient – rather than the grade of the accident – as decisive, and stipulated in some detail the heads of loss in respect of which compensation would be awarded. Eleven items were listed: (1) medical expenses; (2) loss of income (subject to a cap of three times annual earnings in the place the medical accident occurred); (3) a food allowance during hospitalization; (4) expenses incurred looking after the patient; (5) a living allowance in the event of disability; (6) a disability allowance for the purchase of appliances; (7) funeral expenses; (8) the living expenses of a dependent; (9) a traffic allowance; (10) a lodging allowance; and (11) a solatium for emotional harm, capped by

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Medical Accident Regulations 2002, supra note 49, at art. 20. See Chinese Med. Ass’n, About the CMA, http://www.cma.org.cn/ensite/. Medical Accident Regulations 2002, supra note 49, at art. 21. See Xi & Yang, supra note 1, at 70–71 (citing evidence from a number of local surveys to report that the percentage of medical accident claims upheld by identification panels under the 2002 Regulations was in many places less than 10 percent).

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reference to annual living expenses in the place of the accident.60 Conspicuous because of its absence from this list is compensation for death itself, in contrast with the ordinary rules of tortious liability where such compensation is expressly allowed (in addition to compensation for the living expenses of dependents and a solatium for emotional harm resulting from the bereavement).61 This is the principal reason why the legal community has taken comprehensive measures to sideline the Medical Accident Regulations 2002 when proceedings are brought in court. A significant feature of the administrative liability scheme as amended in 2002 was the requirement to apportion liability to reflect not only the grade of the accident but also both the extent of responsibility to be attributed to the medical fault and the role played by the patient’s underlying condition.62 For example, where a fifty-one-year-old man was treated in hospital for an abdominal injury and died, the main cause of death being the hospital’s medical mistakes, and a contributing cause being the man’s previous liver problems, this constituted a Grade I medical accident where the hospital had to bear the main responsibility, but, taking account of the patient’s pre-surgery medical conditions, the defendant’s liability was determined to be only 80 percent.63

IV. The Tort Liability Regime A.

Recourse to the General Principles of Civil Liability

Responding to dissatisfaction about the low levels of compensation paid under the administrative liability regime (at that time governed by the Rules of 1987), the SPC began unobtrusively to allow injured patients access to higher compensation awards by recognizing their ability to bring their claim on the basis of tortious liability arising under the GPCL; if

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Medical Accident Regulations 2002, supra note 49, at art. 50. The solatium for emotional harm is calculated by reference to annual average living expenses in the place where the medical accident occurs. In the case of death, a maximum of six times the annual amount may be paid; in the case of non-fatal disability, the maximum is three times the annual amount. See id. at art. 50(11). See infra Part V(IV).B.4. Medical Accident Regulations 2002, supra note 49, at art. 49. [Yang v Unnamed County Hospital] (People’s Court of Sheyang County, Jiangsu Province May 19 2006). The authors are very grateful to Benjamin Liebman for pointing them towards this decision and providing them an English translation.

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successful, the compensation would be calculated under the more generous damages rules of the GPCL rather than those of the administrative liability regime. In a formal Reply to the High Court of Tianjin in 1992, the SPC stated that the local court could properly handle medical accident cases in accordance with either the relevant provisions of the GPCL, or the State Council’s Medical Accident Regulations (combined with the local rules implementing the Regulations), according to the specific conditions of the case.64 The SPC’s Reply thus allowed the court in Tianjin to make a compensatory award under the GPCL that was much higher than would have been possible under the administrative liability regime. Even though the medical community insisted that the GPCL should not be applied so indiscriminatingly that it came to replace the administrative regime,65 the courts began to show a preference for the GPCL from this time on. This move towards tort liability was consolidated in 2003 – just one year after the administrative liability regime was reformed – when the SPC issued a Notice on the Trial of Civil Cases Involving Medical Disputes with Reference to the Medical Accident Regulations, which explicitly established a dual system of liability for medical malpractice.66 The relationship of the two liability regimes to each other, and the differences between them, may now be considered with reference to the four criteria proposed above: the cause of action, the burden of proof, the identification process, and the assessment of damages.

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Zui Gao Ren MinFa Yuan Guan Yu Li Xinrong Su Tian Jin shi di’er Yi Xue Yuan Fu Shu Yi Yuan Yi Liao Shi Gu Pei Chang Yi An Ru He Shi Yong Fa lv Wen Ti de Fu Han, 1992 nian 3 yue 24 ri. (《最 高人民法院关于李新荣诉天津市第二医学院附属医院医疗事故赔偿一案如何适用法律问 题的复函》（1992 年 3 月 24 日）) [Reply of Supreme People’s Court to the Question of How to Apply Laws of the Medical Accident Compensation Case “Li Xinrong vs. Tianjin Second Medical College Subsidiary Hospital” (Mar. 24, 1992)]. Hu Xiaoxiang(胡晓翔), Zai Lun Dui “Yi Liao Shi Gu Chu Li Ban Fa” de Ping Jia – Bu Ke Lan Yong “Min Fa Tong Ze”, Zhong Guo Wei Sheng Shi Ye Guan Li 1998 nian di 7 qi, di 364–367 ye. (再 论对《医疗事故处理办法》的评价──不可滥用《民法通则》，《中国卫生事业管理》 1998 年第 7 期，第 364－367 页。) [Xiaoxiang Hu, Reevaluation of Medical Accident Rules 1987 – GPCL Should Not Be Applied Indiscriminatingly, 7 Admin. of Pub. Health China, 364–367 (1998)]. Zui Gao Ren Min Fa Yuan “Guan Yu Can Zhao ‘Yi Liao Shi Gu Chu Li Tiao Li’ Shen Li Yi Liao Jiu Fen Min Shi An Jian de Tong Zhi,”, 2003 nian 1 yue 6 ri, fa [2003] 20 hao. (最高人民法院《关于 参照审理医疗纠纷民事案件的通知》，2003 年 1 月 6 日，法[2003] 20号) [Notice of the Supreme People’s Court on “The Trial of Civil Cases Involving Medical Disputes with Reference to the ‘Medical Accident Regulations’”] Jan. 6, 2003 [hereinafter SPC Notice on the Medical Accident Regulations].

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B.

Elements of the Tort Liability Regime

1.

Cause of Action

The SPC Notice provided that, where a lawsuit is brought before any court67 regarding a dispute over compensation for medical malpractice which occurred after the 2002 Regulations came into force, it is to be resolved by referring to the relevant provisions in the Regulations; for disputes over compensation for patient injury attributed to factors other than medical malpractice, the provisions of the GPCL apply.68 Thus, if a patient sued the hospital on the basis of a medical accident, the court would decide the case under the administrative liability regime. If the patient chose to sue the hospital on the basis of fault sufficient to establish ordinary civil liability (commonly termed “medical fault,” though the GPCL laid down no special rule for fault in a medical context), the court would decide the case according to the GPCL and, most importantly, would calculate the damages according to the SPC Interpretation dealing with compensation for personal injury in civil cases.69 We consider below the huge difference this made to the quantum of compensation. In practice, the courts allowed patients the freedom to sue hospitals on the basis of medical fault rather than medical accident, and most patients chose to proceed on this basis in view of the advantages of the tort liability regime.

2.

Burden of Proof

Though the burden of proof in civil litigation normally lies on the plaintiff, in 2002 a Judicial Interpretation of the SPC introduced a reversal in the burden of proving causation and fault in claims alleging medical

67 68 69

Cases for medical malpractice are usually brought in a basic people’s court or intermediate people’s court. SPC Notice on the Medical Accident Regulations, supra note 66, §I para. 1. “Zui Gao Ren Min Fa Yuan Guan Yu Shen Li Ren Shen Sun Hai Pei Chang An Jian Shi Yong Fa lv Ruo Gan Wen Ti de Jie Shi,” 2003 nian 12 yue 4 ri You Zui Gao Ren Min Fa Yuan Shen Pan Wei Yuan Hui di 1299 ci Hui Yi Tong Guo, Zi 2004 nian 5 yue 1 ri Shi Xing. (《最高人民法院关于审 理人身损害赔偿案件适用法律若干问题的解释》，2003 年 12 月 4 日由最高人民法院审 判委员会第1299次会议通过，自 2004 年 5 月 1 日起施行。) [“Interpretation of the Supreme People’s Court of Some Issues Concerning the Application of the Law on the Trial of Cases to Compensation for Personal Injury,” adopted at the 1,299th meeting of the Judicial Committee of the Supreme People’s Court on Dec. 4, 2003, coming into force on May 1, 2004] Dec. 26, 2003 [hereinafter SPC Interpretation on Compensation for Personal Injury].

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fault.70 This was a crucial feature of the tort liability regime applying to medical injuries as developed at this time by the courts in parallel to the administrative liability regime. The relevant passage stipulates: “In tort actions relating to medical practice, medical institutions shall bear the burden of proving both the lack of a causal relationship between the medical practice and the harmful consequences, and the absence of medical fault.”71 In short, causation and fault were presumed and had to be disproved by the hospital. This contrasted with the administrative liability regime where the burden of proof was always on the plaintiff.

3.

The Identification Process

The SPC also decided that a dual system should apply to the process of identification, depending on whether administrative or tortious liability was at stake.72 If, in civil proceedings pursued on the basis of medical accident, the court decided – upon application by either party concerned or in the exercise of its own powers – that there should be a technical identification, this would be conducted by a medical association prescribed by regulation. However, where an identification procedure was required in a dispute over compensation for patient injury not attributed to a medical accident (i.e., in an action brought under the tort liability regime), a “judicial identification” would be organized by the court itself, rather than by the health administration (as under the 1987 Rules) or a medical association (as under the 2002 Regulations).73 This was important because, under the administrative liability system, most technical identifications concluded that there had been no medical accident,74 and medical institu-

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“Zui Gao Ren Min Fa Yuan Guan Yu Min Shi Su Song Zheng Ju de Ruo Gan Gui Ding,” 2001 nian 12 yue 6 ri You Zui Gao Ren Min Fa Yuan Shen Pan Wei Yuan Hui di 1201 ci Hui Yi Tong Guo, Zi 2002 nian 4 yue 1 ri qi Shi Xing. (《最高人民法院关于民事诉讼证据的若干规定》，2001 年 12 月 6 日由最高人民法院审判委员会第 1201 次会议通过，自 2002 年 4 月 1 日起施行） [“Several Stipulations of the Supreme People’s Court on Evidence in Civil Actions,” adopted on Dec. 6, 2011 at the 1,201st meeting of the Judicial Committee of the Supreme People’s Court, effective Apr. 1, 2002] Dec. 21, 2001, at art. 4(8). Id. SPC Notice on the Medical Accident Regulations, supra note 66, §II para. 1. Ren Min Fa Yuan Dui Wai Wei Tuo Si Fa Jian Ding Guan Li Gui Ding, 2002 nian 2 yue 22 ri You Zui Gao Ren Min Fa Yuan Shen Pan Wei Yuan Hui di 1214 ci Hui Yi Tong Guo, Zi 2002 nian 4 yue 1 ri qi Shi Xing. (《人民法院对外委托司法鉴定管理规定》，2002 年 2 月 22 日由最高人民 法院审判委员会第 1214 次会议通过，自 2002 年 4 月 1 日起施行。) [“Provisions on the Administration of Judicial Identification upon Entrustment by the People’s Court,”, adopted on Feb. 22, 2002 at the 1,214th meeting of the Judicial Committee of the Supreme People’s Court, effective Apr. 1, 2002] Mar. 27, 2002. See Xi & Yang, supra note 59 and accompanying text.

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tions were consequently exempted from liability to a large extent. Judicial identifications proved more likely to find in favor of the patient and consequently to allow the latter to obtain compensation.75

4.

Assessment of Damages

The most important difference between administrative and tort liability regimes lay in the assessment of compensation. For medical accidents, assessment was under the framework established by the Regulations of 200276 though the amounts payable were stipulated by reference to local conditions.77 Taking Beijing as an example, the maximum sum of compensation payable in respect of a medical accident was approximately 100,000 RMB in 2010.78 But if the patient chose to sue the hospital on the basis of medical fault, the compensation was calculated in accordance with the principles ordinarily applicable to tort liability,79 and the maximum compensation payable was much higher – about 400,000 RMB in 2010. The big differential of 300,000 RMB was mainly attributable to the award of compensation for death80 that is made where the claim is brought in tort but not where it is brought under the administrative regulations. The medical community argued that the general approach to the assessment of compensation for tortious personal injury should not apply to medical accidents, which should be governed exclusively by the 2002 Regulations.81 However, it proved to be another story in practice, and at 75

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See id. (reporting that judicial identifications conducted by one certified institution in Beijing found in favor of the patient in over 60 percent of cases, as compared with less than 10 percent reported in respect of technical identifications in several areas). In such cases, Section III of the SPC Notice on the Medical Accident Regulations provides for the application of the provisions on compensation (Articles 49, 50, 51 and 52) in the 2002 Regulations themselves. SPC Notice on the Medical Accident Regulations, supra note 66, §III. Medical Accident Regulations 2002, supra note 49, at items 2–5,7,10, 11, art. 50. In 2010, the average monthly exchange rate fluctuated between approximately $1=RMB6.6 and $1=RMB 6.8. Specifically, SPC Interpretation on Compensation for Personal Injury, supra note 69, at art. 17. Id. at art. 29 (providing that compensation for death shall be payable at the rate of twenty times the per capita disposable income of urban residents, or per capita net income in the case of rural residents, at the locality of the court accepting the case (based on the previous year’s income figures)). However, if the victim is age sixty or over, the period is reduced by one year for each year of age added; if the victim is age seventy-five or over, the period is calculated as five years. Id. Chou Yonggui (仇永贵), Yi Liao Shi Gu Sun Hai Pei Chang Bu Shi Yong “Ren Shen Sun Hai Pei Chang Si Fa Jie Shi,” Zhong Hua Yi Yuan Guan Li Za Zhi 2004 nian di 12 qi, di 737–738 ye. (“ 医 疗事故损害赔偿不适用《人身损害赔偿司法解释》”，《中华医院管理杂志》2004 年第

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least one local court (the Beijing Higher People’s Court) provided for the topping-up of compensation for medical accidents with reference to the GPCL and any relevant judicial interpretation where the sum assessed under the 2002 Regulations left the patient under-compensated.82 This effectively unified the measure of compensation irrespective of the cause of action the patient chose.

C.

Effect on the Administrative Liability Regime

The increasing recourse to the ordinary principles of tortious liability had dramatic effects on the utilization of the administrative liability regime. Just three years after the 2002 Regulations were implemented, there were significantly fewer applications for technical identification as both medical institutions and patients sought to avoid the attribution of patient injury to a medical accident: the administrative liability regime was “left in the cold” by the parties concerned.83 Patients turned to the GPCL because they wanted more compensation; hospitals, on the other hand, thought the administrative sanctions they faced under the 2002 Regulations too harsh because they might entail, in serious cases, an order by the health administration to suspend activities or the revocation of their practicing licenses, while the medical workers responsible for the accident would be subject to criminal investigation or, in less serious cases, disciplinary measures, as well as mandatory suspension of their activities and revocation of their practicing certificates.84 To avoid these administrative sanctions, hospitals were often prepared to admit civil liability voluntarily, even if this meant

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12 期，第 737－738页。) [Yonggui Chou, Interpretation of the Supreme People’s Court of Some Issues Concerning the Application of Law for the Trial of Cases on Compensation for Personal Injury Should Not Be Applied in Compensation for Medical Accidents, 12 Chinese Hosp. Mgmt 737, 737–38 (2004)]. Bei Jing Shi Gao Ji Ren Min Fa Yuan Guan Yu Yin Fa “Bei Jing Shi Gao Ji Ren Min Fa Yuan Guan Yu Shen Li Yi Liao Sun Hai Pei Chang Jiu Fen An Jian Ruo Gan Wen Ti de Yi Jian (Shi Xing)” de Tong Zhi. (北京市高级人民法院关于印发《北京市高级人民法院 关于审理医疗损害赔偿纠 纷案件若干问题的意见(试行)》的通知) [Notice of Beijing Higher People’s Court on Several Problems Concerning the Trial of Disputes Arising from Medical Malpractice (for Trial Implementation)] Jul. 13, 2005, at art. 21] (“To determine the compensation standard for medical malpractice, provisions from Article 49 to 52 of the Regulations for the Handling of Medical Accidents should be applied; if by following the Regulations the patient is left uncompensated, the GPCL and any relevant judicial interpretation shall be applied to increase the compensation”.). Liu Hong (刘虹)，“Yi Liao Shi Gu Chu Li Tiao Li” Shi Shi San nian Yuan He Bei Leng Luo, Yi Yuan Ling Dao Jue Ce Can kao 2006 nian di 9 qi di 39–41 ye. (《医疗事故处理条例》实施三年 缘何被冷落”，《医院领导决策参考》2006 年第 9 期，第 39－41 页。) [Hong Liu, Why are the Regulations on Handling Medical Accidents Left in the Cold Three Years After Their Implementation, 9 Decision-Making Assistant for Hosp. Superintendents 39, 39–41 (2006)]. Medical Accident Regulations 2002, supra note 49, at art. 55.

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paying more compensation. The courts also preferred to rely on the GPCL and to determine the sum of compensation according to the general principles established by the SPC. The 2002 Regulations thus became increasingly marginalized.85

V.

Reform of Medical Liability under the Tort Liability Law of 2009

A.

Antecedents

The dual system of liability and compensation for medical injury created chaos in practice, at a time when pressure for reform also came from the increasing number of disputes between doctors and patients, and widespread concerns about defensive medicine.

1.

Increasing Disputes between Doctors and Patients

According to a survey by the Chinese Medical Association in 2003, among 326 medical institutions investigated, 321 (98 percent) were involved in medical disputes of one type or another.86 A further survey in 2005 by the China Hospital Management Association looked at the incidence of disputes in 270 hospitals. Even in high-rated (Grade 3-A)87 hospitals, there were on average over thirty lawsuits every year, and more than one million RMB was paid as compensation in them. Doctors were assaulted, threatened, and abused in 73 percent of all hospitals; in 60 percent of hospitals patients besieged and threatened hospital superintendents out of dissa-

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See Wang Lianggang, (王良钢)， “Yi Liao Shi Gu Chu Li Tiao Li” Zai Yi Liao Jiu Fen Min Shi Su Song Zhong de Bian Yuan Hua, Dang Dai Yi Xue 2005 nian di 10 qi, di 26 ye. (《医疗事故处理条 例》在医疗纠纷民事诉讼中的边缘化”，《当代医学》2005 年第 10 期，第 26 页。) [Lianggang Wang, Medical Accident Regulations 2002 Marginalized in Dealing With Medical Civil Disputes, 10 Modern Med. 26 (2005)]. Fan Jing & Jiang Chao (樊静、姜潮)， Yi Liao Jiu Fen de Xian Zhuang Ji Dui Yi Yuan He Yi Wu Ren Yuan de Ying Xiang, Zhong Guo Yi Yuan Guan Li 2003 nian di 1 qi, di 29–30 ye. (《医疗纠纷 的现状及对医院和医务人员的影响》，《中国医院管理》2003 年第 1 期，第 29–30 页。) [Jing Fan & Chao Jiang, Status Quo of Medical Disputes and Their Influence on Hospitals and Medical Personnel, 1 Mgmt. of China’s Hospitals 29, 29–30 (2003)]. According to Articles 4 and 5 of the Administrative Rules for Hospital Grading (for Implementation) (1989), hospitals are divided into ten grades (from highest to lowest): 3-Top, 3-A, 3-B, 3-C, 2-A, 2-B, 2-C, 1-A, 1-B and 1-C. Yi Liao Shi Gu Fen Ji Biao Zhun (Shi Xing), Zhong Hua Ren Min Gong He Guo Wei Sheng Bu Ling di 32 hao. (医疗事故分级标准(试 行), 中华人民共和国卫生部令第 32 号) [Administrative Rules for Hospital Grading (for Trial Implementation), Ministry of Health Order No. 32] (Jul. 19, 2002), arts. 4, 5]. At the time of writing, there are no 3-Top rated hospitals in China, so 3-A is actually the highest grade.

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tisfaction with the outcomes of their treatment; in 77 percent of hospitals patients and their families refused to leave the premises or to pay their bill after treatment; in 62 percent of hospitals patients’ families laid wreaths and created mourning halls on the premises following the patient’s death.88 Increasing numbers of these disputes resulted in litigation. Taking the Haidian district court in Beijing as an example, eighty-nine medical disputes were tried in 2003, 103 in 2004, 124 in 2005, 138 in 2006, and 160 in 2007.89

2.

Concerns about Defensive Medical Treatments

The increasing number of hospital-related disputes raised concerns that medical personnel might be induced to carry out defensive and passive medical treatments to avoid liability,90 though reliable empirical evidence that this in fact occurred is lacking. According to a questionnaire survey of 487 clinicians shortly after the 2002 Regulations were implemented, 76 percent felt psychologically pressured; 42 percent said they were losing self-confidence.91 It has also been claimed (though without reliable supporting data) that, to avoid

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Fu Zhongyu (傅忠宇)， Gou Jian He Xie Yi Huan Guan Xi de Dui Ce Si Kao, Yi Xue Yu She Hui 2007 nian di 7 qi. (《构建和谐医患关系的对策思考》，《 医学与社会》 2007 年第 7 期。) [Zhongyu Fu, Thoughts on Measures That Aim at Building a Harmonious Hospital-Patient Relationship, 7 Med. & Soc’y 11, 11 (2007)]. On the role played by entrepreneurial “hospital chaos makers,” see Ding, supra note 1, at 2–3. Bei Jing Shi Hai Dian Qu Ren Min Fa Yuan Ke Ti Zu. (北京市海淀区人民法院课题组), Guan Yu Yi Liao Jiu Fen An Jian Fa lv Shi Yong Qing Kuang de Diao Yan Bao Gao, Fa lv Shi Yong 2008 nian di 7 qi, di 62 ye. (《关于医疗纠纷案件法律适用情况的调研报告》，《法律适用》 2008 年第 7 期，第 62 页。) [Research Team of the Haidian District Court of Beijing, An Investigative Report on the Application of the Law in Medical Disputes, 7 Legal Application 62 (2008)]. Unfortunately, there are no reliable national estimates of the number of medical injury claims pursued in Chinese courts. It should however be noted that the “loser pays” rule applying to court fees (but not lawyers’ fees, which are always borne by the client unless there is a contingent fee contract) acts as some disincentive to meritless claims. Xu Ping, Wang Shuhui & Wang Yunling (徐萍、王书会、王云岭)， Shi Lun “Yi Liao Shi Gu Chu Li Tiao Li” Yu Yi Sheng de Zi Wei Yi Xue Xing Wei, Zhong Guo Yi Xue Lun Li Xue 2006 nian di 1 qi, di 59 ye. (试论《医疗事故处理条例》与医生的自卫医学行为”，《中国医学伦 理学》2006 年第 1 期，第 59 页。) [Ping Xu, Shuhui Wang & Yunling Wang, On the Relationship between Medical Accident Regulations 2002 and Defensive Medical Treatment by Medical Personnel, 1 Ethics in Med. 59, 59 (2006)]. Qin Hong, Zou Xiaoping & Yang Hui (秦红、邹晓平、杨会)， “Yi Liao Shi Gu Chu Li Tiao Li” Dui Si Bai Ba Shi Qi Ming Lin Chuang Yi Sheng Xin Li Zhuang Kuang de Ying Xiang Ji Dui Ce, Zhong Guo Quan Ke Yi Xue 2004 nian di 7 qi, di 475 ye. (《医疗事故处理条例》对 487 名临床 医生心理状况的影响及对策”，《中国全科医学》2004 年第 7 期，第 475 页。) [Hong Qin, Xiaoping Zou & Hui Yang, The Influence of the Medical Accident Regulations 2002 on 487 Clinicians’ Psychology and Countermeasures Against It, 7 China Gen. Med. 475, 475 (2004)].

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lawsuits and compensation awards, medical institutions require patients as a matter of course to undergo excessive or unnecessary examinations, and that medical personnel also avoid offering or refuse to undertake risky interventions, and instead carry out only passive treatments which, though less likely to lead to iatrogenic injury, may not be in the patient’s best interests.92 Such attitudes may also have affected medical education and training. In 2002, in another questionnaire about the new Regulations’ influence in this area, 35 percent of respondents said that they were unwilling to supervise interns, and 59 percent said that they were reluctant to instruct students in how to operate.93

3.

The Chaos Resulting from the Dual Dystem of Medical Liability94

The emergence of the dual liability system for medical malpractice can be attributed to three basic factors: first, the health administration’s excessive emphasis on the uniqueness of medical institutions and its determination to give special protection to them; second, patients were forced to seek a more favorable compensation system to overcome the limits prescribed in the Regulations; and third, the court system tolerated a situation in which medical accident and medical fault were alternative causes of action, and even went so far as to create parallel systems for “identification” and the assessment of compensation. The disadvantages of such a state of affairs are obvious. The creation of a dual system under which limits on liability under the administrative regulations could easily be circumvented by recourse to the more favorable rules (so far as the patient was concerned) of ordinary tortious liability aggravated disputes between doctors and patients. Defensive and passive medical treatment – to the extent (if any) that it stemmed from the increased liabilities – harmed the interests of all patients, who could be obliged to pay for unnecessary examinations while at the same time being denied treatments which, though risky, were in their best interests. Lastly the disunity of judicial approaches harmed the authority

92 93 94

See also the evidence of a number of other local surveys cited by Xi and Yang, supra note 1, at 71–72. Qin, Zou & Yang, supra note 91. Yang Lixin (杨立新)，Zhong Guo Yi Liao Sun Hai Ze Ren Zhi du Gai Ge, Fa Xue Yan Jiu 2009 nian di 4 qi, di 84–85 ye. (《中国医疗损害责任制度改革》，《法学研究》2009 年第 4 期， 第 84－85 页。) [Lixing Yang, Reform of the Liability System Relating to Medical Harm in China, 4 Chinese J. Law, 84–85 (2009)].

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of justice itself. This chaotic state of affairs was calling out for further reform by the time of the Tort Liability Law (TLL) of 2009.95

B.

Legislative History

The TLL was the outcome of a long history of unsuccessful attempts at codification in P.R. China. Following previous failed attempts to introduce a Civil Code, it was decided to proceed incrementally by way of a series of enactments dealing with particular areas of civil law.96 The first draft of the TLL was actually the title on tort liability (Title VIII) in a new draft Civil Code of 2002.97 This made no specific provision for medical liability. It was in the second draft of December 21, 2008, that a new chapter on Liability for Injury in Medical Treatment was added, reflecting the legislature’s conclusion that a specific provision was necessary in view of the chaos that had arisen in practice. Apart from one significant amendment (relating to the burden of proof),98 this was the regime introduced in the final version of the Law adopted on December 26, 2009. The TLL had three basic goals in reforming the medical liability system: (1) to establish a single cause of action for medical malpractice to unify the application of law; (2) to seek a balance between the interests of the patient and the medical institution; and (3) to promote the sound development of state-funded medical services (Medicare).99 Its approach may be evaluated by reference to the four basic elements which we have highlighted with

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Zhong Hua Ren Min Gong He Guo Qin Quan Ze Ren Fa (《中华人民共和国侵权责任法》) [promulgated by the Standing Comm. Nat’l People’s Cong., Dec. 26, 2009, effective July 1, 2010] [P.R.C. Presidential Decree], available at http://www.gov.cn/flfg/2009-12/26/ content_1497435.htm (last visited Nov. 6, 2011) [hereinafter TLL]. For analysis in English, see Helmut Koziol & Yan Zhu, Background and Key Contents of the New Chinese Tort Liability Law, 1 J. Eur. Tort L. 328 (2010); Surya Deva, The PRC Tort Law: A Big Step Forward, 2 City U.H.K.L. Rev. 383 (2010). The legislature of P.R. China attempted to introduce a Civil Code on three previous occasions (1954–1958, 1962–1966 and 1979–1982), but failed each time – for primarily political reasons. The first effort was halted by the Great Leap Forward and Movement of People’s Commune in 1958, the second was halted by the Great Cultural Revolution begun in 1966, and the third was delayed because of the political belief that a civil code would be premature with economic reform underway. See Gu angran (顾昂然) ，Xin Zhong Guo Min Shi Li Fa Gai Shu, Fa lv Chu Ban She 2000 nian Ban, di 1-3,9 ye. (《新中国民事 立法概述》，法律出版社 2000 年版，第 1－3，9 页。) [Angran Gu, A Brief Introduction to the Civil Law Legislation of the New China 1–3, 9 (2000)]. George W. Conk, Translation: A New Tort Code Emerges in China: An Introduction to the Discussion with a Translation of Chapter 8–Tort Liability, of the Official Discussion Draft of the Proposed Revised Civil Code of the People’s Republic of China, 30 Fordham Int’l L.J. 935 (2007). See infra Part V.C.2. Yang, supra note 94, at 84–85.

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respect to the preexisting liability regimes: namely, the basis of the cause of action, the burden of proof, the identification process, and the assessment of damages.

C.

Four Dimensions of the TLL

1.

Basis of the Cause of Action

The TLL adopts the term “liability for injury in medical treatment” to denote the field of its application. The language can be traced back to a Regulation issued by the Supreme People’s Court in 2008, which used the phrase “dispute relating to compensation for injury in medical treatment.”100 The term “medical accident” was deliberately avoided because of its use under the administrative liability regime.101 The aim was to mark a clear break between the TLL and the 2002 Regulations in the area of medical liability. The 2002 Regulations are still binding on the health administration in its adjudications on administrative liability, but the courts are no longer bound by them. The relevant chapter of the TLL begins with a general statement of the responsibility of the medical institution both for its own fault and for that of its medical staff. Article 54 of the TLL provides: “If a patient suffers injury in the course of medical diagnosis or treatment, and the medical institution or medical personnel are at fault, the medical institution shall bear compensatory liability.” This umbrella clause subsumes two specific liabilities for medical fault that the Law goes on to specify, dealing respectively with the breach of medical ethical duties and the breach of medical technical duties. As the provision makes clear, the medical institution’s liability in each case may

100 “Min Shi An Jian An You Gui Ding”, 2007 nian 10 yue 29 ri You Zui Gao Ren Min Fa Yuan Shen Pan Wei Yuan Hui di 1438 ci Hui Yi Tao Lun Tong Guo, Zi 2008 nian 4 yue 1 ri qi Shi Xing. (《民 事案件案由规定》,2007 年 10 月 29 日由最高人民法院审判委员会第 1438 次会议讨论 通过，自 2008 年 4 月 1 日起施行) [Regulation on Causes of Action in Civil Cases, promulgated by the Judicial Committee of the SPC on Oct. 29, 2007, effective Apr. 1, 2008]. Following amendment by the SPC on February 18, 2011, Section 351 of the Regulation now treats a dispute relating to compensation for injury in medical treatment as a “tort liability dispute”, with specific recognition of both “disputes relating to liability for infringement of a patient’s right to be informed and to consent” and “disputes relating to liability for medical products.” Both discussed further infra Parts V.C.1.a, V.C.1.c. 101 Ai Erken(艾尔肯)， Lun Yi Liao Sun Hai, Bei Fang Fa Xue 2008 nian di er qi, di 49 ye. (《论医 疗损害》，《北方法学》 2008 年第 2 期，第 49 页。) [Erken Ai, On Medical Malpractice, 2 N. Legal Sci.46, 49 (2008)].

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be either personal (i.e., for its own fault) or vicarious.102 Additionally, the same chapter of the TLL specifies a separate strict liability for the medical institution as the supplier of medical products. In all, then, the TLL provides for three basic types of liability for injury resulting from medical treatment, and these are now addressed in more detail in the sections below.103

a. Liability for Breaching Medical Ethical Duties. The first form of medical fault addressed in the TLL is the breach of medical ethical duties. In effect, this recognizes a liability for injury resulting from the failure to obtain informed consent to treatment. Article 55(1) of the TLL establishes the medical ethical duties in the following terms: In the course of diagnosis and medical treatment, medical personnel shall give the patient an explanation of the nature of his illness and the medical measures proposed. If surgery, special examination, or special therapy needs to be carried out, the medical personnel shall give the patient a timely explanation of the medical treatment risks, alternative medical treatment plans, and other relevant considerations, and get his written permission. If it is not appropriate to give the explanation to the patient, the medical personnel shall give the explanation to the close relatives of the patient and get their written permission.104 The second paragraph of Article 55 of the TLL provides for liability for breach of the specified duties: “[i]f the medical personnel fail to fulfill the duties in the preceding paragraph, and cause injury to the patient, their medical institution shall bear compensatory liability.” It may be noted that the liability is for “injury,” and not merely the violation of the patient’s civil rights or interests, and that there appears therefore to be

102 There is therefore no need to rely on the general provision on vicarious liability in Article 34 of the TLL. On the medical institution’s liability under the TLL for organizational fault, see Gert Brüggemeier, European Civil Liability Law Outside Europe. The Example of the Big Three: China, Brazil, Russia, 2 J. Eur. Tort L. 1, 7–8 (2011). 103 Yang, supra note 94, at 89. 104 There is an exception to the above-mentioned information duties in Article 56 when it is impossible to seek the consent of the patient or his or her close relatives: “If, due to an emergency such as saving a patient on the verge of death, it is impossible to seek the consent of the patient or his close relatives, appropriate medical measures can be taken immediately upon approval by the principal of the medical institution or any authorized person.” It should be emphasized that there is no duty on the principal of the medical institution or any authorized person to approve emergency medical measures. So this exception is just a privilege and does not entail a duty to act.

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no right to compensation for infringement of the patient’s autonomy or dignity in the absence of physical harm or serious emotional harm.105

b. Liability for Breaching Medical Technical Duties. Article 57 of the TLL is about liability for breaching medical technical duties: “[i]f, in the course of diagnosis or medical treatment, medical personnel fail to fulfill the duty of diagnosis and medical treatment corresponding to the state of medical treatment then and there, and cause injury to the patient, their medical institution shall bear compensatory liability.” As the content of the applicable standard of care (“the duty of diagnosis and medical treatment corresponding to the state of medical treatment then and there,” i.e., at the time and place the treatment was given) is not specified in the TLL or in other legislation, it becomes a further question for the courts to decide.

c. Liability for Medical Products. The third type of medical liability covered by the TLL is with respect to injuries caused by medical products. Here the liability is strict rather than fault-based – even so far as the medical institution is concerned. However, where the patient claims compensation from the medical institution rather than the manufacturer of the product – or, as the case may be, a supplier of blood for transfusion – it has the right to indemnity from the liable manufacturer or supplier of blood. The reason for what (in international perspective) is a rather unusual strict liability on the medical institution as supplier is the special role played by hospitals in China as suppliers of pharmaceutical products. It is commonly recognized that Chinese hospitals derive a significant proportion of their income from the sale of drugs, and indeed that they profit from excessive and unnecessary sales. This is quite different from the situation in other countries. In fact, drug sales make up about 50 percent of the revenues of most hospitals in China. Taking Shanghai as an example, the total revenue of state-owned hospitals in 2007 was 39 billion RMB, which consisted of: (1) government subsidy of 3.64 billion RMB (9.5 %); (2) income from the provision of medical services amounting to 16.94 billion RMB (43 %); (3) drug sales amounting to 17.51 billion RMB

105 See also Zhu Wang （王竹）, Jie Shi Lun Shi Ye Xia de Qin Hai Huan Zhe Zhi Qing Tong Yi Quan Qin Quan Ze Ren, Fa Xue 2011 nian di 12 qi ji jiang fabiao. (《解释论视野下的侵害患者 知情同意权侵权责任》，《法学》2011 年第 12 期即将发表。) [Zhu Wang, Tort Liability for Infringement on the Right of Informed Consent of Patients under the Framework of Heurematic Law, 12 Legal Sci. __ (2011, 12th Issue)].

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(45 %); and (4) income from other sources of 950 million RMB (2.5 %).106 The percentage of drug sales in the revenues of private hospitals is even higher than that in state-owned hospitals. Overall, the hospital system is the major outlet for the sale of medicines in China. In Shanghai, from 2002 to 2007, hospitals accounted for 79 percent of the drug market, compared with 21 percent comprised by drugstores.107 In 2009, the market for medicines in China as a whole was 580 billion RMB, of which hospitals accounted for 430 billion RMB (74 %) and drugstores only 150 billion RMB (26 %).108 Driven by mutual financial interest with the drug companies, hospitals have become the only sellers of some drugs in China. Article 59 of the TLL accordingly provides for medical institutions to bear liability for defective pharmaceutical products: If a defect in a drug, sterilizing agent or medical device, or a substandard blood transfusion, causes injury to a patient, the patient may claim compensation from the manufacturer or the blood supplying institution, or may claim compensation from the medical institution. If the patient claims compensation from the medical institution, after the medical institution has paid the compensation, it has the right to claim indemnity from the liable manufacturer or blood supplying institution.

2.

Burden of Proof

The new law does not explicitly deal with proof of causation,109 but makes significant changes in the principles applicable to the proof of fault. The

106 Wang Shiling(王世玲), Hu Gong Li Yi Yuan Shou Zhi Bao Gao Chu Lu Zhi Xing Yao Pin Ling Cha Jia Que Kou San Shi Yi, 21 Shi Ji Jing Ji Bao Dao 2010 nian 4 yue 14 ri. (《沪公立医院收支 报告出炉执行药品零差价缺口 30 亿》，《21 世纪经济报道》2010 年 4 月 14 日。) [Shiling Wang, Financial Reports of Public Hospitals in Shanghai: 3 Billion Yuan Government Subsidy Needed to Cover Deficit, 21st Century Rep. (Apr. 14, 2010)], available at http://health. sohu.com/20100414/n271494256.shtml (last visited Nov. 9, 2011). 107 Id. 108 Shi Chang Gui Mo Zhan Bi Bai Fen Zhi Qi Shi Si Yi Yuan Reng Wei Yao Pin Xiao Shou Zhu Qu Dao, Di Yi Cai Jing Ri Bao 2010 nian 8 yue 30 ri. (《市场规模占比 74 % 医院仍为药品销售主 渠道》，《第一财经日报》，2010 年 8 月 30 日。) [Taking up 74 % of the Market, Hospitals are still the Main Channel for the Sale of Drugs, First Financial Daily (Aug. 30, 2010)], available at http://money.163.com/10/0830/01/6FA2PBLC00254ITK.html (last visited Nov. 9, 2011). 109 The concept of cause is left undefined in the TLL, but specific provision is made for cases of causal uncertainty as between alternative defendants (Article 10) and multiple sufficient causal contributions (Article 11). TLL, supra note 95. The TLL gives no indication whether the basic notion of cause embraces legal as well as factual causation, nor as to how the line is to be drawn between consequences attributable to the tort and

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burden of proving fault, or (as the case may be) the absence of fault, on the part of the medical institution is no longer on the hospital or doctor (as it was under the SPC Stipulations on Evidence in Civil Litigation)110 but primarily on the patient. According to the new law, if a patient suffers injury in the course of diagnosis or medical treatment, and the medical institution or its medical personnel are at fault, the medical institution shall bear compensatory liability.111 On the other hand, fault on the part of the medical institution is presumed in special circumstances. If a patient is injured, and any of the following circumstances apply, fault on the part of the medical institution is taken to be established unless the medical institution proves the contrary: (1) violation of provisions of laws, administrative regulations, ministerial rules, or other standards regarding diagnosis and medical treatment; (2) concealing or refusing to provide medical record materials related to the dispute; and (3) falsifying, distorting, or destroying medical record materials.112 In fact, this provision is a significantly watered-down version of what was proposed when the reform of tort law was revived in 2008 with the publication of a second draft of the Tort Liability Law (building on the first draft included in the proposal for a Civil Code of 2002). The second draft included a reversal of the burden of proof by which, if a patient’s injury appeared to be caused by a diagnosis or medical treatment by medical personnel, a causal relationship between such diagnosis or treatment and the harm suffered by the patient would be presumed unless the medical personnel provided proof to the contrary.113 This provision was deleted in the third draft of November 6, 2009114 and does not appear in the TLL as enacted. This may be understood as the implicit rejection of presumed causation in the area of medical malpractice. So far as patients

110 111 112 113

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those which are too remote or outside the scope of the risk attributable to the defendant. Chinese scholarship has not yet given significant consideration to the recognition of liability for loss of chance as a means of circumventing difficulties of proof. See also Ken Oliphant, Uncertain Causes: the Chinese Tort Liability Act in Comparative Perspective, in Towards A Chinese Civil Code: Historical and Comparative Perspective (Chen Lei & C.H. van Rhee eds., Brill 2012). Several Stipulations of Supreme People’s Court on Evidence in Civil Litigation, supra note 70, at art. 4(8); see also supra Part V.B.2. TLL, supra note 95, at art. 54. Id. at art. 58. See Tort Liability Law of P.R. China (second officially discussed edition/Dec. 21, 2008), translated by Zhu Wang and George W. Conk, unpublished [hereinafter Tort Liability Law, second draft Dec. 2008]. See Tort Liability Law of P.R. China (third officially discussed edition/Nov. 6, 2009), available at official website of NPC: http://www.npc.gov.cn/npc/xinwen/lfgz/flca/200911/06/content_1525914.htm.

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are concerned, the new law thus marks a step backwards not only from the presumption of both fault and causation under the approach previously adopted by the SPC, but also (insofar as proof of causation is concerned) from the second draft of 2008.

3.

The Identification Procedure

Unfortunately, the TLL does not resolve the controversial question of who should act as the organizer of the identification process it requires. However, just one day before the TLL was to enter into force, the SPC issued a Notice Addressing Several Issues Relating to the Application of the Tort Liability Law115 according to Article 3 of which a people’s court applying the TLL in a case where technical identification is required shall itself take responsibility for organizing the process.116 In other words, there should be a judicial identification, not an identification by a committee appointed by the health administration.

4.

Assessment of Damages

There is no special provision in the TLL dealing with compensation for injury arising from medical treatment. Consequently, the general approach applicable to compensation for tortious personal injury, found in Articles 16 to 23 of the Law, is to be followed. Article 16 of the TLL provides:117 One who infringes on the rights or interests of another, and causes physical injury, shall compensate for the reasonable expenses of medical care, nursing, and transportation, etc., for the purposes of therapy and restoring good health, as well as for reduced income due to loss of working time. One who causes disability shall also pay for the cost of prostheses and compensation for disability. One who causes death shall also pay funeral expenses and death benefits.118

115 Notice of Supreme People’s Court Addressing Several Issues Relating to the Application of the Tort Liability Law of P.R. China, (promulgated by the SPC, June 30, 2010). (A “Notice” is an informal but binding direction by the SPC to the lower courts.) 116 Id. at §III. 117 Id. at § 4. 118 TLL, supra note 95, at art. 16.

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The succeeding Articles of the TLL deal (inter alia) with compensation on death (Article 18) and compensation for serious emotional damage (Article 22).119

VI. Another Step Backwards on Its Way? The reform of tort liability for medical malpractice in China is still a work in progress, and it seems certain that there will be further reform, whether by incorporation of the rules of tortious liability for medical malpractice in a Civil Code, or a specific enactment on medical treatment or medical malpractice,120 or by a comprehensive SPC interpretation that directly addresses all unresolved questions. Whether the direction of such reform will be “forwards” or “backwards” remains to be seen, but our inclination is to think that it will be the latter, if only because the TLL fails to resolve a number of disputed issues related to the four dimensions highlighted for analysis in this paper and, by default, seems to validate solutions favoring the medical community’s interests over those of patients. We now briefly address each of the four in turn, highlighting possible options for further reform. First, in considering the basis of the cause of action, it seems likely that clarification will be required of the standard of care to which doctors are held in performing their technical duties. The “then and there”121 medical standard adopted as the criterion to judge medical misconduct is arguably too imprecise, and should be supplemented with reference to specific factors. In fact, the second draft of the TLL contained a provision (deleted in the final version) which expressly required the court to consider the location of the medical institution, its accreditation, and the qualifications

119 On the damages that may be awarded under the TLL, see Koziol & Zhu, supra note 95, at 343–344. 120 Ai Erken & Fang Bo(艾尔肯、方博) ， Wo Guo Yi Liao Sun Hai Pei Chang An Jian Fa lv Shi Yong Wen Ti Yan Jiu Bao Gao, He Bei Fa Xue 2010 nian di 2 qi, di 130–131 ye. (《我国医疗损害 赔偿案件法律适用问题研究报告》，《河北法学》2010 年第 2 期，第 130－131 页。) [Erken Ai & Bo Fang, The Research Report Concerning the Application of Law for the Medical Malpractice Compensation Cases of China, 2 Hebei L. Sci. 121, 130–131 (2010)]. 121 See TLL, supra note 95, at art. 57; supra Part IV.C.1.b. In their translation of the TLL, Yan Zhu and Helmut Koziol use the expression “at the time,” which is the direct translation of the Chinese word. Yan Zhu & Helmut Koziol, Tort Liability Law of the People’s Republic of China, 1 J. Eur. Tort. L. 362, 370 (Yan Zhu & Helmut Koziol trans., 2010). But in Chinese, “at the time”, usually refers to a given place as well as a given time. The standard is therefore to be understood as referring to local practice, and does not mean (for example) imposing the standards of the big cities on practitioners in remote rural localities.

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of its medical personnel.122 An almost identical provision has now found its way into guidance issued to the local courts in Beijing by the city’s Higher People’s Court.123 In a country so large and with such substantial differences in healthcare delivery between different areas – especially between urban and rural areas – it is easy to see that such a provision might be considered desirable. However, insofar as it rubber-stamps local practice even if it fails to attain reasonable quality standards, such reform could well be seen as contrary to the interests of patients. Another possible reform adverse to such interests would be the introduction of limits on the liability of medical institutions for defective pharmaceutical products. Arguably, it is unfair to treat medical institutions as sellers (and, as such, strictly liable for defects) in cases of all types. At the least, since blood suppliers in China are nonprofit institutions who act in the public interest, there seems to be a case for introducing a cap on their liability in damages. From the patient’s perspective, the best that could be said for such a reform is that it would serve to ensure the continued supply of blood for transfusion in the interests of all patients. Secondly, regarding the burden of proof, the major open question is proof of causation. Under the pre-TLL approach of the SPC, the burden of proving the absence of a causal relationship between the medical treatment and the patient’s injury, as well as the absence of medical fault, fell on the hospital.124 The TLL puts the burden of proving fault on the patient in most cases – though Article 59 prescribes a set (albeit limited) of factors whose presence raises a presumption of fault – but it does not deal explicitly with the burden of causation, which is not unimportant in medical cases. It seems likely that, in the absence of a specific provision in the TLL, the burden of proving causation will follow the ordinary rule, and therefore fall on the plaintiff. It is arguable, however, that a more nuanced approach is necessary to balance the interests of the competing parties, and in particular to make allowance for the information and resource asymmetry that very often obstructs proof of causation. We therefore take the liberty of suggesting that Chinese law should follow the German approach of shifting the burden of proving causation to the 122 See Tort Liability Law, second draft Dec. 2008, supra note 113. 123 Bei Jing Shi Gao Ji Ren Min Fa Yuan Guan Yu Yin Fa “Bei Jing Shi Gao Ji Ren Min Fa Yuan Guan Yu Shen Li Yi Liao Sun Hai Pei Chang Jiu Fen An Jian Ruo Gan Wen Ti de Zhi Dao Yi Jian Shi Xing”. (北京市高级人民法院关于印发《北京市高级人民法院关于审理医疗损害赔偿纠纷 案件若干问题的指导意见（试行）》) [Guiding Notice of Beijing Higher People’s Court on Several Problems Concerning the Trial of Disputes Arising from Medical Malpractice (for Trial Implementation)] (promulgated by the Judicial Comm. of Beijing Higher People’s Court, Nov. 18, 2010). 124 Several Stipulations of the SPC on Evidence in Civil Actions, supra note 70, at art. 4(8).

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hospital in cases of gross negligence in medical treatment.125 The serious character of the treatment error provides a reason for moving the risk of causal uncertainty from the patient to the hospital. Thirdly, we come to the identification process, which is likely to be the most important practical problem relating to medical malpractice suits to arise in the immediate future.126 As patients do not trust technical identifications conducted by the health administration, and hospitals do not trust judicial identifications, scholars have suggested the adoption of a combined system.127 Judicial identification under the charge of a specified person would be maintained and carried out in a different jurisdiction from that in which the injury occurred in order to avoid any conflict of interest on the part of the local medical association, and any perception that it might be deliberately protecting its members. At the same time, technical identification would be conducted by clinical professionals together with medico-legal experts to guarantee an objective and just identification result. Although such a process involves a duplication of resources, the hope is that it would ultimately command more respect – at least in cases where the two processes come to the same result. Turning lastly to the assessment of compensation, the principal question awaiting resolution is whether the general approach adopted in the TLL with respect to personal injury leaves room for special rules in the area of medical malpractice. It is quite conceivable that pressure could mount to enact rules limiting the damages recoverable in tort by reference to existing provisions of the Medical Accident Regulations, for example, the apportionment of liability by reference to the respective roles played by the medical fault and the patient’s preexisting condition.128 As a cap currently applies to compensation for emotional harm in medical malpractice claims brought under the administrative liability regime,129 this too could conceivably be adopted for the purposes of liability in tort, if it is

125 See Marc Stauch, The Law of Medical Negligence in England and Germany: A Comparative Analysis 87–92 (2008). 126 Wang Cheng(王成), Yi Liao Qin Quan Xing Wei Fa lv Gui Zhi de Shi Zheng Fen Xi―Jian Ping “Qin Quan Ze Ren Fa” Di Qi Zhang, Zhong Guo Fa Xue 2010 nian di 5 qi, di 116–118 ye. (医疗侵 权行为法律规制的实证分析 – – – 兼评《侵权责任法》第七章，《中国法学》2010年第 5期，第116－118页。) [Cheng Wang, Analysis of Legal Regulation of Medical Tort and Evaluation of Chapter Seven of Tort Law, 5 China L. 113, 116–18 (2010)]. 127 Ai Erken & Fang Bo(艾尔肯、方博), Lun Yi Liao Sun Hai Jian Ding Zhi Du, Shi Dai Fa Xue 2009 nian di 5 qi, di 25 ye. (《论医疗损害鉴定制度》，《时代法学》2009 年第 5 期，第 25页。) [Erken Ai & Bo Fang, Discussion of the Appraisement System of Medical Malpractice, 5 Presentday L. Sci. 20, 25–26 (2009)]. 128 See infra Part III.B.2.d. 129 Id.

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considered useful to limit the liability of medical institutions. Neither of these possible reforms would be in the interests of patients.

Conclusion P.R. China faces numerous healthcare challenges in the coming years as it strives to develop an equitable system of universal health care for its citizens. Relative to the magnitude of that task, the development of appropriate mechanisms to provide compensation and accountability with respect to medical injuries is a rather small matter. Yet it is not unimportant. The popular unrest provoked by the perceived unfairness of the liability system in the early years of the present century sat ill with the commitment to “social harmony and stability” that is proclaimed in the opening Article of the new Tort Liability Law.130 It is still too early to assess, however, whether the steps taken forwards and backwards, to the left and to the right, as the “dance pattern” of the reform process has slowly unfolded, have adequately balanced the rights and interests of the dancing partners, or to predict what new steps they will be required to learn in the future.

130 TLL, supra note 95, at art. 1.

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Medical Malpractice and Compensation in France Part I: The French Rules of Medical Liability since the Patients’ Rights Law of March 4, 2002 Florence G’sell-Macrez*

Introduction The French law of medical malpractice must be understood within the context of a French health care system that is characterized by the division among the public sector, primarily public hospitals, and private practitioners or institutions, which may be either non-profit organizations or for-profit establishments that depend on their fees for funding. Indeed, 86 percent of the salaried health professionals work in the public sector,1 and 65 percent of the available beds are located in public hospitals.2 With regard to physicians, only 46.5 percent of physicians work independently in private practice, while 41.7 percent are employed by public or private hospitals, and 11.8 percent do both private practice and hospital work.3 The weight of the public sector is also palpable through the action of the Sécurité Sociale (Social Security), the public health insurance program that was established in 1945.4 The Social Security takes care of all health costs, though it does not fully cover these expenses since reimbursement is

* 1

2 3

4

Professor of Private Law, Université de Bretagne Occidentale. I thank my friend William Chan for his precious comments on an earlier draft of this article. Yvon Berland, Démographie médicale hospitalière [Hospital Medical Demography] § 1.3.1, at 25 (2006), available at http://www.securite-sociale.fr/communications/rapports/2006/berland/rapport_berland.pdf. Id. at 122 tbl3.2.1. Conseil National de l’Ordre des Médecins [National Council of the Order of Physicians], Atlas de la Démographie Médicale en France [Atlas of Medical Demography in France] 15 tbl. 7 (2010), available at http://www.conseil-national.medecin.fr/sites/default/files/Atlas %20National%20CNOM%202010.pdf. Within the French context, the expression “Social Security” refers to the public social insurance system, which mostly covers health care, like Medicare or Medicaid in the United States, or retirement pensions.

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regulated through uniform rates and tariff references. About 75.5 percent of the total health expenditures are covered by the public health insurance system, whereas 9.4 percent are paid by patients and 13.4 percent by complementary insurance.5 Most practitioners conform to the Tarif de convention (tariff references), which stipulates the fixed rates to be charged by doctors set by the national convention for all health services. In principle, patients are free to choose their doctor, but this freedom of choice has been diminished by Law 2004-810 of August 13, 2004, for the “coordination of care,”6 which requires each insured individual to choose a “primary care physician” (“médecin traitant”).7 Since health is considered a matter of public policy, there is traditionally in France a ministry of public health that is in charge of conducting health policies. In addition, various public agencies are very active in the field, especially in prevention and deterrence of medical accidents. The High Council of Public Health (Haut Conseil de la Santé Publique [HCSP]) contributes to the definition of public health goals.8 The French Agency for Sanitary Safety of Health Products (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS])9 guarantees the efficiency, quality, and proper use of health products. The French National Authority for Health (Haute Autorité de Santé [HAS]) manages “a number of activities designed to improve the quality of patient care and to guarantee equity within the healthcare system.”10 The HAS activities “range from assessment of drugs, medical devices, and procedures to publication of guidelines to accreditation of healthcare organisations and certification of doctors.”11 The Regional Agencies for Health (Agences Régionales de Santé [ARS]), were created in 2010 and are responsible for safety, preventive actions, organizing the

5 Annie Fenina et al., Direction de la Recherche, des Études, de l’Évaluation et des Statistiques [French Directorate for Research, Studies, Evaluation, and Statistics], Les Comptes Nationaux de la Santé en 2009 [National Accounts of Health in 2009] 5 tbl.2 (2010), available at http://www.sante.gouv.fr/IMG/pdf/er736.pdf. 6 Loi 2004-810 du 13 août 2004 relative à l’assurance maladie [Law 2004-810 of August 13, 2004 on Health Insurance], Journal Officiel de La République Française [J.O.] [Official Gazette of France], August 17, 2004, p. 14598. 7 Code de la Sécurité Sociale [CSS] art. L. 162-5-3. The primary care physician is a general practitioner (or more rarely, a specialist) who may refer the patient, if necessary, to a particular specialist. The primary care physician manages the patient’s personal record, which contains all necessary information regarding the patient’s health. 8 Missions, Haut Conseil de la Santé Publique, http://www.hcsp.fr/explore.cgi/hcsp? ae=hcsp&clef=43&menu=0672 (last visited Mar. 29, 2011). 9 Agence Française de Sécurité Sanitaire des Produits de Santé, http://www.afssaps.fr/ (last visited Apr. 3, 2011). 10 About HAS, Haute Autorité de Santé, http://www.has-sante.fr/portail/jcms/c_5443/eng lish?cid=c_5443 (last visited Apr. 3, 2011). 11 Id.

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supply of care based on population needs, risk management, control of management of health facilities, pilot programs to improve work practices, and collection and interpretation of health data.12 The Agencies also aim to foster cooperation between health professionals and health facilities to improve the care of patients.13 Despite the action of these various public institutions, the lack of sufficient prevention policies, especially in terms of “risk management,” is often highlighted.14 This is why recent texts were adopted concerning prevention policy.15 In this context, Law 2002-303 of March 4, 2002, relative aux droits des malades et à la qualité du système de santé (hereinafter the Patients’ Rights Law) has unified medical malpractice liability rules, regardless of the actors involved – public or private.16 This Law defines patients’ rights and sets forth general principles regarding the responsibility of health professionals and health institutions, which are now in the Code of Public Health (Code de la Santé Publique) [CSP].17 However, despite the unification of medical malpractice rules, disputes still have to be brought before administrative or civil courts, according to whether the medical malpractice has occurred in a public hospital or in a private practice or institution. It should also be noted that victims may initiate prosecution before criminal courts against any health professional if it appears that he or she committed a criminal offense. And physicians may be brought before disciplinary courts in case of violation of the Code of Ethics (Code de déontologie médicale).

12

13 14

15

16

17

See generally Rémi Pellet, Les médecins libéraux et la loi n˚2009-879 du 21 juillet 2009, «Hôpital, Patients, Santé et Territoires» (HPST) [Private Physicians and Law 2009-879 of July 21, 2009 on Hospital Reform, Patients, Health, and Territories], Union Régionale des Médecins Libéraux de Midi-Pyrénées [Regional Union of Private Physicians of Midi-Pyrénées], Apr. 2010, available at http://www.remipellet.com/pages/publications/art%20R%E9mi% 20Pellet%20Les%20m%E9decins%20lib%E9raux%20et%20la%20loi%20HPST.pdf. Id. See Missions et objectifs de la Prévention Médicale [Missions and Objectives of La Prévention Médicale], La Prévention Médicale, http://www.prevention-medicale.org/l-association/ nos-missions-doc/missions.html (last visited Mar. 30, 2011). La Prévention Médicale is a non-profit organization promoting prevention and deterrence of medical risks. See Décret 2010-1408 du 12 novembre 2010 relatif à la lutte contre les événements indésirables associés aux soins dans les établissements de santé [Decree 2010-1408 on the Prevention of Adverse Events Associated with Care in Health Facilities], J.O., Nov. 16, 2010, p. 20428. Preventive actions shall be decided by the direction of the hospital, Code de la Santé Publique [CSP] art. R. 6111-2, and implemented by a healthcareassociated risk manager, CSP art. R. 6111-4. Loi 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé [Law 2002-303 of March 4, 2002 on Patients’ Rights and the Quality of the Health System], J.O., March 5, 2002, p. 4118 [hereinafter Patients’ Rights Law of March 4, 2002]. Id.

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The Patients’ Rights Law of March 4, 2002, not only provides for new liability rules but also organizes the compensation of injuries that cannot be attributed to any misconduct.18 When the injury results from acts of prevention, diagnosis, or treatment, and when such injury is abnormal with respect to the patient’s previous health and its likely evolution,19 the victim’s claim may be brought before the National Fund for Compensation of Medical Accidents (Office National d’Indemnisation des Accidents Médicaux [ONIAM]).20 In addition, the ONIAM is in charge of compensating the victims who cannot get compensated by the health professional or his/her insurer, even if liability rules are applicable. The compensation schemes that complement civil liability in such cases are said to be based on the principle of “solidarité nationale” (national solidarity): the term reflects the idea that the whole community supports the cost of such risks. Finally, the Patients’ Rights Law of March 4, 2002 regulates the settlement of disputes between patients and health professionals. This piece will focus on the cases where a medical accident is likely to justify the responsibility of the practitioner. We will first consider the general conditions of the health professional’s liability (Part I), before turning to the question of administration and adjudication of claims (Part II).

I.

General Conditions of Medical Liability

Before the Patients’ Rights Law of March 4, 2002, medical malpractice liability in the private sector was viewed as a matter of contract law, due to a famous ruling of the Cour de cassation in the Mercier case.21 This case overruled previous decisions according to which physicians were liable under tort law.22 Since 1936, a contract was deemed to be formed between

18 19 20 21

22

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Id. CSP art. L. 1142-1. See Geneviève Helleringer, Medical Malpractice and Compensation in France, Part II: Compensation Based on National Solidarity, 86 Chi.-Kent L. Rev. 1019, 1127 (2011). Cour de cassation [Cass.] [supreme court for judicial matters] civ., May 20, 1936, D.P. I 1936, 1, 88, concl. Matter, rapp. L. Josserand; Gaz. Pal. 1936, 2, 41, note A. Besson; S. Jur. I 1937, 1, 321, note A. Breton; Revue Trimestrielle de Droit Civil [Quarterly Journal of Civil Law] [RTD civ.] 1936, 691, obs. R. Demogue. Mireille Bacache, La responsabilité médicale sans faute: passé, présent et avenir [Medical Liability Without Fault: Past, Present, and Future], in Liber Amicorum Christian Larroumet 19, 19 (2009); see Code civil [C. civ.] arts. 1382–1383; Cass. req., June 18, 1835, D.P. I 1835, 1, 300, concl. Dupin; S. Jur. I 1835, 1, 401 Philippe le Tourneau et al., Droit de la Responsabilité et des Contrats [Law of Liability and Contracts] DALLOZ ACTION 4199 (8th ed. 2010); see also Philippe Pierre, Assurance, responsabilité et santé : réflexions sur une trilogie en devenir [Insurance, Liability, and Health: Reflections on a Trilogy in the Making],

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a doctor and a patient, thereby excluding the application of tort law principles. However, there was no deemed contract when the patient was unable to accept care23 (and his or her family, partner, or designated contacts could not be contacted), and the liability regime was then one based on tort law principles. The Patients’ Rights Law of March 4, 2002, modifies the legal basis for medical liability, which is now regarded as a “legal regime” that is neither contractual nor tortious.24 This change has been very recently confirmed in an important decision of the Cour de cassation on January 28, 2010,25 which merely mentions Article L. 1142-1 of the CSP without referring to Article 1147 of the Civil Code like previous decisions usually did. However, in the case where the physician breaches his or her duty to inform, the applied provision is now Article 1382 of the Civil Code, which means that, in such case, the physician’s responsibility is based on tort law.26 There are traditionally three basic requirements to establish such liability.27 The first requirement is negligence or, in the case of a no-fault exception, any fact likely to justify civil liability. The second requirement is the victim’s injury, which must warrant compensation and is often a loss of a chance, as we shall see. The third requirement is a causal link between the physician’s negligence and the victim’s harm. We will thus study those three conditions.

A.

Facts Likely to Justify the Physician’s Responsibility

The Patients’ Rights Law of March 4, 2002, reaffirms the principle of fault-based liability in medical malpractice cases. However, it also admits the physician’s strict liability in specific circumstances.

23 24 25

26 27

Symposium, Assurance, Responsabilité et Santé [Insurance, Liability, and Health], Hors-série [Special Issue] Revue de Droit Sanitaire et Social [RDSS] 7 (2010). For example, in the case where the patient was unconscious. Bacache, supra note 22, at 20. Cass. 1e civ., Jan. 28, 2010, Bull. civ. I, No. 20; D. 2010, 1801, « Point de vue » D. Bert; RDSS 2010, 375, obs. F. Arhab-Girardin; Constitutions 2010, 304, obs. X. Bioy; see also P. Sargos, Deux arrêts « historiques » en matière de responsabilité médicale générale et de responsabilité particulière liée au manquement d’un médecin à son devoir d’information [Two “Historic” Decisions on Medical Malpractice and Liability Associated with a Physician’s Breach of the Duty to Inform], D. 2010, 1522. See Helleringer, supra note 20, at 1140. On medical malpractice liability, see generally A. Castelletta, Responsabilité médicale, Droit des malades [Medical Liability, Patients’ Rights] (2d ed. 2004); S. Welsch, Responsabilité du Médecin [Liability of the Physician] (2d ed. 2003).

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1.

Liability Based on Fault

a. Liability for Negligence. Since the Mercier decision of 1936, French Law has traditionally considered that the physician was under an obligation de moyen,28 which implies that the victim must establish the physician’s negligence, not merely the fact that the expected result (recovery) was not reached. Indeed, the contracting party who is under an obligation de moyen must strive to achieve the desired result by using reasonable diligence, whereas the obligation de résultat requires the defendant to achieve the promised result at any cost.29 Today, the physician’s negligence is a requirement clearly stated in the first paragraph of Article L. 1142-1 CSP. This provision also applies to public health services whose liability was admitted a long time ago by administrative courts for gross negligence (faute lourde),30 and then, since 1992, for simple negligence.31 Traditionally, the contract of care was deemed to include the commitment of the practitioner to give his or her patient “conscientious and attentive care and, subject to exceptional circumstances, in line with what is known by science.”32 This formula appears, slightly modified, in the Code of Ethics, which is now part of the CSP.33 Article L. 1111-5 para. 1 CSP uses more modern language to express the same principle in terms of subjective rights of the patient: Any person, given his health and the emergency response that it requires, is entitled to receive the most appropriate care and to receive treatment whose effectiveness is recognized and which guarantees the best safety in light of established medical knowledge. Acts of prevention, investigation, or treatment should not, in the state of medical knowledge, make him take risks that are disproportionate to the expected benefits. 28

29 30 31 32

33

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Cass. 1e civ., June 28, 1989, Bull. civ. I, No. 266; D. 1990, 413, note Y. Dagorne-Labbe; Cass. 1e civ., Feb. 25, 1997, Bull. civ. I, No. 72; Revue Générale de Droit des Assurances [General Review of Insurance Law] [RGDA] 1997, 857, obs. Ph. Rémy; Cass. 1e civ., Oct. 13, 1999, JCP 2000 II No. 97-21451, 10270, note A. Dorsner-Dolivet. See generally John Bell, Sophie Boyron & Simon Whittaker, Principles of French Law 342– 43 (2d ed, 2008); Barry Nicholas, The French Law of Contract 50 (2d ed. 2005). I.e., misconduct of particular severity. Conseil d’État [CE] [highest administrative court] Nov. 8, 1935, Rec. Lebon 1019. CE Ass., Apr. 10, 1992, Rec. Lebon 171, concl. Legal. Cass. 1e civ., Nov. 24, 1987, No. 85-13993, D. 1989 Somm. 61, obs. M. Jean Penneau (“des soins consciencieux et attentifs et, réserve faite des circonstances exceptionnelles, conformes aux données acquises de la science”). See CSP art. R. 4127-32; P. Sargos, La révolution éthique des codes de déontologie des professions médicales et ses conséquences juridiques et judiciaires [The Ethical Revolution of Codes of Medical Professional Conduct and the Legal and Judicial Effects Thereof], D. 2007, 811.

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The established standard of scientific knowledge to be considered is the one that existed when the physician performed the therapeutic act of care, not the one that existed at the time of the judgment. For example, it was recently decided that the use of an innovative treatment was not negligent in a case where there were no known adverse effects, where the usual medical treatment had failed, and where no surgical treatment was possible, even though the authorization for marketing the treatment had not been provided for this specific use.34 In general, French courts are not very demanding for negligence to be established so that the victims can be compensated. A simple mistake35 or clumsiness36 may be characterized as negligent. With regard to diagnosis, it should be noted that misdiagnosis is not a fault per se.37 The physician is considered negligent only if he or she failed to gather the necessary resources to complete his or her mission.38 Hence, the persistence of the doctor in his or her diagnosis, in spite of signs justifying a review of such diagnosis, is negligent39 and the physician is at fault if the misdiagnosis could have been avoided through further examination or by appealing to more specialized colleagues.40 Recently, the Conseil d’État sanctioned a hospital that did not proceed with the necessary investigations in order to verify the presence of a tumor: the patient’s kidney had been removed when there was no tumor.41 Negligence has been retained in case of “unreasonable obstinacy in investigations or therapy” for the prolonged reanimation of a child born in a state of apparent death.42 The negligence

34

35 36

37 38

39 40 41 42

Cass. 1e civ., Dec. 11, 2008, No. 08-10255, Gaz. Pal. 2009, Somm. 1463, obs. E. Ferré; see also Cass. 1e civ., Sept. 18, 2008, No. 07-15427, Gaz. Pal. 2008, Somm. 4142, obs. F. Célestin; Revue Des Contrats [Journal of Contracts] 2009, 1028, note O. Deshayes. CE, Jan. 9, 1957, Rec. Lebon 22 (surgeon forgot compress in patient’s body); see also CE, Nov. 22, 1967, Rec. Lebon 439; CE, Feb. 13, 1963, Rec. Lebon 985. Cass. 1e civ., Sept. 18, 2008, Bull. civ. I No. 205; Gaz. Pal. 2008, Somm. 4147, obs. C. Baby-Gareau; D. 2009, Panorama [Pan.] 1305, obs. J. Penneau; RTD civ. 2009, 123, obs. P. Jourdain; see also Cass. 1e civ., Jan. 17, 2008, No. 06-20568, Responsabilité Civile et Assurance [Tort Liability and Insurance] [RCA] 2008, 111, note C. Radé. See Cass. 1e civ., Mar. 1, 2005, Bull. civ. I, No. 104; D. 2005, Informations Rapides, 796 (no liability where psychiatrist had not detected patient’s intention to commit suicide). The CSP provides that the physician must always make his or her diagnosis with the utmost care and devote the necessary time to his or her analysis with the help of the bestsuited scientific methods. CSP art. R. 4127-33; see Cass. 1e civ., Sept. 30, 2010, No. 0968372. Cass. 1e civ., Nov. 13, 2008, No. 07-18008, JCP 2009, II, 10030, note Pierre Sargos. Cass. 1e civ., July 8, 2008, Bull. civ. I, No. 190. CE Mar. 30, 2009, No. 304462. Tribunal Administratif [TA] [regional administrative court of first instance] Nîmes, June 2, 2009, L’Actualité Juridique Droit Administratif [Legal News – Administrative Law] [AJDA] 2009, 2474, concl. D. Riffard (unreasonable obstinacy of doctors who conducted prolonged resuscitation of a child born in a state of apparent death).

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requirement also applies to the case of the installation of a device in or on the patient or of an investigation that implies certain risks. Negligence can be committed in the context of the operation of a health service, for example, if certain elements are omitted in the patient’s record43 or if a nurse did not contact in due course the physician responsible for the service.44 In very few cases, negligence is assumed. Article L. 1121-10 CSP provides for a presumption of negligence that weighs on the shoulders of any laboratory conducting experiments. The laboratory compensates for damage arising from biomedical research, unless it is able to establish that the damage is not attributable to its negligence. Finally, it should be noted that medical negligence may also amount to a criminal offense like unintentional manslaughter45 or involuntary harm to the integrity of the person.46 Physicians and health professionals are increasingly confronted with criminal proceedings for acts committed in the exercise of their functions. Criminal courts have the ability to award compensation to the victim through the “action civile,” under which the health professional can be criminally convicted and the victim can obtain damages directly from the criminal court. Such a procedure is advantageous for the victims because they benefit from the evidence gathered by the penal judge. It should also be noted that under French Law, corporations (“personnes morales”) can be criminally responsible. Criminal convictions concerning health professionals have been increasing in recent years, especially unintentional manslaughter47 and unintentional injuries.48 Indeed, French courts appear to be relatively severe in medical malpractice cases. For example, the Criminal Division of the Cour de cassation has recently sentenced for manslaughter a physician who had supervised an intern for a coelioscopy, during which the intern provoked a hemorrhage that resulted in the patient’s death.49

43 44 45 46 47 48 49

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CE, Jan. 8, 1959, Rec. Lebon 19. CE, Nov. 4, 1970, Rec. Lebon 648. See Code Pénal [C. pén.] art. 221-6. See C. Pén. arts. 222-19, 222–20. See Cass. crim., Feb. 13, 2007, Bull. crim., Nos. 43, 44; JCP 2007, II, 10107, comm. P. Mistretta. See Cass. crim., Oct. 19, 2004, Bull. crim. No. 246; Revue de Sciences Criminelles [Journal of Criminal Justice] 2005, 77, obs. Mayaud. Cass. crim., Feb. 10, 2009, Bull. Crim. No. 33.

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b. Liability for Breach of the Duty of Disclosure (“Obligation d’information”). In addition to the classic case where the physician commits negligence in performing his mission, the practitioner may also be liable for breach of his or her duty of disclosure. Indeed, the physician must disclose to his or her patient the risks of treatment or operation and obtain his or her well-informed consent. This duty was defined by case law50 before being reaffirmed by the Patients’ Rights Law of March 4, 2002 in Article L. 1111-2 CSP. The Cour de cassation states that such a duty of disclosure “is rooted in the requirement to respect the constitutional principle of safeguarding the human person.”51 The reference to the principle of human dignity explains that the decision condemning the practitioner who has failed to deliver complete information is based on Article 1382 of the Civil Code, which means that such responsibility is now a matter of tort law.52 Previously, the doctor was not obliged to inform the patient of exceptional risks. However, the Cour de cassation ruled that the physician must inform the patient of all the “inconveniences that may arise”53 and all risks, even exceptional ones.54 Echoing civil courts, administrative courts adopted a similar position.55 The Patient’s Rights Law of March 4, 2002 relaxed the rule in Article L. 1111-2 para. 1 CSP that requires information on frequent risks or on serious but normally predictable risks. Thus the disclosed information relates to the various investigations, treatments, or preventive measures that are proposed, their usefulness, their degree of urgency,

50 51

52

53

54

55

Cass. req., Jan. 28, 1942, D.C. Jur. 1942, 63; Gaz. Pal. 1942, 1, 177. Cass. 1e civ., Oct. 9, 2001, Bull. civ. I, No. 249 (“dans l’exigence du respect du principe constitutionnel de sauvegarde de la dignité de la personne humaine”); D. 2001, 3470, note D. Thouvenin; JCP 2002, II, 10045, note O. Cachard; Contrats Concurrence Consommation [Competitive Consumer Contracts] [CCC] 2002, No. 22, note L. Leveneur; RTD civ. 2002., 176, obs. R. Libchaber. See Cass. 1e civ., June 3, 2010, Bull. civ. I, No. 573; D. 2010, 1522, note P. Sargos; D. 2010, 2092, chron. N. Auroy & C. Creton; RDSS 2010, 898, note F. Arhab-Girardin; RTD civ. 2010, 571, obs. P. Jourdain; JCP 2010, II, 1453, note Stéphanie Porchy-Simon; JCP 2010, II, 1917, chron. Philippe Stoffel-Munck & Cyril Bloch; Revue Lamy Droit Civil [Lamy Civil Law Journal] [RLDC] 2010, No. 3931. Cass. 1e civ., Feb. 17, 1998, Bull. civ. I, No. 67; Les Petites Affiches [LPA] May 6, 1999, note Halliez; RTD civ. 1998, 681, obs. P. Jourdain; see Cass. 1e civ., Oct. 7, 1998, Bull. civ. I, Nos. 287, 291; JCP 1998, II, 10179, concl. J. Sainte-Rose, note P. Sargos; RTD civ. 1999, 111, obs. P. Jourdain ; JCP 1999, I, 147, obs. G. Viney. Cass. 1e civ., Oct. 9, 2001, Bull. civ. I, No. 252; Cass. 1e civ., Oct. 7, 1998, Bull. civ. I, Nos. 287, 291; D. 1999, 145, note S. Porchy; D. 1999, 259, note D. Mazeaud; RTD civ. 1999, 83, obs. J. Mestre; RTD civ. 1999., 111, obs. P. Jourdain. See CE Sect., Jan. 5, 2000, No. 181899; JCP 2000, II, 10271, note Jacques Moreau; Revue Française de Droit Administratif [French Administrative Law Journal] [RFDA] 2000, 641, concl. Chauvaux; RFDA 2000, 654, note P. Bon; AJDA 2000, 137, chron. M. Guyomar & P. Collin; Revue de Droit Public [Public Law Review] 2001, 412, obs. C. Guettier.

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their consequences, the frequent or serious risks that could be reasonably anticipated, the likely consequences of refusal, and other possible solutions.56 The mere fact that the intervention is medically necessary does not exclude the duty of disclosure.57 The practitioner also has a duty to advise for or against such treatment or operation and must make the patient aware of the consequences of his or her possible refusal or consent.58 However, there are exceptions to the duty of informing the patient. If the patient’s psychological condition does not allow an understanding of the medical advice or the consequences of his or her decision to accept or refuse the treatment or operation, the physician must keep the information to himself59 and reserve the truth for the family. These limits to informing the patient must be based on legitimate reasons and on the interest of the patient, which must be “assessed according to the nature of the pathology, its foreseeable evolution, and the personality of the patient.”60 In 1997, the Cour de cassation ruled that the burden of proving the performance of the duty of disclosure rests on the doctor.61 The Patients’ Rights Law of March 4, 2002, has confirmed this solution.62 Since performance of the duty is a fact, proof can be established by all means. Therefore, the doctor (especially surgeons) should pre-constitute evidence of the fulfillment of his or her duty to inform by preparing a document containing the information provided in the clearest possible manner that should be signed by the patient. A physician who fails to disclose information “deprives the patient of an opportunity to escape, by a better decision, the risk that eventually realized,” and the patient’s harm then becomes a specific harm.63 The compensable damage is determined by measuring the lost opportunity of avoiding the treatment or operation.64 In other words, the non-compli-

56 57 58 59 60 61

62 63 64

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Id. See Cass. 1e civ., July 18, 2000, Bull. civ. I, No. 227. Cass. 1e civ., Nov., 15, 2005, Bull. civ. I, No. 418; JCP 2006, II, 10045, note P. Mistrella. CSP art. R. 4127-35. Cass. 1e civ., May 23, 2000, Bull. civ. I, No. 159; D. 2000, 470, note P. Jourdain. Cass. 1e civ., Feb. 25, 1997, Bull. civ. I, No. 75; D. 1997, Somm. 319, obs. J. Penneau; Gaz. Pal. 1997, 1, 274, rapp. P. Sargos, note J. Guigue; RTD civ. 1997, 434, obs. P. Jourdain; RGDA 1997, 852, obs. Ph. Rémy. See CSP art. L. 1111-2. Cass. 1e civ., Feb. 7, 1990, Bull. civ. I, No. 39; see Cass. 1e civ., Dec. 7, 2004, Bull. civ. I, No. 302; D. 2005, 403, note P. Jourdain. Cass. 1e civ., Feb. 13, 2007, No. 06-12372; CCC 2007, No. 143, obs. L. Leveneur.

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ance with the obligation to inform the patient is the loss of chance (“perte de chance”) to escape the risk that eventually realized. Therefore, the failure to disclose information should be without consequences when the medical treatment was indispensable, as the patient had no choice if he or she wanted to recover.65 Until very recently, the Cour de cassation rejected compensation for moral distress resulting from the fact that the patient had not obtained the relevant information.66 However, the Cour de cassation has overruled its previous decisions on the subject. On June 3, 2010, the court ruled that a patient who did not receive the complete and necessary information suffered a moral distress for which the patient should be compensated.67

c. Vicarious Liability. A physician or a clinic may be vicariously liable in various circumstances. For example, in the case of surgery, a surgeon directs and coordinates the actions of the members of the team that he or she has formed. As team leader, the surgeon is responsible for all the members of the medical team (e.g., anesthesiologist, nurse, midwife) that he or she has chosen. Then he or she has a right of recourse against the negligent professional who caused the harm. When the practitioner is employed by a private institution, the physician’s independence does not preclude his or her subordination with respect to vicarious liability.68 Despite the fact that such independence belongs to “the general principles of law,”69 it does not prevent a physician from being employed by a hospital or any private institution.70 Therefore, while, in principle, a clinic or private hospital should not be responsible for the actions of the physician or surgeon because of the independence of

65

66 67 68 69

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Cass. 1e civ., Dec. 11, 2008, No. 08-10255, Gaz. Pal. 2009, 1, Somm. 1463, obs. E. Ferré; Cass. 1e civ., Feb. 4, 2003, Bull. civ. I, No. 40; D. 2004, Somm. 600, obs. J. Penneau; Droit et Patrimoine [Law and Heritage] [Dr. et patr.] Sept. 2003, 111, obs. F. Chabas; Cass. 1e civ., June 20, 2000, Bull. civ. I, No. 193; CE, July 24, 2009, No. 305372. Cass. 1e civ., Dec. 6, 2007, Bull. civ. I, No. 380; D. 2008, 192, note P. Sargos; JCP 2008, I, 125, obs. Philippe Stoffel-Munck; LPA Mar. 26, 2008, note P. Royer. Cass. 1e civ., June 3, 2010, Bull. civ. I, No. 573. See C. Civ. art. 1384; Cass. crim., Mar. 5, 1992, Bull. crim., No. 101; RTD civ. 1993, 137, obs. P. Jourdain; JCP 1993, 22013, note F. Chabas. Tribunal des conflits [TC] [reconciles disputes between the Conseil d’État and the Cour de Cassation], Feb. 14, 2000, Bull. t. confl., No. 2; RFDA 2000, 1232, note D. Pouyaud. Indeed, the Code of Medical Ethics forbids the physician to “alienate” his or her independence. CSP art. R. 4127-5. Cass. soc., Oct. 27, 1978, Bull. civ. V, No. 725; see L. Mélennec, Le médecin salarié. Les critères du salariat médical [The Salaried Physician: The Standards of Medical Wages], Gaz. Pal. 1998, 1, doctr. 440.

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those skilled in the art,71 the Cour de cassation decides otherwise in cases where an employment contract has been signed.72 Thus, private clinics are liable for their salaried practitioners working as employees, including nurses or midwives.73 Hence, doctors and other private clinic employees shall not be personally liable when they do not exceed the limits of the mission assigned to them by their employer.74 On the contrary, when the physician is self-employed, he or she is responsible for his or her own acts. However, even when the doctor is personally liable, the clinic still is responsible for any breach of its own duty of care,75 which varies depending on the circumstances and the patient’s condition.76 For damage suffered by the patient of a public hospital, the personal responsibility of the practitioner is normally not likely to be engaged. The fault is covered by the service, unless it may be regarded as entirely separable from the service. Indeed, French administrative law draws a distinction between the public service’s negligence (faute de service) and the agent’s personal fault, which is committed if the practitioner places himor herself outside the normal scope of his or her mission in light of the seriousness of his or her misconduct. This might be so when a physician refuses to treat a patient77 or when a hospital physician does not reveal in due course an error in the injection administered to a patient.78 Except in such cases, the patient who suffers a harm that he or she finds to be attributable to the conditions under which he or she was treated should seek the responsibility of the public institution.

71 72 73 74

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The situation is different for public hospitals. Cass. 1e civ., June 4, 1991, Bull. civ. I, No. 185; RTD civ. 1992, 123, obs. P. Jourdain; JCP 1991, 21730, note J. Savatier; Gaz. Pal. 1992, 2, 503, note F. Chabas. Cass. 1e civ., May 26, 1999, Bull. civ. I, No. 175;D. 1999, 719, obs. E. Savatier; D. 1999, 386, obs. J. Penneau; RTD civ. 1999, 634, obs. P. Jourdain. See Cass. 1e civ., July 12, 2007, Bull. civ. I, No. 270; D. 2007, 2908, note S. Porchy-Simon; D. 2008, Pan. 506, obs. J. Penneau; D. 2008, pan. 2899, obs. P. J.; JCP 2007, II, 10162, note S. Hocquet-Berg; RDSS 2007, 1108, obs. F. Arhab; RCA 2007, No. 334, obs. H. Groutel; RTD civ. 2008, 109, obs. P. Jourdain; Cass. 1e civ., Nov. 9, 2004, Bull. civ. I, Nos. 260, 262; D. 2005, 253, note F. Chabas; D. 2005, Pan. 403, obs. J. Penneau; D. 2006, 111, obs. C. Riot; RTD civ. 2005, 143, obs. P. Jourdain. Cass. 1e civ., Nov. 13, 2008, Bull. civ. I, No. 255; D. 2008, AJ 3010; D. 2009, Pan. 1306, obs. J. Penneau; RCA 2009, No. 21; JCP 2009, II, 10030, note Pierre Sargos; RDC 2009, 533, note Jean-Sébastien Borghetti (poor organization). Cass. 1e civ., July 18, 2000, Bull. civ. I, No. 221; RTD civ. 2001, 146, obs. P. Jourdain (lack of monitoring). CE, July 4, 1990, No. 63930, Rec. Lebon tbl. 841; 1991, Somm. 291, note P. Bon & P. Terneyre. CE, Dec. 28, 2001, No. 213931; AJDA 2002, 359, concl. Remy Schwartz.

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2.

Strict Liability

At the time when medical liability was based on contract law (i.e., before the 2002 Law), physicians or clinics were sometimes deemed to owe an “obligation de résultat” to their patient in certain very specific circumstances. In such cases, they were liable because the expected result (safety in conducting analyses, for example) was not reached, even though no negligence was established. Today, strict liability is provided for in various texts, especially in cases where the physician provides health products and when the patient gets infected with a hospital-acquired or nosocomial infection.

a. Strict Liability for Products Provided by Health Professionals. The CSP states that health professionals are strictly liable for any damage caused by the health products (produits de santé) provided to patients.79 Evidently, the law requires that the provided product be defective. Such products may be pharmaceuticals,80 cosmetics, poisonous substances and preparations, vaccines,81 contraceptives, insecticides, dietary foods for special medical purposes, or medical devices.82 In doing so, the law reaffirmed previous solutions developed by the courts. For example, physicians or dentists have long been strictly liable for the safety of supplied prostheses83 even though negligence must be established regarding the installation of prostheses.84 Moreover, the Cour de cassation has ruled that transfusion agencies85 are strictly liable for harm caused by the poor quality of the blood products

79 80

81

82 83

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CSP art. L. 1142-1 para. 1. In particular, CSP art. L. 5111-1 gives a definition of the notion of drug (“médicament”), which reflects the definition of the Directive No. 2004/27 of March 31, 2004. See Directive 2004/27, of the European Parliament and of the Council of 31 March 2004 Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, 2004 O.J. (L 136) 34, 36. However, the State is liable for damages resulting from mandatory vaccinations, even if they are provided by a local GP or a private center, CSP art. L. 3111-9, and compensation paid by the National Fund for Medical Compensation (ONIAM). See CSP art. L. 5111-1. See Cass. 1e civ., Oct. 29, 1985, Bull. civ. I, No. 273; RTD civ. 1986, 762, obs. Huet; Cass. 1e civ., Nov. 22, 1994, Bull. civ. I, No. 340; RTD civ. 1995, 375, obs. P. Jourdain; Cass. 1e civ., Nov. 23, 2004, Bull. civ. I, No. 286; D. 2005, Pan. 403, obs. J. Penneau; RTD civ. 2005, 139, obs. P. Jourdain; D. 2005, IR 17. Cass 1e civ., Feb. 4, 2003, Bull. civ. I, No. 40; RCA 2003, comm. No. 142. Since January 1, 2000, the French Blood Establishment (“Etablissement Français du Sang)” has been the single operator of blood transfusions. CSP art. L. 1222-1. And since the passage of Ordinance 2005-1087 of September 1, 2005, claims concerning blood pro-

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that they provide.86 Such a strict obligation of safety (“obligation de sécurité de résultat”) was extended to clinics in the case where they provide blood products.87 It should be noted here that compensation was made easier when the courts relaxed the causation requirement. Indeed, when the victim proves that his or her viral contamination followed a blood transfusion and that no other mode of contamination existed, the burden of proof is shifted to the defendant, who has to prove that the provided blood products were not defective.88 Such presumption is now provided by various provisions of the Code,89 which have even abandoned the requirement of the absence of another possible factor. The Cour de cassation has also decided that health professionals owe an obligation of safety for the things they use in the course of any therapeutic act.90 However, physicians may be liable only when the thing they use is defective: for example, a physician’s liability was excluded in a case where the patient had an allergic reaction to the physician’s gloves.91 In addition, the Conseil d’État decides that public health institutions are strictly liable for the defective products they supply or the materials they use.92 For contaminated transfusions (e.g., HIV, hepatitis), administrative

86 87 88

89 90

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ducts must be brought before administrative courts. CSP art. L. 1222-9; Ordonnance 2005-1087 du 1er septembre 2005 relative aux établissements publics nationaux à caractère sanitaire et aux contentieux en matière de transfusion sanguine [Ordinance 2005-1087 of September 1, 2005 on National Public Health Care Institutions and Litigation Concerning Blood Transfusion], Journal Officiel de la République Française [J.O.] [Official Gazette of France], Sept. 2, 2005, p. 14262. Cass. 1e civ., Apr. 12, 1995, Bull. civ. I, No. 179; JCP 1995, II, No. 22467. Cass. 2e civ., Apr. 21, 2005, Bull. civ. II, No. 108; D. 2005, IR 1303; LPA Dec. 30, 2005, 3, note E. Georges; RCA 2005, No. 223, obs. Radé. Cass. 1e civ., Jan. 18, 2005, Bull. civ. I, No. 32; Cass. 1e civ., June 18, 2002, Bull. civ. I, No. 169; D. 2002, IR 2307; Cass. 1e civ., July 17, 2001, Bull. civ. I, No. 234; Cass. 1e civ., May 9, 2001, Bull. civ. I, No. 130; D. 2001, 2149, rapp. P. Sargos; RTD civ. 2001, 889, obs. P. Jourdain. See CSP art. L. 3122-2 (HIV); Patients’ Rights Law of March 4, 2002, supra note 16, at art. 102 para 1 (Hepatitis C). Cass. 1e civ., Nov. 9, 1999, Bull. civ. I, No. 300; D. 2000, 117, obs. P. Jourdain; D. 1999, IR 266; Defrénois 2000, 251, obs. D. Mazeaud; JCP G 2000, II, 10251, note Philippe Brun; JCP 2000, I, 243, obs. G. Viney; LPA Oct. 26, 2000, 23, obs. Y. Dagorne-Labbé. Cass. 1e civ., Nov. 22, 2007, Bull. civ. I, No. 366; D. 2008, 816, note M. Bacache; JCP 2008, II, 10069, note I. Corpart; RCA 2008, No. 31, note S. Hocquet-Berg; RDC 2008, 320, note J.-S. Borghetti; see also Cass. 1e civ., Feb. 4, 2003, Bull. civ. I, No. 40; RCA 2003, comm. No. 143. CE, July 9, 2003; APHP/Mme Marzouk RFDA 2003, 1037; AJDA 2003, 1946, note M. Deguergue; RCA 2004, No. 19, note C. Guettier.

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courts have also granted compensation to victims without requiring proof of any negligence.93 Finally, it should be noted that the provisions of Law 98-389 of May 19, 1998, on products liability94 may threaten the existing rules.95 This Law implemented in the Civil Code the provisions of the Directive of July 25, 1985, on products liability96 and established a strict liability of manufacturers (and providers) of defective products for harm caused by such products.97 Yet such a regime contains substantial differences from the provisions of the Code of Public Health. Under these rules, manufacturers are strictly liable for the defective products they put in circulation, but providers are liable only in the case where the manufacturer cannot be identified.98 In addition, the limitation period is shorter under the products liability regime.99 And the defendant is exempted from liability when it is established “that the state of scientific and technical knowledge when the product was put into circulation did not allow for the detection of the existence of the defect,”100 though such exemption is excluded for damage caused by a product or element of the human body.101 Since specific liability regimes are, in principle, excluded by the general regime of products liability, one could wonder if the provisions of the CSP still are applicable to defective health products.

b. Strict Liability for Hospital-Acquired Infections (“Nosocomial Infections”). With regard to nosocomial (hospital-acquired) infections, the Cour de cassation has ruled that physicians and private health institutions were under a “safety obligation of result.”102 In other words, anytime

See CE ass., May 26, 1995, Cts N’Guyen, Jouan, Cts Pavan Rec. Lebon, 221; RFDA 1995, 748, concl. Daël; AJDA 1995, 508, chron. J.-H. Stahl & D. Chauvaux; JCP 1995, II, 22468, note J. Moreau. 94 Loi 98-389 du 19 mai 1998 relative à la responsabilité du fait des produits défectueux [Law 98-389 of May 19, 1998 on Liability for Defective Products], J.O., May 21, 1998, p. 7744. 95 M. Bacache, supra note 22, at §§ 22–35. 96 Council Directive 85/374/EEC of 25 July 1985 on the Approximation of Laws, Regulations and Administrative Provisions of the Member States Concerning Liability for Defective Products, 1985 O.J. (L 210) 29. 97 See C. civ. arts. 1386-1 to -18. 98 C. civ. arts. 1386-1, -7. 99 See C. civ. arts. 1386-16 to -17. 100 C. civ. art. 1386-11. 101 C. civ. art. 1386-12. 102 Cass. 1e civ., Feb. 18, 2009, Bull. civ. I, No. 37; D. 2009, Actualités Juridiques [AJ] 630; RDSS 2009, 359, obs. A. Vignon-Barrault; RTD civ. 2009, 543, obs. P. Jourdain; Cass. 1e civ., Oct. 18, 2005, Bull. civ. I, No. 365; D. 2006, 689, obs. J. Penneau; D. 2006, 705, 93

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the infection may be attributable to medical care, clinics and physicians are strictly liable, unless they establish that the victim’s harm resulted from an external cause (cause étrangère). There is no presumption of causal link between care and infection, so it is for the patient to demonstrate that his or her infection was contracted in the hospital. Whereas this ruling concerned both private practitioners and health institutions, the Patients’ Rights Law of March 4, 2002 confirmed it only for health care institutions.103 Private practitioners are no longer under this rule. Thus, while clinics and health institutions are still strictly liable for hospital-acquired infections, physicians are liable only for negligence for all interventions that occurred after September 5, 2001.104 In cases where the physician’s civil liability is not incurred, the victim may still obtain compensation in the name of the welfare system (solidarité nationale): Law 2002-1577 of December 30, 2002 decided that the ONIAM bears the cost of compensating infections that result in death or in a permanent disability rate above 24 %.105 In the public sector, hospitals’ liability was originally based on the notion of negligence in the organization and operation of the service. In this context, administrative courts created a presumption of negligence, according to which the accidental introduction into the patient’s body of a microbial organism during hospitalization revealed the hospital’s negligence.106 However, the Conseil d’État had a rather strict interpretation of the rule and excluded, for example, endogenous infections, i.e., infections that resulted from bacteria that were already present in the body of the patient but appeared on the occasion of hospitalization.107 Now, public hospitals are strictly liable, and Article L. 1142-1 para. 2 CSP provides that health institutions are responsible for damages resulting from hospitalacquired infections, except in the case where they establish an external cause for the victim’s harm.

103 104 105 106

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note O. Smallwood & F. Vialla; Cass. 1e civ., June 29, 1999, Bull. civ. I, No. 222; D. 1999, 559, note crit. D. Thouvenin; D. 1999, 395, obs. J. Penneau; RTD civ. 1999, 841, obs. P. Jourdain; see Cass. 1e civ., June 14, 2007, Bull. civ. I, No. 233; D. 2007, IR 1870; Cass. 1e civ., Apr. 4, 2006, Bull. civ. I, No. 191; RTD civ. 2006, 567, obs. P. Jourdain. See Code de la Santé Publique art. L. 1142-1 Cass. 1e civ., June 21, 2005, Bull. civ. I., No. 276. Loi 2002-1577 du 30 décembre 2002 relative à la responsabilité civile médicale [Law 2002-1577 of Dec. 30, 2002 on Medical Liability], J.O., Dec. 31, 2002, p. 22100. See CE, Feb. 19, 1992, M No. 73403; CE, June 14, 1991, M No. 65459; CE, Mar. 1, 1989, B No. 61406; CE, Dec. 9, 1988, Cohen Rec. Lebon 431; AJDA 1989, 405, obs. J. Moreau; D. 1989, Somm. 347, obs. F. Moderne & P. Bon. CE, Sept. 27, 2002, Ms. N No. 211370.

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c. Strict Liability for Harm Resulting from Therapeutic Hazards (“Aléa Thérapeutique”). If an accident occurs in the course of medical care where no negligence was committed, the victim cannot be compensated. Before the Patients’ Rights Law of March 4, 2002, administrative judges established a compensation scheme guided by fairness for the benefit of patients of public hospitals. In the Bianchi decision in 1993,108 the Conseil d’État set out several requirements109: therapeutic act necessary for the treatment or diagnosis of the patient, with an exceptional but known110 risk, absence of any predisposition of the patient to such risk, damage directly related to the achievement of hazard, and extremely serious injury.111 Compensation was to be granted only for disorders that presented an obvious abnormality that was out of proportion to those the patient suffered before care112 and did not constitute a reasonably foreseeable development of the patient’s previous state.113 The mechanism was defined narrowly, and the application of the rule was therefore limited.114 Since the Patients’ Rights Law of March 4, 2002 created a compensation scheme for medical hazards in cases where victims suffer serious harm (permanent disability of 24 % or temporary incapacity of more than six months),115 this rule should henceforth concern a very small number of victims.

108 CE Ass., Apr. 9, 1993, Bianchi Rec. Lebon, 127. Three years earlier, the seminal Gomez decision had paved the way. See Cour administrative d’appel [CAA] [Administrative Court of Appeal] Lyon, Dec. 21, 1990, Cts Gomez Rec. Lebon, 498. 109 CE Ass., Apr. 9, 1993, Bianchi Rec. Lebon, 127 (“lorsqu’un acte médical nécessaire au diagnostic ou au traitement du malade présente un risque dont l’existence est connue mais dont la réalisation est exceptionnelle et dont aucune raison ne permet de penser que le patient y soit particulièrement exposé, la responsabilité du service public hospitalier est engagée si l’exécution de cet acte est la cause directe de dommages sans rapport avec l’état initial du patient comme avec l’évolution prévisible de cet état, et présentant un caractère d’extrême gravité”) (“when a medical act necessary for the diagnosis or treatment of the patient presents a risk whose existence is known but improbable, and there is no reason to believe that the patient is particularly predisposed, the public hospital is deemed liable if its execution of the act is the direct cause of injury unrelated to the initial state of the patient, and the injury is extremely serious”) 110 The fact that an accident is due to a risk that was unknown at the time of surgery can preclude compensation. CE, Oct. 24, 2008, No. 297994 M. et Mme Chottin; CE, July 7, 2006, No. 264217, Lagorio 111 CE, July 25, 2007, No. 293793 Mme Russo a.,; CE, July 25, 2007, No. 285061 M. Juillard. 112 CE, Jan. 14, 2009, No. 284434 CPAM des Ardennes. 113 CE, July 25, 2007, No. 274682 CHG d’Avignon; CE, May 16, 2007, No. 287206 Martinet. 114 See CE Sect., Nov. 3, 1997, No. 153686, Hôpital Joseph Imbert d’Arles AJDA 1997, 1016, 959, chron. T.-X. Girardot & F. Raynaud; CE, Oct. 27, 2000, No. 208640, D. 2001, 1196, concl. Chauvaux; AJDA 2001, 307, note M. Deguergue; LPA 2001, No. 132, 18, note C. Guettier; LPA 2002, Somm. 449, note P. Bon & D. de Béchillon; see also CE, Oct. 27, 2000, No. 201790, Centre Hospitalier d’Aubagne [Hospital of Aubagne] 2001, 1196, note D. Chauvaux; Droit Administratif [Dr. adm.] 2001, No. 132, note C. Esper. 115 See CSP art. L. 1142-1-1.

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B.

The Causal Link

1.

Causation Criterion

The proof of causal link is required to compensate the consequences of any breach of contract or any tort, but the causation criterion is difficult to determine. The theory of the equivalence of conditions has commonly been applied in French civil law,116 so that a factor must be a but-for condition of the damage to qualify as a cause. This means that causation is not established unless it is shown that the damage would not have occurred absent the factor in question. For example, there is no causal link if it is established that, had the victim been fully informed of the risks of surgery, he or she still would have chosen to undergo it.117 The equivalence of conditions is also applied in cases where the patient shows pathological predispositions. Indeed, the peculiarities of the patient do not prevent the courts from judging that the physician’s misconduct caused the harm and justifies full compensation – for example, in cases where the medical malpractice had revealed a pre-existing and latent disease118 or where the patient had an allergic reaction to the gloves used by the surgeon.119 However, the principle of equivalence is not always applied as such by the courts. The notions of direct link120 or adequate causation are sometimes invoked as well. For example, despite the earlier cases, the Cour de cassation has decided to ignore the victim’s contributory negligence to the accident in cases of blood contamination after a traffic accident.121 Similarly, the Criminal Division of the Cour de cassation has refused to link the death of the victim of a hospital-acquired infection to the accident that made

116 Geneviève Viney & Patrice Jourdain, Les Conditions de la Responsabilité de Droit Civil [Conditions of Civil Liability],¶ 355 (3d ed. 2006); see also Florence G’sell-Macrez & Duncan Fairgrieve, Causation in French Law: Between Pragmatism and Policy, in Perspectives on Causation (Richard Goldberg ed., Hart, Oxford, 2011). 117 Cour d’appel [CA] [regional court of appeal] Paris, Nov. 20, 2003, RCA 2004, Comm. No. 76, obs. Ch. Radé. 118 See Cass. 1e civ., Dec. 7, 1999, Bull. civ. I, No. 337. 119 See Cass. 1e civ., Nov. 22, 2007, Bull. civ. I, No. 366; RDC 2008, 320, note J.-S. Borghetti. 120 Cass. 3e civ., Feb. 19, 2003, No. 00-13253, RCA 2003, Comm. No. 125; RTD civ. 2003, 508. 121 Cass. 2e civ., Oct. 20, 2005, Bull. civ. II, No. 274; RTD civ. 2006, 122, obs. P. Jourdain; D. 2006, Pan. 1930, obs. P. Jourdain.

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hospitalization necessary.122 In certain medical malpractice cases, the Civil Chambers of the Cour de cassation have sometimes judged that the victim’s harm could not be considered as resulting from a previous accident123 or from earlier medical malpractice,124 even when such events had made the surgery necessary. Moreover, in French administrative law, most commentators have asserted that the requirement of causal link is expressed by the courts through the test of la théorie de la causalité adéquate,125 and there is a good deal of consensus on the use of this test by the administrative judiciary.126 Chapus asserts that the correct inquiry is whether the defendant’s act could ‘in the normal run of things’ be considered as having played a ‘particular’ role in causing the damage.127 Consequently, it is not possible to speak of a uniform application of the equivalence principle: it varies on a case-by-case basis.

2.

Causation Proof

In principle, the burden of proof is upon the claimant to prove that the defendant’s wrongful act has generated his or her damage. In this context, causation is considered as a legal fact (“fait juridique”) that can be proved by all means (“par tous moyens”). This implies that all types of evidence are admissible. Moreover, the assessment of the evidence submitted by the claimant falls within the sovereign appreciation of lower courts (“appreciation souveraine des juges du fond”). However, the French Cour de cassation has the ability to review the grounds given by trial judges to justify their decisions. In many cases, judges resort to the use of presumptive evidence by basing their decision on Article 1349 of the Civil Code, which defines presumptions as “the consequences that a statute or the court draws from a known fact to an unknown fact.” Specifically, Article 1353 C. civ.

122 Cass. crim., Oct. 5, 2004, Bull. crim., No. 230. It should be noted that this case applied the new provisions of the law of July 10, 2000, which require proof of serious misconduct if the causal link is indirect. Id. 123 See Cass. 2e civ., Feb. 4, 1987, Bull. civ. II, No. 38. 124 Cass. 1e civ., Sept. 30, 1997, Bull. civ. I, No. 259; RCA 1997, Comm. 373. 125 ‘Adequacy theory’ or ‘adequate cause theory.’ See Jacques Moreau, 2 Droit Public: Droit Administratif 598 (3d ed. 1995); see also Walter Van Gerven, Jeremy Lever & Pierre Larouche, Tort Law 421 (2000); Piere Vialle, Lien de Causalité et Dommage Direct dans la Responsabilité Administrative [Causation and Damages in Direct Administrative Liability], 90 Revue de Droit Public et de la Science Politique en France et à l’Étranger [Journal of Public Law and Political Science in France and Abroad] 1243, 1268 (1974). 126 See also CE, Oct. 14, 1966, Marais D. 1966, 636, concl. Galmont; CE, June 9, 1995, Lesprit,AJDA 1995, 745, concl. Arrighi de Casanova. 127 René Chapus, 1 Droit Administratif Général ¶ 1413 (15th ed. 2001).

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provides that presumptions “are left to the insight and carefulness of the judges, who shall only admit serious, precise, and concurrent presumptions.” In this context, the Cour de cassation controls the arguments used by judges to justify the admission or rejection of a causal link.128 The formula “serious, precise, and concurrent presumptions” is generally used.129 Here it should be noted that “evidence by exclusion” is a form of presumptive reasoning. If no other factors explain the occurrence of the damage, then the defendant’s behavior is deemed to be a cause – for example, if the patient’s hypertension cannot be explained by anything other than taking a specific drug.130 Whilst French courts generally try to assert their independence vis-à-vis the views of experts, experience shows that, in fact, the impact of science on the judicial determination of causation is significant.131 The French system is particularly marked by the judicial delegation of technical matters to a court-appointed expert. Nevertheless, the Cour de cassation has recently illustrated the willingness of the French judiciary not to follow systematically the view of appointed court-experts. Litigation concerning the Hepatitis B vaccine has given rise to important decisions of the Cour de cassation in a context where there is no tangible scientific evidence of the vaccine’s toxicity. Confronted with victims of neurological disorders such as multiple sclerosis, French judges have gradually changed their minds. In 2003, the Cour de cassation refused to accept the existence of a causal link between Hepatitis B vaccination and multiple sclerosis because of the scientific uncertainty of that link as highlighted by experts.132 However, in 2008, the Cour de cassation handed down six important decisions in which it was accepted that such a causal link could be established by “serious, precise, and concurrent” presumptions, notwith-

128 See Cass. 1e civ., Feb. 4, 2003, Bull. civ. I, No. 40; D. 2004, Somm. 600, obs. J. Penneau; Dr. et patr., Sept. 2003, 111, obs. F. Chabas. 129 See Cass. 1e civ., Jan. 24, 2006, Bull. civ. I, No. 34; D. 2006, Pan., 1931, obs. P. Jourdain; JCP 2006, II, 10082, note L. Grynbaum; RCA 2006, No. 89, note C. Radé; RTD civ. 2006, 323, obs. P. Jourdain. 130 Cass. 1e civ., Jan. 24, 2006, Bull. civ. I, No. 35; JCP 2006, I, 166, No. 5, obs. Ph. StoffelMunck ; JCP 2006, II, 10082, note L. Grynbaum; RTD civ. 2006, 323, obs. P. Jourdain. 131 Cass. 1e civ., Feb. 27, 2007, No. 06-10063, RCA 2007, No. 165 (“l’existence d’un lien causal … ne pouvait se déduire du seul fait que l’hypothèse d’un risque vaccinal non démontrée ne pouvait être exclue”) (“the existence of a causal link . . . could be inferred from the mere fact that the hypothesis of an unproven vaccine risk could not be excluded”) . 132 Cass. 1e civ., Sept. 23, 2003, Bull. civ. I, No. 188; RCA, 2003, chron. 28, Ch. Radé ; D. 2004, 898, note Y.-M. Sérinet & R. Mislawski; JCP G 2003, II, 10179; RLDC 2004, 11, chron. S. Hocquet-Berg; RTD civ. 2004, obs. P. Jourdain.

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standing scientific uncertainty and lack of conclusive statistical data.133 Since then, the Cour de cassation has had the opportunity to reaffirm its position on several occasions in cases concerning multiple sclerosis134 as well as other neurological disorders.135 In such cases, two considerations are taken into account by judges: first, the fact that no other factor could explain the disease (victim in good health, no medical history); second, the temporal proximity between the injection of the vaccine and the appearance of the first symptoms. It should also be mentioned here that the Conseil d’État has adopted a similar position and criteria in litigation arising from the compulsory vaccination against Hepatitis B.136 However, in other recent vaccine cases, French judges have denied the existence of a causal relationship when other factors could explain the disease137 or when the evidence brought by the claimants did not appear sufficient to constitute “serious, precise, and concurrent presumptions.”138 “Serious, precise and concurrent presumptions” are “presumptions of fact,” which must be distinguished from “presumptions of law” (“présomp-

133 Cass. 1e civ., May 22, 2008, Bull. civ. I, Nos. 147, 148, 149; May 22, 2008, Nos. 0510593, 06-18848, 07-17200; RCA, 2008, étude 8, ch. Radé; RDSS 2008, 578, J. Peigné; JCP 2008, II, 10131, L. Grynbaum; RTD civ. 2008, 492, P. Jourdain; Gaz. Pal. 2008, No. 283, 49, S. Hocquet-Berg; RDC 2008, 1186, J.-S. Borghetti; JCP 2008, I, 186, P. Stoffel-Munck. 134 See Cass. 1e civ., July 9, 2009, Bull civ. I, No. 176; D. 2009. Actualités Juridiques [AJ], 1968, obs. I. Gallmeister; D. 2010, 49, obs. P. Brun & O. Gout; RTD civ. 2009, 723 & 735, obs. P. Jourdain; Gaz. Pal. 2009, No. 225, 9, avis A. Legoux; RCA 2009, étude 13, Ch. Radé. 135 See Cass. 1e civ., June 25, 2009, Bull. civ. I, No. 141; JCP G 2009, No. 41, 308, note P. Sargos; RCA 2009, comm. 293 136 See CE, Mar. 9, 2007, No. 267635; JCP A 2007, 2108, note D. Jean-Pierre; JCP A 2007, 2277, note S. Carpi-Petit; JCP 2007, II, 10142, note A. Laude; AJDA 2007, 861, concl. T. Olson; Aude Rouyère, Variations jurisprudentielles à propos du lien de causalité entre vaccination contre l’hépatite B et sclérose en plaques: Questions de méthode [Jurisprudential Changes Regarding the Causal Link Between the Hepatitis B Vaccine and Multiple Sclerosis], RFDA 1011 (2008). Indeed, the Patients’ Rights Law of March 4, 2002, enabled healthcare professionals vaccinated against hepatitis B before entry into force of Law 91-73 of January 18, 1991, which imposed such a vaccination, to obtain compensation for multiple sclerosis. Patients’ Rights Law of March 4, 2002, supra note 16, at art. 104; see Loi 91-73 du 18 janvier 1991 portant dispositions relatives à la santé publique et aux assurances sociales [Law 91-73 of January 18, 1991 on Public Health and Social Insurance], J.O., Jan. 20, 1991, p. 1048. The Conseil d’État admitted that when certain conditions are met, such as the clinically recognized symptoms of the disease within three months maximum after the injection and the absence of any factor of the disease in the patient’s history, compulsory vaccination against hepatitis B could be regarded as the origin of the damage. CE, Feb. 18, 2009, Gaz. Pal. 2009, 20, note D. Cristol. 137 See Cass. 1e civ., Jan. 22, 2009, Bull. civ. I, No. 11; RDC 2009, No. 3, 1028, obs. O. Deshayes. 138 Cass. 1e civ., Sept. 24, 2009, Bull. civ. I, No. 185; D. 2009, 2426, obs. I. Gallmeister; RCA 2009, Comm. 328, obs. Ch. Radé; see also Cass. 1e civ., Nov. 25, 2010, No. 0916556.

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tions de droit”) that require the judge to assume a certain fact once another fact is established. Presumptions of law can be created by the legislature or by the judge. For instance, mandatory presumptions are prescribed by law for certain kind of injuries, especially diseases resulting from contaminated blood transfusions.139 When the legislator or the judge decides to reverse the burden of proof, this action amounts to a presumption of law. For instance, the Cour de cassation has recently decided to reverse the burden of proof for the benefit of victims in cases where the defendant could not be identified,140 thus creating a new presumption of law in diethylstilbestrol (DES) litigation. More recently, in a case where the victim of a hospital-acquired infection had been treated in various institutions, it was decided that all institutions were jointly and severally liable unless they were able to establish that they did not cause the infection.141 Finally, it should be emphasized that French courts tend to compensate the uncertainty of causal judgments by widely using the concept of “loss of chance”.142 In a seminal case, a doctor had committed an error of diagnosis on a child who remained crippled: the judges condemned the doctor to pay damages for the loss of “chances of cure.”143 Since this decision, French courts often use the “loss of chance” concept in order to compensate the victims, even though the causal link is uncertain. It is often decided that, if the patient was not thoroughly informed, he or she should be compensated only for the loss of chance to escape the risk. Moreover, compensation is granted for loss of chance when the patient should have benefited from an earlier or better treatment, but it is impossible to determine whether the patient would have recovered if such treatment had been provided.144 Thus, the victim must establish that his or her chance of survival, recovery, or even fewer sequelae, would

139 See supra text accompanying notes 85–89. 140 Cass. 1e civ., Sept. 24, 2009, Bull. civ. I, Nos. 186, 187; D. 2009, Actualités Juridiques [AJ], 2342, obs. Gallmeister; D. 2010, Pan., 49, obs. Brun; JCP 2009, 304, obs. Mistretta; JCP 2009, 383, note Hocquet-Berg; RLDC 2009, 65, No. 3605, obs. Bugnicourt; RLDC 2010, 01, No. 67-10, note B. Parance; Cass. 1e civ., Jan. 28, 2010, Bull civ. I, No. 22. 141 Cass. 1e civ., June 17, 2010, Bull. civ. I, No. 137. 142 Florence G’sell-Macrez, Recherches sur la notion de causalité [Research on the Notion of Causality] ¶¶ 455–457 (2005), thèse Paris 1; see also Jacques Boré, L’indemnisation pour les chances perdues, une forme d’appréciation quantitative de la causalité d’un fait dommageable [Compensation for Lost Opportunities: A Form of Quantitative Assessment of Causality of an Injury], JCP G 1974, I, 2620; Gérard Mémeteau, Perte de chances et responsabilité médicale [Loss of Opportunities and Medical Liability], Gaz. Pal. 1997, II, 1367. 143 Cass. 1e civ., Dec. 14, 1965, Bull. civ. I, No. 707; JCP G, 1966, II, 14753, note R. Savatier; see also Cass. 1e civ., Jan. 27, 1970, Bull. civ. I, No. 37; JCP G 1970, II, 16422, note Rabut; G. Viney et P. Jourdain, op. cit. para 370. 144 See Cass. 1e civ., July 8, 1997, Bull. civ. I, No. 239.

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have been greater if the doctor had given a good diagnosis or appropriate care145 or if the decision to hospitalize the patient had been taken earlier.146 With regards to the public sector, it should be noted that before 2000, the Conseil d’État did not apply the concept of loss of chance to hospital liability and decided cases on an all-or-nothing basis. Then two decisions ruled that the “loss of a chance to escape an event that finally occurred should correspond to a fraction of the various heads of damage sustained.”147 The Conseil d’État has recently extended compensation for loss of chance to malpractice cases.148 In addition, the Criminal Division of the Cour de cassation sometimes hands down convictions for manslaughter in cases where only a chance of survival was lost, i.e., where it could not be established with certainty that the patient would not have died if properly cared for.149 However, when healing, survival, or improving the patient’s condition remains highly speculative in the absence of medical malpractice, no legal remedy is possible because the fault did not cause the victim to lose a substantial chance.150 Although the courts do not admit officially that compensation for loss of chance is a way to relax the causation requirement,151 they accept the principle of measuring compensation in reference to the extent of the lost opportunity. When the impact of the defendant’s action (or forbearance) is difficult to measure, the defendant’s liability is modulated according to

145 Cass. 1e civ., July 8, 1997, Bull. civ. I, No. 238; JCP 1997, 22921, rapp. P. Sargos; Cass. 1e civ., July 16, 1991, Bull. civ. I, No. 248; Gaz. Pal. 1992., 1, Somm. 152, obs. F. Chabas; Cass. crim., Mar. 20, 1996, Bull. crim., No. 119; RTD civ. 1996, 912, obs. P. Jourdain; Cass. 1e civ., July 10, 2002, Bull. civ. I, No. 197. 146 Cass. 1e civ., Nov. 25, 1997, No. 95-21785, RCA 1998, No. 58. 147 CE Sect., Jan. 5, 2000, Assistance publique – Hôpitaux de Paris c/ M. Guilbot and Consorts Telle Nos. 181899, 198530, RFDA 2000, 641, concl. D. Chauvaux; RFDA 2000, 654, note P. Bon; AJDA 2000, 137, chron. M. Guyomar & P. Collin; RDSS 2000, 357, note L. Dubouis; LPA 2000, note C. Clément; JCP 2000, II, 10271, note J. Moreau. 148 See CE Sect., Dec. 21, 2007, Centre Hospitalier de Vienne c/ M. Joncart No. 289328, RFDA 2008, 348, concl. T. Olson; AJDA 2008, 135, chron. J. Boucher & B. BourgeoisMachureau; JCP 2008, 14, 27, chron. B. Plessix; JCP Adm. 2008, Comm., 2078, C. Paillard; see also CE Feb. 18, 2010, Consorts Ludwig No. 316774, RFDA 2010, 791, note M. Canedo-Paris. 149 Cass. crim., Jan. 9, 1979, Bull. crim., No. 14; JCP 1980, 19272, note F. Chabas; Cass crim., June 29, 1999, Bull. crim., No. 162; D. 2000, Somm. 30, obs. Y. Mayaud; Cass. crim., Nov. 13, 2002, Bull. crim., No. 203; D. 2004, 1336, note Conte. 150 Cass. 1e civ., June 20, 2000, Bull. civ. I, No. 193; D. 2000, Somm. 471, obs. P. Jourdain; Defrénois 2000, 1121, obs. D. Mazeaud; Cass. 1e civ., Nov. 13, 2002, Bull. civ. I, Nos. 265, 266; RTD civ. 2003, 98, obs. P. Jourdain; Cass. 1e civ., Feb. 4, 2003, Bull. civ. I, No. 40; D. 2004, 600, note J. Penneau; Cass. 1e civ., Dec. 6, 2007, Bull. civ. I, No. 380; D. 2008, 192, note P. Sargos; JCP 2008, I, 125, Nos. 3, 15, obs. Ph. Stoffel-Munck; RTD civ. 2008, 272, obs. J. Hauser; RTD civ. 2008, 303, obs. P. Jourdain. 151 See Cass. 1e civ., Nov. 17, 1982, Bull. civ. I, No. 333; JCP 1983, II, 20056, note M. Saluden; D. 1984, 305, note A. Dorsner-Dolivet.

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the probability that he or she has caused the damage152: thus the entire injury is not compensated.153 Khoury has pointed out the extreme flexibility of French law on the subject and the proximity of the mechanism of compensation for missed opportunities with liability based on increased risk.154

C.

The Victim’s Harm

Article 16-3 para. 1 of the Civil Code provides that the integrity of the human body cannot be impaired except in case of medical necessity for the person.155 However, in medical malpractice cases, the damage alleged by the victim often is a lost opportunity for an improvement in his or her condition, because it is difficult to assess what would have happened if the victim had been properly cared for. The Cour de cassation has even admitted that the victim’s heirs could be compensated for the loss of a chance of survival.156 But there are other kinds of compensable harm. For instance, victims in a chronic vegetative state or who are unconscious can be compensated for moral distress insofar as compensation for damage does not depend on the victim’s subjective feeling, but its finding by the court and its objective evaluation.157 Moreover, being contaminated with HIV is compensable as such even if AIDS has not been triggered: the courts use the concept of “specific harm of contamination” (“prejudice spécifique de contamination”) in order to compensate the fact of being contaminated.158 152 Cass. 1e civ., Jan. 28, 2010, Bull. civ. I, No. 19; D. 2010, 947, note G. Maître; JCP 2010, No. 474, note S. Hocquet-Berg,;RTD civ. 2010, obs. P. Jourdain. 153 See Cass. 1e civ., Mar. 27, 1973, Bull. civ. I, No. 115; Cass. 1e civ., July 8, 1997, Bull Civ. I, No. 239; Cass. 1e civ., July 10, 2002, Bull. civ. I, No. 197. 154 Lara Khoury, Causation and Risk in the Highest Courts of Canada, England and France, 124 Law Quarterly Review 103–31, (2008). 155 C. civ. art. 16-3 (“Il ne peut être porté atteinte à l’intégrité du corps humain qu’en cas de nécessité médicale pour la personne”). 156 Cass. 1e civ., Oct. 14, 2010, Bull. civ. I, No. 889. 157 Cass. 2e civ., Feb. 22, 1995, Bull. civ. II, No. 61; D. 1995, Somm. 233, obs. D. Mazeaud; JCP 1995, I, 3853, obs. G. Viney; D. 1996, Jur., 69, note Y. Chartier; JCP 1996, II, 22570, note Y. Dagorne-Labbe; RTD civ. 1995, 629, obs. P. Jourdain; see also Marie-Annick Péano, Victimes en état végétatif: une étape décisive [Victims in a Vegetative State: A Milestone], RCA 1995, chron. no 13; Laurence Ravillon, Le statut juridique de la personne en état végétatif chronique [The Legal Status of the Person in a Persistent Vegetative State] RDSS 191, (1999). 158 Cass. 2e civ., Apr. 2, 1996, Bull. civ. II, No. 88; JCP 1996, I, 3985, no 12, obs. Viney (”[ce prejudice] comprend l’ensemble des préjudices de caractère personnel . . . tant physiques que psychiques et résultant, notamment, de la réduction de l’espérance de vie, des perturbations de la vie sociale, familiale et sexuelle ainsi que des souffrances et de leur crainte, du préjudice esthétique et d’agrément ainsi que de toutes les affections opportunistes consécutives à la déclaration de la maladie “) (“this harm includes all harms of a personal nature . . . both physical and

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Finally, when a child is born disabled or malformed, administrative and judicial courts do not preclude recognition of a parent’s right to compensation if, for example, the child was born disabled as a result of a failed abortion attempt.159 When a physician commits an error in prenatal diagnosis regarding the possibility of a genetic or congenital disability, the damage caused by the physician’s misconduct does not correspond to the handicap, but to the birth of the child. Both the Conseil d’État160 and the Cour de Cassation161 have accepted the principle of compensating the parents in such a case. Moreover, in the notorious Perruche case, in 2000, the child himself won a claim for “wrongful life.”162 Since this latter decision generated much criticism and controversy in France, the Patients’ Rights Law of March 4, 2002 has intended to break the trend initiated by the Perruche decision by stating that “no one can claim an injury solely because of his or her birth.”163 In addition, this Law provides that a person born with a disability due to medical negligence can obtain compensation for his or her damage only when the wrongful act was the direct cause of the disability, or worsened it, or when the practitioner wrongfully avoided taking the measures likely to lessen its impact.164 In other cases, disabled persons have the right to benefit from the solidarity of the entire national community, which is provided for in Law 2005-102 of February 11, 2005, which created a new “compensation benefit” in addition to the existing aids.165 In any case, since the provisions of the Patients’ Rights Law of

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psychological, resulting, particularly, in the reduction of life expectancy, disruption of social, family, and sexual life, as well as suffering and fear, disfigurement, loss of enjoyment, as well as all opportunistic infections resulting from the onset of the disease”); Cass. 2e civ., Sept. 24, 2009, , Bull. civ. II, No. 226. CE Ass., July 2, 1982, Dlle R, Rec. Lebon 260; Gaz. Pal. 1983, 1, 193, note F. Moderne; D. 1984, 425, note J.-B. d’Onorio; Cass. 1e civ., June 25, 1991, Bull. civ. I, No. 213; D. 1991, 566, note Ph. le Tourneau. See CE Sect., Feb. 14, 1997, CHR de Nice c/ Épx Quarez Rec. Lebon 44; concl. Pécresse; RFDA 1997, 382, note B. Mathieu; AJDA 1997, 430, chron. D. Chauvaux & T.-X. Girardot; JCP 1997, II, 22828, note J. Moreau; RDP 1997, 1139, note J.-M. Auby & J. Waline; D. 1997, Somm. 322, obs. J. Penneau. Cass. 1e civ., Mar. 26, 1996, Bull. civ. I, No. 155; RTD civ. 1996, 623, obs. P. Jourdain; JCP 1996, I, 3985, obs. G. Viney; D. 1997, 35, note J. Roche-Dahan; D. 1997, Somm. 322, obs. J. Penneau; LPA 1996, No. 147, note Y. Dagorne-Labbe. Cass. ass. plén. Nov. 17, 2000, Bull. ass. plén., No. 9; D. 2000, III, Point de vue C. Labrusse-Riou & B. Mathieu; JCP 2000, Act. 2267, F. Terré; JCP 2000, I, 279, obs. G. Mémeteau; JCP G 2000, II, 10438, concl. J. Sainte-Rose, rapp. P. Sargos, obs. F. Chabas; LPA 2000, 9, note M. Gobert; D. 2001, 332, note D. Mazeaud; D. 2001, 336, note P. Jourdain; JCP 2001, I, 286; RTD civ. 2001, 149, obs. P. Jourdain. Patients’ Rights Law of March 4, 2002, supra note 16, at art. 1 (“Nul ne peut se prévaloir d’un préjudice du seul fait de sa naissance.”). Id. Loi 2005-102 du 11 février 2005 pour l’égalité des droits et des chances, la participation et la citoyenneté des personnes handicapées [Law 2005-102 of Feb. 11, 2005 on Equal

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March 4, 2002 reduce the existing rights of the victims to obtain compensation, it has been decided that such provisions should be applied only to cases where the child was born after the Law entered into force.166

II.

Administration and Adjudication of claims based on liability rules

Since the Patients’ Rights Law of March 4, 2002, all health professionals and health institutions are under the obligation to buy insurance against their own liability,167 except for public institutions, which are their own insurers.168 Articles L1142-25 and -26 CSP provide for criminal sanctions in the absence of insurance.169 In the case where the liable health professional is not covered (e.g., coverage elapsed or insurance limits are reached), or if the insurer’s offer is insufficient, the victim can ask for compensation from the ONIAM.170 It should be emphasized that compensation through public welfare (“solidarité nationale”) is subsidiary to compensation based on liability rules, which means that the ONIAM shall only compensate medical accidents when no health professional or institution

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Rights and Opportunities, Participation, and Citizenship of People with Disabilities], J. O., Feb. 12, 2005, p. 2353. Conseil constitutionnel [CC] [Constitutional Court] decision No. 2010-2QPC, June 11, 2010, J.O. 10847; Cass. 1e civ., July 8, 2008, Bull. civ. I, No. 190; CE Sect., Feb. 19, 2003, Maurice Rec. Lebon 41; RCA 2003, Comm. No. 208, note C. Guettier; Case of Draon v. France, App. No. 1513/03, at ¶¶ 112–114 (Eur. Ct. H. R. Oct. 6, 2005), available at http://cmiskp.echr.coe.int/tkp197/search.asp?skin=hudoc-en (accessed by entering case name, application number, and judgment date in relevant fields); Case of Maurice v. France, App. 11810/03, at ¶¶ 121–123 (Eur. Ct. H. R. Oct. 6, 2005), available at http:// cmiskp.echr.coe.int/tkp197/search.asp?skin=hudoc-en (accessed by entering case name, application number, and judgment date in relevant fields); see generally Rémi Pellet, La décision QPC du 11 juin 2010 du Conseil constitutionnel et l’assurance des praticiens et établissements de santé [The QPC Decision of June, 11, 2010, of the Constitutional Court and Insurance for Practitioners and Health Institutions, Hors-série [Special Issue] RDSS 127 (2010), available at http://www.remipellet.com/pages/publications/art%20RP%20sur% 20QPC%2011%20juin%202010.pdf. CSP art. L. 1142-2. In 2002, a “Bureau central de tarification” (Central Bureau of Tariffs) was created, and it is in charge of determining the premiums for this compulsory insurance. Code des Assurances [Insurance Code] [C. ass.] art. L. 252-1; see Laurent Leveneur, L’intervention du Bureau central de tarification en matière d’assurance de responsabilité civile médicale [The Intervention of the Central Bureau of Tariffs in Medical Liability Insurance], RDSS 59 (2010). M. Dupont, Un établissement de santé « propre assureur »: l’expérience de l’Assistance publiquehôpitaux de Paris, [A “Self-Insured” Health Care Facility: The Experience of the Assistance Publique-Hôpitaux de Paris] RDSS 91 (2010). CSP arts. L. 1142-25, 1142-26. See CSP article L. 1142-21-1 (concerning obstetricians, surgeons, and anesthetists); see also Cristina Corgas-Bernard, L’assurance de responsabilité civile des professionnels libéraux de la santé [The Liability Insurance of Private Health Practitioners], RDSS 75 (2010).

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may be held liable.171 However, the Cour de cassation has recently decided that the two systems shall complement each other when full compensation cannot be granted through liability.172 The Patients’ Rights Law of March 4, 2002 has provided for a new procedure to the benefit of the victims, in order to promote simple and quick compensation. Today, the victims have two options: (1) they can bring their claim before a conciliation commission, or (2) they can file a lawsuit against the health professional.173

A.

Adjudication Through Conciliation Commissions

The Patients’ Rights Law of March 4, 2002 and the Law of December 30, 2002174 provide for regional commissions of conciliation and compensation for medical accidents (“Commission Régionale de Conciliation et d’Indemnisation des accidents médicaux, affections iatrogènes et infections nosocomiales” [CRCI]) in each region.175 This new organization aims to provide new ways to solve disputes through amicable means and to help the victims obtain prompt compensation. CRCIs were created by the Decree of May 3, 2002176 and are meant to be an alternative to courts. CRCIs are chaired by a magistrate and composed of twenty persons, divided into six major categories of members representing patients, health professionals, hospital practitioners, health institutions and facilities, ONIAM, and insurers. The mission of CRCIs is twofold. The first is to promote, through conciliation, the resolution of disputes arising in connection with a medical treatment. The second function of CRCIs is to solve disputes in order to facilitate compensation for the victims of medical accidents who suffer from serious injuries.

171 See CSP art. L. 1142-1 para 1. 172 On March 11, 2010, the Cour de cassation ruled that compensation for loss of chance could be complemented by the ONIAM for the rest of the damage. Cass. 1e civ., Mar. 11, 2010, Bull civ. I, No. 63; D. 2010, 1119, note M. Bacache; JCP G 2010, I, 379, note Jourdain. 173 Patients’ Rights Law of March 4, 2002, supra note 16, at. 174 Loi 2002-1577 du 30 décembre 2002 relative à la responsabilité civile médicale [Law 2002-1577 of December 30, 2002 on Medical Liability], J.O., Dec. 31, 2002, p. 22100. 175 CSP art. L. 1142-5. 176 Décret 2002-886 du 3 mai 2002 relatif aux commissions régionales de conciliation et d’indemnisation des accidents médicaux, des affections iatrogènes et des infections nosocomiales prévues à l’article L 1142-5 du code de la santé publique [Decree 2002886 of May 3, 2002 on the Regional Commissions of Conciliation and Compensation of Medical Accidents, Iatrogenic, and Nosocomial Infections in Code of Public Health Art. L. 1142-5], J.O., May 7, 2002, p. 9025.

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As a conciliator, the CRCI seeks to reach a conciliation agreement between the victim and the health professional or the insurer of the liable health professional.177 It is possible to bring a request for conciliation before a CRCI when medical care was not satisfactory or in case of disagreement with a health professional or health institution. To be admissible before the commission, the dispute must have originated on a medical incident occurring on or after September 5, 2001. The claimant and the health professional are heard by the commission as a whole or by a single member of the commission, or by an independent mediator, depending on the will of the complainant. The result of the conciliation is stated in a document signed by the claimant and the concerned health professional. CRCIs also have a mission of dispute resolution in cases of injuries of some importance. To be admitted to this procedure, claims must be related to accidents that occurred after December 5, 2001, and caused serious injuries.178 In such a case, the victim can take the case to the competent Regional Commission, which has six months to give an opinion based on expertise (if necessary). At this stage, two solutions are possible. First, the commission can make a rejection notice, either because the damage is not attributable to medical care, or because no negligence was committed and the damage is not an abnormal result with regard to the patient’s initial state.179 Second, the commission may believe that the patient’s harm can be compensated. Notice is then transmitted to the institutions responsible for the payment of compensation. It can be either the insurer of the health professional if such compensation can be based on liability rules, or the ONIAM if compensation can be granted on public welfare (“solidarité nationale”) principles.180 In the first case, the insurer of the responsible health professional must make a compensation offer that provides full compensation to the victim within four months. If the victim accepts the offer, a settlement is concluded and payment must be made within one month. The concluded agreement is a “transaction,” within the meaning

177 CSP art. L. 1142-5. 178 A serious injury is defined as permanent partial disability of 24 % or temporary incapacity of at least six consecutive months or six non-consecutive months in a period of twelve months or even, in exceptional cases, inability to carry on business or particularly serious disturbances in the conditions of existence. Décret 2003-314 du 4 avril 2003 relatif au caractère de gravité des accidents médicaux, des affections iatrogènes et des infections nosocomiales prévu à l’article L. 1142-1 du code de la santé publique [Decree 2003-314 of April 4, 2003 Concerning the Serious Nature of Medical Accidents and Iatrogenic and Nosocomial Infections Under Article L. 1142-1 of the Code of Public Health, J.O., Apr. 5, 2003, p. 6114; see CSP art. L. 1142-8. 179 See Helleringer, supra note 20, at 1128–29. 180 See Helleringer, supra note 20, at 1135–36.

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of Article 1144 of the Civil Code which means it ends any possibility of litigation, except in cases where the victim’s state has worsened after the settlement was concluded. In case of refusal of the insurer’s offer, or if the period of four months is exceeded, the victim can bring the claim before the ONIAM, which then replaces the insurer and makes an offer under the same conditions as discussed previously. In such a case, the ONIAM has a right of recourse against the liable professional or institution insofar as civil liability rules may found such recourse. For its part, the insurer can also challenge the CRCI’s opinion before the court. As of today, approximately 60 percent of claims are treated by a settlement concluded through CRCIs.181 However, the new system has not resulted in a reduction of the proceedings before the courts, which may be explained by the fact that CRCIs’ decisions are often contested before the courts.182 The activity of CRCIs is presented in the report that the ONIAM publishes twice a year.183 The ONIAM also publishes an indicatives scale of amounts to be awarded.184

B.

Adjudication Through Courts

Victims are not obliged to enter into a conciliation procedure under the auspices of the Regional Commissions. They may also proceed against the liability insurer through direct action. Moreover, they can go to court if they are not satisfied with the opinion of the CRCI or with the compensation offer proposed by the insurer of the liable health professional or institution. A victim who has already started proceedings before a court may still bring the claim before the appropriate Regional Commission, as

181 Dr. Hubert Wannepain, Observatoire des Risques Médicaux [Observatory of Medical Risks], Installation et Activité de L’Observatoire de Risques Médicaux,: Prevu par L’Article L 1142-29 du Code de la Sante Publique [Installation and Activity of the Observatory of Medical Risks: Provided for by Section L. 1142-29 of the Code of Public Health] 13 (2007), available at http://www.oniam.fr/rapport/ORM-2005-2006_VF.pdf. 182 See Béatrice Courgeon & Catherine Letouzey, Rapport sur les decisions de justice et avis CRCI rendus en 2008 [Report on Judicial Decisions and CRCI Opinions Rendered in 2008], Hors série [Special Issue] Responsabilité: Revue de formation sur le risque médical [Liability: Journal of Mediacl Risk Education] 75, 75–79 (2009), available at http://www.macsf.fr/ file/docficsite/pj/ce/c5/24/04/risque-professions-sante-1890.pdf. 183 ONIAM, Rapport d’Activité: 2ème semestre 2009 [Activity Report: Second Half of 2009] 4–7 (2010), available at http://www.oniam.fr/rapport/RapportOniam2009sem2. pdf. 184 ONIAM, Référentiel Indicatif d’Indemnisation par l’ONIAM [Indicatives Repository of Compensation by ONIAM] (2009), available at http://www.oniam.fr/textes/referentiel_ oniam_20090701.pdf.

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long as the court and the Commission are informed.185 With respect to fault-based medical liability, courts appear more severe than CRCIs: 66 per cent of claims before courts end up in sanctions, whereas fault is characterized by CRCIs in only 33 percent of cases.186 It should be noted that patients are not the only ones who can enter into proceedings against health professionals by basing their claims on liability rules. Social Security agencies also have a right of recourse against the responsible practitioner for everything they paid to the victim. The limitation period for actions relating to medical liability was reduced to ten years in 2002,187 then reduced again to five years,188 though the limitation period is still ten years for claims relating to personal injuries.189 However, the fact that the limitation period starts at the moment of “consolidation,” i.e., the moment when the healing or permanent damage to the victim is stabilized, which may be difficult to determine, counteracts the recent reduction of such period. Although the Patients’ Rights Law of March 4, 2002 unified the law of medical malpractice from a substantive perspective, the duality of jurisdiction remains. This means that the action shall be filed either in front of civil or administrative courts. In 2005, the “Observatoire des risques médicaux” (Observatory of Medical Risks), created by Law 2004-810 of August 13, 2004190 and attached to the ONIAM, started collecting and analyzing data on medical accidents in order to better understand the cost of claims and to identify the most avoidable accidents.191 In this respect, it is generally highlighted that the number of claims has significantly increased since the beginning of the 1990s and that the reform of 2002 did not reverse this trend, despite the creation of the new compensation scheme based on national solidarity.192 In 2008, the number of claims concerned 2.5 percent of private practitioners. 44 percent of surgeons faced a claim, and 67 percent of the cases

185 CSP art. 1142-7. 186 Courgeon & Letouzey, supra note 182, at 75–76. This aspect is explained by the fact that victims go to court only in cases where the practitioner’s misconduct is obvious. 187 See CSP art. L. 1142-28. 188 See C. civ. art. 2224; Loi 2008-561 du 17 juin 2008 portant réforme de la prescription en matière civile [Law 2008-571 of June 17, 2008 on Reform of Limitations for Civil Actions], J.O., June 18, 2008, p. 9856. 189 C. civ. art. 2226. 190 Loi 2004-810 du 13 août 2004 relative à l’assurance maladie [Law 2004-810 of August 13, 2004 on Health Insurance], J.O., Aug. 17, 2004, p. 14598. 191 See CSP art. L. 1142-29; generally Wannepain, supra note 181. 192 See generally Courgeon & Letouzey, supra note 182, at 75–81.

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submitted to courts ended in liability.193 The awarded amounts have also increased: while the average cost of a claim was E120,000 in 2002, it was E256,000 in 2007.194 Observers agree on the fact that the medical liability insurance sector has been experiencing a major crisis over the past decade, which has led to a net increase in insurance premiums.195 Some proposals have thus been made in order to limit the number of trials, like forcing the victims to first bring their claims before CRCIs or creating a procedure of selection of cases by the competent court.196 But such reforms remain to be done.

193 Id. at 75–82. 194 N. Gombaud, La situation de l’assurance de responsabilité médicale [The Situation of Medical Malpractice Insurance], RDSS 51 (2010); see also Courgeon & Letouzey, supra note 182, at 81 figs.12–13, 82 fig.14. 195 Gombaud, supra note 194, at 51; see also generally Inspection Générale des Finances & Inspection Générale des Affaires Sociales [Inspectorate General of Finance & Inspectorate General of Social Affairs], Conclusions du Rapport d’enquête sur l’assurance de responsabilité civile médicale [Conclusions of the Inquiry on Medical Liability Insurance] (2004), available at http://lesrapports.ladocumentationfrancaise.fr/BRP/ 044000073/0000.pdf. 196 Muriel Fabre-Magnan, Un remède possible aux abus de la responsabilité (et de l’irresponsabilité) médicale : le filtrage des actions en responsabilité médicale [A Possible Remedy for Breach of Medical Responsibility (and Liability): Filtering Medical Liability Claims, in Études Offertes à Geneviève Viney 399–418 (2008).

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Medical Malpractice and Compensation in France Part II: Compensation Based on National Solidarity Geneviève Helleringer*

Introduction Under certain circumstances, the damage cannot be attributed to any misconduct on behalf of a health provider amounting to medical malpractice: on the contrary, the damage occurs pursuant to the performance of regular acts of prevention, diagnosis, or treatment. Title IV of the Act (L. n°2002-303) of March 4, 2002 provides for the creation of a compensation fund for victims of certain harms independent of any medical malpractice.1 Schematically, and distinctively from the compensation process by insurers of liable professionals, compensation of the victim will in such cases result from a compensation scheme similar to that available for victims of terrorism and crimes. It is based on national solidarity and dispensed by the National Fund for Compensation of Medical Accidents (ONIAM).2 Previous specific existing compensation funds3 (such as the fund for victims of HIV infection through blood transfusion, created in 1991), the jurisdiction of which was not necessarily conditional upon the absence of liability on behalf of healthcare providers, were merged into the new general procedural and compensation scheme set for ONIAM.4

* Dr. G. Helleringer, J.D. (Columbia), St Catherine’s College, Oxford, Essec. 1 Loi 2002-303 du 4 mars 2002 relative aux droits des malades et à la qualité du système de santé [Law 2002-303 of March 4, 2002 on Patients’ Rights and the Quality of the Health System], art. 98, Journal Officiel de la République Française [J.O.][Official Gazette of France], Mar. 5, 2002, p. 4118. 2 Id; ONIAM stands for: « Office National d’Indemnisation des Accidents Médicaux ». 3 Mustapha Mekki, Les fonctions de la responsabilité civile à l’épreuve des fonds d’indemnisation des dommages corporels, 8 Les Petites Affiches 3 (2005). 4 Loi 2002-303, supra note 1.

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A specific compensation scheme may be triggered by the victim under the auspices of cases for which national solidarity is accountable.

I.

Typology of Cases Covered by National Solidarity

Only limited types of losses fall under national solidarity compensation schemes.5 Medical hazards and hospital-acquired infections are the two cases added to the scope of national solidarity compensation in 2002, whereas blood infections and other cases have been recognized as such for a longer time.

A.

Medical Hazards

The March 4, 2002 Act provides for specific compensation rules for a medical hazard defined as “the occurrence of an accidental risk inherent to the medical procedure and which occurred without any fault of the practitioner and could not be controlled.”6 Compensating for the consequences of such medical hazards is beyond the scope of the obligations under which the physician is contractually bound toward his patient.7 And the law now implicitly provides that the burden of therapeutic risk solely belongs to society.8 In order for such damages to be compensated as caused by medical hazard unrelated to medical malpractice, the following requirements have to be met. First, there shall be no malpractice case, and hence damages cannot be compensated, on the basis of medical malpractice liability.9

5 For a recent example, see Cour de cassation [Cass.] [supreme court for judicial matters] 1e civ., March. 31, 2011, Bull. civ. I, to be published, Responsabilité civile et assurances 2001, 33, obs. C. Radé. 6 Cour de cassation [Cass.] [supreme court for judicial matters] 1e civ., Nov. 8, 2000, Bull. civ. I, No. 287, D. 2001, 570, obs. Y. Lambert-Faivre, D. 2001, 2236, obs. D. Mazeaud, D. 2001, 3083, obs. J. Penneau, R.T.D.Civ 2001, 154, obs. P. Jourdain; Cass. 1e civ, Mar. 27, 2001, No. 99-13.471, 2001 Bull. civ. I, No. 86, D. 2001, 1284; Cass. 1e civ., Nov. 13, 2002, Bull. civ. I, No. 265, R.T.D.Civ. 2003, 98, obs. P. Jourdain, R.D.C. 2003, 47, obs. P. Jourdain; Cass 1e civ., Nov. 29, 2005 Bull. civ. I, No 456, D. 2006, 689, obs. J. Penneau; Cass 1e civ., Nov. 22, 2007, Bull. civ. I, No. 366, D. 2008, 816, note M. Bacache, J.C.P. 2008, II, 10069, note I. Corpart, R.C.A. 2008, 31, note S. Hocquet-Berg, R.D.C. 2008, 320, note J.-S. Borghetti; Cass. 1e civ, Sept. 18, 2008, Bull. civ. I, No. 206, Gaz. Pal. 2008, 2, Somm. 4147, obs. C. Baby-Gareau, R.D.S.S. 2008, 1154, note D. Cristol, D. 2009,1305, obs. J. Penneau, R.T.D.Civ. 2009, 123, obs. P. Jourdain. 7 Id. 8 See Code de la Santé Publique art. L.1142-1, II. 9 An exception was granted for hospital-acquired infections, see id. at I.

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Second, the damage must be directly attributable to acts of prevention, diagnosis, or treatment.10 This criterion of accountability is supplemented by a criterion of abnormality: the damaging consequences must be regarded as abnormal in relation to the patient’s health status and foreseeable evolution.11 Thus, excluded from the compensation scheme by the national solidarity is the natural evolution of the disease for which the patient received care and accidents that are highly probable under the condition of the patient and/or nature of the act or treatment performed. Third, compensation is only due when the medical is hazard caused a serious harm. The threshold of seriousness is set in the law by reference to the magnitude of the loss in functional capacities and the impact on the personal and professional life of the patient.12 The computed criterion measures the degree of permanent or temporary disability of the victim.13 Compensation shall be granted to victims whose disability rate is superior to twenty-five percent and is either permanent or temporary but lasted for six months minimum over a twelve-month period.14 In addition, the severity can also be recognized when the victim is declared permanently unfit for the occupation held prior to the occurrence of the damaging accident.15 In other words, victims who suffer an injury caused by a medical hazard and whose disability rate remains below the twenty-five percent threshold will not be entitled to any compensation. In addition, compensation is also set aside when the prior health condition of the patient can account for the hazard.16 This means that, in practice, a vast majority of the victims of medical hazards are granted no compensation. There is no question about the fact that a threshold is necessary; however, it may have been set too high, and the newly introduced compensation of medical hazard in 2002 may be regarded as a mere signal, without substantive effect. Had the floor been set at ten percent of disability, whether permanent or temporary, but suffered for a minimum of six months in a twelve-month period, eightyfive percent of the victims would still have been excluded from the 10 11 12 13 14 15 16

Id. at II. Id. Id. Id. Code de la Santé Publique art. D. 1142-1. Id. Conseil d’Etat [C.E.] [supreme court for administrative matters] 4 and 5 sub-sections united, Jul. 24, 2009, No. 305372; Conseil d’Etat [C.E.] 4 and 5 sub-sections united, Jan. 14, 2009, No. 284434.

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mechanism, but the victims between ten percent and twenty-five percent of permanent invalidity, who amount to ten percent of the total number of victims, would then have been compensated.

B.

Hospital-Acquired Infections

Since the Act of December 30, 2002, compensation for hospital-acquired infections is not conditional anymore upon proof of an event of force majeure exempting the professional from liability.17 As an exception to the general scheme of compensation, hospital-acquired infections resulting from treatment after January 1, 2003, and corresponding to a permanent disability greater than 25 % may be compensated on national solidarity funds, even if civil liability of a health professional is incurred.18 Otherwise, the conditions set forth in the general compensation scheme for medical hazard apply. It is worth noting that the public health impact and the associated costs of hospital-acquired infections have been considered at the national and European levels. The Council of Europe adopted a recommendation19 and so did the EU Council.20 These recommendations advise the introduction of a framework aimed at improving patient safety and preventing hospital-acquired infections in particular.21 At the national level, a regulation aimed at preventing adverse events associated with healthcare22 was adopted on November 12, 2010.23 Such events shall be prevented through

17 18 19

20 21 22

23

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Loi 2002-1577 du 30 décembre 2002 relative à la responsabilité civile médicale [Law 2002-1577 of Dec. 30, 2002 on Medical Liability], [J.O.], Dec. 31, 2002, p. 22100. Id. See Council of Europe, Comm. of Ministers, Recommendation to Member States on Management of Patient Safety and Prevention of Adverse Events in Health Care, Rec. 2006(7) (May 24, 2006). Council Recommendation of 9 June 2009 on Patient Safety, Including Prevention and Control of Healthcare Associated Infections, 2009 O.J. (C 151) 1, 5–6. Id. at 4–6. Adverse events (événements indésirables associé aux soins) associated with healthcare are defined as any incident detrimental to a hospitalized patient that occurs during the execution of a medical act of prevention, investigation or treatment, Code de la Santé Publique art. R. 6111-1. Loi 2010-1408 du 12 novembre 2010 relatif à la lutte contre les événements indésirables associés aux soins dans les établissements de santé [Decree 2010-1408 of November 12, 2010 on the Fight Against Adverse Events Associated with Care in Health Facilities], [J. O.], Nov. 16, 2010, p. 20428.

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better management of risks associated with healthcare.24 In practice, prevention actions shall be decided by the executive director of the considered hospital, together with the Medical Commission (CME).25 They shall be implemented by a healthcare associated risk manager.26

C.

Blood Transfusions Infections

1.

HIV Infection

The HIV-dedicated compensation fund created in 1991 was merged in 200427 into ONIAM.28 Therefore, the common scheme, along with standard conditions, now applies to victims of HIV infection through blood transfusion seeking compensation. The following specifics may, however, be highlighted. Victims, or their heirs, must demonstrate a human immunodeficiency virus infection and blood product transfusions or injections of blood products.29 They shall inform ONIAM of all the information available to them.30 The Code of Public Health establishes for victims a rebuttable presumption of causality between HIV infection and transfusion or injections.31 It is, however, for the plaintiff to prove the causal link (by any means, including “serious, precise and consistent presumptions” within the meaning of the Civil Code).32 ONIAM may rebut this presumption by showing, by all means (including serious, precise and concordant presumptions) that alleged transfusions cannot be the cause of the contamination.33

24 25 26 27 28 29 30 31 32 33

Id. Code de la Santé Publique art. R. 6111-2. Code de la Santé Publique art. R. 6111-4. Loi 2004-806 du 9 août 2004 relative à la politique de santé publique [Law 2004-806 of August 9, 2004 on Public Health Policy], art. 115, [J.O.], Aug. 11, 2004, p. 14277. Code de la Santé Publique art. L. 3122-1. Code de la Santé Publique art. L. 3122-1. Code de la Santé Publique art. L. 3211-2. Code Civil [C. civ.] art. 1353. Id. Id.

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2.

Hepatitis C Infection

The idea of establishing a compensation fund for victims of post-transfusion hepatitis C was long rejected; however, it finally prevailed in 2008.34 Pursuant to a newly enacted provision of the Code of Public Health, ONIAM must compensate victims for damage resulting from contamination by hepatitis C from a transfusion of blood or an injection of blood products that took place in French territory.35 This compensation scheme is largely based on the one set up for HIV victims. In particular, victims or their heirs, who send their claim to ONIAM, must give evidence of contamination by hepatitis C and of blood transfusions or injections of blood products. As for HIV victims, a rebuttable presumption of causality between the hepatitis C infection and transfusion or injection is established by the law.36 ONIAM shall then investigate the circumstances of contamination, especially under the conditions laid down in Article 102 of the Act of March 4, 2002.37

3.

Additional Grounds

Since 2002, ONIAM’s jurisdiction has tended to expand to specific cases of medical personal harm for which the national solidarity is accountable. In addition to the aforementioned cases of hepatitis C infection, the national solidarity compensation scheme encompasses a growing number of harms gathered under the auspices of ONIAM, including infections resulting from mandatory vaccination,38 care provided by a professional healthcare provider out of his or her field of specialization,39 and harm resulting from growth hormone administration.40

34

35 36 37 38 39 40

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Loi 2008-1330 du 17 décembre 2008 de financement de la sécurité sociale pour 2009 [Law 2008-1330 of December 17, 2008 on the Financing of Social Security], art. 67, [J. O.], Dec. 18, 2008, p. 19291. Code de la Santé Publique art. L. 1221-14. Code de la Santé Publique art. L. 3122-2. See Loi 2002-303, supra note 1, at art. 102. Code de la Santé Publique art. L. 3111-9. Code de la Santé Publique art. L. 1142-1-1. Code de la Santé Publique art. L. 1142-22.

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II.

Administration and Adjudication of Claims Based on National Solidarity

Claims of certain types or pushed forward through certain procedural routes are adjudicated by ONIAM, notwithstanding the availability of rights of recourse.

A.

Administrated Claims

Under the Statute of March 4, 2002, compensation based on national solidarity may be claimed by victims under three types of circumstances. First, national solidarity provides compensation for damages not related to medical malpractice (that is, when no health professional or institution may be held liable)41 in cases of medical hazards and hospital-acquired infections and under certain conditions of serious harm.42 In such cases, ONIAM’s jurisdiction is subsidiary, which means that a preliminary assessment of the case is to be made by an external commission.43 Second, and notwithstanding the fact that healthcare providers may be found liable, national solidarity also provides compensation for infections related to blood transfusion and other grounds.44 In such cases, ONIAM’s jurisdiction is not subsidiary but direct. Third, national solidarity may also make up for the absence of available compensation on behalf of the liable person’s insurer.45 This may happen when the healthcare provider is covered by insurance but coverage has elapsed, when insurance coverage limits are exceeded, or when no offer was made by the insurer. Fourth, national solidarity provides for reimbursement of insurers who entered a compensation agreement with the victim in cases where such insurers can demonstrate that their client was not liable for the harm.46 The role and importance of national solidarity has inflated. New specific compensation schemes are occasionally set up on the ground of national

41 42 43 44 45 46

Code de la Santé Publique art. L. 1142-1 I. Loi 2002-303, supra note 1. See infra p. 171 seq. See generally Loi 2002-303, supra note 1. Id. at art. 98. Id.

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solidarity. The latest addition results from a statute of 2010 and relates to the compensation of harm suffered by victims of nuclear tests.47 When victims (or their assignees) have received compensation from the Fund, can they still act in court against the authors of the harm? If the victim was “fully” compensated for his or her losses by the Fund, he or she retains no interest on which to sue. On the other hand, if compensation was not full, he or she retains an interest in seeking further compensation on the basis of civil liability rules. However, the Cour de cassation did not give this answer: it ruled that compensation awarded by the Fund is supposed to be “full” and therefore deprives the victim of any interest to seek additional compensation at law.48 This holding was condemned by the European Court of Human Rights. The court held that it deprived the victim of concrete and effective access to court in a situation where such victim could legitimately believe that bringing parallel actions in front of the Fund and the courts was possible.49 The highest administrative Court, the Conseil d’Etat, had the same approach. In the event the administrative judge makes a decision at a time when compensation by the Fund is not yet finalized, the administrative court must grant appropriate relief, but the State will then be subrogated in the victim’s rights against the Fund.50 Nevertheless, the First Civil Chamber of the Cour de cassation adopted, in turn, the restrictive position already adopted by other chambers.51 Then, in an attempt to put an end to the resistance of trial courts, the plenary chamber also ruled similarly.52 This solution is questionable: first, as to the right to a fair trial; second, the fact that the victim has the power to refuse the offer of the Fund and to have his or her case judged by the Court of Appeal of Paris is a procedural argument rather than a substantive one. The only limit to the action of the victim is the rule of non-overlapping, which should lead the court to deduct from the assessed compensation all amounts already awarded to the victim by the Fund.

47

48

49 50

51 52

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Loi 2010-2 du 5 janvier 2010 relative à la reconnaissance et à l’indemnisation des victims des essais nucléaires français [Law 2010-2 of January 5, 2010 on the Recognition and Compensation of Victims of French Nuclear Testing], [J.O.], Jan. 6, 2010, p. 327. Cour de cassation [Cass.] 2e civ., Jan 26, 1994, Bull. civ. II, No. 41, D. 1995, 55, Gaz. Pal. 1994, 2, 525; Cass soc., Jan. 26, 1995, Bull. civ. V, No. 42, D. 2996, 40, J.C.P. 1995, I, 2853, obs. G. Viney. Bellet v. France, Eur. Ct. H.R., App. No. 23805/94 (1995). Conseil d’Etat, notifications of 15 Oct. 1993 No 148888 and No 148889, J.O. Nov. 3 1993, p. 15195, R.F.D.A. 1994, 553, ccl. B. Frydman; Conseil d’Etat, Sept 23 1998, 1998 Lebon No. 184162. Cour de cassation [Cass.] 1e civ, July 9, 1996, Bull. civ. I, No. 303. Cour de cassation [Cass.] ass. plén, June 6, 1997, Bull. Ass. Plen., No. 8, J.C.P. 1997, I, 4070, at No 36, obs. G. Viney.

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It should be noted that the French supreme court, the Cour de cassation, has recently recognized that national solidarity and the civil liability compensation system could complement each other under certain circumstances. In a case judged on March 11, 2010, the court decided that victims of breach of duty to disclose could be compensated through both regimes.53 In this specific case, the victim was partially compensated for loss of chance to avoid the suffered harm and was also granted compensation from ONIAM for the rest of the damage.54 This ruling will enable victims to benefit from full compensation. On a more theoretical level, this important decision appears to make a distinction between the chance of loss on the one hand, and the personal harm resulting from the medical accident, on the other hand. Such distinction can be reflected at the level of triggering events: one is a technical negligence that caused the personal harm; the other is a breach of the duty to disclose that caused the loss of chance. Code of Public Health art. L. 1142-1 I can then be reinterpreted: national solidarity is subsidiary to the liability of healthcare providers only in relations to technical negligence but not in case of any breach of duty to disclose.55

B.

Procedural Routes to ONIAM

Compensation based on national solidarity may be granted by ONIAM at the outset of proceedings initiated in different channels. First, the victim may have initiated a claim in court and be awarded compensation in this forum. In practice, judges will determine the level of compensation, which will be incurred either by the healthcare provider’s insurer or by ONIAM.56 Although the Act of March 4, 2002 unified the law of medical malpractice from a substantive perspective,57 the duality of jurisdiction remains. This means that the action may be filed either in civil or administrative courts. It shall be noted that filing an action in court remains available to victims not only as an original alternative to filing a case with the CRCI, but also in order to challenge the advice given by the CRCI or the offer made either by ONIAM or by liability insurers.

53 54 55 56

57

Cour de cassation [Cass.] 1e civ., Mar. 11, 2010, D. 2010, 1119, note M. Bacache, J.C.P. 2010, I, 379, note P. Jourdain. Id. See Code de la Santé Publique art. L. 1142-1 I. See Loi 2008-1330, supra note 34: ONIAM will compensate in cases where no liability of a health-care provider can be evidenced, or, e.g., when the damage is the consequence of a hospital-acquired infection, an infection through blood transfusion. See generally Loi 2002-303, supra note 1.

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Second, pursuant to the 2002 statutory reform, the victim may initiate a procedure in front of a Commission for conciliation and compensation for medical accidents, iatrogenic complaints, and hospital-acquired infections.58 Such a Commission has regional jurisdiction and its mission is dual: first, facilitating the amicable settlement of disputes by seeking a conciliation agreement between the victim and the insurer of the liable health professional; and second, settling medical accidents in the scope of national solidarity.59 If the Commission reaches the conclusion that a provider was at fault, the liable health care provider, or his or her insurer, is informed and is expected to make an offer for compensation.60 In the event no offer is made within four months, the victim may ask ONIAM in order to obtain an offer for compensation by default, on the basis of the Commission’s assessment.61 If the Commission reaches the conclusion that there was a medical hazard, a hospital-acquired infection, or any other grounds prompting compensation on the ground of national solidarity, it will inform ONIAM and indicate the nature and scope of the losses.62 ONIAM is in this case accountable for calculating the amount of compensation due.63 Third, ONIAM may be directly seized by the victim for cases in which it has direct jurisdiction.64 Initiating such procedure for compensation does not eliminate the possibility for the victim to take appropriate legal action for damages.65 However, the law imposes on the victim an obligation to inform. Pursuant to the Code of Public Health, the victim has to inform ONIAM along with the judge of the referral of ONIAM about pending proceedings.66

58

59 60 61 62 63 64 65 66

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Code de la Santé Publique art. L. 1142-5. The Commission is chaired by a magistrate of the judicial or administrative Court. It is composed of twenty persons, divided into six major categories of members representing consumers, healthcare professionals, hospital practitioners, institutions and health facilities, see Code de la Santé Publique art. L1142-6. Code de la Santé Publique art. L. 1142-5. Code de la Santé Publique art. L. 1142-14. Id. Code de la Santé Publique art. L. 1142-x. Code de la Santé Publique art. L. 1142-x. Code de la Santé Publique art. L. 1142-x. Code de la Santé Publique art. L. 1142-x. Code de la Santé Publique art. L. 1142-17.

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C.

Adjudication Proceedings in Front of ONIAM

Once ONIAM has seized jurisdiction, the adjudication of the claim is handled as follows: Within three months of receipt of the application, which can be extended at the request of the victim or his or her beneficiaries, ONIAM, through its Compensation Committee, examines whether the conditions for compensation are met.67 It searches the circumstances of the contamination and carries out investigations.68 The Compensation Committee may conduct hearings, and the plaintiff is allowed to be assisted or represented by a person of his choice. Where the evidence supplied is admissible, ONIAM is required to pay within a month one or more provisions if the request was made.69 ONIAM shall submit to any claimant an offer of compensation within a period, the duration of which is fixed by decree, and which cannot exceed six months from the day ONIAM receives the full justification of harm.70 This provision is also applicable in cases of aggravation of damage.71 The offer is sent to the applicant by registered letter with return receipt. It indicates the assessment made by ONIAM for each loss and the amount of damages that accrue to the victim, given the benefits he or she has already received or may receive from other third-party payers.72 Acceptance of the offer by the victim amounts to a settlement.73 Any pending legal action is deemed withdrawn. In the event the victim rejects the offer, civil court judges have jurisdiction to assess the rights of the victim. The rejection of the offer made by ONIAM terminates the rejected offer that may therefore be withdrawn by ONIAM. Such withdrawal may take place before the adjudication of the claim is completed, as was recently confirmed by the Supreme Court.74 In any event, the victim is not entitled to any (minimum) compensation on the basis of the rejected offer in front of the civil court. However, the victim will have a right of action against ONIAM if he or she considers the

67 68

69 70 71 72 73 74

Code de la Santé Publique art. L. 3122-2. The investigations may not be resisted on privilege. Id. People who must deal with documents and information provided to ONIAM are bound by professional secrecy under the conditions and subject to the penalties provided under the Criminal Code. Code Pénal [C. pén.] art. 226-13 and 226-14. Code de la Santé Publique art. L. 3122-2. Code de la Santé Publique art. L. 1142-17. Code de la Santé Publique art. L. 3211-5. Code de la Santé Publique art. L. 3122-5. Code de la Santé Publique art. L. 1142-17. Cour de cassation [Cass.] Civ. 1, Jan. 6, 2011, No. 09-71201.

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offer insufficient, or if ONIAM does not present the offer within the deadline or if it rejects the application. Victims are not prevented from filing a concurrent claim on the basis of general rules of civil liability. There is a prior obligation imposed on the victim to inform ONIAM of any judicial proceedings pending.75 Where legal action is brought after the referral of ONIAM, the judge must be informed by the victim.76 This is why it is crucial to organize mutual information on the status and result of proceedings between the courts and ONIAM administrative or possible judicial seizures.77 The action for redress of ONIAM will then take the form of a procedural intervention to the proceedings between the victim and the person responsible before the civil court, criminal court, or administrative tribunal.78 ONIAM may also become a party to the proceeding to each of these jurisdictions, even for the first time on appeal.79 It can then use all remedies available by law.80 If the action of the victim was brought before a civil court, but the facts that caused the damage gave rise to criminal prosecution, civil court is not obliged to freeze proceedings until final determination of criminal jurisdiction.81

D.

Regulatory Principles Applying to Rights of Recourse

It should be noted that the acceptance by the victim or his assignees of a compensation offer made by ONIAM does not deprive the third-party payers, e.g., the social security fund, from the right to proceed against the responsible third party.82 Civil liability rules shall apply to that matter, substance and procedure-wise. Provisions articulating general law and

75 76 77

78 79 80 81 82

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Code de la Santé Publique art. L. 1142-17. Id; Code de la Santé Publique art. L. 3122-3, para. 1. Loi 93-906 du 12 juillet 1993 instituant des dispositions particulières de procédure intéressant le fonds créé par l’article 47 de la loi 91-1406 du 31 décembre 1991 portant diverses mesures d’ordre social et modifiant le décret 92-759 du 31 juillet 1992 relatif aux actions en justice intentées à l’encontre du fonds devant la cour d’appel de Paris [Decree No. 93-906 of July 12, 1993 Establishing Specific Procedural Provisions Concerning the Fund Created by Section 47 of Law 91-1406 of December 31, 1991 Containing Different Social Order Measures and Amending Decree 92-579 of July 31, 1992 on Lawsuits Brought Against the Fund before the Court of Appeal of Paris], [J.O.], July 17, 1993, p. 10075. Id. Id. Id. Code de la Santé Publique art. L. 3122-4. Id.

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special rules were enacted so that victims do not receive greater compensation than the harm they suffer and that the perpetrators of harm do not escape their responsibility. Thus, the victim should inform the Compensation Fund of any judicial proceedings initiated. In the event the damage compensated through national solidarity relates to medical malpractice,83 ONIAM, national social security, and any other third-party payer has subrogation rights against the healthcare providers recognized civilly liable only pursuant to civil liability rules of recourse.84 No right of recourse is granted when medical hazards are compensated. However, third-party payers have a right of recourse for negligence in cases of hospital-acquired infections and blood transfusions.85 They also have such a right of recourse when payment was made on behalf of a defaulting insurer.

III. Awarded Compensation As set forth above, compensation for medical harm may be based on civil liability or national solidarity. In either case, compensation for all damage suffered by a victim is expected.86 And admittedly, compensation should cover the full damage, though statutory law may provide for specific guidelines in the matter.87 Personal damages are computed by reference to standardized assessment scale weighing the different types of harm (i.e. disability, suffering, esthetic harm, sexual harm). A difference is made between permanent and temporary harms. Such a scale cannot adequately reflect the richness of human life from a spiritual, intellectual, sensorial, emotional, or professional perspective. Though it is merely indicatory, it is part of French legal culture. A first specific scale for physiological deficiencies was devised in 1980, inspired by the American Medical Association, and was soon followed by competing scales. An official assessment scale was adopted at the national level in 2003.88 It provides for a diversity of compensable harms as well as 83 84 85 86 87 88

See supra p.106 seq., describing the different claims falling under ONIAM’s jurisdiction. Code de la Santé Publique art. L. 3122-4. Code de la Santé Publique art. L. 3122-4. Conseil constitutionnel [CC] [Constitutional Court], decision of December 13, 1985. Conseil constitutionnel [CC] [Constitutional Court], decision No. 2010-2 QPC, June 11, 2010, [J.O.] June 12, 2010, p. 10847. Loi 2003-314 du 4 avril 2003 relatif au caractère de gravité des accidents médicaux, des affections iatrogènes et des infections nosocomiales prévu à l’article L. 1142-1 du code

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corresponding rates (on a sliding scale reflecting the intensity of the harm).89 A summa division is set between extra-patrimonial loss awards and patrimonial ones.90 The latter account for expenses incurred (e.g., medical costs, additional costs in housing and transportation, etc.) and lost professional gains.91 The growing importance of compensation schemes based on national solidarity may appear to be a double-edged evolution. It has improved the status of victims of medical harms: they are increasingly integrally compensated more quickly and under more flexible conditions thanks in particular to the legally established presumptions. However, compensation by ONIAM, like any other national solidarity fund, may deprive victims of certain procedural safeguards provided by civil liability principles. This is particularly so when the compensation fund assesses the damage and compensates it.92 Compensations awarded by courts are, on average, more generous for the victims than the ones awarded by compensation funds. On a more systemic level, the articulation between national solidarity and civil liability principles raises questions. Are the two grounds subsidiary one to the other, complementary, or exclusive one from the other? The answer to this question is all the less satisfactory because a specific fund, like ONIAM, may play different roles depending on the harm that is considered. As mentioned, on the one hand, ONIAM’s main jurisdiction (i.e., on medical hazards and hospital-acquired infections) is subsidiary and can only come into play when no healthcare provider is found liable.93 However, such main jurisdiction also supplements the insurer’s failure or insufficient coverage.94 It is also an alternative jurisdiction for hospitalacquired infections leading to the death of the victim or a permanent functional disability rate greater than 25 %.95 It is finally a jurisdiction complementary to civil liability in relation to breach of the duty to inform

89 90 91

92 93 94 95

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de la santé publique [Decree 2003-314 of April 4, 2003 on the Seriousness of Medical Accidents, Iatrogenic, and Nosocomial Infections Under Section L. 1142-1 of the Code of Public Health], [J.O.], Apr. 5, 2003, p. 6114. See generally, id. Id. For the ONIAM indicatory compensation scale, see Office National d’Indemnisation des Accidents Medicaux [ONIAM], Référentiel Indicatif d’Indemnisation par L’ONIAM, Jan. 7, 2009, http://www.oniam.fr/textes/referentiel_oniam_20090701.pdf. See Anne Guegan-Lecuyer, Dommages de masse et responsabilité civile, no. 180 s. (LGDJ 2006). Code de la Santé Publique art. L. 1142-1 II. Code de la Santé Publique art. L. 1142-15. Code de la Santé Publique art. L. 1142-1-1.

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by the healthcare provider.96 On the other hand, ONIAM’s accessory jurisdiction (i.e., on infections through blood transfusion or injections, growth hormone harm, and compulsory vaccination harm) is not subsidiary and may be put into play even if conditions to find healthcare providers liable are present. In certain cases (e.g., compulsory vaccination harm), such jurisdiction is alternative: victims may choose to be compensated either by the liable healthcare provider or by ONIAM. Such was also the case for infections through blood transfusion until 2008: since then, compensation by ONIAM has purely and simply been substituted to compensation by the liable blood transfusion center.97 Such diversity in applicable schemes and in the relationship between national solidarity and civil liability principles is a factor of complexity for the victims. Harmonization of procedures and awarded compensations as well as clarification of the relationships between national solidarity and civil liability principles would be welcome developments in this dynamic field of the law.

96 97

Cour de cassation [Cass.] 1e civ., Mar. 11, 2010, supra note 53. Loi 2008-1330, supra note 34, at art. 67.

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Medical Malpractice and Compensation in Germany Marc S. Stauch*

Introduction By way of introduction, and to give some context, it may be helpful to say a few words about how health care provision is organised in Germany. The country has the oldest system of mass health care coverage in the world. Its beginnings stem from one of Otto von Bismarck’s social reforms of the 1880s, which established a system of statutory health insurance funds (Gesetzliche Krankenkassen) for workers, and were financed partly by the employer and in part by deductions from the worker’s salary.1 In subsequent years, the ambit of the system was gradually extended to other groups in society so that nowadays virtually every citizen has health insurance coverage. Some ninety percent of the population are members of one of the statutory public funds, while the remainder – typically persons in higher income brackets, who are allowed to opt out of the public insurance scheme – are privately insured. In total, about 250 billion euros are spent on health care provision annually (over ten percent of Germany’s gross domestic product).2 In recent years, the German federal state has increased the level of control it exercises over the system, above all by establishing quality assurance and auditing initiatives in an effort to reduce costs. This has been expressed in reforms to Title V of the Sozialgesetzbuch [SGB] [Social Code],3

*

Dr. jur. (Göttingen), M.A. (Oxon.), Senior Research Fellow, Leibniz University Hannover, Germany. 1 Krankenversicherungsgesetz [KVG] [Health Insurance Act], June 15, 1883, Reichsgesetzblatt [RGBl.] at 73. 2 Germany – National Expenditure on Health, World Health Org., http://www.who.int/nha/ country/deu.pdf (last modified Mar. 2010). 3 See Sozialgesetzbuch V Gesetzliche Krankenversicherung [SGB V] [Social Code Title V Social Health Insurance], Dec. 20 1988, Bundesgesetzblatt [BGBl.] I at 2447. The reforms were introduced by the GKV-Gesundheitsreformgesetz 2000 [GRG] [Public Health Insur-

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imposing quality assurance duties on deliverers of health care to publicly insured patients. Nonetheless, the system as a whole remains notably decentralized in character. The state provides the underlying statutory framework (in Title V of the SGB), but leaves the detailed ordering and running of the system to the key non-state actors in the area.4 Thus the financing of medical treatment is a matter for the health insurance funds, which contract with doctors and hospitals to provide the necessary care. Doctors operating alone or in partnerships and providing primary or specialized care, are private actors, remunerated on a feefor-service basis by the insurance funds. For their part, hospitals may be either public institutions (run by a given regional municipality or other public body) or private bodies. Of the latter, around half are charitable in nature, including hospitals run by various religious orders, while the rest are commercial, for-profit enterprises. As regards the regulation of health care providers, this too is devolved, occurring on different levels in line with the federal nature of the German political system. Thus hospitals are primarily regulated by the laws of the individual states (Länder), rather than by the federal government (Bund). Individual doctors – those working in primary care as well as those employed in hospitals – are subject to a dual system of control. In the first place, they must be licensed to practice by the federal level licensing (Approbation) authority. Secondly, they are required to join, and are bound by the professional rules (Standesrecht) of, the relevant state-level medical council (Landesärztekammer) in their region.5 As is the problem in other countries, there has been an increasing recognition in Germany of the prevalence of avoidable patient injury in the course of medical treatment. In 2007 an expert committee charged with monitoring developments presented statistics (compiled on the basis of 184 studies) suggesting an annual rate of preventable adverse events (vermeidbare unerwünschte Ereignisse) of 2–4 % in hospital care, and a PAE-related mortality rate of 0.1 %.6 Given that some 17 million in-patient treatments

ance Reform Act of 2000], Dec. 22, 1999, BGBl. I at 2626, available at http://bundesrecht. juris.de/gkvrefg_2000 (inserting new provisions §§ 135 into SGB V). 4 See Ursula Weide, A Comparison of American and German Cost Containment in Health Care: Tort Liability of U.S. Managed Care Organizations vs. German Health Care Reform Legislation, 13 Tul. Eur. & Civ. L.F. 60, n.72 (1998). See generally Michael Simon, Das Gesundheitssystem in Deutschland 103–07 (3d ed. rev. and updated 2010). 5 Erwin Deutsch & Andreas Spickhoff, Medizinrecht 19–22 (6th ed. rev. and expanded 2008). 6 Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen,[Advisory Council on the Assessment of Developments in the Health Care System] Cooperation and

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take place each year, this corresponds to half-a-million injuries and 17,000 preventable deaths.7 This realization has triggered an interest in recent years in initiatives designed to promote patient safety, in particular through enhanced risk management systems. Specific German measures in this area will be looked at further, towards the end of the paper, in Part III C. First though we shall consider matters from the ex post facto perspective of a case where medical injury to a patient has occurred. In such a situation, what are the potential legal consequences in terms of accountability and redress mechanisms that may follow?

I.

The Potential Legal Consequences of Medical Injury

A.

Criminal Law

The first possibility is that the treating doctor may be subject to criminal proceedings. Indeed, it has been estimated that around 3,000 criminal investigations against doctors are commenced with respect to medical errors each year.8 Leaving aside cases where the patient dies (in which a charge of negligent manslaughter (fahrlässige Tötung) may arise under section 222 of the Strafgesetzbuch [StGB] [Penal Code],9 there are two main offenses that come into consideration. In the first place, German law recognizes a crime of negligent bodily injury (fahrlässige Körperverletzung), which is penalized under section 229 of the StGB.10 Thus even in cases of comparatively minor injury, where a patient suspects the injury arose from negligence, he has the option of reporting the doctor to the police. Secondly, German law places very stringent validity requirements on consent to medical treatment; as discussed in more detail later, any deficit in information (including the non-disclosure of risks and alternatives) may render consent void.11 In such cases, the doctor could potentially face a charge of assault (Körperverletzung) under section 223 of the StGB.12

7 8 9 10 11 12

Responsibility: Prerequisites for Target-Oriented Health Care 63 (2007), available at http://www.svr-gesundheit.de/Gutachten/Gutacht07/KF2007-engl.pdf. Id. Klaus Ulsenheimer, Arztstrafrecht in der Praxis [Medical Practitioners and Criminal Law in Practice] 3 (4th ed. rev. and expanded 2008). See Strafgesetzbuch [StGB] [Penal Code], Nov. 13, 1998, BGBl. I at 3322, as amended, § 222. StGB § 229. See infra Part II B. StGB § 223.

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Admittedly, in around ninety-five percent of cases, the action will be stayed for lack of evidence or public interest.13 Moreover, in cases that proceed to trial, the doctor will usually secure an acquittal. Here, (in contrast to private law) the prosecution is required to prove subjective fault on the doctor’s part (i.e., that he was individually capable of avoiding the mistake in question).14 Similarly, as regards a charge of assault following inadequate consent, it must be shown that, if the patient had received the wrongfully withheld information, he would have refused the treatment.15 The onus of proof with respect to all matters remains on the prosecution: the proof modifications or reversals that (as we shall see later) are such a feature of German private law in this area do not apply. In the relatively rare case of a conviction, the doctor will generally pay a fine. However, if the court finds a gross dereliction of duty on his part and sees a risk of repetition, it may ban him from practicing for up to five years.16 In principle, commencement of a criminal action against a doctor, as well as its outcome, does not prejudice any private law action the patient has with respect to the same injury. It is true that concerns have sometimes been raised that patients may use the threat of a criminal investigation to pressure the doctor into settling a damages claim. However, this may merely antagonize the doctor and stiffen his resolve to defend the claim. Thus patient-solicitors normally advise their clients against taking such a course.17

B.

Professional and Disciplinary Sanctions

Besides exposure to potential criminal liability, the doctor may have to answer for a medical injury before various professional bodies and/or, in the case of a doctor employed in a hospital, his employer. As noted above, doctors are required to join the medical council of the state in which they practice and will be subject to that council’s professional rules. These rules

13 14 15

16 17

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See Ulsenheimer, supra note 8, at 4. Deutsch & Spickhoff, supra note 5, at 295–96. See Bundesgerichtshof [BGH] [Federal Court of Justice], June 29, 1995, Neue Zeitschrift für Strafrecht [NStZ] 34, 1996. Again this is in contrast to the position under private law. See Part II B. StGB § 70(1). See Karl Otto Bergmann & Carolin Wever, Die Arzthaftung [Medical Malpractice Liability] 197–98 (3d ed. 2009).

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include a duty to treat patients conscientiously and appropriately.18 However, the doctor will not be called to account for an ordinary failure leading to injury, even where there was fault in a legal sense. Rather, a gross failure of care is required, or injury in circumstances that imply a breach of an anterior professional duty, such as the failure to keep up-todate with medical knowledge by continuing professional training.19 In these cases, the doctor will be required to appear before one of the professional tribunals (Berufsgerichte), attached to the administrative courts.20 Where the allegation is made out, sanctions may include a fine and/or a practice ban.21 In addition, where there is a finding against the doctor in the relevant professional proceedings (or indeed in a criminal trial), this may lead the federal level approbation authority to act to remove his general practicing certificate. The authority has this power in cases where the doctor’s conduct demonstrates unworthiness or unreliability to such a degree that he no longer commands the trust and confidence required of a doctor.22

C.

Fault-Based Compensation in Private Law

The above mechanisms focus upon the doctor, with the aims of securing accountability and reducing the risk to patients from delinquent practitioners. However, they do not offer redress in a direct sense to the patient. Instead, if the latter wishes to obtain compensation for the injury he has suffered, he must turn to the institutions of private law. In Germany an increasing number of patients are availing themselves of this option: today it is estimated that between 20,000 and 40,000 private law claims commence each year.23 Under the Bürgerliches Gesetzbuch [BGB] [Civil Code],24 the patient generally has the choice of bringing an action in contract or in tort (or in both).

18

19 20 21 22 23 24

See Bundesärztekammer [BÄK] [Fed. Med. Council], Musterberufsordnung für die Deutschen Ärztinnen und Ärzte [MBO] [Model Professional Code for Medical Practitioners] § 11 (2006). The BÄK is the umbrella organization for the regional medical councils. See Bergmann & Wever, supra note 17, at 207–09. See id. at 207–08. Id. Bundesärzteordnung [BÄO] [Federal Medical Practitioners Act], Apr. 16, 1987, BGBl. I at 1218, as amended, § 5(2); See also Bergmann & Wever, supra note 17, at 210–11. See the discussion of the empirical data infra, at Part III A. See Bürgerliches Gesetzbuch [BGB] [Civil Code], Aug. 18, 1896, RGBl. at 195, repromulgated Jan. 2, 2002, BGBl. I at 42, as amended, available at http://www.gesetze-im-internet.

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Admittedly, in the past there were differences between these two routes, as there were discrepancies in the respective rules; however, the key differences relevant to medical malpractice claims were removed in 2002 by reforms to the BGB,25 so that now the rules in effect duplicate each other.26 Looking first at contractual liability, the patient can sue on the basis of the doctor’s alleged breach of his contractually assumed duties. This applies not only to patients who have private insurance, and pay the doctor in full before recouping this money from their insurer, but also to (the majority of) patients whose treatment is paid for by a statutory public insurance fund.27 The general basis for liability for breach of contract is set out in the BGB as follows: Section 276 Responsibility of the obligor (1) The obligor is responsible for intention and negligence, if a higher or lower degree of liability is neither laid down nor to be inferred from the other subject matter of the obligation, including but not limited to the giving of a guarantee... (2) A person acts negligently if he fails to exercise reasonable care. Section 280 Damages for breach of duty (1) If the obligor breaches a duty arising from the obligation, the obligee may demand damages for the damage caused thereby. This does not apply if the obligor is not responsible for the breach of duty.28 As these provisions indicate, contractual liability in Germany is based on fault, in the sense that, even after a breach of contract is made out, the defendant has the chance to exculpate himself by showing lack of fault (intention or negligence).29 In fact, with regard to contracts for medical

25

26 27

28 29

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de/bgb/, translated at Bundesministerium der Justiz, http://www.gesetze-im-internet.de/ englisch_bgb/. See Schadensrechtänderungsgesetz [Act Altering the Law of Damages], July 19, 2002, BGBl. I at 2674; Schuldrechtsmodernisierungsgesetz [Act Modernizing the Law of Obligations], Nov. 26, 2001, BGBl. I at 3138. The relevant differences were that damages for pain and suffering used to be available in tort alone and a longer limitation period applied in contract. Christian Katzenmeier, Arzthaftung [Medical Malpractice Liability] 79–81 (2002). This reflects the non-requirement of consideration in German contract law. Thus a private law contract exists between a doctor and a publicly-insured patient. See SGB V § 76(4). BGB §§ 276(1)–(2), 280(1), translated at Bundeministerium der Justiz, supra note 24. See id. at § 280(1). As is made clear by the way the provision is framed, the burden of persuading the court that there was no fault falls upon the obligor (i.e., defendant).

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treatment, matters usually do not reach this stage. The reason is that such contracts are generally treated as service contracts, under which the doctor is not held to a strict duty of achieving a given result (such as a cure), but simply one of careful performance.30 In other words, the doctor’s fault (i.e. negligent performance) must already be shown at the initial stage of establishing a breach of contract. In relation to hospital treatment, the effect of the contractual rules is to focus liability upon the hospital authority. In the majority of cases the patient will enter into a contract with both the hospital and the particular doctor(s) treating him. Besides being vicariously liable for the defaults of its employees, the hospital will be directly liable for the conduct of doctors occupying managerial positions.31 Moreover, there has been an increasing tendency in malpractice cases to impose direct liability with respect to organizational failures.32 Moving on to tortious liability, the basis for this is found in section 823 (1) BGB, which provides as follows: “A person who, intentionally or negligently, unlawfully injures the life, body, health, freedom, property or another right of another person is liable to make compensation to the other party for the damage arising from this.”33 Here again, fault in the form of intention or negligence is a precondition for liability. In this regard the same definition of negligence applies as for contract, namely the failure (under section 276 (2) BGB) to exercise reasonable care. Again, the patient may choose to bring his action against an individual doctor and/or the hospital. As previously hinted, a claim in private law represents by far the most significant way for patients injured during medical treatment to gain redress. Accordingly, in Part II below, we shall look in more detail at the rules that determine the existence and extent of a valid claim in a particular case. There too we shall consider an essential adjunct to the system, in the form of medical liability insurance, as well as the system of extra-judicial ‘medical arbitration boards’ in Germany, aimed at encouraging the abandonment or settlement of claims.

30 31 32

33

See Deutsch & Spickhoff, supra note 5, at 73–74. BGB §§ 31, 89, 278, translated at Bundeministerium der Justiz, supra note 24. See generally Bernd-Rüdiger Kern, Organisationsverschulden in der Judikatur [Organizational Fault in the Case Law], in Patientensicherheit, Arzthaftung, Praxis- und Krankenhausorganisation [Patient Safety, Medical Malpractice, and the Organization of Practices and Hospitals] 59 (Dietrich Berg & Klaus Ulsenheimer eds., 2006). BGB § 823(1), translated at Bundeministerium der Justiz, supra note 24.

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D.

Strict Liability and No-Fault Compensation for Medical Product Injury

In the case of injury attributable to medical products, German law also offers the possibility of compensation independent of fault. First and most significant, are injuries caused by medicinal drugs. Thus in 1976, in the wake of the Thalidomide (Contergan) disaster, the German Parliament enacted the Arzneimittelgesetz [AMG] [Medicinal Products Act].34 This provides in section 84 for liability against pharmaceutical manufacturers in cases where a medicinal product, used as prescribed, causes injury that, in light of the overall level of medical scientific development, may be regarded as unacceptable.35 In addition, following initiatives at the EC level, injury from non-pharmaceutical medical products is covered within the more general “strict liability” regime for consumer products under the Produkthaftungsgesetz [ProdHaftG] [Products Liability Act].36 Both the AMG and ProdHaftG regimes are regarded as complex in terms of their scope of application, and are relatively seldom used. One common difficulty has been establishing the causal link between a given product and an injury. In this regard, some reforms were made to the AMG in 2002, easing the patient’s situation. Now, once he shows the medicine was capable of causing the injury he suffered, absent a plausible alternative explanation, the presumption will be that it did so in his case; there is also a right to obtain information from the manufacturer as to the medicine’s known effects.37 Despite these changes, the pharmaceutical industry reported that between mid-2002 and mid-2005, it received just 220 compensation claims under the AMG, and seventy requests for information.38 In the second place, there are two limited pockets of no-fault liability with respect to medicinal product injuries. The first of these covers victims of

34 35

36 37

38

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See Arzneimittelgesetz [AMG] [Medicinal Products Act], Dec. 12, 2005, BGBl. I at 3394, as amended, translated at Bundeministerium der Justiz, supra note 24. See also Deutsch & Spickhoff, supra note 5, at 844. In this regard, the AMG does not embody strict “causal” liability: a patient who suffers an adverse reaction to the drug in its normal form is not entitled to compensation, if the drug fulfilled an important medical need and alternative treatment was not available. Produkthaftungsgesetz [ProdhaftG] [Products Liability Act], Dec. 15, 1989, BGBl. I at 2198, as amended (transposing the EC Product Liability Directive, 85/374 EC). AMG §§ 84(2), 84a(1). See also Valentin Saalfrank, Neue Aspekte der Arzneimittelhaftung [New Aspects of Medicinal Product Liability], in Arzneimittelsicherheit – Wunsch und Wirklichkeit [The Safety of Medicinal Products – Wish and Reality] 90 (Ilse Dautert et al. eds., 2008); Gerhard Wagner, Die Reform der Arzneimittelhaftung im Entwurf eines Zweiten Schadensrechtsänderungsgesetzes [The Reform of Medicinal Product Liability in the Draft Second Bill Altering the Law of Damages], 31 Versicherungsrecht [VersR] 1336 (2001). Saalfrank, supra note 37, at 91.

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Thalidomide (Contergan) and was set up in 1971 under the Conterganstiftungsgesetz [ConStiftG] [Thalidomide Foundation Act].39 The relevant scheme provides for compensation (mainly in the form of a fixed monthly pension) from a fund financed by contributions by the federal government and the drug manufacturers.40 The second German no-fault scheme was established in 1995 to provide compensation to patients infected with HIV as a result of receiving contaminated blood. This was introduced by the HIV-Hilfegesetz [HIVHG],41 inter alia in the light of the difficulties of proof experienced by such patients in bringing a claim under section 84 of the AMG. Although no-fault compensation for medical injury thus plays a limited role in modern Germany, it is worth remarking that things were different in the former German Democratic Republic (GDR). There, a partial nofault scheme of “additional support for victims of medical injury” operated, which covered iatrogenic injury, absent fault, if this was severe and in gross disproportion to the seriousness of the condition being treated.42 A rationale that has been suggested for the scheme was of counterbalancing the duty on GDR citizens to seek treatment to safeguard their economic productivity. Be that as it may, after German reunification, the scheme was no longer seen as socially justified, and it was disbanded in 1994.43

E.

Social Security, Insurance, and Subrogation Issues

Patients who neither qualify for private law compensation nor fall within one of the limited statutory strict liability and no-fault schemes must fall back on the general system of social security. This provides injured and/or disabled persons with access to collective social protection irrespective of

39 40 41 42

43

Conterganstiftungsgesetz [ContStiftG] [Thalidomide Foundation Act], Dec. 17, 1971, BGBl. I at 2018, repromulgated June 25, 2009, BGBl. I at 1537. See Christiane Wendehorst, Compensation in the German Health Care Sector, in No-Fault Compensation in the Health Sector 261, 270 (Jos Dute et al. eds., 2004). HIV-Hilfegesetz [HIVHG], July 24, 1995, BGBl. I at 971, last amended by G, Oct. 31, 2006, BGBl. I at 2407. See Wendehorst, supra note 40, at 272; Wagner, supra note 37. Anordnung über die Erweiterung der materiellen Unterstützung der Bürger bei Schäden infolge medizinischer Eingriffe [Ordinance on the Material Support of Citizens Injured By Medical Interventions], Dec. 16, 1974, GBl. 1975, no. 3, at 53. The scheme was partial in two ways. First, if there was fault (or rather – as, under the GDR-civil code, the onus of proof was here on the doctors – its absence could not be shown), fault-based liability applied. Secondly, the scheme extended to iatrogenic injuries only, not to failures to benefit from deficient treatment. See also, Katzenmeier, supra note 26, at 229. Katzenmeier, supra note 26, at 268–69.

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the source of injury, and in Germany is relatively generous. Thus the costs of further remedial treatment are covered by the medical insurance funds in the normal way, as are the ongoing costs of nursing care in cases of long-term disability.44 In addition, if the patient was employed and is now unable to work, his employer is required to continue to pay his salary for the first six weeks of absence; thereafter, he is entitled to statutory invalidity benefit (payable by the medical insurance funds), at seventy percent of his previous salary, for eighteen months.45 At a later point he will also become eligible for his statutory pension, albeit in a lower sum.46 In some cases, the patient may also have augmented social security benefits through private insurance.47 In cases of established medical malpractice, the relevant insurance-providers, having paid out sums to or for the patient, will have a right of recourse against the doctor’s or hospital’s liability insurer.48 Until a few years ago, such cases remained the exception: due to high administrative costs, the preference was for advance global settlements within the insurance sector, by which the liability insurers set aside a sum to cover injuries caused by their insured, and the patient insurance funds waived recourse.49 However, latterly, against the backdrop of financial pressure on the social security system, this has changed. Indeed, since 2004, hospitals have been under a duty to inform social insurance providers in cases in which their insured has suffered injury from putative medical negligence.50 It is now reported that some fifteen percent of damages in malpractice claims go to patients’ social and private insurance providers via subrogation.51 44 45 46 47 48

49 50

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Id, at 205–06. Id. at 207. Id. at 207–08. Id. Sozialgesetzbuch X Sozialverwaltungsverfahern und Sozialdatenschutz [SBG X] [Social Code Title X Social Administration and Social Protection], Aug. 5, 2010, BGBl I. at 1127, § 116(1) (addressing statutory health funds); Versicherungsvertragsgesetz [VVG] [Insurance Contracts Act], Apr. 14, 2010, BGBl. I at 410, § 86(1) (addressing private insurance companies). Katzenmeier, supra note 26, at 212–13. See Sozialgesetzbuch V Gesetzliche Krankenversicherung [SGB V] [Social Code Title v Social Health Insurance], Dec 20, 1988, BGBl. I at 2477, as amended, § 294a. See also Friedrich-Christian Beck & Axel Hausch, Das Recht des Patienten auf informationelle Selbstbestimmung im Spannungsverhältnis zum Akteneinsichtsanspruch der Krankenkassen nach § 294a SGB V [The Patient’s Right to Information Autonomy in Tension with the Health Insurance Funds’ Right to Access Health Records Under § 294a SGB V], 59 VersR 1321 (2008). See Anja Krüger, Im Spannungsfeld Zwischen Ärztlichen Standards und Wirtschaftlichkeitsgebot, Ärzte Zeitung, Oct. 14, 2010, at 2, available at http://www.aerztezeitung.de/praxis_ wirtschaft/recht/article/623876/arzthaftpflicht-zwischen-behandlungsfehlern-

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II.

The System of Private Law Compensation

In practice, as previously mentioned, private law provides the patient’s primary route to reparation for medical injury. As well as serving to close gaps in social security protection (particularly with respect to persons who are not employed or who suffer long-term disability), it provides the only means for the patient to recover non-pecuniary damages for pain and suffering (Schmerzensgeld). As we saw in Part I C, the legal basis for the treating side’s liability is found in key provisions of the German Civil Code [BGB]. However, the rules that then determine the existence, or not, of liability in a given case are largely a product of judge-made law.52 Indeed, over the last fifty years, the courts have created a subtle and involved jurisprudence, with a significant number of cases going all the way to the Bundesgerichthof [BGH] [Federal Court of Justice].53 An important distinction at the outset, as to how claims are classified and dealt with, is between cases of treatment malpractice (Behandlungsfehler), and those of disclosure malpractice (Aufklärungsfehler).

A.

Treatment Malpractice Claims

1.

Faulty Treatment

As discussed earlier, fault is a requirement for liability to arise; this is so whether a claim is based on contract or tort. Typically negligence will be at issue, which as we saw is defined as the failure to exercise reasonable care.54 In the case of a doctor, the BGH has held the applicable standard of care to be that of “a respectable and conscientious medical professional of

52

53

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wirtschaftlichkeit.html; see also Jens Flintrop & Heicke Korzillius, Arzthaftpflicht: Der Schutz wird Teurer [Medical Liability Cover: The Cost is Increasing], Deutsches Ärzteblatt, Apr. 16, 2010, at A 692, available at http://www.aerzteblatt.de/v4/archiv/artikel.asp? id=74090. For an account of the relevant rules, see Marc Stauch, The Law of Medical Negligence in England and Germany – A Comparative Analysis (2008). See infra Addendum to this chapter for the forthcoming changes, that will from 2013 place the main rules on a statutory footing. The BGH is the final appeal court for private law actions. In the thirty or so years before 2002 (when the German civil procedure rules changed to require leave from the intermediate appellate courts) the BGH typically heard between ten to twenty medical malpractice appeals each year. Since then, the number has fallen to between five and ten each year. Bürgerliches Gesetzbuch [BGB] [Civil Code], Aug. 18, 1896, RGBl. at 195, repromulgated Jan. 2, 2002, BGBl. I at 42, as amended, § 276(2).

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average expertise in the relevant field.”55 This is an objective test, with the result that if a doctor undertakes a task for which he does not (yet) have sufficient competence, he will generally be liable. In a leading decision on the duties of junior doctors, the BGH stated: [A junior doctor] owes the same duty of skill and care to the patient as any other doctor... If he recognises, or ought to recognise, that the patient will be exposed to a heightened risk of injury as a result of his inexperience, he should not proceed to treat against the dictates of his medical conscience and own better judgment.56 As this suggests, a junior doctor may be exculpated on the basis that he could not reasonably have known of his own lack of necessary skill. In such a case, liability will be placed exclusively upon the hospital for an organizational failure in deploying him for the relevant task and/or failing to supervise him.57 A further effect of the objective approach is that a hospital may not defend itself by pleading a lack of resources. At the same time, some variation in care between hospitals is accepted as inevitable, so that – provided a threshold standard of care is satisfied – a small local hospital need not operate to the same level as a university hospital.58 A more controversial issue concerns the standard owed in emergency situations (outside a hospital). Here, on the face of it, the “Good Samaritan” doctor may avail himself of section 680 BGB, which restricts the liability of “rescuers” to cases where their conduct was wilful or grossly negligent. However, the courts have as yet left open how far this provision would apply to someone with professional medical training.59 In assessing a particular case, if the doctor has met the required standard of care, the courts will be guided in the first place by the opinion evidence of other doctors as to whether his conduct was justified. Indeed, the BGH has held that a judge is not entitled to find negligence on the basis of ideas of his own, without the support of the experts.60 At the same time, the 55 56 57 58 59 60

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Bundesgerichtshof [BGH] [Federal Court of Justice], Jun. 13, 1960, Neue Juristische Wochenschrift [NJW] 600, 1961. Bundesgerichtshof [BGH] [Federal Court of Justice], Sept. 27 1983, Neue Juristische Wochenschrift [NJW] 655 (657), 1984. Id. See Bundesgerichtshof [BGH] [Federal Court of Justice], Sept. 22, 1987, Neue Juristische Wochenschrift [NJW] 763, 1988; see also Katzenmeier, supra note 26, at 283–84. See Oberlandesgericht [OLG] [Higher Regional Court] München, 6 Apr. 2006, Neue Juristiche Wochenschrift [NJW] 1883, 2006. Bundesgerichtshof [BGH] [Federal Court of Justice], Mar. 2, 1993, Neue Juristische Wochenschrift [NJW] 2378, 1993.

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courts are willing to look critically at practices accepted by the medical experts and will sometimes find them wanting. As the BGH stated in a medical negligence case from 1964: [T]he fact a given practice is customary will not be enough to exclude negligence if at the same time there is a failure to do all that is necessary, according to the rules and experience of medical science, to safeguard the patient from bodily harm.61 At least as significant, in terms of finding fault, are situations classified by the courts as involving “fully masterable risks” (voll beherrschbare Risiken). This covers cases where the harm to the patient stems from a risk arising out of the treatment environment. In such cases the occurrence of the risk per se qualifies as a breach of one of the treating side’s subsidiary obligations under the treatment contract, which – unlike the primary duty of attempting a cure – are construed strictly. As the BGH noted in a leading case from 1977, where a patient suffered brain damage due to a defect in the anaesthetic equipment: The hospital authority owed a contractual duty of care with respect to the provision of a properly functioning oxygen machine. The objective breach of this led to the damage in question... The principle [that the doctor will not be held contractually to the achievement of a given outcome] does not apply to the fulfilment of fully-masterable subsidiary obligations, in particular the guaranteeing of safe technical equipment during treatment.62 Here, in line with the scheme of contractual liability outlined in section 280(1) of the BGB, it will be for the doctor and/or hospital to show they are not liable for the breach.63 Nonetheless, the burden of justification will be a heavy one: the court is frequently able (with the benefit of hindsight) to identify precautions that could and should have been taken against the risk. As commentators have noted, the result is to tighten liability in the direction of strict liability.64

61 62 63

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Bundesgerichtshof [BGH] [Federal Court of Justice], Oct. 13, 1964, Neue Juristische Wochenschrift [NJW] 345 (346), 1965. Bundesgerichtshof [BGH] [Federal Court of Justice], Oct. 11, 1977, Neue Juristische Wochenschrift [NJW] 584 (584–85), 1978. See supra text at note 29. This is also consistent with a general approach in the German law of obligations, involving the concept of “Verkehrssicherungspflichten” (positive duties on those in control of a situation to ensure a safe environment). See Basil S. Markesinis & Hannes Unberath, the German Law of Torts: A Comparative Treatise 86–87 (4th ed. 2002). See Katzenmeier, supra note 26, at 167–68.

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In recent years, the German courts have subjected an increasing number of the treating side’s duties to this form of analysis, developing in the process an extensive case law.65 In addition to cases of defective equipment, categories where it is applied include injuries stemming from positioning on the operating table, as well as post-operative infections.66 More generally, it will encompass a failure of planning or control at institutional level, e.g., the non-availability of sufficiently skilled staff, inadequate supervision of junior doctors, or deficient communication within the medical team. Here there will be a finding of direct liability against the hospital.67

2.

Causation

Assuming a faulty breach of duty is established, it remains necessary for the patient to show that his injury arose from this, rather than e.g., simply as an unavoidable consequence of his underlying medical condition. Here German law employs the “conditio sine qua non formula,” which restricts liability to cases in which the defendant’s fault cannot be “eliminated in thought” (hinweggedacht) without the patient’s injury too ceasing to exist.68 For practical purposes this is the same as the “but for test” used under the common law. In both cases the key question is whether or not the defendant’s faulty conduct was a necessary condition for the injury – i.e., did it make a difference? As with the use of the “but for test,” there is little theoretical difficulty with this approach in medical malpractice cases. Thus instances of genuine causal over-determination, which can pose trouble for a sine qua non analysis, are very rare.69 Similarly, it is unusual, once the factual causation hurdle is satisfied, for objections to be taken on grounds of no legal (or proximate) causation: usually the patient’s injury is squarely within the

65 66

67

68 69

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See Bergmann & Wever, supra note 17, at 5 (suggesting that around half of the cases involve such an analysis). As to infections, it must first be shown that the source was within the treating side’s control, such as stemming from a member of the medical team. Bundesgerichtshof [BGH] [Federal Court of Justice], Mar. 20, 2007, Neue Juristische Wochenschrift [NJW] 1682, 2007. See Rüdiger Martis, Aktuelle Entwicklungen im Arzthaftungsrecht – Behandlungsfehler und Beweislastumkehr [Current Developments in Medical Liability Law – Treatment Malpractice and Reversals of Proof], 19 Monatschrift für Deutsches Recht [MDR] 1082, 1088 (2009). See Markesinis & Unbreath, supra note 63, at 103–04. See Richard W. Wright, Causation in Tort Law, 73 Cal. L. Rev. 1735, 1775 (1985) (discussing instances where each of two or more independent causal sets would have been sufficient to cause the plaintiff’s injury).

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risk from which the doctor was obliged to protect him.70 Nevertheless, as is well known, considerable difficulties remain of an evidential nature, namely how to decide, against a background of concurrent risk factors (the typical situation in medical cases), that it was the doctor’s fault – rather than one of those other factors – that featured in the causal set for injury.71 The inventive response of the German courts to these difficulties is examined under “proof issues.”

3.

Proof Issues

The burden of showing the faulty breach of duty by the doctor/hospital, as well as the factual causal link between this and his injury, is prima facie upon the patient. Moreover, it is a burden he must satisfy to the strict German civil proof standard of “judicial conviction.”72 On the face of things, given the notorious normative and factual complexity of medical malpractice claims, this makes life very difficult for a patient-plaintiff. In practice, though, patients in Germany have less to fear from evidential problems than may be supposed. There are three main reasons for this. In the first place, the civil courts in Germany, rather than simply arbitrating between the respective contentions of the parties, engage actively in seeking the truth as to what occurred. This “inquisitorial” approach is reflected in the way that evidence is gathered and assessed. Thus in the context of a medical malpractice claim, the court will appoint one or more neutral experts to assist it. Such experts, who have access to the full written documentation in the case, such as medical records and the testimony of the patient and treating doctors, are required to prepare a report (Gutachten) detailing their conclusions on the relevant factual and normative issues.73 Though not binding on the judges, who will supplement their understanding by oral questioning of the various witnesses

70 71

72

73

But see Part II B for a discussion of non-disclosure cases. Wright, supra note 69, at 1788. See also Marc Stauch, Causation, Risk and Loss of Chance in Medical Negligence, 17 Ox. J. Leg. S. 205 (1997) (applying this approach to medical malpractice cases). Zivilprozessordung [ZPO] [Code of Civil Procedure], Dec. 5, 2005, BGBl. I at 3202, as amended, § 286(1). This standard approximates the “beyond a reasonable doubt” standard that common law jurisdictions reserve for criminal proceedings. See Michael Bohlander, The German Advantage Revisited: An Inside View of German Civil Procedure in the Nineties, 13 Tul. Eur. & Civ. L.F. 25, 41–42 (1998). The patient at the same time has a general right to access his medical records, and may commission his own expert to give evidence on his behalf. Bundesgerichtshof [BGH] [Federal Court of Justice], Nov. 23, 1982, Neue Juristische Wochenschrift [NJW] 328, 1983.

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(including the experts), such reports will carry strong weight in the decision of the court. In medical injury claims, with their complex facts and the informational inequality between the parties, judges have taken special account of the patient’s difficulties. This also has a constitutional law dimension, given the patient’s right to a fair hearing under Article 103 (1) of the Grundgesetz [GG] [Basic Law].74 Thus in an important decision from 1979, the Bundesverfassungsgericht [BVerfG] [Federal Constitutional Court] affirmed the need for the courts to ensure “equality of arms” (Waffengleichheit).75 Subsequently, the BGH has stressed that trial judges – while remaining neutral – should generally be ready to intervene and ask questions or suggest lines of questioning to the patient’s legal representative.76 In the second place, and also with the aim of securing “equality of arms,” the German courts have developed a number of specific doctrines in treatment malpractice cases, whose effect is to relax the strict standard of proof, or in some cases to shift the burden of proof from the patient to the treating side. In this regard, we have already noted the existence of the figure of “fully masterable risks,” which in some cases places the onus from the outset on the treating side to explain and justify how a particular injury occurred.77 In addition, the courts have applied a formal presumption in cases of inadequate documentation by the treating side. Here, they will assume, in the absence of a record of a given measure, e.g., a diagnostic test or therapeutic procedure, that the same was omitted. In cases where such a measure was normatively indicated, then (assuming the treating side is unable to rebut the presumption by independent evidence), this will lead to a straightforward finding of negligence.78 As noted earlier, one area where evidential uncertainty is especially likely is with regard to the question of factual causation: the patient is exposed to several risks, those posed by his illness and by treatment, and it may simply be impossible – on the current state of the science – to identify their respective contributions and say that, but for faulty treatment, the patient would have avoided injury. Here, in some cases, the courts have been

74 75 76 77 78

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Grundgesetz für die Bundesrepublik Deutschland [Grundgesetz] [GG] [Basic Law], May 23, 1949, BGBl. I at 1, art. 103(1). Entscheidungen des Bundesverfassungsgerichts [BVerfGE] [Federal Constitutional Court], July 25, 1979, 52 BVerfGE 131. See Katzenmeier, supra note 26, at 390–92. See supra text accompanying note 63; see also Stauch, supra note 52, at 74–76. See Katzenmeier, supra note 34, at 470.

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prepared to relax the high proof standard of “judicial conviction.” In particular, where the injury may be seen as “secondary” to some earlier infringement of the patient’s bodily integrity or health (caused by the defendant), the courts will assess the putative link between the initial and secondary harm, according to the balance of probabilities.79 Far more significantly, though, the courts have developed a doctrine allowing for a full-scale proof reversal on causation in cases of “gross treatment error” (grobe Behandlungsfehler). In line with this, where the treatment was particularly negligent and created a more than negligible risk of the injury in suit, the onus shifts to the treating side to prove it was not causative. As such a proof reversal will nearly always be determinative as regards the question of liability, it is appropriate to consider further what the courts mean by a gross treatment error. In a case from 1983, the BGH commented on the issue as follows: A mistake that, while amounting to a breach of duty, is of the type that may on occasion befall even a careful and conscientious doctor, is not sufficient; rather the mistake, while not necessarily subjectively inexcusable – e.g. if attributable to special factors affecting the particular doctor – must be one that, in terms of the training and qualifications objectively required of doctors, is no longer comprehensible – i.e. is a mistake of the sort that a doctor simply ought not to make.80 At the same time, it is recognized that the factors making an error “gross” vary with the circumstances so that no conclusive or exhaustive definition is available.81 In this regard, the views of the medical experts will be crucial: a judge may not find an error to be “gross” if the experts are equivocal as to whether there was even ordinary negligence.82 However, the court is entitled to take account of the overall history of the patient’s

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80 81 82

This approach derives from the greater freedom the courts have, under section 287 of the ZPO, to assess proof going to the extent, rather than the existence, of liability (normally relevant to fixing quantum). The BGH applied it in the treatment malpractice context, for example, where a doctor misdiagnosed a fractured finger and thus failed to set it in plaster (the primary injury). Subsequently, when the patient re-injured the finger, the result was permanent atrophy of the bone (the secondary injury). Bundesgerichtshof [BGH] [Federal Court of Justice], Feb. 12, 2008, Neue Juristische Wochenschrift [NJW] 1381, 2008. Bundesgerichtshof [BGH] [Federal Court of Justice], May 10, 1983, Neue Juristische Wochenschrift [NJW] 2080 (2081), 1983. Katzenmeier, supra note 26, at 441–42; see also Stauch, supra note 52, at 87–92. Bundesgerichtshof [BGH] [Federal Court of Justice], May 29, 2001, Neue Juristische Wochenschrift [NJW] 2792, 2001.

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treatment and may treat a series of smaller mistakes, none of which is gross by itself, as having cumulatively attained this status.83 In relation to misdiagnosis cases, the BGH has noted the ambiguity with which illnesses may appear, and has suggested that a court should find gross fault only in cases of “fundamental error.”84 However, such a finding is easier where proper diagnostic tests were not carried out. Indeed, here the degree of the treating side’s culpability (in not conducting the tests) may be irrelevant. This is because the courts have treated purely hypothetical gross errors as a trigger for the proof reversal as to causation. Thus a reversal has been granted in cases where, if the results from a negligently omitted test had been to hand, it would have been grossly faulty for the treating side not to have taken further measures.85 As discussed later, the approach of the German courts in relation to gross errors has been the subject of criticism.86 One consequence of its use up until now, though, is that it has largely pre-empted interest in responses to causal uncertainty based on proportional recovery for “loss of chance.” Under the existing rules, the patient generally is already better placed, at least where he can show an actual or hypothetical gross error by the treating side: in such a case he will normally achieve full recovery, even where the likelihood that the error played a part in his injury is quite small.87 The third and last reason why the prima facie tricky proof rules in treatment malpractice cases often do not pose a barrier to the patient recovering compensation is that in a significant number of cases he can side-step them altogether by reformulating his claim as one of “disclosure malpractice.” It is to this form of claim that we now turn our attention.

B.

Disclosure Malpractice Claims

1.

Background

Claims for disclosure malpractice provide an alternative basis of argument in cases of iatrogenic injury. Instead of showing the injury stemmed from

83 84 85 86 87

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Id. at 2793. See Martis, supra note 67, at 1085. See, e.g., Bundesgerichtshof [BGH] [Federal Court of Justice], Apr. 27, 2004, Neue Juristische Wochenschrift [NJW] 2011, 2004. See Part III B. See, e.g., BGH, NJW 2011, 2004 (evidence showed that it was ninety percent probable that proper treatment would not have helped the patient).

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fault in the execution of treatment, the patient may argue that, insofar as the risk of such injury was indeed inherent in the treatment, the doctor failed in his anterior duty to warn of it. As a result, so the argument continues, the patient’s agreement to treatment was defective and the doctor should be liable for the injuries arising from it. In Germany the comparative ease of proof and lack of causal limitations in respect of such claims have made them a popular avenue of redress for medical injury: it has been estimated that patients raise arguments based on inadequate disclosure in around one-third of actions.88 The starting point for such a claim is the basic rule found in most countries that medical treatment is unlawful in the absence of the patient’s consent. In Germany, as well as giving rise to criminal liability, such treatment will qualify as unlawful bodily injury within section 823(1) of the BGB – the so-called Körperverletzungsdoktrin.89 Importantly (in contrast to treatment malpractice claims), the proof burden from the outset rests upon the doctor to show that he had the patient’s consent, i.e. as a defense rendering the treatment lawful. A second very significant point is that for consent to be valid, the doctor must not only have provided basic information as to the nature and purpose of treatment, but also must have informed the patient adequately about treatment risks and alternatives. In German law, unlike under the common law, there is no division of actions into battery and negligence; instead any situation of inadequate information disclosure, be it an egregious failure to tell the patient anything at all, or a simple slip in forgetting a trivial but disclosable risk, will equally give rise to an unlawful bodily injury under section 823(1) of the BGB.90

2.

Standard of Disclosure

The German courts have evolved a high standard of required information disclosure. A subjective approach is taken, according to which the doctor should divulge every matter that may conceivably affect the decision of the individual patient, including quite negligible risks. As the BGH stated in a decision from 2000:

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Katzenmeier, supra note 26, at 357 n. 248. Very often the patient will argue the point in the alternative as a back-up to his primary claim of treatment malpractice. Id. at 112. At the same time, the doctor will be in breach of his contractual duties to the patient. Id., at 324–26.

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Determinative, as regards the doctor’s duty to disclose, is not a given probability of a risk materialising, expressed in statistical terms. Rather, the decisive questions are how far the risk is particularly associated with the treatment and whether its occurrence would have a grave impact upon the patient’s lifestyle... In principle this means that, on occasion, extremely rare risks may have to be disclosed.91 On this basis, risks measured in fractions of millions have on occasion been held disclosable.92 However, risks that are a matter of common knowledge need not be divulged. Moreover, as regards the detail of information provided, the courts have held it is normally sufficient for the patient to receive a general picture of a given risk (im Großen und Ganzen), in terms of what its occurrence could mean for him. A technical disquisition is not required.93 Sometimes consent will also be nullified by a failure adequately to inform the patient of treatment alternatives. At least where these are in general use, then, where the risks attaching to each option are distinct, they should be discussed with the patient, e.g., if there is a choice between surgery and more conservative treatment.94 Moreover, where an alternative (to the treatment the doctor proposes) is favoured by mainstream medical opinion, this too should be made clear.95

3.

Causation

The positioning of non-disclosure of risk cases in German law, as akin to a battery under the common law, leaves relatively little room for factual causal limitations. Thus the question of whether the patient would have agreed to treatment if he had known of the risk is of subordinate importance: the unlawful act is the treatment, and the injury flowed from that. On other hand, the courts have allowed the doctor to raise the argument that the patient would have agreed to treatment anyway, as a form of defense known as “hypothetical consent” (hypothetische Einwilligung).96 91 92 93 94 95 96

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Bundesgerichtshof [BGH] [Federal Court of Justice], Feb. 15, 2000, Neue Juristische Wochenschrift [NJW] 1784 (1785), 2000. E.g., id. (where the risk of paralysis from the polio vaccine was one in 4.4 million). Bundesgerichtshof [BGH] [Federal Court of Justice], Feb. 7, 1984, Neue Juristische Wochenschrift [NJW] 1397, 1984; Katzenmeier, supra note 26, at 327–28. Deutsch Deutsch & Spickhoff, supra note 5, at 176. Bundesgerichtshof [BGH] [Federal Court of Justice], Mar. 18, 2003, Neue Juristische Wochenschrift [NJW] 1862, 2003. See BGH, NJW 1395 (1397), 1984. The defense is an instance of the general doctrine of rechtmäßiges Alternativverhalten [lawful alternative conduct], under which a defendant can

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Here, though, the burden of proof will be upon the doctor (and to the strict section 286 ZPO standard); in line with this, even if the doctor establishes that it would have been objectively against the patient’s interests to refuse the treatment (notwithstanding knowledge of the risk), it will be sufficient in rebuttal for the patient to persuade the court that he would have been placed in a dilemma (Entscheidungskonflikt) as to whether to consent. He need not show that he would actually have refused.97 In addition, the doctor may sometimes try to plead the absence of legal causation. This possibility arises in cases where the risk whose nondisclosure made the treatment unlawful did not materialise, and the injury instead stemmed from a different and non-disclosable risk. Here it may be argued that the prevention of such injury was not within the protective purpose (Schutzzweck) of the disclosure rule. Generally, though, the courts have been unwilling to accept such arguments,98 which they see as inimical to patient autonomy. As the BGH stated in a case from 1989: Consent to medical treatment is something that can only be given or withheld in its entirety ... Accordingly, where there is a deficit in disclosure, the treatment as a whole is unlawful, regardless of whether the risk that materialised was itself disclosable or not; to the extent that the lack of disclosure involved fault on the doctor’s part, he will thus be liable in principle for all of the treatment’s injurious consequences.99

C.

Damages and Liability Insurance Issues

Where the patient establishes liability for his injury, be it on the basis of treatment or disclosure malpractice, he is entitled to full reparation under section 249(1) of the BGB. This provides:“(1) A person who is liable in damages must restore the position that would exist if the circumstance obliging him to pay damages had not occurred.”100

argue that the unlawful aspect of his conduct did not cause the ensuing harm. Katzenmeier, supra note 26, at 347–48. 97 Bundesgerichtshof [BGH] [Federal Court of Justice], Dec. 11, 1990, Neue Juristische Wochenschrift [NJW] 1543, 1991; Katzenmeier, supra note 26, at 349. 98 See Stauch, supra note 52, at 118–20. One situation where such an argument was accepted was where the risk that materialized and injured the patient (in the course of overall unlawful treatment) had itself been disclosed. See BGH, NJW 1784 (1785), 2000. 99 Bundesgerichtshof [BGH] [Federal Court of Justice], Feb. 14, 1989, Neue Juristische Wochenschrift [NJW] 1533 (1535), 1989. 100 Bürgerliches Gesetzbuch [BGB] [Civil Code], Jan. 2, 2002, BGBl. I at 42, as amended, § 249(1), translated at http://www.gesetze-im-internet.de/englisch_bgb/index.html.

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As in other countries, damages will encompass both a pecuniary aspect, based on the financial loss occasioned by the injury to the patient (materielle Schäden), and a non–pecuniary element, reflecting the patient’s pain and suffering (immaterielle Schäden/Schmerzensgeld). As regards the former, this will include past and future nursing care, necessary adaptations to the patient’s home, lost earnings, and legal costs. Such sums can be very significant, especially for the long-term disabled. In recent years there has been a rise in pecuniary damages awarded by the courts, with compensation sometimes running into several million euros.101 As to damages for pain and suffering, German courts had in the past a reputation for awarding fairly modest sums in comparison to courts in other countries. However, while this still appears to be so at the lower end of the personal injury spectrum, it is no longer true in relation to more serious harm.102 A significant development was a BGH decision in 1992, which recognized such damages also for gross mental impairment, where the plaintiff remains subjectively unaware of his situation.103 As a result, high sums of damages are now awarded in cases of severe brain-damage leading to minimal consciousness. In recent decisions concerning severely disabled neonates, awards of half-a-million euros and more appear to have become the norm.104 Naturally, a critical issue in such cases is the doctor’s and/or hospital’s ability to pay. In this regard, while not a statutory precondition to practice, the Standesrecht of the doctors’ medical councils requires them to carry liability insurance (Haftpflichtversicherung).105 Similarly, the vast majority of hospitals, though not strictly required, have taken out such an insurance policy.106 In the past this non-mandatory approach does not

101 See Michael Petry, Entwicklung der Schadenaufwendungen im Heilwesenrisiko [Developments in the Costs of Compensating Injury in the Health Care Sector], in Arzthaftung – Mängel im Schadensausgleich? [Medical Practitioner Liability – Failings in Reparation?] 93 (Ilse. Dautert & Alexandra Jorzig eds., 2009). 102 See Hans-Berndt Ziegler & Matthias Ehl, Bein ab – arm dran. Eine Lanze für höhere Schmerzensgelder in Deutschland [Left Without a Leg to Stand on: A Plea for Higher Awards for Pain and Suffering in Germany], Juristische Rundschau [JR] 1, 1 (2009). 103 Bundesgerichtshof [BGH] [Federal Court of Justice], Oct. 13, 1992, Neue Juristiche Wochenschrift [NJW] 781, 1993. 104 Ziegler & Ehl, supra note 102. Taking account of pecuniary damages and the child’s putative loss of future earnings, total settlements in such cases are typically between one and two million euros. See also Petry, supra note 101. 105 BÄK, supra note 18, § 21; see also Bergmann & Wever, supra note 17, at 241–42. 106 Bergmann & Wever, supra note 17, at 241–42. In the case of a few large public hospitals funded by the Länder, these remain “self-insurers”, i.e., they pay damages out of their overall (publicly-financed) budget.

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appear to have created major problems.107 However, in the light of the higher awards, and an associated rise in premiums, there is now concern that some doctors may no longer be adequately insured:108 this and other liability insurance issues are considered further in Part III A.

D.

The Medical Arbitration Boards

In Germany, a mechanism exists that is designed to clear the way towards settlement, by the treating-side’s liability insurer or the patient abandoning his legal action, in the form of a system of medical arbitration boards (Gutachterkommissionen and Schlichtungsstellen). The formation of these boards began on the initiative of the regional medical councils in the mid-1970s – a time of a marked rise in malpractice litigation and growing distrust between doctors and patients. By establishing them, the profession hoped to defuse these tensions and demonstrate openness.109 Today there are twelve such boards, attached to the Landesärztekammer, which operate across Germany. Their general remit is to offer an expert report (Gutachten) outside the formal process of litigation, as to whether there was faulty treatment causative of injury. The proceedings remain cost-free for the patient, being financed by the Landesärztekammer, with contributions from hospital authorities. Typically, a claim will be assessed by expert panels of between three-to-five members, one whom is legally qualified and the others doctors (including one from the relevant specialty).110 A key principle is that submitting to a board’s adjudication is voluntary. Patients retain the option of bringing legal proceedings (though if this occurs, the board will stay its own investigation)111; the doctor too is not required to agree to the proceedings – albeit in practice they are usually happy to do so. Subsequently, the board’s decision as to whether there was faulty treatment is not binding on the parties. The boards are not surro-

107 Katzenmeier, supra note 26, at 197–98. 108 See Markt: Medizin: Ärzte ohne Haftpflicht [Medicine: Doctors Without Liability Insurance] (Westdeutscher Rundfunk broadcast Feb. 8, 2010) (wherein the medical lawyer and commentator, K.-O. Bergmann, suggested that up to five percent of doctors may be practicing without adequate insurance). 109 See Christina Meurer, Außergerichtliche Streitbelegung in Arzthaftungssachen [The Out-of-Court Settlement of Medical Liability Issues] 16 (2008). 110 Deutsch & Spickhoff, supra note 5, at 357; Bergmann & Wever, supra note 17, at 176. 111 Bergmann & Wever, supra note 17, at 180.

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gate courts, and will avoid contentious points of fact or law.112 Instead, they reach their findings on a review of largely agreed evidence (including the patient’s medical records and affidavits from the patient and doctor); on average, it takes around fourteen months for them to issue a decision.113 The working of the medical arbitration boards has generally been perceived as a success, at least in less complex cases, and the take-up upon them has increased steadily over time. Statistics published on the website of the Bundesärztekammer show that in 2009, nearly 11,000 new applications were made.114 On average the boards identify medical negligence as the cause of injury in around a quarter of the cases they investigate; and in around seventy percent of these, the doctor’s liability insurer will then proceed to settle. Conversely, where no error is found, the large majority of patients will abandon their claim.115

III. Assessment of the Current Situation A.

Empirical Data

As noted earlier, it has been estimated that between 20,000 and 40,000 private law claims commence in Germany every year.116 In the absence of a central collection point for such statistics, the precise figures remain uncertain, but information from the insurance sector may be indicative. With regard to cases against hospitals, data compiled over several years by the Ecclesia Insurance Group, the leading hospital liability insurer, in-

112 Thus where there is a factual disagreement – for example, as to what was said in a nondisclosure case – the board will not adjudicate. Similarly, faced with complex and disputed evidence on the issue of causation, it will leave its findings open. Unlike a court, it is not required to make positive findings of fact. 113 See Meurer, supra note 109, at 62–63. During this time, the limitation period in respect of potential legal proceedings will be suspended. 114 See BÄK, Statistische Erhebung der Gutachterkommissionen und Schlichtungsstellen [Statistical Survey of the Medical Arbitration Boards] (2009), available at http://www. bundesaerztekammer.de/downloads/Gutachterkommission_Statistik_2009.pdf. As noted, supra note 18, the BÄK acts as the umbrella organization for the Landesärztekammer. 115 See Deutsch & Spickhoff, supra note 5, at 362–63. 116 See Part I C; Katzenmeier, supra note 26, at 41 (suggesting a figure of 20,000 to 35,000); Martin Hansis & Dieter Hart, Medizinische Behandlungsfehler in Deutschland [Medical Treatment Malpractice in Germany] (2001), available at http://www.gbe-bund.de/ gbe10/owards.prc_show_pdf?p_id=7130&p_sprache=d&p_uid=gasts&p_aid=70384018&p_lfd_nr=1.

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dicate a claim-rate of just under 0.1 % per patient-treatment.117 Extrapolated to the overall number of hospital treatments in Germany, this produces an annual figure of around 17,000 claims for that sector alone. In terms of historical development, there was a sharp rise in the rate of litigation over the last four decades of the twentieth century, with the estimated annual number of claims rising from a few hundred at the end of the 1950s to 6,000 at the end of the 1970s and reaching the present figure by the beginning of the new century.118 In the last decade the numbers have apparently remained fairly stable: this is supported by the figures collated by the Bundesärztekammer in respect of the estimated onethird of claims that go before the arbitration boards. As noted, in 2009, there were some 11,000 such proceedings, only a small increase over the figure (10,500) for 2005.119 Only eight percent of claims will go to trial (and even fewer to judgment). The rest are settled by the doctor/hospital’s liability insurer or abandoned, in some cases following adjudication by an arbitration board. According to figures released by the medical liability insurer DBV-Winterthur for 2005, it settled 47 % and rejected the other 53 % of the claims notified to it.120 Of cases that end up in court, the patient will succeed in around thirty to forty percent of them. A survey in 2009, which examined medical malpractice cases dealt with at first instance by the Landgericht in Dortmund, found the patient was successful in part or whole in 50 out of 130 cases; of these, 36 involved late settlements (9 with the court’s assistance).121 Measured against the total number of medical treatments performed, it is apparent that the rate of malpractice litigation in Germany even today remains relatively low.122 What by contrast has increased dramatically in recent years is the overall cost to the system of such litigation. This is due not least to the higher sums of damages payable in cases of proven

See Petry, supra note 101, at 105. Katzenmeier, supra note 26, at 40–41. See BÄK, supra note 114. Patrick Weidinger, Aus der Praxis der Haftpflichtversicherung für Ärzte und Krankenhäuser – Statistik, neue Risiken und Qualitätsmanagement [Lessons from Liability Insurance Practice for Doctors and Hospitals – Statistics, New Risks, and Quality Management], 24 Medizinrecht [MedR] 571, 572 (2006). DBV-Winterthur was subsequently absorbed by the AXA insurance concern to form the Deutsche Ärzteversicherung, which is now the leading German medical practitioner liability insurer. 121 See Gisela Kothe-Pawel, Die Erfolgaussichten von Klagen im Arzthaftungsprozessen anhand der Ergebnisse vor dem Landgericht Dortmund im Jahr 2009 [The Prospects of Success for Medical Malpractice Claims Based on the Experience of the Dortmund Regional Court in 2009], 28 MedR 537, 537 (2010). 122 See supra text accompanying note 117.

117 118 119 120

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causative negligence, reflecting increased awards both for pecuniary and non-pecuniary losses, as well as longer life expectancies.123 Above all there has been a leap in the size of awards in the most serious cases of injury, which, while making up less than one percent of claims, now account for two-thirds of total sums paid out.124 Thus from 1981–2001, the average cost to the liability insurers of each claim (including those that were settled or abandoned) trebled, and the sum appears to have doubled again in the last decade.125 Overall, liability insurers probably now pay out in excess of a billion euros each year in respect of medical injury claims.126 The consequence has been a drop in the number of companies willing to offer such insurance, as well as an escalation in the premiums required by those that remain.127 In fact, in April 2010, the Deutsche Ärzteversicherung announced a premium rise for doctors in general practice from 350 to 770 euros per year.128 In high-risk specialties the figures are many times higher: thus, even before the latest rises, obstetrical gynaecologists were paying over 10,000 euros per annum for coverage.129 In July 2010, a compromise saw the health insurance funds130 agree to subsidize the premiums of childbirth midwives after the latter raised doubts as to their continuing viability as a profession.131 In light of such developments, it may not be too much to speak of an incipient crisis in the medical liability insurance sector. A possible response that has been mooted is for a cap on damages to be introduced for medical injury cases.132

123 See Part II C; Petry, supra note 101, at 95. 124 Petry, supra note 101, at 96. 125 Katzenmeier, supra note 26, at 42. According to the Deutsche Ärzteversicherung, the average payout per medical injury claim rose from 9,400 euros in 1998 to 21,100 euros in 2008. Flintrop & Korzillius, supra note 51. 126 In 2003, the annual costs to hospital liability insurers alone stood at 400 million euros. Bergmann & Wever, supra note 17, at 2. 127 Petry, supra note 101, at 97. 128 Flintrop & Korzillius, supra note 51. The concern reported a loss (i.e., shortfall in premiums collected relative to its liabilities) of some 100 million euros for each of the previous three years. 129 Petry, supra note 101, at 97. 130 I.e., the funders of medical care in Germany as described in the Introduction. 131 See Press Release Ass’n of German Liability Insurers, Statement of Chairman of the Ass’n of German Liability Insurers (July 13, 2010), available at http://www.gdv.de/Downloads/ Pressemeldungen_2010/PD28_Halbzeitbilanz_SU_Rede_Pohlhausen.doc. 132 Petry, supra note 101, at 104.

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B.

Evaluation of the Private Law Redress Rules

Returning to the legal redress rules examined in Part II, and in particular those that go to the existence as opposed to the extent of a claim, there have been various criticisms of the case law of the German courts over the years. As regards treatment malpractice, this is true especially of the reversal of proof as to causation in cases of gross errors. As commentators have pointed out, this is a judicial inroad into the proof rules laid down by the legislature, which lacks a convincing theoretical basis. In addition, the difficulty of defining what counts as a “gross” error has led to unpredictable outcomes.133 Some writers (and judges) defend the courts’ approach as a matter of practical justice, noting that otherwise patients would often find it impossible to win their claims.134 However, the views of those who urge its abandonment in favour of a proportionate approach to recovery in doubtful causation cases appear to be gaining ground.135 Equally controversial has been the approach of the judiciary in cases of disclosure malpractice. Here, there has been criticism of the courts’ Körperverletzungsdoktrin (classifying medical treatment prima facie as assault).136 In addition, with regard to the standard of information disclosure, commentators have pointed to the legal uncertainty created by the courts’ highly subjective approach to the risks that they hold disclosable. Doctors as well have expressed disquiet at the encroachment upon their clinical autonomy: the perception they have is of duties imposed by medical laymen, which take little account of the patient’s best interests.137 Overall, what seems clear is that the redress rules lead to over-compensation from the standpoint of corrective justice.138 Thus in some cases, fault 133 See Katzenmeier, supra note 26, at 454–55; Thomas Steiner, Der grobe ärztliche Behandlungsfehler in der Praxis [The Gross Medical Treatment Error in Practice], 60 VersR 473 (2009). 134 See Gerda Müller, Neue Perspektiven beim Schadensersatz [New Perspectives in the Law of Compensation], 57 VersR 1289, 1296 (2006). 135 See Gerhard Wagner, Schadensersatz – Zwecke, Inhalte, Grenzen[The Law of Compensation – Aims, Substance, Limits], in 35 Karlsruher Forum 2006, 93 (Egon Lorenz ed., 2006); Oliver Dopheide, Der Grobe Behandlungsfehler, eine Beweislastverteilung nach Kollektiven? [Gross Treatment Errors – Shifting the Burden of Proof on a Collective Basis?], 58 VersR 1050 (2007); Steiner, supra note 133; but see infra Addendum to this article. 136 See Dieter Hart, Autonomiesicherung im Arzthaftungsrecht – Ein Beitrag zur Entkoppelung von ärztlicher Aufklärungspflicht und Körperverletzung [Securing Autonomy in Medical Malpractice Law – A Contribution to Decoupling Disclosure Malpractice from the Law of Assault], in Festschrift Für Heinrichs 291 (Andreas Heldrich ed., 1998); Katzenmeier, supra note 26, at 114–15. 137 Katzenmeier, supra note 26, at 350. 138 From that standpoint, the defendant should be liable for injury arising from his faulty conduct, and not otherwise.

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has arguably been replaced by a de facto strict liability standard: this is true both in disclosure malpractice cases, where as noted, it is difficult to anticipate what risks doctors are required to disclose, and in relation to the application of the fully masterable risks doctrine in treatment malpractice cases.139 Secondly, the approach taken to factual causation issues in both types of claims gives rise to a significant number of “false positives”: the patient will sometimes be compensated for an injury he would have suffered anyway, even if the doctor/hospital had performed impeccably.140 Up until now, though, this “patient friendly” approach has met with a large degree of acceptance. The courts have addressed key problems for patients in medical injury litigation (as to information deficits and proof). Insofar as over-compensation results, this has been seen by many as acceptable “loss-spreading” within a social democratic society.141 Another important point relates to the access of justice enjoyed by patients. Thus the costs of bringing a claim remain broadly in line with those for other forms of private litigation, and are often covered by legal costs insurance held by the patient.142 In addition, as noted in Part II D, the patient always has the option of referring his claim to one of the cost-free medical arbitration boards. This general satisfaction is reflected in the relative lack of interest in replacing the present approach to compensating medical injury with a “no fault” insurance-based scheme. Though there were some initiatives in this direction in the 1970s, the consensus is that such a scheme would be both difficult to design equitably and too expensive.143 As noted in Part I D, after Germany reunification, the former partial no-fault scheme in the German Democratic Republic was wound up. Nevertheless, as suggested in further below, the established consensus is now under increasing pressure.

139 See Katzenmeier, supra note 26, at 167, 539. 140 As discussed in Part II A, where a gross treatment error is found, even in case of a modest risk, it is for the doctor to show (per impossibile) that this did not cause the injury. Similarly, in a disclosure malpractice action, the doctor’s prospects of successfully raising the defense of “hypothetical consent” are only slightly better. 141 See Katzenmeier, supra note 26, at 539–40. 142 As a rule, legal fees in Germany are calculated as a proportion of the amount of damages claimed, as set by the Rechtsanwaltvergütungsgesetz [RVG] [Lawyers Remuneration Act]. See Matthias Kilian, Alternatives to Public Provision: The Role of Legal Expenses Insurance in Broadening Access to Justice: The German Experience, 30 J.L. & Soc’y 31 (2003) (discussing the prevalence of legal costs insurance). 143 Katzenmeier, supra note 26, at 259; Stauch, supra note 52, at 144–45.

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C.

Patient Safety Initiatives

Recently, there has been growing interest in initiatives aimed at improving patient safety: as noted in the introduction, this has been triggered in part by evidence from international studies as to the true incidence of injury in the context of medical care.144 Though in Germany the private law system has not been seen as part of the problem (indeed it is credited in some respects with promoting safety),145 it is clear that alone it is not sufficient. One problem is that its impact depends on the patient bringing a legal action; however, only a small proportion of problems can be identified in this way. A major impetus in the direction of improved safety has come from within the medical profession itself. This is reflected in the bodies that have come into being in recent years with the remit of addressing the issue. Thus in 1995 the Bundesärztekammer and the association of public health insurance doctors formed the Ärztliches Zentrum für Qualität in der Medizin [ÄZQ] (Center for Quality in Medicine); in 2005, the Center inaugurated a Forum Patientensicherheit (Forum for Patient Safety).146 The same year also saw the formation of the Aktionsbündnis Patientensicherheit (German Coalition for Patient Safety), a charitable association whose membership comprises doctors, professional organizations, health care institutions, insurers, and patient organizations.147 Central to efforts at improving patient safety are gathering information as to past incidents, and the formulation and dissemination of strategies to reduce repetition in the future.148 Here, a significant source of information in Germany is represented by the records of the medical arbitration boards, which, as noted, deal with a significant proportion of cases where patients suspect negligence. Most of the boards publish regular case

144 For a fuller account of such initiatives, see Marc Stauch, Patient Safety and Clinical Risk Management in Germany, in Patient Safety, Law Policy and Practice 165 (John Tingle & Pippa Bark eds., 2011). 145 For example, the courts’ use of the “fully masterable risks” approach, discussed supra text accompanying notes 56–59, arguably has encouraged a more proactive approach to risk management by hospitals. See also Dieter Hart, Patientensicherheit, Risikomanagement, Arzneimittelbehandlung und Arzthaftungsrecht [Patient Safety, Risk Management, Pharmaceutical Treatment and Medical Malpractice Law], 25 MedR. 383, 390 (2007). 146 See Forum Patientensicherheit, http://www.forum-patientensicherheit.de/english (last visited Apr. 12, 2011). 147 See Aktionbündnis Patientensicherheit [APS], http://www.german-coalition-for-patient-safety.org/ (last visited Apr. 12, 2011). Among other things, it has formed several working groups. The APS is dedicated to drawing up protocols on the avoidance of common categories of mistakes, e.g., wrong-site surgery and drug prescription errors. 148 See Hart, supra note 145, at 383.

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studies bringing particular incidents that they have dealt with to the attention of doctors in the region. Since 2006, data as to all cases dealt with by the boards, have been the subject of systematic collation and analysis.149 In addition, the Forum Patientensicherheit and the Aktionsbündnis Patientensicherheit have been involved in setting up critical incident reporting systems, allowing healthcare professionals to register near misses anonymously on-line. Germany now has two main systems of this kind: cirsmedical.de, aimed mainly at health professionals in hospitals, and jeder-fehler-zaehlt.de (“every mistake counts”), for doctors in private practice.150 An ongoing project is the creation of an Institute for Patient Safety at the University of Bonn to do further research, using systems and root-cause analysis, into the background to medical injuries.151

Conclusion Overall, the German system for compensating for medical injury illustrates the imagination and freedom of the courts in developing the rules they deem necessary to do justice in this complex area. The case law is characterized by considerable subtlety, as well as a tendency to assist the patient. As noted, the effect is over-compensation (on a corrective justice approach), but this has been seen as an aspect of permissible loss redistribution. At least in the past, in the context of the affluent conditions of German society, with costs shared between the social security system and liability insurers, this was a stable solution with broad support, which kept reform initiatives in this area largely off the political agenda. This position is now under threat in light of the ever higher sums of damages awarded in a minority of cases, as well as the increasing tendency for patients’ social and private insurers to invoke their rights of subrogation. As noted above, this is beginning to produce a crisis in the medical liability insurance sector. Although some commentators have expressed the hope that patient safety initiatives, once they bear fruit, may lead to a fall in such cases, this seems unlikely: as noted, one of the findings underlying the patient safety movement is how rarely cases of medical

149 Meurer, supra note 109, at 142–43. 150 See CIRS Medical, http://www.cirsmedical.de/ (last visited Apr. 12, 2011); Jeder Fehler Zaehlt!, http://www.jeder-fehler-zaehlt.de/ (last visited Apr. 12, 2011). 151 See Aktionbündnis Patientensicherheit, Agenda Patientensicherheit 2008, 10–11 (2008), http://www.aktionsbuendnis-patientensicherheit.de/apsside/Agenda_2008.pdf.

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injury lead to a compensation claim. It will at any rate be interesting to see how matters develop in the future.

Addendum Following a 2011 whitepaper on “Patient Rights in Germany” [Grundlagenpapier: Patientenrechte in Deutschland],152 the German Bundestag (lower house of parliament) in November 2012 passed a bill on Patient Rights [Patientenrechtegesetz [PRG]]: the Act is expected to enter force in March or April 2013 and aims to improve the patient’s position in the health care system, including his ability to make good claims in cases of putative medical malpractice. Most significantly, and to enhance transparency, the Act will codify the key malpractice jurisprudence of the courts by inserting a new subtitle, ‘Treatment Contract’ [Behandlungsvertrag], at §§ 630a – h of the Civil Code [BGB]. This will include the various proof modifications granted to the patient, such as the rule shifting the burden of proof as to causation in cases of “gross” treatment errors, as well as the strict rules on informed consent.153 Changes are also to be introduced to Title V of the Social Code [SGB], providing inter alia for patients to be supported by their health insurers when bringing claims, and putting patient safety initiatives such as critical incident reporting on a statutory footing. The impact of this statute, which arguably has potential to further strain the compensation system, not least by raising claims awareness, will be watched with interest.

152 The whitepaper is available (in German) at: http://www.bmj.de/SharedDocs/Downloads/DE/pdfs/Grundlagenpapier_Patientenrechte.pdf?__blob=publicationFile 153 The bill, together with full explanatory notes, is available (in German) at: http://www. bmj.de/SharedDocs/Downloads/DE/pdfs/RegE_Gesetz_zur_Verbesserung_der_Rechte_von_Patientinnen_und_Patienten.pdf?__blob=publicationFile

209

Medical Malpractice: The Italian Experience Claudia Di Marzo*

Introduction In Italy, over the last two decades, medical professional liability has become a prominent issue in healthcare policy and a major concern for healthcare economics. The main reason for this scrutiny is the dramatic increase in medical malpractice litigation1 and its impact on professional liability insurance. The latter, in particular, has resulted in a rapid rise in insurance premiums and in numerous restrictions regarding the extent of insurance coverage.2

*

Claudia Di Marzo is Assistant Professor at the University of Palermo Law School, as well as Associate Tutor for the Civil Law course at the University of Palermo Postgraduate School for Legal Professions. She holds a Ph.D in Private Law and practices as a Civil lawyer in Palermo. During her Ph.D, she was a Visiting Scholar on a short-term research grant at the British Institute of International and Comparative Law of the University of London and at the Chicago-Kent College of Law of the Illinois Institute of Technology. She has also been involved in International Research Projects. Among her publications, there are commentaries on the Italian Civil Code (Articles 1988–1991 on non-contractual obligations), as well as a monograph and journal articles in the fields of mass torts and complex liability. All translations are the author’s unless otherwise indicated. 1 One indicator of the evolution of malpractice litigation in Italy is the annual report of the Association of Insurance Companies. According to this source, between 1994 and 2008 the number of claims filed annually against hospitals and medical practitioners showed an increase of 800 percent, rising from 3,150 to almost 30,000. A survey conducted by the Italian Associations of Anaesthetists and Reanimators reveals that every year approximately 12,000 claims for damages are brought exclusively against physicians. Such findings have been thus far confirmed by multiple insurance-related organizations. However, it must also be underlined that discrepancies between sources are not at all unusual. See Angelo Fiori & Daniela Marchetti, Medicina legale della responsabilità medica 8 (2009). 2 According to the Association of Medical Practitioners Unjustly Accused of Malpractice, insurance companies have seen a disproportionate increase of 250 percent over the last 15 years. Caro-assicurazioni per i medici, chirurghi plastici pagano fino a 10mila euro, Adnkronos (Apr. 12 2011), http://www.adnkronos.com/IGN/News/Cronaca/Caro-assicurazioni-peri-medici-chirurghi-plastici-pagano-fino-a-10mila-euro_241386359.html.

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In response to this rise in malpractice pressure, physicians have been adopting more and more changes in their practices,3 by taking allegedly unnecessary precautions or by withholding treatment that may be in the patients’ best interests but may also result in patients filing complaints. Recognized as having a significantly negative influence on costs and quality of care, such phenomena clearly demonstrate the existence of a crisis in the current Italian medical liability system. This crisis can be better understood by highlighting the importance of the interconnections between the lack of explicit regulations concerning the nature of the physician-patient relationship and medical liability, and the mixed approach taken by courts when dealing with medical malpractice cases. This approach has recently become even more confusing, given the complication introduced by the blurring of the boundaries between any kind of liability: contract and tort, as well as civil and criminal. The issue of defining the nature of the physician-patient relationship has been addressed with specific reference to situations in which the physician’s duty of care is not grounded in a contractual agreement with the patient, but instead stems from an employment relationship with a public or private hospital. In such cases, since the Italian Civil Code (C.c.) does not expressly define the physician’s relationship with the patient, courts and academics have been advancing different interpretations. The traditional view was that no direct legal relationship could be established between the physician and the patient, and, as the injured party, the patient relied exclusively on a cause of action in tort. This view has been gradually replaced by several opposing theories, which lean toward a contractual interpretation of the relationship. Based on these approaches, medical negligence is currently held to be the failure to fulfill a specific obligation, instead of the violation of a general duty of care. Needless to say, the resulting liability is contractual.

3 According to Salvatore Mazzamuto, Note in tema di responsabilità civile del medico, in 2 Europa e diritto privato 501, 509 (2000), the practice of defensive medicine results in two contradictions: on the one hand, it discourages progress and scientific discovery, which necessarily postulate mistakes and misconceptions; on the other hand, it entails the risk of having one medical practice for rich people and another for poor. It often happens, that physicians, who are willing to perform the newest and most innovative procedures, take precautions against the risk of patients’ filing complaints by raising prices for all procedures; but in doing so, they deprive poor people of healthcare access. For similar concerns, see also Luca Nivarra, La responsabilità civile dei professionisti (medici, avvocati, notai): il punto della giurisprudenza, in Europa e diritto privato 513, 533–34 (2000).

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The treatment of medical malpractice cases as one of contract (as opposed to one of tort) appears to be a policy adopted in order to provide the claimant the possibility of recovering damages even in problematic cases, such as when the nature of the situation makes it difficult (or impossible) for the claimant to prove fault and causation by the defendant. The changing landscape of medical liability has a number of implications, which include: (1) the assignment of the burden of proof (along with the distinction between obligations of means and obligations of outcomes); (2) the proof of causation (along with further reference to the difference between civil and criminal standards of proof regarding causation-infact); (3) the role of informed consent; and (4) the prescription regime. While achieving the aims of improving compensation for patients suffering adverse effects and, perhaps, providing incentives for the avoidance of such adverse effects, the new approach in question appears to be the major cause for the rapid increase in medical malpractice litigation, resulting in obvious repercussions on expenditures for liability insurance on the part of hospitals and physicians.

I.

The Problematic Nature of Medical Liability

According to the traditional view,4 a patient’s hospital admission, for either hospitalization or a routine checkup, involves the formation of a contract for professional services between the patient and the hospital,5

4 Cass., sez. III, 21 dicembre 1978, n. 6141, Giur. it. 1979, I, 1, 953; Cass., sez. III 24 marzo 1979, n. 1716, Foro it. 1980, I, 1115, Giur. it. 1981, I, 297, Giust. civ. 1979, I, 1440, Resp. civ. prev. 1980, 90; Cass., sez. III, 04 agosto 1987, n. 6707, Foro it. 1988, I, 1629. More recently, Cass., sez. III, 27 luglio 1998, n. 7336, Resp. civ. e prev. 1999, II, 996 (comment provided by Marilena Gorgoni, Disfunzioni tecniche e di organizzazione sanitaria e responsabilità professionale medica); Cass., sez. III, 01 settembre 1999, n. 9198, Giust. civ. Mass. 1999, 1877; Cass., sez. II, 11 marzo 2002, n. 3492, Giust. civ. Mass. 2002, 435; Cass., sez. III, 14 luglio 2003, n. 11001, Giust. civ. Mass. 2003, 5; Cass., sez. III, 21 luglio 2003, n. 11316, Giust. civ. Mass. 2003, 7–8; Cass., sez. III, 28 maggio 2004, n. 10297, Foro it. 2005, I, 2479; Cass., sez. III,19 aprile 2006, n. 9085, Giust. civ. Mass. 2006, 4. The same opinion has been expressed by many others, including Francesco Galgano, Contratto e responsabilità contrattuale nell’attività sanitaria, in 38 Rivista Trimestrale di Diritto e Procedura Civile 710, 711 (1984); Giovanni Iudica, Danno alla persona per inefficienza della struttura sanitaria, in 66 Responsabilitá Civile e Previdenza 3, 7 (2001). 5 App. Catanzaro 07 maggio 2004, Juris data (“[T]he relationship between the patient and the hospital stems from an atypical contract, for which there is no fixed form, nor it is needed an expression of willingness to contract made by parties. This contract does not contain only provisions on hospitality services (board and lodging), but provides also qualified medical and paramedical staff, all the requisite tools in the case of complications after the surgery, and the administration of drugs”). The decision conforms to Cass., sez. un. 01 luglio 2002, n. 9556, Nuova giur. civ. comm. 2003, I, 689 (comment provided

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where the hospital undertakes the obligation to provide due care in the patient’s treatment under the terms of the contract. According to other jurisprudence,6 people have a potestative right to healthcare access, the exercise of which results in a binding relationship with medical and health services managers, such as public hospitals.7 As a result, public hospitals’ liability is deemed to be contractual, meaning that the hospitals incur liability while executing a course of action imposed by a preexisting binding relationship. Even though both views confirm the contractual nature of the patienthospital relationship, in practice, a hospital-employed physician is engaged to fulfill an obligation that is owed by the hospital. However, she does not personally enter into the contract, and she is not a party in the binding relationship between the patient and the hospital. This is certainly true if one considers, on the one hand, that the patient is not entitled to choose the specific physician who is to provide her with treatment, and, on the other hand, that the physician is acting on the hospital’s behalf. Given these premises, one can conclude that the hospital and the hospitalemployed physician are both responsible to the patient when failing to carry out the requisite behavior on the grounds of contractual liability and tort liability, respectively, in accordance with the doctrine of accumulation or concurrence of liabilities.8 by C. Favilli, La risarcibilità del danno morale da lesioni del congiunto: l’intervento dirimente delle Sezioni Unite). 6 Cass., sez. III, 01 marzo 1988, n. 2144, Nuova giur. civ. comm. 1988, I, 604; Cass., sez. III, 27 maggio 1993, n. 5939, Rafaella De Matteis, La responsabilità medica 16 (1995); Cass., sez. III, 11 aprile 1995, n. 4152, Foro it., Rep. (1996), headword Professioni intellettuali, n. 176; App. Torino 20 giugno 1997, Foro it. 1998, I, 586; Cass., sez. III, 02 dicembre 1998, n. 12233, Danno e resp. contr. 1999, 777; Cass., sez. III, 22 gennaio 1999, n. 589, Corr. giur. 1999, 441(comment provided by Adolfo di Majo, L’obbligazione senza prestazione approda in Cassazione), Foro it. 1999, I, 3332 (comments provided by Francesco Di Ciommo, Note critiche sui recenti orientamenti giurisprudenziali in tema di responsabilità del medico ospedaliero; A. Lanotte, L’obbligazione del medico ospedaliero è un’obbligazione senza prestazione o una prestazione senza obbligazione?). 7 According to Article 1173 of the Italian Civil Code, obligations may arise from a contract or a tort, but may also depend on any other act or fact suitable to producing them in accordance with the law. Art. 1173 Codice Civile [C.c.]. As a consequence of this extension, courts have held that potestative rights can be considered as sources of obligations, fitting into those acts or facts suitable to producing them in accordance with the law. 8 Cass., sez. III, 09 gennaio 1979, n. 129, Giust. civ. Mass. 1979, 66; Cass., sez. III, 01 aprile 1980, n. 2105, Dir. economia assicur. 1980, 160, 562, Mass. Giur. lav. 1980, 602; Cass., sez. lav., 07 agosto 1982, n. 4437, 49 Resp. civ. e prev. 1984, 78 (comment provided by Chiara Somarè, Alcune considerazioni in tema di diligenza); Cass., sez. III, 26 marzo 1990, n. 2428, Giur. it. 1991, I, 1, 600; Cass., sez. lav.,23 giugno 1994, n. 6064, Foro it. 1995, I, 201; Trib. Pescara 02 maggio 1996, n. 621; Cass., sez. III, 13 marzo 1998, n. 2750, Foro it.

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Although rigorous and methodically correct, this approach has been hotly contested.9 In particular, it has been questioned whether the physician’s position before the patient is comparable with that of a tortfeasor, considering the existence of an unquestionable relationship between the patient and the physician, committing the physician to carry out the same duties that he would if bound by a contract.10 Criticism has also been expressed with regard to the contradictory solution of subjecting the hospital and the hospital-employed physician to different liability rules, notwithstanding the fact that the hospital’s liability stems from the physician’s failure to perform the requisite treatment (as well as the physician’s liability).11 Apart from these concerns, courts have had to tackle a number of additional problems arising from medical malpractice cases. With regard to situations in which the facts of the case have made it impossible for the claimant to prove the substantive requirements for tort liability (i.e., that the defendant’s faulty conduct caused the harm), courts have gradually recognized the inadequacy of the traditional test commonly used to establish medical liability and have begun to reward claimants based on the existence of an equitable imperative of protecting an obviously injured claimant. The need to improve patient protection has led to increasing divergence, on the part of the courts, from the traditional approach, in order to pursue differing theories, which suggest resorting to contractual liability in civil proceedings brought against hospital-employed physicians. Five different arguments have been put forward to support this conclusion: 1) Application of Article 28 of the Constitution (Cost.); 2) Application of the contract for the benefit of third parties;

1998, I, 3521, Resp. civ. e prev. 1999, 272 (comment provided by Enzo Ronchi, Colpa grave del medico: valutazione tecnico-giuridica lasciata al mero arbitrio). Accumulation of claims is generally admitted if need be to ensure the greatest protection possible for fundamental human rights, such as the right to health. In the absence of an appiglio normativo (specific regulation), both equity and empirical contingencies are believed to influence the application of the doctrine of accumulation of liabilities. See Umberto Breccia, Le obbligazioni 672 (1991). 9 See, e.g., Mazzamuto, supra note 3, at 503–04. The author argues that the use of tort liability to compensate medical malpractice damages should be abandoned either for theoretical or practical reasons. In fact, from a theoretical point of view, this use of tort liability conforms to an idea of medical activity serving only a protective function; while from a practical point of view, it makes it too difficult for the patient to satisfy the burden of proof as well as to observe the prescription regime. 10 Id. at 503. 11 Id. at 505.

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3) Application of the contract with protective effects in favor of third parties; 4) Application of the obbligazione senza prestazione doctrine; and 5) Application of the contatto sociale doctrine. The possibility for contractual liability to be imposed upon hospitalemployed physicians was first acknowledged when courts cited Article 28 of the Constitution,12 which provides, “Functionaries, government officials and State employees shall be directly responsible under criminal, civil, and administrative law for acts committed in violation of rights.”13 In addition, arising from the notion that the liability of the hospitalemployed physician and the liability of the hospital itself have a common root found in physicians’ negligent performance of their duties, courts have concluded that hospital-employed physician’s liability (and likewise the hospital’s liability) is contractual and professional.14 In effect, Article 28 of the Constitution recognizes a direct liability to be imposed upon State employees, and hospital-employed physicians certainly are State employees.15 However, the Article also refers to the legislation defining the features of this liability, and under civil law, liability can result either from a contract or from a tort. Furthermore, the circumstance that the hospital-employed physician’s liability and the hospital’s liability have a common root does not necessarily imply that, in both instances, the type of liability is contractual and professional.16

12

13

14 15 16

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Cass., sez. III, 01 marzo 1988, n. 2144, Giur. it. 1989, I, 1, 300 (comment provided by Roberto Cercone), Resp. civ. e prev. 1988, 992 (comment provided by Gabriele Travaglia, Sulla responsabilità del medico pubblico dipendente); Cass., sez. III, 01 febbraio 1991, n. 977, Giur. it. 1991, I, 1, 1379; Cass., sez. III, 27 maggio 1993, n. 5939, Rafaella De Matteis, La responsabilità medica 16 (1995); Cass., sez. III, 11 aprile 1995, n. 4152, Foro it., Rep. 1996, headword Professioni intellettuali, n. 176; Cass., sez. III, 02 dicembre 1998, n. 12233, Danno e resp. contr. 1999, 777 (“[I]n the case of wrong performance carried out in a public hospital, the hospital, as manager of public health service, and the physician are both responsible on the grounds of contractual liability ex art. 28 Cost.”). See Art. 28 Costituzione [Cost.]. The official translation of the provision provides: “Officials of the State or public agencies shall be directly responsible under criminal, civil, and administrative law for acts committed in violation of rights. In such cases, civil liability shall extend to the State and to such public agency.” The orientamento giurisprudenziale (case law) discussed above goes back to Cass., sez. III, 01 marzo 1988, n. 2144, Giur. it. 1989, I, 1, 300. Art. 28 Cost. Cass., sez. III, 22 gennaio 1999, n. 589, Foro it. 1999, I, 3332. See also, Carlo Rossello, Responsabilità contrattuale ed aquiliana: il punto sulla giurisprudenza, in 2 Contratto e impresa 642, 642–78 (1996) (referring to the case when the same fact is a source of contractual

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The trend has therefore shifted to applying the contract for the benefit of third parties in order to explain where this contractual liability comes from.17 Since the actual purpose of a physician’s employment contract is to provide hospital patients with due care, it has been suggested that patients (being the true intended beneficiaries of that employment contract’s primary obligation) are entitled to require the physician to carry out the obligation. For the same reason, if the physician fails to perform that obligation, patients are also granted the right to bring actions for damages against the physician for breach of contract. A major problem with this approach is that hospital patients who have been damaged as a result of a breach of duty (which is their legal right according to the physician’s employment contract) do not claim damages under that contract, but do so under the separate contract for professional service that they have formed with the hospital. Similar criticism18 has been expressed regarding the proposal to apply the scheme of a contract with protective effects in favor of third parties19 to the hospital-physician agreement. Considered a “refinement” of the traditional contract for the benefit of third parties, the contract with protective effects in favor of third parties

17

18

19

liability upon one person and a source of extra-contractual liability upon another person). Trib. Milano 24 giugno 1999, Corr. giur. 2000, 382. See also Adolfo di Majo, La Protezione Del Terzo Tra Contratto E Torto, in Europa e Diritto Privato 1, 1–26 (2000); Basil Markesinis & Hannes Unberath, The German Law of Torts: A Comparative Treatise 59–64 (4th ed. 2002). The concept of contract with protective effects in favor of third parties has been developed by German courts, having recourse to a doctrine called Vertrag mit Schutzwirkung für Dritte. This construct enabled courts to overcome the narrow provisions of German law of delict, and more specifically the general restriction of recovery for negligently inflicted pure economic loss under section 823 of the Bürgerliches Gesetzbuch [BGB] [Civil Code] and the weak rule for vicarious liability embedded in section 831 of the BGB. The possibility of extending the scope of the contract for the benefit of third parties depends on the distinction between primary (primäre Leistungspflichten) and secondary obligations arising from a contract. The latter obligations are often considered as collateral duties of protection (Schutzplichten). Only those duties that fall within the scope of the contract can be extended towards third persons. As a result, third parties are entitled to claim compensation for damages in case of breach of secondary obligations. For a general outline of the concept of contract with protective effects in favor of third parties, see B. S. Markesinis et al., The German Law of Obligations 276–82 (1st ed. 1997); B. S. Markesinis, An Expanding Tort Law-The Price of a Rigid Contract Law, 103 LAW Quarterly Review 354, 356–59 (1987). Cass., sez. III, 14 luglio 2003, n. 11001, Giust. civ. Mass. 2003, 5; Cass., sez. III, 14 giugno 2007, n. 13953, Foro it. 2008, I, 1990. For a clear description of the contract in question, see Markesinis & Unberath, supra note 17, at 59–64.

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has been used in order to allow certain persons,20 who are not parties to a contract but derive advantage from its implementation, to frame a claim in contract in the case of breach of one of that contract’s secondary obligations (i.e., duties of care and protection). Although acknowledged by the Court of Cassation, the highest court in Italy,21 the contract with protective effects in favor of third parties does not seem to be an appropriate argument for contractual liability to be imposed upon hospital-employed physicians because the physician’s duties toward a patient, as established in the physician’s employment contract, cannot be considered secondary obligations at all. In addition, if the right to demand the execution of the contract’s primary obligation were not to be attributed to the patient, his interest (in the contract) would not be satisfied. Another significant argument, put forward in order to justify the application of contractual liability upon hospital-employed physicians is based on the concept of obbligazione senza prestazione ai confini tra contratto e torto22 (obligation without making the performance compulsory [under the physician-patient relationship] at the boundary between contract and tort). According to this doctrine, even in the absence of a contract between the physician and the patient, the physician’s competence is binding in regards to the observance of duties of care and protection. These duties differ from the obligation to give the patient necessary treatment; although, the failure to fulfill them might expose the physician to contractual liability.

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German courts have adapted the contract with protective effects in favor of a third party to comply with the doctrine of privity. Four criteria generally apply in order to determine whether a third-party beneficiary falls within the scope of protection afforded by contract: 1) a close relationship (Näheverhältnis) between the obligor and the third-party beneficiary; 2) a justifiable interest of the obligee in the third-party benefit; 3) objective standards (Objektive Erkennbarkeit) capable of establishing thirdparty beneficiaries at the moment when the obligor enters into the contract; and 4) a third-party beneficiary’s right to be included within the contract’s sphere of protection (Schutzwürdigkeit des Dritten). For further observations, see Markesinis et al., supra note 18, at 359. Cass., sez. I, 22 novembre 1993, Nuova giur. civ. comm. 1994, 690 (comment provided by Vincenzo Zeno-zencovich, Il danno al nascituro). See Carlo Castronovo, L’Obbligazione Senza Prestazione Ai Confini Tra Contratto E Torto, in Le Ragioni Del Diritto: Scritti In Onore Di Luigi Mengoni 157, 197–99 (Giuffrè ed., 1995); Carlo Castronovo, La Nuova Responsabilita Civile 443–548 (3d ed. 2006).

Italy

The above-described approach has been widely adopted,23 but some doubt has been cast on its reliability.24 In particular, it has been argued the obbligazione senza prestazione doctrine admits the existence of duties of care and protection on the part of the physician, but it does not recognize the same physician as also bound by an obligation of performance. This being the case, one can conclude that whilst the duties of care and protection certainly provide the patient with support if his condition has worsened, these same duties do not guarantee the outcome of the requisite medical performance. In other words, the physician will be held contractually liable for negligent performance, but he may not be prosecuted directly by the patient in the event that he did not fulfill the obligation. A more convincing approach to the core problem of defining the nature of the hospital-employed physician’s liability was introduced by the Court of Cassation in decision No. 589/1999. According to this case, physicians can be held contractually liable under the doctrine of contatto sociale (social contact).25

23 24

25

See, e.g., Adolfo di Majo, L’obbligazione senza prestazione approda in Cassazione, in 4 Corriere Giuridico 441, 446 (1999). Criticism in this regard has been expressed by Massimo Paradiso, Il dovere del medico di informare il paziente. Consenso contrattuale e diritti della persona, in La responsabilità medica 139–40 (Dott. A. Giuffrè ed., 1982). In addition to the issue discussed in the text, it might be argued that the duties of care and protection, which constitute the physician’s obbligazione senza prestazione according to the reasoning above, are not dissimilar from those duties which fall within the bounds of reasonable care. Equally, the situation described by the doctrine in question is not different from other non-contractual circumstances where the lack of reasonable care gives rise to tort liability. It is sufficient to consider the case of the treatment of personal data, regulated by the Decreto Legislativo [D.Lgs.] 30 giugno 2003, n. 196. As established by Article 15 of the decree, tort liability applies in the case of infringement of the right of privacy as a consequence of the processing of personal data. Article 4 D. Lgs. 196/2003 states that compensation for damages can be allowed in both cases of electronic and manual processing of personal data. In the latter case, the interaction between the data-processor (i.e., the recipient) and the data-subject (i.e., the subject of the personal information) is self-evident; notwithstanding, the recipient’s failure to use reasonable care while processing the data, which has resulted in injury to the right to privacy of the data-subject, is sanctioned under tort law. Cass., sez. III, 22 gennaio 1999, n. 589, Foro it. 1999, I, 3332. The Court confirms that “the social conscience, preceding even the law itself, is not restricted to asking the professional operator not to do (i.e., to respect the legal sphere of the person who consults him, trusting in his competence), but also requires action, in which the professional operator’s ability is demonstrated ... In other words, medical care wouldn’t be different whether it originated from a contract for professional service or not. This is due to the fact that being a public service, which cannot be provided without a special license ... and being a protected profession, application of medical care would not be different whether there was a contract or not.” Id. The same approach has emerged in later jurisprudence. See Cass., sez. III, 28 maggio 2004, n. 10297, Foro it. 2005, I, 2479; Cass., sez. III, 21 giugno 2004, n. 11488, Rep. Giust. civ. 2004, headword Responsabilità Civile, n. 413, 4918; Cass., sez. III, 19 aprile 2006, n. 9085, Giust. civ. Mass. 2006, n. 4;

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The contatto sociale doctrine comes into effect when the physician agrees to take on the patient’s case, and the resulting physician-patient relationship is configured as a de facto contractual relationship.26 In general, so-called de facto contractual relationships are relationships which reproduce the scheme of true contracts, whose regulations they also follow. This means that, although originating as mere interactions between two persons, de facto contractual relationships are in fact binding on both sides, and are therefore sources of obligations.27 In particular, the relationship between a hospital-employed physician and hospital patients follows the model of contract for professional services. It thus imposes a duty on the physician to carry out all of the activities deemed reasonably necessary to restore the patients’ health and exposes him to contractual liability for failing to fulfill this obligation.28 Despite widespread adherence on the part of the jurisprudence to the doctrine of contatto sociale, some scholars have criticized this approach.29 In particular, it has been argued that medical activities carried out by hospital employees constitute performance on the part of those employees but not an obligation. Accordingly, a more appropriate paradigm would be the management of someone else’s affairs.30 In addition, the same scholar has hypothesized a vinculum of joint liability31 between hospital and physician for the application of due care on the part of the physician.

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Cass., sez. III, 24 maggio 2006, n. 12362, Rep. Giust. civ. 2006, headword Responsabilità Civile, n. 563, 4705; Cass., sez. un., 26 giugno 2007, n. 14712, Resp. civ. e prev. 2009, 2, 161; Cass., sez. un., 11 gennaio 2008, n. 577, 4 Resp. civ. e prev. 2008, 849 (comment provided by Marilena Gorgoni, Dalla matrice contrattuale della responsabilità nocosomiale e professionale al superamento della distinzione tra obbligazioni di mezzo/di risultato). Cass., sez. III, 22 gennaio 1999, n. 589, Foro it. 1999, I, 3332. The legal basis of the obligations discussed above can be found in Article 1173 C.c., the contatto sociale being considered a fact suitable to producing obligations in accordance with the law. See generally Stefano Fallace, La responsabilità da contatto sociale (2004); Ilenia Sarica, Il contatto sociale tra le fonti della responsabilità civile: recenti equivoci nella giurisprudenza di merito, in Contratto e impresa 97 (2005). Cass., sez. III, 13 aprile 2007, n. 8826, 9 Resp. civ. e prev. 2007, 1824; Cass., sez. un., 11 gennaio 2008, n. 577, 4 Resp. civ. e prev. 2008, 849. See Mazzamuto, supra note 3, at 504; Antonino Scalisi, Professione medica: doveri, divieti e responsabilità, in 10 Danno e Responsabilità 965, 981 (2007). According to Scalisi, the physician’s duty to provide due care finds its source in the law and, foremost, in the Constitution, in which Article 2 compels the observance of the duty of social solidarity, and Article 32 safeguards health as a fundamental right of the individual and as a collective interest. Id. (citing Art. 2, 32 Cost.). Mazzamuto, supra note 3, at 504. Id. at 506.

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This vinculum would render the relationship between the hospital and the physician relevant to the outside world. It would also enable the court to quantify damages only once and would finally recognize the contractual nature of liability of both parties – hospital and physician.32

II.

The Assignment of the Burden of Proof Between Parties

A.

Proving Fault

Once the contractual nature of medical liability has been established, compensation for damages can be awarded to the patient (claimant) if he provides proof of the breach of contract by the physician (defendant), unless the physician can prove the impossibility of performance as a result of conditions not attributable to him. Although this assigning of the burden of proof is currently applied in medical malpractice cases, more sophisticated analysis reveals a number of shifts in the way courts have handled the issue. In fact, when dealing with medical malpractice cases, courts previously modified the ordinary assignment of the burden of proof, established by Article 1218 C.c.,33 by applying the distinction between obligations of means and obligations of outcome.34 32

33

34

Under this approach, liabilities of both hospital and physician seem to become interdependent. However, one may come to a different conclusion if one considers that the physician’s duty to apply due care stays the same notwithstanding the circumstance that the contract (for professional service) between the hospital and the patient or the (employment) contract between the hospital and the physician be null and void. In any of these cases, exposure to liability on the part of the physician, depending entirely on the relationship with the patient, would be readily distinguishable from the possibility to impose liability also upon the hospital. Art. 1218 C.c. (“[T]he obligor who does not perform the obligation exactly is liable for damages unless he proves that the non-performance or the delay was due to impossibility of performance for a cause not attributable to him.”) (translation provided by Mario Beltramo et al., The Italian Civil Code 322 (1969)). The distinction between obligation of means and obligation of outcomes has been criticized by many legal scholars. See, e.g., Michele Giorgianni, Obbligazione, in Novissimo digesto italiano 581, 598 (Antonio Azara ed., 1965); Massimo Bianca, Diritto civile vol. 4, L’obbligazione 71 (1990); Carlo Castronovo, Profili Della Responsabilità Medica, in Studi in Onore Di Pietro Rescigno vol. 5, 117–36 (1998); Enrico Quadri, La responsabilità del medico tra obbligazioni di mezzi e di risultato, in 12 Danno e responsabilità 1165, 1165 (1999); Adolfo di Majo, Mezzi e risultato nelle prestazioni mediche: una storia infinita, in 1 Corriere Giuridico 38 (2005). The distinction must be considered obsolete after Cass. n. 8826/2007. In this decision, the Court of Cassation explained that the distinction between obligations of means and obligations of outcome cannot be used as a device to support physicians’ lack of responsibility in the case of failure to achieve a specific objective. After stating that the

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The expression “obligation of means” refers to a contractual obligation whereby the obligor needs to make the utmost effort to achieve the obligee’s desired objective, though she is not required to actually realize that end. Therefore, the obligor cannot be held automatically liable if she fails to achieve the obligee’s intended outcome. She is only responsible if her performance has failed to meet the requisite degree of diligence. With regard to the proof required to be shown by the obligor, the result is that she simply needs to prove that she has applied proper diligence. On the contrary, the obligation of outcome requires the obligor to achieve a stated end. Therefore, if she fails to achieve that end, she can be absolved of liability only by proving impossibility of performance due to an unforeseeable and unavoidable independent cause. Once the possible regulations regarding a physician’s duty of care have been established, an account should be given on the consequences which follow from the definition of such a duty either as an obligation of means35 or as an obligation of outcome.36 The consequences affect both the liability rules, which courts have applied to each type of obligation, and the assignment of the burden of proof between parties. In this regard, when considering the physician’s duty of care as an obligation of outcome, courts used to apply Article 1218 C.c., requiring the

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distinction has been enforced under the law of obligations, the Court explained that an obligor must make diligent efforts to achieve a specific result in both cases: either he owes an obligation of outcome or an obligation of means. Moreover, the Court stated, in the obligation of outcome, the obligee’s desired result cannot be ensured in any case, since the obligor is absolved of liability when he failed to perform the obligation due to an unforeseeable and unavoidable event. Finally, the Court rejected the argument that an obligor needs to prove the unforeseeability and unavoidabilty of the event that caused his failure to perform the obligation only in cases where he owed an obligation of outcome. In fact, according to the Court, this argument conflicts with Article 1218 C. c. See Luigi Mengoni, Obbligazioni di «risultato» e obbligazioni di «mezzi» (studio critico), in 1 Rivista del Diritto Commerciale e del Diritto Generale delle Obbligazioni 185, 187 (1954). See Cass., sez. III, 25 novembre 1994, n. 10014, Nuova giur. civ. comm. 1995, I, 937, where the court clearly states that “the professional obligation owed to a client (in view of the assigned duties) consists in performing professional activity [which may be] necessary and useful in the specific case in order to achieve the result that, through professional-technical means, the client is aiming for (the so called obligation of means or of conduct). Therefore, briefly, the professional is bound to perform professional activity as required or useful in the specific case and to apply requisite diligence.” Id. A conforming opinion can be found in Trib. Milano 22 maggio 2004, Giust. a Milano 2004, 44. See Cass., sez. II, 08 agosto 1985, n. 4394, 51 Resp. civ. e prev. 1986, I, 44 (comment provided by Cesare Vaccà, L’intervento di chirurgia estetica è obbligazione di risultato?).

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patient (obligee) to produce proof of having an agreement with the physician (obligor), and then simply alleging a breach of duty by the physician. On the contrary, when considering the duty of care as an obligation of means, courts used to apply Article 1176, Section 2 C.c.;37 in other words, the patient, in addition to being required to provide proof of the contract, also needed to prove a breach of duty by the physician. To better understand how courts have applied this “self-constructed” regulation, a distinction must be made between medical cases involving routine treatment and cases requiring complex procedures. In routine cases, courts required the patient-claimant to prove that the kind of treatment she had been given was routine and that she suffered damage as a result of that treatment. Once the claimant had satisfied this burden of proof, in order to avoid liability, the physician-defendant had the burden of proving the exact performance or the impossibility of performance due to a superseding cause that was unforeseeable, unavoidable, and external to his conduct.38 On the other hand, in complex cases, the defendant only had the burden of proof regarding the issue of the complex nature of the treatment. Once established, the burden then shifted to the claimant to prove the carelessness of the performance and the causal link between the physician’s conduct and the damage suffered.39 This changed in 2001, when the Court of Cassation40 declined to apply the distinction between routine cases and complex ones in the assignment of the burden of proof between parties.

37

38

39

40

Article 1176 C.c. states that “1. In performing the obligation the obligor must employ the diligence of a normal prudent person. 2. In meeting the obligations pertaining to the practice of a profession, the level of care has to be evaluated according to the nature of the practiced profession.” Art. 1176 C.c. (translation provided by Guido Alpa & Vincenzo Zeno-Zencovich, Italian Private Law, 237–39 (2007)). Cass., sez. III, 21 dicembre 1978, n. 6141, Giur. it. 1979, I, 1, 953; Cass., sez. III, 16 novembre 1988, n. 6220, Giust. civ. Mass. 1988, n. 11; Cass., sez. III, 11 marzo 2002, n. 3492, Giust. civ. Mass. 2002, 435. Cass., sez. III, 15 gennaio 1997, n. 364, Foro it. 1997, I, 771 (comment provided by Alessandro Palmieri, Relazione medico paziente tra consenso “globale” e responsabilità del professionista); Cass., sez. III, 04 Febbraio 1998, n. 1127, Giur. It. 1998, I, 1800; Cass., sez. III, 22 gennaio 1999, n. 589, Foro it. 1999, I, 3332. Cass., sez. un., 30 ottobre 2001, n. 13533, Foro it. 2002, I, 769.

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In a contract dispute, the Court established the principle that [a]n obligee, who brings a legal action against an obligor in order either to obtain the performance, the termination of the contract, or to claim compensation for damages, only needs to prove the legal basis for his right (i.e., the contract) and allege breach of duty by the obligor; while the obligor-defendant assumes the burden to prove the performance or the impossibility of performance due to a superseding cause.41 In 2004, the Court of Cassation42 extended this principle to medical malpractice cases: Regardless of the type of treatment or procedure, the patient who brings an action [for damages] needs to prove the existence of a contract (or a social contact) with the physician and allege the breach of duty by the physician. The burden then shifts to the physician, who is required to prove that he fulfilled the duty [in a manner] conforming to the requisite standard of diligence and that an external event, unforeseeable and unavoidable, actually caused the damage.43 As a consequence, the distinction between routine and complex treatment no longer stands as the standard by which the burden of proof is assigned between parties. According to the Court of Cassation,44 “this distinction shall rather be applied when the judge evaluates the degree of diligence required in a specific case and the extent of the corresponding fault.” In a more recent decision,45 the Court also repudiated the traditional view, which considered a physician’s obligation an obligation of means. To be more precise, the Court asserted that “the hospital-employed physician 41 42

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Id. Cass., sez. III, 28 maggio 2004, n. 10297, Foro it. 2005, I, 2479. See also Cass., sez. III, 21 giugno 2004, n. 11488, Giust. civ. 2005, I, 2115 (comment provided by Emanuela Giacobbe, Brevi osservazioni sul danno da “nascita indesiderata”, ovvero un bambino malformato non ha dirirtto a nascere). Cass., sez. III, 28 maggio 2004, n. 10297, Foro it. 2005, I, 2479. Consistent with this opinion, see Cass., sez. III, 19 aprile 2006, n. 9085, Giust. civ. Mass. 2006, 4; Cass., sez. III, 13 aprile 2007, n. 8826, 7 Resp. civ. e prev. 2007, 1824 (comment provided by Marilena Gorgoni, Le conseguenze di un intervento chirurgico rivelatosi inutile); Cass., sez. I, 10 ottobre 2007, n. 21140, Giust. civ. Mass. 2007, 10; Cass., sez. un., 11 gennaio 2008, n. 577, 4 Resp. civ. e prev. 2008, 849 (comment provided by Marilena Gorgoni); Cass., sez. un., 11 gennaio 2008, n. 584, Foro it. 2008, I, 451. Conforming to the same view, Cass. 14 febbraio 2008, n. 3520, Dir. e Giust. 2008 (“[T]he physician/obligor has the burden of proof on the issue of the lack of fault (sub specie of a superseding cause, unforeseeable and unavoidable); while the patient is required to prove the existence of a [contractual] relationship with the physician and the fact that he was entrusted with the treatment, and to allege the aggravation of his own condition.”). Cass., sez. III, 28 maggio 2004, n. 10297, Foro it. 2005, I, 2479. Cass. 13 aprile 2007, n. 8826, 7 Resp. civ. e prev. 2007, 1824.

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and the hospital itself are contractually bound to reach an intended outcome ... which is the outcome that can normally be achieved in relation to the patient’s conditions, the physician’s skill and the hospital’s ability in technical and organizational management.”46 With reference to the Court’s statement, it is widely held that Article 1218 C.c. is the only liability rule to be applied in the case of breach of a contractual duty. However, prominence is given to Article 1176 Section 2 C.c. when considering the standard of diligence to which medical professionals must conform. In this regard, the same Court affirmed that because medical obligations pertain to the practice of a profession, the requisite standard of diligence varies according to the different types of treatment or procedure to be performed as laid out by Article 1176 Section 2 C.c.47 At the same time, the limitation of liability to instances of intent or gross fault (as introduced by Article 2236 C.c. in cases where the performance of an obligation entails the solution of uncommon technical complications)48 should be restricted to problematic cases where “different diagnostic and therapeutic methods or surgical techniques are still discussed among medical scientists” and the damage occurred despite scrupulous attention paid by the physician in diagnosing and treating the disease.49 Another significant restriction introduced by the Court of Cassation regarding the range of Article 2236 C.c. consists in the choice of whether to apply the limitation of liability established by that article to damages caused by imperizia (the unintentional failure to observe and/or the violation of the cautionary rules of proper conduct for a hypothetical agent in the specific field of reference). On the contrary, even in cases of particularly complex treatments or procedures, this limitation of liability does not subsist with damages caused by negligence (the failure to apply proper diligence in the execution of a contract in order to obtain the intended result) or imprudence (the

46 47 48

49

Id. Id. Art. 2236 C.c. (“If performance entails the solution of uncommon technical complications, the person engaged in that specific activity is not liable for damages, except for cases of intent or gross fault”). Cass., sez. III, 19 maggio 2004, n. 9471, 1 Danno e resp., 2005, 23 (comment provided by Rafaella De Matteis, La responsabilità medica ad una svolta?).

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carelessness about the consequences of a conduct), for which the physician is responsible in any case.50 This account represents the prevailing view regarding the assignment of the burden of proof between physician and patient. This view is fully consistent with the normal evidentiary and procedural rules regarding this burden of proof, such as the proximity of proof principle, which provides that the burden of proof for any fact should be placed upon the party which is in the best position to produce it (because, for example, it is the closest to the sources of proof).51

B.

Proving Causation-In-Fact

In the cases discussed above, the Court of Cassation dealt with the assignment of the burden of proof regarding the issue of the breach of duty by the defendant. It is now to be established which party should bear the burden of proving the existence of a causal link between the defendant’s conduct and the resulting damage.52

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The Court of Cassation has reached this conclusion by observing that if the faulty conduct consisted of a lack of expertise, its evaluation on the part of the judge cannot necessarily be severe since the judge needs to consider that a pathology might have been influenced by the biological singularity of the patient, that clinical data are not obligatory, and that it is always possible to make an error of evaluation in clinical checking, with the resulting diagnosis proving to be faulty. Therefore, if the physician has not applied medical expertise, he will be responsible only in cases of gross fault (with the exception of the treatment being a routine case). In this regard, see Cass., sez. III, 08 luglio 1994, n. 6464, Resp. civ. e prev. 1994, 1029 (comment provided by Marilena Gorgoni, Il diritto di programmare la gravidanza e risarcimento del danno per nascita intempestiva); Cass., sez. III, 18 novembre 1997, n. 11440, Giust. civ. Mass. 1997, 2206; Cass., sez. III, 13 gennaio 2005, n. 583, 10 Giust. civ. 2006, 2186. With reference to the proximity of proof rule, see Cass., sez. III, 21 giugno 2004, n. 11488, Giust. civ. 2005, I, 2115. Whatever the treatment of medical malpractice cases may be, a number of causal links need to be established in order to obtain compensation for damages. If treated as tort cases, in accordance with Article 2043 C.c., it is necessary to produce proof of the existence of two causal links: 1) the relationship between the conduct (either negligent or intentional) and the damage-event (i.e., economic and non-economic damage) (causation-in-fact); and 2) the relationship between the damage-event and the damage-result (i.e., compensable consequences) (legal causation). On the contrary, the treatment of medical malpractice cases as contract cases involves the application of Article 1218 C.c., which requires the proof of the existence of a causal link between the failure to fulfill an obligation and the damage to be compensated (damageresult). However, a closer look at the issue reveals that no damage-result can come into effect if no damage-event has occurred previously. This being the case, one can conclude that, notwithstanding the change of the liability rule, in both instances two causal links must be established.

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The distinction between the breach of duty, which is concerned with fault, and the occurrence of damage, which is concerned with causation, is of considerable significance. This is especially true because the aspects of fault and causation are often mingled, as in the case of the increase in the use of the objective fault concept and in relation to cases where the damage was caused by an omission. For the purpose of attributing ultimate liability, both aspects should be established; but, while fault can be defined as the failure to perform an obligation in a manner conforming with an objectively specified standard of diligence, causation is the external relation between conduct and damage, with neither reference to the defendant’s mental state nor to his expectations regarding avoidable damage.53 Further elements to be considered in tracing a clear distinction between fault and causation are the tests commonly applied to establish each of these aspects of liability. In fact, while causal explanation is supposed to depend on the degree of statistical or logical probability of the actual occurrence of a disputed fact, the tests used to determine fault by the defendant are deemed to be: (1) the distinction between routine cases and complex ones; (2) the worsening of the patient’s condition or the onset of a new illness; (3) the evaluation of the requisite degree of fault according to the type of treatment or procedure to be performed;54 and (4) the fulfillment of the duty to inform the patient about risks posed by treatment, as well as the obtaining of informed consent from the patient.55 In addition, the Court of Cassation, Criminal Division, has specified that a charge of fault cannot be derived from the mere fact of the failure to observe or the violation of a precautionary rule, but it is necessary to verify whether the rule was aimed at avoiding exactly the type of event which took place (objectification of risk), the liability being otherwise objective on the grounds of the mere “versari in re illicita”.56

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Cass., sez. III, 06 ottobre 2004–18 aprile 2005, n. 7997, Corr. giur. 2006, 257 (comment provided by Federico Rolfi, Il nesso di causalità nell’illecito civile: la Cassazione alla ricerca di un modello unitario). With regard to routine treatments, the requisite degree of fault for liability to be imposed upon the physician is the lowest and is presumed in cases where the health conditions of the patient deteriorated or a new pathology has appeared. On the contrary, with regard to complex treatments which entail procedures not studied or tested thoroughly enough, the requisite degree of fault is either gross fault or intent. In both cases, though, the medical professional needs to have been a specialized physician and to have paid scrupulous attention in diagnosing and treating the patient’s problem. Cass., sez. III, 06 ottobre 2004–18 aprile 2005, n. 7997, Corr. Giur. 2006, 257. Cass. Pen., sez. IV, 17 maggio 2006, n. 4675, 10 Foro it. 2007, II, 550.

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Once the main differences between fault and causation have been specified, the point at issue is the assignment of the burden of proof regarding the causal link between the defendant’s conduct and the damage (causation-in-fact). The prevailing view57 until 2008 was that the patient had the burden of proving the causal link between a breach of duty by the physician (merely alleged) and the damage. Moreover, according to the same view, the failure to satisfy this burden (of proof) would preclude the judge from investigating the alleged fault by the defendant.58 Two lines of argumentation were used to support this view: 1) In the absence of specific tests for determining causation-in-fact in the Civil Code, it is necessary to have recourse to Articles 40 and 41 of the Penal Code, which provides that the plaintiff bears the burden of proof (at trial). 2) From Articles 1223, 1225, and 1227 C.c., it can be reasoned that the obligee, who claims damages for a breach of contract, bears the burden of proving that the damages are immediate and direct consequences of the conduct inducing the breach of contract. This changed in 2008, when the Court of Cassation made it clear that the allegation of a breach of duty by the defendant needs to be substantiated by the claimant. To be more precise, the Court asserted that the claimant’s allegation cannot concern whatever breach of duty, it should rather contain a clear statement about a breach of duty, which may be able to cause damage (i.e., theoretically able to cause damage). Once the claimant (has) made this allegation, the burden shifts to the defendant to prove performance or lack of causation between a breach of duty and damage.59 By considering the evidence of “general” and “potential” causation satisfactory, the Court seems to provide unsteady grounds for obtaining “specific” proof of causation.

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Cass., sez. III, 06 ottobre 2004–18 aprile 2005, n. 7997, Corr. Giur. 2006, 257. Cass. 19 aprile 2006, n. 9085, Giust. civ. Mass. 2006, 4; Cass. 24 maggio 2006, n. 12362, Giust. civ. Mass. 2006, 5; Cass. 31 luglio 2006, n. 17306, Giust. civ. Mass. 2006, 7–8. Cass. 11 gennaio 2008, n. 577, 4 Resp. civ. e prev. 2008, 849.

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C.

Proving Causation Under the Criminal Law and Under the Civil Law

Bearing in mind that the defendant’s liability is limited to those (economic and non-economic) damages that result directly from her (negligent or intentional) conduct,60 it must be established which test should apply in order to determine the limits of this liability or, in other words, recoverable damages. As previously noted, under the Italian Civil Code, there are no relevant provisions with this purpose. For this reason, courts and scholars have been arguing for years as to whether the test applied in criminal cases to establish causation could also extend to civil cases. The test in question is called condicio sine qua non. According to this test, any act/omission can be considered a cause of damage if the damage would not have occurred but for that act/omission. The process of establishing the existence of a causal link between an act/ omission and damage requires the application of counterfactual analysis,61 which achieves effective explanatory power when it is coupled with fully verified scientific generalizations. However, it hardly ever happens that the evidence employed to establish causation results in objective certainty about what happened on the particular occasion. In most cases, the evidence merely supports the proffered causal explanation and/or excludes other potential competing causes with a sufficiently high degree of probability to result in the judge having the requisite degree of belief in the truth of the disputed fact. However, the degree of proof required to support the judge’s belief varies according to the type of case. In criminal cases, it becomes more stringent since the prosecution is required to prove guilt beyond a reasonable doubt, which is the highest level of the burden of persuasion, as established by Section 1 of Article 533 of the Code of Penal Procedure (C.p.p.).

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Pursuant to Article 1223 C.c., compensation for damages arising from non-performance or delay includes the loss sustained by the creditor and the profit of which he has been deprived, inasmuch that both are direct and immediate consequence of the nonperformance or delay. Art. 1223 C.c. The basic idea of counterfactual theories of causation is that the meaning of causal claims can be explained in terms of counterfactual conditionals of the forms “if A had not occurred, C would not have occurred.”

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On the contrary, in civil cases, the prevailing jurisprudence62 has long adhered to the rule that the claimant must prove his case based upon the standard of preponderance of the evidence,63 which is considerably lower than the standard applied in criminal cases. On the issue of the identity or divergence of the evidentiary standards which should apply in the two types of cases, the United Sections of the Court of Cassation have recently intervened,64 explaining that the difference between the standard of “preponderance of the evidence” and “beyond a reasonable doubt” is the result of the diversity of the values at stake in criminal cases as opposed to the equivalence of the values at stake in civil cases. Although confirming the difference between the two types of cases,65 the Court also affirmed that the preponderance of the evidence standard cannot be described as merely enough evidence to make it more likely than not that the fact the claimant seeks to prove is true. In fact, for

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Cass., sez. un., 11 gennaio 2008, n. 581, 4 Resp. civ. e prev. 2008, 827. Further support for this view can be found in certain decisions by the European Court of Justice. See Case C-12/03P, Comm’n v. Tetra Laval BV, 2005 E.C.R. I-987, 1056; Case C-295/04, Manfredi v. Lloyd Adriatico Assicurazioni SpA, 2006 E.C.R. I-6619. In common law countries, the preponderance of the evidence standard is satisfied when the allegedly applicable causal explanation is more likely to be true than not true, considering the “weight, quality and persuasiveness” of the evidence. Some courts and scholars believe that the standard is to be considered satisfied if there is a greater than 50 percent ex ante statistical probability that the proffered causal sequence actually occurred. Cass., sez. un., 11 gennaio 2008, n. 576-85, 4 Resp. civ. e prev. 2008, 827. On the same issue, the Third Section of the Court of Cassation had intervened before the pronouncements of the United Sections of Gennaio 2008, and had adopted a criterion of probabilistic causation, without distinguishing in the application of this criterion between the type of proceeding (be it civil or criminal). See Cass., sez. II, 21 gennaio 2000, n. 632, Danno e resp. 2001, 72; Cass., sez. III, 04 marzo 2004, n. 4400, Riv. it. medicina legale 2004, 789. Three different arguments have been put forward to explain the reason why in medical malpractice cases civil causation would be autonomous from criminal causation. The first to be stressed is the function of the criminal justice system, as opposed to the function of the civil liability system. In fact, the former has a sanctioning function, whereas the latter has a compensatory function. Secondly, it has been remarked that the civil liability system does not exclude cases in which liability is objective or presumed, also as a result of the presumption of causation; this happens because the protection of the person who has suffered a damage is the primary aim to achieve in the civil liability system. Thirdly, there has been a noticeable difference between the interests protected by each of these systems. In fact, while the Penal Code regulates (criminal) offenses with predetermined interests in mind, the civil liability system appears to be more flexible. As confirmation of this, the concept of “unfair damage” under the terms and conditions of Article 2043 C.c. could be considered. It has been also demonstrated that in criminal law the offender is the principal figure in the proceedings and the principle of tipicità applies; on the other hand, in civil law, the primary position rests with the damaged party and the problem lies in allocating costs for damages.

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determining liability, this standard needs to be “qualified” by further elements, taken from the case under consideration, and capable of transforming into certainty the proffered causal explanation expressed until then in probabilistic terms. By also requiring the causal explanation to be provided with logical reliability, the Court of Cassation seems to be referring to a widely known opinion, which the United Criminal Sections (of the same Court) delivered in 2002 (Franzese opinion),66 and in which the point of arrival in the Court’s criminal jurisprudence on the issue of causation is briefly outlined. As confirmation of this, it seems useful to quote the United Criminal Sections No. 30328/2002 in the part where the Court stated: [I]t is not consented to automatically deduce from the coefficient of probability expressed by the statistical law, the confirmation or otherwise of the accusatorial hypothesis on the existence of a causal link, since the judge needs to verify the validity of that hypothesis on the particular occasion by making reference to the circumstances of the fact and all available proof; thus, at the end of the explanatory legal reasoning, which has also served to exclude interference from other potentially competing factors, it will be proved to be justified and judicially certain that the physician’s [...] conduct was a necessary condition in the damage with a high degree of rational credibility and logical probability.67 A brief report on the opinions given by the Court of Cassation subsequent to the January 2008 pronouncements by the United Sections reveals that the inquiry into causation does not always achieve a convincing result, often through failing to conform to the United Sections’ understanding of the preponderance of the evidence standard.

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Cass. Pen., sez. un., 10 luglio 2002, n. 30328, Cass. Pen. 2002, 3643. Reasoning from the circumstance that the arguments used by the United Criminal Sections of the Court of Cassation to establish causation are the same in civil jurisdictions and equally able to influence the judge’s belief, Carlo Castronovo, Sentieri Di Responsabilità Civile Europea, in 4 Europa e Diritto Privato 787, 820–22 (2008) considers unacceptable, from the point of view of the internal coherence of our legal system, that the Court of Cassation – Civil Division – keeps sustaining that the standard of “beyond a reasonable doubt” applies in criminal cases, while the standard of “preponderance of the evidence” applies in civil cases. Id. The Author objects that formulae such as those are extraneous with respect to our juridical tradition and arbitrary in our legal system, where the jurisprudence cannot create law with formulae so sharp and definite that only the Legislator can use them. What remains is the power of the judge to accept the probabilistic causal explanation to the extent that his free belief would make him think this to be satisfactory. Id.

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In fact, although some opinions have endorsed verdicts on causation based upon a virtual certainty standard rather than upon mere statistical probability, many others have applied considerably less stringent standards, such as “reasonable certainty”, “concrete, actual and not hypothetical possibility of a favorable outcome”, “reasonable certainty about the existence of a not insignificant probability”, “moral certainty”, and “reliable and significant possibility of a favorable outcome”. By not being based on a particular instance, these formulations have inevitably encouraged interpretations of the burden of persuasion with specific regard to the judge sitting on the case.

D.

The Role of Informed Consent

The need to obtain the consent of a patient before engaging in any treatment is enshrined in the Italian Constitution, which provides that “no one may be obliged to undergo any health treatment except under the provisions of the law.”68 Considered a necessary prerequisite for legitimate medical treatment,69 the consent of a patient must be personal, although it might be obtained from a “legally authorized representative” in cases where the patient who should give the consent is a minor or an interdicted person, and the treatment appears to be necessary or beneficial.70 Concerning the additional characteristics of this consent, it needs be free, spontaneous, deliberate, detailed, informed, and revocable at any time.71

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See Art. 32, § 2, Cost. The Italian Constitutional Court has recently stated that informed consent is grounded in Articles 2, 13, and 32 Cost., and consequently that two distinct rights can be recognized: the right to self-determination and the right to health. In fact, every individual has the right to be provided with all information regarding the nature and possible developments of the therapy, as well as the right to receive necessary treatment. See Corte Cost. 23 dicembre 2008, n. 438, 5 Foro it. 2009, I, 1328. See also Nivarra, supra note 3, at 524–25 (“the right to health is the fundamental parameter, if not the exclusive parameter, by which the performance of the physician is to be evaluated.” In other words, the (patient-)creditor’s interest is identified with the right to health “to which an integral part is the right to be analytically informed about the method or procedure and the result of the medical treatment.”). Cass., sez. III, 25 novembre 1994, n. 10014, Nuova giur. civ. comm. 1995, I, 937; Cass., sez. III, 15 gennaio 1997, n. 364, Foro it. 1997, I, 771. See also Mengoni, supra note 34, at 372. Antonino Scalisi, Famiglia e diritti del minore, in 10 Famiglia, persone e successioni 815, 815–29 (2006). Id.

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The consent must also be made explicit, but it might also be presumed in the case of imminent danger to the patient, as long as the treatment does not go beyond what is needed to avoid the danger.72 Finally, the consent cannot be valid forever; it must be rebus sic stantibus (i. e., things thus being). Because of this, the physician is bound to obtain consent again, if during the course of the treatment circumstances have changed, and it is necessary to modify the initial schedule of therapy.73 Consistent with the recognition of informed consent is the establishment of the duty on the part of the physician to provide the patient with detailed information so that he is completely aware of the type of treatment, possible risks, expected results, and possible adverse effects.74 This duty is explicitly stated in the Code of Medical Deontology, which advises the physician to clearly and thoroughly inform the patient regarding the diagnosis, prognosis, and therapy perspectives. The patient should also be aware of the likely consequences of applying the therapy and of omitting the therapy (within the known limits of medical knowledge, and taking into account the patient’s cultural level, emotions, and capacity to comprehend).75 The failure to obtain properly informed consent for treatment has been generally treated as an actionable legal wrong, regardless of whether the treatment was negligently performed or resulted in any physical damage.76 On the other hand, the failure to obtain a competent patient’s consent is treated as an actionable, legal wrong in many jurisdictions, including almost all common law and many civil law jurisdictions, only if the failure has caused a physical damage that would not have occurred if proper information had been provided. Both approaches may be contested on the same grounds.

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See Art. 54 Codice Penale [C.p.]. Cass., sez. III, 02 luglio 2010, n. 15698, Giust. civ. 2011, I, 433. Cass., sez. III, 16 maggio 2000, n. 6318, 20 Dir. e Giust. 2000, 14; Cass., sez. III, 23 maggio 2001, n. 7027, Foro it. 2001, I, 2504. See Massimo Paradiso, La responsabilità medica: dal torto al contratto, in 47 Rivista di Diritto Civile 325, 343 (2001) (“the source for a physician’s duty to inform is the same as the source for the physician-patient relationship, be this the contract or the law. Thus, no account should be taken of the interpretation that assigns the duty to inform to one’s good faith or to the responsibilities of care and protection, which are accessory to the main obligation ... On the contrary, the point here is not to safeguard interests which exist beyond the physician’s obligation, but to integrate the proper content of this obligation.”). See Art. 29-31 Codice Deontologico [C.deont.]. Cass., sez. III, 14 marzo 2006, n. 5444, 3 Riv. it. medicina legale 2007, 865.

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It can certainly be affirmed that omitted or incomplete information imputable to the physician makes it impossible for the patient to competently decide whether to undergo treatment or not, and consequently infringes her right to self-determination. In such a case, the physician’s performance must therefore be considered as an actionable legal wrong. However, it seems an impractical solution (on the ground of causation in fact) to attribute to the physician any physical harm to the patient’s health resulting from his actions, because such an imputation would depend on the choice made by the properly-informed patient. Besides, it cannot be denied that the physical damage occurring to the patient is a consequence of medical treatment and not a consequence of the omitted or defective information. One may argue that if the information had not been omitted or defective, the patient would not have suffered any physical damage;77 but, such an inference is illogical because (as already stated) the physical damage is a consequence of the physician’s performance, while the infringement of the patient’s right to self-determination entails, on the grounds of causation, merely an inquiry into whether the properly-informed patient would have decided to undergo treatment. The same conclusion was recently reached by the Court of Cassation, which provided: [D]ue to the fact that the surgery would not have been performed, only if the patient had refused it, in order to establish the causal link between the infringement of the patient’s right to self-determination (caused by the omitted information on the part of the physician) and the infringement of the right to health (due to negative, blameless consequences of the surgery) ... it should be possible to state that the patient would have refused treatment if he had been properly informed; otherwise the physician’s omitted conduct (i.e. the information given to the patient) would in any case have been unable to avoid damage (infringement of the right to health).78

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App. Milano 02 maggio 1995, Foro it. 1995, I, 1418 (holding that the infringement of the right to self-determination represents the starting point of a causal sequence whose end point is the infringement of the right to health, as it can be inferred from the fact that, with the right to self-determination being respected, either the physical damage would not have occurred or the risk of its occurrence would have been transferred upon the patient). Cass., sez. III, 09 febbraio 2010, n. 2847, 9 Guida al dir. 2010, 75 (comment provided by Francesco Agnino, La responsabilità medica: lo stato dell’arte della giurisprudenza tra enforcement del paziente e oggettivazione della responsabilità sanitaria, in 5 Corriere Giuridico 628 (2011).

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The Supreme Court continued, stating that in the counterfactual analysis, which is needed to establish the existence of a causal link, the patient bears the burden of proving that she would have refused the medical treatment had she been properly informed.79 According to the Court, multiple reasons justify this apportionment of the burden of proof between parties. Firstly, the creditor (i.e., the patient) is the party who is normally bound to prove the causal link between the failure to perform the treatment on the part of the physician and the damage suffered.80 Additionally, since the fact to be proven is that the patient had refused the treatment, this (i.e., patient’s refusal) being a personal choice, the distribution of the burden of proof between parties is established on the “proximity” of proof principle. All things considered, the mere infringement of the right to self-determination (when not coupled with damage to health) may result in a noneconomic damage to the patient, which could be compensated if proven and if it has exceeded normal tolerability.81

Conclusion From what has been presented since the beginning of this work, it is clear that the most recent developments in our medical liability system have gradually led to an exponential increase in the number of cases for which damages can be obtained and to a parallel rise in personal injury claims. Both these effects relate to the “contractualization” of medical liability, which has made it easier for the claimant to prove the conditions for liability. For instance, establishing fault on the part of the defendant has become a marginal aspect82 to the extent that it has gradually faded away as a consequence of the recourse to alternative probative mechanisms (such as presumption).

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Id. Id. Cass., sez. un., 11 novembre 2008, n. 26972, 1 Resp. civ. e prev. 2009, 38 (comment provided by Pier Giuseppe Monateri, Il pregiudizio esistenziale come voce del danno non patrimoniale), Danno e resp. 2009, 19. As far as contractual liability is concerned, the general rule is that “the obligor, who does not exactly perform the obligation, is responsible for damages unless he proves that the failure to perform the obligation or the delay in the performance has been due to impossibility of performance for a cause not imputable to him.” Art. 1218 C.c. It is clear from the provision that the objective fact of the non-performance or delay is sufficient to impose contractual liability.

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The same phenomenon (i.e., the “contractualization” of medical liability) has also rendered the role of “filter” carried out by causation more vague and limited against an increase in the number of cases of compensable damages, and also due to the growing importance of informed consent. However, a necessary observation is that, on the one hand, there are more damages for which compensation can be obtained, and on the other hand, medical liability has become less and less personal. This fact is related to the circumstance that the more complex the treatment to be performed becomes, the more difficult (and sometimes useless) it is to establish the liability of a particular person because the damage is often the result of different factors, partly human and partly organizational. Coupled with the reduced importance of “individual fault” in medical malpractice cases is the fact that hospitals offer financial coverage to their personnel if involved in a malpractice case.83 The personnel then are bound to pay compensation only in the (improbable) case of intentionally causing the damage. All these factors raise a serious question about the capacity of the Italian medical liability system to promote prevention of damages rather than to simply repair damages. There is a need for a more complex regulation of health-safeguarding objectives, above and beyond the strictures of the traditional setup. For many years medical liability reform has garnered the attention of scholars;84 but, over the last year the overall scene has been enhanced by a series of proposals characterized by a more solid scientific basis.85

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However, it may be observed that over the last few years hospitals have encountered difficulties in finding suitable insurance coverage due to the shift in the insurance policy and raise in insurance premiums. The insurance policy, which currently applies to hospitals, is called “claims made”. The coverage deals with incidents arising on or after the retroactive date of the policy and which are reported during the duration of the policy. The “claims made” policy allows insurance companies to contain the costs of providing coverage to the hospitals; but it is not as convenient for the hospitals. In fact, if a hospital is for some reason cancelled by an insurance company, it may not have coverage in the future for activities performed in the past. See, e.g., Giulio Ponzanelli, La responsabilità medica ad un bivio: assicurazione obbligatoria, sistema residuale no-fault o risk-management?, in 8 Danno e responsabilità 428, 428–30 (2003); Luca Nocco, La gestione del rischio clinico ed il monitoraggio degli errori medici: spunti di riflessione in chiave comparatistica, in 8 Danno e responsabilità 444, 444–52 (2003). For a clear overview of the main proposals elaborated during this legislature, see Giovanni Comandé, Dalla responsabilità sanitaria al no-blame regionale tra conciliazione e risarcimento, in 11 Danno e responsabilità 977, 977–88 (2010).

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Of considerable interest, from the point of view of civil law, is the proposal to compel public and private hospitals to insure against liability for damages caused to third parties by their personnel.86 Under the terms of the reform project, the institutions that do not fulfill the obligation to possess compulsory insurance cannot be accredited. It is also specified that a patient who claims to have suffered damage as a consequence of medical malpractice (i.e., the allegedly damaged party) can bring an action only against the hospital (and not against the physician). Another reform project,87 applying a precautionary principle, states that hospitals bear the responsibility for damages suffered by patients during the providing of medical services, unless they can prove to have adopted all possible measures available to science and skills to avoid harming the patient. In addition, the project extends the obligation for compulsory insurance to “autonomous medical and non-medical operators”.88 In regards to the modalities of providing insurance coverage, the reform project envisages a declaration of availability on the part of insurance companies in order to create a warranty fund for the victims of medical malpractice and to allow direct actions against the insurance companies. Similar provisions can be found in a different reform project,89 according to which any medical center, either public or private hospital or other body, is responsible for damage occurring in the medical center and caused by the personnel (either physician or otherwise) that the medical center has employed (even on an occasional basis), unless the medical center can prove to have adopted all possible measures to avoid the damage. The medical center can ask the personnel involved in the damage for compensation only in cases of intent, which has been ascertained through a formal judgment. In conclusion, all the reform projects suggest the recourse to a range of procedures in order to resolve medical malpractice disputes prior to, or during, the use of litigation, which on the contrary can be very costly and time-consuming.

86 87 88 89

Id. at 980. The proposal has been elaborated by the Centro Studi Federico Stella sulla Giustizia Penale e la Politica Criminale within article 26. Id. at 981. The reform project has been elaborated by the Società Italiana degli Studiosi di Diritto Civile. Id. (Article 2 of the Società Italiana degli Studiosi di Diritto Civile reform project). Id. at 983. The reform project has been elaborated by the Federazione nazionale degli ordini dei medici chirurghi e degli odontoiatri.

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Up to the present time, there is only one reform which has been adopted by the Parliament. It establishes that from March 21, 2011, it is compulsory to make an application for conciliation to resolve disputes in medical liability before having recourse to litigation.

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The Law of Medical Misadventure in Japan Robert B Leflar*

Introduction This article sets out the essential and distinctive features of the Japanese systems – criminal, civil, and administrative – for sanctioning persons causing medically related injury and for compensating the injured.1 The article seeks to place those systems in historical and social context. Patients in Japan obtain their health care on a price-controlled, fee-forservice basis. Insurance coverage is virtually universal: since 1961, every legal resident has been entitled to receive care through a mixture of private and public plans.2 The proportion of GDP that Japan devotes to health care, 8.5 percent as of 2008, is less than almost all other advanced industrial nations, and only about half that of the industrialized world’s

*

Ben J. Altheimer Professor of Legal Advocacy, University of Arkansas School of Law, Fayetteville; Professor, College of Public Health & Division of Medical Humanities, University of Arkansas for Medical Sciences, Little Rock; Visiting Professor, Keio University Faculty of Medicine, Dept. of Health Management, Tokyo. I thank Chiaki Sato of the University of Tokyo for his able research assistance, and Dan Foote, Norio Higuchi, Naoki Ikegami, Futoshi Iwata, Yasushi Kodama, and Mark Ramseyer for their comments on earlier drafts of the manuscript. I acknowledge with gratitude the research grant support of the University of Arkansas School of Law and the Pfizer Health Research Foundation [Pfizer Zaidan]. All translations are the author's unless otherwise indicated. Japanese as well as nonJapanese names are given surname last, for consistency's sake. Japanese cases are parenthetically denoted by their common sobriquets. Yen amounts are stated in dollars at the approximate prevailing exchange rate for the year in question – in 2011, about US $ 1 = ¥ 80. 1 The article is not confined to medical malpractice, in the sense of treatment failing to meet the legal standard of due care. The article’s scope also encompasses other medically related death and injury; hence the use of “misadventure,” a term bequeathed to us in this context by the New Zealanders. See Geoffrey Palmer, Compensation for Incapacity: A Study of Law and Social Change in New Zealand and Australia 255 (1979); Ken Oliphant, Defining “Medical Misadventure”: Lessons from New Zealand, 1 Med. L. Rev. 4 (1996). 2 John C. Campbell & Naoki Ikegami, The Art of Balance in Health Policy: Maintaining Japan’s Low-Cost, Egalitarian System 1–20 (1998).

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least efficient health care system, the United States.3 Yet Japan’s longevity and infant mortality statistics are among the world’s best,4 and technological sophistication at Japan’s top hospitals parallels that available anywhere. Nevertheless, iatrogenic harm – injury resulting from medical care – has long been a simmering concern. The number of civil malpractice claims, though relatively small, rose steadily through the 1980s and 1990s.5 During the same period, dissatisfaction with physicians’ paternalistic attitudes, a scandal over HIV-contaminated blood supply, a national debate over brain death issues, and concern over excessive and irrational drug prescriptions combined to undercut the public’s previously almost unquestioned faith in medicine’s beneficence.6 These developments fed a growing current of public opinion favoring transparency in medicine, reflecting movements toward greater openness in other spheres of society. Marking this trend toward transparency, around the turn of the 21st century, were court decisions advancing principles of informed consent,7 enactments of information disclosure measures,8 and provisions for patients’ access to their medical records.9

3 OECD.Stat Extracts, http://stats.oecd.org/index.aspx (last visited July 8, 2011); Colin Pritchard & Mark S. Wallace, Comparing the USA, UK and 17 Western Countries’ Efficiency and Effectiveness in Reducing Mortality, 2 J. Royal Soc’y Med. Short Rep. 60 (2011), available at http://image.guardian.co.uk/sys-files/Guardian/documents/2011/08/07/JRSMpaperPrit Wall.pdf (noting inefficiency of US health care system). 4 Jonathan Cylus & Gerard F. Anderson, Multinational Comparisons of Health Systems Data, 2006 (Commonwealth Fund 2007), available at http://www.commonwealthfund. org/Content/Publications/Chartbooks/2007/May/Multinational-Comparisons-of-HealthSystems-Data – 2006.aspx (last visited March 27, 2011). See generally Nayu Ikeda et al., What Has Made the Population of Japan Healthy?, 378 The Lancet 1094 (2011) (survey of reasons for Japanese longevity). 5 See infra note 53, fig. 2. 6 See Robert B Leflar, Informed Consent and Patients’ Rights in Japan, 33 Hous. L. Rev. 1 (1996) [hereinafter Leflar, Informed Consent]. 7 See, e.g., Judgment of Supreme Court Feb. 29, 2000, 54 Minshu- 582 (damages awarded Jehovah’s Witness for violating her blood transfusion refusal, despite transfusion’s lifesaving effects) [hereinafter Jehovah’s Witness case]. The case is available in English translation in Curtis J. Milhaupt, J. Mark Ramseyer & Mark D. West, The Japanese Legal System: Cases, Codes and Commentary 347–356 (2006). 8 Gyo-sei kikan no hoyu--suru jo-ho- no ko-kai ni kansuru ho-ritsu [Law on Access to Information Held by Administrative Organs], Law No. 42 of 1999 [hereinafter Information Disclosure Law]. This national law was preceded by various local freedom of information ordinances, a process well described in David Boling, Access to Government-Held Information in Japan: Citizens’ “Right to Know” Bows to the Bureaucracy, 34 Stan. J. Int’l L. 1 (1998). 9 See Ministry of Health & Welfare (Japan), Karute-to- no shinryo- jo-ho- no katsuyo- ni kansuru kentokai ho-kokusho [Report of the Study Commission on the Use of Medical Charts and Information] (1998); Robert B Leflar, Law and Health Care in Japan: The Renaissance of Informed Consent, in Timothy Stoltzfus Jost, Readings in Comparative Health Law & Bioethics 154, 159 (2d ed. 2007) [hereinafter Leflar, Renaissance] (summarizing health

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Beginning in 1999, reports of a series of errors at hospitals of high repute filled the headlines and newscasts. The first notorious case arose from switched-patient surgeries in Yokohama.10 Under the eyes of the nation’s media, subsequent cases occurred in quick succession in Tokyo itself. A nurse accidentally injected a toxic agent, killing her patient.11 An inexperienced team of young doctors bungled delicate laparoscopic surgery while insufficiently trained on the equipment, having also neglected to secure an adequate supply of the patient’s rare blood type.12 A child died after an operation at a major pediatric cardiovascular surgery center,13 one among a series of children’s deaths at the center. In each of these cases, physicians and hospital personnel altered medical records, gave misleading accounts of events to bereaved families or investigating officials, or engaged in other untrustworthy acts. Many other cases of alleged malpractice surfaced around the country. Media coverage of these iatrogenic deaths and injuries sparked public questioning of the medical profession’s self-policing mechanisms – questioning that the profession was ill-prepared to answer. Institutional structures to monitor the quality of Japan’s medical care have historically been weak. Medical licensure and discipline authority, exercised by the Ministry of Health, Labor & Welfare, seldom inquired into failures of patient safety.14 Hospital peer review was conducted with a soft touch, if at all, and the claimed impartiality of hospitals’ internal reviews of adverse events was met with increasing public skepticism. The hierarchical system of medical education and job placement strongly discouraged any open questioning

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ministry measures promoting patient access to medical records); and infra note 93 and accompanying text. At Yokohama City Medical University Hospital, a lung patient had part of his heart valve removed, and a heart patient with a similar name had part of his lung excised. Three doctors and two nurses were found criminally liable for professional negligence. Judgment of Yokohama Dist. Ct. Sept. 20, 2001, 1087 Hanrei Taimuzu 296 (Yokohama switched-surgery case). After this event at Tokyo’s Hiro- Hospital, two nurses were convicted of criminal professional negligence, and the hospital director was found guilty of submitting a false death certificate and failing to report the death to police in a timely fashion. Judgment of Supreme Court April 13, 2004, 58(4) Keishu- 247 [hereinafter Hiro- Hospital case]. See Robert B Leflar & Futoshi Iwata, Medical Error as Reportable Event, as Tort, as Crime: A Transpacific Comparison, 12 Widener L. Rev. 189, 192–95 (2005), reprinted in 22 Zeitschrift für Japanisches Recht/J. Jap. L. 39, 43–45 (2006) (recounting Aoto Hospital story). See Robert B Leflar, “Unnatural Deaths,” Criminal Sanctions, and Medical Quality Improvement in Japan, 9 Yale J. Health Pol’y L. & Ethics 1, 6 (2009), reprinted in 29 Zeitschrift für Japanisches Recht/J. Jap. L. 5, 9 (2010) [hereinafter Leflar, “Unnatural Deaths”] (recounting Tokyo Women’s Medical University Hospital story). See id. at 20 & n. 87 (summarizing research of Dr. Etsuji Okamoto and author’s interview with health ministry staff concerning work of the Ministry’s medical discipline committee, the Medical Ethics Council (Ido- shingikai)).

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of practices taught by revered professors (who controlled career postings), even if such practices were outmoded or scientifically unproven.15 The hospital accreditation system fostered good safety practices only marginally; hospitals need not receive accreditation to qualify for reimbursement for examinations, procedures and medications provided to patients, and only 29 percent of hospitals are accredited today.16 The nation’s patchwork death inquiry system functioned with efficacy in only a few urban areas, and even there, seldom focused on medical-practice-associated causes of death and their prevention.17 Civil litigation over alleged malpractice, as discussed below, provided only a modest and intermittent brake on medical error. Until the 2009 introduction of a no-fault system for compensating obstetrical injuries, administrative compensation systems were confined to a few limited categories of disease sufferers. In short, at the turn of the 21st century, weaknesses in professional selfregulation, administrative oversight, the death inquest system, and civil litigation left Japanese medicine to operate within an accountability vacuum.18 Attempting to fill part of that gap in public accountability, the criminal justice system – its workings amplified by the media – stepped up its engagement with iatrogenic harm cases.

I.

Prosecutions and Their Consequences

A.

Prosecutions in Medical Cases

Prosecutors have typically brought charges against health care personnel on any of three grounds. The first, and most common, is “professional

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See, e.g., Campbell & Ikegami, supra note 2, at 188–189 (criticizing quality assurance and peer review in Japanese hospitals); Hideki Hashimoto, Naoki Ikegami et al., Cost Containment and Quality of Care in Japan: Is There a Trade-Off? 378 The Lancet 1174, 1178 (2011) (“Physicians’ practice patterns tend to be idiosyncratically set by the chair and professor of the university clinical department.”). Of Japan’s 8,650 hospitals, 2,469 are accredited as of November 2011. Japan Council for Quality Health Care, Byo-in kino- hyo-ka kekka no jo-ho- teikyo- [Information on Results of Hospital Evaluations], available at http://www.report.jcqhc.or.jp. In any case, accreditation criteria do not address compliance with standards of evidence-based medicine or honesty with patients about adverse events. Tatsuya Fujimiya, Legal Medicine and the Death Inquiry System in Japan: Their Development and a Comparative Study, in Medicine and the Law: Proceedings of the 119th International Symposium on the Comparative History of Medicine, East and West 129, 152, 156 (Yasuo Otsuka & Shizu Sakai eds., 1998) (article from a 1994 symposium); Leflar, “Unnatural Deaths,” supra note 13, at 25–30. This argument is developed more fully in Leflar, “Unnatural Deaths,” supra note 13, and Leflar & Iwata, supra note 12.

Japan

negligence causing death or injury.”19 This crime is derived, like most of Japan’s Criminal Code, from the German penal code.20 The mens rea required for conviction, as a formal matter, is simple negligence, although as a practical matter the cases in which prosecutors obtain convictions typically involve acts or omissions amounting to gross negligence or recklessness.21 A second ground for prosecution is concealment or destruction of evidence.22 Physicians and nurses attempting to cover up medical mistakes by altering patients’ medical charts have been found criminally liable for this offense.23

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Keiho- [Criminal Code] art. 211 (Gyo-mujo- kashitsu chishisho--to-). The typical defendants charged with this crime are traffic offenders, but other professionals such as architects, pilots, and physicians are sometimes sanctioned as well. When convicted, such professionals are fined but rarely serve prison sentences. See Haruo Yamaguchi, Iryo- jiko no keiji shobun to purofuesshonaru o-tonomii [Criminal Sanctions for Medical Accidents and Professional Autonomy], 695 Niigata-ken ishikaiho- 2, 2 tbl.1 (2008) (reporting four cases of imprisonment out of 253 criminal sanctions in medical cases from 1950–2007). However, while under investigation physicians, like other suspects, may languish in police detention for a considerable period. For example, Dr. Kazuki Sato-, who was arrested, prosecuted, and acquitted in the Tokyo Women’s Medical University Hospital case, Leflar, “Unnatural Deaths,” supra note 13, at 6, was detained and interrogated for three months. Interview with Dr. Kazuki Sato-, in Tokyo (Aug. 7, 2009). Moreover, even if a convicted professional’s ultimate formal sanction is merely pecuniary, the conviction itself is usually enough to force a career change, through either loss of medical license or personal shame, so effectively the punishment is ultimately quite significant. Although criminal prosecutions and civil damage claims are formally separate, they sometimes proceed in parallel fashion, and the proceedings of each can influence the other. See infra note 21. See Hiroshi Oda, Japanese Law 416 (2d ed. 1999). See Leflar, “Unnatural Deaths,” supra note 13, at 16 n. 65 for a discussion of what “negligence” means in criminal law in Japan and France. Tokyo prosecutors responsible for medical cases informed the author that during the first wave of these prosecutions the most important factors in decisions about whether to prosecute were the bringing of a complaint by the patient or family, the degree of injury, the flagrancy of the medical personnel’s acts or omissions, the clarity of proof of negligence, and failure by medical personnel to provide compensation and apologies. Interview with Shu-ji Iwamura, Takayuki Aonuma, and Atsushi Sato-, Tokyo District Prosecutor’s Office, and Prof. Futoshi Iwata, Sophia University, in Tokyo (July 25, 2001). The prosecutors averred, perhaps disingenuously, that social goals such as deterrence of medical error formed no part of their motivation for bringing charges. Keiho- [Criminal Code], art. 104 (Sho-ko inmetsu-to-). A related crime is the creation, with the purpose to use, of false official documents. Keiho- [Criminal Code], art. 156 (Kyogi ko--bunsho sakusei-to-). The CEO of Hiro- Hospital in Tokyo was convicted of this crime. See Hiro- Hospital case, supra note 11. See, e.g., Leflar, “Unnatural Deaths,” supra note 13, at 6 (recounting Tokyo Women’s Medical University Hospital case). Plaintiffs’ attorneys charge that tampering with patient charts was a frequent practice, at least in the past. See, e.g., Hirotoshi Ishikawa, Karute kaizan wa naze okiru [Why Medical Records Are Falsified] (2006); see also J. Mark Ramseyer, The Effect of Universal Health Insurance on Malpractice Claims: The Japanese

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The third basis for recent prosecutions of physicians is failure to notify police in a timely fashion of “unnatural deaths.” Physicians once assumed that this notification requirement, found in Article 21 of the Medical Practitioners’ Law,24 applied only to violent deaths, suicides, infectious diseases threatening public health, and the like. However, when the CEO of Tokyo’s Hiro- Hospital in 2000 submitted a falsified death certificate for a patient killed by an accidental toxic injection and delayed reporting the death to police, prosecutors – fully aware of intensified public concern over medical errors – charged the CEO with violating Article 21. The Supreme Court, affirming his conviction in 2004, confirmed that the “unnatural death” notification requirement may encompass deaths causally related to medical management.25 The Hiro- Hospital CEO’s arrest and subsequent conviction placed hospital administrators in a dilemma. For purposes of medical care, no clear definition of “unnatural death” exists. When a patient dies following less-than-optimal care, should the hospital routinely notify police, inviting criminal investigation disruptive of hospital routine and patient care, or avoid notification and risk public condemnation for a cover-up and possible criminal prosecution? The number of reports to police of medically related death and injury, and the number of cases police referred to prosecutors, increased for several years after 1999 (Figure 1). The “unnatural death” notification requirement, and the concomitant (if variable and sporadic) police oversight of medical practice, generated intense controversy.

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Experience, 2 J. Legal Analysis 621, 662–663 (2010) [hereinafter Ramseyer, Malpractice Claims] (citing evidence that chart alteration “commonly happens”). Ishi ho- [Medical Practitioners’ Law], Law No. 201 of 1948, art. 21. Judgment of Supreme Court April 13, 2004, 58(4) Keishu- 247. One observer affiliated with the Japan Medical Association contends that “violation of Article 21 serves only as a hook for the [criminal] investigation of professional negligence resulting in death.” Rintaro Sawa, A Healthcare Crisis in Japan: Criminalizing Medical Malpractice, 51 Japan Med. Ass’n J. 235, 240 (2008).

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300 250 200

Reports to Police Cases Police sent to Prosecutors

150 100 50 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Figure 1: Medical accidents reported to police; cases police sent to prosecutors, 1997–2010.26

Critics of the criminal justice system’s involvement in monitoring medical mistakes raise concerns relating to police lack of medical expertise, disruption of patient care by criminal investigations, disproportionality of criminal sanctions to the inadvertence typical of lapses in care, and criminal law’s tendency to focus on individual blame rather than addressing more significant problems of system failure.27 Even granting the substantial merit of these criticisms, criminal law’s prominence in regulating medical quality in the early years of this century is understandable in light of these factors: (1) public expectation that the criminal justice system’s protective reach does not stop at the hospital doors; (2) police and prosecutors’ commitment to professional duty in enforcing the criminal code, applicable by its terms to medical personnel as to everyone else; and (3) the need in a democratic society for public accountability of the medical profession for its errors, a need not adequately fulfilled in Japan by professional self-regulation, administrative oversight, the death inquest system, or civil litigation.

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Nat’l Police Agency, Iryo- jiko kankei todokede-to- kenso- no ido-, rikken so-chisu- [Trends in Reports of Medically Related Cases and of Cases Sent to Prosecutors] (Aug. 8, 2011), reported in Iryo- jiko todokede gensho- tsuzuku; Keisatsu rikken mo 7.4 %-gen [Decline in Medical Accident Reports Continues; Cases Sent to Prosecutors also Decrease 7.4 %], Nihon keizai shinbun (Aug. 8, 2011) [hereinafter Police Reports on Medical Cases]. See Leflar, “Unnatural Deaths,” supra note 13, at 14 & n. 53 (summarizing criticisms).

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B.

Response by the Health Ministry and the Medical Profession

The Ministry of Health, Labor & Welfare (MHLW) had given short shrift before 1999 to patient safety issues. In reaction to the controversy over highly publicized medical errors, the ministry, beginning in 2000, created a small patient safety office, drafted guidance manuals for hospitals to designate risk management staff, set up adverse event tracking systems and review committees,28 established local “medical safety support centers” to handle patients’ complaints and questions,29 required a class of large specialized hospitals to make reports to a quasi-public entity of accidents causing harm,30 and launched a study of the incidence of adverse events in Japanese hospitals. In this study 4,389 records were randomly selected from 18 top hospitals that volunteered to participate. Reviewers employing criteria based on a previous Canadian study31 found an adverse event rate of 6.8 percent, and concluded that of those adverse events, about 23 percent were preventable.32 Troubled by the prospect of police investigations and possible criminal liability while also recognizing the importance of clearer accountability in the handling of medical accidents, four major medical specialty societies

28

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31 32

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MHLW, Iryo- jiko jo-ho- shu-shu--to- jigyo- [Medical Accident Information Collection Project], http://www.mhlw.go.jp/topics/bukyoku/isei/i-anzen/jiko/index.html (last visited July 5, 2011); MHLW, Risuku maneijimento manyuaru sakusei shishin [Guidelines for the Creation of Risk Management Manuals] (2000). The medical safety support centers (iryo- anzen shien senta-) received statutory authorization in a 2006 amendment to the Medical Services Law, Iryo- Ho- art. 6(11). This entity is the Japan Council for Quality in Health Care (Nihon iryo- kino- hyo-ka kiko-). 273 hospitals are required to report adverse events, and roughly 400 others do so on a voluntary basis. See Japan Council for Quality Health Care, Div. of Adverse Event Prevention, Project to Collect Medical Near-Miss/Adverse Event Information: 2009 Annual Report 22 (2010), available at http://www.med-safe.jp/pdf/year_report_english_2009.pdf [hereinafter JCQHC Report]. One suspects that many institutions are less than diligent in performing their reporting obligations from the fact that of the 273 hospitals to which the reporting requirement applied in 2009, sixty-one submitted no reports at all. Id. at 25. For an account of these administrative developments, see Leflar & Iwata, supra note 12, at 208–210. G. Ross Baker et al., The Canadian Adverse Events Study: The Incidence of Adverse Events among Hospital Patients in Canada, 170 Can. Med. Ass’n J. 1678 (2004). Hideto Sakai, Iryo- jiko no zenkokuteki hassei hindo ni kansuru kenkyu- [Report on the Nationwide Incidence of Medical Accidents: III] 5, 18 (2006) (reporting 6.0 percent adverse event rate, later corrected by MHLW to 6.8 percent); see also Shunya Ikeda, Iryojiko hassei hindo cho-sa kara erareta wagakuni no kanja anzen no genkyo- to kadai [Patient Safety Issues Raised by the Study of Medical Accident Incidence], 14 Kanja anzen suishin ja-naru 56 (2006) (summarizing study results). Estimates of annual preventable iatrogenic deaths were not given. Since hospitals experiencing serious quality difficulties were likely underrepresented in the study, the results cannot be deemed representative of Japanese hospitals as a whole.

Japan

proposed to MHLW a new system (independent of the criminal process) to review patient deaths possibly connected to medical management, inform the parties of facts found, and suggest preventive measures. The health ministry, understaffed and eager to demonstrate progress in addressing patient safety issues, agreed to fund a “Model Project for the Investigation and Analysis of Medical Practice-Associated Deaths.” The Model Project, launched in four urban regions in 2005 for an initial term of five years and now continuing on an extended basis in ten regions, is aimed at conducting impartial, high-quality peer reviews of possibly iatrogenic hospital deaths by experts unaffiliated with the hospital in question.33 Findings are reported to both the family and the hospital; a summary is made public, with names of the patient, medical staff, hospital, and location redacted; and suggestions for prevention of recurrences are offered. The Ministry of Justice and the National Police Agency gave up none of their jurisdiction over medical crime but acquiesced in the Model Project’s operation, for the most part holding back from criminal investigations and prosecutions in the regions in which the project operated.34 Results from the Model Project are mixed. On the one hand, case uptake and review efficiency have not met expectations. Cooperation from hospitals in participating regions has been uneven – fewer than 100 cases were submitted for review during the project’s initial five-year period – and despite the low numbers, delay in issuing case findings has been common.35 On the other hand, the quality of case reviews has likely been superior to most internal hospital reviews conducted prior to the project’s inception, and the project’s method – bringing together physicians, nurses, attorneys, academics, and health bureaucrats working toward common goals – has probably improved interdisciplinary cooperation in a society still hierarchically structured, each field generally in silo-like separation from the others.

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See Nihon iryo- anzen cho-sa kiko- [Japan Medical Safety Research Organization], Shinryoko-i ni kanren-shita shibo- no cho-sa bunseki moderu jigyo- [Model Project for the Investigation & Analysis of Medical Practice-Associated Deaths], http://www.medsafe. jp (last visited July 9, 2011). For a detailed overview of the Model Project, see Leflar, “Unnatural Deaths,” supra note 13, at 31–39. Reasons for the low case uptake include physicians’ unfamiliarity with the case review process, rules that the process be invoked by hospitals not families, limitation of the Model Project to death cases (excluding nonfatal injuries), and a shortage of pathologists to perform the needed autopsies. See Leflar, “Unnatural Deaths,” supra note 13, at 36– 39; Norihiro Nakajima et al., Interim Evaluation of the Model Project for the Investigation and Analysis of Medical Practice-Associated Deaths in Japan, in 2009 (1) J. Med. Safety 34 (Union of Risk Management for Preventive Medicine 2009).

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Data collection and analysis for the Model Project and for the health ministry’s other adverse event reporting systems are undertaken by the Japan Council for Quality Health Care (JCQHC), a quasi-public entity that also performs hospital accreditations.36 To some extent, JCQHC’s information dissemination efforts have aided the objective of improving health care quality by encouraging medical facilities’ experience-based learning. However, despite the public’s enormous appetite for medical information, neither the health ministry nor JCQHC has made available much hospitalspecific health outcomes information.37 Transparency regarding statistics about adverse events in health care is still a distant goal. Building on the Model Project’s structure, the health ministry and the then-governing Liberal Democratic Party offered a proposal in 2008 essentially to expand the project’s methods nationwide, setting up what would have amounted to a national structure for peer reviews of questionable hospital deaths, independent of the criminal justice system. Both patients’ rights groups and the Japan Medical Association – usually divided by distrust – supported the proposal. However, the proposal was attacked by a well-organized chorus of antiregulatory critics within the medical profession. These critics were concerned that external reviews of hospital adverse events would be overly centralized and cumbersome,38 that the Article 21 “unnatural death” reporting requirement would not be abolished, and that police would not be entirely removed in all cases from the monitoring of medical practice. The opposition Democratic Party of Japan issued its own proposal, somewhat closer to the position of the antiregulatory critics.39 Many thought that the two proposals had enough in common that a compromise could be hammered out. But after the

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See JCQHC Report, supra note 30, for a description of the information collection program. The health ministry does require hospitals to report the number of operations they conduct annually for various specified procedures. Media outlets obtain this information and compile rankings of hospitals by procedure volume. See, e.g., Shujutsu-su- de wakaru ii byo-in [Telling Good Hospitals from the Number of Operations] (Shu-kan Asahi ed., 2010); Iryo- to kango [Medical and Nursing Care], in Yomiuri shimbun (2008), updated version available at http://www.yomiuri.co.jp/iryou/medi/jitsuryoku. For an analysis based in part on these reports, see J. Mark Ramseyer, Universal Health Insurance and the Effect of Cost Containment on Mortality Rates: Strokes and Heart Attacks in Japan, 6 J. Empirical Legal Stud. 309 (2009) (concluding that price controls diminish availability of sophisticated care, costing lives). Or perhaps too embarrassing. Most physician critics of the health ministry proposal seemed to this observer to be hospital-based, while the JMA, which supported the proposal, chiefly represents smaller doctor-owned clinics. The health ministry proposal would have impacted hospitals far more than clinics. For an explanation and analysis of the two rival proposals, see Leflar, “Unnatural Deaths,” supra note 13, at 39–48.

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Democratic Party of Japan swept into power in the Summer 2009 elections, other issues took political precedence, among them Japan’s continued economic slump and, most recently, the nation’s response to the disastrous earthquake, tsunami, and nuclear power plant meltdown of March 2011 in northeast Japan. At this writing the proposed national peer review system remains on the back burner. However, with the August 2011 launching of a commission to study reforms in Japan’s medical liability systems,40 it may be that peer review improvement projects will be placed back on the table.

C.

One Prosecution Too Many: The Medical Professionals’ Counterattack and the String of Acquittals

Police led obstetrician Katsuhiko Kato- in handcuffs out of Ohno Hospital in rural Fukushima prefecture in 2006, after belatedly learning of the 2004 death of one of his patients subsequent to a particularly difficult childbirth. The reaction against Dr. Kato-’s humiliating arrest (broadcast on national news), detention, and prosecution was intense: petitions and remonstrances poured into the National Police Agency from medical organizations across the country.41 The fervor of this reaction launched a movement led by physicians employing the slogan “iryo- ho-kai” – “the collapsing health care system.” The “iryo- ho-kai” movement has engineered a significant shift in public opinion. The movement’s proponents have called editorial and political attention to the shortage of physicians willing to attend childbirths, particularly in rural areas, and to repeated instances of hospital emergency rooms turning away ambulances for fear of liability exposure.42 As one chief cause of these problems, the movement has targeted alleged abuses of the criminal justice system, much as medical “tort reformers” attack the civil justice system in the United States. To be sure, other factors have

40 41

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See infra notes 143–145 and accompanying text. For a listing of the protest petitions, see Fukushima kenritsu Ohno Byo-in no iryo- jiko mondai ni tsuite [The Medical Accident Problem at Ohno Fukushima Prefectural Hospital], http://www.med.or.jp/nichikara/fseimei/index.html (last visited July 6, 2011). The slogan was apparently coined by physician Hideki Komatsu. See Hideki Komatsu, Iryo- ho-kai [The Collapsing Health Care System] (2006). For an account of the causes of morale problems among Japanese physicians and structural difficulties within Japanese medicine, see Hideo Yasunaga, The Catastrophic Collapse of Morale Among Hospital Physicians in Japan, 2008 Risk Mgmt. & Healthcare Pol’y 1, available at http://www.dovepress. com/getfile.php?fileID=3935.

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contributed to Japan’s shortages in obstetrical care, such as the adoption of a residency matching system undercutting traditional hierarchical job placement practices that once ensured a supply of young physicians to smaller hospitals. Nevertheless, the Ohno Hospital prosecution served as an effective rallying point for critics of the criminal justice system’s medical oversight role. The “iryo- ho-kai” movement offers sympathetic portrayals of the plight of overworked, harassed, underappreciated physicians and the importance of protecting them from overreaching prosecutors. The movement appears to have turned media and public attention away, to a considerable extent, from concerns over medical error. The “iryo- ho-kaa-i” movement’s efforts have borne fruit not only on the editorial pages, but also perhaps in the minds of some of the nation’s judges. Acquittals in criminal trials are extremely rare in Japan; more than 99 percent of criminal trials result in convictions.43 But in four successive recent cases, including Dr. Kato-’s prosecution, medical personnel were acquitted of all charges, and in the two cases that prosecutors appealed,44 the acquittals were affirmed.45 This series of acquittals, in the wake of medical society protests against physicians’ arrests, constitutes a major public embarrassment for Japan’s procuracy. Police and prosecutors have been further embarrassed by the recent arrests for unprofessional conduct of a top detective in the medical investigation unit of the Tokyo police force46 and of a top prosecutor for altering evidence in the unsuccessful prosecution of a health ministry official for alleged corruption.47 These acquittals and scandals, in the

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See J. Mark Ramseyer & Minoru Nakazato, Japanese Law: An Economic Approach 178 (1999) (overall conviction rate in 1994 of 99.9 percent). Japanese appellate procedure allows prosecutors to appeal not-guilty judgments on grounds of both fact and law without violating the double jeopardy principle. See id. at 175. Judgment of Fukushima Dist. Ct. Aug. 20, 2008, 16 Iryo- kaisetsu hanrei 20 (Ohno Hospital case) (no appeal); Judgment of Tokyo High Ct. March 27, 2009, aff’g Judgment of Tokyo Dist. Ct. Aug. 27, 2007, 1282 Hanrei Taimuzu 233 (Tokyo Women’s Medical U. Hospital heart surgery case); Judgment of Nagoya Dist. Ct. Feb. 27, 2007, 1296 Hanrei Taimuzu 308 (obstetrics case) (no appeal); Judgment of Tokyo High Ct. Nov. 20, 2008, 1304 Hanrei Taimuzu 304, aff’g Judgment of Tokyo Dist. Ct. March 28, 2006 (Kyorin U. waribashi [chopstick] case). See, e.g., Current, Former Cops Arrested over Info Leak, Daily Yomiuri, July 23, 2011, at 1 (arrest of Lt. Shirotori for leaking police documents to cosmetic surgery hospital under investigation for alleged case of fatal malpractice). See Lead Prosecutor in Muraki Case Arrested; Maeda Admits Tampering with Seized Floppy Disk, Japan Times, Sept. 22, 2010, at 1, available at http://search.japantimes.co.jp/print/ nn20100922a1.html; Prosecutors Face Reforms, Restructuring, Daily Yomiuri, Aug. 13, 2011, at 15 (“unprecedented crime” committed by special investigation squad).

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author’s view, mark a watershed point in Japanese medical jurisprudence. Henceforth, police and prosecutors will be considerably more cautious in targeting health care personnel.48 Pressures for medical quality improvement must come chiefly from other directions.

II.

Civil Liability

Compared to the specter of criminal prosecution with its career-shattering effects, civil liability for medical injury has probably been less worrisome to Japanese physicians in recent years. Civil malpractice insurance is cheap,49 and in any case hospital-employed physicians – 64 percent of the total number of doctors50 – are covered by their hospitals’ liability insurance policies. Nevertheless, civil liability trends are a matter of concern to the medical profession. The number of civil claims filed in court far exceeds the number of criminal prosecutions,51 and rose steadily from the 1980s until the peak year of 2004, following which court filings have declined (Figure 2). In addition, the number of claims settled out of court is doubtless a substantial multiple of the number of court filings.52

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49 50 51

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The number of medical cases police sent to prosecutors peaked in 2006, the year of the Ohno Hospital arrest and subsequent protests, and has since diminished somewhat. See supra Figure 1. Police investigations of medical crimes have not ceased, however, and prosecutions continue to be brought. In 2010 police sent papers to prosecutors in seventy-five medical cases, down from the peak of ninety-nine in 2006. See Police Reports on Medical Cases, supra note 26; Lasik Surgeon Held over Infections; Unsanitary Procedures, Lack of Sterilization Alleged at Defunct Ginza Clinic, Daily Yomiuri, Dec. 8, 2010, available at http://www.yomiuri.co.jp/dy/national/T101207004781. htm?ref=dyolwsj. See infra notes 116–122 and accompanying text. See Yasunaga, supra note 42, at 2 (2006 data). In 2003, for example, seventeen prosecutions were brought against physicians. See Toru Hiyama et al., The Number of Criminal Prosecutions Against Physicians Due to Medical Negligence Is on the Rise in Japan, 26 Am. J. Emergency Med. 105 (2008). In the same year, 1,003 civil malpractice cases were filed. See infra note 56. Rough estimates of the number of settlements are given below. See infra notes 106–112 and accompanying text.

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1200 1000 800 600 400 200

1976 1977 1978 1979 1980 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1990 2001 2002 2003 2004 2005 2006 2007 2008 2009 2000 2010

0

Figure 2. Medical Malpractice Civil Cases Filed in Court, 1976–2010.53

This section of the article first sets out the salient doctrinal features of the substantive civil law of compensation for medical injury. The article then addresses key aspects of procedural law and practice, including the institution of health care divisions of trial courts in some metropolitan areas, practices relating to case settlement, estimates of the total numbers of malpractice claims (in court and out) and of medical malpractice premiums and payouts, and information on court filing fees and plaintiffs’ attorneys’ compensation practices. Finally, the new system for nofault compensation of certain obstetrical injuries is described.

A.

Substantive Law of Medical Malpractice

1.

Theories of Recovery

Civil claims for medical injury may be brought under either the Civil Code provision governing tort54 or the provision governing nonperformance of

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The Administrative Office of the Supreme Court compiles the yearly number of new medical malpractice filings. See Supreme Court of Japan, Iji kankei sosho- jiken no shori jo-kyo- oyobi heikin shinri kikan [Disposition of Medically Related Litigation and Mean Durations of Proceedings] [hereinafter Supreme Court Medical Malpractice Case Statistics], http://www.courts.go.jp/saikosai/about/iinkai/izikankei/toukei_01.html (last visited Sept. 7, 2011). Civil Code art. 709, General Principle of Tortious Act: “A person who violates intentionally or negligently the right of another is bound to make compensation for damage arising therefrom.” Hiroshi Oda, Basic Japanese Laws 146 (1997).

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contract,55 and there are many examples of each. As a practical matter it generally makes little difference under which theory a claim is brought, for the standards and principles applied are the same in either case. The plaintiff must prove in contract cases a breach of the physician’s or hospital’s obligation, which is equivalent to proving a breach of the applicable standard of care in tort. In most cases, the plaintiff must prove under either theory that the breach caused ascertainable damages.

2.

Standard of Care

The Supreme Court has expressed the legal standard of care to which physicians are held as “the standard prevailing in clinical medical practice at the time of treatment.”56 Physician custom is not invariably congruent with the legal standard of care, however. The Supreme Court has recognized that sometimes adherence to the custom of average medical practitioners does not fulfill the duty of care, as when a defendant doctor, following general practitioners’ common practice of ignoring an anesthetic drug’s labeled directions for use, failed to monitor the patient’s blood pressure in timely fashion.57 Japanese courts hold large, sophisticated hospitals and their physicians to a higher standard of care in some respects than doctors in small clinics lacking equivalent resources. To quote the Supreme Court’s 1995 decision in a celebrated case involving a premature infant’s blindness from retinal injury, in determining the applicable standard of care the court “must consider various circumstances such as the nature of the [defendant] facility and the distinctive characteristics of the region’s medical environment.”58 This is taken to mean that the standard of care expected of a medical facility and its personnel depends on the facility’s size and function.59 The standard of knowledge (chiken) expected of physicians depends on their specialty; non-specialists in a field are not held to the same 55

56 57 58 59

Civil Code art. 415, Claim for Damages for Non-Performance: “If an obligor fails to effect performance in accordance with the tenor and purport of the obligation, the obligee may claim damages ...” Id. at 98. Judgment of Supreme Court March 30, 1982, 1039 Hanrei jiho- 66, 106. Judgment of Supreme Court Jan. 23, 1996, 50 Minshu- 1, 1571 Hanrei jiho- 57 (perukamin-S case). Judgment of Supreme Court June 9, 1995, 1537 Hanrei jiho- 3, 883 Hanrei Taimuzu 92 [hereinafter infant retrolental fibroplagia case]. See, e.g., Toshihiro Suzuki et al., Iryo- jiko no ho-ritsu so-dan [The Law of Medical Accidents] 36–37 (2009) (commentary on infant retrolental fibroplagia case). This approach is somewhat analogous to the resource-based locality rule applied in some US jurisdictions. See, e.g., Hall v. Hilbun, 466 So.2d 856 (Miss. 1985) (the leading case on

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standard as specialists.60 However, if a physician or facility is unable to treat a patient’s particular condition, whether due to lack of knowledge, skill, or resources, the care provider comes under a legal duty to transfer the patient to a facility that offers the requisite level of services.61

3.

Level of Proof

The level of proof required of plaintiffs on breach of duty and causation is “a high degree of probability” (ko-do no gaizensei).62 The phrase suggests a level of confidence somewhat higher than the “preponderance of the evidence” standard prevailing in civil cases in common law jurisdictions.63

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medical standards of care in Barry R. Furrow et al., Health Law: Cases, Materials and Problems 327–336 (6th ed. 2008)). The Court recognized, however, that the time required for the diffusion of medical knowledge from one field to another is “relatively short.” Infant retrolental fibroplagia case, supra note 58, 1537 Hanrei jiho- at 7–8, 883 Hanrei Taimuzu at 97; Suzuki et al., supra note 59, at 37. Iryo- ho- [Medical Service Law], Law No. 205 of 1948 as amended, art. 1, para. 4 no. 3; Judgment of Supreme Court Nov. 11, 2003, 57 Minshu- 1466, 1845 Hanrei jiho- 63 (acute encephalopathy case); Suzuki et al., supra note 59, at 42–43. Judgment of Supreme Court Oct. 24, 1975, Minshu- 1417, 792 Hanrei jiho- 3 (lumbar procedure case, addressing proof of causation). See infra note 64. The standard is of judicial rather than statutory origin. The “high degree of probability” standard is expressed clearly by courts with regard to causation issues, but less clearly with regard to proof of breach of the duty of care. Judges, lawyers, and academics have suggested to the author that in practice, judges actually decide breach-of-duty issues on something like a preponderance standard, but write their opinions as though the evidence as to whether the breach of duty was established was clearly convincing. See Takeshi Kojima, Japanese Civil Procedure in Comparative Law Perspective, 46 U. Kan. L. Rev. 687, 708 (1998) (“[M]ere proof by a preponderance of the evidence is not enough.”). Just what “a high degree of probability” means is a matter of debate. Kevin Clermont, while recognizing the existence of controversy, has argued that the standard of proof in Japanese civil cases “requires that facts be proven to a high probability similar to beyond a reasonable doubt.” Kevin M. Clermont, Standards of Proof in Japan and the United States, 37 Cornell Int’l L.J. 263, 263 (2004) (emphasis added). He linked the Japanese standard to the intime conviction standard employed in French civil law. This writer’s interviews with Japanese judges indicate, however, that Clermont’s characterization of the Japanese proof standard as “similar to beyond a reasonable doubt” is too stringent. Ramseyer and Nakazato, relying on an old Tokyo District Court case, fell into the opposite error regarding malpractice claims based on tort. They stated that “[a]lthough tort plaintiffs must usually prove causation and lack of care, in malpractice cases courts deliberately switch the burden. As a result, to defend, a doctor will need to show that he met the standard set by other doctors in his specialty in his community.” Ramseyer & Nakazato, supra note 43, at 67 (citing Judgment of Tokyo Dist. Ct. June 7, 1967, 485 Hanrei jiho- 21, 25–26). The authors apparently took an atypical case involving facts allowing for a res ipsa-like presumption of negligence, and generalized its ruling to apply to all tort-based malpractice cases. Ramseyer corrected the error in a subsequent article. Ramseyer, Malpractice Claims, supra note 23, at 673–674.

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Neither the Civil Code nor the case law offers an exact prescription of how judges are to decide closely balanced issues of fact. Regarding causation, the Supreme Court has stated that at least something less than a scientific standard of certainty will suffice.64 The author’s interviews with numerous trial judges, from several courts and encompassing the range of judicial seniority, reveal not so much a contrariety of opinion regarding the standard as an insistence that flexible case-by-case determinations are needed. The ambiguity of the standard of proof inevitably follows from the need for discretion in addressing the subtle factual circumstances presented by many injury claims, and relates both to institutional concern with preserving the court system’s legitimacy and to trial judges’ personal desire for “cover” when their judgments are reviewed on appeal. Just as US judges, sending factually controverted cases to juries, are disburdened by the lenient standard of appellate review of juries’ factual findings, so Japanese trial judges take a certain comfort in the degree of deference that appellate courts usually allow the trial judges’ determinations (sometimes written, perhaps, with the same enhanced certainty of an umpire’s emphatic call of a close play at the plate) of whether plaintiffs’ proofs met the “high degree of probability” standard.65 The potential rigor of the “high degree of probability” standard is also mitigated in three other ways: (1) the application of a res ipsa-like rebuttable presumption of negligence where the facts warrant it;66 (2) the adoption

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See Judgment of Supreme Court Oct. 24, 1975, 29 Minshu- 1417 (lumbar procedure case). Reversing the Tokyo High Court’s finding of no proof of causation, the Supreme Court stated: Proof of causation is to be established not by the standard of natural science admitting of no doubt, but rather by an overall examination of the totality of evidence informed by common experience (keikensoku ni terashite). Where specific facts can be shown to have brought about specific results with a high degree of probability (ko-do no gaizensei), such that ordinary people could hold a doubtless assurance of the fact of the [causal] relationship, that constitutes necessary and sufficient proof of causation. Id. at 1419–20. The logically muddled nature of this pronouncement is aptly discussed in Shigeto Yonemura, Runba-ru shiko--go no no--shukketsu to inga kankei [Causation and Cerebral Hemorrhage Following Lumbar Procedure], 183 Jurisuto 154 (2006) (case commentary). Kevin Clermont advanced a similar point in a recent essay. Kevin M. Clermont, Standards of Proof Revisited, 33 Vt. L. Rev. 469, 473 (2009). Appellate review of lower courts’ factual findings, however, is more rigorous in Japan than in the United States. The High Court will accept additional evidence on appeal, which may supplement or contradict the District Court’s fact-findings. See Minsoho- [Code of Civil Procedure], art. 296–297; Ramseyer & Nakazato, supra note 43, at 145. See, e.g., Suzuki et al., supra note 59, at 55, 193–194 (explaining ichio- no suitei (rebuttable presumption)); Shintaro- Kato-, Iryo- kago sosho- (I) [Medical Malpractice Litigation (I)], in Minji ho- III [Civil Law III] 265, 271–273 (Kaoru Kamata et al. eds., 2005) (same); cf. Judgment of Supreme Court Jan. 23, 1996, 50 Minshu- 1, 1571 Hanrei jiho- 57 (perukamin-S case)

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of “loss of chance” doctrine to justify partial compensation where negligence is proven but its causal consequences are difficult to ascertain;67 and (3) judges’ common practice of pressuring attorneys to settle for partial compensation cases in which negligence is established but proof of causation is hazy.68 An indication that Japanese jurisprudence has moved toward a less rigorous stance regarding proof burdens is the 2000 Supreme Court case recognizing a “loss of chance” remedy for negligent failure to diagnose and treat a malady for which timely diagnosis and treatment would have afforded the patient a “considerable possibility” (so-to- no kano-sei), but not a “high degree of probability” (ko-do no gaizensei), of survival.69 Given that the preservation of life is a “fundamental value” worthy of legal protection, the Court ruled that the value’s invasion by an act of medical negligence required a legal remedy.70 The Court later expanded the loss-of-chance principle to encompass cases in which medical negligence was followed not by death but rather by serious impairment, but the level of impairment the patient would have suffered absent negligence was not proven to a high degree of probability.71 Subsequent cases in the lower courts have adopted a principle of proportionate liability, scaling damages in rough accordance with the percentage possibility of survival or full recovery had the defendant acted with due care.72

67 68

69 70 71 72

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(ignoring drug label indications, absent rational reasons, is basis for negligence finding). See also Judgment of Tokyo Dist. Ct. June 7, 1967, 485 Hanrei jiho- 21, 25–26, excerpted in Ramseyer & Nakazato, supra note 43, at 67 (early rebuttable presumption case). See infra notes 69–71 and accompanying text. Interview with Wataru Murata, C.J. and Nozomu Hirano, J., Tokyo District Ct., 34th Div., in Tokyo (Aug. 10, 2010) [hereinafter Tokyo Judges 2010 Interview]; interview with noted plaintiffs’ attorney Toshihiro Suzuki and associates, in Tokyo (Aug. 2, 2010). See also Shunko Muto, Concerning Trial Leadership in Civil Litigation: Focusing on the Judge’s Inquiry and Compromise, 12 Law in Japan 23, 28 (1979), reprinted in Milhaupt, Ramseyer & West, supra note 7, at 185, 189–190 (2006) (judge’s similar advice to trainee judges in 1979). Judgment of Supreme Court Sept. 22, 2000, 54 Minshu- 2574, 1728 Hanrei jiho- 31 (myocardial infarction case). Id. The plaintiff was awarded a solatium (isharyo-) of ¥ 2 million (US $ 18,000). Judgment of Supreme Court Nov. 11, 2003, 57 Minshu- 1466, 1845 Hanrei jiho- 63 (acute encephalopathy and failure-to-transfer case). Damages may be awarded even if the patient’s chance of survival or full recovery was less than 50 percent. Tokyo Judges 2010 Interview, supra note 68; interview with Yoshio Kato-, noted plaintiff’s attorney, in Nagoya (July 26, 2010).

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4.

Informed Consent and Related Actions

Apart from the duty to provide medical care meeting legal standards, physicians also have a duty to obtain from patients what has come to be called (for lack of any equivalent expression in standard Japanese) info-mudo konsento. Adapting the Western concept of patient autonomy to established customary patterns and departing from a line of previous cases granting high deference to medical custom, Japanese courts came to recognize that in some circumstances traditional principles of medical ethics, according precedence to the duty to save human life at all costs, must give way to patients’ sometimes contrary personal values.73 A leading Supreme Court case recognizing this principle affirmed a damage award to a Jehovah’s Witness who was given a blood transfusion despite her contrary expressed intent. Although the procedure was medically successful – she survived her cancer far longer than was predicted – the Supreme Court nevertheless affirmed a consolation or solatium (isharyo-) award for “emotional suffering” of the nominal sum of ¥ 500,000 (US $ 5,000).74 This case constituted Japan’s recognition – contrary to US informed consent precedents requiring “decision causation”75 – that a dignitary interest apart from physical harm is worthy of protection in informed consent cases. Parallel to physicians’ duty to obtain the patient’s informed consent before treatment is the physician’s obligation to explain accurately the results of treatment, including adverse results. This duty of explanation of treatment outcomes (benmei gimu) is held to arise from the patient-physician contractual relationship. The principle has been tested in recent years in cases in which patients and families were not given honest explanations

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Detailed examinations of the development of informed consent theory and practice in Japanese medicine can be found in Leflar, Informed Consent, supra note 6, and Leflar, Renaissance, supra note 9. Jehovah’s Witness case, supra note 7. Excerpts of both the High Court and Supreme Court opinions are translated into English in Milhaupt, Ramseyer & West, supra note 7, at 347–356. The term “decision causation,” indicating the requirement that a plaintiff prove that had risk disclosure been sufficient, the plaintiff would have decided on a different treatment course leading to less physical harm, was coined in Alan Meisel & Lisa D. Kabnick, Informed Consent to Medical Treatment: An Analysis of Recent Legislation, 41 U. Pitt. L. Rev. 407, 438–439 (1980) and popularized in Aaron Twerski & Neil B. Cohen, Informed Decisionmaking and the Law of Torts: The Myth of Justiciable Causation, 1988 U. Ill. L. Rev. 60 (1989). For an argument that deprivation of informed choice should give rise to an action for dignitary harm in U.S. medical negligence and prescription drug litigation, see Margaret A. Berger & Aaron D. Twerski, Uncertainty and Informed Choice: Unmasking Daubert, 104 Mich. L. Rev. 257 (2005).

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of adverse outcomes, and courts have awarded solatium damages for physicians’ breaches of this duty.76

5.

Damages

Apart from solatium awards for intangible and dignitary injury, damages in Japanese medical malpractice cases are standardized in accordance with injury severity levels as defined in the traffic accident compensation system.77 Once negligence and causation are determined, the plaintiff is entitled to an award within these fairly definite limits. Punitive damages are not available.78 Awards for injury in Japanese medical malpractice cases do not seem to differ radically in amount from awards in other advanced nations, and may exceed them.79 Mark Ramseyer, drawing on a database of actions filed in 2004, observed that in wrongful death cases, for example, median and 76

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For example, in a suit against a hospital and its staff for brain damage suffered by a child from heart stoppage due to a medication error and subsequent inadequate resuscitation efforts, the court found that the hospital had engaged in a cover-up of the facts. In addition to awarding damages and costs of ¥ 243 million (US $ 2.2 million) plus interest on the malpractice counts, the court awarded ¥ 1 million (US $ 9,000) for the contract breach. Judgment of Kyoto Dist. Ct. July 12, 2005, 1907 Hanrei jiho- 112, 124–125. See also, e.g., Judgment of Tokyo High Ct. Sept. 30, 2004, 1880 Hanrei jiho- 72; Suzuki et al., supra note 59, at 66. Shigemi Oshida, Yasushi Kodama & Toshihiro Suzuki, Jitsurei ni manabu iryo- jiko [A Real-World View of Medical Accident Cases] 20–21 (2002). Pain-and-suffering damages in death cases include awards to surviving family members for their grief, and may be adjusted up or down for unusual circumstances. Id. Damage amounts for each level of injury severity are set out in publications available not only to judges, lawyers, and liability insurers, but also to the general public. See, e.g., Minji ko-tsu- jiko sosho-: Songai baisho--gaku santei kijun [Civil Traffic Accident Litigation: Computation Standards for Damages] (Tokyo 3rd Bar Ass’n ed., 2006) (generally known as “Akahon” [“the Red Book”]). For a description of damage calculations using the Red Book, see Eric A. Feldman, Law, Society, and Medical Malpractice Litigation in Japan, 8 Wash. U. Global Stud. L. Rev. 257, 266 (2009), originally published as Eric A. Feldman, Suing Doctors in Japan: Structure, Culture, and the Rise of Malpractice Litigation, in Fault Lines: Tort Law as Cultural Practice 233 (David M. Engel & Michael McCann eds., 2009). Damages of a given level of severity in medical malpractice cases may somewhat exceed those in auto accident cases, perhaps taking into account the additional difficulty of proving malpractice liability. Yoshiharu Kawabata, “Health-Related Litigation and Its Reform Through a Practitioner’s Eyes,” address at Penn State Dickinson School of Law Freeman Symposium on Health, Law, and Justice in Asia (Apr. 28, 2006) [hereinafter Kawabata, Dickinson Lecture] (plaintiffs’ attorney’s estimation of 10–20 percent damages bonus in malpractice cases). Ramseyer & Nakazato, supra note 43, at 89 n. 53. See Leflar & Iwata, supra note 12, at 200 & n. 40 (observing similar scale of damages in Japanese and US wrongful death cases). By contrast, Eric Feldman views the Japanese scale of damages as both “more predictable and more modest” than US levels. Feldman, supra note 77, at 266. A caveat: in performing international comparisons over time of

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mean damage awards were respectively ¥ 37.5 and ¥ 40.6 million (roughly US $ 350,000 at then-current exchange rates)80 – recoveries higher in real terms than those observed on average in the high-award US jurisdiction of Florida.81 Most malpractice claims are settled (either extrajudicially or during the litigation process) or dropped, rather than being tried to judgment.82 Settlement negotiations in any medical malpractice case depend on assessments by plaintiff and defense counsel of the strength of plaintiff’s proof of three elements: (1) negligence, (2) causation, and (3) damages. One result of Japan’s standardized damages schedule is that prejudgment negotiations become relatively predictable in respect of the damages element. Not only judges, lawyers, and liability insurers, but hospital management and patients and families as well, have access to the formulas for calculating damage amounts.83 In many US medical malpractice actions, plaintiffs’ and defendants’ attorneys’ widely varying assessments of the plaintiff’s damages obstruct resolution of the case. In Japan, these

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malpractice awards (or anything else), yen-denominated sums have grown considerably, relative to other currencies, concomitantly with the rise in the yen’s exchange value. Ramseyer, Malpractice Claims, supra note 23, at 653. Awards ranged from ¥ 200,000 to ¥ 189 million (US $ 2,000-$ 1.6 million). Id. Judges arrive at these damage awards by calculating, in addition to out-of-pocket medical and funeral expenses, the present value of the decedent’s expected earnings, subtracting almost half of that value for foregone living expenses, and adding a standardized amount for pain and suffering – a method drawn from the standardized evaluation of traffic accident damages, see supra note 77. Payments from collateral sources are not included in damage awards. For a helpful summary of the law of damage calculations in tort, see Eri Osaka, Reevaluating the Role of the Tort Liability System in Japan, 26 Ariz. J. Int’l & Comp. L. 393, 395–396 (2009). A study of Florida malpractice awards from 1990–2003 found that the median and mean payments for wrongful death claims were $ 195,000 and $ 290,000. Neil Vidmar et al., Uncovering the Invisible Profile of Medical Malpractice Litigation: Insights from Florida, 54 DePaul L. Rev. 315, 340 (2005) (tbl. 7); see also Leflar & Iwata, supra note 12, at 200 (similar analysis). Attorneys experienced in medical malpractice have informed the author that the vast majority of settled claims are never filed in court. See Leflar & Iwata, supra note 12, at 199–200 n. 35, and interviews, infra note 106 (characterizing informally settled claims as “the sunken part of the iceberg”). Of claims filed in court, about 40 percent are litigated to final judgment. Ramseyer, Malpractice Claims, supra note 23, at 625–627; Akihito Hagihara et al., Standard of Care and Liability in Medical Malpractice Litigation in Japan, 65 Health Pol’y 119, 125 (2003). For an example of a damage calculation website for traffic accidents, see Sho-gai isharyojido- keisanki/bengoshi jitsumu-yo- [Automatic Personal Injury Compensation Calculator for Attorneys’ Use], http://www.asahi-net.or.jp/~zi3h-kwrz/law2consocalj.html (last visited July 11, 2011). Damage calculations are informed to some extent by the circumstances of each case, however, so repeat players such as experienced lawyers will have a better sense of likely damages than members of the general public consulting the “Red Book.”

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valuation conflicts are muted. This is a partial explanation for the lower litigation rates for Japanese medical malpractice claims in comparison with the US.84 Patients’ medical and rehabilitation expenses resulting from medical misadventure are covered, in the main, by the health insurance programs in which virtually all patients are enrolled. As a legal matter, the insurance programs have a right of subrogation to patients’ claims against providers whose negligence necessitated the expenses. As a practical matter, subrogation claims appear to be rare, although they are not unknown in cases of serious impairment where medical and rehabilitation expenses are very high.85 One reason for their rarity, according to an experienced hospital defense attorney, is that in settled cases the release agreement frequently contains a clause prohibiting the parties from disclosing the settlement or its amount to anyone, even the social insurance entity.86 If the insurer that covered the patient’s medical expenses never learns of the claim or the settlement, and has no hawk-like monitor examining the case, then its subrogation right never comes into play.

B.

Key Aspects of Procedural Law and Practice

1.

In General

Japanese civil litigation is conducted by professional judges without juries,87 in keeping with principles of German law introduced in the late 19th century. Typically two or three judges hear each case. Trials take 84

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See J. Mark Ramseyer & Minoru Nakazato, The Rational Litigant: Settlement Amounts and Verdict Rates in Japan, 18 J. Legal Stud. 263 (1989) (arguing that clear damage guidelines for traffic accident cases promote out-of-court settlements, largely explaining low Japanese litigation rates); Ramseyer & Nakazato, supra note 43, at 90–99 (same). Interview with Yasushi Kodama, a leading hospital defense attorney, Miyakezaka Sogo Law Offices, in Tokyo (Aug. 14, 2010) (giving examples of patients left in a vegetative state). However, in catastrophic injury cases the social insurance system limits patients’ self-pay burden to 1 percent of charges over an income-based ceiling (the “high-cost health care expenses system,” ko-gaku ryo-yo-hi seido). Since collateral source payments (such as those from the social insurance system) are not recoverable under Japanese tort law, patients’ recoverable damages – and consequently, the amounts to which health insurers would be subrogated, standing in injured patients’ shoes – tend to be much smaller than in most US catastrophic injury cases. Id. Kodama memorably characterized this phenomenon as “the puzzle of the Sphinx.” Under a recently-introduced reform, non-professional “lay assessors” (saiban-in) sit with professional judges in hearing certain serious criminal cases. Saiban-in no sanka suru keiji saiban ni kansuru ho-ritsu [Act Concerning Participation of Lay Assessors in Criminal Trials], Law No. 63 of 2004, available at http://law.e-gov.go.jp/announce/H16HO063.html. See Kent Anderson & Emma Saint, Japan’s Quasi-Jury (Saiban-in) Law: An Annotated Translation of the Act

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place in sequential hearings over a period of months or years, and attorneys for all parties submit documentary evidence, testimony, and arguments on a scheduled basis during this period.88 Medical malpractice trials in particular, with their typically complex and controverted facts, have been notorious for their prolonged duration. One infamous case, Dickensian in its protracted length, required twenty years for its ultimate resolution in the Supreme Court in favor of the injured patient.89 Additional criticisms of the medical injury litigation system have centered on inadequate discovery procedures and the difficulty of coping with the allegedly frequent alteration of medical charts by hospital personnel,90 making it hard for plaintiffs to obtain accurate evidence about adverse events. These criticisms have been answered to some extent by expansion of discovery procedures in a 1998 reform of the Civil Procedure Code91 and by the routine availability on demand of patient charts through evidence preservation (sho-ko hozen) actions92 and direct patient requests to the medical facility.93

2.

Discovery of Peer Review Findings

An issue that concerns physicians and hospitals in Japan, as it does in the United States, is the availability for litigation purposes of peer reviews of

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Concerning Participation of Lay Assessors in Criminal Trials, 6 Asian-Pacific L. & Pol’y J. 9 (2005). This new system does not apply to civil cases. See Ramseyer & Nakazato, supra note 43, at 139–141 (describing discontinuous trial system). Judgment of Supreme Court Jan. 23, 1996, 50 Minshu- 1, 1571 Hanrei jiho- 57 (perukamin-S case). For a moving account of the case by the plaintiff’s attorney, see Yoshio Kato-, Kyu-sai shisutemu ga jiko bo-shi ni kino- suru [Remedial Systems Prevent Accidents], 18 Iji ho-gaku [J. Med. L.] 94, 98–99 (2003). See Ishikawa, supra note 23 (setting out examples of altered medical charts); Ramseyer, Malpractice Claims, supra note 23 (noting that the practice “commonly happens”). Civil Procedure Code, art. 220 (recognizing general principle of discoverability of specifically identified documents, with some exceptions). See Shozo Ota, Reform of Civil Procedure in Japan, 49 Am. J. Comp. L. 561 (2001); Toshiro M. Mochizuki, Baby Step or Giant Leap? Parties’ Expanded Access to Documentary Evidence under the New Japanese Code of Civil Procedure, 40 Harv. Int’l L.J. 285, 299–309 (1999). See Minsoho- [Code of Civil Procedure] art. 234–242 (authorizing and governing evidence preservation actions) (English translation available at http://www.japaneselawtranslation.go.jp/law/?re=02 (input “Code of Civil Procedure”)). See Nihon ishikai [Japan Medical Ass’n], Ishi no shokugyo- rinri shishin [Physicians’ Professional Ethics Guide] § 2(7) (2008 rev. ed.), available at http://dl.med.or.jp/dl-med/ teireikaiken/20080910_1.pdf (recognizing physicians’ duty to disclose medical records). The Japan Medical Association expanded its view of patients’ right of access to their medical records following the enactment of the Law Concerning the Protection of Personal Information, Law No. 57 of 2003, effective in 2005.

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adverse events. Such reviews have become more common in the past decade pursuant to guidance issued by the health ministry,94 and are standard procedure in cases handled by the Model Project.95 Three legal grounds support at least partial release of peer review documents: (1) national and local Freedom of Information rules applicable to public hospitals;96 (2) an implied contractual obligation of hospitals to investigate medical accidents and report the results to patients and families;97 and (3) liberalized discovery procedures under the revised Civil Procedure Code.98 In a leading case interpreting the new discovery rules, the Tokyo High Court ruled that the portion of the hospital report containing factgathering interviews with hospital personnel was non-disclosable in order to protect interviewees’ “free formation of ideas,” but the portion of the report containing “objective” conclusions about the patient’s course, the causes of her death, and proposed corrective measures must be disclosed.99 Experienced defense attorneys routinely advise hospital clients to prepare for disclosure of anything that goes into such case reports.100

3.

Judicial Administration Reforms

Responding to criticisms of excessive delays in medical malpractice litigation, the Supreme Court’s administrative office instituted several reforms aimed at improving the celerity and efficiency of the judicial process. The most noteworthy of these reforms were (1) clearly delineated time-lines for trials; (2) concentrated evidence gathering; (3) the use of judge-appointed expert witnesses; and (4) the creation of health care divisions (iryo- shu-chu-bu) in some metropolitan district courts. The first three reforms were launched in 1998, at the time of a reform of the Civil Procedure Code. The health care divisions began operating in 2001.101

See Leflar & Iwata, supra note 12, at 205–206 (citing guidance documents). See supra notes 33–35 and accompanying text. See Information Disclosure Law, supra note 8. See, e.g., Judgment of Kyoto Dist. Ct. July 12, 2005, 1907 Hanrei jiho- 112, 124–125. See also supra note 76 and accompanying text. 98 See Leflar & Iwata, supra note 12, at 206–213. 99 Judgment of Tokyo High Ct. July 15, 2003, 1842 Hanrei jiho- 57, 1145 Hanrei taimuzu 298 (Saitama Medical University case). 100 Tokyo Judges 2010 Interview, supra note 68; interview with Yasushi Kodama, a leading hospital defense attorney, Miyakezaka Sogo Law Offices, in Tokyo (July 30, 2010). 101 For discussions of these reforms, see Feldman, supra note 77, at 273–275; Robert B Leflar, Public and Private Justice: Redressing Health Care Harm in Japan, 4 Drexel L. Rev. 243, 256–261 (2011). 94 95 96 97

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1400

Newly filed Cases Cases closed Mean Time to Disposition (Days), Nationwide

1200 1000 800 600 400 200

Med Mal Speciality Courts launched Civil Procedure Reforms 1994 1995 1996 1997 1998 1990 2001 2002 2003 2004 2005 2006 2007 2008 2009 2000 2010

0

Figure 3: Disposition of Medical Malpractice Civil Cases Filed in Court, 1994– 2010.102

As Figure 3 indicates, the duration of litigated medical cases began declining even before these reforms were launched, but the reforms appear to have succeeded in further reducing litigation delays.

4.

Settlement Practices, Overall Claiming Levels, and Malpractice Insurance Premiums

Malpractice case filings in court, set out in Figure 2 above,103 represent only a fraction of all medical injury claims made by patients and paid by medical providers or their liability insurers. Extrajudicial dispute resolution is encouraged both by law104 and through the activities of entrepreneurial academics.105 What proportion of all medical injury claims is filed in court is difficult to ascertain, since insurers are famously close with their payout data. Three leading Tokyo attorneys, one representing hospitals, one the Japan Medical Association, and the third plaintiffs, all suggested to the author that court-filed claims constitute merely the “tip of the iceberg” of all claims.106 102 Supreme Court Medical Malpractice Case Statistics, supra note 53. 103 See supra note 53 and accompanying figure. 104 Saiban-gai funso- kaiketsu tetsuzuki no riyo- no sokushin ni kan-suru ho-ritsu [Law for the Promotion of the Use of Extrajudicial Dispute Resolution Procedures], Law No. 151 of 2004, as amended, available at http://law.e-gov.go.jp/announce/H16HO151.html. 105 See, e.g., Yoshitaka Wada & Toshimi Nakanishi, Iryo- konfurikuto manejimento: medieishon no ronri to giho- [Medical Conflict Management: Mediation Theory and Skills] (2006); Yoshitaka Wada, Iryo- ADR [Medical ADR] (2009). 106 Interview with Yasushi Kodama, a leading hospital defense attorney, Miyakezaka Sogo Law Offices, Tokyo, and Tatsuo Kuroyanagi, Kuroyanagi, Kaneko & Iwamatsu Law

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Mark Ramseyer has constructed a useful range of estimates of overall medical malpractice claiming levels, including claims not filed in court, from three sources: (1) court statistics, (2) insurance premiums, and (3) informed observer estimates.107 Court claims data are firm: 1,110 malpractice claims were filed in court nationwide in 2004, for example, or one lawsuit per 115,000 Japanese residents.108 Insurance premium data are less precise, and require somewhat speculative manipulations.109 Estimates from knowledgeable Japanese observers of the claims made/court claims filed ratio, while worthy of respect, are unverifiable. Employing each of these sources in turn, Ramseyer provides a range of estimates of annual medical malpractice claims in Japan based on 2004 data: between 2,230 and 13,875 total claims per year, in court and out,110 with the likely truth somewhere between. Japan’s population is 127 million, so that represents a range of one malpractice claim annually per 9,000 to 60,000 residents. To give international perspective to that range, annual malpractice claims (in court and out) in the US, with its population of about 300 million, were credibly estimated in 2006 as 50,000 to 60,000, that is, one claim per 5,000 to 6,000 residents,111 or between 1.5 and 12

107 108 109

110 111

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Office, Tokyo, in Naha, Okinawa (Feb. 25, 2006); interview with Yoshiharu Kawabata, Kasumigaseki Sogo Law Offices, in Tokyo (July 27, 2009) [hereinafter Kawabata interview]. Similarly, a 2001 study estimated that only 8 percent of malpractice claims are litigated. Kazue Nakajima et al., Medical Malpractice and Legal Resolution Systems in Japan, 285 J. Am. Med. Ass’n 1632, 1635 (2001) (drawing on JMA closed-claim data from 1973–81). It was once a common practice for physicians and hospitals to offer mimaikin, small gifts of money in token of sympathy, to injured patients and families (whether or not they had legal representation) before any lawsuit was filed. See Robert B Leflar, Personal Injury Compensation Systems in Japan: Values Advanced and Values Undermined, 15 U. Haw. L. Rev. 742, 749 (1993). That practice has become less common since public distrust of medical skill and probity following the publicized disasters of 1999–2004 made the offering of small mimaikin seem “ridiculous.” Interview with Yasushi Kodama, a leading hospital defense attorney, Miyakezaka Sogo Law Offices, in Tokyo (Aug. 4, 2011). Ramseyer, Malpractice Claims, supra note 23, at 663–668. See Supreme Court Medical Malpractice Case Statistics, supra note 53. The population of Japan in 2004 was about 127 million. Ramseyer estimates that annual malpractice insurance premiums total about ¥ 69 billion (US $ 860 million). Ramseyer, Malpractice Claims, supra note 23, at 664. A recent estimate from Sompo Japan, a major liability insurer, puts the total somewhat lower, at ¥ 41 billion (US $ 510 million). Sompo Japan Insurance Inc., Ishi baisho- sekinin hoken ni tsuite [Physicians’ Liability Insurance] (Aug. 3, 2011) (on file with author). Of this sum, roughly 60 percent is paid out to claimants. Ramseyer, Malpractice Claims, supra note 23, at 664. Id. at 667. Michelle M. Mello & David M. Studdert, The Medical Malpractice System: Structure and Performance, in Medical Malpractice and the U.S. Health Care System 11, 13 (William M. Sage & Rogan Kersch eds., 2006), cited in Ramseyer, Malpractice Claims, supra note 23, at 667.

Japan

times Ramseyer’s estimated Japanese claiming rate. Annual medical malpractice claims filed in court (not extrajudicially) in 2004 in Canada, with a population of 32 million, amounted to 1,083 claims,112 or one lawsuit per 30,000 residents, about four times Japan’s per capita lawsuit filing rate of one lawsuit per 115,000 residents.113 A reasonable approximate estimate would be that a Japanese patient is one-fourth to one-sixth as likely to make a claim against a medical provider as a North American patient.114 Malpractice liability insurance to cover these claims is provided to clinic physicians in private practice chiefly through private insurance plans organized by national and prefectural medical associations, and to private and many public hospitals through commercial carriers such as Sompo Japan and Tokyo Marine.115 Private physicians’ standard insurance policies come with a ¥ 1 million (US $ 13,000) deductible and cover liability up to ¥ 100 million (US $ 1.3 million). Standard hospital policies cover the same liability level, but typically with no deductible.116 Physicians employed by hospitals receive standard coverage under their hospitals’ policies, but some physicians purchase additional personal coverage.117 Excess liability insurance covering large-claim liability above standard policy limits, considered “vitally important” to self-insured hospitals in the US,118 is avail-

112 Canadian Health Services Research Foundation, Myth: Medical Malpractice Lawsuits Plague Canada (2006), available at http://www.chsrf.ca/publicationsandresources/ Mythbusters/ArticleView/06-03-01/70e601b8-487a-44d0-b390-4e4a0a453493.aspx, cited in Ramseyer, Malpractice Claims, at 667–668. 113 For an earlier comparison of malpractice claim filing rates in Japan and several Western nations, see Nakajima et al., supra note 106, at 1638. An extensive literature, unnecessary to explore here, seeks to explain the difference in propensity to litigate between Japan and the US. For overviews of the debate, see, for example, John Owen Haley, Authority without Power: Law and the Japanese Paradox 108–111 (1991); Milhaupt, Ramseyer & West, supra note 7, at 141–176 (2006); Andrew D. Feld, Culture and Medical Malpractice: Lessons from Japan. Is the “Reluctant Plaintiff” a Myth? 101 Am. J. Gastroenterology 1949 (2006). 114 Adding some credence to this estimate are statistics from major liability insurer Sompo Japan indicating that physician and hospital liability insurance, as a proportion of all casualty insurance, is 0.37 percent in Japan and 1.52 percent in the U.S., approximately a 1 to 4 ratio. See Sompo Japan Insurance Inc., supra note 109, at 9 (calculated from figures given in table). 115 Some national hospitals and national university hospitals cover liability costs through taxpayer-funded operating budgets or through a quasi-public entity, Kokuritsu byo-in kiko- [National Hospital Organization], rather than by purchasing liability insurance from private firms. See http://www.hosp.go.jp/ (National Hospital Organization website). For a useful description of the structure and operation of Japanese malpractice insurance systems at the turn of the 21st century, see Nakajima et al., supra note 106. 116 Sompo Japan Insurance Inc., supra note 109, at 3–4. 117 Ramseyer, Malpractice Claims, supra note 23, at 664–665; Kawabata interview, supra note 106. 118 Frank A. Sloan & Lindsey M. Chepke, Medical Malpractice 247 (2008).

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able in Japan for liability in the range of ¥ 100–200 million (US $ 1.3-$ 2.5 million). However, there are so few large claims that marketing reinsurance for claims exceeding these amounts is uneconomical.119 Liability insurance does not constitute a significant part of ordinary practitioners’ daily concerns, although hospital administrators must keep the issue in mind. Liability insurance is regulated nationally by the Financial Services Agency, which has control over rate-setting. For physicians in private practice, premiums are uniform nationwide: ¥ 70,000 yen annually (US $ 875, tax-deductible), with no differentiation based or practice specialty or location.120 Hospital-employed physicians pay somewhat less.121 Since a 2004 premium revision, hospitals’ insurance premiums, once also uniform, have varied somewhat depending on their bed count and treatment levels. Hospitals insured by the Japan Hospital Federation with more than 500 beds, for example, pay ¥ 23,160 (US $ 290) per bed per year, while hospitals with 200–299 beds pay ¥ 21,536 (US $ 270).122 Hospitals’ premiums are experience-rated, to some extent;123 physicians’ premiums are not.124

119 Interviews with Satoko Nishimura, insurance policy specialist, in Tokyo (July 19 and Aug. 3, 2011); see also Kodama interview, supra note 85 (effect of “high-cost health care expense system” on liability for catastrophic injury). 120 This ¥ 70,000 premium is charged to JMA members owning clinics or small hospitals. Physicians may also purchase additional insurance to cover the ¥ 1 million deductible and liability for injuries resulting from non-medical acts, such as slip-and-falls at physician-owned hospitals. This additional insurance sells for ¥ 8,620 (US $ 110). Sompo Japan Insurance Inc., supra note 109, at 3–4. 121 Non-JMA members (mainly hospital-employed physicians) can purchase a standard policy for ¥ 55,000 (US $ 700), and physician trainees for ¥ 34,000 (US $ 400). Id. These doctors are typically covered by the hospital’s liability insurance anyway, so it is unclear to the author why many of them purchase it. 122 Zenkoku ko-shi byo-in renmei no byo-in baisho- sekinin hoken-to- no goannai [Japan Hospital Federation Guide to Hospital Liability Insurance] 5–8 (2010); interview with Mitsugu Ikeda, Japan Hospital Federation, in Tokyo (July 29, 2010). The Japan Hospital Federation (JHF) includes a selection of public and private hospitals including the Japan Red Cross hospital group. University hospitals carrying out high-risk procedures on a frequent basis, non-JHF members, are reported to pay higher premiums in the range of ¥ 30,000 (US $ 375) per bed. See Leflar, “Unnatural Deaths,” supra note 13, at 8 n. 28. Smaller hospitals of less than 100 beds, where fewer high-risk procedures are performed, are charged only ¥ 16,000 (US $ 200) per bed. Sompo Japan Insurance Inc., supra note 109, at 4. 123 Ikeda interview, supra note 122; Nishimura interviews, supra note 119. 124 Nishimura interviews, supra note 119; Nakajima et al., supra note 106, at 1635. Claims experience for individual physicians is too limited to warrant the expense of compiling experience ratings. Cf. Sloan & Chepke, supra note 118 (explaining limitations of experience rating in the US medical malpractice insurance market). The actuarial difficulty of rating individual physicians’ likely future claim exposure is even greater in Japan, with its low litigation rates, than in the US.

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5.

Plaintiffs’ Attorney Fees and Court Filing Fees

One barrier confronting patients considering medical malpractice lawsuits, identified by numerous scholars and critics of the Japanese court system, has been plaintiffs’ attorneys’ fee structure.125 In contrast to the United States, in which pure contingent fee arrangements with no up-front payments are standard, in Japan plaintiffs customarily had to pay lawyers a substantial up-front retainer according to a standardized schedule enforced by the bar association, plus a filing fee to the court based on the amount claimed. Together, these payments amounted to the yen-equivalent of several thousand dollars, closing the courthouse door to most seriously injured patients without substantial means.126 Recent reforms have lowered these barriers somewhat: court filing fees in high-damage cases substantially decreased in 2003,127 and the bar association withdrew its attorney fee schedule as contrary to antimonopoly law.128 Currently, some attorneys handling malpractice cases for plaintiffs offer potential clients a degree of flexibility in payment arrangements. For example, the attorney may charge a fee for preliminary case evaluation smaller than the standard retainer and, if the attorney takes the case, a discounted retainer amount may be paid in installments; or the retainer may be decreased while the attorney’s share of the recovery, contingent on success, is increased. A contingency arrangement of 15–25 percent of the total recovery, with various adjustments, is common.129 Still, most attorneys are said to work within the basic framework of the former customary fee schedule.130

125 See, e.g., Shoichi Maeda et al., The Problems of Medical Malpractice Litigation in Japan: The Significant Factors Responsible for the Tendency of Patients to Avoid Litigation, 3 Legal Med. 56, 59–61 (2001) (retainer and filing fees as significant barriers to litigation); Eric A. Feldman, Why Patients Sue Doctors: The Japanese Experience, 37 J.L. Med. & Ethics 792, 796–797 (2009) (same); Robert B Leflar, The Regulation of Medical Malpractice in Japan, 467 Clinical Orthopedics & Related Res. 443, 445 (2009) (same). 126 See Maeda et al., supra note 125, at 61 tbl. 9 (noting start-up fees of ¥ 3 million – then about US $ 24,000 – for cases involving minor plaintiffs claiming lifelong earning deprivation). Occasionally patients do file pro se claims, however, and once in a while, they win. Id. at 59–60; interview with Shunsuke Funase, successful pro se plaintiff, in Naguri, Saitama-ken (Aug. 9, 2009). 127 Feldman, supra note 125, at 797 n. 45. Filing a claim for ¥ 10 million (US $ 125,000) now requires a filing fee of ¥ 50,000 (US $ 625); a claim of ¥ 100 million (US $ 1.25 million) requires a fee of ¥ 320,000 (US $ 4,000). For the current filing fee schedule, see http://www.courts.go.jp/saiban/tetuzuki/tesuuryou.html (last visited July 16, 2011). 128 Kawabata, Dickinson Lecture, supra note 77. 129 Kato- interview, supra note 72; Suzuki and associates interview, supra note 68. Kato- and Suzuki are both leaders of cooperating groups of plaintiffs’ attorneys specializing in medical malpractice cases. 130 Kato- interview, supra note 72; Suzuki interview, supra note 68; Feldman, supra note 77, at 264 & n. 24

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III. The No-Fault Compensation System for Obstetrical Injury Japan has a notable history of enacting no-fault administrative compensation systems providing relief for injured persons apart from that available under the civil law, whose various limitations made compensation in circumstances of high social concern difficult or impossible. These compensation systems include schemes aiding people injured by environmental pollution, vaccinations, adverse drug reactions, infections from biological products, blood transfusions, and asbestos exposure.131 The most recent of these no-fault administrative compensation systems provides relief to parents of a limited class of newborn infants with severe brain damage. Birth injury cases are among the most serious in every legal system. Profound brain injuries compounded with lifelong rehabilitative needs add up to enormous potential damages. Obstetricians face the prospect that even a minor slip may subject them and their insurance carriers to vast damage judgments.132 Litigation over birth-related injuries has generated considerable concern among Japanese obstetricians. Among civil malpractice actions, suits over obstetrical injuries have apparently resulted in a higher-than-average proportion of plaintiffs’ judgments.133 Of perhaps even greater concern, prosecutors instituted criminal proceedings in 2006 (intensely publicized, but ultimately unsuccessful) against an obstetrician who lost a patient

131 See Osaka, supra note 80, at 400 (listing laws); Takao Tanase, The Role of the Judiciary in Asbestos Injury Compensation in Japan, in Fault Lines: Tort Law as Cultural Practice 233, 247–248 (David M. Engel & Michael McCann eds., 2009) (noting centrality of administrative compensation rather than private litigation as Japan’s “archetype”); Akio Morishima & Malcolm Smith, Accident Compensation Schemes in Japan: A Window on the Operation of Law in a Society, 20 U. Brit. Colum. L. Rev. 491 (1986) (early analysis of development of no-fault systems). This significant phenomenon has received scant attention in many respected English-language treatises on Japanese law. See, e.g., Milhaupt, Ramseyer & West, supra note 7; Ramseyer & Nakazato, supra note 43, at 125 & n. 58 (sole mention); Oda, supra note 20. 132 The subtleties of the litigation process in a birth-damaged baby case, and their impact on the lives of plaintiffs, defendants, and their attorneys, are set out in memorable fashion in Barry Werth, Damages (2008) (first published1988). 133 See Nana Uesugi et al., Analysis of Birth-Related Medical Malpractice Litigation Cases in Japan: Review and Discussion Towards Implementation of a No-Fault Compensation System, 36 J. Obstetrical & Gynæcological Res. 717 (2010) (69 percent of sixty-four cases in database of reported birth defect cases resulted in some recovery); compare Ramseyer, Malpractice Claims, supra note 23, at 626–627 (some recovery in 30–40 percent of all medical malpractice cases litigated to final judgment). It is possible, however, that the publishers’ selection of cases to be reported biased the database used by Uesugi et al. in favor of cases in which plaintiffs recovered. See id. at 642–644.

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during a difficult delivery, casting a shadow of fear over the profession and giving impetus to the antiregulatory iryo- ho-kai movement described above.134 At the instigation of the Japan Medical Association, the Japan Society of Obstetrics & Gynecology, and the then-governing Liberal Democratic Party, the health ministry initiated a no-fault compensation system for a limited class of obstetrical injuries.135 Launched on January 1, 2009, the system is modeled in some respects on Florida’s neurological injury compensation system.136 It is administered by the quasi-public Japan Council for Quality Health Care (JCQHC), and is financed through a fixed per-birth levy from the social insurance system paid to private insurance companies that stand to reap profits (or possibly suffer losses) from the system’s operation.137 The system’s stated goals are to provide prompt compensation, without the need for legal proceedings, to parents of infants suffering cerebral palsy related to brain injuries during childbirth, and to improve the quality of maternal care and prevent future cases.138 Of particular note, Japan’s obstetrical injury compensation system was instituted in a manner that required no legislation. It is a voluntary system – no childbirth facility is obligated to participate. It is operated

134 See supra, text pt. I.C. 135 Criteria for compensation are rather strict. Infants must be diagnosed with cerebral palsy of the first or second degree of severity, must weigh more than 2000 grams at birth, and with few exceptions must be born after thirty-three weeks of pregnancy. Infants who die within six months and those whose anomalies are congenital are excluded from compensation. Eligibility determinations are performed by expert panels. The level of compensation is fixed: a one-time payment of ¥ 6 million (US $ 75,000), plus ¥ 24 million (US $ 300,000) paid out over the first twenty years of the child’s life, for a total of ¥ 30 million (US $ 375,000) per child. MHLW, Sanka iryohosho- seido ni tsuite [The Obstetrical Compensation System], http://www.mhlw.go.jp/ topics/bukyoku/isei/i-anzen/sanka-iryou/index.html (last visited Aug. 6, 2011). 136 The Florida system, like Virginia’s Birth-Related Injury Fund, is a no-fault system for compensation of some serious neurological injuries sustained during or close to childbirth. For an overview of the two systems, see Sloan & Chepke, supra note 118, at 280– 287. 137 The cash flow is circuitous. Funding for the system is generated by a levy of ¥ 30,000 (US $ 375) on each birth. JCQHC collects this amount from hospitals and maternity clinics that choose to participate, and channels the money to the private insurers. The hospitals and clinics in turn collect an identical amount from each expectant mother. By Cabinet Order, the amount of the lump-sum childbirth subsidy that each mother receives from her health insurance plan was increased by the same ¥ 30,000 at the time the compensation system was launched. See Taro Tomizuka & Ryozo Matsuda, Introduction of No-Fault Obstetric Compensation, Health Pol’y Monitor (Oct. 2009), available at http://hpm.org/survey/jp/a14/4. 138 Tomizuka & Matsuda, supra note 137.

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outside of government by JCQHC. Social insurance funds finance the system, and no specific legislative appropriation is needed. Parents still have a right to sue medical providers for negligence, as before the system was instituted. Although it is premature to evaluate the new compensation system, it does appear to have gained traction. Essentially all childbirth facilities in the nation (99.7 percent) have signed up to participate.139 For births occurring in 2009, the first year of operation, as of mid-2011 the system had reviewed 152 applications for compensation and accepted 139.140 This appears to exceed by a substantial margin the proportion of cerebral palsy cases compensated by the Florida system.141 For a recently launched program, the new system seems to be capturing a substantial proportion of cerebral palsy cases. It remains to be seen whether the system’s financing will suffice in the long term, but it is running a considerable surplus at present, greatly benefitting participating private insurers (and imposing a substantial cost onto the social insurance system).142 The new system’s effects on the quality of obstetrical care and on malpractice claiming practices remain to be researched. The success or failure of the no-fault obstetrical compensation system may also have implications for the future of Japan’s medical malpractice system as a whole. Support for no-fault compensation comes from what

139 Dai-8-kai Sanka iryo- hosho- seido un’ei iinkai shidai [Agenda for 8th Meeting of Obstetrical Compensation System Management Committee], at 3 (July 6, 2011) (table in agenda materials), available at http://www.sanka-hp.jcqhc.or.jp/pdf/obstrics_meeting_08.pdf. The high participation rate is chiefly explained by the fact that neither the hospital or clinic, nor the expectant mothers for whose custom the hospitals and clinics compete, bear any financial risk from participation, due to the cost pass-through explained in note 137 supra. Interview with Naoki Ikegami, Chair, Dep’t. of Health Policy & Management, Keio U. Sch. of Medicine, in Tokyo (Aug. 8, 2011). 140 Compensation System Committee Agenda, supra note 139, at 5. 141 The Florida compensation system, and a similar system operating in Virginia, are reported to be compensating no more than 2 percent of cerebral palsy cases in those states. See Sloan & Chepke, supra note 118, at 282. One estimate placed the annual incidence of cerebral palsy cases in Japan at about 630, Tomizuka & Matsuda, supra note 137, although it is unclear whether that estimate is based on a disease definition congruent with the standards for compensation applied in the new Japanese system. Supposing the estimate of 630 cases is not far off the mark, and well over 100 of them are accepted for compensation in a year, it is clear that the Japanese system is capturing a far higher percentage of cases for compensation than the Florida system. 142 In 2009, the system’s first full year of operation, it collected ¥ 31.5 billion (US $ 340 million) in premiums (¥ 30,000 × 1,054,340 births). Through the end of 2010, the system had accepted compensation claims for ninety-nine applications regarding those 2009 births, thereby incurring payment obligations over twenty years totaling just ¥ 3 billion (99 × ¥ 30 million, see supra note 135) – only a tenth of premiums collected. Compensation System Committee Agenda, supra note 139, at 17.

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some outside observers might consider unlikely quarters. For example, the Japan Medical Association has long espoused the merits of a national no-fault compensation system for medical injures in general.143 The Japan Federation of Bar Associations has likewise come out in favor of a no-fault system, albeit of a different nature.144 The Ministry of Health, Labor & Welfare has just launched a blue-ribbon study commission on no-fault compensation for medical injury.145 Administrative compensation systems based on no-fault principles have a solid grounding in Japanese legal tradition over several decades.146 If the obstetrical injury compensation system proves successful, it is not beyond contemplation that broad-based support for a general no-fault compensation system for medical injury could emerge.

Conclusion Distinctive features of Japanese law and society relating to medical misadventure include the following: Criminal law: In the early years of the 21st century, after a series of publicized errors at hospitals of high repute focused public attention on slipshod practices and dishonesty in the medical world, the criminal justice system, amplified by media reportage, sounded a wake-up call to

143 See, e.g., “Bunben ni kansuru no-sei mahi ni tai-suru sho-gai hosho- seido” no so-ki jitsugen o [Toward Prompt Institution of an “Injury Compensation System for Birth-Related Cerebral Palsy,”], 1080 Nichi-i nyu-su 1 (Sept. 5, 2006) (JMA publication quoting former JMA president Taro- Takemi as favoring no-fault compensation for medical injury in 1972), available at http://www.med.or.jp/nichinews/n180905a.html; Nihon ishikai [JMA], Iryo- jiko cho-sa seido no so-setsu ni muketa kihonteki teigen ni tsuite [Basic Proposal for the Establishment of a Medical Accident Investigation System] 15–16 (June 2011) (favoring no-fault compensation system), available at http://dl.med.or.jp/dl-med/teir eikaiken/20110713_2.pdf. 144 Japan Federation of Bar Associations, “Iryo- jiko mukashitsu hosho- seido” no so-setsu to kihonteki na wakugumi ni kansuru ikensho [Proposal Concerning the Establishment and Fundamental Framework of a “No-Fault Compensation System for Medical Accidents”] (2007), available at http://www.nichibenren.or.jp/library/ja/opinion/report/data/070316_2_000.pdf. Attorney Yoshio Kato-, leader of a distinguished group of plaintiff-side malpractice specialists, has long advocated a no-fault system. See, e.g., Yoshio Kato-, The Center for Patient Safety and Medical Victims’ Relief: A Plan, http:// homepage2.nifty.com/pcmv/PCMV.html (last visited July 18, 2011). Kato- has been influential in persuading the bar association to support a no-fault system. 145 Iryo- no shitsu no ko-jo- ni shi-suru mukashitsu hosho- seido-to- no arikata ni kan-suru kento-kai [Commission for the Study of No-Fault Compensation Systems Conducive to Health Care Quality Improvement], Kaisai yo-ko- [Outline of First Meeting] (Aug. 26, 2011), available at http://www.mhlw.go.jp/stf/shingi/2r985200000ln6bl.html (click first attached file). 146 See supra note 136 and accompanying text.

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a medical profession previously lacking in accountability mechanisms. The health ministry and organized medicine responded with various measures to improve patient safety; the extent to which those measures may have been effective is unknown. Prosecutors’ sometimes-excessive involvement in policing medical quality, however, has recently provoked a reaction from the medical profession eliciting media and public sympathy, perhaps contributing to an unusual string of acquittals of medical defendants, and clipping the prosecutors’ wings. Civil law: Civil Code provisions governing compensation for medical injury are fault-based and do not differ greatly in principle from rules applied in North America and Western Europe. The burden of proof of causation is relaxed in informed consent and loss-of-chance cases. Procedural reforms, including the institution of health care divisions of district courts in some metropolitan areas, have helped speed up the pace of judicial proceedings, once notoriously glacial. Damage awards appear to be at least as high on average as in the United States, at current exchange rates, and are applied on a more consistent, standardized basis than in the United States. The volume of claims filed in court is considerably lower than North American levels, and has declined since the peak year of 2004. Most compensation payments are made outside, not within, the court system. Even so, overall claiming rates are low relative to North American practices. Malpractice insurance premiums, uniform nationwide for physicians in private practice without regard to specialty or geography, are far cheaper than in the United States. Administrative compensation programs: Building on a tradition of no-fault administrative compensation schemes for people injured by pollution, defective drugs, vaccines, blood transfusions, and asbestos, Japan instituted in 2009 a nationwide no-fault compensation system for infants with severe birth-related brain injuries. Backed by the medical establishment, financed through public funding, administered by a quasi-public entity and offering substantial profit opportunities (as well as a theoretical risk of loss) to private insurers, the new compensation system has already achieved virtually universal buy-in by childbirth facilities hoping for protection from future litigation. Evaluation of the system’s operation is still premature but worthy of scholarly attention. Should the obstetrical compensation system prove successful, it may serve as a springboard for the expansion of no-fault principles to cover a wider scope of medical injuries. Both the Japan Medical Association and the Japan Federation of Bar Associations are on record as favoring a no-fault compensation system of some sort, and a blue-ribbon commission is now examining the topic.

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Addendum The Ministry of Justice has recently compiled a comprehensive but unofficial set of English translations of Japanese laws. This useful, carefully constructed compilation is available at http://www.japaneselawtranslation. go.jp/law/. The translations there of the basic torts and contracts provisions, Articles 709 and 415 of the Civil Code, are more precisely reflective of the Japanese originals than the translations used in notes 54 and 55 of the originally published version of this paper, reprinted above. Here are the Ministry of Justice's translations of those provisions: Art. 709, Damages in Torts: “A person who has intentionally or negligently infringed any right of others, or legally protected interest of others, shall be liable to compensate any damages resulting in consequence.” Art. 415, Damages Due to Default: “If an obligor fails to perform the purpose of its obligation, the obligee shall be entitled to demand damages arising from such failure. The same shall apply in cases it has become impossible to perform due to reasons attributable to the obligor.”

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Treatment Injury in New Zealand Stephen Todd*

Introduction This article discusses medical malpractice and compensation in New Zealand, but there is not much in it about liability. The reason is that in New Zealand, a statutory accident compensation scheme makes provision for the payment of compensation to the victims of personal injury that is suffered in ways that are covered by the scheme. One of these ways is personal injury caused by medical treatment, and in nearly all cases the victims will receive compensation pursuant to the statutory scheme rather than common law damages. If the circumstances are such that the scheme applies, then actions for damages are barred. Only in rare cases falling outside the ambit of the scheme might there be scope for suing the doctor or other person responsible for causing the injury, or his or her employer, and in this way recovering such damages. Although the focus of the article is on compensation for medical injuries, the initial part of the article is broader in that it places the discussion in the context of the accident compensation scheme in New Zealand as a whole. This part gives a brief overview of the nature of the scheme, its relationship with rules of liability at common law, the benefits it provides, and how it is funded and administered. Then the main part of the article looks at the provisions in the scheme for compensation for the victims of medical injury. It includes discussion of the extent of the statutory cover, problems of causation, how the relevant provisions have operated in practice, and the costs that have been incurred in administering the scheme and delivering the benefits. It covers as well some consideration of the alternative ways in which a doctor or other professional person may be held accountable for the consequences of wrongful conduct notwith-

*

Professor of Law, University of Canterbury, New Zealand; Professor of Common Law, University of Nottingham, United Kingdom.

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standing the bar on suing. In the final part there is an evaluation of the scheme as a whole and, more specifically, of the cover it provides in medical cases.1

I.

The New Zealand Accident Compensation Scheme

A.

The Woodhouse Report

The reasons for the introduction of the New Zealand accident compensation scheme, and its fundamental design, are found in the Report of the Royal Commission inquiring into personal injury law in New Zealand (usually known as the Woodhouse Report after the name of its Chairman, the Honorable Justice Woodhouse).2 The Royal Commission was charged with investigating and reporting “upon the law relating to compensation and claims for damages for incapacity or death arising out of accidents (including diseases) suffered by” employees.3 Accordingly, it examined the remedies for injured employees at common law and under the workers’ compensation legislation4 in order to determine whether change was needed and, if it was, to consider what form it might take.5 Having made its inquiries, the Commission was convinced that both the action for damages and the workers’ compensation system fell clearly short of providing a satisfactory system of compensation. First, the common law process could be seen to cause serious injustice and to perpetuate a number of anomalies. The key objections were that the fault theory had developed into a legal fiction, for the economic consequences of negligent conduct were spread via insurance over the whole community; the risks of litigation – the difficulties of proof, the ability of advocates, the reactions of juries, and mere chance itself – turned the system into a lottery; and the tort system was cumbersome, inefficient and extravagant in operation to the point that the cost of administration absorbed more than forty percent of the total amount of money flowing into the system.6 As for the workers’ compensation scheme, this scheme worked upon a limited principle, was 1 The descriptions of the history of the scheme and of some of its core provisions and the cases interpreting them that follow in this article are based partly upon the accounts in Stephen Todd, The Law of Torts in New Zealand ch. 2, ¶ 2.2 (5th ed. 2009). 2 Royal Comm’n of Inquiry, Compensation for Personal Injury in New Zealand 19–28 (1967) [hereinafter Woodhouse Report]. 3 Id. at 11. 4 Workers’ Compensation Act 1956. 5 Woodhouse Report, supra note 2, at 19. 6 Id. at 49–50, 52.

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formal in procedure, was meager in its awards, and was ineffective in the field of prevention of accidents and the physical or vocational restoration of the injured.7 These last two areas, it was said, “should be at the forefront of any general scheme of compensation.”8 The Commission concluded that both the action for damages and workers’ compensation fell clearly short of providing a satisfactory system of compensation. It recognized that an overall solution might be the integration of a comprehensive scheme of accident compensation into the social security framework covering both accidents and illness.9 There would be great advantage in doing this, for it would give an organic structure and unity to the whole process. However, integration was not feasible if compensation would then have to take the form of the same flat rate payments for all, which would be unacceptable and unjust. The only way in which a comprehensive system could operate equitably was by linking benefits to earning capacity and by taking into account permanent physical disability. The Commission thought that the next move might be in this direction, but did not itself pursue the matter.10 It was seen as unwise to attempt one massive leap when two considered steps might be taken, but the experience gained by taking the first step would assist in moving towards a comprehensive plan. As for the first considered step, the Commission recommended that there should be a comprehensive system of accident prevention, rehabilitation and compensation which would avoid the disadvantages of the existing processes, meet the requirements of “community responsibility, comprehensive entitlement, complete rehabilitation, real compensation and administrative efficiency,” and satisfy the requirement of financial affordability.11 The object should be compensation for all injuries, irrespective of fault and regardless of cause. In due course Parliament acted on these recommendations, but the second step has never been taken. So New Zealand has developed two different systems for compensating incapacity, depending on the cause of the incapacity in question, with markedly less generous benefits being available under the social security scheme than those which apply in the case of accident compensation. The distinction has returned periodically to haunt the operation of the accident scheme and remains in full force today.

7 Id. at 97. 8 Id. 9 Id. at 179–80. 10 See id. at 181. 11 Id. at 107.

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B.

Implementation

The Woodhouse proposals were enacted in the Accident Compensation Act 1972.12 In its original form the proposed scheme covered only employees injured at work and victims of motor accidents. However, before it came into force there was a change of government, and the new administration substantially widened its ambit so that it provided for compensation for all accident victims suffering personal injury by accident.13 At the same time, the Act barred the right to sue or to claim workers’ compensation for those covered by the scheme, following Woodhouse’s view that these remedies became irrelevant.14 So the legislation denied access to the courts in return for the perceived advantages of the statutory scheme. The exchange has sometimes been spoken of as a “social charter,” “social contract,” or “social compact.”15 The purposes of the 1972 Act were to promote safety, to promote the rehabilitation of persons who suffered personal injury by accident covered by the scheme, and to make provision for the compensation of those persons or their dependants.16 Where coverage existed it was compulsory. No one could opt out and seek damages instead.17 Victims of injury were entitled to weekly compensation for loss of earnings at the rate of eighty percent of the claimant’s earnings prior to the accident, up to a prescribed maximum figure, lump sums for loss of bodily function, pain and suffering and loss of amenity, again with prescribed maximum figures, medical expenses and other incidental costs, and death benefits.18 Payments were funded by levies payable by employers, the self-employed and motor vehicle owners, and also out of general taxation.19 The scheme was administered by the Accident Compensation Commission, with functions which included the making of payments to those entitled and the taking of various steps to promote safety and rehabilitation.20 Other features included the processes for making a claim, limits on entitlements, dispute resolution, incentives to safety and issues of economic deterrence, the

12 13 14 15 16 17 18 19 20

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Accident Compensation Act 1972. Id. § 54. Id. § 5. Brightwell v. Accident Comp. Corp. [1985] 1 NZLR 132 (CA) 139–40; Queenstown Lakes Dist. Council v. Palmer [1999] 1 NZLR 549 (CA) 555. Id. § 4. Accident Compensation Act § 5. Id. § 103. Id. §§ 71–74. Id. §§ 6, 16.

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basis for calculating the levies, and further matters of management and administration.21 We will consider certain of these features to the scheme in some detail when we turn to examine its operation in the particular field of medical injuries.

C.

Developments to 2010

Since the passing of the 1972 Act there have been four reenactments of the accident compensation scheme as a whole – in the Accident Compensation Act 1982,22 the Accident Rehabilitation and Compensation Insurance Act 1992,23 the Accident Insurance Act 1998,24 and the Injury Prevention, Rehabilitation, and Compensation Act 2001.25 We need to look briefly at the aims of each of these enactments. The Accident Compensation Act 1982 left coverage untouched, made some minor changes to entitlements, turned the Accident Compensation Commission into the Accident Compensation Corporation (ACC) with a board of directors, and, most significantly, placed the funding of the scheme explicitly on a pay-as-you-go basis.26 Under pay-as-you-go funding, levies for the year pay all of that year’s costs, including both new and old claims. They do not cover the continuing costs of claims extending into future years. Under full funding, levies must meet all the costs of claims made during the year. They do not include past claims, but do include the continuing cost of claims for the full duration of an injury. At its inception the scheme was not fully funded, but because there were no old claims payments in were substantially greater than outgoings. This partial funding in the early years meant that substantial reserves were accumulated, leading to pressure from employers to reduce the cost of accident compensation. The government of the day took heed and made substantial cuts in the levies. As a result, the reserves were depleted very rapidly, and this contributed to the scheme’s growing financial instability. The government once again intervened, by imposing huge levy increases (in some cases exceeding five

21 22 23 24 25 26

Id. §§ 15–20. Accident Compensation Act 1982. Accident Rehabilitation and Compensation Insurance Act 1992. Accident Insurance Act 1998. Injury Prevention, Rehabilitation, and Compensation Act 2001. Accident Compensation Act 1982.

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hundred percent) and by asking the Law Commission to review how the scheme was operating and to make recommendations accordingly. The Law Commission’s 1988 Report denied that the scheme was facing a financial crisis and, far from recommending cuts, it strongly supported expanding the scheme so as to bring sickness and non-accidental incapacity under its umbrella.27 The Commission considered that the demarcation between injury and illness was clearly anomalous and that it ought to disappear, sooner rather than later. It thought that this could be done in stages, by accepting congenital incapacities already supported by the social welfare system, by later taking in higher level disabilities and finally including others less serious.28 On the other hand, lump sum payments were seen as illogical in relation to the income maintenance purposes of the injury scheme, and for sickness they would become incongruous.29 Serious lost physical capacity and any economic loss were better met by periodic payments. Lump sums should, therefore, be abolished. The Commission was satisfied that their scheme would not lead to an explosion in costs and could be funded by levies, investment income and taxation, much as already happened. While the costs of the scheme had been rapidly going up, by far the largest area of increase was in the amounts payable to those who claimed in earlier years who were still in receipt of payments from the Corporation. The cost of claims in the first year had increased only by small amounts. In 1987 the whole of the real increase in spending was for earlier years.30 So the scheme was doing what it was intended to do – compensating the seriously incapacitated without a limit of time. The Labour government accepted the Commission’s recommendations and tabled a Bill creating a comprehensive income maintenance and rehabilitation scheme available to all persons who suffered incapacity, regardless of cause. However, shortly afterwards, the government lost power in the election of 1990, and the Bill accordingly lapsed. The incoming National government then came to the conclusion that the existing scheme was too expensive and abruptly changed direction. Following the election the new Minister of Labour issued a Policy Statement reviewing the state of the scheme.31 This condemned the funding

27 28 29 30 31

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New Zealand Law Commission, Report No. 4 Personal Injury: Prevention and Recovery (Government Printer, Wellington 1988) [hereinafter 1988 Report]. Id. Id. Id. Dep’t of Labour, Accident Compensation – A Fairer Scheme, (Government Printer, Wellington 1991).

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base for the scheme as unfair, because employers were funding nearly seventy percent of the total costs while work accidents accounted for only about forty percent of those costs, and earners paid nothing towards the cost of non-work injuries.32 And more critically, the review maintained that the increasing numbers of people receiving compensation, higher benefits, and the expansive interpretation by the courts of “personal injury by accident” in delimiting coverage had caused costs to run out of control.33 It was proposed to solve these difficulties by a reform of the scheme that widened and reallocated its funding base, reduced its costs and removed some of the judicial extensions to its coverage. The Accident Rehabilitation and Compensation Insurance Act 1992 was intended to meet these concerns and achieve these objectives.34 As regards funding, pay-as-you-go was retained, but substantial changes were made to existing sources of funding and new sources were introduced.35 In particular, employers met only the cost of providing coverage for injury sustained in the course of employment (except where a motor vehicle was involved), and all earners paid a levy to meet the cost of coverage for accidental injury.36 As regards benefits, there was a new “work capacity” test aimed at moving accident compensation claimants who could not find work onto the unemployment benefit; rehabilitation assistance was available only in restricted circumstances; lump sum payments for loss of faculty and pain and suffering were abolished and replaced by an “independence allowance” set at low levels; and entitlement to compensation ended when a claimant became entitled to superannuation payments.37 Further savings were sought to be made by reining in the ability of the judges to give an expansive interpretation to the provisions governing the ambit of the scheme.38 The bases for cover formerly all fell within the broad concept of “personal injury by accident,” but now they were treated as separate categories and made subject to a series of detailed definitions.39 Judicial discretion in determining their limits was largely removed.

32 33 34 35 36 37 38 39

Id. Id. Accident Rehabilitation and Compensation Insurance Act 1992. Id. at pt. VII. Id. §§ 100, 113. Id. §§ 37–44. Id. § 3. Cover as presently provided continues to be based on the 1992 categories, but with some amendment. See text accompanying notes 65–71.

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The next significant development came with the passing of the Accident Insurance Act 1998.40 This left cover and benefits as they were but privatized the delivery of the statutory benefits for the victims of accidents at work.41 The monopoly control exercised by the Accident Compensation Corporation was removed and employers were obliged to insure with a private insurance company or a new state-owned enterprise set up to compete with the private companies.42 A regulatory regime aimed to make sure that persons with cover received their entitlements.43 The purpose behind the reform was to facilitate freedom of choice, promote a greater emphasis on safety and rehabilitation, and encourage the efficient management of claims.44 The government view was that a publicly-administered scheme lacked sufficient incentives to safety and efficiency. The introduction of private enterprise would reduce the overall costs of injury, by an increased focus on prevention and rehabilitation and on the monitoring of workplace safety performance. Further, pay-as-you-go funding restricted the ability of the Corporation to reward innovation in injury prevention, as employers paid premiums that related largely to injuries that had already occurred. So henceforth the scheme was to be financed on a fully funded basis. Whether these hopes for efficiency and accident prevention would have been fulfilled cannot be known, for the new privatized regime was in force for just one year. A new Labour government was elected at the end of 1999, and one of its first acts was to restore the public monopoly. It saw no necessary or sufficient connection between the issues of paying victims and reducing accidents. It also rejected the view that the ACC operated inefficiently. On the contrary, there was no duplication in the provision of services and administrative costs were very low.45 However, full funding

40 41 42 43 44 45

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Accident Insurance Act 1998. For evaluations see Stephen Todd, Privatization of Accident Compensation: Policy and Politics in New Zealand, 39 Washburn L.J. 404, 474–87 (2000). Accident Insurance Act 1998. Accident Insurance Act 1998 § 169. Id. § 168. Id. at pmbl. In the election in November 2008 the National Party regained power, and one of its policies is to reintroduce private insurance covering accident compensation liabilities. INCREASING CHOICE IN WORKPLACE ACCIDENT COMPENSATION (June, 2011), (available at http://dol.govt.nz/consultation/increasing-choice/increasing-choice.pdf) has made a number of proposals. These include extending the Accredited Employers Programme (as to which see infra text accompanying note 286), allowing choice of workplace insurance cover in competition with the ACC, subjecting insurers to prudential regulation, and appointing a market regulator to monitor and enforce employer and insurer compliance with legal requirements.

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was thought to be desirable and this was retained in the new legislation that the government introduced shortly afterwards. This legislation – the Injury Prevention, Rehabilitation, and Compensation Act 2001 – once again left the provisions for coverage largely undisturbed.46 Entitlements also were not much changed, the significant exception being the reintroduction of lump sum compensation for impaired amenity (but not for pain and suffering).47 So in core respects the previously existing law continued. The new developments in the 2001 Act were primarily in the field of accident prevention, and to this end it introduced new processes and strategies aimed at reducing the incidence of injury and promoting safety and security. However, provision for cover for medical accidents was extended by amendment in 2005,48 in a way which will be explained below and which has had very significant practical consequences. A further amendment in 2008 extended cover to include work-related mental injury.49 Finally, in 2010, the name of the 2001 Act was changed to the Accident Compensation Act 2001,50 thus returning to the original, and surely appropriate, title.

D.

Relationship with the Common Law

From the inception of the accident compensation scheme there has been a bar on suing in New Zealand for damages for personal injuries or death. The bar is presently found in section 317(1) of the 2001 Act, which simplifies the original wording in the 1972 and 1982 Acts. It provides: “No person may bring proceedings independently of this Act, whether under any rule of law or any enactment, in any court in New Zealand, for damages arising directly or indirectly out of –(a) personal injury covered by this Act; or (b) personal injury covered by the former Acts.”51 The bar cannot be avoided by failure to make a claim or a purported denial or surrender of rights under any of the Acts or a lack of entitlement to any

46 47 48 49 50 51

Injury Prevention, Rehabilitation, and Compensation Act 2001 pt. 2. Id. § 69. Injury Prevention, Rehabilitation, and Compensation Amendment Act (No 2) 2005 § 13. Injury Prevention, Rehabilitation, and Compensation Amendment Act 2008 § 9. Accident Compensation Amendment Act 2010 § 5. Accident Compensation Act 2001 § 317(1). For the earlier bars, see Accident Compensation Act 1972 § 5(1); Accident Compensation Act 1982 § 27(1); Accident Rehabilitation and Compensation Insurance Act 1992 § 14(1); Accident Insurance Act 1998 § 394(1).

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particular benefit.52 A similar bar applies in the case of personal injury caused by a work-related gradual process, disease, or infection.53 The scope of the statutory bar was examined by the Court of Appeal in Queenstown Lakes District Council v. Palmer.54 In this case the plaintiff sought damages for the shock and mental injury that he suffered after witnessing the death of his wife in a rafting accident which was caused, he alleged, by the negligence of the defendant.55 It was argued that this was a claim for damages “arising ... ‘indirectly’ out of a personal injury covered by the Act,” that is, the death of Mrs. Palmer, but Thomas J, delivering the judgment of the court, was satisfied that the common law action was not barred.56 Section 14(1) of the 1992 Act (the predecessor to section 317(1) of the 2001 Act) did not apply, because the proceedings brought by Mr. Palmer did not arise indirectly out of Mrs. Palmer’s death.57 The critical words in section 14 (1) were “personal injury covered by this Act,” and the relevant personal injury had to be personal injury for which damages were sought.58 Yet Mr. Palmer was not seeking damages for his wife’s death. The relevant injuries for which he was seeking damages were the mental injuries which he himself suffered as a result of the alleged breach of a duty of care owed to him by the defendants. Mrs. Palmer’s death was simply part of the sequence of events which provided the factual basis for his claim. Thomas J was satisfied that the legislative history and the policy behind the legislation, and indeed common sense, supported this view.59 Persons covered under the Act were denied access to the courts at common law in return for the perceived advantages of the statutory scheme. The legislation reflected this policy from the outset. The purpose of the provision barring common law claims was to prevent persons who suffered personal injury being compensated twice over, once under the statute and then at common law, not to prevent them recovering any compensation at all. So the application of the Act and the corresponding scope for common law proceedings would automatically adjust as and when the scope of the cover provided by the Act was extended or contracted.60 To the extent that

52 53 54 55 56 57 58 59 60

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Accident Compensation Act 2001 § 317(7). Id. § 318(1)–(2). Oddly there are no similar anti-avoidance provisions as in section 317(7), but these are implicit in the bar itself and are in fact unnecessary. [1999] 1 NZLR 549 (CA). Id. Id. Id. Id. Id. Id.

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the statutory cover was extended, the right to sue at common law would be removed; to the extent that the cover was withdrawn or contracted, the right to sue at common law would be revived. Any other view would lead to fundamental injustice, depriving a person in Mr. Palmer’s position both of compensation and of damages. The bar on suing does not extend to any proceedings relating to any damage to property, or any express term of any contract or agreement,61 or any personal grievance arising out of a contract of employment.62 However, there can be no award of compensation in such proceedings for personal injury covered by the scheme,63 nor indeed in any other kinds of proceedings, such as a criminal prosecution.64

E.

Cover

1.

Categories of Cover

The provisions for cover under the accident compensation scheme over the years have become increasingly detailed, and presently they are divided up under twelve specific heads of claim. However, cutting through this prolixity, the various bases for cover fall broadly into four core categories. These are personal injury caused by an accident;65 personal injury by way of medical treatment;66 personal injury caused by employment-related disease or infection;67 and personal injury by way of mental injury suffered as a consequence of physical injury,68 by the victims of certain

61

62 63 64

65 66 67 68

E.g., Brittain v. Telecom Corporation of New Zealand Ltd [2001] 2 NZLR 201 (CA) (confirming that proceedings for a benefit founded on an insurance contract providing for additional payments in the event of injury are not barred). Accident Compensation Act 2001 § 317(2). Id. § 317(3). Sentencing Act 2002 § 32(5) provides that a court making a sentence of reparation “must not order the making of reparation in respect of ... loss or damage ... for which the court believes that a person has entitlements under the Accident Compensation Act 2001.” In Davies v. Police [2009] 3 NZLR 189 (SC) paras. [2], [24]–[25], [34], [37] the Supreme Court held that the inquiry should be into whether there was cover for the type of loss for which there were entitlements under the Act, not into the sums actually payable. Accordingly, a criminal court could not make a reparation order to compensate a victim for the difference between her full loss of income and the eighty percent loss for which she was compensated under the 2001 Act. Accident Compensation Act 2001, § 20(2)(a). Id. § 20(2)(b)–(d), (f)–(i). Id. § 20(2)(e), (j). Id. § 26(1)(c).

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specified sexual offences,69 or which is work-related.70 The victim in any of these cases can make a claim for compensation to the Accident Compensation Corporation pursuant to a simple administrative process.71

2.

Personal Injury

In every case the cover provided under the Act depends on the claimant having suffered “personal injury.” This is defined as meaning death; physical injuries; mental injury suffered because of the claimant’s physical injury, or caused by certain criminal acts, or which is work-related; or damage (other than wear or tear) to dentures or prostheses.72 Personal injury does not include personal injury caused wholly or substantially by a gradual process, disease, or infection unless it is work-related, caused by treatment, is consequential on another, covered, personal injury, or is consequential on another treatment injury.73 Nor does it include a heart attack or stroke unless this constitutes a treatment injury or is workrelated.74 It is clear that the reference to “physical injuries” in the definition is intended to be all-embracing. The definition specifically states that such injuries include “a strain or a sprain,” but otherwise the concept is not further defined.75 Seemingly it should be understood as meaning any condition involving harm to the human body, including harm by sickness or disease, that is more than merely trifling or fleeting.76 Mental injury, by contrast, is statutorily defined, this being a “clinically significant behavioural, cognitive, or psychological dysfunction.”77

69 70 71 72 73 74 75 76

77

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Id. §§ 21, 26(1)(d), sched. 3. Id. §§ 21B, 26(1)(d). Id. § 48. Id. § 26(1). Id. § 26(2). Id. § 26(3). Id. § 26(1)(b). Todd, supra note 1, at para 2.4.01. This suggestion was approved in Falwasser v. AttorneyGeneral. [2010] NZHC 410 para [90]. It was held in this case that a plaintiff suffered physical injuries from exposure to pepper spray, and that his common law claim against the police accordingly was barred. Id. at para [91]. Accident Compensation Act 2001 § 27. The definition is based upon the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders.

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3.

Residual Actions for Damages

It is apparent at least that “physical injuries” has a very broad meaning. But there may still be certain forms of injury which do not qualify under the statutory definition and which may be actionable at common law. A clear example is mental injury in secondary victim cases. Further, assuming that some form of personal injury, as defined, has been suffered, it may fall outside the particular categories which are covered for compensation and, again, may be potentially actionable. The most significant examples probably are personal injury which is not caused by an “accident,”78 and injury by disease or by heart attack or stroke which is not otherwise covered as having been caused by treatment or as being workrelated. In these and certain other cases a common law action can still be maintained where the harm is alleged to have been caused by tortious conduct by another. The ambit of cover in each of the four core categories is defined by the Act in close detail. Our concern is with the provisions governing injury caused by medical treatment, and we will be looking at these in Part II below.79 A further possible basis for an action is where the plaintiff seeks to recover exemplary, rather than compensatory, damages. Quite early on, in Donselaar v. Donselaar, the Court of Appeal decided that actions for exemplary damages could still be maintained.80 Richardson J explained that proceedings for exemplary damages were not “proceedings for damages arising directly or indirectly out of” a person’s injury or death, where the statutory bar applied, because exemplary damages did not arise out of the plaintiff’s injury and were not directed to the plaintiff’s loss.81 In its contemporaneous decision in Taylor v. Beere, the Court of Appeal confirmed that exemplary or punitive damages were intended to punish and

78

79

80 81

The core meaning of “accident” (defined at length in section 25(1)) is “a specific event” involving “the application of a force ... or resistance external to the human body.” Accident Compensation Act 2001 § 25(1). It does not cover, for example, seeing or hearing about injury to another, or a child suffering from foetal alcohol syndrome due to her mother having drunk alcohol during the pregnancy, Winikerei v. ARCIC 27/7/05, Fogarty J, HC Wellington CIV-1999-485-000008, or a child suffering from cerebral palsy caused by an antenatal force external to the foetus but occurring within the mother, Sam v. ACC [2009] 1 NZLR 132 (HC) at para [43], or a person inhaling smoke, Simm v. ACC [2006] NZHC 1634 (HC) at paras [1]–[3]. For discussion of the other categories, see Todd, supra note 1, at para 2.4.02 (personal injury by an accident), para 2.4.03 (mental injury), para 2.4.05 (work-related disease, heart attacks and strokes). [1982] 1 NZLR 97 (CA) 98, 107. Id. at 109.

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deter a defendant guilty of outrageous or contumelious conduct.82 Recently, in Couch v. Attorney-General, the New Zealand Supreme Court limited the remedy by deciding that it should be available only in cases of advertent or reckless wrongdoing.83 Negligence, even where gross, would not suffice.

F.

Claimants

All persons who suffer personal injury in New Zealand are entitled to claim,84 although non-residents are eligible only for limited benefits.85 The scheme also applies to persons ordinarily resident in New Zealand who suffer death, physical injuries and consequential mental injuries or personal injury as a result of medical treatment while outside New Zealand, and the injury is one for which there would be cover if the personal injury had occurred within New Zealand.86

G.

Benefits

Where there is cover there is a right to compensation. The statutory entitlements available to victims of personal injury are treatment and rehabilitation, earnings-related compensation, lump sum compensation for permanent impairment, and death benefits.87 The Corporation is liable to pay the cost of necessary and appropriate medical treatment and of social or vocational rehabilitation.88 The purpose of social rehabilitation is to assist in restoring a claimant’s independence to the maximum extent practicable, and it can cover such benefits as aids and appliances, home help, child care, modifications to the home, assistance with transport and training for independent living.89 Voca-

82 83 84

85

86 87 88 89

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[1982] 1 NZLR 81 (CA) 84–86. [2010] 3 NZLR 149 (SC) at para [1]. Accident Compensation Act 2001 § 20. There is an exception in section 23, concerning accidents on ships or aircraft coming to, travelling around or leaving New Zealand. Id. § 23. In particular, non-residents do not qualify for earnings-related compensation, because they must be persons receiving income as defined in the Income Tax Act 1994. See the definition of “employee” in section 6. Id. § 6. Id. § 22. Special provision is made for injury by work-related disease where this is suffered outside New Zealand. Id. § 24. Id. § 69. Id. §§ 69(1)(a), 75–96, sched. 1, pt. 1. Id. §§ 79, 81(1).

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tional rehabilitation is available to persons covered by the Act who are entitled to weekly compensation.90 It seeks to help a claimant maintain or obtain employment or regain or acquire vocational independence.91 Earnings-related compensation has always been, and remains, a key benefit.92 It is payable to claimants who were earners at the time of the personal injury and who are unable, because of their injury, to engage in their employment.93 There are special provisions dealing with, inter alios, earners not in permanent employment, the self-employed, low earners and potential earners.94 The amount payable is eighty percent of the claimant’s weekly earnings, as calculated in accordance with detailed statutory formulae.95 All calculations are subject to a maximum weekly payment of NZ$ 1,341.31, which is adjustable in relation to movements in average weekly earnings.96 Lump sums may be awarded to compensate for permanent impairment, but not for pain and suffering.97 There is a minimum impairment threshold of ten percent and the minimum payment is NZ$ 2,500.98 The maximum sum, which is payable for impairment of eighty percent or more, is set at NZ$ 100,000.99 These figures are adjusted annually in line with the Consumer Price Index.100 The amount payable in any particular case is calibrated so that more seriously injured claimants receive proportionately more than less seriously injured claimants. Where death ensues, the Act makes provision for the payment of benefits to the deceased’s dependants.101 These include funeral grants, certain survivors’ grants, and weekly compensation for loss of dependency.102 A claimant who qualifies for compensation may be disentitled to relief, fully or partially, on a number of grounds. They include: the claimant wilfully inflicting injury on himself or herself or committing suicide;103

90 91 92 93 94 95 96 97 98 99 100 101 102 103

Id. § 85. Id. § 80(1). Id. §§ 69(1)(b)–(c), 100–06, sched. 1, pt. 2. Id. § 103. Id. at sched. 1, pt. 2, cls. 35–38, 42, 47. Id. sched. 1, pt. 2, cl. 32. Id. sched. 1, pt. 2, cl. 46. Id. § 69(1)(d), sched. 1, pt. 3, cl. 54. Id. sched. 1, pt. 3, cl. 56(3). Id. sched. 1, pt. 3, cl. 56(4). Id. §§ 116, sched. 1, pt. 3, cl. 56(5). Id. § 69(1)(e). Id. § 69(1)(e), sched. 1, pt. 4, cls. 64–66, 70–71. Id. § 119.

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the claimant seeking compensation as a spouse or dependant in circumstances where he or she has been convicted of the murder of the deceased person;104 the claimant being in prison;105 and the claimant being injured in the course of committing a criminal offence punishable by a maximum term of imprisonment of at least two years, unless the Minister responsible for the scheme is satisfied that there are exceptional circumstances exempting the claimant from the operation of this provision.106 These ultimately are penal provisions, preventing payment of what would otherwise be perfectly valid claims, for reasons of public policy.

H.

Claims Process

The Act sets out a simple process for making a claim. All that is necessary is that a person should lodge a claim for cover and/or a specified entitlement.107 On receiving it the Corporation must decide whether it accepts that cover exists, and if satisfied that it does, provide information about relevant entitlements and facilitate access to those entitlements.108 There is a one year time limit for making a claim, the start of the period running from the date of the personal injury, but the Corporation must not decline a late claim unless its lateness prejudices the Corporation’s ability to make decisions about the claim.109 The Corporation must make reasonable decisions in a timely manner, give notice in writing of any decision, give reasons if the decision is adverse to the claimant, and provide information about review and appeal rights.110 A dissatisfied claimant may apply for a review of any of the Corporation’s decisions, including a decision under a Code of Claimants’ Rights.111 An independent reviewer conducts the review hearing in accordance with detailed rules of procedure.112 An appeal lies to the District Court,113 and further appeals on matters of law may be taken, with leave, to the High Court114 and thence to the Court of Appeal.115

104 105 106 107 108 109 110 111 112 113 114 115

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Id. § 120. Id. § 121. Id. §§ 122. Id. § 48. Id. § 50. Id. § 53. Id. §§ 54–64. Id. § 134. See id. pt. 5. Id. § 149. Id. § 162. Id. § 163.

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I.

Funding

The funding for accident compensation comes from levies on activities where accidents tend to occur and also from general taxation.116 The levies originally were payable by employers, the self-employed and motor vehicle owners, and over the years new sources of funding have been added. Today the levies fund four accounts: the Work Account (for work-related injuries of employees, private domestic workers and self-employed persons); the Motor Vehicle Account (for motor vehicle injuries); the Earners’ Account (for earners’ non-work injuries); and the Treatment Injury Account (for injuries caused by treatment).117 In addition there is the NonEarners’ Account (for injuries to non-earners other than motor vehicle injuries or treatment injuries), funded out of general taxation.118 As was earlier explained, the levies in the 1980s and 1990s were calculated on a pay-as-you-go basis. However, since the Accident Insurance Act of 1998 all of the accounts save for the Non-Earners’ Account have been required to be fully funded.119 The premiums for each account must cover all the costs of claims made in any particular year, including all future costs.120 Formerly a separate Residual Claims Account funded the continuing cost of past claims which were unfunded on a pay-as-you-go basis, but in 2010 this account was folded into the Work Account.121 These outstanding residual liabilities are required to be fully funded by 31 March 2019.122 The levies funding the Work Account are collected from employers, private domestic workers and the self-employed, those for the Motor Vehicle Account from vehicle registrations and from the sale of petrol, and those for the Earners’ Account directly from employees’ earnings.123 In the case of the Treatment Account, a statutory power to impose levies on registered health professionals and organizations that provide treatment under the Act has never been implemented. Rather, the Account is funded from the Earners’ and Non-Earners’ Accounts according to the mix of earner and non-earner clients.124

116 117 118 119 120 121 122 123 124

Id. pt. 6. Id. § 392. Id. § 392(1)(c). Accident Insurance Act 1998 §§ 282–307. Accident Compensation Act 2001 § 169. Id. § 21. Id. § 169. Id. §§ 167(2), 213, 218. Id. § 228(2).

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J.

Administration

The Accident Compensation Corporation (ACC) is responsible for administering the accident compensation scheme.125 The Corporation is a Crown entity,126 and is managed by a Board appointed by the Minister.127 The duties of the Corporation are, inter alia, to determine cover, provide entitlements, manage the Accounts, collect levies, and administer dispute resolution procedures.128 Its functions include carrying out these duties, promoting “measures to reduce the incidence and severity of personal injury,” and managing “assets, liabilities and risks in relation to the Accounts.”129 The Corporation must comply with the Minister’s directions relating to the policy of the Government in relation to its functions, duties and powers.130 An annual “service agreement” sets out the quality and quantity of services provided by the Corporation, including its desired outcomes and objectives in performing its functions, duties and powers.131 An Annual Report provided to Parliament gives an overview of its performance over the past year and its plans for the future.132

II.

Medical Injuries

As originally enacted, the accident compensation legislation provided cover for “personal injury by accident” without specific reference to adverse outcomes of medical treatment.133 Then shortly after its introduction the Act was amended, by adding “medical, surgical, dental or first aid misadventure” as an illustrative category but without any further definition. So, within the one general concept, the courts had a largely unfettered discretion in deciding quite where the parameters of the scheme ought to be set. And they took advantage of this statutory flexibility, by emphasizing that a generous approach was in keeping with the policy of the Act of providing comprehensive cover for all those suffering personal

125 Id. § 3. 126 Id. § 259(4). 127 Id. § 267. “The Minister” means “the Minister of the Crown who ... is ... responsible for the administration of [the] Act. Id. § 6. 128 Id. § 165. 129 Id. § 262. 130 Id. § 270. 131 Id. § 271. 132 See, e.g., Accident Comp. Corp., Annual Report (2010), available at http://www.acc.co. nz/search-results/index.htm?ssUserText=annual+report+2010 [hereinafter 2010 Report]. 133 Accident Compensation Act 1972 § 4(b).

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injury in New Zealand, “wherever, whenever, and however occurring.”134 More particularly, we can see this kind of approach being taken in the cases considering the meaning of medical misadventure. Early decisions show the courts developing a two-limb test, by asking whether there had been either medical negligence or medical mishap.135 As regards negligence, the Court of Appeal in Green v. Matheson accepted that this was medical misadventure, which included insufficient or wrong treatment, failure to inform, misdiagnosis, misrepresentation (innocent or fraudulent) or administrative shortcomings.136 If the plaintiff’s claim was mishandled, it was her misfortune or ill-luck, and this fell squarely within the idea of misadventure.137 As regards mishap, this was a quite unforeseeable adverse consequence of treatment which had been properly administered and which did not involve negligence.138 In Childs v. Hillock the two-limb approach was confirmed in the Court of Appeal.139 Hardie Boys J considered that it achieved a proper balance between recognizing (i) that the patient’s misfortune or mishap could be the result of negligence, or other non-culpable error in treatment, or an unintended consequence of correct treatment, and (ii) that not every medical intervention is successful and that many are attended by risk.140 So his Honour accepted the need to differentiate between medical patients who were covered for compensation and patients who were simply receiving medical treatment because they were ill.141 Some unexpected or “accident-like” event was required so that the case was removed from the category of sickness or disease, which was not covered, to medical misadventure, which was.142 Indeed, the legislature then followed the lead taken by the courts, by providing in the 1992 Act that medical misadventure meant personal injury caused by medical error or medical mishap.143 “Medical error” was defined as meaning medical negligence, and “medical

134 ACC v. Mitchell [1992] 2 NZLR 436 (CA) 438–39. 135 See ACC v. Auckland Hosp. Bd. [1980] 2 NZLR 748 (HC) 751; Bridgeman v. ACC [1993] NZAR 199 (HC). 136 [1989] 3 NZLR 564 (CA) 572–73. 137 Id. at 573. 138 See Auckland Hosp. Bd., supra note 135, at 751. 139 [1994] 2 NZLR 65, 72 (CA). 140 Id. 141 Id. 142 Id. 143 Accident Rehabilitation and Compensation Insurance Act 1992 § 5(1).

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mishap” as meaning an adverse consequence of properly administered treatment that was “rare” and “severe.”144 These further requirements were defined in their turn in close detail.145 The provisions introduced in 1992 were carried over into the Accident Insurance Act 1998 and then the Injury Prevention, Rehabilitation and Compensation Act 2001.146 Shortly afterwards, however, a review undertaken by the ACC jointly with the Department of Labour expressed dissatisfaction with the very concept of medical misadventure as defined in the statute.147 In particular, the need to prove a medical error was seen as quite anomalous in the context of a no fault compensation scheme. It perpetuated a blaming culture and meant that the scheme was required to resolve the same kinds of difficulties that arose under the tort system that it replaced. This in turn led to considerable cost in investigating claims and delay in deciding them. The medical mishap provisions also were criticized, being seen as confusing and arbitrary. They often bore little relationship to the circumstances of the patient, resulting in claimants unfairly missing out on cover. Following a consultation process the review recommended that the concept of medical misadventure be abandoned and that instead there should be cover for unintended injuries in the treatment process. This would include all adverse medical events, whether or not preventable, provided they were unintended or, on another formulation, outside the expected and likely range of consequences of treatment. This recommendation formed the basis for the amendments to the scheme in 2005,148 introdu-

144 Id. More specifically, the Act stated that “medical error” meant the failure of a registered health professional to observe a standard of care and skill reasonably to be expected in the circumstances. Id. It was not medical error solely because desired results were not achieved, or subsequent events showed that different decisions might have produced better results, or the failure in question consisted of a delay or failure attributable to the resource allocation decisions of the organization. Id. 145 Id § 5. An adverse consequence was “rare” only if the probability was that it would not occur in more than one percent of cases in which that treatment was given. Id. § 5(2). There was no medical mishap where an adverse consequence was rare in the ordinary course but was not rare for that particular person, and the greater risk was known to the person prior to the treatment. Id. § 5(3). The consequence was “severe” only if it resulted in the patient dying, or being hospitalized as an inpatient for more than fourteen days, or suffering significant restriction or lack of ability lasting more than twenty-eight days in total. Id. § 5(4). 146 Accident Insurance Act 1998 §§ 34–37; Injury Prevention, Rehabilitation and Compensation Act 2001 §§ 32–34. 147 Accident Comp. Corp., Review of ACC Medical Misadventure: Consultation Document (2003). 148 Injury Prevention, Rehabilitation, and Compensation Amendment Act (No 2) 2005, § 13.

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cing the concept of “treatment injury.”149 Their primary aim was to move away from any need by a claimant to prove fault by a registered health professional in order to qualify for compensation. The hope was that professionals would be more willing to cooperate in the claims process and that there would be a partnership between ACC and the health sector that encouraged a climate of learning and also protected public safety.

A.

Cover

The extent of coverage for medical injury now is defined in six overlapping heads of claim. These are: personal injury that is treatment injury suffered by the person;150 personal injury that is a secondary infection passed on by a victim of treatment injury to his or her spouse or child or to any other third party, whether directly or through his or her spouse;151 personal injury caused by treatment for personal injury for which the person has cover;152 personal injury caused by gradual process, disease, or infection that is treatment injury suffered by the person;153 personal injury caused by a gradual process, disease or infection consequential on treatment given to the person for personal injury for which the person has cover;154 and personal injury that is a cardiovascular or cerebrovascular episode that is treatment injury suffered by the person.155 Subparagraphs (b), (c), (f) and (i) are the exclusive determinants of cover for personal injury that is suffered by way of some form of “treatment injury,” which is defined as meaning, inter alia, personal injury suffered by a person seeking or receiving treatment from a registered health professional.156 Until 1992 it was possible to mount alternative arguments, that what had occurred either was medical misadventure or was personal injury by accident in the ordinary sense. However, the Act provides now that an “accident” does not include an occurrence which is

149 See Ken Oliphant, Beyond Misadventure: Compensation for Medical Injuries in New Zealand, 15 Med. L. Rev. 357 (2007) [hereinafter Oliphant (2007)]. 150 Accident Compensation Act 2001 § 20(2)(b). 151 Id. §§ 20(2)(c), 32(7). 152 Id. § 20(2)(d). 153 Id. § 20(2)(f). 154 Id. § 20(2)(h). 155 Id. § 20(2)(i). 156 Id. §§ 20(2), 32(1)(a). “Registered health professional” means, inter alia, “a chiropractor, clinical dental technician, dental technician, dentist, medical laboratory technologist, medical radiation technologist, midwife, nurse, occupational therapist, optometrist, pharmacist, physiotherapist, podiatrist, or registered medical practitioner.”Id. § 6(1).

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treatment given “by or at the direction of a registered health professional.”157 So coverage for personal injury by an accident and for medical treatment does not overlap. However, the Act provides separate coverage under paragraph (d) for personal injury that is a consequence of treatment for another “personal injury for which the person has cover,” and under paragraph (h) for “personal injury caused by a gradual process, disease, or infection consequential on treatment given to the person for personal injury for which the person has cover.”158 It is not clear why these provisions have been included, for in each case there must be an initial personal injury for which a person has cover under another head. If treatment for personal injury is given by a registered health professional, at least as a general rule it appears that the provisions for treatment injury and for the consequences of treatment will cover the same ground.159 We do not need to take this question any further and will turn to the provisions governing treatment injury, looking first at relevant principles of causation and then at the meaning of this newly-introduced concept.

B.

Treatment Injury

1.

Proof of Cause

In order for there to be cover for a treatment injury, the personal injury must be “caused by” the medical treatment.160 In the context of litigation the ordinary rules of proof, invoking the so-called “but for” test, require that a plaintiff prove on the balance of probabilities that the defendant’s conduct was a cause of his or her loss. But sometimes the cause may not be capable of such proof, perhaps because of the particular circumstances in which an accident or event happened or because of the limits to scientific understanding in the particular field. In such cases it is perfectly possible for the courts to hold the plaintiff to the normal requirements, so that if the necessary evidence cannot be adduced the action fails. But this strict approach can have harsh consequences, and in certain special cases the courts have been persuaded to modify the ordinary rules. In an outstanding example, the House of Lords in England has developed a doctrine of 157 Id. § 25(2)(a). 158 Id. § 20(2)(d), (h). 159 See Childs v. Hillock [1993] NZAR 249 (not discussed on appeal at [1994] 2 NZLR 65 (CA)). 160 Accident Compensation Act 2001 § 32(1)(b).

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risk, pursuant to which a plaintiff can succeed if he or she can prove that the defendant caused or increased the risk of an outcome, as opposed to proving that the defendant caused the outcome itself.161 The question we must now consider is whether this or other similar modifications to the ordinary principles of causation can apply in New Zealand in the context of a claim for accident compensation.

a. Atkinson and Ambros. The clear answer, as laid down in the decision of the Court of Appeal in Atkinson v. Accident Rehabilitation Compensation and Insurance Corporation, is that modifications of this kind cannot apply to disputes about cover for accident compensation.162 A child received negligent medical treatment in the course of surgery shortly after birth, leading to hypoxia.163 The child later was found to be suffering from brain damage, and a claim for accident compensation was made on his behalf.164 The claim failed, on the ground that the hypoxia could not be causatively linked to the brain damage.165 Richardson P, delivering the judgment of the court, recognized that it may have contributed to the damage, but it was not proved that it had contributed.166 The statute focused on outcomes, not on risk of injury or potential for injury. To accept a lesser statutory test of increased risk or to adopt a reversed onus approach would be inconsistent with the statutory language and scheme.167 Public policy considerations had led to common law modifications of this kind in relation to causation, but the public policy of the accident compensation scheme had to be drawn from its statutory provisions and these were outcomes-focused.168 “Risk or potentiality of injury [was] not enough to attract cover.”169 And that conclusion “may well have been seen as part of the policy package” governing the scheme as a whole.170

161 See Lara Khoury, Causation and Risk in the Highest Courts of Canada, England and France, 124 L.Q. Rev. 103, 110–13 (2008); M H Tse, Tests for Factual Causation: Unravelling the Mystery of Material Contribution, Contribution to Risk, the Robust and Pragmatic Approach and the Inference of Causation, 16 Torts L.J. 249 (2008). 162 [2002] 1 NZLR 374 (CA) paras [19]–[26]. 163 Id. at para [22]. 164 Id. at para [2]. 165 Id. at paras [22]–[26]. 166 Id. 167 Id. at para [24]. 168 Id. at para [25]. 169 Id. 170 Id.

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The view taken in Atkinson came under challenge in ACC v. Ambros, where the Court of Appeal returned to the causation question and gave it extended consideration.171 Mrs. Ambros died of a heart attack which was secondary to a rare condition called spontaneous coronary artery dissection (SCAD).172 She had just given birth to her first child, and SCAD was commonly associated with pregnancy and childbirth.173 The question at issue was whether her death was caused by medical error in failing to diagnose her condition and, accordingly, was covered under the Accident Insurance Act 1998.174 The High Court upheld the claim,175 and the Accident Compensation Corporation appealed from that decision. Glazebrook J, delivering the judgment of the court, noted that the 1998 Act was passed against a background of the causation principles set out in Atkinson, and was satisfied both that it had to be seen as legislative acceptance of those principles and also that the case was correctly decided.176 “In ordinary usage, one would not normally say that an injury was caused by medical error when that injury was highly likely to have occurred without the error.”177 Atkinson also was consistent with English authority, and in particular with Wilsher v. Essex Area Health Authority, where the House of Lords declined to hold that causing an increase in the risk of harm by contributing one of several possible causes could be treated as causing the harm.178 Accordingly, as the High Court test did not accord with Atkinson, and there were no grounds for reviewing that decision, the appeal should be allowed.179 Glazebrook J then turned to consider an alternative causal test put forward by counsel appearing as amicus curiae, that where a personal injury is alleged to arise from a failure of medical diagnosis and/or treatment, and (a) is the very injury which the diagnosis and/or treatment was intended to prevent, and (b) is part of the medical event in respect of which the diagnosis and/or treatment was given, then, prima facie, the

171 [2008] 1 NZLR 340 at paras [8]–[9]. The description of this case is based upon a section of my article, Stephen Todd, The Court of Appeal, Accident Compensation and Tort Litigation in The Permanent New Zealand Court of Appeal: A Celebration of 50 Years (Rick Bigwood, ed., 2009). 172 [2008] 1 NZLR 340 at para [1]. 173 Id. 174 Id. at paras [2]–[3]. 175 Ambros v. ACC (unreported) High Court, Auckland, CIV 2004-404-3261, 21 March 2005). 176 [2008] 1 NZLR 340 at paras [17]–[18]. 177 Id. at para [18]. 178 Id. at para [19]; Wilsher v. Essex Area Health Auth. [1998] A.C. 1074 (H.L.) 1090–92. 179 Id. at para [21].

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injury has been caused by the failure of the diagnosis and/or treatment.180 In her Honour’s opinion, whether this modification of ordinary principle ought to be accepted required examination of the manner in which courts in other jurisdictions had dealt with difficulties of proof and uncertainty in the evidence.181 There were a number of situations where dissatisfaction with the result of the traditional test of causation had led to calls for modification to the “but for” test. One of these was the principle laid down in McGhee v. National Coal Board182 and applied in Fairchild v. Glenhaven Funeral Services Ltd.183 and Barker v. Corus UK Ltd.,184 that where there was one noxious agent rather than multiple agents, a material contribution to the risk posed by that agent was equivalent to a material contribution to the damage.185 However, the principle was contrary to Atkinson and was not applicable in New Zealand. Another was the possibility of claiming damages for the loss of a chance of avoiding a bad outcome, but Hotson v. East Berkshire Area Health Authority186 declined to extend the relevant principles to a claim of medical negligence in failing to diagnose an injury. Rather, it affirmed the traditional test, asking if a failure to diagnose or treat was on the balance of probabilities a cause of the harm.187 Applying Hotson in New Zealand, a claimant might not receive accident compensation cover if an injury had two possible causes, and it was more likely that the injury was caused by an event which did not attract cover as opposed to other events which did. Furthermore in Gregg v. Scott,188 decided after Fairchild, the House of Lords still maintained the rule in Hotson. Loss of chance analysis had had a mixed reception in other common law jurisdictions,189 but whatever the developments elsewhere, the analysis was incompatible with the accident compensation regime. Either there was cover or there was not. There was no ability to discount compensation, and

180 181 182 183 184 185 186 187 188 189

Id. at para [9]. Id. at paras [79]–[84]. [1973] 1 W.L.R. 1 (H.L.) 4–5. [2003] 1 A.C. 32 (H.L.) 68. [2006] 2 A.C. 572 (H.L.) 593–94. For later discussion of the principle, see Sienkiewicz v. Greif (UK) Ltd [2011] 2 WLR 523 (S.C.). [1987] 1 A.C. 750 (H.L.) 760–63. Id. [2005] 2 A.C. 176 (H.L.) 234.. Ambros, [2008] 1 NZLR 340 paras [44]-[45], where Glazebrook J noted that the analysis was rejected by the Supreme Court of Canada in Laferrière v. Lawson, (1991), 78 D.L.R. 4th 609, 657(h)–658(a), that differing views were expressed in the High Court of Australia in Naxakis v. West General Hospital (1999) 197 CLR 269, and that a number of decisions in state jurisdictions in Australia had accepted it. See also Tabet v. Gett (2010) 240 CLR 537.

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no conceptual need to do so where a wrongdoer was not himself or herself liable for the injury. Applying Atkinson, any risk needed to be realized in the occurrence of personal injury which was proved to have been caused by the risk factor involved. So if an omission to treat caused an identifiable added injury, cover would be available for that injury. Turning to informed consent cases, Glazebrook J noted that in both Chappel v. Hart190 and Chester v. Afshar191 a surgeon who had failed to warn of a risk was held liable in circumstances where an explanation would on the balance of probabilities have caused delay, but the same treatment would have been likely to have been undertaken at a later date with a similar risk of injury. The decisions were primarily based on a policy choice to impose liability in order to ensure that the duty to obtain informed consent was respected by medical practitioners, which policy had little relevance to a no fault accident compensation regime. Another view, which could be seen as being in accordance with the Atkinson test, was that the claims were attributable to the materialization of the risk and not to the exposure to the risk.192 So the “but for” test could be seen as met if the chances of the risk materializing on the later occasion were slight. Yet her Honour declined to endorse that approach, noting Lord Hoffmann’s view that the argument was similar to saying that a win at the casino was caused by going there on Tuesday because the chances were slight that there would have been a win had the punter gone there on Wednesday.193 Glazebrook J accordingly determined that none of these developments applied in the context of the accident compensation scheme.194 Even so, there were a number of ways in which the courts had otherwise dealt with difficulties of proof and uncertainty. These included a shifting of the evidential burden of proof, the drawing of inferences of cause in circumstances where science could not determine the matter, showing a statistical link between particular events and an injury, and establishing proximity between an alleged cause and its alleged effect. Taking these factors into account, her Honour was satisfied that a combination of some very limited statistics, the proximity between the omissions and Mrs. Ambros’ death and the increased monitoring had her condition been diagnosed 190 (1998) 195 CLR 232, 285 (H.C.A.). 191 [2005] 1 A.C. 134 (H.L.) 140–42. 192 See Clerk and Lindsell on Torts paras. 2–15 (Anthony Dugdale & Michael A. Jones, eds. 19th ed. 2006). 193 Ambros [2008] 1 NZLR 340 at paras [48]–[52]; Lord Hoffmann, Causation, 121 L.Q. Rev. 592, 602 (2005). 194 Ambros, [2008] 1 NZLR 340 at paras [51]–[52].

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sufficed to make the question of causation arguable.195 So the matter was referred back to the High Court for determination.196

b. Modification of Ordinary Rules? Ambros considered, and declined to apply, three different routes pursuant to which an ordinary approach to causation might be modified. First, there is the risk principle articulated by the House of Lords in McGhee, Fairchild, and Barker, holding that in defined circumstances it may be sufficient to prove that the defendant caused an increased risk of a damaging outcome, as opposed to the outcome itself. A core control on this principle is the so-called single agency rule, applied in Wilsher, holding that the principle cannot apply where there are multiple possible causal agents. Yet the claims in Fairchild were not obviously more deserving than the claim in Wilsher, and the causal uncertainty was no less acute. The House of Lords seemingly settled on proof of a risk posed by a single agent for essentially pragmatic reasons, to provide a remedy in deserving cases and to have a workable rule that does not undermine the application of ordinary rules of causation in other cases. However, even accepting the single agency rule, at common law it remains uncertain whether or when the risk principle can apply outside mesothelioma cases.197 Acceptance of the principle only in some limited circumstances is likely to lead to inconsistency in the law, although it may be that this is a price worth paying in order to allow compensation in particularly deserving cases. Second, there is the idea of a lost chance. The concept of risk describes the probability of a negative outcome. Its “mirror image” is the loss of the chance of a positive outcome.198 Sometimes the courts redefine the nature of the plaintiff’s loss. They award damages not for an outcome but for the loss of a chance of a better outcome, whether in actions founded upon statute, for breach of contract, or for tort. The recovery of damages in such a case does not depend on proof that the benefit of the chance could be assessed as being more likely than not. Rather, the question is whether the chance that was lost was “real” or “substantial,” as opposed to the loss of a mere

195 Id. at paras [53]–[78]. 196 Id. at paras [113], [115]. 197 In the UK the recovery of damages in mesothelioma cases is now governed by section 3 of Compensation Act 2006, reversing the rule of proportionate liability introduced by the House of Lords in the Barker decision. Compensation Act, 2006, c. 29, § 3 (U.K.). 198 John G. Fleming, The Law of Torts 229 (9th ed. 1998), 229.

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speculative possibility.199 So when exactly can claims properly be framed as being for the loss of a chance? The decisions show that in cases involving hypothetical physical injury the chance principle is not applied and the plaintiff must adduce proof on the balance of probabilities that he or she would have avoided the adverse physical outcome in question. In particular, Hotson200 and Gregg201 in the UK, Laferrière v. Lawson202 in Canada and Tabet v. Gett203 in Australia decline to apply a chance analysis to negligent omissions to provide medical treatment or advice. By contrast, in cases involving hypothetical financial damage, many decisions show that the plaintiff need prove only that he or she lost a substantial chance of avoiding that outcome.204 A possible justification for the distinction, to which Gregg lends some support,205 lies in the distinction between deterministic events in the natural world and indeterministic events involving the unfathomable actions of human agents.206 Speaking very broadly, uncertainty about the cause of harm may be the result of lack of knowledge, not random unpredictability of outcome, in which case the cause may be classified as deterministic and is for the plaintiff to prove. Harshly perhaps, an analysis of this kind puts the risk of losing due to scientific uncertainty on the plaintiff. Only inherent uncertainty can be the subject of a lost chance. Third, there are the decisions of the High Court of Australia in Chappel and of the House of Lords in Chester. On one view, the decisions were primarily based on a policy choice to impose liability in order to ensure that the duty to obtain informed consent was respected by medical practitioners. On another, the claims were attributable to the materialization of the risk and not to the exposure to the risk. So the “but for” test could be seen as met if the chances of the risk materializing on the later occasion were slight. Yet we have seen that the latter argument is not convincing, for the reasons explained by Lord Hoffmann and endorsed by Glazebrook J in Ambros. So the decisions stand as significant departures from orthodox principles of causation. One commentator has observed that Chester not only opens the

199 Davies v. Taylor, [1974] A.C. 207 (H.L.) 216; Benton v. Miller & Poulgrain [2005] 1 NZLR 66 (C.A.) at paras [57]–[58]. 200 Hotson v.E. Berkshire Area Health Auth., [1987] 1 A.C. 750 (H.L.) 760–61. 201 Gregg v. Scott [2005] 2 A.C. 176 (H.L.) 187–90. 202 [1991] 1 S.C.R. 541, 608. 203 (2010) 240 CLR 537, paras [150]–[52]. 204 See, e.g., Sellars v. Adelaide Petroleum NL (1994) 179 CLR 332, 355–56; White v. Jones [1995] 2 A.C. 207 (H.L.) 234; Jackson v. Royal Bank of Scotland [2005] 1 W.L.R. 377 (H.L.) 387–88; Benton v. Miller & Poulgrain [2005] 1 NZLR 66 (C.A.), at paras [78]–[86]. 205 [2005] 2 A.C. 176 (H.L.), at paras [79], [220]. 206 See generally Helen Reece, Losses of Chances in the Law, 59 Mod. L. Rev. 188, 192–94 (1996).

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door to full recovery in almost all cases involving the breach of the medical duty to inform, but could easily be extended to all instances of professionally rendered advice.207 While there is no sign as yet of this happening, we remain in the dark about when exactly policy will justify departing from a subjective test of causation in cases where the plaintiff has relied on another to give skilled advice. None of the principles considered above could operate to modify the need to prove the cause of Mrs. Ambros’ death. The question was whether Mrs. Ambros died as a result of her underlying condition or of medical error in failing to diagnose that condition. The increased risk arose out of separate agencies, only one of which was covered for compensation.208 So the case was similar in principle to the decision in Wilsher and the risk principle could not apply. The damage could not be analyzed in terms of a lost chance of a better outcome either, for we have seen that the chance principle has not been applied in medical cases involving physical harm. As for the special rule about informed consent, this obviously was not relevant to the particular facts in issue. So the case had to be determined on the basis of ordinary principles governing proof of cause. The question remains whether any of the modifying principles ought to be imported into an inquiry into the cause of an injury for the purpose of cover for accident compensation. Glazebrook J thought not, and this very arguably is the better view. If a risk principle were to be introduced into the scheme, the same difficulty would arise in deciding what kinds of risks ought to justify compensation. While this question perhaps could be resolved pragmatically, it is certainly doubtful whether a step of this kind ought to be taken at all. There is no special justification for modifying the ordinary rules of causation in the context of a no fault, nonliability based, compensation system. The compensation scheme must have defined boundaries, and proof on the balance of probabilities that a victim’s injury comes within them is the appropriate test. Parliament having set these boundaries, they cannot be expanded simply because the concept of accident compensation is seen as deserving of support or a particular victim has needs which, without cover, cannot easily be met. Why include a person exposed by medical treatment to a small risk of disease in circumstances where the treatment probably did not cause the

207 Lara Khoury, Chester v. Afshar: Stepping Further Away from Causation?, 2005 Sing. J. Legal Stud. 246, 258–59 (2005). 208 However, if there is an injury and a finite set of possible causes all within the definition of “accident” then there is proof that the injury was caused by accident. Sam v. ACC [2009] 1 NZLR 132 (HC) paras [20], [46].

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disease, yet exclude a person suffering from the same harm who has not been exposed to that risk? A victim who cannot prove that “but for” medical treatment he or she would not have contracted a disease must be in the same position as all other victims of the disease. Again, it is hard to see that compensation for loss of a chance of a better medical outcome ought to have a place in the scheme. To repeat Glazebrook’s J observation, there is no ability to discount compensation, and no conceptual need to do so where liability is not in issue. Indeed, the concept has in any event been rejected at common law, this primarily because of its very significant implications. In Gregg, Lord Hoffmann thought that the wholesale adoption of possible rather than probable causation as the criterion of liability would be so radical a change in the law as to amount to a legislative act.209 It would have enormous consequences for insurance companies and the health service. In similar vein, Lord Phillips and Baroness Hale both emphasized that the change would introduce very great and unwarranted complexity into the law.210 Seemingly it would do something similar to the accident compensation scheme. As for the informed consent principle, the policy in Chappel and Chester of imposing liability in order to encourage medical practitioners to obtain their patients’ informed consent to treatment is hardly relevant to a no fault scheme. So once again we can support Ambros in deciding that these cases should not apply.

2.

Nature of Treatment Injury

“Treatment injury” means personal injury suffered by a person seeking or receiving treatment from a registered health professional that is caused by treatment and that is not a necessary part or ordinary consequence of the treatment, taking into account all the circumstances including the person’s underlying health condition and the clinical knowledge at the time of the treatment.211 It does not include: (a) personal injury that is wholly or substantially caused by a person’s underlying health condition; (b) personal injury that is solely attributable to a resource allocation decision; or (c) personal injury that is a result of a person unreasonably withholding or delaying consent to undergo treatment.212 The fact that treatment did not achieve a desired result does not of itself constitute treatment injury.213

209 210 211 212 213

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Gregg v. Scott [2005] 2 A.C. 176 (H.L.) 198–99. Id. at 210, 234. Accident Compensation Act 2001 § 32(1). Id. § 32(2). Id. § 32(3).

New Zealand

There is no cover in certain cases, considered below, where personal injury is suffered in the course of a clinical trial.214 Where treatment results in an infection suffered by a patient, cover extends to secondary victims of that infection in certain cases.215 “Treatment” (for the purpose of deciding whether or when treatment injury has occurred) is given a wide definition. It includes: (a) the giving of treatment; (b) a diagnosis of a condition; (c) a decision on the treatment to be provided (including a decision not to provide treatment); (d) failure or delay in providing treatment; (e) obtaining or failing to obtain a person’s consent to treatment; (f) the provision of prophylaxis; (g) the failure of any equipment used as part of the treatment process; and (h) the application of any support systems used by the organisation responsible for providing the treatment.216 Formerly, in order to establish medical misadventure, a claimant had to establish that there had been a “mishap” or “error,” as defined. The definition of “treatment injury” abandons any reference to either concept, yet both are necessarily relevant in determining whether a treatment injury has occurred. First, as regards mishap, there is no cover for personal injury that is a necessary part or ordinary consequence of treatment. The only example given in the explanatory note to the Bill introducing the new provisions was a surgical incision during an operation. That may be clear, but the answers to many other questions are not. Treatment very frequently will pose a risk of recognized but unwanted side effects. Are these an “ordinary consequence” of treatment? Of course, the risks of treatment can vary enormously, from those that are certain or virtually certain to those that are vanishingly small. At some point a court must be able to say that they were not “necessary” or “ordinary.”217

214 215 216 217

Id. § 32. Id. § 32(7). Id. § 33(1). The relevant question here is whether the injury can be seen as a necessary part or ordinary consequence at the time when the treatment commenced rather than when the nature of the claimant’s condition became apparent during the course of treatment. In McEnteer v. ACC [2010] NZCA 126 the claimant had suffered an aneurysm which ruptured during surgery and which had to be clipped temporarily for longer than normal, resulting in brain damage. It was argued for the claimant that while the surgeon knew a temporary clipping was needed, so cover for that was excluded, he was not to know that the aneurysm would rupture needing a longer clipping, and that this was therefore an unanticipated development causing injury for which there was cover. Id. at [13]. The Court of Appeal rejected the argument, holding that it would require an abstracted expectation of an average outcome based on hypothetical treatment and would open up much scope for debate for no discernable reason. Id. at paras [18]–[19].

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ACC takes the view that known complications are not necessarily excluded, as the ordinary consequence criterion is interpreted to refer to injuries which are “expected” or “usual.”218 But how this threshold might be represented in percentage terms is hard to say. There must indeed be a risk of “category creep,” whereby increasingly probable consequences are accepted as treatment injuries.219 Without a doubt the threshold for coverage has shifted, from consequences that were “rare” in the determination of whether there had been medical misadventure to those now that are not necessary or ordinary. But the courts still must determine whether there has been some kind of mishap justifying coverage. In this respect the law has reverted from detailed definition back to judicial discretion. Second, as regards error, let us take the requirement that the personal injury should not be wholly or substantially caused by a person’s underlying health condition. Where there is a failure to treat and the patient’s condition gets worse, or treatment does not alleviate a condition, how do we determine whether the continuing injury is caused by the treatment or by the underlying condition? It may be that we need to make an inquiry into the causal potency of the underlying treatment relative to that of treatment.220 Perhaps a claimant must establish on the balance of probabilities that treatment, or different treatment, would have improved the patient’s condition or prevented it from getting worse. The Corporation is no longer required to find fault, but the requirement that the claimant show that the health professional should have treated or should have treated differently is likely to involve the claimant needing to show that the health professional was negligent in making his or her decisions about treatment. Furthermore, the Act provides that it is not of itself treatment injury because desired results are not achieved. So the scheme is not intended to underwrite a lack of success in medical treatment. But when might there be treatment injury when desired results are not obtained? An obvious answer is when the wrong treatment is given. In addition, “treatment” is defined as including, inter alia, a decision not to provide treatment, a failure to provide treatment or to provide treatment in a timely manner, failing to obtain a person’s consent to undergo treatment, and the failure of any equipment, device, or tool used as part of the treatment process. While negligence is not formally required, all of these points suggest that it necessarily reappears in deciding whether treatment injury can be shown to exist. 218 Accident Comp. Corp., Treatment Injury Profile 3 (Sept. 2010) (kindly provided to the author by Dylan Tapp, Clinical Analyst, ACC) [hereinafter ACC Treatment Injury Profile]. 219 Oliphant (2007), supra note 149, at 383. 220 Id. at 384.

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3.

Treatment Injury in Operation

Evidence of the continuing significance of mishap and error can be found when we consider the figures showing how claims for medical misadventure used to be handled and how treatment injury has operated in practice in the five years since its introduction. Prior to 2005 the difficulties facing claimants seeking to prove that they had suffered medical misadventure led to frequent disagreement as between claimant and the ACC, both in determining whether the closely defined requirements for “mishap” were satisfied and also in resolving contested issues of negligent error. Fewer than three thousand medical misadventure claims were made annually, and only forty percent were accepted as being entitled to cover.221 Of these, eighty-six percent were based on medical mishap and fourteen percent on medical error.222 They comprised only a small percentage of all injuries accepted under the accident compensation scheme and took much longer than the average to resolve.223 But the picture now is very different. The most significant change is a dramatic increase in the number of claims lodged with ACC. There were 1,434 medical injury claims in 2004–05, 2,846 in 2005–06, 3,964 in 2006–07, 5,073 in 2007–08, 5,472 in 2008–09 and then a small drop to 5,210 in 2009-10.224 In June 2010 the total number of treatment injury claims reached 31,103, and the overall acceptance rate climbed to sixty-six percent.225 By comparison, the total number of ACC claims made over the same period has risen only slowly, and the most recent figures show a small decrease. There were 1,523,946 claims in 2004–05;

221 Accident Comp. Corp.. Claimant Profile: Medical Misadventure Claimants (Feb. 2003). 222 Id. at 3. 223 In 2002 medical misadventure claims comprised only 0.05 % of all accepted injuries. See Wellington Dept. of Labour & ACC, ACC Background Paper: A Comprehensive Study of the Cost of Accepted Medical Misadventure Claims 4 (Mar. 2003). 224 Accident Comp. Corp, Annual Report 56 (2006), available at http://www.acc.co.nz/ publications/index.htm?ssUserText=annual+report [hereinafter 2006 Report]; Accident Comp. Corp., Annual Report 26 (2007), available at http://www.acc.co.nz/publications/index.htm?ssUserText=annual+report [hereinafter 2007 Report]; Accident Comp. Corp., Annual Report 12 (2008), available at http://www.acc.co.nz/publications/index.htm?ssUserText=annual+report [hereinafter 2008 Report]; Accident Comp. Corp., Annual Report 2009, 48, available at http://www.acc.co.nz/search-results/index.htm?ssUserText=annual+report+2009 [hereinafter 2009 Report]; 2010 Report, supra note 132, at 9. Oliphant (2007), supra note 149, at 385–86 notes that that most of the rise in the number of claims in 2005–06 as compared to 2004–05 could be attributed to treatment-only claims. This strongly suggested that the abandonment of the “severity” threshold in the definition of medical mishap had led to a pronounced increase in the number of claims for minor treatment injury. The rise in account expenditure was not considered likely to be commensurate, but, as will be seen, this may have been too sanguine a view. 225 Figures supplied in ACC Treatment Injury Profile, supra note 218.

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1,604,359 in 2005–06; 1,685,995 in 2006–07; 1,755,899 in 2007–08; 1,752,452 in 2008–09; and 1,662,347 in 2009-10.226 So treatment injury claims constitute only a very small percentage of the total number of claims for accident compensation, but that percentage has risen a little over the five year period. There also has been a doubling of the acceptance rate. While ACC still declines many more claims for treatment injury than claims under the other accounts, the disparity has been reduced in recent years. In 2004–05, the last year of the medical misadventure regime, 70.6 % of claims were declined, whereas in 2008–09, under the treatment injury regime, the figure was 35.5 %.227 The most common reasons for declining a claim were that no physical injury could be identified (16 %), there was no causal link between treatment and the injury (9 %), the injury was an ordinary consequence of treatment (4 %), and the injury was wholly or substantially caused by the underlying health condition (4 %).228 If we make a comparison with all claims once again, the overall percentage of declined claims in 2004–05 was 3.9 % and in 2008–09 it was 2.5 %.229 It seems likely that this latter small drop is attributable or mainly attributable to the substantial drop in declined claims for treatment injury. The median time taken to determine the question of cover has dropped dramatically. Whereas the average time taken to determine a misadventure claim was approximately five months, in 2009 it was thirty-seven days.230 Some decisions are taken very quickly, while others still can take up to nine months. Commonly accepted injuries include wound infection, allergic reaction, hematoma and bruising claims, nerve damage, dental damage, skin damage or injury or tear, and pressure ulcers. The top ten treatment injuries are generally high volume, low cost claims, although in aggregate they entail substantial cost. A number of observations can be made about these developments. First, the data collected by ACC concerns (necessarily) the “adverse events” providing the foundation for claims for treatment injury, bearing out the point that mishap and error are inherent in that concept. ACC is an

226 2006 Report, supra note 224, at 56; 2007 Report, supra note 224, at 26; 2008 Report, supra note 224, at 12; 2009 Report, supra note 224, at 48; 2010 Report, supra note 132, at 9. 227 Accident Comp. Corp., ACC Injury Statistics 2008/2009 9 (2010), http://www.acc.co. nz/PRD_EXT_CSMP/groups/external_ip/documents/reports_results/wpc088561.pdf. 228 Figures supplied in ACC Treatment Injury Profile, supra note 218, at 4. 229 Accident Comp. Corp., ACC Injury Statistics 2008/2009 8 (2010), http://www.acc.co. nz/PRD_EXT_CSMP/groups/external_ip/documents/reports_results/wpc088561.pdf. 230 Figures supplied in ACC Treatment Injury Profile, supra note 218, at 4.

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accident scheme, not an illness scheme, and an accident-like event remains necessary in order for there to be cover for a medical injury. Second, before 2005 most medical misadventure claims were for a “rare” and “severe” medical mishap. In the new definition there must still be a mishap of some kind, but now it is an injury that is not a necessary part or ordinary consequence of treatment, is not caused by the patient’s underlying health condition, and is not simply a failure to achieve the desired result of the treatment. It seems highly likely – perhaps certain – that the very substantial increase in claims noted above is due to the lowering of the threshold for what qualifies as a mishap. The concept, albeit unexpressed, is implicit in the notion of treatment injury. Third, negligent error remains highly significant in establishing such injury. We do not know with any confidence whether instances of negligence have gone up or down or stayed the same, as ACC no longer makes findings of error,231 but for reasons already stated every case of negligent treatment will constitute treatment injury. ACC does provide statistics about adverse event notifications,232 and the most common of these concern delays in giving treatment or failures to diagnose or to treat, and mistakes in the administration, dispensing and prescribing of medicines. The task of defining what is and what is not covered for accident compensation in the context of medical treatment is bound to be difficult and probably cannot be resolved in an entirely satisfactory fashion. Medical injury frequently lies near the dividing line between accident and illness. For as long as the accident compensation scheme provides cover for accidents but not for illness (save for occupational disease), it will remain necessary to search for an unexpected accident or event which can separate a medical injury from ordinary treatment of an illness or disease.

231 However, there is some evidence that the number of public hospital errors that caused or could have caused major harm to patients has recently increased. The Health Quality and Safety Commission has reported that in 2009–10 there were 374 patients involved in a “serious” or “sentinel” event (as to which see infra text accompanying note 246), of whom 127 died, whereas in 2008–9 there were 308 such events including ninety-two deaths. Martin Johnston, Hospital Errors Causing Serious Harm Climb, N.Z. Herald (Nov. 17, 2010, 2:04 PM), http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&object id=10688172. The chairman of the Commission’s interim board has suggested that the rise is probably the result of better reporting by the staff involved. Id. 232 See infra on reporting of medical risks.

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4.

Costs

In light of the escalating number of claims, it is not surprising that ACC’s accounts show a dramatic increase in the costs of compensation for treatment injury. Annual expenditure on the account, including the continuing costs of the former medical misadventure account, has risen from $ 48.6m in 2004–05 to $ 56.5m in 2005–06, $ 69.2m in 2006–07, $ 86.3m in 2007–08, $ 109.8m in 2008–09, and then down a little to $ 106m in 2009-10.233 This spectacular increase has far exceeded the Treasury estimates of the costs of the 2005 reform. Replacing medical misadventure with treatment injury was predicted to result in an annual increase of $ 8.7m, with transitional costs amounting to a one-off $ 12m.234 Expenditure on the ACC scheme as a whole over the same period also has risen, but not so quickly. Total expenditure was $ 2.2 billion in 2004–05, $ 2.5 billion in 2005–06, $ 2.8 billion in 2006–07, $ 3.1 billion in 2007–08, $ 3.5 billion in 2008–09, and just under $ 3.3 billion in 2009–10.235 Until recently the escalating costs of the treatment injury account were not matched by an equivalent rise in funding. The net annual deficit rose from $ 103.5 million in 2004–05 to $ 598.6 million in 2008–09, but then a small surplus of $ 4.7m was recorded in 2009-10, while the account deficit rose from $ 332.5 million in 2004–05 to $ 1.4 billion in 2009-10.236 At the same time ACC’s outstanding claims liabilities have grown from $ 9.4 billion in 2004–05 to $ 23.8 billion in 2008–09 and $ 24.4 billion in 2009–10.237

233 Accident Comp. Corp., Annual Report 100 (2005), available at http://www.acc.co.nz/ publications/index.htm?ssUserText=annual+report [hereinafter 2005 Report]; 2006 Report, supra note 224, at 97; 2007 Report, supra note 224, at 93; 2008 Report, supra note 224, at 90; 2009 Report, supra note 219, at 79; 2010 Report, supra note 132, at 57. Ken Oliphant, Compensation, Ideology and Patient Safety in New Zealand’s No Fault System, 3 Opinio Juris in Comparatione, 1, 12 n. 29 (2009) [hereinafter Oliphant (2009)] notes that up to and including the 2007 Report, a figure was given for “total expenditure” whereas in 2008, a comparable figure required the aggregation of the figures for “total claims paid,” “claims handling costs,” “net operating costs,” and “injury prevention costs.” I have followed this example for 2009 and 2010. 234 Ruth Dyson, Cabinet Social Development Committee, Medical Misadventure Review – Conclusions and Recommendations 2004, ¶¶ 14, 38, 66–71. 235 2005 Report, supra note 233, at 92; 2006 Report, supra note 224, at 88; 2007 Report, supra note 224, at 83; 2008 Report, supra note 224, at 80; 2009 Report, supra note 219, at 71; 2010 Report, supra note 132, at 47. The figures for 2008, 2009 and 2010 are an aggregation of “total claims paid,” “claims handling costs,” “net operating costs,” “injury prevention costs,” and “levy collection costs,” 236 2005 Report, supra note 233, at 100; 2006 Report, supra note 224, at 97; 2007 Report, supra note 224, at 93; 2008 Report, supra note 224, at 90; 2009 Report, supra note 219, at 79; 2010 Report, supra note 132, at 57. 237 2009 Report, supra note 224, at 3; 2010 Report, supra note 132, at 29.

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The above figures indicate that notwithstanding some recent improvement the accident compensation scheme is facing severe financial problems. Some commentators would dispute this conclusion. While certain increased costs are the consequence of expanded cover and entitlements,238 most, it is said, flow from the requirement introduced in 1998 that the scheme be fully funded, initially by 2014 and now by 2019.239 This requirement is seen as unnecessary and driven by a political ideology favouring eventual privatisation of the scheme.240 This, however, is not the view of the New Zealand Government. The Minister for ACC stated in the 2009 Report that the growth in ACC’s liabilities should have been recognized and addressed some years earlier and was unsustainable. The annual report disclosed financial difficulties in all of ACC’s accounts, driven by years of significant increases in costs and increasing numbers of claims. The underlying cause had been a shift from ACC being a public insurance scheme to it becoming an extension of the welfare state. So the Government had embarked upon a programme of reform aimed at strengthening ACC’s governance, improving rehabilitation and promoting injury prevention, and embarking on a substantial stocktake taking a long-term view on how the scheme’s performance could deliver better value for money.241 Indeed, recent figures show that ACC’s liabilities have stabilized and that there was a surplus of about $ 2.5 billion in 2009-10.242

C.

Professional Accountability

The accident compensation regime can provide compensation for the victims of medical injury. But such victims may wish to achieve various objectives apart from compensation, in particular to find out how their injury happened, to help prevent it happening again, to receive an acknowledgment of responsibility and to hold a negligent professional accountable for his or her conduct. These kinds of objectives can be met to

238 Geoff Cumming, Truth the Casualty of Crisis Management, N.Z. Herald (Mar. 14, 2009), http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=10561589 (stating that these extra costs accounted for $ 537 million of ACC’s total liability of $ 21.8 billion in the 2009 financial year). 239 See supra note 122 and accompanying text. 240 See Joanna Manning, Access to Justice for New Zealand Health Consumers 17 (Mar. 24, 2010) (unpublished paper) available at http://www.hdc.org.nz/education/hdc-medicolegal-conference-2010-a-decade-of-change (summarizing arguments from the Retirement Policy and Research Centre). 241 2009 Report, supra note 224, at 3. 242 2010 Report, supra note 132, at 2.

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a greater or lesser extent in a number of different ways. In addition, if a medical injury is not covered for accident compensation, there may remain the option of bringing a civil action for damages.

1.

Reporting of Medical Risks

Before 2005, the ACC had a responsibility to report all findings of medical error to the relevant professional body and to the Health and Disability Commissioner. However, the requirement was seen as a reason why health professionals were reluctant to co-operate in the claims process, fearing the possible repercussions.243 So when the new treatment injury provisions abandoned the need to prove error, the reporting requirements were changed as well. A reporting obligation now arises if the Corporation believes, from information collected in the course of processing claims for treatment injury, that there is risk of harm to the public, in which case “the Corporation must report the risk, and any other relevant information, to the authority responsible for patient safety in relation to the treatment that caused the personal injury.”244 In this respect, then, public safety concerns must prevail when balanced against the objectives underlying the 2005 changes of encouraging co-operation and promoting a shift away from a blaming culture. The ACC has well-developed processes for assessing risk and notifying the appropriate persons or bodies. Its Treatment Injury Centre considers the potential for risk of harm to the public using information collected when assessing cover, and events posing sufficiently serious risks are considered and assessed by an internal ACC panel.245 All “sentinel” events – events during treatment resulting in unanticipated death or major permanent loss of function – are notified to the Director General of Health, together with all “serious” events – those with the potential for causing death or major permanent loss of function – in cases where there is a high or moderate likelihood of recurrence.246 The Director-General then decides whether the notification is disseminated to the treating facility, and also determines the response that is needed to improve safety. In rare cases the 243 Summary of ACC Medical Misadventure Consultation, August 2003, p 1. 244 Accident Compensation Act 2001 § 284. It is likely that the ACC will also report to a newly instituted National Health Safety and Quality Commission, which will act as a central agency for adverse data event collection and promotion of patient safety. An interim board was set up in June 2010, with the new Commission planned to be up and running in 2011. 245 ACC Treatment Injury Profile, supra note 218. 246 Id.

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ACC will notify a registration authority if it has expert clinical advice that there are serious competence concerns. If there is a serious and immediate risk of harm to the public notifications can be made very quickly.247 The change in the statutory requirements for cover, and in particular the removal of the formal requirements that there should be a finding of error or mishap, has had the consequence that ACC does not now collect detailed information about the causes of medical injuries. Accordingly, the onus has shifted to the notified authorities to make their own investigations into any issue of culpability. Over the period from July 2005 to June 2010 ACC made 1,661 notifications of its belief that there was a risk of harm to the public.248 Easily the most common reason was delay and failure to treat in relation to the diagnosis and management of cancer and, less commonly, to visual problems, birth asphyxia, and testicular torsion. Other common reasons were wrong medication administration in relation to the person, drug, dose, route, and time; bile duct injuries and bowel perforations involving, inter alia, identifiable technical issues with surgical technique, premature failure of hip, and knee prostheses; and cerebrovascular accidents and hypoxic brain injury relating to coronary artery bypass graft, angiograms, cardiac valve surgery, and insertion of cardiac catheters.249

2.

Complaints

A Code of ACC Claimants’ Rights seeks to meet the reasonable expectations of claimants seeking accident compensation in their dealings with the Corporation. It provides, inter alia, a procedure for the lodging and dealing with complaints about breaches of the Code and the consequences and remedies for breach.250 A regime for making complaints about medical treatment is provided by the Health and Disability Commissioner Act 1994.251 The Act lays down a procedure for making complaints to the Health and Disability Commissioner in respect of breaches of the Code. The Commissioner may investigate a complaint, deliver an opinion and make recommendations for remedial action. There is no power to award damages. Serious cases may

247 248 249 250 251

Id. at 7. Id. Id. Health and Disability Commissioner Act 1994 §§ 39–47. Id.; see generally Manning, supra note 240.

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be referred to the Director of Proceedings, who can institute disciplinary proceedings or civil proceedings in a Human Rights Review Tribunal.252 The Tribunal has the power to award damages to compensate for pecuniary loss and expense, loss of any benefit, and humiliation, loss of dignity and injury to feelings, and to punish for any action that was in flagrant disregard of the rights of the aggrieved person.253 Compensatory damages for personal injury covered by the Accident Compensation Act 2001 are excluded.254 So proceedings before the Tribunal are likely to be brought only by consumers seeking exemplary damages or who have suffered no physical injury.

3.

Actions for Damages

A medical professional also may be held accountable by way of a civil action for damages. Yet in light of the cover for treatment injury, there is very limited scope for bringing such an action in a medical context. Obviously any common law liability will depend on proof of negligence, yet negligence by a registered health professional, including negligence in relation to treatment, diagnosis, failing to treat, giving advice and obtaining consent to treatment, normally gives rise to coverage for treatment injury. Conversely, if conduct is not negligent and there is no cover, there is no scope for a common law action either. Even so, there remains the possibility of actionable negligence in exceptional cases where there is no cover, perhaps because there is a special statutory exclusion, or there is no “personal injury” as defined in the statute.

a. Clinical Trials. An exception to cover arises out of certain special rules applying to clinical trials.255 Persons who suffer injury as a result of treatment given as part of a clinical trial who have not agreed in writing 252 Health and Disability Commissioner Act 1994 §§ 45(2)(f), 49(1)(a). 253 Id. at §§ 52, 54, 57. In Marks v. Dir. of Health and Disability Proceedings [2009] 3 NZLR 108 (C.A.) at para [62] the Court of Appeal held that an “aggrieved person” was a consumer whose rights under the Code had allegedly been infringed and that the parents of a suicide victim seeking to bring an action against their son’s psychiatrist did not qualify. Manning criticizes the decision and recommends its reversal on the grounds that this would give a wider group the opportunity to bring proceedings and would promote accountability and improvements in the quality of services. Manning, supra note 240, at 6–7. 254 Accident Compensation Act 2001 § 52(2). 255 Accident Compensation Act 2001 § 32(4)-(6); Nicola Peart & Andrew Moore, Compensation for Injuries Suffered by Participants in Commercially Sponsored Clinical Trials in New Zealand, 5 Med. L. Rev. 1 (1997).

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to participate in the trial are covered, as are persons who suffer such injury in the course of a trial certified by an accredited ethics committee as not being principally for the benefit of the manufacturer or distributor of the medicine being trialled. But if a person has agreed in writing to participate in a trial which is certified only as being for the benefit of the manufacturer or distributor, injury suffered by the participant is not covered. So a common law remedy founded on negligence by a sponsoring company or an investigator might be available.256 The justification for this exception to cover is obscure. Seemingly it is founded upon the participant’s consent to any risk, but consent is not a bar to compensation in other contexts. A drunken driver and his passenger arguably consent to the risk of injury in a collision, yet both can make claims for compensation.

b. Stillbirths. Whether a stillbirth is a personal injury to the mother can be disputed. In Harrild v. Director of Proceedings257 a majority in the Court of Appeal held that a mother had suffered personal injury on account of the death of the foetus in consequence of negligence by her doctor. Elias CJ was not attracted by the stark choice of treating the unborn child either as the same as the mother or as distinct. She considered that where severance of the physical link between mother and unborn child occurs through the death of the child as a result of medical error, then physical injury is suffered by the mother.258 Keith and McGrath JJ thought similarly.259 Blanchard and Glazebrook JJ, by contrast, considered that on the majority view a mother and foetus are treated as a single entity, which ignores

256 The practice of ethics committees in certifying a trial is to ensure that adequate compensation is available in the event of injury, by requiring the company concerned to abide by the New Zealand Researched Medicines Industry Guidelines on Clinical Trials. These provide for payment for “more serious injury of an enduring and disabling nature” irrespective of proof of negligence, but state that compensation may be abated to the extent that injury has arisen through a significant departure from the agreed trial protocol, or the wrongful act of a third party, or contributory negligence by the patient. The amount of any compensation “should be appropriate to the nature, severity and persistence of the injury.” The Preamble contemplates that adherence to the guidelines is without legal commitment, and certainly the question whether or how they might be legally enforceable by a patient is unclear. Guidelines on Clinical Trials Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial, Researched Medicines Industry (Aug. 2008), http://www.medicinesnz.co. nz/assets/Uploads/compensation-guidelines-0808-final.pdf. 257 [2003] 3 NZLR 289 (C.A.) at paras [22], [42], [135]. 258 Id. at para [21]. 259 Id. at paras [42], [135].

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biological reality.260 This perhaps is the more convincing view, but unless the question comes to be reconsidered by the Supreme Court, there is cover for a negligently caused stillbirth and there can be no action for damages.

c. Pregnancy and Unwanted Births. Cases involving pregnancy and unwanted births also require special consideration. The question arose in Accident Comp. Corp. v D,261 where the Court of Appeal, in a majority decision, determined that unwanted pregnancy was not a “personal injury” under the 2001 Act because it was not a “physical injury.” But then in Allenby v H262 the Supreme Court held, in a unanimous decision, that a patient who suffered mental illness after becoming pregnant following a sterilisation procedure carried out by the appellant doctor had suffered “personal injury”, as defined, and was covered for compensation. Elias CJ said that it needed to be shown that the claimant had suffered “personal injury caused by medical misadventure” (the relevant events having occurred before the 2005 changes), and her Honour was satisfied that this expression covered physical impact upon the person, expansively viewed. An infection caused by medical misadventure was covered, and so was a strain or sprain. “Treatment” included lack of treatment, so physical consequences which could have been prevented might also be an “injury”. The Act was concerned with establishing entitlements for impairment, rehabilitation and treatment, and physical impact which was significant enough to support such responses, which clearly included pregnancy, was physical injury within the meaning of the Act. Further, while many of the physical consequences of impregnation were the result of a gradual process, these also were covered where they were consequential on personal injury or its treatment for which original personal injury the person had cover.263 So the physical consequences of impregnation by rape (if accepted to be an “accident” within the meaning of the Act264) were included as well. Her Honour added that a gradual process did not need to be intrinsically harmful and that “gradual process” was an expression of general application.265

Id. at paras [66]–[69]. [2008] NZCA 576 (C.A.). Allenby v H [2012] NZSC 33, [2012] 3 NZLR 425. Id, s 20(2)(g),(h). Id, s 25(1)(a)(i), which requires that there be “the application of a force or resistance external to the human body”. 265 The joint judgment of Blanchard, McGrath and William Young JJ, given by Blanchard J, made a number of similar points. A further question was whether accepting cover in the instant case or in the case of rape would open the door to claims for other unwanted 260 261 262 263 264

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Allenby determined only that the patient concerned was covered under the Act for the “physical effects” of her pregnancy.266 Any mental injury she suffered as a consequence of the unplanned birth which met the statutory threshold267 accordingly was covered as a personal injury caused by medical misadventure. But what about the costs of bringing up an unplanned child? Allenby says nothing about this. It is clear that upbringing costs cannot be claimed as such under the accident compensation scheme. Rather, they would have to be claimed in the guise of a claim for lost earnings. But it is very doubtful whether the words of the Act can support any such claim. This is because the earnings are lost not because of the personal injury – the physical effects of the pregnancy on the mother – but because of the need to care for the child who is the consequence of the pregnancy. The statute is concerned with physical injury to the mother, not the economic consequences of the relationship between parent and child.268 The latter constitutes a separate and independent head of financial damage.269 In short, the “injury” is the pregnancy, not bringing up the child. It seems, then, that a claim for damages at common law for a loss of this kind is not barred by the accident compensation scheme. But whether it ought to succeed is another question.270

d. Informed Consent Cases. We have seen that in Accident Comp. Corp. v. Ambros Glazebrook J considered that the informed consent cases apparently relaxing the requirement of proof of cause of an injury should not be imported into the accident compensation regime.271 Accordingly, a failure

266 267 268 269 270 271

pregnancies, such as could result from a failed condom or from unprotected sexual intercourse. Blanchard J said that where a woman chose to engage in sexual intercourse, during which she suffered no physical harm but as a result of which she fell pregnant, it could not sensibly be said that there had been an “accident” within the statutory definition. The definition of “accident” had to be adjusted for the particular context, as the interpretive section, s 6, enabled. Although in physical terms there was an application of force in any act of sexual intercourse, a resulting pregnancy should not be treated as an accident consequent upon an application of force where a woman had truly given her consent to the act of intercourse. That plainly would be outside the purpose of the accident compensation scheme. Tipping J, who delivered a brief concurring judgment, also took this view. But Elias CJ expressed considerable doubt about whether the concept of consent was useful in the context of the legislation and the meaning of “accident.” [2012] NZSC 33, [2012] 3 NZLR 425, at [84]. See n 77. For development of this argument, see S Todd, “Accidental Conception and Accident Compensation” (2012) 28 PN 196. See McFarlane v Tayside Health Board [2000] 2 AC 59, at 76, 79, 89, 99–100, 109 (HL). See S Todd, above n 1, at para 6.9.03. [2008] 1 NZLR 340 (C.A.) at para [51].

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to warn of a small risk of medical treatment, which risk later eventuates, is not covered for compensation and to this extent might be actionable in damages. However, the occurrence of the adverse event following a failure to warn is likely nonetheless to amount to treatment injury, on the basis that this is not a necessary part or ordinary consequence of the treatment, with cover accordingly.

e. Mental Injury. A patient suffering mental injury as a consequence of physical injury caused by medical negligence is covered for compensation.272 However, cover does not extend to mental injury suffered by a secondary victim. An example is where a husband suffered “reactive depression” as a result of being unable to continue sexual relations with his wife after she was injured due to medical misadventure.273 So an action for damages could lie in this kind of case.

f. Miscellaneous. There arguably is no personal injury where surgery leads to no physical or mental health problems, but, due to the doctor’s negligence, it does not produce the desired results.274 Again, a doctor can be liable in battery for wrongful physical contact not causing actual injury. Mental injury to a patient caused by professional misconduct is actionable as well.275

g. Exemplary Damages. The option of a claim for exemplary damages remains. In A v. Bottrill276 the Privy Council upheld the availability of exemplary damages in a bad case of medical negligence, but the decision was overruled in Couch v. Attorney-General,277 where the Supreme Court required that there be advertent or reckless wrongdoing. The test is likely to be difficult to satisfy, certainly in a medical context.

272 Accident Compensation Act 2001, § 26(1)(c). 273 ACC v. F [1991] 1 NZLR 234 (HC) 240. 274 Kate Tokeley, Accident Compensation and Cosmetic Surgery, 1998 N.Z.L.J. 5, 5–6 (1998) (discussing the question in relation to wrong-sized breast implants). 275 L v. Robinson [2000] 3 NZLR 499 (HC) at para [1], [44]. 276 [2003] 1 AC 449 (PC). 277 [2010] 3 NZLR 149 (SC); see supra note 83.

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Conclusion Let us now attempt to evaluate New Zealand’s scheme, with particular reference to the way in which it operates in the field of medical injury. We will consider whether it provides adequate compensation, has defensible boundaries, is administratively efficient, and operates as an incentive or a disincentive to safety-conscious behavior.

A.

Adequate Compensation?

The statutory scheme in operation in New Zealand arguably performs well in its core function of providing a source of compensation for the victims of accidents. The statutory benefits, in particular earnings-related compensation, are reasonably generous and compare favorably with flat rate social security payments. Inevitably there will be winners and losers by comparison with common law damages. In Queenstown Lakes278 Thomas J remarked on the notion of a social contract and a trade-off between the loss of common law rights and the gaining of accident compensation benefits, and said also that damages and compensation were never intended to correspond. Uncertainty of recovery at common law was exchanged for a no-fault scheme which included provision for rehabilitation as well as ongoing earnings-related compensation. Disparity between the two would always exist. So some injury victims will or might in some sense be worse off, but most will benefit from the scheme. And, of course, the key advantage of accident compensation is that it is available for nearly all injury victims, not just those who can establish the liability of another to pay compensation.

B.

Defensible Boundaries?

There is no accident compensation simply for disease or illness, unless work-related. In Queenstown Lakes, Thomas J drew attention to this point as well, commenting that difficulties would necessarily arise out of the line between injuries arising from accidents and other injuries and conditions which were not attributable to accidents.279 These difficulties are acute in the case of alleged medical injury by way of sickness or illness, for treatment is given (or is not given when it should be) to patients who are already sick 278 [1999] 1 NZLR 549 (CA) 557. 279 Id.

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or ill. As we have seen, the solution has been to allow claims for injury caused by unexpected mishaps or wrongful treatment or failure to treat. The line between such compensable treatment injury and the non-compensable condition requiring the treatment is bound to be hard to draw. Ultimately any compensation scheme has to set boundaries. The boundaries to the accident compensation scheme as they presently exist are founded very broadly on a distinction between human and natural causes. These may be hard to defend, but there is no natural limit upon which all can agree. A line has to be drawn somewhere, and wherever it is it will create difficulties and anomalies in relation to cases which are excluded. So if illness were to be included, it would still be necessary to define the qualifying circumstances, and some borderline cases would be excluded. And there is practical value in the accident/illness divide. Most cases giving rise to the question whether another was liable for the injury are covered, the difficulties created by tort litigation are largely avoided, and victims by and large receive adequate compensation. More generally, if illness and disease were to be covered there would be major financial implications, the scheme would transmute into part of the social security system, and payments inevitably would at least be substantially reduced.280 Of course, accepting the need to show some kind of “accidental” event, the question remains quite how to define that event. The 2005 amendments lowered the bar in medical injury cases and made the qualifying conditions

280 Social security payments in New Zealand are made pursuant to the provisions of the Social Security Act 1964 § 1A. These may supplement accident compensation entitlements, particularly in cases where the claimant is a non-earner whose entitlement is limited to a lump sum. Where there is no accident compensation cover, a person’s only source of income may be a social security benefit. The relationship between accident compensation and social security is governed by the Accident Compensation Act 2001 and the Social Security Act 1964, which seek to prevent double payments and which make provision for transfers or reimbursements of money between the ACC and the Work and Income Service of the Ministry of Social Development. Accident Compensation Act 2001, §§ 252–53; Social Security Act 1964 §§ 71, 71A. The social security scheme makes provision for three main types of benefit for incapacitated persons. The invalid’s benefit is payable to New Zealand residents over the age of 18 who are totally blind or permanently or severely restricted in their capacity for work (but excluding self-inflicted conditions). Social Security Act 1964 § 40. An emergency benefit is payable on grounds of hardship where a person cannot qualify for any other benefit and by reason of disability cannot earn a sufficient livelihood. Id. § 61. Survivors’ benefits or domestic purposes benefits are payable in certain circumstances to wives or husbands or those who had been in a relationship in the nature of marriage on the death of the other in respect of the costs of bringing up dependent children, and an orphan’s benefit is payable to the principal caregiver of a child whose parents are both dead. Id. §§ 21, 27B, 28. Further supplementary allowances and grants, such as the disability allowance and the child disability allowance are available. Id. §§ 39A, 69C.

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much easier to satisfy. The predictable result has been the striking increase in the number of treatment injury claims over the last five years. The reforms of 2005 have been said to cement the distinction between incapacities caused by human interaction and incapacities which are natural,281 which no doubt is true in that we must still distinguish between the treatment (human cause) and the underlying condition (natural cause). But the reform might equally be seen as weakening the distinction, in allowing many more claims for injuries which are attributable to unexpected developments and events which are neither especially rare nor, it may be, easily separable from the underlying condition. At all events the reform widens the idea of an accident in this context and extends cover to more people suffering harm in the course of medical treatment. This is at the cost of rather greater uncertainty as to the extent of cover, coupled with the need for an increase in funding for the treatment account.

C.

Administratively Efficient?

This brings us to consider the whole question of costs and funding. A major advantage of an event-based compensation scheme is that claims can be made quickly and processed efficiently. The cost of delivering the statutory benefits avoids the very substantial costs associated with the need to prove liability before compensation can be paid. The costs of administering the scheme are relatively low and have remained stable over the last five years. In 2009, the scheme’s operating costs amounted to 13.4 % of claims paid, levy collection costs were 1.6 % of total revenue, and investment costs were 0.34 % of investment assets.282 A comparison between the administrative costs in the work account and those of similar Australian schemes shows that in 2006–07 ACC spent 19.7 % of total scheme expenditure on claims management and other administration, whereas the Australian average was 25.2 %.283 Comparisons with the costs of litigation are revealing. An estimate of the cost of tort litigation in the UK concluded that about fifty-five pence of the insurance pound was paid out to injured victims, and about forty-five pence was swallowed up in administration.284

281 Oliphant (2009), supra note 233, at 17. 282 2009 Report, supra note 224, at 21 (total operating costs include both “operating costs/ claims paid” and “injury prevention costs/claims paid”). 283 Id. 284 P Cane, Atiyah’s Accidents, Compensation and the Law 397 (7th ed., 2006) (commenting that no other compensation system is anything like as expensive).

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Critics might argue that administrative efficiency can be bought at too high a cost. They might say, inter alia, that removing a right to sue for injury and substituting a right to make a claim from a compulsorily funded statutory body, irrespective of the claimant’s or anyone else’s responsibility for the injury, is likely to encourage malingering and to lead to bureaucratic inertia and ever-increasing costs. Perhaps there is some evidence in support of this kind of thesis in the seemingly relentless rise in the costs of accident compensation that we have already noted. But at least some of the increase is due to widening provisions for cover and entitlements, and it is in any event impossible to come to a considered conclusion without good evidence about all the causes of the increase. We can say only that some element of abuse is endemic in all compensation systems, that steps are being taken to control costs and improve ACC’s finances, and that better performance is perfectly achievable.

D.

Disincentive to Safety-Conscious Behavior?

Possibly a stronger argument, and certainly one that attracts articulate support, is that a compensation scheme of this kind removes a deterrent to injury-producing activity and operates as a disincentive to safety conscious behavior. This raises large questions which cannot be addressed adequately here. However, we might note that the Woodhouse Report did not see proof of fault as useful in injury prevention,285 and the New Zealand Law Commission concluded that the alleged deterrent role of tort was not significant.286 Let us, briefly, consider the evidence. A number of studies starting back in the 1960s show that the value of tort liability as a deterrent to unsafe conduct or as an incentive to take care is certainly unproven and is likely to be negligible.287 Evidence provided by

285 Woodhouse Report, supra note 2, at para 319. 286 1988 Report, supra note 27, at para 81. 287 See, e.g., Terence George Ison, The Forensic Lottery: A Critique on Tort Liability as a System of Personal Injury Compensation (1967); Eli P. Bernzweig, By Accident Not Design: The Case for Comprehensive Injury Reparations (1980); Stephen D. Sugarman, Doing Away with Personal Injury Law: New Compensation Mechanisms for Victims, Consumers, and Business (1989); Don Dewees & Michael Trebilcock, The Efficacy of the Tort System and Its Alternatives: A Review of the Empirical Evidence, 30 Osgoode Hall L.J. 57 (1992). Compare Gary T. Schwarz, Reality in the Economic Analysis of Tort Law: Does Tort Law Really Deter?, 42 UCLA L. Rev. 377, (relying on anecdotal evidence to conclude that tort law might still be “somewhat successful” in achieving its stated deterrence goals). In Stephen Todd, Privatization of Accident Compensation: Policy and Politics in New Zealand 39 Washburn L.J. 404, 478–82 (2000) I attempted to review the literature on this topic, and found it was difficult to come to any clear conclusion. For a recent and helpful review, see

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some more recent studies confirms this conclusion. For example, Tess and Armstrong, comparing empirical evidence on fault, no-fault and hybrid schemes across a number of dimensions, including availability of benefits, costs of the scheme and prevention incentives, saw no-fault schemes as coming out ahead.288 As regards prevention of accidents in particular, their conclusion was that fault, no-fault and blended systems appeared to perform similarly and, importantly, that there were far more important drivers of safety improvements than the threat of tort.289 In the specific field of medical malpractice the consensus is similar. So Mello and Brennan, in a US study, considered that evidence of a deterrent effect was limited and vulnerable to methodological criticism.290 The data did not support the notion that the malpractice system sent a strong deterrent system to providers. Sloan and Chepke, in like vein, stated that it was difficult to find good evidence that negligence liability deterred medical errors.291 As regards the New Zealand scheme in particular, Oliphant concluded that it remained an open question whether introducing nofault in place of liability in private law had had a positive or negative effect on patient safety, or no effect at all.292 At best, evidence about the deterrent impact of imposing tort liability for causing injury is equivocal, and certainly a link with lower accident rates is not easily shown. Indeed it is strongly arguable that holding people accountable for their conduct can be achieved in other, more effective, ways. We have seen that there are a number of alternative methods of achieving accountability by medical professionals operating in New Zealand. A further point deserving note is that market incentives aimed at reducing accidents can of course operate within the accident compensation scheme. The ACC Accredited Employers Programme (AEP) gives employers significant discounts on their ACC levies in exchange for taking responsibility for their employees’ work injury claims. Recent proposals to extend the scheme include reducing barriers on participation by providing a greater

288

289 290 291 292

Harold Luntz, Torts and Insurance: The Effect on Deterrence, in Torts in Commercial Law Simone Degeling, James Edelman & James Goudkamp (eds.), Thomson 2011. Kirsten Armstrong & Daniel Tess, Institute of Actuaries of Australia, Fault Versus No Fault – Reviewing the International Evidence (Nov. 9–12, 2008), http://www.actuaries.asn. au/library/GIS08_3d_Paper_Tess,Armstrong_Fault%20versus%20No%20Fault%20-% 20reviewing%20the%20international%20evidence.pdf. Id. at 27. Michelle M. Mello & Troyen A. Brennan, Deterrence of Medical Errors: Theory and Evidence for Malpractice Reform, 80 Tex. L. Rev. 1595 (2002). Frank Sloan & Lindsey Chepke, The Law and Economics of Public Health (2007). Oliphant (2009), supra note 233, at 19.

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range of risk-sharing arrangements, reducing compliance costs faced by employers by providing more flexibility in meeting financial entry requirements, and offering other risk-sharing arrangements to small employers outside the AEP.293 The ACC Workplace Safety Management Practices Programme and the Workplace Safety Discount Programme also provide levy discounts for businesses showing sound health and safety practices. Until recently there was no general discount on levies, analogous to an insurance no-claims discount, for businesses showing a good safety record.294 Historically the work levy has been based on injury rates across industry categories, without any differentiation according to a particular business’s safety record. However, in April 2011 ACC introduced a system of experience rating, under which a business’s work levy can be modified based on its claims history.295 So experience rating seeks to reward those businesses with safer workplaces and to encourage a focus on improving workplace safety. A further proposed reform, as already noted,296 will allow private insurers to provide insurance cover in respect of accident compensation entitlements in competition with the ACC. The aim of the proposal is to improve safety, rehabilitation and efficiency in the workplace. The document asks a number of questions about the proposed changes, and feedback from interested persons has been invited.

E.

Overview

One’s assessment of the accident compensation scheme may turn very much on personal disposition concerning the legislative imposition of a compulsory, state-controlled, scheme, funded by levies in the nature of taxation, in a field which traditionally has been the preserve of private

293 INCREASING CHOICE IN WORKPLACE ACCIDENT COMPENSATION (June, 2011), supra note 45. 294 Whether this should be attempted has been debated. The Law Commission in its 1988 Report drew attention to the uncertainties involved and also to possible inequities. Small firms might be subject to statistically random fluctuations in accident rates, which might occur despite taking all proper precautions. See 1988 Report, supra note 27, at para 140–49. Subsequent studies show inconclusive results. 295 EXPERIENCE RATING – MAKING ACC WORK LEVIES FAIRER FOR INDIVIDUAL BUSINESSES (2011) (available at http://www.acc.co.nz/for-business/experience-rating/ index.htm?IdcService). 296 INCREASING CHOICE IN WORKPLACE ACCIDENT COMPENSATION (June, 2011), supra, note 45.

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action and initiative. If one is happy with the idea, or at least can live with it, one can attempt to judge the scheme on its results, unhampered by ideological conviction.297 In summary, the compensation is reasonably generous and is available with the minimum of formality; the boundaries are defensible, with the result that, broadly speaking, medical injury outside the ordinary consequences of treatment and not attributable to a patient’s pre-existing condition is compensable; the scheme operates quite efficiently, so for the most part available resources are used to meet the needs of qualifying claimants rather than for administrative purposes; there is little evidence that barring tort claims has compromised safety standards; the need in some cases to hold individuals accountable for wrongdoing can be met by the use of a detailed statutory process for the making of complaints; the level of funding needed to meet the costs of the scheme can be achieved by levies which compare favorably with the costs of alternatives, such as by insurance against tort liability; and while there certainly have been escalating costs, these are explicable at least partly by the change from pay-asyou-go to full funding, and seemingly they are reasonably manageable. The accident compensation scheme has survived many challenges, some financial, some operational, some ideological, and no doubt these will continue. All difficulties will not simply disappear. However, by comparison with the tort system it has been and continues to be a distinct success.

297 For a variety of reviews of the first thirty years, see Looking Back at Accident Compensation: Finding Lessons for the Future, 34 Vict. U. Wellington L. Rev. 189, 467 (2003) (containing the papers delivered at a conference at Victoria University of Wellington in August 2002); The Future of Accident Compensation, 35 Vict. U. Wellington L. Rev. 775–974 (2004) (containing the papers delivered at a second conference in December 2003); see also Accident Compensation Symposium, 2008 N.Z.L. Rev. 3, 140 (containing papers paying tribute to Sir Owen Woodhouse on the 40th anniversary of the day the Woodhouse Report was presented to Parliament). For an overview see Accident Compensation Corporation New Zealand: Scheme Review (2008), a report commissioned by the ACC by Price Waterhouse Coopers, Sydney, which concluded that the implementation of the Woodhouse Principles via the ACC scheme had afforded New Zealand’s society and economy four decades of added economic and social value.

325

Medical Malpractice and Compensation in Poland Kinga Ba˛czyk-Rozwadowska*

Introduction 1. The Polish health care system has undergone many significant changes recently. The Institutional Health Care Providers Act (Ustawa o zakładach opieki zdrowotnej) of August 30, 19911 officially repealed the former framework of State health care (pan´stwowa słuz· ba zdrowia) and paved the way for establishing private activities, including the provision of health care, the pharmaceutical industry, medical supplies, ambulatory diagnostic services, as well as a wide range of hospital services.2 However, until January 1, 1999 it was still a taxation-based system in which the majority of medical services were financed by Government sources through budget allocation (made by the Ministry of Finance).3 On January 1, 1999, the Universal Health Insurance Act (Ustawa o powszechnym ubezpieczeniu zdrowotnym) of February 6, 19974 came into force, introducing national health insurance (powszechne ubezpieczenie zdrowotne) based on the principles of equal treatment, social solidarity, equal access to health care services, and a free choice of medical care providers. These principles reflected Article 68 of the newly enacted Polish Constitution of April 17, 1997, which vests everyone with the right to have his health

*

1 2 3 4

Doctor of Law (since 2006), Assistant Professor at the Faculty of Law and Administration of the Nicholas Copernicus University of Torun´, Poland, Department of Civil and International Commercial Law (Chamber of Medical Law); specializes in tort law, law of obligations, medical law and consumer law; author of a book (monograph) Civil Liability for Medical Malpractice and other publications (articles, glosses) concerning in particular medical law and tort law. Dziennik Ustaw [Journal of Laws] 1991, No. 91, item 408 (Pol.) – as amended. M. Nesterowicz, E. Bagin´ska, Medical Legislation in Poland, Yearbook of European Medical Law, Lidingö 11 (2005). For more information, see M. Nesterowicz, E. Bagin´ska, A. den Exter Medical Law, the Hague-London-New York 24 (2002). Dziennik Ustaw [Journal of Laws] 1997, No. 28, item 153 (Pol.).

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protected (Section 1) as well as the right to equal access to publicallyfunded medical services (Section 2).5 The fundamental idea of the national health insurance was to separate the purchasing of health care services from the delivery of these services (a “purchaser-provider split”). A system in which health care was to be contracted seemed to be the best way to encourage competition between medical services providers to bid for contracts with the institutions in charge of financing public health care.6 Therefore, the Universal Health Insurance Act established so-called health insurance funds (Kasy Chorych),7 responsible for collecting premiums from the insured and purchasing medical services by signing performance-based contracts with both public and private health care facilities (hospitals, clinics, medical centers) as well as individual health care professionals (doctors and other members of the medical profession, e.g., nurses, midwives, laboratory assistants).8 These contracts determined the type and scope of health care provided, the terms and conditions of rendering services, maximum cost settlement, principles of medical service quality, quality monitoring and control mechanisms, as well as the principles of supervision, documentation, and complaint procedures. In 2003, due to the need to centralize the insurance scheme, health funds (Kasy Chorych) were replaced with one state entity called the National Health Fund (Narodowy Fundusz Zdrowia (NFZ). However, no other structural changes were made to the overall arrangement of health care. The actual national health insurance scheme operates pursuant to the provisions of the Publicly-Funded Health Care Services Act (Ustawa o s´ wiadczeniach zdrowotnych finansowanych ze z´ ródeł blicznych) of August 28, 2004.9 The scheme is still obligatory for almost all citizens (those who are not subject to the insurance mandate may acquire an insurance coverage voluntarily).10 Eligibility for health care services is thus no longer auto-

5 See Kinga Ba˛czyk-Rozwadowska, Odpowiedzialnos´c´ cywilna za szkody wyrza˛dzone przy leczeniu 141–142 (2007). 6 Id. 7 Under the Universal Health Insurance Act 15 regional health insurance funds (regionalne Kasy Chorych) and 1 industry-specific (sectoral) pool (branz· owa Kasa Chorych) were established. Universal Health Insurance Act, Journal of Laws of 1997, No. 28, item 153, as amended. Although they were modeled on the German Krankenkassen (of a Bismarckian type), some elements of their organizational structure reflected the configuration of Polish health care during the pre-war period. See M. Nesterowicz, E. Bagin´ska, A. den Exter, Medical Law Monograph, Int’l Encyclopaedia of L. 65 (2007). 8 Id. 9 Publicly Funded Health Care Services Act of 2004 (Dziennik Ustaw [Journal of Laws] 2004, No. 210, item 2135 (Pol.)). 10 See M. Nesterowicz, Prawo medyczne, 33 (9th ed. 2010).

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matic (as it was in the former taxation system) but is based on the payment of premiums. However, apart from employed persons’ income contributions (up to 9 % of the taxable income) and farmers (using a formula based on the estimated uniform rural production), national health insurance can also be financed with income from bank deposits, donations, legacies, and other sources indicated in the Act. In return for the premiums, the insurance scheme provides the insured and other people entitled by the statute (minors under the age of eighteen and other family members of the insured, the unemployed, disabled, mothers on maternity leave, veterans, etc.) with a wide range of medical services that cover nearly all areas of health care (diagnosis, therapy, hospitalization, specialist treatment, rehabilitation, as well as sanitary transport, emergency care, and provision of drugs and other medical appliances).11 These services, called standard (guaranteed) procedures, constitute a health care benefit package, and they are rendered free of charge or in return for partial payments by health care providers that become participants of the insurance scheme by entering into contracts with the National Health Fund.12 Within the scope of insurance, the insured are also entitled – under certain conditions – to medical treatment abroad13 and to a whole or partial refund of drugs, medical products, and appliances as well as orthopedic equipment. Highly specialized health care procedures of certain types (e.g. bone marrow and liver transplantations) are financed directly by the Ministry of Health.14 Health care providers which do not participate in the national health insurance scheme offer medical services for a charge, on a commercial basis. These “non-standard procedures” are accessible to all patients who are interested in them, and they play an important role in the overall health care system, since the accessibility of medical care financed from public sources is, in practice, limited, particularly for specialized treatment.

11 12

13 14

See Publicly-Funded Health Care Services Act, supra note 9, art. 15 as amended. The detailed lists of medical services covered by the health care benefit package have been published in 13 Ordinances of the Ministry of Health of 28–30 August 2009. See Dziennik Ustaw [Journal of Laws] 2009, No. 139, items 1136–1148 (Pol.). Certain medical services are qualified into a standard category by the Ministry of Health according to the statutory criteria listed in Article 31a of the Law of 2004 and the recommendations of the President of the Agency of Accreditation of Medical Technologies. See supra note 9, art. 31a. See Marcin. S´ liwka, Prawo Medyczne 59–63 (Miroslaw Nesterowicz, ed., 9th ed. 2010) See the Ordinance of Ministry of Health of 13 December 2004, concerning highly specialized medical procedures financed by the State; see also Dziennik Ustaw [Journal of Laws] 2004, No. 267, item 2261 (Pol.).

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2. Civil law, with its compensation mechanisms (instruments), is the main source of reimbursement for personal injury, with social security insurance and private health insurance being of secondary importance in this regard. Social security insurance has functioned on the grounds of the Social Security Insurance Act (Ustawa o ubezpieczeniu społecznym) of October 13, 199815 as a system independent from national health insurance. This kind of insurance, obligatory for most of the citizens, provides money and other assistance in the case of illness, work disability, maternity leave, and retirement. The benefits are paid by a State entity the Social Security Insurance Administration (Zakład Ubezpieczen´ Społecznych), which collects premiums from the insured and administers the scheme.16 Until the introduction of the new health care system in 1999, Poland had a rather limited experience with private health insurance. At present, this kind of insurance, governed by the general provisions of the Civil Code (Article 805 and the following) and the standard terms of insurance, is becoming more and more common and gradually grows in importance.17 The reason for this growth is the relatively low quality of NFZ services and effectively limited access to public health care, especially to medical services rendered by specialists (long “waiting lists” for more sophisticated treatment).18 However, private insurance may (and will) serve solely as a voluntary supplement as long as national health insurance is obligatory. Statutory rules would be required to give patients the choice between public (national) and private health insurance, since as long as the former is compulsory, premiums must be paid even if the patient does not make any use of his or her health care benefit package (when he needs a certain kind of medical treatment).19

15 16 17 18

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Official Journal 2009, No. 205, item 1585 – unified text. See E. Lechnio-Dziubin´ska et. al., Ubezpieczenia społeczne (2011). See K. Policha, B. Wojno Aktualne problemy prywatnych ubezpieczen´ zdrowotnych, Prawo Asekuracyjne 14 (2008). In practice, private voluntary health insurance functions in two alternative forms: as group-based insurance (common for employers) or an individual health care benefit package. The costs of such insurance depend on the scope of services covered; the price for a standard packet for one person may vary from PLN 60 (15 E) to PLN 600 (150 E) per month. According to statistical data, as of the beginning of 2011 not more than 18 % of Poles have entered into a private health insurance contract of any type. Gazeta Metro, 28 March 2011. A number of bills have been drafted to regulate the status of private health insurance and its relation to the national health insurance (the latest dating from October 2010). However, none of them has proposed a free choice between the national and private health insurance. The latter is usually to serve as a supplementary cover only. See

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I.

Grounds for Civil Liability

1. In the event that damage arises from medical malpractice, civil liability may be attributed exclusively to whoever has performed the treatment, irrespective of whether it is a participant of the insurance system or not. There is no possibility to claim compensation from the National Health Fund, because this institution neither provides health care itself (its role is limited to purchasing medical services by entering into contracts with hospitals and doctors) nor it is an owner, co-owner, or a share-holder of a health care facility. However, as a legal person exercising State (official) authority to ensure and organize health care (in view of Article 68 of the Polish Constitution),20 the National Health Fund may be responsible for damage that results from the lack of proper quality of medical services, inadequate supervision and control over professionals, improper choice of insurance scheme participants (hospitals and doctors), lack of medical services that should have been contracted, etc.21 The legal grounds of this liability are the amended Article 417 of the Civil Code (in force since June 17, 2004),22 which constitutes tortious liability for the unlawful acts and omissions of all legal persons exercising State authority. Since this is an objective, risk-based liability, it is not necessary to prove the damage perpetrator’s fault to seek compensation.23 2. Liability for medical malpractice can be either contractual or tortious. What kind of liability regime is applicable in the circumstances of a certain case depends on the status of the doctor (the hospital) and the nature of medical services that have been rendered to a patient. If health care is provided within the scope of national health insurance, there is no contract between a patient and a hospital or a doctor, since the

20

21 22

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Dominika Sikora, Dodatkowa polisa zdrowotna z ulga˛, Gazeta Prawna No. 206 (2837), 21 October 2010. Ewa Bagin´ska, Odpowiedzialnos´c´ odszkodowawcza za wykonywanie władzy publicznej, 287 (2006); Miroslaw Nesterowicz, Glosa do wyroku Sa˛du Okre˛ gowego w Lublinie z 4. IV.2002 r. (IC 656/99), [Commentary on the Judgment of the Regional Court in Lublin], Prawo i Medycyna 127–128 (2004/3). Bagin´ska, supra note 20, at 287; Nesterowicz, supra note 20, at 127–128. Law of 17 June 2004 (Journal of Laws 2004, No. 162, item 1692), amending the Civil Code (Law of 23 April 1964; Journal of Laws 1964, No. 210, item 2135). Section 1 of the amended Article 417 states: “The liability for damage caused by an illegal act or omission in the course of the exercise of public authority rests on the State Treasury, a local authority or any other legal person who exercises an authority conferred upon it by law.” Ewa Bagin´ska, Poland (Ewa Bagin´ska trans.), in European Tort Law: Basic Texts 131 (Ken Oliphant & Barbara C. Steininger eds., 2011) (citing Civil Code art. 417 (Dziennik Ustaw [Journal of Laws] 1964) (Pol.)) [hereinafter Bagin´ska, Pol. Civ. C.]. See Bagin´ska, supra note 20, at 286–287; K. Ba˛czyk-Rozwadowska, supra note 5, at 196.

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source of the provider’s obligation toward a patient is statutory provisions (regulations of Publicly-Funded Health Care Services Act of 28 August 2004). Consequently, in the case of damage, provisions of ex delicto liability are applied exclusively (Article 41524 of the Civil Code, which constitutes liability for the tortfeasor’s own acts and omissions, or Article 43025 of the Civil Code, constituting vicarious liability for a fault of a subordinate). A contract between parties (qualified as a contract of rendering services to which provisions of Article 750 of the Civil Code are applied)26 is concluded only when a patient receives treatment outside the insurance scheme, at a private clinic or a doctor’s office. The breach of that contract may then give rise to the provider’s ex contractu liability (according to Article 47127 or Article 47428 of the Civil Code). However, in most malpractice cases provisions of tortious liability are applied. According to case law and doctrine, a doctor who causes personal injury (a bodily impairment and/or health disturbance) not only performs his contractual obligations improperly but, at the same time, acts inconsistently with the general duty of care by which he is bound, regardless of the legal relationship with a patient.29 Ex contractu liability is then in concurrence with tortious liability and, pursuant to Article 443 of the Civil

24 25

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Article 415 states: “Any person who by his fault has caused damage to another person is obliged to redress it.” Bagin´ska, Pol. Civ. C., supra note 22, art. 415. Article 430 states: “A person who on his own account entrusts the performance of an act to a person who at the performance of the act is under his control and has a duty to abide by his instructions is liable for any damage caused by that person’s fault in the course of performance.” Id. at art. 430. Article 750 states: “The provisions of mandate [Articles 734–749] shall apply respectively to contracts on performance of services not regulated by other provisions.” The Polish Civil Code., 135 (O. A. Wojtasiewicz, trans., D. Kierzkowska, ed., 2000), , [hereinafter O. A. Wojtasiewicz, The Polish Civil Code]. Under this contract on performance of services a health care provider is obliged to perform treatment with due care and diligence required by the medical profession. He then guarantees medical attention free of faults and mistakes, and is not responsible for failure to achieve a certain result (a successful treatment or cure). M. Nesterowicz, supra note 10, at 75. Compare M. Sos´niak, Cywilna odpowiedzialnos´c´ lekarza, 30 (1st. ed., 1968). Article 471 states: “The debtor shall be obliged to redress the damage resulting from the non-performance or improper performance of the obligation unless non-performance or improper performance were due to the circumstances for which the debtor is not liable.” Wojtasiewicz, supra note 26, at 136. Article 474 states: “The debtor shall be liable, as for his own acts and omissions, for acts and omissions by the persons with the assistance of whom he performs the obligation, as well as the persons whom he entrusts with the performance of the obligation. The above provision shall also apply where the obligation is performed by the statutory representative of the debtor.”Id. at 136. In view of doctrine, in the field of medical malpractice contractual duties only strengthen and reinforce the general duty in tort to respect patients’ interest in the integrity of the body. Stefan Grzybowski, Odpowiedzialnos´c´ cywilna lekarza, Odpowiedzialnos´c´ cywilna za wyrza˛dzenie szkody 130, 133 (S. Grzybowski, ed., 1969).

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Code, the injured is entitled to choose legal grounds for seeking indemnity.30 In practice, patients prefer the ex delicto regime because of the wider scope of damages,31 including compensation for a non-pecuniary loss32 and the statute of limitations, which is far more convenient for a claimant (especially after the latest amendment of Article 4421 of the Civil Code).33 The plaintiff’s choice of liability provisions is binding on the court (bearing in mind that only one compensation may be awarded). However, it is not possible to create a “combined” regime which comprises certain (and most favorable for a claimant) elements of ex contractu and ex delicto liability.34 Civil liability, whether contractual or tortious, may be attributed to a doctor or a hospital when any of these persons’ own (faulty) acts or omissions result in damage. However, it may be also a hospital’s vicarious liability for injuries caused by fault of its doctors or other medical staff. 3. A doctor who works outside the scope of the NFZ insurance and renders medical services individually, within his own private practice (as an entrepreneur, within the meaning of the Business Activity Freedom Act

30

31 32 33

34

Article 443 states: “The fact that the act or omission from which the damage arose constituted the non-performance or the improper performance of a pre-existing obligation does not preclude a claim for damages in tort, unless the pre-existing obligation provides otherwise.” Bagin´ska, Pol. Civ. C., supra note 22, art. 443; see also the judgment of the Supreme Court of 28 April 1964 (II CR 540/63), OSPiKA 1965, item 197 and the judgment of the Supreme Court of 10 October 1997 (III CKN 202/97), OSN 1998/3, item 42. See infra note 144. See infra note 144. The Law of 16 February 2007, Dziennik Ustaw [Journal of Laws] 2007, No. 80, item 538 (in force since 10 August 2007). Section 3 of the amended Article 4421 states: “In a personal injury case, a claim shall not be barred before a period of three years from the date on which the injured learned about the injury and about the person obliged to redress it.” Section 4 states: “The claims of a minor for redress for damage resulting from personal injury shall not be barred before a period of two years from the date he obtains the age of majority” which is eighteen years. Bagin´ska, Pol. Civ. C., supra note 22, art. 421. Case law did make several attempts to create such a combination but this solution was finally disapproved by the Supreme Court. The only possibility is to claim compensation for pecuniary and non-pecuniary loss on appropriate grounds by means of the concurrence of liability if such a possibility in casu exists. In the judgment of 17 December 2004 (II CK 300/04), OSP 2006/2, item 20 cmt. by M. Nesterowicz, the Supreme Court admitted that claiming damages for material loss ex contractu (pursuant to Article 471 of the Civil Code) does not exclude the indemnification of pain and suffering (on the grounds of Article 445 of the Civil Code, in conjunction with Article 443) if the results of the improperly performed obligation (defective artificial limbs) are so grave for the injured person that they constitute at the same time a tort as defined by Article 415 of the Civil Code. See also M. Nesterowicz, Zados´c´uczynienie pienie˛ z· ne ex contractu i przy zbiegu odpowiedzialnos´ci deliktowej, Pan´stwo i Prawo 23 (2007/1).

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of 2 July 200435), bears civil liability for any damage resulting from his negligent conduct. Although there is, as a rule, a binding contract between that doctor and a patient, which gives rise to ex contractu liability (pursuant to Article 471 of the Civil Code), in the great majority of cases Article 415 of the Civil Code is applied concurrently. A patient may claim damages in tort even if certain obligations of the doctor laid down in the contract (e.g., the duty to pay additional visits, to perform an operation personally without delegating these tasks to a colleague, etc.) were not fulfilled or fulfilled improperly, provided the breach of these obligations has caused a personal injury. A doctor who runs his individual private practice and employs medical staff such as assistants, subcontractors, or subordinates (anesthesiologists, nurses, midwives, laboratory assistants, etc.) is liable for the misconduct of the members of that staff, regardless of whether the resulting damage is caused by his own fault. In such cases, liability is objective, based on the principle of risk pursuant to Article 474 of the Civil Code or Article 430 (applied concurrently as delictual grounds). Consequently, a doctor may not be exempt from it by proving that he was diligent selecting his subordinates or that he exercised proper supervision and control over the employed staff. However, a patient who suffered the damage must present the evidence of fault (negligence) of an individual perpetrator (a certain member of the doctor’s personnel) or at least (as far as Article 430 is concerned) prove the existence of the so-called anonymous fault (fault by an unidentified person).36 4. In the case where a doctor does not work individually but renders medical services in a health care facility, it is necessary to establish whether he performs treatment on the grounds of a contract of employment (as a hospital’s employee37 within the meaning of Article 2 of the

35 36

37

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Dziennik Ustaw [Journal of Laws] 2007, No. 155, item 1095, art. 4 (Pol.) as amended. Gerard Bieniek, Komentarz do Kodeksu cywilnego. Ksie˛ ga trzecia. Zobowia˛zania. Tom I 344 (G. Bieniek, ed., 2002). For discussion of the concept of anonymous fault, see infra notes 99–103. Pursuant to Article 44a of the Health Care Institutions Act, an employment relationship is obligatory for doctors – principals of a hospital and heads of a hospital. However, these doctors usually work as employees only part-time, while during the rest of the working time they render medical services as independent contractors. This situation creates difficulties, since in the case of damage inflicted on a patient it may be difficult to establish which of the two capacities of the doctor will be the legal basis for the case against him. See M. Nesterowicz, Odpowiedzialnos´c´ cywilna zakładu opieki zdrowotnej za lekarza jako podwładnego, Pan´stwo i Prawo 4 (2008/9).

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Labour Code38) or pursuant to a civil law contract (as a so-called independent contractor). The distinction is important, because if damage arises from medical malpractice, different provisions are applied and liability may be attributed to different persons. 4.1. A doctor who works as a hospital’s employee is protected under the provisions of the Labour Code. He is then not individually liable for the damage inflicted on patients in the course of treatment and due to his fault (so-called employee immunity, Article 120 § 1 of the Labour Code).39 Consequently, the injured person can pursue his claims only against the health care facility (the doctor’s employer, irrespective of whether it is a public hospital, a doctor’s cooperative, a medical center, or a private clinic), which is obliged to redress the damage (in full) according to the provisions of the Civil Code. The doctor who caused the damage does not act as a party in the lawsuit and he may appear in the court (if ever) only as a witness presenting evidence of the circumstances of the case.40 As case law provides, the exclusion of the doctor’s liability towards the patient extends also to the claims of the insurance company, which cannot recourse the doctor for the sums paid to the injured person on the grounds of Article 828 § 1 of the Civil Code (cessio legis).41 In the majority of malpractice cases, the injured persons are reimbursed on the grounds of Article 430 of the Civil Code, which constitutes the hospital’s objective (risk-based) liability for damage caused by fault (negligence) of a subordinate doctor.42 However, if medical care was rendered on

38 39

40

41

42

Law of 26 June 1974, Journal of Laws No. 24, item 141. The same rules are applied for doctors who render health care as functionaries (in a function-based relationship) in the armed forces, in the police, or in the prison medical service. M. Nesterowicz, supra note 36, at 125. This solution has been criticized by doctrine as being disadvantageous (and, as it is pointed out, unfair) for the injured. See M. Nesterowicz, Odpowiedzialnos´c´ cywilna za działania zespołów lekarskich, Materiały sympozjum naukowego Prawo a medycyna u progu XXI w. 50 (M. Filar, ed., 1987). See the resolution of the Supreme Court of 7 November 1977 (III CZP 80/77); OSN 1978/ 5 – 6, item 84. The Supreme Court ruled that the Labour Code is a special act introducing employee protection separate from the Civil Code, and Article 828 of the Civil Code, which constitutes the insuring party’s right assignment, is not applied thereto. In view of doctrine and case law, the relation of superiority (dependency) between the health care institution and the doctor exists, even though the latter is independent from a hospital as far as the professional sphere of medical activity (diagnosis and therapy) is concerned. See Ba˛czyk-Rozwadowska, supra note 5, at 189. Compare the judgment of the District Court in Lublin of 4 April 2002 (I C 656/99), Prawo i Medycyna 184 (2004/3), cmt. by M. Nesterowicz; the judgment of the Supreme Court of 13 December 2007 (I CSK 384/07), OSP 2009/2, item 20; and the judgment of the Appellate Court in Lublin of 4 March 2009 (I ACa 12/09), unreported.

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a contractual basis, outside the scope of the NFZ insurance, it is also possible to claim damages from a hospital ex contractu, pursuant to Article 474 of the Civil Code. The health care facility which has indemnified the injury (whether on the grounds of Article 430 or Article 474 of the Civil Code) acquires the right of recourse to the doctor. The recourse may be claimed if all premises of the tortfeasor’s liability are met, in particular the employee’s fault and the extent of the patient’s damage (Article 116 of the Labour Code). However, the scope of recourse is limited to a maximum of the threefold monthly remuneration of the employee (Article 119 of the Labour Code). The right to full recourse, which comprises the entire damage, may arise only when the injury was inflicted intentionally,43 when the doctor acted outside the course of treatment (without a functional connection to the execution of his vocational duties44), and when the hospital is insolvent or improperly insured (Article 122 of the Labour Code)45. In the aforementioned situations the restitutional function of compensation and the protection of the employer’s (hospital’s) interest in being reimbursed prevails over the necessity to safeguard the property of an employee. In order to be successful in claiming recourse (whether limited or full), a hospital must present all the facts that prove the doctor’s liability (in particular negligence or another kind of his unintentional fault), demonstrate the scope of the damage and establish the causal link between that damage and the doctor’s negligent improper (faulty) conduct. Obviously, if an individual perpetrator cannot be found or if it is impossible to establish his identity (e.g., in the case of anonymous fault), no recourse is possible. In practice, recourse claims (or suits) are very rare. Damages are usually paid to the injured person by the insurance company that a hospital has entered into a contract with, so there are in fact no grounds for recourse. On the other hand, if a health care provider itself indemnifies the injury, the matter of recourse is usually settled between the parties (the employer and the employee) by means of an out-of-court agreement (unless the

43

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As case law provides, damage caused by intentional fault is hardly ever a case in the field of medical malpractice. It may appear, e.g. when a doctor refuses to treat or to admit to a hospital a patient in an emergency situation. See M. Nesterowicz, Kontraktowa i deliktowa odpowiedzialnos´c´ lekarza za zabieg leczniczy, 85 (1972). See the judgment of the Supreme Court of 11 October 2007 (IV CSK 174/07), Przegla˛d Sa˛dowy 2008/9, 34 See also the resolution of the Supreme Court (in a panel of seven judges) of 7 June 1975 (III CZP 19/75), OSN 1976, item 20 and the judgment of the Supreme Court of 11 April 2008 (II CSK 618/07), ZDP 2009, item 41.

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employer has renounced the pursuance of this limited indemnity at all). This solution is particularly favorable for the doctor, who may then have his indemnity reduced. Such a reduction is usually made after consideration of all circumstances of the case, in particular the economic status of the doctor, his family’s living conditions, as well as his attitude towards professional tasks and obligations. However, the refund a doctor is obliged to pay may not be reduced if the damage was caused intentionally or when the doctor was convicted by a criminal court (with a final verdict) for not fulfilling (neglecting) his vocational duties..46 4.2. A doctor who performs treatment in a health care facility on the grounds of a civil law contract (which may be a contract of rendering services within the meaning of Article 750 of the Civil Code or a contract of granting an order to perform treatment regulated by Article 35 Sections 1– 4 of the Health Care Institutions Act of August 31, 1991) is not protected under the provisions of the Labour Code. Consequently, he bears civil liability for any damage inflicted on patients in the course of treatment, pursuant to Article 415 of the Civil Code. Liability of an independent contractor is joint and several with the health care institution with which the doctor has concluded a contract, pursuant to Article 441 Section 1 of the Civil Code47 or Article 35 Section 5 of the Health Care Institutions Act (for contracts of granting an order to perform treatment48).49 As case law provides, it is not possible for a doctor to prove in the malpractice suit that he contributed to the existence or emergence of damage to a lower or greater extent than the other joint tortfeasor (a hospital or another doctor.50 Since Article 441 of the Civil Code (as a ius cogens mandatory provision) accepts no exceptions to the joint and several liability, each of the defendants (tortfeasors) should be ready to compensate all the damage sustained by the patient (however, with the right to recourse after the injured is fully reimbursed).51

46 47 48

49 50

51

Nesterowicz, supra note 10, at 126. Section 1 of Article 441 states: “If several persons are liable for damage caused by a tort, their liability is joint and several.” Bagin´ska Pol. Civ. C., supra note 22, art. 441. These contracts are concluded by doctors with a public health care facility as a subcontract to the main contract between the facility and the National Health Fund. Ba˛czykRozwadowska, supra note 5, at 145. Nesterowicz, supra note 10, at 67. The judgment of the Supreme Court of 2 December 1970 (II CR 542/70), OSN 1971, item 153 and the judgment of the Supreme Court of 25 August 1978 (III CZP 48/78), OSN 1979/4, item 64 The judgment of the Supreme Court of 2 December 1970 (II CR 542/70), OSN 1971, item 153 and the judgment of the Supreme Court of 25 August 1978 (III CZP 48/78), OSN 1979/4, item 64. Compare Bieniek, supra note 36, at 398–399.

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In the case of multiplication of possible defendants, patients usually proceed against a health care institution since that sort of party (debtor) makes recovery easier than an individual perpetrator. The institution’s recourse against the individual perpetrator is subject to the provisions of the Civil Code, and its scope depends on the circumstances of a given case. Full recourse is possible when damages are paid by a hospital which indemnifies the patient, in spite of the lack of its fault, provided the injury was caused by fault or another kind of negligence on the part of the doctor (Article 441 § 3 of the Civil Code).52 However, if the damage resulted from the improper conduct of both a doctor (who, e.g., performed an operation negligently) and the health care institution (which, e.g., did not provide the doctor with the adequate surgical equipment) and only the latter redressed the injury in full, it may demand from the doctor the refund of an appropriate part according to the fault of that person and the extent to which he contributed to the emergence of the damage (Article 441 § 2 of the Civil Code).53 5. Liability of a health care provider may arise in the case where the damage is inflicted on a patient as a result of the improper organization or mistakes in the functioning of a hospital itself. Circumstances of that kind constitute the so-called organizational fault (wina organizacyjna), which, as a legal person’s own fault, shall not be attributed to a certain member of medical staff (in particular, a doctor) but to the entire health care institution.54 Consequently, the legal grounds for a hospital’s liability are, as a rule, Article 415 of the Civil Code (or, less often, Article 416 of the Civil Code if damage is caused by fault of a legal person’s agency55), in

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53

54

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Section 3 of Article 441 states: “A person who redresses the damage for which he is liable in spite of the absence of fault has a right of recourse against the perpetrator if the damage occurred due to the latter’s fault.” Bagin´ska, Pol. Civ. C., supra note 23, art. 441. Section 2 of Article 441 states: “If the damage resulted from acts or omissions of several persons, the person who redresses the damage may demand reimbursement from the others of the appropriate part depending on the circumstances of the case, in particular the fault of the given person and the degree to which the latter contributed to the occurrence of the damage.” Bagin´ska, Pol. Civ. C., supra note 22, art. 441. As of 1 January 1999 (in consequence of the reform of the health care system) public health care providers (samodzielne publiczne zakłady opieki zdrowotnej) were granted legal personality and they may bear their own responsibility. Liability for damage incurred in private hospitals may be attributed to a person or institution that runs the hospital (as its founding entity), e.g. a partnership, foundation, legal or physical person, or a religious union. Ba˛czyk-Rozwadowska, supra note 5 at 124; see also U. Drozdowska, Problematyka odpowiedzialnos´ci cywilnej zakładów opieki zdrowotnej – wybrane zagadnienia, Radca Prawny 22 (2002/3). See the judgment of the Supreme Court of 13 V 2005 (I CK 662/04), OSP 2009/12, item 134 and the judgment of the District Court in Szczecin of 26 April 2007 (II CSK 2/07), OSP 2009/1, item 6.

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concurrence with Article 471 when the patient was treated on a commercial basis, outside the scope of the insurance scheme (Article 443 of the Civil Code). As case law provides, the improper organization or malfunctioning of a hospital may appear in many forms. First, the health care provider can bear liability for a failure to provide patients with a “safe hospital stay.”56 The hospital should then take all necessary precautions to ensure the expected hygiene and safety standards to prevent risks of any harm. Furthermore, hospital facilities and furnishing ought to be designed in the way that prevents accidents, like slipping on a wet floor or falling off a hospital bed or operating table.57 According to case law, the scope of the duty to provide a safe stay depends on the type of health care facility as well as the patient’s health condition. For example, a mental hospital is obliged to take special precautions to ensure the total care to the unconscious and mentally disturbed patients to prevent them from injuring themselves (the judgment of the Supreme Court of 19 November 1969, II CR 294/69)58 and third parties (other patients, visitors to the hospital, and passers-by; pursuant to the judgment of the Supreme Court of 15 June 1981, I CR 174/81).59 The duty to provide a safe hospital stay also includes protecting patients from infections (such as hepatitis B and C, the HIV-virus, staphylococcus, etc.) which may be acquired in connection with the treatment (nosocomial infections).60 The health care provider is then obliged to maintain the sufficient conditions of the hygiene and asepsis to avoid transmitting

56

57 58

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According to statistical data, injuries caused by a failure to provide patients with a safe hospital stay result in ten percent of all malpractice suits. Adam Makosz, Szpitale płaca˛ coraz wie˛ cej za błe˛ dy lekarskie, Gazeta Prawna, (July 13, 2010). M Nesterowicz, Odpowiedzialnos´c´ cywilna zakładu leczniczego za bezpieczen´stwo pacjenta podczas hospitalizacji, Pan´stwo i Prawo 40 (2001/3). OSPiKA 1970, item 249. This case concerned a patient who, due to the lack of a proper supervision of the hospital’s staff, managed to jump out of the window and suffered serious injuries. It is important to mention that such behavior was not qualified by the court as a patient’s contribution to the damage. See also the judgment of the Appellate Court in Poznan´ of 28 June 1995 (I ACr 39/95), OSA 1996/7-8, item 36. In this case a patient, who had previously manifested suicidal tendencies, was able to leave hospital on his own and to bring about his death by a train. OSPiKA 1982/11, item 188. This case concerned a mentally disturbed patient who had arbitrarily left hospital and inflicted damage on a passer-by. Nosocomial infections are still a great problem for Polish hospitals, since they concern around 24 % of all malpractice suits. Adam Makosz, supra note 56. According to statistical data, in the late 1990’s, 60 % of adult patients and 80 % of minors under the age of two were infected with hepatitis B at hospitals. W. Magdzik, Wirusowe zapalenie wa˛troby typu “B” jako zakaz· enie szpitalne, Profilaktyka i zwalczanie zakaz· en´ szpitalnych, materiały Sympozjum Kierowniczej Kadry Medycznej 15 (1997).

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contagious diseases and spreading bacteria.61 This duty includes the use of properly sterilized equipment and appliances,62 as well as separating those who are infected or who might be carriers of certain viruses from the rest of the patients treated in the same ward (department).63 In the judgment of the Supreme Court of December 14, 1973 (II CR 692/73),64 a hospital was found liable for the damage suffered by a patient who had had his wound infected after surgery (cyst removal). In the court’s opinion, the injury (gaseous gangrene) was due to the breach of hygiene standards by the medical personnel who had not dressed the wound in the treatment room but in the sick room, where there had been other patients suffering from serious bacterial infections. Furthermore, the hospital’s ward was overcrowded and not cleaned properly (with dirt, dust, and insects in the sick rooms) to provide a safe treatment.65 In another judgment of July 10, 1998 (I CKN 786/97),66 the Supreme Court admitted that infecting a patient with a contagious disease (hepatitis B) at the defendant’s hospital proves that the latter failed to provide this patient with a safe hospital stay. Omission as such constituted negligence for which a hospital was liable on the grounds of Article 415 of the Civil Code. The duty to provide safe treatment also extended to prevention of hospital-acquired infections. Secondly, a hospital may be responsible for injuries which result from the use of faulty and defective medical equipment. In the judgment of May 11, 1983 (IV CR 118/83),67 the Supreme Court ruled that a health care facility was obliged to take special care of its apparatuses, surgical instruments, and other treatment appliances so that they would not be dangerous either for patients or for the operating team. Therefore, it is necessary for a hospital to undergo periodical check-ups of all equipment, carried out by professional service providers. Moreover, doctors are obliged to exercise ad hoc control before each use of the apparatus and medical instruments in order to find any visible defects or faults that may cause 61 62 63 64 65

66 67

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See the judgment of the Appellate Court in Kraków of 14 October 1992 (I ACr 374/92), OSA 1992, item 44. The judgment of the Supreme Court of 28 October 1983 (II CR 358/83), OSPiKA 1984, item 187. The judgment of the Appellate Court in Wrocław of 28 April 1998 (I ACa 308/98), Prawo i Medycyna 147 (2002/12) cmt. by M. Nesterowicz. OSPiKA 1975, item 94. See also the judgment of the Appellate Court in Lublin of 2 May 2006 (I C 496/04, unreported), concerning a newborn infected with septicaemia (sepsis) due to failure to observe hygiene requirements at the defendant’s hospital. Unreported. OSN 1983/12, item 201. This case concerned a patient who had suffered serious burns as a result of the use of a defective electric knife during lung surgery.

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an injury.68 However, liability of a hospital may not arise if the damage inflicted on a patient results from latent defects that came into being during the manufacturing process (due to faulty construction or use of improper materials) and the doctor who was applying the equipment could not have detected the defects and, consequently, could not have avoided the injury, in spite of being careful and diligent.69 Injuries of that kind should be, as a rule, indemnified by the producer, importer, or professional seller of the medical equipment, pursuant to Article 4491 of the Civil Code, which constitutes a strict product liability regime.70 Thirdly, a health care facility may be responsible for the damage caused by an unjustified refusal to admit a patient to the hospital and the delay in rendering necessary medical care (only if, by means of immediate help, the injury could have been avoided) as well as for injuries resulting from lack of a sufficient number of properly qualified doctors (anesthesiologist, surgeons, etc.) and other members of medical personnel (nurses, midwives, laboratory assistants, etc.). The rule is that a hospital, whether public or private, cannot (and has no right to) refuse the treatment and care if a patient requires immediate assistance because of an emergency situation in which his health or life is threatened (Article 7 of the Institutional Health Care Providers Act). In the judgment of December 11, 2002 (I CKN 1386/00),71 the Supreme Court explained that a refusal to treat a patient and perform a medically justified and necessary operation in a public hospital cannot be a free decision of a doctor. In the court’s opinion, such a refusal should always be confirmed by a specialist in the respective field of medicine and described in detail in the patient’s medical record. Otherwise, the hospital may be responsible not only for a further deterioration of the patient’s health but also for the lack of improvement (losing the chance of improvement) which could have appeared if he had been given the necessary treatment.

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69 70

71

See the judgment of the District Court in Lublin of 4 April 2002 (I C 656/99), Prawo i Medycyna 122 (2004/3), cmt. by M. Nesterowicz (concerning a patient who suffered serious burns to his feet and tissue necrosis as a result of the use of a faulty thermophore after a kidney operation). See also Kinga Ba˛czyk-Rozwadowska, Odpowiedzialnos´c´ cywilna za szkody wyrza˛dzone pacjentom w zwia˛zku z uz· yciem wadliwego lub niesprawnego sprze˛ tu medycznego, Prawo i Medycyna 57 (2002/11). Nesterowicz, supra note 10, at 378. There is a proposal in the doctrine that a hospital should be attributed strict liability (pursuant to Article 4491 of the Civil Code) for all damages caused by defective equipment, however with the right of recourse to the manufacturer or seller of that equipment. Id. Reported in the electronic version – LEX 75348.

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Fourthly, an improper organization of a hospital may consist of “technical” faults and mistakes that cause the damage. According to case law and doctrine, an example may be an erroneous identification of a patient which results in performing the treatment (surgery) on a wrong person. In the judgment of 10 December 1952 (C 584/52),72 the Supreme Court found a hospital liable for the injury suffered by a patient who had mistakenly had her uterus removed instead of having her uterine cervix sutured following rupture during delivery (which was a routine treatment). The court held that the injury resulted from the improper organization of the hospital, in particular from the mistakes of both a nurse who had prepared and brought the wrong person to the operating room as well as a doctor who had failed to verify the patient’s identity, examine her, or check the medical records before a sophisticated operation. Another example of a technical mistake that may give rise to hospital liability for improper functioning is a disorder (disarray) in medical records which resulted in a long-term, compulsory, and burdensome treatment of a patient who, in fact, did not suffer from tuberculosis but had been mistakenly handed the results of another patient’s diagnostic test by a member of the hospital’s staff and then treated as a person suffering from it (the judgment of the Supreme Court of 4 July 1969, PR 179/69).73 6. Civil liability of health care providers coexists with civil liability (third party) insurance. Since 2007, this insurance has been obligatory for all health care providers (whether public or private hospitals, doctors, or other members of medical staff) that render medical services on the grounds of contracts concluded with the National Health Fund (pursuant to Article 136 (b) of the Publicly-Funded Health Care Services Act). Liability insurance is also compulsory for independent contractors who render health care in hospitals pursuant to contracts of granting an order to perform treatment on the grounds of Article 35 of the Institutional Health Care Providers Act. In each of the aforementioned cases, liability insurance is a necessary premise (a prerequisite) of entering into a contract to perform treatment and, consequently, becoming a participant of the health insurance scheme. The scope and conditions of both kinds of insurance are regulated in a detailed manner in the Ordinances of the Minister of Finance.74

72 73 74

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Pan´stwo i Prawo 366 (1953/8–9). OSN 1970, item 71 cmt. by M. Nesterowicz. See the Ordinance of 23 December 2004 (concerning compulsory liability insurance of health care providers concluding contacts of granting an order to perform treatment). Journal of Laws 2004, No. 283, item 2825; see also the Ordinance of 28 December 2007

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An even newer solution is compulsory liability insurance for all doctors that render medical services in Poland pursuant to the amended Article 48 (b) of the Physician’s and Dentist’s Professions Act (Ustawa o zawodach lekarza i lekarza dentysty) of December 5, 199675). Since January 1, 2010, these doctors have been obliged to have insurance coverage, irrespective of whether they run an individual or a group private practice (in a form of a partnership, doctors’ cooperative, etc.) or work in a public or private health care facility (a hospital, medical centre, clinic, etc.). The only exceptions are doctors who render medical services exclusively on the grounds of a contract of employment as employees within the meaning of the Labour Code (Article 48(b) Section 2 of the Physician’s and Dentist’s Professions Act). As previously mentioned, they do not bear civil liability for the damage inflicted on patients in the course of treatment, and Article 120 of the Labour Code provides them with sufficient legal protection.76 The scope and terms of the new liability insurance are regulated in a detailed manner in the Ordinance of Minister of Finance of 26 April 2010.77 According to its provisions, the insurance covers all injuries inflicted on patients due to the faulty acts and omissions of an insured doctor, provided the damage is caused in the course of treatment and within the doctor’s vocational duties (§ 1 of the Ordinance).78 There is no possibility for an insurance company to limit its duty to pay indemnities in the insurance contract (§ 2 point 3 of the Ordinance). The minimum insurance sums have been established with respect to the types of medical specialization.79

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77 78

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(concerning compulsory liability insurance of health care providers). Journal of Laws 2008, No. 3, item 10. Dziennik Ustaw [Journal of Laws] 2008, No. 136, item 857 (Pol.). Article 48b was amended by the new Law on Medical Chambers of 2 December 2009 (Dziennik Ustaw [Journal of Laws] 2009, No. 219, item 1708). The Announcement of the Secretary of State M. Twardowski of 25 January 2010 (concerning the compulsory liability insurance of doctors who render medical services exclusively on the grounds of a contract of employment). Dziennik Ustaw [Journal of Laws] 2010, No. 78, item 515 (Pol.). The Ordinance came into force on 12 June 2010. The exclusions of the insurer’s liability, enumerated in § 2 points 1–4 of the Ordinance, concern e.g. injuries to property, injuries resulting from contractual indemnities a doctor is obliged to pay, injuries inflicted on patients after the suspension of the right to perform treatment, and injuries resulting from vis maior incidents and acts of terror. Id. The minimum insurance sums are as follows: the PLN equivalence of 100,000 E for doctors who specialize in oncology and clinical oncology, anesthesiology, gynecology and obstetrics, intensive care, urology, neurology, laryngology and otolaryngology, emergency medicine, ophthalmology; the PLN equivalence of 50,000 E for dentists and dental surgeons; and the equivalent of 25,000 E for remaining doctors.

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The idea of obligatory insurance for all health care providers is of significant importance and should not be underestimated. Since currently all doctors and institutional health care providers, both participants and nonparticipants of the health insurance scheme, have coverage, the goal to provide patients and health care professionals with a sufficient protection (offered by complex liability insurance) seems to have been achieved.

II.

Liability Based on Fault

1.In all fields of medical malpractice, civil liability is based on fault. As previously mentioned, fault may be a necessary premise of a doctor’s or hospital’s liability for their own acts and omissions which cause the damage. If fault is committed by a member of medical staff (in particular, a doctor), it may constitute a prerequisite of that hospital’s vicarious liability, even when it appears in its objective-like form of the so-called anonymous fault. Fault usually consists of negligence (niedbalstwo), which is defined as failure to work with due care and diligence while treating a patient. The doctor’s conduct is negligent if, according to the current state of medical knowledge, a doctor has not exercised due care required by the profession.80 Apart from negligence, fault may involve any kind of carelessness, lack of skill, inadequate attentiveness, imprudence, or insufficient knowledge. The study of case law proves that a doctor’s or hospital’s fault may, in particular, consist of performing an obviously unnecessary operation or treatment;81 rendering medical care without required qualifications, unless there is an emergency situation (the judgment of the Supreme Court of October 9, 1945, C I 188/4582); prescribing improper drugs (the judgment of the Supreme Court of 3 December 195883); leaving surgical instruments in the patient’s body after an operation (the judgment of the Supreme Court of 25 February 1972; II CR 610/7184); or omitting necessary care or diagnostic tests (the judgment of the Supreme Court of 10

80

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B. Lewaszkiewicz-Petrykowska, Wina lekarza i zakładu opieki zdrowotnej jako przesłanka odpowiedzialnos´ci za szkody wyrza˛dzone przy leczeniu, Prawo i Medycyna 125 (1999/1); M. Sos´ niak, supra note 26, at 122; M. Nesterowicz, Kontraktowa, supra note 43, at 84. The judgment of the Supreme Court of December 10, 1952, C 584/52. Zbiór Orzecznictwa SN 1945-46, item 18. Pan´stwo i Prawo 200 (1960/1). Nowe Prawo 1349 (1973/9). The case concerned a patient, who had suffered an injury as a result of a small piece of bone forceps being left in his skull (epicranium) after a brain operation.

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March 2006; IV CSK 80/8585). In the judgment of 29 September 2000 (V CKN 527/2000),86 the Supreme Court held that it was a doctor’s fault to have accidentally severed a healthy organ (common hepatic duct) during an operation in the abdominal cavity (a removal of chollecystis). The rule is that damage as such may not burden a patient and cannot be treated as a risk which a patient accepts while giving his valid consent to surgery (the judgment of the Supreme Court of 9 January 1971, II CR 421/71).87 The standard of due care is objective in nature, oriented towards what is expected in medicine as required at the time of the treatment.88 In practice, the courts in medical malpractice suits establish the scope of doctor duties and the desired standard of care (which is an abstract model of an experienced, diligent doctor of a respective medical discipline) and compare it to the conduct in question, taking into consideration all relevant circumstances of the given case, like the time and place of performing the treatment, the urgency of the procedure, the condition of the patient, etc.89 The required duty of care is then related to medical specialization. Therefore a specialist-standard ought to be applied if any doctor (whether an expert in a certain field of medicine or not) undertakes treatment requiring specialized knowledge and skills, unless there is a case of emergency.90 The standard of care has been set at a high level because of the professional nature of doctor and hospital activity (according to Article 355 § 2 of the Civil Code, which requires higher diligence standards from all professionals) and the object of this activity, which are the most precious human interests such as human health and life. In the judgment of October 29, 2003 (III CK 34/02)91 the Supreme Court stated that a doctor was obliged to perform treatment in accordance with the highest due care that could be required from a professional in view of current medical knowledge. The doctor’s fault may then consist in a failure to exercise the highest diligence that is possible in the course of certain medical procedures and

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OSP 2007/1, item 11. OSN 2001/3, item 42. M. Nesterowicz, Prawo medyczne 45 (7th ed., 2005). Id. Id. See the judgment of the Supreme Court of 9 October 1945 (C I 188/45), Zbiór Orzecznictwa 1945-46, item 18. In this case a patient died after having haematoma removed by gynecologist instead of a qualified surgeon. The court found the operation unnecessary and medically unjustified since there had existed some other, less radical, ways to treat haematoma. OSP 2005/4, item 6.

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treatment of the diseases of particular types (the judgment of the Appellate Court in Kraków of October 12, 2007, I ACa 920/07).92 As case law also points out, the standard of care that medical professionals should observe ought to be the highest possible since the consequences of a doctor’s conduct may be serious, far-reaching, and sometimes irreversible (the judgment of the Appellate Court in Kraków of March 9, 2001, I ACa 124/0193). It is then irrelevant whether the source of the doctor’s obligation to perform treatment is a contract or a statutory provision. A duty to observe high standards of care is always the same (identical in content), because a patient is at all times entitled to professional care based on the standard of an experienced physician in a respective medical discipline. Also, financial considerations cannot modify this duty, because once the doctor-patient relationship exists, it remains the same whether the services are rendered gratuitously or for an ordinary payment.94 However, the requirements to observe high standards of care cannot lead to the imposition on doctors such duties that are impossible to be performed in practice. In view of case law and doctrine, this solution would mean the doctor’s sui generis liability based on the principle of risk, which obviously contradicts the nature of the medical profession (the judgment of the Appellate Court in Warszawa of March 3, 1998; I ACa 14/98).95 Fault usually exists in a form of negligence, but it may also appear as gross negligence.96 As case law provides, dolus [intent] (whether directus [purpose] or eventualis [knowledge of consequences]) appears but sporadically in medical malpractice suits. In the doctrine, a distinction is also made between fault which concerns medical aspects of a doctor’s activity (e.g., lack of sufficient knowledge and skills, imprudence and negligence) and fault of another kind (lack of a proper supervision over the patient, an

92 93 94 95

96

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Prawo i Medycyna 124 (2010/1). Przegla˛d Sa˛dowy 132 (2002/10). Nesterowicz, supra note 10, at 86. Wokanda 1998, item 10. In this case, a newborn who had suffered from pneumonia was infected with hepatitis B during his blood transfusion. The defendant’s hospital proved its due diligence by showing that the blood for the plaintiff had been purchased from a blood donation centre, stored in accordance with all necessary procedures and transfused with sterile, single-use equipment by qualified medical staff. The court admitted that an omission to check the blood’s quality could not constitute the hospital’s fault (negligence) because the donation centre was obliged to supply “safe blood”, free of viruses. However, compensation was granted on the grounds of the principle of rightness (boni mores) and equity, pursuant to Article 419 of the Civil Code, derogated in 2004. The judgment of the Supreme Court of 22 March 1973 (I CR 73/73), unreported; Miroslaw Nesterowicz, Commentary on the judgment of the Appellate Court in Lublin of 1 February 2006 (I C 213/04), Prawo i Medycyna 128 (2009/4).

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unjustified refusal to render medical services, performing treatment without the patient’s consent, etc.).97 However, as a rule, a certain degree of fault or its type does not have to be proved, since culpa levissima (the slightest fault) is sufficient to attribute liability to either a doctor and a hospital in the ex delicto regime.98 On the other hand, in the case of ex contractu liability, any contractual exclusion of intentional fault is invalid, pursuant to Article 473 § 2 of the Civil Code. Furthermore, any stipulation which limits a doctor’s or hospital’s liability for negligence (culpa levis) should be deemed null and void as contrary to law and the principles of rightness (boni mores) and equity (zasady słusznos´ci) on the grounds of Article 58 § 2, Article 3531 and Article 3853 point 2 of the Civil Code. 2. Since fault is a subjective premise of civil liability, proving it requires a thorough analysis of an individual perpetrator’s decision concerning his unlawful conduct (an act or omission). In particular, a court should verify whether a doctor could have avoided causing damage if he had performed the treatment with due care and diligence required in the circumstances.99 However, in the field of medical malpractice, a prerequisite of fault may be fulfilled even if the subjective fault mentioned above is missing. According to the theory of anonymous fault (wina anonimowa), in the case where it is impossible to determine the damage perpetrator for whom a hospital is vicariously liable, the latter may be attributed liability provided that the damage has been caused by negligence of an unidentified member of the hospital’s staff (a doctor, a nurse, a laboratory assistant, etc.).100 Since in such cases fault is assumed without identifying damage perpetrator, evidence of unlawfulness of a certain medical conduct is effectively sufficient to claim damages.101 The concept of anonymous fault is of significant importance because it simplifies proof of fault for those plaintiffs who otherwise could have serious problems with receiving due indemnity. Therefore, anonymous fault is applied relatively often in medical malpractice cases. In the judgment of December 29, 1993 (I C 298/92)102 the District Court in Bydgoszcz found a hospital liable for injury suffered by a patient who had been infected with hepatitis B due to a failure to observe requirements of Nesterowicz, supra note 10, at 81. B. Lewaszkiewicz-Petrykowska, supra note 80, at 125. Id. Nesterowicz, supra note 10, at 371; see also the judgment of the District Court in Bydgoszcz of 29 December 1993 (IC 298/92), unreported. 101 M. Safjan, Prawo i medycyna. Ochrona praw jednostki a dylematy współczesnej medycyny 85 (1998). 102 Nesterowicz, supra note 10, at 371. 97 98 99 100

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hygiene by one of its doctors, whose identity could not be established. In the court’s opinion, the impossibility to identify the damage perpetrator could not release the hospital from liability (on the grounds of Article 430 of the Civil Code103) if it was proved that negligence had existed and resulted in the emergence of that damage. Therefore, it was not relevant which of the doctors had been culpable, provided that the injury had been causally connected with a failure to neglect the professional duties.104 3.In the field of medical malpractice a distinction is made between fault and medical error (or, more precisely, error in the medical art105). Both case law and doctrine have defined medical error narrowly, as conduct concerning the professional sphere of a physician’s activity, which is diagnosis and therapy inconsistent with medical knowledge accessible to the doctor at the time of treatment (the judgment of the Supreme Court of 1 April 1955, IV CR 39/54).106 A misconduct which involves other areas of the doctor’s performance (different from diagnosis and therapy) cannot be deemed as error. As case law provides, an example is leaving medical instruments in the patient’s body after an operation, a breach of requirements of hygiene and asepsis, using defective medical equipment, exposing a patient to an excessive dose of X-ray radiation, mistakes in medical records and documentation, and mistakes in the results of diagnostic tests.107 However, misconduct as such may also give rise to civil liability of a doctor or hospital if all premises of that liability have been in casu fulfilled.108

103 Bieniek Commentary 2002, supra note 36, at 343. 104 Compare the judgment of Supreme Court of 26 May 1994 (II CRN 244/94), unreported; see also the judgment of the Supreme Court of 21 November 1974 (II CR 638/74), OSPiKA 1975, item 108 and the judgment of Supreme Court 17 April 1974 (II CR 13/ 74), OSPiKA 1974, item 207, adjudicated on the grounds of art. 417 of the Civil Code (in the wording preceding the amendment of 17 June 2004). 105 There is an ongoing dispute in doctrine concerning the notion of error. See Kinga Ba˛czyk-Rozwadowska, Bła˛d lekarski w s´wietle doktryny i orzecznictwa sa˛dowego, Prawo i Medycyna 5 (2009/3). Compare M. Nesterowicz, Kontraktowa, supra note 43, at 78; Agnieszka Liszewska, Odpowiedzialnos´c´ karna za bła˛d w sztuce lekarskiej, 24 (1998); Zdzisław Marek, Bła˛d medyczny. Odpowiedzialnos´c´ etyczno-deontologiczna i prawna lekarza, 35 (2007). 106 OSN 1957/1, item 7. 107 For example, in the judgment of 17 February 1967 (I CR 435/66), OSN 1967, item 177, the Supreme Court ruled that an infringement of the duty to apply rules of asepsis during surgery could not be considered an error because observing such rules constituted an essential obligation of all members of the hospital’s staff and had not required special medical knowledge. 108 This distinction was made before the Civil Code came into force (in the mid 1950’s) when case law admitted that a hospital could be vicariously liable for a doctor only when the latter had committed an error, while liability for negligence of another kind

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Error in the art of medicine in the aforementioned, narrow, meaning is an objective category (as some authors point out – an objective component of fault109), which does not refer to a person who commits it or to the circumstances of the given case. As such, error does not determine the provider’s liability per se. If the doctor is to be made liable, his wrongdoing should be, at the same time, negligent. In the case where there is no negligence, liability for error may not arise, even if damage exists and is causally connected with the doctor’s improper conduct. In view of case law, there are, in particular, no grounds for the doctor’s liability if a healthy patient, manifesting symptoms of a certain disease, is mistakenly diagnosed with an illness and the following treatment is not detrimental to that patient (the judgment of the Supreme Court of December 8, 1970; II CR 543/70110). A similar ruling could be passed if, for example, an injury occurred as a result of anatomical abnormalities which could not be predicted before an operation and also in the case when the current state of medical knowledge made it impossible for the doctor to diagnose a rare illness, as yet not described in the literature. 4. In the case when certain medical misconduct is subject to both civil and criminal proceedings, there is no duty to establish negligence twice. Pursuant to Article 11 of the Code of Civil Proceedings of November 17,1964,111 if a doctor was convicted of a criminal offense, factual findings concerning his faulty conduct which served as grounds for the final sentence of the penal court are binding for a civil court in the following civil proceedings.112 Therefore, if negligence (as a fault which justifies the tortfeasor’s criminal liability) has already been established by the criminal court, the civil court takes for granted the fact that a tort (delict) has been committed and, consequently, establishes only the existence of a causal link (probability) and the damage and also ascertains the scope of com-

109 110 111 112

might be attributed only to an individual doctor. See Ba˛czyk-Rozwadowska, supra note 5 at 55. Nesterowicz, supra note 10, at 79-80. OSN 1970, item 137. Law of 17 November 1964, (Dziennik Ustaw [Journal of Laws] 1964, No. 43, item 296 (Pol.) – as amended. Criminal liability of doctors (and other members of medical staff) is governed by the general provisions of the Penal Code (Law of 6 June 1997; Journal of Laws 1997, No. 88, item 553 – as amended), concerning unintentional crimes and offenses against life and health (Chapter XIX of the Penal Code). There is no special model of “medical liability,” except in Article 192, which penalizes performing treatment without the patient’s consent; Articles 150 and 151, concerning euthanasia; Articles 152–153, involving voluntary and involuntary abortion; and Article 157a, which concerns prenatal injuries. See M. Filar, Lekarskie prawo karne 84 (2000).

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pensation. In the criminal case of August 19, 1953 (IK 295/53)113 adjudicated in the last instance by the Supreme Court, the lower courts established fault of an obstetrician who had left the hospital during his working hours while his patient was going through a complicated childbirth. Lack of proper, highly qualified medical care and continued supervision had resulted in a rupture of the uterus, excessive bleeding, and the patient’s death, for which the doctor was found criminally liable. Omission as such constitutes a delict of civil law and could serve as grounds for a compensation claim (of the family members of the deceased, pursuant to Article 446 of the Civil Code). However, if the criminal proceedings have not been finished yet, but the ascertainments that have already been made may influence the settlement of a civil case, the civil court can (and, in practice, usually does) suspend the proceedings until the final judgment of the criminal case. The same situation occurs when criminal proceedings have not been started yet.114 It is also worth mentioning that when a criminal action fails (e.g., the proceedings are discontinued due to the death of the perpetrator), civil litigation is still able to proceed and, as case law proves, may influence the burden of proof that a plaintiff is obliged to carry. In the judgment of the Supreme Court of 23 July 2004 (III CK 0071/03)115 the fact that a doctor had been found guilty of the criminal offense of exposing a patient to the direct danger of losing his life or suffering from a significant bodily impairment (Article 160 § 2 and § 3 of the Penal Code) served as grounds for determining causality in a civil litigation suit. In particular, it is possible to presume the existence of a causal link between the perpetrator’s faulty conduct and the damage (pursuant to Article 231 of the Civil Code) even if a criminal court has not in casu established causality in a way that is required by Article 361 § 1 of the Civil Code (and – as such – is binding for the civil court by virtue of Article 11 of the Code of Civil Proceedings).116

113 Pan´stwo i Prawo 381 (1954/2). 114 The judgment of the Supreme Court of 27 November 1961 (II CR 1043/60), OSN 1963/ 2, item 35.; see M. Je˛ drzejewska, K. Weitz, Kodeks poste˛ powania cywilnego. Cze˛ s´c´ pierwsza. Poste˛ powanie rozpoznawcze, t. I, 118–119 (T. Erecin´ski, ed., 2009). 115 Unreported. In this case a patient died one day after he had left hospital. The reason of his sudden death was a rupture of an abdominal aortic aneurysm which was not diagnosed properly by a rentgenologist (error in diagnosis) and, consequently, not treated at all by a cardiologist (therapeutical error). 116 In the discussed case the rentgenologist was found guilty of causing a direct threat to the patient’s life (which is only a formal offense that does not require the result of faulty conduct of an accused) but not for the death itself. However, the mere fact of conviction allowed the civil court to assume that there had been a causal link between

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III. Burden of Proof and Causation 1. The general rule is that a patient is burdened with proving damages, fault and a causal connection between the faulty conduct and damages (Article 6 of the Civil Code). However, in the field of medical malpractice, these strict requirements have been lowered by case law in order to be more convenient for a claimant. Otherwise it would be too difficult (if not impossible) to establish negligence and to explain whether the damage resulted from the doctor’s wrongdoing or whether the issue was only the progression of the patient’s initial disease.117 1.1. While in the ex contractu regime the defendant’s fault (concerning his own act and omissions) is statutorily presumed on the grounds of Article 471 of the Civil Code,118 no such statutory presumption exists for tortious liability. However, in the ex delicto regime the doctor’s or hospital’s fault and/or causation may be established by means of a factual presumption (indirect evidence). According to Article 231 of the Code of Civil Proceedings, the court is allowed to determine fault if, after taking into consideration the findings that were previously made, it is possible to draw the conclusion that such fault really exists. In other words, fault must be obvious in view of all circumstances of the case, unless there is evidence to the contrary. From that point of view, factual presumption serves as prima facie evidence, quite similar to the res ipsa loquitur (“things speak for themselves”) rule adopted in common law jurisdictions.119 Prima facie evidence is usually applied by courts in medical malpractice cases concerning a hospital’s failure to provide patients with a safe hospital stay, in particular, the so-called sponge cases and healthcarerelated (nosocomial) infections involving hepatitis B or C, staphylococcus and the HIV-virus. As for the first category, the court deems negligence obvious when it establishes that surgical instruments (probes, needles, forceps, etc.) or pieces

the rentgenologist’s faulty conduct (error in diagnosis) and the death, and, consequently, that the death of the patient had caused a significant worsening of the living standards of the closest members of the family members of the deceased (secondary victims entitled to compensation on the grounds of Article 446 of the Civil Code). 117 See the judgment of the Appellate Court in Kraków of 14 October 1992 (I ACr 374/92), OSA KR II, item 44; compare the judgment of the Supreme Court of 13 June 2000 (V CKN 34/00), unreported. 118 See Wojtasiewicz, supra note 27, at 136. 119 Compare Marcin S´ liwka, Cie˛ z· ar dowodu w procesach medycznych – mie˛ dzy domniemaniami faktycznymi a dowodem prima facie. II. Domniemania faktyczne a dowód prima facie, Archiwum Medycyny Sa˛dowej i Kryminologii 4 (2004/1).

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of any tampons, plugs, or bandages were left in the patient’s body during an operation, irrespective of what object was ignored (forceps, probes, and needles are treated in the same way as tampons, plugs, or bandages, which are more likely to be overlooked due to their absorptiveness). In the case of infections, the provider’s fault and/or causation is presumed on the grounds of the breach of a duty to observe the rules of hygiene and asepsis while treating a patient. In the judgment of January 11, 1972 (I CR 516/71)120 the Supreme Court ruled that if the patient’s death had been preceded by the negligence of doctors and other medical staff during surgery and the pre-operation period (failure to verify the patient’s blood group, lack of blood supplies for complicated surgery in the abdominal cavity, lack of sufficient qualifications of an anaesthesiologist, etc.), the court might deem causal link established on the grounds of factual presumption, provided that a conclusion could be drawn that the current medical knowledge exclude such a connection.121 However, according to latest case law, hospital infections are not deemed self-evident. It is necessary for a plaintiff to prove the existence of a certain act which has been inconsistent with the requirements of hygiene and asepsis.122 It may be, for example, the improper sterilization of medical instruments (the judgment of the Supreme Court of October 28, 1983, II CR 358/83)123 and apparatuses (the judgment of the Appellate Court in Gdan´sk of June 26, 1992, I ACr 254/92),124 faulty disinfection or clean-up of the hospital premises which is a source of dust and dirt in the hospital ward (the judgment of the Supreme Court of 14 December 1973, II CR 692/73).125 In the judgment of April 28, 1998 (I ACa 308/98)126 the Appellate Court in Wrocław established that the defendant’s dialysis center had not taken necessary precautions to minimize the risk of transmitting infections. In particular, there were no separate rooms and dialysis apparatuses for patients, who could be infected with hepatitis and HIV or might be carriers of AIDS and jaundice. Besides, multiple-use equipment had been applied. The conclusion was that, in such circumstances, not only was 120 OSN 1972, item 59. 121 Compare the judgment of Appellate Court in Kraków of 14 October 1992 (I ACr 374/92), OSA 1992, item 44. 122 See B. Janiszewska Praktyka sa˛dowa w sprawach cywilnych a zakaz· enia szpitalne)-cze˛ s´c´ I, Prawo i Medycyna (2009/2). 123 OSPiKA 1984, item 187. 124 OSP 1993/10, item 195. 125 OSPiKA 1975, item 94. 126 Prawo i Medycyna 147 (2002/12), cmt. by M. Nesterowicz.

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fault evident, but also a causal link between the defendant’s negligence and the patient’s damage (infection with AIDS and hepatitis B) could be presumed without proof. Since the defendant did not succeed in proving to the contrary, the claimant was granted compensation.127 In the judgment of February 9, 2000 (I ACa 69/00)128 the Appellate Court in Kraków applied indirect evidence, taking into consideration the fact that the injured person had been treated in the ward at the time when a significant number of patients (10 %) were infected with hepatitis B and the defendant’s hospital had not undertaken any measures to isolate them and, consequently, to prevent the spread of the virus. The hospital ward had therefore become a “source of epidemics.” 1.2. As for causality, Article 361 § 1 of the Civil Code requires an adequate causal connection between faulty acts or omissions and the damage.129 The theory of adequate causality assumes that a person liable to pay compensation bears liability only for normal consequences of his acts or omissions from which the damage has resulted. Normal effects are those which generally occur in similar circumstances; it is not important whether the same result appears every time.130 However, in medical malpractice cases it is not required for the causality to be determined “in a certain manner.”131 According to case law and doctrine, it may be sufficient to establish “probability of a high degree (the highest possible in casu)” that a doctor’s or hospital’s faulty conduct caused the damage in question.132 The dominant opinion is that as far as the human 127 An appeal of the defendant (dialysis centre) was dismissed by the Supreme Court (the judgment of 13 June 2000, V CKN 34/00). 128 Wokanda 1998, item 7. 129 This provision is said to be original with respect to other countries, since it states expressis verbis that adequacy is a criterion of normative evaluation of the results of a certain event (conduct). Z. Radwan´ski, System prawa cywilnego. Prawo zobowia˛zan´. Cze˛ s´c´ ogólna, 255 (3rd. ed., 1981). Compare Andrzej Koch, Zwia˛zek przyczynowy jako podstawa odpowiedzialnos´ci w prawie cywilnym 155 (1975). 130 In order to establish adequate causation it is necessary to find out first whether the hypothetical elimination of a certain act or conduct (event A) would eliminate the existence of the damage (fact B). If the answer is affirmative, causal connection between the conduct and the damage is deemed established (A is a conditio sine qua non of B). Second, it should be verified whether event A is a condition that generally (in view of statistical data, general or specialized knowledge in a certain domain) gives rise to the result B. The estimation is made ex post, on the grounds of all the established facts and ascertainments that were previously made during the proceedings. Id.; see also Bagin´ ska, Pol. Civ. C. supra note 22, at 516. 131 M. Nesterowicz, E. Bagin´ska, A. den Exter, Medical Law 50 (2007). 132 Compare the judgment of the District Court in Wrocław of 11 December 1998 (I C 299/ 97), cited by M. Nesterowicz, Prawo medyczne 307 (7th ed., 2005). Any particular percentage rate is not required; however, the probability should be of the highest extent possible (as opposed to “absolute” certainty). In medical malpractice cases, the

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body is concerned, certainty hardly ever exists, thus the requirements to prove it seem neither real nor justified.133 Therefore, the plaintiff should not be required to prove in what way and at what exact moment he became infected, since such proof has usually not been possible in practice. In the judgment of June 13, 2000 (V CKN 34/00)134 the Supreme Court ruled that medical knowledge, due to its imperfection, cannot provide satisfying answers to each question which concerns the human body.135 Many factors may have an influence on the existence of damages, and it is necessary for a court to establish to what extent a doctor’s or hospital’s fault may be a probable cause of this damage when compared to other reasons (e.g., independent development of the disease). However, the evidence that factors other than the doctor’s negligence could have resulted (but did not have to result) in the injury shall not release the doctor or hospital from liability. As doctrine provides, even in the case of either multiplication of such reasons or the increased risk of treatment – resulting, for example, from the patient’s health condition – the provider’s liability cannot be excluded if at least one of the factors that caused the patient’s injury was that doctor’s or hospital’s negligence or any other kind of fault (a lack of knowledge, imprudence, etc.).136 Moreover, in medical malpractice cases the burden of causality is, in practice, not only lowered (by replacing the requirement of “absolute” or “exclusive” certainty with the premise of probability of a high degree) but it may be reversed as well, particularly in the area of healthcare-related infections. The courts, aware of the difficulties a plaintiff has to face to

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standard of proof of causal link between the improper conduct and the damage is then lower in comparison to other areas of civil liability. The courts have not made any general rules that apply to the estimation of “probability”; they rather decide on a “case by case” basis and use different terminology, e.g. “probability of high degree” (the aforementioned judgment of the District Court in Wrocław of 11 December 1998; I C 299/97), “sufficient dose of probability” (the judgment of the Supreme Court of 17 June 1969, I PR 74/67; OSN 1968/2, item 26) or “prevailing probability” (the judgment of the Supreme Court of 5 July 1967, II CR 165/69, OSPiKA 1969/7 – 8, item 155). The judgment of the Appellate Court in Katowice 20 October 2006 (I ACa 966/06; LEX 269615). In this case compensation was claimed by a patient who had her kidney removed and had been infected with staphylococcus as a result of negligent postoperation care. LEX 52689. Since the court not only lowered the burden of proof but also reversed it, the defendant hospital, in order to be exempt from liability, had to rebut the probability or at least impair it by showing that there had been some other probable reasons for the patient’s injury. Reversal as such has been common in malpractice cases concerning hospitalacquired infections. See the aforementioned judgment of the Supreme Court of 11 January 1972 (I CR 516/71). Nesterowicz, supra note 10, at 96.

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prove a causal link between faulty conduct and the damage, deem probability established on the grounds of factual presumption, according to Article 231 of the Code of Civil Proceedings. In the judgment of January 22, 1998 (II UKN 465/97)137 the Supreme Court ruled that a high degree of probability may be also presumed (by means of indirect evidence), provided this presumption is a logical conclusion derived from properly established facts that serve as the premise of such a presumption.138 Thus, in order to be exempt from liability, the defendant doctor or hospital should rebut the probability or at least impair it by showing that there had been some other probable reasons for the patient’s injury.139 In view of case law and doctrine, it is not necessary for a causal connection (probability) between negligent conduct and the injury to be direct (like in a typical sponge case, where a medical instrument is left in the patient’s body) since indirect intermediate causality may also serve as a prerequisite of a valid compensation claim (e.g., when the improperly performed operation causes the necessity to operate again and during the next operation an injury appears).140 In the judgment of November 4, 1960 (II CR 411/59)141 the Supreme Court assumed that there was a normal causal connection between a lack of proper supervision on the part of the defendant’s hospital and an accident which had occurred when a mentally disturbed patient jumped out of the window. In the Court’s opinion, the fact that the cause of the patient’s injury was remote was of no relevance, as long as the result thereof (severe bodily impairment of a patient) could be qualified as normal in view of Article 361 § 1 of the Civil Code. This view has been confirmed in the judgment of the Supreme Court of June 17, 2009 (IV CSK 37/09).142 The Court ruled that physicians who neglected to examine a one-year old baby closely enough, which resulted in the failure to diagnose cerebral palsy and a two-year delay in starting the necessary treatment, were liable for the further deterioration of the patient’s health even though the doctors’ fault was not the direct reason of the injury. The Court explained that cerebral palsy, which had appeared as a consequence of organic brain damage, was not causally connected with the doctors’ negligent omission. However, a failure to make a correct

137 OSNP 1999/1, item 24. 138 Compare the aforementioned judgment of the Supreme Court of 11 January 1972 (I CR 516/71). 139 Compare the aforementioned judgment of the Supreme Court of 13 June 2000 (V CKN 34/00) 140 Id. 141 OSPiKA 1962/9, item 251. 142 OSP 2010/9, item 93 cmt. by M. Nesterowicz.

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diagnosis was the indirect reason for diminished (by 20 %) chances of the child’s health improvement.

IV. Compensation 1. While on the grounds of contractual provisions it is only possible to claim compensation for pecuniary loss,143 the ex delicto regime provides the injured with a wide scope of compensation for personal injury, including pecuniary and non-pecuniary loss for the injured himself (Articles 444– 445 of the Civil Code)144 and, in the case of his death, for secondary victims (immediate members of his family) and for pecuniary loss only for those whom he had a statutory duty to support or voluntarily and permanently supported (Article 446).145 The Polish Civil Code does not limit the amount of damages that should be paid for a personal injury. Therefore, a doctor or a hospital found to be liable has to indemnify the patient for any and all damage which results from negligent treatment. Any contractual limitations are deemed invalid (pursuant to Articles 58 and 3531 of the Civil Code). 2. A pecuniary loss has to be compensated in full, according to Article 361 § 2 of the Civil Code (comprising damnum emergens and lucrum cessans). A patient may claim a single-payment indemnity for medical care costs and loss of income (Article 444 § 1 of the Civil Code) and, when his disability is permanent, periodical payments in the form of annuity (Article 444 § 2 of the Civil Code).146

143 However, in the view of academic doctrine it seems necessary to make it possible for the injured to claim compensation for a non-pecuniary loss also in the ex contractu regime. See M. Safjan, Naprawienie krzywdy niemaja˛tkowej w ramach odpowiedzialnos´ci ex contractu in: Odpowiedzialnos´c´ cywilna. Ksie˛ ga pamia˛tkowa ku czci Profesora Adama Szpunara 255 (M. Pyziak-Szafnicka, ed., 2004); M. Nesterowicz, supra note 10, at 20. 144 Judgment of the Supreme Court of 13 June 2000 (V CKN 34/00), Prawo i Medycyna 22 (2005/2). 145 See Ewa Bagin´ska, Roszczenie o zados´c´uczynienie na podstawie art. 446 § 4 kodeksu cywilnego na tle dos´wiadczen´ europejskich, Kompensacja szkód komunikacyjnych. Nowoczesne rozwia˛zania ubezpieczeniowe 138 (K. Ludwichowska, ed., 2011). 146 Section 1 of Article 444 states: “In the case of bodily injury or damage to health, damages shall include all costs arising therefrom. Upon the request of the injured person, the person obliged to redress the damage shall pay the sums required for the costs of medical treatment in advance and, if the injured person becomes disabled, he shall also pay the sums required to train him for an alternative occupation in advance.” Section 2 states: “If the injured person completely or partially loses his ability to work or if his needs increase or his future prospects are diminished, he may demand an appropriate annuity from the person obliged to redress the damage.” Bagin´ska, Pol. Civ. C. supra note 22, art. 444.

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Medical care costs are interpreted broadly as all necessary expenses incurred by the patient as a result of the injury, including consultations with the best specialists,147 an expensive treatment abroad,148 and the necessary medical equipment and drugs which are not covered by the health insurance scheme.149 As case law provides, these are also costs of transport to a health care facility (for consultations, rehabilitation services, further auxiliary tests, etc.); expenses resulting from visits to a hospital paid by relatives; and costs of home medical care and assistance rendered by a nurse, social worker, etc.150 However, in order to receive compensation, a patient should prove that the aforementioned costs are justified (in view of medical knowledge) and necessary to alleviate the personal injury he has sustained. What is more, the injured is the only person entitled to make a claim even if medical care costs were in casu borne by third parties (the patient’s relatives, members of his close or closest family, statutory or factual guardians, etc.).151 Upon the demand of the patient, the doctor or health care institution liable for the damage should, in advance, deposit the sum needed to cover the costs of treatment. In the judgment of the Supreme Court of December 13, 2007 (I CSK 384/07)152 the Court ruled that the right to claim an advance payment arose irrespective of whether the injured person was entitled to medical services within the scope of the health insurance scheme and whether he was at all able to incur these costs by himself, at least partially. In the court’s opinion, the only condition to make such a claim is to present evidence that a certain kind of treatment (or medical services), qualified as a sub-standard procedure not covered by the NFZ insurance, is in casu necessary and justified in view of current medical knowledge. Therefore, a health care provider cannot be obliged to make an advance payment when it has been proved that all the costs of medical

147 The judgment of the Supreme Court of 26 June 1969 (II PR 217/69), OSN 1970/3, item 50; the judgment of the Appellate Court in Katowice of 26 November 1991 r. (III APr 75/91), OSA 1992/6, item 38. 148 The judgment of the Supreme Court of 13 December 2007 (I CSK 384/07), unreported. 149 The judgment of the District Court in Katowice of 12 December 2003 (II C 911/01/05), Prawo i Medycyna 122 (2005/12). 150 The judgment of the Supreme Court of 21 March 1973, OSPiKA 1974, item 183. 151 The judgment of the Supreme Court of 4 July 1969 (I CR 116/69), OSN 1970, item 82. 152 Unreported. This case concerned a minor who had suffered serious injury (right hand paresis) as a result of a negligently performed delivery. He proved that an advance payment was necessary to cover the costs of an expensive operation in Texas (USA) as well as all the expenses for transport and accommodation. The court found the claim justified. Compare the aforementioned judgment of 26 June 1969 (II PR 217/69).

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care are incurred by the National Health Fund or the Ministry of Health (if highly qualified procedures financed by the State are concerned153). As for annuity, an original solution of Polish law is that it may be awarded in three circumstances: when the victim has completely or partially lost his ability to work, when his needs have increased, and when his future prospects have been diminished.154 Any of these conditions, whether alone or concurrent with the others, entitles the injured to make a claim. Claims for annuity are relatively frequent in medical malpractice cases, due to the unique nature of personal injury. In the case of December 12, 2003 (II C 911/01/05)155 the Appellate Court in Wrocław granted an annuity for the increased needs (PLN 700 per month; 175 E) of a patient who had suffered serious injuries as a consequence of the unnecessary removal of the lower part of his large intestine and pelvirectal sphincter (fistula). While estimating the amount of damages, the court took into consideration the costs of purchasing necessary somatic and anti-depressive drugs; expenses for periodical consultations with psychiatrists and psychologists (due to his breakdown and depression); costs for a special low-fiber diet and vitamins; and the costs of additional clothes, bed clothes, and sanitary equipment not refunded within the NFZ insurance. As case law provides, the increased needs usually serve as grounds for an annuity claimed by minors. In the aforementioned judgment of June 17, 2009 (IV CSK 37/09)156 the Supreme Court ruled that if due to the doctor’s negligence (an omission to diagnose cerebral palsy early enough to start proper treatment in time), the patient had lost his chances for health improvement, the main goal of the annuity for increased needs was to redress a pecuniary loss which involved higher, continuous expenses (for rehabilitation, physiotherapy, professional indoor care, consultations with specialists, etc.) that would be incurred in the future for a defined or undefined period of time. When the damage is evident but there are some difficulties with estimating its scope (because rehabilitation is still in progress or the treatment has not been completed) the court may grant, at its discretion, an amount of money which it deems appropriate in view of all circumstances of the relevant case (pursuant to Article 322 of the Code of Civil Proceedings).

153 See the aforementioned Ordinance of Ministry of Health of 13 December 2004 (concerning highly specialized medical procedures financed by the State). 154 See Judgment of the Supreme Court of 13 June 2000 (V CKN 34/00). 155 Prawo i Medycyna 122 (2005/2). 156 OSP 2010/9, item 93.

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Detailed and precise findings that prove the extent of pecuniary loss are then not always necessary, which makes this legal solution advantageous for claimants. Therefore, Article 322 of the Code of Civil Proceedings is applied in a significant number of malpractice cases, in particular those that concern annuity.157 Furthermore, if the injured is granted either a single-payment indemnity or an annuity (or both), the defendant may be liable for further loss that may appear in the future as a result of the same event. This legal principle adopted by case law is to prevent a possible a future claim from falling under what is known in common law countries as the statute of limitations.158 According to the prevailing view of case law and doctrine, accident insurance benefits received by the injured from social security insurance are deducted from the amount of compensation awarded by the civil court on the grounds of Article 444 of the Civil Code (compensatio lucri cum damno).159 However, no deduction can be made in the case where a patient (or a person acting on his behalf) voluntarily concluded an accident insurance contract (known in Polish as NW) with a commercial insurer (Article 829 of the Civil Code). The opinion is that a person who takes care of his interests and pays premiums to have better protection against certain risks or events should not be treated in the same way as the injured who was not so provident (the rule of compensation lucri cum damno is then not applied).160 3. Unlike the situation concerning material damages, compensation for a non-pecuniary loss is at the court’s discretion. Therefore, even in the case where all necessary premises of the defendant’s liability have been met, it is up to the court to decide whether a patient should be indemnified for pain and suffering. If a claim is deemed justified, the court may grant an amount which is appropriate to the damages in question.161 A reimburse-

157 The judgment of Supreme Court of 25 November 1999 (II CKN 476/88), Nesterowicz, supra note 10, at 100–101. 158 See, e.g., the judgment of the Supreme Court of 12 April 1970 (III PZP 34/69), OSN 1970, item 217. 159 A. S´ mieja, Prawo zobowia˛zan´-cze˛ s´c´ ogólna. Tom 6 680 (A. Olejniczak, ed., 2009); A. Szpunar, Odszkodowanie za szkode˛ maja˛tkowa˛. Szkoda na mieniu i osobie, Bydgoszcz 85 (1998). 160 Id.; see also the judgment of Supreme Court (PSiAPiUS) of 23–24 April 1965 (III PO 3/ 65); OSN 1965/12, item 198. 161 The judgment of the Supreme Court of 15 September 1999 (III CKN 339/98), OSP 2000/4, item 66. As case law provides, a claim for moral damages can be dismissed only when the degree of pain and suffering is minor (the judgment of the Supreme Court of 23 January 1974, OSPiKA 1975, item 171). Furthermore, each decision of the court,

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ment is made exclusively in the form of a single-payment, pursuant to Article 445 of the Civil Code.162 There are no statutory rules concerning the assessment of damages for pain and suffering; thus, in this area, the courts make decisions on a caseby-case basis, taking into consideration all relevant circumstances and referring to the directives offered by case law and doctrine. According to these directives, the scope of compensation should depend, first of all, on the extent of the non-pecuniary loss (the degree of pain and suffering).163 Further relevant criteria are the severity of physical and moral consequences of the injury, the victim’s age, degree of the tortfeasor’s fault, duration of the disease, patient’s prospects for future personal and professional life, and the possibility of further health deterioration.164 In the judgment of the District Court in Bydgoszcz of July 19, 1999 (I C 1150/98)165 the court granted moral damages to a woman who, after being misdiagnosed with breast cancer, had undergone a medically unjustified removal of both breasts. While estimating the scope of damages, the court took into consideration the age of the patient (twenty-four), the lack of medical grounds for surgical procedures, the irreversibility of the injury, the emotional shock, mental distress, necessity to be treated by psychiatrists and neurologists (due to severe depression), as well as further consequences of the disfigurement of the body for the patient’s private life: the inability to work for a long time, isolation, divorce, etc. The behavior of a person liable for the redress of damage may also influence the extent of compensation for a non-pecuniary loss. In the judgment of January 9, 1978 (IV CR 510/77)166 the Supreme Court admitted that it might be possible to increase the scope of the indemnity

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whether awarding or refusing moral damages, should be based on objective criteria and well-grounded in the motives of the judgment. A Szpunar op. cit., 79. Section 1 of Article 445 states: “In the cases specified in [Article 444], the court may award to the injured person an appropriate sum as compensation for non-pecuniary harm.” Ewa Bagin´ska, Roszczenie o zados´c´uczynienie na podstawie art. 446 § 4 kodeksu cywilnego na tle dos´wiadczen´ europejskich,Kompensacja szkód komunikacyjnych. Nowoczesne rozwia˛zania ubezpieczeniowe 138 (K. Ludwichowska, ed., 2011). The resolution of the Supreme Court of 8 December 1973 (III CZP 33/73), OSN 1974/9, item 45. Nesterowicz, supra note 10, at 104; M. Wałachowska, Zados´c´uczynienie za szkodE˛ niemaja˛tkowa˛ 127 (2007). OSP 2002/4, item 59 cmt. by M. Nesterowicz. Compare other cases concerning unnecessary treatment or operation – the judgment of the Supreme Court of 24 February 2005 (V KK 375/04), Prawo i Medycyna 125 (2006/1), cmt. by J. Wyrembak; the judgment of 4 July 1969 (I PR 178/69), OSN 1970/4, item 71. OSN 1978/11, item 210. This case concerned a woman who had suffered rupture of the pubic symphysis during delivery. After the injury had appeared, she was not offered

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when a health care institution did not take any measures to provide the injured (a woman who suffered a serious bodily impairment during delivery) with the appropriate advice and assistance. In the Court’s opinion, such an attitude of the defendant’s hospital to the injured person added to the damage (pain and suffering of the patient), so granting a higher amount of compensation seemed justified. In addition, the transitory nature of pain and suffering does not make it impossible for a patient to claim compensation for a non-pecuniary loss. In the judgment of March 20, 2002 (V CKN 909/00)167 the Supreme Court ruled that the mere fact that moral damage had not existed at the time of the judgment did not exclude a successful compensation claim. In addition, a reimbursement may be claimed by a person who is not aware or does not seem to be aware of the moral harm because of his mental disturbance or age. Both Polish case law and doctrine are not likely to apply percentage schemes and average remuneration rates for the degrees of permanent bodily injury. In the judgment of the Appellate Court in Kraków of February 18, 1998 (I ACa 715/97)168 the court held that such “guidelines” might be helpful to settle claims for moral damages but, as not very comprehensive, they could not be decisive. In particular, a comparison between an amount of compensation for non-pecuniary loss and an average remuneration rate may not be made automatically without taking into consideration all relevant circumstances of the case in question, such as the direct results of the damaging act (any bodily impairment, or mental disturbance), further deterioration of the patient’s health, the emotional attitude to the sustained damage, and any permanent results thereof. The court made this distinction because compensation for a nonpecuniary loss is given as a special kind of damage which is usually not easy to estimate (the judgment of the Appellate Court in Białystok of 9 April 1991, I ACr 53/91).169 Recent case law suggests that damages for a non-pecuniary loss serve the purpose of compensation. The principle of a moderate award for pain and suffering, which required the compensation to correspond with the stan-

any support by the hospital; in particular, she was given no psychological assistance and no directions concerning further medical treatment. 167 Przegla˛d Sa˛dowy 141 (2003/4) cmt. by K. Ba˛czyk. 168 OSA 1999/2, item 7. 169 OSA 1992, item 50; see also the judgment of the Supreme Court of 28 VI 2005 (I CK 7/ 05), LEX 153254.

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dard conditions of living of an average member of society,170 has fortunately lost its importance and is applied as a subsidiary criterion or it is not taken into consideration at all. In the precedent-setting judgment of March 10, 2006 (IV CSK 80/85)171 the Supreme Court ruled that the main factor which should be taken into account while estimating the quantum of damages was the degree of pain and suffering. The principle of moderate compensation might be then applied as a supplementary one, provided its application does not interfere with the compensatory function of moral damages. Since the courts follow this new direction, the amounts of moral damages have become slightly higher lately. For example, in 2006 minors who had suffered cerebral palsy as a result of negligent treatment during their delivery were awarded around PLN 300,000 (75,000 E),172 and in late 2009 and 2010 the courts used to grant not less than PLN 500,000 (128,205 E) to compensate this kind of injury.173 However, in 2011 as much as PLN 900,000 (225,000 E) was awarded for that specific kind of injury.174 As for hospital infections, while in the late 1990s compensation for infection with hepatitis B amounted to PLN 5,000 (1,300 E) for adult patients and as much as PLN 8,000 (2,000 E) for minors; and PLN 20,000 to 50,000 (5,130 E to 12,820 E) for hepatitis C. Accordingly, in 2000 to 2010 these amounts were doubled or even tripled (e.g., in 2010 the average compensation for a non-pecuniary loss resulting from hepatitis C amounted to PLN 375,000, which is equivalent to 93,750 E). While a claim for redressing material damages devolves upon the heirs (according to the general rules of succession law), a claim for compensation for a non-pecuniary loss, due to its personal nature, expires with the death of the injured. However, this rule is not applied when a person responsible for the redress of damage has acknowledged the claim in writing or when a suit was filed before the death of the injured 170 The judgment of the Supreme Court of 24 June 1965 (I PR 203/65), OSPiKA 1996/4, item 92. 171 OSP 2007/1, item 11 cmt. by M. Nesterowicz. In this case a twelve-year-old girl was negligently diagnosed with kidney cancer. She underwent chemotherapy and one of her kidneys was immediately removed. The actual disease was very rare but could have been diagnosed if further examination (biopsy) had been ordered. 172 See the judgment of the Appellate Court in Poznan´ of 8 February 2006 (I ACa 1131/05), unreported. 173 According to statistical data, cases concerning injuries sustained in connection with delivery give rise to 37 % of all malpractice suits. Adam Makosz, supra note 56. 174 The judgment of the Appellate Court in Kraków of 2 March 2011. Apart from moral damages, the court granted an annuity of PLN 4,800 (1,200 E) and a single-payment indemnity for medical care costs amounting to PLN 9,500 (2,375 E), Gazeta Prawna (3 March 2011).

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(Article 445 § 3 of the Civil Code).175 The inherited claim should then be accepted by the adjudicating court in the same amount as it would have been the injured person’s at the time of his death. The fact that the heirs have their own claims resulting from the death of the patient (as secondary victims, on the grounds of Article 446 of the Civil Code) is of no importance and may not influence any court’s decision.176 4. If a patient dies as a result of medical malpractice, indemnity may be sought by secondary victims on the grounds of Article 446 of the Civil Code. As it was already mentioned, they can pursue up to two claims for pecuniary loss as well as a claim for a non-pecuniary loss. The kind of claim and, consequently, the scope of compensation depends on the circumstances of the case, in particular the nature and intensity of the relationship between the claimant and the deceased. First, the persons with respect to whom the deceased had a statutory duty of maintenance (according to the provisions of the Family and Guardianship Code177) may claim the so–called compulsory pension from the doctor or hospital obliged to redress the damage, irrespective of whether the injured himself had de facto fulfilled this duty before he died (Article 446 § 2 Sentence 1 of the Civil Code). This group of secondary victims comprises descendants and ascendants of the patient, his brothers and sisters, spouse, adopted parent and adoptee as well as other kin. Other persons related to the deceased can be awarded the so-called facultative pension if the patient, before his death, voluntarily and permanently (but without a legal obligation) supplied them with means of maintenance. However, the rule is that a court grants such a pension at its discretion, after having established that the claim is justified in view of the principle of rightness (boni mores) and equity (pursuant to Article 446 § 2 Sentence 2 of the Civil Code). It is then necessary to consider all circumstances of the case, in particular the personal and economic situation of the claimant after the death of his maintenance supplier (breadwinner). The Civil Code offers no definition of “other persons closely related to the deceased,” but according to case law and doctrine this group comprises brothers and sisters of the deceased, his parents and children, as well as a person in a quasi-marital relationship (a partner), and certain other persons. There is a rule that de facto relations, not family ties, should

175 Compare the judgment of the Supreme Court of 25 March 1975 (II CR 53/75), LEX 7682. 176 Gerard Bieniek, Komentarz do Kodeksu cywilnego. Ksie˛ ga trzecia. Zobowia˛zania. Tom I 611 (G. Bieniek, ed., 2008). 177 The Law of 25 February 1964, Journal of Laws 1964, No. 43, item 296 – as amended.

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be decisive to deem a person “closely related” in terms of Article 446 § 2 of the Civil Code.178 Both obligatory and facultative pensions should be calculated in accordance with the needs of the claimant as well as the financial possibilities and potential earning circumstances of the deceased. The health care provider liable for the damage is obliged to pay the annuity for the period of the likely duration of the maintenance duty.179 According to doctrine and case law, there is no possibility to award one joint pension for all secondary victims who are entitled to it. A claim for annuity is personal by nature, and the court should decide about each claimant separately, considering all relevant circumstances of the case.180 Second, the closest members of the family of the deceased may claim an appropriate single-payment indemnity, pursuant to Article 446 § 3 of the Civil Code, if the death of the injured resulted in a considerable deterioration of the former’s living standards. The Civil Code neither gives a definition of the closest family members nor explains who may belong to this group. According to case law and doctrine, this category comprises of parents and children of the deceased and other persons related to them, such as close and remote ascendants and descendants as well as in-laws.181 The Supreme Court found that a person entitled to a single-payment indemnity may also be an aunt or an uncle182 who had been keeping the household for the deceased, an illegitimate child brought up by grandparents as a foster child,183 and a stepmother who had taken care of her step-son since the earliest days of his life.184 The dominant view is that the notion of family should be inter-

Z. Radwan´ski, A. Olejniczak Zobowia˛zania-cze˛ s´c´ ogólna. Zarys wykładu, 257 (2009). A. Cisek, Kodeks cywilny. Komentarz 801(E. Gniewek, ed., 3rd ed. 2008) Id. A. Szpunar, Wynagrodzenie szkody wynikłej wskutek s´mierci osoby bliskiej 156 (2003); Kinga Ba˛czyk-Rozwadowska, Roszczenia odszkodowawcze rodzin poszkodowanych pacjentów po nowelizacji kodeksu cywilnego (art. 446 § 4 k.c.), Prawo i Medycyna 32–33 (2010/2). 182 The judgment of the Supreme Court of 31 May 1938; Zbiór Orzecznictwa SN 1939, item 100. 183 The judgment of the Supreme Court of 5 August 1970 (II CR 313/70), OSN 1971/3, item 56. 184 The judgment of the Supreme Court of 10 December 1969 (III PRN 77/69), OSN 1970/ 9, item 160. There is a question whether a person in a quasi-marital relationship and, in particular, a partner of the same sex may be qualified as the closest member of family within the meaning of art. 446 § 3 of the Civil Code. See Ba˛czyk-Rozwadowska, supra note 181, at 33; A. Daszewski, Od stosownego odszkodowania do zados´c´uczynienia pienie˛ z· nego za krzywde˛ dla najbliz· szych członków rodziny zmarłego, Prawo Asekuracyjne 20 (2008/4). 178 179 180 181

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preted broadly as describing not only legal but also actual relations between persons living in the same household, provided this relation is serious, constant, and stable (family sensu largo).185 As case law provides, a single-payment indemnity aims at rewarding that kind of pecuniary loss which has not been covered (or may not be covered) by an annuity awarded on the grounds of Article 446 § 2 of the Civil Code. These are, in particular, broadly interpreted material damages (a pecuniary loss) that are difficult to evaluate, like the worsening of the economic situation of the claimant, loss of possibility of either improving his living conditions in the future or fulfilling the intended life goals (if e.g., after the death of a family breadwinner an adolescent child has to give up his studies in order to start working gainfully to support his family or help them with the household).186 The rule is that a court should apply only objective criteria to verify whether such a pecuniary loss exists and whether it results from the death of the closest family member. The mere subjective feeling that the claimant’s living standards have deteriorated may not merit compensation.187 The indemnity for the deterioration of living standards can be sought by secondary victims, irrespective of any other claims these persons are entitled to make, in particular on the grounds of Article 446 § 2 and § 4 of the Civil Code. However, it is up to the court to decide whether the persons in question should in casu be awarded and in what amount. Third, the new provision of Article 446 § 4 of the Civil Code (in force since August 3, 2009) entitles the closest members of family to claim compensation for pain and suffering resulting from the death of the injured. Each member of the family is allowed to pursue this claim separately, independently of the others and irrespective of whether he has been granted an annuity or single-payment indemnity for a considerable worsening of their living standards.188 185 Ba˛czyk-Rozwadowska, supra note 181, at 33. 186 Before the Civil Code was amended with Article 446 § 4 (discussed below), an indemnity for the deterioration of living standards used to cover also some elements of a nonpecuniary loss. In particular, the courts assumed that the death of a little child resulted in a deterioration of the living standards of his parents not only when it caused actual material loss. The parents’ pain and suffering also impaired their everyday activity and, consequently, affected the possibility of improving their living conditions in the future. See Radwan´ski, supra note 178, at 258; the judgment of the Supreme Court of 13 May 1969 (II CR 128/69), OSPiKA 1070/6, item 122; the judgment of the Supreme Court 15 October 2002 (II CKN 985/00), unreported. 187 The judgment of the Supreme Court of 4 November 1980 (IV CR 412/80), unreported. 188 Kinga Ba˛czyk-Rozwadowska, Roszczenia odszkodowawcze rodzin poszkodowanych pacjentów po nowelizacji kodeksu cywilnego (art. 446 § 4 k.c.), Prawo i Medycyna 28 (2010/2).

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Moral damage suffered by secondary victims is mostly of a psychical nature since it involves all negative feelings and experiences of the closest family member after the death of the injured person. As doctrine provides, it may be psychical pain, emotional shock or breakdown, feelings of sadness, hopelessness and loneliness, as well as a loss of meaning of continued existence.189 In light of this view, moral damage sustained by the closest members of family can also involve helplessness, perplexity, loss of support and assistance in household activities, feeling of lost hope, and loss of motivation to overcome the hardships of everyday life.190 However, it is not necessary to prove that a plaintiff has suffered a certain type of illness or mental disease (e.g., neurosis, depression or another kind of mental disturbance) that has been confirmed by a doctor in a respective field of medicine. Determining the existence and scope of such damage requires taking into consideration all relevant circumstances of the case and making a thorough analysis of the individual situation of the claimant. Since the latter may (and usually will) be subjective and likely to overestimate his non-pecuniary loss, the court should establish that the pain and suffering are real and of the kind that would render compensation justified.191 Since Article 446 § 4 of the Civil Code is a new regulation, there arises a question about establishing adequate causality between the death of the injured and the moral damage suffered by the closest member of the family in question. Both life experience and medical science acknowledge that the death of the closest relative usually results in serious moral harm: emotional distress and breakdown, which may also manifest itself in a form of certain mental diseases. It is then probable that the courts will find probability of high degree sufficient to justify a claim for compensation based on Article 446 § 4 of the Civil Code or will require only a conditio sine qua non to be established with certainty. The necessity of providing secondary victims with a sufficient legal protection as far as compensation is concerned may also make the courts assume the existence of pain and suffering without any proof, only on the grounds of the close relation between the claimant and deceased (especially in the case of spouses and parents-children relationships). All of aforementioned claims based on Article 446 of the Civil Code are secondary victims’ own claims. They may be pursued irrespective of 189 Id. Compare M. Wałachowska, Wynagrodzenie szkód poniesionych na skutek doznania wstrza˛su psychicznego spowodowanego s´miercia˛ osoby bliskiej, Przegla˛d Sa˛dowy 46 (2004/7–8). 190 See the judgment of the Supreme Court of 25 July 2000 (III CKN 842/98), LEX 513/57. 191 Ba˛czyk-Rozwadowska, supra note 181, at 29.

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whether a certain family member is an heir of the deceased (in view of provisions of succession law) or not. These claims are also independent of the claims of the injured person himself and from the remuneration that he had been awarded before he died.192 5. Moral damages are not limited to situations where, as a result of medical malpractice, a patient suffers a personal injury within the meaning of Articles 444 and 445 of the Civil Code. Pursuant to Article 4 Section 1193 of the new Law on Patients’ Rights and Patients’ Ombudsman of November 6, 2008,194 it is possible to claim compensation for a non-pecuniary loss when a patient’s rights have been infringed even if the patient has not sustained any bodily impairment or health disturbance at the same time. The object of protection under the Law on Patients’ Rights is not human life and health as such but a special category of non-material interests of a patient: his privacy, dignity, personal autonomy, and freedom to decide about the integrity of the body.195 However, Article 4 requires an infringement of the patient’s rights to be faulty and causally connected with acts or omissions of a doctor or a hospital.196 If these premises are fulfilled, the court may, at its discretion, award moral damages on the grounds of Article 448 of the Civil Code.197 It is not important whether the liability of a doctor or a hospital is in casu tortious (pursuant to Article 415 or 430 of the Civil Code) or contractual (pursuant to Article 471 or 474 of the Civil Code), since Article 4 concerns all health care providers, irrespective of their status (public or private) and the form in which they render medical services.198 As case law provides, compensation for a non-pecuniary loss may be granted, in particular, for performing treatment without the patient’s valid consent, even if the medical procedures were carried out properly (lege artis)

192 Id. 193 Section 1 of Article 4 states: “A person harmed by a negligent breach of his rights as a patient may claim pecuniary compensation for non-pecuniary harm in an action based on Article 448 of the Civil Code”, Bagin´ska, Pol. Civ. C. supra note 22, art. 4. 194 Dziennik Ustaw [Journal of Laws] 2008, No. 52, item 417 (Pol.) – as amended. 195 See the judgment of the Supreme Court of 29 May 2007 (V CSK 76/07), OSN 2008/7–8, item 9 cmt., M. Wałachowska. 196 M. Nesterowicz, Zados´c´uczynienie pienie˛ z· ne za doznana˛ krzywde˛ w “procesach lekarskich”, Pan´stwo i Prawo 17 ( 2005/5). 197 Article 448 states: “In the case of an infringement of personal interests, the court may, independently of other measures necessary to remove the results of the infringement, award the injured person an appropriate sum as compensation for non-pecuniary harm or may, at his request, award an appropriate sum to a social cause chosen by him. Art. 445 § 3 shall apply.” Bagin´ska, Pol. Civ. C., supra note 22, art. 448. 198 M. Wałachowska, Ustawa o prawach pacjenta i Rzeczniku praw pacjenta. Komentarz 11 (M. Nesterowicz, ed., 2009); Nesterowicz, supra note 10, at 17.

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and resulted in the improvement of his health.199 However, if a doctor’s conduct performed without the patient’s consent has caused a bodily impairment or a health disturbance, the injured person can either claim compensation for pain and suffering on the grounds of Article 445 of the Civil Code or he may pursue his claims for moral damages using Article 4 (in conjunction with Article 448 of the Civil Code), indicating the mere infringement of his right to decide about the integrity of his body. Thus, in view of case law and doctrine, the relation between Article 445 of the Civil Code and Article 4 is deemed an alternative concurrence of liability provisions.200 Furthermore, the patient is allowed to seek indemnity for being treated without his consent if a certain kind of treatment was necessary to save his life or prevent him from serious disability. This view was confirmed by the Supreme Court before the enactment of the Law on Patients’ Rights, in the judgment of October 14, 2005 r. (III CK 99/05).201 In this case, a claimant was diagnosed with kidney cancer, and the only possible method to treat and save her life was a resection of that kidney. The operation was performed lege artis, but without the patient’s consent; the doctors presumed that the consent had existed, taking into consideration the necessity of the treatment and the fact that the patient, aware of the danger, would have certainly agreed. The Supreme Court ruled that a claim for moral damages could be justified also in the case where a certain medical treatment or an operation had been carried out without the patient’s consent.202 In another precedent-setting judgment of October 27, 2005 (III CK 185/05)203 the Supreme Court ruled that a statement (declaration) in which Jehova’s witness objected to any kind of blood transfusion was binding on a doctor (or hospital), provided that the patient’s will had been expressed consciously and clearly enough to eliminate any doubts about the patient’s intentions. In the court’s opinion, since the law protects the patient’s autonomy and freedom to decide about the integrity of the body, irrespective of the motives for refusing treatment, a lack of patient consent to medical procedures of a certain kind is always binding on the doctor. Consequently, treatment or surgery carried out against the patient’s will

199 The judgment of the Appellate Court in Warszawa of 31 March 2006 (I ACa 973/05), LEX 252827. 200 Nesterowicz, supra note 10, at 32. 201 OSN 2006/7–8, item 137 cmt. by M. S´ widerska, K. Ba˛czyk-Rozwadowska and B. Janiszewska. 202 Compare the judgment of the Supreme Court of 14 November 1972 r. (I CR 463/72), NOWE PRAWO 1975/4, 585 cmt. by M. Nesterowicz. 203 Biuletyn SN 2006/2, item 9.

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always renders the doctor’s conduct unlawful and justify the patient’s claim for compensation. According to doctrine, the mere knowledge about the necessity of treatment and the dangers connected with the omission to take certain precautions does not exclude the duty of the doctor (hospital) to respect the autonomy of the patient and his freedom to decide about the integrity of the body.204 Furthermore, the above mentioned circumstances may not justify any medical procedure carried out without the patient’s consent, since such conduct remains illegal as long as the patient has no desire to be treated. However, two questions arise: whether in similar cases moral damages should be awarded in lower amounts and whether a claim for compensation could be found by the court to be contrary to the principles of rightness (boni mores) and equity and, as such, not taken into consideration at all.205 6. Compensation for both pecuniary and non-pecuniary loss may also be claimed in criminal proceedings.206 The injured, as a civil law claimant (and in case of his death, secondary victims – persons closest to the injured207), is allowed to attach a so-called adhesion claim (powództwo adhezyjne) to the criminal prosecution on the grounds of Article 62 of the Code of Criminal Proceedings (adhaeret causae criminali).208 However, the injured party may claim compensation only for those pecuniary and nonpecuniary losses that result directly from the criminal offense committed by the accused.209 204 See M. S´ widerska, Zgoda pacjenta na zabieg medyczny 15 (2006). 205 Compare Wałachowska, supra note 198, at 26 and Nesterowicz, supra note 10, at 138. 206 The proceedings consist then of two parts. One of them is a criminal action that aims at attributing criminal guilt to the perpetrator and convicting him. The second part is a civil litigation which goal is to reimburse the loss sustained as a result of a criminal delict. See P. Mierzejewski, Kompendium prawa karnego 205 (2010). 207 According to Article 115 § 11 of the Code of Criminal Proceedings, a person closest to the injured is his spouse, ascendant or descendent, siblings, a person related by affinity (an akin of the same line or degree), adopter or adoptee and a person in a quasimarriage relationship. See Code of Criminal Proceedings art. 115 (Dziennik Ustaw [Journal of Laws] 1997, No. 89, item 555 (Pol.) – as amended). 208 Law of 6 June 1997, Journal of Laws 1997, No. 89, item 55. Article 62 of the Code of Criminal Proceedings states: “Until the judicial proceeding in the main trial are commenced, the injured person may bring a civil action (adhesion claim) against the perpetrator to have his damage, sustained as a direct result of the criminal offense, compensated in criminal proceedings.” Id. at art. 62. However, there is no possibility to initiate adhesion proceedings if the same claim for compensation is either subject to other litigation, e.g. a civil one (lis pendens), or has already been concluded with a final valid decision (res iudicata). 209 According to doctrine, it is impossible to claim compensation for a mere non-pecuniary loss. P. Mierzejewski, Kompendium prawa karnego 20 (2010). Compare J. Gajewski, Przebieg procesu karnego, 147 (2008).

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The rule is that a person who makes an adhesion claim is exempt from the duty to pay an admittance fee (wpis), which is generally required to initiate civil proceedings.210 If the claim is accepted by a criminal court (wholly or even partially), these costs are awarded at the expense of the accused (pursuant to Article 643 of the Code of Criminal Proceedings). The civil claimant would bear them only when the adhesion claim was dismissed (pursuant to Article 644 § 1 of the Code of Criminal Proceedings). In practice, the injured person hardly ever initiates adhesion proceedings. Medical malpractice cases are complicated, time-consuming, and more expensive than criminal litigation, since they usually require expert opinions (especially when the injuries sustained by a patient result from errors in the medical art).211 In criminal proceedings, priority is given to the perpetrator’s criminal liability, which ought to be established as quickly as possible in order to fulfill the repressive and preventative function of penal law. Thus, there is a high probability that the criminal court leaves the adhesion claim unrecognized, pursuant to Article 415 § 2 and § 3 of the Code of Civil Proceedings. The decision as such is obligatory when the accused has not been convicted, the evidence revealed during the trial is found insufficient to adjudicate adhesion claim, and any supplement thereof causes excessive lengthiness of the proceedings.212

V.

Professional Liability of Doctors

Except for civil and criminal liability, doctors, as members of medical chambers (izby lekarskie),213 may also bear professional liability for conduct 210 According to the provisions of the Law on Costs of Civil Court Proceedings of 28 July 2005 a plaintiff is to make a payment of 5 % of the amount of damages he claims, however not less than PLN 30 (7,5 E) and not more than PLN 100,000 (25,600 E). See Dziennik Ustaw [Journal of Laws] 2005, No. 167, item 1398 (Pol.); see also J. Jodłowski et. al., Poste˛ powanie cywilne 300–310 (6th. ed. 2009). 211 The average time to decide a case is two to four years for less complicated cases (where there is no cassation to the Supreme Court). However, it may even be eight to ten years for more difficult cases concerning errors in the medical art, in which a medical expert opinion is usually required. 212 See P. Mierzejewski, supra note 205, at 207; J. Gajewski, supra note 209, at 148. 213 Regional medical chambers and the Central Medical Chamber are institutional manifestations of doctors’ professional ‘self-government.’ They supervise the performance of the medical profession by carrying the disciplinary proceedings, represent the interests of doctors, adopt the rules of medical ethics and take care of physicians’ professional education and the development of vocational skills. Medical chambers also grant the doctors the right to practice the medical profession; they are also the keeper of the register of doctors who have been permitted to perform treatment. M. Nesterowicz, E. Bagin´ska, A. den Exter, Medical Law Monograph, International Encyclopaedia of Laws 35(2007).

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contrary to the principles of ethics and medical deontology214 and the breach of provisions concerning the performance of the medical profession (przewinienie zawodowe), pursuant to the regulations of Chapter 5 of the new Law on Medical Chambers of December 2, 2009.215 Disciplinary proceedings are carried by regional medical courts (composed of three judges) and the Supreme Medical Court of Professional Liability, which adjudicates in the second instance (in a panel of three to five members, including a judge of the Supreme Court as chairman).216 Under certain conditions, an appeal (the so-called Extraordinary Appeal) may be made to the Supreme Court.217 No petition of the injured patient (pokrzywdzony) is required, since the proceedings are initiated upon a motion of a disciplinary commissioner (rzecznik odpowiedzialnos´ci zawodowej), who acts as the prosecutor and is responsible for conducting preparatory proceedings.218 In the case where the same professional misconduct is subject to a civil or criminal litigation, the medical court is allowed to suspend its proceedings until civil or criminal proceedings are finished if their result may influence the disciplinary judgment.219 The medical court (in the trial) or disciplinary commissioner (during the preparatory proceedings) may also initiate mediation between the accused doctor (obwiniony) and the injured patient. A mediator is a doctor appointed for this function by the medical chamber of the locality where the doctor practices his profession. Medical courts may exclusively issue the following penalties: a warning, a reprimand, a fine, a suspension of the right to practice as a doctor for a

214 Principles of ethics and medical deontology are embodied in the Code of Medical Ethics (Kodeks Etyki Lekarskiej) of 2 January 2004, adopted by the 7th Extraordinary National Congress of Physicians. The Code determines standards of performing the medical profession, principles of medical practice, doctor’s duties towards the patient and the population as a whole, mutual relations between doctors, and the principles of scientific research and medical experiments. See M. Nesterowicz, E. Bagin´ska, A. den Exter, Medical Law Monograph, International Encyclopaedia of Laws 64 (2007). 215 Dziennik Ustaw [Journal of Laws] 2009, No. 219, item 1708 (Pol.). 216 M. Nesterowicz, E. Bagin´ska, A. den Exter, Medical Law Monograph, International Encyclopaedia of Laws 64 (2007). 217 An extraordinary appeal to the Supreme Court may also be lodged against a valid judgment regarding professional liability by the Minister of Health and the President of the Central Medical Chamber. M. Nesterowicz, E. Bagin´ska, A. den Exter, supra note 216, at 65. 218 These proceedings consist of making all the ascertainments and investigations necessary to explain the circumstances of the alleged professional misconduct. If the commissioner finds punishing a doctor for a certain professional misconduct justified, the latter is charged and consequently interrogated. M. Filar, S. Krzes´, E. Marszałkowska-Krzes´, P. Zaborowski, Odpowiedzialnos´c´ lekarzy i zakładów opieki zdrowotnej, 281 (2004). 219 M. Nesterowicz, E. Bagin´ska, A. den Exter, supra note 216, at 64.

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period ranging from six months to three years, and a deprivation of the right to perform the profession. The sentence of the court (a convicting judgment), together with the doctor’s name and medical license number is added to the public Register of the Disciplinarily Punished Doctors and Dentists held by the Central Medical Chamber.220 However, as case law provides, if a doctor is found guilty, the court may, in certain circumstances, decide not to award a punishment.221 In the case where the doctor has been found innocent or the procedure has been quashed as a result of an Extraordinary Appeal or as a result of proceedings being resumed, the doctor is entitled to claim compensation from the regional medical chamber. No proceedings on professional liability may be initiated if three years have elapsed since the commitment of the act.

Conclusion As for attitudes and concerns about the existing compensation system, the first thing which requires approval is the current tendency to assure better protection of the non-material interest of patients by, on the one hand, awarding higher sums for a non-pecuniary loss and, on the other, providing additional grounds for moral damages under the Law on Patients’ Rights. The other good solution is the complex liability insurance, which is compulsory for all health providers, whether or not they participate in the national health insurance scheme. However, despite some moderation concerning the burden of proof, the requirement of the doctor’s or hospital’s fault is still troublesome for the injured. The situation of patients who suffer injuries where no one is guilty (so-called medical accidents) is particularly difficult. After the amendment of the Civil Code of June 2004, they may not claim damages on the grounds of the principle of rightness (boni mores) and equity any more (derogated Article 419 of the Civil Code). Besides, malpractice suits are still long and expensive, while their result is usually uncertain and not

220 The rules of holding a Register of the Punished Doctors were laid out in the Ordinance of Minister of Health of 13 July 2010 concerning the form and procedures of holding of the Register of the Disciplinarily Punished Doctors and Dentists and the way of executing the final judgments of medical courts (Journal of Laws 2010, No. 130, item 884). 221 See the judgment of the Supreme Court of 18 February 1994 (I PN 1/94), OSNAPiUS 1994/1, item 16. Compare Filar, et al., supra note 218, at 281.

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easily predicted. There is an increasing number of cases every year,222 because patients are more aware of their rights and prone to claim reimbursement if these rights are not observed. Therefore, an introduction of a no-fault liability regime in Poland may be taken into account. The existing systems of that kind could serve as good examples, especially the Swedish No-Fault Patient Insurance (NFPI) and the French scheme which combines elements of fault and no-fault liability. It seems that implementation of a no-fault compensation system, at least for medical accidents in Poland, is the best possible solution to improve the mechanisms of damage compensation and to prevent the spread of a potential malpractice crisis.223

Addendum 1. The Act on Health Care Institutions (Ustawa o zakładach opieki zdrowotnej) of 30 August 1991 was officially repealed by the Act on Healthcare Activity (Ustawa o działalnos´ci leczniczej) of 15 April 2011, which came into force on 1 July 2011 (Journal of Laws of 2011, No. 112, item 654 as amended). The new Act regulates the basic principles of performing healthcare activities (which are provision of medical services and promotion of health) by public healthcare institutions, government agencies, private enterprises and other entities enumerated in Article 4 of the Act. One of the new ideas of the Act is the possibility to transform public healthcare institutions, created under the former Act of 30 August 1991, into capital associations (partnerships). However, despite the change of laws the fundamental principles of civil liability for medical malpractice remain unchanged.

222 According to statistical data, in 1991 there were 260 (reported) claims concerning medical malpractice and 80 of them were adjudicated in favor of the plaintiff. In 1999, this number increased to 968 (in 509 of them compensation was granted). As for the last ten years, it is estimated that there have been around 1,500 malpractice suits annually. Adam Makosz, supra note 56. 223 However, there is a bill of November 2010 which proposes a no-fault compensation scheme for injuries resulting from so-called medical misfortune (niepowodzenie lecznicze). The draft defines medical misfortune as an activity concerning diagnosis, therapy or application of medical products which is inconsistent with requirements of current medical knowledge, provided it results in infections, bodily impairment, health disturbance, or the patient’s death. According to the proposed bill, medical misfortune claims are to be adjudicated by independent district commissions in special, simplified procedures that will be less formal, less expensive and much quicker than civil law suits. See E. Kowalewski, M. Wałachowska, M. S´ liwka, Kompensacja szkód wynikłych z “błe˛ dów medycznych”. Ocena projektowanych rozwia˛zan´ prawnych, Prawo i Medycyna 22 (2010).

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2. On 1 January 2012, an amendment to the Law on Patients’ Rights and Patients’ Ombudsman of 6 November 2008 came into force (Journal of Laws of 2011, No. 113, item 660) and established a new extra-judical (no fault) compensation system (Chapter 13a, Articles 67a-67o of the Law). This new regime, based on the Scandinavian NFPI scheme and the French Law of 4 March 2002), is to redress injuries sustained in hospitals due to so-called medical events (zdarzenia medyczne). A medical event has been defined by the Law as an activity concerning diagnosis, therapy or application of medical products which is inconsistent with the requirements of current medical knowledge and which results in infections, bodily impairment, health disturbance or the patient’s death. All hospitals (as defined by the above-mentioned Act on Healthcare Activity) are obliged to insure themselves against medical events, beginning 1 January 2014 (up to which time the insurance is voluntary). According to the Law, medical event claims are adjudicated in special, two-stage, simplified procedures that are less formal, less expensive (with a fixed fee of PLN 200, or E 50, to initiate the proceedings) and much quicker than civil law suits (the maximum time limit of four months to settle a case). At the first stage, the claim is adjudicated by an independent district commission (medical claims board), which establishes the sole fact whether the activity in question was a medical event in the definition of the Law; the damage and amount of compensation cannot not be determined by the commission. The decision of the board is binding on the insurer, who is then obliged to make an offer of compensation for both pecuniary and non-pecuniary loss to the claimant (the 2nd stage of the procedures). The compensation proposed by the insurer may not exceed the statutory limits (damage caps): PLN 100,000 (E 25,000) for personal injury due to medical error, wrong application of medicine or causing the patient to contract a contagious disease, and PLN 300,000 (E 75,000) in the case of a patient’s death. If the patient accepts the insurer’s offer, he has to give up any further claims stemming from losses that occurred before filling the motion. However, if he rejects it, he may still pursue the case in court. The decision of the commission has a force of the court judgement and can be enforced in the execution proceedings without being confirmed by a court. A new system has been criticized by doctrine. On one hand, it is said that a no fault compensation regime is a good mechanism to overcome the problems that are inherent in the existing model of medical malpractice, especially the requirement of proof of fault attributed to the health care professional. On the other hand, the scope of the new system is limited to injuries sustained in the course of hospital treatment and does not cover 374

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medical accidents (therapeutic risks and other damages no one is responsible for due to the lack of fault). Besides, the question has been raised whether the new compensation scheme is really a no fault system, since the requirement of establishment of inconsistency with the current medical knowledge, set up by the Law as the basic prerequisite in determining the existence of medical misadventure, has the notion of fault. Last but not least, the sums which may be claimed are far too low, and there seems to be no reasonable justification for paying up to PLN 300,000 to the successors of the injured party and only up to 100,000 to the patient who is alive and still suffers injury. For more information about the new Polish no fault compensation system see: E. Kowalewski (red.) Kompensacja szkód wynikłych ze zdarzen´ medycznych. Problematyka cywilnoprawna i ubezpieczeniowa, Torun´ 2011

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Malpractice in Scandinavia Vibe Ulfbeck*, Mette Hartlev** and Mårten Schultz***

Introduction There are different welfare state models, and the Nordic model has certain characteristics not prevalent in other models.1 First of all, the Nordic model is a universal model where entitlements to social services are based on residency or citizenship and not on employment relation or need. There is a comprehensive social benefit scheme and social services are normally free or subsidized at the point of delivery. Furthermore, there is strong public involvement in the social and economic area to promote equality of the highest standard (and not just equality with regards to basic needs). Thus, the Nordic welfare model is very influenced by an egalitarian ideology. The Nordic model in relation to tort law (with emphasis on personal injury law) must be understood in this context. On a general level, Scandinavian tort law is a law of delict. The analysis revolves around the basic concepts of culpa, causation, adequacy, and damage. The culpa rule – the basic principle that holds that liability presumes

Vibe Ulfbeck, LL.,D, is professor of private law at the Faculty of Law – University of Copenhagen. Her major interests include tort law and the interplay between private law and public law. She is director of Center for Enterprise Liability (CEVIA) and a member of the European Group on Tort Law (EGTL). She is also a member of the advisory board of the Journal of European Tort Law and has participated in a number of EU funded research projects. ** Mette Hartlev, PhD, LL.D, is professor of health law at the Faculty of Law – University of Copenhagen. Her major research interests include health law, patients’ rights, biolaw and bioethics, and science and technology studies. She is a member of the editorial board of the European Journal of Health and has participated in a number of EU funded research projects. *** Mårten Schultz, professor of private law, Stockholm University. 1 Jon Magnussen, Karsten Vrangbæk, Richard B. Saltman Jon Magnussen & Pål E. Martinussen, Introduction: The Nordic Model of Health Care, in Nordic Health Care Systems: Recent Reforms and Current Policy Challenges 3, 3–20 (Jon Magnussen, Karsten Vrangbæk & Richard B. Saltman eds., 2009). *

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negligence – provides the standard for personal responsibility. The culpa rule is a dogma in the Scandinavian legal systems: it lies at the core of tort analysis. In reality, however, many injuries will never be tried under the general rules of fault liability. The shift from the general culpa rule to different insurance solutions is in fact considered a foundational development of the Scandinavian welfare states in general. It is probably not an exaggeration to say that the introduction of overreaching compensation mechanisms was a core constituent in the construction of the Nordic welfare states. This development often goes under the name of the Nordic model.2 In relation to compensation for injuries, the Nordic model can be characterized in different ways. From a policy point of view, the most fundamental and almost banal idea is that personal injury should always be compensated. To achieve this goal, it has generally been agreed that the cost of personal injury compensation is in general best carried by collective entities. The legal system has provided rules that promote the idea that costs resulting from personal injuries are borne by collective entities. A more detailed picture of the Nordic model in this respect will reveal a complex interplay between social insurance and other kinds of collective compensation schemes as well as personal insurance, and – to a lesser extent – tort law. The Nordic model is not the same as the New Zealand approach to personal injuries; the idea was never that the taxpayer should cover all costs of personal injuries. In fact one of the basic ideas was that the costs instead should be covered by insurance paid for by the party responsible for activities that were thought to be particularly risky (and thus not paid (directly) by the taxpayer).3 In a narrow sense the Nordic model is sometimes used as a collective term for four important compensation schemes: (1) traffic accidents, (2) patient injuries, (3) pharmaceutical injuries, and (4) work-related injuries.4 These 2 For some general accounts of the Swedish or Nordic approach to tort law, see Jan Hellner, Compensation for Personal Injury: The Swedish Alternative, 34 Am. J. Comp. L. 613 (1986) [hereinafter Hellner, The Swedish Alternative]; Jan Hellner, Compensation for Personal Injuries in Sweden: A Reconsidered View, 41 Scandinavian Stud. Law 249 (2001) [hereinafter Hellner, A Reconsidered View]; Carl Oldertz, Security Insurance, Patient Insurance, and Pharmaceutical Insurance in Sweden, 34 Am. J. Comp. L. 635 (1986). See Guido Calabresi, Policy Goals of the “Swedish Alternative,” 34 Am. J. Comp. L. 657 (1986) for reflections on the Swedish alternative from a policy point of view. 3 Of course, indirectly the system is tax funded. Thus, when public hospitals must pay for insurance, the expenditures of the hospitals rise. These expenditures must be paid by the state, which ultimately means the taxpayer. 4 See Hellner, A Reconsidered View, supra note 2, at 269–70. See Bill W. Dufwa, Development of International Tort Law Till The Beginning of the 1990s From a Scandinavian Point of View, 41 Scandinavian Stud. Law 87 (2001) for a more overarching account of Swedish tort law from an international perspective.

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different insurance systems are crucial to an understanding of malpractice and medical liability in Swedish law since they all entail that fault liability is pushed aside in their respective areas. In a more extensive sense one can see the Nordic model as encompassing not only these comprehensive compensation schemes but also as a providing a general outlook on the relationship between personal injury compensation and insurance.

I.

The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events

A.

Regulatory Methods in the Nordic Health Care Systems

The Nordic approach to compensation for medical malpractice must be understood in the broader context of the Nordic health care systems in terms of organization, regulation, professional duties, and financing. The organization of health care services varies slightly among the Nordic countries. Different organizational levels may be operating (e.g., state, regions, and municipalities), and some fluctuation between centralization and decentralization may be observed.5 In general, financing of the health care services is the public’s responsibility, and most services are covered by a tax-paid health service scheme (a so-called Beveridge model). However, private service providers are also, to an increasing extent, operating in the Nordic countries: in some situations people would rather pay for treatment at private hospitals than make use of the available public health care schemes.6 The strong involvement of public financing also affects the nofault compensation scheme as compensation ultimately comes from the taxpayers. This may have an impact on the level of compensation. In general, health care professionals are subject to legal regulation stipulating rights and duties, and most groups of health care professionals are covered by a licensing system operated by the public health care authorities (and not by the professions themselves). This provides the authorities with the power to survey and control the professional performance of health care professionals and also to issue sanctions in cases of malpractice. In serious cases the professional’s license may be withdrawn. Together with complaint

5 Pål E. Martinussen & Jon Magnussen, Health Care Reform: The Nordic Experience, in Nordic health care systems: Recent Reforms and Current Policy Challenges, supra note 1, at 21– 52. 6 This is, for example, the case in Denmark. Mette Hartlev, Forwards or Backwards? New Directions in Danish Patients’ Rights Legislation, 18 Eur. J. Health L. 365, 367–69 (2011).

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mechanisms, this serves the purpose of preventing medical malpractice. Patients are entitled to complain both with regard to violations of patients’ rights (e.g., right to information) and in cases of medical malpractice. The complaint procedures are organized differently in each of the Nordic countries.7 Recently, there has been an increasing interest in improving patient safety, for example, through obligations to report adverse events. This promotes a “learning approach” to adverse events with the purpose of preventing risks and faults in the future. As may be clear from this brief description of the broader context, there are various mechanisms in the Nordic health care systems that serve the purpose of preventing medical malpractice. Consequently, the compensation system must be viewed in connection with these other mechanisms.

B.

Compensation Systems

A noteworthy feature of the Scandinavian system’s approach to malpractice is the Nordic countries’ various patient insurance systems. Sweden was the first Nordic country to develop a patient insurance system8. Here, the first patient insurance scheme was introduced in 1975. Afterwards, the development in Sweden spread. Thus, a patient insurance act was adopted in Finland in 1984, in Norway in 1988, and in Denmark in 1992.9 All of these acts were inspired by the Swedish scheme, although they were not entirely identical. The current Patient Injuries Acts will be referred to as the Swedish PIA,10 the Finish PIA,11 the Norwegian PIA,12 and the Danish KEL13.

7 Ulrika Winbland & Ånen Ringard, Meeting Rising Public Expectations: The Changing Roles of Patients and Citizens, in Nordic Health Care Systems: Recent Reforms and Current Policy Challenges, supra note 1, at 126–50. 8 Edvard Nilsson, Ulf K. Nordenson, Carl Oldetz & Erland Strömbäck, Personskaderättens utveckling – ersättning på grund av individiuell skadeståndsrätt eller kollektiv försäkring, in Patient – och läkemedelsförsäkringen vid ett vägskäl. Vänbok till Carl E Sturkell, 19– 21 (1996). 9 See Bo von Eyben, Alternative Compensation Systems, 41 Scandinavian Stud. Law 193, 201– 02 (2001) for a description of this development. 10 Patientskadelag (Svensk författningssamling [SFS] 1996:799) (Swed.). 11 Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 (Fin.). 12 Lov om erstatning ved pasientskader mv. (Pasientskadeloven) [Patient Injury Act] No. 53, June 15, 2001 (Nor.). 13 Lov om klage- og erstatningsadgang inden for sundhedsvæsenet [Law on the Right to Complain and Receive Compensation within the Health Service] No. 706, June 25, 2010 (Den.).

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When it comes to the details of the way the systems are organized, the Swedish system can serve as an illustration. Liability insurance in Sweden is mandatory and regulated in the Patient Insurance Act. Patient insurance is supplied by a company called Landstingens Ömsesidiga Försäkringsbolag (LÖF).14 All county council districts (landsting), which are the chief suppliers of health care in Sweden, have taken up insurance with the LÖF.15 Private health care providers also fall under the insurance scheme as regulated by their contracts with the county council districts. Malpractice is sometimes seen as an area of the law where the Scandinavian systems have been especially successful in avoiding the perceived absurdities in other jurisdictions.16 Scandinavian lawyers will generally talk about malpractice law in the U.S., or rather the stories about malpractice law in the U.S., with a tone of horror in their voices. One of the most common arguments in favour of the Nordic model in this area is that it successfully avoids the (supposedly) perverse effects of malpractice law in the U.S. A side effect is that malpractice law in Scandinavia is sometimes obscure.

C.

Liability Systems

Tort law is a legal discipline that has gone from being perceived as a part of criminal law to a “pure” civil law subject in Scandinavian law. There are still remnants of the idea that tort law is connected to criminal law, noticeable for instance in the fact that the rules on defences in the Criminal Code are thought to apply also in tort law, without it even being mentioned in any tort law legislation. Also, tort law has gone from the situation where there were very few statutory rules that directly (i.e., without being considered as applied by analogy) dealt with tort liability. This changed in the nineteenth century. The most important legislative input in the development of the current understanding of fault liability is undoubtedly the introduction of statutes of tort liability. In Sweden, the Tort Liability Act came into force in 1972.17 This act was the first overarching legislation on tort liability in Swedish law. Previously, the main source of tort principles in legislation was the sixth 14 15 16

17

See Patientförsäkringen LÖF, http://www.patientforsakring.se/ (last visited Oct. 20, 2011). Id. For a comparative study between Swedish and U.S. law, see Lotta Westerhäll, An Introduction to Medical Malpractice Law in the United States and Sweden – the Rights of Patients (1992). Skadeståndslag (Svensk författningssamling [SFS] 1972:207) (Swed.).

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chapter of the Penal Act, a predecessor of today’s Criminal Code.18 The Tort Liability Act was never intended to be a full codification of tort law. Many basic criteria for liability were left out of the statute. For instance, the general requirement of causation is not mentioned at all in the act. Still, it is clear from the preparatory works that causation was still to be considered a requirement of liability.19 Many other basic liability requirements, as well as other tort principles, were also left uncodified.20

D.

The Relationship Between the Systems

Theoretically, there are several ways in which a patient who has suffered injury may claim compensation. He can be compensated in the form of damages under the rules of tort law, he can claim compensation under the patient insurance scheme and, in addition, he can sometimes claim compensation under his own private insurance. However, most often, the cases will be dealt with under the insurance schemes. Nevertheless, all of the Scandinavian legal systems except for one (the Danish system) allow for the ordinary tort law rules to be applied as an alternative to the compensation systems. Thus, even if the patient has the right to obtain compensation under the special insurance scheme, he normally still has the choice to instead claim compensation under tort rules if he so prefers. In Swedish law, the patient insurance then works as liability insurance. The possibility of using tort law instead of the alternative compensation scheme is seldom used. Very few medical malpractice cases are thus dealt with directly under the rules of tort law. If a case went to court the plaintiff would bear the burden of proving the circumstances on which she bases her claim. This means that the burden of proof for loss, causation, and fault falls on the plaintiff. The patient’s position is substantially better within the patient insurance scheme.

18 19 20

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strafflagen (Svensk författningssamling [SFS] 1864:11); brottsbalken (Svensk författningssamling [SFS] 1962:700) (Swed.). Proposition [Prop.] 1972:5 Kungl. Maj:ts proposition med förslag till skadeståndslag m. m. [government bill] (Swed.) at 21. Similar developments were seen in the other Nordic countries. In Denmark the first Tort Liability Act came into force in 1984. Bekendtgørelse af lov om erstatningsansvar [Act on Liability] No. 885, Sept. 20, 2005 § 28 (Den.). In Norway, the Tort Liability Act dates back to 1969. Lov om skadeserstatning (Skadeserstatningsloven) [Damages Act] No. 26, June 13, 1969 (Nor.).

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The few malpractice cases that do go to court, therefore, most often concern injuries that the patient insurance does not cover.21 In Danish law, the system is a little different. Here, application of the ordinary tort law rules is precluded if the patient has the right to obtain compensation under KEL.22 The idea behind the system is to channel liability to the patient insurance. However, this rule does not apply in the case of product liability. In these cases, the right to claim damages under tort law as an alternative to the patient insurance is upheld.23 The reason for this is that the Danish product liability rules are based on an E.U. directive that requires that the injured party can sue the producer.

II.

The Details of the Applicable Liability and Compensation Systems

A.

Patient Injury Compensation Systems

1.

Introduction

Since the patient insurance systems for all practical purposes are the key to understanding Scandinavian malpractice law, the following will focus on these compensation systems and not on ordinary tort law. Although all of the Scandinavian patient injury systems are based on the same basic idea, there are still differences between the compensation systems when it comes to the details. The following is an attempt to give a fuller description of the central, common rules in the insurance schemes and to point out some differences.

2.

Basis for Compensation

a. The Experienced Specialist Standard. The experienced specialist standard is a common feature of the Nordic medical malpractice compensation systems.24 According to this rule, compensation shall be paid for an 21 22

23 24

See infra pt. II.A.3.b. See Lov om klage- og erstatningsadgang inden for sundhedsvæsenet [Law on the Right to Complain and Receive Compensation within the Health Service] No. 24, Jan. 21, 2009 § 26 (Den.). See id. § 28. The rule is found in the following: for Denmark, see id. § 20 para. 1(1); for Finland, see Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 2 para. 1(1) (Fin.); for Sweden, see 6(1) §Patientskadelag (SFS 1996:799) (Swed.). In contrast, the experienced

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injury if it may be assumed that an experienced specialist in the field in question under the given circumstances would have acted differently during examination, treatment, or the like, thereby avoiding the injury.25 The term “experienced specialist” means that the evaluation must be based on an optimus vir standard.26 This refers to the best doctor in the particular field as opposed to any good and reasonable doctor. Thus, the classic fault rule is not in play. In contrast, the overall question is if the patient has received the treatment, which according to medical science and experience, would have been the best for him. If the experienced specialist would have acted differently and thereby avoided the injury, the patient is entitled to compensation. The evaluation, in other words, is objective and implies a hypothetical course of events. Under this hypothetical course of events, the actual doctor is “replaced” with the best doctor. It should be noted, however, that the rule does not imply that the patient has an absolute right to receive the optimal treatment. Under Danish law, this follows from KEL section 20, paragraph 1, clause 1, which specifies, “...in the given circumstances.”27 Thus, the resources and facilities that were available in the specific situation must be taken into consideration. Lack of resources, which may lead to a lack of personnel or a lack of the newest technical equipment, may be a valid excuse and imply that there is no right of compensation according to the specialist rule. However, if the experienced specialist in a given situation could have sent the patient to a more experienced specialized hospital and refused to treat the patient himself because of a lack of resources, the patient may be entitled to compensation. It is a requirement that the referral could have avoided the injury. If a transfer would not have been an option (e.g., if urgent measures had to be taken to save the patient’s life), the experienced

25 26 27

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specialist standard is not found in the Norwegian PIA; instead, there is strict liability for injuries caused by treatment. See Sten Foyn, Anne Margrethe Lund & Ola Viken, Pasienters Rettsstilling 190 (1990). See Skadeståndslag (Svensk författningssamling [SFS] 1972:207) (Swed.). Bøje Pommer, Patientskadeerstatning 72 (2011); Bo von Eyben & Helle Isager, Lærebog i erstatningsret 396 (2011). Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 20 para. 1(1) (Den.). See Lov om erstatning ved pasientskader mv. (Pasientskadeloven) [Patient Injury Act] No. 53, June 15, 2001 § 2 para. 2 (Nor.), for Norwegian law.

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specialist could not have avoided the injury by a transfer, and the patient would not be entitled to receive damages.28

b. The Failure of Apparatus. Another common feature is the “failure of apparatus” rule.29 This rule deals with injuries due to the malfunction or failure of technical apparatus, instruments, or other equipment used for or in connection with examination, treatment, or the like. The rule establishes strict liability. If the injury results from malfunction of equipment falling under the rule, the patient is entitled to compensation. The reason why the equipment did not function is of no importance. In this respect, the rule goes further than the product liability rules. Thus, the rule does not require that the equipment is defective within the meaning of the Product Liability Act, and there is no “state of the art” defence available. The main purpose of the rule is to ensure that it is no concern to the patient what kind of technical failure has occurred. However, if the malfunction or failure of the technical equipment is in fact within the scope of the Product Liability Act, the patient has the choice to claim damages under this Act instead of invoking the special patient insurance schemes.30 As a starting point, the level of compensation will be the same under the two sets of rules. It should be noted that the failure of apparatus rule covers any equipment that is being used during the examination or treatment. It is of no importance how complicated or simple it may be.

28

29

30

Kristina Sprove Askjær, Niels Hjortnæs & Peter Jakobsen, Erstatning inden for sundhedsvæsnet 85 (2008); Bøje Pommer, Patientskadeerstatning 82 (2011); Bo von Eyben & Helle Isager, Lærebog i erstatningsret 397 (2011). The rule is found in the following: Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 20 para. 1(2) (Den.); Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 2 para. 1(2) (Fin.); 6(2) §Patientskadelag (SFS 1996:799) (Swed.); Pasientskadeloven [Patient Injury Act] No. 53, June 15, 2001 § 2 para. 2(b) (Nor.). In Danish law, this follows explicitly from Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 28 (Den.). See UfR 2001.2338H, 2344 (2001) (Den.). The case concerned a kidney transplant carried out at a public hospital.

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c. The Alternative Treatment Rule. Both Danish and Swedish law recognize the “alternative treatment rule.”31 According to this rule, compensation shall be paid if, on the basis of a subsequent evaluation, the injury might have been avoided using another available treatment technique or treatment method that would have been just as successful in treating the patient’s illness from a medical point of view. The rule is relevant in situations where the doctor had an alternative between the treatment he used and another available treatment, which would have been just as effective, that would have been a better choice for the patient. Again, the theme is not what the individual doctor should have done but what from an objective point of view would have been the better choice. Thus, the alternative treatment rule is not a fault-based rule. This most clearly becomes apparent when looking at the exact wording of the rule. The keywords of the alternative treatment rule are “... subsequent evaluation.”32 This means that when evaluating whether the injury could have been avoided, not only is information available at the time of the treatment taken into consideration, but also information that becomes available after the treatment or examination has taken place.33 In this sense, the evaluation of what was unavoidable is determined using hindsight. Nevertheless, the alternative method or technique must have been a current option that was actually available when the patient was treated or examined. The doctor must have had a real choice when treating the patient. This alternative or choice does not have to be a skill that the doctor masters himself. If an alternative method exists somewhere else in the health service system, the doctor must refer the patient.34 d. The Reasonableness Rule. The Nordic compensation systems also – to varying degrees – apply a reasonableness rule. In the Danish and Finnish systems, this reasonableness rule is of a general nature. It provides that compensation must be paid if injury occurs as the result of examina-

31

32 33 34

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See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 20 para. 1(3) (Den.); 6(1) §Patientskadelag (SFS 1996:799) (Swed.). Similar rules are not found in the Finnish PIA or the Norwegian PIA; however, under the Norwegian PIA this should be seen in the light of the strict liability rule. See discussion, supra pt. II.A.2.b. 6(1) §Patientskadelag (SFS 1996:799) (Swed.). Kristina Sprove Askjær, Niels Hjortnæs & Peter Jakobsen, Erstatning inden for sundhedsvæsnet 95 (2008). See UfR 2007.477H (2007) (Den.), for an illustration of the application of the rule. The court rejected liability for not having carried out surgery prior to a brain haemorrhage.

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tion, including diagnostic procedures or treatment in the form of infections or other complications that are more extensive than the patient should reasonably have to bear.35 The following aspects must be taken into account: the severity of the injury, the patient’s illness and general state of health, the rareness of the injury, and the general possibility of taking the risk of its occurrence into consideration. Also under the Norwegian PIA a general reasonableness rule is acknowledged.36 Under Swedish law, a similar rule applies, but only in relation to infections.37 Under Danish law, this rule is meant to encompass the injury situations that are not within the scope of KEL section 20, paragraph 1, clauses 1–3. The Danish KEL section 1, paragraph 1, clause 4 applies in the situation where damages cannot be claimed by using clauses 1–3, and where not awarding the patient damages would be even more inappropriate under a reasonableness test.38 The rule rests on the basic assumption that some injuries must be accepted by the patient. In order to be compensable, the injury must be disproportionate compared to the underlying disease and the consequences that could normally be expected of it. This means that the more serious the initial disease, the more substantial complications must be accepted.39

e. “Accidents” In Sweden, certain injuries caused by accidents may be compensated under the PIA, for instance, when a patient suffers an injury caused through a fire at a hospital.40 An equivalent rule is found in Finnish law.41 In contrast, Danish and Norwegian compensation systems only compensate such accidents if there would have been a basis for liability under ordinary tort law rules.42

35

36 37 38 39 40 41 42

See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 20 para. 1(4) (Den.); Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 2 para. 1(7) (Fin.). See Pasientskadeloven [Patient Injury Act] No. 53, June 15, 2001 § 2 para. 3 (Nor.). 6(4) §Patientskadelag (SFS 1996:799) (Swed.). See infra Part II.A.2.g. Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 20 (Den.). See UfR 200I.2505H, 2509 (2001) (Den.), for an illustration of the application of the rule. The case concerned damage to intestine caused by radiation treatment. See 6(5) §Patientskadelag (SFS 1996:799) (Swed.). See Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 2 para. 1(5) (Fin.). See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 21 para. 2 (Den.); Pasientskadeloven [Patient Injury Act] No. 53, June 15, 2001 § 2 para. 1(e) (Nor.).

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f. Wrong Diagnosis. In the Swedish PIA there is a special rule on injuries caused by an incorrect or delayed diagnosis. Such injuries are compensable under the patient injury scheme.43 Compensation for wrongful diagnosis is awarded only if it may be assumed that an experienced specialist in the field in question under the given circumstances would have acted differently. A similar rule applies under Danish law.44

g. Infection. In Swedish law, as well as in Finnish law, there is a special rule dealing with compensation for infections. Thus, if an injury results from an infection which originates from an examination, treatment or similar action, the patient has a right to be compensated, unless the patient is required to endure the injury in view of the predictability of the infection, the degree of severity of the injury sustained, the nature or difficulty of the illness or impairment that was being treated and the patient’s overall health.45

3.

Causation

a. The Concept of Causation in Scandinavian Law. Causation is a general requirement for liability, and it is also a prerequisite for compensation from patient insurance. It is generally assumed that the requirement of causation is to be understood uniformly – it has the same meaning in tort law as well as patient insurance law. However, the question of how Scandinavian law deals with uncertain causation in medical malpractice cases is difficult to answer for several reasons. The concept of causation in Scandinavian law is more vague than in many other legal systems. Scandinavia does not have the firm basis in a conditio sine qua non view of causation that most other Western countries share, and instead the Scandinavian tort law systems operate with a more open, pragmatic approach to the causal requirement.46 For example, courts are open to finding ways around the difficult problems of uncertain causation through flexible variations of the concept of causation. Before some specific problems associated with causation in cases of malpractice are addressed, a few 43 44 45

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See 6(3) §Patientskadelag (SFS 1996:799) (Swed.). See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 21 para. 1 (Den.). See Potilasvahinkolaki [Patient Injury Act] Act No. 585 of July 25, 1986 § 2 para. 1(3) (Fin.); 6(4) §Patientskadelag (SFS 1996:799) (Swed.); cf. 6(2) §Patientskadelag (SFS 1996:799) (Swed.). See generally Mårten Schultz, Kausalitet (2007).

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general remarks should be made on the how the concept of causation is perceived in the Scandinavian legal systems. The causal inquiry in Scandinavian law is generally perceived of as a twotier process. The first step is the factual-causation inquiry: did the intentional or negligent act of the defendant actually cause the damages or injuries of the plaintiff? The second step is the adequate-causation inquiry: was the act or event in question an adequate cause of the damages or the injuries of the plaintiff?47 In English legal terminology this is usually referred to as the proximate-cause inquiry, or placed under headings such as “remoteness” or “foreseeability.” In other words, it deals with excluding from the scope of liability acts or events that, even though in fact causally connected with the conduct, are considered too unforeseeable or remote. In the Scandinavian countries, these demarcation problems primarily fall under the heading of “adequacy,” or the adequacy test.48 The requirement of causation can often pose special problems in malpractice cases. From the Scandinavian perspective, the problem of establishing causation in a particular case sometimes converges with the problem of capturing what the requirement actually entails. There seem to be some differences between the Scandinavian systems when it comes to the concept of causation. In the Scandinavian systems the requirement of causal connection does not follow from any provisions of the different statutes, but is generally said to belong to the unwritten general and fundamental tort law principles. The absence of statutory support is perhaps not surprising since the Scandinavian legislators never intended to codify tort liability law in its entirety: none of the Scandinavian countries have a civil codification. For an understanding of the content of general tort law principles, Scandinavian lawyers will generally fall back on other legal sources, such as the preparatory works of the legislation and decisions by the Supreme Court. The preparatory works do not give any clear guidance on the issue of causation in any of the Scandinavian countries. The only Supreme Court

47

48

Whether causation is a link between events, facts, or some other entities has been a matter of debate. See, e.g., Tony Honoré, Necessary and Sufficient Conditions, in The Philosophical Foundations of Tort Law 367, 367 (David G. Owen ed., 1995). See also J.L. Mackie, The Cement of the Universe 248 (L. Jonathan Cohen ed., 1974); D.H. Mellor, The Facts of Causation 119–20 (1995); Donald Davidson, Causal Relations, in Essays on Actions and Events 149, 149 (1980); D.H. Mellor, The Singularly Affecting Facts of Causation, in Metaphysics and Morality: Essays in Honour of J.J.C. Smart (1987), reprinted in Matters of Metaphysics 201, 201 (1991). See Håkan Andersson, Skyddsändamål Och Adekvans 29–36 (1993) for a thorough investigation. See also Mårten Schultz, Adekvansläran (2010).

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in Scandinavia that has taken a more or less clear stand on the issue of the concept of causation is the Supreme Court in Norway. The Norwegian court has thus stated that the causal requirement is generally to be understood in accordance with the conditio sine qua non theory, which entails that the assessment of causation is carried out through a but-for test.49 In the absence of clear guidance from the courts the main source for understanding the concept of causation is legal literature. The leading works indicate that the Scandinavian systems seem to uphold something like a but-for test as a first step but it is less clear than in many other jurisdictions. As for Denmark, the conditio sine qua non approach seems to be considered the starting point for the causal analysis. The leading textbook by Bo von Eyben and Helle Isager thus holds that the first question in an investigation of causation is the but-for test.50 Within the Swedish discussion, one cannot find any dominant, favored approach for dealing with actual causation the way the so-called sine qua non test (but-for test) has been used in many other jurisdictions.51 It has previously been argued that the conditio sine qua non approach captures the concept of causation also in Swedish law. Today the picture is more complex. Recent Swedish publications have argued for alternative approaches to causation, especially for some sort of NESS test.52 Norwegian authors have put forward other models of causation; especially noteworthy in this regard is Nils Nygaard’s so-called risk realisation theory.53 According to some scholars, Nygaard’s theory resembles John Mackie’s INUS-approach to causation (which resembles with the NESS test).54

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50 51

52

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In Rt. 1992, § 64 the Norwegian Supreme Court thus states (in translation): “The requirement of causation between an act or an omission is generally fulfilled when the damage would have occurred if the act or omission is thought away. The act or omission is then a necessary condition for the damage.” Bo von Eyben & Helle Isager, Lærebog i erstatningsret 286 (2011). For comparative accounts on the application of the so-called sine qua non theory in other jurisdictions, see Tony Honoré, Causation and Remoteness of Damage, in 6 International Encyclopedia of Comparative Law 7 (A. Tunc ed., 1983); 2 Christian von Bar, The Common European Law of Torts 433–98 (2000). See Schultz, supra note 46. The notion of NESS has been introduced by Richard W. Wright, building on the account in Hart & Honoré’s seminal Causation in the Law, as well as on ideas by the philosopher John Mackie. See H.L.A. Hart & Tony Honoré, Causation in the Law 112 (2d ed. 1985). For Richard W. Wright’s analysis, see Richard W. Wright, Causation in Tort Law, 73 Calif. L. Rev. 1735, 1788 (1985); Richard W. Wright, Causation, Responsibility, Risk, Probability, Naked Statistics, and Proof: Pruning the Bramble Bush by Clarifying the Concepts, 73 Iowa L. Rev. 1001, 1019 (1988); Richard W. Wright, Once More Into the Bramble Bush: Duty, Causal Contribution, and the Extent of Legal Responsibility, 54 Vand. L. Rev. 1071, 1101–03 (2001). Nils Nygaard, Skade og ansvar 326 (5th ed. 2000). See Bjarte Askeland, Erstatningsrettslig Identifikasjon 85 (2002).

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It should be clearly stated that the Scandinavian stance on the issue of cause-in-fact is ambiguous and difficult to interpret. It seems clear that the but-for test does not have the dominant position that it has in many other countries.55 However, a couple of points can be made with some certainty. The twofold causal inquiry is generally taken for granted.56 Also, the apparatus of necessary and sufficient conditions is seen as a tool that in some way could be used when carrying out the first factual inquiry. There are some that still argue that this inquiry is to be, or should be, more or less, carried out in accordance with the but-for test, but other writers are more cautious and do not take a firm position on any specific method.57 The general impression is that it is difficult to clearly state how the core view on causation in Scandinavian law actually is to be understood. An illustrative example of this skepticism towards causal theory is the late professor Jan Hellner’s review of Hart and Honoré’s seminal Causation in the Law. The review criticized Hart and Honoré’s argument that the approach to analyze causation from a common sense perspective could even lead to begriffsjursprudenz, a legal system-building pursuit so detested in Scandinavia.58 Within the Scandinavian legal systems, the conceptual analysis associated with causation in other jurisdictions has been considered misguided, especially in light of the well known flaws of the traditionally favored conditio sine qua non theory. It is therefore very unusual that the terminology of necessary and sufficient conditions is even mentioned in judgments and other legal texts. The attitude seems to be

55

56 57

58

Concerning the comparative claim that the but-for test is dominant in many other jurisdictions, see von Bar, supra note 51, at 437. See also Jaap Spier & Olav A. Haazen, Comparative Conclusions on Causation, in Unification of Tort Law: Causation 127, 127 (Jaap Spier ed., 2000) (“All jurisdictions recognise causation as a requirement of tortious liability and all legal systems consider a condicio sine qua non as such as a first test.”). That is, a dichotomy between the cause-in-fact inquiry and the legal process of evaluation is taken for granted. See Schultz, supra note 46, at ch. 8. Cf. Jan Hellner, Causality and Causation in Law, 40 Scandinavian Stud. Law. 111, 132 (2000) (“Most writers do not seem to take any clear position on this point, or may be that they frame the problems in other terminology.”). Jan Hellner is one of the leading Scandinavian tort scholars in legal history. For his review of Hart & Honoré’s Causation in the Law, see Jan Hellner, Book Review, in Svensk Juristtidning 525, 525–26 (Birger Ekeberg et al. eds., 1960). See also Andersson, supra note 48, at 306 n.74; Bill W. Dufwa, Flera skadeståndsskyldiga [Joint and Several Torts] 935 n.44 (1993); Aleksander Peczenik, Causes and Damages 379–380 (1979); Ulf Persson, Skadestånds – Och Försäkringsrättsliga Studier 114–117 (1962). For a less critical view towards the common sense approach, see Folke Schmidt, Orsaksproblemet under debatt, in Svensk Juristtidning 209, 209 (Birger Ekeberg et al. eds., 1954); Mårten Schultz, Further Ruminations on Cause-In-Fact, 41 Scandinavian Stud. L. 478, 479–80 n.61 (2001).

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changing, especially among scholars, but the “pragmatic” approach to causation still holds strong in the courts.

b. The Problems of Causation in Malpractice Law. In general, it may be assumed that malpractice law, as well as patient injury law, takes the analysis of the basic concepts of tort law for granted. The concept of causation in a malpractice case, and also when it comes to compensation under the rules of patient insurance, is thus the same concept as that employed in the general law of torts. A more interesting issue is whether special doctrines or principles can be allowed to influence the analysis of causation in malpractice law as a complement to the traditional apparatus. Malpractice cases have challenged traditional legal analysis in many jurisdictions. These challenges have produced new legal doctrines, such as the doctrine of loss of chance and probabilistic causation. The Scandinavian legal systems have not really had a discussion on these issues. From a comparative perspective this might be seen as strange, perhaps even underdeveloped.59 An explanation can be found in the previous account. Few malpractice cases are tried under the rules of tort law and claims under the patient insurance scheme seldom reach the courts. It seems that the development of tools such as the doctrine of loss of chance, proportional liability, or probabilistic causation is at least partly a product of the difficulties of providing reasonable results within the traditional conceptual apparatus, for instance in some malpractice cases. The Scandinavian legal systems take a more open, pragmatic approach to basic concepts such as causation, but also of the different concepts of damages (e.g., physical injury), so that situations that have provoked courts to develop the loss of chance doctrine in other jurisdictions could be handled through a flexible interpretation of the standard concepts.

c. Relaxation of Evidence. It is a common approach in Scandinavian law to seek solutions to problems of causation within the law of evidence. To put it somewhat provocatively, courts, and to some extent also scholars, sometimes seem to think that the problems of capturing the essence of the causal requirement can be solved by relaxing the burden of proof. This holds also for malpractice cases.

59

392

See discussion, supra pt. I.E.

Scandinavia

In Denmark, the difference between the general rules of private tort law and KEL is that the requirement for evidence is relaxed for causal connection between the examination or treatment and the injury. According to KEL, it is sufficient if on a balance of probabilities there is causation. KEL section 20 states that “[c]ompensation shall be paid if, on the preponderance of the evidence, the injury was caused...”60 Thus, the right to compensation is not dependent on proof of causation to the level of certainty that the Danish courts would normally require. In fact, probability of 51 percent is enough.61 A similar rule exists in Sweden. In section 6 of the PIA it is stated that for the purpose of patient insurance compensation it is sufficient if the patient, on the preponderance of the evidence, establishes causation.62 Also, the Norwegian PIA contains a special rule dealing with evidentiary matters in relation to causation. Thus, section 3 in the Norwegian PIA states that if the cause of an injury of a patient cannot be brought to light, and it is likely that the injury is caused by an external influence during the treatment, it is normally to be assumed that the injury was caused by a failure in the supply of the health care service.63

d. Assessment of Damages. In all of the Scandinavian systems, it is the starting point that compensation of a patient injury is calculated in accordance with the general principles of damage in the law of torts.64 This means that a patient who receives compensation under the patient injury scheme will get the same compensation that a court would have awarded if the case had been tried under the rules of tort law. In general, the level of compensation for personal injuries in the Scandinavian coun-

60

61

62 63 64

Lov om klage- og erstatningsadgang inden for sundhedsvæsenet [Law on the Right to Complain and Receive Compensation within the Health Service] No. 24, Jan. 21, 2009 § 20 para. 1 (Den.). See, e.g. UfR 2006.1717H, 1719 (2006) (Den.); The court did find sufficient proof of causation. UfR 2006.1114H, 1114 (2006) (Den.); Damage to shoulder and arm whic occurred shortly after surgery was not considered caused by the surgery. UfR 2002.1690H/2, 1693 (2002) (Den.) The requirement of causation was regarded fulfilled. 6 §Patientskadelag (SFS 1996:799) (Swed.). Lov om erstatning ved pasientskader mv. (Pasientskadeloven) [Patient Injury Act] No. 52, June 15, 2001 § 3 (Nor.). See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 24 para. 1 (Den.); Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 3 (Fin.); Pasientskadeloven [Patient Injury Act] No. 53, June 15, 2001 § 4 (Nor.); 8 §Patientskadelag (SFS 1996:799) (Swed.).

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tries is lower than the level of compensation known in other countries.65 In addition, in all of the Scandinavian legal systems, the amount payable in a case of a patient injury is limited, so that minor injuries are not compensable.66

III. Available Empirical Data The Danish Patients Insurance Association, the Finnish Patient Insurance Centre, the Norwegian System of Compensation to Patients, and the Swedish Patient Insurance Scheme have excellent and updated statistical information on their websites to which we refer for those who are looking for more detailed empirical data.67 In general, the number of claims regarding medical malpractice has increased during the last years in most Nordic countries and so has the annual compensation awarded by the nofault compensation schemes. For example, in Denmark the number of claims rose from 5,519 in 2008 to 7,489 in 2010.68 This increase may partly be explained by increased activity in the health care services. The success rate varies slightly from year to year but is normally around 35.3 to 35.7 percent.69 In total, the compensation awarded by the Danish Patient Insurance Association has increased from 437.6 million DKR in 2008 to 660.5 million DKR (approxi-

65

66

67

68

69

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See von Eyben, supra note 9, at 194 (stressing that comparisons are made difficult by the fact that there are large differences between the social security systems and that way these systems are coordinated with ordinary tort law). In Swedish law, a “fee” is deducted from the compensation, which under the Patient Injury Act is 5 percent of the base amount defined by law (approx. 2600 SEK in 2011, or roughly 300 Euro). See 9 §Patientskadelag (SFS 1996:799) (Swed.). In Danish law, compensation cannot be obtained for losses below 10.000 DDK (or roughly 1300 Euro). See Law on the Right to Complain and Receive Compensation within the Health Service No. 24, Jan. 21, 2009 § 24 para. 2 (Den.). In Finnish law, the rule states that there is no compensation for minor injuries. See Potilasvahinkolaki [Patient Injury Act] No. 585, July 25, 1986 § 3 (Fin.). In Norwegian law, there is no compensation for losses of less than 5000 NKR. See Pasientskadeloven [Patient Injury Act] No. 53, June 15, 2001 § 4 para. 1 (Nor.). For Denmark, see Patientforsikringen, www.patientforsikringen.dk (last visited Oct. 3, 2011). For Finland, see Potilasvakuutuskeskus, www.potilasvakuutuskeskus.fi (last visited Oct. 3, 2011). For Norway, see Norsk Pasientskadeerstatning, www.npe.no (last visited Oct. 3, 2011). For Sweden, see Patientförsäkringen LÖF, http://patientforsakring. se (last visited Sept. 18, 2011). Årsberetning for 2010, Patientforsikringen, 3 (Jun. 12, 2011), http://www.patientforsikring en.dk/da/Udgivelser-og-tal/Statistik/Hospitalstal.aspx (follow “2008–2010 (pdf)” hyperlink). Årsberetning for 2010, supra note 68, at 5.

Scandinavia

mately 88 million Euro) in 2010.70 The average compensation has been 183.560 DKR from 2008–2010.71 Turning to Norway, the number of claims has increased gradually to 4,352 claims in 2010, of which 32.3 percent were successful.72 The total annual compensation awarded by the Norwegian System of Compensation to Patients has been constantly increasing and amounted to 818.4 million NKR in 2010 (approximately 100.2 million Euro).73 Consequently, the average compensation is significantly higher in Norway than in Denmark. Also, Sweden has seen a rise in the number of claims from 9,000 in 2005 to an estimated number of 12,000 in 2011.74 Forty-four percent of the claims made from 2005 to 2010 were successful.75 Compared to the other Nordic countries, the Finnish Patient Insurance Centre has not experienced the same increase in claims – to the contrary, there has been a decline in claims in 2009 and 2010 compared to previous years. However, with 7,295 claims in 2010, the numbers are significantly higher than in Denmark and Norway, and the success rate is about the same (around 30 percent).76 The total amount of annual indemnities has increased during the last years, but not so dramatically as in Norway and Denmark. In 2010, the Finnish Patient Insurance Centre paid 32.6 million Euro in compensation.77

Conclusion It is the general impression that the patient injury compensation systems in the Nordic countries have worked well. The overall purpose with the

70

71 72 73 74 75

76

77

Årsberetning 2010, Patientforsikringen, 16–17, http://www.patientforsikringen.dk/da/ Udgivelser-og-tal/Aarsberetninger.aspx (follow “pdf” hyperlink) (last visited Oct. 3, 2011). Årsberetning for 2010, supra note 68, at 17. Antall mottatte saker per år, Norsk Pasientskadeerstatning (Feb. 2, 2011), www.npe.no (follow “Statistikk” hyperlink; then follow “Antall mottatte saker per år” hyperlink). Utbetalinger per år, Norsk Pasientskadeerstatning (Feb. 2, 2011), www.npe.no (follow “Statistikk” hyperlink; then follow “Utbetalinger per år” hyperlink). Phone call with Patientförsäkringen LÖF (March 21, 2011). See http://www.patient forsakring.se/Arlig-statistik.html, for full statistics. Skadeanmälningar till Patientförsäkringen LÖF, Patientförsäkringen LÖF, http://patient forsakring.se/resurser/dokument/arlig_statistik/Rapportmall_Stockholm.pdf (last visited Oct. 3, 2011). Patient insurance claims reported 2006–2010 and Patient insurance claims decided 2006– 2010, available at http://www.potilasvakuutuskeskus.fi/www/page/pvk_www_2795 (last visited Nov. 2, 2011). Patient insurance claims decided 2006–2010, supra note 76.

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compensation systems was to make it easier for patients to obtain compensation. In this respect, the compensations systems have definitely been a success.78 Another goal was to introduce a model that would be more economical than trying cases in court. In this respect, the systems have perhaps been less successful. Thus, the administrative costs of running the systems have proved to be rather high.79 One concern sometimes articulated is that by turning patient injuries into an insurance issue rather than a liability issue, the focus is exclusively on compensation of the injured party. The preventive effect which liability rules are normally also assumed to possess is non-existent under an insurance system. On the other hand, by placing the insurance obligation and the insurance expenditures on the entity that would otherwise have been the target of tort law claims this concern is to some extent countered. It could also be argued that it can sometimes have symbolic value for the injured party to have it recognized by a court that there is liability based on fault for an injury. However, it should be remembered that the other side of the coin would be the possibility no recognition of the claim at all, since very often it would not be possible to prove fault. Finally, seen from a broader European perspective, there could of course be concern that the Nordic insurance-based system will come under pressure in light of the harmonization attempts in the E.U.80 For instance attempts to harmonize the levels of compensation for personal injury could disturb the balance of the insurance-based system. Also, other harmonization attempts could pose a challenge to the Nordic model.

78 79 80

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Kristina Sprove Askjær, Niels Hjortnæs & Peter Jakobsen, Erstatning inden for sundhedsvæsnet 44 (2008). Id. at 43. See von Eyben, supra note 9, at 195.

Medical Malpractice and Compensation in South Africa L.C. Coetzee* and Pieter Carstens**

I.

The Overall Scheme for Preventing and Redressing Medical Errors and Adverse Events, Including Regulation, Criminal and Civil Liability, and Social and Private Insurance, and the Relationships Among These Various Systems

A.

Regulatory Methods1

1.

Government Licensing Authorities for Doctors and Hospitals

The practice of the medical profession in the Republic of South Africa is primarily regulated by a number of statutory enactments.2 The most important statute governing medical practice is the Health Professions Act.3 The Act provides for the establishment of the Health Professions Council of South Africa (HPCSA), the statutory regulatory body responsible for, inter alia, controlling and exercising “authority in respect of all matters affecting the training of persons in, and the manner of the exercise of the practices pursued in connection with, the diagnosis, treatment or prevention of physical or mental defects, illnesses or deficiencies

* ** 1

2 3

Senior Lecturer in Law, University of South Africa, Pretoria, South Africa; B.L.C., University of Pretoria; LL.B., University of Pretoria; LL.M., University of South Africa. Professor in Medical and Criminal Law, University of Pretoria, Pretoria, South Africa; B.L. C., University of Pretoria; LL.B., University of Pretoria; LL.D., University of Pretoria. See generally P. Carstens & D. Pearmain, Foundational Principles of South African Medical Law 249–81 (2007); Sybrand A. Strauss, South Africa, in International Encyclopaedia of Laws 45–58 (Herman Nys ed., 2007). Apart from the provisions of the Constitution of the Republic of South Africa, 1996, and the provisions of the common law. Health Professions Act 56 of 1974.

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in human kind.”4 Briefly, the Act provides for control over the education, training, registration, and practices of a variety of health professionals.5 The Health Professions Act provides for the establishment of “a professional board with regard to any profession in respect of which a register is kept in terms of [the] Act,” by the Minister of Health acting on the recommendation of the HPCSA.6 Twelve such boards have thus far been established.7 Within the context of the present discussion, the Medical and Dental Professional Board (MDPB) – responsible for all registered medical and dental practitioners, and the training of medical and dental students8 – needs to be mentioned specifically. Legally, the professional boards fall under the overall control of the HPCSA, although, de facto, they function largely independently.9 No person may practise within the Republic of South Africa as a medical practitioner unless he or she is registered in terms of the Health Professions Act.10 The Minister of Health may, on the recommendation of the HPCSA and the relevant professional board, “by regulation define the scope of any other health profession registrable in terms of [the Health Professions] Act by specifying the acts which shall for the purposes of the application of [the] Act be deemed to be acts pertaining to that profession.”11 Such regulation may only be made, however, after the relevant professional board “has been given the opportunity of submitting ... recommendations as to the definition of the scope of the profession in question.”12 The Health Professions Act prohibits any person from practising within South Africa any health profession the scope of which has been defined by the Minister, unless he or she is registered in terms of the Act in respect of

4 Id. §§ 2, 3. 5 Id. § 3. The Act can be characterised as the “charter” of the medical practitioner in South Africa. However, it also governs the practice of dentistry, psychology, and a variety of supplementary health services apart from nursing, midwifery, pharmacy, homeopathy, chiropractic, traditional healing and the like. Id. § 17. Ministerial regulations governing topics ranging from the registration of students through disciplinary control over professionals have been promulgated from time to time under the Act. 6 Id. § 15. 7 Professional Boards, Health Professions Council of South Africa, http://www.hpcsa.co.za/ board_overview.php (last visited Apr. 15, 2011). 8 Professional Boards: Medical & Dental, Health Professions Council of South Africa, http:// www.hpcsa.co.za/board_meddent.php (last visited Apr. 15, 2011). 9 Strauss, supra note 1, at 45. 10 Health Professions Act § 17(1)(a). 11 Id. § 33(1). 12 Id.

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such profession.13 Contravention of this provision amounts to an offence14 which is punishable by a fine or imprisonment for a period not exceeding twelve months, or both a fine and such imprisonment.15 The HPCSA is the statutory regulatory body responsible for exercising control over medical practitioners, dentists, psychologists, and certain categories of medical personnel, such as physiotherapists, radiographers, medical technologists, optometrists, and emergency care personnel. Our courts have recognised that the HPCSA is in effect the sole repository of the power to decide what is ethical and what is unethical in medical practice.16 The HPCSA is also acknowledged as: [T]ruly a statutory custos morum of the medical profession, the guardian of the prestige, status and dignity of the profession and the public interest in so far as members of the public are affected by the conduct of members of the profession to whom they had stood in a professional relationship.17 The HPCSA has wide powers under the Health Professions Act, and may, inter alia, perform the following actions: “render financial assistance to professional boards to enable them to perform their functions”; consider, after consultation with the relevant professional board, “any matter affecting the professions registrable with the [HPCSA]”; consistent with national health policy determined by the Minister, “make representations or take such action in connection therewith as the [HPCSA] deems advisable”; “delegate to any committee or any person such of its powers as it may from time to time determine”; and “make rules on all matters which the [HPCSA] considers necessary or expedient in order that the objects of [the Health Professions] Act may be achieved.”18 Importantly, the HPCSA is empowered to establish such committees as it may deem necessary,19 including disciplinary committees, and is obliged to establish ad hoc disciplinary appeal committees.20 It may delegate to any committee such 13 14 15 16

17

18 19 20

Id. § 34(1). This prohibition is subject to the provisions of sections 32(c) and 39. Id. Id. § 34(2). Id. § 39(2). Pretorius v. Suid-Afrikaanse Geneeskundige & Tandheelkundige Raad 1980 (2) SA 354 (T) at 358–59; cf. S. African Med. & Dental Council v. Shapiro 1954 (2) SA 578 (T) at 587; Groenewald v. S. African Med. Council 1934 TPD 404 at 410, 416. Veriava v. President of S. African Med. & Dental Council 1985 (2) SA 293 (T) at 307; see also De la Rouviere v. S. African Med. & Dental Council 1977 (1) SA 85 (N) at 97; Phathela v. Chairman Disciplinary Comm. S. African Med. & Dental Council 1995 (3) SA 179 (T) at 182; Groenewald 1934 TPD at 410. Health Professions Act § 4(a)–(f). Id. § 10(1)(a). Id. § 10(2).

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of its powers as it may from time to time determine, but is not divested of any power so delegated.21 The HPCSA derives its income from registration, examination, annual, and any other fees, payable in terms of the Health Professions Act.22 The HPCSA is further responsible for recommending to the Minister of Health the establishment of “a professional board with regard to any health profession in respect of which a register is kept in terms of [the Health Professions] Act.”23 The professional boards also have wide powers under the Act, inter alia, the removal and restoration of names to and from a register, and the suspension of a registered person from practising his or her profession pending the institution of a formal inquiry; the appointment of examiners and moderators, the conducting of examinations, and the granting of certificates; the approval of training schools; the considerations of any matter affecting any profession falling within the ambit of the professional board, and the making of representations or the taking of such action in connection therewith as the professional board deems advisable; and the recognition of local and foreign qualifications.24 Professional boards have the “power to institute an inquiry into any complaint, charge or allegation of unprofessional conduct against practitioners registered under [the Health Professions] Act.”25 In practice, professional boards do not conduct such inquiries themselves, but appoint a professional conduct committee to do so.26 The Act defines “unprofessional conduct” essentially as “improper or disgraceful or dishonourable or unworthy conduct.”27 On finding the practitioner guilty of such conduct, the committee may impose one or other of the following penalties: (a) a caution or a reprimand or a reprimand and a caution; or (b) suspension for a specified period from practising or performing acts specially pertaining to his profession; or

21 22 23 24 25 26

27

400

Id. § 10(1)(b). Id. § 13. Id. § 15(1). Id. § 15B. Id. § 41. Id. Such a committee is appointed by a professional board by virtue of its powers under section 15(5)(f) of the Act read with the regulations published in Government Notice R979 of 13 August 1999. See also section 15(5)(fA), which has been inserted into the Act after the promulgation of the regulations. Id. § 1.

South Africa

(c) removal of his or her name from the register;28 or (d) a fine not exceeding R10 000;29 or (e) a compulsory period of professional service as may be determined by the professional board; or (f) the payment of the costs of the proceedings or a restitution.30 Any person who is aggrieved by a decision of the HPCSA, a professional board, or a disciplinary appeal committee, may appeal to the appropriate division of the High Court.31

2.

Medico-Ethical Codes of Conduct

“Although courts of law are clearly not bound by medico-ethical codes of conduct and medical practices when determining liability for medical malpractice, the ethical precepts and prevailing practices of the medical profession will be an important consideration in ascertaining what constitutes medical malpractice.”32 There are several national and international medico-ethical codes of conduct that govern the conduct of doctors and the practice of medicine. In South Africa, the HPCSA must, “in consultation with a professional board, from time to time make rules specifying the acts or omissions in respect of which the professional board may take disciplinary steps.”33 These rules of conduct – the Ethical Rules of Conduct for Practitioners Registered Under the Health Professions Act34 – constitute the most important national medico-ethical code of

28

29

30 31 32 33 34

The effect of a suspension or removal from the register is that the person concerned is disqualified from carrying on his or her profession and that his or her registration certificate is deemed to be cancelled until the period of suspension has expired or until his or her name has been restored to the register by the professional board. Id. § 44. If an appeal is lodged against a penalty of erasure or suspension from practice, such penalty remains effective until the appeal is heard. Id. § 42(1A). If, on reasonable grounds, the professional board is of the opinion, upon investigation of the complaint, charge or allegation of unprofessional conduct against a registered practitioner, that it will impose a fine on conviction after an inquiry, the registered practitioner may be given the option of an admission of guilt and payment of such fine. Id. § 42(8), (9). Id. § 42(1)(a)–(f). Id. § 20(1). Strauss, supra note 1, at 40–41; see also Carstens & Pearmain, supra note 1, at 264. Health Professions Act § 49(1). Proc R717 in GG29079 of 4 Aug. 2006. We do not intend to discuss in detail the rules of conduct, but merely wish to mention the categories of rules currently pertaining to doctors and dentists in general. These categories are the following: advertising and canvassing or touting; information to be included on professional stationery; the

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conduct. It is important to note, however, that the professional board’s power of inquiry is not limited to acts or omissions specified in these rules.35

3.

Reporting of Medical Errors and Adverse Events to the Health Profession Council of South Africa

Under the Ethical Rules of Conduct for Practitioners Registered Under the Health Professions Act,36 a student, intern or practitioner is obliged to “report any unprofessional, illegal or unethical conduct on the part of another student, intern or practitioner.”37 Of course, prevention is better than finding a cure, and, to this end, the Rules provide that a student, intern, or practitioner must “report impairment in another student, intern or practitioner to the board if he or she is convinced that such student, intern or practitioner is impaired,”38 and must: [R]eport his or her own impairment or suspected impairment to the board concerned if he or she is aware of his or her own impairment or

35 36 37

38

402

naming of a practice; itinerant practice; fees and commission; partnership and juristic persons; covering; supersession; impeding a patient from obtaining the opinion of another practitioner or from being treated by another practitioner; casting reflections on the professional reputation of colleagues; professional confidentiality; retention of human organs; the signing of official documents; certificates and reports and the information they should contain; issuing of prescriptions; professional appointments; secret remedies; defeating or obstructing the council or board in the performance of its duties; performance of professional acts; exploitation; medicine; financial interest in hospitals; reporting of impairment or of unprofessional, illegal or unethical conduct; research, development and use of chemical, biological and nuclear capabilities; and dual registration. Another medico-ethical code of conduct worth mentioning is the guidelines on ethics for medical research of the South African Medical Research Council (MRC). The MRC guidelines – the last complete edition of which was the third revised edition, published in 1993 – are currently being reviewed. The following five booklets have thus far been published: Book 1: Guidelines On Ethics For Medical Research: General Principles (2002); Book 2: Guidelines On Ethics For Medical Research: Reproductive Biology And Genetic Research (2002); Book 3: Guidelines On Ethics For Medical Research: Use Of Animals In Research And Training (2004); Book 4: Guidelines On Ethics For Medical Research: Use Of Biohazards And Radiation (2002); Book 5: Guidelines On Ethics For Medical Research: HIV Preventive Vaccine Research (2003). Health Professions Act § 49(1). Proc R717 in GG29079 of 4 Aug. 2006. Id. R. 25(1)(c). Neither “unprofessional conduct” nor “unethical conduct” is defined for the purposes of these rules. It is submitted that, since a practitioner is required under Rule 21 to “perform, except in an emergency, only a professional act (a) for which he or she is adequately educated, trained and sufficiently experienced; or (b) under improper conditions and in appropriate surroundings,” id. R. 21, conduct in contravention of Rule 21 will be regarded as unethical conduct that should be reported to the professional board. Id. R. 25(1)(a).

South Africa

has been publicly informed, or has been seriously advised by a colleague to act appropriately to obtain help in view of an alleged or established impairment.39 “Impairment” is defined in the rules to mean “a mental or physical condition which affects the competence, attitude, judgment or performance of professional acts by a registered practitioner.”40

B.

Liability Systems

The relationship between doctor or hospital and patient is essentially governed by private law, and, to be more precise, the law of contract and the law of delict (tort).41 However, public-law considerations are growing in importance in the wake of the introduction of the 1996 Constitution and national legislation. The majority of the South African population depends on the public sector for health care.42

1.

Contract43

A patient who consults a doctor in private practice enters into a contractual relationship with the doctor, and a patient who presents for medical treatment at a hospital enters into a contractual relationship with the relevant (private or provincial) hospital authority. In the latter instance, both the hospital authority and the staff of the hospital (including the doctors) may incur liability for the negligent conduct of the hospital employees.44 No legal formalities are required for the conclusion of the contract between doctor or hospital and patient. The contract comes into being by mere consensus between the parties,45 but, in practice, both private and state hospitals usually require their patients to sign an admission form

39 40 41 42 43

44 45

Id. R. 25(1)(b). Id. R. 1. Strauss, supra note 1, at 59. Carstens & Pearmain, supra note 1, at 283. See generally Carstens & Pearmain, supra note 1, at 283–88; N.J.B. Claassen & T. Verschoor, Medical Negligence in South Africa 115–18 (1992); Introduction to MedicoLegal Practice 5 (Mahomed A. Dada & D. J. McQuoid-Mason eds., 2001); Strauss, supra note 1, at 59–64; S.A. Strauss & M.J. Strydom, Die Suid-Afrikaanse Geneeskundige Reg [The South African Medical Law] 104 (1967). Introduction to Medico-Legal Practice, supra note 43, at 5. Claassen & Verschoor, supra note 43, at 115.

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and require written consent for surgery. The contract may be concluded expressly or tacitly, and may be written or oral.46 Doctors in private practice normally enter into tacit agreements with their patients.47 Express agreements between doctor or hospital and patient are not unusual, especially in cases of specialised procedures. Where no express agreement has been reached, the implied terms of the contract between the parties will depend upon the specific circumstances of the case.48 Usually, the implied agreement between doctor and patient entails that the doctor undertakes to examine the patient, to diagnose his or her ailment, and to treat the patient with such professional skill, competence, and judgment as the average or ordinary medical practitioner in the particular branch of the profession possesses, and with the amount of care that may reasonably be expected from such a practitioner.49 The doctor ordinarily undertakes to act in accordance with the recognised, accepted, customary, or usual practices of medicine.50 Any unusual procedures contemplated by the medical practitioner should first be discussed with the patient. Ordinarily, by taking on a case, a doctor or hospital does not guarantee that the patient will be cured or that the intervention will be a success; of course, the possibility of an express or implied warranty to that effect does exist.51 In the normal course of events, the doctor undertakes no more than to treat or operate upon the patient with due competence, care, and skill – namely, that which may be expected from a medical practitioner in the particular branch of the profession.52

46 47 48 49 50

51

52

404

Strauss, supra note 1, at 60. Id. Id. Id. Id. (citing Van Wyk v. Lewis 1924 AD 438 at 448, 469–70; Allot v. Paterson & Jackson 1936 SR 221 at 224; cf. Collins v. Adm’r, Cape 1995 (4) SA 73 (C) at 81–82; Coppen v. Impey 1916 CPD 309 at 314; Kovalsky v. Krige (1910) 20 CTR 822 at 823; Buls v. Tsatsarolakis 1976 (2) SA 891 (T) at 893; Clinton-Parker v. Adm’r, Transvaal 1996 (2) SA 37 (W) at 56, 58; Applicant v. Adm’r, Transvaal 1993 (4) SA 733 (W) at 738.) Diagnosis and treatment are not always involved, as the contract may also involve medical examinations for non-therapeutic interventions (such as cosmetic surgery, experimentation, or prophylactic measures) or medical examinations for other purposes such as employment. Id. at 61 n.2. Strauss, supra note 1, at 61 (citing Van Wyk 1924 AD at 456; Coppen 1916 CPD at 314; Kovalsky 20 CTR at 823; Verhoef v. Meyer 1975 (T), 1976 (A) (unreported); Chalk v. Fassler 1995 (W) (unreported); Behrmann v. Klugman 1988 (W) (unreported); cf. Buls 1976 (2) SA at 893 (question raised but not answered)); see also Sybrand A. Strauss, Doctor, Patient and the Law: A Selection of Practical Issues 35–36, 41, 176–77 (1991). Id.; see also Introduction to Medico-Legal Practice, supra note 43, at 5, 22; Strauss, supra note 51, at 41.

South Africa

A doctor or hospital that fails to perform in accordance with, or that departs or deviates from, the express or implied terms of the contract, commits a breach of contract.53 Since medical practitioners are expected to exercise reasonable skill and care, it will amount to breach of contract for a medical practitioner to perform his or her duties in a negligent manner.54 Breach of contract may result in the doctor or hospital being held liable for patrimonial loss, or in the doctor or hospital being unable to recover a fee for services rendered.55 However, non-pecuniary (non-patrimonial) damages cannot be recovered in contract.56 Specific performance is not a likely remedy, since the doctor renders a personal service to the patient.57 The medical practitioner cannot unilaterally withdraw from the agreement once treatment has commenced.58 Once the treatment has been completed, the agreement comes to an end and the doctor can no longer be expected to attend to the patient.59 An undertaking on the part of a doctor to examine a patient and to diagnose his or her condition does not amount to an undertaking on the part of the doctor to personally treat the patient.60 A doctor may refer the patient to another doctor for treatment without fear of being held liable for breach of contract.61 In fact, a failure to refer a patient to a specialist when the doctor lacks the necessary knowledge or skill to treat the patient may amount to negligence.62

53

54 55

56 57 58

59 60 61 62

Strauss, supra note 1, at 62. Examples of such conduct would include where a doctor other than the one agreed upon performs the medical intervention, or where the medical intervention differs from the one agreed upon. Id. at 62 n.2 (citing Strauss & Strydom, supra note 43, at 107; Burger v. Adm’r, Kaap 1990 (1) SA 483 (C), Recsei’s Estate v. Meine 1943 EDL 277). Claassen & Verschoor, supra note 43, at 116. Strauss, supra note 1, at 62 (citing Recsei’s Estate 1943 EDL 277; McCallum v. Hallen 1916 EDL 74; Sutherland v. White 1911 EDL 407; Hewatt v. Rendel 1925 TPD 679; cf. Oates v. Niland 1914 CPD 976; Kruger v. Boltman 1933 (1) PH A 3 (E); Shiels v. Minister of Health 1974 (3) SA 276 (RA)). Id. (citing Adm’r, Natal v. Edouard 1990 (3) SA 581 (A) at 590, 593; Edouard v. Adm’r, Natal 1989 (2) SA 368 (D) at 385; cf. Jansen van Vuuren v. Kruger 1993 (4) SA 842 (A) at 848–49). See Myers v. Abramson 1952 (3) SA 121 (C) at 124. Claassen & Verschoor, supra note 43, at 117. Note, however, that in terms of section 20 of the National Health Act, a “health care provider may refuse to treat a [patient or client] who is physically or verbally abusive or who sexually harasses him or her.” National Health Act 61 of 2003 § 20(4). Strauss, supra note 1, at 63 (citing Kovalsky v. Krige (1910) 20 CTR 822 at 822); Claassen & Verschoor, supra note 43, at 117. Claassen & Verschoor, supra note 43, at 117. Id. Id.; Introduction to Medico-Legal Practice, supra note 43, at 5.

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2.

Delict (Tort)63

In terms of the law of delict, doctors and hospitals are expected to exercise reasonable care to prevent harm from occurring to their patients.64 Should a patient suffer damage or loss as a result of a doctor or hospital’s wrongful failure to take reasonable care, the doctor or hospital may incur liability for negligence.65 A doctor or hospital that intentionally violates the patient’s physical integrity may be held liable for assault, whilst a doctor or hospital that intentionally violates the patient’s privacy may incur liability for injuria.66 The State Liability Act makes provision for the delictual liability of the state.67 The vicarious liability of the state is recognised in that a delictual claim against the state shall be cognisable by a court of law if the claim arises out of any wrong committed by any servant of the state acting in his capacity and within the scope of his authority as such.68 Both patrimonial loss and non-pecuniary damages are recoverable in delict.69

3.

Criminal Law70

The relationship between doctor or hospital and patient is not governed directly by criminal law. However, there are various common-law crimes that the doctor may conceivably commit in the course of practising

63

64

65 66 67 68 69

70

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See generally Carstens & Pearmain, supra note 1, at 489; Claassen & Verschoor, supra note 43, at 118–24; Introduction to Medico-Legal Practice, supra note 43, at 22; Strauss, supra note 1, at 64–65; Strauss & Strydom, supra note 43, at 159. Strauss, supra note 1, at 64–65 (citing Correira v. Berwind 1986 (4) SA 60 (Z) at 66; cf. Michael v. Linksfield Park Clinic (Pty) Ltd. 2001 (3) SA 1188 (SCA); Van Wyk v. Lewis 1924 AD 438 at 443–44, 455–56; Collins v. Adm’r, Cape 1995 (4) SA 73 (C) at 81). Id. at 64. Id. at 64–65. State Liability Act 20 of 1957 § 1. Id. Strauss, supra note 1, at 63 (citing Adm’r, Natal v. Edouard 1990 (3) SA 581 (A) at 590, 595; Edouard v. Adm’r, Natal 1989 (2) SA 368 (D) at 389; Clinton-Parker v. Adm’r, Transvaal 1996 (2) SA 37 (W); cf. Jansen van Vuuren v. Kruger 1993 (4) SA 842 (A) 848–49; Collins v. Adm’r, Cape 1995 (4) SA 73 (C) at 83; Pringle v. Adm’r, Transvaal 1990 (2) SA 379 (W)). See generally Claassen & Verschoor, supra note 43, at 127–28; Strauss, supra note 1, at 65; Strauss & Strydom, supra note 43, at 338.

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medicine, including murder,71 culpable homicide,72 assault,73 criminal defamation,74 crimen iniuria,75 fraud,76 perjury,77 and contempt of court.78 Culpable homicide – which in South African law is defined as the negligent and unlawful causing of the death of another human being79 – is by far the most relevant of these. In South African law, the conduct of a doctor who intentionally contributes to, or causes the death of, a patient, amounts to murder. Active euthanasia is therefore regarded as murder.80 Because culpable homicide is the only common-law crime for which the proof of negligence (as opposed to intention) is sufficient, it is the only common-law crime for which a professionally negligent practitioner can be held liable.81 In South African case law, conviction of culpable homicide resulted, for instance, from a negligent over-prescription of medicine,82 a blood transfusion performed on the wrong patient,83 an excessive amount of contrast medium administered to a baby,84 failure to insert an endo-

71 72 73

74 75 76 77

78

79 80 81 82 83 84

C.R. Snyman, Criminal Law 447 (5th ed. 2008) (“Murder is the unlawful and intentional causing of the death of another human being.”). Id. at 451 (“Culpable homicide is the unlawful, negligent causing of the death of another human being.”). Id. at 455 (“Assault consists in any unlawful and intentional act or omission (a) which results in another person’s bodily integrity being directly or indirectly impaired, or (b) which inspires a belief in another person that such impairment of her bodily integrity is immediately to take place.”). Id. at 475 (“Criminal defamation consists in the unlawful and intentional publication of matter concerning another which tends seriously to injure his reputation.”). Id. at 469 (“Crimen iniuria consists in the unlawful, intentional and serious violation of the dignity or privacy of another.”). Id. at 531 (“Fraud is the unlawful and intentional making of a misrepresentation which causes actual prejudice or which is potentially prejudicial to another.”). Id. at 343 (“Perjury consists in the unlawful and intentional making of a false statement in the course of a judicial proceeding by a person who has taken the oath or made an affirmation before, or who has been admonished by, somebody competent to administer or accept the oath, affirmation or admonition.”). Id. at 325 (“Contempt of court consists in unlawfully and intentionally (a) violating the dignity, repute or authority of a judicial body or a judicial officer in his judicial capacity; or (b) publishing information or comment concerning a pending judicial proceeding which has the tendency to influence the outcome of the proceeding or to interfere with the administration of justice in that proceeding.”). Id. at 451. S v. Hartmann 1975 (3) SA 532 (C). Ferdinand F.W. van Oosten, Professional Medical Negligence in Southern African Legal Practice, 5 Med. & L. 17, 22 (1986). See, e.g., R v. Van Schoor 1948 (4) SA 349 (C); S v. Mkwetshana 1965 (2) SA 493 (N); R v. Van der Merwe 1953 (2) PH H124 (W). S v. Berman 1996 (T) (unreported). S.A. Strauss, Oormatige Toediening van Kontrasmiddel: Strafbare Manslag [Excessive Administration of Contrast Medium: Culpable Homicide], 8 (1) S. Afr. Prac. Mgmt. 27 (1987) (citing S v. Bezuidenhout 1985 (A) (unreported)).

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tracheal tube correctly and to monitor the patient properly during anaesthesia,85 and failure by a general practitioner to call in a specialist obstetrician when complications set in during delivery.86 Statutory crimes that may be perpetrated by a doctor in the course of practising medicine include those created under the Inquests Act,87 the Human Tissue Act,88 the Births and Deaths Registration Act,89 the Choice on Termination of Pregnancy Act,90 the Sterilisation Act,91 the Mental Health Care Act,92 the National Health Act,93 and the Children’s Act.94

4.

Relationship Between the Liability Systems

The relationship between doctor or hospital and patient is ordinarily of a contractual nature.95 Where no contract is formed between the parties,96 the relationship between them is governed by the law of delict.97 However, the same act or omission by a doctor or hospital may result in both contractual and delictual liability since a breach of a duty of care and negligence may constitute both breach of contract and a delict.98 A breach of contract or the commission of a delict by a doctor may, in addition, result in criminal liability where the doctor’s wrongful conduct

85 86

87 88 89 90 91 92 93 94 95 96

97

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S v. Kramer & Another 1987 (1) SA 887 (W). S.A. Strauss, Versuim van Geneesheer om Spesialis-Verloskundige by Probleem-Bevalling in te Roep, Stel Nalatigheid Daar [Failure of General Practitioner to Call in Specialist Obstetrician in Case of Complicated Delivery Constitutes Negligence], 9 (1) S. Afr. Prac. Mgmt. 7 (1988) (citing S v. Nel 1987 (T) (unreported)). Inquests Act 58 of 1959 § 20. Human Tissue Act 65 of 1983 § 34. Births and Deaths Registration Act 51 of 1992 § 31. Choice on Termination of Pregnancy Act 92 of 1996 § 10. Sterilisation Act 44 of 1998 § 9. Mental Health Care Act 17 of 2002 § 70. National Health Act 61 of 2003 §§ 57(5), 89. Children’s Act 38 of 2005 § 305. Strauss, supra note 1, at 59. Id. at 59 n.2 (providing the example of an emergency where urgent, life-saving treatment is performed on an unconscious patient) (citing Stoffberg v. Elliott 1923 CPD 148 at 150). Id. at 59. It is still being debated whether a so-called “constitutional delict” exists in our law. See Carstens & Pearmain, supra note 1, at 556–67; Strauss, supra note 1, at 59 n.3; Deborah Louise Pearmain, A Critical Analysis of the Law of Health Service Delivery in South Africa 825–37 (Nov. 2004) (unpublished LLD thesis, University of Pretoria). Strauss, supra note 1, at 59 (citing Van Wyk v. Lewis 1924 AD 438 at 438, 443, 450–51, 455–56; Adm’r, Natal v. Edouard 1990 (3) SA 581 (A) at 585; Castell v. De Greef 1994 (4) SA 408 (C) at 420, 425; Edouard v. Adm’r, Natal 1989 (2) SA 368 (D) at 389; Correira v. Berwind 1986 (4) SA 60 (Z) at 63, 66).

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satisfies the requirements of the definition of a common-law crime.99 Common-law crimes that may overlap with a breach of contract or the commission of a delict by the doctor include murder, culpable homicide, assault, criminal defamation, crimen injuria, and fraud.100

C.

Compensation Systems

No social insurance system for medical malpractice or adverse medical events exists in South Africa. There is also no compensation scheme for criminally caused injuries. Those wishing to recover from private practitioners or institutions have no alternative but to institute proceedings either in contract or delict in a court of law. Most of these cases will be settled out of court.101 Those wishing to recover from a state institution, whether in contract or delict, can do so in terms of the State Liability Act.102 This might be more difficult than one would imagine. In Nyathi v. MEC for Department of Health, Gauteng,103 the applicant sought confirmation by the Constitutional Court104 of a declaration by the High Court that the provisions in section 3 of the State Liability Act that “[n]o execution, attachment or like process shall be issued against a defendant or respondent in any such action or proceedings or against the property of the State”105 was unconstitutional and invalid.106 The salient facts of this case are indeed very disconcerting. On August 1, 2002, “the applicant suffered 30 % second- and third-degree burn wounds after a paraffin stove was thrown at him.”107 He was admitted to the Pretoria Academic Hospital for treatment on the same day.108 “[A] central venous line was incorrectly inserted into his right carotis communis artery.”109 On the next day, he was transferred to Kalafong Hospital where the medical staff “failed to timeously diagnose the incorStrauss, supra note 1, at 65. Id.; see also supra notes 71–79 and accompanying text. See infra note 244 and accompanying text. State Liability Act 20 of 1957 § 1. 2008 (5) SA 94 (CC). Under section 172(2)(a) of the Constitution of the Republic of South Africa, 1996. State Liability Act 20 of 1957 § 3. The constitutional validity of the provision was challenged “on the basis that it violated, inter alia, the rights to equality and dignity, enshrined in [sections] 9 and 10 of the Constitution [of the Republic of South Africa, 1996], respectively.” Nyathi 2008 (5) SA at 95. 107 Id. at 99. 108 Id. 109 Id. 99 100 101 102 103 104 105 106

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rect insertion of the central venous line.”110 As a result of the conduct of the medical staff at the two hospitals, the applicant suffered a stroke and severe left hemiplegia which left him in need of full-time care and medical treatment.111 He “used to receive a social grant of R570 per month and his wife’s total monthly income was R1600.”112 The two of them “had to support their four children and provide for their daily living expenses.”113 On July 25, 2005 – almost three years later – the applicant instituted an action in the High Court against the Member of the Executive Council for Department of Health (MEC), “claiming damages in the sum of R1,496,000 for the pain caused by the stroke and disability suffered as a result of the negligent and improper care he received at the two hospitals.”114 After initially resisting the applicant’s claim, the MEC later admitted liability.115 “The only remaining issue was the amount payable to the applicant.”116 More than a year later, on July 27, 2006, “the applicant’s attorneys wrote to the State Attorney stating that the applicant’s health was deteriorating rapidly,” that he “urgently required treatment and medication,” and that he “could not afford to pay the necessary medical and legal costs while the hearing scheduled for [May 23, 2007,] was pending.”117 They requested that an interim payment of R317,700 be made within fourteen days, failing which they would approach the court for relief.118 On August 3, 2006, the State Attorney reported that it had referred the matter to the MEC and that the MEC had asked for one week within which to pay.119 Twenty days later, the State Attorney advised the applicant’s attorneys that the MEC was taking issue with paying the requested amount as an interim payment instead of a final payment.120 The MEC “requested that payment be deferred until the trial court had decided the issue of costs.”121 “In September 2006, having received no further response from the [MEC], the applicant lodged an application in terms of Uniform Rule 34A,” which

110 111 112 113 114 115 116 117 118 119 120 121

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Id. Id. Id. Id. Id. Id. Id. Id. Id. Id. at 100. Id. Id.

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provides for an application for an interim payment,122 “and served it on the State Attorney during October 2006.”123 “The matter was unopposed and the court ordered the [MEC] to make an interim payment to the applicant in the amount of 317,700 and to pay the applicant’s costs on the attorney and client scale.”124 On December 1, 2006, “[t]he applicant, having received no payment, sent a copy of the court order together with a letter to the State Attorney,” stating “that should the first respondent fail to comply with the court order within the prescribed 30-day period, the applicant’s attorneys would proceed with an application to compel him to do so.”125 The MEC failed to comply with the court order.126 The Constitutional Court confirmed the order of constitutional invalidity of the court a quo and suspended the declaration of invalidity for a period of twelve months to enable Parliament to pass legislation providing for the effective enforcement of court orders.127 The court held that section 3 unjustifiably differentiated between the state and private judgment debtors.128 It did not afford a judgment creditor who had secured judgment against the state the same protection and benefit afforded to a judgment creditor who had secured judgment against a private litigant.129 Furthermore, section 3 placed the state above the law, as it did not positively oblige the state to comply with court orders.130 The Court further held that section 3 violated the constitutional rights to dignity131 and access to courts.132 Having found that the limitation imposed on these rights by section 3 was not reasonable and justifiable as intended in the Constitution’s limitation clause,133 the court proceeded to assess the effectiveness of the existing procedures to secure the satisfaction of judgment debts, which it considered essential in determining whether section 3 was con-

122 Uniform Rules of Court, R. 34A(1) (“In an action for damages for personal injuries or the death of a person, the plaintiff may, at any time after the expiry of the period for the delivery of the notice of intention to defend, apply to the court for an order requiring the defendant to make an interim payment in respect of his claim for medical costs and loss of income arising from his physical disability or the death of a person.”). 123 Nyathi 2008 (5) SA at 100. 124 Id. 125 Id. 126 Id. 127 Id. at 123. 128 Id. at 109. 129 Id. at 107. 130 Id. This was held to be incompatible with the plain language of sections 8, 34, 165(4), and 165(5) of the Constitution of the Republic of South Africa, 1996. Id. 131 Id. (citing S. Afr. Const., 1996, § 10). 132 Id. (citing S. Afr. Const., 1996, § 34). 133 Id. at 110 (citing S. Afr. Const., 1996, § 36(1)).

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stitutionally compliant.134 The existing provisions designed to assist judgment creditors in claiming from the National Revenue Fund and the Provincial Revenue Fund135 did not contain sufficiently accessible and simple procedures for the payment of judgment debts. Therefore, they did not constitute a reasonable fulfillment of the state’s constitutional obligations and failed to deal with how court orders were to be satisfied.136 In his judgment, Justice Madala (for the majority) remarked that “deliberate non-compliance with or disobedience of a court order by the State detracts from the ‘dignity, accessibility and effectiveness of the courts.’”137 He also pointed out that “[t]he applicant was made to wait for an extremely long time for money required to pay for his treatment” without which “he stood a very slim chance of survival.”138 Although “[t]he State was made fully aware of this very desperate situation, [it] provided no relief,” which showed a lack of “recognition for his worth and importance as a human being.”139 “Having waited for many months, the applicant eventually received interim payment” once he approached the Constitutional Court, but he “only lived a short while thereafter.”140 Justice Madala added that “[r]eliance on the State’s goodwill and moral standards has in this case proved to be futile.”141 In his review of the response of our courts to section 3, Justice Madala made the following pronouncements: An assessment of the cases that have dealt with the Act and the liability of the State for its negligent actions have revealed that courts have been facing immense challenges in this area of the law. The various High Courts have approached the matter very differently and with disparate consequences. However, the common denominator is that judicial officers have recognised that there is a serious problem caused by the fact that a judgment creditor who obtains an order sounding in money, may find that order unenforceable against the State.

134 Id. at 111. 135 Id. at 112. The provisions are contained in the Public Finance Management Act 1 of 1999 and the attendant Treasury Regulations. See GN R225 in GG27388 of 15 Mar. 2005. 136 Nyathi 2008 (5) SA at 113. 137 Id. at 108. 138 Id. at 109. 139 Id. 140 Id. 141 Id.

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In more recent years, and in particular the period from 2002 onwards, courts have been inundated with situations where court orders have been flouted by State functionaries, who, on being handed such court orders, have given very flimsy excuses which in the end only point to their dilatoriness. The public officials seem not to understand the integral role that they play in our constitutional State, as the right of access to courts entails a duty not only on the courts to ensure access but on the State to bring about the enforceability of court orders.142 He expressed his dissatisfaction with the conduct and attitude of certain state officials in no uncertain terms: In my view there can be no greater carelessness, dilatoriness or negligence than to ignore a court order sounding in money, even more so when the matter emanates from a destitute person who has no means of pursuing his or her claim in a court of law. But we now have some officials who have become a law unto themselves and openly violate people’s rights in a manner that shows disdain for the law, in the belief that as State officials they cannot be held responsible for their actions or inaction. Courts have had to spend too much time in trying to ensure that court orders are enforceable against the State precisely because a straightforward procedure is not available.143

1.

Sufficient Insurance Cover To Be Required for Private Health Establishments

Once section 46 of the National Health Act comes into operation, it will require every private health establishment to maintain insurance cover sufficient to indemnify a user for damages that he or she might suffer as a consequence of a wrongful act by any member of its staff or by any of its employees.144 In the terminology of the Act, “user” means a patient or certain other parties such as a minor patient’s parent, or in the case of a person who is incapable of taking decisions, his or her spouse or partner, adult siblings, and other specified persons.145 “Health establishment” is defined in the Act as “the whole or part of a public or private institution, facility, building or place, whether for profit or not, that is operated or designed to provide inpatient or outpatient treatment, diagnostic or

142 143 144 145

Id. at 113 (citations omitted). Id. at 114. National Health Act 61 of 2003 § 46. Id. § 1.

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therapeutic interventions, nursing, rehabilitative, palliative, convalescent, preventative or other health services.”146 This definition is drafted in such wide terms that it includes also the practice of private practitioners. Although most private hospital networks do have professional indemnity insurance, once section 46 of the Act comes into operation, it will become mandatory, and failure to comply will hold the risk of criminal sanction. Hospitals will therefore be responsible for maintaining sufficient insurance cover for staff, such as nurses, whereas medical practitioners attending to patients at the hospital will be responsible for their own insurance cover as they are independent contractors.

2.

Private Indemnity (Medical Protection Society)

More than 26,000 medical practitioners in South Africa belong to the Medical Protection Society (MPS).147 The organisation has been in South Africa for over fifty years.148 There are various differences between the medical indemnity offered by an organisation such as the MPS, and that offered by commercial insurers:149 The MPS is a not-for-profit mutual organisation offering discretionary indemnity to their members (even in unusual circumstances).150 The MPS offers unlimited cover for legal problems arising from medical practice,151 whereas commercial insurers will usually provide limited cover only. The MPS will not deny cover in respect of activities involving a contravention of the provisions of criminal law,152 whereas the fine print of a commercial insurance policy may do just that. The MPS provides cover even where the medical practitioner’s membership has lapsed, provided the membership dues were paid up at the time

146 Id. 147 About MPS, Medical Protection Society, http://www.medicalprotection.org/southafrica/ guide/about-mps (last visited Nov. 4, 2010). MPS also claims to have over 270,000 members worldwide. Id. 148 Id. 149 Strauss, supra note 51, at 247–48; About MPS, Medical Protection Society, http://www. medicalprotection.org/southafrica/guide/about-mps (last visited Nov. 4, 2010). 150 About MPS, supra note 149. 151 MPS Indemnity, Medical Protection Society, http://www.medicalprotection.org/southafrica/guide/mps-indemnity (last visited Nov. 4, 2010). 152 Unusual Requests for Assistance, Medical Protection Society, http://www.medicalprotec tion.org/southafrica/guide/unusual-requests-for-assistance (last visited Nov. 4, 2010). Importantly, medical negligence resulting in the death of a patient would constitute the crime of culpable homicide. In the section on criminal law, a number of offences that doctors may commit in the course of practising medicine have been mentioned. See supra Part I.B.3.

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of the incidence which led to the claim,153 whereas commercial insurers may make cover conditional upon the policy still being valid at the time the medical practitioner issued. The MPS further provides legal advice and representation to members in a wide range of circumstances, including legal representation and advice from specialists in the field of medical litigation, and assist member to resolve specific ethical and medico-legal dilemmas as they arise in their practice.154

D.

Relationships Among the Compensation Systems, the Liability Systems, and the Regulatory Systems

The Inquests Act provides for all matters pertaining to the holding of an inquest following the death (or suspected death) of a person from what is believed to be a cause other than a natural one.155 In the medical malpractice context, the Act plays an important role in the initiation of criminal proceedings for culpable homicide or murder against a medical practitioner who has caused the death of a patient in a negligent or intentional manner. The Inquests Act provides that any person who has reason to believe that any other person has died due to other than natural causes must report this to a policeman.156 The Health Professions Act provides that the death of a person undergoing a therapeutic, diagnostic, or palliative procedure, or the death of a person as a result of such a procedure, shall not be deemed to be a death from natural causes as contemplated in the Inquests Act.157 The same applies if any aspect of such a procedure has been a contributory cause of the person’s death.158 The effect of this provision is that an inquest must be held following such a death before a death certificate can be issued. A policeman who has reason to believe that any person has died from other than natural causes must investigate or cause to be investigated the circumstances of the death and report the death to the magistrate of the district concerned.159 The policeman investigating the circumstances of the death must submit a 153 MPS Indemnity, supra note 151. 154 Benefits of Membership, Medical Protection Society, http://www.medicalprotection.org/ southafrica/guide/benefits-of-membership (last visited Nov. 4, 2010). 155 Inquests Act 58 of 1959 § 2(1). 156 Id. § 2. In view of the focus of this enquiry, no attempt shall be made to set out the relevant sections of the Inquests Act in detail. The provisions of the Act that may have a bearing on inquests to be held following an unnatural death at the hands of a medical practitioner will be set out and only to the extent strictly relevant to the present study. 157 Health Professions Act 56 of 1974 § 56. 158 Id. 159 Inquests Act § 3(1)(a)–(b).

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report thereon, together with all relevant statements, documents, and information, to the public prosecutor.160 If criminal proceedings are not instituted in connection with the death, the public prosecutor must submit those statements, documents, and information submitted to him to the magistrate of the district concerned.161 If on the information submitted to him it appears to the magistrate that the death was not due to natural causes, he must ensure that an inquest as to the circumstances and cause of the death is held by a judicial officer.162 Importantly, if the judicial officer who held the inquest finds that the death was brought about by any act or omission prima facie involving or amounting to an offence on the part of any person, he must cause the record of the proceedings to be submitted to the Director of Public Prosecutions within whose area of jurisdiction the inquest was held.163 When the record of any inquest that has been submitted164 to an Director of Public Prosecutions is no longer required by such Director of Public Prosecutions, it must be returned to the magistrate of the district in which the inquest was held.165 In terms of section 19(2) of the Inquests Act, such record is deemed to form part of the records of the magistrate’s court of the district wherein the inquest was held.166 The provisions of the Inquests Act do not prevent the institution of criminal proceedings against any person in connection with any death, whether or not an inquest has commenced in respect of such death.167 Where a registered practitioner has, either before or after registration, been convicted of any offence by a court of law, the professional board is empowered to institute an inquiry if it is of the opinion that such offence constitutes unprofessional conduct.168 Such practitioner is liable upon conviction of one or other of the penalties mentioned in section 42 of the Health Professions Act.169 In terms of section 45(1), however, before the imposition of any penalty, such practitioner must be afforded the opportunity of tendering an explanation to the council in extenuation of the

160 Id. § 4. The public prosecutor may, if he deems it necessary, call for any additional information regarding the death. Id. 161 Id. § 5(1). 162 Id. § 5(2). The judicial officer responsible for holding such an inquest is stipulated in section 6. Id. § 6. 163 Id. § 17(1)(b). 164 Id. § 17. 165 Id. § 19(1). 166 Id. § 19(2). 167 Id. § 21(1). 168 Health Professions Act 56 of 1974 § 45(1). 169 Id.

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conduct in question.170 The court that has convicted a registered practitioner of an offence must, where there appears to be prima facie proof of unprofessional conduct, direct that a copy of the record of its proceedings be transmitted to the professional board.171 In Suid-Afrikaanse Geneeskundige & Tandheelkundige Raad v. Strauss, it was held that, notwithstanding the use of the words “before the imposition of any penalty” in the proviso of section 45(1), the accused doctor should, after proof of his or her conviction in a court of law, be afforded the opportunity to put his or her defence to the charge of unprofessional conduct.172 The court reasoned that “a strictly literal interpretation of section 45(1) would lead to a disciplinary inquiry being eroded to the point where it amounted to a farce wherein the disciplinary committee merely fulfilled the function of a rubber stamp,” which would offend the principles of natural justice and fairness and would be “diametrically opposed to and incompatible with the obvious intention of the Legislature.”173 The obligation to direct that a copy of the record of its proceedings be transmitted to the relevant professional board is not restricted to a court that has convicted a registered practitioner of an offence. In fact, “[w] henever in the course of any proceedings before any court of law it appears to the court that there is prima facie proof of unprofessional conduct on the part of a registered person,” or of conduct which, when regard is had to such person’s profession, is unprofessional, the court is bound to “direct that a copy of the record of such proceedings, or such portion thereof as is material to the issue, be transmitted to the [relevant] professional board.”174 It appears, therefore, that any civil and criminal proceeding is covered.

170 171 172 173 174

Id. Id. § 45(2). 1991 (3) SA 203 (A) at 212. Id. at 205. Health Professions Act § 45(2).

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II.

The Details of the Applicable Liability and Compensation Systems

A.

Criteria Defining Qualification for Compensation

1.

Liability Based on Fault

In South Africa, liability for professional medical negligence, in its civil law context, is primarily rooted in the Law of Obligations (translating into the Law of Contract and the Law of Delict (Tort)). As a result, it is trite law that all compensation for medical negligence (inclusive of medical error and any adverse event) is based on fault (in the form of culpa). Thus, generally speaking, a physician’s negligence is legally assessed with reference to the yardstick of the “reasonable expert in the same circumstances.” In any given context, negligence means that the defendant or the accused failed to foresee the possibility of harm (bodily or mental injury or death) occurring to another in circumstances where the reasonable person (diligens paterfamilias) in the defendant’s or accused’s position would have foreseen the possibility of harm occurring to another and would have taken steps to avoid or prevent it. The generic test for negligence is thus one of foreseeability and preventability.175 Although the test for negligence is fundamentally objective, it does contain subjective elements when the negligence of an expert is assessed. “Where the defendant or the accused is an expert, the standard of negligence is upgraded from the reasonable layperson to the reasonable expert. Where the expert is a [medical practitioner], the standard is that of the reasonable [medical practitioner] in the same circumstances.”176 The test for medical negligence was enunciated in the case of Mitchell v. Dixon,177 where Acting Chief Justice Innes observed, “A medical practitioner is not expected to bring to bear upon the case entrusted to him the

175 See generally Carstens & Pearmain, supra note 1, ch. 9. 176 Ferdinand F.W. van Oosten, South Africa, in International Encyclopaedia of Laws 81–82 (R. Blanpain ed., 1996); see also Claassen & Verschoor, supra note 43, at 13–26; Introduction to Medico-Legal Practice, supra note 43, at 22; Strauss, supra note 51, at 243; F.F.W. van Oosten & S.A. Strauss, Legal Liability, in Clinical Forensic Medicine and Medical Jurisprudence 40 (P.A. Carstens & P.W.W. Coetzer eds., 2002); P.A. Carstens, Die Strafregtelike en Deliktuele Aanspreeklikheid van die Geneesheer op grond van Nalatigheid [The Criminal and Delictual Liability of the Doctor for Negligence] 144 (2006) (unpublished LLD thesis, University of Pretoria); Blyth v. Van den Heever 1980 (1) SA 191 (A) at 221; Magware v. Minister of Health 1981 (4) SA 472 (Z) at 476–77; cf. Carstens & Pearmain, supra note 1, at 619. 177 1914 AD 519.

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highest possible degree of professional skill and care, he is bound to employ reasonable skill and care; and he is liable for the consequences if he does not.”178 In Van Wyk v. Lewis,179 reference is made to “the general level of skill and diligence possessed and exercised at the time by the members of the branch of the profession to which the practitioner belongs.”180 What is required, however, is not the highest possible degree of professional care and skill, but reasonable knowledge, ability, experience, care, skill, and diligence.181 Van Oosten correctly states that the standard that is required: [I]s thus based not on what can be expected of the exceptionally able doctor, but on what can be expected of the ordinary or average doctor in view of the general level of knowledge, ability, experience, skill and diligence possessed and exercised by the profession, bearing in mind that a doctor is a human being and not a machine and that no human being is infallible.182 In essence, “the standard of medical negligence is the recognized and accepted practices of the medical profession, provided these are not unreasonable and dangerous.”183 The test of medical negligence is the same in civil cases as in criminal cases.184 Medical practice is affected by many statutory provisions, as well as the common law, and many actions of a doctor that may result in civil liability or a disciplinary inquiry may also involve a contravention of criminal law. A prime example is medical negligence that results in the death of a patient and would constitute the criminal offence of culpable homicide. 178 Id. at 525; see also Coppen v. Impey 1916 CPD 309 at 314; Kovalsky v. Krige (1910) 20 CTR 822 at 823. 179 Van Wyk v. Lewis 1924 AD 438 at 438. 180 Id. at 444. 181 Id. at 470–71; Mitchell v. Dixon 1914 AD 519 at 525; Blyth 1980 (1) SA at 221; Lee v. Schönnberg (1877) 7 Buch 136; Collins v. Adm’r, Cape 1995 (4) SA 73 (C) at 81; Castell v. De Greef 1993 (3) SA 501 (C) at 509; R v. Van Schoor 1948 (4) SA 349 (C) at 350, 352; Coppen 1916 CPD at 314; Kovalsky 20 CTR at 823; R v. Van der Merwe 1950 (4) SA 124 (O); Allott v. Paterson & Jackson 1936 SR 221 at 224; Buls v. Tsatsarolakis 1976 (2) SA 891 (T) at 893; Esterhuizen v. Administrator Transvaal 1957 (3) SA 710 (T) at 723–24; Pringle v. Adm’r, Transvaal 1990 (2) SA 379 (W); S v. Kramer, 1987 (1) SA 887 (W) at 893; Dube v. Adm’r, Transvaal 1963 (4) SA 260 (W) at 266; Dale v. Hamilton 1924 WLD 184 at 200; Magware 1981 (4) SA at 476–77; cf. Michael v. Linksfield Park Clinic (Pty) Ltd. 2001 (3) SA 1188 (SCA) at 1192; Ex parte Rautenbach 1938 SR 150 at 151; S v. Van Almenkerk, 2006 (T) (unreported); Clinton-Parker v. Adm’r, Transvaal 1996 (2) SA 37 (W) at 39–40, 69–70. 182 Van Oosten, supra note 176, at 82 (citations omitted). 183 Id. at 83; Claassen & Verschoor, supra note 43, at 22; Van Oosten & Strauss, supra note 176, at 42. 184 Van Schoor 1948 (4) SA 349 (C); Van der Merwe 1950 (4) SA 124 (O); cf. Van Oosten, supra note 81, at 22.

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The standard of care and skill, in context of medical negligence, required of a general practitioner is to be distinguished from the standard of care and skill required of a medical specialist. Simply stated, if the physician is a general medical practitioner, the test is that of the reasonable general practitioner.185 If the physician is a specialist, the test is that of the reasonable specialist with reference to the specific field of medical specialization.186

2.

The Role of the South African Constitution, 1996

The common law pertaining to medical negligence is now subject to the supremacy of the South African Constitution of 1996. The Constitution, with its strong socio-economic rights base in terms of which everyone has access to health care services (including reproductive health care187), has catapulted health care into the public arena.188 Traditionally, South African medical law focused primarily, although not exclusively, on private health care emanating from a strongly developed private law application with specific reference to the law of contract and delict. Universal access to health care and the notion of the public good, in context of the values, spirit, and purpose of the Constitution, as well as the reality that the majority of South African citizens are dependent on public health care, in the absence of a national health insurance system, have now had the effect that public health care has, to a certain extent, usurped private health care. This effect would also influence the understanding and application of the law pertaining to medical negligence and in some instances calls for a development or “reconfiguration” of the common law in step with the provisions of the Constitution.189

185 Strauss & Strydom, supra note 43, at 268; Van Oosten, supra note 176, at 83; Van Oosten & Strauss, supra note 176, at 45; Carstens, supra note 176, at 137. 186 Strauss & Strydom, supra note 43, at 268; Van Oosten, supra note 176, at 83; Van Oosten & Strauss, supra note 176, at 45; Carstens, supra note 176, at 137. 187 S. Afr. Const., 1996, § 27. 188 See D. Brand, Introduction to Socio-Economic Rights in the South African Constitution, in SocioEconomic Rights in South Africa 1 (D. Brand & C.H. Heyns eds., 2005); C. Ngwena & R. Cook, Rights Concerning Health, in Socio-Economic Rights in South Africa 107 (D. Brand & C.H. Heyns eds., 2005); see also A. Clapham & M. Robinson, Realizing the Right to Health 11 (Chair of Political Philosophy of the University of Zurich ed., 2009); I. Currie & J. de Waal, The Bill of Rights Handbook 566 (2005). 189 In pursuance of section 39(2) of the Constitution. See also Carmichele v. Minister of Safety and Sec. 2002 (1) SACR 79 (CC); see generally Carstens & Pearmain, supra note 1, ch. 2.

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3.

Nature of Damages and Compensation

In terms of the Law of Obligations (Contract and Delict) the same medical negligence (negligent act or omission) may constitute both a breach of contract and delict. In such a case of concurrence of actions, the patientplaintiff can rely on the breach of contract or alternatively on delict. If he or she establishes both claims, damages should be awarded on the basis of the most advantageous claim. The patient-plaintiff may rely on both a breach of contract and delict in the same proceeding. In the case of such cumulative pleading, it is understood that the patient-plaintiff cannot recover more than the actual loss he or she has suffered. At the same time, if both claims are proved, the patient-plaintiff should be awarded damages on the basis of the cause of action most advantageous to him or her. Only pecuniary (patrimonial damages) may be recovered in contract, while pecuniary and non-pecuniary (non-patrimonial) damages can be recovered in delict. Recoverable pecuniary damages include medical costs (past as well as future), loss of income (past and future earnings), maintenance, etc. The ambit for recoverable non-pecuniary damages include not only compensation for actual physical pain, but also shock, discomfort and mental suffering, disfigurement, loss of amenities of life and disability, and loss of expectation of life – conveniently called loss for “pain and suffering which embraces all these non-pecuniary misfortunes, past and future.”190 It is possible to claim for detectable psychiatric injury, provided that there was actual psychological injury caused by medical negligence and the psychological harm is significant.191 Pecuniary loss and non-pecuniary loss is simply a matter of proof on a preponderance of probabilities and in most instances the services of actuaries are called in to quantify/ calculate the pecuniary loss suffered by the patient-plaintiff, taking into account the inflation rate (in terms of loss of future earnings), depreciation, life expectancy, retirement age, etc. The calculation of non-pecuniary damages is more complex and controversial and in this regard courts are in principle guided by policy considerations and comparable precedent.192 Patient-plaintiffs usually recover damages jointly and severally in the event of medical negligence claims against more than one defendant

190 P.Q.R. Boberg, The Law of Delict 516 (1984). 191 See Rd. Accident Fund v. Sauls 2002 (2) SA 55 (SCA); Barnard v. Santam Ltd. 1999 (1) SA 202 (SCA); Clinton-Parker v. Adm’r, Transvaal 1996 (2) SA 37 (W). 192 See generally M.M. Corbett & D.P. Honey, 6 The Quantum of Damages in Bodily and Fatal Injury Cases (2010) (discussing damages awarded in the context of specific injuries to specific body parts); M.M. Corbett, J.L. Buchanan & J.J. Gauntlett, The Quantum of Damages in Bodily and Fatal Injury Cases (3d ed. 1985).

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doctor or hospital, and provision is made in the Apportionment of Damages Act for instances of contributory negligence.193 There has also developed a tendency for defendants (doctors/hospitals) against whom a medical negligence claim was successfully instituted by a patient-plaintiff to institute action against one another for a re-apportionment of damages in terms of the Act,194 specifically if the doctor/hospital-defendants are aggrieved by the apportionment of damages and the amount awarded to the patient-plaintiff. The most powerful deterrent against medical negligence litigation in South Africa is the risk that the patient-plaintiff runs of an order of costs being made against him if his case fails. The general rule in our system is that the loser pays the costs – his own legal costs as well as the taxed costs of his opponent on the so-called “party and party” scale.195 The cost factor therefore constitutes a powerful incentive for settlement of cases out of court, depending on the merit and quantum of the case. Punitive damages (as known in the United States) are not awarded in cases of medical negligence in South Africa.196

193 Apportionment of Damages Act 34 of 1956 § 1. 194 See id. § 2(1); cf. Wright v. Medi-Clinic Ltd. 2007 (2) All SA 513 (C). 195 In South Africa a so-called “contingency fee” is conditionally allowed since 1999 in terms of section 2 of the Contingency Fees Act, which reads as follows: (1) Notwithstanding anything to the contrary in any law or the common law, a legal practitioner may, if in his or her opinion there are reasonable prospects that his or her client may be successful in any proceedings, enter into an agreement with such client in which it is agreed(a) that the legal practitioner shall not be entitled to any fees for services rendered in respect of such proceedings unless such client is successful in such proceedings to the extent set out in such agreement; (b) that the legal practitioner shall be entitled to fees equal to or, subject to subsection (2), higher than his or her normal fees, set out in such agreement, for any such services rendered, if such client is successful in such proceedings to the extent set out in such agreement. (2) Any fees referred to in subsection (1) (b) which are higher than the normal fees of the legal practitioner concerned (hereinafter referred to as the ‘success fee’), shall not exceed such normal fees by more than 100 per cent: Provided that, in the case of claims sounding in money, the total of any such success fee payable by the client to the legal practitioner, shall not exceed 25 percent of the total amount awarded or any amount obtained by the client in consequence of the proceedings concerned, which amount shall not, for purposes of calculating such excess, include any costs. It should, however, be noted that it is a practice rule with the General Council of the Bar of South Africa, that member advocates are only allowed to enter into contingency fee agreements with clients claiming for personal injury with prior permission from the Bar Council. 196 Cf. Collins v. Adm’r, Cape 1995 (4) SA 73 (C).

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B.

Causation and “Loss of Chance”

1.

General Rules on Causation

In Muller v. Mutual and Federal Insurance Co. Ltd., the court observed: [T]he problem of causation in delict involves two distinct enquiries. The first is whether the defendant’s wrongful act was a cause of the plaintiff’s loss (“factual causation”); the second is whether the wrongful act is linked sufficiently closely to the loss for legal liability to ensue (“legal causation” or remoteness).197 In Minister of Police v. Skosana, the court observed that: Causation in the law of delict gives rise to two ... distinct problems. The first is a factual one and relates to the question of whether the negligent act or omission in question caused or materially contributed to the harm giving rise to the claim. If it did not, then no legal liability can arise and caedit quaestio. If it did, then the second problem becomes relevant, viz. whether the negligent act or omission is linked to the harm sufficiently closely or directly for legal liability to ensue or whether, as it is said, the harm is too remote. This is basically a juridical problem in which considerations of legal policy may play a part.198 Therefore the test for factual causation is, except in the most unusual of circumstances, the causa (conditio) sine qua non. The plaintiff must show that the harm would not have arisen but for the actions or omissions of the defendant. The courts decide the question of legal causation on the basis 197 1994 (2) SA 425 (C) at 449F–449G; see also S v. Mokgethi En Andere 1990 (1) SA 32 (A); Int’l Shipping Co. (Pty) Ltd. v. Bentley 1990 (1) SA 680 (A) at 700E–701F; Siman & Co. (Pty) Ltd. v. Barclays Nat’l Bank Ltd. 1984 (2) SA 888 (A) at 914F–915A; Minister of Police v. Skosana 1977 (1) SA 31 (A) at 34E–35D. 198 Skosana 1997 (1) SA at 34–35 (citing Silva’s Fishing Corp. (Pty) Ltd. v. Maweza 1957 (2) SA 256 (A) at 264; Kakamas Bestuursraad v. Louw 1960 (2) SA 202 (A) at 222). Acting Judge Farlam then quoted W.L. Prosser, who stated: A cause is a necessary antecedent: in a very real and practical sense, the term embraces all things which have so far contributed to the result that without them it would not have occurred. It covers not only positive acts and active physical forces, but also preexisting passive conditions which have played a material part in bringing about the event. In particular it covers the defendant’s omissions as well as his acts. Id. at 35 (quoting W.L. Prosser, Law of Torts 237 (1971)). The judge then observed: The test is thus whether but for the negligent act or omission of the defendant the event giving rise to the harm in question would have occurred. This test is otherwise known as that of the causa (conditio) sine qua non and I agree with my Brother VILJOEN that generally speaking (there may be exceptions) no act, condition or omission can be regarded as a cause in fact unless it passes this test. Id. (citing Portwood v. Svamvur, 1970 (4) SA 8 (RA) at 14; Da Silva & Another v. Coutinho, 1971 (3) SA 123 (A) at 147).

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of a number of factors that relate essentially to public policy. The importance of public policy in the constitutional legal order prevails in South Africa. Public policy is informed by the values and principles of the Constitution. Thus decisions as to legal causation must also be informed by constitutional values and principles.199 The potential for convergence of the principles of the law of contract and of delict is evident from the judgment in Silver v. Premier, Gauteng Provincial Government, where the court refused to distinguish between the test for causation in considering the contractual as opposed to the delictual claim of the patient.200 This is particularly relevant in the context of claims involving health care services since the facts upon which the claim is based, whether in contract or in delict, are likely to be the same in many instances.

199 Cf. Carstens & Pearmain, supra note 1, at 509. 200 Silver v. Premier, Gauteng Provincial Gov’t 1998 (4) SA 569 (W); see also Carstens & Pearmain, supra note 1, at 509. On the subject of the sine qua non test the court observed that: I am aware that the plaintiff’s claim is founded in contract and, in the alternative, in delict. But I see no reason why the sine qua non test should not apply equally to the contractual claim in casu. The loss sustained by the plaintiff is said to have been caused by the breach of an implied term of an agreement that the hospital through its staff and employees would exercise due care, skill and diligence in providing nursing care. Precisely the same facts are relied upon as constituting a breach of the implied term as are relied upon as constituting a breach of the duty of care owed to the plaintiff. It would be anomalous if the same result did not follow irrespective of the cause of action. Furthermore, although the question of remoteness of damage for breach of contract is approached (in the absence of a contractual stipulation as to the basis on which compensation is to be made) by determining whether the damage flowed naturally and directly from the defendant’s breach or is such a loss as the parties contemplated might occur as a result of such breach, it must, in my view, follow as a matter of logic that as a general rule, the test for factual causation would first have to be satisfied. There will, of course, be exceptions, such as that cited by [P.J.] Visser and [J. M.] Potgieter in Law of Damages (1993) para 6.3.2 at 80–1: ‘(W)here a building contractor X is not able to build because Y, who has to deliver cement, and Z, who has to supply bricks, both fail to honour their contractual obligations on the same day and thus cause damage to X (eg he loses profit). According to the conditio sine qua non ’test,’ neither Y nor Z has caused damage since, if the breach of contract of each is notionally eliminated, the damage does not fall away!’ The learned authors express the view that common sense must be employed in such cases – an approach emphasised by Corbett JA in [Siman & Co. (Pty) Ltd. v. Barclays Nat’l Bank Ltd., 1984 (2) SA 888 (A) at 917, 918A] and employed by Lord Wright in [Yorkshire Dale Steamship Co. Ltd. v. Minister of War Transport [1942] 2 All ER 6] and by Beadle CJ in [Portwood v. Svamvur 1970 (4) SA 8 (RA) at 15F–G]. Silver 1998 (4) SA 599 (W) at 574–75.

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2.

“Loss of a Chance”

Apart from an excellent monograph written by Van den Heever on the application of the doctrine of a loss of chance in medical negligence cases,201 there is presently no reported judgments on the subject (in context of medical negligence actions) in South Africa, and the positive law position therefore remains uncertain.202 An assessment of the application of the doctrine of loss of a chance in medical negligence underscores the difficulties often encountered by courts when adjudicating on causation in medical negligence in the face of multiple causation theories. Although reasons for and against the application of the doctrine have been persuasively argued and canvassed,203 in general it seems as though factors militating against the application of the doctrine in medical law include the possibility of opening the floodgates for speculative claims, the idea of “playing god” by placing a value to human life, and the danger of an increase of the incidence of the practice of defensive medicine. On the other hand, factors or considerations that substantiate the application of the doctrine in medical law include the recognition of “a chance” having calculable value, the erosion of a patient-plaintiff’s autonomy, considerations of fairness to a patient-plaintiff who is saddled with a difficult burden of proof, and general deterrence.204 Whether South African courts, in context of medical negligence, will be prepared to apply the doctrine of a loss of a chance is doubtful, but at least a moot point, specifically if reliance is placed on comparable English law. In all probability resistance by the courts to apply the doctrine will ultimately emanate from policy considerations.205

201 P. van den Heever, The Application of the Doctrine of a Loss of a Chance to Recover in Medical Law (2006). 202 In Oldwage v. Louwrens [2004] 1 All SA 532 (C) at 105–15, the doctrine was referred to, but not discussed; similarly in McDonald v. Wroe [2006] 3 All SA 565 (C) at para. 37, reference was made to the Australian case of Chapel v. Hart (1998) 195 CLR 232 at para. 17, but no discussion in this regard was entertained. 203 Cf. Helen Reece, Losses of Chances in the Law, 59 Mod. L. Rev. 188 (1996); Niels Jansen, The Idea of Lost Chance, 19 Oxford J. Legal Stud. 271 (1999); Marc Stauch, Causation, Risk and Loss of a Chance in Medical Negligence, 17 Oxford J. Legal Stud. 205 (1997); see also Van den Heever, supra note 201, at 78. 204 See Van den Heever, supra note 201, at 115. 205 See Carstens & Pearmain, supra note 1, at 833.

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C.

Liability for Failure to Obtain Informed Consent

Van Oosten has extensively discussed the legal liability that may be incurred for no disclosure of information at all, for insufficient disclosure, and for excessive disclosure.206 In this regard he states that: The legal consequences of a medical intervention performed without the patient’s effective consent are that the doctor/hospital may incur liability for breach of contract,[207] civil or criminal assault (a violation of bodily integrity),[208] civil or criminal injuria (a violation of dignitas/ privacy),[209] or negligence,[210] as the case may be.211 In addition the medical practitioner or hospital may be unable to recover a professional fee.212 Van Oosten and Strauss state that “[t]his applies irrespective of whether or not the intervention was administered with due care and skill and eventually proves to have been beneficial to the patient.”213 Van Oosten further opines that the violation perpetrated by a doctor who performs the wrongful or unlawful operation is one against the patient’s physical integrity or dignity/privacy rather than one against

206 Ferninand F.W. van Oosten, The Doctrine of Informed Consent in Medical Law 455 (1991); cf. Introduction to Medico-Legal Practice, supra note 43, at 8; Strauss, supra note 1, at 70. 207 Cf. Castell v. De Greef 1994 (4) SA 408 (C) at 425. 208 Cf. Louwrens v. Oldwage, 2006 (2) SA 161 (SCA) at 174; Broude v. McIntosh 1998 (3) SA 60 (SCA) at 61 (questioning, but not overturning, this construction of assault); Lampert v. Hefer 1955 (2) SA 507 (A); Castell v. De Greef 1993 (3) SA 501 (C) at 425; S v. Binta 1993 (2) SACR 553 (C) at 561; Burger v. Adm’r, Kaap 1990 (1) SA 483 (C) at 489 (“Dit is heeltemal duidelik dat dit die regsposisie is dat as ‘n dokter ... sonder toestemming van die pasiënt opereer dit aanranding is [The legal position is crystal clear: it amounts to assault if a doctor operates without the patient’s consent]”); Richter v. Estate Hammann 1976 (3) SA 226 (C) at 232; Stoffberg v. Elliot,1923 CPD 148; S v. Kiti 1994 (1) SACR 14 (E) at 18; S v. Sikunyana 1961 (3) SA 549 (E) (stating that a medical practitioner who performs a dangerous operation with his patient’s consent incurs no criminal liability (for assault) if just cause for the operation exists, for the law does not regard his conduct as improper); Fowlie v. Wilson 1993 (N) (unreported); Layton & Layton v. Wilcox & Higginson 1944 SR 48; Esterhuizen v. Adm’r, Transvaal 1957 (3) SA 710 (T) at 718; Pop v. Revelas 1999 (W) (unreported); see also Oldwage v. Louwrens [2004] 1 All SA 532 (C); McDonald v. Wroe [2006] 3 All SA 565 (C) at para. 39 (holding that absence of consent was a violation of the patient’s constitutional right in terms of section 12(2)(b)). 209 See Stoffberg 1923 CPD at 152. 210 Louwrens 2006 (2) SA at 174; Lymbery v. Jefferies 1925 AD 236; Richter v. Estate Hammann, 1976 (3) SA 226 (C) at 232; Prowse v. Kaplan 1933 EDL 257; Allott v. Patterson & Jackson 1936 SR 221 at 221–22, 224; Layton & Layton v. Wilcox & Higginson 1944 SR 48 at 50; Dube v. Adm’r Transvaal 1963 (4) SA 260 (W) at 269. 211 Van Oosten, supra note 176, at 63. 212 Id. (citing Recsei’s Estate v. Meine 1943 EDL 277). 213 Strauss, supra note 1, at 70; Van Oosten, supra note 176, at 69.

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his or her health.214 This view accords with the applicable provisions of the Constitution. As proposed elsewhere, the absence of informed consent should be seen in context of the Constitution as an infringement of one’s right to bodily integrity as contemplated in terms of section 12(2)(b).215 The onus of proving non-disclosure liability rests with the patient or the state, depending upon whether it is a civil action or a criminal prosecution.216 Once a prima facie case of non-disclosure has been established, the doctor will have to refute the allegation of non-disclosure by adducing evidence that the requisite disclosure has indeed taken place.217 Van Oosten opines in this regard that since disclosure documents and consent forms cannot serve as a meaningful substitute for a disclosure conversation, the former should be afforded evidential value, but should not be considered as conclusive evidence that the requisite disclosure in fact occurred.218

D.

Matters of Proof and Gathering of Evidence

1.

Matters of Proof

a. General. The onus of establishing civil liability for medical negligence on the doctor’s part lies with the patient in a civil case and the prosecution in a criminal case. In a civil case liability must be established on a preponderance of probabilities. In a criminal case the guilt of the accused must be proved beyond reasonable doubt.219 In proceedings before an In214 Id. at 64 n.6 (citing Van Oosten, supra note 206, at 31, 452). 215 See Carstens & Pearmain, supra note 1, at 676. 216 In this regard Van Oosten states that, in the unlikely event of a doctor being charged with culpable homicide or sued for damages for causing the death of the patient by non-disclosure, it will not only have to be proved that the non-disclosure unlawfully or wrongly caused the patient’s death, but also that it was reasonably foreseeable in the circumstances. Van Oosten, supra note 206, at 455 n.83. 217 See Strauss, supra note 51, at 281. 218 Van Oosten, supra note 206, at 455–56. 219 Strauss, supra note 1, at 100 (citing Van Wyk v. Lewis 1924 AD 438; Mitchell v. Dixon 1914 AD 519; Touyz v. Reyneke 1994 (A) (unreported); Blyth v. Van den Heever 1980 (1) SA 191 (A) at 207; Lee v. Schönnberg (1877) 7 Buch 136; Castell v. De Greef 1994 (4) SA 408 (C) at 420, 425; R v. Van Schoor 1948 (4) SA 349 (C) at 349–50; Coppen v. Impey 1916 CPD 309; St Augustine Hosp. (Pty) Ltd. v. Le Breton 1975 (2) SA 530 (D); Webb v. Isaac 1915 EDL 273; Allott v. Paterson & Jackson 1936 SR 221; Buls v. Tsatsarolakis 1976 (2) SA 891 (T) at 893; Esterhuizen v. Adm’r Transvaal 1957 (3) SA 710 (T); Pringle v. Adm’r, Transvaal 1990 (2) SA 379 (W); S v. Kramer 1987 (1) SA 887 (W) at 897); Dale v. Hamilton 1924 WLD 184); see also Claassen & Verschoor, supra note 43, at 26; L.H. Hoffmann & D.T. Zeffertt, The South

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quest Court, the presiding magistrate has to make a finding on a preponderance of probabilities,220 and in disciplinary proceedings beAfrican Law of Evidence 26 (4th ed. 1988); C.W.H. Schmidt, Bewysreg [Law of Evidence] 23 (2000); Strauss & Strydom, supra note 43, at 274; P.J. Swikkard & S.E. van der Merwe, Beginsels van die Bewysreg [Principles of the Law of Evidence] 546–58 (2005); S.A. Strauss, Geneesheer, Pasiënt en die Reg: ‘n Delikate Driehoek [Doctor, Patient and the Law: a Delicate Triangle], Tydskrif vir die Suid-Afrikaanse Reg [J. S. Afr. L.] 1 (1987); Broude v. McIntosh 1998 (3) SA 60 (SCA) at 61; Oldwage v. Louwrens [2004] 1 All SA 532 (C). Note that, should the plaintiff be unable to prove his/her case on a preponderance of probabilities, judgment will be given in favour of the defendant; a court may, however, also order absolution from the instance. In delict, the plaintiff bears the onus to prove a wrongful act/omission on the part of the physician, as well as the element of fault (in the form of negligence) and that the act or omission caused him to suffer damages or personal injury. See Hoffmann & Zeffertt, supra, at 496; Schmidt, supra, at 39; Matthews v. Young 1922 AD 492; Botha v. Van Niekerk 1947 (1) SA 699 (T). Where a defendant raises a special defence such as consent, contributory negligence, or prescription, the onus of proof will be on the defendant. See Hoffmann & Zeffertt, supra, at 530; Schmidt, supra, at 41, 132; Mabaso v. Felix 1981 (3) SA 865 (A); Joubert v. Combrinck 1980 (3) SA 680 (T); see also Swikkard & Van der Merwe, supra, at 546. The state has to prove all the elements of the crime (in this case culpable homicide, where it is alleged that the medical practitioner negligently caused the death of the patient) beyond reasonable doubt, i.e., an act or omission which unlawfully and negligently caused the death of the patient. 220 Cf. Inquests Act 58 of 1959, § 16(2) (with reference to the phrase “prima facie”); cf. Claassens v. Landdros Bloemfontein 1964 (4) SA 4 (O). The proof of medical negligence is important in context of judicial inquests, specifically where a patient died due to unnatural causes (e.g., the anaesthetic death) and the possible negligence of the attending physician has to be investigated (mention can be made of the form GW 7/ 24 to be completed in terms of § 56 of the Health Professions Act, as amended, in context of anaesthetic deaths); the judicial inquest is often the “front runner” of a later criminal prosecution on a charge of culpable homicide against a physician. It is to be noted that a judicial inquest is not a criminal trial but an inquisitorial inquiry aimed at transparency for the administration of justice and to install confidence. See Timol v. Magistrate Johannesburg 1972 (2) SA 281 (T) at 278H–288A; see also Wessels v. Additional Magistrate Johannesburg 1983 (1) SA 530 (T) at 532E–532G; S v. Ramaligela 1983 (2) SA 424 (V) at 430D. At the inquest, conducted by a magistrate or a judge, the presiding officer will have before him/her the post mortem report and other documentation relevant to the death of the patient. Normally the pathologist/doctor who conducted the post mortem examination will be subpoenaed to testify at the inquest. In terms of § 16(2) of the Inquests Act, the presiding officer has the duty to make the following findings: a) the identity of the deceased; b) the cause or likely cause of death; c) the date of death; d) whether the death has been caused by an act or omission on the part of someone that prima facie constitutes an offence – the only relevant offence here in context of medical negligence is culpable homicide. At the end of the inquest an assessment has to be made whether on the evidence as a whole, all the elements for this crime, on a preponderance of probabilities are present. Clearly the findings in terms of the said section 16(2)(b) and (d) are paramount with reference to a possible criminal prosecution against a doctor. In this respect the post mortem examination and the report of the pathologist are vital. If the presiding officer makes a positive finding in respect of section 16(2)(d) he or she is obliged to submit the inquest record to the Director of Public Prosecutions who will then as a matter of course normally decide to institute criminal prosecution. In addition, a copy of the inquest record is submitted to the Registrar of the HPCSA to assess whether disciplinary proceedings on account of unprofessional conduct should be instituted against the doctor. See Health Professions Act § 45(2); Suid-Afrikaanse Geneeskundige & Tandheelkundige Raad v. Strauss 1980 (2) SA 354 (T) at 212. A doctor,

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fore a disciplinary committee of the HPCSA, the pro forma-complainant has to prove the charges of unprofessional conduct against the respondent-medical practitioner on a preponderance of probabilities.221

subpoenaed to testify at an inquest, is not obliged to answer self-incriminating questions. See Magmoed v. Janse Van Rensburg 1991 SACR 185 (C); In re Mjoli, 1994 (2) SA 815 (T); see generally Strauss, supra note 51, at 437; Strauss, supra note 1, at 156 n.1 (pointing out that a “person” for purposes of the Inquests Act, does not include a stillborn baby); Van Heerden v. Joubert (1994) (4) SA 793(A) (in which Van Heerden v. Joubert 1992 (T) (unreported) was overruled); see also I. Gordon, R. Turner & T.W. Price, Medical Jurisprudence 333–34 (3d ed. 1953); cf. Carstens, supra note 176, at 313–18; T. G. Schwär, J.A. Loubser & J.D. Olivier, Die ABC van Geregtelike Geneeskunde [The ABC of Forensic Medicine] 412 (1984). As to the role of assessors and forensic pathologists at inquests, see R v. Solomons 1959 (2) SA 352 (A); T.T. Noguchi & L. Sathyavavgiswaran, The Role of Forensic Pathologists in the Quality Assurance and Safety of the Patient Care, in Published Conference Proceedings of 15th World Congress on Medical Law Sydney Australia 26 (2004); T.T. Noguchi, Medical Malpractice Claims and Quality Improvement as Viewed by a Forensic Pathologist, 56 Japanese J. Legal Med. 205 (2002); see also K. Müller & G. Saayman, Forensic Science in Medicine: What a Doctor Should Know, 45 S. Afr. Fam. Prac. 41 (2003); G. Saayman & F.F.W. van Oosten, Forensic Medicine in South Africa–Time for Change?, 13 Med. & L. 129 (1994). 221 The nature of the proceeding before a disciplinary committee of the Professional Board for Medical and Dental Practitioners of the HPCSA has been discussed in some detail in case law. See De La Rouviere v. S. Africa. Med. & Dental Council 1977 (1) SA 85 (N) at 97; De Beer v. Health Professions Council of S. Africa 2005 (1) SA 332 (T); VRM v. Health Professions Council of S. Africa 2003 JOL 11944 (T); Thuketana v. Health Professions Council of S. Africa 2002 4 All SA 493 (T); Veriava v. President S. African Med. & Dental Council 1985 (2) SA 293 (T) at 307; Pretorius v. S. Africa Geneeskundige & Tandheelkundige Raad 1980 (2) SA 354 (T) at 358–59; see also Strauss, supra note 51, at 369; Carstens, supra note 176, at 318–24; J. Taitz, The Disciplinary Powers of the South African Medical and Dental Council, in 1 Acta Juridica 56 (1988); J. Taitz, Review of the Disciplinary Proceedings of the Medical and Dental Council, 105 S. Afr. L. J. 25 (1988). Note that the HPCSA is not an organ of state. Korf v. Health Professions Council of S. Africa 2000 (1) SA 1171 (T); Mistry v. Interim Nat’l Med. and Dental Council of S. Africa [1997] 3 All SA 519 (D). Disciplinary committees of the Professional Board for Medical and Dental Practitioners function as quasi-judicial administrative tribunals and are bound by the constitutional provisions as articulated in section 33 of the Bill of Rights and the provisions of the Promotion of Administrative Justice Act 3 of 2000. See M. Beukes, The Constitutional Foundation of the Implementation and Interpretation of the Promotion of Administrative Justice Act, in The Right to Know: South Africa’s Promotion of Administrative Justice and Access to Information Acts 1 (C. Lange & J. Wessels eds., 2004). Disciplinary committees are thus legally bound to conduct hearings against medical practitioners with procedural fairness, which includes reasonableness, and to provide adequate reasons for their decisions. See C. Hoexter, Unreasonableness in the Administrative Justice Act, in The Right to Know, supra, at 148; J. Wessels, ‘Adequate reasons’ in Terms of the Promotion of Administrative Justice Act, in The Right to Know, supra, at 116–32. Decisions of a disciplinary committee of a Professional Board for Medical and Dental Practitioners of the HPCSA may be taken on review to the High Court. See J.R. de Ville, Judicial Review of Administrative Action in South Africa 384–85 (2003). In context of the nature and scope of evidence to be led at a disciplinary hearing against a medical practitioner, it is significant to note what was stated by Judge Ramsbottom in McLoughlin v. South African Medical & Dental Council 1947 (2) SA 377 (W) at 395: The [Medical] Council and the Disciplinary Committee are bodies of a different kind. They are entrusted with the most important duties; they have the power to compel the attendance of witnesses; evidence is given on oath and any person who gives false

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It is to be noted, by way of a summary, that generally the application of the maxim res ipsa loquitur is treated by the courts as a particular form of inferential reasoning, requiring careful scrutiny and giving rise to an inference of negligence rather than a presumption of negligence.222 The South African courts thus far have been reluctant to apply the maxim to cases of medical negligence. Recent case law, however, suggests that the maxim could only be invoked where the medical negligence alleged depends on absolutes and the evidence shows that a particular result would not have followed but for the alleged negligence.223 Persuasive arguments have been put forward that the maxim should be applied in specific circumstances with regard to the proof of medical negligence.224 In this respect, general principles for the effective application of the maxim in cases of medical negligence are advanced, inter alia, that principles of procedural equality and constitutional considerations dictate that the maxim be applied in cases of medical negligence. As a general rule of evidence, a plaintiff in a medical negligence action is required to present expert medical evidence in support of allegations thereof. In this regard, expert medical evidence is pivotal in support or defence of medical negligence.225 The South African Supreme Court of

222 223 224

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evidence on oath before the Council or the committee or who refuses to answer commits and offence; the parties have the right to counsel and witnesses are examined and cross-examined; a legal assessor may be appointed ‘to advise on matters of law procedure and evidence’ .... In my opinion a body of this kind [the Medical Council] should be held much more strictly to the rules of procedure and evidence than a body such as [the council of clubs, trade unions, and the like.]” Id. (emphasis added). See Strauss, supra note 1, at 100. Pringle v. Adm’r, Transvaal 1990 (2) SA 379 (W). Patrick van den Heever, The Application of the Doctrine of Res Ipsa Loquitur to Medical Negligence Cases: A Comparative Survey 63, 329–32 (Jan. 2002) (unpublished LLD thesis, University of Pretoria), available at http://upetd.up.ac.za/thesis/available/etd08062007-165205/. Plaintiffs often find it difficult to obtain medical experts who are prepared to testify against their colleagues. This resistance is described in the literature as a “conspiracy of silence,” a term coined in the United States. See D. Giesen, International Medical Malpractice Law 513 n.7 (1988) (“It is a matter of common knowledge, often mentioned in judicial opinion and other authorities, that the plaintiff in a medical malpractice case is often unable to find a medical expert willing to testify against a fellow physician. ... It goes without saying that the plaintiff’s inability to obtain favourable expert testimony poses the possibility of great miscarriage of justice.”); cf. Strauss, supra note 51, at 245; Melvin M. Belli, An Ancient Therapy Still Applied: The Silent Medical Treatment, 1 Vill. L. Rev. 250 (1956); L. Norton, Ethics in Medicine and Law: Standards and Conflicts, Legal Med. Ann. 206 (1977); see also M. M. Belli, “Ready for the Plaintiff!,” 30 Temp. L.Q. 408, 434 (1957) (warning the medical profession “for Hippocrates’ sake ... [i]n your own enlightened self-interest, break this conspiracy before the public does it for you!”). Although there is a greater willingness amongst medical practitioners to testify against fellow practitioners, specifically in cases of gross

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Appeal in the case of Michael v. Linksfield Park Clinic (Pty) Ltd. had the opportunity to enunciate the general applicable considerations in assessing expert medical evidence.226

b. Gathering of Evidence. For the purpose of gathering evidence pertaining to medical negligence, there are different rules which may be invoked to obtain such evidence, depending on the forum in which the doctor’s or hospital’s negligence is adjudicated. In a criminal trial and in inquest proceedings, the doctor may request certain sections (documents like sworn statements) from the police docket and may also request further particulars for purposes of trial.227 At disciplinary hearings against a doctor before the Professional Board of the Health Professions Council of South Africa on a charge of professional misconduct (inclusive of alleged medical negligence), the defendant-doctor (respondent) is also entitled to further particulars to the charge, as well as the initial letter of complaint of the patient originally lodged with the Registrar, and the findings of the prelim committee who assessed the prima facie merits of the case against the doctor.228 In the context of civil litigation, patient-plaintiffs may invoke the Promotion of Access to Information Act, to obtain access to medical records and other related information.229 The Act was introduced “[t]o give effect to the constitutional right of access to any information held by the State and any information held by another person and that is required for the exercise or protection of any rights.”230 It should, however, be noted that the Act does not apply to medical records and related medical information requested for civil proceedings after the commencement of the proceedings.231 Where legal proceedings in a medical negligence action have commenced, there is a strict discovery procedure to be followed for the production and discovery of expert medical reports, and

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negligence, it seems that it is still problematic for plaintiffs to readily acquire the services of medical experts in this regard. 2001 (3) SA 1188 (SCA) at 1200A–1201F; see Carstens & Pearmain, supra note 1, at 861 (discussing this case). Criminal Procedure Act 55 of 1977 § 87; see also Shabalala & Five Others v. Attorney-Gen. of the Transvaal 1996 (1) SA 725 (CC); S v. Shiburi 2004 (2) SACR 314 (W). Cf. Carstens & Pearmain, supra note 1, at 269. Promotion of Access to Information Act 2 of 2000. Id. pmbl. The Act was introduced to give effect to the provisions of section 32 of the Constitution of the Republic of South Africa, 1996, which governs access to information. Id. § 7; see The Right to Know, supra note 221 (discussing and analyzing the Act); see also Unitas Hospital v. Van Wyk [2006] SCA 32 (RSA).

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similar documents (inclusive of a pre-trial conference) as prescribed, inter alia, by the Rules of the Supreme Court Act.232

III. Available Empirical Data on Medical Errors and Adverse Events, the Operation of the Systems Designed to Prevent and/or Redress such Errors and Events, and the Prevalence and Impact of Measures Designed to Reduce Medical Errors and Adverse Events, Improve System Performance, or Reduce System Costs Obtaining empirical data on medical negligence in South Africa has proved very difficult. Despite numerous phone calls and e-mails to officials in the National Department of Health, the various Provincial Departments of Health, the National Department of Justice, the Health Professions Council of South Africa, and the Medical Protection Society, not a single piece of empirical data was provided by any of these parties. Websites for the most part do not provide up-to-date, detailed information. This left the authors out in the cold, turning to media reports for answers. It has been reported, for instance, that “[n]early 2,000 doctors in public and private healthcare in South Africa are facing claims of negligence.”233 According to one media report, “[a]bout 80 % of the claims stem from incidents in the public health sector.”234 It has been claimed that over a two year period doctors in South Africa’s “public hospitals have cost taxpayers more than R1 billion in lawsuits because of botched operations.”235 The KwaZulu-Natal Health Department apparently spent R376m in 2008/ 2009, and R547m in 2009/2010 on lawsuits.236 Three weeks into the new financial year, the provincial department had paid out R87m in medical legal bills and had 294 cases pending.237 The province of Mpumalanga spent R666,643 in 2008/2009, and R19m in 2009/2010 on medically related legal bills.238 Gauteng spent R2.8m in 2008/2009, and R10m in

232 Rules of the Supreme Court Act 59 of 1959 R. 35–37; see also E. Morris, Technique in Litigation 114 (J. Mullins & C. Da Silva eds., 2010). 233 Subashni Naidoo, Thousands of Doctors ‘Negligent,’ Sunday Times, June 6, 2010, http:// www.timeslive.co.za/sundaytimes/article489475.ece/Thousands-of-doctors-negligent. 234 Id. 235 Edwin Naidu, Botched Operations Blight SA, The Sunday Independent, May 2, 2010, http://www.iol.co.za/news/south-africa/botched-operations-blight-sa-1.482422. 236 Id. 237 Id. 238 Id.

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2009/2010 on medical legal fees.239 The Western Cape spent R4m in 2008/ 2009, and R6m in 2009/2010.240 The North West Province spent R11.5m in 2008/2009, and R1.7m in 2009/2010.241 The Free State Health Department paid out R916,000 in 2008/2009, and R577,000 in 2009/2010.242 The Eastern Cape spent more than R8m on legal fees in 2009/2010.243 Many cases are settled out of court – perhaps as much as 70 % of all claims.244 It has been reported, for instance, that in May 2010 four cases of medical negligence were settled in Johannesburg, with payouts of up to R7m.245 According to figures claimed in media reports to have been obtained from the Medical Protection Society, more than 800 of its members (±3.08 %) are facing active claims of alleged negligence, with another 1,000 complaints still be to assessed.246 In his report for 2009, the Chief Executive of the MPS – a membership organisation with more than 270,000 members in over forty countries – reported “poor claims experience” for the organisation as a whole, and remarked that “[t]he worst of the adverse claims experience has been in the UK and South Africa, although we are beginning to see a rise in both the frequency and average size of claims in most countries in which we operate around the world.”247 He expressed major concern about the “quite startling increase in the value of high claims in the UK, where some settlements have leapt by 40 % or more as compared with similar claims settled in the recent past,” and remarked that “a similar worrying trend is also beginning to emerge in South Africa.”248 The MPS promotes safer practice by running risk management and education programmes to reduce avoidable harms.249 A confidential counselling service for members was introduced in South Africa in 2009, and has reportedly been very favourably received by members.250 Medico-legal

Id. Id. Id. Id. Id. Naidoo, supra note 233. Id. Id. Medical Protection Society, Financial Stability in Challenging Times: Annual Report and Accounts for the Year Ended 31 December 2009, 2 (2010), available at http://www. medicalprotection.org/Default.aspx?DN=609d6af5-5421-49a4-baeb-f5fa0cb2b3bf. 248 Id. He indicated that this worrying trend will inevitably mean higher subscriptions for all UK members. Id. 249 Id. at 3. 250 Id. 239 240 241 242 243 244 245 246 247

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consultants are available round-the-clock to help members with legal and ethical dilemmas arising from their professional practice, clinical negligence claims, complaints, disciplinary procedures, police investigations, regulatory inquiries, inquests, and the like. “Most claims relate to botched cosmetic surgery, children born with brain damage, birth defects not diagnosed timeously and Caesarean sections not done when needed.”251 It should be noted that South African law recognises actions for wrongful pregnancy and wrongful birth, but not wrongful life. Not surprisingly, the subscription rate for specialists doing obstetrics and gynaecology tops the list at R130,540 for the year January 1, 2010, through December 31, 2010.252 Plastic and reconstructive surgeons fall in the “very high risk” category with a corresponding subscription rate. Claims worth more than R1m account for over 18 % of the total number.253 This amounts to an increase of nearly 550 % in ten years. Claims for amounts above R5m have increased nine fold in the past decade.254 Several claims have been brought for amounts in excess of R30m.255 According to media reports, statistics from the Health Professions Council of South Africa show that the names of forty-four medical practitioners have been removed from the register since 2005 as a result of having been found guilty of unprofessional conduct.256 Between April 2008 and March 2009, approximately ninety medical practitioners were found guilty of unprofessional conduct.257 The conduct complained of included insufficient care, refusing to treat patients, misdiagnosis, practising outside the particular practitioner’s scope of competence, overcharging, and charging for services not rendered.258 Between January 2008 and October 2008, forty-seven practitioners were found guilty of unprofessional conduct relating to substandard service or inadequate treatment.259

251 Naidoo, supra note 233. 252 Subscription Rates, Medical Protection Society, http://www.medicalprotection.org/ southafrica/membership/subscription (last visited Nov. 4, 2010). 253 Naidoo, supra note 233. 254 Id. 255 Id. 256 Id. 257 Id. 258 Id. 259 Categorisation of Finalised Professional Conduct Inquiries (January 2008–October 2008), Health Professions Council of South Africa, http://www.hpcsa.co.za/downloads/conduct_ ethics/conduct_inquiries_2008.pdf (last visited Nov. 4, 2010).

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IV. Attitudes and Concerns About the Liability and Compensation Systems The medical malpractice and compensation scenario in South Africa cannot be properly understood without an insight into the broader socioeconomic and, specifically, healthcare situation in the country. South Africa is a developing nation, with pockets of highly developed infrastructure and highly trained and skilled people. “Health care varies from the most basic primary services provided by the State for free” to the indigent, “to highly specialised hi-tech services available in both the public and private sectors.”260 The total population in South Africa is in the order of 49 million. “The private sector spends about R66-billion to service 7million people” through private medical insurance.261 This sector also provides services “to foreigners looking for top-quality surgical procedures at relatively affordable prices.”262 The public sector spends about R59 billion on the rest of the population.263 This amounts to 3.05 % of the GDP.264 In April 2006, there were 33,220 doctors registered with the HPCSA in private and public practice combined.265 Two thousand Tunisian doctors and 450 Cuban doctors are deployed in rural areas.266 Transforming measures (encompassing legislation, health care policies and public-private partnerships) for the health sector are envisioned.267 Poverty and other poverty-related diseases like tuberculosis and cholera place a huge strain on the health system, but HIV/AIDS poses the biggest threat.268 South Africa has the fifth highest number of notified tuberculosis cases in the world.269 Over five million South Africans live with HIV. At this moment, half-amillion are sick with AIDS and require antiretroviral treatment. The majority still struggle to access it. More than two years ago the Department of Health committed to placing 380,000 people on treatment ... (in the Operational Plan for Comprehensive HIV and AIDS Care, Man-

260 Healthcare in South Africa, MediaClubSouthAfrica, http://www.mediaclubsouthafrica. com/index.php?option=com_content&view=article&id=102:healthcare&catid=34:de velopmentbg (last visited Apr. 15, 2011). 261 Id. 262 Id. 263 Id. 264 Id. 265 Id. 266 Id. 267 Id. 268 Id. 269 Id.

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agement and Treatment for South Africa, published 19 November 2003). Yet only 36 % of this target has been met. ... [M]illions more are at risk .... [S]uffering is being hidden behind a veil of state-supported AIDS denialism.270 We are still reaping the consequences thereof. Currently, there is a National Strategic Plan in place to address challenges posed by HIV/AIDS with increased expenditure. One of the biggest challenges facing the South African system of liability and compensation for medical malpractice is the shortage of qualified health care practitioners. “Doctors and nurses carry a very heavy workload because of vacancies, an increase in the number of patients coming for treatment and lack of resources.”271 The chairman of the South African Medical Association, Norman Mabasa, said that the current incidence of medical malpractice is the result of “the skills shortage in the public health system.”272 Exhaustion is common.273 Mabasa has said that “[j] unior doctors are forced to work without supervisions and there is serious neglect in terms of nursing care.”274 The ombudsman of the Health Professions Council of South Africa, Abdul Barday, also acknowledged that “doctors in provincial hospitals worked under trying conditions.”275 “Analysis of figures for registered doctors in relation to the general population and international standards,” based on 2004 figures, “indicates that South Africa is substantially better supplied with doctors than its immediate neighbors, but grossly undersupplied when compared to many developed countries.”276 South Africa had a rate of 7.7 medical practitioners per 10,000 population, whilst Austria, for instance, had a rate of thirty-five, and Canada a rate of twenty-one.277 Vast amounts of money are spent to educate health care workers who are lost to developed nations as a result of recruitment. In 2001, there were almost 1,500 South

270 Memorandum Handed over to UN and SA Government in Pretoria on 30 May, Treatment Action Campaign (May 30, 2006), http://www.tac.org.za/community/node/2206. 271 Naidu, supra note 235. 272 Id.; Naidoo, supra note 233. 273 Naidu, supra note 235; Naidoo, supra note 233. 274 Naidoo, supra note 233. 275 Naidu, supra note 235. 276 The Shortage of Medical Doctors in South Africa: Scarce and Critical Skills Research Project, Dep’t of Labour 12 (March 2008), http://www.labour.gov.za/downloads/documents/research-documents/Medical Doctors_DoL_Report.pdf. 277 Id. at 12, 15.

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African doctors in Canada; 17 % of all doctors in Saskatchewan earned their first medical degree in South Africa.278 The president of the South African Association of Personal Injury Lawyers, Ronald Bobroff, attributes the high number of negligence cases in the private and state sectors to a lack of accountability and poor management.279 Ambulance services, for instance, do not always respond timeously, resulting in lawsuits.280 This is attributed to poor management and the use of unsuitable vehicles.281 Health Minister Dr. Aaron Motsoaledi is reported to have said that the amount paid out in lawsuits was unacceptable.282 Motsoaledi has told Parliament’s portfolio committee on health that he planned to commission an investigation into the reasons for the increase in litigation and the state of care in public hospitals.283 The Nyathi case illustrates how difficult it can be, especially for the indigent, to successfully claim damages from, and enforce judgment against, the state.284 Poorer members of the community not only face the higher risks associated with an understaffed and under-resourced public health sector, but also the hurdle of high legal costs. Another concern is the fact that “the conspiracy of silence” is still a reality. Reported medical negligence actions where judgment is given against the medical practitioner remain relatively scarce. The rise in litigation can perhaps not be attributed purely to a rise in the incidence of negligence. As a result of a greater actualisation of constitutional rights, there has been an increase in access to information, transparency, and accountability through the recently enacted legislation. It is submitted that this, together with greater consumer awareness, may have led to an increase in medical litigation. Greater specialisation in medicine and the less personal nature of the relationship between specialists and patients is another possible contributing factor.

278 Amy Jo Ehman & Patrick Sullivan, South Africa Appeals to Canada to Stop Recruiting Its MDs, 164 (3) Can. Med. Ass’n J. 387 (2001), available at http://www.ncbi.nlm.nih.gov/ pmc/articles/PMC80740/pdf/20010206s00029p387.pdf. 279 Naidoo, supra note 233. 280 Naidu, supra note 235. 281 Id. 282 Id. 283 Id. 284 See Nyathi v. MEC for Dep’t of Health, Gauteng 2008 (5) SA 94 (CC).

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Medical Malpractice and Compensation in the UK Richard Goldberg*

Introduction It is timely to be writing a paper on medical malpractice and compensation in the UK. As we shall see, several issues are currently commanding attention in England and Wales and in Scotland. Indeed, it is fair to say that at no time in recent years has the future of clinical negligence litigation in the UK been as uncertain as it is now. In the first part of this paper, I examine the context in which medical malpractice liability is operating in the UK. We will see that the fact that the state-run National Health Service (NHS) is the major healthcare provider has several implications, since funding for medical malpractice compensation in the NHS comes from the taxpayer. For several years, the civil justice system has been failing to meet the needs of litigants in clinical negligence claims, and I examine the commissioned reports that have attempted to address these problems. I go on to examine the most recent empirical evidence on the incidence and funding of claims in England and Scotland, to show a trend of increasing expenditure on clinical negligence, particularly in England. A statutory framework for the empowerment of some of the Chief Medical Officer’s recommendations in his report, Making Amends, is present in the NHS Redress Act 2006, and this is briefly assessed. In Scotland, while medical negligence remains the primary route to bringing a claim for compensation for medical injury, no-fault compensation is now the favored way forward of the Scottish Government for the NHS in Scotland. A No-Fault Compensation Review Group has just reported and I examine

*

Reader in Law, School of Law, University of Aberdeen, UK. I wish to thank Professor Sheila McLean, Emeritus Professor of Law and Ethics in Medicine, University of Glasgow, for helpful initial discussions.

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its recommendations, which provide a radical development in the field of compensation for medical malpractice. The heart of the paper examines the existing basis of medical liability, with particular emphasis on the problems in establishing negligence and factual causation. Finally, I examine in the context of clinical negligence claims both the recommendations for reforming the costs of civil litigation in England and Wales and the dramatic changes being introduced to the Legal Aid system, in particular the abolition of legal aid for clinical negligence cases.

I.

The Context of Medical Malpractice Liability

By far the majority of the healthcare provisions in the UK are under the NHS. Since its establishment in 1948 by the then Labour Atlee Government, it has grown to become the world’s largest publicly funded health service. With the exception of charges for some prescriptions and optical and dental services, the NHS continues to remain free at the point of use for any resident in the UK. While funded centrally from national taxation, NHS services in England, Northern Ireland, Scotland, and Wales are managed separately.1 There is some private sector healthcare, which the Conservative part of the coalition government is keen to expand over the next few years, but the NHS continues to be the primary healthcare provider in Great Britain and Northern Ireland. This has major consequences in that when compensation and legal costs are payable as a result of medical malpractice in the NHS, this money comes from the taxpayer. Indeed, in England this money comes out of the Department of Health’s own budget. In an era of increasing austerity in public service provisions in the UK, there is great concern as to the increasing costs to the public purse of clinical negligence claims. This concern had been present for several years before the recent world financial crisis,2 but now, more than ever before, it has become the dominant issue in clinical negligence litigation.

1 NHS, Overview, (4 April, 2009), available at http://www.nhs.uk/NHSEngland/thenhs/ about/Pages/overview.aspx. 2 See generally Chief Medical Officer’s Report, in Making Amends: A Consultation Paper Setting Out Proposals for Reforming the Approach to Clinical Negligence in the NHS (U.K. Dep’t of Health 2003) [hereinafter Making Amends], available at http://www.dh.gov.uk/prod_ consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4060945.pdf.

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In his review of the Civil Justice System in 1996, Lord Woolf singled out medical negligence for the most intensive examination because it was in that area that the civil justice system was failing most conspicuously to meet the needs of litigants.3 Lord Woolf emphasized five major problems with the system: (1) the excessive disproportion between costs and damages in medical negligence, especially in lower value cases; (2) the often unacceptable delay in resolving claims; (3) the overly long pursuit of unmeritorious claims and the defense of clear-cut claims; (4) the lower success rate than in other personal injury litigation; and (5) the greater suspicion and lack of cooperation between the parties than in many other areas of litigation.4 The resulting revision of the Civil Procedure Rules contained several measures to improve the litigation process in medical negligence cases, although whether this has resulted in a significant reduction of costs remains to be seen.5 Sir Ian Kennedy, in the Final Report of the Bristol Royal Infirmary Inquiry, highlighted the weaknesses of the current system of providing compensation to those suffering harm arising out of medical care.6 Indeed, the Report went further in recommending the abolition of the clinical negligence system and its replacement with “an alternative system for compensating those patients who suffer harm arising out of treatment from the NHS.”7 In response to such calls for reform, the Department of Health initiated a review of the system of handling claims for compensation and complaints, which resulted in a report by the Chief Medical Officer in 2003.8 While rejecting a wide-ranging no-fault scheme for all types of injury, primarily on the grounds of costs and the practicalities in framing it,9 the Chief Medical Officer proposed “a composite package of reform”10 which would apply to England only, and which involved a new system of providing 3 Rt. Hon. Lord Woolf, Access to Justice: Final Report 170 (Her Majesty’s Stationery Office 1996). 4 Id. 5 Civil Procedure Rules, 1998, S.I. 3132 [hereinafter C.P.R.]; Michael A. Jones, Medical Negligence para. 1-028 (Sweet & Maxwell, 4th ed. 2008). See especially C.P.R., 1998, S.I. pt. 35 (Experts and Assessors). Note the overriding objective of the Civil Procedure Rules, which is to deal with cases justly, having regard to, inter alia, saving expense, dealing with the case in ways that are proportionate to the amount of money involved, the importance of the case, the complexity of the issues, and the financial position of each party. C.P.R. r. 1.1. 6 Learning from Bristol: The Report of the Public Inquiry into Children’s Heart Surgery at the Bristol Royal Infirmary 1984−1995 C.M. 5207, (I) 442 (The Bristol Royal Infirmary Inquiry 2001). 7 Id. at 451. 8 Making Amends, supra note 2. 9 Id. at 113. 10 Id. at 115.

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redress for patients harmed “as a result of seriously substandard NHS hospital care” (The NHS Redress Scheme).11 There would be four main elements to these arrangements: (1) an investigation of the incident that is alleged to have caused harm and the resulting harm; (2) provision of an explanation to the patient of what happened and why, and of the action proposed to prevent repetition; (3) the development and delivery of a package of care, providing remedial treatment, therapy, or continuing care, where necessary; and (4) payments for pain and suffering, out-of-pocket expenses, and the costs of care or treatment, which the NHS could not provide.12 The NHS Redress Scheme would also encompass a care and compensation package for seriously neurologically impaired babies, including those with cerebral palsy, where the impairment was related to or resulted from the birth.13 The overall goal of these proposed reforms was that they would be “fair both to individual patients and meet their needs as well as making care safer for all NHS patients.”14 This has been subject to criticism, because it has been pointed out that it is far from obvious that the litigation system needs to be changed “in order to make healthcare safer.”15

II.

Recent Empirical Evidence on the Numbers and Funding of Claims.

A.

England

In England, the principal statistics are now published in the Annual Report and Accounts of the authority that indemnifies English NHS bodies against claims for clinical negligence, namely, the National Health Service Litigation Authority (NHSLA).16 The numbers of claims made on

11 12 13 14 15

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Id. at 119. Id. at 119. Id. at 120–121. Id. at 117–118. Jones, supra note 5, at 49. While “[t]here is no evidence that the litigation process makes health less safe there is plenty of evidence that the less safe health care is, the more litigation there will be.” The NHSLA was established in November 1995. See the National Health Service Litigation Authority (Establishment and Constitution) Amend. (No. 2) Order 2005 No. 1445; See also NHS Litigation Authority Factsheet 1: Background Information (NHSLA 2001) (providing that the NHSLA was established in November 1995 to indemnify English NHS bodies against clinical negligence), available at http://www.nhsla.com/NR/rdonlyres/C9A80E892BFA-44F5-A01C-90B86D765B2D/0/NHSLAFactsheet1August2011.pdf.

United Kingdom

an annual basis has been largely static, although the latest figures from the NHSLA’s Annual Report and Accounts 2010 have seen an increase in claim numbers; expenditures on clinical negligence continues to increase. Number of claims received 7,000 Clinical Non Clinical

6,500

6,652 6,088

6,000 5,609

5,697 5,426

5,500

5,470

5,000 4,500 4,074 4,000

3,766

3,743 3,497

3,500

3,293

3,380

3,000 2004/05

2005/06

2006/07

2007/08

2008/09

2009/10

Graph 1. Number of claims received by NHSLA. Source: NHSLA Annual Report and Accounts, 2010 at 13; © Crown Copyright 2010.

As we can see from Graph 1, the number of clinical negligence claims reported to the NHSLA in 2009–10 was 6,652, which represents a 10 percent increase over 2008–09 (6,088) which, in turn, recorded an 11 percent increase over 2007–08 (5,470).17 While the NHSLA has described these

17

The National Health Service Litigation Authority: Report and Accounts 2010 (Her Majesty’s Stationery Office 2010). Since submission of this paper, the NHSLA Report and Accounts 2010–2011 have now been published. The number of clinical negligence claims reported to the NHSLA in 2010/11 was 8,655, which represents a 30 percent increase over 2009/10 (6,652). The NHSLA suggests that the significant increase in claims may be explained by the requirement for claims to now send the NHSLA a copy of the Letter of Claim at the same time as it is sent to the defendant NHS body, at which point they now record the claim. They are analyzing patterns and trends to obtain a better understanding of the increase. The National Health Service Litigation Authority: Report and Accounts 2010–2011, 12–13 (Her Majesty’s Stationery Office 2011), available at http://www.nhsla.com/NR/rdonlyres/3F5DFA84-2463-468B-890C-42C0FC16D4D6/ 0/NHSLAAnnualReportandAccounts2011.pdf.

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figures as a matter for concern, the claim numbers for the years 2004, 2005, and 2006 were relatively stable.18 The NHSLA has examined the reasons for the growth in volume of claims, and remains convinced that a major factor is the availability of the “ ‘so-called’ no win no fee market,”19 which enables claimants to litigate without financial risk, and which proves very lucrative for claimant solicitors.20 It is submitted that, when viewed in the context of the previous three years of relative stability, the increase in claim numbers during the last two years should not give rise to the degree of concern that has emanated from the NHSLA. In this context, it should be remembered that it is difficult to identify reliable, definitive evidence concerning the number of medical errors and claims occurring as a whole, and great care must be used when attempting to draw conclusions from the figures available.21 However, it is fair to say that overall legal costs are rising. The Authority’s expenditure on clinical negligence claims has continued to rise over the last two years. Graph 2 shows that the figures have risen from £633,325,000 in 2007–08 to £769,226,000 in 2008–9, and to £786,991,000 in 2009–10.22

18 19 20 21 22

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Id. at 7. Id. Id. Vivienne Harpwood, Medicine, Malpractice and Misapprehensions 46 (Routledge Cavendish 2007). The National Health Service Litigation Authority: Report and Accounts 2010, supra note 17, at 15; The National Health Service Litigation Authority: Report and Accounts 2010– 2011, see supra text accompanying note 17, at 14. The legal costs figure has risen to £863,400,000 in 2010–11.

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Payment (in Mio. £) 700 614.342

CNST ELS Ex-RHAS

600

650.973

500 424.351 400 300

384.390

456.301

168.203

171.562

329.412

200

135.065

169.414

153.246

100 0

150.805

4.068

7.716

1.794

5.462

4.078

0.954

2004/05

2005/06

2006/07

2007/08

2008/09

2009/10

Graph 2. Payments made in clinical claims Source: NHSLA Annual Report and Accounts, 2010 at 15; © Crown Copyright 2010.

As of March 31, 2010, the provisions for periodical payments (i.e., damage settlements that include payments made on a regular basis, usually throughout the claimant’s life, in place of the traditional single lump sum) now total £1.88 billion.23

B.

Scotland

In Scotland, the NHS Health Boards currently fund all settlements of clinical negligence claims, but receive additional protection from disproportionate losses through participation in the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS), a risk-sharing scheme whose membership is mandatory for all NHSScotland healthcare bodies.24 The Central Legal Office of NHSScotland defends claims on behalf of the NHS

23

24

The National Health Service Litigation Authority: Report and Accounts 2010–2011, see supra text accompanying note 17, at 16. As of March 31, 2011, the provisions for periodical payments totalled £2.41 billion. See Anne-Marie Farrell, Sarah Devaney & Amber Dar, No-Fault Compensation Schemes for Medical Injury: A Review para. 1.2 (Scottish Gov’t. Soc. Research 2010). In 2008–09, the NHS Boards contributed £27 million to CNORIS. Nicola Sturgeon MSP, Deputy First Minister and Cabinet Secretary for Health and Wellbeing, Scottish Parliament Written Answers, S3W-32002 (March 11, 2010), available at http://www.scottish.parliament.uk/Apps2/Business/PQA/Default.aspx.

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Boards. While claims rose during the 1990s, there has been a declining trend since 1999.25 In 2008–09, there were 362 potential clinical negligence claims notified to the Health Boards (342 medical and dental and 20 nursing).26 During 2008–09, 171 claims were settled with £26,007,747 paid out in settlements,27 with adverse legal costs amounting to £2.5 million.28 While the number of settled claims from 1989–2009 has only increased slightly with respect to the total awards and costs of settled claims from 1989–2009, the average sum awarded has risen significantly over that period. In addition, for claims with awards below £20,000, during the period 1998–2009, the costs have been rising and currently can be greater than the awards made. In addition, significant costs are incurred for unsettled claims: during the period of 1998–2009, the costs rose from around £300,000 to over £1 million.29

C.

Summary

While the numbers and expenditures in Scotland are dwarfed by those in England, this is unsurprising since Scotland has a population of five million and England has a population of fifty million. It is clear, however, that in Scotland, while the number of claims is declining, claim costs are increasing, especially for claims with awards below £20,000 and costs for unsettled claims. Therefore, there are concerns about the increase in the cost of claims in both England and Scotland. However, the number of claims in England remains relatively static (other than the increases in the last two years) and the number of claims in Scotland is actually declining.

III. NHS Redress Act 2006 A statutory framework for the empowerment of some of the Chief Medical Officer’s recommendations in Making Amends is present in the NHS Redress Act 2006.30 It provides for the establishment by regulations of a 25

26 27

28 29 30

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Sheila A. M. McLean, No-Fault Compensation Review Group: Report and Recommendations Vol. 1 paras. 2.15, 2.16 (Scottish Gov’t. 2011), available at http://www.scotland.gov. uk/Topics/Health/NHS-Scotland/No-faultCompensation/NFCGReport. Farrell et al., supra note 24, at para. 1.2. Nicola Sturgeon MSP, Deputy First Minister and Cabinet Secretary for Health and Wellbeing, Scottish Parliament Written Answers, S3W-30597 (January 25, 2010), available at http://www.scottish.parliament.uk/Apps2/Business/PQA/Default.aspx. Farrell et al., supra note 24, at para. 1.2. McLean, supra note 25, at paras. 2.19–2.25. NHS Redress Act, 2006 ch. 44.

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scheme of NHS Redress.31 The Act creates a statutory framework to empower the Secretary of State to create a scheme to enable “redress to be provided without recourse to civil proceedings.”32 These Regulations have yet to be issued. The NHS Redress Scheme will apply where a “qualifying liability in tort” arises in connection with the provision, as part of the health service in England, of qualifying services by: (1) the Secretary of State; (2) a Primary Care Trust; (3) a designated Strategic Health Authority; and (4) a body or other person providing services whose provision is the subject of arrangements with the Secretary of State, a Primary Care Trust, or a designated Strategic Health Authority.33 A “qualifying liability in tort” is defined as liability in tort owed: (a) in respect of or consequent upon personal injury or loss arising out of or in connection with breach of a duty of care owed to any person in connection with the diagnosis of illness or the care or treatment of any patient, and (b) in consequence of any act or omission by a healthcare professional.34 It is clear that liability under the scheme is fault-based rather than no-fault compensation.35 The NHS Redress Scheme does not apply to liability that has been the subject of civil proceedings.36 It applies to services provided in a hospital (in England or elsewhere), but the Secretary of State can extend the scheme by regulations.37 However, the Scheme is inapplicable to primary dental services, primary medical services, general ophthalmic services, and pharmaceutical services.38 While the claimant’s right to bring civil proceedings is not removed, civil proceedings and the NHS Redress Scheme will be mutually exclusive. Accordingly, the Act establishes that the Redress Scheme must provide for a settlement agreement to include a waiver of the right to bring civil proceedings.39 Conversely, the Scheme must also

31 32 33 34 35 36 37 38 39

Id. § 1(1). Id. Id. § 1(2)–(3). Id. § 1(4). Jones, supra note 5, at 57. But cf. J. K. Mason & G. T. Laurie, Mason and McCall Smith’s Law and Medical Ethics 128 (Oxford Univ. Press, 8th ed. 2010) (sed quaere). NHS Redress Act, 2006 ch. 44 § 2(2). Id. § 1(5). Id. § 1(6). Id. § 6(5).

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provide for the termination of its proceedings if the liability to which they relate becomes the subject of civil proceedings.40 Since the Regulations have not yet been issued, it remains to be seen how the Act will operate in practice. It has been said that since it is intended that the Scheme be overseen by the NHSLA,41 there may be a potential conflict of interest, with the NHSLA acting as judge and jury in its own cause.42 The proposed scheme has been further criticized on several grounds. The following arguments have been made: (1) that, while the scheme is likely to provide nominally greater access to justice for low value claims, it is unlikely overall to result in greater access to justice for injured patients, especially given its fault-based eligibility criteria; (2) that the scheme lacks sufficient independence from the NHS in terms of its investigation procedures; and (3) that the scheme fails to provide for the accountability of healthcare professionals.43 While the scheme has yet to be implemented in England, a Welsh version of the scheme is being introduced in 2011.44

IV. Patients’ Rights Bill in Scotland: The No-Fault Compensation Review Group Report (McLean Report) The NHS Redress Act does not apply to Scotland. However, extensive consultation on the possible content of a Patients’ Rights Bill45 indicated that no-fault compensation was the favored way forward of the Scottish Government for the NHS in Scotland.46 The Consultation Paper stressed the “need for further work on the practical implications and potential costs of a change in compensation arrangements” before making any firm decision on future arrangements.47 In August 2009, the Scottish Government announced the creation of a short-life working group, the No-Fault

40 41 42 43

44 45 46 47

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Id. § 6(6). Id. § 11(1). Mason & Laurie, supra note 35, at 128. Anne-Marie Farrell & Sarah Devaney, Making Amends or making things worse? Clinical Negligence Reform and Patient Redress in England, 27 Legal Studies 630–648 (2007); McLean, supra note 25, at para. 2.32. McLean, supra note 25, at paras. 2.32, 2.37–2.41. See Patients’ Rights: A Public Consultation on a Patients’ Rights Bill for Users of the NHS in Scotland (Scottish Gov’t. Healthcare Policy and Strategy Directorate 2008). Id. at para. 69. Id.

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Compensation Review Group, chaired by Professor Sheila McLean,48 in order to progress this work. The Group’s remit was to consider the potential benefits for patients in Scotland of no-fault compensation, and whether such a scheme could be introduced alongside the existing clinical negligence arrangements, taking into account: (1) the cost implications; (2) the consequences for healthcare staff, and the quality and safety of care; (3) the wider implications for the system of justice and personal injury liability; and (4) the evidence on how no-fault compensation has operated in other countries.49 The Group was also charged with making recommendations on the key principals and design criteria that could be adopted for a no-fault compensation scheme.50 The Group reported in February 2011, concluding that the current system for dealing with claims in relation to injuries sustained during NHS treatment is not meeting the needs of patients, and potentially creates an atmosphere of tension between patients and their healthcare providers.51 In addition, the widely accepted view that patients are more interested in a meaningful apology, an explanation, and assurances about future practices was reinforced by the empirical research undertaken and by part of the review.52 The group explored several well-established no-fault schemes in other jurisdictions, in particular the New Zealand and Swedish models.53 The report recommended that consideration be given to the establishment of a no-fault compensation scheme for medical injury along the lines of the Swedish model.54 While the proposed new system would remove the need to prove negligence, it would still require proof that harm was caused by treatment. The thorny issue of causation is therefore not eliminated by the proposed system. Although the Swedish model provided a basis for the no-fault system, the Group recommended that eligibility for compensation should not be based on the so-called “avoidability” test as used in Sweden (i.e., that patients are eligible to receive compensation if they have suffered injury that could have been avoided),

48 49 50 51 52 53 54

International Bar Association Professor of Law and Ethics in Medicine in the University of Glasgow. McLean, supra note 25, para. 1.4. Id. at para. 1.5. Id. at para. 7.1. Id. Id. at para. 7.6. Id. at para. 7.11.

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but instead by using a clear description of which injuries are not eligible for compensation.55 The McLean Report recommended that the no-fault scheme cover all medical treatment injuries that occur in Scotland.56 Such injuries could be caused, for instance, by the treatment itself, failure to treat, or faulty equipment, in which case there would be third party liability.57 The Report additionally recommended that the scheme extend to all registered healthcare professionals in Scotland, and not simply to those employed by NHSScotland.58 Claimants who fail under the no-fault scheme should retain the right to litigate, based on an improved litigation system.59 Should a claimant be successful under the no-fault scheme, any financial award made should be deducted from any subsequent award made as a result of litigation.60 Appeal from the adjudication of the no-fault scheme should be available to a court of law on point of law or fact.61 The group suggested that more patients could have claims resolved under such a system than are currently achieving resolution through the courts, and that the proposed scheme will not lead to expenditures greatly above that which the NHS currently pays in compensation and legal fees.62 Its research team provided a paper that assumes a 20 percent increase in claims under the proposed scheme and that 40 percent of the claims that fall under the litigation system would receive an award under the proposed no-fault scheme.63 It also assumes that such additional claims will be low value claims.64 However, the report concedes that further analysis may be required to test the availability of these assumptions.65 In welcoming the recommendations, the Scottish Government has proposed to investigate thoroughly how such a scheme would work in practice, and it will undertake a further analysis of the cost implications.66

55 56 57 58 59 60 61 62 63 64 65 66

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Id. Id. at para. 7.3. Id. at para. 7.11. Id. Id. Id. Id. Id. at para. 7.4. Id. Id. Id. No-Fault Compensation Review Group Report: Scottish Government Response (Scottish Gov’t. 2011), available at http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/NofaultCompensation/NFCSGResponse.

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V.

Basis of Liability for Medical Injury

A.

Contract, Tort, and Delict67

Most claims for compensation for medical malpractice are brought in tort (England) and delict (in Scotland), the overwhelming majority of which are for the tort/delict of negligence. A contractual relationship does not subsist between an NHS doctor and a patient within the NHS.68 However, in the Scottish Sheriff Court decision of Dow v. Tayside University Hospitals NHS Trust,69 it was held that it could be possible under Scots law (without the requirement of consideration in the formation of a contract) for a doctor providing treatment under the National Health Service (Scotland) Act 1978 to enter into a contractual relationship with an NHS patient, but only where it was clear that the doctor concerned was exceptionally entering into a contract and was not relying on the statutory relationship alone.70 Such an additional contract would need to be expressed in clear terms and would need to demonstrate an intention to add an additional liability on the part of the doctor, corresponding with the requirements of a unilateral promise.71 However, if the patient/doctor relationship is a private one rather than one under the NHS, there will be a contractual relationship and it will be possible to bring an action for damages in contact.

B.

The Requirements of Negligence

A person seeking compensation for clinical negligence must establish three things: (1) that the defendant owed the patient a duty of care; (2) that the defendant was in breach of that duty; and (3) that the breach of duty of care caused harm to the patient. 67

68

69 70 71

See generally Jones, supra note 5, at ch. 2; Rachel Mulheron, Duties in Contract and Tort, in Principles of Medical Law 133 (A. Grubb, J. McHale & J. Lang eds., Oxford Univ. Press 2010). Reynolds v. The Health First Med. Grp., [2000] Lloyds’ Rep. Med. 240 (Hitchin County Court) (Eng.) (arrangement between doctor and patient in NHS based on statutory obligation rather than contract) (applying Pfizer Corp. v. Ministry of Health, [1965] A.C. 512, 535–6 (Lord Reid) (provision of medicinal product by a pharmacist to a patient under an NHS prescription not a sale, as there is no contract between patient and pharmacist; pharmacist is under a statutory obligation to supply the product to the patient on the presentation of the prescription and the correct prescription charge)). 2006 S.L.T. (Sh. Ct.) 141. Id. at [19]. Id. at [20].

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C.

Duty of Care72

A duty of care owed by a doctor to his patient has long existed in English and Scots law. Such a duty predates the seminal decision of Donoghue v. Stevenson73 as well as Lord Atkin’s celebrated “neighbour principle”, which requires the exercise of reasonable care towards all who are foreseeably likely to be injured in person or property by one’s acts or omissions.74 The relationship between doctor and patient also satisfies the so-called tripartite test of Caparo v. Dickman, which requires that the loss to the claimant be reasonably foreseeable, that there be a close degree of proximity between the parties, and that it is “fair just and reasonable” to impose a duty of care.75 While establishing a duty of care owed to the patient in clinical negligence is not generally problematic, the establishment of the other two requirements – that the doctor was in breach of his duty of care to the patient and that this breach caused the patient harm – is problematic. It is to the first of these two requirements that we now turn.

D.

Standard of Care76

In order to establish that the defendant was negligent, the claimant must show that the defendant fell below the required standard of care. The standard of care demanded of the doctor is the standard of the reasonably skilled and experienced doctor. In Bolam v. Friern Hospital Management Committee, McNair J directed the jury: The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill; it is a well-established law that it sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.77

72 73 74 75 76

77

452

See generally Mulheron, supra note 67. [1932] A.C. 562. Id. at 580. [1990] 2 A.C. 605 at 616–618 (Lord Bridge), 628 (Lord Roskill), and 633–634 (Lord Oliver). See generally Jones, supra note 5, at ch. 3; Phillipa Whipple & Paul Havers, Breach of Duty, in Principles of Medical Law (A. Grubb, J. McHale & J. Lang eds., Oxford Univ. Press, 3d ed. 2010). [1957] 1 W.L.R. 582 at 586.

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In what became known as the Bolam test, he said: [A doctor] is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art...merely because there is a body of opinion who would take a contrary view.78 Therefore, where medical opinion is divided, Bolam establishes that a doctor is not negligent merely because he adheres to one body of opinion rather than another.79 This was confirmed by the House of Lords in Maynard v. West Midlands Area Health Authority.80 The House of Lords in Maynard and also in Sidaway v. Board of Governors of the Bethlem Royal Hospital81 were subject to relentless criticism by academics in the 1980s and early 1990s, including Kennedy and Grubb, for elevating “to the status of an unquestionable proposition of law derived from Bolam”82 that professional practice would not be reviewed by the courts. However, over the last twenty years, we have seen an increasing inclination of the courts to question the conduct of physicians, and also to challenge the credibility of medical experts and even, on rare occasions, to override clinical judgment.83 This pattern culminated in the decision of the House of Lords in Bolitho v. City and Hackney HA,84 which was heralded two years later as spawning “a velvet revolution”85 in assessing reasonable care in medical negligence. In Bolitho, the House of Lords held that in applying the Bolam test, as opposed to merely accepting a body of opinion, the court had to be satisfied that exponents of the body of opinion relied upon could demonstrate that such an opinion had a “logical basis,” and that this assessment would need to be carried out on a risk-benefit basis.86 However, Lord Browne-Wilkinson, delivering the opinion of the House of Lords, qualified his position in emphasizing that “it will very seldom be right for a judge to reach the conclusion that views genuinely held by a

78 79 80 81 82 83 84 85 86

Id. at 587. Id. [1985] 1 All E.R. 635 at 638–639 (Lord Scarman). [1985] A.C. 871. See Ian Kennedy & Andrew Grubb, Medical Law: Text with Materials 452 (Butterworths, 2d ed. 1994). Harvey Teff, The Standard of Care in Medical Negligence – Moving on From Bolam, 18 O.J.L.S. 473, 474–5 (1998). [1998] A.C. 232. Margaret Brazier & Jose Miola, Bye-Bye Bolam: A Medical Litigation Revolution, 8 Med. L. Rev. 85, 86 (2000). [1998] A.C. 232, 241–242 (Lord Brown-Wilkinson).

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competent medical expert are unreasonable.”87 Accordingly, it has been held that if each body of medical opinion is capable of withstanding logical analysis, “there is no basis for a finding of negligence against the doctor in choosing one rather than the other.”88 Bolitho has therefore been said to “devalue the trump card which Bolam presented to the medical profession, but only in limited circumstances.”89 Post-Bolitho, the Court of Appeal has proceeded to weigh risks and benefits to determine whether an expert’s opinion had a “logical basis” in Marriott v. West Midlands HA90 and in Penney, Palmer and Cannon v. East Kent HA.91 The High Court has also done so in a disclosure of information decision.92 However, the Court of Appeal has sometimes failed to provide sufficient scrutiny of expert evidence in this way. A prime example is the decision in Vadera v. Shaw,93 where it has been submitted that insufficient judicial scrutiny was made of the evidence of a GP and her experts in deciding that her administration of a contraceptive pill to a twenty-two year old Asian patient with a high blood pressure reading of 150/100 was not negligent.94

E.

Causation95

Merely showing that a defendant was in breach of a duty owed to the claimant and that the claimant suffered damage does not suffice to ground an action in negligence. The defendant’s breach must have caused the claimant’s damage and, additionally, the damage must be such that the law regards it proper to hold the defendant responsible for it. These two requirements jointly constitute causation and are often separately referred

87 88 89 90 91 92 93 94

95

454

Id. at 243. Birch v. Univ. Coll. London Hosp. NHS Found. Trust, [2008] E.W.H.C. 2237 (Q.B.) [55]. J. K. Mason & G. T. Laurie, Mason and McCall Smith’s Law and Medical Ethics 139 (Oxford Univ. Press, 8th ed. 2010). [1999] Lloyd’s Rep. Med. 23, 28 (Beldam, L.J.). [2000] Lloyd’s Rep. Med. 41, 48, 50. Birch, [2008] E.W.H.C. 2237 (Q.B.) at [69]–[70], [73], [77], [79]. (1999) 45 B.M.L.R. 162 (C.A.). See Richard Goldberg, The Contraceptive Pill, Negligence and Causation: Views on Vadera v. Shaw, 8 Med. L. Rev. 316, 323 (2000) (Court of Appeal failed to ask whether the clinical practice of putting a twenty-two-year-old Asian woman on the contraceptive pill with a blood pressure reading of 150/100, and having failed to exclude the possibility of sustained hypertension before prescribing that pill, could withstand logical analysis). See generally Richard Goldberg, Causation and Defences, in Principles of Medical Law 325 (A. Grubb, J. McHale & J. Lang eds., Oxford Univ. Press, 3d ed. 2010); Jones, supra note 5, at ch. 5.

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to as (1) cause in fact and (2) cause in law or remoteness, although discussion will be confined in this paper to cause in fact.

1.

Difficulties in Proving Causation in Clinical Negligence Cases

It is fair to say that causation in the context of medical law is fraught with difficulty.96 Such difficulty is due both to the complexity of the factual circumstances themselves and to the (perhaps unnecessarily) complex nature of the law when the principles are applied to the facts. As to the former, the complex and, to some extent, indeterminate nature of medical science means that the causal nexus between A and B may be hard to demonstrate. Indeed, it could be said that the more medicine is portrayed as a scientific endeavor, rather than as an art or a combination of both art and science, the harder it becomes on occasion to demonstrate to the satisfaction of the law a causal link between breach and damage.97

96 97

See Goldberg, supra note 95, at 6.02 et seq. (on which much of this section is based); Perspectives on Causation (Richard Goldberg ed., Hart Publ’g. 2011). Id. See, e.g., Bonthrone v. Millan, [1985] (Lord Jauncey) (existence of cryptogenic (unknown) causes to eliminate possible causal connection between pertussis vaccine and brain damage), cited in Diana Brahams, Pertussis Vaccine and Brain Damage: Two Claims Before the Courts, 2 The Lancet 1137 (1985); Loveday v. Renton and Welcome Found Ltd. [1990] 1 Med. L.R. 117 (whooping cough vaccine); Kay’s Tutor v. Ayrshire and Arran Health Bd., [1987] 2 All E.R. 417 (penicillin overdose not capable of causing or aggravating deafness). It has recently been observed that while epidemiological evidence can be useful, it must be viewed with caution; without further non-statistical evidence courts are reluctant to proceed to find the existence of a causal relationship. See Sienkiewicz v. Greif, [2011] U.K. S.C. 10, [2011] 2 W.L.R. 523 at [152], [163] (Lord Rodger), [170], [172] (Baroness Hale), [190]–[192] (Lord Mance), [204]–[206] (Lord Kerr). See also the observations of Brooke, L.J., in Wardlaw v. Farrar, [2003] 4 All E.R. 1358, Rep. Med. [2004] P.I.Q.R. 19 at [35]–[36]. See generally Richard W. Wright, Proving Causation: Probability versus Belief and Richard Goldberg, Using Scientific Evidence to Resolve Causation Problems in Product Liability: UK, Europe and US Experiences, both in Perspectives on Causation (Richard Goldberg ed., Hart Publ’g. 2011). Even where in principle a connection can be shown between the type of harm suffered by the claimant and a specific hazard, it may be extremely difficult to demonstrate that the individual claimant’s condition was caused by exposure to that hazard as opposed to another factor for which the defendant was not responsible. See Jones, supra note 5, at 455 (citing Plater v. Sonatrach, [2004] E.W.H.C. 146 (Q.B.) (claimant unable to prove on balance of probability that his HIV infection had been caused by a contaminated needle or syringe after he had been given an intravenous injection at defendant’s clinic since he had been unable to exclude other possible causes of HIV infection)).

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2.

The Burden of Proof

In the area of clinical negligence, as in all other aspects of civil litigation, the burden of proof is on the claimant who must prove causation, and it must be established on a balance of probabilities.98

3.

The “But For” Test

The standard approach to causation in the law of tort or delict is represented by the “but for” test: that the damage suffered by the claimant would not have been suffered but for the defendant’s breach of duty. The assumption of the law is that it is possible to show (and, therefore, that the law should demand demonstration) that A would not have happened but for B. The corollary of that assumption is that if the “but for” test cannot be satisfied, causation is not proved and the defendant, irrespective of any breach of duty, is not liable. While represented as a principle concerned with fact, it is, of course, self-evident that what is involved is a matter of policy. A limit is placed on the potential liability of the defendant by demanding that a particular form of causal nexus be shown. There are numerous circumstances, particularly in medical law, when this policy defeats the claim of the claimant. The clearest example is when the defendant’s breach of duty may have been part of the background leading to the claimant’s injury. If the defendant can demonstrate that the injury would have occurred in any event, regardless of any breach of duty, then the claimant’s action will fail. A classic example of this is Barnett v. Chelsea and Kensington Hospital Management Committee.99 In that case, the plaintiff was taken to the defendants’ casualty department after he drank some tea that contained arsenic.100 Although the defendants were held negligent in failing to treat him, it was held that the refusal to treat him was not a cause of the deceased’s death because the nature of the arsenic introduced into his tea was such that he would have died regardless.101

98 99 100 101

456

Pickford v. Imperial Chem. Indus. Plc., [1998] 3 All E.R. 362, [1998] 1 W.L.R. 1189 (H.L.). [1969] 1 Q.B. 428. Id. at 430. Id. at 430–439.

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4.

Cumulative Causation

Difficulties of proving causation appear to have been reduced by modifying the “but-for” test to make it easier for the claimant to prove that the defendant’s negligence caused his injury or damage. Where the factors are cumulative, the court, following the decision of the House of Lords in Bonnington Castings v. Wardlaw,102 has the option of finding the defendant liable. If the factors taken together led to the claimant’s injury, then the defendant’s breach, as a contributing factor, may be held to have made a contribution that can be described as material, if it is not de minimis.103

5.

Material Increase in Risk

If the claimant can establish that the defendant’s negligence contributed to the risk of damage, he may be able to recover. In McGhee v. National Coal Board,104 the House of Lords was prepared to infer that the failure to provide showers materially increased the risk of contracting dermatitis from the brick dust and that, in itself, established a causal link with the defendant’s fault.105 The reason for doing so was the lack of available evidence, such that the claimant could not meet the “but for” test and establish that the breach had caused or made a material contribution to the injury.106

6.

Alternative Causation

By contrast, where the injury could have been caused by any one of a number of distinct factors, the material contribution principle will not 102 [1956] A.C. 613. 103 For the recent successful attempts at utilizing this in the context of multiple causal factors, see Bousted v. Nw. Strategic Health Auth., [2008] E.W.H.C. 2375, [2008] L.S. Law Med. 471, [70]–[71] (since on the evidence there were concurrent cumulative causes of intraventricular hemorrhage, the claimant had satisfied the burden of proving that the defendant’s breach of duty in delaying proceeding to a Caesarean section had made a material contribution to his brain damage); Bailey v. Ministry of Def., [2008] E.W.C.A. Civ. 83, [2009] 1 W.L.R. 1052 (C.A.), [46] (cumulative causes (non-negligent pancreatitis and negligent lack of care), where contribution of negligent cause was more than negligible; “but for” test modified and claimant would succeed); Canning-Kishver v. Sandwell & W. Birmingham Hosps. NHS Trust [2008] E.W.H.C. 2384 (Q.B.), [36]–[37] (contribution of cardiac collapse occasioned by the breach of duty constituted a contribution to the cerebral atrophy that was more than negligible; claim succeeded). 104 [1972] 3 All E.R. 1008, 1011, [1973] 1 W.L.R. 1. 105 Id. at 1, 5, 12–23. See Ernest Weinreb, A Step Forward in Factual Causation, 38 M.L.R. 518, 523 (1975) (discussing the burden of proof for negligence cases after McGhee). 106 Id.

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work in the claimant’s favor. This is illustrated by the House of Lords’ decision in Wilsher v. Essex AHA.107 In Wilsher, the baby’s RLF (retrolental fibroplasia) could have arisen from any of at least five separate and distinct factors.108 The defendant’s breach (excess oxygenation) was responsible for only one of these.109 It was impossible to assert that the breach was the sole cause of the RLF.110 It was equally untenable to argue that the breach materially contributed to it; it may have had no effect whatsoever.111 The House of Lords held that to show that the defendant’s negligence materially increased the risk of the claimant’s injury did nothing to exclude the other causes; therefore, it was impossible for the court to infer that the defendant was the cause of the injuries.112

7.

Reinstating McGhee: Fairchild

In the landmark decision of Fairchild v. Glenhaven Funeral Services Ltd.,113 their Lordships refuted the narrow construction of McGhee that had been placed upon it by the House of Lords in Wilsher.114 It was, therefore, not to be seen as an application of the traditional “but for” test, but, rather, as a departure from it in exceptional (and specific) circumstances. The claimants were exposed to asbestos dust over a long period of time whilst working for successive employers.115 They developed mesothelioma, a cancer of the lung.116 Claims were brought against some – but not all – of the employers. The evidence was that mesothelioma was caused by exposure to asbestos dust, but it was not known whether it was caused by a single fibre or whether multiple fibres were necessary or made development of the cancer more likely.117 Based on the evidence, it could not be said which employer’s breach of duty in exposing the claimants to asbestos dust had caused, or materially contributed to, their injuries.118 There

107 108 109 110 111 112 113 114 115 116 117 118

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[1988] AC 1074. Id. Id. at 1090–1091. Id. Id. Id. [2002] U.K.H.L. 22, [2003] 1 A.C. 32. Id. With the exception of Lord Hutton who preferred to see McGhee as a case where it was proper to make a factual inference of causation. Id. at [108] and [109]. Id. at [3]–[5]. Id. Id. at [7]. Id.

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was a “scientific deficit” in the evidence.119 The House of Lords unanimously held that each of the employers was liable to the claimant for their injuries.120 The Law Lords held, on policy grounds, that the McGhee test of “material increase in risk” applied to fix each employer with responsibility for the claimants’ injuries.121 Where successive employers had failed to protect an employee from a disease (mesothelioma), but it could not be proved on a balance of probability which employer had caused the injury, the conduct of each employer in exposing the claimant to a material increase in risk to which the claimant should not have been exposed was to be treated as if it had made a material contribution to the disease.122 It was just to depart from the “but for” test of causation where, as in this case, the injustice of holding an employer responsible for injury that he may not have caused (or contributed to) was outweighed by the injustice of leaving the employees without compensation.123

8.

The Scope of Fairchild and Clinical Negligence Cases

The extent to which the Fairchild principle operates has been subject to judicial discussion in the Court of Appeal. While it has been observed that “great caution is required before any development of the Fairchild exception should be allowed,”124 it is clear that the conditions required to be satisfied for its application were not intended to exclude its application to other conditions and circumstances, and the exception will not be limited to cases of mesothelioma.125 In Sanderson v. Hull,126 Smith L.J. attempted to formalize the principles from Fairchild by adopting127 Lord Rodger’s con-

119 Id. 120 Id. at [35], [45], [74], [118], [171]. Subject to the issue of contribution proceedings between the defendants inter se, which was not before the House. 121 Id. at [33]. 122 Id. at [2], [34] (Lord Bingham), [42] (Lord Nicholls), [47], [65], [67] (Lord Hoffmann), [116] (Lord Hutton), and [168] (Lord Rodger). 123 Id. at [33]–[34] (Lord Bingham), [45] (Lord Nicholls), and [56], [62] (Lord Hoffmann). The Fairchild exception applies to “single exposure cases” (where only one defendant exposed the victim to asbestos, and the only other exposure creating a risk of developing mesothelioma was environmental exposure to low-level asbestos dust in the atmosphere). Sienkiewicz v. Greif, [2011] UK S.C. 10, [2011] 2 W.L.R. 523, [103], [113] (Lord Phillips), [160] (Lord Rodger), [173] (Lady Hale), [184] (Lord Brown), [188] (Lord Mance), and [203] (Lord Kerr). 124 Sanderson v. Hull, [2008] E.W.C.A. Civ. 1211, [2009] P.I.Q.R. P7, [34] (Smith, L.J.). 125 Id. at [42], [45]. 126 [2008] E.W.C.A. Civ. 1211, [2009] P.I.Q.R. P7. 127 Id. at [50], [53].

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ditions128 for its application. As expressed by Smith L.J., there were five main elements to the Fairchild principle operating to relax the need to satisfy the “but for” test of causation.129 First, the claimant must show that the current state of scientific knowledge leaves it inherently impossible for the claimant to prove exactly how his injury was caused.130 Second, the defendant’s breach of duty must have materially increased the risk of injury to the claimant.131 Third, the defendant’s conduct must have been capable of causing the claimant’s injury.132 Fourth, the claimant must show that the injury was caused by the eventuation of the kind of risk created by the defendant’s wrongdoing.133 Fifth, the injury must be caused by the same agency as was involved in the defendant’s wrongdoing (or an agency that operates in a similar way).134 It is clear that Lord Rodger’s conditions in Fairchild are at a higher level of generality than those of Lords Bingham and Hoffmann,135 but in their principled approach they arguably provide the clearest guidance to practitioners and litigants as to Fairchild’s scope. Since an essential element of the development of Fairchild will be the first element, namely, the inherent impossibility for the claimant to prove enough to satisfy the “but for” test,136 it is likely that the Fairchild test will have little impact in medical negligence cases. In cases where there is a “scientific deficit” in the evidence, it is unlikely that the factual context will work in a claimant’s favor. Usually, the claimant will be unable to show that the injury suffered was precisely that which flowed from the doctor’s (or other’s) breach of duty but, rather, that it was the result of one of a number of possible causative events each (or some) of which lacks the same essential characteristics of the risk created by the doctor – as in Wilsher itself (and the Law Lords cast no doubt on the actual outcome in

128 Fairchild, [2002] U.K.H.L. 22 at [169]–[170], and Barker v. Corus Ltd., [2006] U.K.H.L. 20, [2006] 2 A.C. 572 at [97]. 129 Sanderson, [2008] E.W.C.A. Civ. 1211 at [53]. 130 Id. 131 Id. The Fairchild threshold of material increase in risk is anything more than de minimis. See Rolls Royce Indus. Power (India) Ltd. v. Cox., [2007] E.W.C.A. Civ. 1189 (C.A.) at [21]. 132 Sanderson, [2008] E.W.C.A. Civ. 1211 at [53]. 133 Id. 134 Sanderson, [2008] E.W.C.A. Civ. 1211 at [53]. 135 See [2002] U.K.H.L. 22 at [2] (Lord Bingham), and [61] (Lord Hoffmann). 136 Id. at [43].

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Wilsher).137 Second, and perhaps more significantly, attempting to apply McGhee in the medical context may not invoke the same policy response from the judges because of the impact that extending liability would have on the NHS and its budget.138 The remarks of Lord Hoffmann in Fairchild suggest that the McGhee/Fairchild approach is unlikely to be imported: It is true that actions for clinical negligence notoriously give rise to difficult questions of causation. But it cannot possibly be that the duty to take care in treating patients would be virtually drained of content unless the creation of a material risk of injury were accepted as sufficient to satisfy the causal requirements of liability. And the political and economic arguments involved in the massive increase in liability of the National Health Service which would have been a consequence of the broad rule favoured by the Court of Appeal in Wilsher’s case are far more complicated than the reasons given [in McGhee] for imposing liability upon an employer who has failed to take simple precautions.139 137 Wilsher was approved per Lord Bingham, at [22], per Lord Hoffmann, at [70], per Lord Hutton, at [118], and per Lord Rodger, at [149] and [170]. For an example post-Fairchild of a multiple potential cause decision decided in line with Wilsher, see Temple v. S. Manchester Health Auth., [2002] E.W.C.A. Civ. 1406, where the claimant alleged that the defendant’s negligence had caused his cerebral oedema as a result of diabetic ketoacidosis. Various theories existed as to the possible causes of cerebral oedema. One of the theories was that cerebral oedema might be produced where a patient was infused at less than normal salinity, and it was on this basis that the trial judge had found the defendants negligent. As in Wilsher, there were a number of different causes which were in play and which might have operated independently or cumulatively. The state of knowledge was such that it was not known whether the giving of a low saline infusion was ever the cause of cerebral oedema. The Court of Appeal upheld the trial judge’s conclusion that no causal link had been established on a balance of probabilities. Note that the Fairchild exception has no application to cases where the claimant’s injuries arise from a single incident. Clough v. First Choice Holidays and Flights Ltd., [2006] E.W.C.A. Civ. 15, [2006] P.I.Q.R. P22 at [43]. 138 But quaere if the claimant was treated in a private hospital or clinic? 139 [2002] U.K.H.L. 22 at [69]. But see Snell v. Farrell, (1990) 72 D.L.R. (4th) 289 (Can. Sup. Ct.). Note the unsuccessful attempt to apply the Fairchild exception to a case involving a negligent dispensing of the wrong contraceptive pill. In Wooton v. J. Docter Ltd. & Anor., [2008] E.W.C.A. Civ. 1361, [2009] L.S. Law. Med. 63, the claimant contended that because the current state of scientific knowledge precluded her from establishing that “but for” the erroneous dispensing of the contraceptive Logynon for Microgynon, she would not have become pregnant, she could invoke the alternative and exceptional principles identified in Fairchild. Invoking Lord Rodger’s principles in Fairchild to the facts of the case, (as explained by Smith L.J., in Sanderson, [2008] E.W.C.A. Civ. 1211 at [53]), counsel for the claimant contended that the current state of scientific knowledge rendered it inherently impossible for the claimant to prove exactly how her injury was caused. The negligent dispensing of Logynon was capable of causing a failure of contraception and materially increased that risk. The claimant’s pregnancy was the result of the kind of risk created by the pharmacist’s wrongdoing, and the pregnancy was caused by the same agency which the reduction in levonorgestrol permitted to occur. Counsel for the defendant stated that the “but for” test continued to apply, and that unlike Fairchild, “[t]he biology was understood”. Id. at [39]. Statistical analysis

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9.

Loss of a Chance

Following the decision of the House of Lords in Fairchild – to take a flexible approach towards the problems of causation on policy grounds – the question of whether a loss of a chance (in the sense of a diminution of life expectancy by reference to worsened statistical chances of survival) should be recognized as damage giving rise to a claim in negligence was addressed by the House of Lords in Gregg v. Scott.140 The claimant’s GP negligently failed to diagnose that he suffered from non-Hodgkin’s lymphoma.141 The cancer was subsequently diagnosed.142 The expert evidence was that the negligent delay in diagnosing the condition reduced the claimant’s chance of survival for a five-year period from 42 percent to 25 percent.143 Could he recover damages in these circumstances? Following Hotson v. East Berkshire AHA,144 the trial judge held that the claimant had failed to prove that the delay had made any difference to the outcome for him.145 As a result, he had failed to prove that the negligence caused or materially contributed to any injury.146 The Court of Appeal (by a majority) rejected the claimant’s action for the “lost chance” of recovery from cancer.147 By a majority of 3:2, the House of Lords dismissed the claimant’s appeal.148 Two arguments were presented by the claimant.149 The first, the “quantification argument,” was that the delay had caused him physical injury in the form of enlargement of the tumor, because the trial judge had found that if he had been treated earlier, the cancer would not have spread as quickly as it did.150 He argued that he was entitled to compensation for this injury, including damages

140 141 142 143 144 145 146 147 148 149 150

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failed to establish an increase in risk due to a reduction in the intake of progesterone by 100 mcg or at most 200 mcg. The Court of Appeal held that the claimant had failed to establish that the erroneous intake of two Logynon pills materially increased the risk of contraceptive failure. Id. at [40]. The claimant could not invoke any principle from Fairchild or Barker to overcome the trial judge’s finding that the reduction in intake of progesterone did not increase, let alone materially increase, the risk of contraceptive failure. [2002] E.W.C.A. Civ. 1471, [2003] Lloyd’s Rep. Med. 105. Id at [5]. Id. Id. Hotson v. E. Berkshire Area Health Auth., [1987] 1 A.C. 750 (H.L.). Gregg, [2002] E.W.C.A. Civ. 1471 at [6]. Id. at [6]–[7]. Id. at [7]. [2005] U.K.H.L. 2, [2005] 2 A.C. 176 at [91]. Id. at [66]. Id. at [67].

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for the reduction in the chance of his survival.151 The second, the “loss of a chance argument,” was that the reduction in his chance of survival was itself a recoverable head of damage.152 A majority of their Lordships rejected the first argument of the claimant, the so-called “quantification argument.”153 Lord Hoffmann said that the issue to be addressed was whether the claimant’s likely premature death would be attributable to the defendant’s delay in treatment.154 He concluded that the claimant was unable to show on a balance of probabilities that the delay in treatment would have caused his likely premature death, since he would probably have been in the same position of his life being shortened to less than ten years in any event.155 Lord Hope dissented from this view of the facts.156 He considered that on a balance of probabilities, the delay in treatment had caused the spread of the tumor with consequent pain and suffering, and that this gave him a cause of action for the pain and suffering caused by that injury and for the effect of the cancer on his life expectancy.157 A majority of their Lordships also dismissed the claimant’s “loss of a chance argument” that the defendant’s negligence in failing to diagnose the cancer tumor had reduced the claimant’s chance of survival from 42 percent to 25 percent, and that this was something of value and recoverable on policy grounds.158 However, the effect of their ruling on whether loss of a chance of a favorable outcome could ever be a recoverable head of damage in a clinical negligence case remains inconclusive. Lord Hoffmann said that the claimant was attempting to extend the Fairchild exception so that damages should be awarded for the possibility that the injury had been caused by the doctor.159 In his view, the outcome of the claimant’s disease was determinate in that the cancer would inevitably reduce his life.160 He stated that the outcome was not random, but was governed “by the laws of causality” and an inability to establish that the delay in diagnosis caused the reduction in expectation of life could not be remedied “by treating the outcome as having been somewhat indetermi-

151 152 153 154 155 156 157 158 159 160

Id. Id. at [66]. Id. at [68]. Id. Id. at [71], [57]–[58] (Lord Nicholls), [191] (Lord Phillips), [202] and [205] (Baroness Hale). Id. at [92]. Id. at [96]. Id. at [68]. Id. at [84]. Id.

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nate.”161 He expressly rejected the adoption of the loss of a chance approach in clinical negligence cases, concluding that adopting such a rule would be a rejection of Wilsher, Hotson, and the qualifications and restrictions with which their Lordships hedged the Fairchild exception.162 No new arguments or change of circumstances could justify “such a radical departure from precedent” which would “amount to a legislative act” that would have “enormous consequences for insurance companies and the National Health Service.”163 Baroness Hale also rejected the loss of a chance approach.164 In her view, redefining the definition of personal injury from being in outcome terms to one being in loss of opportunity terms “would cause far more problems in the general run of personal injury claims than the policy benefits are worth.”165 However, Lord Nicholls and Lord Hope were in favor of a claim succeeding on a loss of a chance basis in a clinical negligence action in a restricted set of circumstances.166 Lord Nicholls was willing to accept a claim for loss of a chance in cases where the patient’s condition “gave rise to significant medical uncertainty” as to what the outcome would have been in the absence of negligence.167 He distinguished Hotson, where there was no significant uncertainty as to what would have happened to Hotson’s leg if treated properly, from Gregg, where there was “considerable medical uncertainty about what the outcome would have been had Mr. Gregg received appropriate treatment nine months earlier.”168 In his view, Mr. Gregg’s prospects of recovery had he been treated promptly, expressed in percentage terms of likelihood, represented the medical reality of his position.169 The law, he said, “should be exceedingly slow to disregard medical reality in the context of a legal duty whose very aim is to protect medical reality.”170 Lord Hope also distinguished Gregg from Hotson.171 In Hotson, the “fundamental question of fact to be answered (whether the boy’s fall was the cause of his avascular necrosis) related to a point in time before the

161 162 163 164 165 166 167 168 169 170 171

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Id. at [80]. Id. at [85]. Id. at [85], [90]. Id. at [225]. Id. Id. at [59], [121]. Id. at [38], [44]. Id. at [38]. Id. at [42]. Id. at [42]. Id. at [108].

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negligent failure to treat began.”172 Accordingly, it was to be treated “as a matter of past fact.”173 By contrast, the injury that affected the claimant’s prospects of a successful recovery, namely the enlargement of the tumor, still lay in the future at the time when the claimant was seen by the doctor.174 While Lord Phillips upheld the decision of the trial judge on the facts, he left open the possibility of a claim for loss of a chance.175 On the facts, the case’s complications persuaded him that it was “not a suitable vehicle” to award damages for the reduction of the prospects of a cure, when the long-term result of treatment was still uncertain.176 However, he did not rule out the possibility of a claim for loss of a chance where the medical treatment resulted in an adverse outcome and negligence increased the chance of that outcome, recovery of damages being proportionate to the increase in chance of the adverse outcome.177 It therefore seems arguable178 that a claim for loss of a chance of a better medical outcome could be made where the patient’s condition gives rise to “significant medical uncertainty” as to what the outcome would have been in the absence of negligence,179 and “where medical treatment has resulted in an adverse outcome and negligence increased the chance of that outcome.”180 In Barker v. Corus UK Ltd.,181 Lord Hoffmann said that the majority of their Lordships in Gregg rejected the claimant’s case, not on the ground that there was some conceptual objection to treating diminution in the chances of a favorable outcome as actionable damage, but on the basis that adopting such a rule in Gregg “would in effect have extended the Fairchild exception to all cases of medical negligence, if not beyond, and would have been inconsistent with Wilsher.”182 This distinguishing of Gregg enabled Lord Hoffmann to characterize the gist of the damage in the Fairchild-type case as the creation of the risk or chance of causing the disease, without the possibility of inconsistency between the decisions.183 However, it has been argued that Lord Hoffmann’s formulation in Barker

172 173 174 175 176 177 178 179 180 181 182 183

Id. Id. Id. at [109]. Id. at [190]. Id. Id. See especially Jones, supra note 5, at 509–512; see also Clerk & Lindsell On Torts 110–11, 115, 118 (Michael Jones ed., Sweet & Maxwell, 20th ed. 2010). Gregg v. Scott, [2005] U.K.H.L. 2 at [38], [44] (Lord Nicholls). Id. at [190] (Lord Phillips). [2006] U.K.H.L. 20, [2006] 2 A.C. 572, [2006] 2 W.L.R. 1027, [39]. Id. Id. at [35].

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“renders precarious the authority of Hotson.”184 Accordingly, the position in English law after Hotson and Gregg remains unresolved.

VI. Reforming the Costs of Civil Litigation in England and Wales: Implications of the Jackson Report for the Costs of Clinical Negligence and the Ministry of Justice Reform of Legal Aid A.

Jackson Report

The Jackson Review of Civil Litigation Costs,185 arguably the most comprehensive review of civil litigation costs since the Woolf Report, contains several recommendations that will, when implemented, have profound implications for the costs of clinical negligence cases. The Jackson Report notes that Conditional Fee Agreements (CFAs), of which “no win no fee” agreements are the most common, have been the “major contributor to disproportionate costs in civil litigation in England and Wales.”186 As we have previously seen, in their Report and Annual Accounts of 2010, the NHSLA agree with Sir Rupert Jackson and are convinced that a major reason for the growth in volume of clinical negligence claims is the availability of this “ ‘so-called’ no win no fee market.”187 The two key drivers of cost under these CFAs are: (1) the lawyer’s success fee; and (2) the after-the-event (ATE) insurance premium that is usually taken out when a CFA is entered into (to cover the claimant against the risk of having to pay the defendant’s costs).188 Both the success fee and the ATE insurance premium are currently recoverable from an unsuccessful defendant.189 The Jackson Report noted that a significant part of the costs being paid by the NHSLA to claimant solicitors relates to these two drivers of cost: success fees and ATE insurance premiums.190 Sir Rupert has made two controversial recommendations that would dramatically affect costs in clinical negligence cases. First, he has recommended

184 See Jane Stapleton, Occam’s Razor Reveals an Orthodox Basis for Chester v. Afshar, 122 L.Q.R. 426, 448 n.77 (2006). 185 Rupert Jackson, Review of Civil Litigation Costs: Final Report (Her Majesty’s Stationery Office 2010). 186 Id. at xvi. 187 The National Health Service Litigation Authority, Report and Accounts 2010–2011, supra note 17, at 7, 13. 188 Jackson, supra note 185, at xvi, rec. 2.1. 189 Jackson, supra note 185, at xvi. See further Harpwood, supra note 21, at 56–59. 190 Jackson, supra note 185, at 316.

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that success fees and the ATE insurance premiums should cease to be recoverable from unsuccessful opponents in civil litigation.191 This, he believes, would lead to significant cost savings, whilst still enabling those who need access to justice to obtain it.192 It will be open to clients to enter into “no win no fee” type agreements with their lawyers, but any success fee will be borne by the client, not the opponent.193 This is likely to mean that the success fee comes out of the damages awarded to the client.194 Jackson has noted, with approval,195 that success fees and ATE insurance premiums are not recoverable in Scotland, where the equivalent speculative fee agreement system works satisfactorily.196 Second, he recommended what he termed “qualified one-way costs shifting.”197 This means that “the claimant will not be required to pay the defendant’s costs if the claim is unsuccessful, but the defendant will be required to pay the claimant’s costs if it is successful.”198 It is “qualified” in that unreasonable (or otherwise unjustified) party behavior may lead to a different costs order, and the financial resources available to the parties may justify two-way costs shifting in certain cases.199 The justification for qualified one-way cost shifting in the context of clinical negligence is that it would no longer require claimants to take out ATE insurance.200 It would also benefit defendants, as paying their own costs, win or lose, would be substantially cheaper than running the risk of paying the ATE insurance premium in those cases where they lose.201 In its consultation paper on Implementation of the Jackson Report, the Ministry of Justice supported these reforms.202 It recommended that the success fee and the ATE insurance premium no longer be recoverable from the losing party in all categories of cases funded under CFAs, but that, in

191 192 193 194 195 196

197 198 199

200 201 202

Id. at xvi, rec. 2.2 Id. Id. Id. at xvi–xvii. Id. at 90, 112. See Brian Gill, 2 Report of the Scottish Civil Courts Review 95 (Scottish Civil Courts Review 2009); see also Proposals for Reform of Civil Litigation Funding and Costs in England and Wales: Implementation of Lord Justice Jackson’s Recommendations CP 13/10, 25 (Ministry of Justice 2010) [hereinafter Proposals for Reform]. Jackson, supra note 185, at xvii, 193. Id. at xvii. Id. For the view that the qualified aspect of one-way costs shifting creates slightly too much risk on the part of the claimant and fails to reach the optimum balance, see Rob Heywood, Saving Costs in Clinical Negligence: The Jackson Report Recommendations, 124–139, 137 (2010). Jackson, supra note 185, at xvii. Id. at 87. Proposals for Reform, supra note 196, at 27.

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order to protect those who merit protection against adverse costs, qualified one-way cost shifting should be introduced.203 Sir Rupert also recommended that both solicitors and barristers should be permitted to enter into contingency fee agreements with their clients (which are known as “damages-based agreements” (DBAs)) in contentious cases.204 These DBAs are a type of “no win no fee” arrangement like CFAs, since the legal representative is only paid if the case is successful and does not receive any payment if the case is lost.205 DBAs are distinguishable from CFAs in that the payment received by the legal representative is calculated by reference to the damages awarded to the client, as opposed to an uplift on the representative’s base costs.206 Accordingly, DBAs permit representatives to claim a proportion of their clients’ award of damages as their fee.207 However, Sir Rupert recommended that costs should be recoverable against opposing parties on a conventional hourly rates basis, and not by reference to a contingency fee.208 He also recommended that contingency fees must be regulated and should not be valid unless the client has received independent advice.209 The introduction of DBAs has been supported by the Ministry of Justice.210 There is no doubt that they could be utilized in clinical negligence cases, in that it would be these cases where legal representatives would be keen to claim a proportion of their client’s award of damages as their fee. However, a legitimate concern would be that there would be no incentive to take on borderline cases in the clinical negligence field, reducing access to justice in many complex

203 Id. at 27, 32. While Jackson proposed that this would be qualified by an evaluation of the claimant’s behaviour in the litigation and the claimant’s financial resources, Jackson, supra note 185, at xvii, the Ministry of Justice has suggested that, in order to achieve the necessary certainty, there will be a presumption that the claimant would not be liable to pay the defendant’s costs. It would then be open for the defendant to apply to the court for an order that, since the claimant is “conspicuously wealthy” or the defendant is uninsured, the claimant should be liable for all or a fixed amount of defendant’s costs if the claim fails. Proposals for Reform, supra note 196, at 49–50. 204 Proposals for Reform, supra note 196, at 70. “Damages-based agreements” (DBAs) is the statutory term under section 58AA of the Courts and Legal Services Act 1990 [as amended by section 154 of the Coroners and Justice Act 2009] for agreements sometimes known as contingency fees. However, “contingency fee” is a broad term which technically covers all private legal funding arrangements between representatives and claimants in which the payment of a fee to the representative is contingent on the successful outcome of the case, including CFAs. 205 Id. 206 Id. 207 Id. 208 Jackson, supra note 185, at xviii–xix. 209 Jackson, supra note 185, at xviii–xix, 133. 210 Proposals for Reform, supra note 196, at 70–75.

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cases where proof of negligence and/or causation may be extremely difficult to establish.

B.

Reform of Legal Aid in England and Wales

The UK Government has seen the CFA, shorn of the lawyer’s success fee and the ATE, but with the protection of qualified one-way cost shifting, as the way to fund clinical negligence cases. Currently, clinical negligence cases against the NHS are funded approximately 50:50 between legal aid and CFAs (the latter in the form of no win no fee agreements).211 However, in the face of a reduction of 23 percent in its overall budget, in November 2010 the Ministry of Justice proposed “fundamental reform” of the legal aid scheme.212 It considered that legal aid funding was not justified for clinical negligence cases, since there was a viable alternative in the form of CFAs, which were likely to be more readily available in these cases than in other claims.213 The government therefore proposed to exclude civil legal aid from all clinical negligence cases.214 While recognizing that there were likely to be cases such as obstetrics, with high disbursement costs, which were currently funded by legal aid, but for which clients might find it hard to secure funding under a CFA, they did not consider that this represented a sufficiently high proportion of cases to justify retaining clinical negligence within the scope of legal aid.215 On June 21, 2011, the Secretary of State for Justice confirmed this position in his introduction of the Legal Aid, Sentencing and Punishment of Offenders Bill,216 stating that with 80 percent of clinical negligence cases being undertaken on a no win no fee basis, and only 20 percent using legal aid, a no win no fee basis of funding was “probably the better way forward.”217

211 212 213 214 215 216

519 Parl. Deb., H.C. (6th ser.) (2010) 160. Proposals for Reform, supra note 196, at 3, 5. Id. at 61. Id. Id. at 62. 21 June, 2011, Parl. Deb., H.C. (2011) 166 (The Lord Chancellor and Secretary of State for Justice (Mr. Kenneth Clarke) speaking). Clause 8(1) of the Legal Aid, Sentencing and Punishment of Offenders Bill provides that the civil legal services described in Part 1 of Schedule 1 of the Bill are available to an individual. Part 2 of Schedule 1 lists the services that are not included in the services described in Part 1, including civil legal services provided in relation to personal injury and death and civil legal services provided in relation to negligence. 217 Id. at 174. But see, e.g., the Government’s own admission that clinical negligence cases against the NHS are funded approximately 50:50 between legal aid and CFAs (the latter in the form of no win no fee agreements). 519 Parl. Deb., H.C. (6th ser.) (2010) 160.

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It is likely that there will be several losers in access to justice for clinical negligence if this approach is adopted. This is particularly a concern in cases assessed as having a 50:50 chance of success.

Conclusion This paper has examined medical liability in the UK, primarily from the perspective of clinical negligence in the NHS. We have seen that several reports have pointed to failure in the civil justice system with respect to clinical negligence claims. However, fourteen years after the Woolf report, medical negligence claims are subject to the same difficulties as they were then. A major problem, as we have seen, is that these claims are complex. It is difficult to establish a breach of duty of care in clinical negligence cases, and even if that hurdle is overcome, there is the perennial problem of establishing causation. What is clear from the empirical data of the NHLSA’s Annual Report and Accounts is that there is a trend of increasing costs of funding claims. However, in respect to its concern over increase in claim numbers, when viewed in the context of the previous three years of relative stability, it is premature to suggest that such an increase in claim numbers during the last two years should give rise to the degree of concern that appears to have emanated from the NHSLA. Indeed, it is clear that there has been a marked increase in access to justice over the last ten years in this area and this is to be welcomed. Nonetheless, there is something to be said for the view that the benefits have mostly gone to savvy claimant lawyers operating under no win no fee arrangements, especially for low value claims. The UK Government sees the CFA, shorn of the lawyer’s success fee and the ATE, but with the protection of qualified one-way costs shifting, as the way to fund clinical negligence cases.218 It considers that legal aid funding is not justified for clinical negligence cases, since there is a viable form of alternative, in the form of CFAs, which are likely to be more readily available in these cases than in other claims.219 It has been submitted that there will be several losers in access to justice for clinical negligence when the Legal Aid, Sentencing and Punishment of Offenders Bill is enacted, especially in cases assessed as having a 50:50 chance of success.

218 Proposals for Reform, supra note 196, at 61. 219 Id.

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While the proposed changes to legal aid in England and Wales are a source of concern, these changes do not apply to Scotland.220 The McLean report’s recommendations that consideration should be given to the establishment of a no-fault compensation scheme for medical injury along the lines of the Swedish model and that such a scheme cover all medical treatment injuries that occur in Scotland,221 are radical developments in the field of compensation for medical malpractice. The Scottish Government has welcomed its proposals, but the devil will remain in the details of how such a scheme would work in practice, with its associated cost implications. Moreover, while the proposed new system would remove the need to prove negligence, it would still require proof that harm was caused by treatment. The thorny issue of causation is therefore not eliminated by the proposed scheme.

220 Legal Aid, Sentencing and Punishment of Offenders Bill, 2011, Bill [205] cl. 117(1) (U.K.). 221 McLean, supra note 25, at 6.

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Medical Malpractice and Compensation in Global Perspective: How Does the U.S. Do It? David A. Hyman* and Charles M. Silver**

Introduction We face a daunting challenge: describe in limited space the manner in which the United States regulates medical practice by compensating patients harmed by medical treatments, and summarize the enormous empirical literature addressing these subjects. The task would be difficult even if the United States had a single system for handling these issues. In fact, it has a patchwork of arrangements that divide responsibility among diverse governments (federal and state), regulators (medical boards, insurance commissioners, and others), and private entities (including, but not limited to, hospitals, insurance carriers, physicians, and patients). The health care system in the U.S. is famously fragmented, making both regulation and summarization trying affairs.1 One level of complexity is the result of federalism: the United States has more than fifty distinct state-level regulatory and legal systems, each with its own variations and idiosyncrasies.2 Consider a simple example: more than thirty states cap damages in medical malpractice cases. In states that

*

David A. Hyman is the Richard W. and Marie L. Corman Professor and Director of the Epstein Program in Health Law and Policy and Professor of Medicine at the University of Illinois College of Law. ** Charles Silver is the Roy W. and Eugenia C. McDonald Endowed Chair in Civil Procedure and Co-Director of the Center on Lawyers, Civil Justice, and the Media at the University of Texas at Austin School of Law. 1 Einer Elhauge, Why We Should Care About Health Care Fragmentation and How To Fix It, in The Fragmentation of U.S. Health Care: Causes and Solutions 1, 3 (Einer Elhauge ed., 2010). 2 Yes, we know how many states there are. But, when you include the District of Columbia and Puerto Rico (not to mention Guam and the other territories) there are more than fifty separate systems of malpractice law/entities with regulatory authority over the practice of medicine. Thus, there are fifty-six Medicaid program, even though there are only fifty states. U.S. Dep’t. of Health & Human Servs., Medicaid Program Overview, A Profile of

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limit damages, the details of the cap vary widely. A few states restrict total damages, but most limit only non-economic damages (i.e., pain and suffering). The caps are set at different levels, and only some adjust for inflation. Some caps vary depending on whether the plaintiff is deceased. Others are tied to the number of defendants. Some impose different caps depending on whether the defendant is a physician or an institutional defendant (i.e., a hospital or nursing home). Thus, there is substantial state-level variation in the amount of damages that may be awarded in medical malpractice cases even in states that cap damages – variation that naturally increases when states that do not cap damages are added to the mix. Further complications result from the interaction of the state and federal systems. Although states possess primary regulatory authority over both the practice of medicine and civil and criminal litigation, the federal government plays an important role as a major purchaser of health care services: through Medicare, Medicaid, and SCHIP, and as a provider of health care services through the Veterans Administration and the Indian Health Service; through the U.S. Food & Drug Administration’s exclusive licensing authority regarding the sale of pharmaceuticals and medical devices; through federal regulation of controlled substances (which influences pain management practices); and through federal regulation of billing practices (through the civil False Claims Act and criminal prohibitions on health care fraud and abuse). The federal government’s role may also grow if it ends up operating the exchanges that are to be adopted pursuant to the Patient Protection and Affordable Care Act (PPACA). To be sure, federal courts play a less significant role than state courts. Federal authority over malpractice is limited to cases brought under the Federal Tort Claims Act, and concurrent jurisdiction in cases involving citizens of different states where more than $ 75,000 is at issue.3 But federal courts have played leading roles in high-profile lawsuits affecting health care policies, including cases in which physicians have challenged private payers’ reimbursement practices, cases in which physicians, pharmacies, and nursing homes have sought to overturn reductions in Medicaid payments imposed by states, and cases in which states and private parties have argued that the PPACA is unconstitutional. A final level of complexity results from the multiplicity of entities with implicit or explicit authority over the practice of medicine, including Medicaid, 6 (Sept. 2000), available at https://www.cms.gov/TheChartSeries/downloads/ 2Tchartbk.pdf. 3 The Federal Tort Claims Act covers malpractice actions involving federal employees and volunteers at federally qualified health centers and free clinics.

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medical schools, residency programs, accrediting agencies, specialty boards, teaching and community hospitals, courts, and state licensing agencies. State and federal agencies also maintain registries or databases of adverse events, payouts in malpractice cases, infection rates, and mortality and morbidity rates for medical procedures. If one broadens the field to encompass insurers, there are public and private entities covering various sections of the population, whose purchasing and coverage rules can influence the frequency of adverse medical events and the financial consequences for those who suffer a medical injury. Liability insurers, who absorb losses and sometimes refuse to continue coverage, may also influence treatment patterns. There is one area marked by simplicity and clarity: apart from the population-specific coverage of Medicare (people who are sixty-five years and older and those in chronic renal failure), Medicaid (the poor), and SCHIP (children below a specified income level), the United States does not have a social insurance system. Thus, for a clear majority of the population, there is no occasion to describe the interaction between the social insurance and tort systems. Even for those who participate in these programs, there is little to discuss, since they have historically occupied different spheres. Administrators of the Medicare and Medicaid programs, for example, have long viewed their job as paying for the care received by their beneficiaries, and have not troubled themselves unduly about the quality and cost-effectiveness of that care. Until quite recently, when a Medicare or Medicaid beneficiary suffered a medical injury, both programs simply paid the resulting bills – creating exactly the wrong incentives. Neither program took steps to improve the way providers responded to malpractice claims. To the contrary, as things currently stand, both programs probably weaken the liability system’s ability to police negligent practitioners. Because both programs pay for the bills that result from a medical injury, they have a statutory subrogation right that entitles them to share in any recovery. The amounts left over once Medicare and Medicaid have been repaid are often too small to motivate patients to sue – let alone to motivate a plaintiffs’ attorney to take their cases. Part I turns to a more detailed description of the details of the regulatory, liability, and compensation systems. Part II explores the literature on medical error/adverse events, and the performance of the liability system. Part III evaluates how ordinary citizens feel about the liability system. Part IV describes how incentives shape the performance of these interlocking systems. Part V offers a perspective from our work with closed malpractice claims from Texas. Part VI concludes.

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I.

Details of the Applicable Regulatory and Liability/ Compensation Systems

A.

Regulating the Delivery of Medical Care

To practice medicine, an individual must graduate from a medical school, complete an accredited residency, and obtain a license to practice medicine from a state licensing board – with the requirements varying from state to state. Licenses do not typically differentiate based on medical specialty; both a pediatrician and a neurosurgeon secure an identical license to practice medicine from the issuing authority. All fifty states impose a requirement for Continuing Medical Education (CME) to maintain licensure.4 However, no state requires malpractice/error-prone physicians to undergo more frequent CME, or take affirmative steps to reduce the frequency of these problems. A physician may obtain board certification in a particular specialty or specialties, but certification is voluntary. However, many boards require CME as a condition of continued board certification. Once physicians are licensed, other entities can influence the scope of their practice. A physician who wishes to admit patients to a hospital must obtain “privileges” at that institution. Hospitals can condition the granting of privileges in various ways, and may limit the services that physicians may provide using hospital resources (i.e., a hospital is unlikely to allow a pediatrician to perform neurosurgery). Hospitals generally require physicians to maintain malpractice coverage in a specified amount, with the precise amount varying from hospital to hospital. Physicians may also become direct employees of a hospital or of a managed care plan, and those entities can also impose restrictions on the scope of practice. Hospitals are accredited by private entities. These accrediting entities profoundly influence the behavior of hospitals, because loss of accreditation means that the hospital may not be paid for the services it provides (at least not by public payers).5 4 State Medical Licensure Requirements and Statistics 2010, American Medical Association (2010), available at http://www.ama-assn.org/ama1/pub/upload/mm/40/table16.pdf. 5 The Joint Commission on Healthcare Organizations (JCAHO) has played a significant role in recent years in encouraging hospitals to adopt patient safety initiatives. Kelly J. Devers et al., What Is Driving Hospitals’ Patient-Safety Efforts?, 23 Health Aff. 103, 112–13 (2004). JCAHO has not always had this reputation, as an excerpt from an online posting by a hospital administrator indicates: We never worried about JCAHO until the three months prior and the two days of the inspection. In the three months prior we backdated all the documentation that we needed to get through the inspection, and in the two days they were there we spent telling them

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State medical boards are supposed to regulate the quality of health care provided by state-licensed physicians, but in practice these boards are lax. A 2011 report studied how state medical boards handled the cases of 10,672 physicians whose clinical privileges were revoked or restricted by a hospital.6 They found that state medical boards had taken no action in over half of these cases. Because hospitals generally restrict clinical privileges only in response to the worst cases, this study suggests that state medical boards are failing to address even the problems that are identified for them by others. In reality, the most significant “regulator” of health care practice is the payment system. At least at the federal level, payment policy is health policy, and health policy is payment policy. In recent years, public and private payers have taken baby steps in the direction of using their payment systems to reward error-free care. These programs have been variously described as “value-based purchasing,” “payment for performance,” and non-payment for “never events.” Unfortunately, these efforts have not changed the core incentives created by the dominant encounterbased, quality-insensitive, fee-for-service payment system that otherwise rules the roost.

B.

Liability/Compensation Systems

1.

Fault-Based (Negligence)

In the United States, the determination of liability and compensation is almost entirely the province of the civil tort system. As detailed below, there are small pockets of no-fault liability, but negligence is the rule for most patients in most settings. Plaintiffs may not recover for injuries stemming from adverse events or errors unless a provider was negligent – and as outlined in Part III, most negligently injured patients do not recover, regardless. Malpractice straddles the divide between contract and tort. Most lawsuits arise out of a consensual relationship between physician and patient, creating an implied duty to exercise reasonable care. States have struck how focused we were on quality, etc. As long as the paperwork is in order, people can be dying in the halls and there could be guppies in the IV fluid; the JCAHO wouldn’t notice. Mark A. Hall et al., The Law of Health Care Finance and Regulation 373 (1st ed. 2005). 6 See generally Alan Levine et al., State Medical Boards Fail to Discipline Doctors with Hospital Actions Against Them (2011), available at http://www.citizen.org/documents/ 1937.pdf.

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down attempts to modify or eliminate this duty by contract, although many have allowed contracting over other terms (such as whether plaintiffs must arbitrate their claims). States have also experimented with a wide array of tort reforms, including a number of process-based reforms (e.g., screening panels, certificates of merit, and abbreviated statutes of limitation). Table 1 gives a sense of the range of tort reforms that jurisdictions have adopted. Insurance Market Reforms

Joint underwriting associations/patient compensation funds Prior approval of rate increases Mandatory reporting of closed claims

Medical Quality Reforms

Peer review protections Mandatory reporting of liability payouts and errors Requirement for continuing medical education

Tort Reforms

Aimed at the number of lawsuits ■ ■ ■ ■

Arbitration Attorney fee controls Certificates of merit Pretrial screening panels

Aimed at the size of recoveries ■

■ ■

Damage caps (punitive, non-economic, and total damages) Abrogation of joint and several liability Offset for collateral source payments

Aimed at plaintiffs’ difficulty (or costs) of winning ■ ■ ■

Expert witness requirements Informed consent limits Professional standard of care, and not ordinary negligence

Aimed at functioning/cost of judicial process ■ ■ ■ ■

Mediation Notice of intent to sue Mandatory pretrial conferences Alternative Dispute Resolution

Source: See Randall R. Bovbjerg, Legislation on Medical Malpractice: Further Developments and a Preliminary Report Card, 22 U.C. Davis L. Rev. 499 (1989). Table 1: Malpractice Reforms

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The failure to exercise reasonable care is treated as a tort, and tort remedies are available for breach. For most specialties, states have largely abandoned the “locality rule” that treated compliance with local custom as a complete defense. However, legislatures have responded by imposing limitations on who can testify about the standard of care – effectively reimposing a modified version of the locality rule while simultaneously increasing the costs of litigating such cases (since limiting the supply of experts effectively increases the fees that those experts can command). In order to recover, plaintiffs must prove “negligence” – that their providers failed to exercise due care. As always, the plaintiff must establish the four elements of a tort lawsuit: (1) duty, (2) breach, (3) proximate cause, and (4) damages. “Duty” means that there was a relationship between patient and provider sufficient to trigger an obligation to exercise due care in the treatment of the patient. (Most of the time, duty is a non-issue, particularly if there is a pre-existing relationship between provider and patient.) “Breach” means that the provider failed to exercise the care expected of a reasonably skilled provider. Establishing breach requires expert testimony, since the touchstone for establishing liability is proof of a deviation from the standard of care. (In some states, customary treatment is by definition not negligent, but most states have moved to a more demanding standard.)7 “Proximate cause” means that the breach of the standard of care was the cause in fact of compensable injury. Thus, injuries that are too remotely related to the alleged cause cannot result in compensation. Causation often involves complicated issues, which is part of the reason that malpractice litigation is expensive. Indeed, for most malpractice cases, causation is the primary issue in dispute. Many states allow for recovery of “lost chance,” but there is variation in how large the chance must be. Similarly, although all states allow for recovery if the physician has not obtained informed consent, such cases are not usually sufficiently remunerative for them to be brought, barring exceptional circumstances.8 In all states, the plaintiff bears the burden of proof on all issues (i.e., they must prove their position is “more likely than not”). If the plaintiff is seeking punitive damages, many states impose a higher burden of proof (“clear and convincing evidence”) and other procedural barriers. There are 7 Philip G. Peters, The Quiet Demise of Deference to Custom: Malpractice Law at the Millennium, 57 Wash. & Lee L. Rev. 163, 170, 188 (2000). 8 David M. Studdert et al., Claims, Errors, and Compensation Payments in Medical Malpractice, 354 New Eng. J. Med. 2024, 2026 (2006).

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also constitutional limitations on the size of punitive damages (they must generally be less than ten times the compensatory damages) and the processes employed to determine whether such damages are appropriate.9 To be sure, punitive damages are not that common in medical malpractice cases, occurring in fewer than 5 percent of tried and settled cases.10 Compensatory damages take two forms: economic (e.g., lost earnings and medical bills), and non-economic (e.g., pain and suffering). Proving damages is generally straightforward for economic losses, but can be difficult or contentious when parties disagree about patients’ future earnings or the severity or likely duration of patients’ disabilities. Non-economic damages are more speculative, but they are strongly correlated with economic damages.11 Criminal liability for malpractice is extraordinarily rare. (One of us referred to it elsewhere as “the unicorn” of malpractice policy).12 The decision to initiate such cases lies with prosecutors at the county, state, and federal level, some of whom are elected. When such cases are brought, they are often the result of a highly visible death that resulted from egregious misconduct. For example, a pharmacist who diluted chemotherapy drugs was criminally prosecuted and sentenced to prison.13 A less clear-cut scenario involves physicians who practice pain management, and were prosecuted for writing “excess” prescriptions after patients overdosed or were caught selling the pharmaceuticals.14 Finally, nurses have been prosecuted for criminal negligence following the administration of an incorrect dose or the wrong medicine to a patient that subsequently died.15 9 See State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 425 (2003); Nitin Sud, Punitive Damages: Achieving Fairness and Consistency after State Farm v. Campbell, 72 Def. Couns. J. 67, 77 (2005). 10 See Thomas H. Cohen, U.S. Dep’t of Justice, NCJ No. 203098, Medical Malpractice Trials and Verdicts in Large Counties, 2001 2 (2004), available at http://bjs.ojp.usdoj.gov/ content/pub/pdf/mmtvlc01.pdf; Bernard Black et al., Stability, Not Crisis: Medical Malpractice Claim Outcomes in Texas, 1988–2002, 2 J. Empirical Legal Stud. 207, 213 (2005). 11 Id. 12 See David A. Hyman, Collateral Damage, 27 Health Aff. 1476, 1477 (2008). 13 Pam Belluck, Prosecutors Say Greed Drove Pharmacist to Dilute Drugs, N.Y. Times, Aug. 18, 2001, available at http://www.nytimes.com/2001/08/18/us/prosecutors-say-greed-drovepharmacist-to-dilute-drugs.html; National Briefing | Midwest: Missouri: 30-Year Sentence For Druggist, N.Y. Times, Dec. 6, 2002, available at http://www.nytimes.com/2002/12/06/us/ national-briefing-midwest-missouri-30-year-sentence-for-druggist.html. 14 Marc Kaufman, DEA Revises Rule on Prescribing Painkillers, Wash. Post, Sept. 7, 2006, available at http://www.washingtonpost.com/wp-dyn/content/article/2006/09/06/ AR2006090601756.html. 15 Rebecca Cady, Criminal Prosecution for Nursing Errors, 11 JONA’s Healthcare Law, Ethics and Regulation 10 (Jan–Mar. 2009).

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In some instances, civil fraud claims are brought against physicians for conduct that could also be characterized as malpractice. Such claims are often initiated by whistle-blowers, who receive a share of any proceeds. For example, after two whistle-blowers filed complaints, the Department of Justice pursued False Claims Act litigation against two physicians and a hospital for performing unnecessary surgery. In this case, individual plaintiffs also brought malpractice claims against the physicians and hospital. Even though the facts were quite egregious, criminal charges were not brought, and there was a package settlement of the malpractice and civil False Claims Act claims.16 Dissatisfied patients have two primary means of complaining. They can contact the relevant state’s licensing board, which may revoke or limit the licenses of physicians found to have acted improperly. The utility of this mechanism varies greatly from state to state – some are much more likely to initiate disciplinary proceedings against individual physicians than others – but speaking generally it seems that only the most egregious cases are likely to interest state medical boards.17 Dissatisfied patients can also sue, when they can find lawyers willing to represent them. Securing a recovery when liability is contested is all but impossible without help from a plaintiffs’ lawyer.18 Obtaining counsel is harder than one might imagine. Because plaintiffs’ lawyers work on contingency, they screen cases carefully and decline most requests for representation. One study found that a plaintiffs’ law firm declined twenty-nine of thirty requests for representation, a 97 percent rejection rate, and also paid independent physician-experts to review the cases it took.19 Once cases are accepted, plaintiffs’ lawyers research claims extensively using compulsory process, and they frequently drop cases when new information creates doubt about the merits. In exchange for accepting a case, a plaintiffs’ lawyer will typically demand a contingent fee of one-third or more of any proceeds plus any expenses incurred. If the case is unsuccessful, the plaintiff need not pay anything. Health insurers who paid for post-injury treatment are entitled to reimbursement out of the proceeds of any malpractice claim. In practice, this

16 17 18 19

Stephen Klaidman, Coronary: A True Story of Medicine Gone Awry 261–81 (2007). See generally Levine et al., supra note 6. Charles Silver & David A. Hyman, Access to Justice in a World Without Lawyers: Evidence from Texas Bodily Injury Claims, 37 Fordham Urb. L. J. 357, 373–74 (2010). LaRae I. Huycke & Mark M. Huycke, Characteristics of Potential Plaintiffs in Malpractice Litigation, 120 Annals Internal Med. 792, 796 (1994).

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means that plaintiffs often walk away with less than half the amount recovered. When there is a payment, it is most often the result of a voluntary settlement. Relatively few claims (5–10 percent) go to trial, and when the case is tried, defendant-physicians win 75–80 percent of the time. Although the physician is the named defendant, the real party in interest is almost always a private malpractice insurer (from whom the physician has purchased a policy). Physicians rarely use personal assets to satisfy malpractice claims.20 As a practical matter, the stakes in malpractice suits are capped by the limits of physicians’ insurance coverage, regardless of the severity of patients’ injuries or the amounts that juries believe patients ought to receive.21 Federal law requires insurance companies and other entities to report payouts in malpractice cases to the National Practitioner Data Bank (NPDB). Although researchers use the NPDB to study trends in malpractice cases and other matters, neither providers nor regulators appear to use the information it contains to improve quality of care or reduce the frequency of medical errors. State laws require hospitals to report hospital-acquired conditions, including injuries patient suffer as a result of medical mistakes, but under-reporting is rampant. One report found that 90 percent of errors went unreported.22 In most states, clinical practice guidelines have not played a material role in malpractice litigation. Such guidelines can serve as either a sword (where deviation from the guideline is deemed to create a prima facie or per se case of malpractice) or a shield (where compliance with the guideline eliminates the possibility of liability). One scholar recently proposed that providers should be immune from civil liability when they comply with treatment guidelines promulgated by private entities, but the private entities would be liable if their guidelines were negligently constructed.23

20 21

22 23

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Kathryn Zeiler et al., Physicians’ Insurance Limits and Malpractice Payments: Evidence from Texas Closed Claims 1990–2003, 36 J. Legal Stud. 9, 11 (2007). David A. Hyman et al., Do Defendants Pay What Juries Award? Post-Verdict Haircuts in Texas Medical Malpractice Cases, 1988–2003, 4 J. Empirical Legal Stud. 3, 53 (2007); Charles Silver et al., Malpractice Payouts and Malpractice Insurance: Evidence from Texas Closed Claims, 1990– 2003, 33 The Geneva Papers on Risk & Ins. – Issues & Practice 177, 188 (2008); Zeiler et al., supra note 20, at 10. David C. Classen et al., “Global Trigger Tool” Shows That Adverse Events In Hospitals May Be Ten Times Greater Than Previously Measured, 30 Health Aff. 581, 586 (2011). Ronen Avraham, Private and Competitive Regulation of Medicine, 6 The Economists’ Voice 2, 3–4 (2009), available at http://www.bepress.com/ev/vol6/iss8/art2.

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2.

No-Fault Liability (Strict Liability)

No-fault liability for medical error has proven far more popular with academics than with legislators. There are only a few pockets of strictliability for medical malpractice in the United States. Qualifying birth injury cases in Virginia and Florida are excluded from the tort system, and are handled through an administrative system. Ironically, plaintiffs with strong cases prefer to litigate in the tort system, since they can recover a greater amount, while plaintiffs with weak cases prefer the no-fault system. Products liability cases involving medical devices (whether the plaintiff is alleging design or manufacturing defect) also qualify for strict liability treatment. Vaccine injury cases are handled by the U.S. Court of Federal Claims. The 1986 National Vaccine Injury Act created a no-fault system for handling such claims. Claimants must show that they experienced one of several enumerated adverse effects shortly after vaccination. The burden of proof is the same as in civil litigation – more likely than not. Compensation covers medical and legal expenses, loss of future earning capacity, and up to $ 250,000 for pain and suffering. There is also a death benefit of up to $ 250,000. Legal expenses may be compensated as well. The program is funded by an excise tax on every purchased dose of covered vaccine.24

C.

Limitations on Liability/Contracting out of Liability

As noted previously, many states cap liability exposure for either noneconomic or total damages. Table 2 contains a list of these states, and outlines the details of the applicable caps. As Table 2 reflects, there is considerable variation in the design of these caps. We recently published a paper estimating the effect of each of these caps using a common set of cases, and found extraordinary variation in the likely impact.25 Total damages caps had the largest impact, other design details (e.g., the level of the cap, and whether it scaled based on the number of defendants) mattered as well.

24 25

See Stephen D. Sugarman, Cases in Vaccine Court – Legal Battles over Vaccines and Autism, 357 New Engl. J. Med. 1275, 1276 (2007). David A. Hyman et al., Estimating the Effect of Damage Caps in Medical Malpractice Cases: Evidence from Texas, 1 J. Legal Analysis 355, 405–06 (2009).

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State

Cap Type

Cap Level

Louisiana

Total

$ 500,000 plus future medical expenses

New Mexico

Total

$ 600,000 plus future medical expenses

Colorado

Total, non-economic

$ 1 million total; $ 300,000 non-economic

Indiana

Total

$ 1.25 million

Massachusetts

Total (hospitals); non-economic (all)

$ 20,000 total (non-profit hospitals); $ 500,000 non-economic (all defendants)

Nebraska

Total

$ 1.75 million

Virginia*

Total

$ 1.95 million

California

Non-economic

$ 250,000

Idaho*

Non-economic

$ 250,000

Kansas

Non-economic

$ 250,000

Montana

Non-economic

$ 250,000

West Virginia*

Non-economic

$ 250,000, except $ 500,000 in death cases

Oklahoma*

Non-economic

$ 300,000

Texas

Non-economic

$ 250,000-$ 750,000, depending on number and type of defendants

Nevada

Non-economic

$ 350,000

Ohio

Non-economic

Greater of $ 250,000 or three times economic damages, up to $ 500,000

Hawaii

Non-economic

$ 375,000

Georgia

Non-economic

$ 350,000-$ 1.05 million, depending on number and type of defendants

South Carolina

Non-economic

$ 350,000-$ 1.05 million, depending on number and type of defendants

Alaska

Non-economic

$ 400,000

Utah

Non-economic

$ 409,000

Illinois

Non-economic

pitals

Mississippi

Non-economic

$ 500,000

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State

Cap Type

Cap Level

North Dakota

Non-economic

$ 500,000

South Dakota

Non-economic

$ 500,000

Maryland*

Non-economic

$ 650,000

Missouri

Non-economic

$ 350,000

Florida

Non-economic

$ 500,000, except $ 1 million in death cases

Michigan*

Non-economic

$ 641,000

Wisconsin

Non-economic

$ 750,000

*Adjusted for inflation. Source: See David A. Hyman et al., Estimating the Effect of Damage Caps in Medical Malpractice Cases: Evidence from Texas, 1 J. Legal Analysis 355 (2009). Table 2: State Damages Caps

There has been considerable academic interest in contracting out of liability. Courts have proven considerably less enthusiastic about such contracts, striking them down on various grounds. However, many states allow contracting into arbitration, or some other form of alternative dispute resolution, as long as certain procedural protections are provided.

D.

Immunity from Liability

Federal law eliminates liability for service providers who serve as volunteers in nonprofit institutions, including but not limited to free clinics, as long as the harm was not caused by willful or criminal misconduct, gross negligence, reckless misconduct, or a conscious, flagrant indifference to the rights or safety of the individual harmed by the volunteer. Historically, many states provided for absolute immunity of nonprofit hospitals (“charitable immunity”). Charitable immunity has been almost entirely abrogated, although Massachusetts retains a very low cap on damages in cases involving nonprofit hospitals. Federal law also exempts doctors and nurses who treat military personnel at hospitals run by the Veterans Administration. Injured patients can receive compensations from the hospitals, however.

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II.

Empirical Data on Medical Errors/Adverse Events and Malpractice Litigation

The empirical literature on medical errors/adverse events and malpractice litigation is vast. We address each issue in turn.

A.

How Common Are Medical Errors and Adverse Events?

In 2001, the Institute of Medicine made front-page news by estimating that medical errors kill 44,000 to 98,000 hospitalized patients annually and injure many more.26 Recent studies put the number of deaths much higher.27 One source, which studied Medicare patients treated in hospitals from 2000–2002, estimated that almost 195,000 deaths each year “were potentially attributable to ... patient safety incident[s].”28 Depending on the source, medical error is the eighth-, sixth-, or third-leading cause of death in the U.S.29 Fatal injuries are only the tip of the adverse event/medical error iceberg, since over a million people are injured by medical treatments annually in the U.S. One study concluded that medical errors and quality problems in outpatient care resulted in “116 million extra physician visits, 77 million extra prescriptions, 17 million emergency department visits, 8 million hospitalizations, 3 million long-term admissions [and] 199,000 additional deaths.”30 1.7 million hospitalized patients acquire infections, many of which are preventable, each year. Researchers estimate that approximately 51 million prescriptions filled nationwide contained some type of error, including 3 million mistakes that were potentially harmful. Adverse drug events (ADEs) are estimated to result in more than 770,000 injuries and deaths each year. A study by the HHS Inspector General concluded that 13.5 percent of hospitalized Medicare beneficiaries experienced adverse events during their hospital stays, with 44 percent of these events “clearly

26 27

28 29

30

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Inst. of Medicine, To Err Is Human: Building a Safer Health System 31 (Linda T. Kohn et al. eds., 2000). See, e.g., Classen et al., supra note 22, at 586; HealthGrades, Patient Safety in American Hospitals 1 (2004) (180,000 deaths at least partly attributable to health care), available at http://www.healthgrades.com/media/english/pdf/HG_ Patient_Safety_Study_Final.pdf. Id. David A. Hyman & Charles Silver, The Poor State of Health Care Quality in the U.S.: Is Malpractice Liability Part of the Problem or Part of the Solution?, 90 Cornell L. Rev. 893, 901 (2005). Barbara Starfield, Is US Health Really the Best in the World?, 284 JAMA 483, 484 (2000).

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or likely preventable.”31 The OIG estimated that these adverse events cost the Medicare program roughly $ 4.4 billion in 2008. Articles published in a 2011 theme issue of Health Affairs provide a comprehensive portrait of medical injuries and their associated costs. One study finds that a commonly used approach for identifying mistakes captures only one-tenth of the serious adverse events that occurred in hospitals.32 Using a new method, the Global Trigger Tool developed by the Institute for Healthcare Improvement, the authors found that adverse events occurred in a shocking 33.2 percent of hospital admissions.33 A second study, which relied on claims data, found that medical errors generate over $ 17 billion in direct medical costs.34 A third study attempted to quantify the total social cost of medical errors based on the amounts people are willing to pay to avoid risks to their health. It found that medical errors, which account for 187,000 deaths in hospitals and 6.1 million injuries, entail an annual social cost ranging from $ 393 billion to $ 958 billion.35 No matter how one slices the data, or where one looks, the evidence is clear that medical errors and adverse events are distressingly common in the U. S. Some of these incidents are attributable to incompetence/inattention by an individual named physician, but many more are the result of systems-level failings, whose frequency is elevated because of the fragmented nature of the U.S. health care system.

B.

Malpractice Litigation

The malpractice system deals with medical errors/adverse events after they occur – although it is supposed to create an ex ante incentive to avoid such outcomes. There are many excellent literature reviews of the performance

31

32 33

34 35

Dep’t. of Health & Human Servs., Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries 15, 22 (2010), available at http://oig.hhs.gov/oei/reports/ oei-06-09-00090.pdf. Classen et al., supra note 22, at 586. Cheryl Clark, 1 in 3 Hospitalized Patients Suffers an Adverse Event, HealthLeaders Media (Apr. 7, 2011), available at http://www.healthleadersmedia.com/print/QUA-264653/1in-3-Hospitalized-Patients-Suffers-an-Adverse-Event. Jill Van Den Bos et al., The $ 17.1 Billion Problem: The Annual Cost Of Measurable Medical Errors, 30 Health Aff. 596, 602 (2011). John C. Goodman et al., The Social Cost Of Adverse Medical Events, And What We Can Do About It, 30 Health Aff. 590, 591, 593 (2011).

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David A. Hyman and Charles M. Silver

of the medical malpractice system, including several recent book-length treatments.36 We focus here on the frequency of claiming; compensation patterns (including the efficiency with which the liability system sorts cases); and time trends in claiming and payouts.

1.

Claiming Frequency (relative to rate of medical error/adverse events)

Although the conventional wisdom is that Americans are exceptionally litigious, there is evidence that “Americans are no more innately lawsuit prone than the Japanese, the supposed saints of non-litigiousness.”37 Studies of patients injured by medical malpractice indicate that “the great majority of patients who sustain a medical injury as a result of negligence do not sue.”38 One researcher estimates that ten to twenty claims are asserted for every 100 malpractice-related injuries.39 Rather than show that Americans sue too often, “the medical setting has provided the strongest evidence that the real tort crisis may consist in too few claims.”40 The first major study, which focused on patients hospitalized in California in 1974, estimated that negligent injuries exceeded malpractice claims by a factor of ten.41 Later studies, which focused on patients hospitalized in New York and Colorado/Utah, found ratios of negligent injuries to law-

36 37 38 39 40

41

488

See generally Tom Baker, The Medical Malpractice Myth (2005); see also Frank A. Sloan & Lindsey M. Chepke, Medical Malpractice (2008). Thomas F. Burke, Lawyers, Lawsuits, and Legal Rights: The Battle over Litigation in American Society 3 (2002). Studdert et al., supra note 8, at 2025. Michael J. Saks, Medical Malpractice ... By the Numbers, in Litigating Medical Malpractice Claims 399, 401 (ALI-ABA, 2008). Paul C. Weiler et al., A Measure of Malpractice: Medical Injury, Malpractice Litigation, and Patient Compensation 62 (1993) (reporting results of an extensive study of malpractice in New York hospitals); see also Lori B. Andrews, Studying Medical Error in Situ: Implications for Malpractice Law and Policy, 54 DePaul L. Rev. 357, 370 (2005). Don Harper Mills, Medical Insurance Feasibility Study – A Technical Summary, 128 West. J. Med. 360, 362–64 (1978); see also California Med. Ass’n & California Hosp. Ass’n, Report on the Medical Insurance Feasibility Study (Don H. Mills ed., 1977); Patricia M. Danzon, Medical Malpractice: Theory, Evidence and Public Policy 66 (1985).

United States of America

suits roughly in the range of 5–7:1.42 Other sources also find that injuries greatly outnumber lawsuits.43 Looking outside of peer-reviewed journals, one finds ample evidence that the frequency of errors greatly exceeds the number of claims. At the national level, in 2000 there were roughly 87,000 medical malpractice lawsuits filed – but that figure is less than the IOM’s upper-end estimate of a modest subset of medical errors (i.e., those that result in death).44 At the state level, in 2009, a Florida agency received reports of 4,137 injury incidents from medical facilities but the number of new malpractice claims was only 855.45 The same pattern is replicated in earlier years.46 Finally, a study of 1,047 patients at a Chicago hospital found that although 17.7 percent experienced “one or more errors with a serious injury,” only thirty nine (3.7 percent) requested their medical records, only five (