Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings: Comparative Law Perspectives (Ius Comparatum - Global Studies in Comparative Law, 53) 3030669998, 9783030669997

Table of contents :
Contents
Chapter 1: Compensation Schemes and Extra-Judicial Solutions in Case of Medical Malpractice. A Commentary on Contemporary Arra...
Preliminary Remarks
International Law on Health Within a Comparative Perspective
Patient as a Consumer of Healthcare Services
European Union Law Perspective
Dealing with Medical Malpractice
Compensation Schemes
Extra-Judicial Solutions
General Conclusions
Annex: Questionnaire-Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings
A. Compensation Schemes for Damages Caused by Healthcare
B. Alternatives to Court Proceedings
C. Proposals de lege ferenda
D. Systemic Remarks
References
Documents
Chapter 2: L´indemnisation des dommages résultant des soins de santé et les alternatives aux procédures judiciaires - Rapport ...
Introduction
Plan des développements qui suivent
Les régimes de réparation des dommages résultant d´accidents médicaux
Introduction
La responsabilité civile et la procédure civile
Le droit matériel et ses exigences
Les responsabilités contractuelle et extracontractuelle: un choix
La responsabilité contractuelle
La responsabilité contractuelle du médecin: le contrat médical
La responsabilité contractuelle des établissements de soins
La responsabilité extracontractuelle
Les principes
La charge de la preuve
La faute - une condition nécessaire de la responsabilité aquilienne
La faute - les contours prétoriens de la faute
Les difficultés probatoires
La situation particulière de la méconnaissance du devoir d´information
Le lien de causalité entre la faute et le dommage
Les contours prétoriens de la causalité
La preuve du lien causal
Les possibilités d´exonération du médecin
Le dommage et sa réparation
Les contours prétoriens du dommage et les conditions de sa réparation
Les principes civilistes gouvernant la réparation des dommages
Les postes de dommages réparables
La preuve du dommage
Les modes de réparation du dommage
La prescription
La procédure civile et ses exigences
L´action directe de la victime
Introduction de la demande et l´expertise
La responsabilité pénale et la procédure pénale
Introduction
Les aspects procéduraux
La coexistence des responsabilités civile et pénale
Une procédure souvent délaissée
Évaluation des procédures judiciaires
Les inconvénients de la procédure judiciaire
Les avantages de la procédure judiciaire
Les Voies Alternatives aux Procedures Judiciaires
L´intervention du Fonds des accidents médicaux
Introduction
Les innovations de la loi
Le champ d´application de la loi
Introduction
Le domaine d´application ratione materiae
Le domaine d´application ratione personae
Les conditions de l´intervention du Fonds
Introduction
L´accident « avec responsabilité »
Une intervention exceptionnelle du Fonds
L´accident médical « sans responsabilité »
La notion d´accident sans responsabilité
Évaluation de la procédure devant le Fonds
Des objectifs louables
Une mise en œuvre délicate
La voie de la médiation
La médiation régie par le Code judiciaire
Introduction
Deux types de médiations
Évaluation
La fonction de médiation « droits du patient »
Les droits légaux des patients
Évaluation
Conclusion
Chapter 3: Compensation Schemes for Damages Caused by Healthcare in Brazil
Introduction
The Function of Civil Liability: Additional Punitive Purposes or Purely Compensatory?
General Evaluation of the Brazilian Indemnification System
Relevant Normative Framework for:
Defining and Determining the Existence of Fault
Establishing a Relevant Standard of Care
Identifying the Existence of an Accidental Risk Related to the Physicians Performance (aléa thérapeutique)
Determining the Burden of Proof
Compensation Schemes for Medical Malpractice in Public and Private Hospitals
Prescription/Limitation of Actions
Alternatives to Lawsuits
Administrative Proceedings Before Self-Government Professional Associations
Mediation
Arbitration
Conclusion
References
Chapter 4: La responsabilité médicale et hospitalière en droit civil québécois : Principes généraux et alternatives à la voie ...
Introduction
LA responsabilité médicale et hospitalière en droit civil québécois : où en sommes-nous?
L´intensité de l´obligation des médecins et des hôpitaux et certaines considérations relatives à la détermination de la faute
L´intensité de l´obligation des médecins et des hôpitaux
L´analyse objective des faits à laquelle appelle la détermination de la faute : Le cas des médecins
L´incidence d´une condamnation ou d´un acquittement disciplinaire sur la responsabilité civile d´un professionnel
L´impact de la contravention à une norme déontologique sur la responsabilité civile du médecin
La nature de la responsabilité civile du médecin et de l´hôpital : contractuelle ou extracontractuelle?
La responsabilité du fait d´autrui en matière extracontractuelle et en matière contractuelle : certaines distinctions d´intérê...
Évolution et solution
La qualification du préjudice et certaines règles particulières concernant le préjudice corporel
La qualification
Les règles applicables en matière de préjudice corporel
Le lien de causalité
La possibilité de réclamer des dommages punitifs en sus des dommages-intérêts compensatoires
LE RECOURS AUX MODES ALTERNATIFS DE RÉSOLUTION DES CONFLITS COMME ALTERNATIVE À LA VOIE JUDICIAIRE ET L´OPPORTUNTIÉ D´IMPLANTE...
La possibilité de recourir à un mode alternatif de résolution des conflits comme alternative à la voie judiciaire
L´accès à la justice au Québec et la consécration de la priorisation des modes alternatifs de résolution des conflits à l´occa...
La problématique persistante de l´accès à la justice au Québec et certaines initiatives entreprises afin d´y pallier
La réforme de la procédure civile et le nouveau Code de procédure civile de 2016
Le rôle des MARC en droit civil québécois
Les principaux MARC et la diversité des options proposée par le législateur
Le choix de recourir à un mode alternatif de résolution des conflits et de ses modalités : un exercice coopératif impliquant p...
Le recours à un mode alternatif de résolution des conflits implique une obligation de confidentialité
Le recours à un mode alternatif de résolution des conflits n´emporte pas renonciation à agir en justice
L´avenir de la responsabilité médicale et hospitalière en droit civil québécois : vers un régime d´indemnisation sans égard à ...
Conclusion
Bibliographie
TABLE DE LA LÉGISLATION
TABLE DE LA JURISPRUDENCE
MONOGRAPHIES, OUVRAGES COLLECTIFS ET ARTICLES
Chapter 5: Medical Mal Practice and Mediation in Cyprus: Mediation as a Potential Way of Resolving Medical Mal Practice Disput...
Basic Principles, Key Features and Benefits of Mediation as an ADR Method
Legislative Framework of Mediation in Cyprus
Introduction to Medical Mal Practice
Medical Mal Practice in Cyprus
Medical Mediation
Bioethical Mediation or Mediation in Bioethics Disputes
Final Remarks: he Cypriot Reality on Medical Mediation-Proposals
References
Chapter 6: Compensation for Damages in the Cases of Medical Malpractice: Estonian Perspective
General Compensation Scheme
Court Proceedings
Limiting the Number of Medical Litigation Cases
The Normative Basis for HealthCare Providers Liability
Contractual Liability
Delictual Liability
Standard of Care
The Burden of Proof
Damages
The Aims and Limits of the Compensation for Damages
Non-Pecuniary Damages
Alternatives to Court Proceedings
General
Organisations Striving to Protect Patient´s Rights
Patient Insurance Act
References
Chapter 7: The French Medical Accident Compensation Scheme. A Critical Assessment of the Patients´ Rights Act of 4 March 2002
Introduction
General Overview of the French Compensation Scheme
Legal Background of the 2002 Reform
The Compensation Procedure
The Funding of the Medical Accident Compensation Scheme
The Rationale of Extrajudicial Compensation
Shortcomings of the French System
The Debates About the Criterion of Seriousness
The Complexity of the Legal Framework
The Weakness of the Conciliation
The Amount of Damages Awarded by the Compensation Commissions
The Ambiguous Role of the Compensation Office ONIAM
Conclusion
References
Chapter 8: Legal Questions Concerning Medical Malpractice Liability: Substantive Law and Its Enforcement
Procedural Framework, Purpose and Comparative Legal Positioning of Medical Malpractice Liability
Legislative and Judicial Framework Conditions of Medical Malpractice Liability
Medical Specialist´s Standard
Presentation in Trial and Proof
Substantiation
Experts
Burden of Proof
Principle and Exceptions
Prima Facie Evidence
Fully Manageable Treatment Risk
Consent and Information
Insufficient Documentation
Insufficient Qualification, Especially Beginner´s Surgery
Gross Malpractice
Gross Malpractice and Ordinary Findings Assessment Error
State Liability and Private Liability
Out-of-Court Dispute Resolution: Arbitration Boards and Expert Panels, Mediation
Ongoing Legal-Political Discussion in Germany and Lex Ferenda
References
Chapter 9: Challenges and Contradictions About Medical Malpractice in Hungary
General Issues and Numbers About Medical Malpractice in Hungary
The Relevant Legal Framework for Medical Malpractice in Hungary
Mediation as an Alternative to Court Proceedings
Agencies and Institutions Dealing with Medical Malpractice in Hungary
Challenges and Proposals About Medical Malpractice in Hungary
References
Chapter 10: The Judge, the Legislator and the Mediator. The Long Journey of Medical Malpractice in Italy
Damages Caused by Healthcare in Italy: An Introduction
The Nature and Purposes of Medical Liability
An Area of Growing Concern: Parliamentary Measures
The Normative Framework: A Matter of Case Law
Standard of Diligence
Burden of Proof
Causation
The Recent Legislative Reforms
Tools to Limit the Number of Medical Litigation Cases and Mechanisms to Diminish the Amount of Financial Compensation
Alternatives to Court Proceedings: Compulsory Mediation
The Contested Introduction of Compulsory Mediation
Mediation in Practice
and the New ``Pre-Action Expert Report´´
Concluding Remarks
References
Chapter 11: Liabilities for Damages Resulting from Medical Treatment and Dispute Resolution System in Japan
Liabilities for Damages Resulting from Medical Treatment
Compensation Schemes for Damages Caused by Medical Malpractice
Contractual Liability and Tort Liability
Issues Relating to a Doctor´s Negligence
Framework for Identifying Negligence
Establishing the Framework for Identifying Negligence in Accordance with the Medical Standard of Care
Medical Standard of Care and Medical Practices
A Doctor´s Duty When His/Her Ability Is Above the Medical Standard of Care
Issues Regarding Causation
Compensation Schemes for Damages Caused by the Side Effects of Drugs
Alternatives to Court Proceedings
Criticism of Medical Malpractice Lawsuits
Alternative Dispute Resolution (ADR) for Medical Accidents
Civil Conciliation
Alternative Dispute Resolution Service Provided by Local Bar Associations
Other Organizations
Other Systems to Remedy or Prevent Medical Accidents
No-Fault Compensation Schemes
Medical Accidents Investigation System
References
Chapter 12: Innovating Compensation for Medical Liability in the Netherlands
The Dutch Landscape of Medical Liability
The Legal Relationship Between Healthcare Professional and the Patient
The Relationship Between Healthcare Professional, Healthcare Provider and the Liability Insurance Company
Open Disclosure and Apologies
The Current Debate on Compensation of Damage Caused by Healthcare
What Makes Medical Liability More Difficult?
It´s Not (Only) About the Money
Patients´ Needs, the `Second Victim´, and the Importance of `Just Culture´
Efforts for Reform
The Healthcare Quality, Complaints and Disputes Act (Wkkgz)
Healthcare Complaints Law as a Non-adversarial Alternative to Liability Law
An Independent Complaints Officer or `Patient Contact Person´
Short Timeframe for Handling Claims and Complaints
Independent Healthcare Disputes Tribunal
Efforts from the Bottom-Up
Code of Conduct on Medical Incidents (GOMA)
The OPEN Learning Network of Hospitals
Conclusion
References
Chapter 13: Medical Injury in New Zealand
An Overview
History of Accident Compensation in New Zealand
Ambit of Cover
Categories of Cover
Personal Injury
Personal Injury by an Accident
Mental Injury
Occupational Disease, Heart Attacks and Strokes
Exemplary Damages
Treatment Injury
Background to the Treatment Injury Provisions
Definition of Treatment Injury
Personal Injury in Treatment Injury Cases
Causal Connection
Necessary or Ordinary Consequences of Treatment
Wrong Decisions
Residual Common Law Actions
Unwanted Pregnancies
Operation of the Scheme
Benefits
Making Claims
Funding
Administration
Evaluation
Affordability
Adequacy of Compensation
Deterrence, Incentives to Safety and Likelihood of Abuse
Accountability
Boundaries
Conclusion
References
Chapter 14: Medical Negligence Proceedings in Singapore: Instilling a Gentler Touch
Introduction
The Healthcare Industry in Singapore
The Current Legal Framework for Determining Medical Malpractice
Standard of Care
The Need to Show a Causal Connection Between Injury and Negligent Act
Towards a Less Adversarial Approach
The Promotion of Mediation as a Primary Way of Resolving Medical Disputes
Greater Court Case Management and Use of Pre-Action Protocols
The Use of Medical Assessors
The Advent of Mediation for Medical Disputes
Healthcare Mediation Scheme
Mandatory Mediation in Disciplinary Proceedings
Mediation Programs for Court Proceedings
The Effectiveness of Medical Mediation Programs
A Gentler Touch: An Attainable Goal?
References
Chapter 15: Damages in Medical Malpractice Cases and Alternatives to Court Proceedings: A Slovenian Perspective
Introduction
Compensation Schemes for Damages Caused by Healthcare
Compensation Claim
Liability for Medical Malpractice
The Basis of Medical Liability
Accidental Risk
Burden of Proof
Medical Malpractice Litigation
Alternatives to Court Proceedings
Proceedings Before a Competent Person of the Health Service Provider
Proceedings Before the Commission of the Republic of Slovenia for the Protection of Patient Rights
Mediation and Arbitration
Aim, Philosophy and Efficiency of Alternatives to Court Proceedings
Protection of Patients´ Rights
Pretrial Screenings
Proposals De Lege Ferenda
Systemic Remarks
Wait-Related Damages
Compensation for Quality Deficit in Healthcare
Fair Distribution of Limited Resources and Their Accessibility
Liability for Defects in Medical Products
Liability for Lack of Adequate Healthcare
Compensation for Infringement of Patients´ Rights
Conclusions
References
Chapter 16: Excessive Litigation for Harm Arising from Medical Malpractice in South Africa: Reasons, Consequences and Potentia...
Seeking Compensation for Harm Arising from Medical Malpractice
Instituting Contractual Claims for Harm Arising from Medical Malpractice
Instituting Delictual Claims for Harm Arising from Medical Malpractice
The Burden of Proof and the Effect of the Maxim Res Ipsa Loquitur in Medical Malpractice Cases
Concurrency of Liability for Harm Arising from Medical Malpractice
Excessive Litigation for Harm Arising from Medical Malpractice
The Availability of Pretrial Conditions, Time Limits and Limitation of Legal Practitioners´ Fees As a Way to Curb the Growth o...
Reasons for the Expansion of Liability for Harm Arising from Medical Malpractice
Consequences of the Expansion of Liability for Harm Arising from Medical Malpractice
The Use of Alternative Dispute Resolution Procedures in the Context of Medical Malpractice
Alternative Dispute Resolution Procedures That Are Generally Available to Victims of Medical Malpractice
The Legal Bases of the ADR Procedures
The Nature of the ADR Procedures: Voluntary or Compulsory?
The Aim and Philosophy of ADR Proceedings
The Regulation of the Medical Health Profession by the HPCSA
Proposals for Reform of the Law Relating to the Compensation of Harm Arising from Medical Malpractice
The Increased Use of ADR Procedures
Potential Reform Options Outlined in the SALRC Report
The Proposed State Liability Amendment Bill
Conclusion
References
Books and Articles
Chapter 17: Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings
Prelude: Overview of Taiwan´ Medical Malpractice Law: Walking Out of the Shadow of Criminal Liability
Compensation Schemes for Damages Caused by Healthcare
A Combination of Fault-based and Cause-based Compensation Scheme
Contractual Liability
Tort Liability
Vaccine Injury Compensation Program (VICP) 1988
Drug Injury Relief Program (1999)
Childbirth Accident Relief Program (2012)
Normative Framework
Defining and Determining the Existence of Fault, Standard of Care, and Accidental risk
Determining the Burden of Proof
Public and Private Hospitals
Efforts to Decrease the Frequency and Severity of Medical Litigation Cases
Alternatives to Court Proceedings
Settlements
Mediation
Administrative Mediation
Court-Facilitated Mediation
Arbitration
Taiwan Healthcare Reform Foundation ()
Proposals De Lege Ferenda
Systemic Remarks
References
Chapter 18: Alternative Compensation Schemes for Medical Malpractice in the United Kingdom
The Shape of Compensation for Medical Malpractice in the UK
The Relevance of Tort Law
The Relevance of Contract Law
Recovery and Regulation
Criticisms of the Overall Framework for Recovery
Related Redress Schemes in the Medical Context
Conclusion
Unpacking the Relevant Legal Rules
Understanding Fault in the Context of Medical Malpractice
Applying the Fault Concept in the Context of Medical Malpractice
Burdens and Standards of Proof in the Context of Medical Malpractice
The (Ir)relevance of the Public or Private Status of an Institution
Procedural Requirements in the Context of Medical Malpractice
Damage Caps and Limitations on Recoverable Harm
Particular Rules and Institutions Regarding Medical Malpractice in the UK
Procedural Protocols
Public Protection Agencies
Statutory Apology Rules
Disclosure in the Litigation Context
References
Cases
Statutes and Statutory Instruments
Books, Articles, Chapters
Reports

Citation preview

Ius Comparatum – Global Studies in Comparative Law

Dobrochna Bach-Golecka   Editor

Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings Comparative Law Perspectives

Ius Comparatum – Global Studies in Comparative Law Founding Editors Jürgen Basedow, Max Planck Institute for Comparative and International Private Law, Hamburg, Germany George A. Bermann, Columbia University, New York, USA

Volume 53

Series Editors Katharina Boele-Woelki, Bucerius Law School, Hamburg, Germany Diego P. Fernández Arroyo, Institut d’Études Politiques de Paris (Sciences Po), Paris, France Editorial Board Members Joost Blom, University of British Columbia, Vancouver, Canada Vivian Curran, University of Pittsburgh, Pittsburgh, PA, USA Giuseppe Franco Ferrari, Università Bocconi, Milan, Italy Makane Moïse Mbengue, Université de Genève, Geneva, Switzerland Marilda Rosado de Sá Ribeiro, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil Ulrich Sieber, Max Planck Institute for Foreign and International Criminal Law, Freiburg, Germany Dan Wei, University of Macau, Macau, China

As globalization proceeds, the significance of the comparative approach in legal scholarship increases. The IACL / AIDC with almost 800 members is the major universal organization promoting comparative research in law and organizing congresses with hundreds of participants in all parts of the world. The results of those congresses should be disseminated and be available for legal scholars in a single book series which would make both the Academy and its contribution to comparative law more visible. The series aims to publish the scholarship emerging from the congresses of IACL / AIDC, including: 1. of the General Congresses of Comparative Law, which take place every 4 years (Brisbane 2002; Utrecht 2006, Washington 2010, Vienna 2014, Fukuoka 2018 etc.) and which generate (a) one volume of General Reports edited by the local organizers of the Congress; (b) up to 30 volumes of selected thematic reports dealing with the topics of the single sections of the congress and containing the General Report as well as the National Reports of that section; these volumes would be edited by the General Reporters of the respective sections; 2. the volumes containing selected contributions to the smaller (2-3 days) thematic congresses which take place between the International Congresses (Mexico 2008; Taipei 2012; Montevideo 2016 etc.); these congresses have a general theme such as “Codification” or “The Enforcement of Law” and will be edited by the local organizers of the respective Congress. All publications may contain contributions in English and French, the official languages of the Academy.

More information about this series at http://www.springer.com/series/11943

Académie Internationale de Droit Comparé International Academy of Comparative Law

Dobrochna Bach-Golecka Editor

Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings Comparative Law Perspectives

Editor Dobrochna Bach-Golecka Faculty of Law and Administration University of Warsaw Warsaw, Poland

ISSN 2214-6881 ISSN 2214-689X (electronic) Ius Comparatum – Global Studies in Comparative Law ISBN 978-3-030-66999-7 ISBN 978-3-030-67000-9 (eBook) https://doi.org/10.1007/978-3-030-67000-9 © Springer Nature Switzerland AG 2021 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG. The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Contents

1

2

3

4

Compensation Schemes and Extra-Judicial Solutions in Case of Medical Malpractice. A Commentary on Contemporary Arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Dobrochna Bach-Golecka

1

L’indemnisation des dommages résultant des soins de santé et les alternatives aux procédures judiciaires – Rapport belge . . . . . . . . . Catherine Delforge and Camille Delbrassinne

41

Compensation Schemes for Damages Caused by Healthcare in Brazil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gisela Sampaio da Cruz

71

La responsabilité médicale et hospitalière en droit civil québécois : Principes généraux et alternatives à la voie judiciaire . . . . . . . . . . . Patrice Deslauriers and Sebastian Fernandez

97

5

Medical Mal Practice and Mediation in Cyprus: Mediation as a Potential Way of Resolving Medical Mal Practice Disputes . . . . . . . 139 Anna Plevri

6

Compensation for Damages in the Cases of Medical Malpractice: Estonian Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Dina Sõritsa and Janno Lahe

7

The French Medical Accident Compensation Scheme. A Critical Assessment of the Patients’ Rights Act of 4 March 2002 . . . . . . . . . 179 Jonas Knetsch

8

Legal Questions Concerning Medical Malpractice Liability: Substantive Law and Its Enforcement . . . . . . . . . . . . . . . . . . . . . . . 195 Andreas Spickhoff

v

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Contents

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Challenges and Contradictions About Medical Malpractice in Hungary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215 Balázs Tőkey

10

The Judge, the Legislator and . . . the Mediator. The Long Journey of Medical Malpractice in Italy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225 Alessandra De Luca

11

Liabilities for Damages Resulting from Medical Treatment and Dispute Resolution System in Japan . . . . . . . . . . . . . . . . . . . . . . . . 247 Hideki Ishibashi and Chihara Watanabe

12

Innovating Compensation for Medical Liability in the Netherlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269 Berber Laarman and Arno Akkermans

13

Medical Injury in New Zealand . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 Stephen Todd

14

Medical Negligence Proceedings in Singapore: Instilling a Gentler Touch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337 Dorcas Quek Anderson

15

Damages in Medical Malpractice Cases and Alternatives to Court Proceedings: A Slovenian Perspective . . . . . . . . . . . . . . . . . . . . . . . 353 Damjan Možina and Karmen Lutman

16

Excessive Litigation for Harm Arising from Medical Malpractice in South Africa: Reasons, Consequences and Potential Reform . . . . 371 Bernard Wessels

17

Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . 411 Hsiu-I Yang

18

Alternative Compensation Schemes for Medical Malpractice in the United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433 Colm Peter McGrath

Chapter 1

Compensation Schemes and Extra-Judicial Solutions in Case of Medical Malpractice. A Commentary on Contemporary Arrangements Dobrochna Bach-Golecka

Abstract The article deals with compensation schemes and alternative methods of dispute resolution in situations of damages resulting from medical malpractice. The topic is analysed within different perspectives. Firstly, the examination of human rights and public international law provisions is performed in order to identify the meaning of the right to health and the right to healthcare as a possible benchmark of healthcare provision in a domestic context. Moreover, this international legal approach is supplemented with European Union law analysis. Secondly, the relevant contemporary phenomena in the provision of healthcare are being dealt with. In this context patients are regarded as consumers of healthcare services while within the contemporary approach both parties of the medical relationship are treated as equal in their competence to make valid decisions concerning prospective treatment. Nowadays the authority of physician is based in her or his professional qualifications and the patient’s competence is rooted in the construction of informed consent procedure. Therefore the current process of providing healthcare resembles a scientific endeavour rather than a relationship with paternalistic legal element, it is not any more a dual medical contract but a situation concentrated on healthcare activities, with multilateral dimension and co-shared decision-making, alongside many lines of internal communication. Those characteristics of medical service are crucial within the process of identifying patterns of compensation arrangements and extra-judicial solutions in case of medical malpractice. The article aims at evaluating the possible and most often used methods of alternative dispute resolution in healthcare context within selected jurisdictions.

D. Bach-Golecka (*) Faculty of Law and Administration, University of Warsaw, Warsaw, Poland e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_1

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D. Bach-Golecka

Preliminary Remarks The contemporary legal theory seems to stress the importance of normative power of legal provisions, “the force of law” in the words of Frederick Schauer (Schauer 2015). This binding element of law plays a crucial role in the implementation phase of legal norms. Yet within human rights provisions the force of law is limited due to the internal characteristics of public international law which is based upon the agreement of states and subject to the enforcement methods undertaken at domestic level. Hence it may be stated that human rights are noble in character but weak in respect. The above remarks may serve as a broader legal context applicable to the normative framework related to the organization of healthcare system and enjoyment of the right to health. Those provisions are broadly recognized as international standards of human rights protection still subject to the enforcement techniques designed by states. Hence the question arises about the possible sanctions for non-enforcement or wrong enforcement of the right to health and the right to healthcare? Are there valid legal provisions dealing with situations of medical malpractice on domestic and international level? And if so, what is their nature— are those penal or civil, obligatory or voluntary, mandatory or soft-law instruments? What is the effectiveness of their usage for the proper application and implementation of a substantive right to health? It seems impossible to answer properly those questions within a single article or even in series of articles hence the present volume is devoted to a specific situation of adoption of civil law instruments designed to cope with instances of damages resulting from healthcare, with a supplementary limitation to those instruments that are used in extra-judicial settings. This specification deliberately excluding court proceedings is arranged on purpose, in order to focus primarily on contemporary developments in those non-criminal legal procedures which are designed to encompass the interests of parties engaged in healthcare services. The choice to exclude penal instruments from the scope of national reports and to concentrate on civil arrangements may be justified by various reasons. Firstly, the topic of malpractice and criminal liability seems to be well analysed within the contemporary legal doctrine (Ferrara et al. 2013). Secondly, it seems that civil law instruments provide for different opportunities for parties engaged in a dispute resulting from medical malpractice—those arrangements may fulfil compensatory aims (also with the possible accompaniment of various administrative procedures), transparency purposes, preventive goals or psychological relief. It may therefore expand outside the basic dual structure of legal complaint, based on an interaction between the patient and health practitioner, as it may also serve the accomplishment of more general, systemic, and even scientific goals. There are different groups of stakeholders engaged in the process of coping with health damages—primarily patients (alongside families of patients) and health practitioners, and on a secondary basis those actors engaged in healthcare provision within the administrative and managerial perspective: hospitals and their managers,

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public authorities (government) fulfilling the fundamental responsibility of securing the appropriate level of health of a population of a particular political community. Thirdly, one may also discern the possible involvement of medical insurers. Lastly, one may focus upon the impact of various individuals actively engaged in the process of deliberation on healthcare dispute: legal and para-legal practitioners such as judges, barristers, mediators, experts or advisors. The inclusion in the analysis of those various stakeholders’ perspective seems conducive to a proper understanding of the functioning of contemporary legal compensatory regimes. The paper is divided into separate parts dealing with particular aspects of the topic of compensation schemes and extra-judicial solutions in case of medical malpractice. Firstly, a focus on international law seems to be necessary in order to establish a proper meaning of the right to health and the right to healthcare, to pinpoint the actors responsible for the implementation of those rights. Within this section a notion of “minimum core” obligations would be presented alongside the explanation of the scope of international assistance and co-operation within the accomplishment of those core obligations. Secondly, the international approach would be supplemented with a European health law analysis—in order to establish whether there are traces indicating the possible evolution towards a common standard in European healthcare provision, based on the case-law of the Court of Justice of the European Union or within the recently adopted secondary EU law provisions based on health technology assessment. The third part of the paper is dealing with various aspects of contemporary provision of healthcare and the modifications of a traditional healthcare relationship resulting from the advancement of modern medicine, interrelationship with consumer law, rise of individual rights and the growth of new artificial technologies. The last part of the paper is focused upon different arrangement designed to cope with instances of medical malpractice and their impact upon the legal position of the parties to the dispute as well as the overall evaluation of compensatory system. A special attention is paid to the usage of alternative dispute resolution techniques and their growing importance in coping with cases of medical malpractice. As a conclusion the final commentary remarks are made in order to help a proper assessment of various legal procedures adopted globally.

International Law on Health Within a Comparative Perspective It seems that the need to provide for compensation schemes and various civil law arrangements in case of medical malpractice is firmly rooted within the international legal milieu. Therefore it should be analyzed whether there is one universal international standard of health protection or whether there are differences in health protection in particular countries due to the lack of willingness to participate in the particular international legal regime, adoption of various standards of human rights

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due to the civilizational and cultural characteristics or weak compliance and ineffectiveness inherent in traditional law (Gostin 2014, p. 70). Hence one may examine the topic of global health law within the boundaries of comparative international law that takes into account a specific legal situation of a particular state within the scope of obligations stemming from international human rights law, both within universal and regional perspectives.1 Traditionally, it was the task of governments and public authorities, with the assistance of various non-governmental organizations and charitable institutions, to organize healthcare facilities within the territory of the state. The evolution of the international human rights law did not challenge this primary responsibility of national authorities for the state of health of their population. It rather reinforced their mandate as healthcare providers and organizers. Nevertheless it is possible to discern a new aspect introduced within the scope of international human rights law in its healthcare context, namely the emergence of an individual right to health and healthcare (Toebes 2009, p. 366). In particular, one may quote the constitution of the World Health Organization adopted in 1946, which in its preamble stated the definition of health and recognized an individual right to health alongside the responsibility of governments for the health of their peoples, in the following manner: Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. The health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest co-operation of individuals and States. The achievement of any State in the promotion and protection of health is of value to all. Unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger. Healthy development of the child is of basic importance; the ability to live harmoniously in a changing total environment is essential to such development. The extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health.

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Within the right to health and healthcare a special focus should be given to the normative force of international documents, such as the Universal Declaration of Human Rights and the International Covenant of Economic, Social and Cultural Rights. As for the latter document, such countries as Cuba and the United States of America have signed but not ratified the treaty while Malaysia, Mozambique, Saudi Arabia, Singapore or United Arab Emirates have neither signed nor ratified the treaty. Hence, the task of comparative international law would be to evaluate the binding force of international legal instruments in order to ascertain whether those are valid or not for a particular state, irrespectively of the philosophical inquiry about the force of legal instrument as such (cf. Schauer 2015).

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Informed opinion and active co-operation on the part of the public are of the utmost importance in the improvement of the health of the people. Governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.

Within the above-quoted recitals of the WHO constitution it seems important to underline those aspects related to possible compensation schemes. Firstly, health which had been defined in a broad manner encompassing physical, social and mental well-being of an individual, is being regarded as a human right. Secondly, governments are responsible for the health of their peoples with the requirement to provide adequate health and social measures. Thirdly, the WHO constitution also requires co-operation among individuals and public authorities. Fourthly, right to health contains a profound international dimension—the health of all peoples is conducive to the attainment of global peace and security, and vice versa unequal development and disparities in health promotion in different countries may be regarded as a common global danger. Within this context the establishment of the World Health Organization (Treaty signature in July 1946, entry into force in April 1948) was designed as a vital action in order to promote co-operation among the Contracting Parties, with the aim of protecting the health of all peoples. A similar notion on health as a human right contains Universal Declaration of Human Rights adopted in 1948—art. 25 of UDHR elaborates upon health entitlements alongside other social benefits’ claims, namely: Art. 25 1. Everyone has the right to a standard of living adequate for the health and wellbeing of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control. 2. Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection. Universal Declaration on Human Rights was originally intended as a declaratory, legally non-binding instrument, an aspirational but not legal document (Brown 2016, pp. 34–35). Nevertheless it is claimed that nowadays the Declaration forms part of customary international law. Thus it could be used as a template for national legislation in order to provide a continuum between the international standard of human rights and protection under public and in particular constitutional law in particular countries. Moreover, it must be underlined that international human rights treaties are complemented with regional instruments—like the European Convention for the Protection of Human Rights and Fundamental Freedoms, the American Convention on Human Rights, the African Charter on Human and Peoples’ Rights. Within this regional focus on geographically identified human rights treaties, a special attention should be given to the Cairo Declaration on Human Rights in

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Islam adopted in 1990, which was developed more within religious and not solely geographical context. The Cairo Declaration contains provisions on a human right to medical care, namely: Art. 17 (a) Everyone shall have the right to live in a clean environment, away from vice and moral corruption, an environment that would foster his self-development and it is incumbent upon the State and society in general to afford that right. (b) Everyone shall have the right to medical and social care, and to all public amenities provided by society and the State within the limits of their available resources. (c) The State shall ensure the right of the individual to a decent living which will enable him to meet all his requirements and those of his dependents, including food, clothing, housing, education, medical care and all other basic needs. This provision is formulated in an analogous manner to the art. 25 of the Universal Declaration on Human Rights. Therefore one may state that irrespectively on the controversies connected to the emergence of a separate Declaration on Human Rights in Islam and the possible differentiation between the two documents (Mwamburi and Fahm 2018, pp. 137–138) the specific right to health and healthcare are designed in a similar manner in their substantive construction and parallel in their procedural form. It seems that the emergence of the Cairo Declaration on Human Rights in Islam prompted the international community to adopt (by consensus) the Vienna Declaration and Programme of Action within the World Conference on Human Rights held in Vienna in 1993. The aim of the conference and its subsequent document was to strengthen the normative force and uniform understanding of human rights regime. Vienna Declaration emphasizes equal importance between human rights of civil, political, economic, social and cultural nature, stating explicitly in art 1, par. 5 that: All human rights are universal, indivisible and interdependent and interrelated. The international community must treat human rights globally in a fair and equal manner, on the same footing, and with the same emphasis. While the significance of national and regional particularities and various historical, cultural and religious backgrounds must be borne in mind, it is the duty of States, regardless of their political, economic and cultural systems, to promote and protect all human rights and fundamental freedoms.

Commenting on the impact and significance of the Vienna Declaration one may underline the dual consequences stemming from the above document: on the hand Declaration stresses the importance of universality and indivisibility of human rights, on the other hand it recognizes the significance and validity of cultural, historical and religious peculiarities of the states. This dual dilemma reflects the present difficulties to unite international community within a uniform human rights document embedded with a normative legal force. Moreover, it should be borne in mind that declarations in international law are understood as non-binding instruments and examples of soft law (Blutman 2010).

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Vienna Declaration underlined the importance of the Universal Declaration of Human Rights as a source of inspiration and a basis for the United Nations Organization in the subsequent development of international human rights instruments, in particular the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights. As far as the substantive content of the right to health is concerned the relevant international law provisions contain the direct and clear requirement of national authorities to provide “the highest attainable standard of health”. It is the International Covenant on Economic, Social and Cultural Rights of 1966 that stipulate human right to health and right to healthcare in the following terms: Art. 12 1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (a) The provision for the reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child; (b) The improvement of all aspects of environmental and industrial hygiene; (c) The prevention, treatment and control of epidemic, endemic, occupational and other diseases; (d) The creation of conditions which would assure to all medical service and medical attention in the event of sickness. Hence, there is no uniform standard of health protection as the requirement of “highest attainable” level of health protection is by its very nature a specific standard, based on available resources within the economic and social level of development of a given country. Therefore such phenomena as waiting lists for medical treatment, deficits of quality of healthcare, limitations of access to healthcare should be viewed within a particular situation of the institutional provider of healthcare. According to the General Comment No. 14 of the United Nations Committee on Economic and Social Rights the right to health should be understood as including the characteristics of availability—functioning public health facilities, goods and services indispensable in healthcare have to be available in sufficient quantity within a given country.2 Moreover, those health facilities should be accessible—in the sense of equality of treatment (non-discrimination), physical (geographical) vicinity, economic affordability and information accessibility. Another criteria that all health

2 Facilities necessary for implementing the right to health are varied in their nature and include such determinants of health as safe and potable drinking water, sanitation infrastructure, hospitals and healthcare clinics, essential drugs (scientifically approved and unexpired) and trained medical personnel with domestically competitive salaries. It seems therefore that the notion of medical malpractice should be related to the possible infringements of the above-stated requirements of health availability; General Comment No. 14, para. 12.

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facilities, goods and services should comply with are acceptability in the sense of being respectful of medical ethics and culturally appropriate, and quality in the sense of being scientifically and medically appropriate and of good quality. One may wonder whether there is no absolute or minimum content of the right to health? Is this right a purely subjective provision that is subject to diminishing evolution in its substantive part in situation of financial crisis or radical economic poverty of a state? The concepts of “minimum core” or “minimum essential levels” pertain to obligations which are of a nonderogable character, constituting presumptive legal entitlements and obligations of strict liability (Young 2008, p. 115). General Comment No. 14 stipulates minimum essential levels of the right to health, including essential primary health care.3 The core obligations are to be fulfilled primarily and directly by a particular state. In the human rights discourse however, an issue of extraterritorial scope of economic, social and cultural rights has been debated, focusing on the principle of responsibility and the need to provide international assistance and cooperation (Langford et al. 2013; Bueno de Mequita et al. 2010; Skogly 2006). Therefore it is possible to distinguish the category of individual and collective spheres of engagement of public authorities within the implementation methods of the right to health.4 This obligation of international cooperation seems to be of vital importance for those states with economic deficiencies as for them external assistance may prove crucial for fulfilling the obligation of providing healthcare. Therefore the category of the so-called core obligations of states within the basic obligation to ensure the highest attainable standard of health is connected to this extraterritorial perspective of mutual responsibility of the international community.5 It seems that the normative situation without such an international extraterritorial involvement in human rights issues may result in questioning the very legitimacy of human rights regime. Then one may question the effectiveness of the human rights regime as a means of combatting inequalities and providing for social and economic justice (Moyn 2018). According to human rights scholars social inequalities result also in health inequalities (Marmot 2015). The United Nations Committee on Economic and Social Rights has issued various statements concerning the recommended human rights implementation techniques (General Comment No. 3, General Comment No. 14). Hence it seems beneficial to provide certain commentary upon them. Firstly, it is vital to place

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General Comment No. 14, para. 43. This conclusion is strengthened by precise statement of the art. 2 para 1. of the International Covenant: “Each State Party to the present Covenant undertakes to take steps, individually and through international assistance and co-operation, especially economic and technical, to the maximum of its available resources, with a view to achieving progressively the full realization of the rights recognized in the present Covenant by all appropriate means, including particularly the adoption of legislative measures.” 5 The idea is based upon the soft law document adopted in September 2011 entitled Maastricht Principles on Extraterritorial Obligations of States in the Area of Economic, Social and Cultural Rights (Bach-Golecka 2014; De Schutter et al. 2012). 4

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implementation obligations within the broader perspective of progressive realization of those obligations acknowledging also the constrains due to the limits of available resources. Secondly, there are—nevertheless—various obligations which are of immediate effect. In relation to the right to health states are under the obligation to guarantee that the right will be exercised equally, without discrimination of any kind. Steps taken by states should be deliberate, concrete and targeted as expeditiously and effectively as possible towards the full realization of the health right. The possibility of taking retrogressive measures is strongly limited and allowed only in situations when those measures are duly justified, after most careful consideration of all alternatives in the context of full use of maximum available resources. In relation to the right to health, state authorities should concentrate on three types of obligations: firstly, the obligation to respect requires states to refrain from interfering directly or indirectly with the enjoyment of the right to health; secondly, the obligation to protect requires states to take measures that prevent third parties from interfering with the right to health guarantees; thirdly the obligation to fulfil contains more detailed obligations to facilitate, provide and promote. This last type of obligation is the most elaborated one containing specific requirements to adopt appropriate legislative, administrative, budgetary, judicial, promotional and other measures towards the full realization of the right to health. Summarizing the above-presented remarks on the international human rights regime on healthcare provision it must be stated that the need to provide for compensation schemes and various alternatives to judicial proceedings in case of medical malpractice may be regarded as one of the factors conducive to respecting the international standard of health protection. While the right to health and right to healthcare had been enshrined in various international human rights treaties, implementation activities are reserved for national authorities. Therefore there is no uniform technique that is intended to execute the right apart from some monitoring competences of human rights agencies. Therefore, state parties to international human rights treaties are obliged to comply with those reporting procedures in order to induce a proper implementation of human rights provisions.

Patient as a Consumer of Healthcare Services The construction of international standard of health protection is based upon two pillars: on the one hand it is possible to discern the obligation of public authorities to organize health system and provide healthcare for the entire population of a particular country, on the other hand there is also an individual entitlement to health. The meeting point of those two perspectives: collective and individual, active and passive, provider and recipient sides—may be a healthcare service understood as an organized action aiming at health recovery and improvement of health condition of an individual patient. There are multifaceted new phenomena in the arrangement of healthcare that have a profound impact on the contemporary medical practice. Firstly, one may point to

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the increasing usage of new technologies in medicine (Reiser 2009), the impact of prospective involvement of artificial intelligence (Fosch Villaronga 2019) and consequences of processing big data in healthcare (Panesar 2019; Natarajan et al. 2017). Secondly, the current characteristics of healthcare policies may be depicted as a parallel and somehow paradoxical process of the pressing need to increase the level of financial means devoted to healthcare alongside the necessity to respect and implement financial constraints (Olsen 2009; Costa-Font et al. 2009). Thirdly, a recent phenomenon in healthcare is a new position of patients within medical environment, resulting in a modified vision of doctor-patient relationship and consequently in a changed construction of the healthcare service. The primary characteristics of the novel patient construction is her or his increased confidence and rise in healthcare knowledge (“doctor Google effect”), resulting in patients’ empowerment. The phenomenon of empowered self (Franck 1999) may be linked to the philosophical theory of individualism, based upon the principle of self-determination within the individual sphere. Self-determination means an ability, capability and willingness to create one’s identity, desire to selfconstruct oneself. An individually constructed identity may be connected to such legal issues as the choice of education, profession, place of residence, citizenship, name or surname, sex and sexual preferences, opinions, beliefs or religion, etc. A similar series of effects of the rise of an individual occur also within the sphere of healthcare; and the most profound of them may be described as the “democratization” of healthcare relationship connected to the demise of paternalism between physician and the patient. The contemporary evolution aims at treating both parties of the medical relationship as equal in their competence to make valid decisions concerning prospective treatment: the authority of physician is based in her or his professional qualifications, the patient’s competence is rooted in the construction of informed consent procedure. Therefore the current process of providing healthcare resembles more a scientific endeavour than solely bilateral communication, it is being performed within multilateral healthcare personnel dimension and co-shared decision-making, alongside many lines of internal communication (Malby and Anderson-Wallace 2017). Within the literature dealing with patients’ rights, elaborating in particular upon norms concerning informed consent, one may distinguish two major reasons for non-truthful disclosure of information to patients: firstly, promoting the patients’ best interests and secondly, preserving their autonomy (Cheng 2015). Nevertheless it seems that the reason connected to the protection of patients’ best interest is not regarded as a legitimate ground for non-disclosure of information or for providing misinformation, as it is argued the notion of best interest is based upon the principle of paternalism. Physician may understand best interest of a particular person in a different manner than the person himself/herself. Therefore, non-truthful disclosure of information should be limited solely to those situations when truthful disclosure would be conducive to limiting patients’ autonomy. On the other hand, providing for incorrect information to the patient may be regarded as a treatment error. In particular, information about errors or failures in treatment may be regarded as falling within the duty of providing all relevant

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information on the medical course of action. Physicians should hence adhere to selfdetermination education, within the meaning of fostering patients’ autonomy. In this vision patients should be treated “(. . .) as adult who are capable of understanding that medical treatment is uncertain of success and may involve risks”.6 Taking the above remarks into account one may conclude that the shift has moved from a reasonable physician standard to a reasonable patient standard—or the dual standard of reasonableness placed upon both parties to the medical treatment case. Within this context Olivier Quick indicated the transformation of the standard of professional dominance into an urge of patients’ safety (Quick 2017). This is a significant challenge that should require modified regulatory approaches to legal standards, education, training and culture conducive to improving patients’ safety, with an increased participation of patients themselves and their carers in securing their safety as the primary aim of healthcare treatment. The emphasis on safety may be embodied in designing safety management systems in hospitals, but also in collecting records on medical errors. It seems that those instances of medical malpractice must be examined and analysed in order to enhance safety in healthcare provision. The analysis of contemporary healthcare relationships show certain features that may prove crucial within the process of identifying patters of compensation arrangements and extra-judicial solutions in case of medical malpractice. The current model of healthcare seems to be based upon six main elements:7 firstly, the growing importance of medical knowledge; secondly, the need to provide appropriate level of care for patients; thirdly, the necessity to ensure efficient communication along double lines of patients and professionals. Two other elements deal with professional requirements: fourthly, the need to ensure professional standards of ethics and responsibility in the provision of healthcare and fifthly, the necessity to include practice as essential component of healthcare provision. Medical practice should be based on patterns of treatment, teaching and learning from medical records. Lastly, as a sixth point of current healthcare model one may discern a proper empathic pro-patient attitude within the system, advocating for them as clients, consumers and final recipients of medical services. Another possible impact of patients understood as individual consumers of healthcare services is the phenomenon of medical tourism (Glenn Cohen 2015; Hall 2013) which may also be analysed within the specific goal of healthcare—i.a. reproductive aims (Paraskou and George 2017) or suicide attempts (Sperling 2019). A specific type of medical tourism is the development of cross-border healthcare in the European Union, providing for individual mobile patients an alternative route of access to healthcare services.

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Montgomery v Lanarkshire Health Board [2015] UKSC 1; [2015] AC 1430. I am grateful to Prof. Patricia O’Sullivan, Director of Research and Development in Medical Education at San Francisco School of Medicine, University of California, for bringing my attention to those important elements of healthcare model.

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European Union Law Perspective The right to health and right to healthcare within the European human rights framework is regulated in the provisions of the Charter of Fundamental Rights of the European Union, which stipulates in the art. 35 the entitlement of an individual within the interrelationship of domestic law and European law, namely: Art. 35 Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all the Union’s policies and activities. Moreover, the impact of European Union health law upon the subject of compensation schemes and extra-judicial solutions in case of medical malpractice may be visible upon three decisive normative frameworks. Firstly, the influence is visible within deep involvement of patients as consumers of healthcare in the formation of a European regulatory framework; secondly the impact is connected to the case-law of the Court of Justice of the European Union within the so-called “medical line of adjudication” (Bach-Golecka 2015), stipulating possible standards of providing healthcare; and thirdly, it is linked with the process of gradual cooperation on health technology assessment. Within the first level, focused upon patients’ involvement perspective, it has to be underlined that the emergence and integration of EU health law may be connected to the direct involvement of active, conscious and “belligerent” European citizens, convinced about their rights stemming from the internal market fundamental freedoms and prepared to fight for their proper implementation and application in domestic legal regimes (Eigmüller 2013). Moreover, increased mobility of European citizens raised the importance of providing an adequate legal framework in order to guarantee their access to the necessary medical treatment while temporarily staying outside their member state of origin. It is the impact of those individuals’ actions which initiated judicial proceedings leading to direct involvement of the European institutions, such as the Court of Justice of the EU, European Commission, Parliament and the Council. Those institutions had actively engaged in a legislative process resulting in the adoption of the directive 2011/24/EU of 9 March 2011 on the application of patients’ rights in cross-border healthcare (“Mobile Patients’ Directive”). Within the second perspective based on the process of a medical line of adjudication of the European court one may mention such judgments as in the joined cases C-286/82 and C-26/83 Luisi and Carbone, the case C-159/90 Grogan and the milestone verdicts, commencing the development of an affluent line of subsequent rulings of the Court, in the cases of C-120/95 Decker and C-158/96 Kohll. Those judicial proceedings were initiated by the European citizens who firmly believed in the validity and importance of the Treaty provisions on internal market fundamental

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freedoms while the Court insisted and consistently repeated its original decision to include medical services as services regulated by the EU norms, irrespectively of domestic arrangements concerning the functioning of healthcare systems in the member states.8 In particular, the Court of Justice of the EU stressed responsibilities of the member states for the determination of their health policy and underlined that the process of organization, functioning and delivery of medical care and health services (art. 168 par. 7 TFEU) is not immune from the influence stemming from the EU law. Hence, public authorities engaged in realizing those competencies of the member states, should take into account basic tenets of the freedom to provide services. On the other hand, according to the standpoint of the Court of Justice, specific character of healthcare provision may justify the usage of the overriding reasons of general interest. The Court had identified in this aspect such interests as planning requirements relating to the aim of ensuring sufficient and permanent access to a balanced range of high-quality healthcare treatment in the member state; the wish to control costs of healthcare and to avoid, as far as possible, any waste of financial, technical and human resources. An important statement of the Court of Justice of the EU relevant for the subject of compensation schemes and extra-judicial solutions in case of medical malpractice comes from the judgment in joined cases C-157/99 Geraets-Smits and Peerbooms. The statement concerned the possible standard of medical treatment that should be used by domestic authorities in the process of healthcare provision. The facts of the case seems relevant here: Mr Peerbooms, a Dutch citizen, fell into a coma following a road accident, in December 1996. He was taken to the hospital in the Netherlands, and transferred in a vegetative state to the clinic in Austria in February 1997. According to judicial summary of the case, the Innsbruck clinic gave the patient special intensive therapy using neurostimulation. As a result of this treatment Mr Peerbooms came out of the coma, was able to leave the Austrian clinic in June 1997 and was transferred to the clinic in Netherlands to continue his rehabilitation. Within the administrative proceedings concerning cross-border medical treatment the Dutch healthcare authorities refused however to pay for the treatment Mr Peerbooms received in Austria stating that the neurostimulation technique should be regarded as an experimental procedure. It was used in the Netherlands only at two medical centers and solely for patients under the age of 25 years. Hence Mr Peerbooms who at the time of accident was 35 years old, was not a patient entitled to receive this treatment, and his request to refund the therapy that proved medically efficient had to be rejected. According to the explanations provided for in the files of 8

Therefore the Court developed specific rights and requirements, both for services providers and services recipients, on specific character of hospital treatment (in the case C-368/98 Vanbraekel; joined cases C-157/99 Geraets-Smits and Peerbooms; case C-8/02 Leichtle), on procedural provisions concerning prior authorization (in the joined cases C-385/99 Müller-Fauré and Van Riet; case C-56/01 Inizan; case C-145/03 Annette Keller; C-372/04 Watts) and in the most recent caselaw, on the situation of insufficient resources in the healthcare system (in the case C-173/09 Elchinov; case C-268/13 Petru).

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domestic court submitted to the Court of Justice of the EU, the refusal was based on the fact that, owing to the experimental nature of therapy using neurostimulation and the absence of scientific evidence upon its effectiveness, that type of treatment should not be regarded as normal within the professional circles concerned nor, consequently, as a healthcare benefit qualifying for reimbursement. The Court provided for remarks explaining the meaning of proposed medical or surgical treatment regarded as “normal in the professional circles concerned” (par. 83–98 of the judgment). The Court underlined that it is for the legislation of each member state to organize its national social security system and to determine the conditions governing individuals’ entitlement to benefits. In particular, a member state inspired with the aim of reducing financial costs of healthcare provision, may establish a limitative list excluding certain medical products and services (including specific hospital treatment) from reimbursement under its social security scheme. According to the Court, the European Union law may not in principle have the effect of requiring a member state to extend the list of medical services available and to be paid for by the social insurance system. The influence of the Union law is of an indirect character and thus member states must not disregard the European provisions; instead they should construct domestic lists of medicinal products in accordance with objective criteria and without reference to the origin of the products. National authorities are not allowed to justify their reimbursement decisions in a discretionary manner. The Court underlined the conclusions from the settled case-law that national derogations from fundamental freedoms, and in particular freedom to provide services, must be based on objective, non-discriminatory criteria, which are known in advance, and should be exercised without discretion or arbitrariness. Domestic procedures must ensure that requests from private parties are dealt with objectively, impartially, within a reasonable time and refusals to those requests are capable of being challenged in judicial or quasi-judicial proceedings. The precise meaning of proposed medical or surgical treatment regarded as “normal in the professional circles concerned” should therefore be clearly determined as otherwise it could be left open to a vast array of interpretations. In this context two major lines of interpretation are possible: national vision, according to which regard should be taken to those healthcare activities which are considered normal only in the national medical circles; and international vision, according to which regard should be taken to the state of international medical science and medical standards generally accepted at international level. According to the Court of Justice of the EU the latter vision is a correct interpretation of the phrase “normal in the professional circles concerned” on the basis of which the relevant circle is international medical science. In particular, member states should take into consideration all the relevant available medical information, such as scientific literature and studies, authorised opinions of healthcare specialists. It seems that from the institutional point of analysis it was the activism of the European Court that has provoked public debate concerning the scope of interference of the EU law on the provision of healthcare in the member states and led to the subsequent codification of case-law within the adopted Mobile Patients’ Directive

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(Greer 2013). The first conclusions of directive’s application in the member states stress the importance of territoriality in the organization of healthcare (Vollaard 2017) and lack of profound judicialisation of healthcare policies in selected member states (Martinsen and Diaz-Asensio 2017). The Mobile Patients’ Directive itself aims at securing the individual right of access to healthcare, a medical treatment that could be provided at a proper time and in a proper quality, corresponding to the needs of an individual patient. Nevertheless in the doctrine of European law there are various opinions as far as the normative force of the right of access to healthcare is concerned. Sometimes it is claimed that the individual right to healthcare in EU law may be treated as a kind of “escape route” for patients wishing to get access to medical services of better quality in the member states other than the member state of patients’ origin. Hence, EU law provides for a different option in the application of the right to health: instead of relaying and being subjected to the real conditions and deficiencies of domestic healthcare system, an individual is able to use and benefit from better healthcare systems in the other member state. An individual patient plays here an active role in designing a course of medical treatment and the choice of healthcare provider, and is not limited in those actions by possible inadequacies of domestic medical system. A major drawback however seems to be the financial requirement of the regime designed for in the Mobile Patients’ Directive, requiring the patients to finance themselves their access to medical services in other member states, subject to specific refund provisions. Another opinion on the normative force of the right to healthcare in EU law underlines that the right is still in the process of emergence, in statu nascendi, hence the vital role and impact of the Mobile Patients’ Directive lies not in its substantive provisions but rather within its procedural and administrative requirements which strengthen the institutional position of an individual vis-à-vis the authorities of the member state. Within the third perspective of the possible impact of European Union health law upon the subject of compensation schemes and extra-judicial solutions in case of medical malpractice, the process of gradual cooperation on health technology assessment should be examined. It seems that the provisions of Mobile Patients’ Directive aiming at the increased co-operation of the member states, especially within the process of e-health (telemedicine), rare diseases, reference networks and prospective standardization, may serve as a platform for the future development of cross-border healthcare in the European Union. The directive stresses the importance of the phenomenon of constant progress in medical sciences and health technologies, resulting both in opportunities and challenges to the health systems of the member states. It seems that initiating a voluntary process of cooperation in the evaluation of new health technologies may bring positive financial results through economies of scale and avoidance of duplication of assessment efforts. Moreover, the Mobile Patients’ Directive stresses the importance of mutual assistance among the member states, including cooperation on standards and guidelines on quality and safety of healthcare services. In particular, it is possible to use the instrument of European

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reference networks between healthcare providers and centres of expertise in the member states (art. 12 of the Mobile Patients’ Directive). Those networks should facilitate cooperation in order to exploit innovations in medical sciences and health technologies, to ensure mobility of expertise (in a virtual or physical manner), to develop, share and spread information, knowledge and best practices in the process of diagnosis and treatment. A vital provision concerning European reference networks deals with their goal of encouraging the development of quality, safety benchmarks and best practices. It seems therefore that the process of gradual evolution of the possible standards in the provision of healthcare within the European Union may be linked to voluntary cooperation and assistance among the member states, based upon the specific provisions on reference networks and procedures on health technology assessment. Those provisions are not obligatory for the member states, hence the process would not lead to unification of the European standard of healthcare. Nevertheless the process which adopts mechanisms of softlaw (Terpan 2015; Blutman 2010) may prove conducive to the gradual identification of common European standard of healthcare.

Dealing with Medical Malpractice The above reflections were focused upon the process of gradual development and identification of the standards of medical care within international human rights law and within regional European law perspective. The relevant provisions pinpoint obligations of public authorities within the provision of healthcare towards the population of a particular political community and also determine the appropriate level of available medical care. It seems that this standard of care is not completely subjective and subordinated to the specific conditions of an individual state but is rather dependent upon the universally adopted standard of medicine within international academia of healthcare sciences. Therefore it may be stated that this scope of analysis was a public one, with a primary focus on the conditions and requirements for a proper functioning of the healthcare system in a given state. One may state that the relevant standard of care of professional physicians is to be determined within domestic perspective, in accordance with inner regulations specifying the required standard. It seems that the obligation is structured as the obligation of means in order for physician to pursue appropriate course of actions, rather than to provide a specific result—to cure a patient or to deliver a requested medical outcome.9 Nevertheless one may state that the concept of inner standard of medical care is still an imprecise notion as it does not include the identification of those 9

There is a possibility to include a contractual obligation by healthcare provider to achieve certain outcome, most often in case of aesthetic medicine. In Europe, especially in German speaking countries, this type of healthcare activities is not deemed in high esteem within professional medical circles which may result in low social acceptance, with simultaneous paradoxical increase in the number of patients (Brandl and Schrader 2019).

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entities which are entitled to settle the appropriate standard: should this competence be left solely to medical professional circles or should the standard by determined by forces outside the profession, such as the government (public authorities), private health insurers or judicial system? In case of adopting the first solution and designating professional medical associations to articulate medical practice guidelines, the action could serve twofold aims (Mehlman 2012). On the one hand, guidelines would provide a positive function in order to define the appropriate standard of care within codes of good practices or codes of medical ethics, and on the other hand would define negatively the so-called “safe harbours” allowing avoidance of malpractice liability by those physicians who demonstrated that they had complied with the prescribed guidelines. It is vital to underline that both procedures which may be adopted in order to define the appropriate standard of care may possibly result in negative phenomena. In case of selecting the entities outside the professional medical circle the required standard may be provided in an economically unrealistic, technically difficult, too lax or too severe manner to be used by physicians. In case of selecting the entity responsible for defining the medical standard within the healthcare professionals, the problems with identification of a single standard emerge as well as providing the guidelines with a normative force, higher than soft law binding status. It seems that the middle option, of identifying the requested standard by physicians with the prospective collaboration of public authorities may be regarded as a means of avoidance of the above-presented drawbacks. As the standard of care is recognized as being determined with regard to the external circle of medical professional experts one may question what is the procedure for its precise identification. It seems that there is no generally accepted standard of care within the international sphere hence this process is being left to determination by public authorities of the particular state. The process of identification may be conducted with the aim of legal acts adopted by legislature, focusing on overall conditions of performing medical practice. The scope of standard of care within healthcare services may also be determined with the aid of inner professional regulations, provided for by medical professional authorities (medical selfgovernment) and granted subsequently legal validity by public authorities of the state. One may also discern the other possible method of determination of the required standard of care, with the involvement of medical experts in judicial proceedings, and identification of the medical practice (and reversely, malpractice) by judges on case-by case basis. It should be underlined that recognition and determination of the standard of medical care identifies the sphere of required medical practice, and subsequently, malpractice. Hence one may define the notion of “medical malpractice” as an instance of a seriously relevant infringement of medical practice, determined with regard to the required standard of care. The situation of medical malpractice is ex definitione specific, rooted in a particular instance of the provision of medical services to a given patient by individual healthcare provider or a group of healthcare providers, in a determined medical unit, with a usage of specific medical products in order to provide an individually identified course of treatment based on previously

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chosen healthcare techniques. In particular, a situation of medical malpractice may result from infringement of physician’s professional duties concerning provision of appropriate medical treatment, informing and advising patients and showing care, assistance, vigilance and support. Still one must admit that an instance of medical malpractice possess a radically different dimension as it is based upon the private impact of a particular relationship between healthcare provider and healthcare recipient. Hence the examination of the subject of medical malpractice and means designed to cope with this negative phenomenon seem to vary substantially from the previous analysis, based upon the study on international human rights law and European Union legal regime. In contrast, the medical malpractice study is focused primarily upon the concrete instruments and regulations adopted within particular legal regimes, with the aim to offer retribution, compensation, or reconciliation mechanisms for damages resulting from healthcare. This remark directs the medical malpractice analysis into the realm of private law with the essential and necessary comparative perspective. Therefore it is possible to distinguish separate proceedings designed to analyse situations of medical malpractice and to cope with their negative consequences. Firstly, one may indicate criminal prosecution procedures with the aim of providing sanction for a criminal offence, resulting within the medical milieu with gross negligence manslaughter or other criminal assault. In most of the instances damage to patients’ health results from carelessness and error of the healthcare practitioner. The prospective criminal sanction is designed in order to fulfil such fundamental goals as providing retribution, determining a proportionate punishment and serving preventive function. Nevertheless, it must be stated that the use of criminal law within the medical context is sometimes questioned (Herring 2012, pp. 104–105), arguing that carelessness seems to be an insufficient basis for criminal liability. Therefore one may think in this context rather about professional disciplinary proceedings which may perform similar functions as criminal law procedure. Disciplinary proceedings vary however from the ordinary criminal law procedure with their highly specialized content, focused upon medical standards, performance and outputs. Hence those may be described as a medical procedure designed in order to provide for effects very similar in their content to those used in the ordinary criminal procedure but applied within the specialized, medical context (Healy 1999). One may state that the benefits of professional medical disciplinary proceedings are of a twofold nature: on the one hand the construction of procedure seems specialized, efficient, and focused on the particular character of providing healthcare treatment, on the other hand this very same medical specialization may lead to negative phenomena connected to the ill understood professional group solidarity, resulting with possible lenient attitude of the corps entrusted with the task of providing judgments and sentences. The closed character of those groups, inner circles of medical professionals involved in the disciplinary proceedings, may lead to those negative consequences. It seems that the possible remedies are situated within the use of transparency principle, ensuring media coverage of debated cases and

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building of an institutional memory of disciplinary bodies. Hence this professional medical procedure may perform the attributable positive functions. The third option of dealing with instances of medical malpractice, apart from the criminal law proceedings or a procedure based upon professional medical disciplinary involvement, is connected to the broad sphere of civil law. Within this context one may discern two generally adopted procedures: firstly, traditional judicial proceedings based upon the involvement of judiciary in the resolution of the particular case of medical malpractice and damage resulting from healthcare, and secondly compensation schemes based upon the idea of substituting judicial proceedings with the involvement of other expert bodies then judiciary and using the procedures of a partly civil and partly administrative character, focused on no fault regimes of compensation. Nevertheless, it seems proper to conclude that the contemporary evolution of domestic regulations focused on the civil law procedures dealing with instances of medical practice within the above-presented two fundamental sections may, for the clarity of analysis, be formally divided into two units: one based on judicial involvement and the other situated within compensation schemes. The interrelationship between the two proceedings is a complex one as in many cases it was the inefficiencies of judiciary method of dealing with medical malpractice that led to the emergence and subsequent development of compensatory regimes. The other characteristics positioning judiciary and compensatory procedures as different regimes is the clear, private law foundation of judicial proceedings and a mixed, civil and administrative foundation of compensatory regimes. The dynamics of the contemporary process within the regulatory activities of public authorities indicate certain preference for the adoption of compensation schemes in order to cope efficiently with the growing number of cases with medical malpractice and damages resulting from healthcare. There are still some additional remarks to be done to supplement the proposed division of procedures designed to address instances of medical malpractice, namely: criminal law proceedings, professional medical disciplinary involvement, civil law judicial proceedings and compensatory regimes. Firstly, one has to mention the increased importance and growing usage of the alternative methods of dispute resolution in medical cases. It seems that this phenomenon may be linked to the analysed above evolution of patients as consumers of healthcare services; evolution which tends to transform the patients’ status, from a passive, non-expert and partially subordinated party of healthcare relations into an active, partially expert and equal party of healthcare relations. The consequences of this evolution are visible also within a procedural sphere connected to the determination of methods in order to deal with instances of medical malpractice. The growing adoption and usage of alternative methods of dispute resolution in medical cases seems to correspond to the newly identified and recognized needs of patients which do not fit properly into traditionally determined divisions of criminal and civil law. Those needs are based upon psychological, emotional, empathetic and spiritual dimension of medical services and hence they may be addressed within all identified procedures designed to deal with instances of medical malpractice. In this sense, those needs and

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alternative methods adopted to address them are cross-cutting the boundaries of traditional legal procedures and hence they may be visible within all identified procedures. The second remark to be addressed within the procedural analysis of methods designed to deal with medical malpractice is the growing importance of claims which would not concern “individual” ill performance of a professional healthcare practitioner but would rather deal with general systemic elements of healthcare system, endangering the proper functioning of the system and resulting in instances of malpractice towards particular patients. One may focus within this general approach upon the notion of institutional healthcare provider responsibility (hospital, medical units and their managerial staff), institutional medical products provider responsibility or general responsibility of public authorities to organize a properly functioning healthcare system, able to provide medical services of a proper quality at a proper time for all individual members of a political community. Within this last aspect such phenomena may be analysed as waiting lists for particular medical treatment, discriminatory differentiation in access to healthcare services and access to services of a good quality. Moreover, one may focus upon instances of infringement of monitoring functions of public authorities, in situations of exercising medical profession without necessary healthcare qualifications. There are also possible instances of maladministration, corruption or fraud in healthcare system that may be analysed within the broad concept of medical malpractice in the institutional sense. The competences of public authorities are connected to their sphere of functional autonomy as far as the design and organization of a particular healthcare system are concerned but it must be underlined that instances of malfunctioning of the system may also result in damage resulting from healthcare of a particular patient. It may be stated that situations of medical malpractice may also result as an effect of various interrelated factors, connected both to the particular person of healthcare provider and the medical institution of service provision. Within personal factors one may indicate such elements as professional qualifications and state of medical knowledge of a physician, choice and provision of healthcare treatment in accordance with the medical state of art, maintaining a regular and informed dialogue with patients, in accordance with informed consent requirements and provision of healthcare with due diligence and care. Within institutional factors (single healthcare unit perspective) one may indicate such elements as providing the necessary resources, healthcare equipment, drugs, medical products and other means available to a particular physician being engaged in the course of treatment. Within institutional factors (general healthcare provision perspective) one may indicate such elements as respecting planning requirements in the process of organizing healthcare system, in connection to medical schools, geographical location of hospitals and other healthcare units, appropriate distribution of human, technical and financial resources in accordance with general healthcare needs of a given population of a particular territory. There are differences between patients and physicians as far as the final outcome of medical malpractice litigation is concerned. Both players usually have

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heterogeneous beliefs about the final judicial resolution of the case: patients tend to be more optimistic and doctors more pessimistic when the severity of injury is higher, still the joint optimism diminishes as severity increases. Those factors may have an impact on the settlement probability and amount of total compensation granted by the court in particular medical malpractice case (Merlo and Tang 2019). The scope of analysis contained in the present volume is limited to selected aspects of procedures and methods dealing with medical malpractice. It concerns the means that are most interesting, relevant and actively used by public health authorities within the contemporary comparative perspective. Therefore the reports included in the volume, based on the examination of domestic regimes alongside the questions and topics provided for in the questionnaire, are focused primarily upon two carefully selected issues: firstly, the functioning of compensation schemes treated as alternatives to court proceedings, and secondly, the usage of alternative means of dispute resolution treated as extra-judicial solutions. Other proceedings based upon the criminal, disciplinary and civil procedures are analysed too, still the scope of examination is of a supplementary and complementary character. The choice of the main topics of comparative analysis seem to be legitimized procedurally, by the broadly recognized phenomenon of inefficiencies in judicial proceedings and substantively, by growing importance and “empowerment” of patients as active consumers of healthcare services.

Compensation Schemes The first compensation schemes were introduced in New Zealand (1974) and in Europe most consistently in Scandinavian countries. In those and other jurisdictions the introduction of compensation schemes in case of medical malpractice was motivated by various reasons still it is possible to find those factors that were common to different countries (Bączyk-Rozwadowska 2013). Within the literature dealing with medical liability a phenomenon of “malpractice crisis” was identified and linked to inefficiencies of the traditional civil law procedures based upon judicial decision-making competences. Those negative aspects concerned the prolongation of judicial proceedings, high financial costs of trial for patients participating in those proceedings, with the economic burden of legal representation (contingent fees) incumbent upon them, uncertainty as for the judicial result prospectively granting, restricting or even refusing compensation for victims of damages resulted from healthcare services. One could evaluate such situation as limiting access to justice for patients. In general those factors resulted in a very low number of medical judgements positively granting compensation for patients-victims of medical malpractice. In this context one may also indicate other factors contributing to the negative evaluation of judicial litigation in case of medical malpractice, such as profound cognitive problems connected to the technical and highly specialized language used widely within the texts of medical expert opinions, lack of access for potential

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victims of medical malpractice to the necessary records and documentation on applied treatment, or a phenomenon of solidarity of healthcare practitioners unwilling to testify to the detriment of their colleagues. Another negative phenomenon was the rise of the so-called “defensive medicine” designed and performed with the primary aim of preventing the rise and recognition of medical liability of healthcare professionals. Defensive medicine may be defined as “departing from normal medical practice as a safeguard from litigation” (Brogiene 2019, p. 37). It may take the form of performing more unnecessary tests, referring patients to consultants or to hospitalization. Many physicians take this attitude as a part of defensive professional culture. The negative consequences of defensive medicine is diminishment in the quality of care and contributing to waste of the limited resources in healthcare sector. The development of defensive medicine may be regarded as physicians’ responsive technique in order to cope with the risk of increased litigation in case of medical malpractice. Those healthcare actions that are undertaken as a means of selfprotection by medical staff comprise in various additional unnecessary tests or unwillingness to adopt a particular course of treatment that may be regarded as being too risky. The major negative consequence of defensive medicine is the rise in the financial cost of healthcare; moreover its usage prevents the development of medicine based upon scientific progress made also on errors. Within this context there is still another possible strategy that physicians may follow—apart from engaging in defensive medicine techniques—which is based upon the acquisition of medical malpractice insurance. This latter choice transfers the risk of litigation from physician to the insurer (Antoci et al. 2019). Nevertheless, it must be underlined that within the contemporary healthcare legal literature there is a consistent critique of defensive medicine; moreover, recent approaches to liability reform aims to discourage defensive medicine (Agarwal et al. 2019). Historically compensation schemes for damages resulting from healthcare originated alongside other systems of compensation: firstly, one can mention industrial (work) injuries compensation system, and secondly, road (communication) injuries compensations. One may state that medical malpractice compensation system was designed to complement those two others systems which were connected to most frequent situations of experiencing injuries in situations of everyday life. Hence introduction of systems that were ex definitione designed as containing simple structures and procedures, focused on fast problem-solving of an injured individual, may be regarded as a parallel process. The fundamental aim was to make it easier for a person to receive compensation without a need for him or her to engage in judicial proceedings which were experienced in most cases as being prolonged, expensive, substantively and procedurally complicated procedures and uncertain as their final outcome is concerned. Compensation schemes offered a substantial relief from those negative characteristics of judicial regime. Firstly, those schemes were designed upon the fundamental notion of no fault—and subsequently did not contain a requirement to state fault of healthcare practitioner as a necessary prerequisite to grant compensation. The new idea was to focus solely on an existence and scope of an experienced damage resulting from medical malpractice and the causal link between the damage

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and actions or omissions undertaken by healthcare practitioners within the course of medical treatment. Secondly, the fundamental construction of compensation schemes was to offer relief to an individual who experienced injury—in the form of compensation designed in order to cope with the damage and oriented as restoring the conditions before the accident (occurrence of damage). Procedurally medical compensation schemes were constructed upon the newly introduced commissions or other collective entities, separate from judicial bodies. The construction idea of those institutions was to include as their members representatives of the groups engaged in the medical situation: health practitioners, lawyers and patients, sometimes also insurers. The aim of introducing such a composition of members was to secure the legitimacy of compensation system—in order to be socially regarded as impartial and effective, in the sense of capable of reaching a compromise among the parties most interested in the solution of the case. Secondly, medical compensation schemes were designed as a cost-free, fast and effective procedures, with minimized formal requirements. The third distinctive feature of compensation schemes is its written character, based upon the desire to avoid a direct dispute between the parties involved. Hence, the procedure from patients’ (consumers) side does not require a subsequent contact with health practitioner or health provider. Such an arrangement may be evaluated on a twofold basis. On the one side, it corresponds to the basic foundations of consumer protection law providing for legal regimes oriented towards the protection of consumers’ interests as the weaker side of legal relationship (Micklitz and Saumier 2018). The written procedure and the analysis of the complaint by a collective body, external to the parties of a particular medical service resulting with a health damage, seem to secure the principle of trust between the patient and healthcare practitioner. The proceedings of the compensation commission are based upon the examination of expert opinions provided for by representative of medical profession and individuals not directly engaged in the situation giving rise to compensation complaint. This structural element inevitably is conducive to the smooth and efficient proceedings of compensation commission. On the other hand, one may pinpoint that those structural elements which were designed in order to secure the interests of patients and to enhance the effectiveness of compensation proceedings, may simultaneously be regarded by the very same patients as infringing their entitlements which arose as a result of medical malpractice. The patients may demand a more personal approach towards the issue of compensating for damages caused by healthcare, with their psychological need of securing certain actions of a non-compensatory (non-financial) character. Those actions may involve, i. a. an official statement about the facts and omissions of the case, possible explanations for the emergence of malpractice, assurance of adopting measures in order to prevent the occurrence of similar situations in the future, expression of an apology from the healthcare practitioner. Therefore one may conclude that those emotional needs of patients regarding themselves as victims of medical malpractice may not be properly and sufficiently addressed within the compensation schemes. It is there, however, were the necessity of using

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complementary mechanisms is clearly identifiable; those empathic instruments are adopted within extra-judicial, alternative means of medical dispute resolution. As for the negative aspects of introducing compensation schemes one may indicate in this context the compulsory nature of the scheme and the limitation or loss of the right to sue. As for the financial element of compensation awards, one may argue that due to the systematic reasons the average level of those awards seems to be ex definitione lower than the level of compensations granted in judicial proceedings.10 The arrangement which is commonly used within domestic compensation schemes in particular jurisdiction is based upon the inclusion of limits as for the maximum compensation award in an individual case or the minimal amount of damage under consideration. Therefore there is an intrinsic tension between the fundamental principle of full compensation for damages and the structural element limiting the amount of granted awards (damage caps). The introduction of triviality threshold may be linked to pragmatic, economic aspects of the construction of compensation schemes in order to avoid the necessity of dealing with minimal, non-significant claims. Hence this element of compensatory procedure is based upon the principles of rationality and flexibility granting certain scope of autonomy for the bodies monitoring compliance with particular substantive norms, and allowing them to abstain from dealing with minimal claims (de minimis rule). Another negative aspect of compensatory regimes may be connected to the automatic, mechanic feature of the proceedings which typically do not require direct participation of the parties of the medical relationship in the compensatory proceedings. On the patients’ side this factor results in the lack of addressing emotional and psychological needs linked to the feeling of experienced harm, as well as cognitive demands focused at the process of identification of the circumstances of malpractice. Therefore the performance of apology actions by healthcare practitioner is hindered or even impossible. It seems that those structural elements of compensatory proceedings may lead to prospective rise of parallel criminal or disciplinary claims in order to establish firmly individual active involvement of the members of healthcare staff within the occurrence of health damage. Those claims in principle could be initiated by patients. On the physicians’ side (as well as other members of the healthcare personnel) the formal and indirect character of compensation schemes impedes upon the prospective preventive aspect of compensation schemes. Once again and similarly to the approach experiences by patients, cognitive demands urging for the clarification of the circumstances of a particular damage occurrence, may not be properly and fully satisfied. The overall result is the diminishment of the preventive role of compensatory proceedings. There is no single, uniform and universal compensation scheme for damages caused by healthcare. Particular compensation regimes vary in their foundational principles and detailed rules of functioning, similarly to the existing differentiation

10

This argument may be evaluated on a twofold basis: within individual perspective the level of prospective compensation is usually lower than secured in judicial proceedings; within collective (general) perspective fixed compensation amounts can provide significant monetary benefits.

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among domestic healthcare systems (Koch 2011). The process of emergence of compensation schemes and their subsequent development and rise in importance are mostly due to the level of inefficiency of the previously existing regimes (malpractice crisis) based upon judicial proceedings and other enforcement procedures, linked to social security systems. Therefore the differences among compensation schemes are based upon the various sets of legitimate types of damages, including relatively modest list of damages to broad catalogues encompassing also negative effects of medical experiments or of clinical drug testing.11 Moreover, it is possible to distinguish specific compensation schemes enacted in order to deal with particular types of healthcare damages, resulting from negative side-effects of vaccinations, specific types of illnesses or applying particular drugs. Specific compensation schemes may also be used by different hospitals, by their voluntary action and with the usage of their compensatory funds. The other perspective of differentiation among compensation schemes is connected to the parties eligible to take an active part in the compensation proceedings, to lodge a complaint and to receive compensation. Moreover, compensation schemes are using various types of compensation awards, based upon single lump sum or upon periodic payments. The other source of possible comparison among compensation schemes arises from the funding source of the system, which may be based within insurance-type of funds, financed from taxes, contributions from healthcare entities, or public budget money. The procedure used in the compensation schemes may resemble a public procedure (a quasiadministrative procedure, like in France), still without much of the bureaucratic burden. A certain type of nucleus of compensation scheme may be visible in the collective arrangements provided for within judicial systems, aiming at establishing a common methodology for courts to determine an appropriate (just and decent) level of compensation in cases of damages resulting from medical malpractice (pain, suffering, loss of faculties, amenities, rules on possible increase or decrease in compensation in a particular case). An example of such an attempt may be the regulatory situation of medical and health law in the Czech Republic (Holčapek 2013). One may question the normative force of such extra-judicial and extra-legislative arrangements still in practice the impact of such arrangements may be vital for ensuring the parallel outcome of judicial compensation judgments. Another type of partial implementation of compensation schemes within a jurisdiction (with Taiwan as example) may be based upon the introduction of specific administrative no-fault systems, connected to a particular type of damage, such as vaccine injury, accidents during childbirth or drug adverse reaction. Specific duties which may be linked to those particular compensation schemes may be connected to actions of care, assistance, report and evaluation.

11

One may conclude that the there is a negative correlation between the scope of damages subject to compensatory proceedings and the financial amount of the fixed compensation claim. Hence, the broader the scope of damages’ types, the lower amount of individual compensatory award.

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Extra-Judicial Solutions The need to apply various alternative methods of dispute resolution (ADR) may be connected to possible negative evaluation of judicial procedures, in particular related to the prolonged duration in time of those proceedings, the complexity of litigation and the burden of formalities connected to the need to present, determine and respond to opinions based on medical expertise. Nevertheless one should also bear in mind positive aspects of judicial procedures, most notably the high formal status and credibility of a judgment delivered by an independent and impartial judge. There are also some jurisdictions, most notably Germany, with successful judicial malpractice litigation record, due to the most rigorously trained medical experts and also due to facilitations on the burden of proof. Within other jurisdictions, like in Spain, it is claimed that no significant differences between noneconomic damages in civil and administrative appeals are to be found. Hence even in the current era of juridification and judicialization judicial litigation path should not be abandoned (Amaral-Garcia 2019). While in most cases the reason of introducing ADR is the phenomenon of overload of judicial procedures dealing with medical malpractice cases there are jurisdictions were the mutual interrelationship between judicial and alternative methods of dispute resolution is of the opposite character—there the number of suits in court is relatively low because the parties are willing to settle down the dispute within bilateral negotiations and reach an agreement without the need to initiate court proceedings. It seems that fostering the process of using alternative methods of dispute resolution is conducive to acknowledging situations of errors and offering reasonable compensation to injured parties. This process facilitates open communication, transparency and trust. Within the scope of alternative methods of dispute resolution one may indicate therefore such instruments that were designed primarily to help patients as possible victims of medical malpractice to be granted compensation or at least non-prolonged resolution of the case. In this latter instance it is possible to discern various means with the aim of providing for specific, simplified, fast-track procedures, especially while dealing with low value claims. Within the instruments used in connection to alternative means of dispute resolution one may discern such methods as arbitration, mediation, negotiation or conciliation procedures. In some jurisdictions a special role had been granted to the ombudsperson. It seems that the usage of ADR is most frequent in those states where patient-physician relationship is being treated as a consumer-type relationship. It should be underlined that those remarks are applicable also within the adoption of compensation schemes still both regimes address different needs of patients. Compensation regimes are focused upon the settlement of the medical dispute in a financially satisfactory manner, with the primary aim to provide for a compensation adequate to the experienced damage. Alternative means of dispute resolution aim at fulfilling different patients’ needs, correlated with the sphere of psychology, emotions and spiritual dimension.

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Among alternative methods of dispute resolution one may distinguish mediation which may be characterized as a structural and confidential process based upon the cooperation of the parties to the dispute, with the engagement of the neutral, independent, impartial and professional mediator. The mediator’s aim is to foster an amicable solution to the dispute, with the usage of various communication and negotiation techniques. The proposed solution is usually not binding in the sense of being solely a proposal of dispute resolution which is per se neither an obligatory nor a recommended option. It is possible to distinguish two various types of mediation, firstly, mediation recommended by the judge, in the course of judicial proceedings or within the pre-trial phase of the judiciary action and secondly, a voluntary mediation undertaken by the parties without such an active role of the judge. The mediatory proceedings are confidential and therefore do not attract publicity as in case of judicial procedure; the outcome of mediation is binding for the parties in accordance with domestic legislation. One may underline positive aspects of mediation in its possible amicable character which is difficult to maintain within litigation, with its clear lines of division and conflict. In mediation proceedings the parties are more prone to reach a peaceful settlement of the dispute as there are structural incentives to accomplish an effective solution, acceptable to both parties. In many cases the heart of the dispute discussed in mediatory proceedings is focused upon emotional needs of apology and prospective reconciliation of the participants of malpractice situation, with an urge to adopt measures in order to prevent the occurrence of similar events in the future. It seems therefore that alternative methods of dispute resolution are applied in recognition of a “human” aspect of medical malpractice situations—as patients do not require superhuman cognitive capabilities of physicians or their infallibility; they are willing to accept the possible occurrence of side-effects of the proper course of applied medical treatment or other unexpected events. There are different arrangement as far as the possible usage of alternative means of dispute resolution are concerned. Those limitations may concern the objects of damage, restricting access to those methods in case of grave damages, like death of the patient, serious bodily injury or sexual assault. Another category of limitation is based upon prescribed time-limits, allowing for a commencement of mediation or conciliation procedures solely within the pre-trial or pre-inquiry period. There may be two-side mediation, comprising of the patients’ and physicians’ sides, and multiparty mediation, involving other actors, like insurance companies, in the mediation process. The possible usage of ADR is connected to the contemporary health policy of public authorities; sometimes it would be possible to link the incentives to apply those means with the overall reform of health systems. Within the contemporary health systems based upon Bismarckian foundation principles one may identify the trend to introduce major reforms, especially in the period following the financial crisis. Those reforms rely on the policy learning process within actor coalitions and they also take into account such factors as ambiguity and timing. Therefore, as the study analysis reveals, major policy change may result as a learning outcome, either combined with a negotiated agreement or with a window of opportunity opening the

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problem stream (Bandelow et al. 2019). The application of ADR techniques may also be subject to the policy based upon flexible approach, designed in order to cope with the difficulties experienced within a particular health system. Therefore in some domestic jurisdictions increased usage of ADR may be encouraged in order to decrease the number of medical judicial proceedings in courts. In other jurisdictions ADR techniques may be used as a means not only to alleviate the courts’ caseload but rather to prevent medical dispute from being transformed into a judicial case. Another reason for recent ADR increased usage is the intention to facilitate smooth and rapid analysis of the facts of the medical case, with the involvement of professional medical experts. Therefore one may conclude that the usage of ADR techniques is not completely voluntary in the sense of being the result of a free decision of parties to the dispute but rather their factual application is being reinforced by deliberate action of public authorities, aiming at the fulfilment of particular medical malpractice resolution goals. One should not overestimate the role of public authorities in promoting the usage of ADR techniques. It seems that the adoption of relevant legal provisions enabling the parties to use ADR in order to settle medical malpractice disputes may not be a sufficiently effective method to increase the application of ADR instruments. There is a need, as the Cypriot example reveals, to supplement the legal provisions with the promotion activities, first providing information and secondly, advertising on positive aspects of ADR techniques in comparison to traditional judicial procedures. In other words, there is a need to transform the prevailing “litigation friendly” system of resolving cases of healthcare damage into an environment conducive to mediation solutions which seems more responsive to patients’ needs. Moreover, one may indicate another crucial factor in fostering the usage of ADR mechanisms which is based on gaining support of legal professionals and to engage in the process of convincing them on the positive aspects of the increased application of extra-judicial instruments for the resolution of healthcare disputes. It seems that representatives of bar associations may adopt different standpoints as far as the usage of ADR techniques is concerned: negative, fearing about the possible loss of income stemming from judicial litigation (as Italian example reveals) or positive, based primarily on the efficiency of dispute resolution (as indicates Japanese example). Therefore one may conclude with the need to maintain a dialogue between public regulators and representatives of legal professionals. The emotional needs to be addressed within medical malpractice mediation proceedings are not solely those of patients’ but also those of physicians’ and other members of healthcare team. As far as patients’ emotions are concerned those may be linked to feelings of grief, despair, anger, frustration, isolation, desire for revenge or confrontation with medical staff. As far as physicians’ emotions re concerned those are connected to such feelings as shame, loss of self-respect and selfconfidence, frustration, fear about the possible negative consequences of medical malpractice. One may conclude that there is a certain common perspective within the emotional side of healthcare damages which is based on feelings of sadness, both of

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patients’ and physicians. This psychological aspect should therefore be regarded as an indicator for commencement of mediation procedures.12 Summarizing the above statements it may be concluded that the intention to introduce and use ADR techniques may produce negative standpoint within the legal professionals’ milieu as they may fear the drop or loss in revenues. It seems that such a reserved attitude may be eased with the introduction of the requirement of mandatory patient’s assistance by a legal representative. The financial cost of using ADR techniques is going inevitably to rise, still the support of lawyers to use those means would be gained. There is also a certain level of flexibility as far as the prospective usage of ADR instruments are concerned. Voluntary ADR mechanisms are typically encompassed within such means as negotiations, mediations and arbitration. In those jurisdictions where the ADR means is not fully provided for in the judicial system one may state that some of those techniques may be used by the parties as de facto instrument of settlement of claims stemming from medical malpractice rather than legally provided means of addressing the healthcare damage claim. As for evaluation of specific ADR instruments it may be stated that the comparison of arbitration as an alternative method of resolution of medical malpractice disputes and judicial proceedings reveals that arbitration is a faster and cheaper way of dispute settlement. Nevertheless, arbitration may be flawed with lack of necessary professional legal expertise and enforcement difficulties. The later problem may be resolved within the scheme of judicial proceedings’ involvement—in Estonia the Supreme Court declared in 2014 the requirement that all decisions of arbitral tribunals should pass the court proceedings in order to be recognized and declared subject to enforcement. Still one may argue that such an arrangement is a complex and superfluous procedure and diminishes the prospective positive aspects of arbitration method of conflict resolution. In some jurisdictions, like in Germany, ADR instruments may also be used in a pre-trial period, with prospective judicial proceedings being possible to be commenced only after a conciliation effort had been undertaken. In other jurisdictions, like in Hungary, ADR is almost unknown with no reform expected in the near future. In other jurisdictions, like South African, the aim and philosophy of ADR proceedings may be clearly visible within overall judicial litigation preponderance. Mediation option is regarded as more time-efficient (the largest number of mediations are completed within the period of one day!), financially affordable, promoting constitutional and human rights guarantee of access to justice and the principle of equality. The involvement of mediator may prove crucial for reaching a mutually amicable settlement, for combatting the factual imbalance between the parties: stronger professional physician and weaker patient victim and for proposing an individually designed win-win solution instead of win-loose result.

12

The psychological element of mediation procedures indicate also the need to train physicians and other members of healthcare teams in effective communication skills, dialogue, and empathic sensitivity.

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Some jurisdictions, such as the Singapore regime, provide for a special role of ADR instruments in an attempt to modify an adversarial medical litigation paradigm—in particular through the promotion of mediation and negotiation, more active involvement of judges in court proceedings and the appointment of expert medical assessors in order to assist judges in medical malpractice trials. Similar emphasis on caring for victims of medical malpractice and their families is visible in Japan, with recent development of out-of-court dispute resolution options available to patients. In some jurisdictions, like in Taiwan, patients engage in the specific “procedure game”, commencing criminal proceedings in order to get help from prosecutors and access to expert opinions, and then to move to civil proceedings in order to get compensation. Still in reality it may turn out that the majority of criminal proceedings is being won by physicians, and in the result patients are less prompt to succeed in civil courts. Physicians themselves are eager to engage in defensive medicine in order to avoid emotional distress and suffering connected to long litigation processes. Hence, introduction of ADR techniques seems as a patientfriendly endeavour, with the aim of restoring certain balance and equality between the parties. In many jurisdictions, like in Slovenia, the benefits of using alternative methods of dispute resolution are clearly visible and hence much welcomed, although within the contemporary practice ADR is not very often used in practice. It seems that the minimal usage of ADR instruments is a bilateral communication procedure before a competent person at the medical unit of healthcare provider, at the earliest stage of the dispute. This initial, informal and rudimentary procedure may be used as a platform for discussing the medical malpractice claim, examine the circumstances and possibly achieve an amicable solution, with undertaken attempts of proper communication and reconciliation between the parties. This goal may be achieved through various detailed provisions and schemes, such as the inspiring and innovative projects initiated recently in the Netherlands, aiming in particular at transforming the organizational culture of dealing with medical malpractice cases from ‘blame culture’ to ‘just culture’.

General Conclusions The required standard of medical care may be determined according to the duty of the health practitioner of taking actions normally evaluated as prudent and diligent within a particular set of circumstances of medical situation. Hence the personal pattern of such diligent behavior is encapsulated within a model of bonus medicis, being a professional equivalent of bonus pater familias. Moreover, one may indicate not solely the conduct of a prudent and diligent physician, but the same comparative procedure may be used in order to evaluate the actions of hospitals or other healthcare services institutional providers. The contemporary evolution of understanding of this required standard of medical care underlines the necessity of taking into account a particular type of medical specialization of a given healthcare

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practitioner and the need to relate to the state of medical knowledge at a precise moment of time of medical service provision. Another aspect of the contemporary provisions on liability for medical malpractice within domestic legal regimes is the phenomenon of broadening the scope of actors, both natural and institutional, participating in the liability proceedings. Hence, various members of the healthcare team may be held liable for medical malpractice, both assistant physicians (residents) or non-physicians such as nurses. Moreover, institutional liability of hospitals, clinics or other health suppliers should be recognized, with differentiated regimes of liability for public and private institutions. One of the tentative conclusions of the conducted research upon the topic of compensation schemes for damages caused by healthcare and alternatives to court proceedings may be the scope of possible internationalization of healthcare law, in parallel way to the process of enforcement and internationalization of consumer law (Durovic and Micklitz 2016). Should international legal documents, like the United Nations Guidelines for Consumer Protection of 2015,13 be applicable to medical services? Is the future legal development of health law to be included within the broad category of consumer law? This question is a vital one as it seems that the positive answer and inclusion of healthcare services into the broad category of different services regulated under the auspices of consumer law may well fit to the gradual evolution and recent development of consumer law (Lima Marques and Wei 2018). The starting point for this process of inclusion may be the need to ensure the proper implementation and effectiveness of the right to health and right to healthcare, recognized in international human rights law and made operative on domestic level. Hence it is to public authorities to choose from a plethora of various procedures based upon criminal, civil, disciplinary law alongside compensatory regimes with alternative means of dispute resolutions, those specific proceedings to be operationalized within domestic legal regime. It seems that the guidelines enshrined in consumer law may serve both aims: as a point of departure and as a final destination. One of the overall conclusions stemming from national reports on the topic of compensation schemes for damages caused by healthcare and alternatives to court proceedings is the recognition of vital importance of maintaining a regular, thorough and clear communication between patients and physicians (and other members of healthcare personnel). Respecting the condition of preserving efficient means of dialogue may also fulfil preventive functions, discouraging patients from initiating formal judicial proceedings. The preventive aspect is not so visible within extrajudicial proceedings, and especially within the prospective usage of the alternative means of dispute resolution.

13

The Guidelines were adopted by the UN General Assembly in resolution 39/248 of 16 April 1985, later expanded by the Economic and Social Council in resolution 1999/7 of 26 July 1999, and revised and adopted by the UN General Assembly in resolution 70/186 of 22 December 2015.

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While maintaining clear, regular and efficient communication between healthcare practitioners and patients is of crucial importance for maintaining peaceful relationships between them, with vital preventive goals but also as a means of managing situation in case of damage occurrence, it must be stated, however, that the emergence of conflicts during the communication process seems inevitable. Those communication conflicts occur more often in multi-ethnic healthcare settings as a result of societies’ increased ethno-cultural diversity and are essentially related to different approaches to what constitutes ‘good care’—should it be based on a biomedical model, with structured communication and central decision-making or should care rather be inspired by a holistic lifeworld-oriented approach (Van Keer et al. 2015). As a general conclusion of the topic one may indicate the aim of domestic authorities to guarantee the members of their political communities efficient access to justice in case of medical malpractice. It seems that the rise of compensation schemes in case of damages resulting from healthcare is regarded as one of the means to accomplish the result of providing justice to every person within human rights perspective, irrespectively of his or her cognitive capability, lack of financial resources, lack of professional legal support or advice. Hence those decisions of public regulators to construct compensation schemes and to promote extra-judicial means for dealing with situations of medical malpractice should be regarded as a pragmatic solution, designed to cope with inefficiency of judicial system. The most frequent phenomena of such inefficiency may be linked to the financial barrier connected to high costs of participation in judicial proceedings and long timeduration of those proceedings, sometimes resulting from the large number of healthcare cases and hence, massive litigation in cases of medical malpractice. Decisions of public authorities may concern not solely the construction of appropriate judicial arrangements but also provision of certain instruments that would prove conducive to the prospective usage of ADR mechanisms. Therefore, public regulator may provide for prioritization of the use of private dispute prevention and resolution, before engaging public judicial procedures. One of means that public authorities may use, as the actions undertaken in Canada (Québec) reveal, is the process of organization of training of mediators and arbitrators, which is performed not solely by public institutions but also by professional organizations and associations. Hence a process of specialization and gradual involvement of lawyers in ADR proceedings occurs, with their possibility of structuring the phases of dispute resolution proceedings. One of the frequent contemporary phenomena is a significant increase in the rise of claims in medical malpractice that may result, as in Italy and South Africa, in the negative consequences within the insurance market: the rapid rise in the amount of premiums may lead to the decrease in the number of persons insured and hence, a restricted extent of the insurance coverage. The unsustainably high number of lawsuits against physicians and hospitals may have its roots in a greater awareness of patients’ rights and the risen expectations for good medical healthcare. Thus the structural response may concern the need for more effective monitoring of the

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quality of healthcare services, emphasis on health risk prevention, and the rise of defensive medicine (Toraldo et al. 2015). One of the general conclusions stemming from the national reports is the high level of complexity of medical malpractice cases. Therefore, this may be ground reason for the prolongation of judicial proceedings and high financial costs connected to the need to ensure expert evaluation of the particular healthcare situation. In many cases the need to ensure expert evaluation is based on more than one expert opinion, hence leading to a further degree of complication with the need to evaluate among possible concurring opinions and the requirement for the judge or collective commission to order another professional statement. Public authorities (public regulator or health insurance institution) may provide, as in Estonia, expert opinions regarding general level of medical science at the time of medical malpractice dispute or may issue statements on the appropriate level of care which could be expected on the side of healthcare provider. Those opinions may be supplemented by more general guidelines, based upon cost-effective and evidencebased standards, rooted in the local conditions of the place of treatment. Another difficulty connected to the high degree of complexity of medical malpractice cases is the issue of access to medical files, documentation concerning the treatment record which in practice may be hard to be obtained by patients. Once received, medical records are subject to expert evaluation. Those factors may lead to further delays in medical malpractice proceedings. It seems that one of the general conclusions stemming from the above general report and national reports below, on the topic of compensation schemes and extrajudicial solutions in case of medical malpractice would be to advocate the introduction and development of precisely those mechanisms: compensation schemes and ADR instruments, within various jurisdictions. The reasons for such an advocacy are twofold: firstly, it is the mysterious and complex nature of healthcare treatment which results in interrelated reasons of occurrence of medical malpractice. According to statistical reports most medical injuries relate to unavoidable human error in a context of system failure (Watson and Kottenhagen 2017) hence it is crucial to design such procedures that would be conducive to proper examination of reasons of medical malpractice. It seems that the instruments of compensation schemes and ADR mechanisms are adequate tools for the accomplishment of those goals. Therefore this feature may be regarded as a second explanation for the overall support for the global spread of no-fault compensation schemes and ADR instruments. It may prove conducive for guaranteeing a high level of patient safety— with such positive consequences as a relatively open physician-patient communication, possibility of reconciliation, swift and appropriate patient compensation, blame-free reporting of medical malpractice and organizational learning. The mutual relationship between liability-based judicial procedures and compensation schemes for medical injuries may also be assessed within the discerned functions of those procedures (Oliphant 2013). Judicial litigation is based upon the three functions of compensation, prevention and accountability while compensation schemes are limited solely to the first compensatory goal. Still there is no empirical evidence for the detrimental effect of this separation of procedures for patients’

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safety. Therefore it seems that the proper suggestion would be to engage in further empirical research to test the efficacy of the rival approaches. There is also a need to ensure the involvement of legal academia in submitting proposals of common medical professional standards (Ferrara et al. 2013).14 The notion of access to justice within medical malpractice claims may have a multifaceted meaning, linked not solely to fair trail rules enshrined in human rights provisions but also within various factual elements such as accessibility of lawyers, legal aid, justice and law, legal text, mechanisms of judicare, social conditions of the so-called paths to justice (Winczorek 2019). Obligation of states to ensure access to court (fair trail) may also be understood as encompassing the requirement to provide legal assistance (legal aid) for those patients in financial difficulties. Therefore the examined topic of compensation schemes and alternatives to court proceedings in case of damages caused by healthcare should be focused upon not solely within theoretical legal perspective (law in books) but also within the empirical perspective of social relationships (law in action). The ultimate goal of those provisions lies within the contemporary individualistic legal approach, rise of patients’ autonomy in healthcare proceedings (Safjan 1998) and the efforts to enforce patients’ rights.

Annex: Questionnaire—Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings A. Compensation Schemes for Damages Caused by Healthcare 1. Is the overall compensation scheme for medical malpractice organized within the court system or administrative system? Is it possible to discern a mixture (hybrid) way of procedural arrangements? Do compensation schemes serve additional punitive purposes or fulfill a pure indemnity function (without a personalization of healthcare damage)? What is the general evaluation of a particular compensation scheme in terms of efficiency and fairness? Is the possible negative evaluation prone to formulating proposals of gradual reforms or radical change? 2. What is the relevant normative framework for: (a) Defining and determining the existence of fault?

14

As a relevant example may serve the document developed under the patronage of the European Academy of Legal Medicine, presenting European Guidelines on Medico-Legal Methods of Ascertainment and Criteria of Evaluation in Medical Responsibility and Liability.

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(b) Establishing a relevant standard of care (is the level of the accepted medical knowledge (ars medica) determined domestically or with a specific reference to the medical science within international perspective? Is the other criterion used (i.a. bonus pater familias)? Is physicians’ obligation determined as a pure obligation of means, characterized by diligence and irrespectively of the attainment of a specific result or provided for as a specific type of the obligation of means (obligation renforée)? (c) Identifying the existence of an accidental risk related to the physicians’ performance (aléa thérapeutique)? (d) Determining the burden of proof? (is the patient required to demonstrate the physician’s fault, the causal connection and the received damage? are there instruments to strengthen patients’ weaker position such as reversal of the burden of proof, acceptance of the rule res ipsa loquitur)? 3. Are there differences in regulation concerning compensation schemes for medical malpractice in public and private hospitals? 4. Is there a tendency to limit the number of medical litigation cases? (i.a. pretrial conditions, specific initial requirements concerning the involvement of third parties (neutral medical experts), possible limits of attorneys fees, time limits for commencing litigation)? 5. Is there an inclination to use various mechanisms in order to diminish the amount of financial compensation (i.a. caps in the amount the plaintiff may receive/ defendant may be required to pay, introduction of periodic payment rule rather than a lump sum of compensation)?

B. Alternatives to Court Proceedings 1. Are there any procedures with the aim to substitute court proceedings in case of medical malpractice? What is their legal basis? Do they operate as mandatory or voluntary procedures? Are there any experimental projects with the goal of reducing the negative impact of court proceedings, such as increasing volume and cost of malpractice litigation, lengthy litigation process, involvement of adversarial experts and lawyers, chilling and stigmatizing effect on medical errors transparency? 2. What is the overall aim and philosophy of those alternative proceedings? Are they based in cost-efficiency requirements for controlling medical liability costs? Are they aiming at strengthening patients’ rights? Is the primary goal of those procedures to improve quality and safety standards of healthcare? Do they possess a preventive character in order to deter a possible substandard of medical care? 3. Is there a public entity (agency) dealing with medical malpractice, striving to protect patients’ rights? What is the precise mandate of the institution? Are the health damages compensation procedures centralized in one body? Is it regarded as an efficient means to safeguard the interests of victims of damages caused by healthcare?

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4. Has international arbitration of medical malpractice disputes been contemplated as a means of resolving claims in cross-border healthcare? 5. What is the specific character of the procedures aiming at substituting court proceedings? Is their efficiency evaluation available? Have any of the following programs been practiced? (a) Alternative dispute resolution (ADR) practices arranged between risk management professionals, insurers and patients (both formal and informal, such as i.a. presuit mediation programs or presuit voluntary binding arbitration) (b) Apology laws (“I am sorry” laws protecting statements of early regret, apology or fault, made to patients by healthcare practitioners, without the possibility to use them in medical malpractice litigation) (c) Communication and resolution projects (discussions between the patient, healthcare practitioner, insurance institution in order to provide explanation of the event, apology and possibly compensation) (d) Disclosure programs (e) Dispute resolution and mediation arrangements (with assistance of a state entity (agency) within the process of negotiations among the parties concerned) (f) Mediation (negotiation facilitated by a third-party neutral mediator) (g) Pretrial notifications (mandatory advance notice of the intention to sue presented to the defendant by plaintiff) (h) Pretrial screenings (informal screenings before medical malpractice litigation by an expert neutral party in order to assess the relative strength of each party’s arguments and to determine whether the merits are to be presented in trial) (i) Safe harbors (defense to medical malpractice claim if shown physicians’ adherence to appropriate professional guidelines).

C. Proposals de lege ferenda 1. Is the issue of alternative procedures to court proceedings in case of medical malpractice a current and debated topic within domestic legislative circles? What is the standpoint of the civil law doctrine and legal theorists? Are judges in favour of limiting judicial proceedings and strengthening the alternative means of dispute resolution? 2. Are there any reform proposals currently at stake? If any, do those attempts aim at traditional (tort litigation in courts) or innovative (alternative dispute resolution mechanisms, administrative systems) regulation of medical liability?

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D. Systemic Remarks 1. What is the basis for compensation based on lack of healthcare in case of the existence of waiting lists for medical treatment? Is there a possibility to grant compensation in case of deficits of quality in healthcare? Are there instruments conducive to safeguarding equal distribution of limited resources within the provision of medical services in order to ensure their accessibility? What is the basis for possible compensation in case of defects in medical products? 2. What would be the basis for possible institutional responsibility (of public authorities, public hospital, private hospital) for lack of adequate healthcare? Is there a possibility to grant compensation in case of infringement of the patients’ rights? Would it be possible to grant compensation in order to compensate non-material damages, in case of breach of privacy or dignity of patients?

References Agarwal R, Gupta A, Gupta S (2019) The impact of tort reform on defensive medicine, quality of care and physician supply: a systematic review. Health Serv Res 54:851–859 Amaral-Garcia S (2019) Medical malpractice appeals in a civil law system: do administrative and civil courts award noneconomic damages differently? Law Soc Rev 53:386–419 Antoci A, Maccioni AF, Galeotti M, Russu P (2019) Defensive medicine, liability insurance and malpractice litigation in an evolutionary model. Nonlinear Anal Real World Appl 47:414–435 Bach-Golecka D (2014) Ekstraterytorialność a prawo do ochrony zdrowia. Koncepcja praw podstawowych (core obligations). Polski Przegląd Stosunków Międzynarodowych 4:51–71 Bach-Golecka D (2015) Mobilny pacjent. Korzystanie z transgranicznej opieki zdrowotnej w prawie Unii Europejskiej. Instytut Wydawniczy EuroPrawo, Warszawa Bączyk-Rozwadowska K (2013) Odpowiedzialność cywilna za szkody wyrządzone przy leczeniu. Towarzystwo Naukowe Organizacji i Kierownictwa, Toruń Bandelow NC, Vogeler CS, Hornung J, Kuhlmann J, Heidrich S (2019) Learning as a necessary but not sufficient condition for major health policy change: a qualitative comparative analysis combining ACF and MSF. J Comp Policy Anal 21:167–182 Blutman L (2010) In the trap of a legal metaphor: international soft law. Int Comp Law Q 59:605–624 Brandl D, Schrader V (2019) Controversies in aesthetic medicine. The frame conditions 1: society and identity of the aesthetic doctor. Cosmetic Med 5:15–19 Brogiene D (2019) The defensive medicine isn’t the best way to avoid mistakes. World Med J 65:37–39 Brown G (2016) The universal declaration of human rights in the 21st century: a living document in a changing world. Open Book Publishers, Cambridge Cheng KY (2015) Truth-telling, best interests, and autonomy. In: Pope J (ed) Patient rights: ethical perspectives, emerging developments and global challenges. Nova Science Publishers, New York, pp 97–102 Costa-Font J, Courbage C, McGuire A (eds) (2009) The economics of new health technologies. Incentives, organization, and financing. Oxford University Press, Oxford de Mequita B, Hunt P, Khosla R (2010) The human rights responsibility of international assistance and cooperation in health. In: Gibney M, Skogly S (eds) Universal human rights and extraterritorial obligations. University of Philadelphia Press, Philadelphia, pp 104–129

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De Schutter O et al (2012) Commentary to the Maastricht Principles on extraterritorial obligations of states in the area of economic, social and cultural rights. Hum Rights Q 34:1084–1169 Durovic M, Micklitz HW (2016) Internationalization of consumer law: a game changer. Springer Eigmüller M (2013) Europeanization from below: the influence of individual actors on the EU integration of social policies. J Eur Soc Policy 23:363–375 Ferrara SD, Boscolo-Berto R, Viel G (eds) (2013) Malpractice and medical liability. European state of the art and guidelines. Springer, Heidelberg Fosch Villaronga E (2019) Artificial intelligence, healthcare and the law: regulating automation in personal healthcare. Routledge, London Franck TM (1999) The empowered self. Law and society in the age of individualism. Oxford University Press, Oxford Glenn Cohen I (2015) Patients with passports: medical tourism, law and ethics. Oxford University Press, Oxford Gostin LO (2014) Global health law. Harvard University Press, Cambridge Greer SL (2013) Avoiding another directive: the unstable politics of European Union cross-border health care law. Health Econ Policy Law 8:415–421 Hall M (2013) Medical tourism. The ethics, regulation, and marketing of health mobility. Routledge, London Healy J (1999) Medical negligence: common law perspectives. Sweet & Maxwell, London Herring J (2012) Medical law and ethics. OUP, Oxford Holčapek T (2013) Medical and health law in the Czech Republic. In: Beran RG (ed) Legal and forensic medicine. Springer, Heidelberg, pp 245–259 Koch BA (ed) (2011) Medical liability in Europe. A comparison of selected jurisdictions. De Gruyter, Berlin Langford M et al (eds) (2013) Global justice, state duties: the extraterritorial scope of economic, social and cultural rights in international law. Cambridge University Press, Cambridge Lima Marques C, Wei D (eds) (2018) Consumer law and socioeconomic development: national and international dimensions. Springer Malby B, Anderson-Wallace M (2017) Networks in healthcare. Managing complex relationships. Emerald Publishing, Bingley Marmot M (2015) The health gap. The challenge of an unequal world. Bloomsbury, London Martinsen DS, Diaz-Asensio JAM (2017) A judicialisation of healthcare policies in Denmark and Spain? The universalist healthcare model meets the European Union. Comp Eur Polit 15:414–434 Mehlman MJ (2012) Professional power and the standard of care in medicine. Arizona State Law J 44:1165–1235 Merlo A, Tang X (2019) Bargaining with optimism: identification and estimation of a model medical malpractice litigation. Int Econ Rev 60:1029–1061 Micklitz HW, Saumier G (eds) (2018) Enforcement and effectiveness of consumer law. Springer Moyn S (2018) Not enough. Human rights in an unequal world. Harvard University Press, Cambridge Mwamburi AH, Fahm AGO (2018) Islam and human rights with special reference to the universal human rights and the Cairo declaration on human rights. Shariah J 26:123–140 Natarajan P, Frenzel JC, Smaltz DH (2017) Demystifying big data and machine learning for healthcare. CRC Press Oliphant K (2013) Medical malpractice and compensation: comparative observations. In: Oliphant K, Wright RW (eds) Medical malpractice and compensation in global perspective. de Gruyter, Berlin, pp 513–562 Olsen JA (2009) Principles in health economics and policy. Oxford University Press, Oxford Panesar A (2019) Machine learning and AI for healthcare: big data for improved health outcomes. Apress, London Paraskou A, George BP (2017) Legal and economic considerations surrounding reproductive tourism: emerging research and opportunities. Business Science Reference, London

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Quick P (2017) Regulating patient safety. The end of professional dominance? Cambridge University Press, Cambridge Reiser SJ (2009) Technological medicine. The changing world of doctors and patients. Cambridge University Press, Cambridge Safjan M (1998) Prawo i medycyna. Ochrona praw jednostki a dylematy współczesnej medycyny. Oficyna Naukowa, Warszawa Schauer F (2015) The force of law. Harvard University Press, Cambridge Skogly S (2006) Beyond national borders: states’ human rights obligations in international cooperation. Intersentia, Antwerp Sperling D (2019) Suicide tourism: understanding the legal, philosophical, and socio-political dimensions. Oxford University Press, Oxford Terpan F (2015) Soft law in the European Union – the changing nature of EU law. Eur Law J 21:68–96 Toebes B (2009) Right to health and health care. In: Forsythe DP (ed) Encyclopedia of human rights. Oxford University Press, Oxford, pp 365–376 Toraldo DM, Vergari U, Toraldo M (2015) Medical malpractice, defensive medicine and role of the “media” in Italy. Multidiscip Respir Med 10:1–7 Van Keer RL, Deschepper R, Francke AL, Huyghens L, Bilsen J (2015) Conflicts between healthcare professionals and families of a multi-ethnic patient population during critical care: and ethnographic study. Crit Care 17:1–13 Vollaard H (2017) Patient mobility, changing territoriality and scale in the EU’s internal market. Comp Eur Polit 15:435–458 Watson K, Kottenhagen R (2017) Patients’ rights, medical error and harmonisation of compensation mechanisms in Europe. Eur J Health Law 25:1–23 Winczorek J (2019) Dostęp do prawa. Ujęcie socjologiczne. Wydawnictwo Naukowe Scholar, Warszawa Young KG (2008) The minimum core of economic and social rights: a concept in search of a content. Yale J Int Law 33:113–175

Documents CESCR General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12). Adopted at the Twenty-second Session of the Committee on Economic, Social and Cultural Rights, on 11 August 2000 (Contained in Document E/C.12/2000/4). CESCR General Comment No. 3: The Nature of States Parties’ Obligations (Art. 2, Para. 1, of the Covenant). Adopted at the Fifth Session of the Committee on Economic, Social and Cultural Rights, on 14 December 1990 (Contained in Document E/1991/23).

Chapter 2

L’indemnisation des dommages résultant des soins de santé et les alternatives aux procédures judiciaires – Rapport belge Catherine Delforge and Camille Delbrassinne

Résumé Différentes voies coexistent et peuvent être mises en œuvre en présence d’un accident médical. À côté des procédures judiciaires classiques, devant les juridictions civile et pénale, des voies alternatives peuvent être mobilisées, via une saisine du Fonds des accidents médicaux ou un accord amiable obtenu à l’issue d’une médiation. En l’état actuel du droit belge et des pratiques, malgré ses difficultés probatoires, son coût et ses lenteurs, la voie judiciaire, principalement celle d’une procédure civile, reste privilégiée par une majorité de patients.

Introduction Prétendre exposer les dispositifs assurant l’indemnisation des dommages résultant de soins de santé peut inviter à exposer plusieurs régimes légaux, certains fondés sur la faute, d’autres qui la présument, d’autres encore qui n’en font pas une condition du droit à réparation. Dans l’exposé qui suit, nous limiterons notre propos à la réparation des dommages causés aux personnes1 (lésions corporelles et décès) consécutifs à un accident médical, entendu comme celui qui résulte de l’intervention d’un médecin (prestation ou omission), que ce soit dans le cadre d’une pratique individuelle ou au sein d’une institution de soins publique ou privée.2 Nous exclurons, dès lors, certains fondements qui auraient pourtant pu être pertinents par la liaison qu’ils présentent avec la dispensation de soins, comme la responsabilité pouvant être imputée aux fabricants de médicaments prescrits ou administrés aux

1 Nous laisserons donc de côté les dommages causés aux biens, pourtant également indemnisables en droit belge. Ajoutons que ce texte est finalisé au 1er janvier 2018. 2 La Belgique ne connaît pas le dualisme retenu en France.

C. Delforge (*) · C. Delbrassinne Université Saint-Louis, Bruxelles, Belgique e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_2

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patients,3 ainsi que la possible mise en cause de l’État, que ce soit dans le cadre du contentieux objectif de l’indemnité pouvant être mis en œuvre dans le cadre des dommages consécutifs à une vaccination obligatoire4 ou du contentieux subjectif devant les juridictions judiciaires.5 Soulignons d’emblée que, sous réserve de l’intervention du Fonds des accidents médicaux,6 les accidents médicaux ne font pas l’objet d’un dispositif spécifique et ne justifient donc aucune dérogation aux règles contenues dans le Code civil de 1804. La réparation des dommages qui en résultent demeure ainsi entièrement soumise aux règles du droit commun, soit celles qui sont applicables à tout accident dommageable. Ainsi, spécialement, les conditions de mise en œuvre de la responsabilité, les règles probatoires qui s’y appliquent – spécialement les articles 1315 du Code civil et 870 du Code judiciaire, qui font par principe reposer la charge de la preuve sur le demandeur en justice – et les principes régissant la réparation des dommages7 gouverneront toute demande de réparation mue par la victime, directe ou indirecte,8 d’un accident médical.

Plan des développements qui suivent Différentes voies coexistent et peuvent être mises en œuvre en présence d’un accident médical. À côté des procédures judiciaires classiques (chapitre 1), devant les juridictions civile (section 1) et pénale (section 2), des voies alternatives peuvent être mobilisées (chapitre 2), via une saisine du Fonds des accidents médicaux (section 1) ou un accord amiable obtenu à l’issue d’une médiation (section 2).

3

Loi du 25 février 1991 relative à la responsabilité du fait des produits défectueux, Mon.b., 22 mars 1991. Dans un tel cadre, un médecin ou un établissement de soins ne pourrait engager sa responsabilité qu’à titre subsidiaire, dans l’éventualité où l’identité du fabricant n’est pas connue. 4 Article 11 des lois coordonnées relatives au Conseil d’État. 5 Songeons, par exemple, à la mise en cause de la responsabilité (articles 1382 et 1383 du Code civil) de l’État dans le cadre de la commercialisation de certains produits de santé s’il devait s’avérer que les dispositifs de pharmacovigilance n’étaient pas suffisants en présence de produits présentant un risque disproportionné pour la santé. 6 Voy. infra. 7 Voy. infra. 8 Le dommage, alors dit « par ricochet » ou « par répercussion », est indemnisable et soumis aux règles du droit commun.

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Les régimes de réparation des dommages résultant d’accidents médicaux Introduction L’immunité (civile et pénale) des actes de soins ne bénéficie aux prestataires que si les actes ont été posés dans un but thérapeutique,9 avec le consentement libre et éclairé du patient10 (sauf circonstances particulières, comme l’urgence) et étaient diligents, prudents et conformes aux données actuelles de la science. À défaut, l’atteinte portée à l’intégrité physique du patient peut être constitutive d’une infraction pénale,11 mais aussi d’une faute civile, contractuelle ou extracontractuelle.12 Le patient qui s’estime victime d’un dommage causé par un acte ou une omission de soins peut citer celui qu’il estime responsable devant les juridictions civiles (action civile) ou intervenir dans le cadre d’une procédure répressive (action civile accessoire de l’action publique).

La responsabilité civile et la procédure civile Le droit matériel et ses exigences Les responsabilités contractuelle et extracontractuelle: un choix En matière civile, une summa divisio distingue les responsabilités civiles contractuelle et extracontractuelle (ou aquilienne), lesquelles peuvent, en ce domaine, dès lors que l’on est en présence d’une atteinte à l’intégrité physique, toutes deux trouver application.13 En pareille hypothèse, les victimes ont le choix du 9

Deux critères sont appliqués: celui de la « nécessité médicale » (l’acte doit participer au bien-être physique ou psychologique du patient eu égard à son état de santé) et celui de la proportionnalité (l’acte ne doit pas exposer le patient à des risques disproportionnés eu égard au résultat escompté, à son état de santé préexistant et à son évolution prévisible). Voy. C. DELFORGE, « La responsabilité civile du médecin au regard de la prescription de médicaments », R.G.D.C., 2003, p. 370, n 7. 10 Voy. les articles 7 et 8 de la loi du 22 août 2002 relative aux droits du patient (Mon.b. 26 septembre 2002). Voy. à ce propos infra n 43. 11 Voy. infra. 12 Voy. infra. 13 Selon la Cour de cassation, entre contractants et dans le périmètre du contrat, le contrat prime et la victime ne peut donc pas préférer la voie aquilienne. La Cour de cassation enseigne toutefois que la responsabilité aquilienne d’un cocontractant (ou de son agent d’exécution) peut être mise en œuvre s’il est établi que (i) la faute est à tout le moins « mixte » (elle constitue aussi une erreur de conduite au sens de l’article 1382 du Code civil) et que (ii) le dommage n’est pas purement contractuel (Cass., 7 décembre 1973, R.G.A.R., 1974, n 9317 ; Cass., 29 septembre 2006, R.W., 2006-2007, p. 1717). Ces conditions sont rencontrées en présence d’une infraction pénale (Cass., 25 avril 1983, Pas., 1983, I, 958 ; Cass., 10 juin 2015, R.G. P.15.0419.F), spécialement en cas d’atteinte à

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dispositif qu’elles entendent mettre en œuvre et, dès lors, des dispositions légales fondant la demande d’indemnisation: pour la responsabilité contractuelle, les articles 1137-1147 du Code civil;14 pour la responsabilité extracontractuelle, les articles 1382 et 1383 du Code civil (faute personnelle), voire, dans certaines circonstances, les articles 1384, alinéa 1er (responsabilité du fait des choses dont on a la garde)15, 1384, alinéa 3 (responsabilité du commettant vis-à-vis de ses préposés lorsqu’ils causent un dommage dans le cadre de leurs fonctions)16 ou 1384, alinéa 4 (responsabilité de l’instituteur vis-à-vis de ses élèves pendant qu’ils sont sous sa surveillance)17 du même code. La première question qui se pose ainsi est celle de savoir si un contrat existe, la réponse à cette question permettant de qualifier la relation de soins et d’y appliquer les dispositions idoines.

La responsabilité contractuelle La responsabilité contractuelle du médecin: le contrat médical Depuis un célèbre arrêt Mercier rendu par la Cour de cassation française le 20 mai 1936,18 il est admis, en Belgique également,19 que le médecin peut20 être lié à son patient par un contrat médical lorsqu’il a été librement choisi par lui. En vertu d’un tel contrat, le médecin s’engage à prodiguer des soins consciencieux, attentifs et conformes aux données acquises de la science. De son côté, le patient est tenu de rémunérer un tel service et de prêter son concours à l’exécution du contrat, ce qui implique notamment de se soumettre aux directives relatives au suivi du traitement.21

l’intégrité physique (Cass., 26 octobre 1990, R.C.J.B., 1992, p. 497, note de R.-O. DALCQ). L’infraction se fonde alors sur les articles 418 et 420 du Code pénal. 14 On rejoint alors la qualification du contrat d’entreprise (article 1710 du Code civil). 15 Par exemple, lorsque le matériel utilisé par le prestataire présente un défaut qui est la cause du dommage. 16 Sont principalement visées les relations de subordination, ou hiérarchiques, ce que l’on rencontre notamment lorsque le prestataire est dans les liens d’un contrat de travail vis-à-vis d’une institution de soins. 17 On songe au médecin maître de stage. 18 Cass.fr.civ.1, 20 mai 1936, D., 1936, pp. 88-96. 19 La Cour de cassation belge semble l’admettre implicitement dans un arrêt du 4 octobre 1973 (Pas., 1974, I, 121). La jurisprudence (voy. not. Civ. Bruxelles, 20 mars 2017, Rev. dr. santé, 20172018, pp. 122-134) et la doctrine (voy. not. C. DELFORGE, op.cit., R.G.D.C., 2003, pp. 368 et s., n 4 et s. et les références citées) suivent cet enseignement. 20 L’existence d’un tel contrat sera généralement exclue en présence de situations d’urgence, d’inconscience ou de troubles mentaux et, plus largement, toutes les fois que le patient n’a pas fait le choix du prestataire. 21 À défaut, sa responsabilité pourrait être mise en œuvre et justifier un partage de responsabilité.

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Le médecin n’est par principe tenu qu’à une obligation de moyens (article 1137 du Code civil) en raison du caractère aléatoire de son intervention;22 « soigner n’est pas guérir ». L’obligation sera, toutefois, qualifiée « de résultat » (article 1147 du Code civil) en l’absence d’aléa23 ou lorsqu’un résultat déterminé a été promis par le prestataire.24-25 Qualifier l’obligation de résultat a une incidence sur le plan probatoire dès lors que la (double) preuve, par le patient, de l’obligation contractée et de la non-obtention du résultat, permettra de présumer la faute du prestataire, lequel ne pourra se libérer qu’en établissant l’existence d’une cause étrangère exonératoire. La victime se trouve donc dans une situation plus avantageuse puisqu’elle n’a plus à établir positivement une faute en considération des engagements consentis – ce qu’il lui reviendrait de faire si l’obligation était de moyens.26 Soulignons, enfin, qu’un prestataire peut aussi engager sa responsabilité en raison du fait d’autrui, le médecin devant par principe répondre non seulement de ses fautes, mais également de celles commises par ceux qu’il se substitue27 dans l’exécution de ses obligations contractuelles28 lorsque ces substituts sont intervenus sans une demande ni le consentement du patient.29 Il s’agit d’une application du principe général de la responsabilité (contractuelle) personnelle.30

La responsabilité contractuelle des établissements de soins Une relation contractuelle peut également se nouer avec un établissement de soins. Ainsi, lors de l’admission d’un patient à l’hôpital, deux cas de figure peuvent se présenter: soit le patient contracte uniquement avec l’hôpital, soit il contracte avec ce dernier et avec le médecin qui assurera son suivi.

22 Voy. not. Civ. Anvers, 26 février 1992, R.G.D.C., 1993, p. 401 ; Liège, 17 janvier 2005, J.L.M.B., 2006/27, p. 1185 ; Civ. Gand, 16 avril 2007, Rev.dr.santé, 2007-2008, p. 371; Liège, 22 janvier 2009, J.L.M.B., 2009/25, p. 1161, note de G. GENICOT ; Bruxelles, 7 juin 2016, R.G.A.R., 2017, 15354. 23 Tel est, par exemple, le cas en matière de stérilisation: Chr. LEMMENS, note sous Civ. Gand, 16 avril 2007, Rev. dr. santé, 2007-2008, p. 379. 24 La jurisprudence retient généralement ce principe en matière de chirurgie esthétique de pur confort. 25 Sur la distinction, voy. Cass., 15 janvier 2010, R.G. C.09.0138F. 26 Cass., 16 décembre 2004, Rev. dr. santé, 2004-2005, p. 298 ; Cass., 16 décembre 2004, Rev. dr. santé, 2004-2005, p. 299, note S. LIERMAN. 27 On les nomme « agents d’exécution ». Il pourrait s’agir d’un confrère, d’un assistant, d’un membre du personnel infirmier, etc. Les principes énoncés n’énervent en rien celui d’une possible responsabilité personnelle des agents d’exécution. 28 Voy. not. Civ. Turnhout, 12 septembre 1994, R.G.D.C., 1995, p. 249. 29 Cette précision est notamment importante dans l’hypothèse de l’intervention d’un confrère. Lorsque celle-ci fait suite à une demande du patient ou a lieu avec son consentement, le juge peut conclure à la coexistence de contrats distincts et qu’aucune responsabilité pour autrui n’a lieu d’être. 30 Principe consacré, en matière de contrat d’entreprise, par l’article 1797 du Code civil.

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La première hypothèse se rencontre lorsque le patient choisit l’hôpital, mais non le médecin qui travaille en son sein. Le contrat hospitalier31 ainsi conclu est alors qualifié de contrat all-in,32 en ce sens que l’hôpital est contractuellement tenu de fournir non seulement « les soins normaux (le logement, la nourriture, les soins, la mise à la disposition des locaux, du matériel, etc.), mais aussi les prestations médicales ».33 Dès lors, pour répondre à ses obligations contractuelles, l’établissement doit nécessairement faire appel à des « agents d’exécution » (médecins, infirmiers, aides-soignants, etc.), qui peuvent avoir la qualité de « préposés »34 ou d’indépendants.35 La faute d’un agent d’exécution (préposé ou indépendant) engage36 la responsabilité de l’hôpital,37 ce qui n’exclut toutefois pas une éventuelle responsabilité (aquilienne) personnelle de l’agent lui-même. Il se peut, par ailleurs, et c’est la seconde situation qu’il convient d’envisager, que le patient contracte tant avec le médecin, qui est alors un indépendant, qu’avec l’hôpital. Deux contrats distincts se forment en ce cas, et génèrent leurs propres obligations: un contrat médical et un contrat hospitalier.38 En pareille hypothèse, ce dernier contrat présente toutefois un objet plus limité.39 L’établissement sera, en effet, tenu de fournir les soins médicaux d’accompagnement et de procurer le logement, l’alimentation, l’infrastructure et le personnel soignant alors que les prestations médicales sensu stricto incomberont au médecin.40 Ceci étant, si le médecin et l’hôpital assument a priori des obligations distinctes, la frontière peut se révéler délicate à tracer lorsqu’il s’agit d’imputer une responsabilité contractuelle

31

Ou « contrat d’hospitalisation ». En pareille situation, la jurisprudence refuse généralement de constater l’existence d’un contrat médical distinct du contrat hospitalier. Voy. Civ. Louvain, 6 mars 2013, Rev. dr. santé, 2017-2018, pp. 108-113. 33 Th. VANSWEEVELT, « La responsabilité des professionnels de la santé – Volume 1, La responsabilité contractuelle et extracontractuelle du médecin et de l’hôpital pour leur fait propre », in Responsabilités, Traité théorique et pratique, Kluwer, L. 25, T. II, 2000, p.7. 34 Comme déjà écrit, si le médecin est un préposé, aucun contrat n’est conclu avec le patient (Th. VANSWEEVELT, La responsabilité civile du médecin et de l’hôpital, Marklu, Bruylant, 1996, n 744 et s.), ce qui n’exclut pas une responsabilité personnelle du médecin. 35 Voy. not. Bruxelles, 23 novembre 2010, R.G.A.R., 2011, 14716: un patient se rendant au service des urgences d’un hôpital contracte avec l’institution de soins, non avec l’urgentiste de garde qui le reçoit. 36 Sous réserve, bien entendu, de la preuve des autres conditions de la responsabilité. 37 Civ. Verviers, 16 octobre 1995, Rev. dr. santé, 1998-99, 293 ; Liège, 20 décembre 1995, Rev. dr. santé, 1996-1997, 271 ; Liège, 28 mai 1998, J.L.M.B., 1999, 268 ; Mons, 27 avril 2006, J.L.M. B., 2006, p. 1184 ; Bruxelles, 13 janv. 2010, R.G.A.R., 2010, 14655. 38 Le fait qu’un patient se rende dans un hôpital par l’intermédiaire d’un médecin n’exclut donc pas l’existence d’un contrat hospitalier. 39 Liège, 20 décembre 1995, Rev. dr. santé, 1996-1997, p. 721; Civ. Arlon (3e ch.), 3 juin 2004, J.L. M.B., 2006, p. 1204; Bruxelles, 23 novembre 2010, R.G.A.R., 2011, 14716. 40 Th. VANSWEEVELT, « La responsabilité des professionnels de la santé », op. cit., 2000, p.7. 32

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du fait d’autrui pour les soins médicaux d’accompagnement41 dès lors que de tels actes peuvent être appréhendés comme relevant de l’exécution des missions tant de l’hôpital que du médecin. Il reviendra, en ce cas, et ce n’est guère aisé,42 d’identifier in concreto, pour chaque prestation, si elle a été réalisée dans le cadre du contrat médical ou du contrat d’hospitalisation.43 On notera, enfin, qu’en matière d’infections nosocomiales, la jurisprudence retient le principe d’une obligation de moyens dans le chef des établissements hospitaliers dès lors qu’elles ne peuvent être totalement endiguées malgré le respect de strictes mesures d’hygiène.44 Une obligation de résultat est, par contre, généralement retenue pour ce qui concerne la surveillance des patients.45

La responsabilité extracontractuelle Les principes En l’absence de contrat ou, en sa présence, lorsque les conditions de l’option des responsabilités sont rencontrées,46 la victime peut préférer fonder sa demande d’indemnisation sur le droit de la responsabilité extracontractuelle. La première, et principale, source de responsabilité, issue d’une combinaison des articles 1382 et 1383 du Code civil, est une responsabilité personnelle pour faute. Ces bases légales peuvent être invoquées en toutes circonstances, et vis-à-vis de toute personne, dès lors que trois conditions sont établies: une faute, un dommage et un lien de causalité entre la faute et le dommage. Ces exigences, quoiqu’identifiées par la loi, ne sont pas légalement précisées dans leur contenu. Leurs contours ont donc été façonnés au gré d’une jurisprudence et d’une doctrine foisonnantes, parfois hésitantes.

La charge de la preuve Comme en matière contractuelle, les articles 1315 du Code civil et 870 du Code judiciaire dictent que c’est sur le demandeur en justice que repose la charge de la preuve des conditions de la responsabilité.47 C’est donc lui également qui supportera

41 Administration d’injections, fourniture de médicaments, accomplissement d’examens de laboratoire ou, encore, surveillance du patient. 42 Voy. not. Gand, 28 juin 2006, Rev. dr. santé, 2008-2009, 408 ; Gand, 20 déc. 2007, Bull. ass., 2009, 53. 43 B. FOSSEPREZ et A. PÜTZ, « Les intervenants au procès civil en responsabilité médicale », Con. M., 2014/4, p. 195. 44 Voy. Bruxelles, (4e ch.), 19 septembre 2016, R.G.A.R., 2017, 15355 (MRSA). 45 Chr. LEMMENS, note sous Civ. Gand, 16 avril 2007, Rev.dr.santé, 2007-2008, p. 379. 46 Voy. à ce propos Th. VANSWEEVELT, op. cit., 1996, n 760 et s. 47 Cass., 16 décembre 2004, Rev. dr. Santé, 2004-2005, p. 298.

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le risque qu’une telle preuve ne soit pas rapportée. S’agissant toutefois de faits juridiques, tous les modes de preuve sont recevables en justice, en ce compris les présomptions dès lors qu’elles sont graves, précises et concordantes (article 1353 du Code civil).48 Le juge apprécie souverainement leur valeur probante.49

La faute - une condition nécessaire de la responsabilité aquilienne La survenance d’un dommage ne suffit pas,50 pas davantage que la preuve d’un lien de causalité entre le dommage et la prestation de soins.51 Une faute doit être établie, mais, dans ce cadre, la plus légère (culpa levissima) suffit.52

La faute - les contours prétoriens de la faute On enseigne qu’un agent commet une faute s’il méconnaît, de façon libre et consciente53 (composante subjective de la faute), une norme de comportement (composante objective de la faute), laquelle peut être soit formulée (méconnaissance de la loi)54 soit façonnée a posteriori par le juge au moment du procès (méconnaissance de la norme générale de prudence, ou erreur de conduite). Ainsi, même en l’absence de violation d’une obligation légale, les juridictions du fond restent habilitées à apprécier si le médecin a par ailleurs adopté un comportement normalement prudent et diligent dans les circonstances qui étaient celles de la réalisation du dommage.55 Dans ce dernier cas, l’appréciation, in abstracto, du comportement du prestataire est adaptée dans le domaine médical dès lors que sa spécialité et son domaine de compétence affinent nécessairement le niveau des attentes légitimes. Ainsi, pour apprécier si un médecin a commis une faute, le juge appréciera s’il a agi comme aurait agi un autre médecin de la même spécialité normalement prudent et diligent,56

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Bruxelles (4e ch.), 7 juin 2016, R.G.A.R., 2017, 15354. Cass., 4 avril 1974, Arr. Cass., 1974, 861. 50 Cass., 3 mai 1958, Pas., 1958, I, p. 972; Cass., 4 octobre 1973, Pas., 1974, I, p. 125; Cass., 14 décembre 1990, Pas., 1990, I, p. 370, J.T., 1991, p. 743, Dr. circ., 1991, p. 112 ; Cass., 4 février 1994, Pas., 1994, I, p. 149 ; Cass., 10 mai 2001, Pas., 2001, p. 807. 51 Cass., 14 décembre 1990, Pas., 1991, I, 370. 52 Liège (6e ch.), 30 juin 1995, Rev. dr. santé, 1999-2000, p. 49. 53 Le fait illicite, résultant de la méconnaissance de la norme, doit être imputable à son auteur, en ce sens que ce dernier doit avoir agi librement et consciemment. Le discernement doit être apprécié au moment de l’acte dommageable, sachant que la conscience peut être altérée de manière passagère. 54 La faute peut résulter de la transgression matérielle d’une norme légale ou réglementaire impérative qui impose un comportement déterminé à son destinataire. 55 Cass., 27 juin 2002, Pas., 2002, p. 1463. 56 Le bonus pater familias se transforme ainsi en bonus medicis (Th. VANSWEEVELT, op.cit., 1996, p.87). Voy. aussi Liège, 30 juin 1995, Rev. dr. santé, 1999-2000, p. 49 ; Civ. Tongres, 10 septembre 49

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placé dans les mêmes circonstances de fait,57 en tenant compte de l’état des connaissances scientifiques disponibles au moment de l’acte dommageable.58-59 C’est sur la base de ce raisonnement que l’on admet, par exemple, que l’erreur de diagnostic ne constitue pas en soi une faute professionnelle, et ne le devient que si elle n’aurait pas été commise par un médecin normalement prudent et diligent, eu égard aux données acquises de la science.

Les difficultés probatoires Dans la pratique, faire supporter la charge de la preuve de la faute par le patient est particulièrement laborieux. La médecine est une science technique et complexe et il est parfois malaisé de distinguer la faute de l’aléa qui n’est que la conséquence du risque médical.60 Afin de pallier ces difficultés, la jurisprudence tolère un allègement de la charge de la preuve en recevant le critère dit du « cours normal des choses » (res ipsa loquitur). En vertu de celui-ci, les juges s’autorisent à considérer que l’acte posé est fautif dès que l’accident ne pouvait se produire sans l’intervention d’un comportement nécessairement qualifié de tel.61 La jurisprudence pousse d’ailleurs parfois cette logique assez loin, en instaurant une présomption de faute à partir du seul constat du dommage subi suite à une intervention médicale.62

La situation particulière de la méconnaissance du devoir d’information L’article 8, § 1er de la loi du 22 août 2002 relative aux droits du patient63 accorde à celui-ci « le droit de consentir librement à toute intervention du praticien professionnel moyennant information préalable » et précise que « Ce consentement 1998, Rev. Dr. Santé, 1998-1999, p. 232 ; Civ. Courtrai, 4 décembre 1998, Bull. Ass., 2007, p. 106 ; Bruxelles, 7 juin 2016, R.G.A.R., 2017, 15354. 57 Liège, 15 mai 1975, R.G.A.R., 1976, 9521 ; Mons, 28 juin 1994, J.L.M.B., 1996, p.91, note D.-M. PHILIPPE ; Gand, 21 février 1995, Dr. Circ., 1996, p.15. 58 Anvers, 30 juin 1997, Rev. dr. santé, 1999-2000, p. 201, note S. LIERMAN; Liège, 23 décembre 1997, R.G.A.R., 1999, 13168. 59 L’exigence ainsi posée par le droit de la responsabilité aquilienne fait écho à celle consacrée par l’article 5 de la loi du 22 août 2002 relative aux droits du patient et par l’article, 34 § 1er du Code de déontologie médicale (disponible à l’adresse https://www.ordomedic.be/fr/code/). 60 Th. VANSWEEVELT, « La responsabilité des professionnels de la santé», op. cit., 2000, p. 35. Voy. également Liège, 29 septembre 1998, R.G.A.R., 2000, n 13. 61 Trib. Bruxelles, 21 novembre 2011, J.L.M.B., 2013, 797 et Con. M., 2012, 96, note E. LANGENAKEN. Tel est notamment le cas de l’oubli d’un corps étranger dans le corps du patient (Bruxelles, 28 nov. 2011, R.G.A.R., 2012, 14819, note D. SCIEU). 62 Voy. not. Anvers (1ère ch. bis), 16 octobre 2002, Rev. dr. santé, 2001-2002, p.185, qui juge que dès lors que la paralysie dont souffre le patient suite à une intervention n’est pas due à une cause intrinsèque, le dommage ne peut être que la conséquence d’une faute du chirurgien. 63 Mon.b., 26 septembre 2002.

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est donné expressément, sauf lorsque le praticien professionnel, après avoir informé suffisamment le patient, peut raisonnablement inférer du comportement de celui-ci qu’il consent à l’intervention ». Le médecin est donc tenu non seulement d’informer le patient, mais aussi d’obtenir son consentement préalable à l’acte de soins. La question de la charge de la preuve en matière d’information a été tranchée en France dans un arrêt du 25 février 1997.64 Sous le visa de l’article 1315, alinéa 2 du Code civil, la Cour de cassation décidait alors que « le médecin est tenu d’une obligation particulière d’information vis-à-vis de son patient et qu’il lui incombe de prouver qu’il a exécuté cette obligation ». La Cour de cassation belge n’a toutefois pas suivi cet enseignement, jugeant que « le patient, qui invoque que le médecin n’a pas respecté son devoir d’information et qu’il a ainsi subi un dommage, a la charge de le prouver ».65 Il s’agit d’une application des principes généraux en vertu desquels le demandeur en justice a la charge de prouver les conditions de la responsabilité, spécialement lorsque l’on est en présence d’une obligation de moyens - comme notre Cour de cassation semble qualifier l’obligation d’information ainsi édictée. Hors du domaine médical, dans le cadre d’une contestation des frais et honoraires demandés par un avocat,66 la haute juridiction belge a toutefois, par un arrêt du 25 juin 2015,67 décidé « qu’il résulte des règles relatives à la charge de la preuve que c’est à l’avocat qu’il incombe de prouver qu’il s’est conformé à son obligation d’informer son client, et non à ce dernier de prouver le fait négatif que l’information requise ne lui a pas été donnée ». Des auteurs68 et juges69 y ont vu un revirement de jurisprudence, et préconisent de transposer le principe en droit médical. D’autres demeurent toutefois plus sceptiques70 et affirment que l’arrêt ainsi rendu peut également être interprété comme appliquant les principes classiques en matière de charge de la preuve dès lors qu’en l’espèce, c’était l’avocat qui était demandeur en justice puisqu’il poursuivait le paiement de ses honoraires.71 64

Cass. fr., 25 février 1997, R.G.A.R., 1997, 12.858. Cass., 14 décembre 2001, J.L.M.B., 2002, p. 532 ; Cass., 16 décembre 2004, R.G.A.R., 2006, n 14.161, Rev. dr. Santé, 2004-2005, p. 298. 66 De son côté, le justiciable reprochait à son avocat de ne pas l’avoir informé de ce qu’il était dans les conditions pour pouvoir bénéficier de l’aide juridique. 67 Cass., 25 juin 2015, R.G.A.R., 2015, 15219, note F. GLANSDORFF. 68 Fr. GLANSDORFF, note sous Cass., 25 juin 2015, R.G.A.R., 2015, 15219 ; I. REUSENS, « Du devoir d’information du médecin au devoir de collaboration du patient : plaidoyer pour un dialogue thérapeutique », Cons. Man., 2016/2, pp. 97-121. 69 Civ. (francophone) Bruxelles, 20 mars 2017, Rev. dr. santé, 2017-2018, pp. 122-134 ; Civ. Bruxelles, (11e Ch.), 29 février 2016, Rev. Dr. Santé, 2015-2016, liv. 5, 370, note Chr. LEMMENS et Cons. Man., 2016, pp. 97 et s. ; Civ. Bruxelles, 5 janvier 2016, J.T., 2016, pp. 404 et s. 70 M.-A. ORLANDO, « La charge de la preuve du devoir d’information du médecin : un revirement de jurisprudence ? », R.G.A.R., 2017, 15374, qui commente les décisions précitées et cite des décisions en sens contraire. 71 En ce sens M.-A. ORLANDO, op.cit., R.G.A.R., 2017, 15374, qui n’y voit pas un revirement de jurisprudence et se montre critique envers une admission du transfert de la charge de la preuve sur les épaules du médecin. 65

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Une issue pourra peut-être être trouvée dans le cadre de la réforme du Code civil qui verra prochainement le jour en Belgique. S’agissant du régime de la preuve, l’avant-projet actuellement soumis à une consultation publique autorise, en effet, le juge à déterminer librement qui du demandeur ou du défendeur supporte la charge de la preuve lorsque l’application des règles du Code civil aboutit à « un résultat manifestement déraisonnable »,72 ce qui pourrait être le cas dans le domaine médical. Dans le cadre de la réforme de la théorie générale des obligations, ensuite, une nouvelle disposition énoncerait, pour ce qui concerne le devoir d’information précontractuel,73 en cours de négociations, que « la partie qui prétend que l’information lui était due doit prouver l’existence du devoir d’information » et, surtout, que « L’autre partie doit prouver avoir fournir l’information due ».74 Il nous semblerait, pour notre part, opportun d’en faire un principe général applicable en toutes circonstances, au-delà donc des négociations, à tout le moins lorsque l’on est en présence d’un professionnel et d’un consommateur.

Le lien de causalité entre la faute et le dommage Les contours prétoriens de la causalité La victime est, par ailleurs, tenue d’établir l’existence d’un lien causal entre la faute et le dommage dont elle demande la réparation.75 Le droit belge retient majoritairement la théorie dite de l’équivalence des conditions en vertu de laquelle est en lien causal avec le dommage toute faute sans laquelle celui-ci ne se serait pas produit tel qu’il s’est produit in concreto, toute chose étant égale par ailleurs.76 La causalité ainsi entendue est non sélective; elle n’impose aucun jugement de valeur entre les événements ayant contribué au dommage, ou à son aggravation.77 Il s’ensuit qu’en cas de pluralité de fautes en lien causal avec un même dommage, chaque fautif sera tenu de le réparer intégralement sur le plan de l’obligation à la

72

Nouvel article 3 du Livre VIII du Code civil. Resterait, bien entendu, à préciser si l’hypothèse envisagée intègre effectivement ce domaine d’application. 74 Nouvel article 20, alinéa 2 du nouveau Livre VI du Code civil. 75 Cass., 12 juin 2017, R.G. 16.0428N ; Cass., 9 novembre 2012, R.G. C.11.0563.N ; Cass., 25 mai 2011, R.G. P.10.1111.F; Cass., 17 décembre 2009, 2 arrêts, R.G. C.09.0190.N et R.G. C.08.0145.N ; Cass., 11 septembre 2009, R.G. C.08.0199F ; Cass., 26 juin 2008, R.G. C.07.0272.N. Voy. aussi J.-L. FAGNART, « Petite navigation dans les méandres de la causalité », R.G.A.R., 2006, 14080, n 2. 76 Cass., 12 juin 2017, R.G. 16.0428N; Cass., 23 avril 2009, R.G. 07.0568.F; Cass., 23 septembre 2013, R.G. C.12.0559.N; Cass., 6 décembre 2013, R.G. C.10.0204.F; Cass., 11 juin 2009, R.G. C.08.0199F; Cass., 11 septembre 2006, R.G. C.05.0390.F; Cass., 21 février 2001, Pas., n 107 ; Cass., 24 novembre 1999, Pas., n 625 ; Cass., 30 oct. 1973, Arr. Cass., 1974, 250. 77 R.O. DALCQ, Traité de la responsabilité civile, t. II, no 2426. 73

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dette (obligation in solidum).78 De même, la victime79 pourra se voir reprocher sa propre faute lorsqu’elle est en lien causal avec le dommage et, dès lors, voir son droit à réparation limité à due concurrence.80

La preuve du lien causal Le demandeur en réparation doit prouver l’existence d’un lien causal certain entre la faute et le dommage. Il s’agit toutefois d’une certitude judiciaire, non scientifique. Un degré élevé de vraisemblance suffit dès lors que le juge ne peut envisager sérieusement une autre cause au dommage.81 En matière médicale, la preuve de la causalité sera d’autant plus complexe en présence d’un acte de négligence,82 puisqu’il s’agira de démontrer qu’un traitement médical adéquat aurait permis d’éviter le dommage.

Les possibilités d’exonération du médecin Le médecin garde la possibilité d’établir l’existence d’un cas de force majeure ou d’une faute commise par un tiers ou par le patient.83 Ce n’est, toutefois, que si ces causes sont les causes exclusives du dommage qu’il pourra espérer être totalement exonéré. À défaut, si elles ont uniquement contribué à la réalisation du dommage, le médecin restera totalement (force majeure) ou partiellement (fautes concurrentes)84 tenu à la réparation.

Gand (27e ch.), 5 janvier 2000, R.G.A.R, 2001, n 13.393. Il en va de même de ses proches, en cas de faute de la victime directe: voy. spéc. Cass., 16 février 2011, R.G. P.10.1232F, Pas., 2011, n 137. 80 Cass., 16 novembre 2016, R.G.A.R., 2017, 15368; Cass., 13 mars 2013, R.G. P.2012.1830.F ; Cass., 26 septembre 2012, R.G. P.2012.0377.F; Cass., 14 novembre 2012, R.G. P.2011.1611.F; Cass., 10 juin 2010, R.G. C.08.0211.F; Cass., 2 décembre 2009, R.G.A.R., 2010, 14.616; Cass., 9 octobre 2009, R.G. C.07.0370.F; Cass., 8 juin 2009, R.G. C.08.0568.N; Cass., 23 mai 2007, Pas., n 268; Cass., 12 février 2003, Pas., 2003, n 100; Cass. 10 juin 2003, Pas., 2003, n 341 ; Cass., 7 novembre 1990, Pas., n 130; Cass., 20 novembre 1967, Pas., 1968, I, 375. 81 À l’inverse, une simple probabilité ne rencontre pas l’exigence de certitude ainsi posée (Cass., 17 septembre 1981, Arr. Cass., 1981-82, p. 95). 82 Th. VANSWEEVELT, op. cit., 1996, n 491. 83 Th. VANSWEEVELT, op. cit., 1996, n 495 et s. 84 Sur le plan de l’obligation à la dette, comme il a été précisé supra, en cas de fautes concurrentes de tiers (ex. un médecin et un pharmacien, deux médecins), chaque prestataire reste tenu au tout vis-à-vis de la victime. C’est uniquement sur le plan de la contribution à la dette, dans un second temps, qu’une limitation de la part de responsabilité de chacun pourra être prise en compte. 78 79

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Le dommage et sa réparation Les contours prétoriens du dommage et les conditions de sa réparation La victime doit, enfin, établir l’existence et l’étendue du dommage.85 La Cour de cassation consacre une acception large du dommage: est prise en considération toute atteinte à un intérêt ou toute perte d’un avantage légitime.86 Il suffit, à cet égard, que la victime se trouve, après l’accident dommageable, dans une situation moins favorable qu’avant sa survenance.87 Toutefois, pour être réparable, le dommage doit être personnel - mais il peut être indirect, ce qui est aussi le cas du dommage subi par les proches.88 Il doit également être certain89 et légitime.90 Il ne devra, par ailleurs, pas avoir été déjà réparé, par exemple grâce à l’intervention d’un assureur ou d’un organisme public de soins de santé.91

Les principes civilistes gouvernant la réparation des dommages Le droit civil belge consacre trois grands principes de réparation.92 Le premier est celui de la réparation intégrale du dommage, en ce sens que la victime doit être replacée dans la situation qui aurait été la sienne si l’acte fautif n’avait pas été

85 Cass., 16 décembre 2014, R.G. C.03.0407.N; Cass., 15 janvier 2008, R.G. P.07.1247.N; Cass., 13 octobre 1993, J.L.M.B., 1994, p. 52. 86 Cass., 17 octobre 2016, R.G.A.R., 2017, 15388 et 15389;Cass., 16 janvier 1939, Pas., 1939, I, p. 25. 87 J. RONSE, et al., Schade en schadeloosstelling, I, A.P.R., Gand, Story-Scientia, 1984, p.8. 88 Cass., 16 février 2011, R.G. P.10.1232F. En cas de décès, on distingue le préjudice par répercussion (subi par les proches) du préjudice ex haerede (subi par la victime directe entre le jour de l’accident et celui de son décès). La réparation de ce second dommage peut aussi être demandée, au nom de la victime, par ses proches, la créance de réparation intégrant le patrimoine successoral. 89 Ceci n’impose pas qu’il soit déjà né et actuel. Un dommage futur est réparable s’il est établi qu’il se produira de manière certaine. La certitude du dommage doit par ailleurs exister dans son principe, non dans son étendue. 90 Ainsi, par exemple, la victime ne pourra réclamer l’indemnisation de la perte de revenus liés à un travail non déclaré. 91 La victime ne peut cumuler des prestations financières à caractère indemnitaire. En pareille situation, elle est tenue de déduire du montant dont elle sollicite la réparation les postes pour lesquels elle a déjà obtenu une indemnité réparatrice. Le tiers solvens ayant contribué à réparer le dommage disposera d’une action (quasi)subrogatoire afin de récupérer la part qui a été versée à la victime. 92 S’ajoutent des principes du droit judiciaire: (i) le principe dispositif en vertu duquel les parties assument la direction du procès et cantonnent l’office du juge (Cass., 20 novembre 2012, R.G. P.12.0499.N ; Cass., 20 février 2006, R.G. C.04.0366.N), (ii) l’interdiction de statuer ultra petita, au-delà de ce qui est demandé (Cass., 8 janvier 1981, Pas., 1981, I, 495), et (iii) l’obligation de motiver toute décision judiciaire (article 149 de la Constitution).

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commis,93 ni plus94 ni moins.95 Et, sur ce plan, tout dommage, aussi minime soit-il, mérite d’être indemnisé. Dans le prolongement, la victime a un droit de libre disposition de l’indemnité qui lui est allouée: le juge ne pourrait conditionner son octroi à la preuve d’une affectation au poste de dommage qu’il tend à réparer.96 Le second principe est celui de la réparation in concreto du dommage.97 Le juge est tenu de prendre en considération toutes les caractéristiques propres à la situation particulière de la victime et qui ont une influence sur l’étendue de son dommage (âge, sexe, profession, formation, situation familiale, etc.).98 Troisièmement, si la créance de réparation naît le jour de la survenance du dommage,99 l’évaluation de l’ampleur de ce dernier, dans ses composantes passées et futures, doit avoir lieu au jour du prononcé de la décision judiciaire.100 Et le juge devra tenir compte des variations dans la consistance du dommage postérieurement à l’accident lorsqu’elles sont certaines et en lien avec le fait générateur ou le dommage initial.101 La victime doit, pour sa part, agir en personne prudente et raisonnable afin de ne pas aggraver fautivement son dommage.102 L’exigence n’implique toutefois pas de rechercher à tout prix la voie la moins onéreuse, mais bien la plus adéquate.

Les postes de dommages réparables En présence d’une atteinte à l’intégrité physique, le droit belge distingue les dommages matériels et moraux. Aux premiers ressortiront, par exemple, l’incapacité économique, le préjudice ménager, la perte d’une année d’étude ainsi que les frais consentis ensuite de l’accident (frais d’hospitalisation, frais pharmaceutiques et médicaux, frais de prothèses, frais de déplacement, frais administratifs, etc.); des seconds relèvent notamment l’incapacité personnelle,103 le préjudicie esthétique, le préjudice d’agrément, le préjudice sexuel, le préjudice de souffrance (praetium doloris), etc.

93

Cass., 9 avril 2003, Pas., 2003, p.765 ; Cass., 22 juin 2017, R.G. C. 16.0282.F. Cass., 1er février 2013, R.G. C.2012.0205N. 95 Cass., 13 juin 2016, R.G.A.R., 2017, 15359. 96 Voy. D. DE CALLATAŸ, « L’affectation des dommages et intérêts et la détermination du dommage », in Mélanges R.O. Dalcq, Bruxelles, Larcier, 1994, pp. 87-96. 97 Voy. not. Cass., 8 janvier 2016, Bull. ass., 2016, liv.4, 486 ; Cass., 16 avril 2015, R.G. C. 13.0305.F ; Cass., 7 février 2012, R.G. C.11.0451.F. 98 Cass., 14 janvier 1998, R.G. P.97.1060F. 99 Cass., 15 février 2007, R.G. C.05.0274F. 100 Cass., 17 janvier 1929, Pas., 1931, I, p. 99 ; Cass., 23 avril 2012, R.G. C.11.0478N. 101 Cass., 29 septembre 1948, Pas., 1948, I, p. 509. 102 Cass., 27 janvier 2010, R.G. P.09.0770.F. 103 Selon la formulation retenue par le Tableau indicatif pour viser ce que l’on nomme classiquement le dommage moral. 94

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La victime peut également solliciter le paiement d’intérêts compensatoires et moratoires.104

La preuve du dommage L’existence du dommage et la détermination de son étendue requièrent l’intervention d’un médecin-expert. Il revient, ensuite, au conseil juridique de la victime (avocat ou juriste) de traduire l’information technique ainsi reçue en considération des classifications juridiques et d’en proposer une évaluation chiffrée. Sur ce dernier point, on relèvera l’existence d’un référent prétorien: le Tableau indicatif de l’Union nationale des magistrats de première instance et de l’Union royale des juges de paix et de police, dont la plus récente version date de 2016. L’outil se présente comme « un facteur d’uniformisation de la réparation du préjudice corporel »,105 qui peut être aussi un «garde-fou contre des indemnisations inéquitables».106 Ce tableau reste toutefois indicatif; il ne peut contrarier le principe selon lequel le juge dispose d’un pouvoir souverain d’appréciation du dommage et de son mode de réparation.107

Les modes de réparation du dommage Comme en matière contractuelle, la victime a par principe le choix de poursuivre la réparation en nature ou par équivalent.108 En matière d’évaluation du préjudice permanent,109 la doctrine et la jurisprudence connaissent différents modes de calculs, plus ou moins favorables aux victimes et

104

Les intérêts moratoires et compensatoires sanctionnent un retard dans le paiement, mais les premiers indemnisent le dommage résultant du paiement différé de l’indemnité (Cass., 22 juin 2010, R.G. P.09.1912.N) et courent du jour de la survenance du dommage (naissance du droit à réparation) jusqu’à la liquidation de la créance par le juge alors que les seconds portent sur la créance de réparation qui a été liquidée par le juge. Voy. I. SAMOY, S. STIJNS et S. JANSEN, « Dommages et intérêts compensatoires et moratoires », in B. Dubuisson et P. Jourdain (dir.), Le dommage et sa réparation dans la responsabilité contractuelle et extracontractuelle, Études de droit comparé, Bruxelles, Bruylant, 2015, pp. 145-213. 105 Th. PAPART et B. CEULEMANS, Le vademecum du Tribunal de police, 2013, Waterloo, Kluwer, p. 569. 106 Ibidem. 107 Cons. not. Cass., 11 septembre 2009, R.G. 08.0031.F. 108 Cass., 30 janvier 1965, R.C.J.B., 1966, p. 77, note J. DABIN ; Cass., 10 septembre 1971, R.C.J.B., 1976, p. 300, note P. VAN OMMESLAGHE ; Cass., 5 mai 2011, R.G.D.C., 2012, p. 247, note P. WÉRY. 109 L’expert déterminera les périodes d’incapacité temporaire (durant lesquelles l’intensité du dommage varie), la date de consolidation (moment à partir duquel l’expert estime soit que la victime est guérie soit qu’elle subit une incapacité permanente) et l’incapacité permanente.

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dont le choix crispera souvent les positions. Le droit belge connaît trois modes de calcul de ce préjudice: la rente,110 la capitalisation111 et le forfait.112 Pour certains postes, tels les frais consécutifs à l’accident dommageable (frais médicaux et pharmaceutiques, frais d’hospitalisation, aide d’une tierce personne, etc.), l’évaluation est aisée: il suffit de rembourser à la victime les débours qu’elle a effectués et dont elle prouve la réalité et le montant. Dans d’autres cas, comme pour le dommage moral par exemple, une telle précision n’est pas possible et le montant de l’indemnité pourra être fixé forfaitairement par le juge.113 La prescription114 Selon l’article 2262bis, § 1er du Code civil, les actions personnelles, telle celle en responsabilité contractuelle, se prescrivent par dix ans. Par dérogation, l’alinéa 2 énonce, toutefois, que « toute action en réparation d'un dommage fondée sur une responsabilité extracontractuelle se prescrit par cinq ans à partir du jour qui suit celui où la personne lésée a eu connaissance du dommage115 ou de son aggravation et de l'identité de la personne responsable. [Ces] actions [. . .] se prescrivent en tout cas par vingt ans à partir du jour qui suit celui où s'est produit le fait qui a provoqué le dommage ». La coexistence de ces deux délais induit que, dans l’hypothèse où les conditions de l’option entre les responsabilités contractuelle et extracontractuelle sont rencontrées,116 la question de la prescription peut guider le choix de la base légale invoquée. En effet, en matière de responsabilité médicale, il peut arriver que le dommage apparaisse de longues années après l’acte médical. Si l’action en responsabilité contractuelle devait en ce cas être prescrite, l’action fondée sur l’article 1382 du Code civil pourrait ne pas l’être.

110

Il s’agit d’une indemnité périodique, révisable et indexable, ayant vocation à se rapprocher au plus près du dommage tout en protégeant contre tout évènement futur (comme une modification de la situation familiale ou économique de la victime). 111 Il s’agit de la constitution, à dater du jugement ou de l’accord amiable, d’un capital devant permettre à la victime d’être indemnisée, selon le poste de dommage, jusqu’à la fin de sa vie lucrative ou jusqu’à son décès, en tenant compte de son espérance de vie et d’un coefficient compensant l’érosion monétaire. 112 Le Tableau indicatif propose notamment différents forfaits selon l’âge de la victime au jour de la consolidation. 113 Si le juge fixe le forfait en équité, il doit motiver le rejet des autres méthodes de réparation et le fait qu’il ne dispose d’aucune possibilité de déterminer autrement le dommage : Cass., 17 février 2012, J.L.M.B., 2012, p. 683, obs. Th. PAPART. 114 Ces délais de prescription peuvent être interrompus ou suspendus. 115 La connaissance de l’existence d’un dommage n’implique pas celle de son étendue (Cass., 9 décembre 2010, Circulation, Responsabilité et Assurances, 2011, p. 415). Par ailleurs, s’il faut que la victime « soit en mesure d’établir un lien causal entre le fait générateur du dommage et ce dernier, il n’est pas requis à cet égard que la personne lésée ait connaissance d’un lien causal certain et établi » (Cass., 5 septembre 2014, R.G. C.12.0605.N). 116 Voy. supra.

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La procédure civile et ses exigences L’action directe de la victime La victime dispose d’une action directe contre l’assureur « RC » du responsable,117 qui est un garant solvable.118 Dans l’hypothèse d’un dommage corporel très lourd, elle aura intérêt à poursuivre tant le prestataire que son assureur, ce dernier risquant de limiter l’indemnisation du dommage au maximum de son plafond d’intervention.

Introduction de la demande et l’expertise L’introduction de l’action se fait par voie de citation119 ou requête en comparution volontaire.120 Afin de déterminer si un prestataire a commis une faute en lien causal avec le dommage, le juge devra le plus souvent s’entourer de l’avis technique d’un ou plusieurs experts.121 Une telle mesure d’expertise peut être sollicitée dès l’audience d’introduction. Elle permet d’éclairer sur les faits et l’appréciation qu’il convient d’en faire,122 mais présente l’inconvénient de représenter un coût considérable, tant en temps qu’en argent.123 Ainsi, afin d’éviter de diligenter des mesures inutiles, le demandeur qui sollicite une expertise doit convaincre le juge de son opportunité et, dès lors, apporter un début de preuve.124 Dans le cadre de la procédure civile, l’expertise est technique,125 contradictoire126 et subsidiaire.127

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Article 150 de la loi du 4 avril 2014 sur les assurances, Mon.b., 30 avril 2014. Le droit belge n’oblige pas la souscription d’une assurance couvrant la responsabilité professionnelle. 119 Articles 700 à 705 du Code judiciaire. 120 Article 706 du Code judiciaire. Cette voie présente l’avantage de ne pas générer de frais d’huissier. 121 Article 962 du Code judiciaire. 122 En matière de responsabilité médicale, la mission sera généralement double, portant sur l’établissement du fait générateur et l’étendue du dommage corporel. 123 D. MOUGENOT, « Expertise judiciaire. Approche juridique » in. X., Expertise. Commentaire pratique. III.1-1 - III.6-6, Kluwer, 2010, p. 24. 124 Civ. Mons, 29 mai 1991, Bull. ass., 1994, p. 128. 125 L’expert ne peut éclairer le juge que sur les aspects techniques, non sur leur traduction juridique (Cass., 25 novembre 1980, Pas., 1981, I, p. 89). 126 Toutes les parties doivent connaître de tous les éléments de l’expertise ; tout document transmis à l’expert doit l’être aux autres parties. 127 Le juge ne peut être contraint de recourir à une mesure d’expertise (Cass., 29 mars 1974, Pas., 1974, I, p. 782). L’article 875bis du Code judiciaire lui impose de motiver le recours à cette mesure d’instruction. 118

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La mesure d’expertise sera généralement ordonnée avant-dire-droit, avant de statuer au fond. Les conclusions de l’expertise constituent un avis duquel le juge pourra se départir s’il motive sa décision.128

La responsabilité pénale et la procédure pénale Introduction La faute civile peut coïncider avec une infraction pénale, spécialement les délits de coups et blessures et d’homicide involontaires visés aux articles 418 et 420 du Code pénal. En ce cas, le fondement de la demande d’indemnisation restera un fondement puisé dans le droit de la responsabilité civile, seule à avoir une visée indemnitaire,129 mais cette action civile pourra être portée soit devant la juridiction répressive saisie de l’action publique, soit devant une juridiction civile.

Les aspects procéduraux L’action publique est diligentée à l’initiative du Parquet ou suite au dépôt de plainte par la victime. Afin de juger de la légalité et de l’opportunité des poursuites, le Procureur du Roi130 devra réaliser un « ensemble d’actes destinés à rechercher les infractions, leurs auteurs et les preuves, et à rassembler les éléments utiles à l’exercice de l’action publique ».131 Dans la présente matière, le Procureur du Roi sollicite régulièrement l’intervention d’un juge d’instruction, lequel peut seul ordonner une mesure d’expertise.132 Dès que le juge d’instruction, qui doit instruire à charge et à décharge,133 estime son instruction complète, il transmet le dossier au Procureur du Roi, qui trace un réquisitoire de non-lieu (s’il estime les charges insuffisantes) ou de renvoi devant la juridiction compétente. La décision est prise par la Chambre du conseil134 qui, si elle estime les charges suffisantes, prononce une ordonnance de

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Article 962 du Code judiciaire. Voy. Cass., 5 avril 1962, Pas., 1962, I, p.879. La responsabilité pénale, qui donne lieu à une action publique, n’a pas vocation à allouer une réparation; elle sanctionne uniquement un comportement contraire aux intérêts de la société. 130 Magistrat membre du Ministère public porteur des intérêts de la société. 131 Article 28bis, §1er, al. 1 Code d’instruction criminelle (ci-après CiCr). 132 Article 43 du CiCr. 133 Article 56, § 1er, al. 1 du CiCr. 134 Article 127, § 4 du CiCr. 129

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renvoi devant les juridictions de fond.135 C’est le tribunal qui tranchera alors le fond de l’affaire, en condamnant ou en acquittant le prévenu. L’action publique peut être mise en œuvre par le parquet suite à une plainte déposée par la victime.136 Elle pourra alors être mise en mouvement via une citation directe devant la juridiction de jugement137 ou une constitution de partie civile entre les mains du juge d’instruction.138 La partie civile peut bien entendu également intervenir au procès pénal alors que l’action publique a déjà été initiée par le Parquet.

La coexistence des responsabilités civile et pénale En cas de coexistence entre les responsabilités civile et pénale, la victime a le choix de porter sa demande de réparation devant le juge pénal ou devant le juge civil, lequel peut être saisi à l’issue du procès pénal ou l’être parallèlement. En ce dernier cas, toutefois, l’adage selon lequel «le criminel tient le civil en état» impose au juge civil de suspendre sa saisine dans l’attente de la décision pénale.139 Une fois rendue, par ailleurs, la décision pénale a en principe140 autorité de chose jugée sur la décision civile: le juge civil ne peut aller à l’encontre de ce qui a été certainement et nécessairement décidé par le juge répressif relativement aux faits dont il a été saisi et qui fondent la demande de réparation. Ainsi, si un médecin est, au pénal, reconnu coupable de coups et blessures involontaires (article 418 du Code pénal) et si la victime fonde sa demande d’indemnisation sur un comportement qui a été qualifié de tel, le constat de l’existence de l’infraction induira nécessairement la reconnaissance d’une faute civile (article 1382 du Code civil) et il y aura lieu à réparation si la preuve du lien causal et du dommage est rapportée.

Une procédure souvent délaissée La procédure pénale est rarement choisie par les justiciables qui préfèrent la souplesse de la procédure civile. Pour la partie civile, les caractères unilatéral141 et

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En matière médicale, la juridiction compétente sera le tribunal correctionnel. L’action publique n’est jamais mise en œuvre par la victime, mais bien par le Ministère public. 137 Articles 145 et 182 du CiCr. 138 Article 63 du CiCr. 139 À tout le moins s’il existe un risque de contradiction entre les décisions rendues au pénal et au civil. 140 La jurisprudence récente de notre Cour de cassation offre des tempéraments à ce principe. 141 Le caractère unilatéral découle de l’idée selon laquelle le parquet, qui représente les intérêts de la société, doit pouvoir mener son enquête sans être « dérangé » par l’intervention de l’inculpé ou de la partie civile. Cet esprit a connu des tempéraments avec l’entrée en vigueur de la loi du 12 mars 1998 relative à l’amélioration de la procédure pénale au stade de l’information et de l’instruction (Mon.b., 2 avril 1998), qui a offert à l’inculpé et à la partie civile une place plus importante. Les parties 136

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secret142 des phases d’information (par le parquet) et d’instruction (en cas de saisine d’un juge d’instruction) sont, en effet, souvent perçus comme des obstacles.

Évaluation des procédures judiciaires Les inconvénients de la procédure judiciaire La procédure judicaire présente plusieurs inconvénients pour les justiciables. Premièrement, l’arriéré judiciaire étant particulièrement important, la procédure est nécessairement longue, outre que la complexité du litige, le nombre de parties impliquées et le recours à une expertise judiciaire seront des facteurs à mêmes d’allonger sensiblement la durée de la procédure. Le coût de la procédure constitue également un frein important. Outre les frais d’avocats et de la procédure elle-même,143 en matière civile,144 il revient par ailleurs généralement au demandeur d’avancer les frais d’expertise. Enfin, si la demande est ensuite jugée irrecevable ou non-fondée, il conviendra, en outre, de s’acquitter de l’indemnité de procédure, qui est une somme forfaitaire supportée par la partie qui succombe au bénéfice de celle qui obtient gain de cause.145

Les avantages de la procédure judiciaire Malgré ces obstacles, la voie judiciaire reste privilégiée car elle offre un cadre empreint d’indépendance et d’impartialité et bénéficie d’une plus grande crédibilité.146 La reconnaissance du « statut » de victime par un juge influence probablement aussi un tel choix. Enfin, la méconnaissance des voies alternatives au procès semble être un autre élément influent.

peuvent ainsi solliciter la réalisation de mesures d’instruction complémentaires (art. 61quinquies du CiCr). 142 Le caractère secret ne signifie pas que la victime n’a aucun droit de regard, mais que tout accès au dossier est conditionné à une autorisation du juge d’instruction (article 61ter, § 1er du CiCr). 143 Le coût d’une citation se situe en moyenne autour de 250 €. 144 En matière pénale, les frais d’expertise ou de tout autre devoir seront pris en charge par l’État. 145 Article 1022 du Code judiciaire. 146 La réforme de l’expertise, intervenue en 2007, renforce ce sentiment en octroyant un rôle actif au juge: il fixe les délais de convocation des parties et dépôt du rapport, il est le garant du respect du contradictoire et peut, à tout moment, être interpelé si des difficultés sont rencontrées par les parties.

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Les Voies Alternatives aux Procedures Judiciaires L’intervention du Fonds des accidents médicaux Introduction Abrogeant et remplaçant deux lois mortes-nées du 15 mai 2007,147 la loi du 31 mars 2010 relative à l’indemnisation des dommages résultant de soins de santé148 a institué un Fonds (d’indemnisation) des accidents médicaux (en abrégé, et ci-après « FAM »), qui est un service spécial de l’Institut national d’assurance maladieinvalidité.149 Ce fonds peut150 être appelé à intervenir dès qu’un dommage « résulte de soins de santé »,151 c’est-à-dire dès qu’il « trouve sa cause dans une prestation de soins de santé152 et [. . .] découle : a) soit d’un fait engageant la responsabilité d’un prestataire de soins; b) soit d’un accident médical sans responsabilité ». La création de ce Fonds s’inscrit dans une volonté de faire intervenir la solidarité nationale face au risque médical auquel sont confrontés tous les citoyens,153 et de ne pas exclure par principe toute réparation des conséquences dommageables résultant d’un aléa thérapeutique comme l’impose le régime de la responsabilité civile.154 Elle rencontre toutefois aussi les attentes exprimées par les prestataires de soins, spécialement les médecins,155 stigmatisés par la mise en cause de leur responsabilité, tenus de supporter des primes d’assurance de plus en plus élevées et qui, au vu de ces circonstances, peuvent adopter une attitude défensive qui n’est favorable ni au progrès ni à la confiance nécessaire à toute relation de soins.

147

Loi du 15 mai 2007 relative à l'indemnisation des dommages résultant de soins de santé, Mon.b., 6 juillet 2007 ; loi du 15 mai 2007 concernant le règlement des différends dans le cadre de la loi du 15 mai 2007 relative à l'indemnisation des dommages résultant de soins de santé, Mon.b., 6 juillet 2007. 148 Mon.b., 2 avril 2010, p. 19.193, entrée en vigueur le 1er septembre 2012. 149 Le FAM était initialement un organisme public doté d’une personnalité juridique propre. L’intégration au sein de l’INAMI a été réalisée le 1er avril 2013 (voy. la loi du 19 mars 2013 portant des dispositions diverses en matière de santé (I), Mon. b., 29 mars 2013). 150 Cette voie reste en effet facultative tant que le patient ou ses ayants droit n’ont pas obtenu l’indemnisation qu’ils attendent. 151 Article 3, § 1er. 152 Sur cette notion, voy. l’article 2, 4 . 153 Voy. le FAM, Rapport d’activité du Fonds des accidents médicaux 2016, p. 5 (document disponible en ligne à l’adresse http://www.riziv.fgov.be/fr/publications). 154 Voy. aussi l’intervention de la Ministre reproduite dans le rapport du 26 février 2010 fait au nom de la Commission de la santé publique, de l’environnement et du renouveau de la société par Mme C. BURGEON, Doc. Parl., Ch., 2009-2010, 2240/006, p. 4. 155 Ibidem, pp. 4-5.

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Les innovations de la loi La loi du 31 mars 2010 est doublement novatrice. Elle l’est, tout d’abord, en ce qu’elle prévoit une prise en charge collective de certains accidents qui ne sont imputables à aucune responsabilité,156 et que le droit de la responsabilité civile laisse sans réparation.157 Elle l’est, ensuite, par sa volonté d’articuler l’intervention du Fonds avec les procédures judiciaires classiques. En effet, en présence de faits engageant la responsabilité civile, deux voies procédurales sont désormais ouvertes: soit saisir un juge dans le cadre d’une action fondée sur le droit de la responsabilité,158 soit solliciter l’intervention du FAM, dans le cadre d’une procédure gratuite159 (pour le patient)160, amiable et (voulue) plus rapide, procédure qui n’exclura par ailleurs pas un recours judiciaire ultérieur en cas de contestation de la proposition d’indemnisation.161 Les règles applicables à la réparation des dommages devant le Fonds sont celles du droit commun, spécialement les principes de la réparation intégrale et in concreto.162

Le champ d’application de la loi Introduction Le FAM organise l’indemnisation des dommages résultant de soins de santé qui se sont produits après le 2 avril 2010163 sur le territoire belge, indépendamment de la nationalité ou du lieu de résidence du demandeur. En 2016, il a supporté un montant total de 4.012.057,60 euros à titre d’indemnisation.164

Exposé des motifs, Doc. Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 11. Voy. Exposé des motifs, Projet de loi relatif à l’indemnisation des dommages résultant des soins de santé, Doc. parl., sess. ord. 2009-2010, n 52-2240/001, p. 8. Voy. également Rapport du 26 février 2010, Doc. Parl., Ch., 2009-2010, 2240/006, p. 6. 158 Article 3, § 1er ; Projets de loi, Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 9. 159 Article 20. 160 Les frais seront portés à charge du prestataire de soins si sa responsabilité est reconnue. 161 Exposé des motifs, Projet de loi, Doc. parl., sess. ord. 2009-2010, n 52-2240/001, p. 13. 162 Voy. supra. 163 Article 35, § 2. 164 FAM, Rapport d’activités 2016, précité, p.60. Le montant était de 1.230.796,05 euros fin 2015. Depuis sa création, 5.365.428,66 euros ont été versés aux victimes. 156 157

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Le domaine d’application ratione materiae Le FAM peut être appelé à intervenir dès qu’un dommage « résulte de soins de santé ». La causalité s’entend largement: il suffit que la prestation ait eu « un impact (. . .) sur la survenance, l’évolution ou l’ampleur du dommage ».165 Les dommages consécutifs à une chirurgie purement esthétique ainsi que ceux qui sont soumis à la loi du 7 mai 2004 relative à l’expérimentation sur la personne humaine166 sont toutefois exclus (article 3, § 2).

Le domaine d’application ratione personae Le FAM peut être saisi par « toute personne qui s’estime victime d’un dommage résultant de soins de santé ou ses ayants droit ».167 On vise donc les victimes directes168 et indirectes.169 Il faut, par ailleurs, que l’acte ait été posé par un « prestataire de soins ». La notion vise les « institutions de soins de santé » (hôpitaux, centres de transfusion sanguine, laboratoires de biologie clinique principalement)170 et les « praticiens professionnels »171 (médecins, dentistes, pharmaciens, accoucheuses, kinésithérapeutes, infirmiers, etc.).172 Le dommage doit, enfin, trouver sa cause dans une « prestation de soins de santé », c’est-à-dire dans un acte dispensé dans le but « de promouvoir, de déterminer, de conserver, de restaurer ou d’améliorer l’état de santé du patient ou de l’accompagner en fin de vie ».173

Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 23. Article 3, § 2 ; Projet de loi, Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 11. 167 Article 12, § 1er. 168 Si la victime est une personne incapable, mineure ou majeure, elle pourra être représentée. 169 Voy. Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 28. Voy., par ailleurs, C.C., arrêt 111/2014 du 17 juillet 2014. 170 Voy. l’article 2, 3 . 171 Article 2, 2 de la loi. 172 En vertu de l’article 2, 1 . 173 Article 2, 4 de la loi. Notons que la notion s’interprète largement, et vise les actes de soins et les omissions. 165 166

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Les conditions de l’intervention du Fonds Introduction Lorsqu’une victime s’adresse au FAM, celui-ci diligente la procédure et, le cas échéant, prend en charge la réalisation des expertises.174 C’est en soi une protection estimable dans un domaine marqué d’incertitude scientifique, où il peut être difficile d’accéder aux informations pertinentes.175

L’accident « avec responsabilité » Une intervention exceptionnelle du Fonds Si, au terme de la mesure d’expertise, une responsabilité est établie, c’est en principe au prestataire, via son assureur, qu’il revient de supporter la charge de la réparation. La loi prévoit, toutefois, que le Fonds peut exceptionnellement être appelé à indemniser lui-même un tel dommage, en lieu et place du prestataire ou de son assureur.176 C’est le cas lorsque: • le Fonds est d’avis que la responsabilité est établie et qu’elle n’est pas, ou pas suffisamment, couverte par une assurance,177 • le Fonds estime que l’offre d’indemnisation présentée par le prestataire ou son assureur est « manifestement insuffisante »,178 • une contestation est élevée par le prestataire ou son assureur quant à la responsabilité179 ou l’assureur refuse de soumettre une offre d’indemnisation amiable,180 à condition, dans ces deux situations, que le dommage réponde aux critères de gravité énoncés à l’article 5 de la loi.

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Le Fonds est, en effet, tenu d’organiser et de contrôler la tenue d’une expertise ; il s’assurera également de son caractère contradictoire. Quant à la valeur qu’il convient de conférer, dans le cadre d’une procédure en justice, à l’expertise diligentée devant le FAM, voy. Civ. Bruxelles francophone, 20 mars 2017, Rev. dr. santé, 2017-2018, pp. 122-134, note W. BUELENS, pp. 135-139.  175 G. SCHAMPS, op.cit., R.G.A.R., 2014, 15035, spéc. n 8 et 16. 176 Voy. Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 32. Dans ce cas, le Fonds bénéficie d’un droit de subrogation, mais son intervention financière a lieu à ses risques et périls ; il pourrait être tenu de supporter définitivement le montant alloué à la victime si, dans le cadre d’une procédure en justice, le juge conclut à l’absence de responsabilité. 177 Articles 4, 2 et 25, alinéa 1er. 178 Articles 4, 4 et 31. 179 Articles 4, 3 et 30. 180 Article 32.

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L’accident médical « sans responsabilité » La notion d’accident sans responsabilité La loi reconnaît au patient « un nouveau droit subjectif (. . .) qui lui permet d’être indemnisé (. . .) lorsque la responsabilité d’aucun prestataire de soins de santé ne peut être engagée ».181 L’accident médical sans responsabilité reçoit toutefois une définition légale propre, qui limite d’autant les possibilités d’indemnisation: il est un « accident lié à une prestation de soins de santé, qui n’engage pas la responsabilité d’un prestataire de soins, qui ne résulte pas de l’état du patient et qui entraîne pour le patient un dommage anormal ».182 L’anormalité183 suppose que le dommage «n’aurait pas dû se produire compte tenu de l’état actuel de la science,184 de l’état du patient185 et de son évolution objectivement prévisible»,186 le souci étant de limiter l’indemnisation aux seules «conséquences imprévisibles d’une prestation de soins».187 Le dommage doit, par ailleurs, présenter un certain seuil de gravité, déterminé selon les critères, quantitatifs et qualitatifs, précisés à l’article 5.188 Il faut ainsi que le dossier fasse ressortir soit une invalidité permanente au moins égale à 25 %, soit une « incapacité temporaire de travail » de minimum six mois consécutifs ou six mois non consécutifs sur une période de douze mois; soit encore l’existence de « troubles particulièrement graves, y compris d’ordre économique, dans les conditions d’existence du patient » ; soit, enfin, un décès. Un seul de ces critères suffit. Ajoutons que la loi affirme que « L’échec thérapeutique et l’erreur fautive de diagnostic ne constituent pas un accident sans responsabilité ».

Exposé des motifs, Projet de loi, Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 11. Sur les critères précis d’appréciation, voy. W. BUELENS, « Abnormale schade in het Wet Medische Ongevallen: een eerste commentaar bij een advies van het Fonds voor Medische ongevallen», Rev. dr. santé, 2015-2016, pp. 66-73 183 Article 2, 7 de la loi. 184 L’état actuel de la science invite à prendre en considération les risques connus de certaines interventions (Avis n 4 du FAM, disponible à l’adresse http://www.fmo.fgov.be/fr/about-us/avis/ index.html) et les connaissances scientifiques «en ce compris son niveau le plus élevé» (Projet de loi, Exposé des motifs, Doc. parl., sess. ord. 2009-2010, n 52-2240/001, p. 24). 185 Le critère de l’état du patient tient compte de sa situation personnelle, «déterminée en fonction de ses antécédents, de ses prédispositions particulières telles que son âge, ses capacités physiques» (Doc. Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 25). 186 Article 2, 7 . Voy. aussi l’exposé des motifs, Projet de loi, Doc.Parl., Chambre, 2009-2010, n 2240, pp. 24-25 et n 2241, p. 11. 187 Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 23. 188 L’exposé des motifs précise que l’on apprécie ce seuil au regard du dommage résultant de l’accident, à l’exclusion d’éventuels dommages antérieurs (Doc.Parl., Chambre, 2009-2010, n 2240 et n 2241, p. 35). 181 182

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Évaluation de la procédure devant le Fonds Des objectifs louables La loi du 31 mars 2010 répondait à des objectifs louables, rencontrant les intérêts tant des patients que des médecins, et de leurs assureurs. Pour le patient, la gratuité de la procédure constitue un avantage considérable comparé à la procédure civile. Selon les données statistiques communiquées par le FAM, 411 dossiers – la plupart déposés par des victimes directes – ont été traités en 2016, dont un peu plus de 10 % (44 dossiers) ont reçu une issue favorable.189 La plupart des demandes concernent des dommages subis en milieu hospitalier, en pratique ambulatoire ou lors d’une hospitalisation (env. 85 %);190 celles relatives à une pratique médicale en cabinet privé atteignent environ 8,5%.191 Près de la moitié des demandes sont introduites par les patients eux-mêmes.192 Une mise en œuvre délicate Si la procédure devant le FAM est gratuite, encore faut-il préciser que les parties doivent supporter les frais de l’intervention de leurs éventuels conseils (avocat et médecin-conseil).193 De nombreux contrats d’assurance protection juridique ne prennent, par ailleurs, en charge les frais d’avocat que dans le cadre d’une procédure judiciaire, ce qui peut inciter à la préférer. Le législateur avait, par ailleurs, annoncé que la procédure devant le FAM serait plus rapide que la procédure judiciaire. Malheureusement, depuis son lancement en 2012, le FAM a été saisi de 3.768 demandes,194 une cinquantaine lui étant désormais adressée chaque mois195 et 70% de ces demandes attendent encore qu’il soit statué sur leur sort.196

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FAM, Rapport d’activités 2016, précité, p. 39. La majorité des cas concernent toutefois des accidents (péri)opératoires : FAM, Rapport d’activités 2016, précité, p.45. L’orthopédie est le plus souvent en cause (env. 30 %). 191 FAM, Rapport d’activités 2016, précité, p. 32. 192 59,2% des demandes ont été introduites par les patients, 20,2 % par des organismes assureurs et à peine 8,7 % par des avocats (FAM, Rapport d’activités 2016, précité, p. 33). 193 Ce qui n’est toutefois pas une obligation. 194 FAM, Rapport d’activités 2016, précité, p. 24. Les dossiers se répartissent égalitairement entre les deux rôles linguistiques. 195 FAM, Rapport d’activités 2016, précité, p. 26. 196 Ibidem, p.5. 190

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La voie de la médiation La médiation régie par le Code judiciaire Introduction Depuis une loi du 21 février 2005,197 qui sera profondément modifiée en 2018, la 7e partie du Code judiciaire est consacrée à la médiation, que l’on peut entendre, dans ce champ d’application,198 comme (i) un processus structuré, coopératif et confidentiel199 (ii) volontaire200 et de concertation amiable qui (iii) présente la spécificité d’être guidé par un tiers professionnel, neutre, indépendant et impartial qui demeure en retrait de la ou des solutions dégagées à son terme par les parties, solution(s) qu’il aura néanmoins contribué à faire émerger grâce à des techniques d’écoute, de communication et de négociation, sans les imposer ni les recommander.

Deux types de médiations Le Code judiciaire régit deux types de médiation:201 la médiation « judiciaire »202 et la médiation « extrajudiciaire ».203 La première est celle qui prend place dans un cadre judiciaire: un juge a été saisi et ce dernier l’ordonne, avec l’accord des parties, en cours d’instance.204 À son issue, soit les parties sont parvenues à un accord, fût-il partiel, et il peut être homologué par le juge,205 soit, en l’absence d’accord, « la procédure est poursuivie au jour fixé, sans préjudice de la faculté pour le juge, s’il l’estime opportun et moyennant l'accord de toutes les parties, de prolonger la

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Loi du 21 février 2005 modifiant le Code judiciaire en ce qui concerne la médiation, Mon.b., 22 mars 2005, entrée en vigueur le 30 septembre 2005. Cette législation fera prochainement l’objet d’une réforme. 198 C’est une vision restrictive, certaines composantes n’étant pas présentes dans tous les processus de résolution amiable pourtant qualifiés de « médiations » en droit belge. Ainsi, par ex., l’indépendance du médiateur et l’absence d’intervention active dans la recherche d’une solution amiable peuvent faire défaut dans la médiation hospitalière (voy. infra n 43 et 44). 199 Consacrée par l’article 1728 du Code judiciaire. 200 Consacré par l’article 1729 du Code judiciaire. 201 Les autres médiations, soit les médiations « libres » ou hors cadre légal, demeurent envisageables dans la pratique, et ne sont pas en soi invalidées. Elles n’offriront toutefois pas, par elles-mêmes, les garanties légales offertes par le Code judiciaire et, surtout, elles ne permettront pas une homologation judiciaire de l’accord obtenu à leur terme. 202 Régie par les articles 1734 à 1737 du Code judiciaire. 203 Régie par les articles 1730 à 1733 du Code judiciaire. Le terme est impropre, la médiation étant, par définition, un processus volontaire. On préférera le terme de médiation « extrajudiciaire ». 204 Article 1734, § 1er du Code judiciaire. 205 Le juge est tenu d’homologuer l’accord sauf s’il porte atteinte à l’ordre public (article 1736, C. jud.). L’ordonnance d’homologation est un jugement au sens de l’article 1043 du Code judiciaire.

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mission du médiateur pour un délai qu'il détermine ».206 Pour sa part, la médiation « extrajudiciaire » est celle qui est initiée indépendamment ou parallèlement à la saisine d’un juge ou d’un arbitre, mais dans le respect des exigences du Code judiciaire. Dès lors qu’elle est menée avec le concours d’un médiateur agréé, l’accord pourra faire l’objet d’une homologation et, dès lors, se muer en jugement exécutoire.

Évaluation Bien que la médiation se développe depuis quelques dizaines d’années, elle reste peu pratiquée, a fortiori dans le domaine médical, même s’il est difficile de dresser un état des lieux en l’absence de données publiées. Un manque d’information et de sensibilisation du public et une certaine réticence des avocats, voire des assureurs – fût-ce en raison de craintes tenant à un allongement du traitement de la demande si la médiation n’aboutit pas – restent des freins à sa mise en œuvre. Dans ce domaine, s’ajoutent par ailleurs la gravité, pour les patients, de l’accident dont ils s’estiment victimes, et la dimension souvent éminemment conflictuelle de la relation entre parties. Pour ces motifs, les victimes préfèrent s’en remettre aux tribunaux, qui offrent une garantie d’impartialité et manifestent un souci de protection des parties faibles.

La fonction de médiation « droits du patient » Les droits légaux des patients Une loi du 2 août 2002 relative aux droits du patient207 a consacré huit droits que les patients peuvent faire valoir dans leurs relations avec des prestataires et dont la méconnaissance peut justifier une responsabilité:208 (i) le droit à des prestations de qualité; (ii) le droit au libre choix du praticien et celui de modifier ce choix; (iii) le droit à obtenir toutes les informations pouvant être nécessaires pour comprendre son état de santé et son évolution probable, ainsi que le droit d’être informé sur la couverture d’assurance du prestataire et son statut d’autorisation à exercer sa profession; (iv) le droit de consentir librement moyennant une information préalable et, dans le prolongement, le droit de refuser ou de retirer son consentement; (v) le droit à un « dossier de patient », ainsi que le droit de le consulter, de le faire rectifier et d’en obtenir une copie; (vi) le droit à la protection de la vie privée et au respect de son intimité; (vii) le droit de recevoir les soins les plus appropriés visant à prévenir,

Articles 1736 in fine et 1737 du Code judiciaire. Mon.b., 26 septembre 2002. 208 Selon les règles exposées supra. 206 207

2 L’indemnisation des dommages résultant des soins de santé et les. . .

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écouter, évaluer, prendre en compte, traiter et soulager la douleur et, enfin, (viii) le droit d’introduire une plainte concernant le respect des droits légaux ainsi énoncés. L’institution d’une fonction de médiation traduit la mise en œuvre de ce dernier droit: celui de déposer une « plainte » en cas de méconnaissance des autres droits, que ce soit au sein de l’établissement hospitalier au bénéfice duquel un praticien professe209 ou, à défaut, auprès d’une Commission fédérale « droits des patients », dont le Service de médiation « droits du patient » est compétent pour connaître de telles demandes.210 Le processus de médiation est, ici également, gratuit pour le patient.

Évaluation Aucun chiffre officiel n’est publié, mais, en 2013, G. Simon, président d’une association représentative des médiateurs en soins de santé (l’AMIS), dressait un bilan de la fonction de médiation de plaintes.211 L’auteur faisait alors état d’une majorité de plaintes relatives à la qualité des soins (67% pour les hôpitaux et 68% pour les hôpitaux psychiatriques), les autres concernant principalement le respect du droit à l’information (13% pour les hôpitaux et 11% pour les hôpitaux psychiatriques), la consultation du dossier « patient » (8% pour les hôpitaux) ou le consentement libre et éclairé (9% pour les établissements psychiatriques). De leur côté, les médiateurs hospitaliers déclaraient rencontrer plusieurs difficultés, notamment dans le déroulement de la médiation (30%), en ce qui concerne les ressources matérielles et humaines à leur disposition (26%), mais également quant au maintien de leur neutralité et de leur impartialité.212 Si le processus de médiation organisé en vue d’assurer le respect des droits du patient peut aboutir à un accord amiable, encore celui-ci ne concernera-t-il, dans la pratique, que les cas de moindre gravité, par exemple en cas de contestation d’une facture ou en vue d’obtenir la communication du dossier médical. Ce type de procédure apparaît peu adéquat lorsque l’enjeu est d’apprécier une responsabilité et ses conséquences financières.

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Article 30 de la loi coordonnée sur les hôpitaux et les autres établissements de soins (Loi coordonnée le 10 juillet 2008, Mon.b., 7 novembre 2008). 210 Le service fédéral de médiation « droits du patient » est compétent pour connaître des plaintes introduites à l’encontre d’un médecin qui ne professe pas en milieu hospitalier (pratique indépendante) ou qui preste au sein d’un établissement de soins non hospitalier (comme une maison de repos et de soins, par ex.). 211 G. SIMON, « La médiation dans le secteur des soins de santé fête ses dix ans », Hospitals.be, 2013, n 3, p. 8. 212 Les médiateurs hospitaliers sont engagés et rémunérés par l’hôpital, ce qui les prive d’un statut d’indépendance et de neutralité aux yeux des patients. Par ailleurs, en tant que membres du personnel de l’établissement, en contact avec ses autres composantes, ils éprouvent également des difficultés à « dénoncer » les plaintes des patients.

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Conclusion En l’état actuel du droit belge et des pratiques, malgré ses difficultés probatoires, son coût et ses lenteurs, la voie judiciaire, principalement celle d’une procédure civile, reste privilégiée par une majorité de patients. Quant aux processus de médiation, organisés par le Code judiciaire ou en matière de soins de santé, le statut du médiateur (à tout le moins le médiateur hospitalier), l’important déséquilibre qui caractérise toute relation de soins, la complexité et la technicité des dossiers ainsi que la gravité des dommages font que cette voie amiable n’apparaît pas la plus adaptée, à tout le moins lorsqu’il s’agit d’établir un fait générateur de responsabilité. Malgré les atouts vantés, en termes de gratuité, de rapidité et d’intervention financière, le FAM peine, quant à lui, à gagner la place qui devrait naturellement lui revenir parmi les voies d’indemnisation des accidents médicaux. Il reste peu connu, même si les statistiques publiées depuis sa création témoignent de sa saisine de plus en plus fréquente par une majorité de patients qui ne sont pas assistés de conseils juridiques. Il conviendrait de le doter de moyens financiers, matériels et humains à la mesure de l’importance de la mission qui lui est dévolue et de contribuer à sa meilleure visibilité.

Chapter 3

Compensation Schemes for Damages Caused by Healthcare in Brazil Gisela Sampaio da Cruz

Abstract Analysis of medical liability requires a good measure of care. Contemporary Brazilian law on civil liability has evolved beyond the traditional psychological concept of fault, and demands, instead, compliance with standards of conduct and standard procedures as evidence of physicians’ diligence in their professional practice. These standards and procedures are difficult to describe in the abstract and must be extracted from the professional practice of the medical community. Therefore, this article intends to address the current challenge in medical liability law to find mechanisms that can reconcile the expert opinion of medical witnesses and the courts’ (and other decision-makers’) duty to interpret the facts of the case within a legal framework, in order to ensure a fair and reliable application of professional standards and conduct.

Introduction Unlike other most other legal systems, Brazil does not have an organized compensation scheme within the administrative system, even for medical malpractice. This means that in the absence of an administrative system, victims of medical malpractice must look to the courts for compensation. Even if there were an organized administrative compensation scheme, it would not prevent victims of medical malpractice from resorting to the courts if they were dissatisfied with the administrative decision on compensation, since the right to bring action is guaranteed in Brazil by the Constitution.

Assistant Professor of Civil Law, Faculty of Law, State University of Rio de Janeiro – UERJ. Ph.D. in Civil Law from UERJ. Attorney. Translation by Leslie Rose, with the author’s thanks. G. Sampaio da Cruz (*) State University of Rio de Janeiro – UERJ – Faculty of Law, Civil Law, Rio de Janeiro, Brazil e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_3

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Article 5(XXXV) of the Federal Constitution of 19881 provides that the jurisdiction of the judicial courts over any threat or injury to rights cannot be excluded, and consequently the imposition of administrative channels for claims for compensation would be unconstitutional. By virtue of article 5(XXXV) of the Constitution, therefore, the courts effectively have a monopoly over the protection of rights, and this monopoly is expressed as the principle of judicial protection or the principle of unimpeded exercise of jurisdictional control. In fact, article 5(XXXV) provides for two types of constitutional guarantees. The first is that the Judicial Branch has a monopoly in the exercise of jurisdiction to protect rights, and the second is that any person may “invoke the exercise of the courts’ jurisdiction whenever a right, whether individual or not, is claimed to have been injured or simply threatened.”2 These provisions did not, however, prevent the development of arbitration in Brazil, as we will see later in this report. Although Brazil does not have a compensation scheme organized within the administrative system, exceptionally, when medical malpractice occurs in a public hospital—and so attracts the civil liability of the State—the victim or the victim’s legal representative can make a claim for reparation though administrative channels, but this a rare occurrence in Brazil. It is rare for victims to take the administrative route because, as the commentators point out, “the government generally offers a ludicrous sum as compensation or rejects the claim altogether, compelling the victim to turn to the courts.”3 In any case, the administrative route is merely an option open to the victim, who may prefer to make the claim for compensation directly in the courts, rather than go through a compulsory administrative instance.4 And in the vast majority of cases, regardless of whether the medical malpractice occurs in a public hospital or not, the victim will go directly to the courts, given the absence of an efficient administrative system. Even if there were an administrative system for paying compensation for medical malpractice, victims could not be prevented from resorting to the courts if the administrative claim was denied, and victims could not be compelled to make their claims at the administrative level before turning to the courts, because such a requirement would be contrary to Brazilian constitutional principles.

Federal Constitution of 1988: “Art. 5. All are equal before the law, without distinction of any kind. Brazilians and foreigners resident in Brazil are guaranteed the inviolability of the right to life, to liberty, to equality, to security, and to property, on the following terms: . . . (XXXV) – the law may not exclude threat or injury to rights from the appreciation of the Judicial Branch.” (our translation). 2 Afonso da Silva (2012), pp. 134–135. 3 Medauar (2003), p. 399. Our translation. 4 The Constitution of 1988 did away with “conditional jurisdiction” established by Constitutional Amendment no. 7 in 1967. Conditional jurisdiction required that a complainant exhaust all administrative instances before making a claim before the courts. Obviously, conditional jurisdiction was inconsistent with the 1988 Constitution’s adoption of the principle of free access to the courts. 1

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The Function of Civil Liability: Additional Punitive Purposes or Purely Compensatory? In Brazilian law, the function of civil liability is compensatory: its main purpose is to repair economic and non-economic loss caused by the violation of certain duties or conduct. Civil liability operates on the principle of full reparation of the loss, which seeks to put the injured party, to the extent possible, in the situation he or she was prior to the event that caused the damage. The full extent of the damage must be repaired, but nothing more than the damage. In Brazil, therefore, civil liability dos not have a punitive aspect, and consequently there are no “punitive damages” (also referred to as “exemplary damages”, “vindictive damages” or “smart money”). Strictly speaking, then, in Brazil damages may not be fixed in an amount greater than that needed to repair the damage as a way to discourage a repetition of the injurious conduct by the agent or third parties. On the subject of material damages, the Superior Court of Justice (Superior Tribunal de Justiça, Brazil’s highest court for non-constitutional matters) has taken the position that the function of reparation is to restore the status quo ante, and that therefore the quantum of the damages must correspond exactly to the loss suffered, as provided for in article 944 of the Civil Code: “Indemnification is measured by the extent of the damage.”5 When it comes to non-economic damages, however, there are a few decisions6 that allow civil liability to have a punitive character and refer to “punitive damages”, although not precisely on the same lines as the concept of punitive damages under the common law. In effect, faced with the almost insuperable difficulty of determining the precise extent of non-economic loss, reparation of ‘moral damage” is sometimes guided by mechanisms that not only provide compensation to the injured party, but mete out punishment to the offender, even though such mechanisms are contrary to the essential function of civil liability under Brazilian Law. In an attempt to compensate for the insufficiency of criminal liability and, principally, the lack or inadequacy of administrative sanctions,7 moral damages can take on a punitive character. Most scholars, however, take the view that punishment is not, in theory, the task of the civil law: it is the criminal law that should perform that function. Criminal liability has always concentrated on the agent; in contrast, civil liability, especially with the advent of the Federal Constitution of 1988, underwent a significant change in focus: instead of concerning itself with the wrongful or negligent conduct of the agent, it looks primarily to protection of the victim from wrongful injury. 5

The English translation of articles of the Civil Code is taken from Rose (2012). See, for example, the decision in Judgment of 13 March 2012, Rio Grande do Sul State Court of Justice, 19ª CC., AC 70040936841, Rel. Mylene Maria Michel, v.u. 7 We say “principally” here because the worst offenders are precisely companies that hold concessions to provide public services, which in Brazil have not been adequately controlled by regulatory agencies. 6

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As Maria Celina Bodin de Moraes (2003) explains, the change in perspective toward protection of human dignity has had a decisive influence on the criterion for reparation, which is now baaed on the personal condition of the victim. There can be no doubt that the human person is entitled to the broadest protection, and it is precisely for that reason that the civil law must seek out the means that will make it possible to achieve full reparation of the loss suffered. Thus, the author concludes, criteria for fixing the amount of damages should not be “those that are appropriate to punitive or retributive justice, such as the offender’s financial situation and the seriousness of the offence. Elements such as those are related to the damage caused, not the damage suffered.”8 The Brazilian Civil Code of 2002, like the Civil Code of 1916, does not provide that damages should be measured by the degree of the agent’s fault, nor does it impose a punitive function on civil liability, which is possible only in exceptional circumstances.9 Article 944 of the Brazilian Civil Code does provide that “if the disproportion between the seriousness of the fault and the damage is excessive, the judge may reduce, in an equitable manner, the indemnification”, but this does not mean that the degree of fault determines the amount of damages, nor does the provision authorize the court to increase the amount of damages to serve a punitive function that non-economic damages do not in fact have, contrary to the position taken in a few cases.10 What it means, in reality, is that depending on the disproportion between the agent’s degree of fault and the injury caused, reparation may be less than complete, but this is quite different from the (incorrect) notion that in Brazilian law fault serves as a measure for damages, much less that civil liability has a punitive function as a rule. When the Code of 1916 was in effect, under the letter of the law the courts could not take the agent’s degree of fault into account when fixing the quantum of damages. For example, if someone caused another person’s death through negligence, but the degree of negligence was slight, the damages would be the same as if the agent had committed a pre-meditated murder. In practice, however, when the negligence involved was “slight”, courts would take what Díez-Picazo (1999) refers to as a “Salomonic” approach and would adjust the principle of full reparation to the circumstances.11

8

Bodin de Moraes (2003), pp. 332–333. Our translation. The author goes on to explain that there are other criteria are likewise not relevant in a system of full reparation since they refer, in truth, to the conduct in itself. Some examples given by the author are the proportionality between the advantage gained by the person who committed the injurious act and the injury suffered, the presence or absence of intent, foreseeability and good faith, and whether the person had some interest in performing the act or merely wished to injury the other party. 9 When the damage affects a large number of people, “moral damages” can, exceptionally, operate as a lesson to the offender or an example to others, and this function is recognized even by those authors who deny that moral damages have a punitive nature. 10 Judgment of 10 February 2004, Superior Court of Justice (STJ), 3ª T., AgRg. no REsp. 512881, Rel. Ari Pargendler. 11 Díez-Picazo (1999), p. 237.

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When the Civil Code of 2002 came into force, a number of scholars applauded its express provision allowing the court to reduce the amount of reparation on an equitable basis if there is too great a disproportion between the degree of fault and the damage (unlike other systems, under Brazilian law, this is the only criterion for reduction). The provision must, however, be applied with a certain amount of caution. As Carlos Nelson Konder (2007) explains, in using this provision, the decision-maker must not only respect its intrinsic limits, but also “. . . be able to rely on a constitutional principle that would justify making an exception to the principle of full reparation in light of the special circumstances of the case, such as protection of the agent’s right to sufficient assets and income to maintain a dignified level of subsistence.”12 The Civil Code of 2002 therefore maintains the general approach that compensation should be measured by the extent of the damage. The degree of fault does not, in principle, have any influence on the calculation of damages; this rule, however, is not hard and fast, since the legislator, under article 944 of the Civil Code, allows the court (or the arbitrator)13 to reduce the amount of reparation (but never to increase it) when the disproportion between the seriousness of the fault and the damage caused is excessive. The degree of fault, however, never serves as a “measure” for damages.14 Nonetheless, when the injury caused is massive, affecting a large number of people, as in the case of consumer relations or environmental damage, the punitive function of damages can, exceptionally, be recognized. But here again we are dealing with an exception that only confirms the general rule: under Brazilian law, the predominant function of civil liability is to repair loss or injury.

General Evaluation of the Brazilian Indemnification System If the Brazilian indemnification system were to undergo a general evaluation, certainly the sharpest criticism would be directed to reparation of non-economic injury. It has been said—and indeed, it is commonly asserted in Brazil—that moral injury is not subject to “reparation” but to “compensation”, like all non-economic damage. The problem is that in the vast majority of cases, compensation is implemented through the duty to indemnify, as if paying damages was the only possible response—a response that is strictly economic in nature—that the legal

12

Nelson Konder (2007), pp. 3–34. Our translation. In our view, the arbitrator decides according to the law, even though he or she makes use of equity (but does not render a decision ex aequo et bono, for which the express authorization of the parties is required). Instead, it is the sole paragraph of article 944 that allows equity to enter into the decisionmaking process. 14 The degree of fault, in our view, is not even an adequate measure for distributing liability the burden of the injury among the agents. The causal nexus is the element of civil liability best suited to that function. 13

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system can give to the innumerable kinds of injury that can affect human dignity and people’s existential interests. Aside from the problem of quantification, the traditional remedy of paying damages not only encourages mercenary instincts in the victim, it suggests that the injury to existential interests is permitted as long as the “price” is paid, although that price is not defined. In a true distortion of the fundamentals of civil liability, payment of damages conveys the mistaken idea that it is possible to cause injury, as long as the victim is later indemnified. Added to this is the fact that the systems for indemnification, precisely because they were not designed to protect non-economic interests, are not up to the task of repairing non-economic damage: the “formula of equivalence” that applies in the case of damage to property, for example, has produced various controversies over its application to non-economic damage. In this problem-filled scenario, the Brazilian courts, following a trend begun in other jurisdictions, have slowly been experimenting, in a rather timid way, with “demonetizing” reparation for non-economic injury.15 The difficulties point out above with respect to quantification of damages for moral injury show that money is insufficient reparation for non-economic injury. The need for non-pecuniary means of reparation is a logical consequence: although such means do not entirely replace money damages, the two together can effectively compensate non-economic injury and repair, to the extent possible, the victim’s injured existential rights.16 The advantages of non-pecuniary compensation are undeniable. In Brazil, awards of damages for non-economic injury are relatively low, especially in more serious cases, which ends up being yet another attack on the victim, who in turn does not feel adequately compensated. When compensation is paid in kind, it can substitute payment of damages or least ensure that monetary damages are accompanied by a retraction or publication of the judgment granting damages for moral injury,17 making reparation more effective18 and discouraging the proliferation of claims

15

In Portugal, cf. Almeida Costa (2009), p. 599 et seq. Reparation in natura is simply an attempt to put the injured party in the same state he or she would be if the damaging event had not occurred, by furnishing to the injured party a piece of property similar to the one that was destroyed or damaged, for example. It is customary for commentators to say that moral injury, by its very nature, is not compatible with reparation in kind because it does not have any economic content, but little by little scholars are coming to recognize that in some cases reparation in natura is not only possible but absolutely necessary to repair the victim’s injured existential interests. 17 Publication need not be in the Official Gazette; depending on the case, this type of reparation is more effective if the decision or retraction is published in a vehicle that circulates among the public to which the injured party was exposed. 18 Brazil’s Law of the Press (Law 5.250/67) provides for some types of reparation that can be considered reparation in kind, such as retraction by the offender, denial, rectification of the offending report, publication of a reply and even publication of judgment finding the offender liable for defamation. On 30 April 2009, Brazilian constitutional court, the Supreme Federal Court, granted a constitutional challenge (ADPF no. 130/DF) filed by the Democratic Workers’ Party (PDT) against the Law of the Press, arguing that the legislation had not survived as part of the law of 16

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that are merely mercenary. It is also, in the words of Anderson Schreiber (2007), the best answer that civil liability can give “. . . to the criticism, from an economic point of view, that the same law that recognizes the need to protect existential interests ends up monetizing them.”19 Damage caused by healthcare are subject to reparation in natura. The court can order, for example, that an unsuccessful surgery be redone, so as to eliminate the precise damage caused by the defect in the first operation, but this is not always possible in practice.20 When reparation in kind is not possible, the only option open to the victim is to demand reparation in pecunia and, consequently, an award of money. According to article 947 of the Civil Code, “[i]f the debtor cannot perform the obligation in the kind agreed, performance will be replaced by its value in lawful currency.” The Brazilian Civil Code has special rules establishing parameters for awards of injury to health. The first specific rule is found in article 948,21 which deals with damages owed when the victim is killed. According to article 948, indemnification consists, without excluding other reparation, of: “I – payment of expenses incurred in the victim’s treatment, his funeral, and the family’ mourning; II – payment of support to the persons to whom the deceased owed it, taking into account the probable duration of the victim’s life”. The second rule is found in article 949, which deals with non-fatal injury. In such cases, the reparation covers “the expenses of treatment and loss of profit until the end of convalescence, in addition to any other loss that the offended person proves he has suffered.” To conclude, it is fair to say that in principle all reparation should be in natura, to the extent possible, regardless of whether the loss or injury is economic or non-economic. Only when reparation in kind is impossible or unsatisfactory should money damages be awarded. Pecuniary reparation therefore has secondary application. This is not, however, what happens in practice in most cases: “[a]lthough it is secondary in nature, money damages are more frequent, given the difficulties facing reparation in kind in practice, in light of the circumstances of the particular case and, most especially because the damage is such that it is usually impossible to restore the

the land when the 1988 Federal Constitution came into force. Nonetheless, the forms of reparation in kind provided for in the Press Law continue to be used in practice. Scholars also point to withdrawal from the market of the offending book as a type of reparation in kind for injury to the honour of a public person (for other examples, see de Assis (1999), pp. 14–23). In the view of Justice “... the measures provided for in the legislation or referred to by scholars do not constitute actual reparation in kind because they are not capable of completely eradicating the non-economic loss suffered; they are simply attempts to minimize the effects of the loss because it is not possible to restore interests that do not have economic content, as in the case of personality rights.” (our translation) (De Tarso Vieira Sanseverino (2010), pp. 34–40/275–277). 19 Cf. Schreiber (2007), pp. 187–191. Our translation. 20 Martins-Costa and Martins-Costa (2017), p. 4. 21 Civil Code: “Art. 948. In the case of homicide, indemnification consists, without excluding other reparation, of: I – payment of expenses incurred in the victim’s treatment, his funeral and the family’s mourning; II – payment of support to the persons to whom the deceased owed it, taking into account the probable duration of the victim’s life.”

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victim to the situation he or she was in prior to the event that cause the injury.”22 When the victim prefers an award of money damages or monetary compensation is the only option, the real challenge is to prove the extent of the damage suffered, and this task often demands extensive production of evidence, which is not always accessible and is rarely quick or easy to produce. And even when this obstacle is overcome, the victim still must prove that the physician’s conduct was negligent.

Relevant Normative Framework for: Defining and Determining the Existence of Fault In Brazilian law, physicians’ liability is subjective in nature, as can be seen from article 951 of the Civil Code,23 which refers to injury resulting from negligence, imprudence or lack of skill, which are the three traditional facets of fault. The Consumer Defence Code takes the same position with respect to the subjective nature of physicians’ liability in providing, in article 14§4, that liberal professionals are liable on proof that they acted with fault.24 Although under both Codes physicians’ liability is subjective, there are significant differences between them, notably in the burden of proof, which is reversed in favour of the consumer in consumer relations (see article 6(VIII) of the Consumer Defense Code).25 Thus, both the Civil Code and the Consumer Defence Code require a demonstration of fault on the part of the physician before he or she can be held liable. Brazilian law does not have a definition of “fault”, but through the work of legal scholars, “fault” is taken to encompass both malicious or intentional wrongdoing (dolo) and fault is a strict sense. In contrast to malicious or intentional wrongdoing, fault describes conduct that is negligent, imprudent or lacking the expected standard of skill and that violates the rights of another person or causes injury or loss to that person. Brazilian law currently adopts an objective concept of fault, referred to as a “fault measured by standards”, in which the specific characteristics of the agent are

22

De Aguiar Dias (2006), pp. 985–988. Our translation. Civil Code: “Art. 951. The provisions of arts. 948, 949 and 950 apply even in the case of indemnification owed by one who, in the exercise of a professional activity, by negligence, imprudence or lack of skill cause the death of a patient or aggravates his ailment, causing him injury or incapacitating him for work.” 24 Consumer Defence Code, art. 14 §4: “The personal liability of liberal professionals is determined by inquiring into whether fault exists.” Our translation. 25 Consumer Defence Code: “Art. 6. Consumers have the following basic rights: . . . (VIII) facilitation in defending their rights, including a reversal of the burden of proof in the consumer’s favour, whenever the court determines that the consumer’s allegations establish a prima facie case or the consumer is at a disadvantage [in relation to the supplier] under the ordinary rules of experience.” Our translation. 23

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disregarded but the particular circumstances of each case are taken into account. The question of whether fault exists is not determined by looking to the particular qualities, skills and limitations of the agent, but rather the peculiarities of the facts of the case. Within this model, the traditional figure of the bonus pater familias is not a sufficient or complete standard of conduct. The dynamism of social relations, driven by human creativity and increasing specialization of activities, demands multiple, specific standards that reflect the plurality and peculiarities of human activity, and it is this standardization that allows a precise and objective assessment of conduct in the circumstances of each case. In constructing these standards, which are based on the principle of objective good faith (the source of duties of conduct), a wide variety of parameters is taken into account, ranging from guidelines issued by professional associations and codes of ethics to statistical information. The use of court-appointed experts, who have specialist knowledge of the conduct at issue in the case, also contributes to delimiting a model of conduct that is as close as possible to reality and consequently most accurate for the purposes of assessing the offender’s behaviour. The determination of whether fault exists is made by comparing the archetypical conduct expected in the circumstances revealed by the facts of the case and the agent’s actual behaviour. In other words, to prove fault, the victim needs to show that the offender’s conduct fell short of the expected standard. It is an exercise, essentially, in comparing the conduct adopted in actual fact with an abstract model of conduct in like circumstances in order to determine whether there is any discrepancy between them, without looking into the state of mind of the agent. Fault is thus free of any suggestion of guilt. Professional fault—or professional negligence as it is more commonly called in English—will exist when a physician fails in the performance of some duty related to his or her office. In general, medical professionals are held to have the following duties: (i) the duties of assistance, vigilance and care, (ii) the duty to inform the patient, (iii) the duty to administer appropriate treatment, (iv) the duty to protect the patient’s best interest and advise the patient, and (v) the duty to refrain from abuse and misuse of power.26 Most lawsuits related to “medical error” arise from a failure in the duty of appropriate treatment and the duty of care, vigilance and assistance. An unjustifiable delay, for example, in surgical treatment indicated by reason of the seriousness of the initial diagnosis, which then evolved to an even more serious state, can be classified as a defect in the care of the patient.27 Likewise, a physician’s decision to release a patient from hospital without proper investigation will be considered a failure in the

26

Pereira Silva (2016), p. 204. Judgment of 09 may 2017, São Paulo State Court of Justice, 9ª CDPriv., AC 003805315.2012.8.26.0007, Rel. Gladino Toledo Júnior, v.u.

27

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duty of appropriate treatment.28 In emergency situations the duty of diligence may be less exacting, but it is never excluded altogether.29 A significant duty related to medical liability is the duty to inform. A physician has the duty to inform the patient fully as to the risks of treatment, advising on the advantages and disadvantages of the medical procedures and various techniques that will be employed, and to disclose the patient’s current clinical state and the prognosis post-treatment. According to article 34 of the Code of Medical Ethics (CFM Resolution no. 1931/2009), physicians may not “fail to inform the patient of the diagnosis, the prognosis, and the risks and objectives of treatment except when direct communication could harm the patient, in which case the communication must be made to the patient’s legal representative.” (our translation). Related to the duty to inform is the duty to obtain the patient’s informed consent. Consent may be given in a written document that sets out the potential risks which the patient will be exposed to, along with the precautions that should be taken to maximize the chances of success of the treatment. As scholars have noted, however, “the absence of a written instrument does not presuppose a lack of consent, just as the mere existence of a written instrument does not exclude liability for medical negligence.”30 Only in cases where there is an imminent risk to life can a physician carry out a medical procedure without the patient’s consent, according to article 22 of the Code of Medical Ethics.31 The duty to protect the patient’s best interests gives general interpretative guidance in evaluating medical conduct.32 This duty requires the physician to respect and protect the patient’s psycho-physical integrity and dignity, and excludes any possibility of abuse of the patient. In this respect, the duty to protect the patient’s best interest can be seen as an overarching obligation that encompasses other, more specific duties. In summary, there is no rigid standard of fault or negligence by medical professionals for the purposes of civil liability. The existence of fault therefore requires an examination of the facts, in light of the various duties attached to the office exercised by the medical professional. In Brazilian law, a medical professional can be held liable not only for his or her own negligent acts, but also those of others. In some situations, therefore, a physician can have civil liability for acts performed by assistant physicians (such as residents) or by team members who are not physicians (such as nurses). Such a

28

Judgment of 22 february 2017, São Paulo State Court of Justice, 12ª CDPúb., AC 012102778.2006.8.26.0053, Rel. Isabel Cogan, v.u. 29 Martins-Costa and Martins-Costa (2017), p. 10. 30 Martins-Costa and Martins-Costa (2017), p. 13. Our translation. 31 Code of Medical Ethics: “Art. 22. Failing to obtain the consent of the patient or of the patient’s legal representative after having explained the procedure to be performed, except in cases of risk of imminent death.” Our translation. 32 Tepedino (2006), p. 94.

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situation can arise when, for example, a procedure is carried out by a medical team, under the command of a chief physician. In such cases, the chief physician is presumed to be responsible,33 and the chief physician can have joint liability with the physician who effectively engaged in the negligent conduct. Thus, the victim can bring action against either the chief physician or against the physician who was negligent, although the chief physician will have a right of recourse against the physician effectively at fault for the victim’s loss. The liability of hospitals, clinics and suppliers is different from the subjective liability of medical professionals. There are, in fact, two possible regimes of liability in Brazilian law. Hospitals and other public health institutions are subject to the objective extra-contractual liability of the State provided for in article 37§6 of the Constitution,34 and to the rules of the Civil Code for determining the quantum of reparation. In contrast, hospitals and other health institutions in the private sector are classified as suppliers of services under article 3 of the Consumer Defence Code and consequently they have objective liability for injury and loss caused to patients/ consumers, based on article 14 of the code.

Establishing a Relevant Standard of Care Under Brazilian law, the obligation to give appropriate treatment is an obligation that imposes the highest degree of care, requiring that medical professionals exercise all their effort, skill and knowledge in treating their patients. Generally speaking, physicians have obligations of means—i.e. they do not have an obligation to cure the patient or deliver the desired medical outcome, except in aesthetic procedures and aesthetic plastic surgeries, which are normally characterized as obligations of result.35 Even though the obligations are of means, physicians must act in accordance with a high standard of conduct. The Code of Medical Ethics itself provides, among its “Fundamental Principles” that “the whole of a physician’s attention is directed to the health of human beings, to that end the physician must act with the greatest care and to the best of his or her professional capacity.” Thus, when a surgeon undertakes to perform a certain operation, there is no promise to produce a given result and accordingly there is no obligation of result, or

33

Martins-Costa and Martins-Costa (2017), p. 24. “Art. 37. The direct and indirect public administration of all the Branches of Government of the Union, the States, the Federal District, and the Municipalities must respect the principles of legality, impersonality, morality, publicity and efficiency, in addition to the following: . . . §6. Legal entities, regardless of whether they are governed by public or private law, that provide public services are liable for the damage caused by their agents, acting in that capacity, to third parties, although they have a right of recourse against the person responsible in cases of malicious wrongdoing or fault.” Our translation. 35 Judgment of 06 November 2012, Superior Court of Justice (STJ), 3ª T, AgRg no AREsp n.206291/MG, Rel. Massami Uyeda, v.u. 34

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objective liability if the surgery is unsuccessful. In the case of aesthetic plastic surgery, however, most scholars take the position that there is an obligation of result because the surgeon effectively undertakes to improve the patient’s appearance.36 There is a smaller but growing school of thought, however, that argues that the plastic surgeon’s obligation is also an obligation of means because chance is always present in any surgical intervention, because all the possible reactions of the human body are, in truth, unforeseeable. This school of thought reasons that although plastic surgeons promise to “correct” physical appearance, “the truth is that chance is always present in surgical interventions and the reactions of each organisms to the aggression of surgery are unforeseeable. It may be that some plastic surgeons, or even many of them, assure their patients that a certain result will be achieved, but this does not define the nature of the obligation, or alter its legal nature, which continues to be the obligation to provide a service that carries with it a degree of risk.”37 The counterargument to this position is that “. . . the fact that unpredictable and unexpected corporal factors materialize, so that the promised aesthetic result is not achieved, such as keloid (raised scar), does not change the nature of the obligation of result”,38 although it can exclude the physician’s liability if a break in the chain of causation is proved. In the words of Rui Stoco (1999): “. . . the intervention of factors and reactions foreign to the surgery itself does not undermine the theory of the

36

Where aesthetic plastic surgery is concerned, most scholars believe that the surgeon’s obligation is one of result: Cavalieri Filho (1999), p. 140; Stoco (1998), p. 203; Ancona Lopez (2004), p. 70; Rodrigues (2002), p. 252; Theodoro Júnior (2000), p. 71; Gir Gomes (2002), p. 85; Carlos Branco (1996), p. 56; Apoliano Cardoso (2004), p. 136; Zamprogna Matielo (1998), p. 56; de Salvo Venosa (2003), p. 90; Roberto Gonçalves (2003), p. 366, Sztajn (1997), p. 11; Santarelli Zuliani (2003), p. 49; Andrade da Silveira (1991), p. 61; Ferreira de Almeida (1995), p. 18; Borelli Thomaz Júnior (1997), p. 91; Guedes Ferreira Pinto and Gonçalves Torres (1995), p. 144; de Lemos Manuschy (1984), p. 17. The courts tend to take the same position: Judgment of 19 August 2010, Superior Court of Justice (STJ), 3ª T, REsp 1180815/MG, Rel. Nancy Andrighi; Judgment of 10 February 2009, Superior Court of Justice (STJ), 4ª T, REsp 236708/MG, Rel. Carlos Fernando Mathias; Judgment of 03 August 2004, Superior Court of Justice (STJ), 4ª T, REsp 196306/SP, Rel. Fernando Gonçalves; Judgment of 13 april 1999, Superior Court of Justice (STJ), 3ª T, REsp 81101/PR, Rel. Waldemar Zveiter; Judgment of 21 june 1991, Superior Court of Justice (STJ), 3ª T, REsp 10536/RJ, Rel. Dias Trindade; Judgment of 18 march 2004, Rio Grande do Sul State Court of Justice, 10ª CC, AC 70007178304, Rel. Luiz Ary Vessini de Lima; Judgment of 25 September 2003, Rio Grande do Sul State Court of Justice, 5ª CC, AC 70006501472, Rel. Leo Lima; Judgment of 11 September 2003, Rio Grande do Sul State Court of Justice, 5ª CC, AC 70004180808, Rel. Marco Aurélio dos Santos Caminha; Judgment of 15 June 2000, Rio Grande do Sul State Court of Justice, 5ª CC, AC 70000159616, Rel. Clarindo Favretto. 37 Rosado de Aguiar (1995), p. 40. Our translation. See also: O. Adorno (1993), pp. 224–235; Forster (1997), p. 88; Magrini (2001), p. 80; Taggesel Giostri (2001), p. 107; Martins Proença and Dutra Barreiros (2001), p. 55. In the view of Sylvio Capanema, plastic surgery is, in principle, an obligation of means, and should only be considered to be an obligation of result when there is unequivocal evidence that the surgeon assured the patient of the promised result, as a condition to the contract. (Capanema (2003), pp. 46–47). 38 Gir Gomes (2002), p. 86. Our translation.

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physician’s obligation of result, since they constitute effective, autonomous causes for exclusion of liability because they break the etiological nexus.”39 In any event, the general rule is that physicians have an obligation of means, but there is nothing to prevent it from becoming an obligation of result, particularly when a particular result is promised and accepted.40 Moreover, there is a recent rend in Brazilian law to temper the distinction between obligations of means and of result. Alongside its other functions, the principle of objective good faith imposes on the parties to a contractual relationship not just the duty to perform their obligations, but to facilitate performance. Gustavo Tepedino (2003) writes that “. . . the result expected by the creditor, even in obligations known as obligations of means, cannot be treated as something foreign to the debtor. Likewise, the failure to achieve the proposed outcome, in obligations labelled obligations of result, cannot bring with it liability tout court, disregarding the debtor’s endeavours and supervening facts that not uncommonly produce an objective imbalance between the parties’ obligations, making performance excessively onerous for the debtor.”41 The distinction remains useful, however, in delimiting performance of the obligation and thus in defining failure to perform, which occupies a central position in contract law. Failure to perform must be invoked whenever it is necessary, on the facts of the case, to determine the debtor’s liability under the contract or whether, in synallagmatic contracts, the debtor has the right to performance of the obligations promised by the creditor. For liberal professionals, it is especially important to demarcate with precision the scope of their obligations because they are, in many cases, made by oral agreement only.

Identifying the Existence of an Accidental Risk Related to the Physicians Performance (aléa thérapeutique) Uncertainty is an inseparable part of medical activity and for that reason it is impossible to eliminate all risk from therapeutic and surgical procedures. Risk is thus inherent to the practice of medicine and accordingly, even when a physician acts with the utmost diligence, negative consequences can occur for a variety of reasons some of which are internal to the patients themselves, like the lower immunity associated with advancing age. As Miguel Kfouri Neto (2010) explains, “when it comes to human health, it is never possible to assert a priori that the failure to cure the ailment can be imputed to medical error. In no other professional activity is

39

Stoco (1999), p. 298. Our translation. In the medical field, vasectomies, laboratory exams, X-rays, and the like are also obligation of result. (Ancona Lopez (2004), p. 70). 41 Tepedino (2003), p. 294. Our translation. 40

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success subject to so many factors entirely beyond the professional’s control as in the medical profession. The Law cannot ignore this reality.”42 In this scenario, medical liability is, in Brazilian law, subjective (article 927 of the Civil Code)43 and therefore there must be fault on the part of the physician before he or she will have liability for the loss suffered. Put another way, physicians are not subject to objective liability, in which fault is not relevant and the basis for liability is a social allocation of the risk associated with the activity (article 927, sole paragraph).44 There is no great divergence in the precedents on the subject nature of medical liability and the courts take the position that they must determine whether the loss suffered by the patient was caused by the physician’s negligence or other fault.45 The Superior Court of Justice (Superior Tribunal de Justiça, the highest court on non-constitutional issues) has held that “a judge’s appreciation of diagnostic error must be careful, particularly when the scientific methods are debatable or open to doubt, since in these cases professional error cannot be considered to be lack of skill, imprudence or negligence.”46 As we have seen above, Brazilian Law uses standards to determine the existence of fault. Medical conduct is therefore measured against standards that are sensitive to the natural reliance that society places on liberal professionals in the exercise of their profession, but do not require superhuman omniscience or infallibility of physician. Instead, the standards demand the diligence and skill legitimately expected by the patient and by society as a whole. In determining whether fault exists, the decisionmaker will look to standard procedures to determine whether the physician acted appropriately, taking into consideration, among other factors: (i) the state of medical art in connection with the procedure, therapy, examination or other conduct examined, (ii) the ethical rules related to the profession and the principles of bioethics, and (iii) respect for the patient’s existential autonomy, exercised through choices based on an exchange of information with the physician. These factors correspond, in large measure, to the duties of safety and information usually associated with liberal professions. Procedures that are appropriate within scientific standards offer the safety that can legitimately be expected of a professional’s conduct, while informed consent and dialogue between physician and patient represent the core of the physician’s duty to inform. These duties, although useful for didactic purposes, cannot be viewed as distinct categories into which 42

Kfouri Neto (2010), p. 43. Our translation. Civil Code: “Art. 927. Anyone who, through an illicit act (arts. 186 and 187), causes damage to another is obligated to repair it.” 44 Art. 927: “Sole paragraph. The obligation to repair the damage will exist, regardless of fault, in the cases specified by law or when the activity normally carried out by the person who caused the damage entrails, by its nature, risk to the rights of others.” 45 Ex. Judgment of 24 November 2015, Superior Court of Justice (STJ), 3ª T., AgRg no REsp 1537273/SP, Rel. Paulo de Tarso Sanseverino, v.u. 46 Judgment of 31 March 2017, Superior Court of Justice (STJ), 3ª T., REsp 1.622.538/MS, Rel. Nancy Andrighi, v.u. Our translation. 43

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medical acts can be neatly classified: any attempt to do so will fall into the casuistic trap revealed by many legal texts on medical liability. The ethical norms of the profession and the principles of bioethics, for example, deal with matters both of safety and information, and it would not be incorrect to say that the exchange of information between doctor and patient should also conform to standards established by the medical community for similar cases.

Determining the Burden of Proof Under Brazilian rules of procedure, the burden of proving the facts that constitute the cause of action usually falls on the plaintiff, while the defendant has the burden of proving facts that bar, modify, or extinguish the plaintiff’s right to bring action. Under article 6(VIII) of the Consumer Defence Code, however, one of Brazilian consumers’ basic rights is a reversal of the burden of proof, in the consumer’s favour, whenever the court determines that the consumer’s allegations establish a prima facie case or the consumer is at a disadvantage in relation to the supplier under the ordinary rules of experience.47 Since medical obligations usually derive from consumer relations, with the result that the legal regime under the Consumer Defence Code applies, the burden of proof can be reversed, so that the physician must prove that he or she acted diligently in treating the patient. The precedents show that the courts do allow a shift in the burden of proof with a certain frequency, finding that article 6(VIII) of the Consumer Defence Code applies.48 Even outside consumer relations, there are those who contend that the theory of dynamic burden of proof should apply to relations between physicians and their patients. Under this theory, the burden of proof is distributed between the parties to the proceeding, according to which party is in the best position to produce the

Consumer Defence Code: “Art. 6. Consumers have the following basic rights: . . . (VIII) facilitation in defending their rights, including a reversal of the burden of proof in the consumer’s favour, whenever the court determines that the consumer’s allegations establish a prima facie case or the consumer is at a disadvantage [in relation to the supplier] under the ordinary rules of experience.” Our translation. 48 Judgment of 04 July 2017, São Paulo State Court of Justice, 2ª CDPriv., AI 207396062.2017.8.26.0000, Rel. Giffoni Ferreira, v.u.; Judgment of 25 august 2016, Minas Gerais State Court of Justice, 8ª CC, AI 1.0026.15.001417-8/001, Rel. Gilson Soares Lemes, v.u.; Judgment of 26 june 2017, Rio Grande do Sul State Court of Justice, 9ª CC, AI 70073452922, Rel. Tasso Caubi Soares Delabary, v.u.; Judgment of 26 june 2017, Rio Grande do Sul State Court of Justice, 19ª CC, AI 70073291593, Rel. Túlio de Oliveira Martins, v.u.; Judgment of 21 june 2017, Rio Grande do Sul State Court of Justice, 27ª CCConsumidor, AC 0376759-75.2010.8.19.0001, Rel. Marcos Alcino de Azevedo Marques, v.u.; Judgment of 15 december 2016, Rio Grande do Sul State Court of Justice, 26ª CCons., AI 0053026-49.2016.8.19.0000, Rel. Luiz Roberto Ayoub, v.u.; Judgment of 18 july 2017, São Paulo State Court of Justice, 10ª CDPriv., AI 223168029.2016.8.26.0000, Rel. J.B. de Paula Lima, v.u. 47

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evidence.49 Under the dynamic burden of proof theory, in most cases it will be the defendant physician who will have the burden of proving that his or her conduct was diligent, according to the standards expected in the circumstances of the case and recommended by the medical community.

Compensation Schemes for Medical Malpractice in Public and Private Hospitals The personal liability of physicians and other health professionals is distinct form the liability of the hospitals and clinics where they practice their profession. Hospitals and clinics, as legal entities that provide medical services, have objective liability for injury suffered by patients because they are subject to the general regime established by the Consumer Defence Code (article 14), not the specific regime applicable to liberal professionals under article 14§6 of the Code. The causes of injury for which hospitals and clinics may be liable are numerous, ranging from defects in accommodations and food services to the actual medical services performed in the institution. If the loss suffered by the patient results from services performed by a physician on the clinic’s or hospital’s staff, the hospital or clinic will have joint liability with the medical professional under article 932 of the Brazilian Civil Code. Thus, the legal entity will have objective liability for the injury, and that liability will be joint with the physician’s liability, if, of course, the physician is shown to have acted negligently. Essentially, the hospital or clinic has objective liability, as employer, for the acts of its employees, although physician continues to have subjective liability for his or her conduct. The situation is quite different when the physician simply uses the hospital’s or clinic’s premises, without any way representing the legal entity, as when a surgeon makes use of a hospital’s operating theatre. In such cases, liability for the medical services falls exclusively on the physician, and the legal entity has no obligation to indemnify since it simply made its premises available to the medical professional. Where public hospitals are involved, article 37§6 of the Constitution applies, and the public entity responsible for the hospital (the States or the Municipalities) will have objective liability for loss caused to the patient. Fault on the part of the physician will be relevant only with respect to his or her personal liability and with respect to any right of recourse the public entity may have against the physician. The public entity’s liability is objective and extra-contractual. Health care in the public sector is characterized as an essential public service. Liability for failure to provide medical treatment is not attributed to any particular public hospital. Instead, it is the responsible public entities—the Municipalities and the States—that are liable because articles 196 and 198 of the Federal Constitution 49

Nunes de Souza (2015), p. 203.

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provide that public entities must guarantee the right to health care to all citizens.50 If medical negligence occurs, the public entity will have liability for the injury caused by the physician, who is a public servant, and the public entity will also have a right of recourse against the physician. In contrast, if there is no fault on the part of the physician, or the chain of causation between the physician’s conduct and the injury suffered by the patient is interrupted, there will be no duty to indemnify.

Prescription/Limitation of Actions In Brazil, there is no trend to limit the number of medical litigation cases. To bring an action in damages, there are no pretrial conditions, specific initial requirements concerning the involvement of third parties (neutral medical experts), possible limits of attorneys’ fees, and so on. The victim’s claim against the physician must be exercised within the prescription period established by law. The prescription period applicable to a claim will depend on a number of factors. If the claim is for reparation of loss and injury arising out of a consumer relation, which is usually the case in medical claims, the action must be brought within five years, according to article 27 of the Consumer Defence Code.51 If the claim arises out of a relation that is subject to the general rules under the Civil Code, the limitation period would, in principle, be the three-year period established under article 206§3(V)52 for claims for civil reparation. Some scholars, however, argue that the three years under article 206§3(V) of the Civil Code applies only to extra-contractual claims for reparation, and that consequently claims for reparation arising out of contractual relations are subject to the general prescription period of 10 years under article 205 of the Civil Code.53 This position is based on a systemic interpretation of the rules on prescription under the Civil Code: since no specific prescription period exists for a creditor to demand performance from debtor who is in default of the principal obligation under a contract, the prescription period that applies is the general period of ten years (article 205). If the three-year prescription period (article 206§3(V)) were to apply to an action for damages—i.e. to the obligation to provide a substitute for the principal obligation when it cannot be performed or is no longer useful—the action to claim

50 Judgment of 13 July 2016, Rio de Janeiro State Court of Justice, 14ª CC., AC 000007461.2014.8.19.0001, Rel. Juarez Folhes. 51 Consumer Defence Code: “Art. 27. Claims for reparation of damage caused by a product or service contemplated in Section II of the Chapter must be brought within five years, counting from the date the complainant becomes aware of the damage and the agent of the damage.” Our translation. 52 Civil Code: “Art. 206. The following are subject to prescription: . . . §3. In three years: . . . V – claims for civil reparation.” 53 Martins-Costa (2009), pp. 160–162; e Theodoro Júnior (2005), pp. 310; 333–334.

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the substitute for the principal obligation would prescribe before the action to claim performance of the principal obligation itself. The predominant position on this question in the Superior Court of Justice from 2014 to 2016 was that the three-year period applies to extra-contractual liability, while the general ten-year period applies to claims for damages arising out of contractual relationships. At the end of 2016, however, the Superior Court of Justice changed its understanding of the law and held that the three-year period under article 206§3(V) applies both in contractual and extra-contractual claims,54 and this is the interpretation of the law consolidated in Statement 419 issued at the V Civil Law Symposium.55

Alternatives to Lawsuits Administrative Proceedings Before Self-Government Professional Associations In Brazil, the Federal Council of Medicine (CFM—Conselho Federal de Medicina) is the entity that deals with cases of medical error. Under the Constitution, the Council is the body that governs the practice of medicine in the country, with powers to inspect physician’s practices and to establish rules and standards for medical practice. Initially, its jurisdiction was restricted to registration of qualified individuals as physicians and to the application of sanctions under the Code of Medical Ethics. Over time, however, the Council’s powers and its scope of action grew, and currently the CFM exercise a very important political role in society, acting both to defend public health and in the interests of the medical class. The CFM is dedicated to uphold good medical practices and the ethical practice of medicine. The CFM itself describes its mission as “[t]o promote society’s well-being, governing the exercise of medicine by establishing rules and standards, inspection, guidance, training, professional recognition, and organization, both directly and through the Regional Councils of Medicine (CRMs – Conselhos Regionais de Medicina), and to ensure, defend and promote the lawful exercise of the practice of medicine, good professional practices, the respect and dignity of the profession, seeking to protect society from errors in assistance resulting from a precarious health

54

Judgment of 22 November 2016, Superior Court of Justice (STJ), 3ª T., REsp 1.281.594/SP, Rel. Marco Aurélio Bellizze, v.m.; Judgment of 18 may 2017, Superior Court of Justice (STJ), 3ª T., AgInt no REsp 1490387/RS, Rel. Ricardo Villas Bôas Cueva, v.u. 55 Enunciado 419 da V Jornada de Direito Civil: “Art. 206 §3 (V): The prescription period of three years for claims for civil reparation applies both to contractual liability and extra-contractual liability.”

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system.”56 The CFM is divided into a number of Technical Chambers specializing in the various areas57 that contribute to the good practice of medicine. In 2016, the Brazilian Federal Council of Medicine approved the Professional Ethics Code of Procedure under CFM Resolution 2.145/2016. The Code applies throughout the country and must be followed in all Professional Ethics Proceedings (referred to as “PEPs”) before the Federal Council of Medicine and all Regional Councils of Medicine. According to the Professional Ethics Code of Proceeding, when a case of medical malpractice occurs, an inquiry must be conducted before the Professional Ethics Proceeding itself. Essentially, the inquiry is a prior administrative procedure to investigate the events surrounding the medical error so as to determine the actual facts of the case. At the end of the inquiry, article 17 of the Professional Ethics Code of Procedure provides that a report setting out the inquiry’s conclusions must be drawn up, after which the Inquiries Chamber has a number of possibilities open to it: Art. 17. The report setting out the inquiry’s conclusions and the reasons therefor will be submitted to the Inquiries Chamber for its appreciation and the Chamber will then: I. propose conciliation, when appropriate; II. propose terms for adjustment of conduct, when appropriate; III. close the inquiry: if there is no evidence that the Code of Medical Ethics has been violated; IV. initiate a PEP: if there is evidence that the Code of Medical Ethics has been violated, which may be accompanied by a precautionary ban. In that event, the record of the proceeding will be sent to the head of the disciplinary commission, who will sign the directive to initiate the PEP and appoint a council member to preside over the PEP; V. bring an administrative proceeding to determine whether [the medical professional suffers from] an incapacitating illness, on the terms of a specific resolution adopted for that purpose. (our translation).

The Inquiries Chamber is not restricted to opening an administrative inquiry and can propose measures such as conciliation and terms for adjustment of conduct. Under article 18 of the Code, conciliation between the parties is possible only in cases that do not involve serious bodily injury, sexual assault or the death of the patient. Moreover, once the final report on the inquiry has been approved, conciliation is no longer possible. In other words, a conciliation proposal must be made prior to the end of the inquiry procedure. Monetary agreements are prohibited in conciliation. Terms for adjustment of conduct are defined in article 19 of the Professional Ethics Code of Procedure as follows: “Terms for Adjustment of Conduct (TAC) are a legal act by which a natural or legal person, acknowledging, as a rule, that the

56

Our translation. Available at: https://portal.cfm.org.br/index.php?option¼com_content& view¼article&id¼26367&Itemid¼542. 57 For example: The Technical Chamber for Patient Safety, the Bioethics Technical Chamber, the Technical Chamber for Plastic Surgery, the Pediatrics Technical Chamber, the Technical Chamber for Emergency Medicine, the Cardiology Technical Chamber, and the Technical Chamber for Clinical and Surgical Oncology.

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conduct in question offends or may offend collective or individual ethical interests, undertakes to a lawfully empowered body to eliminate the offence or risk by adjusting the person’s conduct to legal and ethical requirements, by signing an instrument to that effect.” (our translation). Like conciliation, under article 19§1 of the Code, a TAC is possible only case in that do not involve serious bodily injury, sexual assault or the death of the patient. Under article 20 of the Code, the contents of TACs are confidential. If neither conciliation or a TAC is possible, an administrative proceeding may be brought, in the form of a PEP. However, it is important to point out that under article 5 of the Professional Ethics Code of Procedure, “proceedings related to and judgment of violations of the provisions of the Code of Medical Ethics (CME) are independent, and are not, as a rule, related to criminal or civil proceedings and decisions involving the same facts.” (our translation). Thus, proceedings before the Federal or Regional Councils of Medicine may be brought independently of any proceeding before the courts. They are therefore not intended to replace lawsuits.

Mediation In Brazil, the legislation governing mediation is Law 13.140 of 26 June 2015 (the “Mediation Law”). Under article 3 of the Mediation Law, “conflicts that deal with disposable rights, or with non-disposable rights which may be settled by agreement, may be submitted to mediation.” (our translation). Mediation in Brazil thus has a very broad scope, and can be used “to resolve an unimaginable range of conflicts, from the simplest problems to the most complex matters.”58 The question of whether “damages caused by healthcare” can be submitted to mediation will depend on the meaning of the disposable rights and nondisposable rights which may be settled by agreement referred to in article 3 of the Mediation Law. In Brazilian law, the term “disposable rights” means a right held by an individual that may be given up by its holder,59 who has full capacity to negotiate with respect to the right, including the power to sell or otherwise alienate the right permanently.60 It follows, therefore, that the law intends to exclude from the scope of mediation precisely non-disposable rights, which are fundamental rights,61 which cannot be renounced or transferred: they are rights that are protected not just in the individual’s interest, but in the interest of society as a whole.62

58

Ozório Nunes (2016), p. 66. Our translation. De Plácido e Silva (2005), p. 469. 60 Carmona (2009), p. 38. 61 Examples: the dignity of the human person, the right to life, and the right to liberty, among others. 62 Ozório Nunes (2016), p. 67. 59

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Brazilian law does, however, allow negotiation with respect to certain non-disposable rights. The idea of negotiable non-disposable rights may seem strange, but they are found in everyday situations such as custody of children, support obligations, and conflicts in rights of succession and inheritance, among other matters related to family and succession law. In other words, “negotiable non-disposable rights” are those that deal with “ascertaining amounts and dividing responsibilities, among other things.”63 Thus, there is a category of rights that are both non-disposable and negotiable and therefore may be submitted to mediation. Because of this peculiarity, article 3§2 of the Mediation Law requires that if the parties to a mediation involving negotiable non-disposable rights come to an agreement, it must be certified by the courts after hearing the Public Prosecution Service. This reasoning leads us to the conclusion that “damages caused by healthcare”, although they involve the fundamental right to health, could be submitted to mediation as long as they were negotiable. Mediation involving losses suffered because of medical error is not at all a common practice in Brazil, compared to other more developed countries, and indeed mediation in general is only beginning to develop in Brazilian law.

Arbitration In Brazil, arbitration, which is governed by Law 9.307/1996 (the “Arbitration Law”), is considered appropriate for resolution of conflicts involving disposable property rights. In contrast to mediation, the Arbitration Law restricts the scope of arbitration by excluding conflicts that involve rights that extend beyond purely individual interests. At first sight, therefore, it might seem that medical malpractice falls outside the scope of arbitration. Nonetheless, it does not seem correct to exclude the possibility of arbitration from all claims related to non-disposable, non-economic rights. The fact is that the consequences of disputes involving medical malpractice can involve property rights, which are arbitrable. The non-disposable nature of the right to health remains intact, but the right to damages owed by reason of liability for medical error is a negotiable right because the amount of damages can be agreed between the parties.64 It follows that a claim for damages for medical malpractice could be submitted to arbitration.

63

Ozório Nunes (2016), p. 67. Our translation. An analogy drawn with the opinion of the respected jurist Carlos Alberto Carmona, although he discusses arbitration (Carmona 2009, pp. 38–39). 64

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The other possible objection to arbitration is that the physician-patient relationship is most often a consumer relation. In fact, both legal scholars65 and the courts66 define the physician-patient relationship as a consumer relationship, even though the Consumer Defence Code expressly excludes liberal professionals’ civil liability from the general regime of objective liability for goods and services in consumer relations.67 Nonetheless, the fact that the physician-patient relationship is a consumer relation does not mean that cases of medical error, even those arising out of contracts of adhesion, cannot be submitted to arbitration, as long as they involve disposable economic rights. It is fundamental, however, that the parties include a valid arbitration agreement in the adhesion contract. The insertion of an arbitration clause in an adhesion contract does not imply that arbitration will be compulsory: compulsory arbitration is prohibited in Brazil by article 51(VII) of the Consumer Defence Code and by the Arbitration Law itself. Article 4§2 of the Arbitration Law provides that an arbitration agreement will only be effective if it is suggested by the party that adheres to the contract, or the adhering party expressly consents both to the contract and to the inclusion of the arbitration clause.68 In effect, the Consumer Defence Code does not definitively prohibit arbitration clauses in consumer contracts. The legislation simply restricts the practice so as to prevent compulsory arbitration of claims.69 In this respect, the Arbitration Law respects the provisions of the Consumer Defence Code and requires that certain criteria must be met, to ensure that arbitration is not brought without the consent of both parties.70 Some scholars take the position71 that the Arbitration Law, in providing that “in contracts of adhesion, an arbitration clause will be effective only if the adhering party initiates the arbitration or expressly agrees to arbitration, in writing, in a document attached [to the contract] or in boldface print [in the contract itself], by signature or initials specifically for the clause”, derogated from the Consumer Defence Code, which provides that “contractual clauses related to the supply of products and services that stipulate compulsory use of arbitration are null as of right”

65

Miragem (2007), p. 2; Vasconcelos dos Santos Dantas (2009), p. 206 e ss. Judgment of 13 December 2005, Superior Court of Justice (STJ), 3ª T., REsp 731.078/SP, Rel. Castro Filho; Judgment of 02 August 2012, Superior Court of Justice (STJ), 4ª T., EDcl no REsp 704.272, Rel. Min. Maria Isabel Gallotti; Judgment of 15 April 2010, Superior Court of Justice (STJ), 4ª T., AgRg no AgRg no Ag 1.229.919/PR, Rel. Sidnei Beneti. 67 Nunes de Souza (2016), pp. 39–40. 68 This is the position taken both by arbitration scholars (Wald (2002), p. 165), and consumer law scholars (Pellegrini Grinover et al. 2001, pp. 524–525). 69 Wald (2002), p. 165. 70 Wald (2002), p. 165. 71 Including Selma Maria Ferreira Lemes, one of the drafters of the bill that became the Brazilian Arbitration Law (Ferreira Lemes 2003, pp. 185–193) and Joao Bosco Lee (Bosco Lee 2002, pp. 69–70). 66

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because the Arbitration Law was enacted in 1996, and therefore after the Consumer Defence Code. The classic rule of interpretation, however, is that later legislation will derogate from earlier legislation only to the extent the legislation is incompatible. This school of thought seems the legislation as being incompatible, and argues that the provisions of the Consumer Defence Code prohibiting insertion of arbitration provisions were revoked, and consumer claims are arbitrable. In summary, it can be said that Brazilian law allows arbitration to be chosen as the means of resolving disputes arising out of consumer relations,72 even if the contract is an adhesion contract, as long as the consumer specifically consents to the arbitration clause. The fact that the physician-patient relationship is often a consumer relation is therefore not a determining argument to exclude medical malpractice claims from arbitration. Nonetheless, the practice is not common in Brazil. Resolution of conflicts through conciliation, mediation and arbitration is seen as a way to relieve the courts of some of their enormous caseload, while ensuring that disputes are resolved fairly, quickly and efficiently, without the intervention of the courts.73 The large volume of lawsuits is one of the main factors behind the change in Brazilian jurists’ attitude toward alternative means of resolving disputes.74 In comparison with other countries, Brazilian courts deal with a much greater number of proceedings per judge, and the overburdened court system is very slow. As a result, mediation and arbitration have gained in prestige and are increasingly promoted as a means to speedier resolution of disputes, both within and outside the Brazilian courts.75 Conciliation, mediation, and arbitration therefore have not only a functional role to play, in alleviating the courts’ caseload, but a social one as well, in bringing disputes to an end more quickly or by avoiding them altogether. In recent years, Brazil has been implementing a new judicial policy76 that recognizes the benefits of alternative dispute resolution methods, notably in the New Code of Civil Procedure (Law 13.129/2015),77 the Mediation Law (Law 13.140/2015), and Resolution 125/2010 adopted by the National Council of Justice.78

72

Carreira Alvim (2000). Footnote 122. Dalla Bernardina de Pinho and Pedrosa Paumgartten (2016), p. 1. 74 Grinover Pellegrini (2007), p. 2. 75 Dalla Bernardina de Pinho and Pedrosa Paumgartten (2016), p. 2. 76 Dalla Bernardina de Pinho and Pedrosa Paumgartten (2016), p. 1; Grinover Pellegrini (2007), pp. 3–5. 77 “Art. 3. . . . §2. Whenever possible, the State will encourage consensual resolution of conflicts; §3. Conciliation, mediation and other methods for consensual resolution of conflicts must be encouraged by judges, attorneys, public defenders and public prosecutors, including during the course of legal proceedings.” Code of Civil Procedure, 2015. Our translation. 78 “The Resolution establishes a National Judicial Policy for the Appropriate Treatment of Conflicts of Interests within the scope of the Judiciary, to disseminate mediation and conciliation proceedings as alternative to judicial process” (Goretti 2017, p. 190). Our translation. 73

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Conclusion Although there is no question that in Brazil the civil liability of physicians and other medical professionals is subjective in nature, it is equally true any analysis of medical liability requires a good measure of care. Contemporary Brazilian law on civil liability has evolved beyond the traditional psychological concept of fault, and demands, instead, compliance with standards of conduct and standard procedures as evidence of physicians’ diligence in their professional practice. These standards and procedures are difficult to describe in the abstract and must be extracted from the professional practice of the medical community. In this task, the courts and other decision-makers will necessarily reply on expert witnesses and other specialists. The current challenge in medical liability law is to find mechanisms that can reconcile the expert opinion of medical witnesses and the courts’ (and other decision-makers’) duty to interpret the facts of the case within a legal framework, in order to ensure a fair and reliable application of professional standards and conduct. The need for alternatives to lawsuits for the resolution of medical malpractice claims is recognized in Brazil, although the subject is little debated, especially among the nation’s legislators. At present, there is no project for reform underway. Among legal scholars and commentators, however, mediation and arbitration are encouraged not only because they are quicker than the traditional lawsuit, but also because they would make it possible for questions of medical malpractice, which are difficult to determine in practice, to be examined by more specialized and technically-qualified decision-makers. In general, the courts are also in favour of limiting the number of lawsuits and strengthening alternative means of dispute resolution, but are resistant to legislative changes that would reduce the scope of their jurisdiction.

References Afonso da Silva J (2012) Comentário Contextual à Constituição, 8th edn. Malheiros, São Paulo Almeida Costa MJ (2009) Direito das obrigações, 12th edn. Almedina, Coimbra Ancona Lopez T (2004) O dano estético, 3rd edn. Revista dos Tribunais, São Paulo Andrade da Silveira R (1991) Responsabilidade civil do médico. Revista dos Tribunais, vol. 674 Apoliano Cardoso H (2004) Responsabilidade civil: doutrina, jurisprudência e prática. ME, São Paulo Assis A (1999) Liquidação do dano. Revista dos Tribunais, v. 759 Bodin de Moraes MC (2003) Danos à pessoa humana: uma leitura civil-constitucional dos danos morais. Renovar, Rio de Janeiro Borelli Thomaz Júnior D (1997) Responsabilidade civil do médico. Revista dos Tribunais, vol. 741 Bosco Lee J (2002) Arbitragem Comercial Internacional nos Países do Mercosul. Juruá, Curitiba Capanema S (2003) Direito das obrigações. Coletânea de textos CEPAD. Editora Espaço Jurídico, Rio de Janeiro Carlos Branco GL (1996) Aspectos da responsabilidade civil e do dano médico. Revista dos Tribunais, vol. 733

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Carmona CA (2009) Arbitragem e Processo: um comentário à Lei n 9.307/96, 3th edn. Atlas, São Paulo Carreira Alvim JE (2000) Tratado Geral da Arbitragem Interno. Mandamentos, Belo Horizonte Cavalieri Filho S (1999) A responsabilidade médico-hospitalar à luz do Código do Consumidor. Revista Forense, vol. 346 Dalla Bernardina de Pinho H, Pedrosa Paumgartten M (2016) Os Desafios Para a Integração entre o Sistema Jurisdicional e a Mediação a partir do Novo Código De Processo Civil. Quais as Perspectivas Para A Justiça Brasileira? In: Assumpção Rezende de Almeida D, Medina Pantoja F, Pelajo S (coords.) A mediação no Novo Código de Processo Civil, 2. ed. Forense, Rio de Janeiro De Aguiar Dias J (2006) Da responsabilidade civil, 11th edn. Renovar, Rio de Janeiro De Lemos Manuschy R (1984) Direito das obrigações. Editora Líber Juris Ltda, Rio de Janeiro De Plácido e Silva (2005) Vocabulário Jurídico, 26th edn. Forense, Rio de Janeiro De Salvo Venosa S (2003) Direito civil: responsabilidade civil, vol 4. Atlas, São Paulo De Tarso Vieira Sanseverino P (2010) Princípio da reparação integral. Saraiva, São Paulo Díez-Picazo L (1999) Derecho de daños. Civitas, Madrid Ferreira de Almeida C (1995) Os contratos de prestação de serviço médico no direito civil português. Revista de Direito do Consumidor, n. 16 Ferreira Lemes SM (2003) Arbitragem e direito do consumidor. Revista Brasileira de Arbitragem, n. 0 Forster NJ (1997) Cirurgia plástica estética: obrigação de resultado ou obrigação de meios? Revista dos Tribunais, vol. 738 Gir Gomes A (2002) A responsabilidade civil do médico nas cirurgias plásticas estéticas. Revista de Direito Privado, n. 12 Goretti R (2017) Mediação e Acesso à Justiça. Podivm, Salvador Grinover Pellegrini A (2007) Os fundamentos da justiça conciliativa. In: Pellegrini Grinover A, Watanabe K, Lagrasta Neto C (coords) Mediação e Gerenciamento do Processo. Atlas, São Paulo Guedes Ferreira Pinto NL, Gonçalves Torres MA (1995) Responsabilidade civil – Parecer de auditores – Obrigações de meio e de resultado – Dever de indenizar. Revista dos Tribunais, vol. 716 Kfouri Neto M (2010) Responsabilidade civil dos hospitais. Revista dos Tribunais, São Paulo Magrini RJ (2001) Médico – Cirurgia plástica reparadora e estética: obrigação de meio ou de resultado para o cirurgião. Revista Jurídica, n. 280 Martins Proença JM, Dutra Barreiros R (2001) Cirurgia plástica estética: obrigação de meio. Revista do Instituto dos Advogados de São Paulo, n. 8 Martins-Costa J (2009) Comentários ao novo código civil. In: Teixeira de Figueiredo, S (coord.). 2nd edn. Forense, Rio de Janeiro, vol. 5, t. II Martins-Costa J, Martins-Costa F (2017) Introdução à Responsabilidade Civil em GinecoObstetrícia. In: Passos Pandolfi E, Ramos Geraldo Lopes J, Martins-Costa HS, Magalhães JA, Menke CH, Freitas F (Orgs.). Rotinas em Ginecologia, 7nd edn. Artmed, Porto Alegre Medauar O (2003) Direito administrativo moderno, 2nd edn. Revista dos Tribunais, São Paulo Miragem, B (2007) Responsabilidade civil medica no direito brasileiro. Revista de Direito do Consumidor, vol. 63 Nelson Konder C (2007) A redução equitativa da indenização em virtude do grau de culpa: apontamentos acerca do parágrafo único do art. 944 do Código Civil. Revista Trimestral de Direito Civil – RTDC, v. 29 Nunes de Souza E (2015) Do erro à culpa: na responsabilidade civil do medico. Renovar, Rio de Janeiro Nunes de Souza E (2016) Responsabilidade Civil dos Médicos e dos Profissionais de Saúde. In: Responsabilidade Civil de profissionais liberais. Forense, Rio de Janeiro O. Adorno L (1993) La responsabilidad civil médica. AJURIS, v. 59

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Ozório Nunes AC (2016) Manual de Mediação: guia prático da autocomposição. Revista dos Tribunais, São Paulo Pellegrini Grinover A et al (2001) Código Brasileiro de Defesa do Consumidor: comentado pelos Autores do anteprojeto, 7nd edn. Forense, Rio de Janeiro Pereira Silva CM (2016) Responsabilidade civil, 11th edn. Forense, Rio de Janeiro Roberto Gonçalves C (2003) Responsabilidade civil, 8th edn. Saraiva, São Paulo Rodrigues S (2002) Direito civil: responsabilidade civil, vol 4, 19th edn. Saraiva, São Paulo Rosado de Aguiar Jr. R (1995) Responsabilidade civil do médico. Revista dos Tribunais, vol. 718. Rose L (2012) O Código Civil Brasileiro em Inglês – The Brazilian Civil Code in English Leslie Rose trans., 2 Renovar, Rio de Janeiro Santarelli Zuliani E (2003) Inversão do ônus da prova na ação de responsabilidade civil fundada em erro médico. Revista dos Tribunais, vol. 811 Schreiber A (2007) Novos paradigmas da responsabilidade civil: da erosão dos filtros da reparação à diluição dos danos. Atlas, São Paulo Stoco R (1998) A teoria do resultado à luz do Código de Defesa do Consumidor. Revista de Direito do Consumidor, n. 26 Stoco R (1999) Responsabilidade civil e sua interpretação jurisprudencial, 4th edn. Revista dos Tribunais, São Paulo Sztajn R (1997) A responsabilidade civil do médico: visão bioética. Revista de Direito Mercantil, Industrial, Econômico e Financeiro, n. 108 Taggesel Giostri H (2001) Algumas reflexões sobre as obrigações de meio e de resultado na avaliação da responsabilidade médica. Revista Trimestral de Direito Civil, vol. 5 Tepedino G (2003) A responsabilidade médica na experiência brasileira contemporânea. In: Alvim A, Cerqueira César JP, Rosas R (coords.) Aspectos controvertidos do novo Código Civil. Revista dos Tribunais, São Paulo Tepedino G (2006) A responsabilidade médica na experiência brasileira contemporânea. In: Temas de direito civil, t. 2. Renovar, São Paulo Theodoro Júnior H (2000) Aspectos processuais da ação de responsabilidade por erro médico. Revista Forense, vol. 349 Theodoro Júnior H (2005) Comentários ao novo código civil. In. De Figueiredo Teixeira, S (coord.), vol. 3, t. II, 3. ed. Forense, Rio de Janeiro Vasconcelos dos Santos Dantas E (2009) Aplicação do Direito do Consumidor no exercício da medicina. In: Macena de Figueiredo A, Lauro Lama R (Coords.) Direito Médico: implicações éticas e jurídicas na prática médica. Lumen Juris, Rio de Janeiro Wald A (2002) A recente evolução da arbitragem no Direito Brasileiro (1996–2001). In: Batista Martins P, Maira Rossani Garcez J (coords.) Reflexões sobre arbitragem. LTR, São Paulo Zamprogna Matielo F (1998) Responsabilidade civil do médico. Sagra Luzzatto, Porto Alegre

Chapter 4

La responsabilité médicale et hospitalière en droit civil québécois : Principes généraux et alternatives à la voie judiciaire Patrice Deslauriers and Sebastian Fernandez

Résumé Après avoir procédé à un rappel des principes applicables dans le domaine de la responsabilité civile médicale et hospitalière en droit civil québécois et, au passage, à une revue de la jurisprudence en cette matière, les auteurs procèdent à une revue de la réforme de la procédure civile québécoise entrée en vigueur le 1er janvier 2016 et expriment leurs réflexions quant aux alternatives à la voie judiciaire s’offrant aux parties dans le cadre d’un litige en matière médicale ou hospitalière au Québec.

Introduction En 1960, lors d’une période caractérisée par divers changements sociaux et un interventionnisme accru de l’État québécois, communément appelée la Révolution Tranquille, le gouvernement du Québec, alors dirigé par l’ancien premier ministre libéral Jean Lesage, adopta la Loi sur l’assurance-hospitalisation,1 laquelle entra en vigueur le 1er janvier 1961. Cette législation marqua non seulement la fin de la mainmise de l’Église catholique sur les services de santé, mais également l’adhésion du Québec au régime fédéral canadien d’assurance-hospitalisation de 1958, initiant de ce fait l’établissement d’un système de santé public en la Belle Province2 où, avant la Révolution tranquille, l’État québécois était éminemment absent du domaine de la santé. Depuis, d’autres mesures ont été prises dans la perspective d’implanter un système de santé public, universel et gratuit pour l’ensemble des

1 2

RLRQ c. A-28. Cette périphrase est employée afin de désigner le Québec en tant que province du Canada.

P. Deslauriers (*) Faculté de droit de l’Université de Montréal et avocat, Montréal, Québec, Canada e-mail: [email protected] S. Fernandez (*) Avocat exerçant sa profession au sein du cabinet Deveau Avocats, Laval, Québec, Canada e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_4

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Québécois, au cœur duquel l’État agi comme principal administrateur et assureur, notamment l’adoption de la Loi sur les services de santé et les services sociaux3 en 1971. On retrouve également ce souci d’accessibilité dans le domaine juridique, où les usagers du système de santé québécois victimes de fautes médicales et hospitalières font, dans l’arène judiciaire, face à de nombreux défis au quotidien. En responsabilité médicale et hospitalière, et comme l’exige habituellement le droit civil québécois,4 la démonstration d’une faute, d’un préjudice et d’un lien de causalité entre ces derniers est nécessaire à la rétention de la responsabilité civile pour donner ouverture à l’indemnisation,5 mais la démonstration de ces éléments n’est pas sans obstacle pour la partie demanderesse, celle-ci devant, par exemple, impérativement démontrer l’existence de la faute alléguée au moyen d’une expertise médicale, à défaut de quoi son recours sera rejeté.6 La problématique de l’accessibilité à la justice, réalité transcendant le domaine médical, interpela le législateur, qui procéda récemment à une réforme de la procédure civile, dont l’une des pierres d’assises s’avère la mise en avant-plan des modes alternatifs de résolution des conflits. Dans le domaine médical plus spécifiquement, tant les auteurs que les magistrats ont réfléchi sur des moyens susceptibles d’accroître l’accès à la justice des victimes d’erreurs médicales et hospitalières, ou encore d’en assurer l’indemnisation. Alors que la Cour d’appel rappelait récemment que « les difficultés financières que peuvent rencontrer notamment les particuliers pour faire valoir leurs droits, même dans un contexte de déséquilibre entre les parties, ne peuvent être résolues par le biais d’une bonification des montants d’indemnisation accordés ou d’une modification par les tribunaux des règles de droit autrement applicables »,7 il convient, après avoir procédé à un rappel de ces règles applicables en matière de responsabilité médicale en droit civil québécois, d’examiner les alternatives à la voie judiciaire qui s’offrent aux usagers du système de santé, ainsi que les perspectives d’avenir proposées dans l’optique d’accroître l’accès de ces derniers à la justice.

3

RLRQ c. S-4.2. Code civil du Québec, RLRQ c. CCQ-1991, art. 1457. 5 Steinberg c. Mitnick, 2016 QCCS 4749, par. 196; Dufour c. Tanios Hanna, 2018 QCCS 4434, par. 29. 6 Gagnon c. Laurendeau, 2019 QCCA 876, par. 6-7. Voir notamment à titre illustratif : Deland c. Lachance, 2012 QCCS 5848; Sullivan c. Aubry, 2013 QCCS 4345; Côté c. Duperré, 2013 QCCS 804; May c. Czyziw, 2014 QCCS 3521; Sévigny c. Filiatrault, 2014 QCCS 1667; Bernard c. Letellier, 2015 QCCS 279; Roy c. Ortho Centre Québec inc., 2016 QCCS 1627; Dussault c. Conseil d'administration du centre hospitalier Jean-Talon et du CSSS du Coeur-de-l'Île, 2017 QCCS 3208. 7 M.G. c. Pinsonneault, 2017 QCCA 607, par. 246. 4

4 La responsabilité médicale et hospitalière en droit civil québécois : Principes. . .

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LA responsabilité médicale et hospitalière en droit civil québécois : où en sommes-nous? Dans la présente section, nous nous attarderons à l’intensité de l’obligation des médecins et des hôpitaux ainsi qu’à certaines considérations relatives à la détermination de la faute (2.1), à la nature de la responsabilité civile du médecin et de l’hôpital (2.2), à la qualification du préjudice de même qu’à certaines règles particulières concernant le préjudice corporel (2.3), au lien de causalité (2.4) et à la possibilité de réclamer des dommages punitifs en sus des dommages-intérêts compensatoires (2.5).

L’intensité de l’obligation des médecins et des hôpitaux et certaines considérations relatives à la détermination de la faute L’intensité de l’obligation des médecins et des hôpitaux Les professionnels de la santé et les hôpitaux sont tenus à des obligations variées : pour les premiers, on retrouve parmi les principales obligations leur incombant, l’obligation de renseigner le patient et d’obtenir son consentement libre et éclairé, l’obligation de poser un diagnostic juste sur sa condition, l’obligation de prescrire et d’administrer un traitement adéquat, ainsi que celle de respecter le secret professionnel,8 alors que pour les seconds, on retrouve une myriade d’obligations pouvant être de nature médicale ou non. À tout événement, les tribunaux québécois considèrent généralement l’intensité de l’obligation à laquelle sont tenus les professionnels de la santé, incluant les médecins, comme étant de diligence ou de moyens,9 et non de résultat.10 Le Code 8

Id., par. 142; Fiocco c. De Varennes, 2017 QCCS 5042, par. 62; Dufour c. Tanios Hanna, préc., note 5, par. 33; Frias Da Costa c. Billick, 2018 QCCS 1248, par. 12; Robitaille c. Picard, 2019 QCCS 1285, par. 48; Bouchard c. Létourneau, 2019 QCCQ 1749, par. 23. 9 Comme le mentionne l’auteur Pierre Deschamps, « on ne saurait exiger d’un médecin qu’il guérisse la personne qu’il soigne à telle enseigne que s’il ne la guérit pas ou n’améliore pas son état de santé, il sera considéré en faute », mais « on peut toutefois s’attendre à ce qu’il prenne les meilleurs moyens possibles en vue d’atteindre le résultat qu’il recherche. » (DESCHAMPS P (1996-97) L’obligation de moyens en matière de responsabilité médicale. 27 R.D.U.S. 139, à la page 169). 10 McCormick c. Marcotte, [1972] R.C.S. 18, 21; Lapointe c. Hôpital Le Gardeur, [1992] 1 R.C.S. 351, 353; St-Jean c. Mercier, [2002] 1 R.C.S. 491, par. 53; Brochu c. Camden-Bourgault, [2001] R.R.A. 295 (C.A.), par. 32-33; Hébert c. Centre hospitalier affilié universitaire de Québec – Hôpital de l’Enfant-Jésus, 2011 QCCA 1521, par. 35; S.T. c. Dubois, 2008 QCCS 1431, par. 20; Steinberg c. Mitnick, préc., note 5, par. 197; Arsenault c. Roy, 2017 QCCS 5554, par. 50; Duchesne c. Lévesque, 2017 QCCS 2692, par. 111; Tremblay c. Centre de santé et de services sociaux MariaChapdelaine, 2017 QCCS 1727, par. 257-258; Dufour c. Tanios Hanna, préc., note 5, par. 30; Topliceanu c. Bojanowski, 2018 QCCS 658, par. 16; Dufour c. Roy, 2019 QCCS 770, par. 176; M.J.

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de déontologie des médecins,11 à son article 83, érige d’ailleurs en norme déontologique la prohibition « de garantir, expressément ou implicitement, l’efficacité d’un examen, d’une investigation ou d’un traitement ou la guérison d’une maladie. »12 Il existe cependant des exceptions à ce principe, le médecin pouvant être, dans certains cas, tenu à une obligation de résultat.13 Il en va de même pour les hôpitaux qui, exception faite des services prodigués qui ne sont pas de nature médicale,14 sont généralement tenus à une obligation de moyens.15

L’analyse objective des faits à laquelle appelle la détermination de la faute : Le cas des médecins Conformément à cette qualification de l’obligation du médecin, et comme le résumait récemment la Cour d’appel, « le critère permettant de déterminer R. c. Girard, 2019 QCCS 1937, par. 186-187 (en appel); Bergeron c. Lapointe, 2017 QCCQ 13291 (Division des petites créances), par. 19; Carpentier c. Hôpital vétérinaire Eardley inc., 2017 QCCQ 10195 (Division des petites créances), par. 5; Gagné c. 3887804 Canada inc., 2017 QCCQ 7403 (Division des petites créances), par. 25; Bouchard c. Létourneau, préc., note 8, par. 21. 11 RLRQ, c. M-9, r. 17. 12 Id., art. 83. Voir également : M.J.R. c. Girard, préc., note 10, par. 189 (en appel). 13 En effet, bien que l’article 83 du Code de déontologie des médecins prohibe aux médecins de promettre à un patient de parvenir à un résultat donné, la transgression par le médecin de cette obligation d’ordre déontologique n’en fait pas moins obstacle à l’intensification de l’obligation lui incombant généralement en obligation de résultat. De plus, la prise en charge par un médecin d’une obligation de résultat qui incomberait en temps normal à un autre membre du personnel hospitalier, comme un infirmier par exemple, n’entraînera pas de ce fait une réduction de l’intensité de cette obligation, un médecin pouvant ainsi être tenu, dans ces circonstances, à une obligation de résultat : Hôpital de Chicoutimi c. Battikha, [1997] R.J.Q. 2121 (C.A.), par. 22 et 27-29. Enfin, le législateur lui-même prévoit certaines situations d’exception où le médecin est tenu à une obligation de résultat, notamment lorsque ce dernier est amené à rédiger une ordonnance individuelle, qu’il est tenu de rédiger lisiblement : Règlement sur les normes relatives aux ordonnances faites par un médecin, RLRQ, c. M-9, r. 25.1, art. 7. 14 Dans ces cas, les hôpitaux sont généralement tenus à une obligation de résultat : CRÉPEAU P-A (1981) La responsabilité civile de l’établissement hospitalier en droit civil canadien. 26 McGill L.J. 673, 714; DE LA SABLONNIÈRE L et PAQUET M-N (2011) La responsabilité hospitalière et l’utilisation du matériel. Dans : Développements récents en droit médico-légal et responsabilité des chirurgiens, Service de la formation continue du Barreau du Québec, EYB2011DEV1823 (La référence). Toutefois, il existe des exceptions à ce principe, notamment en l’obligation incombant aux hôpitaux « relativement au dépôt nécessaire fait par le patient des biens, vêtements et autres objets lui appartenant », qui est plutôt qualifiée d’obligation de diligence ou de moyens : Von Feuersenger c. Centre hospitalier St. Mary’s, [2002] R.J.Q. 3347 (C.Q.) (Division des petites créances), par. 25-34; BERNARDOT A et P. KOURI R (1980) La responsabilité civile médicale, Sherbrooke, Éditions R.D.U.S., no 455 et s., p. 300 et s. 15 Hôpital général de la région de l'amiante Inc. c. Perron, [1979] C.A. 567, 574; Brochu c. Camden-Bourgault, préc., note 10, par. 32; S.T. c. Dubois, préc., note 10, par. 21; Bilodeau c. Ferland, 2016 QCCS 1520, par. 137; Boulenger c. Landry, 2017 QCCS 3769, par. 99; Duchesne c. Lévesque, préc., note 10, par. 38; Noël-Voizard c. Centre de santé et de services sociaux de Lasalle et du Vieux-Lachine, 2007 QCCQ 5118 (Division des petites créances), par. 42-44.

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l’existence d’une faute est donc celui du médecin normalement prudent et compétent, qui agit conformément aux standards généralement reconnus dans la profession et la faute peut être une d’action ou d’omission. »16 Ceci s’avère une simple adaptation au domaine médical et hospitalier du standard de la personne normalement prudente et diligente placée dans les mêmes circonstances qui prévaut en droit civil.17 La détermination de la faute appelle donc à une analyse objective des circonstances exactes dans lesquelles se trouvait le médecin au moment où les faits lors desquels la faute alléguée est survenue,18 ce qui implique de se replacer à l’époque de ces faits:19 en effet, et comme le rappelait la juge L’Heureux-Dubé à l’occasion de l’arrêt Lapointe c. Hôpital Le Gardeur,20 « les tribunaux doivent prendre garde de ne pas se fier à la vision parfaite que permet le recul. »21 Plus particulièrement, cet exercice implique de considérer les connaissances qu’un médecin aurait raisonnablement dû posséder à l’époque des faits lors desquels la faute alléguée serait survenue,22 les ressources, les équipements et les moyens dont disposait et/ou dont aurait dû disposer le médecin à cette époque,23 la spécialité du médecin dans le domaine en cause24 et le fait que le médecin ait dû procéder dans le cadre d’une situation d’urgence ou non,25 ainsi que de comparer le comportement de

16

M.G. c. Pinsonneault, préc., note 7, par. 149. Marcheterre c. Fédération (La), compagnie d'assurances du Canada, 2014 QCCA 1026, par. 35. 18 Sévigny c. Filiatrault, préc., note 6, par. 38. 19 Ter Neuzen c. Korn, [1995] 3 R.C.S. 674, par. 34; Tremblay c. Centre de santé et de services sociaux Maria-Chapdelaine, préc., note 10, par. 260-261; Dufour c. Tanios Hanna, préc., note 5, par. 32; Dufour c. Roy, préc., note 10, par. 178; M.J.R. c. Girard, préc., note 10, par. 190 (en appel). 20 [1992] 1 R.C.S. 351. 21 Id., 362-363. 22 Ter Neuzen c. Korn, préc., note 19, par. 34. 23 « En raison de sa pratique spécialisée en urgence à l'intérieur d'une institution ayant les capacités et les ressources de haut niveau, le Dr Brochu doit être évalué suivant les standards d'un urgentologue spécialisé disposant de moyens et de ressources propres aux grandes institutions hospitalières » : Brochu c. Camden-Bourgault, préc., note 10, par. 35. Voir également : Harewood c. Spanier, [1995] R.R.A. 147 (C.S.); McCormick c. Marcotte, préc., note 10. 24 « Dans le cas d'un spécialiste, tel qu'un obstétricien gynécologue, il faut évaluer la conduite du médecin par rapport à celle des autres spécialistes qui possèdent le degré raisonnable de science, de compétence et d'habileté auquel on s'attend des professionnels au Canada dans cette spécialité. Un spécialiste, comme l'intimé, qui prétend avoir un certain degré d'habileté et de science doit faire preuve de l'habileté du spécialiste moyen dans son domaine » : Ter Neuzen c. Korn, préc., note 19, par. 33. Voir également : Wilson c. Swanson, [1956] R.C.S. 804, 817; Lapointe c. Hôpital Le Gardeur, préc., note 10, 362; M.J.R. c. Girard, préc., note 10, par. 190 (en appel). 25 « Par ailleurs, le médecin expert, après l'étude du dossier constate que compte tenu de l'urgence dans lequel se trouvait la patiente, l'intubation était prescrite bien qu'elle comportait un risque même si elle était bien exécutée. Le bris possible d'une dent valait mieux que la perte d'une vie » : Béliveau c. Ciricillo, REJB 1997-01542 (C.Q.) (Division des petites créances), par. 20. 17

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ce professionnel avec les règles de l’art de leur profession qui étaient alors reconnues.26 À cet égard, il convient de préciser qu’il est établi en jurisprudence que si l’usage d’une pratique professionnelle courante dans un domaine spécialisé par un professionnel peut constituer une preuve de conduite diligente et raisonnable, ce dernier peut néanmoins engager sa responsabilité dans l’éventualité où cette pratique ne serait guère jugée conforme aux normes générales de responsabilité par un tribunal.27 Bien qu’un magistrat ne puisse prétendre à une connaissance équivalente à celle d’un expert témoignant sur une telle pratique afin d’en juger le caractère raisonnable,28 il peut néanmoins, nonobstant l’étendue de ses connaissances dans le domaine spécialisé en cause, considérer l’exercice d’une pratique professionnelle comme étant fautive lorsqu’elle n’est pas conforme aux règles élémentaires de prudence qui peuvent être facilement comprises par un profane ou lorsqu’il s’agit de questions relevant du sens commun.29 Ainsi, le fait qu’une pratique soit généralisée et bien établie n’est pas garant de son caractère raisonnable.30

L’incidence d’une condamnation ou d’un acquittement disciplinaire sur la responsabilité civile d’un professionnel Bien que la responsabilité civile constitue un régime distinct et autonome de la responsabilité déontologique,31 le fait pour un professionnel d’être condamné ou acquitté par un tribunal disciplinaire peut-il avoir une incidence sur l’issue d’un éventuel procès civil? Le verdict de culpabilité prononcé par le Comité de discipline en regard d’une plainte portée contre un professionnel est considéré comme un fait juridique pertinent au litige duquel le tribunal peut tirer les conclusions appropriées, sans toutefois y être lié, à plus forte raison lorsque la preuve retenue par le Comité de discipline sur la plainte en cause repose essentiellement sur les faits en cause dans le dossier au

26 Fiocco c. De Varennes, préc., note 8, par. 63; Dufour c. Tanios Hanna, préc., note 5, par. 30; M.J. R. c. Girard, préc., note 10, par. 190 (en appel); Saindon c. Caouette, 2018 QCCQ 116 (Division des petites créances), par. 41. 27 Roberge c. Bolduc, [1991] 1 R.C.S. 374, 434-437. 28 Leduc c. Soccio, 2007 QCCA 209, par. 76-78. 29 Ter Neuzen c. Korn, préc., note 19, par. 42-51; Hébert c. Centre hospitalier affilié universitaire de Québec – Hôpital de l’Enfant-Jésus, préc., note 10, par. 60-61; Fortier c. Lavoie, 2012 QCCA 754, par. 17-21; BAUDOUIN J-L, DESLAURIERS P et MOORE B (2014) La responsabilité civile. 8e édition, vol. 2 - Responsabilité professionnelle, Cowansville, Éditions Yvon Blais, no 2-62-10, EYB2014RES143 (La référence). 30 Id.; Drolet c. Excavations Lambert inc., 2011 QCCS 5108, par. 89. 31 BAUDOUIN J-L, DESLAURIERS P et MOORE B, préc., note 29, no 2-40, EYB2014RES147 (La référence).

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civil.32 Dans l’arrêt Audet c. Transamerica Life Canada,33 la Cour d’appel enseignait qu’« il est indéniable que la décision du comité de discipline et le jugement en appel de la Cour du Québec sont des faits pertinents au litige »,34 suggérant, de par la généralité de cette affirmation, une ouverture à l’extrapolation de ces principes aux décisions acquittant un professionnel. La Cour d’appel prend également soin de préciser que « la décision du comité ne fait pas preuve des faits y mentionnés, mais uniquement que si ces faits existent, ils constituent une faute déontologique »,35 précision qui permet aisément d’envisager l’ampleur de l’impact d’une décision disciplinaire acquittant ou condamnant un professionnel sur un éventuel procès civil, où des faits similaires, voire les mêmes, seraient en cause. Malgré tout, il demeure, comme nous l’avons vu, que si « l’existence d'un manquement au code de conduite d'un professionnel ou d'un intermédiaire peut être un indice d'une faute civile », il n’en constitue pas nécessairement une.36 Ces principes font l’objet d’une jurisprudence constante,37 mais les tribunaux y apportent certaines nuances. Entre autres, la Cour supérieure, dans une affaire où l’on souhaita produire en preuve non pas une décision portant sur un verdict de culpabilité d’un Comité de discipline, mais plutôt une décision rejetant une requête en rétractation de verdict, distingua cette situation de celle de l’arrêt Hamel c. J.C.38 de la Cour d’appel, et refusa d’en appliquer la règle.39 Récemment, la Cour supérieure vint également spécifier que ces principes s’appliquent uniquement aux décisions rendues par un Comité de discipline au terme d’une audition publique et impartiale par un tribunal indépendant, excluant ainsi les décisions du syndic d’un ordre professionnel,40 qui n’exerce ni pouvoir judiciaire, ni quasi judiciaire,41 et dont la fonction se limite à enquêter et à déposer dénonciation s’il y a lieu.42

32

Hamel c. J.C., 2008 QCCA 1889, par. 56 et 58, citant avec approbation Ali c. Cie d'assurance Guardian du Canada, [1999] R.R.A. 427 (C.A). 33 2012 QCCA 1746. 34 Id., par. 46. 35 Id., par. 47. 36 Id. 37 Voir notamment : 9194-0551 Québec inc. c. Lévesque Lavoie Avocats inc., 2017 QCCQ 8184 (Division des petites créances), par. 60. 38 2008 QCCA 1889. 39 Gestion HC ltée Rail, 2010 QCCS 2252, par. 18-20. 40 Chabot c. Québec (Procureure générale), 2016 QCCS 4306, par. 44. 41 Larose c. Ordre des denturologistes du Québec, 2006 QCCS 667, par. 243. 42 Chabot c. Québec (Procureure générale), préc., note 40, par. 45.

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L’impact de la contravention à une norme déontologique sur la responsabilité civile du médecin Dans l’arrêt Morin c. Blais,43 la Cour suprême du Canada enseigna que la violation d’une norme législative ou réglementaire peut être qualifiée de faute civile si cette norme exprime une règle élémentaire de prudence et est douée d’un lien avec l’incident en cause,44 de telle sorte à ce que cette transgression corresponde à une violation de la norme comportementale objective de la personne raisonnable édictée à l’article 1457 C.c.Q., laquelle s’avère une obligation de moyens.45 Qui plus est, lorsque la contravention à une telle règle « est immédiatement suivie d’un accident dommageable que la norme avait justement pour but de prévenir, il est raisonnable de présumer, sous réserve d’une démonstration ou d’une forte indication contraire, qu’il y a un rapport de causalité entre la faute et l’accident. »46 Encore à ce jour, ces enseignements trouvent application en responsabilité civile québécoise.47 Or, qu’en est-il d’une norme issue d’un code de déontologie qui édicte une règle élémentaire de prudence? La transgression à une telle norme peut-elle se révéler constitutive de faute civile dans le contexte de la responsabilité civile professionnelle, et peut-on, en cette matière, présumer du lien de causalité lorsque telle transgression est immédiatement suivie d’un accident dommageable que la norme en cause avait justement pour objectif de prévenir? Il appert de la jurisprudence que les tribunaux ont déjà utilisé cette règle aux fins de circonscrire la faute de certains professionnels, notamment les avocats,48 les chiropraticiens49 et les dentistes.50 D’ailleurs, JeanLouis Baudouin, alors juge de la Cour d’appel du Québec, soulignait en 1990 l’utilité indéniable des normes énoncées par les dispositions des codes de déontologie qui, bien qu’elles ne lient pas le tribunal, « ont cependant une utilité indiscutable dans la détermination de la faute ».51 Cependant, dans le cas des médecins la jurisprudence n’a pas véritablement pris position. En effet ,la seule décision qui traite de la question a refusé d’appliquer la règle aux motifs qu’il s’agissait , en l’espèce, de simples «

43

[1977] 1 R.C.S. 570. Id., 579-580; Compagnie d’assurances Continental du Canada c. 136500 Canada inc., [1998] R.R.A. 707 (C.A.), 712. 45 Ciment du Saint-Laurent inc. c. Barrette, [2008] 3 R.C.S. 392, par. 34. 46 Morin c. Blais, préc., note 43, 580. 47 Matagami (Ville de) c. Cliche, 2007 QCCA 406, par. 2; Michaud c. Équipements ESF inc., 2010 QCCA 2350, par. 51-53; Promutuel Bagot, société mutuelle d'assurances générales c. Boutique du foyer de Saint-Hyacinthe inc., 2014 QCCA 1314, par. 26-29; Abou-Jaoudé c. Université Laval, 2017 QCCS 1936, par. 318-320; Simms Sigal & Co. Ltd. c. Costco Wholesale Canada Ltd., 2017 QCCS 5058, par. 234 (en appel); Royal et Sun Alliance du Canada, société d'assurances c. Coté (Masteraph Fabrication), 2018 QCCS 613, par. 112-113 (en appel). 48 Lapierre c. Deschamps, 2016 QCCQ 4331 (Division des petites créances), par. 35-37. 49 R.C. c. Bélanger, 2008 QCCQ 1893 (Division des petites créances), par. 16-25. 50 Routhier c. Dre Anne E. Beaudoin inc., 2019 QCCQ 4065 (Division des petites créances), par. 23-26. 51 Caisse populaire de Charlesbourg c. Michaud, EYB 1990-63500 (C.A.), par. 37. 44

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questions de courtoisie entre confrères, de bonnes relations entre professionnels, bref de bonne et saine gestion de la pratique médicale ».52

La nature de la responsabilité civile du médecin et de l’hôpital : contractuelle ou extracontractuelle? En droit civil québécois, la responsabilité peut être de nature extracontractuelle (art. 1457 C.c.Q.)53 ou contractuelle (art. 1458 C.c.Q.)54. Bien que ces régimes aient pour dénominateur commun « le concept de faute qui, si elle entraîne un dommage, oblige celui qui l’a commise à réparation »,55 la qualification du régime de responsabilité et, incidemment, la détermination du régime applicable, peut entraîner des incidences pratiques méritant considération, d’autant plus que la règle du cumul fut expressément rejetée par le législateur québécois à l’occasion de la réforme du Code civil du Québec du début des années 1990.56 Ainsi, il convient de nous attarder

52 Therrien c. Launay, EYB 2005-86098 (C.S.), par. 288 (appel rejeté sur requête, EYB 2005-92515 (C.A.)). 53 Cette disposition se lit comme suit :

« 1457. Toute personne a le devoir de respecter les règles de conduite qui, suivant les circonstances, les usages ou la loi, s’imposent à elle, de manière à ne pas causer de préjudice à autrui. Elle est, lorsqu’elle est douée de raison et qu’elle manque à ce devoir, responsable du préjudice qu’elle cause par cette faute à autrui et tenue de réparer ce préjudice, qu’il soit corporel, moral ou matériel. Elle est aussi tenue, en certains cas, de réparer le préjudice causé à autrui par le fait ou la faute d’une autre personne ou par le fait des biens qu’elle a sous sa garde. » 54

Cette disposition se lit comme suit : « 1458. Toute personne a le devoir d’honorer les engagements qu’elle a contractés. Elle est, lorsqu’elle manque à ce devoir, responsable du préjudice, corporel, moral ou matériel, qu’elle cause à son cocontractant et tenue de réparer ce préjudice; ni elle ni le cocontractant ne peuvent alors se soustraire à l’application des règles du régime contractuel de responsabilité pour opter en faveur de règles qui leur seraient plus profitables. »

55

BAUDOUIN J-L, DESLAURIERS P et MOORE B (2014) La responsabilité civile. 8e édition, vol. 1 – Principes généraux, Cowansville, Éditions Yvon Blais, no 1-46, EYB2014RES5 (La référence). 56 Dans ses commentaires au sujet de la règle énoncée au second alinéa de l’article 1458 C.c.Q., le ministre de la Justice écrivait d’ailleurs : « Cette règle dénie au créancier d'une obligation contractuelle, lorsqu'il réclame à son débiteur réparation du préjudice résultant de l'inexécution de cette obligation, la possibilité d'opter pour le régime extracontractuel; a fortiori, elle dénie au créancier la possibilité d'invoquer de façon cumulative les règles des deux régimes de responsabilité. » (Soulignements ajoutés), Commentaires du ministre de la Justice, Tome 1, Publications du Québec, 1993, p. 888, cité avec approbation dans Leblond c. Dionne, 2006 QCCA 341, par. 23

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aux distinctions entre les régimes extracontractuel et contractuel (1) de même que de l’évolution et des solutions dégagées par les tribunaux au cours des dernières années pour les fins de la détermination de l’applicabilité de l’un ou l’autre de ces régimes (2),57 chose qui n’est pas toujours aisée en matière de responsabilité civile médicale et hospitalière.

La responsabilité du fait d’autrui en matière extracontractuelle et en matière contractuelle : certaines distinctions d’intérêt entre les deux régimes En cas d’application du régime extracontractuel, une personne peut, dans certaines situations, être tenue à la réparation du préjudice causé à autrui « par le fait ou la faute d’une autre personne, ou par le fait des biens qu’elle a sous sa garde. »58 Parmi ces situations, qui sont expressément couvertes par le C.c.Q., à ses articles 1459 à 1469, et pour lesquels des présomptions de faute ou de responsabilité, selon le cas, sont susceptibles d’application, on retrouve celle où le commettant peut être tenu responsable du préjudice causé par la faute de ses préposés dans l’exécution de leurs fonctions. À cet égard, l’article 1463 C.c.Q.59 prévoit une présomption de responsabilité du commettant qui trouvera application s’il y a faute de son préposé, si cette faute a été commise dans le cadre de l’exécution des fonctions du préposé et s’il existe un lien de préposition entre ce dernier et le commettant.60 En responsabilité médicale et hospitalière, en cas d’application du régime extracontractuel, un hôpital pourra ainsi être présumé responsable pour la faute des membres de son personnel, notamment les résidents, les infirmiers, les inhalothérapeutes et les technologues en radiologie.61 Cependant, cette présomption de responsabilité ne saurait jouer contre l’hôpital pour la faute d’un médecin, les tribunaux ayant conclu que la relation entre l’hôpital et le médecin ne relèverait point du contrat de travail et serait dénuée de lien de préposition à proprement dit : en effet,

57

Voir notamment en doctrine : P. KOURI K (2011) La responsabilité civile de l’établissement de santé en droit québécois : regards sur la contribution de Paul-André Crépeau. 41 R.D.U.S. 523, 526-535; LAJOIE A, A. MOLINARI P et BAUDOUIN J.-L. (1983) Le droit aux services de santé : légal ou contractuel ?. 43 R. du B. 675, 678, 715 et 720. 58 Code civil du Québec, préc., note 4, art. 1457 al. 3. 59 Cette disposition se lit comme suit : « 1463. Le commettant est tenu de réparer le préjudice causé par la faute de ses préposés dans l’exécution de leurs fonctions; il conserve, néanmoins, ses recours contre eux. » 60

Compagnie de chemin de fer du littoral nord de Québec et du Labrador inc. c. Sodexho Québec ltée, 2010 QCCA 2408. Voir également : Havre des Femmes Inc. c. Dubé, REJB 1998-04273 (C.A.). 61 LEROUX J-F (2011) La responsabilité médicale dans le contexte de la médecine multidisciplinaire : d'une responsabilité individualisée vers une responsabilité collective. Dans : Développements récents en droit médico-légal et responsabilité des chirurgiens, Service de la formation continue du Barreau du Québec, EYB2011DEV1821 (La référence).

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« l'hôpital, suivant des règles précises, octroie des privilèges d'exercice au médecin », mais « l'octroi de ces privilèges ne confère pas au médecin un statut d'employé ou de préposé. »62 En ce qui concerne le médecin, s’il est admis, pour cette même raison, qu’il ne saurait être le commettant d’un autre médecin, il en va autrement des auxiliaires généralement considérés comme les préposés de l’hôpital, dans la mesure où le médecin peut, selon les circonstances, devenir momentanément le commettant d’un ou plusieurs de ces auxiliaires : tel sera notamment le cas du médecin qui confie une tâche à son résident faisant partie des soins qu’il doit prodiguer à son patient.63 À l’inverse, en cas d’application du régime contractuel, et suivant l’intention du législateur lors de la réforme du Code civil du Québec du début des années 1990, les régimes de présomption de faute et de responsabilité des articles 1459 à 1469 C.c.Q. ne devraient, en théorie, guère trouver application. Toutefois, vu l’existence d’un important courant jurisprudentiel en responsabilité civile québécoise appliquant ces présomptions dans des situations où le régime contractuel s’avère pourtant applicable,64 de même que le refus délibéré de la Cour d’appel de se prononcer sur la question alors qu’elle en avait l’opportunité,65 ces présomptions pourraient potentiellement trouver application en matière contractuelle. Néanmoins, nonobstant toute considération relative à cette question, la responsabilité du fait d’autrui peut tout de même être recherchée en vertu des règles contractuelles : en effet, en droit contractuel québécois, lorsqu’un débiteur confie l’exécution d’une obligation lui incombant à une autre personne, ce débiteur n’en demeure pas moins responsable vis-à-vis de son créancier des actes de la personne à laquelle il a confié l’exécution de l’obligation.66 Cette règle, qui se résume par la maxime latine qui agit per alium agit per se (« celui qui agit par quelqu’un d’autre agit par lui-même »), trouve application en matière médicale et hospitalière.67 À l’inverse de celle du régime extracontractuel en matière de responsabilité du fait d’autrui pour la faute d’un préposé, elle n’exige

62 Hôpital de l'Enfant-Jésus c. Camden-Bourgault, REJB 2001-23496 (C.A.), par. 48. Voir également : Lafrance c. Hôpital St-Luc, EYB 1980-138561 (C.A.), par. 22; Montambault c. Hôpital Maisonneuve-Rosemont, REJB 2001-23081 (C.A.), par. 44; Apponi c. CHUM Hôpital Notre-Dame, 2019 QCCS 329, par. 21. 63 Labrecque c. Hôpital du St-Sacrement, REJB 1996-65658 (C.A.), par. 34-35. Voir également : Lamarre c. Hôpital du Sacré-Cœur, EYB 1996-86833 (C.S.), par. 90-91. 64 Voir notamment à titre illustratif : Accessoires d'Auto Vipa Inc. c. Therrien, 2003 CanLII 47988 (QC CA); Bessette c. Casarcia, [2000] R.R.A. 825 (C.S.); Brasseur c. Desrosiers, 2000 CanLII 18845 (QC CS); Wilson c. 104428 Canada Inc., 2002 CanLII 24889 (QC CS); Royal et Sunalliance du Canada, société d'assurances c. Robitaille, B.E. 2004BE-357 (C.S.); Racicot c. 2864-0928 Québec Inc., 2005 CanLII 24354 (QC CS); N.T. c. 9107-3932 Québec inc., 2008 QCCS 1429;` Plourde c. Commission scolaire de la Capitale, 2012 QCCS 6247. 65 Desrosiers c. Centre hippique de la Mauricie inc., REJB 2004-65900 (C.A.), par. 17-18. 66 Cinepix c. J.K. Walkden Ltd., [1980] C.A. 283, 286; PHILIPS-NOOTENS S, P. KOURI R et LESAGE-JARJOURA P (2016) Éléments de responsabilité civile médicale – Le droit dans le quotidien de la médecine, 4e édition, Cowansville, Éditions Yvon Blais, no 118, EYB2016RCM15 (La référence). 67 Voir notamment à titre illustratif : Lapointe c. Hôpital Le Gardeur, REJB 1989-59049 (C.A.), par. 158, inf. quant à la responsabilité du médecin par [1992] 1 R.C.S. 351; Hôpital de l'Enfant-Jésus

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pas l’établissement d’un lien de préposition entre un commettant et son préposé, la démonstration du fait « que la faute dommageable a été commise dans le cadre de l’exécution du contrat » étant suffisante.68 Dans le cas du médecin spécifiquement, et suivant une logique similaire à celle qui s’impose en matière extracontractuelle, cette règle du régime contractuel permettra la rétention de sa responsabilité personnelle pour la faute des auxiliaires, mais il conviendra de déterminer préalablement si la faute s’inscrivait dans le cadre hospitalier ou médical à proprement dit.69

Évolution et solution En 1957, dans une décision remarquée, la Cour du Banc de la Reine enseigna que la nature de la relation entre un médecin et son patient serait d’ordre contractuel en soutenant qu’il y aurait formation d’un contrat de soins professionnels entre ces derniers « dès que le patient pénètre dans le cabinet du médecin »,70 position qui a été suivie par la jurisprudence.71 En ce qui concerne les hôpitaux, en 1989, la Cour d’appel semblait avoir résolu la question en déterminant, dans l’arrêt Lapointe c. Hôpital Le Gardeur,72 que la nature du rapport entre un centre hospitalier et son patient serait de nature contractuelle.73 Bien que cette position ait également été suivie par la jurisprudence,74 la Cour d’appel vint cependant remettre en question sa propre position en déterminant, quelques années plus tard, que la nature de ces liens pourrait plutôt être extracontractuelle.75 La controverse persiste donc à cet égard, mais nous croyons que l’analyse des arguments au soutien du rejet de la thèse contractuelle peut amener la découverte de nuances susceptibles d’en arriver à une

c. Camden-Bourgault, préc., note 62, par. 66; Mainville c. Cité de la santé de Laval, [1998] R.J.Q. 2082 (C.S.), par. 97-98. 68 PHILIPS-NOOTENS S, P. KOURI R et LESAGE-JARJOURA P, préc., note 66, no 119, EYB2016RCM15 (La référence). 69 Id., no 141 et s., EYB2016RCM15 (La référence). 70 X c. Mellen (1957), B.R. 389, 408. 71 Mellen c. Nelligan, 1957 CanLII 221 (QC CA), par. 78; Chouinard c. Landry, EYB 1987-62641 (C.A.), par. 81-82; Vigneault c. Mathieu, EYB 1991-63618 (C.A.), par. 13. 72 REJB 1989-59049 (C.A.), inf. quant à la responsabilité du médecin dans [1992] 1 R.C.S. 351. 73 Id., par. 19-25. 74 Voir notamment : Mainville c. Cité de la Santé de Laval, préc., note 67; Collins c. Centre hospitalier de Sept-Îles, REJB 2000-20110 (C.Q.). 75 « Le temps est venu pour les tribunaux de prendre acte de ces modifications tant sociales que législatives et d'en tirer les conséquences juridiques appropriées. En l'absence de textes législatifs précis, je conclus qu'il ne saurait y avoir de responsabilité sans faute de l'hôpital. Pour les mêmes motifs, je suis d'avis qu'il n'y a pas de lien de préposition entre l'hôpital et le médecin lors de l'exécution d'un acte médical. J'écarte définitivement la thèse du régime contractuel. De son application résulterait un bien étrange contrat, conclu par une partie, l'hôpital, qui n'est pas libre d'y consentir. Il porterait sur une matière réservée exclusivement, sous peine de nullité, à la profession médicale. Pour l'hôpital, ce contrat serait au surplus sans considération aucune » : Hôpital de l'Enfant-Jésus c. Camden-Bourgault, préc., note 62, par. 43.

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position plus cohérente qu’une simple divergence de positions vouée à persister. En effet, tel qu’il appert de l’arrêt Camden-Bourgault, la Cour d’appel rejeta le régime contractuel au profit du régime extracontractuel puisque l’hôpital ne serait pas libre d’y consentir, ce qui s’avérerait une entrave au consensualisme.76 À cet égard, il convient de préciser que dans cet arrêt, le patient dont il était question s’était rendu à l’urgence de l’hôpital, ce qui pourrait expliquer l’entorse au consensualisme et supposer, a contrario, que si le patient ne s’était pas rendu à l’urgence de l’hôpital et qu’il y avait eu échange de consentements en bonne et due forme, il y aurait pu, en théorie, y avoir contrat.77 Nous sommes d’avis que puisque le contrat de soins médicaux « doit être conclu intuitu personae, en considération d’une personne spécifique »,78 cette interprétation des enseignements de l’arrêt Camden-Bourgault doit prévaloir. Enfin, la jurisprudence subséquente milite également en ce sens, la Cour supérieure ayant, par exemple, constaté l’existence d’un contrat entre un médecin et son patient puisqu’il ne s’agissait pas « d’un cas d’intervention d’urgence ou d’un patient frappé d’incapacité légale. »79

La qualification du préjudice et certaines règles particulières concernant le préjudice corporel La qualification Comme l’enseignait la Cour suprême en 2013, la qualification du préjudice en droit civil québécois est fonction de « la violation initiale, plutôt que [d]es conséquences de cette violation », et il peut résulter du préjudice, nonobstant sa qualification, des pertes pécuniaires et non pécuniaires.80 Ainsi, dépendamment de l’atteinte initiale, le préjudice pourra être corporel,81 moral82 ou matériel.83

76

Id. L’affaire Rizk c. Hôpital du Sacré-Cœur, REJB 1998-09902 (C.Q.), constitue un exemple intéressant : le patient ne s’était pas rendu à l’urgence de l’hôpital et la Cour supérieure détermina que le lien entre le patient et l’hôpital était de nature contractuelle. 78 Marcoux c. Bouchard, [2001] 2 R.C.S. 726, par. 31. 79 E.J. c. Owen, 2009 QCCS 3842, par. 69. 80 Cinar Corporation c. Robinson, [2013] 3 R.C.S. 1168, par. 102. 81 Le préjudice corporel est celui qui relève d’une atteinte à l’intégrité physique d’une personne. 82 Le préjudice moral est celui qui relève d’une atteinte initiale à un droit extrapatrimonial ou à la qualité de vie d’une personne. 83 Le préjudice matériel est celui qui relève d’une atteinte initiale au patrimoine d’une personne. 77

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Les règles applicables en matière de préjudice corporel En responsabilité médicale et hospitalière, le préjudice résultant d’une faute est corporel dans la grande majorité des cas; or, au Québec, ce type de préjudice fait l’objet d’un encadrement particulier. Premièrement, les clauses contractuelles d’exclusion ou de limitation de la responsabilité n’étant valables que si elles visent à limiter celle résultant d’un préjudice matériel,84 les clauses limitant ou excluant la responsabilité civile pouvant résulter d’un préjudice corporel seront, par conséquent, nulles ab initio.85 À cet égard, il importe de souligner que les médecins, à l’instar de plusieurs autres professionnels,86 ne peuvent exclure ou limiter leur responsabilité, conformément à leur code de déontologie.87 Deuxièmement, la Cour suprême du Canada, à la fin des années 1970 et dans le cadre d’une trilogie incluant les arrêts Andrews c. Grand Toy Alberta Ltd.,88 Thornton c. School Dist. No. 57 (Prince George)89 ainsi que Arnold c. Teno,90 a fixé un plafond d’une valeur de 100 000 $,91 applicable uniquement aux pertes non pécuniaires résultant spécifiquement d’un préjudice corporel,92 et dont la valeur doit être ajustée en fonction de l’inflation

84

Code civil du Québec, préc., note 4, art. 1474. Voir notamment à titre illustratif : Allendale Mutual Insurance Co. c. Hydro-Québec, [2002] R.J.Q. 84 (C.A.), par. 27; Morin c. Centre école de parachutisme Atmosphair inc., [2004] R.R.A. 1318 (C.S.), par. 55; Couture c. Fabrique de la paroisse de Saint-Henri, 2013 QCCS 1398, par. 60. 86 Voir notamment : Code de déontologie des architectes, RLRQ, c. A-21, r. 5.1, art. 17; Code de déontologie des arpenteurs-géomètres, RLRQ, c. A-23, r. 3, art. 3.04.01; Code de déontologie des avocats, RLRQ, c. B-1, r 3.1, art. 46; Code de déontologie des comptables professionnels agréés, RLRQ, c. C-48.1, r. 6, art. 21; Code de déontologie des dentistes, RLRQ, c. D-3, r. 4, art. 3.04.01; Code de déontologie des experts en sinistre, RLRQ, c. D-9.2, r. 4, art. 38; Code de déontologie des infirmières et infirmiers auxiliaires, RLRQ, c. C-26, r. 153.1, art. 39; Code de déontologie des médecins vétérinaires, RLRQ, c. M-8, r. 4, art. 10; Code de déontologie des notaires, RLRQ, c. N-3, r. 2, art. 28; Code de déontologie des optométristes, RLRQ, c. O-7, r. 5, art. 24; Code de déontologie de l'Ordre des denturologistes du Québec, RLRQ, c. D-4, r. 6, art. 28; Code de déontologie des pharmaciens, RLRQ, c. P-10, r. 7, art. 11; Code de déontologie des psychologues, RLRQ, c. C-26, r. 212, art. 8; Code de déontologie des représentants en assurance de dommages, RLRQ, c. D-9.2, r. 5, art. 20. 87 Code de déontologie des médecins, préc., note 11, art. 11. 88 [1978] 2 R.C.S. 229. 89 [1978] 2 R.C.S. 267. 90 [1978] 2 R.C.S. 287. 91 Ce montant représentait approximativement 67 361,12 euros. 92 « Je suis d'avis que dans le cas d'un jeune adulte devenu tétraplégique, comme Andrews, la somme de $100,000 représente une indemnisation convenable. Sauf circonstances exceptionnelles, ce montant doit être considéré comme un plafond au chapitre des pertes non pécuniaires, dans les cas de ce genre » : Andrews c. Grand Toy Alberta Ltd., préc., note 88, 265. Voir également: Lindal c. Lindal, [1981] 2 R.C.S. 629, 640; Fortier c. Québec (Procureure générale), 2015 QCCA 1426, par. 91; Manoukian c. Procureur général du Canada, 2018 QCCS 30, par. 447 (en appel). 85

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depuis 197893 et évaluée à la date de l’introduction de l’instance.94 Ainsi, les victimes de fautes médicales et hospitalières ayant subi un préjudice corporel ne peuvent réclamer, au chapitre des pertes non pécuniaires, une somme supérieure à la valeur du plafond. Troisièmement, l’article 1614 C.c.Q.95 prévoit que « les dommages-intérêts dus au créancier en réparation du préjudice corporel qu’il subit sont établis, quant aux aspects prospectifs du préjudice, en fonction des taux d’actualisation prescrits par règlement du gouvernement. » Cette disposition renvoie ainsi au Règlement d’application de l’article 1614 du Code civil sur l’actualisation des dommages-intérêts en matière de préjudice corporel96 et, incidemment, à son seul et unique article,97 qui fixe ces taux d’actualisation à 2% « pour les pertes résultant tant de la diminution de la capacité de gains que de la progression des revenus, traitements ou salaires », et à 3,25% « pour les autres pertes résultant de l’inflation. » Quatrièmement, l’article 1615 C.c.Q.98 permet à la victime d’un préjudice corporel de demander au tribunal de lui réserver, pour une période d’au plus trois (3) ans, son droit « de demander des dommages-intérêts additionnels, lorsqu’il n’est pas possible de déterminer avec une précision suffisante l’évolution de sa condition physique au moment du jugement »,99 mais l’absence de preuve d’expertise attestant du fait que la situation de la victime ne serait guère consolidée

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Cinar Corporation c. Robinson, préc., note 80, par. 95; Ter Neuzen c. Korn, préc., note 19, par. 114; Lindal c. Lindal, préc., note 92, 640-641. 94 P.L. c. J.L., 2011 QCCA 1233, par. 76; Émond c. Lebrun, 2017 QCCS 2988, par. 109; Menkhour c. Couture, 2016 QCCS 1843, par. 73. 95 Cette disposition se lit comme suit : « 1614. Les dommages-intérêts dus au créancier en réparation du préjudice corporel qu’il subit sont établis, quant aux aspects prospectifs du préjudice, en fonction des taux d’actualisation prescrits par règlement du gouvernement, dès lors que de tels taux sont ainsi fixés. » 96 97

RLRQ, c. CCQ, r. 1. Cette disposition se lit comme suit : « 1. Les taux d’actualisation applicables, quant aux aspects prospectifs du préjudice, au calcul des dommages-intérêts dus au créancier en réparation du préjudice corporel qu’il subit sont: 1. pour les pertes résultant tant de la diminution de la capacité de gains que de la progression des revenus, traitements ou salaires, de 2%; 2. pour les autres pertes résultant de l’inflation, de 3,25%. »

98

Cette disposition se lit comme suit : « 1615. Le tribunal, quand il accorde des dommages-intérêts en réparation d’un préjudice corporel peut, pour une période d’au plus trois ans, réserver au créancier le droit de demander des dommages-intérêts additionnels, lorsqu’il n’est pas possible de déterminer avec une précision suffisante l’évolution de sa condition physique au moment du jugement. »

99

Code civil du Québec, préc., note 4, art. 1615.

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au moment du jugement entraîne généralement le rejet d’une telle demande.100 Enfin, l’article 1616 C.c.Q.,101 à son second alinéa, prévoit que « lorsque le préjudice est corporel et que le créancier est mineur,102 le tribunal peut imposer, en tout ou en partie, le paiement sous forme de rente ou de versements périodiques, dont il fixe les modalités et peut prévoir l’indexation suivant un taux fixe », et le créancier pourra exiger « le paiement immédiat, actualisé, de tout ce qui lui reste à recevoir » dans les trois mois qui suivent l’atteinte de sa majorité.

Le lien de causalité En matière médicale et hospitalière, il est établi que la causalité juridique n’a pas à être déterminée « par une précision scientifique » : en effet, si « les experts médicaux déterminent habituellement l’existence de causalité en termes de certitude », une « norme inférieure » est exigée par le droit, et c’est donc au juge des faits, et non aux témoins experts médicaux, qu’il appartient de rendre une décision juridique sur la question de l’existence d’un lien causal.103 Ainsi, et comme c’est généralement le cas en responsabilité civile, « il suffit simplement que la preuve rapportée rende simplement probable l’existence d’un lien direct. »104 Le lien de causalité doit donc, tout comme la faute et le préjudice, être établi selon la balance des probabilités,105 et à cette fin, il est possible de recourir aux présomptions de fait106 « graves, précises et concordantes. »107

100 Voir notamment : Labelle c. Bérard, 2017 QCCS 3983, par. 159; S.M. c. G.G., 2017 QCCS 2716 (en appel), par. 194-198. 101 Cette disposition se lit comme suit :

« 1616. Les dommages-intérêts accordés pour la réparation d’un préjudice sont, à moins que les parties n’en conviennent autrement, exigibles sous la forme d’un capital payable au comptant. Toutefois, lorsque le préjudice est corporel et que le créancier est mineur, le tribunal peut imposer, en tout ou en partie, le paiement sous forme de rente ou de versements périodiques, dont il fixe les modalités et peut prévoir l’indexation suivant un taux fixe. Dans les trois mois qui suivent sa majorité, le créancier peut exiger le paiement immédiat, actualisé, de tout ce qui lui reste à recevoir. » 102

Ces conditions sont cumulatives et font l’objet d’une observation stricte par les tribunaux : Defi Élève-Toi c. Lebeau, 2017 QCCQ 9139 (Division des petites créances), par. 165. 103 Snell c. Farrell, [1990] 2 R.C.S. 311, 328-330; Laferrière c. Lawson, [1991] 1 R.C.S. 541, 607-608. 104 BAUDOUIN J-L, DESLAURIERS P et MOORE B, préc., note 55, no 1-706, EYB2014RES67 (La référence); Lambert c. Bélanger, préc., note 5, par. 41. 105 Laferrière c. Lawson, préc., note 103, 608-609; St-Jean c. Mercier, préc., note 10, par. 106; Benhaim c. St-Germain, [2016] 2 R.C.S. 352, par. 47. 106 Benhaim c. St-Germain, préc., note 105, par. 4. 107 Code civil du Québec, préc., note 4, art. 2849.

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Or, qu’en est-il des situations où la négligence d’un médecin défendeur viendrait compromettre la possibilité pour le demandeur d’établir un lien de causalité, même si ce dernier a pu produire certains éléments de preuve d’un tel lien? La question de savoir si, en pareilles circonstances, un magistrat est tenu de tirer une inférence de causalité défavorable au défendeur était au cœur de l’arrêt Benhaim c. StGermain,108 à laquelle la Cour suprême répondit par la négative, infirmant ainsi le jugement de la Cour d’appel du Québec, où les juges majoritaires en étaient arrivés à la conclusion que la juge de première instance avait erré en droit en omettant de tirer une inférence de causalité défavorable aux défendeurs.109 Plus particulièrement, et contrairement aux juges majoritaires de la Cour d’appel, la Cour suprême ne vit pas en les enseignements des arrêts Snell c. Farrell et St-Jean c. Mercier110 une exigence à ce que les juges des faits tirent une inférence de causalité défavorable à un médecin défendeur « lorsque la négligence de ce dernier compromet la possibilité du demandeur d’établir le lien de causalité, et lorsque le demandeur produit au moins [. . .] « certains » ou « très peu d’éléments de preuve affirmative » », laquelle inférence, bien qu’elle permettrait a priori de dégager le demandeur du fardeau de démontrer l’existence d’un lien causal, serait susceptible d’être repoussée par le défendeur, si ce dernier produit une preuve contraire.111 En fait, de l’avis du plus haut tribunal du pays, l’arrêt Snell c. Farrell enseigne non pas qu’une telle inférence, en pareilles circonstances, doit être tirée, mais qu’elle peut l’être, et que c’est au juge des faits qu’il revient d’évaluer si elle « est justifiée et de quelle manière elle doit être appréciée au regard de la preuve ».112 En d’autres termes, l’existence d’une telle inférence favorable au demandeur n’est pas tributaire des circonstances, mais bien de l’appréciation du juge des faits de ces dernières.

La possibilité de réclamer des dommages punitifs en sus des dommages-intérêts compensatoires En responsabilité civile, le principe de la restitution intégrale (restitution in integrum) veut que la victime soit compensée pour la perte qu’elle a subie et le gain dont elle est privée, ainsi que pour le préjudice futur lorsqu’il est susceptible d’évaluation113 et, en théorie, ne laisse guère place à l’octroi d’une compensation dépassant ce préjudice.114

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[2016] 2 R.C.S. 352. Id., par. 41. 110 [2002] 1 R.C.S. 491. 111 Benhaim c. St-Germain, préc., note 105, par. 41. 112 Id., par. 42. Voir également : Dufour c. Tanios Hanna, préc., note 5, par. 31. 113 Code civil du Québec, préc., note 4, art. 1611. 114 Béliveau St-Jacques c. Fédération des employées et employés, [1996] 2 R.C.S. 345, par. 125. 109

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Or, le législateur québécois « a cependant conféré, par le biais de certaines lois particulières à vocation sociale,115 la possibilité aux tribunaux d'accorder en certains cas des dommages exemplaires116 »,117 et ce malgré une persistance remarquée des tribunaux de consentir à l’introduction de ces dommages en droit civil québécois.118 Les dommages punitifs y revêtent donc un caractère d’exception119 en ce qu’ils peuvent uniquement être accordés lorsque la loi le prévoit,120 conformément à l’article 1621 C.c.Q.,121 et n’ont, par ailleurs, guère pour fonction d’indemniser la victime, revêtant plutôt une fonction punitive, préventive et de dissuasion particulière comme générale.122 Bien que les magistrats jouissent d’une grande 115

Parmi ces lois, voir notamment: Charte des droits et libertés de la personne, RLRQ c. C-12, art. 49 al. 2; Code civil du Québec, préc., note 4, art. 1899 al. 2, 1902 al. 2 et 1968 al. 2; Code de procédure civile, RLRQ c. C-25.01, art. 54 al.1 et 532; Loi sur l’accès aux documents des organismes publics et sur la protection des renseignements personnels, RLRQ c. A-2.1, art. 167; Loi sur la protection des arbres, RLRQ c. P-37, art. 1; Loi sur la protection du consommateur, RLRQ c. P-40.1, art. 272; Loi sur la régie du logement, RLRQ c. R-8.1, art. 54.10; Loi sur les arrangements préalables de services funéraires et de sépulture, RLRQ c. A-23.001, art. 56; Loi sur les décrets de convention collective, RLRQ c. D-2, art. 31. 116 Nous préférons l’expression « dommages punitifs » à celle des « dommages-intérêts punitifs », dans la mesure où les intérêts sur l’indemnité ne remplissent guère ce rôle, ou encore à celle des « dommages exemplaires », puisque cette dernière ne fut pas retenue par le législateur. Voir à ce sujet : BAUDOUIN J-L, DESLAURIERS P et MOORE B, préc., note 55, no 1-373, EYB2014RES37 (La référence). 117 Béliveau St-Jacques c. Fédération des employées et employés, préc., note 114, par. 125. 118 En 1955, la Cour suprême notait qu’« il est depuis longtemps établi que le droit civil de Québec ne connaît pas les dommages punitifs ou exemplaires » : Chaput c. Romain, [1955] R.C.S. 834, 841. Voir également : Duhaime v. Talbot (1937), 64 B.R. 386, 391; Goyer v. Duquette (1937), 61 B.R. 503, 512. 119 À cet égard, il y a convergence entre le droit civil québécois et la common law, où après deux cent cinquante (250) ans d’histoire, ces dommages sont toujours accordés à titre exceptionnel : Markarian c. Marchés mondiaux CIBC inc., 2006 QCCS 3314, par. 582. 120 de Montigny c. Brossard (Succession), [2010] 3 R.C.S. 64, par. 48. À cet égard, il y a divergence entre le droit civil québécois et la common law, où de tels dommages peuvent être octroyés dans les situations où la partie demanderesse parvient à démontrer que la partie défenderesse eut une conduite « malveillante, opprimante et abusive [qui] choque le sens de dignité de la cour » : Richard c. Time Inc., [2012] 1 R.C.S. 265, par. 149. 121 Cette disposition se lit comme suit : « 1621. Lorsque la loi prévoit l’attribution de dommages-intérêts punitifs, ceux-ci ne peuvent excéder, en valeur, ce qui est suffisant pour assurer leur fonction préventive. Ils s’apprécient en tenant compte de toutes les circonstances appropriées, notamment de la gravité de la faute du débiteur, de sa situation patrimoniale ou de l’étendue de la réparation à laquelle il est déjà tenu envers le créancier, ainsi que, le cas échéant, du fait que la prise en charge du paiement réparateur est, en tout ou en partie, assumée par un tiers. » 122

Hill c. Église de scientologie de Toronto, [1995] 2 R.C.S. 1130, par. 196; Québec (Curateur public) c. Syndicat national des employés de l’hôpital St-Ferdinand, [1996] 3 R.C.S. 211, par. 119, 127 et 131; Whiten c. Pilot Insurance Co., [2002] 1 R.C.S. 595, par. 36, 43, 68, 151 et 155; de Montigny c. Brossard (Succession), préc., note 121, par. 47, 49 et 53; Cinar Corporation c. Robinson, préc., note 80, par. 136.

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discrétion dans leur évaluation, le législateur leur impose néanmoins, au second alinéa de l’article 1621 C.c.Q., la prise en considération de certains critères à l’occasion d’un tel exercice, soit « la gravité de la faute du débiteur, de sa situation patrimoniale ou de l’étendue de la réparation à laquelle il est déjà tenu envers le créancier, ainsi que, le cas échéant, du fait que la prise en charge du paiement réparateur est, en tout ou en partie, assumée par un tiers. » À cet égard, il faut dire que l’introduction des dommages punitifs en droit civil québécois, en partie attribuable à l’influence des juridictions de common law canadienne, s’est heurtée à une résistance marquée en jurisprudence préalablement à leur introduction par le législateur québécois. À titre d’exemple, appelée à se prononcer sur la question en 1955 dans l’arrêt Chaput c. Romain,123 la Cour suprême en vint à la conclusion que la « la loi civile ne punit jamais l’auteur d’un délit ou d’un quasi-délit; elle accorde une compensation à la victime pour le tort qui lui a été causé », estimant que la punition relève « exclusivement du ressort des tribunaux correctionnels ».124 Ainsi, le plus haut tribunal du pays refusa de reconnaître que le principe de la restitution intégrale au cœur de la dimension compensatoire de la responsabilité aurait pu laisser quelque place que ce soit à l’octroi d’une compensation supérieure au gain manqué et/ou à la perte subie par le créancier,125 traduisant ainsi un refus catégorique d’introduire les dommages-intérêts punitifs en droit québécois. Parmi les lois prévoyant expressément un recours en dommages punitifs, on retrouve la Loi sur la protection des arbres,126 le Code de procédure civile127 et la Charte des droits et libertés de la personne (ci-après désignée « Charte »),128 une législation à caractère quasi constitutionnel reconnue en tant qu’ « instrument de protection des droits de la personne »,129 qui prévoit la possibilité de réclamer des dommages punitifs au second alinéa de son article 49 en cas d’atteinte illicite et intentionnelle130 à un droit ou une liberté qui y soit protégé, comme le droit à

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[1955] R.C.S. 834. Id., 841; Béliveau St-Jacques c. Fédération des employées et employés, préc., note 114, par. 125. 125 Béliveau St-Jacques c. Fédération des employées et employés, préc., note 114, par. 125. 126 RLRQ c P-37. Voir l’article 1 de cette loi. 127 RLRQ c C-25.01. Voir l’article 54 de cette loi. 128 RLRQ c. C-12. 129 Augustus c. Gosset, [1996] 3 R.C.S. 268, par. 77. 130 « En conséquence, il y aura atteinte illicite et intentionnelle au sens du second alinéa de l'art. 49 de la Charte lorsque l'auteur de l’atteinte illicite a un état d’esprit qui dénote un désir, une volonté de causer les conséquences de sa conduite fautive ou encore s’il agit en toute connaissance des conséquences, immédiates et naturelles ou au moins extrêmement probables, que cette conduite engendrera. Ce critère est moins strict que l'intention particulière, mais dépasse, toutefois, la simple négligence. Ainsi, l’insouciance dont fait preuve un individu quant aux conséquences de ses actes fautifs, si déréglée et téméraire soit-elle, ne satisfera pas, à elle seule, à ce critère » : Québec (Curateur public) c. Syndicat national des employés de l'hôpital St-Ferdinand, préc., note 123, par. 121. 124

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l’intégrité131 ou le droit à la dignité,132 par exemple. Concernant le caractère illicite d’une atteinte à un droit ou à une liberté consacré par la Charte, l’évaluation de ce critère appelle nécessairement à une analyse théorique du ou des droit(s) auquel il fut porté atteinte, les critères légaux, jurisprudentiels et doctrinaux pouvant permettre de conclure à une telle atteinte variant d’un droit à un autre. Par exemple, si l’on pourra notamment conclure à une atteinte illicite à l’article 6 de la Charte en présence d’une atteinte illicite et intentionnelle au droit d’auteur prévu à la Loi sur le droit d’auteur,133 la conclusion d’une atteinte illicite au droit à l’intégrité de la personne prévu à l’article premier de la Charte appellera notamment à une analyse des répercussions des actes commis par le défendeur, tout en considérant que la notion d’intégrité englobe à la fois l’intégrité psychologique, sociale, morale et physique et que l’atteinte doit être « plus que fugace » dans le cas d’une atteinte non physique à ce droit.134 Quant à l’intentionnalité de l’atteinte au sens de l’article 49 de la Charte, elle s’entend non pas d’une volonté de commettre l’acte à la source de l’atteinte illicite, mais bien de la volonté de causer les conséquences de cet acte.135 En effet, la désormais célèbre formulation explicative du critère de l’intentionnalité au sens du second alinéa de l’article 49 de la Charte de la Cour suprême dans l’arrêt Québec (Curateur public) c. Syndicat national des employés de l'hôpital St-Ferdinand136 est on ne peut plus claire à cet égard : En conséquence, il y aura atteinte illicite et intentionnelle au sens du second alinéa de l'art. 49 de la Charte lorsque l'auteur de l’atteinte illicite a un état d’esprit qui dénote un désir, une volonté de causer les conséquences de sa conduite fautive ou encore s’il agit en toute connaissance des conséquences, immédiates et naturelles ou au moins extrêmement probables, que cette conduite engendrera. Ce critère est moins strict que l'intention particulière, mais dépasse, toutefois, la simple négligence. Ainsi, l’insouciance dont fait preuve un individu quant aux conséquences de ses actes fautifs, si déréglée et téméraire soit-elle, ne satisfera pas, à elle seule, à ce critère.137

En ce que ce passage offre des balises importantes et toujours actuelles pour interpréter le second alinéa de l’article 49 de la Charte, quoiqu’aux contours sensiblement poreux, il convient de nous y pencher brièvement. D’abord, il en appert que les atteintes relevant de la simple négligence ou de l’insouciance ne sont pas dans la mire du second alinéa de l’article 49 de la Charte, alors que les atteintes intentionnelles se trouvant au moins à mi-chemin entre l’intention particulière et la négligence ou l’insouciance sans pour autant relever de ces deux 131

Charte des droits et libertés de la personne, préc., note 116, art. 1. Id., art. 4. 133 L.R.C., 1985, ch. C-42. Voir notamment : Construction Denis Desjardins inc. c. Jeanson, 2010 QCCA 1287, par. 46-48; Bell Helicopter Textron Canada Limitée c. Eurocopter, société par actions simplifiée, [2013] FCJ No 1043 (QL), par. 166; Gagné c. Faguy, 2015 QCCQ 11832 (Division des petites créances), par. 61. 134 de Montigny c. Brossard (Succession), préc., note 121, par. 67. 135 Id., par. 68; Augustus c. Gosset, préc., note 130, par. 77-78. 136 [1996] 3 R.C.S. 211. 137 Id., par. 121. 132

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dernières le sont. Qui plus est, il ressort de la lecture de ce passage que le critère de l’intentionnalité au sens du second alinéa de l’article 49 de la Charte comporte à la fois un volet objectif et subjectif.138 En effet, suivant la formulation suggérée par la Cour suprême, il est possible d’arriver à la conclusion qu’une atteinte illicite à un droit ou liberté protégé par la Charte est intentionnelle dans deux cas, soit lorsque l’auteur de l’atteinte illicite « agit en toute connaissance des conséquences, immédiates et naturelles ou au moins extrêmement probables, que cette conduite engendrera » ou lorsqu’il « a un état d’esprit qui dénote un désir, une volonté de causer les conséquences de sa conduite fautive ».139 Le premier cas représente le volet objectif de l’analyse du critère de l’intentionnalité, dans la mesure où il « invite [. . .] à évaluer si une personne raisonnable, placée dans la même situation que l’auteur de la violation, aurait pu prévoir l’ "extrême probabilité" des conséquences fâcheuses subies par la victime », alors que le second constitue le volet subjectif, et ce, en ce qu’il appelle « à adopter la perspective de l’auteur de la violation pour déterminer s’il voulait les conséquences de sa conduite ».140 En outre, nous sommes d’avis que la précision apportée par la Cour suprême, à ce que ce critère soit « moins strict que l’intention particulière », milite en faveur d’une telle lecture du paragraphe 121 de l’arrêt St-Ferdinand. Enfin, aux fins d’en arriver à conclure à l’intentionnalité de l’atteinte, il est à noter que la magistrature peut employer à sa guise l’un ou l’autre de ces volets (objectif ou subjectif),141 liberté de choix qui nous apparaît conforme à la permissivité de l’approche qui s’impose lorsque vient le temps d’interpréter le critère de l’atteinte illicite et intentionnelle du second alinéa de l’article 49 de la Charte et à l’emploi du terme « ou » au paragraphe 121 de l’arrêt St-Ferdinand. En responsabilité civile médicale et hospitalière, il appert toutefois de la jurisprudence que les cas où des médecins ou des hôpitaux furent condamnés à de tels dommages s’avèrent marginaux,142 bien que la possibilité demeure. Le plus souvent, afin de tenter d’obtenir un montant à titre de dommages punitifs, les victimes de fautes médicales et hospitalières prendront appui sur la Charte, les lois statutaires applicables en matière médicale et hospitalière ne prévoyant pas de recours en dommages punitifs pour des cas de figure spécifiquement circonscrits à ce domaine. 138

Construction Val-d’Or ltée c. Gestion LRO (1997) inc., 2006 QCCA 16, par. 23; BRUNELLE C et SAMSON M (2017) La mise en œuvre des droits et libertés en vertu de la Charte québécoise. Dans : Droit public et administratif, Collection de droit 2017-2018, École du Barreau du Québec, vol. 8, 2017, EYB2017CDD168 (La référence). 139 Québec (Curateur public) c. Syndicat national des employés de l'hôpital St-Ferdinand, préc., note 123, par. 121. 140 BRUNELLE C et SAMSON M, préc., note 139, EYB2017CDD168 (La référence). 141 Voir notamment en jurisprudence, à titre illustratif : Cinar Corporation c. Robinson, préc., note 80, par. 119; Construction Val-d’Or ltée c. Gestion LRO (1997) inc., préc., note 130, par. 23-25; Lafferty, Harwood & Partners c. Parizeau, 2003 CanLII 32941 (QC CA), par. 65; Wood c. ComerTech America Inc., J.E. 2004-53 (C.S.), par. 84; Corriveau c. Canoe inc., 2010 QCCS 3396, par. 103-104; Laforest c. Collins, 2012 QCCS 3078, par. 80-81 et 150-151; Menkhour c. Couture, préc., note 94, par. 107; Commission des droits de la personne et des droits de la jeunesse c. D.L., 2007 QCTDP 23, par. 84. 142 Voir notamment : Jagura-Parent c. Dvorkin, ès qualités "Médecin", REJB 1999-11075 (C.Q.).

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LE RECOURS AUX MODES ALTERNATIFS DE RÉSOLUTION DES CONFLITS COMME ALTERNATIVE À LA VOIE JUDICIAIRE ET L’OPPORTUNTIÉ D’IMPLANTER UN RÉGIME D’INDEMNISATION DES VICTIMES SANS ÉGARD À LA FAUTE EN MATIÈRE MÉDICALE Dans la présente section, nous examinerons la possibilité en droit québécois, pour les parties à un litige en responsabilité civile médicale ou hospitalière de recourir à un mode alternatif de résolution des conflits (3.1), puis formulerons quelques remarques concernant les difficultés auxquelles font face les demandeurs partis à de tels litiges de même que sur l’opportunité, au regard de ces dernières, d’implanter un régime d’indemnisation des victimes d’erreurs médicales sans égard à la faute (3.2).

La possibilité de recourir à un mode alternatif de résolution des conflits comme alternative à la voie judiciaire L’accès à la justice au Québec143 et la consécration de la priorisation des modes alternatifs de résolution des conflits à l’occasion de l’adoption du nouveau Code de procédure civile La problématique persistante de l’accès à la justice au Québec et certaines initiatives entreprises afin d’y pallier L’accessibilité à la justice est un défi bien connu des sociétés démocratiques.144 Pendant plusieurs années, divers acteurs du milieu juridique sonnèrent l’alarme et proposèrent l’instigation de réformes visant à accroître l’accès à la justice : au Québec par exemple, l’auteure Michelle Thériault notait que « dès 1990, le Rapport Macdonald recommandait à la communauté juridique du Québec de considérer le recours au tribunal comme un recours ultime et de favoriser une plus grande

143 Bien que l’action collective ne fasse guère l’objet du présent texte, nous reconnaissons qu’il s’agit d’un véhicule procédural permettant d’élargir l’accessibilité à la justice. 144 Voir notamment : BACHAND F (2015) Les principes généraux de la justice civile et le nouveau Code de procédure civile. 61:2 R.D. McGill 447; CAPPELLETTI M et GARTH B (1978) Access to justice. Florence, Éditions Sijthoff and Noordhoff; DESCHAMPS M. (2009) L'accès à la justice, l'affaire de chacun. 50 C. de D. 247; LACOURSIÈRE M (2008) Le consommateur et l'accès à la justice. 49 C. de D. 97; LAFOND P-C (2012) L’accès à la justice civile au Québec – Portrait général. Cowansville, Éditions Yvon Blais; McLACHLIN B (2016) Accès à la justice et marginalisation : l'aspect humain de l'accès à la justice. 57 C. de D. 341; SANTORIENOS, A-M (2012) L'accès à la justice en matière de droits de la personne : le difficile accès au tribunal des droits de la personne. 42 R.D.U.S. 49.

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utilisation des modes alternatifs de règlement des litiges. »145 En 2001, le Comité de révision de la procédure civile, présidé par le professeur Denis Ferland, recommanda dans son rapport (le « Rapport Ferland ») un changement de culture judiciaire et, à l’instar du Rapport Macdonald, de favoriser le recours aux modes extrajudiciaires de résolution des conflits.146 Malgré une réforme de la procédure civile québécoise en 2003 inspirée de ce rapport,147 Me François Rolland, ex-juge en chef à la Cour supérieure, faisait état en 2006 d’une désertion de la classe moyenne des tribunaux de droit commun dont les seules exceptions confirmant la règle sont les dossiers en matière familiale, comme en attesterait notamment la baisse des dossiers ouverts à la Cour supérieure de 54% entre 1990 et 2005,148 et y alla d’une mise en garde en affirmant que dans la mesure où « la plupart des dossiers civils ouverts devant la Cour supérieure [. . .] le sont par des sociétés et non par des individus [. . .], à plus ou moins brève échéance, un dossier civil entre deux personnes physiques sera une rareté ».149 Face à cette problématique, les ordres professionnels ainsi que certaines associations auraient d’ailleurs « formé des milliers de médiateurs et d’arbitres au cours des dernières années. »150

La réforme de la procédure civile et le nouveau Code de procédure civile de 2016 Il y a quelques années, le législateur semble avoir pris acte de cette réalité et fait le pari de résoudre, à tout le moins en partie, cette problématique par l’instigation d’une réforme dont l’un des piliers serait l’implantation d’une nouvelle culture judiciaire fondée sur la justice participative.151 C’est dans cette perspective que le 20 février 2014, l’Assemblée nationale du Québec adopta à l’unanimité la Loi instituant le

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THÉRIAULT M (2015) Le défi du passage vers la nouvelle culture juridique de la justice participative. 74 R. du B. 1, 6, citant avec approbation MINISTÈRE DE LA JUSTICE DU QUÉBEC (1991) Jalons pour une plus grande accessibilité à la justice, Sainte-Foy, Ministère de la justice du Québec. 146 MINISTÈRE DE LA JUSTICE DU QUÉBEC (2001) Rapport du Comité de révision sur la procédure civile: Une nouvelle culture judiciaire, Québec, Ministère de la justice du Québec. 147 Cette réforme, pour l’essentiel, invita les juges « à jouer un rôle plus actif en matière de conciliation entre les parties, notamment par la voie de la conférence de règlement à l’amiable », laquelle fut, à cette occasion, formellement intégrée au Code : LAFOND P-C (2015) Introduction. Dans : Lafond P-C (dir.), Régler autrement les différends, Montréal, LexisNexis Canada Inc., no 0-5, p. 3. 148 ROLLAND F (1er mai 2006) L’accès à la justice : 3 ans après la réforme de la procédure civile. Canadian Forum on Civil Justice, en ligne : CFCJ , p. 8-9. 149 Id., p. 7-8. 150 LAFOND P-C, préc., note 147, no 0-8, p. 4. 151 LAFOND P-C, préc., note 144, p. 193. Voir également : PICHÉ C (2017) Le "dialogue" des parties et la vérité plurielle comme nouveau paradigme de la procédure civile québécoise. 62:3 R.D. McGill 901.

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nouveau Code de procédure civile,152 qui consacre cette réforme de la procédure civile québécoise. À l’occasion du dépôt de son projet de loi, l’ancien ministre de la Justice, Me Bertrand Saint-Arnaud, avait d’ailleurs lui-même affirmé, par cette initiative, vouloir « insuffler un changement de culture chez tous les intervenants du système judiciaire. »153 Ce changement de culture juridique transparaît particulièrement en matière de règlement des conflits:154 en effet, et comme le relate l’auteure Michelle Thériault, l’un des nouveaux principes directeurs encadrant les modes alternatifs de résolution des conflits est que le procès s’avère désormais l’« un des modes à envisager parmi d’autres [. . .] qui ne doit être choisi qu’en dernier ressort, après seulement avoir considéré les autres modes de règlement des différends. »155 Ce nouveau principe directeur nous apparaît d’ailleurs une initiative cohérente avec les nombreuses réitérations de la Cour suprême du Canada quant à « l’importance cruciale du privilège relatif aux règlements lorsqu’il s’agit de favoriser le règlement des différends et d’améliorer l’accès à la justice. »156 Traitant du nouvel article premier du Code de procédure civile, l’honorable Robert Legris, J.C.S., affirmait que cette disposition, en ce qu’elle définit ce que sont les MARC et privilégie leur recours, vient « confirmer et étendre l’évolution jurisprudentielle dont témoignent les 35 dernières années. »157

Le rôle des MARC en droit civil québécois As-tu mis le projet de protocole entre McCarthy et certains cabinets? Je te le joins dans le message où j’envoie le texte.

Les principaux MARC et la diversité des options proposée par le législateur Ainsi, depuis le 1er janvier 2016, le Code de procédure civile accorde une place de premier plan aux modes alternatifs de résolution des conflits (« MARC »).158 Le

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LQ 2014, c. 1. THÉRIAULT M, préc., note 145, 19. 154 Id., 7; LAFOND P-C, préc., note 147, no 0-46, p. 20. 155 THÉRIAULT M, préc., note 145, 20. 156 Union Carbide Canada Inc. c. Bombardier Inc., [2014] 1 R.C.S. 800, par. 1. Voir également : Seidel c. TELUS Communications Inc., [2011] 1 R.C.S. 531 (dissidence des juges LeBel et Deschamps); Sable Offshore Energy Inc. c. Ameron International Corp., [2013] 2 R.C.S. 623; Hryniak c. Mauldin, [2014] 1 R.C.S. 87, par. 1-5. 157 Service d'impartition Industrielle inc. c. Glencore Canada inc., 2016 QCCS 4300, par. 7. 158 Gestion PMOD inc. c. 9e Bit (2015) inc. (9218-9216 Québec inc.), 2017 QCCS 2542, par. 20. 153

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législateur québécois y qualifie la médiation,159 l’arbitrage160 et la négociation161 comme étant les principaux de ces modes162 et prévoit même des dispositions encadrant de manière spécifique l’arbitrage163 et la médiation.164 Il est loisible aux parties de recourir à tout autre mode qui leur convient,165 ces dernières pouvant ainsi choisir, par exemple, de plutôt procéder par voie de partenariat préventif (partnering),166 ou encore de choisir le droit collaboratif comme mode de résolution de leur conflit,167 quoique ces modes ne fassent pas l’objet d’un encadrement

159 Sur la médiation en droit québécois, voir notamment : DE KOVACHICH H (2006) La médiation privée et la conciliation judiciaire. Dans : Développements récents en justice participative : la diversification de la pratique de l’avocat, Service de la formation continue, Barreau du Québec, 2006, Cowansville, Éditions Yvon Blais, EYB2006DEV1253 (La référence); LAFOND P-C et THÉRIAULT M (2015), La médiation. Dans : Lafond P-C (dir.) Régler autrement les différends, Montréal, LexisNexis, pp. 49 et s.; LATULIPPE G (2012) La médiation judiciaire : un nouvel exercice de justice. Cowansville, Éditions Yvon Blais; McCONOMY R (1996) La portée et les limites de la confidentialité des séances en médiation. Dans : Développements récents en médiation, Service de la formation permanente, Barreau du Québec, Cowansville, Éditions Yvon Blais, EYB1996DEV1036 (La référence); ROY S, SCHNEEBALG A et GALTON E (2005), La médiation : préparer, représenter, participer. Cowansville, Éditions Yvon Blais; ST-PIERRE M (2015) La médiation. Dans : Précis de procédure civile du Québec, Volume 2 (Art. 302-320, 345-777 C.p. c.), 5e édition, Cowansville, Éditions Yvon Blais, EYB2015PPC157 (La référence). 160 Sur l’arbitrage en droit québécois, voir notamment : BACHAND F (2001) Assujettissement d’un tribunal arbitral conventionnel au pouvoir de surveillance et de contrôle de la Cour supérieure et contrôle judiciaire d’ordonnances de procédure rendues par les arbitres. 35 R.J.T. 465; F. GAUTHIER D (1997) Survol de l'ensemble du processus d'arbitrage en matière civile et commerciale. Dans : Développements récents en arbitrage civil et commercial, Service de la formation permanente du Barreau du Québec; HOGUE M-J et ROY V (2015) L’arbitrage conventionnel. Dans : Lafond P-C (dir.), Régler autrement les différends, Montréal, LexisNexis, pp. 85 et s.; MARQUIS L (1990) La compétence arbitrale : une place au soleil ou à l’ombre du pouvoir judiciaire. 21 R.D.U.S. 303; MARQUIS L (1993) Le droit français et le droit québécois de l’arbitrage conventionnel. Dans : H. GLENN P, Droit québécois et droit français : communauté, autonomie et concordance, Cowansville, Éditions Yvon Blais. 161 Sur la négociation en droit québécois, voir notamment : ROBERGE J-F (2011), La justice participative. Changer le milieu juridique par une approche intégrative de règlement des différends. Cowansville, Éditions Yvon Blais, pp. 259 et s.; ROBERGE J-F et FRASER V (2015) La négociation. Dans : Lafond P-C (dir.) Régler autrement les différends, Montréal, LexisNexis, pp. 27 et s. 162 Code de procédure civile, préc., note 115, art. 1 al. 2. 163 Id., art. 620-655. 164 Id., art. 605-615. 165 Id., art. 1 al. 2. 166 Pour en savoir plus sur le partenariat préventif, voir notamment : GUAY N (1997) Vers l’avenir. Une nouvelle forme de résolution des conflits : la prévention par le « partnering ». Dans : Baudouin J-L (dir.) Médiation et modes alternatifs de règlement des conflits, Cowansville, Éditions Yvon Blais; RÉGIS C (2015) Le partenariat préventif (le partnering). Dans : Lafond P-C (dir.), Régler autrement les différends, Montréal, LexisNexis, pp. 139 et s. 167 Pour en savoir plus sur le droit collaboratif, voir notamment : CHARTRAND D (2010) Le droit collaboratif : un processus innovateur au Québec. Dans : Du droit de l’enfant à l’intérêt de la famille séparée, Colloque sur la justice familiale, Cowansville, Éditions Yvon Blais; CROTEAU N (2015)

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particulier au Code de procédure civile, exception faite des articles 1 à 7 de cette législation, qui édictent des règles d’application générale à tous les MARC, quels qu’ils soient. Dans le domaine de la responsabilité médicale et hospitalière spécifiquement, forts de cette grande latitude dont jouissent les parties dans la détermination du déroulement de leurs procédés extrajudiciaires, il est de plus en plus fréquent que les avocat(e)s, tant en demande qu’en défense, s’attablent pour tenter de parvenir à un règlement, allant parfois jusqu’à fixer avec précision les différentes étapes du processus de résolution du conflit, les modalités de ces dernières et les délais impartis aux parties afin de compléter leurs devoirs respectifs dans le cadre du processus. Enfin, et avant d’analyser plus amplement ces dispositions, ajoutons que si le législateur encadre parfois de manière particulière le recours à un ou plusieurs MARC dans certaines matières spécifiques, comme en matière familiale (médiation familiale)168 ou en matière d’accidents du travail et de maladies professionnelles (processus de conciliation),169 tel n’est pas le cas du droit de la responsabilité médicale. Les parties à un tel recours peuvent – ou plutôt, et comme nous le verrons ci-après, doivent – néanmoins considérer l’opportunité de recourir à un tel mode. Finalement, il n’existe pas, à l’heure actuelle, de projet pilote en responsabilité médicale, comme c’est notamment le cas en droit de la consommation par exemple où, « depuis le 15 mai 2015, un projet pilote de médiation obligatoire dans les dossiers de consommation soumis à la division des petites créances de la Cour du Québec [était] en cours pour une durée de trois ans dans les districts de Gatineau et de Terrebonne. »170

Le droit collaboratif. Dans : Lafond P-C (dir.) Régler autrement les différends, Montréal, LexisNexis, pp. 121 et s.; SHEA M et CLAIRMONT S (2006) Le droit collaboratif : la diversification de la pratique. Dans : Développements récents en justice participative : la diversification de la pratique de l’avocat, Service de la formation continue, Barreau du Québec, Cowansville, Éditions Yvon Blais, EYB2006DEV1254 (La référence). 168 Code de procédure civile, préc., note 115, art. 616 à 619. Voir également : Règlement sur la médiation familiale, RLRQ c. C-25.01, r. 0.7. Sur la médiation familiale en droit québécois, voir également : BEAUMIER F (2017) La médiation familiale. Dans : Collection de droit 2017-2018, École du Barreau du Québec, volume 4, Personnes, famille et successions, Cowansville, Éditions Yvon Blais, EYB2017CDD46 (La référence); BELLEAU M-C (2015) La médiation familiale au Québec : une approche volontaire, globale, interdisciplinaire et accessible. Dans : Lafond P-C (dir.) Régler autrement les différends, Montréal, LexisNexis, pp. 205 et s.; LAMBERT D et BÉRUBÉ L (2016) La médiation familiale, Étape par étape. Guide du médiateur. 3e édition, Markham, LexisNexis Canada Inc. 169 LAFOND P-C et THÉRIAULT M, préc., note 159, p. 64. 170 Id., no 2-31, p. 60, citant avec approbation Règlement établissant un projet pilote de médiation obligatoire pour le recouvrement des petites créances découlant d’un contrat de consommation, RLRQ, c. C-25.01, r. 1. Pour plus d’informations, voir le site du ministère de la Justice du Québec, en ligne : .

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Le choix de recourir à un mode alternatif de résolution des conflits et de ses modalités : un exercice coopératif impliquant préalablement une obligation de considérer le recours aux MARC Quel que soit le MARC envisagé, il importe de préciser que le recours à un tel mode est volontaire : en effet, si les parties ont chacune une obligation d’envisager cette option,171 c’est ultimement d’un commun accord qu’elles doivent convenir de s’en prévaloir ou non, ainsi que du choix du mode en question, le recours à un tel mode consistant ainsi en principe en une possibilité fondée sur le libre arbitre, la bonne foi172 et la coopération des parties.173 De même, et si le mode choisi par les parties implique la participation d’un (ou plusieurs, selon le cas) tiers pour les assister dans la recherche d’une solution, c’est ensemble que les parties le choisiront.174 Le cas échéant, ce tiers devra « être en mesure d’agir avec impartialité et diligence et de le faire selon les exigences de la bonne foi », mais s’il agit bénévolement, le champ d’application de cette exigence s’en retrouve considérablement réduit, dans la mesure où il n’aura alors « d’autre responsabilité que celle qui découle d’une faute lourde ou intentionnelle. »175 De plus, les parties peuvent également, avec le tiers qu’elles ont choisi ensemble le cas échéant, convenir de la procédure applicable au mode qu’elles ont choisi.176 Enfin, elles partagent les coûts de cette procédure.177 Ceci dit, l’obligation de considérer le recours aux MARC, qualifiée de « levier significatif de la réforme visant à faire évoluer la culture juridique »178 et qui s’impose aux parties en vertu du troisième alinéa de l’article premier du Code de procédure civile, mérite que l’on s’y attarde plus amplement. Bien que cette mesure atteste d’une volonté du législateur d’instaurer un changement de culture en

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Code de procédure civile, préc., note 115, art. 1 al. 3. Rappelons qu’en droit civil québécois, la bonne foi se présume et l’obligation d’agir de bonne foi s’impose en tout temps : Code civil du Québec, préc., note 4, art. 6, 7, 1375 et 2805. 173 Code de procédure civile, préc., note 115, art. 2 al. 1. 174 Id., art. 3 al. 1. 175 Id., art. 3 al. 2. Le législateur québécois définit la faute lourde comme celle « qui dénote une insouciance, une imprudence ou une négligence grossières » : Code civil du Québec, préc., note 4, art. 1474 al. 1. Sur la faute intentionnelle et la faute lourde, voir notamment : Peracomo Inc. c. Société TELUS Communications, [2014] 1 R.C.S. 621, par. 95; BAUDOUIN J-L, DESLAURIERS P et MOORE B, préc., note 55, nos 1-187 et s., EYB2014RES19 (La référence); BAUDOUIN J-L et JOBIN P-G (2013) Les obligations. 7e édition, par P.-G. Jobin et N. Vézina, Cowansville, Éditions Yvon Blais, no 870, EYB2013OBL129 (La référence); LACROIX M (2013) La relativité aquilienne en droit de la responsabilité civile -- analyse comparée des systèmes germanique, canadien et québécois. 59 : 2 R.D. McGill 425. 176 Code de procédure civile, préc., note 115, art. 6. Conformément à cette disposition, si les parties choisissent la médiation ou l’arbitrage comme mode, les règles procédurales du livre VII du Code de procédure civile s’appliqueront de manière supplétive. 177 Id., art. 2 al. 1. 178 ROBERGE J-F, AXEL-LUC HOUNTOHOTEGBÈ S. et GRAHOVIC E. (2015) L'article 1er du Nouveau Code de procédure civile du Québec et l'obligation de considérer les modes de PRD : des recommandations pour réussir un changement de culture. 49 RJTUM 487, no 16. 172

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imposant la considération de la voie extrajudiciaire, on peut douter de son efficacité, cette obligation en étant une de stricte considération. En effet, il appert des commentaires de la ministre de la Justice que la volonté du législateur n’est pas de rendre cette obligation contraignante « au point de rendre irrecevable l’action en justice qui n’aurait pas été précédée d’une tentative de règlement », mais qu’elle devrait néanmoins, de par son caractère impératif, initier « un changement important dans le rôle des juristes qui devraient désormais présenter à leurs clients un ensemble de possibilités pour la résolution des conflits. »179 Ainsi, le législateur semble faire le pari de prioriser l’autonomisme sur l’assujettissement en ce qui concerne le recours aux MARC afin d’instiguer son changement de culture. Néanmoins, cette obligation étant de droit nouveau, il convient de nous pencher sur l’interprétation qu’en ont faite les tribunaux depuis son entrée en vigueur le 1er janvier 2016. D’abord, cette obligation fut qualifiée non pas de résultat, mais de moyens.180 Suivant cette qualification, les parties seraient donc tenues de prendre les moyens raisonnables requis pour considérer l’opportunité de recourir à ces modes. En ce qui concerne sa portée, la professeure Catherine Piché, à l’aube de l’entrée en vigueur du nouveau Code, écrivait que cette obligation impliquerait vraisemblablement que les parties aient « envisagé par un examen attentif l'éventualité d'un règlement à l'amiable » et identifié « – chacune – leurs intérêts et discuté de l'opportunité et de la possibilité de régler le différend ».181 Cette perspective de l’étendue de cette obligation apparaît d’ailleurs cohérente avec l’exigence prévue au Code de procédure civile à ce que les parties exposent dans leur protocole d’instance « la considération qu’elles ont porté à recourir aux modes privés de prévention et de règlement des différends ».182 En effet, il nous apparaît difficilement concevable qu’elles puissent avoir dûment satisfait à cette exigence sans avoir préalablement examiné de manière attentive l’opportunité de recourir à un tel mode. La jurisprudence vient d’ailleurs appuyer cette conception de l’obligation de considération, les tribunaux ayant reconnu qu’elle « sous-entend la communication de l’information pertinente, et ce, avant même d’entamer le recours judiciaire. »183

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MINISTÈRE DE LA JUSTICE DU QUÉBEC (2015) Commentaires de la ministre de la Justice. Code de procédure civile, chapitre C-25.01, Montréal, Wilson & Lafleur, art. 1, p. 19. Pour une illustration pratique de cette perspective, voir : Pharmacie Frédéric Lahoud (avenue Cartier) inc. c. Petit, 2017 QCCS 368, par. 13-14. 180 Duclos c. 9157-4863 Québec inc. (Perez International), 2017 QCCQ 14807, par. 27. 181 PICHÉ C (2014) Droit judiciaire privé, 2e édition, Montréal, Éditions Thémis, p. 33. Voir également : CHAMBERLAND L (2014) Le nouveau Code de procédure civile commenté. Cowansville, Éditions Yvon Blais, p. 3; M. THÉRIAULT, préc., note 145, 20. 182 Code de procédure civile, préc., note 115, art. 148. 183 Envac Systèmes Canada inc. c. Montréal (Ville de), 2016 QCCS 1931, par. 24, à la note de bas de page no 15; Société immobilière GP inc. c. Therrien, 2017 QCCQ 8033, par. 33.

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Il appert également de la jurisprudence que les magistrats s’en tiennent souvent à réitérer l’existence et l’importance de cette obligation en notre droit,184 dans certains cas possiblement dans l’optique d’encourager les parties à résoudre leur litige avant l’audience sur le fond,185 bien qu’il arrive, au-delà de la simple réitération, qu’ils fassent preuve de plus de fermeté. Dans l’arrêt Droit de la famille — 172765,186 la Cour d’appel, soulignant la déférence dont elle doit faire preuve par rapport à l’appréciation de la preuve par la juge de première instance,187 affirme littéralement que si un litige subsiste sur la question de la prise en charge de frais particuliers, « les parties devront soumettre leur différend à un juge de la Cour supérieure après avoir « considéré le recours au mode privé de prévention et de règlement de leur différend ». »188 Ici, l’emploi du verbe « devoir » par la Cour d’appel contraste avec la simple réitération de l’existence de cette obligation au Code de procédure civile en ce qu’il revêt les allures d’un commandement à s’y conformer plutôt que d’une simple suggestion. Il arrive aussi que les magistrats expriment leur déception face à l’ampleur des frais de toutes sortes que les parties ont investies dans un dossier et saisissent ces occasions pour exprimer leur accord avec les règles édictées aux nouvelles dispositions du Code de procédure civile « visant à inciter les parties à un litige à tenter de régler rapidement par mode privée de prévention et de règlement des différends ou par la conciliation judiciaire [. . .], et ce, de façon sérieuse et prioritaire ».189 À l’inverse, les tribunaux ne manquent pas de saluer les tentatives des parties de régler au préalable leur conflit avant de considérer le recours aux tribunaux, et de souligner la conformité de tels comportements au nouveau cadre de la procédure civile privilégiant « le recours à un mode privé de règlement, la transparence et la recherche de solution ».190 Enfin, le recours au MARC lui-même peut revêtir une pertinence d’un point de vue pratique pour les tribunaux à des fins d’interprétation du droit. Dans l’affaire Droit de la famille — 161657191 par exemple, l’honorable Suzanne Gagné, J.C.S., conclut que le recours à la médiation dans les circonstances marqua « le début de la « vie séparée », comme l’aurait fait l’introduction de l’instance en divorce si les parties n’avaient pas choisi de recourir à ce mode privé de prévention et de règlement des

Voir notamment : Droit de la famille — 161435, 2016 QCCA 1034, par. 12-13; Bourque c. Dattilo, 2017 QCCA 161, par. 4; Droit de la famille — 161657, 2016 QCCS 3211, par. 33; 9302-7654 Québec inc. (Team Productions) c. Bieber, 2017 QCCS 1100, par. 38; Houle c. Lafontaine, 2017 QCCS 3036, par. 63. 185 Voir notamment : Droit de la famille — 161161, 2016 QCCS 2283, par. 66 et 71. 186 2017 QCCA 1844. 187 Id., par. 186. 188 Id., par. 187. 189 Harvey c. Langlois, 2017 QCCS 2639, par. 158 (requête pour permission d’appeler rejetée : 2017 QCCA 942). 190 St-Denis c. Ferme Éric Sépul, 2018 QCCS 744, par. 32. 191 2016 QCCS 3211. 184

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différends. »192 Plus encore, la Cour supérieure a déjà rejeté une demande d’exemption à la médiation sur la base du troisième alinéa de l’article premier.193 Finalement, malgré les limites de cette obligation de considération, il est intéressant d’observer que les tribunaux tiennent compte des « objectifs de « changement de culture », d’accès à la justice dans des délais plus courts et à coûts moindres, de qualité de la justice civile et d’application juste, simple, proportionnée et économique de la procédure » visés par le législateur dans l’analyse de certaines demandes, notamment celles en irrecevabilité.194

Le recours à un mode alternatif de résolution des conflits implique une obligation de confidentialité Le Code de procédure civile prévoit également que les parties qui désirent prévenir ou régler un différend par un MARC, de même que le tiers qu’elles ont choisi pour les assister le cas échéant, s’engagent par le fait même « à préserver la confidentialité de ce qui est dit, écrit ou fait ans le cours du processus, sous réserve de leur entente sur le sujet ou des dispositions particulières de la loi. »195 Le tiers assistant les parties en est cependant exempté s’il fournit de l’information « à des fins de recherche, d’enseignement, de statistiques ou d’évaluation générale du processus de prévention et de règlement des différends ou de ses résultats », mais doit néanmoins, malgré cette exception, maintenir la confidentialité de tout renseignement personnel.196

Le recours à un mode alternatif de résolution des conflits n’emporte pas renonciation à agir en justice Enfin, le Code de procédure civile, à son article 7, précise que « la participation à un mode privé de prévention et de règlement des différends autre que l’arbitrage n’emporte pas la renonciation au droit d’agir en justice », ce qui ne fait cependant pas obstruction à ce que les parties, d’un commun accord, puissent s’engager à ne pas exercer ce droit au cours du processus, à moins que cela ne soit nécessaire pour la préservation de leurs droits.197 Finalement, les parties peuvent également « convenir de renoncer à la prescription acquise et au bénéfice du temps écoulé pour celle

192

Id., par. 32. Dans ce cas particulier, il convient de préciser que la partie à l’origine de cette demande avait déjà consentie à la médiation : Droit de la famille — 172652, 2017 QCCS 5160, par. 80-83. 194 Raymond Chabot Grant Thornton c. Directeur général des élections du Québec, 2017 QCCS 3605, par. 53 (requête pour permission d’appeler rejetée : 2017 QCCA 1490). 195 Code de procédure civile, préc., note 115, art. 4. 196 Id., art. 5. 197 Id., art. 7 al. 1. Voir également en jurisprudence : St-Denis c. Ferme Éric Sépul, préc., note 190, par. 34. 193

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commencée », ou encore, « dans un écrit qu’elles signent, de suspendre la prescription pour la durée de la procédure, sans toutefois que cette suspension n’excède six mois. »198

L’avenir de la responsabilité médicale et hospitalière en droit civil québécois : vers un régime d’indemnisation sans égard à la faute? Non seulement la responsabilité civile médicale et hospitalière québécoise présentet-elle ses défis particuliers, mais la complexité de même que la difficulté des litiges en cette matière « ne sont plus à démontrer ».199 Les demandeurs en responsabilité médicale font effectivement face à de nombreux obstacles, notamment l’ampleur des coûts afférents aux expertises qui s’avèrent nécessaires pour les fins de la démonstration de la faute200 ainsi que le refus des tribunaux de reconnaître la possibilité pour les demandeurs en cette matière de réclamer une provision pour frais d’experts.201 Par ailleurs, bien que le législateur prévoie une obligation de considérer le recours aux MARC, ce dernier, de même que, de manière incidente, la possibilité de jouir des bénéfices qui les accompagnent telle que la réduction des frais à débourser par les parties, demeure strictement volontaire. Il semble, en effet, que le législateur, plutôt que de prioriser la coercition à cet égard, ait plutôt fait le pari du volontarisme et d’en faire le fondement d’un éventuel changement de culture. Nonobstant toute considération relative à l’opportunité de ce choix, le constat demeure le même: les demandeurs en responsabilité médicale sont toujours susceptibles de n’avoir que l’arène judiciaire comme option pour résoudre leur conflit en cas de refus de la partie adverse de recourir de plein gré à un mode alternatif de résolution du conflit. Malgré l’adoption d’un nouveau Code de procédure civile, le changement de culture souhaité par cette réforme prendra un certain temps à se concrétiser. Les victimes de fautes médicales ou hospitalières pourront-elles encore se permettre d’attendre? En 2016, la très honorable Beverley McLachlin, ex-juge en chef à la Cour suprême du Canada, rappelait que la mise en place d’« un système de justice ouvert à tous, abordable et efficace est la première étape à franchir dans la poursuite de l’accès à la justice. »202 En responsabilité médicale, ces préoccupations se sont avérées la source de nombreuses réflexions quant aux manières dont l’accès à la justice pourrait être accru pour les victimes de fautes commises dans le domaine médical.

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Code de procédure civile, préc., note 115, art. 7 al. 2. M.G. c. Pinsonneault, 2018 QCCS 1439, par. 23. 200 Fiocco c. De Varennes, préc., note 8, par. 147. 201 St-Arnaud c. L. (C.), EYB 2009-152692 (C.A.), par. 29. 202 McLACHLIN B, préc., note 144, no 8. 199

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Récemment, dans l’affaire Fiocco c. De Varennes,203 l’honorable Benoît Moore, J.C.S. désormais juge à la Cour d’appel, constatant que « les interventions médicales peuvent être source de risques de préjudice sans que l’on puisse démontrer au Tribunal une faute du personnel soignant », était d’avis que la question de l’indemnisation d’un préjudice en matière médicale transcende le strict cadre de cette affaire, se posant plutôt « à l’ensemble de la société ».204 Regrettant devoir rejeté l’action de la demanderesse en l’instance sous motif qu’il doit appliquer la règle de droit fondée sur la notion de faute,205 le juge Moore appelle à une réflexion sur l’opportunité de l’implantation d’un régime d’indemnisation sans égard à la faute en matière médicale,206 tout en rappelant qu’il ne revient pas au tribunal « de juger de l’opportunité d’implanter un tel système d’indemnisation sociale. »207 À l’appui de cette suggestion, le juge Moore observe que « d’autres systèmes, comme la France ou la Nouvelle-Zélande, ont, sous des formes variables, été plus loin en prévoyant un système d’indemnisation sociétale pour les accidents thérapeutiques »,208 et rappelle qu’au Québec, non seulement le législateur a-t-il prévu dans différents domaines de tels systèmes dérogatoires au droit commun,209 notamment en matière d’actes criminels,210 d’accidents de travail211 et d’accidents d’automobile,212 mais qu’il est déjà, en matière médicale, intervenu « afin de prévoir une indemnisation, sans égard à la faute, pour le préjudice découlant d’une campagne de vaccination ».213 Cette décision créa une véritable onde de choc chez les théoriciens du droit.214 En réaction à ce jugement de la Cour supérieure, les professeurs Marie-Ève Arbour, Vincent Caron et Daniel Gardner, dans une lettre d’opinion cosignée par une quarantaine d’avocat(e)s215 et juristes invitant le gouvernement du Québec « de prendre acte des invitations constantes à changer des choses et penser autrement

203

2017 QCCS 5042. Id., par. 126. 205 Id., par. 125. 206 Id., par. 129. 207 Id. 208 Id., par. 128. 209 Comme le soulignait d’ailleurs la Cour suprême du Canada en 2017, de tels régimes, « qui accordent, dans l’intérêt des justiciables, une forme d’immunité contre les recours civils dans le cadre de leur application », n’auraient rien d’exceptionnel au Québec, et ce en raison de leur pluralité : Godbout c. Pagé, [2017] 1 R.C.S. 283, par. 35. 210 Loi sur l'indemnisation des victimes d'actes criminels, RLRQ c. I-6. 211 Loi sur les accidents du travail et les maladies professionnelles, RLRQ c. A-3.001. 212 Loi sur l'assurance automobile, RLRQ c. A-25. 213 Fiocco c. De Varennes, préc., note 8, par. 127. 214 BOULANGER M (Janvier 2018) Commentaire sur la décision Fiocco c. De Varennes – Réflexion en profondeur ou retour vers le futur ?. Repères, EYB2018REP2388 (La référence). 215 Me Patrice Deslauriers, l’un des auteurs du présent texte, était l’un des signataires de cette lettre. 204

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l’indemnisation de l’aléa thérapeutique », rappellent que « toutes les solutions doivent être envisagées »:216 parmi celles-ci, les auteurs relèvent notamment l’implantation d’un système de no-fault, démarche qui « s’inscrirait dans le cadre plus large d’un projet de gestion des risques qui considère les failles de son système de santé comme des erreurs à corriger plutôt que des comportements à réprimer », ainsi qu’ « un partenariat privé public impliquant les médecins, les assureurs et le ministère de la Santé et des Services sociaux. »217 Néanmoins, et nonobstant les mérites et les défauts de l’une et l’autre de ces options, les auteurs soutiennent que l’important est de tenir un débat sur la question.218 Par ailleurs, et comme ces derniers le signalent, les préoccupations exprimées par le juge Moore, et beaucoup d’autres avant lui, ne datent pas d’hier : par exemple, en 1990, l’honorable François Tôth, J.C.S., proposait l’implantation, en matière médicale, d’un système d’indemnisation des victimes sans égard à la faute.219 Commentant cette décision, l’auteur Marc Boulanger estime pour sa part que le remplacement du système actuel au profit d’un système d’indemnisation des victimes sans égard à la faute pourrait se révéler une pente glissante, invoquant notamment les lacunes des systèmes de la Nouvelle-Zélande et de la Suède à cet égard, de même que les problématiques d’ordre pratique auxquelles sont couramment confrontés les demandeurs relativement à leurs réclamations, notamment en raison du grand nombre de réclamations dont est submergé le Tribunal administratif du Québec en matière d’accidents d’automobiles et d’accidents de travail.220

Conclusion En somme, et comme nous avons pu le constater, bien que la responsabilité médicale et hospitalière soit, en principe, régie par les principes généraux de la responsabilité civile, certains magistrats ont parfois tenté, en vain, de suggérer des ajustements à ces principes dans la perspective d’alléger le fardeau des victimes de fautes médicales et hospitalières, notamment en la proposition d’imposer aux tribunaux de tirer une inférence négative défavorable au médecin défendeur lorsque la négligence de ce dernier viendrait compromettre la possibilité pour le demandeur d’établir un lien de causalité. Ainsi, aussi passionnant ce domaine du droit se révèle-t-il d’un

216

ARBOUR M-E, CARON V et GARDNER D (12 décembre 2017) Quelle indemnisation pour les victimes d’erreurs médicales ?. La Presse+, en ligne : . 217 Id. 218 Id. 219 TÔTH F (1990) Contrat hospitalier moderne et ressources limitées : conséquences sur la responsabilité civile. 20 R.D.U.S. 313, 355. 220 BOULANGER M, préc., note 214, EYB2018REP2388 (La référence).

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point de vue théorique, autant, d’un point de vue pratique, la plupart des victimes de fautes médicales et hospitalières ne peuvent partager ce sentiment face aux diverses embuches qui pavent leurs chemins respectifs dans leur quête de justice. La réforme de la procédure civile du législateur s’avère, certes, un pas dans la bonne direction, mais encore faut-il que cette louable réforme soit accompagnée des réflexions collectives appropriées et qu’il en résulte un changement de culture concret. Ainsi, à quoi bon exiger la prise en considération du recours aux MARC si la dimension compromissoire sous-jacente aux règlements hors cour revêt une connotation négative aux yeux d’avocats d’expérience? À notre avis, nonobstant les nombreux bienfaits pratiques des MARC pour les justiciables, leur préconisation doit nécessairement s’accompagner d’une rigoureuse éducation de masse des praticiens, à défaut de quoi cette réforme ne pourrait s’avérer qu’un malheureux coup d’épée dans l’eau, ou à tout le moins faire obstacle à une éclosion du véritable potentiel des MARC à grande échelle. Les nombreuses autres solutions proposées en doctrine et en jurisprudence méritent également réflexion, mais, aussi intéressantes soient-elles, devront nécessairement être le fait du législateur. À l’instar des auteurs Arbour, Caron et Gardner, et des nombreux autres juristes qui ont signé leur lettre ouverte au lendemain de l’affaire Fiocco c. De Varennes, nous sommes d’avis qu’il est temps que ce dernier entame une réflexion en bonne et due forme sur la question.

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M.G. c. Pinsonneault, 2017 QCCA 607; Droit de la famille — 161435, 2016 QCCA 1034; Fortier c. Québec (Procureure générale), 2015 QCCA 1426; Marcheterre c. Fédération (La), compagnie d'assurances du Canada, 2014 QCCA 1026; Promutuel Bagot, société mutuelle d'assurances générales c. Boutique du foyer de Saint-Hyacinthe inc., 2014 QCCA 1314; Audet c. Transamerica Life Canada, 2012 QCCA 1746; Fortier c. Lavoie, 2012 QCCA 754; Hébert c. Centre hospitalier affilié universitaire de Québec – Hôpital de l’Enfant-Jésus, 2011 QCCA 1521; P.L. c. J.L., 2011 QCCA 1233; Compagnie de chemin de fer du littoral nord de Québec et du Labrador inc. c. Sodexho Québec ltée, 2010 QCCA 2408; Construction Denis Desjardins inc. c. Jeanson, 2010 QCCA 1287; Michaud c. Équipements ESF inc., 2010 QCCA 2350; St-Arnaud c. L. (C.), EYB 2009-152692 (C.A.); Hamel c. J.C., 2008 QCCA 1889; Leduc c. Soccio, 2007 QCCA 209; Matagami (Ville de) c. Cliche, 2007 QCCA 406; Construction Val-d’Or ltée c. Gestion LRO (1997) inc., 2006 QCCA 16; Leblond c. Dionne, 2006 QCCA 341; Desrosiers c. Centre hippique de la Mauricie inc., REJB 2004-65900 (C.A.); Accessoires d'Auto Vipa Inc. c. Therrien, 2003 CanLII 47988 (QC CA); Lafferty, Harwood & Partners c. Parizeau, 2003 CanLII 32941 (QC CA); Allendale Mutual Insurance Co. c. Hydro-Québec, [2002] R.J.Q. 84 (C.A.); Brochu c. Camden-Bourgault, [2001] R.R.A. 295 (C.A.); Hôpital de l'Enfant-Jésus c. Camden-Bourgault, REJB 2001-23496 (C.A.); Montambault c. Hôpital Maisonneuve-Rosemont, REJB 2001-23081 (C.A.); Ali c. Cie d'assurance Guardian du Canada, [1999] R.R.A. 427 (C.A); Compagnie d’assurances Continental du Canada c. 136500 Canada inc., [1998] R.R.A. 707 (C.A.); Havre des Femmes Inc. c. Dubé, REJB 1998-04273 (C.A.); Hôpital de Chicoutimi c. Battikha, [1997] R.J.Q. 2121 (C.A.); Labrecque c. Hôpital du St-Sacrement, REJB 1996-65658 (C.A.); Vigneault c. Mathieu, EYB 1991-63618 (C.A.); Caisse populaire de Charlesbourg c. Michaud, EYB 1990-63500 (C.A.); Lapointe c. Hôpital Le Gardeur, REJB 1989-59049 (C.A.) (inf. quant à la responsabilité du médecin par [1992] 1 R.C.S. 351); Chouinard c. Landry, EYB 1987-62641 (C.A.); Cinepix c. J.K. Walkden Ltd., [1980] C.A. 283; Lafrance c. Hôpital St-Luc, EYB 1980-138561 (C.A.); Hôpital général de la région de l'amiante Inc. c. Perron, [1979] C.A. 567; Mellen c. Nelligan, 1957 CanLII 221 (QC CA); Apponi c. CHUM Hôpital Notre-Dame, 2019 QCCS 329; Dufour c. Roy, 2019 QCCS 770; M.J.R. c. Girard, 2019 QCCS 1937 (en appel); Robitaille c. Picard, 2019 QCCS 1285; Dufour c. Tanios Hanna, 2018 QCCS 4434; Frias Da Costa c. Billick, 2018 QCCS 1248; Manoukian c. Procureur général du Canada, 2018 QCCS 30; 2020 QCCA 1486; M.G. c. Pinsonneault, 2018 QCCS 1439; Royal et Sun Alliance du Canada, société d'assurances c. Coté (Masteraph Fabrication), 2018 QCCS 613;

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St-Denis c. Ferme Éric Sépul, 2018 QCCS 744; Topliceanu c. Bojanowski, 2018 QCCS 658; 9302-7654 Québec inc. (Team Productions) c. Bieber, 2017 QCCS 1100; Abou-Jaoudé c. Université Laval, 2017 QCCS 1936; Arsenault c. Roy, 2017 QCCS 5554; Boulenger c. Landry, 2017 QCCS 3769; Droit de la famille — 172652, 2017 QCCS 5160; Duchesne c. Lévesque, 2017 QCCS 2692; Dussault c. Conseil d'administration du centre hospitalier Jean-Talon et du CSSS du Coeur-del'Île, 2017 QCCS 3208; Émond c. Lebrun, 2017 QCCS 2988; Fiocco c. De Varennes, 2017 QCCS 5042; Gestion PMOD inc. c. 9e Bit (2015) inc. (9218-9216 Québec inc.), 2017 QCCS 2542; Harvey c. Langlois, 2017 QCCS 2639; Houle c. Lafontaine, 2017 QCCS 3036; Labelle c. Bérard, 2017 QCCS 3983; Pharmacie Frédéric Lahoud (avenue Cartier) inc. c. Petit, 2017 QCCS 368; Raymond Chabot Grant Thornton c. Directeur général des élections du Québec, 2017 QCCS 3605; Simms Sigal & Co. Ltd. c. Costco Wholesale Canada Ltd., 2017 QCCS 5058; 2020 QCCA 1331; S.M. c. G.G., 2017 QCCS 2716; 2019 QCCA 853; Tremblay c. Centre de santé et de services sociaux Maria-Chapdelaine, 2017 QCCS 1727; Bilodeau c. Ferland, 2016 QCCS 1520; Chabot c. Québec (Procureure générale), 2016 QCCS 4306; Droit de la famille — 161161, 2016 QCCS 2283; Droit de la famille — 161657, 2016 QCCS 3211; Envac Systèmes Canada inc. c. Montréal (Ville de), 2016 QCCS 1931; Menkhour c. Couture, 2016 QCCS 1843; Roy c. Ortho Centre Québec inc., 2016 QCCS 1627; Service d'impartition Industrielle inc. c. Glencore Canada inc., 2016 QCCS 4300; Steinberg c. Mitnick, 2016 QCCS 4749; Bernard c. Letellier, 2015 QCCS 279; May c. Czyziw, 2014 QCCS 3521; Sévigny c. Filiatrault, 2014 QCCS 1667; Côté c. Duperré, 2013 QCCS 804; Couture c. Fabrique de la paroisse de Saint-Henri, 2013 QCCS 1398; Sullivan c. Aubry, 2013 QCCS 4345; Deland c. Lachance, 2012 QCCS 5848; Laforest c. Collins, 2012 QCCS 3078; Plourde c. Commission scolaire de la Capitale, 2012 QCCS 6247; Drolet c. Excavations Lambert inc., 2011 QCCS 5108; Corriveau c. Canoe inc., 2010 QCCS 3396; Gestion HC ltée Rail, 2010 QCCS 2252; E.J. c. Owen, 2009 QCCS 3842; N.T. c. 9107-3932 Québec inc., 2008 QCCS 1429; S.T. c. Dubois, 2008 QCCS 1431; Larose c. Ordre des denturologistes du Québec, 2006 QCCS 667; Markarian c. Marchés mondiaux CIBC inc., 2006 QCCS 3314; Racicot c. 2864-0928 Québec Inc., 2005 CanLII 24354 (QC CS); Therrien c. Launay, EYB 2005-86098 (C.S.) (appel rejeté sur requête, EYB 2005-92515 (C.A.)); Morin c. Centre école de parachutisme Atmosphair inc., [2004] R.R.A. 1318 (C.S.); Royal et Sun alliance du Canada, société d'assurances c. Robitaille, B.E. 2004BE-357 (C.S.); Wood c. Comer-Tech America Inc., J.E. 2004-53 (C.S.); Wilson c. 104428 Canada Inc., 2002 CanLII 24889 (QC CS);

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Bessette c. Casarcia, [2000] R.R.A. 825 (C.S.); Brasseur c. Desrosiers, 2000 CanLII 18845 (QC CS); Mainville c. Cité de la santé de Laval, [1998] R.J.Q. 2082 (C.S.); Lamarre c. Hôpital du Sacré-Cœur, EYB 1996-86833 (C.S.); Harewood c. Spanier, [1995] R.R.A. 147 (C.S.); X c. Mellen (1957), B.R. 389; Duhaime v. Talbot (1937), 64 B.R. 386; Goyer v. Duquette (1937), 61 B.R. 503; Bouchard c. Létourneau, 2019 QCCQ 1749; Duclos c. 9157-4863 Québec inc. (Perez International), 2017 QCCQ 14807; Société immobilière GP inc. c. Therrien, 2017 QCCQ 8033; Collins c. Centre hospitalier de Sept-Îles, REJB 2000-20110 (C.Q.); Jagura-Parent c. Dvorkin, ès qualités "Médecin", REJB 1999-11075 (C.Q.); Rizk c. Hôpital du Sacré-Cœur, REJB 1998-09902 (C.Q.); Routhier c. Dre Anne E. Beaudoin inc., 2019 QCCQ 4065 (Division des petites créances); Saindon c. Caouette, 2018 QCCQ 116 (Division des petites créances); 9194-0551 Québec inc. c. Lévesque Lavoie Avocats inc., 2017 QCCQ 8184 (Division des petites créances); Bergeron c. Lapointe, 2017 QCCQ 13291 (Division des petites créances); Carpentier c. Hôpital vétérinaire Eardley inc., 2017 QCCQ 10195 (Division des petites créances); Defi Élève-Toi c. Lebeau, 2017 QCCQ 9139 (Division des petites créances); Gagné c. 3887804 Canada inc., 2017 QCCQ 7403 (Division des petites créances); Lapierre c. Deschamps, 2016 QCCQ 4331 (Division des petites créances); Gagné c. Faguy, 2015 QCCQ 11832 (Division des petites créances); R.C. c. Bélanger, 2008 QCCQ 1893 (Division des petites créances); Noël-Voizard c. Centre de santé et de services sociaux de Lasalle et du Vieux-Lachine, 2007 QCCQ 5118 (Division des petites créances); Feuersenger c. Centre hospitalier St. Mary’s, [2002] R.J.Q. 3347 (C.Q.) (Division des petites créances); Béliveau c. Ciricillo, REJB 1997-01542 (C.Q.) (Division des petites créances); Commission des droits de la personne et des droits de la jeunesse c. D.L., 2007 QCTDP 23.

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Francine BEAUMIER, « La médiation familiale », dans Collection de droit 2017-2018, École du Barreau du Québec, volume 4, Personnes, famille et successions, Cowansville, Éditions Yvon Blais, 2017, EYB2017CDD46 (La référence); Marie-Claire BELLEAU, « La médiation familiale au Québec : une approche volontaire, globale, interdisciplinaire et accessible », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Alain BERNARDOT et Robert P. KOURI, La responsabilité civile médicale, Sherbrooke, Éditions R.D.U.S., 1980; Marc BOULANGER, « Commentaire sur la décision Fiocco c. De Varennes – Réflexion en profondeur ou retour vers le futur ? », Repères, janvier 2018, EYB2018REP2388 (La référence); Christian BRUNELLE et Mélanie SAMSON, « La mise en œuvre des droits et libertés en vertu de la Charte québécoise », dans Droit public et administratif, Collection de droit 2017-2018, École du Barreau du Québec, vol. 8, 2017, EYB2017CDD168 (La référence); Mauro CAPPELLETTI et Bryan GARTH, Access to justice, Florence, Éditions Sijthoff and Noordhoff, 1978; Luc CHAMBERLAND, Le nouveau Code de procédure civile commenté, Cowansville, Éditions Yvon Blais, 2014; Diane CHARTRAND, « Le droit collaboratif : un processus innovateur au Québec », dans Du droit de l’enfant à l’intérêt de la famille séparée, Colloque sur la justice familiale, Cowansville, Éditions Yvon Blais, 2010; Paul-André CRÉPEAU, « La responsabilité civile de l’établissement hospitalier en droit civil canadien », (1981) 26 McGill L.J. 673; Nathalie CROTEAU, « Le droit collaboratif », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Hélène DE KOVACHICH, « La médiation privée et la conciliation judiciaire », dans Développements récents en justice participative : la diversification de la pratique de l’avocat (2006), Service de la formation continue, Barreau du Québec, 2006, Cowansville, Éditions Yvon Blais, EYB2006DEV1253 (La référence); Luc DE LA SABLONNIÈRE et Marie-Nancy PAQUET, « La responsabilité hospitalière et l’utilisation du matériel », dans Développements récents en droit médico-légal et responsabilité des chirurgiens (2011), Service de la formation continue du Barreau du Québec, 2011, EYB2011DEV1823 (La référence); Marie DESCHAMPS, « L'accès à la justice, l'affaire de chacun », (2009) 50 C. de D. 247; Pierre DESCHAMPS, « L’obligation de moyens en matière de responsabilité médicale », (1996-97) 27 R.D.U.S. 139; Denis F. GAUTHIER, « Survol de l'ensemble du processus d'arbitrage en matière civile et commerciale », dans Développements récents en arbitrage civil et commercial (1997), Service de la formation permanente du Barreau du Québec, 1997, EYB1997DEV66 (La référence); Nicole GUAY, « Vers l’avenir. Une nouvelle forme de résolution des conflits : la prévention par le "partnering" », dans Jean-Louis BAUDOUIN (dir.), Médiation et modes alternatifs de règlement des conflits, Cowansville, Éditions Yvon Blais, 1997; Marie-Josée HOGUE et Véronique ROY, « L’arbitrage conventionnel », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Robert P. KOURI, « La responsabilité civile de l’établissement de santé en droit québécois : regards sur la contribution de Paul-André Crépeau », (2011) 41 R.D.U.S. 523; Marc LACOURSIÈRE, « Le consommateur et l'accès à la justice », (2008) 49 C. de D. 97; Mariève LACROIX, « La relativité aquilienne en droit de la responsabilité civile -- analyse comparée des systèmes germanique, canadien et québécois », (2013) 59 : 2 R.D. McGill 425; Pierre-Claude LAFOND et Michelle THÉRIAULT, « La médiation », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Pierre-Claude LAFOND, « Introduction », dans Régler autrement les différends, sous la direction de P.-C. Lafond, Montréal, LexisNexis Canada Inc., 2015;

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Pierre-Claude LAFOND, L’accès à la justice civile au Québec – Portrait général, Cowansville, Éditions Yvon Blais, 2012; Andrée LAJOIE, Patrick A. MOLINARI et Jean-Louis BAUDOUIN, « Le droit aux services de santé : légal ou contractuel ? », (1983) 43 R. du B. 675; Danielle LAMBERT et Linda BÉRUBÉ, La médiation familiale, Étape par étape. Guide du médiateur, 3e édition, Markham, LexisNexis Canada Inc., 2016; Ginette LATULIPPE, La médiation judiciaire : un nouvel exercice de justice, Cowansville, Éditions Yvon Blais, 2012; Jean-François LEROUX, « La responsabilité médicale dans le contexte de la médecine multidisciplinaire : d'une responsabilité individualisée vers une responsabilité collective », dans Développements récents en droit médico-légal et responsabilité des chirurgiens (2011), Service de la formation continue du Barreau du Québec, 2011, EYB2011DEV1821 (La référence); Louis MARQUIS, « La compétence arbitrale : une place au soleil ou à l’ombre du pouvoir judiciaire », (1990) 21 R.D.U.S. 303; Louis MARQUIS, « Le droit français et le droit québécois de l’arbitrage conventionnel », dans H. Patrick GLENN, Droit québécois et droit français : communauté, autonomie et concordance, Cowansville, Éditions Yvon Blais, 1993; Richard McCONOMY, « La portée et les limites de la confidentialité des séances en médiation », dans Développements récents en médiation (1996), Service de la formation permanente, Barreau du Québec, Cowansville, Éditions Yvon Blais, EYB1996DEV1036 (La référence); Beverley McLACHLIN, « Accès à la justice et marginalisation : l'aspect humain de l'accès à la justice », (2016) 57 C. de D. 341; MINISTÈRE DE LA JUSTICE DU QUÉBEC, Commentaires de la ministre de la Justice. Code de procédure civile, chapitre C-25.01, Montréal, Wilson & Lafleur, 2015; MINISTÈRE DE LA JUSTICE DU QUÉBEC, Rapport du Comité de révision sur la procédure civile: Une nouvelle culture judiciaire, Québec, Ministère de la justice du Québec, 2001; Suzanne PHILIPS-NOOTENS, Robert P. KOURI et Pauline LESAGE-JARJOURA, Éléments de responsabilité civile médicale – Le droit dans le quotidien de la médecine, 4e édition, Cowansville, Éditions Yvon Blais, 2016; Catherine PICHÉ, Droit judiciaire privé, 2e édition, Montréal, Éditions Thémis, 2014; Catherine PICHÉ, « Le "dialogue" des parties et la vérité plurielle comme nouveau paradigme de la procédure civile québécoise », (2017) 62:3 R.D. McGill 901; Catherine RÉGIS, « Le partenariat préventif (le partnering) », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Jean-François ROBERGE, Sèdjro AXEL-LUC HOUNTOHOTEGBÈ et Elvis GRAHOVIC, « L'article 1er du Nouveau Code de procédure civile du Québec et l'obligation de considérer les modes de PRD : des recommandations pour réussir un changement de culture », (2015) 49 RJTUM 487; Jean-François ROBERGE et Véronique FRASER, « La négociation », dans Régler autrement les différends, sous la dir. de P.-C. Lafond, Montréal, LexisNexis, 2015; Jean-François ROBERGE, La justice participative. Changer le milieu juridique par une approche intégrative de règlement des différends, Cowansville, Éditions Yvon Blais, 2011; François ROLLAND, « L’accès à la justice : 3 ans après la réforme de la procédure civile », Canadian Forum on Civil Justice (1er mai 2006), en ligne : CFCJ ; Serge ROY, Avi SCHNEEBALG et Éric GALTON, La médiation : préparer, représenter, participer, Cowansville, Éditions Yvon Blais, 2005; Anne-Marie SANTORINEOS, « L'accès à la justice en matière de droits de la personne : le difficile accès au tribunal des droits de la personne », (2012) 42 R.D.U.S. 49; Martha SHEA et Suzanne CLAIRMONT, « Le droit collaboratif : la diversification de la pratique », dans Développements récents en justice participative : la diversification de la pratique de

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l’avocat (2006), Service de la formation continue, Barreau du Québec, Cowansville, Éditions Yvon Blais, 2006, EYB2006DEV1254 (La référence); Marie ST-PIERRE, « La médiation », dans Précis de procédure civile du Québec, Volume 2 (Art. 302-320, 345-777 C.p.c.), 5e édition, Cowansville, Éditions Yvon Blais, 2015, EYB2015PPC157 (La référence); Michelle THÉRIAULT, « Le défi du passage vers la nouvelle culture juridique de la justice participative », (2015) 74 R. du B. 1; François TÔTH, « Contrat hospitalier moderne et ressources limitées : conséquences sur la responsabilité civile », (1990) 20 R.D.U.S. 313.

Chapter 5

Medical Mal Practice and Mediation in Cyprus: Mediation as a Potential Way of Resolving Medical Mal Practice Disputes Anna Plevri

Abstract The aim of the article is to focus upon situations of medical mal practice in Cyprus and to analyze mediation as a possible means of resolving those disputes. Therefore the basic principles and features of mediation as a method of alternative dispute resolution (ADR) method are presented and their application in Cyprus, especially within the contexts of bioethical disputes. Present legislative framework of mediation in Cyprus is examined and supplemented with proposal de lege ferenda. The paper focuses upon examples of using mediation in medical context in other jurisdictions, in particular Italy, Greece, United States and China.

Basic Principles, Key Features and Benefits of Mediation as an ADR Method Alternative (or amicable or appropriate) dispute resolutions methods include mediation, arbitration and negotiation.1 Mediation is a flexible, cost-effective and confidential out of court method which helps the parties to find their common ground and work towards resolving their dispute by settling and reaching an agreement without delay.2 As a form of alternative dispute resolution (ADR), mediation is the most civilized way to resolve a dispute due to the fact that unlike the adversarial methods of resolving disputes, mediation is arguably best suited to those cases where the parties genuinely wish to avoid prolonging the dispute and preserve their relationship. The powerful tool of dialogue, defines the dynamic of mediation as an ADR method. In this framework,

1

See further, Walker (2017b), pp. 15–31. On the core principles, key points and process of mediation, see Aubrey-Johnson and Curtis (2012), pp. 3–30. 2

A. Plevri (*) University of Nicosia, School of Law, Department of Law, Nicosia, Cyprus e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_5

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mediation is not just an alternative and amicable but an appropriate way to resolve a dispute related to the health service “industry”, where the conflict, the pain, the positions, the interests and specially the needs of the involved parties, have, actually, another importance. More specifically, mediation is a voluntary and confidential method/process of resolving disputes between two or more parties out of court, with the help of a third, neutral, intermediary person, the mediator, who assists the parties in negotiating and reaching a settlement they both accept.3 Furthermore, mediation could be viewed as facilitated negotiation. Mediation represents an opportunity to settle early, reducing (emotional) stress, acrimony and legal costs. At the same time, mediation is a way for the opposing parties to save time through a constructive dialogue. Regarding the key features and benefits of mediation as an alternative dispute resolution method,4 these could be listed as following: 1.1 In comparison to litigation and/or arbitration, mediation is time effective. A dispute may be resolved just in some hours, since no lengthy submissions, cross examination, discovery and legal arguments are involved. This is of significant important since it is well known that “justice delayed is justice denied!” Moreover, a party is likely to agree to a lower amount of monetary compensation if this will be paid quickly. 1.2 Mediation is a voluntary process. This means that the opposing parties are the ones who decide and actually try to resolve their dispute through mediation. The outcome of mediation (if any) is commonly elaborated and agreed by the parties. Even in jurisdictions such as in England and Wales where the civil litigation rules do not make mediation mandatory, there is pressure on parties to go to mediation before going to trial. Mediation clauses are also increasingly used in commercial contracts instead or as a supplement to arbitration clause. In mediation, the parties have the power and opportunity to choose their mediator and they have control on their dispute too. Of course the parties may be compelled to go to mediation but they cannot be compelled to reach a settlement. This, would be contrary to the protection of the right to access to court and the right of a person to be heard by a court in a judicial scheme as well as to each person’s private autonomy. All these rights are of course protected by the Constitution of each state and the European Convention on Human Rights (ECHR, article 6). In mediation, the parties only settle their dispute if they want to settle.5 1.3 The outcome of a mediation is binding and enforceable for the parties according to the provisions of the national mediation legislation of each state6 and when it comes to Europe, according to the provisions of the Directive 2008/52/EC of the

3

See further, Walker (2017b), pp. 15–16, 28–30, 32–36. On the question “Why choose mediation?”, see Aubrey-Johnson and Curtis (2012), pp. 31–51. Regarding the various mediation models, see Walker (2017b), pp. 63–74. 5 Walker (2017b), p. 33. 6 Ibid, pp. 237–240. 4

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European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial disputes.7 1.4 Τhe procedure of mediation in total is confidential.8 This means that any information disclosed during mediation may not be used in subsequent arbitration or litigation proceedings (without prejudice). The element of confidentiality is crucial in all stages of the mediation process, meaning preparation, opening, exploration, negotiation and closing. This specific aspect of mediation is very important in connection with the reputation, fame, personal information, data etc. for both individuals and corporations. It is also remarkable that the advantage of confidentiality in mediation, provides to the parties the opportunity to resolve their differences in a way that will not attract negative publicity. This is of high importance in the medical mal practice area, where the involved parties have actually the chance to disclosure information in a “safe environment”. Αs a concluding remark, “confidentiality goes to the essence of the mediation process”.9 1.5 Through mediation the parties have the chance to restore and preserve their future relationships or even create opportunities of further cooperation etc. The “litigation battle” creates enemies, mediation does not. The human aspect of the conflict has its own role in the mediation procedure and it is an important element of the mediation process and settlement. In addition, in the mediation framework, the parties have the possibility to find effective solutions, tailor made to their interests and needs. This is an opportunity which is not possible in court proceedings, where specific remedies apply and there are limitations on the certain content of court’s orders. So, in comparison to litigation, sustainable monetary or not monetary solutions could arise through mediation and this is a benefit of strategic importance. As an example, a potential outcome of a mediation could be, except of course monetary compensation, the opportunity of an apology and/or an ensurement that

7

On the implementation of the Mediation Directive in the EU, see the June 27th 2017 Report on the implementation of Directive 2008/52/EC of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters (the ‘Mediation Directive’), of the Committee on Legal Affairs of the EU. Rapporteur: Kostas Chrysogonos. Available at: http:// www.europarl.europa.eu/sides/getDoc.do?pubRef¼-//EP//TEXT+REPORT+A8-2017-0238+0 +DOC+XML+V0//EN#title1, accessed April 29, 2018. The main findings of the above report, among other, are: Almost all member states opted to extend the Directive’s requirements to domestic disputes too. A number of member states allow the use of mediation in civil and commercial matters, including family and employment matters, while not explicitly excluding mediation for revenue, customs or administrative matters or for the liability of the State for acts and omissions in the exercise of State authority. All member states foresee the possibility for courts to invite the parties to use mediation. 15 member states introducing the possibility for courts to invite parties to information sessions on mediation. Less than half of the member states have introduced an obligation in their national laws to spread information about mediation. The report also noted the need of a balanced relationship between mediation and judicial proceedings. 8 See Walker (2017b), pp. 33–34, 127–130, 229–237. 9 Ibid, p. 229.

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specific procedures and practices will be changed in order to avert similar errors or adverse events from occurring again at the future. 1.6 When it comes to the cost of mediation, compared to that of litigation and/or arbitration, there is a clear advantage of mediating specially early in the timeline of a dispute.10 It is about the potential cost that one can save from an early settlement. More specifically, the parties can save enormous sums of money by mediating at the right time and help preserve a working relationship. In any case, “the cheapest lawyer is a settlement”.11 Regarding the mediator’s role,12 it should first be noted that the mediator is a third, neutral person, who tries, by using specific skills and techniques such as active listening, open questioning, positive reframing, empathy, acknowledgement of the emotions of the parties and summarizing, to help the opposing parties to reach an amicable solution and resolve their dispute in a mutually acceptable manner. The actual role and duty of the mediator is to encourage the parties of a dispute to reveal to her/him what their true interests and needs are and to share their evaluation of alternative to litigation.13 The mediator is either a judge nor an arbitrator. As a third, neutral, intermediary person, the mediator listens to potential apologies, explores possible points of settlement and realistic solutions, discusses with each party possible agreements and prioritizes the main points of the dispute and the key issues for each party. The mediator does not dictate the outcome of mediation but helps parties to develop and evaluate new options for resolving the crucial issues at hand, tailoring the solution to the specific needs of both parties, and broadening the possible outcomes. Moreover, the mediator listens to potential apologies and explores realistic solutions as possible points of settlement—areas of agreements (ZOPA),14 discusses with each party and prioritizes the key issues of the dispute for each party. Every mediator should practice of course in compliance to the fundamental rules of conduct for mediators according to the national legislation of each state (if any) and in the EU, in accordance to the European Code of Conduct for Mediators.15 The European Code of Conduct for Mediators sets out a number of principles to which individual mediators may voluntarily decide to commit themselves, under their own responsibility. It may be used by mediators involved in all kinds of mediation in civil and commercial matters.

10 This is very important for jurisdictions-legal systems where medical mal practice claims are decided by jury and/or the legal costs in litigation are high. 11 Quote of unknown American. 12 See in detail, Walker (2017b), pp. 39–49, 51–58. Regarding the mediation profession, business or job, see Stephen Walker (2017a) and Walker (2016). 13 Walker (2017b), p. 229. 14 Zone of Possible Agreement. 15 Available at: http://ec.europa.eu/civiljustice/adr/adr_ec_code_conduct_en.pdf, accessed April 29, 2017.

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Legislative Framework of Mediation in Cyprus The legal system of Cyprus is connected to the history of the territory. Cyprus was a British colony until 1960. After 1974, the island is until now divided in two parts. The south part is the Republic of Cyprus, it has a Greek-Cypriot population and is a member of the European Union. The north part of the island is the part where the Turkish-Cypriots live and is not a member of the European Union. While the paper refers to the legal order of the Republic of Cyprus, it must be stated that Cyprus is a state with a mixed legal system16 and not a pure common law jurisdiction. The major parts of the law, though, belong to the tradition of the common law. Mediation has been introduced in Cyprus by the (applicable) Mediation on Civil Disputes Law 159 (I) of 2012,17 which governs the mediation process.18 By this law, the Cypriot legislation has been harmonized with the Mediation Directive 2008/52/ EC19 of the European Parliament and of the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters. The theoretical influence of the “Anglo-Saxon mediation” is more or less present in the model of mediation in European countries,20 especially when it comes to communication techniques and psychology elements in training, principle of confidentiality in the procedure and the fact that the final solution-outcome of mediation should be reached by the parties. The provisions of the above law are applicable to certain aspects of civil and commercial disputes, whether cross-border or not, as well as to cross-border labour disputes. According to the provisions of the Mediation Law, mediation is regulated in Cyprus21 as an alternative, voluntary, out of court, confidential and cost effective dispute resolution method. According to the legislation, there are certain prerequisites for the official registration of mediators to the Mediation Registry of the Ministry of Justice and Public Order, which include necessary mediation training, etc. A register of mediators has been created under the supervision of the Cypriot Ministry of Justice and Public Order, and a number of mediation training courses are taking place in Cyprus on a frequent basis. 16

See Hatzimihail (2013), p. 1, http://digitalcommons.law.lsu.edu/jcls/vol6/iss1/3, accessed October 31, 2017. 17 Available at https://www.uv.es/medarb/observatorio/leyes-mediacion/europa-resto/cyprus-media tion-in-civil-matters-2012.pdf, accessed October 31, 2017. 18 See in detail, Plevri (2018), pp. 233–258. 19 A v a i l a b l e a t h t t p : / / e u r - l e x . e u r o p a . e u / L e x U r i S e r v / L e x U r i S e r v . d o ? u r i ¼O J : L:2008:136:0003:0008:En:PDF, accessed October 31, 2017. See Plevri (2018), pp. 238–240. 20 For a short summary of mediation in China, where there is a millennial tradition in mediation, 4 kinds of procedures and 800,000 centers of mediation, see Tang (2014). 21 Article 2 of Law 159 (I)/2012: ““mediation” means a structured process, however named or referred to, whereby two or more parties to a dispute attempt by themselves, on a voluntary basis, to reach an agreement on the settlement of their dispute with the assistance of a mediator. Provided that, it excludes any attempt that may be made by the Court or judge seized to settle a dispute in the course of judicial proceedings concerning the dispute in question”.

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Mediation in Cyprus is just “a six years old child still trying to make its first steps” in a culture where there is no tradition on mediation even though other types of ADR such as arbitration, are often in practice especially in commercial and construction disputes. In this framework, the current actual mediation practice in Cyprus is moving slowly even though this method of ADR could actually resolve many disputes, in a jurisdiction where a period of time from 3 to 8 years approximately is usually needed in order to achieve a final and enforceable court’s decision in civil and/or commercial disputes because of the large caseload that is overwhelming the courts. As a result, this is causing substantial delays to the administration of justice. Despite the above described reality of the justice system in Cyprus, parties have not yet turned actually to ADR. At this point, the findings of a very recent report on the Functional Review of the Courts System in Cyprus, conducted and delivered by the Institute of Public Administration of Ireland, dated March 27 of 201822 are very enlightening. In the above report it is stated that: (i) “Serious deficiencies with the operations of the courts system highlighted in previous reports e.g. Erotocritou Report (Report of the Supreme Court on operational needs of the courts, 2016)”, (ii) “Comparative EU studies e.g. EU Justice Scoreboard, show that while Cyprus scores relatively highly on judicial independence, it scores poorly on measures of efficiency e.g. length of time for case to be processed through the courts, and measures of quality e.g. information available to the public”. Furthermore, in the content of the report is emphasized that the key challenges of the system are: (i) “Problem of delay in the system is chronic, and the backlog of cases is growing year by year”, (ii) “Average waiting time for hearing of an appeal at the Supreme Court was 6.3 years at end- 2016, with 4300 cases pending at the end of that year”, (iii) “In the past 10 years the number of civil and criminal appeals filed has increased by over 90%”, (iv) “In District Courts the main area of delay is with Civil Cases, where the backlog is increasing year by year”. In addition, in the above report it is noted regarding the delays in Cypriot justice, that there are “serious implications of the delays for reputation, business and investment, and rule of law” and there is “little use of alternative dispute resolution”. As a result it is explicitly stated in the report that “to continue with the current system without major reform is not an option”. It is very important that among the recommendations of the report, especially on the area of ADR, there is a proposal of “introduce ADR mechanisms in consumer disputes and injuries assessments, and consider making recourse to these a requirement prior to recourse to court” and “amend Rules of Court to support mediation, particularly to be encouraged where settlement is a likely outcome”.

22

Available at: http://www.supremecourt.gov.cy/Judicial/SC.nsf/All/ F8C912FFF71E0020C225825D0038F145/$file/Functional%20Review%20of%20Courts%20Sys tem%20of%20Cyprus%20IPA%20Ireland_Final%20Report%20March%202018.pdf, accessed April 29, 2018.

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The provisions of the Cypriot Mediation on Civil Disputes Law 159(I) of 2012, are applicable to certain aspects of civil23 and commercial disputes, whether crossborder or not, as well as to cross-border labor disputes.24 This law is not applicable to family disputes as it is explicitly defined in article 2 of the law regarding its scope. The wording of the above law is wide enough to capture the whole spectrum of commercial disputes as well as every kind of civil dispute such as those caused out of civil liability because of medical mal practice. Moreover, the mediation law does not apply to any dispute in which the parties have no freedom to determine pursuant to the applicable law, and to tax, customs, administrative disputes or disputes concerning the state’s actions or omissions. The above mediation law constitutes an attempt to regulate the mediation process by containing provisions for, among others, the creation of a register of mediators and relevant minimum requirements, mediators’ duties during the mediation process, procedural matters of the mediation process, the role of the court and the issue of the enforcement of any settlement agreement reached. Furthermore, the Financial Ombudsman of the Republic of Cyprus examines consumers’ complaints against credit institutions with a view to settling those disputes and moreover aids and cooperates with certified mediators in order to resolve financial disputes between consumers and banks pursuant to the provisions of Law 84(I)/2010 on “the establishment and operation of a single agency for the out-of-court settlement of disputes of a financial nature (financial ombudsman)”, which was enacted to implement EU Commission Recommendation 98/257/EC. According to the provisions of the Law 84(I)/2010, as amended or replaced, debt restructuring mediations are actually taking place extensively in Cyprus between consumers and banks. Online Dispute Resolution is established in Cyprus for disputes between consumers and businesses via the European Center of Consumers in Cyprus, according to the relevant European legislation, meaning the Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No. 2006/2004 and

Article 2 of Law 159 (I)/2012: “In this Law, unless the context otherwise provides- “civil dispute” means any dispute which may be an object of civil proceedings by the meaning assigned to this term by virtue of the Courts Law and includes labor disputes but does not include family disputes. “Commercial dispute” means dispute arising from a commercial transaction between undertakings or between undertakings and public authorities, as this term is interpreted by the Combating Late Payment in Commercial Transactions Law”. See in detail, Plevri (2018), pp. 243–245. 24 Article 3 of Law 159 (I)/2012: “3. – (1) Subject to the provisions of subsection (2), this Law shall be applied to civil disputes, including cross-border disputes. (2) This Law shall not apply - (a) to any civil disputes, whether cross- border or not, concerning certain rights and obligations, for which the parties are not free to decide themselves under the relevant applicable law; (b) to labor disputes which are not included in the cross-border disputes, notwithstanding if no rights and obligations are raised thereof, for which the parties are not free to decide themselves under the relevant applicable law (c) to any revenue, customs or administrative disputes, or matters relating to the liability of the state for acts or omissions in the exercise of state authority. (“acta jure imperii”). 23

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Directive 2009/22/EC (Directive on consumer ADR)25 and the Regulation (EU) No 524/2013 of the European Parliament and of the Council of 21 May 2013 on online dispute resolution for consumer disputes and amending Regulation (EC) No. 2006/ 2004 and Directive 2009/22/EC (Regulation on consumer ODR).26 Although no relevant official statistics are available, the truth is that the civil and commercial mediation practice in Cyprus today, 8 years after the enactment of the mediation law (159 (I)/2012), is an exception and mediation is not an actual part of the dispute resolution sector in civil and commercial cases.27 The existence of a mediation legislation itself is not enough in order to promote and enhance the use of mediation in practice. This is the case for Cyprus too. The local legal culture performed an indolent resistance to embracing the full benefits of the mediation process. In addition, it is notable that section 15 (1) of the Mediation Law28 provides that the court before which an action is pending may invite the parties to attend an information session on the use of mediation and the possibility of resolving the dispute via mediation. In that case, any of the parties may veto the above suggested possibility and the consent of all parties is required before the power of the court to stay proceedings for mediation to take place is exercised. The general “picture” of the relationship of the (civil) justice system and ADR in Cyprus, is characterized by the combined absence of both a court’s power to compel parties to participate in any form of ADR practice, other than arbitration and a substantive or procedural obligations on litigants to consider ADR prior to commencing proceedings. The above “absences”, are not contributing of course to the development of ADR in Cyprus and to the effective change of the local legal culture.

25 Available at http://eur-lex.europa.eu/legal-content/EN/TXT/?uri¼celex:32013L0011, accessed October 31, 2017. 26 Available at http://eur-lex.europa.eu/legal-content/EN/ALL/?uri¼celex:32013R0524, accessed October 31, 2017. 27 See in detail, Plevri (2018), pp. 245–247. 28 Article 15 of Law 159 (I)/2012: “15. -(1) A Court, before which judicial proceedings are brought, in relation to a case that falls within the scope of this Law, at any stage of the proceedings and before the issue of a decision, may (a) invite the parties to appear before it, to inform them on the use of mediation and the possibility of settlement of their dispute by using this procedure; and (b) upon a common request of all the parties or one of them, with the explicit consent of the others, when appropriate and having regard to all the circumstances of the case, postpone the judicial proceedings so that mediation can take place. (2) In the event that any of the parties does not agree to use mediation, the Court shall proceed with the judicial proceeding. (3) In the decision of the Court to postpone the judicial proceeding, issued by virtue of subsection (1) explicit reference is made to the consent of the parties and to the duration of the mediation, which may not exceed three (3) months. (4) With the completion of the time-limit set out in the Court decision, the parties shall inform the Court of the procedure followed and the result of the mediation and may, in case no agreement on the settlement is reached, ask for extension of the duration of the mediation, for a period not exceeding three (3) months. (5) The Court may, in proprio motu, or, at the request of any of the parties, interrupt the mediation procedure before the end of the time-limit provided for by virtue of this section. (6) A Court decision issued by virtue of subsection (4) or by subsection (5) is not subject to an appeal.”

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In Greece, a first important and total reform of the mediation law in civil and commercial disputes took place in January of 2018. The mediation law 4512/ 17.01.2018 has substantially amended the previous law in force (3898/2010)29 and has regulated the mediation landscape. Law 4512/2018 is no longer in force. It has been replaced by law 4640/2019 who was published on 30 November 2019, abolishing all previous (mediation) laws. In this (latest and in force now) Greek mediation law of 2019, there are provisions who introduce compulsory mediation and more specifically a mandatory initial mediation session (MIMS) in various categories of private law disputes, as a pre-trial procedural condition before the court’s hearing (condition of admissibility of the hearing). Failure to engage in a mediation “attempt” is sanctioned with inadmissibility of the hearing proceedings. First of all, the attorney at law of the claimant is required to inform the party about the possibility or the obligation to resort to mediation. Regardless of the result, a respective document signed by the party and the attorney at law must be submitted to the court, otherwise the latter will not enter into the merits of the hearing of this dispute and a reopening of the case will be ordered. One of the above categories are that of medical liability disputes and more specifically compensation claims of patients or their relatives (family members etc.) against physicians, under the condition that these claims are related to the medical practice (professional activity) of the latest. It is notable that this provision does not include medical mal practice claims on behalf of patients against hospitals or clinics, where of course mediation as an ADR method is possible but not in a mandatory scheme. The reform of mediation legislation in Greece and especially the fact that attorneys at law are compelled by the law to inform in writing their clients about mediation and promote mediation as an ADR mechanism prior to filling any sort of legal action as well as the provisions on the compulsory pre trial mediation in specific categories of disputes, aims to promote and establish mediation in the Greek legal system and that way to reduce delays in the court system. Moreover to harmonize more with the European Mediation Directive. The Greek legislator is trying actually to put in force in Greece, the “Italian mediation model” on compulsory mediation, which has shown successful results so far.30 Back to the Cypriot legal system and according to my view, the reasons for holding back the actual practice of mediation in Cyprus could be summarized as following. Firstly, there is the fact that the majority of people, businesses, companies etc. do not actually know much or even anything regarding this ADR method. This means that the levels of awareness of mediation in Cyprus are very low. In other

Law 3898/2010 titled “Mediation in civil and commercial matters” implemented in Greece the Directive 2008/52/EC of the European Parliament and the Council of 21 May 2008 on certain aspects of mediation in civil and commercial matters. Regarding the mediation landscape in Greece under law 3898/2010, see in detail, Diamantopoulos and Koumpli (2015), pp. 313–343 and Theocharis (2015). 30 See further analysis and statistics on the Italian model at Giovanni (2017). Αccessed April 29, 2018 and http://www.altalex.eu/content/civil-mediation-how-kick-start-it-italian-experience, accessed April 29, 2018. 29

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words, there is misinformation gap regarding the potential benefits mediation may confer over the litigation process in Cyprus. In addition, it has to be noted that the “attitude” of the Bar has contributed in to the above result. Solicitors should play an important role in promoting and encouraging mediation as an effective way of avoiding costly and time-consuming court cases, where there can only be one winner.31 This role could be seen as a duty of both the solicitors and attorneys at law. Moreover, filing an action to court in Cyprus in general, is not too expensive and the costs of civil litigation are not as high as they are in other jurisdictions, for example the UK or in the USA, where ADR methods are “blooming”. Thirdly, courts in Cyprus are not doing enough to promote and encourage mediation at the early stages of a dispute. Finally, the popularity of mediation in Cyprus could increase, if the mediation law would be amended in a way that a power is conferred on the court to compel parties and their legal representatives to engage in the mediation process and moreover to consider, acknowledge and embrace the full benefits of mediation as an effective dispute resolution method.

Introduction to Medical Mal Practice The Hippocrates oath contains the fundamental rule for any physician: “Do no harm”. Another related to medical mal practice ancient quote, is that of Alexander Pope according to whom: “Τo err is human, to forgive, divine”.32 One could define medical error33 and/or medical mal practice in general, as the negligent behavior of a physician in his/her medical practice meaning these cases where a medical practitioner does not act in the framework of his professional diligence. Possible causes of medical errors could be problems in medical institutes and/or hospitals, such as long working hours for juniors or juniors left alone during weekends etc.), inadequate training, aggressiveness of doctors etc. Furthermore the grounds of civil medical liability could be formulated in two categories. Firstly, there are cases where a physician attempts medical practice without the required by law, prior and informed patient consent. Secondly, cases of medical error, such as error in diagnosis, medication, surgery and medical treatment, provide the ground of civil medical liability. Medical error is defined as a negligent action or an omission on behalf of a physician, which are not in the framework of the generally accepted principles, rules and standard of medical science (de lege artis) and more specifically, the above negligent action or omission are not in the framework of the average representative of the group in which this physician belongs and thereby damages are caused to a patient.

31

See Levitt (2017), accessed October 31, 2017. The phrase comes from the poem “An Essay on Criticism”; Butt (1963), p. 160. 33 Three categories of medical errors are error of underuse, error of overuse and error of misuse. 32

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It is important of course to note, that civil medical liability differs from both the criminal liability and the disciplinary responsibility of a physician. Moreover, when a physician attempts medical practice without the required by law notice and informed consent of the patient, according to the provisions of the Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being34 there can be a case of medical mal practice and the patient may claim compensation of any damage to her/his body and/or health, which is causally linked to this medical mal practice. The legal ground of a medical error could be based either to contractual liability, on the basis of a medical treatment contract or health care obligation or to tort liability. In the civil law legal system, there are cases of double ground. It is true that medical mal practice is an area which “gives birth” to several disputes where compensation is claimed in the framework of the “litigation culture”. After filing an action claiming compensation, both parties are about to embark on a long, expensive, emotionally wrenching, highly distressed and time consuming process, which is litigation. In any case, litigation is not the only or the appropriate way to resolve medical mal practice disputes. Another alternative or even more appropriate option is medical mediation as a method of resolving disputes in the health service sector.

Medical Mal Practice in Cyprus The liability of a physician caused by medical mal practice in Cyprus is regulated as civil (tortuous and contractual), criminal (articles 210 and 236 (e) of the Cypriot Criminal Code) and disciplinary. The Cypriot legislative framework on the civil liability of physicians in the framework of their professional practice is consisted by: (i) the Law on Civil Torts (Chapter 148) (last amendment on 2012) or as is it called the “Cyprus Civil Wrongs, Chapter 148 of the Laws”,35 (ii) the Safeguarding and Protection of the Patient’s Rights Law of 2004, Law 1(I)/200536 and (iii) the Private

34 Oviedo Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, was opened for signature on 4 April 1997 in Oviedo (Spain). Available at:https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/ 164, accessed April 29, 2018. This Convention is the only international legally binding instrument on the protection of human rights in the biomedical field. The Oviedo Convention has been ratified by Cyprus on year 2002 and by Greece. on year 1998 (Law 2619/1998). See chart of signatures and ratifications at: https://rm.coe.int/inf-2017-7-rev-etat-sign-ratif-reserves/168077dd22, accessed April 29, 2018. 35 Available at: http://www.cylaw.org/nomoi/arith/CAP148.pdf (1959 edition). Accessed April 29, 2018. 36 Available at: http://www.cylaw.org/nomoi/arith/2005_1_001.pdf (in Greek). Accessed April 29, 2018.

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Hospitals (Establishment and Operation Assessment) Law of 2001 (Law 90 (I)/ 2001)37 (last amendment on 2017). The civil liability of a physician may have a contractual basis too. A breach of an oral or written contract of medical treatment, provides to the patient the right to claim compensation. The Safeguarding and Protection of the Patient’s Rights Law of 2004, Law 1(I)/ 2005, provides specific rights to patients and every right of a patient is related to a corresponding duty and/or obligation of a provider of health service (this term includes a physician, pharmacist, midwife, administrative staff connected or involved to the health service etc.). If any of these rights is violated, then there is legal ground for a compensation claim. The rights of patient according to the above law are, in summary, the following: (i) right to health care of good quality and in a uninterrupted way, (ii) right to choose a physician and health care institution, (iii) right to dignity, physical and mental integrity and safety and the right to dignified treatment in health care, (iv) right to adequate information and (v) right of consent after comprehensive medical information for example on the effects and risks of the proposed treatment. In addition, the Safeguarding and Protection of the Patient’s Rights Law of 2004 regulates the establishment in every district of the Cypriot state of a “Committee for Patients Complaints”. The Officer of the Patient’s Rights of each public hospital of Cyprus, sends patient’s complaints to the above Committee, who is in charge to inform the health provider in case of disciplinary liability. In the content of the Law on Civil Torts (Chapter 148), there are specific provision applying to medical mal practice. In more detail, according to the tradition of common law, there is the tortuous liability in case of a “battery” (article 26 of Chapter 148), where there is a medical action without the consent of the patient and the tortuous liability or because of “negligence” (article 51 of Chapter 148). In article 51 of Chapter 148, there is a list of actions and omissions which constitute “negligence” in the framework of the civil liability of a professional, a physician included. In article 55 of Chapter 148, there is a provision on the doctrine of “Res Ipsa Loquitur”, where the burden of proof goes to defendant in order to prove that there is no case of negligence on her/his behalf. In civil medical liability trial in Cyprus the rule on evidence is that of “balance of possibilities”. In Cyprus, there is a medical malpractice case if professional medical treatment has breached the rule of “standard of care’ for physicians (nurses, dentists, dermatologists, chiropractors, etc. are included) and this has resulted in injury or death. In general, the rule of ‘standard of care’ refers to the quality of medical treatment that a reasonable, careful medical practitioner should provide (average level of skill). The concept of ‘standard of care’ in Cyprus, is very similar to that of what a ‘reasonable man’ would do in a common law case in the UK. So, the measure of the duty of care owed to the patient is “the standard of the ordinary skilled man exercising and

37 Available at: http://www.cylaw.org/nomoi/indexes/2001_1_90.html (in Greek). Accessed April 29, 2018.

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professing to have that special skill”.38 In order to prove the breach of “standard of care” in the Cypriot courts, the plaintiff usually provides an expert testimony from physicians of the specialty as the defendant(s) with an in-depth knowledge on their subject in order to provide the court with subjective and justified evidence on the disputed matters. More specifically, this expert’s opinion (testimony) aims to prove, for example, that because of a lack of recovery or an unsuccessful result from surgery or because of a treatment, the “standard of care” was breached. The expert’s duty is to assist the court understand the scientific criteria required for each condition and treatment so that the court is able to reach its own conclusions on the disputed matters taking into consideration the expert’s assistance on the said matters. In Cyprus, general damages are awarded for the pain and emotional distress suffered. Special damages are awarded for the actual economic loss suffered by the patient such as loss of earnings and the expenses incurred following the damage. Special damages are more easily quantifiable, such as medical bills and related expenses for which documentation has been kept. Legal interest on the damages is also awarded. Additionally, the winning party is awarded the legal costs of the proceedings, calculated on the basis of the scale of damages sought. Regarding general damages, it should be noted that because of their sensitive nature they cannot have a definite price. The specific quantification lies absolutely at the discretion of the court, which takes each case on its own facts. Of course guidance is given by preceding case law, however the court hearing the case has the discretion to award an amount after consideration of the specific circumstances of each case (ad hoc). In general, case law of Cypriot courts suggests a steady increase in the amounts of general damages awarded. The burden of proof of any damage being on the plaintiff, so she/he is the one who has to prove that her/his harm, injury etc. is a direct result of t medical negligence. It is of course important if the plaintiff’s behavior contributed to the bad medical result. In this framework, a patient who alleges medical malpractice needs to prove four elements before a court: (a) the fact that a duty of care was owed by the physician (professional),39 (b) that this duty was breached by the physician professional, (c) that the patient suffered loss and damage and (d) that the loss and damage suffered by the patient was caused directly (direct causal link) by the conduct of the physician (professional), so an error of practice itself will not alone give rise to medical negligence. Examples of medical malpractice derived by case law, include not taking a full medical history from the patient, not paying attention to the complaints expressed by the patient, failing to take measures to further investigate the condition of a patient, failing to take into consideration that the patient did

38

Bolam v. Friern Hospital Management Committee (1957) 2 All. E. R. 118-28. Another importance case law for Cypriot Courts on the matter of the burden of proof, is that of Bolitho and others v. City Hackney Health Authority (1997) 4 Med.L.R. 381. 39 In this context, hospital authorities are liable for the malpractice of their employees or agents pursuant to their non-delegable duty of care, as the duty is not discharged simply by delegating its performance to someone else.

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not respond to the treatment initially provided, failing to use available diagnostic means, misinterpreting the examination results of a patient, etc. There is no doubt, that the medical mal practice lawsuits have been increased the last years in Cyprus, even though the number of claims is not as high as in other countries of Europe, attorneys at law are getting more interested to this area of litigation and patients are now more aware of their rights, especially because of the attention of the media on this kind of cases. Finally, it should be noted that medical mal practice trials in Cyprus are usually lengthy and costly and include costs associated with pursuing the litigation, attorneys at law and expert witness fees, deposition costs, exhibit preparation and court costs. Three cases of medical mal practice ended up to litigation in Cyprus are presented below, proving the fact of lengthy (civil) trials. Eight years were needed in the two first cases and six years in the third, in order a decision to be delivered of the District Courts of Cyprus (first instance courts). In the first case, the court action was of 2008 and the decision delivered on 15.02.2016 by the District Court of Nicosia.40 The claimant’s assertion was based on alleged medical negligence in the course of surgery performed by the defendant who was a neurosurgeon. The court decided to award 150,000 euros as general compensation eight years after the filing of the claim. In the second case, the court action was of 2008 and the decision delivered on 09.08.2016 by the District Court of Nicosia.41 The plaintiff’s claim was based on alleged medical negligence in the endoscopic discectomy procedure during which a hematoma occurred, a complication which resulted in the complete paralysis of her legs. She was immediately subjected to second surgery by the defendant because of the severity of her condition this was unsuccessful. The claimant’s situation is permanent and irreversible. Also due to this fact, the depression that had preceded the accident, was worsened. The court decided to award 200,000 euros as general compensation eight years after the filing of the claim. Finally in the third case, the court action was of 2010 and the decision delivered on 09.12.2016 by the District Court of Limassol.42 As a result of the defendant (a Cypriot clinic) and third party’s failures to diagnose the infarct suffered by the applicant and the failure to give him the appropriate treatment, the claimant suffered permanent heart disease which made her completely incapable of work. The court took into account the fact that the plaintiff had already suffered a severe acute myocardial infarction before visiting the clinic of the defendant. As well as the fact that the claimant had closed arteries without symptoms. The court decided to award 180,000 euros as general compensation six years after the filing of the claim.

40 Summary of this ruling available at Harris Kyriakides Law Firm (2017), p. 4, accessed April 29, 2018. 41 Summary of this ruling available at Harris Kyriakides Law Firm (2017), p. 28, accessed April 29, 2018. 42 Summary of this ruling available at Harris Kyriakides Law Firm (2017), p. 38, accessed April 29, 2018.

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Medical Mediation ADR methods have been introduced as an adjunct or alternative to traditional litigation. Those methods may be implemented before, during, or after litigation and include a variety of mechanisms designed to improve communication and reach resolution of disputes out of court. The fact that all these processes are taking place outside the courtroom, permits and at the same time supports the effective communication or the opportunity of effective communication for the parties. More specifically, in the framework of a mediation process parties are encouraged to communicate, to share information, to express and share positions, thoughts, emotions, interests and needs. In addition, mediation gives the parties the chance to promote collaboration, obtain information from each other and build trust.43 Medical mediation as an ADR mechanism is used, especially in countries like the UK and the USA for resolving disputes arising between doctors and patients, hospitals and patients, hospitals and health professionals, doctors, etc. with their colleagues. As “medical disputes” whose subject is indeed “appropriate” to be mediated indicatively could be: (a) cases of a misdiagnosis or a medical error in a surgery, (b) cases where there is a lack of information of the patient regarding the possible complications and risks of a certain medical act, (c) cases of performance of an inappropriate treatment, etc. In the above disputes where the patients are claiming damages from physicians and/or hospitals or clinics, the amount of compensation could be agreed by the parties, avoiding the costly and time consuming process of litigation, which as it is structured, it is certainly not appropriate to the dignity of the medical profession. In the USA, the ADR processes most commonly used in healthcare cases, due to their various characteristics are binding arbitration, mediation, mediation/arbitration, early neutral evaluation and mini-trials.44 Disputes over healthcare issues extend far beyond traditional lawsuits between patients and physicians. The complexity of many healthcare disputes, the parties desire to continue in business, and many other features of ADR methods, such as arbitration and mediation, make these processes more advantageous for healthcare parties to use than litigation.45 In the USA “landscape”, many of the contracts of the healthcare sector “do not enter the courtroom”, because they contain a mandatory arbitration clause and some of them contain a two-step mediation arbitration process.46 Medical mal practice claims may be contractual and are not always covered by insurance.

43

Fraser (2001), pp. 602–607. See, Benesch (2011), pp. 2–5 https://arbitrationlaw.com/library/why-adr-and-not-litigationhealthcare-disputes-dispute-resolution-journal-vol-66-no-3, accessed April 29, 2018. 45 See, Benesch (2011), p. 1, https://arbitrationlaw.com/library/why-adr-and-not-litigationhealthcare-disputes-dispute-resolution-journal-vol-66-no-3, accessed April 29, 2018. 46 See Benesch (2011), p. 2 https://arbitrationlaw.com/library/why-adr-and-not-litigationhealthcare-disputes-dispute-resolution-journal-vol-66-no-3, accessed April 29, 2018. 44

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The usual reaction of patients after a medical error is anger, feeling of isolation, thinking that confrontation with medical staff may lead to further injury etc. Accordingly, the reactions of family members after an adverse event are usually characterized by anger because of lack of explanations and/or because clinicians turn away from patients after the medical error, when they are most in need of help. From the perspective of the physicians, a medical mal practice event causes them fear for many things. Fear for their reputation, their career, the future and for losing license. In addition, physicians are agonizing over the harm they may have caused, they fear of the loss of colleague’s respect, issues with their self-confidence and usually they are unable to talk about their mistake. In the mediation process, the physicians have the opportunity to explain and provide information on the medical facts and the bad outcome of a medical treatment, surgery etc. but also express their frustrations with being sued. The importance of the improvement of this disrupted communication (because of the medical mal practice) is significant when it comes to the restore of the relationship between patients and physicians. Moreover, this is an outcome that gradually may help opposing parties potentially avoid or minimize the impact of lawsuits and medical mal practice claims. Mediation can actually contribute to patient’s safety due to the fact that once an event is disclosed and mediated, a more open discussion may follow. This allows health care providers such as hospitals and/or clinics etc. to learn from and reduce future medical errors. That can ultimately improve patient safety. In the light of the above, it is notable that medical mediation, offers a constructive pathway to the solution of a variety of disputes, such as medical staff problems, medical malpractice and personal injury claims. One may analyze two practical examples.47 In 1995, Rush Medical Center in Chicago, IL, developed a prototype for ADR in response to the rapid growth in legal costs and unpredictable rising jury awards in malpractice cases. The “Rush model” features a mediation agreement, mediation conferences, and, most notably, co-mediators, including a lawyer who traditionally would represent a plaintiff in a medical liability case and a lawyer who would traditionally defend these cases. In the first five years of the program, 55 cases spanning errors in medication, diagnosis, and treatment were mediated. More than 80% of the cases that underwent mediation were resolved within one year of the lawsuit being filed and within three to four hours of starting mediation. The mediated cases were resolved in half of the time in which non-mediated cases in Cook County were settled or came before a jury. Though payouts were lower, patients were willing to accept the settlement because they were compensated quickly. Another model, the “Pew Demonstration Mediation and ADR Project prototype”, was implemented in four Pennsylvania hospitals in 2002, including a large, decentralized network of urban teaching and suburban hospitals with more than 2500 staffed beds and a suburban community teaching

47 See Ong (2013), accessed April 28, 2018, http://bulletin.facs.org/2013/03/medical-mediation/, accessed April 12, 2016.

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hospital with approximately 500 beds. This model focused on equipping physicians with mediation skills by encouraging physicians to learn communication skills for disclosure conversations; providing experts to help plan, conduct, and debrief disclosure conversations; and using mediation to settle potential claims. Mediation settlements included provisions that met patient and family needs, such as ensuring that policies or procedures were changed to prevent similar errors or adverse events from occurring again. The parties were encouraged to explore both monetary and non-monetary solutions, whereas court proceedings typically result only in judgments. Although only two cases were mediated in this demonstration project, it successfully showed that the apology and change in practices to avert future errors were the most important elements of the settlements. Engaging in mediation, can send a clear message to all involved, but perhaps particularly the patient, that the complaints or claims are being taken seriously and everyone is engaged in trying to resolve the issues quickly. In addition for the clinicians, it can also be helpful to engage in a process that is confidential and away from the public eye, and for the patient to have an apology, and an offer of fair and quick compensation. It is has been already noted that medical mediation is a flexible and voluntary process. It “embraces” the interests of all involved parties, contributes significantly to the risk management of a dispute and promotes a positive image of the health care institutions and that of the medical staff too. In this framework medical can accommodate the particular dispute and reserve the relationship between the patient and the physician. It is of course important to note, that it would be in the interests of the parties involved in medical mediation, to ensure that the binding force of a settlement as an outcome of medical mediation is in the framework of the adapted insurance coverage policies against civil liability of physicians. For that reason, it is strongly advisable, the insurance company to be involved as a party in the mediation process (multi party mediation) and to be bound by any agreement reached. In the past decade, the USA healthcare system has begun to use mediation as an ADR method in order to facilitate communication between patients and physicians after an adverse medical event, to resolve medical malpractice claims, to solve problems between medical staff and of course to help family members and medical professionals make important and wrenching decisions at the end of life.48 The national debate about how to improve health care is still very active in the USA. Hospitals and healthcare providers are under increasing pressure to improve patient safety and communicate more effectively with patients and families.49 Persons involved in the health care sector are also being asked to disclose adverse events and medical errors in order to achieve reduction of the number of malpractice claims.

48 49

See in detail, Liebman (2011), accessed April 28, 2015. Hyman (2011).

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In this framework, the University of Michigan Health System is an excellent example. Since 2004, the University of Michigan Health System applies its innovative approach to medical errors, mishaps, patient safety and near-misses as well as their potential legal consequences including malpractice suits. They call it “the Michigan Model”.50 The “U-M Health System” approach to medical errors, near misses and malpractice claims includes a medical error disclosure program that a series of timely conversations, open discussion and communication with the patient and/or family members after an adverse event or medical error, an apology, the so called policy of “saying sorry”, and an offer of fair compensation. As a result, this program has substantially and steadily reduced the number of malpractice claims against the university and its liability costs. In addition, the University has instituted many changes to their clinical care based on lessons learned from patient complaints. Finally, as it is stated the approach of the “U-M Health System” could be summarized as: “Apologize and learn when we’re wrong, explain and vigorously defend when we’re right, and view court as a last resort.”. The study of the “U-M Health System” confirms that medical mediation provides the opportunity of resolving disputes related to healthcare disputes and that of improving patient safety and the quality of care. As stated above, in the scheme of medical mediation, exchanging information about adverse events and medical errors, giving an apology, and paying fair compensation are element for a possible settlement. Another important advantage and “power” of medical mediation is that a potential settlement between the parties may include monetary compensation and non monetary remedies, such as an (official) promise of making improvements to the health system. Moreover, since the whole mediation procedure and exchange of information between the parties are protected by confidentiality, the process encourages more candid and less strategic communications. In the healthcare setting, the exchange of information through mediation, provides additional benefits for the error disclosure programs. In detail, medical mediation provides to the hospital representatives and healthcare providers the ability to learn about missed or ignored information that contributed to the harm or about ways that established procedures were ignored. These (new) information could contribute to improvements of the health care system. The above argument could not apply in the litigation framework, because there is pressure of not changing medical procedures, protocol and systems during litigation based on the view that a change may be considered as an admission of liability. Moreover, a benefit of medical mediation is the fact that patients and family members can actually learn, often for the first time, exactly what happened to them or their loved ones. This can make them understand the complexities and uncertainties of medical care and the health care system in general. It is actually a way of healing for both patients and physicians which can actually lead to the repair of their

50 See https://www.uofmhealth.org/michigan-model-medical-malpractice-and-patient-safety-umhs, accessed April 28, 2016, where relevant publications and on line resources are available.

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destroyed relationship and the earlier conclusion of the dispute. Finally, litigation is more likely if patients and/or their family members feel that they have not received efficient or any answers to their questions regarding adverse events or medical errors. The comprehensive and innovative approach of the Demonstration Mediation and ADR Project in Pennsylvania under the title: “Medical Error Disclosure, Mediation Skills and Malpractice Litigation”,51 offers four important recommendations that hold potential for easing the medical liability problem while benefiting patients, physicians, and hospitals and these are: (1) Provide communication training to doctors and administrators (especially during disclosure conversations) as part of changing hospital culture from one of defensiveness to one of openness. (2) Create a “consult service” of communication experts within hospitals to help plan conversations with patients and family members and provide emotional support to health care providers involved in errors or adverse events. (3) Offer apologies when appropriate. (4) Offer early, non-evaluative mediation that brings patients or family members together with health professionals to share information and seek solutions. In two medical cases mediated in the (above) Pew Demonstration project, in both cases, the chief of medicine participated in both mediations, along with other hospital representatives. In both cases claims for wrongful death were involved. In one case, the patient, who had end-stage pulmonary disease, died after a resident inserted a subclavian central line. The patient’s widow described to the hospital’s representatives, including the chief of medicine, how she had been treated after being told of her husband’s death. The doctor who related the terrible news abandoned her and left her standing alone in the outside her husband’s room. She also complained that no one had explained to her what had happened. The chief of medicine was particularly upset at how the widow had been treated. He appeared to feel she was owed an explanation and he proceeded to explain to her what the options were for putting in the central line and the risks of each, including a nicked lung. He apologized for the outcome and explained to the widow why the placement of the central line was not negligent, but a risk of the procedure. However, he acknowledged that, in her husband’s case, it might have been better to insert the central line in the patient’s neck, rather than the chest. Finally, the case settled with the hospital’s agreement to pay monetary compensation to the widow, and a promise that they would train the medical staff how to respond to family members grieving as a result of the death of a loved one in the hospital. As an important outcome of this case, the chief of medicine implemented a new procedure for the department of medicine regarding the placement of central lines. The purpose was precisely to avoid further medical mal practice events and of course to avoid harming other patients in the future. In the second case, an elderly man on Coumadin, a blood thinner used to prevent and treat blood clots, was admitted to the emergency room the morning after a fall. The patient was initially misdiagnosed with an inflection rather than internal

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Liebman and Hyman (2005), accessed April 28, 2018.

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bleeding. Then, contrary to hospital policy, the hospital did not allow the patient’s wife to be with him during his final hours. In the mediation procedure, the widow had the chance to express her rage at the hospital for failing to give her husband proper treatment, ultimately leading to his death. The chief of medicine listened to the widow’s story, and when she was done, he apologized by acknowledging the hospital’s responsibility for the misdiagnosis. He also explained what treatments had been administered to the patient. During the mediations process, the widow expressed her feelings and she moved from rage to sadness. Ultimately she expressed gratitude for the apology. In this case as well, the hospital changed one of its procedures after the medical mediation. More specifically, the hospital instituted a new policy requiring patients on Coumadin (or another blood thinner), who are admitted to the hospital through the emergency room as the result of a fall, to be seen by a trauma surgeon. As the above projects and examples show, an apology can be very important to an “injured” party—plaintiff of a claim. Patients and their families expect an apology after a medical error or adverse event, and many physicians wish to apologize but they feel actually constrained by fear that their apology will be interpreted as an admission of liability. Mediation addresses successfully this dilemma because it is a confidential process. As a result, apologies can be given without the fear of legal consequences. Even better, a mediator experienced in communication skills can coach both parties on the matter of the apology, in order to ensure a productive and effective dialogue. Of course, conventional ways of thinking, institutional and professional cultures, as well as unjustified fear, are all barriers to realizing the full benefits of mediation. In order to overcome these barriers, hospital leaders and their attorneys at law, need to rethink how they respond when a patient is harmed by medical care having in mind that mediation can have cathartic benefits for everyone involved in the process. To realize these benefits, attention should be given to bringing not just lawyers, but also patients, family members, and especially physicians to the mediation table.

Bioethical Mediation or Mediation in Bioethics Disputes Bioethical mediation is a new approach to settling bioethical dilemmas that arise when making difficult decisions regarding “appropriate” medical care and other relevant issues and/or dilemmas. This institution is totally unknown in Cyprus, but known in recent years in both Western Europe and the United States of America. Bioethical mediation could be categorized as a form of medical mediation and is consistent with the fundamental principles of mediation, yet there are several variations, left to the special nature and uniqueness of the process. Most commonly, the dispute within this process, is moving around life or death dilemmas and cases regarding appropriate medical care to the elderly and children. Typical examples of disputes or dilemmas that could be included in this process are cases of: (a) a disagreement between parents on an abortion, especially when

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there is evidence of congenital fetal abnormalities, (b) a disagreement between parents regarding the appropriate treatment of infants or children with birth defects or severe illnesses, (c) a disagreement related to the appropriate treatment-care of older people without capacity to consent, (d) a disagreement regarding organ donation or futile therapy, (e) dilemmas regarding the end of life etc. Bioethical Mediation aims to consensual resolution of disputes between health professionals, patients and their family members, and therefore is carried out usually in a hospital by a mediator who is paid by the hospital itself. During this process, with the help of a mediator who is a specialist in bioethics, the involved parties are seeking to find an acceptable solution and that is also in line with the values and ethical principles of medicine practice.

Final Remarks: Τhe Cypriot Reality on Medical Mediation— Proposals It is well known that healthcare is undergoing change at a rapid pace. Unfortunately medical errors will keep happening as it is actually connected to the nature of medicine and part of the training of doctors. Medical technology is advancing at an unprecedented rate, while patients are gaining greater access to information and a greater awareness of their rights. In order to learn from errors we must first identify them. To the view of the author of this paper, the landscape of medical complaints should be “patient-centric”. Essentially, that kind of system requires regulation on medical advice and specific procedures regarding the medical care and medical mal practice adverse events. As its already noted, the list of the factors influencing medical malpractice trials includes patient’s dissatisfaction regarding treatment, lawyer’s attitude and the increased awareness of the public mal practice laws. In Cyprus, despite the fact of the existence of mediation legislation on civil and commercial disputes the last 6 years, the actual practice of mediation in general is unfortunately very “poor”, there is no mediation culture and the existing system of resolving malpractice is totally “litigation friendly”. The involved parties and/or professionals are not seem to be aware of mediation and its potential benefits to the health care system and there is a complete lack of information and knowledge regarding medical mediation even to physicians, hospitals, clinics, insurance companies as well as to the patients. An understanding of ADR in comparison with traditional litigation methods would actually enable physicians to choose the most appropriate mechanism of resolving disputes of the health sector. This understanding of the processes of ADR is crucial in order both physicians and medical staff to be empowered to better communicate in difficult situations and improve their strategies for resolving malpractice claims. The above understanding is something missing in both the communities of physicians and attorneys at law in Cyprus. This could be change if relevant, targeted and dynamic actions and informative projects would take place, such as

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information campaigns, proposals for medical mediation on behalf of hospitals, clinics etc., support and promotion of mediation by the Bar or even legislative initiatives such as promoting motives of the use of medical mediation or putting in force pre-trial compulsory mediation of medical mal practice disputes. The option of “compulsory mediation” as a pre-trial condition before the hearing of a mal practice claim or by court mandate is a possibility for every European legislator in the framework of a justice system and its relationship with ADR. This policy maintains that mediation is an adjunct to, not a replacement for, litigation. The success, flexibility and effectiveness of this model of mandatory mediation may be an issue in comparison to voluntary mediation and remains to be seen. In this context it is crucial that among the recommendations of the report on the Functional Review of the Courts System in Cyprus, conducted and delivered to the Cypriot Ministry of Justice and the Supreme Court by the Institute of Public Administration of Ireland on March 2018, there is a clear proposal of introducing ADR mechanisms in injuries assessments, and consider making recourse to these a requirement prior to recourse to court. In addition, the proposal of amending the Rules of Court in order to support mediation and particularly to be encouraged, where settlement is a likely outcome would be an important “step” towards the improvement of both the judicial reality and the development of mediation in Cyprus. In short, the Cypriot legislator should decide to “do the right thing” for the patients, the medical staff, and the public interest. In this context, “the court should be the last resort”, not the first, when a medical error, complication or near-miss occurs. In the context of resolving healthcare disputes and medical mal practice claims, a legislator could implement the following instruments-mechanisms: 7.1 Establishment of a procedure providing honest and direct communication between the involved parties healthcare provider and the patient, who shall have the opportunity to raise her/his concerns directly to the physician, hospital, clinic etc. The benefits of responding to a patient’s concern and resolving the dispute in a early stage and directly is of significant importance. This way, patients can highlight their concerns directly to their healthcare providers, clarify their doubts, while saving valuable time and money. 7.2 In case that direct negotiations between patients and healthcare providers did not ended in fruitful outcome, the next step should consideration of the voluntary ADR method of mediation. It is also important that fear of litigation prevents openness from doctors. In this covered out of confidentiality process, the communication and negotiation between the parties is going to be assisted, by a neutral third person, a peacemaker, the mediator. As already noted, mediation provides a confidential environment where both patients and healthcare providers can communicate freely and openly, share their perspectives with the goal of working towards a mutually agreeable and customised solution to their needs with the valuable assistance of the mediator. The mediator facilitates parties’ discussions by offering them new perspectives and help them to come up with creative and unique solutions which address everyone’s concerns, interests and need. Of course the mediator will not decide what parties should or should not do neither will decide the content of a

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compromise. Should parties choose to attend mediation, there are important conditions to meet for a successful mediation These include: (i) attendees having authority to settle the dispute; (ii) participation in good faith; and (iii) respecting the confidentiality of all matters discussed for and at mediation. The mediation “platform” is suitable for healthcare disputes because of their unique nature, the fact that these matters includes emotional tension, need of expression of feeling and may involve large quantum of claims for damages. 7.3 If the dispute is not resolved in mediation, the patient can then file for a legal action based in civil liability claiming general and/or special damages against the medical practitioner and/or the healthcare provider in court. In this case, the plaintiff should be prepared for costly and lengthy trial. If the outcome of a medical mal practice trial is successful for the plaintiff, the courts can only award damages as compensation. Finally a proposal towards the direction of reducing medical mal practice disputes could be a “pre-trial control of medical errors” or a “pre-action protocol” for medical mal practice disputes.52 Through this procedure a (flexible) committee in each hospital and/or clinic, under the auspice of the Ministries of Health and Justice could organize a system for detecting, recording and analyzing medical errors, in order not only to resolve the related disputes but to create safeguards and mechanisms to prevent more in the future. This mechanism could also involve a pre-trial investigation of complaints about medical mal practice by a special body of experts, such as “medico-legal committees”, consisted out of physicians, attorneys at law and mediators. This method could also contribute to the limitation of the “industry of medical mal practice claims” which is a reality in almost every state.

References Aubrey-Johnson K, Curtis H (2012) “Making mediation work for you” a practical handbook. Legal Action Group Benesch K (2011) Why ADR and not litigation for healthcare disputes? Healthcare Dispute Resolution Journal. https://arbitrationlaw.com/library/why-adr-and-not-litigation-healthcaredisputes-dispute-resolution-journal-vol-66-no-3 Butt J (ed) (1963) The Poems of Alexander Pope. Yale University Press Diamantopoulos G, Koumpli V (2015) Mediation: the Greek ADR journey through time. In: Esplugues C, Marquis L (eds) New developments in civil and commercial mediation. Ius comparatum - global studies in comparative law, vol 6. Springer, Cham, pp 313–343 Fraser JJ (2001) Alternative dispute resolution in medical malpractice. Pediatrics 107(3):602–607

Proposals for “Pre-action protocol” and mediation in medical mal practice claim are the content of the presentation/paper of Cypriot Judge Despo Michailidou in the framework of the 1st Scientific Conference on Medical Mal Practice in Cyprus (2011), organized by the Union of Private Hospital and Clinics of Cyprus, pp. 54–70 (67–68). Available at: http://www.cyprushospitals.org/wpcontent/uploads/2013/03/IATRIKI-AMELIA.Book_.pdf, (in Greek), accessed April 28, 2018.

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Giovanni M (2017) Civil mediation how to kick start it: the Italian experience. The relevance of training. Available at: http://www.academia.edu/35125411/ADR_Matteucci_2017.10.30_ Civil_mediation_how_to_kick-start_it_the_Italian_experience._The_relevance_of_training. Harris Kyriakides Law Firm (2017) Compensation in accident cases in Cyprus in 2016, 4th edn. https://www.harriskyriakides.law/compensations-of-cases-of-accidents-in-the-year-of-2016. html?id¼358 and https://www.harriskyriakides.law/assets/pdf_files/Translation%20EnglishCompensations%202016.pdf Hatzimihail NE (2013) Cyprus as a mixed legal system. J Civil Law Stud 6(1):37–96 Hyman CS (2011) Mediation and medical malpractice, “Why plaintiffs, hospitals and physicians should be at the table”. In: Martin L, Hyman CS (eds) The benefits of mediation and arbitration for dispute resolution in health law, 4 New York Dispute Resolution Lawyer 2, (NYSBA Summer 2011), Dispute Resolution Journal 66(3), 2011 Levitt R (October 23, 2017) Compulsory mediation edges closer after Civil Justice Council report. https://www.linkedin.com/pulse/compulsory-mediation-edges-closer-after-civil-justice-rogerlevitt/?trk¼v-feed Liebman CB (2011) Medical Malpractice Mediation: Benefits gained, Opportunities lost. Available at: https://scholarship.law.duke.edu/cgi/viewcontent.cgi?referer¼https://www.google.com/& httpsredir¼1&article¼1637&context¼lcp and https://lcp.law.duke.edu/ Liebman CB, Hyman CS (2005) Medical Error Disclosure, Mediation Skills and Malpractice Litigation, a Demonstration Project on Medical Liability funded by the Pew Charitable Trusts in Pennsylvania. Available at: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/ wwwpewtrustsorg/reports/medical_liability/liebmanreportpdf.pdf, and www.medliabilitypa.org Michailidou D (2011) Proposals for “Pre-action protocol” and mediation in medical mal practice. The 1st Scientific Conference on Medical Mal Practice in Cyprus (2011), organized by the Union of Private Hospital and Clinics of Cyprus, pp 54–70 (67–68). Available at: http://www. cyprushospitals.org/wp-content/uploads/2013/03/IATRIKI-AMELIA.Book_.pdf Ong C (2013) Medical mediation: Bringing everyone to the table. Bulletin of the American College of Surgeons, Published March 2, 2013). http://bulletin.facs.org/2013/03/medical-mediation/ Plevri A (2018) Mediation in Cyprus: theory without practice. Cyprus Rev 30(1):233–258 Roth M, Geistlinger M (eds) (2021) Yearbook of international arbitration & ADR, vol. VII, WV and DIKE, pp 209–222 Tang ZS (2014) Mediation in China. http://www.adrmaremma.it/english/tang01.pdf Theocharis D (2015) Mediation as an alternative dispute resolution method. Analysis of law 3898/ 2010. NOMIKI BIBLIOTHIKI Publishers, (in Greek) Walker S (2016) Setting up a business as a mediator. Bloomsbury Professional Walker S (2017a) FAQs for mediators. Bloomsbury Professional Walker S (2017b) Mediation advocacy: representing clients in mediation. Bloomsbury Professional

Chapter 6

Compensation for Damages in the Cases of Medical Malpractice: Estonian Perspective Dina Sõritsa and Janno Lahe

Abstract Although the patients in Estonia see the main problem of Estonian healthcare in availability of healthcare, the errors or misdiagnosis made by healthcare providers occur in Estonia as well. The result of such error or misdiagnosis might be the pecuniary and non-pecuniary damage of the patient. Therefore the question arises which are the patient’s possibilities for compensation. In this paper the compensation for damages in the cases of medical malpractice is discussed in the context of Estonian law. The paper analyses both court and extrajudicial proceedings and focuses among other issues on contractual and delictual liability of the healthcare provider, required standard of care, burden of proof and damages. The discussion of alternatives to court proceedings covers also a draft on creation of the healthcare provider’s liability insurance.

General Compensation Scheme Court Proceedings In Estonia, the overall compensation scheme for medical malpractice is organized within the court system, which aims at to ascertain the tortfeasors, their fault, and oblige them to compensate for the damages (Nõmper 2012, p. 378).1 The law treats

1

The patient may obtain some benefits also from social security system but such benefits are not aimed at the compensation of damages caused by healthcare provider.

D. Sõritsa Harju County Court, Tallinn, Estonia University of Tartu, Tartu, Estonia J. Lahe (*) University of Tartu, Tartu, Estonia e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_6

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the question of the healthcare provider’s liability and compensation for the damages likewise in public and private hospitals. In principle, the parties can solve the dispute by negotiations regarding the compensation of the damages out of court. If the negotiations are not fruitful, the patient can issue the claim against the healthcare provider to compensate for the damages in civil court proceedings.2 For the patient, this is the main method to obtain a decision subject to immediate enforcement in civil matters which is an enforcement instrument in the meaning of Code of Enforcement Procedure (CEP) § 2 (1) subsec. 1. The patient as victim may also issue a claim to compensate of the damages within criminal proceedings (Code of Criminal Procedure (CCrP) § 38 (1) subsec 2). CCrP § 381 (1) subsec. 1 enacts the victim’s right to file a civil action if the objective of the claim is to restore or remedy the well-being of the victim infringed by an act which is the object of the criminal proceedings. The main prerequisite of filing a civil action is that the factual circumstances, which are the basis for the claim, overlap in a substantial part with the facts of the criminal offence proceeded and if such claim could also be heard in civil proceedings. For the patient, the criminal proceedings is definitely an easier way to obtain the compensation, because the burden of proof regarding the factual circumstances, which are the basis for the claim lies with the prosecutor. An alternative to court proceedings are arbitration proceedings in arbitral tribunal. The main premise of settlement of dispute in arbitral tribunal is the parties’ arbitral agreement to have an arbitral tribunal resolve a dispute between them (CCP § 717 (1)). On the one hand, the arbitration proceedings are considered faster and cheaper, because the decision of the arbitral tribunal cannot be appealed. On the other hand, the decision is not predictable as there are not enough lawyers to settle the disputes regarding the healthcare provider’s liability (Nõmper and Sootak 2007, p. 146). In addition, even if the arbitral tribunal satisfies the patient’s claim, the enforcement of the decision may prove difficult if the healthcare provider does not fulfil the decision voluntarily.3

2 According to Code of Civil Procedure (hereinafter CCP) § 3 (1) the court conducts proceedings in a civil matter if a person files a claim with the court pursuant to the procedure provided by law for the protection of the person’s alleged right or interest protected by law. Estonian legal acts are available also in English: www.riigiteataja.ee. 3 According to CEP § 2 (1) subsec 6, the bailiff is authorised to fulfil the decisions of arbitral tribunals permanently operating in Estonia and decisions of another arbitral tribunals, which are declared to be subject to enforcement. CCP § 753 (1) states that a decision of an arbitral tribunal is recognised in Estonia and enforcement proceedings based on the decision of the arbitral tribunal are carried out only if the court has recognised the decision and declared the decision to be subject to enforcement. The Estonian Supreme Court has taken a standpoint that all the decisions of arbitral tribunals shall pass the court proceedings to be recognised and declared to be subject to enforcement. This is because there is no national system according to which it could be evaluated whether the arbitral tribunal is permanently operating or not. The Supreme Court’s decision 3-2-1-142-15 of 20 April 2016, para 15. Decisions of the Supreme Court of Estonia are available at www. riigikohus.ee (in Estonian).

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Limiting the Number of Medical Litigation Cases In Estonia, there seems to be no tendency or need to limit the number of medical litigation cases. In 2012, it was pointed out that the number of cases coming to court is very small in comparison to the violations identified by the expert committee on the quality of health services (Lillsaar and Sedman 2012, pp. 6–7). The scarcity of the suits at law has been explained by the parties’ preference to reach an agreement and not to argue in court. In addition, it is very difficult and expensive for the patient to prove that the treatment was substandard. It should also be noted that the damages adjudged by courts are rather modest (Nõmper 2012, pp. 377–378). The views settled in the case law as well as the amounts of compensation customarily rewarded by courts are generally taken into account in extrajudicial negotiations and agreements. Thus, claiming for the compensation in excess of the normal part of the recovery in court may not be effective. In contrast to the reduction of the number of medical litigation cases, the law does not prevent the patient from issuing the claim to the court. In these cases, there are no compulsory pre-trial proceedings. In addition, the state fee is not charged for an action or appeal to compensate for the damage caused by bodily injury or damage to health (State Fees Act § 22 (1) subsec. 12). The patient could also apply for state legal aid, if he/she is unable to pay for competent legal services due to his/her financial situation (State Fees Act § 6 (1)). However, as pointed out above, there are not enough lawyers to settle the disputes regarding the healthcare provider’s liability. Thus, the legal services offered by the state legal aid may not be sufficient to protect the patient’s rights in court. In addition, the patient will have to compensate for the costs of his/her legal services (as well as the costs incurred by the opposing party), if the court will not satisfy the claim.4 Even if the law does not provide obligatory pre-trial conditions to the patient, it is conventional prior recourse to the court to ask for a second opinion, submit an appeal to the healthcare provider and/or submit an application to the expert committee on the quality of health services. Such conduct is certainly more reasonable than immediate recourse to the courts. The limitation period for a claim of a patient concerning compensation for damage arising from the breach of contract for provision of healthcare services is 5 years as of the time when the patient becomes aware of the healthcare provider’s breach of contract and the infliction of damage (Law Of Obligations Act (LOA) § 771). The claim based on the law of delicts arising from a claim arising from causing death, a bodily injury or damage to health expires in three years (General Part of the Civil Code Act § 153 (1)). The same injury may give justification for a new civil

CCP § 190 (1) and (2). However, the court may release a person from the obligation to pay procedural expenses into the state revenues with good reason, inter alia due to settlement of a matter by compromise. 4

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action if e.g. the patient’s health deteriorates or the damage increases and the patient claims for the damages that he or she has not claimed before.5

The Normative Basis for HealthCare Providers Liability Contractual Liability In Estonia, the contract for provision of healthcare services is regulated in 41st chapter of the LOA.6 The general prerequisites for contractual liability (LOA § 770 (1) and (2)) is the breach of obligation by the health-care provider, the damage caused to the patient, the healthcare provider’s fault (only in case of liability under LOA § 770 (1)) and the causal link between the breach of obligation and the damage. Thus, in the case of liability arising from the breach of contract it should be determined that the healthcare provider has breached the obligation culpably (LOA § 770 (1)). The Estonian Supreme Court has explained that if the healthcare provider’s breach of obligation lies in misdiagnosis or medical error, the existence of fault consists of negligently or intentionally assigning an incorrect diagnosis or treatment, including failure to assign a correct diagnosis and treatment.7 In principle, the healthcare provider’s fault could be excluded if the healthcare provider is not able to influence the course of events (Varul et al. 2009, p. 312).8 Fault is not a prerequisite for the healthcare provider’s liability under LOA § 770 (2) for the actions of the persons assisting in providing healthcare services, i.e. persons assisting the healthcare provider who are not liable personally under LOA § 758 (2) (Varul et al. 2009, p. 312). In principle, the need to wait for the healthcare service does not give the patient a claim against the healthcare provider.9 If a patient feels that he/she has been left

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The Supreme Court’s decision in case no 3-2-1-76-08 of 14 October 2008, para 18. The specific regulation concerning the health-care provider’s liability on the basis of contract for provision of health-care services entered into force on July 1st 2002 with the enforcement of the LOA. 7 The Supreme Court’s decision in case no 3-2-1-171-10 of 8 April 2011, para 17. 8 I. Luik-Tamme and K. Pormeister have stated that it is incorrect to regard fault as not decisive in establishing the health-care provider’s liability. In their opinion, whether or not the health-care provider could be reproached for the negligence should be determined on the basis of establishing the fault, not on the basis of breach of obligation (See more at Luik-Tamme and Pormeister 2014). 9 However, it is important to timely detect the severity of the disease and provide quick assistance to patient in life-threatening condition. In other cases, the reception with the doctor should be provided within a reasonable period of time, depending on the health problem. It has been explained that the system of waiting lists is based on the principle that a person should receive the needed health-care in such a time when his/her health does not deteriorate significantly. Additionally, the person must have access to a doctor’s appointment in the range of waiting time’s maximum limit. The length of the waiting period of a particular person depends on the doctor’s assessment (Health Insurance Act § 38). 6

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without medical care, the patient can contact Estonian Health Insurance Fund.10 Theoretically, in such case a state liability cannot be entirely excluded.

Delictual Liability The existence of the healthcare provider’s contractual liability does not exclude the application of the liability under the law of delicts. LOA § 1044 sec 3 provides that if the death, bodily injury or damage to the health of a person is caused as a result of the violation of a contractual obligation, the tortfeasor shall be liable for such damage on the basis provided in this Chapter. Thus, the patient can issue a claim for compensation for the damages on named alternative grounds.11 General delictual liability (LOA § 1043) is built in three stages. As a general rule, objective elements (Objektiver Tatbestand: the act of the person who causes damage, damaging of the legal rights of the victim, and the causal link between them) are verified in the first stage; the second stage views unlawfulness and the third the fault of the person who causes damage. Verification of the preconditions of liability takes place in the order stated above: therefore, if it becomes evident that causing of damage is not unlawful the culpability of the person who causes damage will no longer be assessed. Thus, fault is one of the prerequisites for general delictual liability (liability for damage caused by major source of danger and liability for defective product do not depend on fault). Fault is established on two stages. Firstly, the intentional or negligent infliction of damage should be established (LOA § 1050 (1)). Then, in case of negligent infliction of damage, it is evaluated whether the negligence is subjectively excusable (LOA § 1050 (2)). The latter means the assessment of the situation, age, education, knowledge, abilities and other personal characteristics of a person. However, according to Estonian case law, the fault of the healthcare provider as a professional is not evaluated under LOA § 1050 (2).12 In case of defects in medical products, LOA enacts the liability of the producer of the medical product (LOA § 1061 (4)). According to LOA § 1061 (1), the producer shall be liable for causing the death of a person and for causing bodily injury to or damage to the health of a person if this is caused by a defective product. Under LOA § 1063 (2), a product is defective unless it is safe to an extent which corresponds to a person’s legitimate expectations, bearing in mind all the circumstances, and above all: (1) the manner and conditions of presentation of the product to the public; (2) the method of use of the product which the victim can reasonably presume; (3) the time of placing the product on the market. According to LOA § 1063 (3), a product shall

10

Estonian Health Insurance Fund, https://haigekassa.ee/en (10.08.2018). The Supreme Court’s decision in case no 3-2-1-171-10 of 8 April 2011, para 12. 12 Decision in case no 3-2-1-78-06 of the Civil Chamber of the Supreme Court of 3 October 2006, para 12. See also Lahe (2013), p. 153. 11

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not be deemed to be defective solely for the reason that a product with better characteristics is later placed on the market.13 Using a defective medical product can be also considered as an error in treatment and give a basis for healthcare provider’s liability.

Standard of Care According to Estonian LOA, the healthcare provider’s fault is one of the prerequisites of civil liability arising from both the breach of contract (LOA § 770 (1)) and delictual liability (LOA § 1050). Therefore the question arises which standard of care should be followed by healthcare provider to avoid civil liability.14 The performance of the healthcare provider’s obligations under LOA must be evaluated considering the first sentence of LOA § 762. LOA § 762 states that health care services shall at the very least conform to the general level of medical science at the time the services are provided and the services shall be provided with a level of care which can normally be expected of providers of healthcare services. The Estonian Supreme Court has stated that if the quality of the doctor’s actions is less than that of an educated and experienced specialist in the specific field, this could be considered a medical error.15 Thus the standard of care of the doctor is assessed according to objective criteria—the basic question is whether the attending doctor acted at least at the same level of professional quality as an experienced and educated doctor of the respective field. The personal characteristic of the doctor has no influence to assessment of fault. The assessment whether the doctor followed required standard of care is a decision of judicial discretion. However, the basis for such decision is still an expert opinion expressed in relevant expertise. According to CCP § 232 (2) no evidence has predetermined weight for a court but it is obvious that it would be extremely difficult for a judge to argue why the court does not agree with experts.16 Thus, in this matter the judicial discretion is quite limited in fact. The expert committee on the quality of health services is competent to assess the quality of health services provided to patients and to make proposals arising from the

13 The Medicinal Products Act regulates the handling of medicinal products, issue of medical prescriptions, granting of marketing authorisations, clinical trials and advertising of medicinal products, and supervision over and responsibility in the area of medicinal products for the purpose of ensuring the safety, quality and efficacy of medicinal products used in Estonia and promoting the use of medicinal products for their intended purposes. 14 It should be added that the negative outcome to the provision of health-care services does not in itself constitute a medical error. As a rule, the health-care provider shall not promise a patient that an operation will be successful (LOA § 766 (2)). 15 The Supreme Court’s decision in case no 3-2-1-78-06 of 3 October 2006, para 12. 16 However, if necessary, the court must appoint a repeated or additional expertise (Decision in case no 3-2-1-78-06 of the Civil Chamber of the Supreme Court of 3 October 2006, para 14).

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assessment to the Health Board, the Estonian Health Insurance Fund and the health care providers (Health Services Organisation Act (HSOA) § 502 (1)). The expert committee gives an expert opinion regarding the general level of medical science at the time the disputable services were provided and a level of care which could be expected of the healthcare provider. The expert committee’s opinion regarding the quality of a healthcare service is also based on the generally accepted medical practice and the principles of medical ethics.17 The Supreme Court has stated that the general level of medical science and the requirements for the specific healthcare service are prescribed primarily in medical treatment guidelines.18 There is no legal framework regulating the development and substantive requirements to these guidelines (Nõmper 2011, p. 163). Advisory Board of Medical Treatment Guidelines has defined these guidelines as documents that make recommendations regarding activities affecting health and provide evidence-based guidelines for healthcare providers about diagnosis and treatment methods, as well as it may contain recommendations for disease prevention and patient education strategies. The information enables to choose between different interventions that affect the health, quality of care and health care resources.19 The deviation from the medical treatment guidelines does not automatically mean the breach of the general standard of care, but there should be a good reason to deviate from the guidelines. In such case, the burden of proof lies with the healthcare provider (Varul et al. 2009, p. 300). The general level of medical science is not limited to the level of Estonia, but the level of the European Union (Varul et al. 2009, p. 300). Thus, establishing the general level of medical science is not confined by local medical treatment guidelines. Foreign medical treatment guidelines are regarded as equivalent, but local conditions should be taken into account (e.g. availability of certain medicaments and medical devices) (Nõmper 2011, p. 163). It should be noted that following the general level of medical science is not always compulsory. LOA § 763 enables the use of generally unrecognised methods20 upon provision of healthcare services, if (1) conventional methods are not likely to be as effective; (2) the patient is informed of the nature and possible 17

The regulation No. 27 of Minister of Social Affairs of 16 May 2008’ The expert committee’s on the quality of health services rules of procedure, procedure of the assessment of the health-care quality and formation of the committee’ § 2 (1) para 4. 18 The Supreme Court’s decision in case no 3-1-1-79-10 of 29 November 2010, para 16. Estonian Health Insurance Fund has established the Advisory Board of Medical Treatment Guidelines, which aims to improve the quality of health-care services by leading the process of developing costeffective and evidence-based treatment guidelines, taking into account the local conditions. 19 Information from the website containing the collection of medical treatment guidelines. Guideline development initiative can come from any organization. The drafting of guidelines is coordinated by specialized working group consisting of representatives from medical treatment field. http:// www.ravijuhend.ee/yldinfo/ (10.08.2018). 20 The generally unrecognised are such methods which are not included in the general level of medical science due to their novelty, or because these methods have not been used before or these are alternative methods (Varul et al. 2009 p. 301).

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consequences of the method and (3) the patient has granted his or her consent to the use of the method (Nõmper 2011, p. 163).

The Burden of Proof The patient’s claim to compensate for the damages can arise from the breach of contract for provision of healthcare services (i.e. contractual basis) and/or from harming the patient’s legally protected right (i.e. delictual basis). In general, according to CCP § 230 (1), each party shall prove the facts on which the claims and objections of the party are based, unless otherwise provided by law. The burden of proof regarding circumstances which are the bases for the healthcare provider’s contractual liability generally lies with the patient (LOA § 770 (3)). Thus the patient must prove the healthcare provider’s breach of obligation, the damage caused to the patient and the causal link between the breach of obligation and the damage. According to Estonian court practice the fault of the obligor is presumed. This presumption results from LOA § 103 sec. 1 second sentence according to which it is presumed that non-performance is not excused.21 In the case of the healthcare provider’s delictual liability, the patient must prove the harming of the patient’s legally protected right, the damage caused to the patient and the causal link between the breach of obligation and the damage. The burden of proving fault lies on tortfeasor: LOA § 1050 (1) provides that unless otherwise provided by law, a tortfeasor is not liable for the causing of damage if the tortfeasor proves that the tortfeasor is not culpable of causing the damage. There are instruments to strengthen patients’ weaker position. The reversal of the burden of proof is applied in two cases. Firstly, the burden of proof is reversed when the provision of health care services to the patient is not documented as required (LOA § 770 (3)).22 The reversal of burden of proof is explained by the allegation that due to insufficient documentation of treatment it would be impossible for the patient to assert the claim in court because the documentation should help the patient to prove his or her arguments. In such case, the healthcare provider shall prove that, regardless of the injury proved by the patient, the healthcare provider has not breached the contract or the breach is not in causal relation to damage or the healthcare provider’s fault is absent.23 There is no

21

Decision in case no 3-2-1-171-10 of the Civil Chamber of the Supreme Court of 8 April 2011, para 17. 22 Under LOA § 769, a provider of health care services shall document the provision of health care services to each patient pursuant to the requirements and shall preserve the corresponding documents. The patient has the right to examine these documents and to obtain copies thereof at his or her own expense, unless otherwise provided by law. 23 The breach of duty to document, which provides a basis for reversing the burden of proof, should be a comprehensive, related to an issue under dispute and reduce the patient's opportunity to assert his/her claim (Varul et al. 2009 p. 312).

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such reversal of burden on proof if the claim is issued under the law of delicts, but the reversal of burden of proof under LOA § 770 (3) could in principle be considered under the law of delicts also (Sõritsa 2012, pp. 33–34). Secondly, if there is an error in diagnosis or treatment and a patient develops a health disorder, which could probably have been avoided by ordinary treatment, the damage is presumed to have resulted from the error. In this case, the burden of proof regarding the damage resulting from the health disorder shall also lie with the patient (LOA § 770 (4)). The Supreme Court has stated that according to LOA § 770 (4) the patient should prove the existence of error and substantiate,24 why the patient supposes that the damage would not have occurred without the error or misdiagnosis. In response, the healthcare provider should prove that the damage did not occur due to the error or misdiagnosis.25 The presumption of causal link in case of damage arising from the medical error or misdiagnosis could in principle be applied both in case of contractual and delictual liability (Sõritsa 2012, p. 33). The patient’s weaker position is also strengthened in the case of the damage as a result of the use of unrecognised treatment methods. In such case, the healthcare provider shall prove the deviation from medical treatment guidelines, if the patient has proved the general level of medical science applicable to the patient’s certain condition (Nõmper 2011, p. 164).

Damages The Aims and Limits of the Compensation for Damages The compensation for the patient’s damages fulfils a pure indemnity function, regardless of whether the damage is compensated as a result of a civil action in civil or criminal proceedings. According to the Estonian LOA, the aim for compensation for damage is to place the aggrieved person in a situation as near as possible to that in which he or she would have been if the circumstances that are the basis for the compensation obligation had not occurred (LOA § 127 (1)). However, several provisions limit the principle of complete compensation of the damage. The purpose of the breached obligation or the protective provision should be taken into account according to § 127 (2) irrespective of the legal basis for compensation for the damage. LOA § 127 (2) stipulates that the damage shall not be compensated to the extent that prevention of damage was not the purpose of the obligation or provision due to CCP § 235—Substantiation of an allegation means giving the court the reasons for an allegation such that, presuming that the reasoning is correct, the court can deem such allegation to be plausible. Unless otherwise provided by law, a person required to substantiate may use all the evidence permitted by law for such purpose, including means of proof not deemed to be evidence by law or not in the procedural form prescribed for evidence, including signed confirmations. 25 The Supreme Court’s decision in case no 3-2-1-171-10 of 8 April 2011, para 16. 24

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the non-performance of which the compensation obligation arose.26 In case of contractual liability a non-conforming party shall only compensate for such damage which the party foresaw or should have foreseen as a possible consequence of non-performance at the time of entering into the contract unless the damage is caused intentionally or due to gross negligence (LOA § 127 (3)). Also, LOA § 127 (5) has to be taken into account, under which any gain (profit) received by the injured party as a result of the damage caused, particularly the costs avoided by the injured party, shall be deducted from the compensation for the damage unless deduction is contrary to the purpose of the compensation. The compensation for the damage could also be reduced if the damage was caused in part due to the victim’s behaviour (LOA § 139 (1)) or if the complete compensation would not be fair towards the tortfeasor (LOA § 140 (1)).27

Non-Pecuniary Damages According to the LOA § 134 (2) in the case of an obligation to compensate for damage arising from depriving a person of liberty, causing bodily injuries to or damage to the health of a person or violation of other personality rights, including defamation of a person, the aggrieved person shall be paid a reasonable amount of money as compensation for non-pecuniary damage. To determine the amount of non-pecuniary damage, the gravity and scope of the violation and the conduct and attitude of the person who caused damage to the aggrieved person after the violation shall be taken into account (LOA § 134 (5)). According to the case law of the Supreme Court, the courts, with regard to establishing reasonable compensation for non-pecuniary damage, regardless of the requests and submissions of the parties, should follow the principle according to which in addition the fault of the person causing the damage and the level of his or her fault, the economic situation of the parties, the role of the aggrieved person and other relevant circumstances, should be considered if failure to take such circumstances into account could result in an unfair award of compensation.28 According to recent analysis of court decisions, in civil cases the amount of compensation for non-pecuniary damage due to infliction smaller and short-term bodily injuries ranged from 100 to 1500 Euros. In the cases of more serious health

26

The person who has breached the contract is not regarded as responsible for the kind of damage, the arising of which the performance of the contract was not aimed to prevent. The Supreme Court’s decision in case no 3-2-1-171-10 of 8 April 2011, para 15. 27 It should be emphasised that LOA § 139 (1) and § 140 (1) are not applicable to the claim of non-pecuniary damage. It has been explained that these provisions do not apply because the amount of non-pecuniary damage is already a decision as a result of judicial discretion (the Supreme Court’s decision in case no 3-2-1-142-16 of 1 February 2017, para 14; no 3-2-1-85-08 of 22 October 2008, para 14). 28 The Supreme Court’s decision in case no 3-2-1-85-08 of 20 October 2008, para 14.

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damage or bodily injury, the compensation for non-pecuniary damage ranged from 500 to 12,000 Euros. In the event of the death of victim, non-pecuniary damage remained in the range of 5000 to 127,800 Euros, with a median of 17,500 Euros (Vutt 2017, p. 19). If the prerequisites of the healthcare provider’s liability are fulfilled, the patient could in principle be rewarded non-pecuniary damages also in case of breach of privacy or dignity. The non-pecuniary damages can be compensated on contractual basis (i.e. based on the breach of healthcare provider’s contractual obligations) or on the basis of law of delicts (i.e. if the healthcare provider has breached the patient’s legally protected right). If the claim for non-pecuniary damages is issued on the basis of the breach of contract, the damage may only be claimed if the purpose of the contractual obligation was to pursue a non-pecuniary interest and the obligor was aware or should have been aware that non-performance could cause non-pecuniary damage (LOA § 134 (1)). In case of delictual liability, upon the establishment of unlawfulness, the type of violation, the reason and motive for the violation and the gravity of the violation relative to the aim pursued thereby shall be taken into consideration (LOA § 1046 (1)). The courts are bound to apply the instruments provided by law to determine fair compensation of both pecuniary and non-pecuniary damage. In addition, the courts are expected to follow the views settled in the case law as well as the amounts of compensation customarily rewarded by courts.29 There are no mechanisms aimed at purely diminishing the amount of financial compensation.

Alternatives to Court Proceedings General As the court proceedings are lengthy and costly, the parties can also settle the dispute in extrajudicial manner. The extrajudicial proceedings are voluntary and do not exclude the resolution of dispute in court. The aim of currently used methods of extrajudicial dispute resolution is mostly sparing both the healthcare provider and the patient from long, tiresome and costly court proceedings. If the patient suspects that the healthcare provider has made an error or given misdiagnosis, the patient can refer to another healthcare provider for a second opinion30 and file a complaint to the healthcare provider. The patient can also 29 It has been pointed out that courts should avoid the outcome where in similar circumstances, the benefits rewarded by courts are not comparable. In addition, the Supreme Court has explained that the compensation for non-pecuniary damage should be comparable in similar circumstances in order to ensure the principle of equality and to maintain the judiciary’s authority. The Supreme Court’s decision in case no 3-2-1-80-13 of 25 September 2013, para 20. 30 Health Insurance Act (HIA) § 40 (1) states that the second opinion is an independent opinion of another medical specialist, which is aimed at evaluating the correctness of the diagnose given to the

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issue a complaint to Health Board regarding violation of law during provision of healthcare services or dissatisfaction with the healthcare services provided by family doctors.31 To obtain an expert opinion whether the health provider has made a medical error while providing the healthcare services, the patient can refer to the expert committee on the quality of health services to obtain the committee’s opinion regarding the quality of the provided healthcare. Thus, the existence of medical error or misdiagnosis can be determined without the need to issue a claim in court. The committee’s opinion is regarded as reliable and it is not excluded that after obtaining the committee’s opinion, the healthcare provider admits the mistake and compensates for the patients’ damage. If the healthcare provider does not admit his mistake, then the committee’s opinion does not exclude the parties’ right to ask for opinion of other medical professionals. Likewise, if the dispute reaches the court, the opinion of the expert committee is not the only possible evidence regarding the quality of the provided healthcare service. As the general level of medical science is not limited to the level of Estonia, the parties can also present the court the opinions the medical professionals of foreign countries. If the healthcare provider has performed following the professional guidelines and according to the general level of medical science and the expert committee on the quality of health services does not detect the existence of medical error, it does not exclude the patient’s right to issue the claim in court. However, it should be borne in mind that the patient has the burden to prove among other prerequisites the healthcare provider’s breach of obligation and/or the healthcare provider’s act, harming the patient’s legally protected right. In many cases, the dispute between the healthcare provider and the patient’s is largely due to absence of a timely apology and insufficient communication. The communication regarding the explanation to the event which resulted in damage to the patient’s health is customarily carried out after the patient issues a complaint against the healthcare provider. The importance of the communication between the healthcare providers and patients has been repeatedly stated as very important. Also, there have been regular communication training available for doctors and the persons assisting the doctor in provision of healthcare services. The patients expect that if the healthcare provider has made a mistake, which has caused damage to the patient’s health, the healthcare provider would admit his mistake. There have been discussion and recommendations regarding the need to develop a system of disclosure of the healthcare provider’s mistakes.32 The system

patient by the medical specialist who gave the initial opinion or the necessity of the medical product or health service prescribed to the insured person, the explained alternatives and expected impact and the risks relating to the provision of the health service. 31 Health Board exercises the state supervision over compliance with the requirements established for health-care providers, but is not competent to evaluate the quality of the health-care service (HSOA § 60). 32 Peamised järeldused ja soovitused seoses patsientide ohujuhtumite teavitamis- ja õppesüsteemidega Euroopas (The main conclusions and recommendations regarding informing

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of registration of procedural complications in surgical specialties that is used in some hospitals in Estonia can be regarded as a step towards disclosure programs. However, according to a survey carried out by the Ministry of Social Affairs, the patients see the main problem of Estonian healthcare in availability of healthcare.33

Organisations Striving to Protect Patient’s Rights In Estonia, there are two main organisations striving to protect patient’s rights. Estonian Patient Advocacy Association (EPAA) is a non-profit non-governmental organisation established in 1994, that’s primary aim is to advocate for the human and civil rights of the patients.34 EPAA offers advocacy and provides free counselling, case management and legal services, represents patients on different levels, helping in negotiations and official procedures. The organisation can help the patient by giving advice regarding the patient’s rights and opportunities in the case of dispute and preparing appeals, petitions, complaints and applications for state legal aid. In addition, the EPAA can direct a patient to an appropriate competent authority, give advice on the interpretation of legislation on healthcare and social affairs and give information on patients’ rights. Estonian Patients Union (EPU) is another organisation striving to protect patients’ social and economic rights. EPU aims to be a ringleader to promote patient-centred health-care policies and to represent and protect the interests and rights of the patients in Estonia and internationally. EPU also offers free counselling, is active in distributing information regarding patients’ rights and aims at developing cooperation at the international level.35 In addition to the above-named organisations, the aim of which is to protect the patient’s rights, there are also other organisations which control the pursuance of the patient’s rights if the patient issues an application. E.g. Estonian Health Insurance Fund reviews the performance of the contract for provision of healthcare services, including the questions of waiting lists and finances; Health Board who evaluates the

and training systems in Europe about the patients’ adverse incidents). http://ec.europa.eu/health// sites/health/files/patient_safety/docs/guidelines_psqcwg_reporting_learningsystems_et.pdf (10.08.2018). 33 Survey ‘The evaluation of health and health care in 2016 by the Estonian population’ https:// www.sm.ee/et/uudised/uuring-eesti-elanike-hinnangul-arstiabi-kvaliteet-hea-muret-teeb-arstiabikattesaadavus (10.08.2018). 34 For past 14 years has EPAA advocated for the rights of 19,550 clients, carried out education work about patients’ rights for 20,500 different stakeholders, litigating test-cases about human rights, raising up number of systemic issues in different levels and influencing decision making in Estonian health and social care system to respect service users’ choices. The organisation’s funding is project-based and it has been also funded from the state budget. See more at http://www.epey.ee/ index.php?page¼3 (10.08.2018). 35 Estonian Patients Union, https://www.patsiendid.ee/meist/epl-pohikiri (10.08.2018).

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compliance with the law within provision of healthcare services. Also it is common to the patients to refer to the Ministry of Social Affairs, as well as to the expert committee on the quality of health services created by the Ministry. However, none of these organizations are competent to oblige the healthcare provider to compensate for the damages incurred to the patient’s.

Patient Insurance Act On 14 February 2017 the Ministry of Social Affairs announced that will present for coordination an intention of developing a draft on creation of the healthcare provider’s liability insurance (Patient Insurance Act). The Ministry of Social Affairs intends to establish a new system, which would enable the patients to extrajudicially obtain compensation arising from the complications accompanied by the healthcare service.36 The minister explained that the new system is useful for both patients and doctors and will motivate the healthcare providers to systematically analyse the cases of malpractice to lead them to a minimum. The cases of health damage will have a fixed marginal rate depending on the severity of the damage.37 It should be emphasised that obtaining the compensation according to the new system would not preclude the patient to issue a claim to the court. However, the new system would have so many advantages that the patient really has no motive to go to court. According to the new system, the patient would only have to issue an application to the corresponding organisation (compare with issuing a complex action to the court), the organisation will collect evidence and documentation (compare with the patient’s burden of proof in the court) and the predicted time expenditure in the new system is 6 months (compare with at least 3 years of court proceedings) (Nõmper 2017, p. 177). A. Nõmper has pointed out that current system does not help to improve the quality of healthcare. The system that is aimed at going to court favours only the concealment of mistakes and the fight to identify the wrongdoer. A. Nõmper has proposed that it would be reasonable to learn from the mistakes and choose a system with a no-fault model, where damages would be compensated by an organisation created for that purpose (Nõmper 2012, p. 378). However, he has also expressed opinion that the proposed system is incomplete without reducing the doctor’s liability, but could nevertheless be regarded as a necessary step and give a possibility to bring the healthcare provider from protection position to an open state of the partnership with the patient.38

36

Prof. J. Lahe has been involved as an expert in the elaboration of this draft. The news of the Ministry of Social Affairs: The state creates medical liability insurance, https:// www.sm.ee/et/uudised/riik-loob-meedikute-vastutuskindlustuse (10.08.2018). 38 A. Nõmper has explained that the proposed new system does not change anything in the doctor’s liability, or alter in any way the doctor’s behaviour. The doctor will remain liable under criminal law 37

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Cooperation with all stakeholders will continue in parallel with the drafting of the new regulation. At the present moment the principles and provisions of the draft are still in very early stages. Therefore there is no reason to analyse these provisions deeply. The judges have not yet expressed their opinion regarding the proposed new system. The planned Patient Insurance Act may reduce the number of medical litigation cases even more because it directs patients to demand compensation from this insurance system. Among other things, the main obstacle by adopting Patient Insurance Act seems to be the question whether the insurance should be provided by private insurers (as is the case with motor insurance) or whether it should be mandatory insurance whereby the insurer is a state authority.

References Lahe J (2013) The concept of fault of the tortfeasor in Estonian tort law: a comparative perspective. Rev Central East Eur Law 38(2):141–170 Lillsaar M, Sedman M (2012) Tervishoiuteenuse osutaja tsiviilõiguslik ja karistusõiguslik vastutus (The health-care provider’s civil and criminal liability). The analysis of court practice. Legal information department of the Supreme Court. http://www.riigikohus.ee/vfs/1344/ Tervishoiuteenuse_osutaja_tsiv_ja_kar_vastutus_analyys_M_Lillsaar_ja_M_Sedman.pdf (10.08.2018) Luik-Tamme I, Pormeister K (2014) Kas süü tervishoiuteenuse osutaja lepingulise vastutuse eeldusena on iseseisev või sisutühi kontseptsioon? (Is the fault as a prerequisite for the healthcare provider’s liability an independent or an empty conception?). Juridica 10:762–780 Nõmper A (2011) Lisandusi Riigikohtu lahendile 3-1-1-79-10 (Additions to the Supreme Court decision 3-1-1-79-10). Juridica 2:162–164 Nõmper A (2012) Eesti võlaõigusseaduse 10 esimest aastat: arsti vastutus vajab reformi (First 10 years of Estonian Law of Obligations Act: the doctor’s liability needs a reform). Eesti Arst 91 (7):376–378 Nõmper A (2017) Meditsiiniõiguslik tagasivaade 2016. aastale ehk veel kord arsti vastutusest (Medico legal retrospect to year 2016 aka once more about the doctor’s liability). Eesti Arst 96(3):175–177 Nõmper A, Sootak J (2007) Meditsiiniõigus (Medical law). Juura, Tallinn Sõritsa D (2012) Tervishoiuteenuse osutaja deliktiõiguslik vastutus (The health-care provider’s delictual liability). Master thesis, University of Tartu. Available at http://dspace.ut.ee/bitstream/ handle/10062/26256/soritsa_dina.pdf (10.08.2018)

for the medical mistake that resulted in the patient’s death or his/her bodily injury. Regarding the civil liability, the new system would only help a small part of the Estonian doctors who actually have the easy alternative to join the Estonian Union of Doctors, who would provide insurance for its members (https://arstideliit.ee/vastutuskindlustus, 10.08.2018). A. Nõmper sees the solution not in the new system of liability insurance but rather in reducing the doctor’s liability. It would also be possible to reduce the criminal liability by creating a separate case of exclusion of unlawfulness (e.g. death or infliction of bodily injury is not unlawful if it took place in the process of provision of health-care services, the doctor has himself reported the case and has been fully cooperative in ascertaining the circumstances of the case). See (Nõmper 2017), pp. 176–177.

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Varul P et al (2009) Võlaõigusseadus III. Komm. Vlj. (Law of Obligations Act III. Commented Edition). Juura, Tallinn Vutt M (2017) Mittevaralise kahju hüvitamise nõuded tsiviil- ja kriminaalasjades esimese ja teise astme kohtutes 2016. aastal (Claims to compensate for non-pecuniary damage in civil and criminal cases in the courts of first and second instance in the year 2016). The analysis of court practice. Legal information department of the Supreme Court. http://www.riigikohus.ee/vfs/ 2206/Mittevaralise%20kahju%20h%FCvitamine%20tsiviil-%20ja%20kriminaalasjades% 202016.pdf (10.08.2018)

Chapter 7

The French Medical Accident Compensation Scheme. A Critical Assessment of the Patients’ Rights Act of 4 March 2002 Jonas Knetsch

Abstract The French Patients’ Rights Act of 4 March 2002 has introduced a general compensation system for healthcare-related injuries and thereby established an attractive alternative to the traditional tort-based lawsuit. Since then, patients may bring compensation requests before one of the 25 regional conciliation and compensation commissions, whose task is to assess the claim and, if appropriate, to deliver a legal opinion to the healthcare insurer (in case of medical malpractice) or the French compensation office ONIAM (in case of therapeutic hazard). More than 15 years after the Patients’ Rights Act came into force, this report intends to assess the system’s performance and to outline prospects for reform.

Introduction For a French tort lawyer, it is almost commonplace to claim that the traditional faultbased tort law action is not an adequate means of providing compensation for an injury, especially when it arises from negligence when receiving healthcare services. Injured patients face a number of constraints: information asymmetry, difficulty determining the applicable standard of care, the unpredictability of the trial and its associated costs, overcoming delays and the strain of litigation. In various countries over the last 30 years, these considerations have led to the introduction of alternative compensation mechanisms or dispute resolution models.1

1 For a comparative overview, see Oliphant and Wright (2013); Ferrara (2013); Hondius (2010); Dute et al. (2004); Faure and Koziol (2001); Giesen (1988). Most recently see Watson and Kottenhagen (2018), p. 1.

J. Knetsch (*) University of Lyon, Jean-Monnet Faculty of Law Saint-Étienne, Saint-Étienne, France e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_7

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The French compensation scheme, originating from the Patients’ Rights Act of 4 March 2002, is one of those responses to the shortcomings of traditional tort law in the field of medical law.2 The 2002 Act has enacted a comprehensive compensation scheme for healthcare-related injuries, whatever their cause, as an alternative to a tort based lawsuit. It has also been an inspiration to other French-speaking countries and can therefore be regarded as a leading legislative model, at least in continental Europe.3 More than 15 years after the Patients’ Rights Act came into force, this paper intends to assess the system’s performance and to report on prospects for reform. To lay the groundwork of this assessment, it is essential to start by giving a general overview of the French compensation scheme (section “General Overview of the French Compensation Scheme”). The report will then concentrate on the policy considerations behind extrajudicial compensation (section “The Rationale of Extrajudicial Compensation”). The challenges and shortcomings of the current framework will constitute the final section of this report (section “Shortcomings of the French System”).

General Overview of the French Compensation Scheme The Patients’ Rights Act of 4th March 2002 has unified liability rules for medical malpractice, regardless of the actors involved (public hospitals, private hospitals or private practice health professionals), and established a new legal framework in order to oblige health professionals to obtain the patient’s informed consent and to allow access to medical records. For the purpose of this report, the following sections will not go into the details of every current issue, especially regarding the patient’s consent and liability rules.4 The paper will focus exclusively on the new procedure the 2002 Act established in order to promote a simple and quick compensation mechanism for medical accident victims (section “The Compensation Procedure”) and on the scheme’s funding (section “The Funding of the Medical Accident Compensation Scheme”). A quick

2

For a more detailed presentation of the scheme in English, see G’Sell-Macrez (2011), p. 1093; Helleringer (2011), p. 1125; Taylor (2003), p. 737; Taylor (2010), p. 70; Taylor (2011), p. 57 and, more recently, Taylor (2015), p. 24. 3 Under Belgian Law, the 2007 and 2010 Acts on the Compensation of Health Care Injuries are directly inspired by the French legislation despite some notable differences, especially as regards the scope of the compensation and the role of the Medical Accident Fund (Fonds des accidents médicaux). For a comparative study of the French and Belgian system, see Gibert et al. (2011), p. 85. In Luxemburg, the enactment of a comprehensive compensation system for victims of medical accidents has been a governmental promise in 2015. 4 For a more detailed presentation of those issues, see Laude et al. (2012), p. 337 and 451; Mémeteau and Girer (2016), p. 505 and 697.

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review of the legal background of the 2002 reform will introduce this (section “Legal Background of the 2002 Reform”).

Legal Background of the 2002 Reform The provisions of the Patients’ Rights Act of 2002 related to the compensation of healthcare-related injuries find their background in a long legal debate on the assistance of medical malpractice victims.5 Since the 1960s, there has been a broad consensus on the inadequacy of the tort law provisions in the French Code civil making the proof of fault ( faute) the requirement for an action of damages. In 1966, the comparative and tort law scholar André Tunc used very clear terms to express the patients’ distress: ‘Although having the feeling, legitimate or not, that a mistake has been made, the patient will not ask for damages due to the high costs, the slowness and the uncertainties of a court action. Even if an action is brought into court, his request will be denied because it is so difficult to proof the fault since he does not know exactly what happened.’6 Even though the highest French courts—the Court of Cassation for the liability of practitioners and private clinics, the Conseil d’État for the liability of public hospitals7—admitted strict liability for damages caused by health products or hospitalacquired infections in the 1990s, these developments were not found to be sufficient.8 There was widespread feeling that a broad legislative reform was needed, especially since judges and legal scholars deemed compensatable another type of healthcare-related injury, the therapeutic hazard (aléa thérapeutique).9 This concept covers all accidents occurring in the course of medical care without any negligence of a healthcare professional and causing injuries that are out of proportion to those the patient suffered before and did not constitute a reasonably foreseeable development of the patient’s previous state.10 After years of debates, the socialist government under Lionel Jospin reached a political agreement and made the French parliament vote on this issue. The Patients’ Rights Act is also named the ‘Kouchner Act’ after the then Minister of Health Bernard Kouchner.

5

See Blanco (2005), p. 24; Mémeteau and Girer (2016), p. 415. See Tunc (1966), p. 42. 7 On this point, see Thouvenin (2011), p. 170. 8 See Taylor (2010), p. 700. 9 On this concept, see Helleringer (2011), p. 1126. In French, see for example Laude (2002), p. 97. 10 The precise scope of aléa thérapeutique do raise a lot of difficulties. See below under section “The Complexity of the Legal Framework”. 6

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The Compensation Procedure As a result of the 2002 reform, patients requesting compensation for an injury they consider related to healthcare have two options; they can file a lawsuit against the private practice doctor or the hospital at which they received care, or they can bring their claim before one of 25 regional conciliation and compensation commissions (commissions régionales de conciliation et de compensation).11 These commissions were created to act as an alternative to courts and are meant to help patients obtain compensation. They are chaired by a judge and composed of 20 other members, divided into six categories, representing patients, health professionals, hospital representatives and insurers.12 When a commission receives a compensation claim, it has 6 months to give an opinion.13 At this stage, two solutions are possible; first, the commission may decide to reject the claim, either because the injury cannot be attributed to medical care14 or because the injury does not have the required severity.15 Second, if the commission believes that the patient’s harm falls under the scope of the 2002 Act, an opinion will then be delivered, either to the health professional’s or hospital’s insurer (in cases of medical malpractice) or to the French Compensation Office of Medical Accidents ONIAM (in cases of therapeutic hazard). The insurer or the office must then make a compensation offer that provides full compensation to the victim within four months.16 If the claimant accepts this offer, a settlement is concluded and the case is closed.17 If not, the claimant may ask the courts to review the compensation offer.18

11 A list of all commissions with their contact details may be viewed on the website http://www. oniam.fr/trouver-ma-commission. 12 Article L 1142-6 and R 1142-5 Code de la santé publique (CSP). On this issue, see Blanco (2005), p. 93. 13 Article L 1142-8 CSP. 14 Article L 1142-1, II CSP. In particular, this excludes injuries due to natural evolution of a patient’s disease. See Helleringer (2011), p. 1126. 15 Article L 1142-1, II and D 1142-1 CSP. Only serious health conditions entitle a patient to claim compensation under the 2002 Act compensation scheme. Compensation may be granted to claimants whose disability rate is superior to 24 percent and is either permanent or temporary but lasted for at least six months of a 12-month period. In exceptional cases, the requirement of seriousness is also fulfilled when the claimant is declared permanently unfit for the occupation they held prior to the occurrence of the damaging accident. See Helleringer (2011), p. 1127. 16 Article L 1142-14 and L 1142-17 CSP. 17 According to Article L 1142-14 (6) and L 1142-17 (5) CSP, the ‘acceptance of the compensation offer is deemed a final settlement agreement’. 18 Article L 1142-14 (9) and L 1142-20 CSP. If the judge decides that an insurer’s offer was ‘manifestly insufficient’, he can order the insurer to pay a penalty to ONIAM representing up to 15% of the full compensation due to the victim.

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Where the insurer does not make an offer to the claimant, ONIAM replaces the insurer so that the claim is not affected by the insurer’s default.19 At every stage of the procedure, the claimant may bring his case before court and ask for a new assessment of the injury’s causes and extent.

The Funding of the Medical Accident Compensation Scheme The source of funding for damages awarded through the medical accident compensation scheme depends on the outcome of the procedure before the conciliation and compensation commission. If the commission concludes that the medical accident was caused by medical malpractice, then the health professional’s insurer will have to pay damages and will finance the cost out of the resources allocated to medical liability insurance (assurance de responsabilité professionnelle médicale), composed of the insurance premiums paid by doctors, public hospitals and private clinics. If the claimant is entitled to damages from the compensation office ONIAM, the issue of funding is a different one, since the ONIAM’s budget is regulated by article L 1142-23 (3) of the French Public Health Code (Code de la santé publique). According to this text, revenue to the ONIAM consists primarily of an annual allocation of the health insurance branch of the Social Security system. Secondarily, the ONIAM receives an annual allowance from the State in order to finance the compensation of accidents due to compulsory vaccination.20 In the event ONIAM replaces a private insurance company who are unwilling to pay damages to the claimant, the compensation office is entitled to exercise a recourse claim and to keep the amount of money paid by the insurer.21

The Rationale of Extrajudicial Compensation The extrajudicial nature of this compensation procedure is generally presented as an asset, both in terms of timeliness and simplicity.22 In fact, the compensation regime has its own website where claimants can download standard application forms and

19

Article L 1142-15 CSP. Article L 3111-9 CSP. 21 Article L 1142-23 (3) 4 CSP. 22 For a broader analysis of the legal policy framework of compensation funds, see Knetsch (2013), para 160 and 418. 20

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can access information about the conditions for compensation and the description of the procedure.23 There is no need for a lawyer, nor for costly investigations about applicable law and court jurisdiction. Providing comprehensive support and information, the compensation commissions wish to be exemplary in matters of assistance to victims and families. One could speak of a single-window administration for those who claim to have suffered a health-related injury, following a ‘quasi-administrative’ procedure, without the burden of bureaucracy.24 The 2002 compensation procedure was designed to remedy the shortcomings of traditional court actions. Indeed, it seems that victims who have been given compensation by courts often regret the very limited role they played in the proceedings. Lessons from victimological studies show that claimants often want to tell their side of the story and to express their emotional needs.25 Even though a judge can pronounce an official condemnation of the tortfeasor’s acts and recognise the claimant’s victim status, the traditional procedure before courts does not offer the ideal context in which to give a voice to the claimant. It is clear that a compensation procedure, whether before courts or before an administrative body, cannot both offer a simple and swift procedure and satisfy all of the claimants’ needs. However, the procedure before the compensation commissions proves that there is an intermediate stage and that it is very possible to find a balance between an efficient procedure and effectively responding to victims. Indeed, the Patients’ Rights Act of 2002 guarantees the claimants comprehensive participation rights and entitles them, in particular, to request a hearing.26 Last but not least, the establishment of the medical accident compensation scheme pursues two additional objectives which should not be underestimated. One of the political aims of the 2002 Act was to channel a certain type of mass litigation, especially for the victims of nosocomial infections or defective drugs (Mediator, Dépakine). By diverting the compensation claims away from the courts and towards the compensation commissions, lawmakers tried to reduce the burden of work on French justice, whose congestion has become chronic over the last 30 years.27 A positive side effect of the transfer of compensation claims towards extrajudicial procedures concerns the patient-doctor relationship. Changes in society have led to more empowered patients, less paternalistic medicine and, in this context, to a growing litigiousness of healthcare.28 In this respect, an administrative

23 http://www.oniam.fr/ (it is noteworthy that the application form only consists of four pages to be completed by computer). 24 In addition to claim dispatching within the French medical accident compensation scheme, there is a close cooperation with other compensation funds, e.g. FGAO (victims of motor vehicle accidents), FGTI (victims of violent crimes and acts of terrorism). 25 On this question, see Orth (2002), p. 313; see also Schneider (2007), p. 409. 26 Art R 1142-16 (3) CSP. 27 On this issue, see Knetsch (2013), para 161. 28 See Burgelin (2003), p. 28; Laude (2010), p. 49 and more recently Laude et al. (2010).

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compensation procedure can have a positive effect on the patient-doctor relationship, since an action before court, implying a direct confrontation between the claimant and the defendant, becomes avoidable. Although statistical data collected by the Observatory of Healthcare Risks are not easy to interpret, there has been a noticeable positive effect on the number of lawsuits related to healthcare injuries.29

Shortcomings of the French System More than 15 years after the implementation of the compensation scheme, a possible reform of the 2002 Act has been discussed. Even though the medical accident compensation scheme should be seen as significant advancement for the rights of patients, a detailed assessment of the system leads to a more nuanced appreciation. The central issue seems to be how to determine the severity of a patient’s injury before granting them access to the extrajudicial compensation (section “The Debates About the Criterion of Seriousness”), but there are other concerns related to the complexity of the legal framework (section “The Complexity of the Legal Framework”), the weakness of the conciliation services under the scheme (section “The Weakness of the Conciliation”), the amount of damages awarded (section “The Amount of Damages Awarded by the Compensation Commissions”) and the ambiguous role of the compensation office ONIAM (section “The Ambiguous Role of the Compensation Office ONIAM”).

The Debates About the Criterion of Seriousness As we already have seen,30 to qualify for compensation under the 2002 Act, the injury suffered by the claimant must be of a sufficiently serious nature, i.e. he or she has to prove a minimum level of permanent or temporary disability. The threshold has been fixed by the government to 24%, which corresponds approximatively to the loss of an eye. In order to take into consideration exceptional cases, a governmental decree of 21 May 2003 entitles claimants, who had been declared permanently unfit for the occupation held prior to the damaging accident, to follow the compensation procedure implemented in 2002.31 Many authors and law professionals deplore this obstacle and argue in favour of a broader approach of extrajudicial medical accident compensation. When the 2002 Act came into force, commentators observed that the requirement of seriousness

29

See Observatoire des risques médicaux 2015, p. 19; ONIAM (2019), p. 21. See above note 15. 31 Art D 1142-1 CSP. 30

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would exclude 97% of medical accident victims from the compensation scheme.32 Even in the 2018 annual report, the ONIAM indicates that 8.7% of the claims filed before one of the Regional Conciliation and Compensation Commission have still been rejected because the injury did not meet the seriousness criterion set out in the law.33 These facts clearly show that the requirement of at least 24% incapacity is a hurdle too high for some claimants and a standard that can be quite difficult to assess. However, the perspective of reducing the seriousness threshold is not as obvious as it might seem.34 To understand the terms of the debate, we must get back to the preparatory work of the 2002 Act. The rationale was to place only the most seriously injured claimants under the very patient-friendly compensation scheme. It would have been impossible for the conciliation and compensation commissions to undertake the mass of compensation claims without forfeiting the personalised procedure that gives claimants the right to request a hearing. With these caveats in mind, the proposals made in recent years have to be measured by the policy considerations underlying the 2002 compensation scheme. In 2009, a member of the National Assembly, Guénhaël Huet, asked for the removal of the threshold to access to the compensation scheme, while at the same time expressing doubts (‘une fausse bonne idée’).35 In a 2011 report to the Minister of Health, Alain Michel Ceretti and Laure Albertini suggested that the threshold be lowered to 15 per cent permanent incapacity, which should not “lead to a major inflow of new compensation claims according to all experts consulted”.36 The predictable outcome of these reform efforts is as yet uncertain, since the financial dimension of this issue cannot be ignored. Any downward adjustment of the seriousness criterion will increase the financial burden on the administration of the compensation scheme. It is therefore a genuine political choice with cost implications, both for the welfare state and private insurers.

The Complexity of the Legal Framework One of the stated objectives of the 2002 Act was to unify medical liability rules before civil and administrative courts. Until then, public hospitals were judged in accordance with the Conseil d’État case law, whereas private clinics and 32 See Lambert-Faivre (2002), p. 1371. See also Barbot et al. (2014), p. 244 (‘the gap between seriously injured people and those [more numerous] with “less serious” injuries, who, “paradoxically”, are still supposed to go to the courts and to pay for lengthy and expensive proceedings [when they do not succeed in the face-to-face negotiation with the healthcare providers or their insurance companies’]). 33 See ONIAM (2018), p. 19. 34 On this issue and particularly on the ‘threshold effect’ related to a lowering of the seriousness criterion, see Médiateur de la République (2009), p. 29. 35 Huet (2009), p. 99. 36 Ceretti and Albertini (2011), p. 223.

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practitioners were subject to a combination of liability rules arising from Court of Cassation case law and statutory law. One of the most significant aspects of the 2002 Act is that the Public Health Code (Code de la santé publique) leaves very little space for distinguishing between public and private law liability rules. In theory, the acts of all health professionals, regardless of status, now fall under the same regulations, even though judicial claims are still to be brought in either civil or administrative courts.37 Criticism about the complexity of the legal framework arises mainly when discussing the rules that the conciliation and compensation commissions and the French Compensation Office ONIAM have to apply in their daily work. Since the enactment of the scheme in 2002, the legislator has added several regulatory layers to the existing rules and extended ONIAM’s jurisdiction to numerous categories of victims who were not initially covered. The compensation of victims of HIV and hepatitis C due to infected blood transfusions, compulsory vaccines, CJD growth hormones, medical research, defective drugs (Mediator, Benfluorex) and nosocomial infections is now provided by the compensation office under conditions that are different from each other and from the basic regulatory framework. Uncertainties also concern legal key concepts, such as medical accident, illness, therapeutic hazard or even fault and causation. Since there is no right of appeal against the opinions of the conciliation and compensation commissions,38 there is a high risk of differences in the way the criteria are assessed in a specific case.39 A National Medical Accident Compensation Commission (CNAMed) was established to unify and consolidate practices throughout the 25 regional commissions;40 however, it does not seem to have succeeded in implementing a uniform interpretation of certain concepts of law. Even in cases where claimants went directly before the civil or administrative courts, the abundant case law shows how difficult it is, for example, to shape the concept of therapeutic hazard (aléa thérapeutique) and to distinguish it from the ‘foreseeable evolution of physical condition’ (évolution prévisible de l’état de santé).41 The Court of Cassation and the Conseil d’État even admit to apportion a medical accident between the ONIAM and a private insurer, considering that the injury was caused by both a medical negligence and a therapeutic hazard.42

Which leads an author to be concerned about ‘the possibility that differences will still appear in the civil and administrative courts’ interpretations of key concepts’ (Taylor 2011, p. 70). 38 See Conseil d’État, 10 October 2007, ref 306590, Sachot. On this opinion (avis), see Appolis and Vialla (2008). 39 See Taylor (2011), p. 70. 40 The Commission presents annual reports, which can be consulted on the internet (http:// solidarites-sante.gouv.fr/ministere/acteurs/partenaires/article/rapports-de-la-cnamed). 41 Art L 1142-1, II (1) CSP. 42 See Conseil d’État, 30 March 2011, ref 327669, ONIAM v Epoux Hautreux; Court of Cassation, 22 November 2017, ref 16-24769. 37

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The Weakness of the Conciliation The statistics of compensation claims brought before one of the regional compensation commissions surely demonstrate the success of the extrajudicial compensation scheme. In 2018, more than 4600 claims have been treated,43 which otherwise would have given rise to a court action or to the victim’s resignation. Those numbers are in sharp contrast to the number of claims for conciliation, which is available to all patients, including those who are not eligible for compensation. Even if there is a positive trend, only 298 claims were received in 2018 and 24 subsequent successful conclusions were reported in ONIAM’s latest annual reports.44 From all the innovations introduced by the 2002 Act, the conciliation procedure before the regional commissions45 is undoubtedly the least attractive to patients. The causes of this failure are multiple. First, the conciliation role of the regional commissions is not well known by the public and, if it is known, is often perceived as a ‘wasteful detour’, to quote an author.46 But the causes seem to be far more fundamental; the dual competence of the regional commissions (compensation and conciliation) is an important factor, since compensation procedures are so timeconsuming for commission members that it is almost impossible for them to carry out conciliation procedures under proper conditions. Furthermore, even if there was enough time for the commissions to promote conciliation in medical malpractice cases, they would have to face a significant lack of skilled conciliators.47 The weakness of patient-doctor conciliation has been acknowledged in France for a long time, and the 2002 Act did not fundamentally change the situation. A number of ideas have already been identified, such as the implementation of a mandatory conciliation procedure prior to a court action48 or the delegation of powers to users’ committees in public hospitals or to the Councils of the Board of Physicians (Conseils de l’ordre des médecins).49 This also explains why the French legal system, albeit a pioneer in medical accident compensation, has lagged behind on the issue of alternative dispute resolution between health professionals and their patients. There seems to be no serious initiatives to implement apology laws or disclosure programmes or to enshrine in law critical incident reporting systems (CIRS) in order to facilitate the regulation of medical accidents outside the courts and the compensation commissions.

43

See ONIAM (2018), p. 14. See ONIAM (2018), p. 14; ONIAM (2017), p. 19. 45 For a comprehensive assessment of those procedures, see Blanco (2005), p. 253. 46 See Taylor (2011), p. 65. 47 See Arhab-Girardin (2011), p. 1098. 48 In 2007, the National Academy of Medicine (Académie nationale de médecine) presented a ‘proposal for a mandatory pre-trial information and conciliation procedure’ (see [2007] Rapports, communiqués et recommandations de l’Académie nationale de médecine 309–322). This proposal led to a draft bill which was never adopted. See Rajot (2008), p. 3. 49 See Arhab-Girardin (2011), p. 1098. 44

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The Amount of Damages Awarded by the Compensation Commissions Another concern is related to the amount of compensation paid to the claimant. The medical accident compensation scheme has been accused of applying a minimalist view of the concept of full reparation (réparation intégrale). In other words, the compensation granted to the claimant is seen to be less comprehensive than damages a court would award in a similar case. Such an analysis may be surprising, since it is hard to see how a full reparation of a personal injury, required by law, can be ‘more or less full’. To get a better understanding of why this issue needs to be investigated, one has to understand the place of non-pecuniary damages under French law.50 In recent decades, civil courts have applied an increasing weight to the compensation of préjudice moral. Although French liability law has always had a very liberal approach towards damage, a significant increase in the number of different heads of non-pecuniary damages can be observed in case law. Compensation of non-pecuniary damages may not only include pain and suffering (souffrances endurées), but also gives rise to separate amounts for the loss of amenity (préjudice d’agrément), sexual impairment (préjudice sexuel) or aesthetic harm (préjudice esthétique).51 In order to assess these different heads of non-pecuniary damages, the National Compensation Office ONIAM has developed compensation guidelines (référentiel d’indemnisation) based on a statistical survey of damages awarded by judicial and administrative courts.52 The benchmarks closely follow the average amount allocated by the courts. However, since the courts have assessed non-pecuniary damages rather arbitrarily until recently,53 the amounts still reveal significant regional disparities and may therefore turn out to be higher than those granted by ONIAM. Those discrepancies encourage claimants to not just accept the benefits awarded by ONIAM or medical liability insurers, but to ask for a judicial review and for additional compensation in order to meet the standards of the most generous jurisdictions.54 Even though there have been concerted efforts to set out unique compensation guidelines which shall apply to court actions and to settlements with 50

See Borghetti (2015), p. 268. Under French law, non-pecuniary damages are divided into several distinct head of damages. See Knetsch (2015), p. 443. For a comparative analysis, see Wagner (2004), p. 322. 52 http://www.oniam.fr/procedure-indemnisation/bareme-indemnisation. See Martin et al. (2005), p. 1656. 53 Quenillet-Bourrié (1995). In 2016, a working group led by the Court of Appeal Judge Benoît Mornet presented compensation guidelines which now are followed by most civil jurisdictions (http://www.ajdommagecorporel.fr/referentiels-d-indemnisation). 54 The issue of the admissibility of those actions has arisen, particularly in France, where legal scholars qualified this question as one of cumul d’indemnités, i.e. of accumulation of damages. After several years of hesitation, particularly due to the opposite view of the Court of Cassation regarding civil liability actions, the problem has been addressed by the legislator. As we have seen before, the 51

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insurance companies and compensation funds such as ONIAM;55 claimants are strongly advised to hire a lawyer56 in order to be fully aware of the value of the compensation offer.

The Ambiguous Role of the Compensation Office ONIAM The final point of criticism is the role of the French compensation office ONIAM, which plays a key role in the compensation scheme. Not only does it grant damages in cases where the compensation commission decides that the injury has been caused by a therapeutic hazard (aléa thérapeutique), but it replaces the liability insurer where no offer has been made to the claimant within a four month period. In addition, over the years ONIAM has been given six additional compensation tasks, for example, in cases of HIV or hepatitis infection due to tainted blood57 or injuries related to health emergency measures58 or defective drugs.59 According to the category, ONIAM officers have to apply different rules to assess each claim, follow different procedures and use different methods for the evaluation of damages.60 What initially appeared to be a gesture of confidence in ONIAM’s abilities and professionalism and looked to be a crucial step towards the creation of a unique contact point for victims of healthcare-related injuries61 has proven fatal for the efficiency of the entire compensation system. In its last annual report, the Court of Auditors (Cour des comptes) criticised ONIAM for its lack of diligence in the treatment of compensation claims and, more generally, for its loose financial and budgetary management.62 There is another reason for the severe crisis within a compensation office designed to radically improve the situation of victims of medical accidents; ONIAM declared, in 2002, that the opinions adopted by the regional commissions did not have any binding authority and that it would be possible to refuse

2002 Act qualifies the acceptance of a compensation offer by the victim as an out-of-court settlement (transaction). See above note 17. 55 Drawing up a reference framework for the assessment of damages is one of the proposals set out in the reform bill on civil liability, presented by the Ministry of Justice in March 2017. An English translation of the reform bill can be consulted at http://www.textes.justice.gouv.fr/art_pix/reform_ bill_on_civil_liability_march_2017.pdf. 56 Representation is not mandatory before the compensation commissions. 57 Article L 1221-14 and 3122-1 CSP. 58 Article L 3231-4 CSP. 59 Article L 1142-24-1 CSP (Mediator) and L 1142-24-10 (Dépakine). See Knetsch (2011), p. 6; see also Jouslain de Noray and Joseph-Oudin (2017), p. 18. 60 See above under section “The Complexity of the Legal Framework”. 61 See above under section “General Overview of the French Compensation Scheme”. 62 See Cour des comptes (2017), p. 67.

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compensation against the commission’s opinion.63 This policy line has been heavily criticised, not only by patients’ representatives but also by legal scholars underlining the risk of dismantling a procedure built on the interlocking of both the commissions and ONIAM. In response to the 2017 report of the Court of Auditors, ONIAM promised to improve its communication with the presidents of each regional compensation commission, but it cannot be excluded that ONIAM’s attitude has irremediably compromised the functioning of and patients’ trust in the 2002 compensation scheme.

Conclusion The 2002 Act is undoubtedly a major piece of French healthcare legislation. The compensation procedure, based on the interaction of an expert commission and an insurer or a public compensation body, is innovative and provides a serious alternative to court procedures. Since 2002, regional compensation commissions have treated more than 50,000 claims, which would otherwise have given rise to a lawsuit or to a private transaction procedure. To ensure that the French compensation procedure remains a success story, it is essential that public authorities respond to the shortcomings that have emerged in recent years. Striking a balance between the openness of the scheme and its costs, strengthening the role played by conciliation, elaborating its unique compensation guidelines, restructuring ONIAM’s financial and personnel arrangements and transforming the commissions’ opinions into binding decisions: these are the main challenges facing the scheme in years to come.

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Chapter 8

Legal Questions Concerning Medical Malpractice Liability: Substantive Law and Its Enforcement Country Report Germany Andreas Spickhoff

Abstract The following contribution gives an overview of the German Law of Medical Liability including the law of evidence. It includes a look on the purposes of medical malpractice liability, the professional standard, the presentation in trial and proof including the position of experts, the burden of proof, especially the very special German rule for reversal of the burden of proof in the medical malpractice lawsuit in cases of gross malpractice, the difference between state liability and private liability and out-of-court dispute resolutions (arbitration boards and expert panels as well as mediation). In the end the contribution deals with the lex ferenda in the German discussion.

Procedural Framework, Purpose and Comparative Legal Positioning of Medical Malpractice Liability If an agreement between the parties involved in a conflict concerning medical malpractice law cannot be reached, typically a normal civil litigation cognitive procedure results from this conflict. Consequently, it is not a public law compensation system that forms the framework within which patients’ claims against the treatment side can be asserted. Therefore, in Germany, medical malpractice liability is not enforced under the regime of public law. In addition to the normal civil litigation cognitive procedure or, as the case may be, potentially upstream of it, it is possible to adhere to out-of-court dispute

This article has been translated from German by Julia Schlicht, Ludwig-Maximilians-University in Munich. A. Spickhoff (*) Ludwig-Maximilians-University, Munich, Germany e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_8

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settlement in the form of arbitration and expert proceedings. Corresponding bodies are located at the State Medical Associations.1 This possibility of out-of-court dispute settlement (please see III. below) has existed in Germany since the 1970s. Under substantive law, medical malpractice liability as well as any other professional and civil liability takes on the so-called compensatory function. Liability is intended to compensate for any damage suffered (by patients) due to misconduct. Within the scope of this compensatory function, liability can also exert preventive effect. In this respect, elements of economic analysis can also be taken into account. By contrast, civil liability for damages does not perform the function of punishment or even just atonement. In remainders, however, the idea of atonement appears at best in the claim for intangible damages (compensation for pain and suffering, § 253 German Civil Code (BGB)) which is adjudged to have compensatory as well as satisfactory function. The compensation function serves to compensate for pain and loss of “joie de vivre”, while the redress function is intended to serve prevention in the aftermath of the misconduct and to sanction the norm up to soothing the patient’s negative feelings.2 From a comparative legal point of view,3 in forensic practice medical malpractice law in Germany is probably one of the most rigorously practiced. It is true that the legal consequences of medical malpractice in civil liability law are known, particularly from the US legal circle, in view of the punitive damages that may be possible there in individual cases, to be greater and in excess of compensation for the damage. The extraordinarily large number of successful medical malpractice lawsuits, on the other hand, enables patients in Germany to assert their claims relatively frequently— which is also due to facilitations of the burden of proof. This is also evident in the fact that doctors and hospitals have found the increase in insurance premiums in recent years to be depressing. For example, liability insurance premiums in the field of gynaecology with obstetrics have risen to more than 60,000 euros per year, which has often led to the closure of corresponding gynaecological departments.4

Legislative and Judicial Framework Conditions of Medical Malpractice Liability Since 2013, the law of the medical treatment contract is regulated by §§ 630a–630h BGB. The legislator has decided to codify the problem of medical malpractice liability, which had previously been regulated by the judiciary. The relevant provisions also substantiate tort liability of physicians in parallel.

1

Overview at Deutsch and Spickhoff (2014), ch. XV. Fundamental BGHZ 18, 149; see also Deutsch and Ahrens (2014), paras 697–700. 3 See also Deutsch and Schreiber (1985) and Fischer and Lilie (1999). 4 Laufs et al. (2021), ch. X paras 136. 2

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Medical Specialist’s Standard According to § 630a para. 2 BGB, the treatment has to be carried out according to the generally accepted professional standards existing at the time of the treatment, unless otherwise agreed. This wording is intended to substantiate or supplement the general definition of negligence contained in § 276 para. 2 BGB. According to § 276 para. 2 BGB, a person acts negligently if he or she fails to exercise reasonable care. In § 630a para. 2 BGB, the time-relatedness of the medical standard, which continues to develop, is emphasized. In all of these cases, the medical specialist’s standard may apply.5 Guidelines issued by the Medical Scientific Society can be adhered to as indication for concretization. The possibility of a deviating agreed upon standard, which is mentioned in the law in a somewhat surprisingly explicit manner, has been justified by the parties’ corresponding disposition options.6 Nevertheless, the parties are not in any way free to agree on a deviation from the required standard in the sense of any reduction of the liability scale or even a release from liability by way of an indemnity clause. However, there are special aspects of liability in the context of healing attempts or the application of new ground methods.7 It is also conceivable that the parties may agree to deviations from the medical standard if the patient does not wish to comply with certain standard measures. A prime example in this context is the Jehova’s Witnesses’ refusal to accept blood donations. Apart from that, however, caution should be exercised in accepting corresponding agreements to reduce liability. In many cases, the jurisdiction has considered an indemnity clause to be contrary to professional ethics and to public policy (§ 138 para. 1 BGB) and therefore to be void.8 The medical specialist’s standard applies to immediate treatment as well as to questions concerning the organization of a medical practice or clinic. Additionally, certain incorrect information towards patients is regarded as treatment error. This concerns the so-called therapeutic safety advisory which has been addressed in § 630c para. 2 cl. 1 and 2 BGB. According to this provision, the person treating is obliged to explain to the patient in a comprehensible manner at the beginning of the treatment and, where necessary, during the course of the treatment, all and any circumstances that are relevant to the treatment, in particular the diagnosis, the anticipated health development, the therapy and the measures to be taken on the occasion of and subsequent to the therapy. If circumstances are recognizable for the treating party which give rise to the presumption of malpractice, he or she shall inform the patient thereof not only on request, but also without request in order to avoid health risks. Therapeutic safety advisory therefore is not about information as prerequisite for the effectiveness of the patient’s consent as ground of justification, 5

See for example BGH NJW 1996, 780; BGH NJW 1987, 1480. BT-Drucks. 17/10488, p. 20. 7 Rehborn (2013), p. 497. 8 OLG Saarbrücken, NJW 1979, 2355. 6

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but rather about enabling the patient to take or refrain from taking measures that contribute to the success or failure of a previously performed treatment. This requires that he/she knows the diagnosis (e. g. cancer) in order to be aware of the fact that due to the weight of his/her illness, follow-up examinations and post-treatment are necessary as well as a behaviour adapted to the disease. The medical specialist’s standard must also be adhered to as far as the so-called self-determination education is concerned. Self-determination education is meant to enable patients to exercise their autonomy. Therefore, according to § 630e para. 1 cl. 1 BGB the person treating is obliged to inform the patient of all and any circumstances which are relevant to consent. This particularly includes the type, extent, implementation, anticipated consequences and risks involved in the measure as well as its necessity, urgency, suitability and prospects for success with regard to the diagnosis or the therapy. Alternatives to the measure must also be referred to in the information if several equally medically indicated, customary methods may lead to significantly different strains, risks or chances of recovery. With regard to compliance with the standard required here, § 630e para. 2 cl. 1 no.1 BGB stipulates that the information must be provided orally by the person treating the patient or by a person who has the necessary training to carry out the measure. Only supplementary reference can be made to documents that the patient receives in text form.

Presentation in Trial and Proof Substantiation Since—at least in the starting point—the principle of party presentation applies to the medical malpractice lawsuit as well, the patient has to establish the medical malpractice case conclusively. However, this only requires a minimum of comprehensible assertion, which allows the conclusion of malpractice. The demands on substantiation in medical malpractice cases are low.9 Even the constitutional right to be heard in accordance with Art. 103 para. 1 of the Basic Law for the Federal Republic of Germany (GG) is infringed if, for example, a court, surprisingly and without prior notice in accordance with § 139 of the Code of Civil Procedure (ZPO), dismisses the action on the grounds that a declaratory motion, in its wording, refers only to malpractice that was not present, but not to existing information errors.10

9

OLG Hamm MedR 2010, 563. BGH GesR 2010, 545; OLG Düsseldorf NJW 2000, 3438; OLG Koblenz MedR 2002, 359 rejected by OLG Karlsruhe VersR 2003, 374; OLG Köln VersR 2003, 375; OLG Köln VersR 1998, 1420. 10

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Experts A liability lawsuit against a physician or a hospital will rarely be possible without a medical expert opinion. Accordingly, the role of medical experts is often decisive for the outcome of the lawsuit. On the motion of a party, the court has the duty to involve an expert to clarify the medical facts of the case in the medical malpractice proceedings. If, in a medical question, the judge wants to base his assessment on findings from specialist literature alone without consulting an expert, he must state that he himself has the necessary expertise for the evaluation of this literature.11 However, it is often difficult to select an expert.12 If an expert declares himself not competent for a segment of the questions asked because this subsection is not within his area of expertise, another expert of the appropriate area of expertise has to be consulted.13 The authorized expert has the right to refuse an expert opinion under the same conditons under which a witness may refuse to testitfy—i.e. in the case of close relationship with one of the parties or in the case of danger of committing a criminal offence. As a rule, the public prosecutor or presiding judge will approach the physician before appointing him as an expert witness. The court has to deal with the expert opinion by means of questions to the expert and by discussing the expert opinion in the judgement itself. The written expertise regularly has to be explained by the expert in oral proceedings. In particular, a necessary clarification of contradictions between several experts, but also within a single expert opinion, gives rise to questions.14 In any case, legal assessments by experts must not be taken over without consideration. The parties may also provide private opinions. Then a court will have to deal with it. One often hears the accusation that doctors, as experts, rarely attest to other doctors’ mistakes. On closer inspection, however, this accusation often proves to be false. Although the expert is aware of the fact that he, in the future, could find himself in the situation of the offender as well, he usually provides an accurate picture of the state of medical science. The expert’s caution in assessing possible mistakes of a colleague is per se understandable. It is based on the subject’s susceptibility to damage, which, in case of doubt, the expert himself has already experienced. Generally speaking, an expert can only assess the actions of another physician reliably and competently if he himself was in the same situation and faced the same danger. Beyond a cautious reluctance not to accuse a colleague of an error prematurely, there is probably only rarely an open attempt to “cleanse”. Should this ever happen, formal or substantive errors are usually committed in such a way that this attempt to provide unjustified assistance in favour of the colleague is not concealed from the court and the parties.

11

BGH VersR 1993, 749. To this see Neuhaus and Krause (2006), p. 605. 13 BGH ZMGR 2009, 55; BGH VersR 2007, 376. 14 BGH VersR 2001, 783, 784; BGH MedR 2002, 28, 29 ¼ NJW 2001, 2791. 12

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Just like a judge, an expert can be rejected by the parties to the proceedings because of concerns of bias, §§ 74 Code of Criminal Procedure (StPO), 406 ZPO. The clarification of this exclusion clause—which is very case-specific—is in a relationship of mutual tension with the difficulty of finding suitable experts in the relevant fields. The more specific the question, the smaller the circle of potential experts. Moreover, there is a legitimate concern about biased opinions and the need to avoid (allegedly) one-sided experts.

Burden of Proof Principle and Exceptions As far as the burden of proof is concerned, the general rule that the claimant bears the burden of proof for the facts giving rise to the claim, while the defendant bears the burden of proof for the facts preventing or destroying the claim also applies in the medical malpractice proceedings.15 However, a number of exceptions to this rule assign the burden of proof to the physician. These exceptions have essentially been codified in § 630h BGB with respect to contractual liability since 2013. However, they have been developed by the jurisprudence in tort law and are therefore—and will continue to be—relevant in tort law as well. In the field of contractual liability, the presumption of fault according to § 280 para. 1 cl. 2 BGB is added. The significance of the presumption is, of course, small because the burden of proof for breach of duty (which includes malpractice as well as errors in providing information), for causality and for the damage is borne by the patient in principle. Since in German liability law—as in contrast to the area of German criminal law where fault is specified in an individual and subjective manner—fault is specified in a general and objective manner,16 there are hardly any cases for the application of the contractual presumption of fault in medical malpractice law—apart from cases of error or lack of ability to be at fault which, in both cases, in accordance with general principles is to be proved by the person who invokes it.17

Prima Facie Evidence Outside the scope of a legal regulation, the so-called prima facie evidence for the proof of causality and fault leads to a generally recognized facilitation of proof for the benefit of patients in appropriate constellations (as, for example, in the field of infection). The prima facie evidence usually applies if, based on medical experience,

15

Leipold (1966), p 43. In place of all BGH VersR 2001, 646; BGH VersR 2003, 1128; Deutsch (1995), p. 117. 17 In more detail Deutsch and Spickhoff (2014), paras 166. 16

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an observer is forced to imagine a certain course of events.18 Prima facie evidence for the proof of causality and fault of the hospital or the physician respectively was assumed in the following cases:19 A patient who had been placed in the room of a Scarlet Sick soon developed scarlet fever himself. In the clinic, a young person comes into contact with a fellow patient suffering from tuberculosis and contracts tuberculosis himself. A plaster bandage, which is designed to cure a fracture of the leg, is not split immediately after the occurrence of circulatory disturbances. After transfusion of a lues patient’s blood, the recipient also suffers from lues. A few days after a knee surgery, the repaired patella ligament ruptures. In the course of the administration of an epilepsy drug in the trial (phase III), irreparable eye damage occurs, which can be triggered by this drug. The physician can shatter the appearance of the patient’s claim by pointing out that an atypical course was possible.

Fully Manageable Treatment Risk If a “general” treatment risk which was “fully controllable” for the party treating and which has led to injury of life, limb or health of the patient has materialised, even the error of the treating party, i.e. the breach of duty within the meaning of § 280 para. 1 cl. 1 BGB, is to be presumed in the context of medical malpractice (§ 630h para. 1 BGB). The concept of a “general” treatment risk, which could theoretically be opposed to a “special” treatment risk, lacks a special sense. Also, this concept is not further defined in the explanatory memorandum. It therefore probably is an unthoughtfully used constituent element of the facts which hardly creates any added value in terms of content, at best causing confusion.20 It is important to stress that there is no presumption of causality by means of this clause. Classic constellations, based on the major case groups and principles of the previous jurisdiction, which have now been essentially codified with regard to the assignment of risk to the sphere of the treatment side in terms of evidence,21 are the following: the use of medical-technical equipment, compliance with hygienic standards (generally speaking, hygiene in hospitals is by no means “fully manageable”) and the “operational safety of nursing staff in hospitals”.22 Another classic case of application is the correct positioning of patients on the operating table.23

18

Laufs et al. (2021), ch. XI paras 55. RGZ 165, 336; BGH VersR 1960, 416; BGH VersR 1961, 613; BGHZ 11, 227; BGH VersR 1957, 252; OLG Köln ArztR 1997, 234; BGH VersR 2007, 995, 996, 997. 20 Like this already Deutsch (2012), pp. 2009, 2011. 21 See BGH VersR 2007, 847. 22 BT-Drucks. 17/10488, p. 28. 23 OLG Köln, VersR 1991, 695; further OLG Hamm, GesR 2006, 448 (impact with head to the upper edge of the vehicle during horizontal transport); KG ArztR 2006, 153 (wheelchair that is not crash-proof, used for the transport of a restless patient; confirmed by BGH). 19

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In contradiction to the genuine presumption of § 630h para. 1 BGB, the explanatory report24 states that the presumption basis can be refuted by shattering the judge’s conviction of the existence of the fully manageable treatment risk. This shattering of the judge’s conviction however, is a prerequisite, which can only be considered relevant in the context of the prima facie evidence.25 § 630h para. 1 BGB, however, requires a genuine refutation of the presumption by successfully adducing the counter-evidence to the full conviction of the court. The prima facie evidence therefore dogmatically—at least according to the prevailing opinion in Germany—is to be clearly distinguished from the genuine reversal of the burden of proof which is triggered by § 630h para. 1 BGB.26 The mere “shattering” of the judge’s conviction is too little to lead the counter-evidence to the full conviction of the court. That the presumption basis has to be refuted by counter-evidence adduced by the treatment side is equally not convincing.27 Rather, the patient generally has to prove the presumption basis, i.e. the prerequisites for the taking effect of the presumption.28

Consent and Information § 630h para. 2 BGB, according to which consent and information (§§ 630d, 630e BGB) are to be proved by the treatment side, offers nothing new. This is because this corresponds to the traditional distribution of the burden of proof which originates in the law of tort and which corresponds to the character of the justification ground of consent (including the patient’s information as central precondition of a valid consent) as defence as well as it has always been transferred to the area of contractual medical liability as well. Unlawfulness constitutes another unwritten part of the contractual liability for fault.29 It is important to recognize that the reversal of the burden of proof according to § 630h para. 2 BGB does not extend to the information duties according to § 630c BGB insofar as these reach beyond those of § 630e BGB. This is particularly relevant with regard to the so-called “therapeutic safety advisory” (non-observance of its principles may cause malpractice) and with regard to economic information. Likewise, there is nothing new in § 630h para. 2 cl. 2 BGB which addresses the case-group of the so-called hypothetical consent of the patient. § 630h para. 2 cl. 2 BGB concerns the treatment party’s objection that the patient would also have

24

BT-Drucks. 17/10488, p. 28. In place of all: Baumgärtel (1996), para 25. 26 BGH NJW 2004, 3624, 3625; Rosenberg et al. (2018), § 116 III 3; Jauernig and Hess (2011), § 50 para 25; Prütting (1983), p. 97; differently formerly Diederichsen (1966a), p. 211; ibid. (1966b) Karlsruher Forum, p. 21; ibid. (1968), pp. 45, 64. 27 BT-Drucks. 17/10488, p. 28. 28 In place of all Schilken (2014), para 471. 29 See Deutsch and Spickhoff (2014), paras 308–310. 25

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consented to the measure had (hypothetical) proper information been provided. In principle, the burden of explanation and proof for the hypothetical causation lies with the treatment side. In contrast to the draft bill, however, the “real conflict of decision” has not been poured into the law. However, the provision allows the previous jurisdiction on the “real decision conflict” to be maintained.30 Accordingly, the patient in response to the objection of hypothetical consent merely has to state that he/she then was in a comprehensible doubt of decision (a “real decision conflict”).

Insufficient Documentation The consequences of inadequate documentation, which does not primarily serve forensic purposes of the evidence, but serves the organizational security of a treatment of the patient as uncomplicated as possible, is governed by § 630h para. 3 BGB in respect to evidence. Unrecorded measures or non-recorded results that should have been recorded or retained in accordance with § 630f BGB are assumed to not have been “carried out”, i.e. to not have been taken.31 Unfortunately, the law does not make any further distinction between documentation and the obligation to assess and record findings.32 Again, it is important to note that the reversal of the burden of proof only reaches as far as the findings would have yielded a result that requires a reaction on the part of the patient.33 Following the case law, the findings assessment error is addressed in § 630h para. 5 cl. 2 BGB.

Insufficient Qualification, Especially Beginner’s Surgery The so-called beginner’s error is governed by § 630h para. 4 BGB. If adequate supervision of the beginner is not documented in sufficient detail, insufficient supervision is assumed (§ 630h para. 3 BGB). In conjunction with paragraph 4, this can imply the presumption of causality as well. § 630 para. 4 BGB regulates an excerpt of the broad range of organisational errors that are otherwisely not addressed in more detail in the text of the law. In the context of information that has to be provided to the patient, in § 630e para. 2 cl. 1 no. 1 BGB, the word “qualification” of the person who provided the self-determination education is replaced by the property of the “training” necessary for it. Concerning the treatment itself, (lack of) “qualification” is relevant. According to the explanatory

30

BGH VersR 1998, 766, 767. Following BGHZ 129, 6, 9; Staudinger (2009), § 823 para I 72; Spickhoff (2014), § 823 para 123. 32 Which corresponds to the common doctrine; see Laufs et al. (2021) ch. IX paras 50; Staudinger (2009), § 823 para I 71, 73; Deutsch and Spickhoff (2014), paras 523, 526; Spickhoff (2014), § 823 paras 124, 132. 33 BT-Drucks. 17/10488, pp. 29, 30. 31

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memorandum,34 § 630h para. 4 BGB particularly deals with so-called beginner’s errors. These are to be avoided by the necessary professional qualification. The difference in the wording of § 630e para. 2 cl. 1 no. 1 BGB (“training” instead of “qualification”) is intended to point out the requirement of a completed professional training as well as the associated necessary theoretical qualification for the implementation of the planned measures.35 At least as far as the “qualification” is concerned, it is not sufficient for the patient to prove that the person performing the procedure for example hasn’t formally completed his/her residency. Rather the patient will have to state and prove that the relevant specialist period and the necessary stages of training had not been accomplished yet so that appropriate control would have been required (provided that this had not happened). Occasionally, specialist examinations are not carried out although the necessary stages of education have long since been completed, simply because a corresponding post at the hospital in which the future specialist works and which he is supposed to receive cannot yet be (re-)occupied. Nonetheless, even without being allowed to hold the corresponding title, the relevant physicians already have the required level of competence. However, if the patient rebukes the lack of a specialist examination and on this basis the lack of competence, the treatment side will have to contest this pleading in substantiated terms. In such case, the existing skills despite the absence of an examination have to be demonstrated by precise presentation of all stages of education that have been completed successfully. It is then incumbent upon the patient, if necessary, to state in turn why the required competence of the physician should not have been present. If all stages of education had already been completed at the time of the implementation of the measure and if the specialist examination has been passed successfully shortly after the treatment, the required qualification at the time of the measure will have to be assumed.

Gross Malpractice The last, but “most famous” rule for reversal of the burden of proof in the medical malpractice lawsuit is regulated in § 630h para. 5 BGB. The first sentence in this paragraph deals with gross malpractice. First of all, the burden of proof lies with the patient. § 630h para. 5 BGB relates to fundamental, objectively severe errors. Their causality for the “first” damage (physical or health injury, sometimes called primary damage) is suspected. The problem with this reversal of the burden of proof lies, dogmatically, in the fact that it has never been possible to place it on a foundation that can withstand dogmatically strong. Essentially, this is an equity decision. The attempt to justify this procedural rule by stating that it is necessary to compensate for the fact that the range

34 35

BT-Drucks. 17/10488, p. 30. BT-Drucks. 17/11710, p. 38.

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of possible causes for the damage has been particularly extended or shifted by the error,36 suffers from the fact that the severity (in the sense of unambiguousness) of an error does not in any way increase the probability of causality for damage in all cases, especially since even several ordinary malpractices can quasi be “added” to gross malpractice.37 The explanatory memorandum does not extend here either.38 It is hardly conceivable why, in contrast to gross malpractice, it should “not be more difficult” for the patient to clarify the treatment process in the event of an ordinary malpractice. However, in terms of legal policy it is true that unlike legislative proposals in Germany, it would be inappropriate (the explanatory memorandum calls it “grossly inequitable”) to extend the reversal of the burden of proof in § 630h para. 5 cl. 1 BGB to ordinary malpractice at the expense of the treatment side. The legal consequence of the genuine reversal of the burden of proof with regard to causality giving rise to liability (so-called “haftungsbegründende Kausalität”) can certainly cause practical hardship in Germany. The trouble is that counter-evidence—which is subject to the standard of proof of § 286 ZPO—can only be led by proving to the full conviction of the court that causality is “extremely unlikely”.39 Therefore, for the general suitability of the causality, it is sufficient that a possible contributory causality of the respective treatment error is merely considered. It goes without saying that mere general suitability is clearly less than probable suitability for the injury felt.

Gross Malpractice and Ordinary Findings Assessment Error In § 630h para. 5 cl. 2 BGB, jurisdiction of the German Federal Supreme Court (BGH) has been cast into law which further aggravates medical malpractice liability which is stringent already. The (ordinary) findings assessment error is affected. The reversal of the burden of proof with regard to causality applies accordingly even if the treating party omitted to take or record a medically-necessary finding in good time where the finding would with sufficient certainty have led to a result which would have given rise to further measures, and if failure to carry out such measures would have constituted gross malpractice. The following case may serve as an example: in the aftermath of a traffic accident, a victim, suffering from many bone fractures and injuries, is admitted to trauma surgery. Due to an ordinary findings assessment error one of the fractures, a pelvis ring fracture, is overlooked. As a result of this, the pelvis ring fracture has not been treated adequately which—if the pelvis ring fracture had been noted—would have caused gross malpractice. Notwithstanding the gross malpractice, these

Steffen and Pauge (2013), para 1515; similar Spickhoff (2014), § 823 para 168. BGH MDR 1994, 1187; OLG Celle VersR 2002, 1558. 38 BT-Drucks. 17/10488, p. 31. 39 BGH VersR 2011, 1148. 36 37

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consequences would, according to the expert, with a 90% probability, have occurred even with the treatment being adequate and the diagnosis being accurate. Nevertheless, the complaint was granted.40 Strictly speaking, an ordinary findings assessment error combined with hypothetical gross malpractice is taken as an occasion to carry out the corresponding reversal of the burden of proof with regard to causality. However, it is hardly justifiable from a legal-political point of view, why at least the causality of the ordinary findings assessment error for the (“hypothetical”) gross malpractice is not subject to the ordinary standard of proof of § 286 ZPO. In this respect, the law takes over the jurisdiction of the liability senate of the BGH41 quite unreflectedly so that to this extent “sufficient probability” suffices. Strictly speaking, in the event of an ordinary findings assessment error, there is a combination of a reduction of the standard of proof concerning the causality of the omission (failure to provide the required findings) for the hypothetical findings, with this omission being classified as gross malpractice, thereby triggering the reversal of the burden of proof until the felt effect of the injury, i.e. with regard to the remainder of the causality giving rise to liability (occasionally also referred to as primary damage).

State Liability and Private Liability Only in exceptional cases will physicians hold a public office. In this case, only a public-law relationship arises within which the state is liable for the official according to the principles of public liability. The bases of liability are old and very controversial from a legal-political point of view. They can be found in § 839 BGB and Art. 34 GG. In principle, official liability applies in the event of an intentional or negligent breach of duty by an official vis-à-vis a third party. Art. 34 GG rules that this liability is transferred to the State. However, the State and its public officials are only liable in a subsidiary capacity vis-à-vis other liable parties. If its officials act negligently, the State can only be held liable if the injured party is unable to obtain compensation by other means. If, for example, a physician works as a troop physician for soldiers of the Federal Armed Forces, the aforementioned applies.42 In principle, an official liability claim can arise in cases where the liability of emergency physicians in the context of a rescue operation is at stake, provided that the performance of the rescue service tasks is attributable to sovereign activities. When and where this is the case it is regulated by state law.43 According to the latest jurisdiction, so-called accident insurance consultants who take action in the context of workplace accidents in order to examine whether an employee is still able to work

40 BGH VersR 2004, 909 ¼ NJW 2004, 2011; to this Katzenmeier (2004), p. 1030; Spickhoff (2004), p. 2345; as to this please also see Spickhoff (2008), pp. 7, 83. 41 To this Spickhoff (2014), § 823 paras 193, 194, also referring to BGH NJW 1996, 1590. 42 BGH NJW 1990, 760. 43 For Bavaria see BGHZ 153, 269.

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or is in need of treatment are, in principle, not liable themselves; their liability is transferred to the State, as long as there are no other liable persons (like for example the person, that culpably caused the workplace accident).44 Overall, the remaining dichotomy of private medical malpractice liability (this is the vast majority of cases) and medical malpractice under State liability in Germany has turned out to be rather unfortunate. This is not least due to the subsidiarity of state liability in Germany which is generally perceived to be rather unfortunate in terms of legal policy. In addition to this, some difficulties in delimitation (like those that have arisen against the background of the most recent jurisdiction in cases of liability for accident insurance consultants) often lead to even experienced lawyers suing the wrong party. After many years of trial, the patient then receives an unsatisfactory judgment as the defendant didn’t have the standing to be sued. In addition to this, if this could or has not been prevented by a third-party notice, there is a risk that the limitation period for claims against the “correct” defendant—which is usually 3 years and commences at the end of the year in which the claim arises if the patient or his lawyer obtains knowledge of the circumstances giving rise to the claim and of the identity of the obligor or would have obtained such knowledge if he had not shown gross negligence—might expire.

Out-of-Court Dispute Resolution: Arbitration Boards and Expert Panels, Mediation Since the mid-1970s, following developments in the United States, the State Medical Associations have set up arbitration boards and expert panels to serve a purpose which has become widely known far beyond the narrow scope of medical malpractice law, namely the out-of-court settlement of medical malpractice claims.45 Such panels have meanwhile been set up and operate for the entire Federal Republic of Germany. While the so-called arbitration boards examine the dispute to the merits, the expert panels focus on medical malpractice. In any case, the violation of the obligation to provide information is not investigated readily.46 Pursuant to § 278 para. 2 ZPO, any oral hearing in civil proceedings since 2002 must be preceded by a conciliation hearing for the purpose of arriving at an amicable resolution of the legal dispute, unless efforts to reach an agreement have already been made before an alternative dispute-resolution entity. In this respect, the medical arbitration boards and expert advisory bodies are also addressed. However, it should be borne in mind that the scope of the arbitration bodies and expert advisory bodies may be limited to the basis of liability (or parts thereof).47 If the reason for liability is 44

BGH NJW 2017, 1742 (to this Spickhoff (2017b), LMK 388784); BGH NJW 2017, 1745. For further details see Deutsch and Spickhoff (2014), paras 836. 46 Weizel (1999), p. 42; Matthies (1981), pp. 1099, 1100. 47 Gehrlein (2002), p. 935 seems to overlook this. 45

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undisputed as a result of the arbitration board’s vote between the parties, but not the extent of liability, unsuccessful involvement of an alternative dispute-resolution entity has not yet taken place. Therefore, a conciliation hearing, which really discusses the asserted claim in its entirety, should only be dispensed with if it appears to be clearly unsuccessful. However, things are different if one of the parties does not accept the arbitration board’s vote with regard to the basis of liability or with regard to a deviation from the medical standard, irrespective of whether one or the other may have been assessed as substantiated or not by the arbitration board or the expert panel. In this case, even if the question if and to which amount a damage has been caused has not yet been negotiated, it can still be assumed that an (unsuccessful) attempt has been made to reach an agreement in front of an alternative dispute resolution entity. In such cases, no further preceding conciliation hearing is required. The procedure is governed by statutes, standing rules or rules of procedure. The initiation of the procedure is voluntary for all parties involved (physician and patient). The principle of oral proceedings does not apply. The panel also selects the experts, generally without the participation of the parties. Arbitration bodies and expert panels are not arbitration courts (§§ 1025 and further ZPO). They are therefore not binding for subsequent legal proceedings. However, it is possible to appoint the experts who have acted as experts in the arbitration procedure or the Commission procedure. Nevertheless, it should not be overlooked that, after the arbitration or expert opinion procedure has been completed, the verdict will probably only be challenged in a relatively small number of cases, and in an even smaller number of cases, a later court decision will lead to a different result. The procedure before arbitration boards or expert panels at the Medical Chambers is basically free of charge and costs for patients. It is doubtful whether the patient’s or the physician’s lawyer’s fees that have incurred in the context of the arbitration or expert opinion proceedings are to be reimbursed by the opposing party. As a rule, the by-laws, standing rules or rules of procedure provide for a deductible for the attorneys’ costs. In any case, it has been decided that the corresponding costs can be reimbursed in the context of subsequent legal proceedings if the complexity of the medical malpractice issues renders representation by a lawyer both appropriate and necessary. The costs for legal representation in the proceedings before the arbitration board for medical malpractice have also been regarded necessary for the treatment side in order to be able to bring an appropriate action in accordance with § 91 para. 1 ZPO so that a hearing fee as well as an evidence fee could be claimed.48 The findings of the arbitration board or the panel of experts can, but do not have to, be accepted by the parties. If approved, this may mean that, for example, the patient accepts by concluding a contract with the physician that the latter is not liable. On the other hand, the physician may concede the established malpractice. Correspondingly, the respective facts are dealt with in the subsequent trial; only the

48

OLG Bremen MedR 2003, 639 (lawyer’s fees); LG Baden-Baden MedR 1987, 159.

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amount of the entitlement remains open.49 Moreover, the vote of a conciliation board or an expert panel does not formally bind a state court either positively or negatively, also with respect to the liability reason. However, the vote can at least be included in the process by means of documentary evidence—apart from the inclusion of the experts appointed in the arbitration or expert opinion procedure.50 The question of whether legal aid is to be granted if the patient has not previously called on a conciliation body or the expert panel has been answered inconsistently. The majority opinion is right to conclude that it is not necessary to call on a conciliation or expert panel before taking legal action in state courts in order to obtain legal aid.51 The possibility of mediation in the physician-patient relationship has not been the focus of discussion in Germany so far.52 If the material compensation for damages suffered by the patient is concerned, mediation is considered to be of little use if the reason for liability is disputed. The situation is different with regard to the level of liability alone and, above all, when patients are primarily concerned with an apology on the part of the treatment side.

Ongoing Legal-Political Discussion in Germany and Lex Ferenda “After the reform is before the reform” is a statement that can be read in Gerhard Wagner’s new commentary on the law of medical treatment contracts.53 Although it has only been in force since 2013, a reform of the law on medical malpractice is once again (or still) being discussed in Germany, mostly in favour of increased patient protection. The hardship fund solutions proposed by Hamburg and Bavaria for victims of malpractice are rejected as being contrary to the system. Indeed, the experience gained with this kind of funds in Austria raises doubts about the efficiency of such solutions. Maximum liability limits do not exist in Germany in the law of medical malpractice liability and hospital liability and are not advocated within the scope of liability based on fault. In terms of legal policy, there is no need for strict liability or absolute liability within the framework of medical malpractice liability and hospital liability (other than in the Europeanized product liability law for medical devices and within

49

See for example LG Baden-Baden MedR 1987, 159; LG Hannover VersR 1989, 1301. BGH NJW 1987, 2300; as in concern to the legal aid procedure OLG Köln VersR 1990, 311. As in regard to the consequences of expert panel decisions see further Neumann (2003), p. 326. 51 OLG Düsseldorf VersR 1989, 645; OLG Celle AHRS 7400/3; OLG Oldenburg MedR 1988, 274; differently LG Aurich NJW 1986, 792 with rejective remark by Matthies; LG Dortmund JZ 1988, 255 with rejective remark by Giesen. 52 To this for example Laufs et al. (2021), ch. X paras 119 with further references. 53 Münchener Kommentar zum BGB (2020), Vor § 630a para 33. 50

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the scope of pharmaceutical liability according to the special regulations of §§ 84 and further of the German Medicinal Products Act (AMG)). Medical liability means professional liability. In Germany, there is currently no direct claim against the liability insurer of physicians who are obliged to take out sufficient professional liability insurance in accordance with the (compulsory) professional code of conduct of the medical chambers of the federal states and so far such a direct claim has rarely been proposed, although it could be reasonable. However, maximum insurance amounts do not in any case limit the liability of physicians and hospitals. Rather, the so-called principle of “Totalreparation” applies (i.e. the entire damage—costs of healing, additional demand, full—probable—loss of earnings and intangible damages—must be compensated for by the liable party). It should be noted that in Germany there is a panel specialised in medical malpractice liability (chamber or senate) at almost all regional courts (LG), at all higher regional courts (OLG) and at the Federal Supreme Court (BGH). This is consistent with corresponding considerations on legally prescribed specialization of panels which are brought forward from outside medical liability law in Germany, too. However, specialisation in medical malpractice cases in Germany has not yet been prescribed by law, but is regarded as irrefutably expedient by all courts and is therefore carried out within the framework of their autonomy. Only professional judges and thus qualified lawyers, not doctors as lay judges, will decide. The latter would easily create the impression of bias in patients as plaintiffs. Hence, the importance of physicians who are as neutral as possible in the medical malpractice lawsuit resides in their role as experts.54 Overall, the practice of medical malpractice liability in German civil proceedings, particularly with regard to the strictness of the duty to provide information, is partly regarded as very or too strict,55 while others still regard it to be not living up to the necessary protection of patients. In the light of the strictness of German medical malpractice law in international comparison, the latter criticism appears to be too extensive. A further strengthening of medical malpractice liability in Germany would increase the danger of the so-called defensive medicine. On the other hand, jurisdiction has led to an approximate state of “equality of arms” between the treatment side and the patient side by means of a large number of measures that have been codified in the law since 2013. Therefore, there is little reason to significantly increase medical malpractice liability in Germany. However, a legal comparison shows that certain alleviations of the burden of proof like the presumption of malpractice due to “fully controllable treatment risks” or the alleviation of the burden of proof in the case of gross malpractice or hypothetical gross malpractice respectively (both laid down in §§ 630h para. 1 and

54 55

For specialization of panels see Spickhoff (2017a), p. 67. See Laufs et al. (2021), ch. V paras 78 (“exaggerated schedule of duties and criticism in detail”).

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para. 5 BGB) have hardly—at least not within the EU—served as a model. Only in Turkey, the Turkish Court of Cassation56 did not grant a reversal of the burden of proof of causality in cases of gross medical malpractice, but, however, assumed a presumption of fault in favour of the patient. The latter, of course, according to § 280 para. 1 cl. 2 BGB, applies to all (not only gross) cases of an established breach of duty in Germany. This should also be taken into account when assessing the situation with regard to legal policy. Because of this, it is more interesting that there is consideration that in the case of established or suspected malpractice (like for example according to § 630h para. 1 BGB—fully controllable risk areas) the standard of proof for causality should be lowered to that of prevailing probability.57 The question remains, whether an additional reversal of the burden of proof of causality for primary damages due to gross malpractice and, in individual cases, also due to ordinary findings assessment errors (§ 630h para. 5 BGB) would still be necessary. From a legal-political point of view, such a reversal of proof is hardly justifiable; apart from considerations of equity or the aspect of some kind of penalty burden of proof—which is heavily criticized dogmatically—there are hardly any arguments in favour of these rules.58 In the event of a corresponding reduction of the standard of proof, which would go along well with the standard of proof for determining the amount of damage (in this respect, the standard of proof of probability is to be applied according to the overall opinion as concerns § 287 ZPO in any case), German medical malpractice law would, in this respect, come within the scope of European consensus again. From the German legal dogmatic point of view, however, the follow-up question arose as to whether and why the lowering of the corresponding standard of proof for causality would be limited to medical malpractice liability. Therefore, from a legal-political point of view, it would be preferable if German procedural law did not set full conviction of the court (i.e. almost 100%) as standard of proof (e.g. for establishing causality), but—as is arguably the case in the majority of other procedural legal systems—if the standard of proof of prevailing probability sufficed, especially with regard to the causality of a medical error for the respective injury. The corresponding proposal, which has been presented repeatedly in Germany, seems appropriate. A respective reduction of the standard of proof would presumably also eliminate the practical need for the relevant special rules on the distribution of the burden of proof.

56

Yarg 13. HD, T.14.3.1983, E. 1982/7237, K.1983/1780; Yarg. HGK, T.13.04.2011, E. 2010/13717, K.2011/129. 57 Laumann (2017), p 4; also see Spickhoff (2008), pp. 7, 69; ibid. BT-Ausschuss Drucks. 17 (14) 0326 (4) v. 9.10.2012. 58 In place of all Laufs et al. (2021), ch. XI paras 91 with further references.

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References Baumgärtel G (1996) Beweislastpraxis im Privatrecht. Heymann, Köln, para 25 Deutsch E (1995) Fahrlässigkeit und erforderliche Sorgfalt, eine privatrechtliche Untersuchung, 2nd edn. 1995. Heymann, Köln, p 117 Deutsch E (2012) Deutsche Sonderwege zur Arzthaftung. NJW 2012:2009 Deutsch E, Ahrens H-J (2014) Deliktsrecht, 6th edn. 2014. Vahlen, Munich, paras 697–700 Deutsch E, Schreiber H-L (1985) Medical responsibility in Western Europe. Springer, Heidelberg Deutsch E, Spickhoff A (2014) Medizinrecht, Arzneimittelrecht, Medizinprodukterecht und Transfusionsrecht, 7th edn. 2014. Springer, Heidelberg, ch. XV, paras 166, 308–310, 523, 526 Diederichsen U (1966a) Zur Rechtsnatur und systematischen Stellung von Beweislast und Anscheinsbeweis. VersR 1966:211 Diederichsen U (1966b) Zur Beweislastverteilung bei Schadensersatzansprüchen aus Vertrag, Delikt und Gefährdungshaftung. In: Karlsruher Forum 1966. Karlsruhe, p 21 Diederichsen U (1968) Fortschritte im dogmatischen Verständnis des Anscheinsbeweises. ZZP 81:45–64 Fischer G, Lilie H (1999) Ärztliche Verantwortung im europäischen Rechtsvergleich. Heymann, Köln Gehrlein M (2002) Arzthaftungsrecht nach der ZPO-Reform. VersR 2002:935 Giesen D (1988) Anmerkung zu LG Dortmund 17 O 23/86. JZ 1988, p 255 Jauernig O, Hess B (2011) Zivilprozessrecht, 30th edn. 2011. Beck, Munich, § 50 para 25 Katzenmeier C (2004) Umkehr der Beweislast bei groben Behandlungsfehlern. JZ 2004:1030 Laufs A, Katzenmeier C, Lipp V (2021) Arztrecht, 8th edn. 2021. Beck, Munich, ch. V, IX, X, XI Laumann K-J (2017) 3 Jahre Patientenbeauftragter und Pflegebevollmächtigter der Bundesregierung: Eine Zwischenbilanz (9th of May 2017). http://www. patientenbeauftragter.de. Accessed 18 May 2017 Leipold D (1966) Beweisregeln und gesetzliche Vermutungen. Duncker & Humblot, Berlin, p 43 Matthies K-H (1981) Probleme der Verjährung bei Anrufen einer ärztlichen Gutachter- oder Schlichtungsstelle. VersR 1981:1099 Matthies K-H (1986) Pflicht zur Anrufung der ärztlichen Schlichtungsstelle. NJW 1986:792 Münchener Kommentar zum BGB (2020) Münchener Kommentar zum BGB, 8th edn. 2020. Beck, Munich, Vor § 630a para 33 Neuhaus K-J, Krause DM (2006) Die Auswahl des Sachverständigen im Zivilprozess. MDR 2006:605 Neumann G (2003) Konsequenzen von Entscheidungen aus Gutachterkommissionen. MedR 2003:326 Prütting H (1983) Gegenwartsprobleme der Beweislast, eine Untersuchung moderner Beweislasttheorien und ihrer Anwendung insbesondere im Arbeitsrecht. Beck, Munich, p 97 Rehborn M (2013) Patientenrechtegesetz 2013 - Behandlungsvertrag, Mitwirkung, Information, Einwilligung, Aufklärung (Teil ½). MedR 2013:497 Rosenberg L, Schwab H, Gottwald P (2018) Zivilprozessrecht, 18th edn. 2018. Munich, Beck, § 113 III 3 Schilken E (2014) Zivilprozessrecht, 7th edn. 2014. Vahlen, Munich, para 471 Spickhoff A (2004) Grober Behandlungsfehler und Beweislastumkehr. NJW 2004:2345 Spickhoff A (2008) Folgenzurechnung im Schadensrecht: Gründe und Grenzen. In: Lorenz E (pub.) Karlsruher Forum 2007. Karlsruhe, pp 7, 69, 83 Spickhoff A (2014) Medizinrecht, 2nd edn. 2014. Beck, Munich, § 823, paras 123, 124, 132 Spickhoff A (2017a) Zur Spezialisierung von Spruchkörpern: Pro und Contra. In: Althammer C, Weller M (pub.) Europäische Mindeststandards für Spruchkörper. Mohr Siebeck, Tübingen, p 67 Spickhoff A (2017b) Haftungsregime für Durchgangsärzte bei der Diagnosestellung. LMK 2017:388784

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Staudinger (2009) Kommentar zum BGB. Ed. 2009. Sellier De Gruyter, Berlin, § 823 paras I 71, 72, 73 Steffen E, Pauge B (2013) Arzthaftungsrecht, 12th edn. 2013. RWS, Köln, para 1515 Weizel I (1999) Gutachterkommissionen und Schlichtungsstellen für Arztpflichtfragen. Dr. Kovac, Hamburg

Chapter 9

Challenges and Contradictions About Medical Malpractice in Hungary Balázs Tőkey

Abstract The current situation of medical malpractice is controversial in Hungary. On one hand the number of medical practice claims is rather law, the courts confirm the fault of healthcare providers quite often and the judicial practice have changed in several aspect to help the plaintiffs who are in disadvantageous position. On the other hand the final compensation are rather low, the liability insurances of the healthcare providers do not ensure real coverage and the alternative dispute resolutions are almost unknown. However, major reforms are not expected in this field in the near future.

General Issues and Numbers About Medical Malpractice in Hungary Before giving a short analysis about the Hungarian medical malpractice we should interpret the Hungarian healthcare system in few words. The Hungarian healthcare system is built on a compulsory, solidarity based health insurance system which has a single payer (Boncz 2009). The clear majority of hospitals are owned and financed by the state. The most important supplier and supporter of healthcare services is the National Healthcare Service Center and healthcare services are funded by the National Health Insurance Fund. It means that the private healthcare services are limited for outpatient treatments which are not typical cases of medical malpractice and private hospitals have no significant role in the Hungarian healthcare system. This fact explains that there are no differences in regulation concerning compensation schemes for medical malpractice in public and private hospitals. According to section 108 (2) of the Act CLIV of 1997 on healthcare only those healthcare providers can receive an operating license which have concluded a B. Tőkey (*) Department of Civil Law, Eötvös Loránd University, Faculty of Law, Budapest, Hungary e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_9

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liability insurance contract. However, the minimal coverage, limits and other conditions are not prescribed by the law. The other problem is that there are only two insurance companies on the market which offer liability insurances for health care providers. Moreover, one of them offers insurances just for healthcare providers which employ less than 20 doctors. It means that the other insurance company is in a monopole position on the market of hospitals. The third problem is that insurance companies can refuse the conclusion of a liability insurance with a healthcare provider. These circumstances have the following effects on the market: the insurance premiums are rather high and have a growing trend, the annual coverage limits are really low—typically approx. 16 000 euros—and the insurance policies are full with exclusion terms (Zákány 2007). E.g. it is typical that a liability insurance does not cover those medical malpractice cases when the harm of the patient is based on lack of informed consent (Kiss 2017). So it happens quite often, that hospitals do not have a liability insurance despite the legal prescription or they have just a formal liability insurance without real coverage because the damages always exceed the very low annual coverage limit and therefore the premium of these insurance are higher than the annual coverage limit. It means that having this liability insurance is a clear loss for these hospitals every year without receiving any protection. Normally the state owned hospitals are the defendants of medical malpractice claims. The National Healthcare Service Center has complied statistics on medical malpractices cases from 2011, the most recent numbers are from 2015 (Kriveczky 2017). According to these statistics the courts receive approx. 150–180 new medical malpractices cases each year. However, there is a growing tend about the number of medical litigation cases—according to the latest unofficial numbers they could be approx. 400 in a year—there are no signs of a tendency to limit the number of medical litigation cases because this number is still not high. The reason for the low numbers of medical malpractice cases could be that patients cannot realize in several cases that they have become a victim of a medical malpractice because of lack of information. Thus the latency of medical malpractice is relatively high in Hungary. The average litigated amounts claimed by the plaintiffs are between 10 and 18 Million Hungarian Forints (approx. between 31 thousand and 57 thousand euros). These law numbers explains the lack of inclination to use various mechanisms in order to diminish the amount of financial compensation. However, the claimed amounts are not high—the first final judgment which awarded a claim over 100 Million Hungarian Forints (approx. 310 thousand euros) for a plaintiff was a case from 2018—only 15 percent of the litigated amounts are awarded by the courts with binding force. However, other sources state that the courts confirm the existence of medical malpractice in 4 from 5 cases (Pribula 2011). In contrast it is not a surprise that the most infected treatments by medical malpractice are obstetricsgynecology, surgery and orthopedy (more than 60% of all medical malpractice cases are coming from these fields). Moreover in more than one third of the cases the courts examine the existence of informed consent (Dósa 2006). In general the legal frame of medical malpractice in Hungary is rather conservative or conventional. The overall compensation scheme for medical malpractice is organized within the court system and it is not possible to discern a mixture (hybrid)

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way of procedural arrangements. The compensation schemes fulfill a pure indemnity function (without a personalization of healthcare damage) and do not serve additional punitive purposes. The litigation procedures are long: usually 4–5 years, but there are cases which last about ten years. One reason of the delay of these litigation procedures could be that the courts likes the interlocutory judgments when they decide just about the liability but they do not decide about the damages (Farkas 2017a). In such cases the court could decide about the damages just after that the interlocutory judgment has become a final decision.

The Relevant Legal Framework for Medical Malpractice in Hungary The healthcare providers shall be liable for the medical malpractice. Though there is a contractual relationship between the patient and the healthcare provider, the rules of tort liability shall apply for medical malpractice cases according to section 244 (2) of Act CLIV of 1997 on healthcare. The reason of this exception is that the new Hungarian Civil Code (Act V of 2013 on the Civil Code) distinguishes between tort (delictual) and contractual liability and contractual liability is a much stricter liability—it is similar to the norms of CISG (United Nations Convention on Contracts for the International Sale of Goods)—than tort liability. And the healthcare providers could not fulfill the requirements of this strict liability thus the legislator has prescribed this exception—the application of the norms of the less strict tort liability for the contractual relationship between the healthcare provider and the patient. Section 6:519 of the Civil Code contains the general provisions on tort liability: any person who causes damage to another person wrongfully shall be liable for such damage. The tortfeasor shall be relieved of liability if able to prove the lack of his fault. It means that he acted like that what could reasonably be expected. So one condition of the liability for medical malpractice is the existence of fault. The relevant standard of care is determined without a specific reference to the medical science within international perspective. According to section 77 (3) of the Act CLIV of 1997 on healthcare all patients shall be treated with the due diligence which could be expected from the persons providing health care services—observing the professional and ethical norms (this is the requirement of reasonable due diligence). The wording of the act was different before because it contained the expression “the highest due diligence”, but the amendment—deleting the word “highest”—had no influence on the jurisdiction. It means that there is no objective liability in the medical malpractice cases but the courts apply an increased expectation in the healthcare of the patients. E.g. the healthcare provider could be liable in those cases as well if all professional and ethical norms were fulfilled during the treatment but the reasons of the patient’s complaints were not detected though they

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were detectable with the expected due diligence (see the decision of the Hungarian Supreme Court Nr. BH2006.400.). The requirement of reasonable due diligence also includes that the healthcare provider shall organize its activities so that performing each task does not hinder each other and does not result any delay in the patient’s care (see the decision of the Hungarian Supreme Court—so called Curia—Nr. BH2013.150.). However, we can say that physicians’ obligation is determined as a pure obligation of means, characterized by diligence and irrespectively of the attainment of a specific result. There is no special normative framework for identifying the existence of an accidental risk related to the physicians’ performance. It shall be taken into consideration in the frame of casual relationship. However, we emphasize that according to the court practice loss of chance damages could be reimbursed in medical malpractice cases (see the decision of the Hungarian Supreme Court Nr. BH2012.10.). According to the judicial practice the existence of a lost chance shall be examined as the existence of a fault and not in the frame of causality (Farkas 2017b). This lost chance shall be a so called realistic chance. It means that this chance must be more than a low theoretical one, we should count with it as a real and possible outcome. In one case, where the experts estimated the patient’s chance of survive under 5% the court stated that this chance is not a realistic chance (see the decision of the High Court of Appeal of Szeged Nr. BDT2013.2841). However, it is not clear how high the reimbursement in such cases should be. According to a high court decision (see the decision of the High Court of Appeal of Szeged Nr. BDT2017.3649) the judicial practice follows the principle that the plaintiff has a right to a proportional compensation which is lower than her/his actual complete damage. However, this decision was overruled by the Hungarian Supreme Court (see the decision Nr. Pfv.22.375/ 2016/6.) stating that the injured party shall be fully compensated what means that compensation could not be lower than her/his complete damage. The other challenging question about medical malpractice cases is how to determine the burden of proof. According to the Civil Code the patient is required to demonstrate the causal connection and the received damage and the health care provider shall prove the lack of fault. However, the courts have started to strengthen patients’ weaker position from the beginning of the twenty-first century. It means that according to the new judicial practice the patient shall prove—in the frame of casual relationship—only the fact that the worsening of his health status occurred during the treatment by the health care provider (see the decision of the Hungarian Supreme Court Nr. BH2011.282.). The reason of this practice is the following: the patient who should prove the causality has nor knowledge neither skills to do it and cannot attach the written evidences because all the documentation about the treatment is in the hospital’s possession. On one hand this change in the judicial practice have a clear influence on the outcome of the medical malpractice cases: the winning rate of plaintiffs in medical malpractice cases in Hungary has become one of the highest rates in Europe (Pribula 2011). On the other hand the legislator legitimated this practice when the Act CXXX of 2016 on the Code of Civil Procedure entered into force on the 1st of January 2018. The new code established a new legal institution called evidentiary

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predicament. Section 265 (2) prescribes that “evidentiary predicament shall be considered to exist if the party proves presumptively that: (a) the opposing party controls all data which are considered indispensable for his motion for the presentment of evidence, and proves that he has taken appropriate measures to obtain such data; (b) evidencing factual claims is beyond his means, however, the opposing party can be expected to refute the facts alleged; or (c) the successful taking of evidence failed due to reasons attributable to the opposing party, and the opposing party did not prove presumptively the opposite of what is contained in Paragraphs a)-c).” And according to section 265 (3) “where an evidentiary predicament exists, the court may recognize factual claims to be corroborated by the party under such predicament as true, if there is no doubt as to their authenticity.” The legislator has acknowledged in the preamble of the new code that the judicial practice has already elaborated the evidentiary predicament in medical malpractice cases and the aim of the introduction of this norm was the confirmation of this practice by establishing a normative basis. On the other hand we can also recognize a positive change in the judicial practice for the healthcare providers. According to judge experiences the courts intend to take in consideration the problem of divided causality (Farkas 2017a). It means if the healthcare provider is liable for the medical malpractice but there are other natural factors as vis major (act of God) which have caused the harm of the patient, the defendant shall not reimburse the damages in total but only in proportion. Beside the burden of proof another procedural question has come up in medical malpractice cases: the experts appointed by the parties or the so called private experts. The old Code of Civil Procedure did not contain norms about the private experts so it was not clear how to evaluate the private expert’s reports. The practice have also changed about this problem. Previously the courts had took them in consideration as an argument of the party, but afterwards the courts have started to compare them against the reports of experts appointed by the court (Farkas 2017a). The new Code of Civil Procedure has solved this problem by the interpretation of the legal institution of private experts. According to section 307 (1) “on proposal the court shall appoint an expert if with regard to a specific issue: (a) neither of the parties adducing evidence proposed to enter a private expert or an expert appointed for other proceedings; (b) each private expert’s report contains cause for concern; or (c) it is necessary to receive information so as to address any concern that may exist with respect to the opinion of the expert appointed for other proceedings, or to receive answers for questions proposed to be asked.” It means that the general form of expert application has become the application of private experts and their report could be accepted as an official expert report. Last but not least there is one more thing which could effect the judicial practice of medical malpractice. This is the new compensation form for non pecuniary

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damages—introduced by the new Civil Code—the so called solatium doloris. The most important effect of this change is that the plaintiffs do not have to prove any concrete harm for being compensated in case of violation one of their personality right (e.g. right to health or right to physical and psychical integrity). The judicial practice based on the new Civil Code is not known yet but probably the calculation of the compensation amounts will change (Szűcs 2017).

Mediation as an Alternative to Court Proceedings The only procedure with the aim to substitute court proceedings in case of medical malpractice is the mediation. The legal basis is the Act CXVI of 2000 on the medical mediation procedure. It operates as a voluntary procedure. The overall aim and philosophy of mediation is to offer the parties a faster and more efficient method to handle their conflict. Its cost are much lower than the cost of litigation. And we must not forget an other important advantage of alternative dispute resolutions: this is the discretion (Simon 2004). Discretion is the reason why we not have any information about the outcome of mediation. So we cannot evaluate the efficiency of mediation in medical malpractice cases. However, we presume that the number of these procedures is rather low. The other reason could be that agreement reached with the help of mediation has no binding effect on the healthcare provider’s liability insurance company and in several cases their interest is not to confirm these agreement but to refer on an exclusion clause of the contract in the litigation procedure (Zákány 2007). The low numbers of mediation cases can also explain why it cannot strengthen patients’ rights and does not have much effect on quality and safety standards of healthcare. Of course, it does not possess a preventive character in order to deter a possible substandard of medical care, either.

Agencies and Institutions Dealing with Medical Malpractice in Hungary There has been a specialized authority (Health Insurance Authority) till 2010 which supervised the hospitals (protection of patients’ rights, controlling the waiting lists, publishing the quality indicators of hospitals, etc.). This authority has investigated the complaints of the patients and could fine the hospitals. The main goal of the establishment of this authority was to control the private insurance companies in a mandatory private health insurance system. However, this reform idea has failed and the operation of the Health Insurance Authority has been terminated. This authority could start an investigation in case of a medical malpractice—as a harm of a patient’s right—and the patients used this tool as a test before starting

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litigation. The costs paid by the patients were really low in this investigation so the potential plaintiffs first waited for the decision of the Health Insurance Authority. If it was positive for them they started litigation. Today—without the Health Insurance Authority which had specialized supervisors and strong controlling power—the protection of patients’ seems to be less efficient. The patients can turn to Patients’ Rights Advocates who assist them in getting to know and exercise these rights: – accessing medical records and documentation and posing relevant questions; – putting complaints into words and initiate an—internal—investigation of these claims; – filing complaints in representing the patient at the management of the healthcare provider; – informing healthcare workers on rules relevant to patients’ rights and their exercise. However, Patients’ Rights Advocates do not have any controlling power. The employer of the Patients’ Rights Advocates is the Integrated Legal Protection Service (IJSZ) which is an independent department of the Ministry of Human Resources. The IJSZ can start an administrative action if it becomes aware of a fact, circumstance, measure or omission that could cause serious violations of patients’ rights. In the frame of this procedure the IJSZ may request information, make suggestions for action or the content of the relevant legislation, and it may make a recommendation to other bodies involved in the procedure. This administrative action is less efficient than the investigations of the former Health Insurance Authority. On one hand the power of IJSZ is rather limited on the other hand IJSZ is part of the Ministry of Human Resources which is responsible for the financing and support of the healthcare providers. It means that IJSZ does not have the necessary independence for an efficient control. So the health damages compensation procedures are not centralized in one body in Hungary. Neither IJSZ, nor the former Health Insurance Authority could decide about the health damages compensations. Patients shall file a claim in civil litigation against the healthcare providers to get compensated for their harms.

Challenges and Proposals About Medical Malpractice in Hungary The situation of medical malpractice is rather controversial in Hungary. The particular compensation scheme does not seem either efficient or fair. On one hand the litigation costs are rather high—compared to the financial situation of the potential plaintiffs—and the latency of medical malpractice is rather high. On the other hand the legal framework of medical malpractice which expects a high standard of care (and the rule of evidentiary predicament) is not in harmony with the financial and

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material conditions of the Hungarian healthcare system. The compensation system for medical malpractice should be centralized—financed directly by the state— because the healthcare providers do not have the necessary financial coverage and it is quite often that the main reason of medical malpractice is the underfunding of hospitals—e.g. lack of equipment or doctors—what is a fault of the state. The system of mandatory liability insurance for healthcare providers is not efficient, either. It is quite often that hospitals have just a formal insurance without real coverage. If the independent liability of healthcare providers remains, at least the minimal coverage limits of the liability insurances should be regulated by the legislator. The role of agencies and institutions dealing with medical malpractice is marginal. Without controlling power and independence they cannot protect the rights of the patients. The low number of medical malpractice cases could be the main reason why the legal frame of medical malpractice in Hungary is rather conservative or conventional. There are no experimental projects with the goal of reducing the negative impact of court proceedings. Mediation is the only available alternative dispute resolution and other programs or solutions (e.g. apology laws, communication and resolution projects, disclosure programs, pretrial screenings and safe harbors) are neither known nor used in medical malpractice cases. The issue of alternative procedures to court proceedings in case of medical malpractice is not a current and debated topic within domestic legislative circles. In the current situation the parties are more interested in starting a lawsuit than in finding an alternative agreement. Although nobody is satisfied with the current situation, there are no signs of the preparation or elaboration of gradual reforms or radical change.

References Boncz I (2009) Hungary. In: Thomson S, Mossialos E (eds) Private health insurance in the European Union – Final report prepared for the European Commission, Directorate General for Employment, Social Affairs and Equal Opportunities, pp 206–214. http://ec.europa.eu/ social/BlobServlet?docId¼4216&langId¼en. Accessed 25 Jan 2019 Dósa Á (2006) Kártérítési felelősség (Tort liability). In: Péter S (ed) Orvosi felelősség (Medical Liability). Semmelweis Kiadó, Budapest, pp 83–150 Farkas A (2017a) Változott-e a bírói gyakorlat az orvosi műhiba perekben? (Is there any change in the jurisprudence of medical malpractice?). Med Et Jur 1:17–20 Farkas A (2017b) A gyógyulási esély elvesztése (The loss of chance for recovery). Med Et Jur 4:18–22 Kiss M (2017) A bizonyítási teher problémája az alperesi oldalon (The problem of burden of proof on the defendant’s side). Med Et Jur 4:11–17 Kriveczky G (2017) Mit tesz az Állami Egészségügyi Ellátó Központ, hogy csökkentse a műhibaperek számát? (What the National Healthcare Service Center does to reduce the number of medical malpractice lawsuits?). Med Et Jur 1:4–7 Pribula L (2011) Az okozatosság értelmezésének változása az egészségügyi szolgáltatók kártérítési felelőssége körében (Change in the interpretation of causality in the liability of healthcare providers). Jogtudományi Közlöny 4:243–249

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Simon T (2004) Szakmai felelősségbiztosítás az állam, az egészségügyi szolgáltatók, a betegek és a biztosítók szemszögéből, avagy érdekazonosságok az egészségügyi szolgáltatók kártérítési felelősségének elbírálása során (Professional Liability Insurance from the Point of View of the State, Healthcare Providers, Patients and Insurers, or Unity of Interests in Assessing the Liability of Healthcare Providers). http://www.384ugyvediiroda.hu/images/pdf/allam.pdf. Accessed 25 Jan 2019 Szűcs P (2017) A sérelemdíj hatása az orvosi műhiba perekre (The effect of solatium doloris on medical malpractice lawsuits). Med Et Jur 1:9–22 Zákány J (2007) Az egészségügyi szolgáltatók kötelező szakmai felelősségbiztosításának aktuális kérdéseiről (On Current Issues of Compulsory Professional Liability Insurance for Healthcare Providers). http://www.debrecenijogimuhely.hu/archivum/4_2007/az_egeszsegugyi_ szolgaltatok_kotelezo_szakmai_felelossegbiztositasanak_aktualis_keerdeseirol/. Accessed 25 Jan 2019

Chapter 10

The Judge, the Legislator and . . . the Mediator. The Long Journey of Medical Malpractice in Italy Alessandra De Luca

Abstract This contribution intends to describe the main features and the evolution of the system to compensate patients for damages caused by healthcare in Italy. In the first part, it outlines the main traits of the regulation developed by the courts on the basis of the general principles established by the civil code, highlighting the gradual shift in favour of patients. Then, it concentrates on the significant legislative measures passed in the last few years in order to tackle the crisis of medical malpractice litigation and reduce the overall costs of the system. The second part focuses on the development of alternative methods of dispute resolution in the field of medical malpractice. The two main ADR processes on which the Italian legislator relies as tools to reduce the number of cases dealt with by the courts are compulsory mediation, established in 2010, and the “pre-action expert report” (accertamento tecnico preventivo—ATP), that, according to the recent Gelli Bianco law is now the main ADR process for all medical malpractice cases.

Damages Caused by Healthcare in Italy: An Introduction The need to compensate patients for damages caused by healthcare in the Italian legal system is centred on the traditional concept of medical liability and on the recourse to the court system. Due to the lack of an ad hoc legislation, for a long time the regulation in this field has been developed by the courts, mainly the Supreme Court of Cassation, on the basis of the general principles established by the civil

This contribution is an updated and revised version of the report published under the title Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings in Italy in 2018 Annuario di diritto comparato e di studi legislativi. Italian National Reports to the International Academy of Comparative Law XXth International Congress. Special edition 2018: 89–112. A. De Luca (*) Department of Legal Sciences, University of Florence, Florence, Italy e-mail: alessandra.deluca@unifi.it © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_10

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code. However, in the last few years, due to the growing public concern regarding this area of litigation, significant legislative measures have been adopted, which, among other things, try to promote the use of ADR in this sector. The regulation is the same whether the healthcare facility is a public or a private one. First, because the same obligations are imposed on all healthcare facilities by the law. Second and foremost, because differences in the compensation of this kind of damages depending from the nature of the healthcare facility would be at odds with the fundamental nature of the right to health as guaranteed by article 32 paragraph 1 of the Italian Constitution (Comandè 2016, pp. 6–8), which reads The Republic safeguards health as a fundamental right of the individual and as a collective interest, and guarantees free medical care to the indigent.1

The Nature and Purposes of Medical Liability The first, basic, question that the courts had to answer involved the nature of medical liability considering the position of the patient vis-à-vis the healthcare institution and the professional. The traditional answer to this question was that the admission to the healthcare facility established an atypical contract (i.e. a contract not explicitly provided for by the legislator) for the provision of professional services between the patient and the institution,2 whereas the relationship between the patient and the health professional employed by the hospital was extra-contractual. Therefore, both were responsible towards the patient, the first on a contractual basis (art. 1218 ff.) and the second on grounds of tort (art. 2043) (Di Marzo 2012, pp. 55–56). In more recent times, a growing debate among academics and the practical problems faced by the courts3 have led the Court of cassation to reconsider its position. The landmark decision no. 589 of January 22, 1999 has thus established that in both cases the liability has a contractual nature, although the basis differs:

1 In the period immediately following the enactment of the Constitution, when a diffuse system of judicial review was in force in Italy, ordinary courts considered this provision—as many other constitutional provisions—merely “programmatic”, meaning that without implementing legislation it could not be applied by the courts. The approach changed after the establishment of the Constitutional Court, in 1956, and the binding nature to this provision has been fully recognized since the end of the 1970s. Luciani (1991), p. 5. 2 According to an alternative view, the basis for the contractual liability of the institution was the exercise of the potestative right to healthcare access by the patient. 3 The main theoretical criticisms to the traditional approach were two. First, that equating the position of the health professional to that of a tortfeasor ignored the relationship actually existing with the patient. Second, that it was contradictory to subject the two liabilities to different regimes when they were so tightly connected and, actually, both derived from the same facts. The major practical problem, instead, was the difficulty in satisfying the burden of proof required to ascertain tort liability. In an attempt to establish the contractual nature of the liability of hospital-employed health professionals, different theoretical approaches were adopted by the courts and/or suggested by legal scholars. Di Marzo (2012), pp. 55–60.

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whereas the responsibility of the institution is based on an atypical contract, the responsibility of the professional is based on the so-called “social contact” doctrine, elaborated by Italian scholars under the influence of German doctrine (Gallo 2017). The shift concerning the nature of professional liability clearly aimed at enhancing the patient’s possibilities to obtain compensation for the damages caused by healthcare. In fact, the adoption of the contractual liability framework instead of the extra-contractual liability one has a series of favourable consequences for patients. First, the ordinary limitation period of ten years applies instead than the five years one. Second, as will be seen, the burden of proof is easier for the patient. This patient-oriented policy derives from a series of factors: a growing attention to the effectiveness of the right to health guaranteed by the Italian Constitution; the significant changes in the organization of the health sector occurred since the late 1970s, first of all the establishment of the National Health Service in 1978; the evolution of the case law concerning damages to person (Andò 2014, pp. 105–109) and, last but not least, the spectacular advances in medicine (Comandè 2010, pp. 977–979). In principle, the compensation scheme has no punitive purposes. Indeed, insofar as the issue of medical malpractice is largely a matter of contractual liability, the main purpose of damages is placing the creditor in the situation that would have existed had the debtor performed her obligation. However, it is worth noting that the punitive function should be excluded also if the relationship between patient and health professional is qualified as extra-contractual. In fact, according to the traditional position of our Court of Cassation, also tort law has a prevailing, if not exclusive, compensatory function,4 whilst the punitive function is performed through criminal law. It is true that this traditional view has been abandoned by the Plenary Session in its recent decision no. 16601 of July 5, 2017, which explicitly recognizes that tort law, besides the primary compensatory function, performs also other functions, first of all a deterrent and a punitive one (paragraph 5). However, given the fundamental principles found in articles 235 and 25, paragraph 26 of the Italian Constitution, this last function may be recognized only if expressly established by a legislative provision.

4 For this reason, punitive damages have always been deemed inconsistent with our legal system and the award of such damages by foreign judgements has been denied enforcement in Italy. See, most recently, Court of Cassation, decision no. 1781 of February 8, 2012. However, a closer look at national legislation shows several provisions concerning damages that clearly perform a deterrence and/or punitive function and at the doctrinal level the issue is far from settled. For a critique of the traditional Italian conception, see Cappelletti (2015), pp. 821–843. 5 “No obligation of a personal or financial nature may be imposed on any person except by law.” 6 “No one will be punished except by virtue of a law in force at the time the offence was committed.”

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An Area of Growing Concern: Parliamentary Measures Following a trend common to the rest of the Western world, in the last decades Italy has witnessed a significant increase in the number of claims for medical malpractice (Ferrara et al. 2013, p. 4)7 and in the volume of litigation.8 As a consequence of this growing pressure, some insurance companies exited the market and the others have restricted the extent of the coverage and increased premiums, in some cases to levels deemed unsustainable by the insured (Comandè 2016, pp. 17–19). Another more distinctive phenomenon that has been registered in Italy in the last decades is the growing tendency for the victims of serious adverse medical events (or their relatives, in case of death) to turn to the criminal system, then bringing a civil action for damages in the criminal proceeding. It is a counter-intuitive phenomenon, given the stricter requirement to ascertain liability in criminal proceedings (Frati and Gulino 2013, pp. 77–78), which can be explained by reference to some specific factors. First, the adoption by Italian courts of a less strict theory of causation in criminal cases since the mid-eighties, which eased the burden of proof. Second, the instrumental use of the criminal system to promote the settlement of the dispute (Aleo 2014, pp. XXV–XXVI), which from the perspective of health professionals has been labelled “penal blackmail” (Ricci et al. 2013, p. 211). Last, but not least, there is also a certain resentment towards doctors and other medical staff by patients and their families, often deriving from an inadequate management of the relationship and of the initial claim (Mastroroberto and Blandino 2013, p. 133). This phenomenon had a negative impact on the criminal system, absorbing a disproportionate amount of resources (the rate of convictions is particularly low), and contravening the principle according to which criminal law should be only a last resort. Furthermore, it contributed to the development of defensive medicine, whose drawbacks are well known. First, it hampers scientific progress, which is naturally made only through errors. Second, it may prevent the recourse to potentially beneficial treatments only because the professional deems them too risky. Third, it increases the costs of healthcare, for example inducing doctors to prescribe unnecessary tests only in order to avoid possible disputes. Last, it distorts the goal of informed consent, which ends up satisfying the need of self-protection by health professionals instead of truly informing patients. Given the increasing political and economic importance of medical malpractice litigation, in recent years there has been a significant Parliamentary attention and a substantial level of legislative activity in this area. The most important results of this

7 In order to get an idea of this phenomenon, it could be useful to refer to the 2015–2016 report of the Italian national association of insurers, where it can be read “the number of claims registered by Italian insurance companies in 2014 was estimated at 28,500, 17,000 of them accounted for institutional policies”. In 1994, instead, the total number of claims was around 9500. ANIA (2016), pp. 168–169. 8 Although statistical data are not available, this increase is uncontested. See, e.g., Di Marzo (2012), p. 53 and Ricci et al. (2013), pp. 211–212.

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interest are the establishment, in 2008, of a Committee of Inquiry on Medical Errors and the Causes of Deficit in the Regional Health Sector, whose final report was published in 2013 (Camera dei Deputati 2013), and the recent passage of two important laws: The law no. 189/2012 (so-called Balduzzi law9), and the law no. 24/2017 (so-called Gelli/Bianco law10).

The Normative Framework: A Matter of Case Law As highlighted above, for a long time the regulation of this field has been developed by the courts, mainly the Supreme Court of Cassation, on the basis of the general principles established by the civil code. What follows is a description of the basic rules governing the three main aspects of the subsystem of medical liability: standard of diligence, burden of proof, and causation.

Standard of Diligence According to article 1176 of the Italian civil code, whereas the general standard required in the performance of obligations is the diligence of a good pater familias (i.e. an ideal reasonable person), “in the performance of obligations inherent to the exercise of a professional activity, diligence shall be evaluated with respect to the nature of that activity”. Therefore, according to this provision, in medical malpractice cases the required standard of care is higher. It is determined with reference to the technical knowledge of professionals operating in the field and varies with respect to the nature of the activity exercised. For example, the standard of diligence for specialist services is different from the one required for generic services. In particular, the nature of the activity performed is relevant according to article 2236 of the civil code, which limits medical liability to cases of malice or gross negligence “if the professional service involves the solution of technical problems of particular difficulty”. The courts, however, have progressively restricted the scope of this provision so that today this limitation to liability may be applied only in particularly complex cases and in situations where the study and experimentation are not enough or there is not a single accepted protocol. Furthermore, in these non-routine cases the limitation of liability is admitted only if the professional adopted a particular diligence and possessed an elevated degree of specialization

9

Law no. 189 of November 8, 2012, that transposed into law and modified the decree law no. 58 of September 13, 2012, in force since November 11, 2012. It is named after the Minister of Health in office. 10 Law no. 24 of March 8, 2017, in force since April 1, 2017, named after its proponents.

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and only for cases of imperizia (i.e. lack of skills), not of imprudenza (carelessness) or negligence (Napoli 2017, p. 76; Di Marzo 2012, pp. 65–66).

Burden of Proof As a result of the jurisprudential evolution referred to above, since 1999 in Italy the issue of damages caused by healthcare is a matter of contractual liability, whether of the health professional or of the healthcare facility. The adoption of the contractual liability framework instead of the extra-contractual liability one has significantly favourable consequences for patients as far as the burden of proof is concerned. In fact, according to the general principles of the law of obligations, the burden of proof differs considerably depending on the contractual or extra-contractual nature of the liability. In case of extra-contractual liability, the claimant has to prove the existence of all the facts that constitute the basis of her claim according to article 2043 of the civil code: a wrongful damage, fault and causation.11 In case of contractual liability, instead, article 1218 of the civil code establishes that the debtor who does not exactly render due performance is liable for damages unless he proves that the non-performance or delay was due to impossibility of performance for a cause not imputable to him.

Therefore, once established that medical malpractice is a case of contractual liability it follows that the claimant has to prove only the non-performance or the non-correct performance of the obligation, besides damage and causation. Then, it is the debtor (i.e. the health professional or the healthcare institution) who is required to prove either that she (it) correctly performed her (its) duty or that the damage is due to reasons that are not attributable to her (or to it). In fact, the regime created by the case law could be fairly described as a reversal of the burden of proof. But, what is the content of the obligation toward the patient? Traditionally, Italian courts have considered the obligation of the health professional as an obligation of means, not of result. Therefore, she was required to act with the prescribed degree of diligence, but she was not responsible for the mere fact that the expected result had not been achieved. This meant that, even if the liability had a contractual nature, the defendant bore only the burden to prove her diligence, not the existence of an unforeseeable and unavoidable cause that prevented her from performing her duty (Feola et al. 2015, p. 349). Then, a revirement of the Court of cassation in 2007 discarded the distinction between obligation of means and obligation of result,

11 Article 2043 of the civil code “Compensation for unlawful acts. Any fraudulent, malicious or negligent act that causes an unjustified injury to another obliges the person who has committed the act to pay damages”. All translations of articles of the Italian civil code come from Beltramo et al. (1969).

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establishing that if the expected result has not been achieved the professional has to prove the existence of an unforeseeable and insurmountable cause.12 In addition to the distinction between obligation of means and obligation of result, for a long time Italian courts have based the regulation of the burden of proof in cases of medical negligence also on another provision of the civil code. As seen above, under article 2236, in case of professional services involving special technical difficulties the liability is limited to cases of malice or gross negligence. For a long time the courts construed this provision as a limit to the application of the general rule concerning the burden of proof established in article 1218, so that if the defendant proved the complex nature of the treatment, it was for the claimant to prove the carelessness of the performance and the causal link. Only in routine cases the burden on the claimant was limited to the proof that she had received a treatment and that she had suffered a damage because of it. In that case, the defendant had to prove either that the obligation had been performed exactly or that it was impossible to perform it for an unavoidable and unforeseeable reason (Di Marzo 2012, pp. 63–64). However, in 2001 the Court of Cassation abandoned the use of this distinction with reference to the burden of proof13 and a few years later applied the new doctrine to medical liability.14 Therefore, as a result of these changes, the patient-creditor has to prove only the existence of the contract and the breach of the duty by the other party, whereas the debtor (professional or institution) has to prove either the correct performance or the impossibility to perform the obligation (Feola et al. 2015, pp. 350–351).

Causation The criteria for the assessment of legal causation are a much-debated issue in Italian legal scholarship and case law, also because there are no specific provisions on this issue in the civil code. The problem, from this perspective, was whether the criteria provided for by articles 40 and 41 of the criminal code could be extended to civil liability. The traditional view was that the criminal code provisions were the correct legal basis and that under this basis the patient-claimant bore the burden to prove the existence of a link between the professional-defendant’s conduct and the damage occurred (Di Marzo 2012, pp. 68–69). According to the more recent decisions of the Court of cassation (Civil plenary session, no. 581 of January 11, 2008, paragraph 8), the starting point is still the

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Court of cassation, no. 8826 of April 13, 2007. Rivista italiana di medicina legale e diritto sanitario 2008: 849. 13 Court of cassation, civil plenary session, no. 13533 of October 30, 2001, in Foro italiano 2002 I: 769. 14 Court of cassation, no. 10297 of May 28, 2004 Foro italiano 2005 I: 2479.

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“condicio sine qua non” theory, established by articles 40 and 41 of the criminal code. However, whereas in the field of criminal liability the proof of a causal link must be “beyond reasonable doubt”,15 in civil cases it should be in terms of probability (“more likely than not”). The decision of the Court of cassation has explained that this difference between a requirement of near certainty and a requirement of mere “preponderance of evidence” is justified by the fact that in criminal proceedings the positions of the prosecution and the defence differ, whereas in civil proceedings the parties are on an equal footing. Although the Court added that this mere probability has to be verified by looking into the case under consideration for elements to confirm the existence of the causal link (and elements that exclude other possible alternatives), this development contributed to increase the burden on healthcare institutions and professionals.

The Recent Legislative Reforms Whereas for a long time medical liability has been regulated mostly by the case law, which progressively shifted the balance in favour of patients, in the last few years significant legislative measures were adopted.16 Overall, their aim is to strike a more balanced composition of the several competing interests at stake, reducing the pressure on practitioners, increasing the availability of insurance coverage and reducing the overall costs of the system. First, the decree law no. 138 of August 13, 201117 introduced the requirement for all professionals, including health professionals, to have an insurance cover for the liabilities deriving from the practice of their activity. Second, article 3 of the decree law no. 158 of September 13, 2012,18 transposed into the law no. 189/2012 (the so called “Balduzzi law”) with amendments, introduced some significant changes in the regulation of medical liability. Namely, paragraph 1 as amended established that if the health professional acted in accordance with guidelines and best practices accredited by the scientific community (without reference to its domestic and/or international nature), criminal liability was excluded in case of culpa levis. However, according to the new provision she may be liable for damages according to article 2043 of the civil code, that is to say for

15

See Court of cassation, criminal plenary session, no. 30328 of September 11, 2002 (so called Franzese ruling, after the name of the defendant), which established the “beyond reasonable doubt” standard. This standard requiring near certainty has been subsequently inserted in the criminal code (article 533), by the Law no. 46 of February 20, 2006. Di Marzo (2012), pp. 71–72. 16 Actually, there had been several bills aiming at a reform of this area of law since the early 2000s. All had in common the establishment of a form of compulsory insurance for civil liability. 17 Article 3, paragraph 5, letter e) of the decree law no. 158 of September 13, 2012, transposed into law with modifications by the law no. 148 of September 14, 2011. 18 The decree law contained “urgent provisions to promote the development of the country through a higher level of health protection”.

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extra-contractual liability. Furthermore, according to paragraph 1, in assessing those damages the court must take into consideration the fact that the health professional complied with the above-mentioned standards of conduct. Paragraph 2, in turn, in order to make it easier for health professionals to find adequate insurance covers, provided for uniform minimum standards and procedures for such compulsory policies and established a guarantee fund. This provision was to be implemented by a Presidential Decree. Finally, paragraph 3 regulated the determination of the amount of damages due in medical malpractice cases with the intent to limit it and to reach a higher level of predictability, both highly desirable conditions especially from the point of view of insurers. The legislative intent behind paragraph 1 was clearly to limit criminal liability for medical errors, in order to contain the costs for healthcare and prevent the negative effects of defensive medicine. Instead, the meaning of the reference to article 2043 of the civil code was highly debated and two opposing interpretations rapidly emerged. On the one side, there were those who read the provision as intended to redefine as extra-contractual the civil liability of health professionals (Gattari 2014, p. 1042; Martini 2013, pp. 16–19). According to this interpretation, the provision was a “radical turnaround” (Feola et al. 2015, p. 353), the return to a position that had been abandoned by the Court of cassation in 1999, aiming at reducing the costs of medical errors by restoring a regulation more favourable to health professionals. On the other side, there were those—including the Court of cassation19—who thought that the provision did not intend to override the established case law on the nature of health professionals’ liability and therefore that article 1218 of the civil code would continue to apply (Gattari 2014, pp. 1040–1041; Bona 2013). Then, in 2014 a new legislative measure20 established that the provision requiring compulsory insurance did not apply to health professionals employed by the National Health Service. On the other side, that same law provided that every healthcare facility (whether public of private) had to subscribe an insurance policy or arrange other (not better defined) “analogous measures” for the liability deriving from their activity (Comandè 2016, pp. 13–14). Actually, all the available data show a trend towards abandoning insurance cover in favour of these other “measures”, especially in the public sector (ANIA 2019, p. 220), with the regions of Tuscany and Liguria at the forefront of the development of these measures. The latest measure is the law no. 24/2017 containing “Measures on patient safety and medical liability”—the so-called “Gelli/Bianco law”—which entered into force on April 1st, 2017. Among the important innovations contained in this law, which

19

Court of cassation, decision no. 8940 of April 17, 2014. Responsabilità civile e previdenza 2014: 803. 20 Article 27 of the decree law no. 90 of June 24, 2014 as transposed into law and modified by the law no. 114 of August 11, 2014.

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tried to achieve a comprehensive reform of medical malpractice, three should be highlighted here.21 First, a series of provisions aiming at developing an effective risk management system in order to prevent the occurrence of adverse events. In particular, article 3 provides for the formalization of a system of guidelines for the improvement of the quality of medical care and the standardization of clinical practice. These guidelines should be developed by public and private bodies and institutions, scientific societies and associations enrolled in a specific list established and regulated by the Ministry of Health. Second, article 6 modifies the provision of article 3 of the Balduzzi law regarding criminal medical liability, eliminating the reference to culpa levis and providing for the insertion of a new provision in the penal code. According to the new article 590 sexies, the healthcare professional is not culpable only if the death or the injury occurred because of unskilfulness (imperizia) and the guidelines—or, lacking the guidelines, the good practices—were complied with, provided that they were adequate to the peculiarities of the case.22 Third, article 7—with the clear intent of restoring the regime existing before 1999—establishes that the liability of health facilities (whether public or private) has always a contractual nature, while the liability of health professionals is regulated by article 2043 of the civil code, that is it has an extra-contractual nature, unless she has entered into an actual contract with the patient. This provision, therefore, has put an end to the debates surrounding the interpretation of article 3 of the Balduzzi law, overriding the position that seemed to prevail in the case law and abandoning the social contact doctrine as a basis for the qualification of the health professional liability as contractual. Hence, in general a presumption will operate according to which the liability of the individual professional is extra-contractual and the claimant will bear the burden to prove the existence of a contract in order to obtain the more favourable treatment as far as the burden of proof and the limitation period are concerned. The practical importance of this change, however, should not be overstated, because in the end in all medical liability cases the issues of fault and causation will continue to be decided on the basis of the expert report. On the contrary, other new elements of the Balduzzi law have not been changed. Namely, the reference to the guidelines and best practices accredited by the scientific community as a criterion for determining the amount of damages is still in force. The possibility to reduce (or increase?) the amount of damages with reference to the conduct of the debtor is clearly an instance of use of the regulation of liability as a preventive tool, which is alien to the Italian legal tradition. Actually, until now there are no examples of use of this power by the courts. However, the provision is

21 Other important innovations concerning the determination of the amount due and the alternatives to court proceedings will be dealt with in the following paragraphs. 22 The meaning of this provision and the relationship with the previous regime established by the Balduzzi law were clarified by the judgment of the plenary session of the Court of cassation no. 8770 of 21 December 2017.

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significant because it reflects a more general trend towards the development of other functions of liability beyond pure indemnity (Franzoni 2017, p. 274). Furthermore, it points to the importance of guidelines for establishing the existence of a liability (Barbarisi 2017, pp. 226–230). Also the provisions concerning compulsory insurance, together with uniform minimum standards and procedures for insurance policies and the establishment of a guarantee fund, were kept (article 10). Article 12 of the law n. 24/2017 added the possibility of a direct action against the insurance companies, which was to enter into force after the adoption of the secondary instruments implementing these measures. A draft of the ministerial decree has been circulated in the summer of 2019, but it has not been adopted yet.

Tools to Limit the Number of Medical Litigation Cases and Mechanisms to Diminish the Amount of Financial Compensation On the basis of what has been written so far, it is clear that limiting the overall number of medical cases that are litigated is one of the goals pursued by the legislative measures adopted in Italy during the last years. However, no specific tool has been adopted to this end, except for compulsory ADR schemes, which will be dealt with below. Concerning the amount of compensations, the fact that the Italian system is court based, coupled with the so called principle of “full compensation of damages” (Bugiolacchi 2017, p. 1033), means that there has always been a conspicuous personalization of damages, in this as well as in all the other fields where physical damages occur (e.g. road traffic accidents). These features have also contributed to what is labelled by many as an overcompensation. However, the strongly perceived need to ensure a certain level of consistency and predictability in the awards has led the courts to devise a more standardized system, especially for less serious damages. For this reason, since the 1990s several courts have developed “tables” attributing a percentage value to permanent physical damages that increases as the seriousness of the damage increases, and establishing the monetary equivalent of each of these values. These tables are not considered absolutely binding, but the court wishing to deviate from them has to give detailed reasons for the decision with reference to the particular facts of the case at hand. Other courts have adopted those tables, thus reducing the level of uncertainty, but only in part, because different courts across the country adopted different tables and the dissimilarities among them were significant. In 2005, the legislator adopted a unified table system, but just for the damages occurred in connection with road traffic accidents.23 The relevant provisions have Legislative decree no. 209 of September 7, 2005 (so called “insurance code”), articles 138 and 139.

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been only partially implemented, with the adoption of a table concerning minor injuries24 whose amounts are significantly inferior to those provided for by the most widespread court-elaborated one, the Tribunale of Milan table. Then, in 2011 decision of the Court of Cassation, section III civil, no. 14480 of June 12 established that, being the most widespread and reliable, this very table had to be adopted nationwide, outside the area of road traffic accidents (Ricci et al. 2013, pp. 224–225), therefore also for medical malpractice cases. The following year, however, the Balduzzi law25 extended the use of the tables provided for the compensation of damages deriving from road traffic accidents to medical malpractice cases. These provisions, which have the potential to reduce the amounts payable, will not be fully implemented until the tables for major injuries will be produced, and for now these tables are not in sight, although the legislative provision concerning them dates back to 2005. In any case, they have attracted some criticism because the two fields are very different. First, the limits to the sum awarded in road traffic accidents are justified by the affordability of premiums, while in medical malpractice this is not at all guaranteed. Second, whereas insurance companies have the duty to conclude insurance contracts concerning traffic accidents, such an obligation does not exist in the area of medical liability (Ponzanelli 2017, pp. 269–270).

Alternatives to Court Proceedings: Compulsory Mediation. . . Notwithstanding the emphasis traditionally placed on the decision by the judge as the normal way of disposing of the controversies common to all civil law countries, in the last decades Italy too shared the general trend towards alternative methods of dispute resolution. In the area of medical malpractice the first interesting experiences were developed by some Regions, the entities entrusted with the management of public healthcare in Italy. In particular, Emilia Romagna in 2005 and Piedmont in 2007 started projects based on training personnel in mediation techniques with the aim of managing internal and external conflicts and establishing a more empathic environment. The expected results of these transformative mediations were a reduction in the overall amount of controversies, based on the assumption that at least a part of medical malpractice cases derives from an ineffective communication and resentment towards the health personnel, as well as an inadequate risk management (Grasso and Coppola 2012, pp. 667–671 and Grasso and Coppola (2014), pp. 169–224). In other Regions such as Tuscany, instead, joint conciliation committees for the management of existing conflicts were established as voluntary ADR. These

24 In fact, article 138, concerning more serious injuries, has just been rewritten by article 1, paragraph 17 of the law no. 124 of August 4, 2017, that modified also article 139. 25 This part of the provision is still in force.

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committees issue conciliation proposals that the parties are free to accept or not (Viciani 2016, p. 247).

The Contested Introduction of Compulsory Mediation At the legislative level, the most important result so far of the ADR movement has been the legislative decree of 4 March 2010, no. 28 on “mediation aiming at conciliation of civil and commercial disputes”. It introduced the first general regulation of mediation for civil and commercial disputes in the Italian legal system, implementing the directive no. 2008/52/EC on mediation in civil and commercial disputes. The legislative decree was implemented and integrated by the Ministerial decree of 18 October 2010, no. 180, on mediation centres, mediators, and mediation costs, later amended by the Ministerial decree of 6 July 2011, no. 145. The hallmark of the new regulation of mediation, and its most controversial feature, was “mandatory out-of-court mediation” that was provided for by article 5, paragraph 1 for the disputes concerning a large and diverse range of subject matters, including medical malpractice.26 In these cases, if the parties have not filed an application for a conciliation attempt before pursuing their claim in court, the judge, also on her own motion, will establish a 15 days deadline to file the application and fix a new hearing after the time limit within which mediation must come to an end, originally 4 months (article 6). This measure was welcomed by many health professionals because it promised to bring a reduction of litigated cases and possibly of insurance costs (Comandè 2011, p. 309). However, the mandatory nature of mediation was strongly opposed by large sections of the legal community, including the Bar, at least in part for the fear of a drop in revenues (Matteucci 2015, pp. 192–193), and as soon as the provisions of the legislative decree concerning mandatory out-of-court mediation came into force (on 21 March 2011), they were challenged before the Constitutional court and the Court of Justice of the European Union. The issue was solved at the national level by the decision of the Constitutional court of 6 December 2012, no. 272,27 which found that the guiding principles and criteria established by the delegating legislation28 did not enable the legislative decree to provide for a mandatory out-of-court mediation. This was enough to hold article 5 unconstitutional, thereby enabling the European Court of Justice to 26 The other were condominium, property rights, division of assets, hereditary succession, leases, gratuitous loans, family company agreements, rental companies, damages resulting from vehicle and boat accidents, defamation by the press or other means of advertising, insurance or banking and financial contracts. 27 Foro italiano 2013 I: 1091. 28 According to article 76 of the Italian Constitution “The exercise of the legislative function may not be delegated to the Government unless principles and criteria have been established and then only for a limited time and for specified purposes.”

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dismiss the request for a preliminary ruling as concerning hypothetical questions.29 As the decision by the Constitutional court had not evaluated the challenged provisions on the merits, the government could pass the decree law of 21 June 2013, no. 69, transposed into and amended by the law of 9 August 2013, no. 98, whose article 84 restored mandatory out-of-court mediation for medical malpractice disputes and for almost all the other areas initially included within the scope of the 2010 provision.30 The new provision, paragraph 1-bis of the legislative decree, is in force since 20 September 2013. It specifies that the duty exists both for claims against professionals (responsabilità medica) and claims against health facilities (responsabilità sanitaria) and, in a clear move intended to gain the favour of the legal profession, has added the requirement for the parties to be assisted by a lawyer in the mediation attempt. Actually, the recourse to the assistance of a lawyer was already very frequent, but the data concerning voluntary mediation shows that a significant percentage of parties choose not to be assisted by a lawyer,31 which means that this concession to the Bar may contribute to increase the costs of mediation.

Mediation in Practice According to the legislative decree, the application for mediation should be filed with a mediation centre, because in Italy mediators are not supposed to act as individuals but only within the framework of centres registered with the Ministry of Justice. Then, the centre selects the mediator, arranges the first meeting within thirty days, and communicates the application and the date for the meeting to the other party. The law no. 98/2013 amended the legislative decree to provide that this first meeting should be devoted first of all to explaining the purpose and procedure of mediation and to ascertain the willingness of the parties to engage in it. Then, only if this willingness exists, the mediator proceeds with mediation. When, as with medical malpractice cases, the subject matter of the dispute falls within the scope of mandatory mediation, attendance of this first meeting is deemed to satisfy the prescribed condition and therefore the parties may file their claim in court (article 5, paragraph 2-bis of the legislative decree). This means that, following the taxonomy recently 29 Court of Justice, Third Chamber, 27 June 2013, C-492/11, Ciro Di Donna v. Società imballaggi metallici Salerno srl (SIMSA). 30 Only cases concerning vehicle and boat accidents were excluded. Actually, during the period when out-of-court mediation had been mandatory it had proved to be particularly ineffective in this type of disputes, because insurance companies did not take part in the procedure in a very high percentage of cases. Luiso (2013), p. 138. 31 In 2016, 40% of claimants and 16% of defendants were not assisted by a lawyer. Ministry of Justice (2016), p. 17.

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proposed by De Palo and D’Urso, the present Italian system does not provide for a full mandatory mediation anymore, but has created what can be labelled as the “Required Initial Mediation Session model” (De Palo and D’Urso 2016, pp. 13–15). Several courts of first instance contradicted this interpretation, with decisions explicitly requiring the parties to attempt to mediate their dispute in order to satisfy the legislative requirement. However, the Court of cassation, in the recent judgment no. 8473 of 27 March 2019 has interpreted the relevant provisions as establishing a mere obligation to attend the first information meeting, either personally or through a representative with full decision-making authority. Article 8, then, contains a provision that can be particularly important in the field of medical malpractice, establishing the possibility to appoint one or more auxiliary mediators in case specific technical knowledge is needed (paragraph 1), and, where this is not possible, providing the possibility for the mediation centre to appoint experts (paragraph 4). However, under article 10 of the legislative decree, which implements one of the basic principles concerning mediation—that is confidentiality-, the statements of the parties and the information acquired in a mediation process cannot be used in subsequent proceedings unless the interested party waives her right. Therefore, it is at least doubtful whether expert reports could be employed in successive judicial proceedings without the consent of all the parties, although there are decisions allowing their use without equating them to court expert reports (Arianna 2016). Furthermore, the presence of these further figures, especially the expert, has the disadvantage of increasing the costs of mediation. Article 6, then, sets the maximum duration of mediation, that in 2013 has been reduced to three months, although nothing prevents the mediation to continue if the parties so agree. With regard to the final stage of mediation, according to article 11, if an agreement is reached, it has to be attached to the records of the procedure. If, instead, the parties fail to reach an agreement, the mediator draws up the records of the procedure where she takes note of this failure. The records of the procedure should also take note of the failure of one of the parties to participate in the mediation, a fact that could have some adverse consequences for the party in the subsequent proceedings. The records are lodged with the mediation centre, which will issue copies upon request by the parties. If the parties do not reach an agreement autonomously, the mediator may also put forward a proposal. She is obliged to make a proposal if, at any stage of the procedure, the parties ask her to do so. Before putting forward the proposal, however, the mediator shall inform the parties about the costs sanctions under article 13 of the legislative decree in case of non-acceptance followed by an equally or more favourable judicial decision. The mechanism of the mediation proposal has been heavily criticized for the element of coercion it contains. In any case, the practice shows that mediators avail themselves of this possibility very rarely (De Luca 2015, p. 357). Contrary to what happens in most other European countries, where “it is very difficult to obtain comprehensive statistical data on mediation” (European Commission 2016, p. 4), the Italian Ministry of Justice regularly collects and publishes such

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data. According to the available publication, it appears that in 2016, the year before the latest legislative reform, 12,254 mediations concerning damages for medical malpractice were started (around 6.5% of the overall number of mediations concerning subject matters for which mediation is compulsory), 11,812 were resolved and 4914 were pending at the end of the year. The average duration of cases where an agreement is reached (no data are reported for cases where it is not reached) was 115 days, a length that is steadily increasing over the years and that is longer than the statutorily established limit of three months. The participation rate in medical malpractice cases is significantly lower than the average rate (which has increased from 27% of cases in 2011–2012 to 46.9% in 2016) being only 38%. Actually, the only subject matter where the percentage is lower is insurance contracts. However, the worse data concerns the success rate: whereas the overall percentage is stable around 43% of cases when parties go further than the first information meeting, in medical malpractice cases an agreement is reached only in 10% of cases (Ministry of Justice 2016). These comparatively disappointing results of mediation might be due to some peculiarities of medical malpractice cases that were probably overlooked by the legislator. First, the complexity of the situations giving rise to claims of medical malpractice, usually involving more than two parties (i.e. patient, practitioners, other health professionals, the health facility, and insurance companies), whose degree of emotional involvement varies significantly and whose interests have a radically different nature, so that a mediation in this field should be more accurately described as a series of mediations. Second, the perceived need that the third neutral has medical knowledge, whereas most mediators have a legal background (Comandè 2011). Third, the peculiar aversion toward mediation of the civil servants representing public health facilities, due to the lack of a provision such as those existing in other fields, which shields them from the risk of being held accountable by the Court of accounts in case of settlement (Pagni 2018, pp. 176–177).

. . . and the New “Pre-Action Expert Report” A greater awareness of these peculiarities is probably behind article 8 of the recent Gelli/Bianco law, which in 2017 introduced the “pre-action expert report” (accertamento tecnico preventivo—ATP) as the main ADR device for all medical malpractice cases, making it compulsory but alternative to the mediation attempt regulated by the legislative decree no. 28/2010. Actually, the original bill aimed at establishing ATP as the only compulsory ADR process, but article 8 was modified during the passage in the Senate to restore the use of mediation, although only as an alternative before the beginning of the proceedings (Pagni 2018, p. 176). As in the new law there are no further provisions concerning mediation, not even those that would have been useful for a coordination between the two ADR processes, it can be inferred that no changes to the previous regime have intervened.

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Therefore, it is now necessary to focus on the pre-action expert report, which is currently the preferred tool to deal with medical malpractice disputes. This instrument was established in 2005, when article 696-bis was added to the code of civil procedure.32 Following a trend that emerges in other European systems,33 the aim of this new provision was to extend the scope of the traditional evidentiary preservation proceeding provided by article 696 of the code, enabling its use in cases where there was no risk of losing the evidence,34 but the intervention of an expert was deemed useful to solve a dispute without resorting to the courts. This happens in particular in the cases where the disagreement between the parties does not focus on a point of law but rather on a complex point of fact that can be ascertained only through non-legal knowledge. Like in an early neutral evaluation, in fact, the expert was explicitly vested with the power to make a conciliation attempt before lodging her report, if possible. In order to promote the conciliation, article 696-bis establishes that, if the attempt succeeds, the court shall make the records of the procedure a title empowering to levy execution and exempts this document from stamp duty (imposta di registro). In case of failure, instead, each party may use the expert report in the subsequent proceedings on the merits. The availability of the new proceedings was limited to the disputes concerning the existence and the quantification of obligations deriving from contracts or torts (Besso 2010, pp. 301–302), therefore—whatever the qualification of medical liability—the use of this ADR technique was already open to the parties. However, as a result of this last legislative intervention, since April 2017 if the parties of a medical malpractice case have not filed an application for a pre-action expert report (or a mediation attempt) before pursuing their claim in court, the judge—also on her own motion—will establish a fifteen days deadline to file the application for ATP. It should be noted that at this point the parties have not the possibility to choose the alternative of mediation. Likewise, if the ADR proceedings have started but have not come to an end, the judge will establish a 15 days deadline to lodge the request to complete the procedure. The last possible moment for the party and the judge to raise this issue is the first hearing. If the parties reach an agreement, the promotional measures provided for by article 696-bis apply. Instead, if the parties fail to reach a conciliation or the procedure is not concluded within 6 months, the claim can proceed as a summary proceeding under articles 702 bis ff. of the Code of civil procedure, the so called procedimento sommario di cognizione (Carratta 2010, pp. 218–222), provided that the party files the claim within 90 days from the filing of the expert report or the expiry of the six months period.

32 Article 3 of the decree law of March 14, 2005, no. 35, transposed into and amended by the law of May 14, 2005, no. 80, in force since March 1st, 2006. 33 The pre-action expert report has significant similarities with the French expertise preventive and the German schriftliche Begutachtung. 34 According to article 696 of the Code of civil procedure, this risk is the condition for admitting the traditional pre-action expert report.

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Participation in the ATP proceedings is compulsory for all parties, insurance companies explicitly included. This provision may be seen as a tool to tackle the well-known insurance companies’ reluctance to participate in ADR but, technically speaking, it is also the consequence of the introduction of a direct action against insurers by article 12 of the law no. 24/2017. Therefore, as the latter measure has not entered into force, there is at present uncertainty among the courts over the applicability of this provision. The obligation to cooperate is assisted by significant costs sanctions. First, the payment of the costs of the procedure and the expert fees, even if the party was successful, thereby establishing a significant derogation to the general loser pays all principle that traditionally regulates the allocation of costs in Italian civil procedure. Second, the payment of an additional sum to the party who did take part in the ATP proceedings, whose amount is determined on an equitable basis by the judge. Furthermore, whereas for compulsory mediation cost sanctions for the refusal to participate may be avoided by proving that it was based on “reasonable grounds”, this is not possible for ATP (Pagni 2018, p. 177). In addition to the compulsory participation in the proceedings, insurance companies are also required to put forward a settlement offer or explain the reasons for not making such an offer. In case the offer is not put forward and the claimant then succeeds in the judicial proceeding, the court has to send the decision to the Institute for the Supervision of Insurance (IVASS). The main advantage of ATP over mediation is clearly the possibility to use the expert report in court in case of failure to reach an agreement, which undoubtedly represents a strong incentive to negotiate, and, in case of failure to reach an agreement, at least achieves a significant procedural economy (Avanza et al. 2011, p. 667). Actually, the judges of several courts of first instance (the tribunale of Florence, for example) already followed the practice of appointing a court expert (consulente tecnico d’ufficio—CTU) at the earliest opportunity, before starting the proof gathering activities. Judges and lawyers were all aware that this promoted better-informed negotiations among the parties and a more efficient proof-taking stage (Cecconi and Cipriani 2014, p. 111). On the other hand, according to the general rules concerning the allocation of costs, the claimant is required to advance the expert fees, which may be substantial, also compared to the costs of mediation. Therefore, financial considerations may suggest opting for mediation. Moreover, mediation may be more appropriate in cases where the controversy does not revolve around complex technical problems such as causation, but focuses on issues such as informed consent (Pagni 2018, p. 180). Other significant differences between the regulation of these two ADR processes deserve attention and could influence the choice of the claimant. First, the maximum length of mediation—the period after which the claim can be brought in court—is three months instead of six. However, if the parties fail to achieve an agreement or the maximum duration is reached, in case of mediation the claimant shall start the ordinary proceeding, whereas in case of ATP the claim can proceed as a summary proceeding. The advantage of this second path is, clearly, its rapidity. However, it should be noticed that the judge could switch to the ordinary proceedings if she

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deems it necessary, for example because the parties have raised issues not considered by the expert.

Concluding Remarks The time passed since the last legislative measure entered into force is too short to see the effects of its implementation and suggest possible changes to the existing regulation in the field of damages caused by healthcare. Rather, on many relevant aspects—mainly concerning insurances—the full implementation of the reform depends on the adoption of secondary instruments, which are still lacking. Therefore, this is the only field in which an intervention is desirable. At the moment, the first significant data that emerge are the substantial reduction in the number of mediations concerning medical malpractice cases both in absolute and relative terms: if in 2016 over 12,000 mediations were initiated, the subsequent year the number fell to 8967, amounting to 5.4% of the total number of compulsory mediations started (Ministry of Justice 2017). In 2018 it dropped further to 6766, only 4.4% of the overall number of compulsory mediations commenced. One obvious explanation could be the recourse to the pre-action expert report, but, unfortunately, figures on the use to this procedure are not available. In contrast, the other data concerning mediation in medical malpractice cases show a positive trend: the participation rate has increased from 38 in 2016 to 44.6% in 2018 and there has been a modest growth also in the success rate, from 10 to 13% of the overall number of cases starts (Ministry of Justice 2018). Two explanations for these improvements can be given. On the one hand, they may just reflect the overall positive trend of compulsory mediation, shown, for example, by the rise in the average participation rate, now at 50.4% (Ministry of Justice 2018). On the other hand, they could be the consequence of the fact that now the parties can choose between two ADR processes and therefore, once expressed a preference for mediation, there is a greater willingness to engage in it, at least by one of them. Although some choices made by the law no. 24/2017 have been criticized and notwithstanding the technical flaws in the contents of article 8, commentators agree on the usefulness and appropriateness of ATP for medical malpractice cases, also compared to mediation. However, the success of the new ADR greatly depends on the capacity of medical experts to acquire an expertise in mediation techniques as well. Actually, doubts about the real capacity of pre-action expert reports to be a successful ADR were raised since the introduction of article 669-bis in the code of civil procedure, exactly for this reason (Bove 2008). The legislator seems aware of this, since article 15 requires court appointed experts to show adequate mediation skills. But in order to achieve meaningful results in this respect a real cultural change is needed, a change that can only happen in the long term.

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Chapter 11

Liabilities for Damages Resulting from Medical Treatment and Dispute Resolution System in Japan Hideki Ishibashi and Chihara Watanabe

Abstract This paper aims to clarify the current situation on liabilities for damages resulting from medical treatment and alternative dispute resolution (ADR) for medical accidents in Japan. Regarding liabilities for damages resulting from medical treatment, this paper focuses on compensation schemes for damages caused by medical malpractice and those for damages caused by the side effects of drugs. As to the former, problems related to negligence and causation among the requirements of tort liability are taken up, and especially concerning causation, the so-called “loss of chance” doctrine is discussed. As to the latter, critical reviews are made on a recent decision of the Supreme Court of Japan on product liability of pharmaceutical companies. Since late 1990s, the number of filing of medical malpractice cases increased and ADR methods have been developed and promoted for resolving medical accident cases instead of lawsuits. In addition to civil conciliation in the courts, local bar associations provide arbitration or mediation services to promote prompt and reasonable resolution based on expertise. It refers to non-fault compensation schemes and medical accident investigation system as well as other organization providing ADR service.

H. Ishibashi (*) · C. Watanabe (*) College of Law, Ritsumeikan University, Kyoto, Japan e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_11

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Liabilities for Damages Resulting from Medical Treatment Compensation Schemes for Damages Caused by Medical Malpractice1 Contractual Liability and Tort Liability Under Japanese law, a doctor must accept civil liability if he/she has caused harm, injury, or death to a patient through his/her medical practices.2 This liability is divided into contractual liability (Article 415 of the Civil Code) and tort liability (Article 709 of the Civil Code).3 These two types of civil liability have different frameworks with unique requirements, and they also differ materially in several respects. The major difference lies in the burden of proof concerning negligence: contractual liability requires the plaintiff to prove that a defendant’s obligation was not performed, but not that the defendant was negligent in his/her actions; whereas a tort liability, by contrast, requires the plaintiff to prove that a wrongful action and negligence have occurred. Having said that, this difference matters little when it concerns the question of medical malpractice. The obligations of a doctor under a medical contract are the “obligations of means (obligations de moyens)”, where the non-performance of an obligation is in fact equivalent to negligence. Hence, even if a contractual liability is chosen as the basis for a case, the patient in effect bears the burden of proving negligence.4 Furthermore, contractual liability and tort liability essentially differ little in their definitions of negligence. The “medical standard of care”, by which negligence is identified under tort law, also covers the doctor’s obligations under a medical contract.5 This means that a patient may exercise his/her right to seek damages under contract law if a doctor fails to provide treatment that

1

A system for civil liability and a compensation system offered by the government may be established to provide compensation for damages caused by medical malpractice. In 1973, the Japan Medical Association (JMA) Liability Insurance System, which corresponds to civil liability, was introduced in order to handle the rising number of damages. With regard to government compensation system, while some have suggested that the government should create a compensation system such as ones that exist under New Zealand law and Swedish law, there is no prospect of its legislation at present. Besides these schemes, in 2009, the Japan Obstetric Compensation System was introduced as a no-fault compensation scheme by using non-life insurance. This will be described in section “Alternatives to Court Proceedings” below. 2 According to Japanese law, the purpose of civil liability is construed as the provision of compensation for damage caused in an individual case. Punitive damages are not allowed. Judgement of the Supreme Court of Japan on March 24, 1993 (Minshū (abbr. of Saikōsaibansho Minji Hanreishū: the Supreme Court Civil Case Law Reports) 47 (4), 3039); Judgement of the Supreme Court of Japan on July 11, 1997 (Minshū 51 (6), 2573). 3 Japanese law does not apply the principle of “non-cumul” in the relationship between contractual liability and tort liability. For the information on how Japanese law has been discussed in terms of this issue, see Hirano (2017). 4 See Nakano (1976), pp. 32–36. 5 See Yonemura (2016), p. 107.

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meets the accepted medical standard of care. That being said, contractual liability is essentially based on the parties’ consent, and the established scopes of the contractual liability and tort liability do not completely agree. Therefore, if the parties to a medical contract have certain special arrangements, it is possible that liability can only be derived from contract law.6 However, in cases where such unique contractual rules are nonexistent, the doctor’s duty can be specified only in accordance with the objectively set medical standard of care. In this light, the liability under a medical contract comes close to tort liability.7 As you can see, whether contract law or tort law should be adopted in order to determine a doctor’s liability is not much of an issue.8 Therefore, with tort liability mainly in mind, we will discuss the issues that are pertinent to negligence (section “Issues Relating to a Doctor’s Negligence”) and causation (section “Issues Regarding Causation”) as the requirements that are set equally for contractual liability and tort liability.

Issues Relating to a Doctor’s Negligence Framework for Identifying Negligence Under Japanese law, negligence in tort law is typically understood as a breach of the duty to prevent a negative effect from occurring.9 From this perspective, citizens have the duty to avoid any foreseeable negative effects; that is, the violation of the rights of others, or damage to the interests of others. Citizens who have breached this duty are considered to have acted with negligence. Whether the effect is foreseeable or not is determined by the standard of the ability of a rational person in the world to which the citizens belong, rather than the ability of the citizens themselves. This means that each citizen has the duty to foresee the effects as predicted by a rational person in the world to which he/she belongs.10 6

See Kawakami (1999), p. 366. Contract law and tort law do not differ significantly also in terms of how they define the liability of hospitals. Contract law treats the action of a person whom an obligor uses to perform his/her obligation (i.e., a doctor) as that of the obligor (i.e., the hospital); while tort law specifies that an employer (i.e., a hospital) is liable for the damages caused by his/her employees (i.e., its doctors) in accordance with the principle of “respondeat superior” (Article 715 of the Civil Code). This applies to public and private hospitals alike. 8 The former contract law and tort law differed significantly in terms of the period for the exercising of the right to seek damages. However, this difference has been expunged by the Act for Partial Revision of the Civil Code 2017. Under this amendment, the right to seek damages due to infringement of life or body, whether it is derived from contract law or tort law, is extinguished if it is not exercised by the victim within five years from the time when he/she comes to know of the damages and the identity of the perpetrator or within twenty years from the time of the perpetration (Article 167 and Article 724–722 of the Civil Code). 9 See Shiomi (2009), pp. 273–274. 10 See Kubota (2018), pp. 67–68. 7

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The above framework applies to identifying a doctor’s negligence. However, in cases of medical malpractice, the framework is usually simplified in order to define negligence as a deviation from the accepted medical standard of care. In the following subsections, the discussion will focus on how medical negligence has been identified in accordance with the medical standard of care under Japanese law.

Establishing the Framework for Identifying Negligence in Accordance with the Medical Standard of Care The medical standard of care came under the spotlight for the first time, as a method to identify medical negligence, when a series of lawsuits were filed over retinopathy of prematurity (ROP).11 ROP is a disease that occurs when highly concentrated oxygen is administered to premature babies with undeveloped blood vessels in the retina. In the 1970s, a treatment called photocoagulation was developed to prevent this and it began to be used in clinical practice. However, some medical institutions failed to conduct funduscopic examinations to see if the premature babies in their care had ROP. Consequently, the ROP in some premature babies remained undetected for longer than it should, or the babies with ROP were not transferred at the right time to different medical institutions that used photocoagulation for treatment. Cases were brought to court across the country hoping to prove that the doctors had breached their duty to conduct the medical examinations or to send the patients to the appropriate institutions.12 On March 30, 1982, the Supreme Court of Japan issued a judgement.13 It stated that, “The medical standard of care in so-called clinical practice at the time of the provision of the medical care by the doctor should serve as the reference point for a doctor’s duty of care.” This clarified the previous standard of “duty of the best care” that had been held according to a judgement issued on February 16, 1961,14 and it also had significance as a precedent in that the criteria for identifying negligence were to be found in the standard of the clinical treatment, rather than in the standard of medicine as knowledge.15 Nonetheless, how the judgement that “the medical standard of care should serve as the reference point for a doctor’s duty of care” should be interpreted is another issue. The discussions about this centered on whether the same medical standard of care would apply nationwide, or if the 11

See Yonemura (2016), p. 109. The following are the judgements of the Supreme Court of Japan regarding ROP: The judgements of the Supreme Court of Japan issued on March 30, 1982 (Hanrei Jihō (Judicial Precedent Reports) 1039, 66); July 20, 1982 (Hanrei Jihō 1053, 96); May 30, 1986 (Hanrei Jihō 1196, 107); January 19, 1988 (Hanrei Jihō 1265, 75); March 31, 1988 (Hanrei Jihō 1296, 46); June 8, 1992 (Hanrei Jihō 1450, 70); June 9, 1995 (Minshū 49 (6), 1499). 13 See id. 14 The judgement of the Supreme Court of Japan issued on February 16, 1961 (Minshū 15(2), 244). 15 The term “standards of medicine” was often used prior to the judgement. See Ueki (2007), pp. 266–269. 12

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standard would vary depending on the medical institution or the individual doctor. The judgement of the Supreme Court of Japan on June 9, 199516 held that, in order to determine the medical standard of care, “various factors, such as the characteristics of the medical institution in question and the properties of the healthcare environment in that location, should be considered. It is unfair to disregard these factors and to apply the same medical standard of care required in accordance with the medical service contract to all medical institutions. Furthermore, if knowledge about a new treatment is shared to a considerable degree across the medical institutions with characteristics similar to the medical institution in question, and if it is found appropriate to expect that the medical institution in question would also have the aforesaid knowledge, the aforesaid knowledge should serve as the medical standard of care to be applied to that medical institution, unless the circumstances are exceptional.”17 Regarding the issue of when photocoagulation had been established, the original court decision18 regarded this to be in August 1975, when the research division of the Ministry of Health and Welfare published its report on this treatment in a medical journal. However, at the hospital run by the defendant, a pediatrician who already knew about photocoagulation had led efforts to create a system for detecting ROP since around October 1973, and he had sent patients with suspected ROP to other hospitals where photocoagulation was available. Therefore, on June 9, 1995, the Supreme Court of Japan considered these factors and overturned the original decision that had denied the defendant’s liability.

Medical Standard of Care and Medical Practices The judgement of the Supreme Court of Japan on June 9, 1995 established the basic framework for the identification of negligence which is based on the medical standard of care.19 The question remains: what is the “medical standard of care”? Although the judgement of the Supreme Court of Japan on March 30, 1982 mentioned above provided a view that partially answered this question, it only clarified that the medical standard of care differs from the level of medical science. Therefore, of all the factors that may influence a doctor’s actions in the clinical setting, what are those that can serve as the “medical standard of care”?

16

See supra note 12. Minshū 49 (6), 1509–1510. 18 The Osaka High Court decision issued on September 24, 1991 (Minshū 49 (6), 1578). 19 On the other hand, the following Supreme Court judgements identified negligence without mentioning the medical standard of care: the judgements of the Supreme Court of Japan issued on November 8, 2002 (Hanrei Jihō 1809, 30); November 14, 2003 (Hanrei Jihō 1847, 30); April 18, 2006 (Hanrei Jihō 1933, 80); November 14, 2006 (Hanrei Jihō 1956, 77). 17

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It is essential to mention the judgement of the Supreme Court of Japan on January 23, 199620 in order to discuss this question. In this case, the plaintiff was a sevenyear-old patient who had undergone an operation for appendicitis at the hospital run by the defendant. The patient’s blood pressure dropped soon after the operation began, and the patient suffered a severe cerebral hypofunction after the operation. A spinal anesthetic was given to the patient just before the operation began, and the surgeon in charge instructed the nurse to measure and report the patient’s blood pressure every five minutes during the operation. However, the label information of the anesthetic stated that the blood pressure should be measured every two minutes for ten to fifteen minutes after the injection. It was recognized that measuring the blood pressure every five minutes after the injection of this anesthetic was the norm in medical practice at that time (1974). Hence, the dispute centered on whether the surgeon had been negligent in the instructions for the measurement of the patient’s blood pressure. The Supreme Court affirmed the doctor’s negligence and stated the following: “The medical standard of care serves as the reference point for a doctor’s duty of care. It does not always agree with the medical practices that an average doctor would carry out. If a doctor has acted according to the norm of medical practice, it does not automatically mean that he/she has fulfilled his/her duty in line with the medical standard of care.”21 Negligence is a concept pertaining to a legal assessment, and a certain value judgement comes into play in determining whether negligence has been committed or not. Therefore, if an existing practice involves something inappropriate, it cannot be recognized as the medical standard of care.22 The Supreme Court judgement on January 23, 1996 described above is significant in that it clearly made this point. As a more recent move, academic societies of clinical medicine have been publishing “clinical practice guidelines” that contain the recommended methods of treating specific diseases. The question to discuss in medical malpractice cases that involve a treatment described under the published guidelines will then become whether the doctor in question should be judged as negligent if he/she has provided a treatment that is different from the one suggested by the guidelines. It has been said that the main purpose of the clinical practice guidelines is to standardize medical procedures by ensuring that a certain level of quality in medical care is provided everywhere in the country.23 In this case, it is reasonable to consider the clinical practice guidelines as the medical standard of care, provided that the individual differences between patients are minor. However, it is more than likely that individual differences between patients with the same disease will exist in the clinical setting. This means that the doctor must decide on the appropriate healthcare for each patient by considering the patient’s unique needs. In such circumstances, a doctor

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The judgement of the Supreme Court of Japan issued on January 23, 1996 (Minshū 50 (1), 1). Minshū 50 (1), 10–11. 22 See Yonemura (2016), p. 113. 23 Yonemura points out that there is the idea of “evidence-based medicine” on the basis. Yonemura (2016), p. 121. 21

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who has provided a treatment that is different from the method suggested by the guidelines should not automatically be judged as negligent. Therefore, the clinical practice guidelines cannot completely agree with the medical standard of care.24

A Doctor’s Duty When His/Her Ability Is Above the Medical Standard of Care As mentioned above, the judgement of the Supreme Court of Japan on June 9, 1995 denied that “the same medical standard of care should equally apply to all medical institutions” and allowed each medical institution to set an appropriate medical standard of care. Then, it should be asked: if a doctor has expertise that is above the standard set for the medical institution he/she works for, does he/she have the duty to provide a more advanced treatment that reflects his/her knowledge and skills? The judgement of the Supreme Court of Japan on June 8, 199225 was for a case in which the court was asked to decide whether the doctor in question, who had given a clinical treatment of ROP several times before, had the duty to provide photocoagulation even though this had not been an accepted medical norm at the time of the plaintiff’s birth (September 1972). The plaintiff claimed that the doctor had “the duty of care to provide conscientious and precise treatment in good faith.” The Supreme Court rejected the plaintiff’s argument, stating the following: “doctors do not have the duty to provide conscientious and precise treatment in good faith that requires a higher level of medical practice than the said medical standard of care, unless they have a special agreement with their patients.” Torts such as traffic accidents and medical malpractices can be classified into certain types, each of which requires a formulaic solution. In this light, the ruling’s stance that negligence should be identified in accordance with the medical standard of care is reasonable in itself. However, each case should be considered in light of its own various factors when determining whether negligence has been committed. In this way, if the case cannot be classified as a predetermined type, the court can take this into consideration in its determination of negligence. Nonetheless, the ruling affirms that a doctor has the duty to provide treatment that requires a higher level of medical practice than the medical standard of care only when there is a “special agreement”, and it is debatable whether setting this type of “extremely tough”26 standard would be appropriate.27

24

See Yasuda (2014), p. 295. See supra note 12. 26 Tejima (1993), p. 113. 27 Kawakami criticizes the judgement of the Supreme Court of Japan on June 8, 1992. Kawakami (1999), p. 370. 25

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Issues Regarding Causation It is also difficult to establish how much of a causal relationship should be proved between the doctor’s treatment and the effect that the patient has suffered. In this regard, the judgement of the Supreme Court of Japan on October 24, 197528 found that: “Proving causation in a court case differs from presenting scientific proof that allows no room for doubt; in such cases, a verdict is reached after examining all the evidence comprehensively in light of experience, to prove with a high degree of probability that the relationship between a certain fact and a certain consequence to which the fact has led may be recognized. The judgement must show enough conviction that the causation is true to the degree that it will cause no ordinary amount of skepticism. And showing such conviction will suffice.” This ruling was made for a case in which the plaintiff, who had contracted purulent meningitis, claimed that he had experienced a seizure after a lumbar puncture and had suffered permanent damage as a result, including intellectual disability. The dispute centered on whether or not the cause of the seizure had been a brain hemorrhage prompted by the lumbar puncture or caused by the purulent meningitis. In other words, the focus was on ascertaining how the plaintiff’s seizure had occurred after the lumbar puncture, and the Supreme Court of Japan demanded that the reason for the occurrence be proved with “high probability”. Regarding the degree of proof in a civil trial, Japanese law requires “high probability”, instead of following the “preponderance of the evidence” standard that is used in U.S. law.29 This means that the above ruling in 1975 confirmed the principle of the degree of proof, which applies to civil trials in general. Incidentally, causation in different contexts often becomes the focus in medical malpractice cases. Doctors are required to provide treatment that is in line with the medical standard of care for their patients in conditions that can change from hour to hour. If a doctor takes an action that is considered inappropriate for some reason and that action leads to an infringement of the patient’s rights, the dispute then revolves around whether the violation would have been avoided if a different appropriate action had been taken; that is, there is a causal relationship between the breach of duty and the infringement.30 In this context, the pathway from the doctor’s action to the infringement is clear, and thus no difficulty arises in proving the causation. However, the issue here is the ambiguity that stems from the process of formulating a hypothesis, and it is this ambiguity that makes proving “causation” difficult. Whether it is reasonable to demand that causation of this type be proved with “high probability” is a difficult question, yet that is what the Supreme Court required nonetheless.31

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Minshū 29 (9), 1417. See Matsumoto and Ueno (2015), p. 439. 30 See Yonemura (2016), p. 147. 31 The judgement of the Supreme Court of Japan on February 25, 1999 (Minshū 53 (2), 235) applied the degree of proof stated in the Supreme Court judgement on October 24, 1975 (“high probability”) 29

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If the causation that originates from a breach of duty is ambiguous by nature, it is easy to anticipate that, in many medical malpractice cases, the plaintiffs will struggle to prove it. In such cases, it is also inappropriate to deny the doctor’s liability on the grounds that the degree of proof falls short of “high probability”. The Supreme Court of Japan in its judgement issued on September 22, 200032 decided as follows: “When it is proved that there was a considerable chance that the patient would have been still alive at the time of his/her death if he/she had received a treatment that was in line with the medical standard of care, the doctor has liability for the damages that were incurred in the tort.” This decision regards the “chance” of the patient’s survival in the absence of the doctor’s negligence as an independent legal interest.33 In this respect, it is similar to the theory of the so-called “loss of chance (perte d’une chance)” doctrine in Anglo-American and French laws. Under Japanese law, however, because the modifier “considerable” is added to the “chance”, this limits the extent to which the liability arising from the infringement of the “chance” must be established. Furthermore, the judicially created doctrine suggested in the ruling in 2000 postulates that, in a case where the victim has died, a causal relationship between the doctor’s negligence and the patient’s death has not been proved. Hence, according to this doctrine, the doctor is not held accountable for anything in cases where the patients are still alive and the chance that their life will be saved has been reduced.34 In addition, the ruling in 2000 ordered the defendant to pay 2 million yen as compensation for mental suffering under the above judicially created doctrine. That is, it did not order the defendant to pay damages that would compensate for the degree of the lost chance. In this light, the nature of the liability in this context differs from the so-called “proportional liability”.35 After the ruling in 2000, the Supreme Court of Japan affirmed a doctor’s liability arising from the loss of a “considerable chance that severe permanent damage could have been avoided” in a case on November 11, 2003, where a patient had suffered “severe permanent damage” after the doctor’s breach of duty.36 This ruling extended the liability arising from the loss of a “chance” to cases of the infringement of the physical body. On the other hand, the Supreme Court firmly maintained the modifier “considerable” in order to define the criterion for a chance that the consequence would have been avoided, whether or not the infringement in question concerned the patient’s life or physical body. Therefore, the Supreme Court rejected the plaintiff’s

to the causal relationship between the doctor’s breach of the duty to conduct examinations and the patient’s death. 32 Minshū 54 (7), 2574. 33 Article 709 of the Civil Code stipulates that the infringement of legally protected interests, as well as that of rights, leads to liability for damages. 34 E. g., Gregg v Scott [2005] UKHL 2. 35 There are also views that the liability for damages according to the degree of chance may be derived from the judicially created doctrine presented in the decision in 2000. E. g. Kubota (2001), p. 70; Shiomi (2009), p. 385. For the information on proportional liability under Japanese law, see Ishibashi (2014). 36 Minshū 57 (10), 1466.

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claim in the case that it failed to fulfill that criterion.37 This means that, in a case where a causal relationship between the doctor’s obvious negligence and the effect of that negligence is ambiguous, the doctor cannot have the liability attributable to the infringement of the expectation of proper treatment. Although affirming this type of liability would have a profound effect in terms of preventing negligence by doctors, it could also have the negative effect of prompting more defensive medicine. The focus in this context, given these two conflicting results, is what stance should be taken toward the liability attributable to the infringement of the expectation of proper treatment. In a judgement issued on February 25, 2011,38 the Supreme Court stated that, regarding a liability of this sort, when the treatment in question is “extremely inappropriate”, such a liability may be considered. Hence, the remaining task here will be to clarify what exactly this ruling meant by “extremely inappropriate” treatment.39

Compensation Schemes for Damages Caused by the Side Effects of Drugs A recipient of a drug who has suffered damage caused by any side effects of the drug may seek to hold the pharmaceutical company liable. This liability used to derive from Article 709 of the Civil Code, which served as a set of general rules about tort liability. However, since the Product Liability Act entered into force in 1995, it has derived from Article 3 of the Act. According to Article 3 of the Act, the manufacturer or importer is liable for the damages arising from an infringement of the life, body or property of others caused by any defect in the delivered product. This liability is based on the fact that the defective product has been placed on the market, and proof of negligence is not required to hold the manufacturer or importer liable.40 Therefore, Article 3 of the Product Liability Act may be deemed as a rule that was made to provide further protection for victims by modifying Article 709 of the Civil Code, which sets forth the liability for negligence, so as to adopt liability without fault.41 This point is, in fact, an issue in many cases about the side effects of drugs.

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The judgement of the Supreme Court of Japan on December 8, 2005 (Hanrei Jihō 1923, 26). Hanrei Jihō 2108, 45. 39 For example, the Osaka District Court issued a ruling on July 25, 2011 (Hanrei Times (Judicial Precedent Times) 1354, 192) on a case in which an expectant mother had died of multiple organ failure the day after childbirth. This decision recognized the fact that an error in telephone communication had caused 30-minutes delay in the blood transfusion as an “extremely inappropriate” action, and ordered the defendant to pay 600,000 yen as compensation for mental suffering. 40 See Shiomi (2011), p. 369. 41 Just like its European counterparts, Japanese law exempts the manufacturer and importer from liability if any defect could not have been discovered in the delivered product given the state of the scientific or technical knowledge at the time when the product was placed on the market (Article 4 of the Product Liability Act). 38

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In general, a manufacturer must provide an explanation, to a certain extent, about the usage of its product that might cause damage. Especially when the product is a drug, a detailed explanation must be given because the product acts on the human body’s physiological mechanisms and may have effects on the health and life of the recipient. An inadequate explanation may also serve as grounds for rating the drug as defective. Regarding this so-called “defect in instructions and warnings”, unlike with other types of defects,42 the actions of the manufacturer or importer will be called into question rather than the nature and condition of the product. This makes the identification of such a defect similar to that of negligence.43 If that is the case, can the Product Liability Act help to provide further protection for victims in cases where defects of this type are in dispute? Regarding this issue, the Supreme Court of Japan made a thought-provoking judgement in a case in which the patients who had received the anticancer drug “Iressa” subsequently contracted interstitial pneumonia and died.44 In this case, the issue was whether or not the defendant, AstraZeneca K. K.,45 had provided proper information about the side effects of Iressa to the medical professionals who had administered the drug. The first edition of the attachment to the Iressa product that was prepared by AstraZeneca K. K. had no “warnings” section; instead, it included the statement “interstitial pneumonia may develop” as the fourth “severe side effect” in the “precautions” section. It also did not specify the qualifications of the physicians who may administer the drug or the medical institutions that may use the drug. In October 2002, about three months after the release of Iressa, AstraZeneca K. K. acted on the instructions of the Ministry of Health, Labor and Welfare to publish “emergency safety information”, which stated that the administration of the drug may cause “serious side effects that include acute lung injury and interstitial pneumonia.” The company also revised the attachment to the product. Given these facts, the Supreme Court of Japan made the following decisions in its judgement issued on April 12, 201346: (a) Given that the clinical trials in Japan had seen no fatal cases resulting from interstitial pneumonia, the defendant considered that the frequency and severity of the interstitial pneumonia that occurs after the administration of Iressa was almost equal to those that occur after the administration of other anticancer drugs, and included a statement about interstitial pneumonia as the fourth “serious side effect” in the first edition of the attachment;

“Defects in production” and “defects in design”. Shiomi (2011), p. 386. 44 The Ministry of Health, Labor and Welfare approved Iressa in July 2002 before the rest of the world. Subsequently, 817 patients reportedly died due to the side effects of the drug by September 2010, including 180 within 6 months after the approval. 45 AstraZeneca K. K. is a subsidiary of the British pharmaceutical company AstraZeneca. It imports and sells Iressa in Japan. 46 Minshū 67 (4), 899. 42 43

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(b) Doctors who provide treatment for lung cancer are aware that interstitial pneumonia is among the side effects of anticancer drugs in general, and that this condition may turn out to be fatal; (c) The defendant published the “emergency safety information” when it became evident that interstitial pneumonia can develop soon after the administration of Iressa and “quickly becomes severe.” However, at the time of the approval of Iressa, it had been impossible to predict these facts from the results of the clinical trials; (d) Given these factors, the statement in the first edition of the attachment cannot be judged to be inappropriate as a description of a side effect that had been foreseeable at the time of the approval of Iressa. Therefore, in the context of the cases involving Victim A and B,47 the Iressa information cannot be judged as defective. The Supreme Court of Japan denied the foreseeability of interstitial pneumonia that would “quickly become severe” after the administration of Iressa and rejected the claims of the plaintiffs. This means that the case required the foreseeability of a specific effect, and that the decision made was, essentially, about the issue of negligence. Hence, what is at issue in this context is the relationship with the fact that Article 3 of the Product Liability Act specifies accepting liability without fault. In this regard, the Tokyo District Court made an interesting decision on August 3, 197848 about the negligence mentioned in Article 709 of the Civil Code, stating that: pharmaceutical companies have the duty to conduct experiments using “techniques of the highest standard” in order to manufacture and sell new drugs, and once they identify “the existence of any side effects or reasonable grounds to suspect the existence of any side effects,” they must take appropriate measures to avoid the occurrence of these effects as soon as possible.49 This imposes a duty on pharmaceutical companies to foresee the effects even while there is only an abstract risk of the effects, and this duty serves as the basis for the duty to avoid negative results. In other words, the decision ordered the pharmaceutical companies to avoid consequences that are difficult to predict. The judgement of the Supreme Court of Japan on April 12, 2013 applied the Article that sets forth the condition of liability without fault and, in effect, derived a liability that was similar to liability for negligence; whereas the Tokyo District Court decision on August 3, 1978, on the other hand, applied the Article that sets forth the liability for negligence and, in effect, derived a liability that was close to liability without fault. When the Product Liability Act was enacted, there were some views that the introduction of Article 3 of the Act would not result in a significant step forward in terms of the protection of victims.50 As the above example shows, the 47

Victim A was given Iressa on August 15, 2002, and Victim B on September 2, 2002. Hanrei Jihō 899, 48. 49 The Tokyo District Court ruling issued on February 1, 1982 (Hanrei Jihō 1044, 19) made almost the same judgement. 50 E. g. Kamata (1995), p. 55. 48

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Article has indeed not resulted in any step forward—rather, it has been a step backward in terms of the protection of victims.51 There is no doubt that the liability stated in Article 3 of the Product Liability Act is in the form of liability without fault. Therefore, at least the presence of “defects in instructions and warnings” should be affirmed in cases that a manufacturer or importer has taken only inadequate measures to avoid negative effects during the stage where there is only an abstract risk of the effects. (Hideki Ishibashi)

Alternatives to Court Proceedings Criticism of Medical Malpractice Lawsuits The above section has outlined the schemes employed to seek damages through lawsuits over medical malpractices and the legal doctrines that are applied. However, strong cases have also been made that medical malpractice litigation is unfit for dispute resolution of such cases; thus, alternatives to court proceedings have also been pursued. The number of medical malpractice lawsuits began to rise in Japan around the 1990s. In 1999, a series of medical accidents52 caught the public attention and resulted in extensive media coverage, which triggered a rapid increase in the number of lawsuits starting from around 2000. Coincidentally, 1999 was also the year that the Justice System Reform Council was established by the Japanese government, and the public was paying more attention to the judicial system in general at that time. As mentioned above, the Supreme Court of Japan issued notable rulings one after another, to remedy for the victims of medical malpractice in the years around 2000. In addition, the Supreme Court set up the Medical Malpractice Litigation Commission, thereby working more closely with the medical community than it had before. In 2001, the Tokyo and Osaka District Courts set up intensive medical divisions for the first time, and the other 8 district courts in major cities followed.53 Nonetheless, even while the courts were beginning to work actively on a trial system for medical malpractice cases, various views were offered that criticized the role of medical malpractice litigation to resolve medical accident disputes appropriately.

51 Based on this assessment, Yoshimura criticizes the judgement of the Supreme Court of Japan on April 12, 2013. Yoshimura (2016), p. 391. 52 Two notable accidents occurred. In one, neither nurse nor physician checked the patients and make wrong surgery on them (Yokohama City hospital case). In the other case, a nurse mistakenly injected potassium chloride fluid and caused death of a rheumatoid arthritis patient, but the hospital did not notify the police of the accident within time limit (Tokyo Hiroo Municipal Hospital case). 53 Ten district courts have intensive medical divisions. Tokyo, Yokohama, Saitama, Chiba, Osaka, Nagoya, Hiroshima, Fukuoka, Sendai and Sapporo.

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First, needless to say, the medical community showed a strong resistance to the prospect of taking medical accident cases to court. In Japan, where people tend to avoid litigation wherever possible, any lawsuits—including civil suits—filed against them are essentially regarded as unwarranted sanctions. For example, in 2006, an obstetrician faced a criminal charge over his patient’s death following an accident at the time of childbirth. Since it was deemed medically impossible to save the patient’s life in this particular case, the medical community’s resistance to criminal charge intensified, as they insisted that the possibility of being sued would cause “the collapse of the medical care system” (Komatsu 2006). This resistance would have a considerable impact on how the Medical Accidents Investigation System described below would be designed and operated. Second, a view was offered that a greater focus should be placed on caring for victims and their families totally. This view emphasized that a lawsuit has limitations in that it cannot meet all the needs of the victim in a medical malpractice case, and that an out-of-court dispute resolution could be a more desirable option. To be more specific, the victims in medical malpractice cases are seeking apologies, the truth, and the prevention of similar errors; while the lawsuit can provide nothing other than monetary compensation. Moreover, it is the patient that must prove the causation and the negligence, which are issues that he/she wishes to determine through the court procedure. That is, there are limitations on how much of the truth can be found through this process. The court system is designed neither to make the defendant apologize nor to ensure the prevention of similar errors. Therefore, alternative dispute resolution (ADR) is more desirable, as it may allow the patients and the medical professionals or institutions to have in-depth dialogues and discussions.54 Third, there is an opinion that, while it also emphasizes the limitations of a medical malpractice lawsuit and advocates ADR, argues for establishing a quasijudicial body that is designed to promptly offer a resolution that reflects the relevant expertise, rather than facilitating a dialogue between the patient and the medical professional. This view is in line with the policy for the further development of ADR in the recent reforms of the judicial system, and could serve as a driving force for the establishment of ADR for various medical malpractice cases. Medical malpractice lawsuits in general are highly technical, and are thus difficult cases, where the trials can require a great deal of time. The average time for civil proceedings for medical malpractice cases was 35.6 months in 2000.55 Act on the Expediting of Trials, which was enacted in 2003, demands that the proceedings of the first instance should finish within two years. An increasing number of such lawsuits would increase the burden on the courts, which again makes ADR appealing as a judicial policy. However, at present, it is not mandatory to try to resolve a medical malpractice case through the

54

See Wada (2007). He intends to promote conversation between physicians and patients in hospital and is critical of promoting quasi-judicial ADR for medical accidents. 55 Especially, when medical experts were appointed by court in order to make opinion, it took long time for judges to select the experts and additional time for the experts to report their opinion.

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civil conciliation offered at the courts or at a private mediation agency before bringing the case to trial court. Fourth, the idea that preventing medical accidents is more ideal than providing compensation for damages caused by medical malpractice has spurred discussions about safety in medical care, along with the need for further efforts to ensure safety. These discussions began in around 1999, the year that some medical accidents caught much of the public attention in Japan, and the need for risk management began to be publicized (“To err is human” (Institute of Medicine 2000)) in the United States. Consequently, hospitals in Japan are now required to have safety management systems in place,56 and to take other safety measures, including collecting case examples of medical errors. Medical safety is said to need a different perspective from the resolution of medical malpractice cases. The Medical Accidents Investigation System has also been set up, in accordance with the view that the causes of medical errors must be analyzed in order to enhance safety in medical care. The fifth and last view that should be mentioned here concerns the hurdle of proving fault in a lawsuit. It has been pointed out that, especially in court cases that deal with medical care, the characteristics such as the technicality and complexity of the treatment in question make it extremely difficult for patient side to prove fault, and thus the necessary compensation for damages caused by errors cannot be made as promptly and appropriately as it should. To address this issue, some medicalrelated areas have adopted a no-fault compensation system that will be discussed below. While this system is not ADR in a narrow sense, we will also touch on the no-fault compensation scheme using the Obstetric Compensation System as an example of a recently adopted system, along with the Medical Accidents Investigation System.

Alternative Dispute Resolution (ADR) for Medical Accidents ADR commonly refers to methods employed to resolve disputes other than law suits, or to the organizations that offer such procedures. In this light, ADR includes the civil conciliation offered at courts. Private ADR, in particular, began to develop after the recent judicial system reform, and in 2007, the Act on the Promotion of the Use of Alternative Dispute Resolution was put into force. Under this act, the agreement-type ADR services that meet certain requirements have been certified by the Minister of Justice.

56 See the outline of measures for medical safety promotion taken by Ministry of Health, Labor and Welfare is: https://www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000123782.pdf (accessed on 15 November 2018). In 2003, the placement of medical safety managers, medical safety department, and patient consultation counters was mandated in special functioning hospitals, which provide advanced medical care and have 400 or more beds. Now, all hospitals and clinics must establish some medical safety administrative structure and medical safety center.

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In 2010, the Ministry of Health, Labor and Welfare set up the Liaison and Coordination Council for Alternative Dispute Resolution (ADR) Organizations for Medical Malpractice Cases57 to facilitate the sharing of experiences in the mainly certified ADR services for medical malpractice cases provided mostly by the bar associations across the country.

Civil Conciliation Civil conciliation is a traditional means to resolve civil disputes by agreements of parties at district courts and mostly summary courts, a kind of judicial ADR. Civil conciliation has been said to fit the needs of Japanese people to resolve dispute peacefully. Civil conciliation is handled by conciliation committee consists of a judge or an attorney who preside the proceedings and two conciliators who are selected from individuals who has some expertise or has extensive experiences in a society (Article 1 of Civil Conciliation Personnel Rules). Civil conciliation is occasionally employed for medical malpractice cases. Since medical professionals, such as doctors, may be available as the expert members of the conciliation committee, court cases are occasionally submitted to conciliation ( fu-chotei) in order to gain expertise and expert’s opinions. However, there is a view that turning to conciliation for this purpose is a deviation from the way that conciliation should be used, which is to form agreement among parties. The reform of the judicial system has made the expert advisors (senmon-iin) available for court proceedings to get explanation of technical matters or to urge settlement; however, these expert advisors are seldom called for in medical malpractice cases in general, while some lawsuits are submitted to conciliation even now. In addition to the lawsuit cases submitted to conciliation, medical malpractice disputes have turned directly to civil conciliation for resolution. The procedure fee is lower than lawsuits and other most ADRs, and the result of conciliation is enforceable, which is a great advantage compared to other ADRs.

Alternative Dispute Resolution Service Provided by Local Bar Associations When the use of ADR is encouraged as an alternative to litigation, arbitration or mediation procedures that are offered by the bar associations are often referred. In the areas of Japan where district courts with intensive medical divisions or their equivalents are located, the bar associations operate ADR services for medical 57

The Liaison and Coordination Council for Alternative Dispute Resolution (ADR) Organizations for Medical Malpractice Cases (http://www.mhlw.go.jp/stf/shingi/other-isei.html?tid¼127350 visited.15 Nov. 2018) aims to share information about the efforts toward ADR for medical malpractice cases across the country. Observers from the courts have also participated. However, the Council has been on hiatus since its 8th meeting that was held in 2013.

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malpractice cases. These associations include: the three Tokyo Bar Associations, as well as Sapporo, Sendai, Osaka, Kyoto, Okayama, Hiroshima, Ehime and Fukuoka Bar These services developed by the bar associations are part of general ADS services. But they usually having systems specially designed to deal with the technical aspects of medical malpractice. ADR service provided by Three Tokyo Bar Associations and Aichi Prefecture Bar Association are said to be successfully operated. That is, the number of cases and the rate of acceptance of the procedure are relatively high.58 The three Tokyo Bar Associations have set a shared framework for handling medical malpractice cases in accordance with the ADR methods offered by each of these associations, and began to operate the “ADR Services for Medical Malpractice Offered by the Three Tokyo Bar Associations” in 2007. Since Tokyo has many attorneys who may be working on multiple medical malpractice cases, the associations can set up a system in which three attorneys serve as the arbitrators, namely: one attorney who acts for the patient, one that represents the medical institution, and one from one of the associations experienced in arbitration and mediation for out-ofcourt settlements. This system continues to successfully operate. After this system was established, those local bar associations with specialized medical law divisions also set up their own departments that would deal with ADR for medical malpractice under the umbrella of the Japan Federation of Bar Associations’ ADR Center. Meanwhile, the Aichi Prefecture Bar Association offers an arbitration and mediation system in which an attorney who does not specialize in medical malpractice cases acts as an arbitrator or mediator. The association also has an arrangement with medical professionals, where it may be requested that they work as expert advisors. With help from a major university hospital, this arrangement has been well-received owing to the technical knowledge and perspectives offered by the expert advisors.

Other Organizations These bar associations are not the only entities that are presently offering ADR services for medical malpractice cases. The Research Society for Medical Malpractice Disputes, an incorporated NPO in Chiba Prefecture, founded the Medical Malpractice Dispute Counseling Center which carries out a certified ADR service in accordance with the Act on the Promotion of the Use of ADR. This involves mediation system in which one doctor and one lawyer act as the mediators.

58

For the number of cases and the rate of acceptance of the sessions at each bar, see https://www. nichibenren.or.jp/library/ja/activity/data/adr_unyoujyoukyou.pdf (accessed on 15 November 2018). If physicians do not consent to the process at first, they cannot initiate the process later. For example, there are many cases for mediation center at Osaka bar association, but in only 46% of these cases, the other party agree to start mediation.

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In Ibaraki Prefecture, the medical association has taken the lead in establishing the Commission for the Neutral Settlement of Healthcare Issues in Ibaraki Prefecture in cooperation with the Ibaraki Bar Association, representatives of the citizens in the prefecture, and experienced academic experts. This Commission has set up an arbitration council that consists of three members, namely: an attorney, an academic expert or a representative of the citizens, and a board member of the medical association, in order to help the medical professional or institution and the patient have communication in order to reach agreement. On the whole, it is noteworthy that a medical association has taken the initiative in establishing an ADR, has contributed funds, and carries out the ADR service, while many medical institutions are still skeptical about the value of ADR. As described above, ADR for medical malpractice, among ADR in a broader sense, refers to the arbitration or mediation procedures conducted out of court by a third party based on the claims made by the patient. While there are various kind of ADR service arrangements for medical malpractice (including those provided by the bar associations), all ADR procedures begin only when the medical institution in question accept to join the process. That is, it is vital that the medical institution agrees to start the procedure. Therefore, it is necessary to foster understanding of ADR in order to make more medical professionals agree to the process. ADR services also tend to go well when they are built on a certain level of cooperation with the medical institutions; whereas in the areas where such cooperation is hard to come by, ADR does not seem to thrive.59

Other Systems to Remedy or Prevent Medical Accidents The limitations of lawsuits gave rise to the idea of promoting early out-of-court dialogues between medical professionals and the victims in medical malpractice cases. The advocates of these dialogues insist that ADR should be further developed in such a way that it encourages communication that is led by the hospitals’ medical care safety management offices.60 While how much the scope of ADR should be expanded and understood would be another question to consider, it would benefit both patients and medical professionals to make diverse dispute resolution methods available in different stages of the disputes of different types. However, the alternative dispute resolution of this sort is not yet widely known, and it has not gained a sufficient degree of understanding from the medical institutions. Hence, it is not frequently used, and medical institutions that are alleged to have committed errors will seldom agree to it.

59 60

See Watanabe (2018). See Wada and Nakanishi (2007).

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No-Fault Compensation Schemes Health problems caused by medical care require long-term treatment, which makes monetary compensation also an issue of vital importance. Therefore, it is necessary to facilitate the prompt payment of the amount of such compensation without proving faults, which is difficult for victims. Certain types of compensation are made for damages caused by the side effects of drugs under the Relief System for Sufferers from Adverse Drug Reactions in accordance with the Act on Pharmaceuticals and Medical Device Agency (PMDA), and for damages attributable to the mandatory vaccinations for children under the Relief System for Injury to Health with Vaccination in accordance with the Immunization Act.61 These systems were introduced as countermeasures against the large-scale suits that were filed for damages caused by the harmful effects of medicines or vaccination accidents at one time. Subsequently, the Obstetric Compensation System was created in 2009 in response to increasing number of medical malpractice lawsuits over accidents during childbirth. Even with present-day medical advances, childbirth still involves a high degree of risk, and a certain percentage of newborns will suffer permanent damage or die in accidents during childbirth. Lawsuits over such accidents can impose considerable burdens on the patients and on medical professionals, while the parents must additionally bear the significant financial burdens involved in raising children with severe disabilities. With the additional issues of an obstetrician shortage and high litigation risks, a no-fault compensation scheme for babies whose brains have been damaged at birth was set up and launched in 2009. For this scheme, the Japan Council for Quality Health Care signs the insurance policies that are offered by non-life insurance companies as the insurers, and the obstetric institutions as well as the expectant and nursing mothers pay the insurance premiums. This scheme covers babies who have suffered severe cerebral palsy due to the management of their births and who weighed 2000 g or more at birth after the thirtythird week of pregnancy. However, it excludes babies who were born with the disorder, or those having other factors as newborns that caused the damage. The amount of the coverage is 30 million yen in total: 6 million yen is first provided as a lump-sum reserve payment; and 1.2 million yen is paid in twenty annual installments until the child turns nineteen. The aim of this scheme is not only to provide compensation but also to analyze the causes of the accidents. The cases for which compensation has been paid are analyzed as examples, and cause analysis reports are then put together to help prevent the recurrence of similar accidents.

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This system was established in 1980.

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Medical Accidents Investigation System It is evident that, in cases where the patients have died due to improper medical care, identifying the causes of these deaths is essential. A judicial autopsy should be performed when a death might have resulted from a crime, and a pathological autopsy should be conducted to determine the medical cause of death. In Japan, however, it was pointed out that the system for identifying the causes of death does not work sufficiently and to address this issue, a “model project” for autopsies related to deaths involving medical care was launched in 2005. As the number of medical malpractice cases rapidly rose, the judicial system began to be increasingly criticized for its apparent lack of understanding of medical care, and the opinion was voiced that such lawsuits would not help to prevent further accidents. Therefore, the demand grew for a system to investigate the cause of medical accidents in order to address the issues highlighted by this criticism and opinion. The medical professionals and institutions hoped that by reporting errors to this investigation system would exempt them from both their duty to notify the police stipulated in Article 21 of the Medical Practitioners’ Act and from criminal prosecution; however, the opposing view demanded that criminal prosecution should remain the last resort for heinous examples of malpractice. The two sides did not reach an agreement, and after an outline of the system was proposed in 2008, the suggestion for the system was shelved. Nevertheless, moves toward setting up the system surfaced again and, in 2014, the suggestion was included in the revision of the Medical Care Act, The Medical Accidents Investigation System was then launched in 2015.62 The Medical Accidents Investigation System works as follows: the administrators of medical institutions must notify the Medical Accident Investigation and Support Center (a third party) of medical accidents if any unexpected deaths occur during the process of medical care. Then, the medical institutions can conduct their own internal investigations, submit a report on the findings, and accumulate such cases for analysis to ensure the future safety of medical care. The System is designed to respect the professional autonomy of medical institutions in that it centers on the reports at their own discretion and involving their internal investigations. Under the Medical Care Act, this System applies to “medical accidents (deaths or stillbirths caused or suspected to have been caused by the treatment provided by medical professionals working at the relevant hospitals, and specified by the Ordinances of the Ministry of Health, Labor and Welfare as unforeseeable for administrators of the medical institutions).” At present, the number of deaths or stillbirths that have been reported to the Center is much smaller than expected, because many of those cases have been judged not to meet the requirement of being “unforeseeable.”

62

For an outline of this system, see website of the Ministry of Health, Labor and Welfare, https:// www.mhlw.go.jp/file/06-Seisakujouhou-10800000-Iseikyoku/0000123782.pdf (accessed on 15 November 2018).

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The System could have been designed to offer a dispute resolution function as well. However, it was eventually launched as a system for the sake of “safety in medical care,” and was clearly separated from dispute resolution. Therefore, it may not demand that an investigation into an accident be conducted at the request of a patient. It also cannot require that the accident investigation reports be disclosed to the patients. Medical institutions are reportedly concerned that their accident reports may be used as evidence in court. This means that their aversion to litigation might be an obstacle to the proper operation of the accident investigation system. Both the Obstetric Compensation System described above and the Medical Accidents Investigation System focus on safety in medical care or on compensation, and they were not created for resolution of medical malpractice disputes. Nonetheless, these Systems can facilitate the out-of-court resolution of problems and to determine the causes of malpractice that the patients, as parties to the disputes demand to know. Hence, the Systems may be considered to be part of the growing movement toward alternative dispute resolution. As discussed above, there has been a shift from seeking damages through typical lawsuits toward using alternative dispute resolution and the system of preventing incidents. However, Japan has not taken active measures to deter people from seeking resolution through litigation, such as by exempting medical professionals and institutions from criminal prosecution if they have offered apologies or have reported their medical errors, or by making ADR mandatory before such cases are brought to court. The number of lawsuits, in fact, has not increased to such a degree that it requires the active discouragement of litigation. This is probably because of the considerable amount of time and money required for a lawsuit and the limited chance of winning a case has effectively deterred people from filing lawsuits. Because “to err is human” improvements of the court proceedings are even more desirable in order to protect the patients’ rights. (Chihara Watanabe)

References Hirano T (2017) Iryōkago Niokeru Seikyūken Kyōgō (Concurrence of actions in medical malpractice cases). Ritsumeikan Hōgaku 369(370):580–606 Institute of Medicine (2000) To err is human: building a safer health system. National Academies Press, Washington DC Ishibashi H (2014) Fuhōkōihō Niokeru Wariaiteki Sekinin no Hōri (Theory of proportional liability in tort law). Hōritsubunka-sha, Kyoto Kamata K (1995) Kekkan (Defects). Hanrei Times 862:51–66 Kawakami S (1999) Shinryō Keiyaku to Iryō Jiko (Medical contracts and medical accidents). In: Isomura T et al (eds) Minpo Trial Kyōshitsu (Trial lessons on civil law). Yūhikaku, Tokyo, pp 352–373 Komatsu H (2006) Iryo Hokai (The collapse of medicine). Asahi Press, Tokyo Kubota A (2001) Judicial precedent review. Jurist 1202:69–70 Kubota A (2018) Fuhōkōi Hō (Tort law), 2nd edn. Yūhikaku, Tokyo

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Matsumoto H, Ueno Y (2015) Minjisoshō Hō (Civil procedure law), 8th edn. Kōbundō, Tokyo Nakano T (1976) Iryōkago Soshō no Tetsuzukiteki Kadai (Procedural issues in medical malpractice cases). Hogaku Seminar (Law Seminar) 258:30–47 Shiomi Y (2009) Fuhōkōi Hō I (Tort Law I), 2nd edn. Shinzan-sha, Tokyo Shiomi Y (2011) Fuhōkōi Hō II (Tort Law II), 2nd edn. Shinzan-sha, Tokyo Tejima Y (1993) Judicial precedent review. Minshōhō Zasshi (Civil Commer Law J) 108 (1):109–114 Ueki S (2007) Iryō no Hōritsugaku (Law for medical care), 3rd edn. Yūhikaku, Tokyo Wada Y (2007) Iryōjikofunsō ADR Kōchiku no Haikei to Kongo no Tenkai (Backgrounds and Agenda for Establishing ADR for medical Accidents). Hogaku Seminar (Law Seminar) 631:43–44 Wada Y, Nakanishi Y (2007) Iryōfunsō to ADR (Medical dispute and alternative dispute resolution). In: Wada Y (ed) ADR: Riron to Jissen (Alternative dispute resolution: theory and practice). Yūhikaku, Tokyo, pp 106–119 Watanabe C (2018) Funsōkaiketsukatei Niokeru Senmonchi: Iryō ADR wo Rei ni (Expertise on the process of dispute resolution: examples of ADR for medical accidents). Chūsai to ADR (J Jap Arbitr ADR) 13:72–79 Yasuda H (2014) Iryō Suijun to Iryō Kankō (Medical standard of care and medical practices). In: Fukuda T, Takahashi Y, Nakamura Y (eds) Iryō Soshō (Medical malpractice lawtuits). Seirinshoin, Tokyo, pp 284–300 Yonemura S (2016) Ijihō Kōgi (Lecture on medical law). Nihonhyōron-sha, Tokyo Yoshimura R (2016) Shiminhō to Fuhōkōihō no Riron (The theory of civil law and tort law). Nihonhyōron-sha, Tokyo

Chapter 12

Innovating Compensation for Medical Liability in the Netherlands Berber Laarman and Arno Akkermans

Abstract In the Netherlands, concerns about the negative experiences of patients with legal procedures following adverse medical events have led to potentially profound changes in the field of procedural complaint- and compensation law. This chapter offers insight into the Dutch legal framework of compensation for damage caused by healthcare. We start by presenting the traditional framework in the paragraph on the Dutch landscape of medical liability. Having laid the groundwork, we try to explain the innovations that have recently been introduced, in the paragraph dealing with efforts for reform. We elaborate on the problems patients experience when they claim for compensation, the impact legal procedures can have on both patients and healthcare professionals, the recent changes in legislation trying to address these problems, and how these changes might entail a new reality force both healthcare and legal professionals.

The Dutch Landscape of Medical Liability The Legal Relationship Between Healthcare Professional and the Patient The Dutch system for compensation of damage resulting from health care is fault based. The rights of patients and the corresponding duties of healthcare professionals are laid down in the Medical Treatment Contracts Act (WGBO) which is part of the Dutch Civil Code (DCC), and the Healthcare Quality, Complaints and Disputes Act (Wkkgz). The WGBO is an act on healthcare professionals’ duties concerning individual patient care, the Wkkgz sets out obligations on complaint management and quality of care, including the out of court resolution of claims for compensation.

B. Laarman (*) · A. Akkermans (*) Faculty of Law of Vrije Universiteit Amsterdam, Amsterdam, The Netherlands e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_12

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The relationship between the healthcare professional and the patient is a specific contract, the medical treatment contract, for which binding rules are given in the WGBO (article 7:446 Dutch Civil Code, hereinafter referred to as DCC), such as the general obligation of the health care professional to observe the standards of good care and to act in conformity with the responsibilities laid upon him by the professional standard that is applicable to him (art. 7:453 DCC). Acting in breach of the duty of providing good care is qualified as failure to fulfill a contractual duty (art. 6:74 in conjunction with art. 7:453 DCC). In case law on the contractual1 liability of professionals the criterion of the ‘reasonably able and reasonably acting’2 professional has been developed to describe the general standard of care that is expected of all professions, i.e. not limited to the medical professions.3 This general criterion is operationalized by the applicable professional standard, depending on the profession involved. The performance of professionals is evaluated by asking what a reasonably able and reasonably acting colleague would have done in the same circumstances. For healthcare professions, the professional standard is composed of the state of the art of medical practice, construed inter alia out of relevant guidelines, protocols and scientific publications. Case law is also an important source, not only of the courts, but especially of the medical disciplinary tribunals, where medical and legal experts decide on the quality of care provided by individual healthcare professionals. The professional standard is a melting pot of standards and norms of different origin, not only in regard of very different sources, but also in the sense that it contains a mixture of standards and norms from international and national origin, and it is difficult to reconstruct which norm originates from where, and to what extent. In general, the level of accepted medical knowledge (ars medica) will be considered from the international perspective of the applicable medical sub discipline, but the test of what a ‘reasonably able and reasonably acting’ colleague would have done in the same circumstances, naturally allows for all the circumstances of the case at hand,4 including circumstances that might be typical for the Netherlands. On the other side of the spectrum, there are norms that formally are of a national origin, such as norms on communication and openness on adverse events, but these as well are often inspired and/or informed by the ideas and practices in other countries. The Netherlands is a very open jurisdiction, both in practice and in theory, and the question whether a certain norm has a national or international origin is not always easy to answer and is rarely relevant.

1

The same criterion applies in tort. ‘Redelijk handelend en redelijk bekwaam’. 3 The norm of the ‘reasonably able and reasonably acting’ professional was first formulated by the Dutch Supreme Court in the Speeckaert/Gradener case, ECLI:NL:HR:1990:AC1103, and later laid down in article 7:453 DCC. 4 The standard is the same for junior or new doctors, and there is some controversy on whether the kind of hospital should be allowed to make any difference (e.g. academic medical center or not). 2

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Logically, following from the obligation to act as a good healthcare provider (and not a perfect one), the complexity of the human body, and the limitations and imperfections of health care, the medical treatment contract is considered to give rise to ‘obligations of means’ (obligation de moyens),5 although the nature of things can be such that that certain obligations, such as the obligation of a surgeon to amputate the right leg and not the wrong one, will nonetheless be qualified as an ‘obligation of result’ (obligation de résultat).6 Dutch legal doctrine is not familiar with the concept of an obligation de moyens renforcée.7 Dutch law is familiar with the concept of aléa thérapeutique to identify adverse medical events that were not caused by errors or any other form of substandard care, but are considered risks inherent to the condition or the treatment of the patient. These are called ‘complications’ (complicaties) and, as Dutch medical liability is fault-based, cannot give rise to liability. There is, however, no separate normative framework for identifying ‘complications’, as they are already singled out by the applicable test of asking what a reasonably able and reasonably acting colleague would have done in the same circumstances. If the care provided was up to standard, any negative health results will be considered a ‘complication’ and will not give rise to a right to compensation. In situations where the patient is unable to consent, no treatment contract is concluded, for instance when the patient is unconscious. In the absence of a treatment contract the basis of liability will be in tort. Dutch tort law is organized starting from a general statutory provision, article 6:162 of the Dutch Civil Code, that mentions three separate forms of unlawfulness. There is some scholarly debate

5 In several civil law jurisdictions a doctrinal distinction is made, originating in French law, between two types of contractual obligation: an ‘obligation of result’(in French: obligation de résultat) is an obligation to achieve a certain result (also known as output based obligations) is distinguished from an ‘obligation of means’ (in French: obligation de moyens), this is an obligation to dedicate a certain amount of resource to achieving a particular result (also known as input based obligations). If a contractual breach is committed in respect of an ‘obligation of result’, the plaintiff has only to demonstrate that the contractual result has not been achieved. The debtor is then deemed liable, except if he can prove that his obligations under the agreement were not fulfilled because of force majeure or an act or omission of the plaintiff. If a contractual breach is committed of an ‘obligation of means’, the plaintiff must prove that the debtor has acted wrongfully by not performing his obligations with the necessary degree of care and diligence. Whether an obligation is deemed to be an ‘obligation of result’ or ‘obligation of means’ will depend partly on the uncertainty of the result to be achieved and partly on the intention of the parties. For further analysis, see Alessi on the distinction between the two (Alessi 2005). In the Netherlands, the distinction is not always made nor always considered relevant, and the Courts are free to decide on issues of proof according to all the circumstances of the case at hand. 6 A medical treatment contract can give rise to ‘obligations of result’ when the parties at the moment of entering into the contract intended the healthcare professional to guarantee a certain and explicitly described result, or that intention can be deemed to have existed based on parties’ declarations and conduct when concluding the agreement. 7 This is a ‘strengthened’ obligation of means, sometimes called the obligation of ‘diminished’ result: it is the debtor’s duty to release himself, but the proof required is easier than that of force majeure.

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on the meaning of these different forms, but in practice these theoretical differences are of no consequence, and for all practical purposes the tortious ground for medical liability can best be translated as the tort of negligence. Here exactly the same criterion applies, namely the test what a ‘reasonably able and reasonably acting’ colleague would have done in the same circumstances. As a result, the doctrinal distinction between contract and tort in medical cases is rarely relevant. A medical professional can also be found liable for using an unsuitable or defective aid (art. 6:77 DCC), for subordinates (an assistant or trainee, art. 6:76 DCC) or an unsuitable building (art. 6:174 DCC).

The Relationship Between Healthcare Professional, Healthcare Provider and the Liability Insurance Company First a note on relevant Dutch legal vernacular: in Dutch healthcare regulations, ‘healthcare professional’8 is a comprehensive term meaning doctors, such as surgeons or physicians, but also general practitioners, dentists and nurses. The ‘healthcare provider’ is the surrounding institution; the hospital, clinic or nursing home. Often the ‘healthcare professional’ and the ‘healthcare provider’ are distinct entities. An exception is when a family doctor or a dentist, or any other professionals who typically work in smaller clinics, have their own individual practice. In the terms of Dutch health care regulations, they are both ‘healthcare provider’ and ‘healthcare professional’. Most Dutch medical specialists work as self-employed entrepreneurs in hospitals. Medical specialists are usually organized in a ‘Medisch Specialistisch Bedrijf’ (MSB, Medical Specialist Enterprise), a partnership organized around one or more medical specialties working within a hospital on the basis of a contract with that hospital. Typically, caring and assisting personnel will be employed by the hospital. Patients receiving treatment in a hospital will, therefore, often have to do with several legally separate contractual partners. This legal dimension of hospital healthcare will of course rarely coincide with the perceptions of patients, and could give rise to all kinds of hampering complications when patients want to exercise their legal rights or undertake other forms of action. This is why article 7:462 Dutch Civil Code provides for so called ‘central liability of the hospital’. Central liability enables patients who experience harm in a hospital9 to address the hospital directly in regard of all treatment received in that hospital (article 7:462 DCC). Central liability is also reflected in liability insurance arrangements, as it

8 The Wkkgz addresses all healthcare providers. This means the same obligations on managing complaints and quality apply to institutions like hospitals and nursing homes, and to individually working practitioners like family doctors and dentists. 9 ‘Hospital’ here can mean a nursing home, psychiatric hospital, academic hospital, specialist clinic, etc.

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logically obliges hospitals to acquire comprehensive intramural liability insurance coverage, providing coverage for all healthcare professionals working within the same hospital, whether they are employees or not (Wijne 2013). All hospitals carry some form of agreed upon deductible excess, but the amounts vary widely, from a relatively small excess on each separate claim to an overall annual excess of several millions. Below the threshold of the deductible excess the level of involvement of the insurance company varies. Some hospitals handle claims below the agreed upon threshold independently from the insurance company. They will have an internal legal department or a complaints officer with the necessary expertise to manage (most) claims properly, and the insurance company’s involvement is limited to accepting payments as part of the deductible excess—if applicable. It might also be that a healthcare provider, when confronted with a more complex claim, involves a professional loss adjuster. At the other end of the spectrum, all claims are referred to the insurance company entirely. In that case a professional claims handler of the insurance company takes over all matters pertaining to the claim, including correspondence with the patient. Between these extremes, many different arrangements and forms of cooperation occur, depending on the hospital, the policy of the insurance company, but also on the case at hand. Sometimes hospitals prefer to refer a certain claim to the insurance company because the patient is still receiving treatment and they fear that legal issues might interfere with the relationship between the patient and the healthcare professional. Conversely, the relationship with the patient may have deteriorated to the point that referring the claim to the insurance company has become the preferable option.

Open Disclosure and Apologies The Healthcare Quality, Complaints and Disputes Act (Wkkgz) obliges healthcare providers to inform patients about the nature and circumstances of adverse events. The Act expects providers to be open and honest about ‘any unintended or unexpected event that relates to the quality of the care, and has resulted, or could result, in noticeable consequences for the client’ (article 10 section 3 Wkkgz). The codification of this obligation by statute was merely the crowning moment of the preceding evolution of the applicable professional standard. The careful reader will have noted that the definition of adverse events as stated in art. 10 section 3 Wkkgz does not include the so-called near misses (‘could have resulted’). It is all but the near misses that have to be brought ‘without delay’ to the attention of the patient on the initiative of the healthcare provider (Article 10 section 3 Wkkgz). The Dutch market for medical liability insurance is dominated by two mutual insurance societies,10 that for some time now have been actively promoting an open and proactive approach of their insured towards adverse events, including open

10

These are VVAA/MediRisk (www.medirisk.nl) and Centramed (www.centramed.nl).

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disclosure and the offering of apologies where appropriate. It is explained to the insured that admitting fault and apologizing must be distinguished from accepting liability, the former belonging to the responsibility of the healthcare professional, and the latter to the responsibility of the insurer or the legal department of the hospital. The prevailing view that the admission of fault and apologies as such do not constitute acceptance of liability has up till now been sustained by the very few court and disciplinary cases that explicitly address this issue.11 Regretfully, it cannot be said that outside the specific domain of medical liability insurance, that is to say, in the domain of professional liability insurance in general, all insurance companies take the same enlightened approach to the issue of admitting fault and apologising by their insured. The Dutch Civil Code does however contain a provision that is relevant to this issue and applicable to all liability insurance policies: Article 7:953 DCC: If a liability insurance prohibits the insured to make certain acknowledgements, then a violation of this prohibition will not have any effect insofar as such acknowledgement is correct. A prohibition to acknowledge facts never has any effect.12

This provision can be understood as being part of the general principle that parties to a civil procedure should be truthful13 and was explicitly introduced to protect those who correctly admit fault from being excluded from their insurance coverage (Zwart-Hink 2017). The medical liability insurers no longer entertain any prohibitions of this kind in their insurance contracts, not only out of well understood selfinterest but simply because such conditions would induce their insured to act contrary to their professional standard. But a recent examination of liability insurance policies available on the internet revealed the survival outside of the medical domain of many ‘outdated’ policy provisions that article 7:953 DCC renders unenforceable and therefore can only misinform the insured about their options in regard of well-founded allegations of mistake or fault (Zwart-Hink 2017). This might help to explain that the ‘popular belief’ that liability insurance stands in the way of admission of fault and the offering of apologies is still widely spread in society and, in spite of all recent efforts, has not yet been completely eradicated among the medical professions.

11

This view is not without controversy (Zwart-Hink 2017). Translation by the authors. Art. 7:953 Burgerlijk Wetboek: ‘Indien een verzekering tegen aansprakelijkheid bepaalde erkenningen door de verzekerde verbiedt, heeft overtreding van dat verbod geen gevolg voor zover de erkenning juist is. Een verbod tot erkenning van feiten heeft nimmer gevolg’. 13 Article 21 Dutch Code of Civil Procedure: The parties are obliged to provide fully and truthfully the facts relevant to the case. If this obligation is not complied with, the court can take the measures it deems appropriate (Translation by the authors). 12

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The Current Debate on Compensation of Damage Caused by Healthcare In the Netherlands at the moment there is no prevailing perception of a ‘medical liability crisis’ asking for measures such as limiting the number of medical litigation cases (other than by increased patient safely and the promotion of the non-adversarial resolution of claims) and diminishing the amount of financial compensation. Rather there are concerns, in both the scholarly and the political debate, that (1) inept responses to complaints and adverse events lead to unnecessary juridification,14 including the undue assertion of claims and the lodging of disciplinary complaints, both giving rise to destructive adversarial processes; that (2) this is to the detriment of both patients and health care professionals; and that (3), where there is a legitimate claim for compensation, it should be honored, but this often takes a long time and is difficult and burdensome, both financially and emotionally.

What Makes Medical Liability More Difficult? To start with the last concern, research has revealed that, however flat the Dutch landscape may be, patients experiencing harm in healthcare may have many mountains to cross when claiming for compensation, more so than in other cases of personal injury such as traffic accidents (Smeehuijzen et al. 2013). There seem to be several reasons for this difference. To begin with, both fault and causality are generally more difficult to establish than, for instance, in case of traffic accidents. Traffic rules are generally quite unambiguous, their violation relatively easy to determine, whereas what follows exactly from a health care provider’s professional standard in a given situation will often be much less clearly defined, allowing for different approaches and depending on different aspects of the case, often with some room for professional discretion. In many cases it may require one or more expert opinions, with all the delays and costs involved, to bring final clarity to a case. Causality, also, will often be more difficult to establish, as distinguishing between the consequences of the incident and what would have been the natural progression of the patients’ condition can be very difficult. In the fault-based Dutch system, the burden of proof lies with the patient, although case law has developed several instruments to alleviate that burden. Three of those instruments should be mentioned here.15 The first instrument is specific to medical cases, and involves a doctrine that sets down heightened requirements to any refutations the healthcare professional might make of submissions of facts by the patient. A simple denial will never do, but will have to be substantiated,

14 Phenomenon where a situation escalates into legal conflict, discussions escalate, opinions harden, parties alienate, and generally it becomes more difficult to achieve a reasonable solution. 15 The number of instruments to be distinguished here is to some extent a matter of appreciation.

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for instance by the provision of documentation like the patient’s medical file.16 It is emphasized that this in itself does not amount to a reversal of the burden of proof, although the result may be the same. The applicable standard is whether the information provided by the healthcare professional is providing the patient sufficient clues to go on in the gathering of facts and delivering of proof to substantiate his claim.17 When the professional fails to meet this standard, the court can accept the patients’ statements as insufficiently disputed or place the burden of proof upon the professional.18 Specific circumstances may give rise to approaches by the court where the distinction from the outright reversal of proof becomes rather subtle, such as when a health care professional has failed to fulfil his obligation to maintain an adequate medical file. An example of this situation is that the court might accept the patient’s claim that no informed consent was given, when the medical file does not note that the required information was provided (which it should), and neither the healthcare professionals’ statements nor any other documentation can convince the court that the information was provided.19 The two other doctrines alleviating the patient’s burden of proof involve the requirement of causation—although the first to mention here is the doctrine of loss of chance, which in many jurisdictions will not be accepted as having anything to do with causality, only as constituting a particular form of compensable damage (Gilead et al. 2013). However that may be—scholarly debate in the Netherlands generally takes a broader view—the doctrine of loss of chance is accepted by the Dutch Supreme Court20 and is widely used in medical malpractice cases. So for instance when in the absence of a timely intervention in a birth process, the new born child is suffering perinatal asphyxia, that might also have occurred if there would have been a timely intervention, the court might ask the medical expert’s opinion about the chance of avoiding damage to the child’s brain when the gynecologist would have acted according to his professional standard, and when that chance is sufficiently substantial, might award damages for the loss of that chance. The second doctrine,

16

Dutch Supreme Court (Hoge Raad) 20-11-1987 ECLI:NL:HR;1987:AD0058 (Timmer/ Deutman). 17 Dutch Supreme Court (Hoge Raad) 20-04-2007, ECLI:NL:HR:2007:BA1093 (Mislukte Sterilisatie). 18 Supreme Court of the Netherlands (Hoge Raad) 18-02-1994, NJ 1994, 368 (Schepers/De Bruin); Supreme Court of the Netherlands (Hoge Raad)13-01-1995, ECLI:NL:HR:1994:ZC1269 (De Heel/ Korver); Supreme Court of the Netherlands (Hoge Raad) 15-12-2006, ECLI:NL:HR:2006:AZ1083 (NNEK/Mourik). 19 Since the medical file is primarily meant to serve medical purposes (good care) and not as a legal instrument, flaws in the medical file in itself do not necessarily lead to a decision in the patients’ favor if the healthcare professional is able to provide the required information in another manner. This is where the distinction between the reversal of the burden of proof and heightened requirements to refutations is upheld. The healthcare professional can repair flaws in the medical file by making a statement or providing witnesses because, in the reasoning of the Dutch Supreme Court, he doesn’t have to provide proof. Supreme Court of the Netherlands (Hoge Raad) 20-04-2007, ECLI:NL:HR:2007:BA1093 (Mislukte Sterilisatie). 20 Supreme Court of the Netherlands (Hoge Raad) 27-10-27, ECLI:NL:HR:2017:2786.

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referred to as ‘the rule of reversal’, was also developed in general liability law, and allows the court to assume but-for causation (conditio sine qua non), unless the defendant produces proof to the contrary.21 This requires a close proximity between the specific protective scope of the norm that was violated (for instance: a protocol instructed in the given circumstances the use of anticoagulants, but no anticoagulants were given) and the risk that materialized (in the example: the emergence of thrombosis). In such a case, despite the possibility that the risk might also have occurred if the norm would have been obeyed (anticoagulants are not always effective), the court may assume, because of the close proximity of protective scope and risk (it is exactly for the risk of thrombosis that the protocol prescribes anticoagulants), that but for the violation, the risk would not have materialized.22 Obviously, this doctrine can only apply when the norm violated has a sufficiently specific protective scope, which is typical for all kinds of ‘safety norms’, but outside that domain hardly ever applies.23 What also seems relevant is that financial barriers to the recovery of claims in health care are often higher than in other domains. The Dutch law of damages holds that the costs of out of court negotiations, including legal representation and expert opinions, are a compensable head of damage, provided that it was reasonable to incur these costs and that they are reasonable as to their amount.24 In case of traffic accidents, where liability is easily established and remaining discussions tend to be about the extent of the damage suffered, this constitutes a substantial alleviation of the position of the plaintiff—and a strong incentive not to go to court, as other, less favorable costs arrangements will prevail there. But in case of alleged medical negligence, where it can take several years and several expert opinions before fault and therefore liability is established, the full financial burden of out of court proceedings rests upon the patient, until he might be relieved by the establishment of liability and the subsequent reimbursement of his reasonable costs—or not. Numbers vary, but over the years a rough average of around 45% of medical malpractice claims tends to be successful.25 Finally, it might be, although reliable data are lacking, that adverse medical events and their aftermath are—in general—also emotionally more burdening than the average traffic accident, because they occur within a relationship of trust between the patient and the health care professionals, whereas no preexisting bond of trust

21

See for the development of this doctrine in the case law of the Dutch Supreme Court: A.J. Akkermans. 22 Supreme Court of the Netherlands (Hoge Raad), 2-3-2001, ECLI:NL:HR:2001:AB0377. 23 For a comprehensive discussion of case law doctrines alleviating the burden of proof of causation, see A.J. Akkermans & Chr. H. Van Dijk (Akkermans and Van Dijk 2012). 24 Article 6:96 section 2 DCC. 25 Most Dutch hospitals are insured with either MediRisk or Centramed. For MediRisk, liability is accepted or a settlement reached in around 45% of the cases (46% in 2013, 41% in 2014, 44% in 2015, 44% in 2016) (published online: https://www.medirisk.nl/kennisbank-preventie/feiten-encijfers.) For Centramed this is 37% over the period of 1994–2016 (published online: https:// centramed.nl/over-centramed/centramed-in-cijfers).

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will be compromised between those involved in a traffic accident. What has empirically been established is that claim procedures can put severe emotional stress on patients. Patients who claim for compensation might experience secondary victimization, a new trauma caused by the nature and course of the legal procedure, as was found in research concerning victims of traffic accidents (Elbers et al. 2013). Research into claimants’ experiences suggests the adversarial nature of procedures is especially stressful (Elbers et al. 2013; Smeehuijzen et al. 2013). The attitude of the healthcare provider, professional or insurance company as experienced by the patient can be hurtful. And, for all the reasons mentioned above, procedures can take years before reaching a final solution.

It’s Not (Only) About the Money It is a constant outcome of research into the motives and experiences of patients pursuing a claim in health care, that financial compensation is often not reported as their sole or even primary motive (Vincent et al. 1994; Relis 2009, 2017). In the Netherlands as well, research has revealed a variety of non-financial needs and motives, that might be prioritized above a monetary award, such as the clarification of what has happened, acknowledgement of fault, the taking of responsibility for the incident and its consequences, the offering of apologies, seeing justice done, and preventing the same incident from occurring again (Smeehuijzen et al. 2013; Lindenbergh and Akkermans 2014). This is consistent with findings among the victims of personal injury in general (Akkermans and Van Wees 2007; Akkermans 2009), the only difference appears to be that non-financial concerns seem even more significant to patients than to others (Lindenbergh and Akkermans 2014). These findings are problematic to traditional liability law. It is clear that the functioning of liability law in its traditional sense—the fair allocation of financial compensation— leaves room for improvement. But for those who seek fulfilment of non-financial needs as described above, the adversarial nature of the traditional civil procedure tends to lead them further astray. Discussions escalate, opinions harden, parties alienate, and generally it becomes more difficult if not impossible to achieve reconciliation. This is considered to be contrary to liability law’s intrinsic restitutionary goals. Patients’ Needs, the ‘Second Victim’, and the Importance of ‘Just Culture’ The healthcare professional has an important, if not central, role to play in responding to the needs of patients. A swift, empathic and open response of the healthcare professional can prevent escalation and unnecessary (legal) conflict.

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There are, however, many barriers that can keep the healthcare professional from the appropriate response.26 On the organizational level, the prevalence of a ‘blame culture’ can obstruct openness for fear of being held personally responsible and the possibility of negative (legal) consequences (Pinto et al. 2013). A strong sense of hierarchy and a limited ability to accept or give criticism can constrain healthcare professionals to speak up about their own or their colleagues (near) mistakes (Aasland and Førde 2005) (Anonymous 2015).27 On a personal level, experiencing disclosure as difficult and fear of the patients reaction can be factors negatively influencing willingness to disclose (Linthorst et al. 2011). Also, the assumption that disclosure is not in the patients’ best interest is mentioned as a barrier to disclosure (Harrison et al. 2014). And last, but certainly not least, healthcare professionals can suffer severely after experiencing an adverse event, a phenomenon that has given rise to the term ‘second victim’ (Wu 2000), an expression not without controversy, yet widely used to express the potential impact of an adverse event on the healthcare professionals involved (Wu et al. 2017). Symptoms vary from worrying about the patient, loss of professional confidence, shame, and worry about loss of reputation, (Schwappach and Boluarte 2009) but also symptoms of a more serious and clinical nature occur such as depression, insomnia, hyper-alertness, PTSS-like symptoms such as flashbacks (Schouten et al. 2018) and suicidal ideation (Shanafelt et al. 2011). It is probably safe to assume this can negatively impact on the ability of professionals to properly disclose. Supporting health care professionals after a medical incident helps to relieve this impact (Seys et al. 2013; Van Gerven et al. 2016) and probably aids in disclosure. Concerns about preventable harm in healthcare have led to a growing attention for ‘culture’ and how culture affects patient safety. Psychology professor James Reason introduced the ‘Swiss Cheese Model’ to visualize the interaction of systemic context and individual acts in the occurrence of errors, (Reason 2000) inciting a lively debate about the sense and nonsense of allocating the responsibility for adverse medical events to individual healthcare professionals.28 The desirable

26

Many barriers, personal, professional, organizational and cultural barriers towards being open have been discussed in literature. For an extensive review of the available literature concerning open disclosure and its impeding factors: Birks et al. (2014). Kaldijan et al provide a clear taxonomy of factors impeding disclosure (Kaldjian et al. 2006) More recently, Carillo et al. analyzed the relationship between factors that contribute to healthcare professionals informing patients and apologizing after an avoidable adverse event. Their research points towards the significance of an organizational culture that favors disclosure, positive example by colleagues, and positive experiences (or the lack of negative experiences) with disclosure as factors that positively impact the attitude towards disclosure (Carrillo et al. 2017). 27 ‘Waardeer de frisse blik van de co: afhankelijkheid bij coassistenten nog altijd sta-in-de-weg’, Medisch Contact, 24 September 2015. Article in the magazine published by the Royal Dutch Medical Association. The article elaborates on the barriers medical students and residents experience in criticizing unsafe behavior by supervisors. Published, fittingly, anonymously by a professor and student of medicine. 28 Debate is mostly centered around finding the balance between ‘no-blame’ and personal accountability. Amongst others: M. Walton, (Walton 2004; Wachter and Pronovost 2009) and the concept of ‘just culture’ as the road in between (Dekker 2007).

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alternative to a blame culture is a ‘just culture’. In a just culture, it is recognized that competent and dedicated professionals may make mistakes, and the often important role of the organisational context in making mistakes is acknowledged, while at the same time a clear line is drawn between acceptable and unacceptable behaviour (Dekker and Laursen 2007; Wachter and Pronovost 2009; Dekker et al. 2009; Dekker and Laursen 2010). In a just culture, adverse events are investigated in order to learn from them without putting the healthcare professional on trial.29 A just culture allows openness to play its pivotal role in both patient safety and the better resolution of adverse events. Support and guidance for ‘second victims’ is an essential part of a just culture. In several Dutch hospitals, peer support systems are being set up to that purpose (Laarman et al. 2016). Talking to peers, learning from the incident, talking to and apologizing to the patient, and adjusting practices to prevent the same from happening again, are among mechanisms that help ‘second victims’ to cope and recover (Plews-Ogan et al. 2016; Coughlan et al. 2017). We lack specific (Dutch) data on whether and how compensation procedures influence the recovery of ‘second victims’. What we do know is that complaint- and disciplinary procedures are often taxing (Laarman et al. 2018; Bruers et al. 2016; Verhoef et al. 2015; Alhafaji et al. 2009).30 Blame, implicit or explicit, is prevalent in legal procedures in healthcare, either as an inherent element of the procedure itself, as is the case in disciplinary law—notwithstanding the fact that disciplinary law in the Netherlands is formally aimed at maintaining quality of care and not punishment—or it seems to inadvertently creep in because of the way procedures are carried out: formal, adversarial and mostly in writing. The good news is that the mechanisms that benefit the recovery of ‘second victims’ correspond directly to patient’s needs after adverse events and facilitate improving patient safety by learning. Supporting ‘second victims’ and helping them to engage in dialogue with the patient, facilitates the recovery of both patient and healthcare professional. This in turn prevents harmful and unnecessary juridification. Supporting healthcare professionals in coping with adverse events is directly linked to both patient safety and to responding to patient’s individual needs.

29 ‘Just culture’, what it takes to be ‘just’, and its importance for patient safety is far more complex than the global description we can offer here but the literature by Dekker referred to here can provide a good starting point for those who are interested. 30 The report by Friele et al is a report on a qualitative study considering the impact on the professional functioning and private lives of publishing disciplinary measures on healthcare professionals. English manuscript accepted for publication in BMJ: Laarman et al, How do doctors in the Netherlands perceive the impact of disciplinary procedures and disclosure of disciplinary measures on their professional practice, health, and career opportunities? A questionnaire among medical doctors who received a disciplinary measure?

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Efforts for Reform The Healthcare Quality, Complaints and Disputes Act (Wkkgz) Concerns about the position of patients led to the aforementioned Healthcare Quality, Complaints and Disputes Act (Wkkgz) which came into force in 2016. The Wkkgz is a legislative attempt to achieve a fundamental change in the way complaints and claims are handled in healthcare, emphasizing an open, informal and proactive response to both claims and complaints. Relevant new statutory provisions are: (1) claims for compensation are considered to be ‘complaints’ in the meaning of healthcare complaints law (see explanation below) and have to be resolved accordingly; (2) an independent complaints officer must be available to patients; (3) a short timeframe for handling complaints/claims applies; and (4) if unsatisfied with the healthcare provider’s response to their complaint/claim, patients can resort to an independent healthcare disputes tribunal that can take binding decisions, including binding awards of damages up to € 25,000. These new statutory provisions seek to improve the patients’ position by providing informal, inexpensive, and quick avenues for the resolution of both claims and complaints.

Healthcare Complaints Law as a Non-adversarial Alternative to Liability Law Since the 1990s, hospitals have had the statutory duty to receive, investigate and resolve any complaints of patients concerning the provided care. What might be called ‘healthcare complaints law’ provides for an internal procedure and is aimed at remedying the patient’s issue. While the procedure before a medical disciplinary tribunal is also triggered by a ‘complaint’,31 this procedure is quite different in both nature and end. The disciplinary procedure is aimed at maintaining quality of care. The procedure is formal, the patients’ complaint serves only as a ‘signal’, the procedure does not seek to provide personal satisfaction, either financially or emotionally, and usually leaves little room for reconciliation.32

Both nationally as internationally, what exactly is meant with the word ‘complaint’ depends on the context. In Dutch healthcare alone, four different legal procedures can be distinguished that are all triggered by a ‘complaint’ (klacht). A complaint can be an issue about healthcare, either big (‘my operation was done wrong’) or small (‘the doctor was impolite’); can be informal (delivered orally and resolved by the healthcare professional himself or a complaints officer) or formal (filed in writing and to be followed up by an official written response of the healthcare provider). As mentioned, a ‘complaint’ can also be lodged at a medical disciplinary tribunal, and, lastly, ‘complaints’ can be made to the National health care contact point (Landelijk Meldpunt Zorg, translation by authors) of the Health Care Inspectorate. The National health care contact point offers advice on how to solve the complaint, but does not investigate complaints itself. 32 Therefore, the medical disputes tribunals make increasing efforts to solve the complaint in a meeting (‘mondeling vooronderzoek’) with the patient and the healthcare professional, prior to the procedure. 31

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The ‘complaints law’ referred to here is all together something different. Both in the Netherlands and internationally, the origins of complaints law lie in situations characterized by inequalities of power. The classic example is the relation between governmental agencies and citizens, but power inequalities can also be found between citizens and non-governmental institutions, large commercial companies and consumers, insurance companies and their insured, and so on. In the Netherlands all sorts and shapes of instruments can be found that are employed to effectuate the right to complain, such as ombudsmen, complaints committees and—officers, organized by institutions internally, externally or somewhere in between, and whether or not in collaboration with consumer—citizen—or patient organizations. What all these institutions have in common is that they seek to empower plaintiffs by ensuring that their complaints are received and properly investigated (Laarman and Akkermans 2017). ‘Healthcare complaints law’ is a part of complaints law that is more extensively regulated by the legislator than most others. The Wkkgz has added to the hospital’s existing statutory duties in regard of complaints, extended them to all health care providers, and has included claims into its definition of complaints. Potentially, this has far reaching consequences. While the substantive rights of claimants to compensation remain determined by the general law of torts and damages, the resolution of claims is to be governed, not by reactive and adversarial civil procedure, but by the proactive and solution focused procedures of healthcare complaints law. In theory this is a fundamental difference. Traditional civil procedure departs from the presumption of the equality of the parties. The facts are established in a process of submission and refutation in which both the initiative and the burden of proof lie with the patient. If a patient does not present sufficient facts to support his claim, or fails to present sufficient proof, it will be rejected. Healthcare complaints law by contrast, departs not from equality, but from its inherent objective of redressing inequality. It requires the health care provider to actively investigate the complaint, take the initiative in the discovery of facts, and to complement or even correct in good faith the presentations made by the patient. It remains to be seen, however, to what extent the healthcare providers will succeed in effecting the paradigm shift in the resolution of claims aspired by the Wkkgz. To begin with, the large majority of claims in the Netherlands are resolved in (sometimes long-drawn-out) out of court negotiations, a context where procedural regimes are of course far less compelling than in a procedure before the court. The Wkkgz now requires healthcare providers to integrate these negotiations into their complaints resolution procedures—or perhaps one might better say, to replace these negotiations, at least initially, by complaints resolution procedure. Clear as the statutory requirements may be, any supervision of compliance can only happen afterwards, if settlement according to complaints procedure has failed and parties have resorted either to court or to an independent healthcare disputes tribunal (see explanation below). At that moment in time effective remedies will be scarce. Secondly, the hospital staff that are involved in the resolution of complaints are traditionally quite separate from those who are involved in the handling of claims.

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The former may be accustomed to the demands of a proactive and solution focused approach in resolving issues, but the latter generally are not. As described above, although some hospitals have an internal legal department that handles claims—all claims, or only those below a certain threshold—many hospitals refer claims to their liability insurer. Most professionals involved, mainly lawyers, both those at the hospitals and at the insurance companies, will have reached their professional maturity within the bounds of conventional adversarial tradition. It will take more than the legislature waving its magic wand to make them change the way they go about their affairs. This is why efforts from the bottom up, such as the Code of conduct on medical incidents and the OPEN learning network of hospitals that are described below, are so important. The most promising developments are to be found among the growing group of hospitals that have taken claims handling into their own hands. In some of these hospitals the conviction has taken root that a claim for compensation is not an exclusively legal issue but concerns the institution as a whole. On the operational level, this means that claims handlers work in a close partnership with complaint officers, quality and safety officers, the healthcare professional in question, and where necessary, the board of directors, to investigate and address not only the claim but also other motives behind it than its ostensible purpose, whether made explicit or not. As mentioned above, financial compensation is often just one of the patient’s issues. And it is a truism that complaints procedure is, in principle, an excellent setting for a more comprehensive approach—so much can be granted to the legislator. An Independent Complaints Officer or ‘Patient Contact Person’ Prior to the adoption of the Wkkgz, nearly every hospital in the Netherlands retained a ‘complaints officer’ (Friele et al. 1999). In 2014, the Association of Health Care Complaints Officers published a professional profile, detailing the goals, tasks, position and competences of complaints officers in hospitals.33 According to this profile, the complaints officer is to contribute to a more equal relationship between patients and health care professionals, mediate conflicts and contribute to a better quality of care by signaling repetitive complaints. The complaints officer acts independently from the board of directors, with respect for the privacy of those involved, and much of his work is confidential. For patients and health care professionals, the complaints officer is easily accessible, and he takes a proactive role, while respecting the professional’s own responsibilities. Core activities are providing ‘first emotional aid’, information, advice and assistance, mediating conflicts, process guidance and monitoring (for example during root cause analysis or claim procedures).34

33

Currently under revision. VKIG Professional Profile (Beroepsprofiel), downloaded from: https://www.vkig.nl/wp-content/ uploads/2017/04/2014_vkig_beroepsprofiel-versie-1_okt-novweb.pdf.

34

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In reality, the majority of complaints officers have up till now played a much more marginal role than this, and the envisioned proactive role rarely materialized in practice. Several explanations have been put forward, such as the difference in educational level between healthcare professionals and complaints officer, the (resulting?) difference in social status, the lack of professionals’ familiarity with complaints procedures, and the negative association with the word ‘complaint’ resulting in professionals not wanting to have anything to do with complaints officers—or all of the above. However this may be, the Wkkgz now obliges all healthcare providers (so not only hospitals) to have an independent ‘person’ available who can ‘offer assistance when patients have a complaint’ and help them find their way (art. 15 Wkkgz). Combined with the far going ambitions of the Wkkgz in regard of the proactive, informal, inexpensive, and quick resolution of both claims and complaints, this seems to imply a more prominent role for complaints officers (van Dijk et al. 2015). In particular, the emphasis of the Wkkgz on proactive complaints management, that effectively seeks to prevent the filing of complaints by solving issues at the earliest opportunity in an informal manner, assigns this ‘person’ a central and active role as a point of contact for patients. Even the label ‘complaints officer’ has become unsuitable, as the focus is on solving issues before they develop into a ‘complaint’, which may explain why these officials are increasingly called ‘patient contact person’, ‘patients’ confidential advisor’ or other varieties of this sort.

Short Timeframe for Handling Claims and Complaints Earlier research into the experiences of patients in complaint procedures showed that hospitals often took a long time to respond to complaints—and sometimes no response was given at all (Kruikemeier et al. 2009). The Wkkgz sets a six-weektimeframe for the assessment of both claims and complaints, with the possibility to extend with 4 weeks (10 weeks in total). If the health care provider does not succeed in providing a satisfactory response—the Wkkgz requires a written ‘conclusion’ (oordeel)—within this timeframe, the patient can refer his complaint to an independent healthcare disputes tribunal (see below). According to the parliamentary history of the Act there is, however, some room for manoeuver, as this written ‘conclusion’ does not necessarily amount to a final judgment; if circumstances so require, it can suffice to explain that more time is needed and to indicate the steps that will be taken to reach a final conclusion.35 The timeframe of 6 weeks serves to ensure that healthcare providers do respond to complaints. This short timeframe, taken together with the goal of informal and quick resolution of claims and complaints, seems to lead to a growing tendency to offer patients the option of a so a called ‘leniency payment’36: a short route to limited 35 36

Kamerstukken I 2015/16, 32,402, 2, item 8. ‘Coulancebetalingen’ (translation by the authors).

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compensation (perhaps comparable to the ‘limited imbursement programs’ in the US) (Mello et al. 2014), without a full-blown investigation in the provided standard of care, and without requiring a final discharge.37

Independent Healthcare Disputes Tribunal The last but—potentially—not the least of innovations of the Wkkgz to be discussed here, is the creation of a low cost and low-threshold alternative to court proceedings by obliging healthcare providers to set up, in collaboration with representative organizations of patients, independent healthcare disputes tribunals. These tribunals are to be officially acknowledged by the Ministry of Health, and can take binding decisions, including binding awards of damages up to € 25,000, and have to do so within 6 months. As mentioned above, patients can resort to a tribunal as soon as the health care provider does not provide a satisfactory response to a complaint within the timeframe of 6, or 10, weeks. The Wkkgz contains only general requirements for the tribunals, the operational details were left to the health care sector to decide upon. This resulted in a list of requirements being drawn up by a national group of representatives of healthcare institutions, patients’ organizations and medical liability insurers (de Groot 2016), on the basis of which requirements 31 different tribunals were established, divided over different sectors of health care. The national list of requirements demands claims for compensation to be assessed according to general liability law. The president of the tribunal will be a lawyer— often a judge or an otherwise experienced adjudicator—and the members have to be nominated by either healthcare providers or patients’ organizations. The composition of the tribunal can further depend on the given case, as at least one of the members is assumed to have sufficient expertise in the medical discipline involved in the dispute. The costs of the procedure differ. No government funding is provided. For patients the costs are low, certainly compared to court proceedings. No representation is required, and in case of a claim a fee of € 50 applies. Consequently, the operational costs of the tribunals have to be born one way or another by the healthcare providers. Details of costs arrangements vary; healthcare providers can pay a fee of € 1.500 up to € 2.300 for every dispute that is brought before the tribunal. The tribunal can require the healthcare provider to reimburse the patient’s fee, but conversely, no costs order can be made against the patient, save for the, probably exceptional, situation that the tribunal is of the opinion that the costs were ‘needlessly caused’. The independent healthcare disputes tribunals of the Wkkgz have drawn a lot of attention, but it remains to be seen whether they will become a success. The dispute tribunals have been in operation since January 2017, and until the fall of 2017, only 242 complaints were filed, of which 69 led to a binding advice, of which an unknown 37

MediRisk (2017) Toelichting ‘Procesflow: Partnership in klachten- en claimopvang’.

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number involved a request for monetary compensation of one sort or another (Bouwman et al. 2017). Given the annual amount of health care claims and complaints, this can only be considered a marginal number.38 There are no available data on why cases are or are not brought before the tribunals, but a combination of factors gives rise to the fear that it might turn out that they will not play more than a marginal role in resolving claims, and that only a limited number of low value and/or weak cases will be brought before them. We cannot elaborate on all issues relevant to this assumption here, but the main concern lies in the combination of the fact that the tribunals do not award legal fees—whereas, as mentioned above, in the context of out of court negotiations, the costs of legal representation and expert opinions are a compensable head of damage—and the fact that a decision of a tribunal cannot be appealed. The motives to exclude the award of legal fees probably involve the desire to prevent unnecessary juridification of relatively ‘small’ cases (that is, up to € 25,000) and the perception (or hope) that lawyer assistance will not be necessary. Understandable as these considerations might be—yet not necessarily correct39—it is difficult to see why a legal counsel or anyone else providing legal support, would ever advise a patient to bring his case before a tribunal, where even if he prevails he will have to bear all his costs; unless the value of the claim and/or the chances of succeeding are estimated as so low, that the lawyer in question is hesitant to take on the case, and prefers the client (patient) to go to the tribunal unrepresented. In any strong case, continuation of out of court negotiations seems to be the preferable alternative, and even if one ultimately has to go to court, if the court finds for the plaintiff it can make a costs order against the defendant (which will not suffice to cover all costs, but still will be significant). It is—in our opinion, regretfully—not an option for the patient to try his case before the tribunal unrepresented, and consider any alternatives later. The decisions of the tribunals are to be binding and cannot be appealed. That is, unless fundamental principles of civil procedure have not been met, such as independence and impartiality, equality of arms,40 and a proper reasoning by the tribunal of its decision. This has to do with the fact that the authority of the tribunal to resolve the issue between the parties is considered to be based on the (implicit) agreement between the parties 38

In 2016, the LMZ received 6.455 complaints; medical liability insurer MediRisk received 785 claims; medical liability insurer Centramed received 870 claims; the Medical Disciplinary Tribunal received 1.646 complaints (Bouwman et al. 2017). It has to be noted that these numbers represent only a fraction of the total amount of complaints, as many complaints are not registered but resolved informally by complaints officers or the healthcare professionals themselves. 39 In our view, the providers of legal support have a crucial role to play in the realization of many aspirations of the Wkkgz, not the least in the success or failure of the tribunals. We cannot elaborate on this here. Even in the no-fault system of New Zealand, research has shown that the assistance of lawyers is highly appreciated by patients and can strongly contribute to reconciliation (Moore and Mello 2017). 40 The principle of equality of arms has been developed by the European Court of Human Rights in the context of the right to a fair trial (Article 6 ECHR). Equality of arms requires that there be a fair balance between the opportunities afforded the parties involved in litigation.

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to accept its decision. This doctrinal categorization is not unproblematic in regard of the healthcare provider, who is obliged by statute to accept the tribunal’s jurisdiction as soon as the patient files his issue there. For this reason, it has even been submitted that this is in violation of article 6 of the European Convention on Human Rights (ECHR) (Dute and Van de Laar 2014). However that may be,41 decisions of the tribunals normally cannot be appealed, and a patient who would appreciate legal support may better think twice before he puts his case to a tribunal.

Efforts from the Bottom-Up As mentioned above, the Healthcare Quality, Complaints and Disputes Act (Wkkgz) aims to achieve a fundamental change in the way complaints and claims are handled in healthcare. However, such a change cannot be achieved by legislation alone, as it requires a change in ‘culture’ among all professionals involved, away from conventional adversarial tradition and towards solution focused, restorative and reconciliatory approaches, that can be considered an integral part of an even wider ranging necessary change in healthcare as a whole, from ‘blame culture’ to ‘just culture’. The Wkkgz was, however, not adopted in a vacuum, but must be understood as the legislator’s response to ongoing developments in the healthcare sector and in society at large. There have been and still are several initiatives ‘from the bottom up’, that in one way or another try to contribute to the comprehensive change that is meant here. We will limit ourselves to discussing two of these, the Code of conduct on medical incidents and the OPEN learning network of hospitals.

Code of Conduct on Medical Incidents (GOMA) In 2010, stakeholders in medical liability (insurance companies, hospitals’ associations, the Royal Dutch Medical Association (KNMG), patient’s attorneys) collaborated in drafting the Code of conduct on open communication after medical incidents and better resolution of medical malpractice claims (Gedragscode Openheid na medische incidenten; betere afwikkeling Medische Aansprakelijkheid, GOMA). The GOMA contains a total of nineteen principles; ten of which are relevant to healthcare professionals and/or providers, urging the swift and proactive investigation of incidents, and a swift, open and proactive response to claims (part A), and nine principles aim to promote the just and expeditious resolution of claims by articulating rules of conduct of patient’s lawyers and insurance companies’ claims

41 This obviously depends on the guarantees, both substantive and procedural, which are in place. See European Court of Human Rights, Guide on Article 6 of the Convention—Right to a fair trial (civil limb), Chapter III, Institutional requirements, available at https://www.echr.coe.int/ Documents/Guide_Art_6_ENG.pdf.

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handlers (part B).42 Although the GOMA is a form of private regulation, its binding force should not be underestimated. Most parties are directly bound to the GOMA as they—or organizations representing them—have formally declared that they will act in accordance with it. Only the patient’s attorneys have made no such declaration, on the basis of the reasoning that they are not free to bind their future clients in any way. They are nonetheless bound indirectly, as the principles of the GOMA are widely accepted and confirmed by both the courts and disciplinary tribunals as a part of the professional standard of all professionals involved (Legemaate et al. 2015). The GOMA is currently under revision. The coming into force of the Healthcare Quality, Complaints and Disputes Act (Wkkgz), which has transferred the handling of medical claims from civil procedure to healthcare complaints law and initiated all the other changes referred to above, requires the elaboration of many operational details. The process of redrafting the GOMA involves numerous expert meetings and other forms of consultation, creating ample opportunity for the exchange of ideas between the different professions and organizations about how best to go forward in the present climate of change. All key activities, such as the consultation and involving of relevant organizations and individuals, the preparation and chairing of expert meetings, the editing and publication of proceedings, and the editing of the consecutive drafts of the Code, are in the hands of academics (your authors among them). Phrased in terms of research methodology, the drafting process is inspired by the principles of participatory action research (PAR).43 The participation of all relevant professions and organizations, the repetitive publication of intermediates, and the involvement of both academics and practitioners, is not only expected to benefit the quality of the outcomes, but also the support the new Code of conduct will need to be successful.

The OPEN Learning Network of Hospitals A second ‘bottom-up’ initiative to be mentioned here, is the OPEN learning network of hospitals. OPEN too, is a collaboration of academics—a multidisciplinary group of social scientists, lawyers (your authors among them) and practitioners, that is inspired by the principles of participatory action research (PAR). The heart of OPEN

42 Phenomenon where a situation escalates into legal conflict, opinions harden and it is increasingly difficult to come to a reasonable solution. 43 Both the redrafting process of the GOMA and the OPEN learning network (to be discussed below) are inspired by the principles of participatory action research (PAR). It is, given its dynamic and context-dependent nature, difficult to find a sole, concise definition of what PAR is. Houh and Kalsem (2015) provide a definition that closely resembles the dynamics of both the redrafting of the GOMA and the OPEN network, when they state: ‘PAR is research that concerns itself with action – making a difference, moving toward solutions – but only when those differences to be made or solutions have been agreed on and determined in community. The research and the action must be participatory, with those who will be affected by the actions – the stakeholders – involved at all stages of the research and decision-making process’ (Houh and Kalsem 2015).

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is the learning network of, at the time of writing, 24 hospitals that are keen to achieve progress in the follow-up of patient safety incidents. The participating hospitals are willing to share the problems they encounter and the solutions they have found with the other hospitals and the researchers. Important activities are not only network meetings, but also the sharing of information in separate interviews, and the drafting and revising of so called ‘knowledge documents’: documents in several forms (leaflets, folders, handouts, but also journal articles) that summarize research findings for practice, are published on the website of OPEN,44 and updated when needed. Key activities, such the preparation and chairing of network meetings, and the drafting and publishing of ‘knowledge documents’, belong to the responsibilities of the researchers. Adverse medical events are a sensitive subject, and building the trust required for a learning network devoted to this issue takes considerable effort and time. But it has been proven to be possible and very much worthwhile. At the network meetings, members feel safe to share dilemmas, fears and barriers to being open. The number of participating hospitals is gradually growing. OPEN has been operational since 2015 and has yielded a significant outcome. The learning network is operating in a climate of change, and there remain more than enough issues to tackle for some years to come.

Conclusion The Netherlands experiences all problems inherent to the compensation of damage caused by healthcare that are common to many jurisdictions. Traditional procedures respond to claims and complaints in an inadequate and unsatisfactory way, to the detriment of both patients and health care professionals. The good news is that there is a clear momentum for change shared by all relevant organizations and institutions. This, however, is not easily achieved. What is required is no less than a change in ‘culture’, away from conventional adversarial tradition and towards solution focused, restorative and reconciliatory approaches, that is to be part of a wider ranging change in healthcare, from ‘blame culture’ to ‘just culture’. This is going to take time. The Healthcare Quality, Complaints and Disputes Act (Wkkgz) has given substantial incentives for such change, but can only succeed to the extent that healthcare providers and relevant others will successfully implement the reforms initiated by the legislator. We have tried to give a concise overview of the present state of affairs. It seems too early to draw any conclusions about the scope and success of the current reform efforts. We do what we can and hope for the best.

44

www.openindezorg.nl, unfortunately, except for some explanation of OPEN, entirely in Dutch.

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Kaldjian LC, Jones EW, Rosenthal GE, Tripp-Reimer T, Hillis SL (2006) An empirically derived taxonomy of factors affecting physicians’ willingness to disclose medical errors. J Gen Intern Med 21(9):942–948 Kruikemeier S, Coppen R, Rademakers JDJ, Friele R (2009) Ervaringen van mensen met klachten over de gezondheidszorg. NIVEL, Utrecht Laarman BS, Akkermans AJ (2017) De afwikkeling van medische schade onder de Wkkgz: De beloften van het klachtrecht voor patiënten, de eerste stappen naar verwezenlijking door de ziekenhuizen en de eerste verrichtingen van de Wkkgz-geschilleninstanties. Tijdschrift voor Vergoeding Personenschade 2017(3):57–79 Laarman BS, Bomhoff MC, Friele RD, Akkermans AJ, Legemaate J (2016) OPEN: open en eerlijke omgang na klachten en incidenten in het ziekenhuis. Schriftelijk verslag van project OPEN. NIVEL, Utrecht Laarman BS, Bouwman RJ, de Veer AJ, et al (2019) How do doctors in the Netherlands perceive the impact of disciplinary procedures and disclosure of disciplinary measures on their professional practice, health and career opportunities? A questionnaire among medical doctors who received a disciplinary measure. BMJ Open 9:e023576. https://doi.org/10.1136/bmjopen-2018023576 Legemaate J, Akkermans AJ, Friele RD (2015) Openheid over medische fouten: waar staan we? Ned Tijdschr Geneeskd 159:1–4 Lindenbergh SD, Akkermans AJ (2014) Ervaringen met verhaal van schade. Van patiënten, verkeersslachtoffers, geweldsslachtoffers, burgers en werknemers (Civilologie / Civilology, 7). Boom Juridische uitgevers, Den Haag Linthorst GE, Kallimanis-King BL, Dekker D, Hoekstra JBL, de Haes JCJM (2011) What contributes to internists willingness to disclose medical errors? Neth J Med 70(5):242–248 Mello MM, Boothman RC, McDonald T, Driver J, Lembitz A, Bouwmeester D, Dunlap B, Gallagher T (2014) Communication-and-resolution programs: the challenges and lessons learned from six early adopters. Health Aff 33(1):20–29 Moore J, Mello MM (2017) Improving reconciliation following medical injury: a qualitative study of responses to patient safety incidents in New Zealand. BMJ Quality Saf 26:788–798 Pinto R, Faiz O, Bicknell C, Vincent C (2013, 1753) Surgical complications and their implications for surgeons’ wellbeing. Br J Surg 100(13) Plews-Ogan M, May N, Owens J, Ardelt M, Shapiro J, Bell SK (2016) Wisdom in medicine: what helps physicians after a medical error? Acad Med 91(2):233–241 Reason J (2000) Human error: models and management. BMJ: Br Med J 320(7237):768–770 Relis T (2009) Perceptions in litigation and mediation. Lawyers, defendants, plaintiffs, and gendered parties. Cambridge University Press, New York Relis T (2017) It’s not about the money, a theory on misconception of plaintiffs’ litigation aims. Pittsburgh Law Rev 68:701–746 Schouten L, Vanhaecht K, Coeckelbergs E, Zeeman G (2018) Onbedoelde schade treft ook de arts: impact van patiëntveiligheidsincident op zorgverleners wordt onderschat. Medisch Contact 37 (3):14–16 Schwappach DL, Boluarte TA (2009) The emotional impact of medical error involvement on physicians: a call for leadership and organisational accountability. Swiss Med Wkly 139 (1–2):9–15 Seys D, Scott S, Wu A, van Gerven E, Vleugels A, Euwema M, Panella M, Conway J, Sermeus W, Vanhaecht K (2013) Supporting involved health care professionals (second victims) following an adverse health event: a literature review. Int J Nurs Stud 50(5):678–687 Shanafelt TD, Balch CM, Dyrbye L, Bechamps G, Russell T, Satele D, Rummans T, Swartz K, Novotny PJ, Sloan J, Oreskovich MR (2011) Special report: suicidal ideation among American surgeons. Arch Surg 146(1):54–62 Smeehuijzen JL, Van Wees KAPC, Akkermans AJ, Legemaate J, van Buschbach S, Hulst JE (2013) Opvang en schadeafwikkeling bij onbedoelde gevolgen van medisch handelen. Vrije Universiteit Amsterdam, Amsterdam

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Chapter 13

Medical Injury in New Zealand Stephen Todd

Abstract In New Zealand the recovery of compensation for medical injury has to be considered in the context of the country’s wide-ranging accident compensation scheme. Accordingly, this paper is structured around an account of the scheme and an assessment of how it operates. It starts with an overview of the core features of the scheme as they apply in the case of medical injury, with particular reference to situations which involve, or may involve, medical malpractice. Turning to the scheme as a whole, the paper considers both its history and, briefly, the extent of cover it provides for all injuries. This sets the scene for a detailed discussion of the cover for medical injury, or “treatment injury” as it is called. Special attention is given to the difficulties in defining the ambit of that cover in the context of a scheme which, for the most part, does not extend to providing compensation for victims simply of illness and disease, and also to the particular problems posed by so-called “wrongful birth” cases. There follows an examination of the operation of the scheme—the benefits that are payable, how the benefits are delivered and how the scheme is funded. And finally there is an attempt to evaluate the scheme and to make some comparisons with claims for medical injury founded upon tort liability.

An Overview New Zealand’s accident compensation scheme provides compensation for injury covered by the provisions of the governing statute—the Accident Compensation Act 2001 (NZ)—irrespective of another person’s fault or liability. The scheme is administered by the Accident Compensation Corporation (the Corporation), which is an independent statutory body. The Corporation has a primary function of promoting

S. Todd (*) University of Canterbury, Christchurch, New Zealand e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_13

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measures to reduce the incidence and severity of personal injury,1 and where injuries occur it must focus on achieving a claimant’s rehabilitation and appropriate quality of life2 and must ensure that claimants receive fair compensation for loss from injury.3 No punitive element is involved in delivering such compensation. Cover for medical injury under the statute depends to some extent on whether a medical professional diagnosing or treating a patient has attained a certain standard of care, and there has been recent debate in the courts about how that standard ought to be defined. The inquiry can overlap with the question whether the professional has been negligent, but the latter is not a necessary element in determining cover under the scheme. There is also cover for medical injury suffered by a patient which is outside the necessary and ordinary consequences of the patient’s treatment, requiring consideration of the circumstances in which injury caused by known medical risks can give rise to a right to compensation. The onus rests on the person claiming accident compensation to establish on the balance of probabilities that his or her claim satisfies the statutory requirements, whether for medical injury or on other bases. Ordinary principles of causation apply in determining the question. Inferences may be drawn from all the circumstances, but there is no place for the operation of the res ipsa loquitur rule. There are time limits for the making of claims. The provisions of the statute apply equally to both public and private hospitals. It is a compulsory scheme, and any attempt to contract out of it is ineffective. All claims seeking damages at common law for injury which is covered by the statute are barred.4 Victims have instead an entitlement to claim compensation from the Corporation. The most significant financial benefit is earnings-related compensation, which is set in accordance with detailed statutory formulae, is adjustable in relation to movements to average weekly earnings, and is subject to an overall cap. Lump sums also are payable and likewise are adjustable and subject to a cap. Rehabilitation assistance and death benefits are available as well. The compensation scheme was introduced because the tort system of awarding damages based upon proof of another person’s responsibility for causing injury was seen as incapable of dealing with the serious social problem of accident victims needing a secure source of financial support after having been deprived, permanently or temporarily, of their capacity to work. The focus is and always has been on the needs of accident victims, not on the responsibility of other persons for causing injury. Patients’ rights under the scheme are protected by a Code of Claimants’ Rights, its purpose being to meet the reasonable expectations of claimants in their dealings with the ACC.5 More generally, a Code of Health and Disability Services Consumers’ Rights, made under the Health and Disability Commissioner Act 1994 and

1

Accident Compensation Act 2001, s 3(a) (NZ) (hereafter ACA 2001). ACA 2001, s 3(c). 3 ACA 2001, s 3(d). 4 ACA 2001, s 317. 5 ACA 2001, s 40. 2

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not tied to the accident compensation scheme, sets out the rights of health consumers and disability services consumers and the obligations and duties of health care providers, lays down a complaints procedure, and provides for remedies for breach of the Code.6 The last of these does not include compensation for personal injury, which must be sought via the compensation scheme. When evaluating the accident compensation scheme one might take into account arguments about, inter alia, operational efficiency, methods of funding, level of benefits, affordability, incentives to take care, deterrents to unsafe practices and the question of accountability of wrongdoers. It will be contended that, on balance, the scheme generally and its application to medical injury in particular emerge from such appraisals rather well.

History of Accident Compensation in New Zealand In 1967 the Report of the Royal Commission of Inquiry into Compensation for Personal Injury in New Zealand (called the Woodhouse Report after name of its chairman, Woodhouse J)7 recommended the barring of actions for damages for personal injury in New Zealand and replacing them with a no-fault accident compensation scheme. The government accepted the Royal Commission’s recommendations and they were brought into effect by the Accident Compensation Act 1972. There have been four re-enactments since then,8 the present statute being the Accident Compensation Act 2001. The scheme remains in full force today, and in a form which is not different in fundamental respects from that contained in the original Act. Let us start by emphasising three basic points. First, the scheme draws a core distinction between personal injury caused by accidents of various kinds and personal injury caused by being ill (although work-related disease is covered). The Royal Commission Report did contemplate the integration of a comprehensive scheme of accident compensation into the social security framework covering both accidents and illness. It recognised that 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. It was seen as unwise to attempt one massive leap when

6

Health and Disability Commissioner Act 1994, Parts 2 and 4 (NZ). Compensation for Personal Injury in New Zealand (1967). 8 Accident Compensation Act 1982 (NZ); Accident Rehabilitation and Compensation Insurance Act 1992 (NZ); Accident Insurance Act 1998 (NZ); Injury Prevention, Rehabilitation, and Compensation Act 2001 (NZ) (renamed in 2010 as the Accident Compensation Act 2001). 7

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two considered steps might be taken, but the experience gained by taking the first step would assist in moving towards a comprehensive plan. So the Commission recommended only an accident scheme. The aim was 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. 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 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. Second, as has already been mentioned, in determining whether a person is entitled to compensation under the scheme the question of another person’s liability for causing personal injury is irrelevant. Compensation flows from a victim suffering personal injury in circumstances covered by the scheme, in which case a claim to the Corporation can be made by way of a simple administrative process. Third, also as has been mentioned, where there is cover under the scheme there is a bar on common law claims for compensation for personal injury, which bar is presently found in s 317(1) of the 2001 Act. This provides that no person may bring proceedings independently of the Act, whether under any rule of law or any enactment, in any court in New Zealand, for damages arising directly or indirectly out of personal injury covered by the present Act or any of the former Acts. 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 particular benefit.9 In Queenstown Lakes District Council v Palmer,10 Thomas J noted that 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 exchange was frequently spoken of as a social contract or social compact. The bar has existed ever since the inception of the scheme. If private claims were allowed it would tend substantially to undermine the benefits of the scheme, and the objections to tort claims would still remain. At the very least it would mean that defendants would still need to be insured against tort liability. More generally, it

9

ACA 2001, s 317(7). The Sentencing Act 2002, s 32(5) (NZ) modifies the principle as to the lack of any entitlement, by providing that a reparation order made by a criminal court can be made in respect of loss or damage for which the victim is not in fact compensated under the ACA 2001. The effect is to allow such an order in respect of the 20% of lost earning capacity which is not recoverable by way of an award of accident compensation: see further n 132 and accompanying text. 10 [1999] 1 NZLR 549 at 556; and see also McGougan v DePuy International Ltd [2018] NZCA 91, [2018] 2 NZLR 916 at [25]–[40].

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would lead inevitably to the extra cost, expense and inefficiency entailed in having two overlapping compensation systems operating side by side.

Ambit of Cover Categories of Cover Let us turn now to the ambit of cover under the scheme. The situations where there is provision for cover are all founded on a victim having suffered personal injury in the defined circumstances. The bases for cover are set out in detail in 12 specific categories in ss 20, 21 and 21B in the 2001 Act,11 but they can be boiled down to four core categories—personal injury by an accident, personal injury by way of mental injury in certain special cases, personal injury by way of occupational illness or disease, and personal injury caused by medical treatment. Our concern is primarily with the last-mentioned of these categories, but in order to understand the scope of the scheme we need to look briefly at the others and at any remaining possibilities for actions for damages. We will then pay separate and detailed attention to cover for medical injuries, called “treatment injury” in the statute.

Personal Injury “Personal injury” is defined in s 26(1) to mean death, physical injuries and certain particular instances of mental injury.12 The reference to death needs no further explanation, and underlies the inclusion in the scheme of dependency claims.13 “Physical injuries” are said to include a strain or sprain14 but otherwise they are not further defined. However, Blanchard J has stated in the Supreme Court that the concept means injuries suffered by the claimant which have some appreciable and not wholly transitory impact on the person but which are not necessarily long-lasting or ones that caused serious bodily harm.15 In essence, then, it means any bodily harm that is more than minimal. So understood, personal injury in the context of the Act certainly includes disease,16 but whether there is cover for disease is a different question. Section 26(2) provides that personal injury does not include personal

11 ACA 2001, s 20(2)(a)–(j) (accidental, treatment and work injuries), s 21 (mental injury) and s 21B (work-related mental injury). 12 ACA 2001, s 26(1). For the definition of “mental injury”, see n 27. 13 See n 134. 14 ACA 2001, s 26(1)(b). 15 Allenby v H [2012] NZSC 33, [2012] 3 NZLR 425 at [56]. 16 Falwasser v Attorney-General [2010] NZHC 410 at [90].

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injury caused wholly or substantially by a gradual process, disease, or infection unless it is personal injury which is work-related, or is treatment injury, or is consequential upon personal injury or treatment for personal injury for which the person has cover. So if the personal injury was not caused wholly or substantially by a gradual process, disease or infection, then that injury will have cover in any of the circumstances specified in the Act. If it was so caused, then the injury will only have cover in those specified circumstances.17 A personal injury is defined by the condition as a whole that a person has. The condition qualifies as personal injury because it has physical impacts, and may include conditions such as pregnancy18 and, arguably, non-idiopathic disease.19

Personal Injury by an Accident The first category in which personal injury is covered for compensation is where the injury is caused by an accident. In the legislation as originally enacted the concept of “accident” was undefined and left to be determined by the courts. The Court of Appeal, drawing upon overseas authority, took a broad view, holding that it meant an unlooked for mishap or untoward event which was not expected or designed.20 However, a detailed and exhaustive definition was introduced in the 1992 Act, and this is now found, with some further additions, in s 25(1) of the 2001 Act. At its core, a qualifying accident is a specific event or a series of events, other than a gradual process, which involves the application of, or the sudden avoidance of, a force or resistance external to the human body. Gravity can constitute the requisite external force or resistance, so strains or sprains can occur by accident on this basis. The definition also gives a series of particular instances of an “accident”, including the inhalation or oral ingestion of any solid, liquid, gas, or foreign object on a “specific occasion” (but excluding the inhalation or ingestion of a virus, bacterium, protozoan, or fungus save where this comes about through the criminal act of another person), a burn or exposure to radiation or rays on a specific occasion (but with special provision for injury caused by exposure to the elements), and the absorption of

17

Calver v Accident Compensation Corp [2019] NZHC 1581, [2019] 3 NZLR 261 at [10]. Allenby v H [2012] NZSC 33, [2012] 3 NZLR 425; see n 109. 19 In Calver v Accident Compensation Corp [2019] NZHC 1581, [2019] 3 NZLR 261 at [75]– [76] Mallon J recognised that idiopathic diseases, that is those that developed in a person from an unknown cause, that were not consequential on covered events remained outside the scope of the Act. Idiopathic diseases would generally be excluded because they were caused by a gradual (internal) process rather than a known external cause. But non-idiopathic diseases with physical impacts which were caused by accident might be covered: see n 22. 20 Green v Matheson [1989] 3 NZLR 564 and Willis v Attorney-General [1989] 3 NZLR 574, applying Fenton v Thorley & Co Ltd [1903] AC 443 at 448. 18

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any chemical through the skin within a defined period of time not exceeding 1 month.21 The most commonly invoked form of “accident” is that involving the application of an external force or resistance, such as a person falling over or being involved in a car crash. It certainly includes the intentional infliction of force, as where a person is the victim of an assault. It also encompasses a series of events constituting an accident or a series of accidents, although this has to be distinguished from a “gradual process”. Sometimes a disease may be caused by an accident rather than by a gradual process, in which case there may then be cover.22 In cases where personal injury may have been caused by a tort but there is no “accident” as defined in the statute (and there is no coverage under one of the other heads), then an action for damages may lie. There are a number of possibilities. The relevant “force” refers to a significant force causative of injury, not the concept of force as used in physics. It does not cover a child suffering from foetal alcohol syndrome due to her mother having drunk alcohol during the pregnancy,23 or a child suffering from cerebral palsy caused by an antenatal force external to the foetus but occurring within the mother.24 Merely seeing or hearing about an event clearly enough is not an accident in the requisite sense, so this is one reason why a secondary victim suffering mental harm cannot claim accident compensation and can seek damages. The same applies where a person suffers shock through fear or stress, without any physical impact or event. Other examples where there is no “accident” and an action for damages could lie include: an importer of a gas heater and a heating engineer causing the inhalation by the occupants of a house of a poisonous gas over a period of time;25 a sexual partner infecting the victim with a venereal disease; a restaurant negligently preparing food causing a customer to contract food poisoning; and a cigarette manufacturer causing smokers to contract cancer.26 Of course, in all of these cases the question whether a private action would succeed would depend on the relevant rules of the common law. “Accident” does not include any of these occurrences where the occurrence amounts to treatment injury, or any ecto-parasitic infection (such as scabies) or the contraction of any disease carried by an arthropod as an active vector (such as malaria from a mosquito bite) unless it is work-related: ACA 2001, s 25(2). 22 In Calver v Accident Compensation Corp [2019] NZHC 1581, [2019] 3 NZLR 261 at [104]–[106] Mallon J held that mesothelioma had been caused by an “accident”. Mesothelioma developed because a person had inhaled asbestos fibres of a quantity that, for that particular person, was a sufficient dose to trigger (at a later date) the disease. The specific occasion required by the statutory definition was the occasion that gave rise to the sufficient dose. There might be a single occasion or several occasions, and in the latter case the occasion on which the last bit of asbestos was inhaled was the specific occasion. 23 Winikerei v Accident Rehabilitation and Compensation Insurance Corp HC Wellington CIV-1999-485-8, 27 July 2005. 24 Sam v Accident Compensation Corp [2009] 1 NZLR 132, affirmed [2010] NZCA 321. 25 Rinnai New Zealand Ltd v Pickard CA13/06, 10 August 2006 (gradual carbon monoxide poisoning). 26 Pou v British American Tobacco (New Zealand) Ltd [2006] 1 NZLR 661. 21

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Mental Injury “Mental injury” is defined in the statute as a clinically significant behavioural, cognitive or psychological dysfunction.27 “Personal injury” includes mental injury where it is suffered because of the claimant’s physical injuries,28 and also mental injury standing alone which is suffered by a victim of various specified sexual or similar offences29 or which is work-related.30 Under the first of these categories, physical victims may be compensated for accompanying mental injury. However, the physical injury must be a cause of the mental injury. It is not enough that an accident triggers a pre-existing mental injury.31 On the other hand, any physical injury is sufficient to support a claim for mental injury even though the physical injury is not itself covered.32 As regards mental injury standing alone, section 21 provides cover for mental injury suffered by the victim of an offence which is specified in schedule 3 of the Act. The list includes sexual violation, incest, sexual intercourse with an underage girl, certain offences of indecency, infection with disease, assault on a child or by a male on a female, and certain offences relating to female genital mutilation. However, a victim who suffers mental injury caused by an offence which is not so specified is not covered and can, therefore, sue. So everything depends on what offence has been committed by the criminal wrongdoer. In KSB v Accident Compensation Corp,33 a claimant sought accident compensation for mental injury that she suffered on discovering that her sexual partner had failed to disclose that he was HIV-positive, although she was not in fact infected. The partner was convicted of the offence of “criminal nuisance”34 but this particular offence is not included in schedule 3. However, the Court of Appeal held that the failure of the claimant’s partner to disclose his HIV status vitiated her consent to sexual intercourse, with the consequence that the sexual partner was guilty of a sexual violation or indecent assault and that there was cover accordingly.35 In so deciding the Court rejected the view taken in England, that ignorance of a sexual partner’s HIV infection did not 27

ACA 2001, s 27. ACA 2001, S 26(1)(c). 29 ACA 2001, ss 21, 21A, 26(1)(d). 30 ACA 2001, ss 21B, s 26(1)(da). 31 Hornby v Accident Compensation Corp [2009] NZCA 576, (2010) 9 NZELC 93,476 (broken arm did not cause pre-existing depression). 32 Accident Compensation Corp v Monk [2012] NZCA 615, [2013] NZAR 1 (lumbar puncture allegedly causing a mental injury not itself covered for compensation, because it was a necessary part of her treatment and was carried out appropriately (see n 77), but assuming it was physical injury and that it caused the claimant’s symptoms then the mental injury was covered. 33 [2012] NZCA 82, (2012) 25 CRNZ 599; compare CLM v Accident Compensation Corp [2006] 3 NZLR 127 (HC). 34 The offence is defined in s 145 of the Crimes Act 1961 (NZ) as including “an unlawful act which the offender knew would endanger the life, safety or health of any individual”. 35 For criticism see Todd (2019a) at [2.4.03]. 28

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vitiate consent to a sexual act,36 and adopted that taken in Canada, that deception in an HIV case in a very real sense went to the nature of the sexual act, changing it to a potential sentence of disease or death.37 Section 21B provides cover for mental injury that is caused by a single event that a person experiences, sees or hears directly in circumstances that are work-related and that could reasonably be expected to cause mental injury to persons generally.38 “Work-related personal injury”, broadly, is personal injury suffered by a person while at his or her place of work, or while travelling to or from work in transport provided by the employer, or while travelling between the place of work and another place for the purpose of getting treatment for a work-related personal injury.39 A person experiences, sees or hears an event directly if he or she is involved in or witnesses the event and is in close proximity to it at the time it occurs.40 Experiencing, seeing or hearing an event directly through a secondary source, like seeing it on television, reading about it in the news media or hearing about it from radio or by telephone, is not enough.41 A “sudden” event includes a series of events that arise from the same cause or circumstance which together comprise a single incident or occasion, but not a gradual occasion.42 Once again, mental injury falling outside the particular statutory requirements is not covered. There is plenty of room here for argument about which side of the line a particular case may fall. Broadly speaking, the criteria for cover seemingly are narrower than those for the recovery of damages at common law, at least in New Zealand,43 so some work-related mental injury may be actionable. Examples may include a claim for work stress, or a claim by a secondary victim who is not directly and proximately involved in the happening of the shock-inducing event.

Occupational Disease, Heart Attacks and Strokes We have seen that the accident compensation scheme does not generally cover sickness and disease. However, there is an exception in the case of occupational diseases. This category of coverage has been included in the scheme since its inception, and is a carry-over from the workers’ compensation scheme that provided for compensation for such diseases prior to the days of accident compensation. So

36

R v Clarence (1888) 22 QBD 23; R v Dica [2004] QB 1257. R v Cuerrier [1998] 2 SCR 371. 38 ACA 2001, s 21B(1)–(2). 39 ACA 2001, s 28(1). 40 ACA 2001, s 21B(5). 41 ACA 2001, s 21B(6). 42 ACA 2001, s 21B(7). 43 Van Soest v Residual Health Management Unit [2000] 1 NZLR 179 is the leading decision in New Zealand. 37

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there is cover for personal injury caused by a work-related gradual process, disease or infection,44 and also for a work-related heart attack or stroke.45 A person suffers personal injury caused by a work-related gradual process, disease or infection in circumstances where he or she performs an employment task or works in an environment that has a particular property or characteristic, this property or characteristic causes or contributes to the injury, is not found to any material extent in the non-employment activities or environment of the person and may or may not be present throughout the whole period of employment, and the risk of suffering the injury is significantly greater for persons performing that task or working in that environment than for other persons.46 A work-related gradual process, disease or infection includes personal injury by way of the occupational diseases listed in schedule 2 of the Act47 that is suffered by a person who is or has been in employment involving a risk of that type of personal injury,48 and in these particular cases proof that the cause of the disease is work-related is not required.49 The exposure must have actually occurred in New Zealand, or the person concerned must have been ordinarily resident in New Zealand when the exposure occurred.50 Diseases may be latent for long periods, creating problems as to coverage where the cause of the disease pre-dates the coming into force of the scheme. In this case the Act extends its reach to include a person who contracts a disease from performing an employment task or working in an environment that has a particular property or characteristic prior to 1 April 1974,51 although certain time limits still need to be met.52 By s 318, all proceedings for damages arising directly or indirectly out of personal injury caused by a work-related gradual process, disease or infection covered by the 2001 Act or former Acts are barred. Heart attacks and strokes also are covered for compensation if caused by physical effort or physical strain that is work-related53 and is abnormal in application or

44

ACA 2001, s 20(2)(e). ACA 2001, s 20(2)(j). 46 ACA 2001, s 30(2). There is an exclusion from cover where the personal injury is related to non-physical stress: s 30(5)(a). As to how the court should go about making an assessment of the risk see, in particular, Knox v Accident Rehabilitation and Compensation Insurance Corp [2000] NZAR 609; Cullen v Accident Rehabilitation and Compensation Insurance Corp [2004] NZAR 481. 47 These include pneumoconiosis caused by sclerogenic mineral dust, silico-tuberculosis, lung cancer or mesothelioma diagnosed as caused by asbestos, and various diseases of a type generally accepted by the medical profession as caused by certain specified industrial substances or their toxic compounds. 48 ACA 2001, s 30(3). 49 ACA 2001, s 30(4). 50 ACA 2001, s 30(4A). 51 ACA 2001, s 30(6)–(7). There is an exception if the person was working outside New Zealand and was not then normally resident in New Zealand: ACA 2001, s 24. 52 See n 141. 53 See n 45. 45

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excessive in intensity for that person.54 Under the earlier Acts the abnormal or excessive strain had to arise out of and in the course of the employment, requiring a frequently difficult determination as to whether a heart attack or stroke was caused by the work or by a pre-existing condition. It seems now that it is sufficient that the episode happened at work and that the activity concerned was abnormal or excessive for the particular claimant as compared with the effort to which the claimant was accustomed. Normal exertion leading to a heart attack or stroke during employment does not qualify.55 There is little scope for actions for damages by primary victims of an occupational disease. Indeed, negligence by an employer in this context normally would be a failure to take reasonable steps to prevent the employment task or the work environment from causing the harm, and any property or characteristic of the task or environment causing the harm is what triggers cover under the Act. However, an employer can be liable for negligence causing an employee to suffer “non-physical stress” in light of its specific exclusion from cover. Further, there is cover for a workrelated disease only for the employee concerned, so if there are secondary victims they could have an action.56 Finally, cover exists for a work-related heart attack or stroke only where the episode is caused by physical effort or strain. Employmentrelated mental stress or strain causing a heart attack or stroke thus can be actionable in damages.57

Exemplary Damages Apart from uncovered claims for compensatory damages, there is the question whether in any category of case a plaintiff suffering personal injury may still maintain an action for exemplary or punitive damages, seeking not compensation for the injury but an award to punish a defendant guilty of outrageous or contumelious misconduct.58 In Donselaar v Donselaar,59 decided quite early on after the accident compensation scheme was introduced, the Court of Appeal held that the statutory bar did not apply and that actions claiming damages of this kind could still

54

ACA 2001, s 28(3). See, for example, Re Archer (1978) 2 NZAR 25 (heart attack when crawling under truck not covered); Re Saunders [1983] NZACR 662 (heart attack by security guard after taking short walk not covered). 56 For a possible example, see Caltex Refineries (Qld) Pty Ltd v Stavar [2009] NSWCA 258, (2009) 75 NSWLR 649 (wife inhaling carcinogenic dust from her husband’s work clothes). 57 See E v Accident Rehabilitation and Compensation Insurance Corp [2000] NZAR 446 (no cover for post-traumatic stress disorder caused by police undercover work); Attorney-General v Gilbert [2002] 2 NZLR 342 (employment stress causing vital exhaustion and coronary heart disease). 58 On the recovery of exemplary damages in New Zealand, see generally Taylor v Beere [1982] 1 NZLR 81. 59 [1982] 1 NZLR 97. 55

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be brought. Allowing them would not undermine the policy of the legislation, for the statutory bar was aimed only at actions for compensation, not actions seeking to punish and deter. 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, as required for the bar to apply, because exemplary damages did not arise out of the plaintiff’s injury and were not directed to the plaintiff’s loss. They were awarded against the defendant because of his or her outrageous conduct in committing the tort. In a strict sense such damages did not “arise” at all, and in a looser sense they could be said to arise out of the acts of the defendant. Donselaar was affirmed by the Supreme Court in Couch v Attorney-General (No 2).60 The defendant contended here that without actionable compensatory damages the tort of negligence was incomplete, and so there was no tort for which exemplary damages might be awarded. On this argument Donselaar would have been wrongly decided, but Tipping J pointed out that Parliament had had several opportunities to include exemplary damages expressly within the bar and had not done so. That represented an acceptance of the Court of Appeal’s conclusion that the policy of the accident compensation legislation was not undermined by permitting claims for exemplary damages in circumstances defined by the courts. So the ordinary need for there to be damage to complete the tort of negligence should for this purpose be seen as satisfied by there being a case for the award of exemplary damages. A further issue of general significance to the award of exemplary damages concerns the relationship of such an award to any criminal proceedings arising out of the same facts. In conjoint appeals in Daniels v Thompson, J v Bell, W v W, and H v P61 the Court of Appeal determined that the conviction or acquittal of the defendant in a prior criminal proceeding arising out of the same matter or event prevented any subsequent recovery of exemplary damages, and that where a prosecution was likely any civil action should be stayed until the prosecution either was concluded or it became clear it would not be brought. The reason was that allowing the civil action after conviction carried the risk that the defendant might be punished twice for the same offence, and if the criminal proceedings resulted in an acquittal the defendant would still be at risk of double jeopardy. Appeals to the Privy Council in W v W and J v Bell62 were dismissed, their Lordships holding that the question was one of public policy and that it was not appropriate for them to interfere with the views of the national court. The majority decision of the Court of Appeal therefore prevailed. But critics argued that it was unjust to victims of criminality and particularly to victims of sexual abuse, who might recover little by way of compensation under the accident compensation scheme. Parliament responded by inserting a new provision in the Accident Insurance Act 1998 aimed at reversing the Court of Appeal’s decision in

60

[2010] NZSC 27, [2010] 3 NZLR 149 at [84]–[90]. [1998] 3 NZLR 22. 62 [1999] 2 NZLR 1. 61

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cases where claimants were covered by the scheme.63 This provision is now found in section 319 of the Accident Compensation Act 2001. It provides, in essence, that claims for damages can still be brought irrespective of whether the defendant has been charged, not charged, convicted, acquitted, or discharged of an offence involving the conduct concerned in the civil claim, but in deciding whether to make an award or the amount of the damages, the court may have regard to any criminal penalty imposed in respect of that offence. The section has affirmed the Donselaar principle whereby exemplary damages may be awarded in cases of personal injury covered by the accident compensation legislation, but left the circumstances in which such damages are available to be determined by the courts.64 Section 319 applies where a person is seeking to recover exemplary damages for conduct that has resulted in personal injury covered by the 2001 Act or a former Act. Normally coverage under the accident compensation scheme means that a victim cannot sue. Here it means that the victim can sue. This bizarre inversion of the normal rule has come about because Parliament failed to distinguish between issues of compensation and issues of punishment. Much of the criticism of the Daniels case was really about the bar on actions for compensatory damages and the low levels of benefits obtainable under the Act in some cases, not about double jeopardy. And this concern was addressed to some extent in the 2001 Act, by returning to the pre-1992 position and restoring lump sums to compensate for lost amenity due to physical or mental injury.65 But whether or not the victims of criminal offending are now treated adequately by the statutory scheme, the issue is one of compensation for loss. It is not appropriately addressed by removing a bar to an award of exemplary damages.

Treatment Injury Background to the Treatment Injury Provisions In order to understand the ambit of cover for medical injuries as presently provided in the 2001 Act we need to look at the history of the matter. In the original 1972 Act there was cover simply for persons who had suffered “personal injury by accident”, without specific reference to adverse outcomes of medical treatment. 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. What exactly this meant was left to the courts to determine, and early decisions show the courts developing a two-limb test, by asking whether there had been either

63

Accident Insurance Act 1998, s 396. Couch v Attorney-General [2010] 3 NZLR 149 at [87]–[90]. 65 ACA 2001, s 69(1)(d), Sch 1, pt 3. Lump sums for pain and suffering were not restored. 64

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medical negligence or medical mishap.66 As regards negligence, the Court of Appeal in Green v Matheson67 accepted that this was medical misadventure, which included insufficient or wrong treatment, failure to inform, misdiagnosis, misrepresentation or administrative shortcomings. If the plaintiff’s claim was mishandled it was her misfortune or ill-luck, and this fell squarely within the idea of misadventure. As regards mishap, this was a quite unforeseeable adverse consequence of treatment which had been properly administered and which did not involve negligence.68 In Childs v Hillock69 the two-limb approach was confirmed in the Court of Appeal. Hardie Boys J considered that it achieved a proper balance between recognising (1) 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 (2) that not every medical intervention is successful and that many are attended by risk. 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. Some unexpected or “accidentlike” 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. Indeed, the legislature then followed the lead taken by the courts, by providing in the Accident Rehabilitation and Compensation Insurance Act 1992 that medical misadventure meant personal injury caused by medical error or medical mishap. “Medical error” was defined as meaning medical negligence70 and “medical mishap” as meaning an adverse consequence of properly administered treatment that was “rare” and “severe”.71 The provisions introduced in 1992 were carried over into the Accident Insurance Act 1998 and then the Accident Compensation Act 2001.72 Shortly afterwards, however, a review of the medical misadventure provisions undertaken by the Accident Compensation Corporation jointly with the Department of Labour in 66

See, in particular, ACC v Auckland Hospital Board [1980] 2 NZLR 748 and Bridgeman v ACC [1993] NZAR 199. 67 [1989] 3 NZLR 564 at 572–3. 68 See ACC v Auckland Hospital Board [1980] 2 NZLR 748. 69 [1994] 2 NZLR 65, 72. 70 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. 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 organisation. 71 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. 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. The consequence was “severe” only if it resulted in the patient dying, or being hospitalised as an inpatient for more than 14 days, or suffering significant restriction or lack of ability lasting more than 28 days in total. 72 Originally the Injury Prevention, Rehabilitation and Compensation Act 2001, but renamed by the Accident Compensation Amendment Act 2010, s 5.

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2003 expressed dissatisfaction with the requirement that cover should depend on proof of either a medical error or a medical mishap.73 In particular, the need to prove a medical error—common law negligence—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 having 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. Health professionals also were reluctant to co-operate in the claims process where they feared repercussions from the Corporation’s legal obligation to report all cases of medical error to the relevant professional body and to the Health and Disability Commissioner.74 The medical mishap provisions requiring that the mishap be “rare” and “severe” and defining these terms in close detail also were criticised, 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. The review examined three main options for change. The first was to retain the existing framework, with some amendments to the definitions of medical error and mishap. Fault would still be required but would not need to be attributed to particular health professionals or organisations. Secondly, there was a “preventability” option, under which injuries sustained in the treatment process would be covered if they could have been prevented. The question would be whether care or treatment could have been done differently, given what was known at the time of the treatment, so as to avoid the injury. The third option was for 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 last option received the most support in the consultation process, and it formed the basis for the amendments to the 2001 Act which were introduced in 2005. These replaced the concept of “medical misadventure” with cover for what is now called “treatment injury”.75 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.76

Definition of Treatment Injury Treatment injury means, broadly, personal injury that is caused by treatment, that is not a necessary part or ordinary consequence of treatment, and that is not wholly or substantially caused by a person’s underlying health condition and the clinical

73

Accident Compensation Corporation (2003). See nn 193, 194 and accompanying text. 75 Accident Compensation Amendment Act (No 2) 2005, s 13. 76 The bases for cover for treatment injury are found in ACA 2001, ss 20(2)(b), (c), (d), (f), (h) and (i). 74

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knowledge at the time of the treatment.77 It does not include personal injury that is wholly or substantially caused by a person’s underlying health condition, personal injury that is solely attributable to a resource allocation decision, and personal injury that is a result of a person unreasonably withholding or delaying their consent to undergo treatment.78 It is not of itself treatment injury because desired results are not achieved.79 There is a specific exclusion from cover in certain cases where personal injury is suffered in the course of a clinical trial.80 “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) the 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.81 The provisions concerning treatment injury are the exclusive determinants of cover insofar as “registered health professionals” are concerned.82 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 statute now provides that an “accident” does not include an occurrence which is treatment given by or at the direction of a registered health professional or by a person outside New Zealand with equivalent qualifications.83 So coverage for personal injury by an accident and coverage for medical treatment do not overlap.

Personal Injury in Treatment Injury Cases “Personal injury” in the context of medical treatment includes personal injury by way of a gradual process, disease or infection that is treatment injury,84 and personal

77

ACA 2001, s 32(1). ACA 2001, s 32(2). 79 ACA 2001, s 32(3). 80 ACA 2001, s 32(4)–(6). 81 ACA 2001, s 33(1). 82 “Registered health professional” (a) means a chiropractor, clinical dental technician, dental technician, dentist, medical laboratory technologist, medical practitioner, medical radiation technologist, midwife, nurse, nurse practitioner, occupational therapist, optometrist, pharmacist, physiotherapist, or podiatrist; and (b) includes any such person who is temporarily or provisionally registered or certified; and (c) includes a member of any occupation included in the definition of “registered health professional” in regulations made under s 322 of the Act: ACA 2001, s 6(1). 83 ACA 2001, s 25(2). 84 ACA 2001, s 20(2)(f). 78

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injury by way of a heart attack or stroke that is treatment injury.85 It includes a secondary infection suffered by a spouse, child or third party where a person suffers an infection that is treatment injury and passes it on to the other person directly or through his or her spouse.86 As will be explained below, it also extends in certain circumstances to an existing condition that does not get better or gets worse, as where a person is not properly diagnosed or treated.

Causal Connection The personal injury must be “caused by” treatment or, formerly, by medical misadventure. In Atkinson v Accident Rehabilitation Compensation and Insurance Corp87 a child who received negligent medical treatment in the course of surgery shortly after birth which led to hypoxia was later found to be suffering from brain damage. His claim for accident compensation failed, on the ground that the hypoxia could not be causatively linked to the brain damage. Richardson P recognised that it may have contributed to the damage, but it was not proved that it had contributed. 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. In so deciding the Court declined to apply certain common law principles of causation which, exceptionally, allow recovery of damages on proof that negligent conduct was capable of causing or aggravating damage and did materially increase the risk of the damage.88 The policy of the statute did not permit this approach. In Accident Compensation Corp v Ambros89 the Court of Appeal confirmed the approach taken in Atkinson. Glazebrook J noted that the 1998 and 2001 Acts were passed against a background of the causation principles set out in Atkinson, and was satisfied that this had to be seen as legislative acceptance of those principles. And in any event, her Honour considered that Atkinson was correctly decided and that the ordinary “but for” principle of causation should apply. In Ambros the question at issue was whether the claimant’s wife died as a result of her underlying condition or as a result of medical error in failing to diagnose that condition, and the Court of

85

ACA 2001, s 20(2)(i). ACA 2001, s 32(7). 87 [2002] 1 NZLR 374. 88 The leading decision is Fairchild v Glenhaven Funeral Services Ltd [2002] UKHL 22, [2003] 1 AC 32. 89 [2007] NZCA 304, [2008] 1 NZLR 340; and see Calver v Accident Compensation Corp [2019] NZHC 1581, [2019] 3 NZLR 261 at [89]–[100]. 86

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Appeal referred the case back to the High Court to determine whether, on the balance of probabilities, an inference of causation could properly be drawn.90

Necessary or Ordinary Consequences of Treatment The concept of “treatment injury” abandons any reference to “mishap” or “error”, yet both will reappear in some form or another in determining whether an injury of this kind 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 recognised 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 the Accident Compensation Corporation or a court must be able to say that they were not “necessary” or “ordinary”. The policy of the Corporation is to treat known complications flowing from medical treatment as not necessarily excluded, depending on whether they are “expected” or “usual”. The Corporation recognises that infections, allergic reactions and the like are known risk factors but may not be regarded as expected, in which case they are not “ordinary” and are covered. Certainly the threshold for coverage has shifted, from consequences that are “rare” to those that are not necessary or ordinary. Indeed, the wider reach of the statutory language seemingly was the cause of a dramatic increase in medical injury claims following the changes in 2005.91 But the courts still must determine whether there has been something out of the ordinary—some kind of mishap—justifying coverage. In this respect the law has reverted from detailed definition back to judicial discretion.92

90

The Corporation subsequently accepted that causation was established and extended cover to A: Ambros v Accident Compensation Corp HC Auckland CIV-2004-404-3261, 13 March 2008. 91 Todd (2011), pp. 1200–1201. 92 In Accident Compensation Corporation v Ng [2020] NZCA 274 at [68]–[69] the Court of Appeal held that “not an ordinary consequence” should be interpreted as meaning an outcome that was outside of the normal range of outcomes, something out of the ordinary which occasioned a measure of surprise. Whether an adverse consequence was inside or outside the normal range of consequences of the medical treatment given to a particular claimant was ultimately a matter of judgment for the decision maker. It was to be exercised on a case-specific basis taking into account all the circumstances of the treatment and the particular claimant. Relevant circumstances would include not only the nature of the harm suffered but also its duration and severity as well as any other circumstances pertaining to the patient which may have rendered them more or less susceptible to the adverse consequence. The decision may be informed by medical studies including relevant statistical analysis (subject to certain reservations at [70]) as well as the clinical experience of the treating physician(s) and other specialists.

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Wrong Decisions A second key question, deserving of close consideration, is whether how far the concept of a medical error remains relevant in determining the cover for treatment injury. 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? Seemingly in each case 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 not required to find fault, but a requirement that the claimant show that the health professional should have treated or should have treated differently is likely, at least in most cases, to correspond with the question whether the health professional was negligent in making his or her decisions about treatment. Again, 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, a failure 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. So the concept of medical error or negligence is likely to underlie a determination whether treatment, or timely treatment, or consent to treatment, should have been given. However, while it may be likely that negligence will be involved, is a finding of negligence necessary in making such determinations? In Adlam v Accident Compensation Corporation93 the New Zealand Court of Appeal paid close attention to this question. The claimant suffered neurological injury immediately prior to his birth, but there were no observable indications before the mother developed a fever, when an emergency caesarean section was quickly and competently performed, that the foetal condition was compromised. Had a caesarean been performed earlier it was likely that the claimant would not have suffered personal injury. The trial judge had held that treatment injury had not been established, and in granting leave to appeal he asked whether the High Court was correct to find: (a) that a “failure to treat” could not occur in circumstances where there were no indications for a different treatment course; (b) that a treatment injury did not occur where, with the benefit of objective hindsight, a different course of treatment could have yielded a better result; (c) that some form of responsibility for either a failure to provide treatment or the provision of treatment had to be established on the balance of probabilities in order for a claimant to receive cover; (d) that determining whether a particular treatment was clinically indicated 93

[2017] NZCA 457, [2018] 2 NZLR 102.

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necessarily required consideration of the alternative option or options available to the health professional, given the state of knowledge at the time, and whether there were contra indications telling against those alternatives? Cooper J, giving the judgment of the court, recognised that a treatment injury had to involve some act or omission that had a causative effect in producing the personal injury, and that the injury was not a necessary part or ordinary consequence of the treatment. In some cases—the administration of a drug with an unanticipated allergic reaction, cutting a nerve during surgery in an unanticipated position—what had occurred clearly were not ordinary consequences. Another kind of case involved a course of treatment properly embarked upon, but badly carried out. Taking as an example a surgical operation that could be carried out in a way that did not cause a particular injury, but the surgeon nevertheless caused it, establishing the injury was not a necessary part of the treatment involved showing that there was a better way of going about the treatment. In any given case there might be a factual dispute about this, and resolving the dispute in favour of cover depended upon showing a proper standard was not met. Similar conclusions could be reached in the case of a diagnosis or a decision on treatment to be provided. These connoted a departure from a standard before there could be said to be treatment injury: a standard that would have been met had a correct diagnosis been given or a correct decision made about providing treatment. Again, the reference in the definition of “treatment” to “a failure to provide treatment, or to provide treatment in a timely manner” necessarily incorporated a standard. It involved a judgment that treatment not provided should have been provided or that something was not done as soon as it should have been done. Further, it would only be where there was a departure from what was clinically indicated that a failure to provide treatment could be regarded as having caused injury in terms of the statute. The need to take into account a person’s underlying health condition and clinical knowledge at the time of the treatment pointed to the same conclusion. Cooper J observed that in order to ascertain whether a treatment injury was a necessary part or ordinary consequence of treatment, it would often be necessary to consider clinical indications relevant to the treatment. If treatment was not provided, in the absence of clinical indications that there should have been treatment, there would be no treatment injury. An assessment of what was an ordinary consequence of treatment had to involve reference to the expected outcome of treatment given in accordance with proper medical practice. It was also the case that non-treatment resulted in the development of a person’s underlying health condition, which was excluded from the definition of treatment injury. In the absence of clinical indications for treatment of the underlying condition, it could not be said that the resultant injury was a necessary part or ordinary consequence of the non-treatment taking into account the person’s underlying health condition at the time. Cooper J, in summary, determined that the relevant provisions, properly construed, meant that in order for there to be treatment injury as a result of a failure to provide treatment it was necessary to show that an alternative treatment that would have prevented the injury suffered could and should have been given, having regard to the clinical indications at the time of the alleged failure. Taken as a whole, the

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provisions indicated a legislative intent to limit cover for persons who suffered injury while undergoing treatment, rather than providing cover for all those who suffered. The injury said to be a treatment injury had to be the consequence of a departure from appropriate treatment choices and treatment actions. The drafting could have simply provided for cover for all injury suffered while a person underwent treatment. But that course was not taken. Rather, boundaries were set out that had the effect of limiting the availability of cover for injury during treatment. A failure in the sense of omitting to take a step required by an objective standard was necessary.94 This led on to a discussion of what the objective standard ought to be. His Honour referred to academic discussion of the matter, and accepted that the concepts of “mishap” and “error” might be involved in a decision as to whether there had been treatment injury.95 However, he considered that the suggestion that these concepts implicitly remained highly relevant and potentially covered the ground went further than justified by the treatment injury provisions of the Act. A distinction could be drawn between finding that a different treatment course should have been followed and establishing there was negligence. While both conclusions would often happily co-exist, the negligence finding was not one required by the Act. An approach focused on negligence reasoning ran the risk of failing to meet the legislative purpose. In some circumstances it might be that a higher standard was appropriate than that captured by the concept of breach of a standard of care if the reference point was simply to skilled and informed practitioners generally operating in a field. His Honour preferred the view taken in Scandinavian patient schemes where the guiding principle was “the experienced specialist standard”. According to this principle, compensation would be paid for an injury if it could be assumed that an experienced specialist in the field in the circumstances would have acted differently during examination, assessment or treatment, at the time of assessment of the claim, thereby avoiding the injury. The classic fault principle was not relevant.96 Applying the principle, there was no suggestion of a breach of an experienced specialist standard in the particular case. There were no observable indications prior to the fever that warranted medical intervention and there were no indications for a different treatment course in the circumstances. As regards the questions posed to the court for decision, the better course was simply to answer question (a) in the affirmative. It was unnecessary to answer the others, and there were assumptions behind some of them that would make it unsafe to answer them in the form they had been posed. A need to judge whether treatment injury has occurred by reference to some external standard is patent. A purely outcome based approach, where, with the benefit of objective hindsight, a different course of treatment could have yielded a better result, would inevitably result in all undiagnosed or incorrectly treated

94

[2017] NZCA 457 at [61]–[62]. Referring to the discussion in Chapter 2 of Todd (2016). 96 Citing Manning (2014), pp. 37–38. 95

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illnesses being covered by the scheme.97 Medical injury frequently lies near the dividing line between accident and illness. Difficulties will necessarily arise in drawing the line in the context of alleged treatment injury by way of sickness or illness, for treatment is given (or not given) to patients who are already sick or ill. 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 separate a medical injury from ordinary treatment of an illness or disease. Accepting this, the question is how the external standard or reference point ought to be defined. The Court of Appeal has determined that the standard required is that of an “an experienced specialist in the field”, whereas the standard required for liability in negligence, broadly, is the standard of the ordinary skilled doctor exercising and professing to have skill and competence98 and acting in accordance with a practice accepted as proper by a responsible body of medical opinion.99 Insofar as it may be necessary to distinguish between different levels of skill and competence within the medical profession, the standard required is that of a reasonably competent doctor in the position held by the doctor concerned.100 The standard set in Adlam apparently is higher, for it judges the question in relation to the standard of a specialist in the field, opening the way to a finding of treatment injury where the doctor concerned attained the standard of a reasonable doctor performing the task in question but not the standard of a specialist in the field. Even so, there will be no difference where the doctor has, by taking on the task, held himself or herself out as sufficiently skilled and competent to perform it to the specialist standard. Furthermore, in the great majority of cases it seems likely that the question will turn simply on whether reasonable professional standards were met by those making diagnoses, or deciding whether treatment should be given, or determining what form any treatment should take. Perhaps the issue here is really about the labelling of a doctor’s decision or conduct. It is true that cover for accident compensation does not depend on a finding of fault or of negligence, and we can easily recognise that a professional person is likely to be keen to avoid such a finding. We also can accept that it is desirable to avoid a blaming culture and to create an environment which fosters co-operation in preventing or avoiding medical mishaps and accidents. The approach taken in Adlam, with the focus simply on what an experienced specialist in the field would have done or decided, arguably may help in achieving such a result. Nothing done or not done by the doctor concerned needs to be characterised as negligent, even if negligence would in fact be established in a common law action.

97

See the judgment of Gendall J, the trial judge, in ACC v Adlam [2016] NZHC 1487 at [43]. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. 99 Bolitho v City & Hackney Health Authority [1998] AC 232. 100 Wilsher v Essex Area Health Authority [1987] 2 WLR 425 at 440, 462 (on appeal on a different question in Wilsher v Essex Area Health Authority [1988] AC 1084). 98

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Residual Common Law Actions An exception to cover arises out of the special rules applying to clinical trials.101 Persons who suffer injury as a result of treatment who have not agreed in writing 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.102 The practice of ethics committees in certifying such a trial is to ensure that adequate compensation is available in the event of injury, by requiring the company concerned to abide by Medicines New Zealand’s guidelines on clinical trials.103 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. However, it is apparent that a common law remedy might be available in any event, and that negligence by a sponsoring company or an investigator opens the way to an action for damages. Apart from this statutory exception, there is limited scope for bringing actions for damages in a medical context. As we have seen, negligence by a registered health professional, including negligence in relation to treatment, diagnosis, failing to treat, giving advice and obtaining consent to treatment, formerly gave rise to coverage for medical error and presently does so for treatment injury, irrespective of its possible wider reach. The bar cannot be avoided by a plaintiff disclaiming medical negligence or pleading administrative error or breach of statutory duty. If what happened to a claimant is medical misadventure or treatment injury, then proceedings are barred however the pleadings claiming damages for such injury may be framed.104 Conversely, if conduct is not negligent and there is no cover, normally there is no room for a common law action either. However, there remains the possibility of actionable negligence or other wrongdoing in certain exceptional cases. These include the situation where a secondary victim suffers mental injury following medical

101

Peart and Moore (1997). ACA 2001, s 32(4)–(6). 103 Medicines New Zealand (2015) Guidelines on Clinical Trials Compensation for Injury Resulting from Participation in an Industry-Sponsored Clinical Trial. 104 Residual Health Management Unit v Downie [2005] NZAR 298. 102

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negligence,105 mental injury to a patient caused by professional misconduct,106 cosmetic surgery that does not produce the desired results,107 and negligence in relation to an unwanted pregnancy and birth. This last example needs separate consideration.

Unwanted Pregnancies In ACC v D108 the Court of Appeal, in a majority decision, determined that unwanted pregnancy following a failed tubal ligation was not a personal injury under the 2001 Act because it was not a “physical injury”: rather, it was a natural event that could not be seen as harm or damage. However, in Allenby v H109 the Supreme Court disagreed, and held that a patient who suffered mental illness after becoming pregnant following a failed sterilisation procedure had suffered personal injury as required by the statute and was covered for compensation as being the victim of medical misadventure (and now would be covered on the basis that this was treatment injury). Her mental injury thus was covered as it came about “because of” physical injury. Elias CJ noted that there would have been cover if the relevant events had occurred before the 1992 Act, because “personal injury by accident” was defined after 1974 to include any “medical misadventure” without any separate need to show there was a personal injury.110 In addition, it was clear that a woman who became pregnant following a sexual assault would have cover, because pregnancy was specifically identified as “actual bodily harm” arising out of a sexual crime.111 Nothing in the legislative history indicated that any change was intended when the new legislation was enacted in 1992. As for the basis for cover under the 2001 Act (the relevant provisions of the 1992 Act having been carried forward to this Act), it needed to be shown that the claimant had suffered “personal injury caused by medical misadventure”, 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

105

See, for example, Accident Compensation Corp v F [1991] 1 NZLR 234 (where coverage may have been wrongly denied under an earlier statute). 106 L v Robinson [2000] 3 NZLR 499 (HC). 107 See Tokeley (1998), discussing the question in relation to wrong-sized breast implants. 108 [2008] NZCA 576. 109 [2012] NZSC 33, [2012] 3 NZLR 425. 110 Accident Compensation Act 1972, s 2(1) (definition of “personal injury by accident”), inserted by the Accident Compensation Amendment Act 1974, s 2(1). 111 Accident Compensation Act 1972, s 105B(1), inserted by the Accident Compensation Amendment Act 1974, s 6.

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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.112 So the physical consequences of impregnation by rape 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. The joint judgment of Blanchard, McGrath and William Young JJ, given by Blanchard J, made a number of similar points. His Honour was satisfied that there was cover before the 1992 Act and that the existing position was not changed by the reforms and restructuring in that Act. The tortuous history of the scheme and the complex drafting of the provisions in the 1992, 1998 and 2001 Acts pointed to two conclusions. The first was that the expression “personal injury” was used in an expansive way. The second was that it was most unlikely that Parliament, having expressly extended the scheme in 1974 to give cover for pregnancy resulting from rape, would have sought to remove that cover without very directly addressing the subject in the new legislative provisions. Impregnation was a physical consequence for the victim of a rape, and should not be differentiated from any other physical consequence, such as a tearing of the vagina, which might be far more transitory. It would be extraordinary if there were to be coverage for a rape victim for physical harm and any mental injury whether or not there was physical injury,113 but not for any impregnation. It had to follow that impregnation resulting from medical misadventure in the form of a failed sterilisation was also a personal injury. To hold there was no cover would be to create what would be an odd gap in the general coverage for medical misadventure. It was submitted also that pregnancy was a natural and necessary process and should not be regarded as physical injury to the mother, even if unwanted. But the development of the foetus following impregnation occurred because of medical error, just as in the case of an undetected tumour. It caused significant physical changes to the woman’s anatomy which, while natural, still caused discomfort and, ultimately, pain and suffering. If a disease or infection consequential upon medical misadventure could be classified by the statute as personal injury, it did not involve any greater stretching of language to similarly include a pregnancy which had the same cause. Blanchard J did not think that accepting cover in the instant case or in the case of rape would open the door to claims for other unwanted pregnancies, such as could result from a bursting condom or from unprotected sexual intercourse, on the basis that there had been a personal injury by an “accident”. Where a woman chose to engage in sexual intercourse, during which she suffered no physical harm but as a

112 113

ACA 2001, s 20(2)(g)–(h). See the earlier discussion of mental injury at nn 27–30.

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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 interpretation 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.114 In Cumberland v Accident Compensation Corp115 the question in issue was whether a woman whose child was born with spina bifida, following a failure to detect that condition during an antenatal ultrasound scan, had suffered a personal injury under the 2001 Act. The Court recognised that the continuation of the pregnancy following the misdiagnosis involved significant physical changes to the anatomy of the mother, and bore comparison with an undetected tumour. Assuming that the mother had been deprived of the opportunity lawfully to terminate the pregnancy, and would have taken that opportunity, then, applying Allenby, this was personal injury.116 Allenby determined only that the patient concerned was covered under the Act for the “physical effects” of her pregnancy.117 Any mental injury she suffered as a consequence of the unplanned birth which met the statutory threshold118 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 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. Entitlement to weekly compensation turns on a claimant’s “incapacity” for employment,119 and this in turn requires that the claimant should be “unable, because of his or her personal injury” to engage in

114

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”. 115 [2013] NZCA 590, [2014] 2 NZLR 373. 116 The relevant scan was provided at the 20 week point. Under s 187A(3) of the Crimes Act 1961, a termination cannot be provided after 20 weeks gestation unless the person doing the act believes that the miscarriage is necessary to save the life of the woman or girl or to prevent serious permanent injury to her physical or mental health. So cover depended on showing that the patient could have obtained a lawful termination had she been properly advised, and the case was referred back to the District Court for determination of the question. 117 [2012] 3 NZLR 425 at [84]. 118 See n 27. 119 ACA 2001, s 100.

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employment.120 So the statute is concerned with the consequences of physical injury to the mother, not the economic consequences of the relationship between parent and child.121 The latter constitutes a separate and independent head of financial damage.122 In short, the “injury” is the pregnancy, not bringing up the child. The preceding argument finds support in the decision of the Court of Appeal in ACC v J.123 The claimant became pregnant following a failed sterilisation, and sought to recover loss of earnings compensation for having to stay at home to look after her child. Cooper and Asher JJ, in a joint judgment, acknowledged the unique nature of the claim. The arrival of a child after pregnancy was not an event easily compared to any other, and nothing referred to in the Act was comparable. But the background in the way the Act provided for the payment of weekly compensation showed that it was concerned with the physical and mental effects of an injury. Once the mother was physically and mentally recovered from her pregnancy and the childbirth she was not unable to work “because of” her pregnancy. Further, medical assessments were a core part of the weekly entitlement scheme, yet they would serve no useful purpose in the claimant’s circumstances as the barrier to her returning to employment was not any ongoing personal injury. While entitlements were not explicitly linked to the physical and mental effects of an injury, the scheme of the Act focused squarely on medical barriers to employment. Counsel submitted that if Ms J’s claim was held not to be covered then her common law rights remained, and that a common law claim for the equivalent of weekly compensation sitting alongside claims under the Act was unattractive. But Cooper and Asher JJ were not by any means certain that Ms J would succeed at common law in light of the denial of such a claim in the UK,124 Ireland125 and Canada,126 and the mixed position in Australia.127 The decisions revealed three broad considerations that the courts had taken into account. First, the law regarded the arrival of a healthy child as a blessing. The costs associated with bringing up that child were regarded as outweighed by the joy and mutual love and affection that the child brings. Second, there were significant challenges associated with quantifying the cost of bringing up a child. Third, the potential scope of liability for the medical practitioner at fault was disproportionate to the duties undertaken and the extent of the negligence. There were also the practical consequences of allowing recovery.

120

ACA 2001, s 103(2). For development of this argument, see Todd (2012). 122 See McFarlane v Tayside Health Board [2000] 2 AC 59 at 76, 79, 89, 99–100 and 109. 123 [2017] NZCA 441, [2017] 3 NZLR 804. 124 McFarlane v Tayside Health Board [2000] 2 AC 59; Rees v Darlington Memorial Hospital NHS Trust [2003] UKHL 52, [2004] 1 AC 309. 125 Byrne v Ryan [2007] 1 IEHC 207, [2009] 4 IR 542. 126 Bevilacqua v Altenkirk 2004 BCSC 945; PP v DD [2017] ONCA 180. 127 In Cattanach v Melchior [2003] HCA 38, (2003) 215 CLR 1, the High Court of Australia, by a 4-3 majority, allowed the claim. However, that position was reversed by statute in New South Wales, South Australia and Queensland. 121

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These included whether the father of the child, or a relative who took responsibility for the child’s care, was able to claim. There was also the fact that all mothers responded differently to the responsibilities of child care, for example by utilising maternity leave or by engaging in full time work with third party care for the child during the working day. All this demonstrated the uncertain outcome of any claim by Ms J at common law. And it remained possible that she had a claim that was not barred by the Act. In summary, Cooper and Asher JJ were satisfied that what was sought by Ms J went beyond that which was contemplated by the Act. Importantly, they did not accept that “loss spreading” of this type was required by the aims and purposes of the scheme, or indeed that it was manifestly equitable. It was not the purpose of entitlements to compensate for all consequences that might follow an accident. The entitlements were rather to assuage income loss for the period of recovery from injury or, if the consequences were permanent, through assessment of the losses arising from that permanent impairment. Ms J’s claim stepped beyond the requirement for an ongoing injury to the person. Where a claimant required no rehabilitation and where there was no issue about the health of that claimant, the claimant was not eligible for compensation under the Act. Kós P dissented. In brief, his Honour took the view that the focus of the question for the court was incapacity rather than injury, and conceptually these were different inquiries. The body might be healed but the incapacity might endure. And Ms J was incapacitated from renewing her employment simply as a matter of direct causation, being legally and morally obliged to care for her child. His Honour added that in the present and progressive state of New Zealand’s law of torts, it was entirely likely that a common law claim could succeed, but because Ms J had cover for the personal injury she was unlikely to be able to pursue a claim for compensatory damages against the surgeon. The majority view is the better one. The need for childcare by someone in Ms J’s position is very real, but to interpret entitlements provided by the accident compensation scheme as extending to childcare responsibilities goes beyond its statutory remit. Rather, it is a matter for the social security system. Further, while a mother’s common law claim in respect of the physical injury of pregnancy and childbirth is barred,128 a claim in respect of the financial consequences of having an unplanned child probably is not. They are quite separate injuries, and the failed sterilisation and consequent pregnancy can be seen simply as “part of the sequence of events which provides the factual basis for”129 the uncovered claim. There is nothing unattractive or anomalous in such a claim being made in circumstances where there is cover for the physical injury of pregnancy. Whether it ought to succeed will depend on the

128

Such a claim succeeded in McFarlane v Tayside Health Board (above n 124) whereas the upbringing claim did not. 129 Queenstown Lakes District Council v Palmer [1999] 1 NZLR 549 at 554, line 16.

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court’s assessment of the impact of the contrasting considerations of policy that are involved in claims of this kind.130

Operation of the Scheme Benefits Where there is cover under the scheme there is a right to compensation. The statutory entitlements are treatment and rehabilitation, earnings-related compensation, lump sum compensation for permanent impairment, and death benefits. The corporation is liable to pay the cost of necessary and appropriate medical treatment and of social or vocational rehabilitation.131 The purpose of social rehabilitation is to assist in restoring a claimant’s independence to the maximum extent possible, and can cover such benefits as aids and appliances, home help, child care, modifications to the home, assistance with transport and training for independent living. Vocational rehabilitation is available to persons covered by the Act who are entitled to weekly compensation. It seeks to help a claimant maintain or obtain employment, or regain or acquire vocational independence. Earnings-related compensation 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.132 There are special provisions dealing with, inter alia, earners not in permanent employment, the self-employed, low earners and potential earners. The amount payable is 80% of the claimant’s weekly earnings, as calculated in accordance with detailed statutory formulae. All calculations are subject to a maximum weekly payment, originally set in 2001 at NZ$1341, that is adjustable in relation to movements in average weekly earnings. The minimum weekly figure in 2020 was NZ$604.80 and the maximum was NZ$2066.58. Lump sums compensate for permanent impairment, including both physical impairment and mental injury caused by a physical injury or sexual abuse, but not for pain and suffering.133 There is a minimum impairment threshold of 10% and the minimum payment is NZ$2500. The maximum sum, which is payable for impairment of 80% or more, is set at NZ$100,000. These figures are adjusted annually in line with the consumers’ price index. The minimum figure in 2020 was NZ$3,595.09 and the maximum was NZ$143,803.50. The amount payable in any particular case is calibrated so that more seriously injured claimants receive proportionately more than less seriously injured claimants.

130 See Todd (2019a) at [6.9.03]. See also Todd (2019b), arguing that claims can better be made on the basis of a claimant’s loss of reproductive autonomy. 131 ACA 2001, ss 69(1)(a), 75–96, Sch 1, Part 1. 132 ACA 2001, ss 69(1)(b),(c), 100–106, Sch 1, Part 2. 133 ACA 2001, s. 69(1)(d), Sch 1, Part 3.

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Lastly, the Act provides for various payments in the event of the death of a person covered by the scheme.134 A funeral grant is payable to the personal representatives and survivors’ grants to a spouse, child under the age of 18, and any other dependent. There can also be compensation for the cost of child care in certain circumstances. Weekly compensation representing loss of dependency is payable to a surviving spouse and dependent children. A claimant who qualifies for compensation may be disentitled to relief on a number of grounds.135 These ultimately are penal provisions, preventing payment of what would otherwise be valid claims for reasons of public policy. They include: the claimant wilfully inflicting injury on himself or herself or committing suicide;136 the claimant seeking compensation as a spouse or dependent in circumstances where he or she has been convicted of the murder of the deceased person;137 the claimant being in prison;138 and the claimant being injured in the course of committing a criminal offence punishable by a maximum term of imprisonment of at least 2 years, unless the Minister responsible for the scheme is satisfied that there are exceptional circumstances exempting the claimant from the operation of this provision.139 As we saw at the outset, the application of the accident compensation scheme cannot be excluded by agreement or otherwise. But there is nothing to stop anyone taking out insurance against suffering personal injury, providing compensation over and above the statutory benefits.

Making Claims Victims can make a claim for compensation pursuant to the statutory claims process. This provides for the lodging of claims and the making of decisions on cover and entitlements.140 Claims for cover must be lodged within 12 months of the date when personal injury is suffered, and for an entitlement within 12 months after the need for it arose.141 However, the corporation must not decline a late claim unless it is prejudiced in its ability to make decisions. The date of the injury is defined in certain particular cases. In particular, in the case of treatment injury it is the date when the victim first seeks or receives treatment for the injury,142 and in the case of

134

ACA 2001, s. 69(1)(e), Sch 1, Part 4. ACA 2001, ss 118–122. 136 ACA 2001, s 119. 137 ACA 2001, s 120. 138 ACA 2001, s 121. 139 ACA 2001, ss 122, 122A. 140 ACA 2001, Part 4. 141 ACA 2001, s 53(1), (3). 142 ACA 2001, s 38(1). 135

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occupational disease it is the earlier of the date of treatment or the date when the injury first results in incapacity.143 A claimant can apply to the corporation for a review of any of its decisions on the claim.144 The application must be in writing and be made within 3 months of the decision in question.145 The corporation is obliged to engage people to carry out reviews, but a reviewer’s duty is to act independently.146 The Act lays down various requirements for the conduct of the review, persons entitled to be present and formalities in relation to the reviewer’s decision.147 The reviewer must put aside the corporation’s decision and look at the matter afresh and on the basis of its substantive merits.148 An appeal lies from a review decision to the District Court.149 An appeal then lies to the High Court on a question of law, with the leave of the District Court or by a special grant of leave from the High Court.150 Similarly, a further appeal lies to the Court of Appeal on a question of law, with the leave of the High Court or by a special grant of leave from the Court of Appeal.151 The decision of the Court of Appeal is final and there is no third appeal to the Supreme Court. The Act provides for the making of a Code of Claimants’ Rights. The purpose of the Code is to meet the reasonable expectations of claimants about how the corporation should deal with them, by, inter alia, providing for the procedure for lodging and dealing with complaints about breaches of the Code, providing for the consequences of and remedies for breaches of the Code, and explaining claimants’ rights to the review of a decision about a complaint.152

Funding Since its inception accident compensation has been funded by levies on activities where accidents tend to occur and out of general taxation. Initially there were levies on employers and the self-employed and on motor vehicle owners, and since then their reach has been widened. Today the levies fund four accounts: the Work Account (for work-related injuries of employees, private domestic workers and self-employed persons); the Earners’ Account (for injury to earners other than

143

ACA 2001, s 37(1). ACA 2001, s 134. 145 ACA 2001, s 135. 146 ACA 2001, ss 137, 138. 147 ACA 2001, ss 140–144. 148 ACA 2001, s 145(1). 149 ACA 2001, s 149. 150 ACA 2001, s 162. 151 ACA 2001, s 163. 152 ACA 2001, s 40. 144

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work injuries, motor vehicle injuries or treatment injuries); the Motor Vehicle Account (for motor vehicle injuries); and the Treatment Injury Account (for injuries caused by treatment injury). These accounts finance most of the costs of the scheme. There is also the Non-Earners’ Account (for injuries to non-earners other than motor vehicle injuries or injuries caused by treatment), funded out of general taxation. The levies are collected by the Corporation from various sources.153 Those 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.154 In the case of the Treatment Account, a statutory power to impose levies on registered health professionals and organisations 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.155 Funds necessary to deal with claims by non-earners are held in a separate account, also managed by the Corporation, and derived from appropriation by Parliament.156 After taking investment income into account, about 20% of the Corporation’s funds are raised in this way.

Administration The accident compensation scheme is administered by the Accident Compensation Corporation, which is a body corporate with powers to hold property, to sue and be sued, to do all such things as a company may do, and to do such other things as are necessary or expedient to enable it to perform its functions and duties.157 Its functions include determining cover, providing entitlements, managing accounts, collecting levies and administering dispute resolution procedures.158 A primary function is to promote measures to reduce the incidence and severity of personal injury.159 As originally conceived, the accident compensation scheme operated as an arm of the state. But in the Accident Insurance Act 1998 the National Government of the time, hostile to the Corporation’s monopoly control, introduced a substantial element of private provision into the delivery of the statutory benefits. In the case of work injuries the Corporation could no longer provide cover. Employers were obliged to insure with a private insurance company or a new state-owned enterprise

153

The provisions are set out in part 6 of the ACA 2001. ACA 2001, ss 167(2), 213 and 218 respectively. 155 ACA 2001, s 228(2). 156 ACA 2001, s 227. 157 ACA 2001, Part 7. 158 ACA 2001, ss 165, 262. 159 ACA 2001, s 263. 154

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set up to compete with the private companies. A regulatory regime aimed to make sure that persons with cover received their entitlements. The Corporation continued to administer the rest of the scheme. Cover and benefits remained substantially unchanged, whether in the private or the public parts of the scheme. The purpose behind the reform, broadly, was to facilitate freedom of choice, promote a greater emphasis on safety and rehabilitation, and encourage the efficient management of claims. 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. This partial privatisation appears to have been conceived as a first step towards changing the accident compensation scheme into a system of universal compulsory insurance. But, as it turned out, the new regime was in force for just one year. One of the first acts of the Labour Government elected at the end of 1999 was to reverse its predecessor’s reforms and 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 Corporation operated inefficiently. On the contrary, there was no duplication in the provision of services and administrative costs were very low. In the election of November 2008 the National Party regained power, and one of its stated policies was to reintroduce private insurance covering accident compensation liabilities. A government paper in 2011160 later made a number of proposals, including extending the Accredited Employers Programme,161 allowing choice of workplace insurance cover in competition with the Corporation, subjecting insurers to prudential regulation, and appointing a market regulator to monitor and enforce employer and insurer compliance with legal requirements. It also was proposed to privatise the work account, earners account and motor vehicle account and to allow the Corporation to compete with private insurers. In the result a number of steps were taken with the aim of providing more incentives within the scheme to achieve safer workplaces, but nothing was done to reintroduce the private provision of benefits or to move further towards a compulsory insurance scheme. Then in the election of 2017 the National Party lost power once again, and the Labour Party formed a coalition government with minor parties. Any prospect of a restructuring of the accident compensation scheme in favour of greater private provision certainly is unrealistic for the immediate future.

160 161

New Zealand Department of Labour (2011). Below n 188.

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Evaluation Affordability The financial history of the accident compensation system has fluctuated wildly. It has faced major financial difficulty at times, but in recent years up to and including 2018 its finances were reasonably sound. However, in 2019, as will be explained, they deteriorated very markedly. Putting aside for the moment the latest developments, let us look at two important, albeit related, reasons for its earlier financial problems. The first relates to the expense of the scheme in its early years. During the 1980s the costs of the scheme ballooned, and the government asked the Law Commission to review how the scheme was operating and to make recommendations accordingly. However, the Law Commission’s report162 maintained that the existing scheme was not facing a financial crisis. By far the largest area of increase in costs 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. So the increase was caused primarily by the scheme coming to maturity. It would level off once those coming into the scheme were balanced by those leaving it, on being rehabilitated or by reaching retirement age or by dying. And this did indeed happen during the 1990s. The related reason is the basis for calculating the levies. During the 1980s and 1990s the levies for the year were set on a pay-as-you-go basis. This means that they were calculated to pay only that year’s costs, including both old and new claims. They did not cover the continuing costs of claims extending into future years. Under a full funding regime, 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. Pay-as-you-go funding initially kept the levies low but stored up problems for the future, for the unfunded costs of continuing injuries still had to be met from year to year as well as the costs of all new injuries. The consequence was that a large unfunded liability began to accumulate. The problem eventually was addressed in the Accident Insurance Act of 1998, which required all of the accounts save for the Non-Earners’ Account to be fully funded. This set the scheme on a sounder financial basis for future injuries. But there remained the unfunded liability from past claims, the costs of which continued into future years. 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. A statutory obligation required these outstanding residual liabilities to be fully funded by 31 March 2019,163 but this objective was in fact achieved in 2015.

162 163

New Zealand Law Commission (1988). ACA 2001, s 169AA.

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In 2010 the Corporation’s unfunded liability amounted to approximately NZ $10 billion, but the position changed markedly for the better in following years. Indeed, in 2015 there was an overall surplus of NZ$1.502 billion.164 However, there was a deficit of NZ$1.865 billion in 2016,165 of $1.258 billion in 2017,166 of NZ $1,356 billion in 2018167 and huge jumps to NZ$10,013 billion in 2019 and NZ $15,959 billion in 2020.168 These last figures appear to be due almost entirely to the impact of falling interest rates world-wide to historical lows and to the impact of the Covid 19 pandemic.169 Again, there was an operating surplus of NZ$607 million in 2017170 and of NZ$28 million in 2018,171 but a plunge to a deficit of NZ$8.675 billion in 2019 and a reduced deficit of NZ$5.946 billion in 2020.172 One substantial reason for the generally good results up to 2018 appears to have been better financial management, although movements in financial markets, levy revenue and claims costs amongst other things no doubt played their part. The acute deterioration in 2019 and 2020 in the scheme’s net deficits, primarily caused by external forces, are not cash losses but actuarial revaluations of the future cost of claims. There are longterm plans to close the gap between assets and liabilities. The figures for the Treatment Injury Account have fluctuated substantially in recent years. Over the last 5 years the annual figures for comprehensive revenue and expense and for account reserves show a surplus of NZ$57 million and deficit of NZ $888 million in 2015,173 deficits of NZ$740 million and NZ$1.628 billion in 2016,174 deficits of NZ$242 million and NZ$1.870 billion in 2017,175 a surplus of NZ$716 million and deficit of NZ$1.154 billion in 2018,176 and deficits of NZ $1.438 billion and NZ$2.592 billion in 2019 and of NZ$1285 billion and NZ$3877 billion in 2020.177 The continuing overall deficits are partly explained by the fact that the account is funded through levies from the Earners’ and Non-Earners’ Accounts 164

Accident Compensation Corporation Annual Report (2015), p. 66. Accident Compensation Corporation Annual Report (2016), p. 64. 166 Accident Compensation Corporation Annual Report (2017), p. 95 [restated in the Annual Report (2018), p. 102, as a deficit of NZ$1.384b]. 167 Accident Compensation Corporation Annual Report (2018), p. 102. 168 Accident Compensation Corporation Annual Report (2019), p. 114; Accident Compensation Corporation Annual Report (2020), p.130. 169 Accident Compensation Corporation Annual Report (2019), p. 11; Accident Compensation Corporation Annual Report (2020), pp 8, 12. 170 Accident Compensation Corporation Annual Report (2017), p. 94. 171 Accident Compensation Corporation Annual Report (2018), p. 101. 172 Accident Compensation Corporation Annual Report (2019), p. 113; Accident Compensation Corporation Annual Report (2020), p. 129. 173 Accident Compensation Corporation Annual Report (2015), p. 65. 174 Accident Compensation Corporation Annual Report (2016), p. 73. 175 Accident Compensation Corporation Annual Report (2017), p. 104. 176 Accident Compensation Corporation Annual Report (2018), p. 111. 177 Accident Compensation Corporation Annual Report (2019), p. 123; Accident Compensation Corporation Annual Report (2020), p. 139. 165

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on the basis of whether the treatment injury claims are from earners or non-earners, and the latter continues to be funded on a pay-as-you-go basis. The former is fully funded, and the investment revenue usually has exceeded the claims paid by substantial, albeit variable, margins in recent years. But, to put the matter colloquially, all bets for the future are off in the present circumstances. How the costs of paying levies compare to insurance premiums covering tort liability in equivalent circumstances and for equivalent benefits is not easy to pin down, although it can be asserted reasonably confidently that levy payments are likely to be lower. Some evidence in support is provided by the undoubted fact that the cost of delivering the statutory benefits avoids the very substantial costs associated with the need to prove liability before compensation can be paid. So claims can be made quickly and processed efficiently. The costs of administering the scheme are relatively low and have remained stable, with operating costs at 11–12% of claims paid.178 Comparisons with the costs of litigation are revealing. An estimate of the cost of tort litigation in the UK concluded that about 55 pence of the insurance pound was paid out to injured victims, and about 45 pence was swallowed up in administration.179

Adequacy of 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 favourably with flat rate social security payments. Inevitably there will be winners and losers by comparison with common law damages. In Queenstown Lakes180 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 huge 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.

In 2020 the figure was 11.71%, with operating costs of NZ$544 million and claims paid at NZ $4.642 billion; Accident Compensation Corporation Annual Report (2020), p. 129. 179 Cane (2006), p. 397. 180 [1999] 1 NZLR 557 at 555, 557. 178

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Deterrence, Incentives to Safety and Likelihood of Abuse An often advanced argument is that accident compensation schemes remove a deterrent to injury-producing activity and operate as a disincentive to safety conscious behaviour. This raises large questions, so 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 unlikely to be significant.181 Evidence provided by 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.182 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.183 In the specific field of medical malpractice the consensus is similar. Mello and Brennan, in a study in the United States, considered that evidence of a deterrent effect was limited and vulnerable to methodological criticism.184 The data did not support the notion that the malpractice system sent a strong deterrent system to providers. Sloan and Chepke similarly stated that it was difficult to find good evidence that negligence liability deterred medical errors.185 As regards the New Zealand scheme in particular, there is a lack of any clear evidence. Oliphant concluded that it remained an open question whether introducing no-fault in place of liability in private law had had a positive or negative effect on patient safety, or no effect at all.186 Whatever the deterrent impact of tort, market incentives aimed at reducing accidents and promoting safe behaviour can and do operate within the accident compensation scheme. The 2001 Act establishes a framework for employers to benefit from levy reductions where there are observable systems to manage safety in the workplace.187 An Accredited Employers’ Programme (AEP) gives employers discounts of up to 90% on their ACC levies in exchange for taking responsibility for and managing their employees’ work injury claims.188 The Corporation recommends the programme as best suited to large employers with levies of more than $250,000 a year. The ACC Workplace Safety Management Practices Programme and the Workplace Safety Discount Programme also provide levy discounts for 181 See, in particular, Ison (1967); Bernzweig (1980); Sugarman (1989); Dewees and Trebilcock (1992); Todd (2000), pp. 478–482. 182 Tess and Armstrong (2008), pp. 9–12. 183 For an overview see Luntz (2010). 184 Mello and Brennan (2002). 185 Sloan and Chepke (2007). 186 Oliphant (2009), p. 19. 187 ACA 2001, s 175. 188 ACA 2001, s 182.

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businesses showing sound health and safety practices. For a long time there was no general discount on levies, analogous to an insurance no-claims discount, for businesses showing a good safety record. Historically the work levy was based on injury rates across industry categories, without any differentiation according to a particular business’s safety record. However, in 2011 the Corporation introduced a system of experience rating, under which a business’s work levy can be reduced based on its claims history.189 Conversely, in terms of sanctions, a provision allows for levies to be increased for employers where the number and severity of workrelated personal injuries is significantly greater than could reasonably be expected of a comparable employer.190 So experience rating seeks to reward those businesses with safer workplaces and to encourage a focus on improving workplace safety. And finally, in another innovation, in 2015 the Corporation introduced vehicle risk rating, under which levies for vehicle registrations are based on the safety rating of vehicles. Removing a right to sue for injury and substituting a right to make a claim for compensation from a compulsorily funded statutory body, irrespective of the claimant’s or anyone else’s responsibility for the injury, might be criticised as likely to encourage malingering and abuse of the compensation system. But it is impossible to come to a considered conclusion on this question without good evidence about the existence of such abuse and its scale. No doubt it exists, but the Corporation takes various steps to verify whether claims are properly made and to prevent fraud. We can say only that some element of abuse is endemic in all compensation systems. There certainly is anecdotal evidence of abusive tort claims, and a recent decision of the UK Supreme Court examining how the rules of deceit should apply in the case of a fraudulent settlement with an insurance company provides an instance.191

Accountability Whether a wrongdoer ought to be held accountable for his or her wrongdoing is a separate question from that which asks whether imposing tort liability has deterrent impact. Holding people accountable for their conduct may be thought to be justifiable simply as a matter of corrective justice, ensuring that wrongdoers pay for their wrongdoing. Of course, seeking to compare a person’s accountability as a tortfeasor with a person’s accountability in the context of an accident compensation system may be criticised as being based on a largely false assumption. Tort liability sometimes is imposed without fault by the defendant, and in cases based on negligence the expected standard of care is determined objectively, irrespective of the defendant’s actual capacity to guard against the risk. Insofar as the defendant can

189

Accident Compensation Corporation (2011). ACA 2001, s 178(1). The matters to be taken into account are listed non-exhaustively in s 178(2). 191 Zurich Insurance Co Ltd v Hayward [2016] UKSC 48, [2016] 3 WLR 637; and see Summers v Fairclough Homes Ltd [2012] UKSC 26, [2012] 1 WLR 2004. 190

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be seen to be culpable, there is no principle of proportionality to link the extent of his or her liability and the degree of his or her culpability. Furthermore, the damages are sometimes reduced on the basis of a crude comparison between the defendant’s responsibility for harm to others and the quite different “fault” of the plaintiff in failing to take sufficient care for his or her own safety. As for who actually pays the damages, very frequently it is the defendant’s insurance company rather than the defendant himself or herself. Certainly doctors and other professionals almost invariably protect themselves in this way. Again, defendants in tort actions frequently are corporate employers, who are held liable for negligence on the part of their employees by the application of the doctrine of vicarious liability. The employee himself or herself rarely has to pay. Accordingly, a tort claim has at most only limited value in fostering corrective justice and the accountability of tortfeasors. And while it is certainly true that, in New Zealand, a blameworthy potential defendant, and in particular a negligent medical professional, cannot normally be sued in a tort action, there are other avenues pursuant to which he or she may be called to account. First, the Accident Compensation Corporation is under a reporting obligation in respect of certain medical risks. The obligation 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.”192 In this respect, 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 Corporation has well-developed processes for assessing risk and notifying the appropriate persons or bodies. In particular, serious events involving death or major injury are notified to the Director General of Health, who decides whether the notification is disseminated to the treating facility and determines the response that is needed to improve safety. In rare cases the Corporation 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. The notified authorities can make their own investigations into any issue of culpability. Second, a Code of Health and Disability Services Consumers’ Rights, made under the Health and Disability Commissioner Act 1994, contains various rights of health consumers and disability services consumers and duties and various obligations of health care providers. The Act provides, inter alia, a procedure for the lodging and dealing with complaints about breaches of the Code and the consequences and remedies for breach,193 and further lays down a procedure for making complaints to the Health and Disability Commissioner in respect of breaches

192

ACA 2001, s 284. This may include the Health Safety and Quality Commission, which acts as a central agency for the promotion of patient safety. 193 Health and Disability Commissioner Act 1994, ss 19, 20 (NZ).

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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 be referred to the Director of Proceedings, who can institute disciplinary proceedings or civil proceedings in a Human Rights Review Tribunal.194 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 a flagrant disregard of the rights of the aggrieved person.195 Compensatory damages for personal injury covered by the Accident Compensation Act 2001 are excluded.196 So proceedings before the Tribunal are likely to be brought only by consumers seeking exemplary damages or who have suffered no physical injury. Third, the Health Practitioners Disciplinary Tribunal197 hears and determines disciplinary proceedings brought against health practitioners. Its main purpose is to promote and protect public health and safety in New Zealand, and is responsible for, inter alia, registering doctors, setting standards, and reviewing practising doctors where there are concerns about their performance or professional conduct. The Tribunal may suspend a doctor’s practice, assess a doctor’s performance in response to concerns expressed by a patient or colleagues, and, if necessary, remove a doctor from the medical register and remove his or her right to practise medicine. Fourth, criminal proceedings remain available in suitable cases. In a particularly notorious example, a surgeon whose allegedly reckless behaviour resulted in his patients frequently dying on the operating table was prosecuted for manslaughter, although his conviction ultimately was quashed on account of irregularities in the conduct of the trial.198 Finally, and insofar as it promotes accountability, there remains the possibility of a civil action for damages for negligence in the exceptional cases of a medical injury where there is no cover. The option of a claim for exemplary damages also remains. In A v Bottrill199 the Privy Council upheld the availability of exemplary damages in a bad case of medical negligence, but the decision was overruled in Couch v AttorneyGeneral,200 where the Supreme Court required that there be advertent or reckless wrongdoing before such damages could be awarded. The test is likely to be difficult to satisfy, certainly in a medical context.

194

Health and Disability Commissioner Act 1994, ss 45(2)(f), 49(1)(a) (NZ). Health and Disability Commissioner Act 1994, ss 52, 54, 57 (NZ). 196 ACA 2001, s 52(2). 197 The Tribunal was created by the Health Practitioners Competence Assurance Act 2003, s 84 (NZ). 198 Ramstead v R [1999] 2 AC 92. In van Soest v Residual Claims Management Unit [2000] 1 NZLR 179 relatives of the deceased patients sued Dr Ramstead seeking compensation for mental injury, but their claims failed as none of them had suffered actionable psychiatric damage. 199 [2003] 1 AC 449. 200 [2010] 3 NZLR 149. 195

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Boundaries 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. In the particular case of medical injuries, difficulties arise out of the need to distinguish between suffering a medical accident and simply being sick or ill. But if illness were to be included, it would still be necessary to undertake the very difficult task of defining the qualifying circumstances, and there would be borderline cases with some being 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 generally 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.

Conclusion Accident compensation schemes are not to everyone’s taste, raising issues in the eyes of some about the compulsory nature of such schemes and the loss of the “right” to sue. Whatever one’s views on such questions, it is apparent that no-fault compensation can provide significant monetary and practical benefits at an achievable cost. In Accident Compensation Corporation New Zealand: Scheme Review,201 an independent report commissioned by the Accident Compensation Corporation in 2008, it was concluded that the implementation of the Woodhouse principles had afforded New Zealand’s society and economy four decades of added economic and social value. An accident compensation scheme can have a wide or narrow focus. New Zealand has the most extensive accident compensation regime in the world, but many countries have more limited schemes covering, for example, criminal

201

Price Waterhouse Coopers (2008).

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injuries,202 road traffic injuries203 and, our present concern, medical injuries.204 Let us summarise some of the benefits of the New Zealand scheme, with particular reference to treatment injury: 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; the level of funding needed to meet the costs of the scheme can be achieved by levies which compare favourably with the costs of alternatives, such as by insurance against tort liability; there is little evidence that barring tort claims has compromised safety standards; and the need in some cases to hold individuals accountable for wrongdoing can be met by the use of processes for the making of complaints, the bringing of disciplinary proceedings and, sometimes, the prosecution of offenders. No doubt any evaluation of comparative benefits, certainly as regards normative questions, are likely always to be contestable. Furthermore, in 2021, with economies around the world thrown into chaos by the Covid 19 pandemic, all normal economic calculations have suddenly been jettisoned. This certainly has had a significant impact on the financing of the New Zealand scheme, but the difficulties nonetheless are manageable. It remains true to say that the New Zealand experience can stand as an example of a broadly well-functioning accident compensation system that has stood the test of time.

References Accident Compensation Corporation (2003) Review of ACC medical misadventure: consultation document Accident Compensation Corporation (2011) Experience rating — making ACC work levies fairer for individual businesses Accident Compensation Corporation (2015) Annual report Accident Compensation Corporation (2016) Annual report

202

In the UK see the Criminal Injuries Compensation Scheme, established under the Criminal Injuries Compensation Act 1995 (UK), to provide ex gratia compensation for the victims of violent crime. 203 In Australia see the Transport Accident Scheme, established by the Transport Accident Act 1986 (Vic), covering people injured in a traffic accident on a no-fault basis. 204 In Sweden see the Patient Insurance System, set up under the Patient Insurance Act 1997 (Swe) to compensate patients for health-related injuries. The Act covers both physical and mental injuries, and requires that a causal relationship must be established between injury and medical care and that it can be demonstrated that injury could have been avoided. And see the No Fault Compensation Review Group: Report and Recommendations (2011), commissioned by the Scottish Government, proposing a no fault medical scheme for Scotland.

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Accident Compensation Corporation (2017) Annual report Accident Compensation Corporation (2018) Annual report Accident Compensation Corporation (2019) Annual report Accident Compensation Corporation (2020) Annual report Bernzweig EP (1980) By accident not design: the case for comprehensive injury reparation. Praeger, New York Cane P (2006) Atiyah’s accidents, compensation and the law, 6th edn. Cambridge University Press, Cambridge Dewees D, Trebilcock MJ (1992) The efficacy of the tort system and its alternatives: a review of the empirical evidence. Osgoode Hall Law J 30:57 Ison TG (1967) The forensic lottery: a critique on tort liability as a system of personal injury compensation. Staples, London Luntz H (2010) Torts and insurance: the effect on deterrence. Torts in commercial law conference, Sydney Manning J (2014) Plus ça change, plus c’est la même chose: negligence and treatment injury in New Zealand’s Accident Compensation Scheme. Med Law Int 14:22 Medicines New Zealand (2015) Guidelines on clinical trials compensation for injury resulting from participation in an industry-sponsored clinical trial Mello MM, Brennan TA (2002) Deterrence of medical errors: theory and evidence for malpractice reform. Texas Law Rev 80:1595 New Zealand Department of Labour (2011) Increasing choice in workplace accident compensation New Zealand Law Commission (1988) Personal injury: prevention and recovery: report on the accident compensation scheme. NZLC R4 Oliphant K (2009) Compensation, ideology and patient safety in New Zealand’s no fault system. Opinio Juris in Comparatione 3:1 Peart N, Moore A (1997) Compensation for injuries suffered by participants in clinical trials in New Zealand. Med Law Rev 5:1 Price Waterhouse Coopers (2008) Accident Compensation Corporation New Zealand: scheme review. Sydney Royal Commission of Inquiry (1967) Compensation for personal injury in New Zealand. Wellington Scottish Government Report (2011) No fault compensation review group: report and recommendations. Scotland Sloan FA, Chepke LM (2007) The law and economics of public health. Now Publishers, Hanover Sugarman SP (1989) Doing away with personal injury law: new compensation mechanisms for victims, consumers and business. Quorum Books, New York Tess K, Armstrong D (2008) Fault versus no fault-reviewing the evidence. Institute of Actuaries of Australia Todd S (2000) Privatization of accident compensation: policy and politics in New Zealand. Washburn Law J 39:404 Todd S (2011) Treatment injury in New Zealand. Chicago-Kent Law Rev 86:1171 Todd S (2012) Accidental conception and accident compensation. J Prof Negl 28:196 Todd S (2016) The law of torts in New Zealand, 7th edn. Thomson Reuters, Wellington Todd S (2019a) Todd on torts, 8th edn. Thomson Reuters, Wellington Todd S (2019b) Common law protection for injury to a person’s reproductive autonomy. Law Q Rev 135:635 Tokeley K (1998) Accident compensation when cosmetic surgery goes wrong. N Z Law J 5

Chapter 14

Medical Negligence Proceedings in Singapore: Instilling a Gentler Touch Dorcas Quek Anderson

Abstract Medical malpractice is an area that traverses a wide range of issues in any society—the quality and cost of healthcare, the insurance industry, the cost of litigation, the impact on medical practice and the heightened emotions arising from injuries. Like many countries, Singapore has been grappling with these issues through implementing various reforms in the legal and healthcare sectors concerning compensation for medical negligence. While monetary compensation has historically been obtained through legal proceedings in the Singapore courts, there is a growing shift towards adopting a gentler touch to deal with the unique issue of medical malpractice. This article examines the current legal framework for medical negligence in Singapore, and the different ways in which the adversarial approach to medical malpractice proceedings is being changed. It also proposes ways to consolidate and refine the current reforms.

Introduction Medical malpractice is an area that traverses a wide range of issues in any society— the quality and cost of healthcare, the insurance industry, the cost of litigation, the impact on medical practice, and the heightened emotions arising from injuries or even loss of lives. Evidently, the question of compensation for medical malpractice impinges on each of these challenges. Like many countries, Singapore has been grappling with these issues through implementing various reforms in the legal and healthcare sectors. Although compensation has historically been obtained through legal proceedings in the Singapore courts, there is a growing shift towards adopting a much gentler touch to deal with the unique issue of medical malpractice. This article examines the current legal framework for medical negligence in Singapore and the different ways in which the adversarial approach to medical

D. Q. Anderson (*) Singapore Management University School of Law, Singapore, Singapore e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_14

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malpractice proceedings is being changed. It concludes with several proposals on how to consolidate and refine the current reforms.

The Healthcare Industry in Singapore The healthcare industry in Singapore has been regulated by principally two bodies— the Ministry of Health and the Singapore Medical Council. The former is a public body that manages policies relating to the public healthcare system and general medical issues, including regulating the practices of healthcare facilities. More than twenty legislative regimes come under its purview, such as the Medicines Act (on the regulation of drugs), the Medical Registration Act, Private Hospitals and Medical Clinics Act, Human Organ Transplant Act and Human Biomedical Research Act. The Singapore Medical Council (SMC) is a statutory board established under the Ministry of Health for self-regulation of the medical profession. It maintains the register of medical practitioners, and regulates the professional conduct and ethics for medical practice. Complaints arising from medical malpractice as well as other misconduct by doctors are dealt with by the SMC by way of disciplinary proceedings. SMC is empowered to strike off the medical practitioner’s name from the register, suspend the registration, impose a financial penalty or censure the practitioner.1 Claims for compensation due to medical malpractice are not handled by these two bodies. There are also no special compensation schemes or administrative systems that have been established for this purpose. These claims may be privately settled between the medical practitioner and patient with the insurer’s involvement. In the absence of settlement, the patient has to commence a civil suit in the court system to claim for compensation arising from medical negligence.

The Current Legal Framework for Determining Medical Malpractice Obtaining compensation in court hinges on successfully establishing a claim based on the tort of negligence. Singapore, having adopted a common law system, has been influenced by the English legal principles underlying the tort of negligence. Negligence is established based on three elements: (a) the practitioner owes the patient a duty of care; (b) he or she has breached that duty by failing to exercise the required standard of care; and (c) when the patient suffered injury as a result of this breach. The duty of care is only found when it is foreseeable that the patient would suffer a 1

Section 53 of Medical Registration Act.

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loss due to the negligence of the doctor; when there is proximity between the patient and doctor in terms of the closeness and directness of their relationship; and there are no policy considerations that negate the necessity of a duty of care.2

Standard of Care Most of the Singapore jurisprudence on medical negligence concerns the standard of care of a medical practitioner. The law generally requires a standard of a reasonable person. Until 2017, the standard of a reasonable medical practitioner used to be understood according to the English case of Bolam v Friern Hospital Management Committee—based on whether the practice is “accepted as proper by a responsible body of medical men skilled in that particular art”.3 The Court of Appeal in 2002 affirmed that the judiciary would not hold a doctor negligent as long as there was a respectable body of medical opinion that supported his or her decision. However, the Court further stated that the expert view must first satisfy a threshold test of logic by showing that the expert directed his or her mind to the risks and benefits relating to the decision, and arrived at a defensible conclusion.4 The underlying rationale for having a specific test for medical negligence is the reality in medical practice of a diversity of views on one matter. A defendant medical practitioner could therefore not be expected to demonstrate that all his peers agreed with his decision; it sufficed to show that a body of other competent members of the procession agreed with him. Thus the Bolam test was deemed a “convenient and efficient means of determining what an ordinary skilled member of the profession would reasonably have done in the defendant’s shoes”.5 In 2017, the Court of Appeal in Hii Chii Kok v Ooi Peng Jin London Lucien decided that the Bolam test would only apply to the areas of diagnosis of the patient’s condition and medical treatment, but not to the practitioner’s advice to the patient. A new legal test which is more patient-centric has been formulated for the latter area of medical practice. Stressing the reality of the evolving doctor-patient relationship into one that was less physician-centred and more of a collaborative process, the court decided that a patient had to be equipped with information reasonably required to arrive at an informed decision. It was therefore incongruous to ignore the patient’s perception in ascertaining the standard of care for advice. 2 Spandeck Engineering (S) Pte Ltd v Defence Science & Technology [2007] 4 SLR(R) 100 at paragraphs 73–85. 3 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 at 587; [1957] 2 All ER 118 at 122. 4 Khoo James v Gunapathy d/o Muniandy [2002] 1 SLR(R) 1024. 5 Hii Chii Kok v Ooi Peng Jin London Lucien and another [2017] 2 SLR 492 at paragraphs 55–57. This test was used to be applied to the issues of diagnosis, treatment and advice to the patient at paragraph 137. It has since been followed by the Court of Appeal in Noor Azlin bte Abdul Rahman v Changi General Hospital Pte Ltd [2019] 1 SLR 834.

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There are three stages to this new test. First the patient must identify the exact nature of information he or she alleged was not provided, and show why it is material. This stage is assessed from the patient’s perspective. Second, the court determines whether the doctor possessed that information. Finally, the court examines the reasons why the doctor withheld the information. The doctor bears the burden here to justify any non-disclosure.6 This recent change in the test for standard of care in medical negligence reflects judicial acknowledgement of the importance of patient autonomy.7 It is also consonant with the shift in global sentiment on the nature of the doctor-patient relationship. As the court noted, the principle of patient autonomy has been gaining ascendance in many countries even as the countervailing principle of physician paternalism has been on the wane.8 This test was amended legislatively in 2019 in relation to the giving of medical advice. Under section 37 of the amended Medical Registration Act, a doctor satisfies the standard of care for advice if he acts in a manner which is accepted by the medical opinion of a respectable body of such healthcare professionals as reasonable professional practice in the circumstances, and this peer professional opinion is logical in that it has compared and weighed the risks and benefits of the conduct in question and arrived at a defensible conclusion.9 The amended bill also provides guidance on what amounts to “material” information that has to be shared with the patient. These amendments were made in response to medical practitioners' feedback about the uncertainty in applying the 2017 test and the resulting adoption of defensive practice.

The Need to Show a Causal Connection Between Injury and Negligent Act Although patient autonomy has been given higher regard in the standard of care for medical negligence, the patient still bears the burden of proof of showing the third element of negligence—that injury was caused by the negligent act. Thus, while the

6

Hii Chii Kok at paragraphs 113–125 and 131–135. Leo (2017). 8 Hii Chii Kok at paragraphs 114–120. See also Menon (2014), paragraph 21, noting that there is a growing alternative view that where giving of advice to patients is concerned, the opinion of doctors should not be determinative since it must ultimately contend with the question of patient autonomy, and that the question of how much information to give does not seem to be beyond the competence of the judicial mind; and Amirthalingam (2015). 9 Opening Speech for Second Reading of the Civil Law (Amendment) Bill and Medical Registration (Amendment) Bill by Mr Edwin Tong, Second Minister for Law on 6 October 2020, available online: https://www.moh.gov.sg/newshighlights/details/opening-speech-for-second-reading-ofthe-civil-law-(amendment)-bill-and-medical-registration-(amendment-bill)-by-mr-edwin-tong-sec ond-minister-for-law-on-6-october-2020 7

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patient may successfully argue that the standard of care was breached in the doctor’s discharge of advice, he may fail at this final stage of showing a causal nexus between the harm caused and the negligence. It has been pointed out that this state of affairs reveals a glaring contradiction since a test that recognizes the centrality of patient autonomy ultimately bars claims in relation to purely autonomy-based negligence when the risks of a patient’s treatment are not materialized.10 In sum, there have been incremental steps taken in Singapore to give more credence to patient autonomy within the negligence framework. However, the patient still faces a rather arduous and uncertain task in successfully establishing a case of medical negligence in the courts. The adversarial litigation system does not make the task any easier, due to the often-prohibitive cost of the litigation process. It is to this topic that the article now turns to.

Towards a Less Adversarial Approach A few years ago, Singapore’s Chief Justice Sundaresh Menon called the legal and medical professions to “reimagine our medical litigation paradigm”.11 Referring to the experiences in other countries, CJ Menon pointed out the urgent need to avoid rising insurance costs for doctors and the practice of defensive medicine due to the fear of litigation, while also protecting the needs of patients who have meritorious medical malpractice claims.12 CJ Menon further noted that patients who commence legal proceedings do not necessarily do so for financial gain, but for an explanation, apology or a real gesture of empathy. The solution may be found more in righting the real problems of dashed expectations and miscommunication than in awarding financial compensation. In addition, medical malpractice cases often have a significance going beyond the immediate facts of the case, such as systemic weaknesses in the practice of medicine that have to be dealt with holistically.13 As such, the Singapore judiciary has spearheaded a drive towards adopting a less adversarial approach to resolving medical malpractice disputes. This gentler touch is being implemented through four strategies: (a) The promotion of mediation as a primary way of resolving such disputes; (b) Greater court case management and use of pre-action protocols to encourage negotiations and to streamline court proceedings; (c) Shifting the adversarial style of court proceedings to a more inquisitorial judgeled approach; and

10

Leo (2017). Menon (2016), paragraph 44. 12 Menon (2016), paragraphs 24 and 43. 13 Menon (2014), paragraphs 38, 39, 46. 11

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(d) Appointing medical assessors to assist judges presiding over medical negligence trials.14

The Promotion of Mediation as a Primary Way of Resolving Medical Disputes These ideas are largely drawn from existing tools used by the Singapore courts in the litigation process. Court-connected mediation programs were introduced in the State Courts and Family Justice Courts more than two decades ago. The State Courts, that handle civil claims less than $250,000, also have used pre-action protocols for motor accident cases and personal injury claims to encourage private settlements. Ten years ago, these courts introduced a pre-action protocol for medical negligence cases after consultation with the healthcare and legal sectors. Under this protocol, potential claimants are required to request for a medical report and write to the relevant doctor to arrange for a without prejudice meeting to discuss the matter, prior to filing any legal proceedings. The doctor and healthcare institution are obliged to disclose such a report setting out clinical findings, treatment prescribed, whether alternatives to treatment were disclosed and an assessment of the claimant’s condition or the cause of death. These steps are intended to encouraged early communication, disclosure of essential documents and a more collaborative approach to resolve the dispute as early as possible.15 If legal action is still required, the case will be called for a Court Dispute Resolution session in the State Courts’ Centre for Dispute Resolution Centre. The process of mediation or early neutral evaluation will be conducted by a judge or other mediator of the Centre to facilitate early settlement of the matter.16 In addition, the Singapore courts have been actively promoting the use of mediation for all civil disputes. Both the Supreme Court and State Courts rely heavily on a procedural rule empowering the courts to give adverse costs orders at the conclusion of a trial to take into account any party’s unreasonable refusal to attempt alternative dispute resolution earlier.17 The State Courts require all litigants to file an “ADR Form” at an early stage of proceedings, indicating their decision whether to use a form of ADR and reasons for any refusal to do so. The judge presiding over the pre-trial conference may note any reasons that are deemed unreasonable, and these could form the basis for a future adverse costs order. If all parties consent to using ADR, the courts will make a referral of the case to the State Courts Centre for Dispute Resolution or any other institution chosen by the parties.18 Similarly, the Supreme Court in 2016 introduced an “ADR Offer” that could be filed 14

Menon (2016), paragraph 43. State Courts ePractice Direction 3 of 2006, paragraph 2. 16 State Courts Practice Directions, paragraph 39. 17 Rules of Court, Order 59 rule 5(c). 18 State Courts Practice Directions, paragraph 39. 15

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by a party who wanted to suggest ADR. The opposing party would be obliged to file an “Response to ADR Offer” to indicate his or her decision concerning the use of ADR. Once again, the court at a pre-trial conference may evaluate the reasons given for refusing the use of ADR.19

Greater Court Case Management and Use of Pre-Action Protocols Leveraging on these existing mechanisms, the Supreme Court recently introduced a series of measures to cumulatively bring about a less adversarial approach towards medical litigation.20 A protocol for medical negligence cases had introduced pre-action disclosure of documents that is similar to the system in the State Courts. After a suit is filed, early disclosure of documents is still required through the filing of the relevant medical records together with the claimant’s statement of claim. The court then engages in pro-active case management by calling the parties for a first meeting early in the civil proceedings to discuss the possibility of attempting mediation. Parties are required to submit their “ADR Offer” and “Response to ADR Offer” prior to this meeting.

The Use of Medical Assessors One novel mechanism introduced by the Supreme Court is the appointment of a medical assessor to assist the judge during the trial.21 Chief Justice Menon explained in 2014 that this is necessitated by the limitations of judicial expertise in the area of medical practice. The judge is often placed in a quandary when confronted with conflicting expert medical evidence.22 There is existing legislation empowering the court to appoint an assessor—a person of skill and experience in the relevant subject matter of the proceedings—to assist the judge to understand the material that is beyond his usual range of expertise.23 Working together with the Singapore Medical Council and the Singapore Judicial College, the courts have appointed a panel of medical assessors comprising senior doctors.24 The medical assessor is expected to sit with the judge in open court while expert evidence is being canvassed. The judge may ask the assessor questions in the presence of all parties to assist him or her to 19

Supreme Court Practice Directions, paragraph 35B. Supreme Court Practice Directions (Amendment No. 3 of 2017). 21 Supreme Court Practice Directions (Amendment No. 3 of 2017), Appendix J, paragraphs 7–10. 22 Menon (2014), paragraphs 50–55 and 60. 23 Supreme Court of Judicature Act, section 10A; and Menon (2014), paragraphs 61–69. 24 Menon (2016), paragraph 44. 20

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understand the technical issues. If the court permits, the assessor may direct pose questions to the witness, but the assessor is not treated as a witness and is not subject to any cross-examination.25

The Advent of Mediation for Medical Disputes Healthcare Mediation Scheme As discussed above, mediation forms the bedrock of the push towards a less adversarial approach towards medical malpractice. Back in 2014, the Ministry of Health started a pilot healthcare mediation scheme with the assistance of the Singapore Mediation Centre. Mediation services were offered at subsidized rates to settle medical disputes, and a dedicated panel of mediators was appointed to handle these disputes.26 The mediators are accredited by the Singapore Mediation Centre and have expertise in handling healthcare issues.27 This program continues to be available for disputes that have not commenced legal proceedings, and also cases that have already been filed in court. Based on the healthcare mediation program’s publicity materials, the mediation process is a facilitative process comprising the usual opening phase, problem-solving phase and a final phase that includes concluding a settlement. Two mediators are appointed for co-mediation of each case. The mediators do not make any decisions or orders on the outcome.28 Since the launch of this scheme, 38 cases have been mediated with a settlement rate of 80%. The Ministry of Health described one such dispute which was remarkably resolved without any payment of compensation: One of the first cases handled by the Healthcare Mediation Unit involved a middle-aged man who was extremely aggrieved that his father had been afflicted with Methicillin-resistant Staphylococcus aureus (MRSA) during his hospital stay. The man insisted on a five-figure sum as compensation, despite the hospital having written to him five times stating that his father had received the appropriate care which was in accordance with standard clinical practice. Burdened by a gnawing fear that his family members and caregivers who interacted with his father were at risk of contracting MRSA, he also visited his Member of Parliament (MP) four times to lodge repeated complaints. As expected, the relationship between the son and the hospital staff was already strained. The son was angry and there was deep distrust, as is often the case in medical disputes. However, the mediators reopened and rebuilt the once fractured communication channels between the parties with a deft sensitivity. Midway during the mediation, it became clear that the son was labouring under the assumption that his father had been infected with MRSA when he was in fact colonised with MRSA. After the mediators explained the difference between

25

Supreme Court Practice Directions (Amendment No. 3 of 2017), Appendix J, paragraphs 10. Business Times Singapore (2018). 27 Khoo and Choo (2018). 28 Ministry of Health Holdings website. 26

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colonisation and infection, and that his father was not ill, he was placated and withdrew his claim for compensation. The matter was resolved amicably without any money changing hands.29

Mandatory Mediation in Disciplinary Proceedings Complaints made against practitioners may also be referred for mediation. In such circumstances, the Singapore Medical Council’s Complaints Committee is empowered by the following rule to refer the matter for mediation whenever it is of the opinion that an investigation is unnecessary:30 A Complaints Committee shall — (a) if it is unanimously of the opinion that the complaint or information is frivolous, vexatious, misconceived or lacking in substance, dismiss the matter and give the reasons for the dismissal; (b) if it is unanimously of the opinion that no investigation is necessary — (i) issue a letter of advice to the registered medical practitioner; or (ii) refer the matter for mediation between the registered medical practitioner and the complainant; or (c) in any other case, direct one or more investigators to carry out an investigation and make a report to it under section 48. This mediation scheme is also administered by the Singapore Mediation Centre. Unlike the Ministry of Health’s healthcare mediation program, the doctors’ and complainants’ participation in this mediation is mandatory once an order has been given by the Singapore Medical Council. However, the mediation fees are borne by the Singapore Medical Council.31 In 2019, a working group evaluating the effectiveness of medical disciplinary proceedings proposed more judicious use of mediation at an earlier stage. Noting that only 14 cases were referred by the Singapore Medical Council to mediation in the past 5 years, the group recommended that the council be empowered to refer the disputing parties to mediation after the complaint is assessed (within 3 weeks of the receipt of complaint), and that cost of mediation be subsidized.32 The Working Group thus recommended empowering the Singapore Medical Council to direct doctors and complainants to attempt mediation, and the

29

Khoo and Choo (2018). Medical Registration Act, section 42(4). 31 Singapore Mediation Centre and Singapore Medical Council Mediation Rules. 32 Workgroup to Review the Taking of Informed Consent and SMC Disciplinary Process (2019), paragraph 174. 30

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subsidisation of the cost of such mediation. These recommendations were incorporated into legislative amendments in 2020.33

Mediation Programs for Court Proceedings For medical negligence claims filed in the State Courts, the parties may attempt ADR in the State Courts Centre for Dispute Resolution, a center established by the courts to offer in-house ADR services. The Centre offers both mediation and early neutral evaluation services, and it appears that both these processes are used for medical negligence disputes.34 With regard to the latter process, a lawyer who was interviewed about the changes introduced by the Supreme Court spoke favorably about the State Courts’ neutral evaluation service in resolving medical malpractice suits at an early stage.35 This process involves the parties getting an assessment of the merits of their case, so as to help them reach an agreement on highly contentious issues.

The Effectiveness of Medical Mediation Programs The effectiveness of the above mediation programs has yet to be comprehensively evaluated in relation to the specific area of medical malpractice. It is also not evident whether the facilitative approach within mediation or the more evaluative approach within neutral evaluation is viewed more favorably by the disputants. The former process, if carried out effectively, would meet the goals of addressing deeper concerns such as mismatched expectations and wider systemic issues in the practice of medicine. The court mediation process has been described by the State Courts to be a largely facilitative approach that respects each party’s choice and emphasizes on joint problem-solving.36 By contrast, a process that focuses narrowly on an evaluation of the legal arguments misses the important opportunity to address broader underlying interests, though it potentially reduces the length of legal proceedings by enabling the parties to have a realistic view of the merits of their respective positions. Nonetheless, it appears that the facilitative approach is favored by many who have called for the greater use of mediation. The Ministry of Health wrote about how mediation humanizes the parties, empowers them to find the most appropriate

33

Supra note 9. State Courts Practice Directions, paragraphs 41–42. 35 Vijayan and Seow (2016) (quoting a lawyer who said that there should be scheme similar to the practice in the State Courts “where are judge can give some indication of any liability involved before the case proceeds to assessment of damages”). 36 Low and Quek (2017), pp. 259–261. 34

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solutions and is eminently appropriate for medical claims because such disputes “cannot be legitimately measured in dollars and cents” but require the addressing of the parties’ differing expectations.37 Another commentator, quoting from a seminal US study, summarized the main reasons for medical negligence claims and how mediation can address these underlying concerns: It identified four themes as reasons for litigation: concern with standards of care – both patients and relatives wanted to prevent similar incidents in the future; the need for an explanation – to know how the injury happened and why; compensation – for actual losses, pain and suffering, or to provide care in the future for an injured person; and accountability – a belief that the staff or organisation should have to account for their actions. Patients who took legal action wanted greater honesty, acknowledgement and empathy for the severity of the trauma they had suffered, and assurances that lessons had been learnt from their experiences.38

It is likely that mediation for medical malpractice will grow in prominence in the future. The push towards a less adversarial approach takes place amidst a consistent drive by the judiciary, the Singapore Ministry of Law and the medical profession to promote the use of mediation alongside the more established processes of litigation and arbitration. Some recent measures taken in this direction include the enactment of a Mediation Act to provide a summary procedure for mediated settlements to be enforced as court judgments, the establishment of the Singapore International Mediation Centre to encourage the use of cross-border mediation and the setting up of the Singapore International Mediation Institute to introduce common mediation standards and professional accreditation.39 The healthcare mediation scheme is also one of many other industry-specific ADR schemes that have been introduced in Singapore.40 As such, the gentler touch towards medical malpractice is likely to be increasingly manifested through the use of a less confrontational way of resolving disputes, and resorting to traditional litigation as a last resort.

A Gentler Touch: An Attainable Goal? There have been some strides made in Singapore to ameliorate the conventional adversarial approach in dealing with medical negligence. However, there are probably deeper changes that have to be made to complement the steps taken towards a “gentler touch”. First, the potential of mediation may be limited if patients and doctors negotiate under the thick shadow of the law of negligence and fear making any concessions that would prejudice their rights at trial. Despite the assurance of confidentiality

37

Khoo and Choo (2018). Loke (2013). 39 Lim and Chua (2017), pp. 1–24. 40 Quek Anderson (2015). 38

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within mediation, such fears may still exist, particularly because mediation is frequently conducted when a civil suit is pending in the courts. Many other countries, including Hong Kong, British Columbia and parts of Australia, have enacted apology legislation to allow medical practitioners to apologize without the fear of legal reprisal.41 While it has been argued that apology legislation may not necessarily decrease the practice of defensive medicine, it has been widely accepted that there is therapeutic value in an appropriate apology made in the right circumstances.42 This is an area that has yet to be examined deeply within Singapore. More importantly, there are other cultural and policy changes that have to complement and support the drive by the judiciary to encourage mediation and give greater pre-action disclosure. In countries such as Australia, US and UK, open disclosure programs have been introduced in the healthcare sector to encourage the disclosure of information about adverse events, apologize for the wrong and work towards ways to prevent the wrong from recurring.43 Many of such changes will help in the prevention of medical malpractice disputes. Once a matter is brought to court, the window of opportunity for candid disclosure may have shut, and many obstacles may hinder the likelihood of holistic restoration. As with many other types of claims, dispute prevention probably has to be the focus of healthcare compensation; intervention at the litigation stage is often less effective. In addition, certain supporting structures as the insurance regime have to be examined in order to encourage the early settlement of brewing disputes. In this connection, the Singapore Medical Council and the Ministry of Health have been considering making insurance coverage mandatory for all doctors.44 While most medical practitioners would purchase insurance, the rising cost of premiums have deterred some private doctors from doing so. This lacuna places the patients at severe disadvantage. The Medical Registration Act currently allows the Singapore Medical Council to require insurance as a condition for renewal of practicing certificates, but this power has yet to be exercised.45 It appears that this power is likely to be wielded in the near future. Finally, the effectiveness of medical negligence mediation programs could be potentially undermined by the increasing dissatisfaction by Singapore doctors with the Singapore Medical Council. The council’s recent disciplinary actions have been criticized by medical practitioners as being unduly strict and inconsistent with the realities of practice.46 At the same time, there have also been complaints that the disciplinary proceedings take an inordinately long duration, thus taking a great toll on the doctors.47 The council’s direction for parties to attempt mediation before

41

Kleefeld (2017). McMichael (2017). 43 Vines (2017). 44 Straits Times, Singapore (2017). 45 Medical Registration Act, section 36(7). 46 Khalik (2017, 2019). 47 Lai (2018). 42

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delving deeper into disciplinary proceedings may thus be perceived unfavorably. Doctors may perceive it as an unnecessary step that delays proceedings and therefore fail to participate actively in the mediation process. Other medical practitioners could treat this as an opportunity to avoid the potentially harsh disciplinary action and feel unduly pressured to reach a resolution in mediation. As a result, the mandatory mediation scheme may not yield the best results, for mediation is most effective when the parties are able to exercise self-determination and are genuinely willing to explore a resolution.48 Recent proposals by a working group tasked to evaluate medical disciplinary proceedings have sought to address the above issues. While early mediation has been recommended, guidelines on referring suitable disputes to mediation have also been formulated. Certain disputes have been deemed inappropriate for the voluntary mediation process, including groundless complaints that should be dismissed by the council, serious offences such as fraud or sexual misconduct and conduct posing threats to patient’s physical safety. These guidelines are meant to ensure that mediation is “not used as a backdoor option for patients to obtain compensation through the disciplinary process”, or seen as a way to privately settle matters of public interest such as sexual misconduct.49 These proposals were accepted by the Ministry of Health and will be implemented in mid-2020.50 Healthcare compensation is an issue traversing a host of inter-related issues, including tort jurisprudence, dispute resolution, access to justice, access to affordable healthcare and the practice of medicine. It has been increasingly acknowledged in Singapore that the litigation system that is premised on a fault-based theory is severely limited in providing compensation for medical malpractice in a costeffective way, without negative ramifications on the healthcare sector and on the doctor-patient relationship. The adversarial elements of the litigation process are therefore being deliberately ameliorated, and a more inquisitorial and facilitative approach being taken to deal with such disputes. The substantive legal principles for medical negligence are also at the cusp of continual reform in order to reflect the changing views of the patient-doctor relationship. The gentler touch for matters that have such great impact on human lives and emotions evidently requires a holistic and multi-dimensional approach.

48 Amirthalingam (2017), arguing that mandatory mediation schemes often do not result in parties owning the dispute and being willing to work with each other to reach a mutually acceptable outcome. 49 Workgroup to Review the Taking of Informed Consent and SMC Disciplinary Process (2019), paragraphs 170–180. 50 Ministry of Health (2019).

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References Amirthalingam K (2015) Medical negligence and patient autonomy: Bolam Rules in Singapore and Malaysia-revisited. Singapore Acad Law J 27:666–693 Amirthalingam K (2017) Medical dispute resolution, patient safety and the doctor-patient relationship. Singapore Med J 58(12):681–684. https://doi.org/10.11622/smedj.2017073 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 at 587; [1957] 2 All ER 118 Business Times Singapore (2018) Singapore Mediation Centre revamps for a better focus Hii Chii Kok v Ooi Peng Jin London Lucien and another [2017] 2 SLR 492 Khalik S (2017) 1000 doctors petition to revoke paediatrician’s suspension. The Straits Times. https://www.straitstimes.com/singapore/1000-docs-petition-to-revoke-paediatricians-suspen sion. Accessed 2 Apr 2020 Khalik S (2019) Doctors ask MOH if they must now spell out all possible side effects after doc fined $100,000 for not doing so. The Straits Times. https://www.straitstimes.com/singapore/health/ doctors-ask-moh-if-they-must-now-spell-out-all-possible-side-effect-after-doctor. Accessed 2 Apr 2020 Khoo YX, Choo JH (2018) Mediation: the first port of call for medical disputes. Singapore Medical Association News, pp 22–23 Khoo James and another v Gunapathy d/o Muniandy [2002] 1 SLR(R) 1024 Kleefeld JC (2017) Promoting and protecting apologetic discourse through law: a global survey and critique of apology legislation and case law. Oñati Socio-legal Series [online] 7(3):455–496. https://papers.ssrn.com/sol3/papers.cfm?abstract_id¼3028811 Lai L (2018) Changes proposed to speed up disciplinary proceedings, improve transparency. The Straits Times. https://www.straitstimes.com/singapore/changes-proposed-to-speed-up-disciplin ary-process-against-doctors-improve-transparency. Accessed 2 Apr 2020 Leo ZW (2017) What role should autonomy play in the law of medical negligence. Singapore Law Watch Commentary Issue, 1 July 2017 Lim G, Chua E (2017) Development of mediation in Singapore. In: McFadden D, Lim G (eds) Mediation in Singapore: a practical guide, 2nd edn. Thomson Reuters, Singapore, pp 1–24 Loke P (2013) Mediation in doctor-patient dispute resolution. Singapore Medical Association Medical News, pp 14–15 Low J, Quek D (2017) An overview of court mediation in the state courts of Singapore. In: McFadden D, Lim G (eds) Mediation in Singapore: a practical guide, 2nd edn. Thomson Reuters, Singapore, pp 259–261 McMichael BJ (2017) The failure of ‘Sorry’: an empirical evaluation of apology laws, health care, and medical malpractice, 16 August 2017. https://papers.ssrn.com/sol3/papers.cfm?abstract_ id¼3020352 Menon S (Chief Justice) (2014) Evolving paradigms for medical litigation in Singapore. https:// www.supremecourt.gov.sg/docs/default-source/default-document-library/media-room/o-ampg-society-of-singapore-on-28-october-2014%2D%2D-evolving-paradigms-for-medical-litiga tion-in-singapore-(final%2D%2D-271014).pdf. Accessed 3 Apr 2020 Menon S (Chief Justice) (2016) Response at opening of legal year 2016. https://www.supremecourt. gov.sg/Data/Editor/Documents/Response%20by%20CJ%20-%20Opening%20of%20the% 20Legal%20Year%202016%20on%2011%20January%202016%20(Checked%20against% 20Delivery%20110116).pdf. Accessed 3 Apr 2020 Ministry of Health Singapore, News Highlights (2019) Workgroup proposes wide-ranging reforms on the taking of informed consent and Singapore Medical Council’s Disciplinary Process (3 December 2019). https://www.moh.gov.sg/news-highlights/details/workgroup-proposeswide-ranging-reforms-on-the-taking-of-informed-consent-and-singapore-medical-council-s-dis ciplinary-process/ Accessed 3 Apr 2020 Quek Anderson D (2015) Twenty-one years of mediation: how do we appraise the development of mediation within Singapore? Asian J Mediation 73 Spandeck Engineering Pte Ltd v Defence Science & Technology [2007] 4 SLR(R) 100

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The Straits Times, Singapore (2017) Insurance for all doctors may become compulsory, 27 July 2017 Vijayan KC, Seow BY (2016) CJ seeks to ease doctors’ fears of malpractice suits. The Straits Times, Singapore, 12 January 2018 Vines P (2017) The value of apologising within a moral community: making apologies work. Oñati Socio-legal Series [online] 7(3):370–389. https://ssrn.com/abstract¼3013328 Workgroup to Review the Taking of Informed Consent and SMC Disciplinary Process (2019) Report on recommendations, 28 November 2019. https://www.moh.gov.sg/docs/ librariesprovider5/default-document-library/wg-report.pdf. Accessed 3 Apr 2020

Chapter 15

Damages in Medical Malpractice Cases and Alternatives to Court Proceedings: A Slovenian Perspective Damjan Možina and Karmen Lutman

Abstract In Slovenian law, the compensation scheme for medical practice is primarily organized within the court system. Its main function is the recovery of damage (indemnity), while it has also a preventive character. Slovenian courts are rather reluctant to award damages in an amount exceeding the “objective” amount of damage (punitive damages). There are several problematic aspects of classical damages claims in medical liability cases, such as the costs and the length of proceedings, the negative effect of a claim on the doctor-patient relationship, a “defensive medicine” resulting of damages claims and being focused on a mistake of the doctor rather than on promotion of safety in the healthcare system. The patients have also difficulties in proving the breach of professional standards due to circumstances such as the lack of expert knowledge or difficult access to evidence. Therefore, alternatives to court proceedings are very welcome, although not very often used in practice. At its earliest stage, a dispute can be resolved in a procedure before a competent person of the health service provider. If no agreement is reached, the patient can start proceedings before the Commission of the Republic of Slovenia for the Protection of Patient Rights. Some further alternative dispute resolution methods are mediation and arbitration.

Introduction In Slovenia, most lawsuits against healthcare providers concern compensation for damage caused by medical negligence. Liability of doctors was traditionally considered as liability in tort. However, lately the case law is turning in the direction of contractual liability. Despite many significant differences between the non-contractual and contractual liability for damage, the main issue—whether a physician breached his duty of care—remains the same.

D. Možina (*) · K. Lutman (*) Department of Civil Law, University of Ljubljana, Faculty of Law, Ljubljana, Slovenia e-mail: [email protected]; [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_15

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The number of actions for damages caused by healthcare has increased in recent years. As the court system in Slovenia is overburdened, the theory and practice promote the use of alternative dispute resolution methods due to their timeefficiency, confidentiality, lower costs, informality and options for a more flexible solution. Among alternatives to court proceedings mediation enjoys the major support, being considered as the most adequate in terms of time and costs. While it could be used more frequently in practice, there have already been some very positive results of its application. For instance the case Nekrep, which concerned a 12-year-old boy who died shortly after admission to hospital due to a misdiagnosis and attracted a lot of public attention, was successfully resolved in the mediation process and ended up with the hospital paying the compensation to the boy’s parents. In recent years, systemic problems in the healthcare field are gaining more attention due to the fact that a large number of treatment errors are caused by systemic problems, not individual providers, and blaming an individual does little to prevent errors and improve patient safety.1 Nevertheless, so far no special compensation scheme for damage caused by systemic problems has been introduced into the Slovenian law.

Compensation Schemes for Damages Caused by Healthcare Compensation Claim In Slovenia, the compensation for medical malpractice can be obtained by filing a regular claim for damages against a medical doctor or a health institution at a court. Since the medical doctors must have their liability insured (compulsory liability insurance), it is also possible for an aggrieved person to claim damages directly from the insurance company. However, the insurance companies offer different insurance contracts; some of them e.g. exclude the coverage of a loss arising from a breach of the information duty by the doctor. The main function of any compensation of loss in Slovenia is the recovery of damage, i.e. indemnity. The secondary function is the prevention of damage.2 But awarding damages in an amount exceeding the “objective” amount with the purpose of penalization (punitive damages) against a public health institution (hospital) was expressly rejected by the courts. The Supreme Court of Slovenia held that, in general, penalization is a task of the state (i.e. criminal law) and not of private law, and, more specifically, that punitive damages against a public health institution, financed mainly by the (state run) system of health insurance, would, in fact,

1

Duffourc (2018), p. 21. See e.g. decision of the Supreme Court of Slovenia, Nr. VIII Ips 170/2011 of 3.9.2012, para. 12; Plavšak et al. (2009), p. 649. 2

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indirectly, “punish” all users (and contributors) of public medical services.3 It seems, however, that the Court did not entirely exclude the possibility of punitive damages against defendants other than public health institutions. Furthermore, although the “preventive” function of damages is generally recognized in Slovenian law and may, in certain circumstances, such as employer’s discrimination or workplace mobbing enable awards of damages in amounts exceeding the “objective” amount of damages (e.g. in the sense of “dissuasive and proportionate” damages from Art. 18 of the EU Directive Nr. 2006/54),4 the delimitation between preventive and punitive damages is unclear. Writers suggest that there are several problematic aspects of classical damages claims in medical liability cases, such as the costs and the length of proceedings, the negative effect of a claim on the doctor-patient relationship, a “defensive medicine” resulting of damages claims and being focused on a mistake of the doctor rather than on promotion of safety in the healthcare system.5 Furthermore, frequently the patients have difficulties in proving the breach of professional standards due to circumstances such as the lack of expert knowledge or difficult access to evidence.

Liability for Medical Malpractice The Basis of Medical Liability For a long time, Slovenian courts considered the damages claims due to medical malpractice to be of delictual (non-contractual) nature.6 The general clause of non-contractual fault liability from Art. 131 (1) Obligations Code7 was being applied. Accordingly, the claimant had to prove the wrongfulness of the medical doctor’s action or omission, legally relevant damage and the causal link between them; the doctor’s fault was presumed until proven otherwise, i.e. that due care according to the professional standards was exercised.8

3

Decision of the Supreme Court of Slovenia, Nr. II Ips 130/2012 of 8.11.2012. Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation, OJ L 204; see also Možina (2016), pp. 371–390. 5 Žnidaršič – Skubic (2018), pp. 87–90, see also: Rovan Vizlar (2017), pp. 89 and 102. For more see: Žnidaršič - Skubic (2015). 6 See e.g. decisions of the Supreme Court of Slovenia, Nr. II Ips 929/2008 of 31.5.2012; Nr. II Ips 1018/2008 of 19.5.2011; Nr. II Ips 214/2008 of 26.5.2011 and Nr. II Ips 302/2011 of 26.4.2012. 7 Obligacijski zakonik (OZ), Official Gazette of the Republic of Slovenia, Nr. 83-4287/2001 with amendments. 8 Ovčak Kos and Božič Penko (2017), pp. 11 and 13. 4

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However, lately the case law seems to be turning in the direction of contractual liability for damage.9 This view also enjoys majority support in the literature.10 Although there are some important differences between the non-contractual and contractual liability for damage,11 the essential question—i.e. whether the doctor violated his duty of care (acted contra legem artis)—is the same. The claimant must prove the breach of this duty (i.e. breach of contract), the existence of damage and the causal link between them. The relevant standard of care is established with reference to the medical science within the international perspective. The highest standard of care for professionals from Art. 6 (2) Obligations Code is applicable, whereby a doctor must not only act with the highest standard of care as such, but must also comply with the (international) medical doctrine. As a rule, a court will nominate a medical expert to assess whether these standards were met. A medical malpractice means a deviation from these standards by the doctor or other hospital personnel, as the case may be, which may cause a deterioration of a health condition of a patient.12 A particular duty of a doctor is also a (pre)contractual information duty: he must inform the patient of possible complications prior to his consent to the procedure. If he fails to properly inform the patient, he assumes the risk of complications regardless of his duty of care, i.e. he is liable for any complications even if his action was impeccable from the point of view of professional care and medical doctrine. The courts do not consider the information duty of a doctor as a condition to the patient's valid consent; rather, it is the doctor’s contractual duty.13 Although, in principle, contractual liability in Slovenian law does not depend on fault but is based on the concept of liability for own sphere of control (the defendant is exempt from liability, if he proves that he could not have performed the contract due to unforeseeable circumstances beyond his control according to Art. 240 Obligations Code), which implies an “obligation de résultat”, the liability of a doctor is nevertheless that of care (“obligation de moyen”) and not of a specific result. Thus, a doctor is exempt from liability if he proves that he had exercised due care, even if the anticipated result failed to come. There are situations, in which it is possible to imagine the doctor’s obligation to be reinforced and becoming an obligation of specific result or very close to that (e.g. when a doctor builds in a special device which is expected to operate in conformity with the contract, such as a pacemaker or a teeth prosthesis). However, no such cases can be found in the (publicly available) case law.

9 See e.g. decisions of the Supreme Court of Slovenia, Nr. II Ips 342/2014 of 22.1.2015, para. 15; Nr. II Ips 94/2015 of 2.7.2015 and Nr. II Ips 207/2015 of 14.1.2016. 10 Cigoj (1989), pp. 108 and 147; Polajnar Pavčnik (1998), p. 94; Ovčak Kos and Božič Penko (2017), pp. 11 and 13. 11 See e.g. Božič Penko (2017), pp. 69, 78 et seq. 12 See e.g. decision of the Supreme Court of Slovenia, Nr. II Ips 80/2011 of 29.3.2012. 13 Decision of the Supreme Court of Slovenia, Nr. II Ips 94/2015 of 2.7.2015; Ovčak Kos and Božič Penko (2017), pp. 11 and 13.

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Accidental Risk Accidental risk is a risk that is realised as a consequence of medical treatment and which could not have been foreseen by the doctors exercising their due care. Since such accidents do not result from the improper or negligent professional activity of the medical practitioner or service, they do not fall within the definition of medical malpractice. Therefore, the practitioner's liability is excluded.14 This was for instance the case, where the patient suffered from severe brain damage due to anaphylactic shock which was caused by the anesthesia.15 Since such reactions are extremely rare (one such case per 6250 patients being treated with anesthesia), the allergy tests should be performed only if the patient previously suffered from anaphylactic shocks or is suspected to be allergic to a particular substance. Taking into account the findings of the expert opinion that no indications for allergy tests being necessary had existed, the Supreme Court held that the doctors and personnel had acted with due care and were therefore not liable for damages arising from the complication. However, as previously mentioned, this rule does not apply to cases where the doctor fails to properly inform the patient. In such cases he is liable for accidental risk being realised regardless of his duty of care.16

Burden of Proof In principle, the claimant must prove the breach of doctor's duty of care (i.e. breach of contract), the existence of damage and the causal link between them. The doctor is exempt from liability if he proves that he exercised due care (the absence of fault). There are circumstances, in which the courts decided to lower the claimant’s burden of proof, in particular with regard to fault or causation. To achieve that, the courts e.g. applied a lower standard of probability (not conviction but reasonable probability)17 or applied a doctrine such as prima facie proof or res ipsa loquitur. However, such cases are rare.18 There is no established case law with regard to these issues in Slovenia. There are also cases where the courts applied the doctrine of “voll beherschbaren Risiken”, i.e. strict liability for risks which the medical institution must have entirely under control, in particular with regard to the functioning of technical equipment or nursing of patients (and not the medical procedures in the narrower sense). Such was e.g. the case where a 4-months old patient with severe

14 See e.g. decisions of the Supreme Court of Slovenia, Nr. II Ips 214/2008 of 26.5.2011 and Nr. II Ips 88/2009 of 26.11.2009. Ovčak Kos and Božič Penko (2018), p. 11. 15 Decision of the Supreme Court of Slovenia, Nr. II Ips 214/2008 of 26.5.2011. 16 Ovčak Kos and Božič Penko (2018), p. 11. 17 See e.g. decision of the Supreme Court of Slovenia, Nr. II Ips 315/2013 of 20.2.2014. 18 See e.g. Dolenc (2010), p. 6.

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brain damage got injured while being nursed in a hospital and the claimants could not prove any fault of the hospital personnel.19

Medical Malpractice Litigation Although the number of medical litigation cases is rising,20 there are no special mechanisms aiming to limit the number of lawsuits. In Slovenian law, the plaintiff has no obligation to inform the defendant about his intention to sue (so-called “pretrial notification”). Furthermore, there are also no disclosure programmes foreseen in the legislation. Therefore, writers stress the importance of alternative procedures, however, they are not frequently used in practice.21 Regarding time limits for commencing litigation, it should be noted that medical malpractice claims are subject to a general five-year limitation period prescribed in the Obligations Code.22 According to the statistics, the compensation amounts, awarded by the courts, are rising, which leads to higher insurance premiums being charged to hospitals. There is a threat that hospitals will, in order to alleviate financial burden, pass it (indirectly) on the patients. However, there are currently no public debates about introducing any mechanisms for diminishing the amount of financial compensations.

Alternatives to Court Proceedings Aiming to facilitate access to dispute resolution and to promote the amicable settlement of disputes, the Slovenian legal system offers some options for alternative dispute resolution in cases of medical malpractice. At its earliest stage, a dispute can be resolved in a procedure before a competent person of the health service provider. If no agreement is reached, the patient can start proceedings before the Commission of the Republic of Slovenia for the Protection of Patient Rights. Some further alternative dispute resolution methods are mediation and arbitration. However, it should be noted that none of the alternative proceedings described below is a prerequisite for litigation.

19 See decision of the Supreme court of Slovenia, Nr. II Ips 314/2013 of 20.2.2014, which confirmed the decision of the Higher Court of Ljubljana, Nr. II Cp 3744/2005 of 5.4.2006. However, in this case the doctrine of controllable risks was applied inadequately as the risk was in fact not entirely under the control of hospital. 20 Žnidaršič – Skubic (2018), p. 87. 21 Rovan Vizlar (2017), p. 104. 22 Art. 346 and 352(3) of the Obligations Code.

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Proceedings Before a Competent Person of the Health Service Provider The Patient Rights Act23 grants a patient who believes that his rights have been violated during medical treatment the right to start the procedure before a competent person of the health service provider (hereinafter referred to as “competent person”).24 This procedure is known as the “request procedure for the first consideration of the infringement”. It aims to discuss the conflict between a patient and the health service provider in a rather informal way and to achieve a proper solution. Since the procedure is intended to resolve the problem at its earliest stage, the request must be filed within a 15- or 30-day period (depending on the alleged breach) after the alleged breach of the patient’s rights occurred or the medical treatment was finished. If the patient gains knowledge of medical malpractice or becomes aware of its consequences after the expiration of these two periods, he is allowed to file the request three months thereafter.25 After the request has been filed, the competent person of the health service provider can conduct an oral hearing to discuss the issue with the injured party and the physician or other medical expert who can explain the circumstances relevant to the present case.26 During the oral hearing the competent person and the patient can reach an agreement. This agreement has the legal nature of a contract and is not directly enforceable.27 The Patient Rights Act gives some examples of resolutions that can be achieved by the agreement. One of them is an apology from the healthcare professionals involved. It should be noted that the Act is not written in a way that would foster open and honest communication between the physician and the injured party, since it does not prevent a statement of apology from being entered into evidence as proof of malpractice, which is often the case in American law. The parties can also agree on reimbursing the unnecessary costs of the medical treatment or on paying a compensation of up to 300 EUR. However, an agreement on a higher amount of compensation can be made outside of this procedure.28 If the competent person ascertains that the medical service provider failed to competently perform its medical duties, he can order to repeat, complete or correct the medical treatment. If the procedure does not end with an agreement or if the medical service provider fails to carry out the oral hearing or fulfill its obligations deriving from the agreement, the

23

Zakon o pacientovih pravicah (ZPacP), Official Gazette of the Republic of Slovenia, Nr. 15/08 and 55/17. 24 Art. 47 of the Act. 25 Art. 59 of the Act. In the decision of the Administrative Court of Slovenia Nr. III U 408/2009 from 14.12.2010, the Court held that the request for the first consideration of the alleged infringement before a competent person of the health service provider was filed in time, since the patient gained knowledge of the circumstances of medical malpractice only when she was hospitalized. 26 Art. 62 of the Act. 27 Kralj in: Balažic et al. (2009), p. 292. 28 Ivanc in: Balažic et al. (2009), p. 282.

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patient may file a request for the second consideration of the infringement before the Commission of the Republic of Slovenia for the Protection of Patient Rights (hereinafter referred to as “request procedure for the second consideration of the infringement”).

Proceedings Before the Commission of the Republic of Slovenia for the Protection of Patient Rights The procedure before the Commission of the Republic of Slovenia for the Protection of Patient Rights (hereinafter referred to as “the Commission”) can be carried out only if the patient previously filed the request for the first consideration of the alleged infringement before the medical service provider. A further procedural prerequisite is that no court or administrative procedure is pending between the same parties concerning the same dispute. The Commission as an administrative body can namely issue legally binding administrative decisions which could otherwise come into conflict with judicial or other administrative decisions on the same matter. The preparatory hearing is the first stage of the procedure. It serves as an open discussion about the factual and legal aspects of the dispute between the member of the Commission, the patient and the representative of the medical service provider. The insurers are also entitled to join the procedure. Parties can reach a settlement or agree to submit their dispute to mediation. The settlement has the legal nature of an “administrative” settlement.29 In order to be legally binding and enforceable, it should meet the requirements of an out-of-court settlement as defined in the Slovenian Obligations Code.30 If the parties do not settle or do not agree to start mediation, the procedure continues before the panel of the Commission. The only exception relates to cases in which the patient claims compensation. Since the Commission is regarded as an incompetent authority to issue legally binding decisions when it comes to compensation,31 the Law imposes an obligation on the member of the Commission to inform the patient about the possibility of filing a lawsuit.32 In other cases the procedure continues before the panel of the Commission. The panel should strive to expedite the proceedings and promote an agreement between the parties. The Act gives an open list of decisions that may be taken by the panel. For example, the Commission can impose an obligation on the medical service provider: (i) to apologise to the patient, (ii) to take measures to eliminate anomalies or failures in the medical treatment, (iii) to take measures to prevent patients from being exposed to medical malpractice in the future, (iv) to repeat, complete or correct the medical

29

Kralj in: Balažic et al. (2009), p. 312. Art. 1050–1059 of the Obligations Code. 31 Judgement of the Administrative Court Nr. IV U 175/2015 of 12.1.2016. See also: Brulc in: Balažic et al. (2009), p. 316. 32 Art. 70 (3) of the Act. 30

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treatment. It can also issue a warning to the medical service provider or to the healthcare professional. The decisions of the Commission are final, legally binding and enforceable. There is no appeal against the decision; however, the parties can start an administrative dispute before the court.33

Mediation and Arbitration Parties can also decide to submit their dispute to mediation. Mediation as an ADR method is also foreseen as part of the proceedings according to the Patient Rights Act. Namely, instead of continuing the procedure before the panel of the Commission, the parties can decide to mediate. The general rules of mediation are laid down in the Mediation in Civil and Commercial Matters Act.34 However, there are some further rules governing mediation in medical matters within the process for the second consideration of the infringement in the Patient Rights Act.35 In comparison to court proceedings, mediation is considered to be more flexible, time-efficient and confidential.36 Thus, it is regarded as the most adequate ADR method in healthcare matters by legal practitioners and scholars. If the parties decide to mediate, they have to choose a mediator from the list of mediators which is maintained by the Health Minister. According to the Patient Rights Act insurers can join the mediation proceedings if both parties agree on their participation. The insurance company usually enters into the mediation procedure instead of the medical service provider.37 Since time-efficiency is one of the goals of mediation, the parties should reach a solution to their dispute within 45 days of signing an agreement to mediate.38 This period can be prolonged by 30 days. The agreement made between the parties and confirmed by the member of Commission is enforceable.39 If no solution is reached between the parties within these time frames, the procedure continues before the panel of the Commission. Despite the many

33

Art 79 of the Act. Zakon o mediaciji v civilnih in gospodarskih zadevah (ZMCGZ), Official Gazette of the Republic of Slovenia, Nr. 56/08. 35 Art. 71 and 72 of the Act. Detailed provisions on the mediation in medical matters can be found in the Rules on healthcare mediation (Pravilnik o mediaciji v zdravstvu, Official Gazette of the Republic of Slovenia, Nr. 77/08). 36 Kogovšek (2007), p. 44. 37 Brulc in: Balažic et al. (2009), p. 322. Other than that, there are no special ADR practices arranged between risk management professionals, insurers and patients. 38 Art. 72 (4) of the Patient Rights Act. 39 Art. 72 (4) of the Patient Rights Act. 34

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advantages of mediation as an alternative dispute resolution method and its elaborate normative framework, it is rarely used in practice.40 Although arbitration is another option among alternative dispute resolution methods, parties rarely decide for it in the healthcare field.

Aim, Philosophy and Efficiency of Alternatives to Court Proceedings Time-efficiency, confidentiality, lower costs, informality and options for a more flexible solution are the main goals of the ADR methods.41 The philosophy underlying the proceedings before a competent person of the health service provider and before the Commission is to enable the patient a fast, simple and efficient way of solving the dispute at its earliest stage in a confidential environment with the free support of a representative of patients’ rights.42 ADR methods established by the Patient Rights Act are based on the principle of time-efficiency and are patient-friendly in terms of costs. Firstly, there is no obligation to pay administrative fees. Secondly, if the patient succeeds in his request before the Commission, he is entitled to have his costs reimbursed by the medical service provider. However, in case his request is not successful, the patient bears only his costs of the procedure.43 In mediation, the parties bear the costs of the mediation internally in equal shares and their own costs in full unless they had agreed otherwise.44 Arbitration is less patient-friendly in terms of costs since the fees and other costs are usually higher than the costs of mediation. Unless the parties had agreed otherwise, the arbitration tribunal can decide that the losing party must reimburse the other side for its costs and its share of the arbitration fee.45 It could be concluded that alternative proceedings in general strive to strengthen patients’ rights especially by their cost-efficiency and informality. On the other hand, they have a preventive character. Namely, extending the range of legal remedies available to patients stimulates medical service providers to maintain or improve the standard of their services. Despite the relatively clear and transparent system of ADR methods, there are some difficulties in applying them in practice. It should be noted that some of them

40 See Kogovšek (2007), p. 44. However, the case Nekrep v. UKC Maribor, which was a medical malpractice case that attracted a great deal of public and media attention in Slovenia, was successfully resolved in the mediation process in 2011. 41 Brulc in: Balažic et al. (2009), p. 317. 42 See Art. 48 of the Patient Rights Act. 43 Art. 67 of the Patient Rights Act. 44 Art. 22 of the Rules on healthcare mediation. 45 Art. 39 of the Arbitration Act (Zakon o arbitraži (ZArbit), Official Gazette of the Republic of Slovenia, Nr. 45/08).

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are either inefficient and/or rarely used in practice. For instance, it follows from the annual report of the president of the Commission of the Republic of Slovenia for the Protection of Patient Rights that medical service providers regularly fail to fulfil their obligations imposed by the Patient Rights Act to carry out oral hearings if the request for the first consideration of the infringement was filed.46 There are also some difficulties in the proceedings before the Commission. In 2016 the Commission resolved only 5 of the 27 filed requests due to problems forming panels or with ensuring the attendance of the participants at the oral hearings. The problem allegedly lies in the aforementioned fact that the competent bodies of the medical service providers often do not carry out the procedure for the first consideration of the alleged infringement, which leads to an extension of the proceedings before the Commission. Another problem the Commission is facing is the lack of administrative support.47 There are no studies on the efficiency of mediation in healthcare disputes available. However, despite some attempts to promote the use of mediation in healthcare disputes,48 patients still relatively rarely decide for this ADR method.49

Protection of Patients’ Rights There are two public entities dealing with medical malpractice cases striving to protect patients’ rights—firstly, representatives of patient’s rights and secondly, the Commission of the Republic of Slovenia for the Protection of Patient Rights. The patient can at any time contact one of the representatives of patient’s rights from the list held by the Ministry of Health who can advise and assist him as well as provide him with basic information, expert assistance or concrete guidance in exercising his rights in the field of healthcare. The term of office of a representative is 5 years and can be renewed. It is regarded as an efficient body to protect patients’ interests.50 The Commission of the Republic of Slovenia for the Protection of Patient Rights is a competent authority for dealing with patients’ requests for the second consideration of the alleged infringement according to the rules of the Patient Rights Act. The term of office for its members is 5 years. In practice, patients relatively rarely decide to file a request before the Commission.51 It follows from its annual 46

See the annual report of the Commission of the Republic of Slovenia for the Protection of Patient Rights of 2016, p. 1; available on: http://www.mz.gov.si/si/pogoste_vsebine_za_javnost/ pacientove_pravice/porocila_o_stanju_na_podrocju_varstva_pacientovih_pravic/. 47 Annual report of the Commission of 2016, pp. 1 and 2. 48 Tomažin (2011), p. 34. 49 Kogovšek (2007), p. 44. 50 See Kožuh (2014) (available on: http://www.fm-kp.si/zalozba/ISBN/978-961-266-174-8/ prispevki/022.pdf). 51 It follows from the annual report of the Commission of 2016 that it received 27 requests in 2016 (down from 37 in 2015).

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reports that it has been facing procedural and administrative problems which cause delays in the decision-making process.52 In Slovenia, health damages compensation procedures are not centralized in one body. Parties can reach an out-of-court compensation settlement at any time and this is most often the case in the mediation process or in the proceedings before the Commission. However, since the Commission cannot issue binding and enforceable decisions about compensation, these disputes are de facto centralized in the courts. The obligation to pay compensation can also be imposed by the Tribunal of the Medical Chamber of Slovenia,53 but it does not often occur in practice.

Pretrial Screenings Early neutral assessment is according to the Act on Alternative Dispute Resolution in Judicial Matters54 one of the methods of ADR which can be performed by the court. The courts have not yet implemented this ADR technique in practice. However, there are some private companies offering services of early neutral assessment either before or during litigation or before filing a legal remedy. Nevertheless, this method is still rather unknown and rarely used.

Proposals De Lege Ferenda The Patient Rights Act was amended in 2017, but the provisions on alternative procedures remained unchanged, since they are not currently a debated topic. Civil law doctrine and legal theorists support ADR methods in resolving disputes in medical matters.55 In the last decade, there were also some programmes and conferences organized by legal practitioners and scholars aiming to promote the use of mediation in medical malpractice disputes. Due to the overburdened court system, judges are also in favor of alternative means of dispute resolution.

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Annual reports available on: http://www.mz.gov.si/si/pogoste_vsebine_za_javnost/pacientove_ pravice/porocila_o_stanju_na_podrocju_varstva_pacientovih_pravic/. 53 Art. 41 of the Rules on organisation and work of the tribunal of the Medical Chamber of Slovenia (Pravilnik o organizaciji in delu razsodišča Zdravniške zbornice Slovenije, Official Gazette of the Republic of Slovenia, Nr. 121/04). 54 Zakon o alternativnem reševanju sodnih sporov (ZARSS), Official Gazette of the Republic of Slovenia, Nr. 97/09, 40/12. 55 Radej Bizjak (2007b), p. VIII.

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Systemic Remarks Wait-Related Damages According to the Review of Slovenian health system, waiting times are a major source of patient dissatisfaction with the healthcare system and a subject of heated public debate in Slovenia.56 However, no (publicly available) case law on waitrelated damages could be found. If unreasonably long waiting times are a consequence of misallocation of financial resources, it is usually a healthcare insurance institution, which is liable for damages, as it is responsible for effective resource allocation.57 In deciding about its liability, it is necessary to evaluate, whether a healthcare institution had acted with due care when allocating the resources, so the sufficient and timely healthcare could have been provided.58 Besides healthcare insurance institution, it is also the state, which can be liable for unreasonably long waiting times.59 Writers suggest that its liability should be established by analogy with the liability for compensation due to unreasonably long court proceedings.60 Namely, both of them are systemic problems. If the state fails to provide a proper healthcare due to unreasonably long waiting lists, it violates Article 2 of the ECHR (right to life which includes right to public health care) and Articles 51, 2 and 34 of the Slovenian Constitution (right to health care, social-state principle and right to personal dignity and safety).61 Article 51 of the Slovenian constitution states in paras. 1 and 2 that “Everyone has the right to health care under conditions provided by law. The rights to health care from public funds shall be provided by law.” As it follows from the provisions of the Health Care and Health Insurance Act,62 the healthcare system should ensure that patients have timely access to medical services.63 Since timely access to healthcare may in some cases mean the difference between life and death, it is often said that healthcare delayed is

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Albreht et al. (2016), p. 173 (available on: http://www.euro.who.int/__data/assets/pdf_file/0018/ 312147/HiT-Slovenia_rev3.pdf?ua¼1). 57 Strban (2004), p. 309. 58 Ibidem. 59 Ibidem, p. 311; Radej Bizjak (2007a), pp. I–VIII. 60 In pilot judgement Lukenda v. Slovenia (Nr. 23032/02 of 6.10.2005) the European Court of Human Rights imposed an obligation on Republic of Slovenia to pay compensation for damage suffered by individuals due to unreasonably long court proceedings. It held that the state is responsible for the violation of Art. 6 para. 1 and of Art. 13 (right to an effective remedy) and the existence of a systemic problem. Following the adoption of the Lukenda judgment, a law has been passed in Slovenia to remedy this systemic situation. The law establishes a non-fault liability for damages in cases of unreasonably long court proceedings. 61 Radej Bizjak (2007a), pp. II and VII. 62 Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju (ZZVZZ), Official Gazette of the Republic of Slovenia, Nr. 72/06 with amendments. 63 See e.g. Art. 1 of the Act.

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healthcare denied.64 The state liability for damage caused by unreasonably long waiting lists is based on the Article 26 of the Slovenian constitution, which represents a general legal framework for the state liability in damages.65

Compensation for Quality Deficit in Healthcare According to the current legislation liability for deficits of quality in healthcare is not a priori excluded. If the lack of quality is a consequence of a systemic problem in a certain medical institution, this institution could be held liable for damages according to the general rules of contractual liability. If the cause of the quality deficit lies in the sphere of the state, it might be responsible for it. This is the case especially when the quality deficit is a systemic problem that results from inadequate legislation and/or inefficiency in the administration, so the problem continues to present a danger affecting every patient seeking medical assistance.66 Nevertheless, in such cases all the prerequisites for state liability should be met—the plaintiff should prove that the state acted unlawfully when exercising its powers which resulted in damage suffered by the plaintiff. Scholars stress that financial capacity of the state should be taken into account67 when deciding if it acted unlawfully when it did not provide a certain level of quality.

Fair Distribution of Limited Resources and Their Accessibility The compulsory health insurance is financed by employers’ and employees’ contributions,68 with the government having a derived constitutional obligation of co-financing the insurance from general taxation in cases of social insurance carrier’s expenses exceeding its revenue.69 Compulsory health insurance is grounded in the principles of vertical and horizontal solidarity and universality. Benefits in kind are exercised according to the needs of the patient’s medical condition. Basic principles are derived from the legislation by means of teleological interpretation. Unlike under

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Radej Bizjak (2007a), p. VII. Ibidem, p. V. For more about state liability see: Možina (2015), pp. 17–57. 66 Similar view was taken in Lukenda v. Slovenia. 67 Možina (2015), pp. 45 and 46. 68 See Social Security Contributions Act, Zakon o prispevkih za socialno varnost (ZPSV), Official Gazette of the Republic of Slovenia, Nr. 5/96 with amendments. 69 This obligation derives from Art. 2 (social state principle), Art. 50 (right to social security) and Art. 51 (right to health care) of the Constitution. In accordance with Art. 50, the state is obliged to safeguard the functioning of all types of social insurance. 65

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the currently valid legislation, they are explicitly stipulated in the draft of the new Health Care and Health Insurance Act.70 The Health Insurance Institute of Slovenia (HIIS), a specialized, self-governing public body implementing the compulsory health insurance in a functionally decentralized system of social security, the Association of Health Institutes of Slovenia, the Ministry of Health and competent chambers agree on a yearly basis on the programme of services provided from compulsory health insurance. They define the capacities and available funds for its implementation. The agreement serves the preparation of individual programmes, programme prices and other basis needed for the conclusion of individual contracts with public and private (concessionaires) health care providers. A special agreement is concluded regarding access to medical devices by the insured persons.71 Individual contracts concluded between the HIIS and health care providers stipulate the type, scope, level of quality and deadlines prescribed for the execution of a particular programme in accordance with medical standards in force at the individual provider, organization or field of medicine.72 HIIS monitors the execution of concluded contracts by means of authorized supervisory medical experts.73 It monitors the exercising of rights, the amounts of cash benefits, billing of medical services, the implementation of contracts, the collection of contributions and its internal financial management.74 A part of monitoring competencies can be transferred to specialized bodies.75 If HIIS notices that the collected funds will not suffice to cover the obligations towards health care providers, it can suggest new negotiations regarding concluded contracts (programmes) or their termination. Generally, all contracts can be concluded only in accordance with funds available to the HIIS.76 At the same time, HIIS reallocates funds between its local offices covering the costs of services concluded by local providers in line with individual contracts.77 The reallocation occurs throughout the year. The use of funds financing programmes and services is monitored by the Ministry of Health. If irregularities are observed, the minister stipulates measures for their elimination.

70 Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju (ZZVZZ-1); available on: http:// www.mz.gov.si/fileadmin/mz.gov.si/pageuploads/zakonodaja/ZZVZZ-1.pdf. 71 See Art. 63 and 63a of the Health Care and Health Insurance Act, Zakon o zdravstvenem varstvu in zdravstvenem zavarovanju (ZZVZZ). 72 See Art. 65 of the ZZVZZ with special provisions regarding concessionaires. 73 Art. 77 of the ZZVZZ. 74 Art. 64 of the Statute of the Health Insurance Institute of Slovenia, Statut Zavoda za zdravstveno zavarovanje Slovenije, Official Gazette of the Republic of Slovenia, Nr. 87/01 with amendments. 75 Art. 67 of the Statute. 76 Art. 63 of the Statute. 77 Art. 57 in conjunction with Art. 2, Art. 10, para. 4 of Art. 22 and para. 9 of Art. 28 of the Statute.

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Liability for Defects in Medical Products There is no special legislation dealing with liability for defects in medical products. Therefore, the general rules on product liability apply. Since the patient is regarded as a consumer,78 Articles 4—11a of the Consumer Protection Act79 are applicable. These provisions are implementing the Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. According to the Consumer Protection Act producer is liable for (pecuniary) damages resulting from a death, personal injury, health problems or damage to, or destruction of, any item of property other than the defective product itself, with a threshold of 500 EUR.80 The Obligations Code is the basis for compensation of non-pecuniary damage. Producer’s liability is considered as delictual non-fault liability.81 Therefore, the plaintiff should prove the existence of defect, legally recognized damage and causal link between them.82

Liability for Lack of Adequate Healthcare Institutional responsibility of hospitals for lack of adequate healthcare is based on contractual liability as contained in the Obligations Code.83 Hospitals are also liable for damage caused by its employees (doctors and personnel), unless it is proved that they acted with due care taking into account all circumstances of the case.84 On the other hand, liability of the state is considered as a special type of liability. It is based on the principles and rules of civil law taking into account public elements, especially the fact that the state is acting ex iure imperii. It derives from Article 26 of the Slovenian Constitution and is mostly developed by case law.85

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Marn (2012), p. 154. Zakon o varstvu potrošnikov (ZVPot), Official Gazette of the Republic of Slovenia, Nr. 98/04 with amendments. 80 Art. 4 of the Consumer Protection Act. 81 Možina (2007), pp. 71–86. 82 Ibidem. 83 See e.g. decision of the Court of Appeal of Ljubljana, Nr. II Cp 4859/2007 of 15.10.2008. 84 Art. 147 of the Obligations Code. 85 Možina (2015), p. 17. 79

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Compensation for Infringement of Patients’ Rights Breach of patient’s right does not necessarily entitles the injured party to compensation. As far as compensation for pecuniary damage is concerned, patient is required to prove the existence of pecuniary loss, causally linked to the infringement of his right. On the other hand, infringement of a personal right is legally recognized non-pecuniary damage according to the Article 179 of the Obligations Code and entitles patient to compensation for non-pecuniary damage, if the right that was infringed is a personal right. As regards the patient’s personal rights, such as the right to privacy and dignity, it is possible to grant compensation for non-pecuniary loss according to Article 179 of the Obligations Code, which imposes an obligation to pay compensation for infringement of personal rights irrespective of the existence of pecuniary damage.

Conclusions In Slovenian law, liability of a health care provider has been for a long time considered to be of non-contractual nature. However, in recent years this approach is changing in favor of contractual liability. It is not based on fault principle but on the concept of liability for doctor’s own sphere of control. Thus, the doctor is exempt from liability if he proves that he could not have performed the contract due to unforeseeable circumstances beyond his control. While the claimant must as a rule prove the breach of the doctor’s duty of care, the existence of damage and the causal link between them, the doctor is exempt from liability, if he proves that he exercised due care, which is interpreted in accordance with the medical science within the international perspective. In some cases the courts decided to facilitate the position of a claimant and to lower his burden of proof by applying a lower standard of probability or a doctrine such as prima facie proof or res ipsa loquitur. Compensation claims are predominantly filed before the court and the number of medical litigation cases in Slovenia is rising. Having in mind that the court system is overburdened, the theory and practice share the view that alternative dispute resolution methods should be promoted in the future. According to the current legislation a dispute can be at its earliest stage resolved in a procedure before a competent person of the health service provider. If no agreement is reached, the patient can start proceedings before the Commission of the Republic of Slovenia for the Protection of Patient Rights. A further alternative dispute resolution method is mediation, while arbitration is rather rare due to its high costs. In the future, more focus should be put on systemic problems, such as waiting times, quality deficit and fair distribution of limited resources. Although waiting times are a major cause for patient dissatisfaction with the healthcare system in Slovenia, there is no publicly available case law on wait-related damages. Despite

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existing general mechanisms for liability of health care institutions or the state, no special compensation schemes have yet been established in the healthcare field.

References Albreht T et al (2016) Slovenia: health system review 2016. Eur Observ Health Syst Policies 18(3) Balažic J, Brulc U et al (2009) Zakon o pacientovih pravicah s komentarjem. GV Založba, Ljubljana Božič Penko A (2017) Nekatera pravna vprašanja v zvezi z odgovornostjo za zdravniško napako v sodni praksi, Pravni letopis, pp 54–64 Cigoj S (1989) Institucije obligacij. Uradni list, Ljubljana Dolenc M (2010) Dokaz prima facie v pravdnem postopku. Pravna praksa 35:6–8 Duffourc MN (2018) Repurposing the affirmative defense of comparative fault in medical malpractice cases to improve patient safety. Indiana Health Law Rev 16(1):21–41 Kogovšek S (2007) Špela: Odškodninska odgovornost zdravnikov, varstvo zasebnosti pacientov in mediacija v zdravstvu. Pravna praksa 39–40:44–45 Kožuh M (2014) Ex post ocena učinkovitosti pravne regulacije pacientovih pravic v Sloveniji pri reševanju pritožbenih poti, Zbornik 11. festivala raziskovanja ekonomije in managementa:177–183 Marn M (2012) Sistem produktne odgovornosti v zdravstvu, Bilten: ekonomika, organizacija, informatika v zdravstvu 2:151–165 Možina D (2007) Odgovornost proizvajalca za proizvod z napako: evropsko obligacijsko pravo izpodriva nacionalno pravo. Podjetje in delo 1:71–86 Možina D (ed) (2015) Odškodninska odgovornost države. GV založba, Ljubljana Možina D (2016) Povrnitev škode zaradi diskriminacije in trpinčenja na delovnem mestu – nekaj misli ob 8. členu ZDR-1. In: Žnidaršič – Skubic V et al (eds) Liber Amicorum Lojze Ude, Pravna fakulteta Univerze v Ljubljani, pp 371–390 Ovčak Kos M, Božič Penko A (2017) Dileme v primerih odškodninskega prava v zvezi z odgovornostjo za medicinsko napako (1.), Odvetnik, 83:11–14 Ovčak Kos M, Božič Penko A (2018) Dileme v primerih odškodninskega prava v zvezi z odgovornostjo za medicinsko napako (2.), Odvetnik 84:10–17 Plavšak N, Vrenčur R, Miha J (2009) Obligacijsko pravo splošni del. GV Založba, Ljubljana Polajnar Pavčnik A (1998) Obligacijski vidik razmerja med bolnikom in zdravnikom, Pravo in medicina, Ljubljana Radej Bizjak M (2007a) Odškodninska odgovornost države zaradi čakalnih dob v zdravstvu, Pravna praksa, 36:I–VIII Radej Bizjak M (2007b) Alternativno reševanje sporov v zvezi z malomarnim zdravljenjem s poudarkom na mediaciji, Pravna praksa 11–26:I–VIII Rovan Vizlar N (2017) Moderni sistemi urejanja odškodninske odgovornosti zdravnika, Pravni letopis pp 89–104 Strban G (2004) Odškodninska odgovornost v obveznem zdravstvenem zavarovanju, Delavci in delodajalci. Ljubljana 2–3:303–329 Tomažin I (2011) Pozitiven pristop k reševanju sporov. Pravna praksa 39–40:34 Žnidaršič Skubic V (2015) Medical law in Slovenia. Wolters Kluwer Žnidaršič Skubic V (2018) Civilno medicinsko pravo, Uradni list, Ljubljana

Chapter 16

Excessive Litigation for Harm Arising from Medical Malpractice in South Africa: Reasons, Consequences and Potential Reform Bernard Wessels

Abstract South Africa does not have a statutory compensation scheme for harm arising from medical malpractice. Victims who suffer harm in this context must institute common law delictual or contractual claims in a civil court in an attempt to obtain compensation. They are not assisted by a reversal of the burden of proof and so they must prove all elements of liability on a balance of probability. They can file the claim against the person responsible for their harm, or they can try to hold the latter’s employer vicariously liable. It appears that most victims institute delictual proceedings against the employer of the person who caused their harm in a culpable and wrongful manner. Although the plaintiff faces particular challenges as far as proof of factual causation and negligence is concerned, we have seen a significant increase in medical malpractice litigation in the last decade. In addition, a remarkable expansion of state liability can be observed for harm arising from medical malpractice in the public health sector. This chapter investigates the reasons for, and consequences of, the increased litigation in respect of medical malpractice. Furthermore, the use of alternative dispute resolution procedures in the context of medical malpractice and the regulation of the medical health profession by the Health Professions Council of South Africa. Lastly, attention is given to certain proposals for reform of the law relating to the compensation of harm arising from medical malpractice.

B. Wessels (*) Stellenbosch University, Department of Private Law, Stellenbosch, South Africa e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_16

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Seeking Compensation for Harm Arising from Medical Malpractice There is no statutory compensation scheme for medical malpractice1 in South Africa.2 Although several statutes impact on healthcare in South Africa,3 there is no legislation that deals specifically with the issue of compensation for malpractice.4 Patients who have suffered harm due to medical malpractice must therefore rely on common-law remedies for compensation.5 More specifically, they will have to institute either contractual or delictual (tortious) claims in a civil court.6 The common-law contractual and delictual principles relevant in this context are briefly discussed below.

Instituting Contractual Claims for Harm Arising from Medical Malpractice A patient who consults a healthcare services provider is likely to enter into a contractual relationship with the latter.7 The conclusion of this contract does not require any legal formalities and the contract is based on consensus.8 Although the conclusion and terms of the contract are essentially regulated by the common law of contract, it may also be influenced by legislation,9 while the fundamental human

It should be noted that “medical malpractice” is a wider term than “medical negligence” because it includes harm that was caused negligently as well as intentionally. See Patel (2008), p. 57. 2 Coetzee and Carstens (2013), pp. 397–437 at 403, 409; South African Law Reform Commission (SALRC) Issue Paper 33 Project 141 Medico-legal Claims (2017), pp. 4, 27, 48; Carstens and Pearmain (2007), pp. 283–283; Coetzee and Carstens (2011), p. 1268. 3 See for example, the following statutes: Health Professions Act 56 of 1974, South African Medical Research Council Act 58 of 1991, Pharmacy Act 53 of 1974, Medical, Dental and Supplementary Health Service Professions Act 56 of 1974, Nursing Act 50 of 1978, Chiropractors, Homeopaths and Allied Health Service Professions Act 63 of 1982, Dental Technicians Act 19 of 1979, Academic Health Centres Act 86 of 1993, Choice of Termination of Pregnancy Act 92 of 1996, Medical Schemes Act 131 of 1998 and the Mental Health Care Act 17 of 2002. See further Carstens and Pearmain (2007), pp. 249–281. 4 SALRC Medico-legal Claims (2017) 4. 5 Coetzee and Carstens (2013), p. 409. 6 Ibid, p. 409. 7 Carstens and Pearmain (2007), pp. 283–289; Coetzee and Carstens (2011), p. 1269; Coetzee and Carstens (2013), p. 403; Administrator, Natal v Edouard 1990 (3) SA 581 (A). 8 Coetzee and Carstens (2011), p. 1269; Coetzee and Carstens (2013), p. 403; Carstens and Pearmain (2007), pp. 283–377. 9 For example, as indicated below, the Consumer Protection Act 68 of 2008 may have a significant effect on the scope of contractual exclusion clauses. See also Pienaar (2016), pp. 10–11; Hutchison and Pretorius (2012), pp. 431–460. 1

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rights entrenched in the Constitution of the Republic of South Africa 108 of 1996 (Constitution) could also have a significant impact in this context.10 Contracts may be concluded tacitly or expressly and may be written or oral.11 Where an express agreement has not been concluded, a tacit agreement has arguably been reached.12 While the implied terms of such a contract may vary depending on the circumstances, it is generally accepted that it includes a term requiring the medical practitioner to act 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.13 This also includes an implied duty to act in accordance with the recognized, accepted, customary, or usual practices of medicine.14 A breach of any of the terms of a medical services contract by the medical practitioner allows the patient to choose between forcing the practitioner to comply with contractual obligations and cancelling the contract.15 Irrespective of the patient’s choice, he or she will also have a claim for damages if, despite the performance or cancellation of the contract, they are left worse off than what would have been the case if there had been no breach.16 Understandably, patients who have suffered harm arising from medical malpractice are typically uninterested in pursuing specific performance and the most soughtafter remedy in this context is therefore damages.17 To claim damages arising from a breach of a contract, a patient must prove the following on a balance of probabilities: breach of contract, harm suffered by the patient, a factual causal connection between the breach and the patient’s harm, and that the harm suffered by the patient is not too remote from the breach of contract to be attributed to the medical practitioner (legal causation).18 Importantly, if a patient decides to institute a contractual claim against the medical practitioner, he or she is only entitled to damages for patrimonial harm, i.e. financial harm that is quantifiable in monetary terms.19 This may include the medical and other expenses incurred arising from a bodily injury (including future

10 See generally Hutchison and Pretorius (2012), pp. 35–40; see also Carstens and Pearmain (2007), pp. 21–227, 413–417. 11 Coetzee and Carstens (2011), p. 1269; Coetzee and Carstens (2013), pp. 403–404. 12 See Loubser and Midgley (2017), p. 327. 13 Coetzee and Carstens (2011), p. 1269; Coetzee and Carstens (2013), p. 404. 14 Coetzee and Carstens (2011), p. 1269; Coetzee and Carstens (2013), p. 404. For a discussion of the potential implied terms relevant in this context, see Carstens and Pearmain (2007), pp. 362–367. 15 Hutchison and Pretorius (2012), p. 310. 16 Ibid, p. 310. 17 Coetzee and Carstens (2011), p. 1270 explains that specific performance is not really a feasible option in the context of medical malpractice, because the doctor has rendered a personal service to the patient, which cannot be remedied. 18 Hutchison and Pretorius (2012), p. 334; Carstens and Pearmain (2007), p. 335. 19 Potgieter et al. (2013), p. 51 define it as “the diminution in the utility of a financial interest in satisfying the legally recognised needs of the person entitled to such interest.”

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expenses), loss of past income, loss of future earning capacity and potentially loss of support.20 Under normal circumstances, medical practitioners or hospitals will not guarantee or provide express warranties that treatment will be successful.21 However, if such an undertaking has been given and breached, the patient may institute a contractual claim where all of the necessary requirements can be proven. Prior to the coming into effect of the Consumer Protection Act 68 of 2008 (CPA), patients who suffered harm arising from medical malpractice could have struggled to claim damages where the liability of the specific medical practitioner or hospital had been contractually excluded or limited. For instance, in Afrox Healthcare v Strydom,22 a patient suffered harm arising from medical malpractice and instituted a contractual claim for damages against the hospital who relied on an exclusion clause to avoid liability.23 The patient argued that he should not be bound by the clause on public policy grounds because, inter alia, it purported to exempt hospital personnel from gross negligence.24 In the alternative, he argued that his attention should have been drawn to the clause and the hospital’s failure to do so constituted a breach of a legal duty owed to the respondent.25 The Supreme Court of Appeal (SCA) found that gross negligence had not been alleged by the respondent and therefore this consideration did not find application in the matter.26 The SCA concluded that the clause was valid and remarked that exclusion clauses of this type had become standard practice in private hospitals and other service providers and that it was not, objectively speaking, unexpected.27 Also, the court found that the admission clerk had no legal duty to bring it to the patient’s attention and was therefore bound by the terms of the clause as if he had read it and had expressly agreed thereto.28 The CPA, which was enacted after Afrox, has changed the legal position regarding exclusion clauses. Applied to the healthcare sector, it may be said that the Act imposes a duty on healthcare service providers to draw the patient’s attention to a contractual clause where it attempts to exclude liability for any activity that could lead to the death or serious injury of a consumer.29 Furthermore, section 51(1)(c) of 20

Potgieter et al. (2013), pp. 453–490. Arguably, a patient’s dependent who wants to claim damages for loss of support arising from medical malpractice could do so via the law of contract if there was a so-called stipulatio alteri in the contract entered into between the patient (breadwinner) and the medical practitioner. In the absence of such clause, however, the dependent would generally have to institute a delictual claim. 21 Coetzee and Carstens (2011), p. 1270. 22 2002 (6) SA 21 (SCA). 23 Para 3. 24 Para 13. 25 Para 7. 26 Para 13. 27 Para 36. 28 Para 36. See also Pienaar (2016), pp. 10–11. 29 Section 49(1) of the CPA; Naidoo v Birchwood Hotel 2012 (6) SA 170 (GSJ) para 7.

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the Act prohibits the exemption from liability for harm directly or indirectly attributable to gross negligence of the supplier of medical services.

Instituting Delictual Claims for Harm Arising from Medical Malpractice Patients may also turn to the law of delict to obtain compensation for the harm arising from medical malpractice if the necessary requirements can be proven.30 Indeed, most of the reported medical malpractice cases involve delictual claims and have been decided on the basis of the law of delict.31 A delict (tort) may be described as the act of one person that culpably and wrongfully causes harm to another person.32 The requirements for delictual liability are as follows: conduct, harm, causation, wrongfulness and fault.33 Generally, to be successful, a patient would have to prove all of these elements on a balance of probabilities. Under certain circumstances, delictual liability may be imposed regardless of whether the defendant was at fault in causing the plaintiff’s harm.34 In the context of medical malpractice, the most important instance of strict liability is arguably vicarious liability, i.e. where an employer in the healthcare sector (typically a privately-owned hospital or the state in the form of the Department of Health) may be held liable for a delict committed by one of its employees during the course and within the scope of their employment—regardless of whether or not the employer was at fault in causing the patient’s harm.35 Indeed, as indicated below, the recent explosion of medical malpractice litigation in the public healthcare sector, and the

30 Contra the position of some scholars who argue that a delictual claim may only exist where a contractual relationship does not exist. The better view is that, where a patient suffers harm at the hand of a medical practitioner, there is a concurrency of claims and that the patient will have to elect whether he/she wants to institute a contractual or delictual claim. See also Loubser and Midgley (2017), pp. 231–239, 327–331. 31 For example, see Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC); Links v Department of Health, Northern Province 2016 (4) SA 414 (CC); Medi-Clinic Ltd v Vermeulen 2015 (1) SA 241 (SCA); Goliath v MEC for Health, Eastern Cape 2015 (2) SA 97 (SCA); Nzimande v MEC for Health, Gauteng 2015 (6) SA 192 (GP); Mokhethi v MEC for Health, Gauteng 2014 (1) SA 93 (GSJ) Buthelezi v Ndaba 2013 (5) SA 437 (SCA); Khoza v MEC for Health and Social Development, Gauteng 2015 (3) SA 266 (GJ). See also Carstens and Pearmain (2007), p. 284. 32 Neethling and Potgieter (2015), p. 4; Loubser and Midgley (2017), pp. 7–8. 33 Neethling and Potgieter (2015), p. 4; Loubser and Midgley (2017), pp. 25–26. 34 Loubser and Midgley (2017), pp. 26, 457–481. 35 The requirements for vicarious liability in this context are as follows: there must be an employeremployee relationship between the medical practitioner and the hospital, the practitioner must have committed a delict and the delict must have occurred during the course and scope of his/her employment.

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concomitant expansion of the state’s delictual liability for harm arising from medical malpractice, is a result of the application of the vicarious liability doctrine. For the purposes of delictual liability in the context of medical malpractice, a patient must prove that there was voluntary, human conduct in the form of a positive act or an omission.36 Conduct would be voluntary where it is subject to the control of the medical practitioner’s will.37 This means that the practitioner must have had the mental capacity to direct muscular activity or to refrain from such activity.38 To prove delictual liability, a patient must also prove harm.39 The South African law of delict recognises patrimonial and non-patrimonial harm.40 The former consists of financial loss arising from the plaintiff’s bodily injury or property damage, or pure financial loss.41 Non-patrimonial harm is divided into two categories: pain and suffering and the infringement of a personality right.42 Pain and suffering includes the following actionable forms of harm: physical pain and discomfort, emotional shock, loss in the amenities of life, disfigurement and shortened life expectancy.43 In the case of infringements of a personality right, the non-patrimonial harm is situated in the factual violation of one of the following recognised personality rights: corpus (bodily integrity), fama (reputation) or dignitas (an umbrella term that encapsulates the rights to dignity, identity and privacy).44 A patient suing in delict would further be required to prove that there is a causal connection between the harm that he/she has suffered and the conduct of the medical practitioner. Causation has a factual and legal component.45 To establish whether the conduct in question factually caused the patient’s harm, the court will apply the “but for” test and the patient must therefore show that the harm he/she suffered would not have occurred but for the conduct of the defendant.46 To apply this test, a hypothetical enquiry is made as to what probably would have happened but for the conduct of the medical practitioner.47 In the case of positive conduct, this involves the mental elimination of the conduct, the substitution of a hypothetical course of lawful conduct and asking whether, upon such a hypothesis, the patient’s harm would

36

Midgley (2016), para 70; Neethling and Potgieter (2015), pp. 25–26. Neethling and Potgieter (2015), pp. 25–26; Carstens and Pearmain (2007), p. 496. 38 See Midgley (2016), para 70; Neethling and Potgieter (2015), pp. 25–26. 39 Neethling and Potgieter (2015), pp. 221–222; Loubser and Midgley (2017), pp. 75–95. 40 Neethling and Potgieter (2015), pp. 223–225; Loubser and Midgley (2017), pp. 75–95. 41 Neethling and Potgieter (2015), p. 229; Loubser and Midgley (2017), pp. 80–86. 42 Neethling and Potgieter (2015), pp. 250–252; Loubser and Midgley (2017), pp. 80–92. 43 Potgieter et al. (2012), pp. 506–512. 44 Potgieter et al. (2012), pp. 506–512; Midgley (2016), para 46; Neethling and Potgieter (2015), pp. 250–252; Loubser and Midgley (2017), pp. 80–92. 45 Neethling and Potgieter (2015), pp. 183–220; Loubser and Midgley (2017), pp. 101–136. 46 See Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) para 35; Links v Department of Health, Northern Province 2016 (4) SA 414 (CC). 47 Midgley (2016), para 177. 37

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have ensued or not.48 If it would in any event have ensued, then the practitioner’s conduct will not be considered the factual cause of the patient’s harm.49 In the case of an omission, a court will substitute the failure to act with hypothetical positive conduct.50 This substitution involves a “sensible retrospective analysis of what probably would have occurred, based on the evidence, and what could be expected to occur in the ordinary course of human affairs rather than an exercise in metaphysics.”51 Neethling and Potgieter take the view that a “causal nexus is simply something which (factually) exists or does not exist and [. . .] that no amount of theorising can take the matter any further”.52 However, it should be remembered that, although the “but for” test is often “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.”53 Consequently, there “are numerous circumstances, particularly in medical law, when this policy defeats the claim of the claimant.”54 For instance, while patients will be successful in claiming compensation for all of the harm they suffered where they are able to use the “but for” test to prove that the practitioner’s malpractice was the factual cause of their harm, they will be unable to receive any compensation where they can merely prove that the practitioner’s conduct created a risk of harm, or reduced their chance of a healthy recovery.55 A medical practitioner’s conduct potentially gives rise to an infinite number of harmful consequences. However, a legal system cannot hold people responsible for all of the harmful consequences of their conduct.56 To limit the practitioner’s potential liability, courts launch a further enquiry into legal causation. This requires a decision as to which of the harmful consequences may be attributed to the practitioner’s conduct.57 In this regard, courts have adopted a so-called flexible approach and the crisp question is whether there is a sufficiently close connection between the practitioner’s conduct and the harmful consequences for the latter to be imputed to the practitioner, taking into account considerations based on fairness, reasonableness and justice.58 In making its determination, courts may apply the

48

International Shipping Co (Pty) Ltd v Bentley 1990 (1) SA 680 (A) 700. Ibid, 700. 50 Neethling and Potgieter (2015), pp. 183–220; Loubser and Midgley (2017), pp. 103–110. 51 Minister of Safety and Security v Van Duivenboden 2002 (6) SA 431 (SCA) para 25. 52 Neethling and Potgieter (2015), p. 183. 53 Goldberg (2013), p. 456. 54 Oliphant and Wright (2013), p. 456. 55 The doctrine of a “loss of a chance” does not apply in the South African law of delict: see Coetzee and Carstens (2011), p. 1289. 56 Loubser and Midgley (2017), p. 123. 57 Neethling and Potgieter (2015), pp. 197–203; Loubser and Midgley (2017), pp. 123–128. 58 See International Shipping Co (Pty) Ltd v Bentley 1990 (1) SA 680 (A); Fourway Haulage SA (Pty) Ltd v SA National Road Agency Ltd 2009 (2) SA 150 (SCA). 49

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existing criteria of direct consequences, reasonable foreseeability and adequate causation and may also determine whether there was an abnormal event that interrupted the causal chain.59 Fault refers to the blameworthiness of the medical practitioner and may take the form of either intention or negligence.60 A prerequisite for proving fault in either form is accountability.61 Accountability consists of the capacity to distinguish between right and wrong as well as the ability to act in accordance with that distinction.62 A patient who argues that the practitioner acted intentionally would have to prove that the latter directed his/her will to bringing about the harmful consequence and was conscious of the fact that causing the harmful consequence was wrongful.63 It is not often that patients suffer harm as a result of a practitioner’s intentional conduct and cases of malpractice are more likely to deal with negligence.64 The standard test for negligence is the one formulated in Kruger v Coetzee.65 Essentially, this requires a plaintiff to prove that a reasonable person in the position of the defendant would have foreseen the reasonable possibility of harm and would have taken reasonable steps to guard against such harm.66 Medical practitioners are professionals and therefore the test for negligence is adapted to accommodate the level of knowledge, care and skill which they possess.67 In Van Wyk v Lewis68 the court explained the level of care that may be expected of a medical practitioner: “[The practitioner must perform] the operation with such technical skill as the average medical practitioner is South Africa possesses and [must] apply that skill with reasonable care and judgment [. . .He or she] is not expected to bring to bear on a case entrusted to him [or her] the highest possible professional skill but is bound to employ reasonable skill and care and is liable for the consequence if he [or she] does not.” To assess the practitioner’s negligence, the court will therefore “have regard 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.”69

59

Neethling and Potgieter (2015), pp. 204–220; Loubser and Midgley (2017), pp. 128–135. Midgley (2016), para 134. 61 Neethling and Potgieter (2015), pp. 131–132. 62 Loubser and Midgley (2017), pp. 139–144. 63 Loubser and Midgley (2017), pp. 144–151; Carstens and Pearmain (2007), p. 524. 64 See the list of cases referred to in footnote 31, all of which deal with the negligence of a medical practitioner. 65 1966 (2) SA 428 (A). See also Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) para 69. 66 Neethling and Potgieter (2015), pp. 137–139. See also Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) para 69; Medi-Clinic Ltd v Vermeulen 2015 (1) SA 241 (SCA) paras 3-4. 67 Loubser and Midgley (2017), pp. 327–331. 68 1924 AD 438 456. 69 Ibid, 444. 60

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The test for negligence has two components: foreseeability and preventability. With regard to foreseeability, it has been settled that, while the precise or exact manner in which the harm occurs need not be foreseeable, the general manner of its occurrence must indeed be reasonably foreseeable.70 Furthermore, what is or is not reasonably foreseeable in any particular case is a fact bound enquiry.71 As a result, “there is seldom any assistance to be had from other cases that do not share all the same facts.”72 Although foreseeability is a flexible concept and there are no hard and fast rules regarding its application, it appears that it depends largely on the degree of probability of the manifestation of harm as well as the extent of the manifested harm.73 In respect of preventability, four factors have been identified to assist courts: the degree or extent of risk created by the defendant’s conduct; the gravity of the harm if the risk materializes; the utility of the defendant’s conduct; and the burden and costs associated with eliminating the risk of harm.74 It is not sufficient to show that the patient’s harm was caused by the practitioner’s culpable conduct. The causation of harm must also have been wrongful for delictual liability to ensue. This element of delictual liability “supplements and overarches the other elements of delict, adding a further value- or policy-based dimension to the enquiry into liability and requiring the exercise of judicial discretion, with the aim to achieve an appropriate balance between the interests of the plaintiff, the defendant’s interests and freedom of action, and the interests of society.”75 It is now settled that the causation of harm to person or property through positive conduct is prima facie wrongful.76 This means that wrongfulness need not be positively established by the patient in such cases; it is presumed, but may be rebutted by the medical practitioner.77 However, wrongfulness is contentious in cases involving the failure to act, the causation of pure economic loss and where there is a conflict of rights.78 In cases involving any of the latter, the causation of

70 Sea Harvest Corporation (Pty) Ltd v Duncan Dock Cold Storage (Pty) Ltd para 22; Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) para 70. 71 Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) para 70; Standard Chartered Bank of Canada v Nedperm Bank Ltd 1994 (4) SA 747 (A) 765. 72 Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) 70. 73 Neethling and Potgieter (2015), p. 150; Loubser and Midgley (2017), pp. 157–161. 74 Loubser and Midgley (2017), pp. 161–167. See also Ngubane v South African Transport Services 1991 (1) SA 756 (A); Cape Metropolitan Council v Graham 2001 (1) SA 1197 (SCA); Loureiro v iMvula Quality Protection (Pty) Ltd 2014 (3) SA 394 (CC). 75 Loubser (2008), p. 63. 76 Country Cloud Trading CC v MEC, Department of Infrastructure Development 2015 (1) SA 1 (CC) para 22. 77 Country Cloud Trading CC v MEC, Department of Infrastructure Development 2015 (1) SA 1 (CC) footnote 9; Van Duivenboden v Minister of Safety and Security 2002 (6) SA 431 (SCA); Minister of Safety and Security v Van Duivenboden 2002 (6) SA 431 (SCA) paras 12, 22. 78 Loubser (2008), p. 59; Country Cloud Trading CC v MEC, Department of Infrastructure Development 2015 (1) SA 1 (CC) para 22. See also Fourway Haulage SA (Pty) Ltd v SA National Road Agency Ltd 2009 (2) SA 150 (SCA).

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harm is not considered to be prima facie wrongful and the plaintiff must therefore prove wrongfulness. In this regard, the Constitutional Court (CC) has described the approach to establishing wrongfulness in Le Roux v Dey (Freedom of Expression Institute and Restorative Justice Centre as Amici Curiae):79 In the more recent past our courts have come to recognise, however, that in the context of the law of delict: (a) the criterion of wrongfulness ultimately depends on a judicial determination of whether — assuming all the other elements of delictual liability to be present — it would be reasonable to impose liability on a defendant for the damages flowing from specific conduct; and (b) that the judicial determination of that reasonableness would in turn depend on considerations of public and legal policy in accordance with constitutional norms.

In the context of medical malpractice, wrongfulness will most often be a contentious issue where the practitioner has failed to act, in which case it will not be presumed and the patient will have to convince the court that it is reasonable to impose delictual liability on the practitioner, taking into account legal and public policy considerations as well as constitutional rights, values and norms. Where a patient has successfully established all of the above elements of delictual liability, the medical practitioner may still escape liability by proving a defense. The South African law of delict recognizes various grounds of justification, but in the context of medical malpractice the defense that would most typically be relied upon is that of consent.80 Writing about consent in the context of medical malpractice, Loubser and Midgley provide the following succinct summary:81 Consent to the intentional causing of harm for a lawful purpose, as in the case of a medical operation, involves a willingness to suffer specific harm. An example is the willingness that a surgeon remove part of an organ because of cancer, together with acceptance of the pain and inconvenience that accompany such an operation. Consent to the risk of harm is less specific. It involves a willingness to risk suffering some harm during a dangerous activity such as a sport that involves the risk of injury. A particular situation may give rise to both forms of consent, for example, a medical operation that involves not only some pain and inconvenience, but also the risk of complications or even death. A patient who is adequately informed of the risks and nevertheless decides to undergo the operation, consents to the pain and inconvenience that will inevitably occur, but also to the possibility of complications or death that may occur, but which hopefully will not.

79

2011 (3) SA 274 (CC) para 122. See Loubser and Midgley (2017), pp. 203–228. 81 Loubser and Midgley (2017), p. 205. See also Esterhuizen v Administrator, Transvaal 1957 (2) SA 710 (T); Castell v De Greeff 1994 (4) SA 408 (C); Broude v McIntosh 1998 (3) SA 60 (SCA). 80

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The Burden of Proof and the Effect of the Maxim Res Ipsa Loquitur in Medical Malpractice Cases When instituting either a delictual or contractual claim against a medical practitioner or health care facility, the patient is not assisted by a reversal of the burden of proof. Regarding the applicability of the maxim of res ipsa loquitur,82 the following remarks may be made. Generally speaking, the maxim, which gives rise to an inference of negligence rather than a presumption of negligence,83 is only relevant in the context of delictual claims. This is because patients are generally not required to prove fault (intention or negligence) when instituting a contractual claim. Such an inference of negligence will be made if “an event occurs in a manner that would not usually occur unless there has been negligence, but there is not necessarily direct evidence of the negligence.”84 Although the South African courts have applied the maxim where delictual claims have been instituted,85 there appears to be consensus among scholars that the maxim does not find application in the context of medical malpractice claims.86 Nevertheless, a recent report published by the South African Law Reform Commission (SALRC) on the rise of medico-legal claims in South Africa (SALRC Report) seems to suggest that there is still uncertainty about the matter, referring to an argument that it is an evidentiary aid that could be developed for application in future cases. To justify its view, the SALRC mentions the judgment in Ntsele v MEC for Health, Gauteng Provincial Government,87 where the High Court stated as follows: Consequently, because the knowledge of the treatment to the plaintiff [. . .] is peculiarly within the knowledge of the defendant’s employees, and the defendant has not adduced any direct cogent evidence to discharge the evidential rebuttal burden of probable negligence, the invocation of the maxim res ipsa loquitur in this kind of exceptional case given the critical missing clinic and hospital records pertaining to the plaintiff’s treatment [. . .] is legally justifiable.

However, subsequent judgments handed down by the SCA seems to ring the death knell for the application of the maxim in the context of medical malpractice cases. In Buthelezi v Ndaba88 Brand JA stated that, as was pointed out in “the locus classicus on medical malpractice, Van Wyk v Lewis, that maxim could rarely, if ever, find application in cases based on alleged medical negligence.” Referring to In South African law, this maxim may be translated as “the facts speak for themselves”—see Loubser and Midgley (2017), p. 174. 83 Coetzee and Carstens (2011), p. 1293. 84 SALRC (2017), p. 30. 85 Patel (2008), p. 59. 86 Patel (2008), p. 59; Mitchell v Dixon (1914) AD 519; Van Wyk v Lewis (1924) AD 438; Castell v De Greef 1994 (4) SA 408 (C). See also Carstens and Van den Heever (2011), p. 18. 87 [2013] 2 All SA 356 (GSJ) para 124. 88 2013 (5) SA 437 (SCA) para 16 (references omitted). 82

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Buthelezi, the SCA remarked in a subsequent judgment, Goliath v MEC for Health, Eastern Cape,89 that courts are reluctant to apply the maxim because “with the best will in the world things sometimes went amiss in surgical operations or medical treatment. A doctor was not to be held negligent simply because something went wrong. For, to hold a doctor negligent simply because something had gone wrong would be to impermissibly reason backwards from effect to cause.”90 In Goliath the court had to decide whether doctors and nursing staff at a provincial hospital were negligent after it was determined that a surgical swab had been left in the patient’s abdomen following a hysterectomy. On appeal the SCA confirmed that the onus was on the patient to prove her case, i.e. that she had sustained harm because of the negligence of the doctors and nursing staff in allowing the swab to be left in her. Further, it held that res ipsa loquitur was merely a convenient phrase used to describe proof of facts sufficient to support an inference of negligence and thereby to establish a prima facie case against a defendant.91 It was not a magic formula and did not entail a shifting of the onus or a suspension of common sense. Specifically, the court emphasised that the maxim should not tempt any court to first draw an inference of negligence from the occurrence itself and then decide whether it was rebutted by the defendant’s explanation. In conclusion, the court remarked that the “time may have come to drop the res ipsa loquitur maxim from the legal vocabulary.”92 Therefore, although the matter requires final adjudication by the CC, it would seem that, for practical purposes, the maxim does not apply in the context of medical malpractice and that the patient would not be able to rely thereon. In short, the patient has the onus to prove negligence on the basis of the test outlined above.

Concurrency of Liability for Harm Arising from Medical Malpractice For the sake of clarity, it may be emphasised that the same conduct of a medical practitioner may constitute a breach of contract as well as a delict. This is because, in the context of medical practice, a practitioner enters into a contractual relationship with a patient, a term of which requires him or her to act with reasonable care, knowledge and skill. Where a practitioner culpably and wrongfully fails to do so, causing the patient harm in the process, it will amount to both a breach of contract as well as a delict. If this occurs, the patient would have to decide which remedy he or she wishes to institute against the practitioner. In this regard, the patient’s choice will

89

2015 (2) SA 97 (SCA). Goliath v MEC for Health, Eastern Cape 2015 (2) SA 97 (SCA) para 9 (references omitted). See also Medi-Clinic Ltd v Vermeulen 2015 (1) SA 241 (SCA) para 27. 91 Paras 9–10. 92 See the headnote in Goliath v MEC for Health, Eastern Cape 2015 (2) SA 97 (SCA). 90

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be affected by a series of factors that are based on the difference between the law of delict and contract law, not the least of which is the fact that a delictual claim would allow recovery for both patrimonial as well as non-patrimonial harm while a contractual remedy caters only for the former.93

Excessive Litigation for Harm Arising from Medical Malpractice The current compensatory regime has been criticized as inefficient insofar as it is characterized by high costs and lengthy proceedings, which, in turn, restricts a patient’s constitutional right to access to justice. Despite the financial challenges and time delays associated with instituting civil proceedings, South Africa has experienced a significant expansion of medical malpractice litigation over the last decade, especially cases where the victims have sought to hold the state vicariously liable in delict for harm arising from the public healthcare sector.94 Although it initially appeared to have side-stepped the global trend towards increasing litigation for medical malpractice, recent data illustrates that “the country may be on the verge of a medical malpractice litigation ‘storm’, as the number and size of claims appear to be increasing rapidly.”95 This appears to be occurring in both the private and public health sectors96 and, at the moment, there is no tendency to limit the number of medical litigation cases or the amounts involved in the litigation. This state of affairs has caught the attention of the state and at the Medico-Legal Summit in 2015, the Minister of Health remarked that “medico-legal litigation had reached a crisis of epic proportions in the country,”97 because the “number of claims increased substantially”.98 To illustrate the rise in medical malpractice litigation in the public sector, regard may be had to the fact that, in 2010, it was reported that “nearly 2 000 doctors in the public and private sectors were facing negligence claims. Of those claims, 80% stemmed from incidents which occurred in the public sector [. . .] As a result, the respective provincial health departments have had to deal with ever escalating medical malpractice costs.”99 With regard to the private sector, Bateman reports

93

Loubser and Midgley (2017), p. 233. Pepper and Slabbert (2011), p. 29. 95 See also Coetzee and Carstens (2011), pp. 1295–1298. 96 Malherbe (2013), p. 83. 97 Dhai (2015), p. 2. 98 Health24 “SA’s shocking medical malpractice crisis” (10 March 2015) available at (accessed 17 January 2018). 99 Oosthuizen and Carstens (2015), pp. 273–275. 94

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Table 16.1 Principal amounts paid out for litigation by the Department of Health during 2010–2014 Province Gauteng Eastern Cape Northern Cape KwaZulu Natal Western Cape Mahikeng Limpopo Free State Mpumalanga TOTAL

2010/2011 R8,291,000.00 R10,260,049.00 R6,810,428.00 R22,695,078.06 R9,210,000.00 R12,550,000.00 R8,229,068.81 R256,081.57 R17,229,427.00 R95,531,132.44

2011/2012 R30,930,758.24 R25,336,038.35 R705,000.00 R10,762,367.72 R15,860,000.00 R753,602.57 R3,457,954.27 R988,604.43 R13,252,319.44 R102,046,645.02

2012/2013 R124,846,892.41 R44,743,495.84 RR14,767,477.56 R11,710,000.00 R7,899,232.50 R6,844,259.18 R327,192.00 R11,310,058.70 R222,448,608.19

2013/2014 R153,612,355.49 R49,513,108.93 R7,107,000.00 R205,312,356.94 R15,680,000.00 R698,940.17 R21,959,395.55 R673,373.00 R44,408,386.64 R498,964,916.72

that members of the Medical Protection Society100 (MPS) experienced a 30% rise in the actual average number of claims over the 4 years preceding 2011.101 Not only has there been a rise in the number of medical malpractice cases, but there has been a dramatic increase in the amounts of compensation awarded to successful litigants.102 At the 2015 Medico-Legal Summit, the acting Chief Litigation Officer of the Department of Justice and Constitutional Development summarized the principal amounts paid out for litigation in the public healthcare sector on behalf of the Department of Health by the State Attorney during the years 2010/2011 to 2013/2014 as follows (see Table 16.1).103 More recent information indicates that the contingent liabilities for medical malpractice within the public healthcare sector are as follows (see Table 16.2).104 As the SALRC Report notes, the private healthcare sector is equally under pressure and has experienced a similar spike in medical malpractice litigation.105 For instance, Bateman asserts that the amounts of compensation awarded in private sector medical malpractice litigation increased by 132% between 2009 and 2010.106 The MPS stated that almost 1 in 5 of the outstanding claims against them as at 2011 100 The Medical Protection Society Limited is the world’s leading protection organization for doctors, dentists and healthcare professionals. It protects and supports the professional interests of more than 300,000 members around the world. Membership provides access to expert advice and support together with the right to request indemnity for complaints or claims arising from professional practice. The MPS is the largest indemnity backer of health care professionals in South Africa. See (accessed on 18 January 2018). 101 SALRC (2017), p. 17; Bateman (2011), p. 216. 102 Howarth (2014), p. 752: “Claims costs depend on the number of claims, the value of those claims, and legal costs. In South Africa, all have increased in recent years.” 103 SALRC (2017), p. 16; Phahlane (2015). 104 SALRC (2017), p. 17. 105 Ibid, p. 17. 106 SALRC (2017), p. 17; Bateman (2011), p. 216.

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Table 16.2 The contingent liabilities of the Department of Health for medical malpractice in 2016 Department of Health Eastern Cape Western Cape KwaZulu Natal Mpumalanga North West Limpopo Northern Cape Free State Gauteng Total:

Annual report for year ending 31/03/2016 31/03/2016 31/03/2016 31/03/2015 31/03/2015 31/03/2015 31/03/2015 31/03/2016 31/03/2016

Contingent liability at year end R13,421,136,000 R182,025,000 R9,957,126,000 R1,459,497,000 R36,157,000 R1,356,921,000 R118,064,000 R940,545,000 R13,452,064,000 R40,923,535,000

was in excess of R1 million, which represents an increase of nearly 550% compared with 2001. Similarly, they indicate that, between 2009 and 2015, there has been an escalation in the approximate value of claims being brought against doctors, with claim sizes increasing by over 14% on average, each year, during that period.107 Significantly, the MPS noted that the number of claims over R5 million has increased by 900% years between 2008 and 2013, with several cases bypassing the R30 million mark.108 This increase in the amount of compensation being paid to successful litigants may further be illustrated as follows: the highest settled claims in South Africa by the MPS were R6 million in 2006, R14 million in 2008 and R33 million in 2013.109 Recently the Minister of Finance stated that these claims have grown an average of 45% per year from 2012 to 2017.110 In the 2016–2017 financial year, the state paid R1.2 billion and the contingent liability arising from claims against the state arising from medical malpractice ran to R56 billion, which is more than a quarter of the budget allocated towards the provision of health services.111 Although South Africa may have been “slow in climbing on the litigation bandwagon”,112 these statistics clearly illustrate the dramatic rise in litigation, as well as the amounts of compensation being paid out.

107

MPS (2015), p. 5. See also SALRC (2017), pp. 15–18. MPS (2015), p. 5. See also SALRC (2017), p. 17; Coetzee and Carstens (2011), p. 1297; Bateman (2011), p. 216. 109 MPS (2015), p. 2. 110 Kahn “Staggered medical negligence bill ‘unfair’ and may endanger patients” Business Day Online (accessed on 13 August 2018). 111 Kahn Business Day Online. 112 Pepper and Slabbert (2011), p. 30. 108

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The Availability of Pretrial Conditions, Time Limits and Limitation of Legal Practitioners’ Fees As a Way to Curb the Growth of Medical Malpractice Litigation There are no pretrial conditions for medical malpractice cases and no specific initial requirements concerning the involvement of third parties in the context of medical malpractice. Regarding time limits for commencing litigation, the principles relating to prescription applies. In this regard, Loubser and Midgley provide the following summary:113 Prescription deals with the effect of the passage of time on obligations [. . .] After a certain period, it is no longer possible to enforce an obligation or debt arising from a delict. One then says that this debt is ‘extinct’ [. . .] The Prescription Act 68 of 1969 provides for prescription periods in respect of different types of ‘debt’. The concept of a ‘debt’ is not defined in the Act, but [. . .] it includes any liability that arises from a delict, contract or any other source of obligation [. . .] Different prescription periods apply to different types of debt, as set out in section 11 of the Act. For any debt, there is a prescription period of three years, unless a specific other period is provided for by section 11 or by any other Act [...] Debts that arise from delict [and contract] fall within this general three-year category, unless another period is provided for by an Act.

In other words, patients who suffer harm arising from medical malpractice generally have a 3-year period to institute their claim, calculated from the moment the debt is due (which is normally when all of the requirements for the cause of action have been met). The problem, however, is that litigation is very timeconsuming. In 2015 the Minister of Justice was reported as stating that the civil justice system was clogged and that the “average period for the finalisation of an opposed civil matter is two and a half years.”114 The SALRC Report also lists the length of litigation as a significant factor that contributed towards the current “growing crisis with regard to medico-legal claims in South Africa.”115 It provides a list of 19 recent medical malpractice cases, stating that “the shortest period that had elapsed between the cause of a claim and its finalisation was 1 year and 6 months, while the longest period was 16 years and 1 month [. . .] It is worrying, however, that 15 out of 20 (i.e. 75%) of the cases referenced took longer than 5 years to be finalised.”116 With respect to the possible limitation of legal practitioners’ fees, attention should be paid to the Legal Practice Act 28 of 2014, which focuses, among other things, on broadening access to justice by putting in place “a mechanism to determine fees chargeable by legal practitioners for legal services rendered that are within the reach

113

Loubser and Midgley (2017), pp. 248–249. Manyathi-Jele (2015) DR 11. 115 SALRC (2017), p. 2. 116 Ibid, pp. 20–21. 114

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of the citizenry”.117 The Act establishes the Legal Practice Council which will exercise jurisdiction over all legal practitioners.118 In terms of section 5(b) of the Act, one of the council’s aims is to ensure “that fees charged by legal practitioners for legal services rendered are reasonable and promote access to legal services, thereby enhancing access to justice”. Further, section 35(4) of the Act obliges the SALRC to investigate and report back to the Minister of Justice with recommendations on a variety of issues, including unaffordability of legal fees for certain people and potential interventions that could improve the situation and promote the right access to justice. However, until such investigation is completed,119 fees in respect of litigious and non-litigious legal services rendered by legal practitioners, juristic entities, law clinics or Legal Aid South Africa will continue to be determined accordance with the tariffs made by the Rules Board for Courts of Law under the auspices of the Rules Board for Courts of Law Act 107 of 1985. At the moment there are no mechanisms to diminish the amounts of compensation awarded to successful patients. All of the above have led legal scholars, healthcare providers and state officials to call for legal reform. Before examining the potential reform possibilities, attention will be given to the reasons for, and consequences of, the expanded liability for harm arising from medical malpractice.120

Reasons for the Expansion of Liability for Harm Arising from Medical Malpractice First, it may be argued that the increase is largely due to a decline in professionalism and standards of medical practitioners, particularly in the public healthcare sector.121 Secondly, recent developments within the South African legal landscape have also contributed to the rise in litigation. Amendments to the provisions of the Road Accident Fund Act 56 of 1996 in particular may have led to attorneys refocusing on claims arising from medical malpractice as opposed to motor vehicle accidents.122 Oosthuizen and Carstens suggest that the Contingency Fees Act 66 of 1997 has created the possibility of litigation to patients who could previously not afford to

117

Section 3(b)(i) of the Legal Practice Act. See section 4 of the Legal Practice Act. 119 This must be done within 2 years after the commencement of Chapter 2 of this Act. Chapter 2 comes into operation 3 years after the date of commencement of Chapter 10 or on any earlier date fixed by the President by proclamation in the Government Gazette. In accordance with a proclamation of the President, Chapter 10 became effective on 1 February 2015 (see Government Gazette No. 38412 dated 23 January 2015). In other words, this must be done before 31 January 2020. 120 SALRC (2017); Carstens and Howarth (2014), p. 69; MPS (2015); Dhai (2015), p. 2. 121 Oosthuizen and Carstens (2015), p. 282. 122 MPS (2015), p. 6. 118

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institute claims. Although the “no win, no fee” arrangement123 promotes the right to access to justice, they argue that it has contributed to some questionable practices, such as the incentive to inflate claims.124 Indeed, it has been suggested that some attorneys purposely encourage patients to pursue litigious routes where they have suffered harm due to medical malpractice.125 Thirdly, patients have also become increasingly more aware of their rights under the Constitution as well as the CPA. This means that patients who have legitimate claims have arguably become more likely to institute claims to receive compensation.126 Fourthly, the MPS has identified a “lack of a patient-centered and robust complaints system”127 as something that left many patients with litigation as the only viable avenue for redress. They argue that the absence of “an efficient and predictable legal process for handling clinical negligence claims allows the size of claims to increase and makes delays endemic”,128 while the cost of settling a claim increases as time goes on.129 Lastly, technological advances have contributed considerably to improved healthcare services. In turn, this has led to an increased life expectancy for extremely compromised patients.130 As Howarth notes, “the worse the injury and the longer the survival, the more the costs of care.”131 Consequently, the specialties where injuries are typically the most severe and survival is likely to be the longest are exposed to a significant risk of claims and the accompanying costs associated with indemnifying against this risk.132 In this context, high liability costs is linked with obstetrics, neonatal care, spinal surgery and neurosurgery.133

123

A contingency fee agreement is an agreement between a legal practitioner and his or her client where the practitioner agrees to charge no fee if the client’s court case is unsuccessful. In the event of a “win”, the practitioner’s fee to be charged may be up to twice the agreed upon normal fee, capped at a maximum of 25% of any monetary amount the client is awarded or recover. 124 Oosthuizen and Carstens (2015), p. 283; Van den Heever (2016), pp. 49–50. 125 Oosthuizen and Carstens (2015), p. 283. 126 Ibid, p. 284. 127 MPS (2015), p. 6. 128 Ibid, p. 6. 129 See MPS (2015), p. 6. See also SALRC (2017), p. 4. 130 Howarth (2014), p. 752. 131 Howarth (2014), p. 752. 132 Ibid, p. 752. 133 Ibid, p. 752.

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Consequences of the Expansion of Liability for Harm Arising from Medical Malpractice Arguably the most worrying consequence of the excessive medical malpractice litigation against the state is that it may potentially undermine the Department of Health’s ability to provide public healthcare in future.134 In holding the state vicariously liable for the culpable wrongdoing of an employee and ordering it to pay the full damages of a victim of medical malpractice, it is the taxpayer who ultimately bears the cost. However, if tax-money allocated for the provision of public healthcare is used to pay the victim’s compensation or to settle civil litigation suits, then less funds will obviously be available to provide medical services to the public and to promote the right to access to healthcare.135 This, in turn, serves to further increase the likelihood of a higher malpractice rate and the accompanying litigation which may be instituted against the state on the basis that it (or its employees) negligently caused harm arising from public healthcare. If left to continue unabated, this could mean that the South African law of delict will ultimately become caught in a vicious cycle of ever-expanding state delictual liability for harm arising from medical malpractice. In other words, the problem is that an already overwhelmed and under-financed public healthcare sector is exposed to the ever-increasing amount of malpractice claims. Consequently, the state faces the “additional burden of having to find money within provincial health departmental budgets to pay claims together with legal costs”136 to successful litigants. This may destabilise the public healthcare system, with less funds available for improving the quality of healthcare or appointing new doctors.137 This, in turn, increases the likelihood of further medical malpractice and consequent claims being instituted against the state. It would seem that the state is aware of this situation: the Minister of Health has requested the SALRC to investigate the matter, while the provincial ministers have raised several arguments in court to develop the common law in an attempt to address the state’s widening liability.138 In turn, the Minister of Justice and Correctional Services has recently introduced the State Liability Amendment Bill to address the current state of affairs. Another deleterious consequence of increased malpractice litigation is that it has directly led to the corollary rise in medical practitioners’ insurance premiums. In turn, this amounted to a major increase of their fees. Regarding the rise of indemnity

134

See Carstens and Howarth (2014), p. 69. See also Wessels (2018). 136 Malherbe (2013), p. 83. 137 Malherbe (2013), p. 83. 138 See, for example: MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2018 1 SA 335 (CC); MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2016 ZASCA 185; Premier, Western Cape v Kiewitz 2017 4 SA 202 (SCA). 135

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insurance, the “2011 annual MPS premium for obstetricians [was] R187 830”139 and, in the last 4 years, the annual premium has increased from around R250,000 to approximately R850,000.140 The increased premiums typically lead to higher healthcare fees and, as a result, the provision of healthcare services may become unattainable for a growing portion of impoverished South African citizens. Also, as Nienaber argues, the increased insurance premiums may mean that practitioners working in high-risk specialties in smaller urban areas or rural settings may be unable to “perform enough treatments or surgeries to justify paying increased indemnity insurance premiums.”141 Consequently, they could decide to move to a more lucrative area or perhaps stop practising altogether, which could potentially result in a diminution of specialists in those areas. This could deprive these smaller, rural communities of access to specialist healthcare altogether. The fact that practitioners are faced with an increased risk of litigation may arguably prompt them to practice defensive medicine and to perform additional medical tests and procedures in an attempt to pre-empt litigation by striving to persuade the legal system that the relevant standard of care was met.142 It is conceivable that this development could produce further adverse outcomes: on the one hand it is argued that it may lead to a higher risk of malpractice litigation which could accompany these extra steps and tests and, on the other hand, it is likely to further hike the cost of healthcare services.143 Another indirect consequence of the rise in claims and the attendant augmented exposure to liability risk is that aspiring medical practitioners may avoid certain areas of practice because of a fear of the accompanying litigation risk.144 This may contribute to a skills shortage in the country, particularly in those areas which are particularly exposed to the risk of litigation.145 In fact, there are reported cases where obstetricians in the private healthcare sector have stopped providing their specialty medical service altogether.146 If this trend continues, it could mean that some pregnant mothers would have to turn to the public healthcare system, exerting more pressure on an already overwhelmed system and potentially contributing to the further expansion of the state’s delictual liability for harm arising from medical malpractice.147

139

Pepper and Slabbert (2011), p. 30. https://www.fin24.com/Economy/r1m-bill-no-one-left-to-deliver-our-babies-20170406 (14-122017). See also South African Law Reform Commission (n 3) 17. 141 Malherbe (2013), p. 83. 142 Malherbe (2013), p. 83. See also Carstens and Howarth (2014), p. 69. 143 Oosthuizen and Carstens (2015), p. 278. 144 Malherbe (2013), p. 83. 145 Ibid, p. 83. 146 https://www.netwerk24.com/ZA/Worcester-Standard/Nuus/waarom-worcester-se-ginekoloeophou-babas-vang-20160921-2 (accessed on 14 December 2017). 147 Malherbe (2013), p. 83; Carstens and Howarth (2014), p. 69. 140

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The excessive medical malpractice litigation and the potentially devastating consequences that it holds for healthcare service delivery in South Africa have sparked a call for reform. The reform proposals, ranging from gradual alterations to radical change, has been included in the SALRC Report and will be discussed below. However, before doing so, attention will be given to the question whether there are alternative dispute resolution (ADR) procedures that could be used in substitution of court proceedings in cases of medical malpractice.

The Use of Alternative Dispute Resolution Procedures in the Context of Medical Malpractice Alternative Dispute Resolution Procedures That Are Generally Available to Victims of Medical Malpractice Parties may elect to resolve disputes privately by themselves (typically through negotiation or mediation), or they may have resort to private adjudication by a third party (mainly through arbitration).148 The salient features of these three ADR procedures are briefly summarized below.149 Negotiation refers to a process by which the disputing parties attempt to resolve their opposing interests voluntarily and typically informally.150 Parties may negotiate directly with each other, or the process may be facilitated by a neutral third party. Negotiation can be used in conjunction with the other ADR methods described below. Mediation is a flexible, voluntary process whereby the parties to a dispute make use of a neutral third party to assist them in resolving their dispute.151 Apart from voluntariness, flexibility and a neutral third party, some of its key features include the following:152 it is conducted confidentially and in private; it takes place on a without prejudice basis;153 it is regarded as cost-efficient and quick; and although the

148

See generally Ramsden (2009); Brand et al. (2012); Wiese (2016). It may be noted that conciliation is an ADR method specifically used for labour-related disputes in terms of the Labour Relations Act 66 of 1995. It involves a process where a labour commissioner meets with the parties in dispute, and explores ways to settle the dispute by agreement. The process is aimed to be informal, fast, uncomplicated, inexpensive and does not allow for any legal representation. Because it is specific to labour-related disputes, it is not used in the medical malpractice context and does not warrant further analysis. See generally Adams and Adams “Dispute Resolution in South Africa” (2012) 2; see also CCMA “Conciliation” available at

(accessed on 14 December 2017). 150 Wiese (2016), p. 12. 151 Wiese (2016), p. 47; Brand et al. (2012), p. 19. 152 Wiese (2016), pp. 47–64; Brand et al. (2012), pp. 24–33. 153 In other words, parties do not give up any rights they have to resort to litigation. 149

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mediator controls the process of mediation, the parties determine the content and outcome of the dispute and mediation is therefore recognized by a large degree of autonomy and self-determination. Arbitration may be defined as “a process whereby the parties to the dispute enter into a formal agreement that an independent and impartial third party, the arbitrator, chosen directly or indirectly by the parties, will hear both sides of the dispute and make an award which the parties undertake through the agreement to accept as final and binding.”154 This method, characterized by the fact that it removes the dispute from the jurisdiction of the courts,155 is less formal than court proceedings, but more formal than mediation or negotiation.156 Before a dispute may be referred to arbitration, the parties must agree to arbitrate and must also agree on the terms and basis for the arbitration, including the rules that will govern the proceedings and the arbitrator that will oversee the process.157 Some of the recognized differences between arbitration and court proceedings include the following. Arbitration is typically a private, confidential process as opposed to the open, public nature of litigation and is arguably less expensive and quicker than court proceedings.158 Whereas arbitration is dependent on the existence of an arbitration agreement, a plaintiff may institute court proceedings without the opponent’s consent.159 Ordinarily the arbitrator’s award is final and binding and not subject to appeal whereas a judgment may be taken on appeal.160 Also, the arbitrator is normally an expert in the field pertaining to the dispute while this is not normally the case in court proceedings.161 In addition to the above, certain procedures recognized under the Health Professions Act 56 of 1974 (HPA) are also relevant in the context of medical malpractice. Unlike the ADR methods, however, these procedures are designed to promote patients’ right to healthcare, discipline practitioners in the healthcare sector and do not focus on the resolution of disputes between patients and practitioners. Nonetheless, it may be the case that, where a negligent practitioner has been disciplined under these procedures, the patient will not continue to institute further court proceedings or ADR procedures. Attention should accordingly be given to them. The HPA establishes the Health Professions Council of South Africa (HPCSA).162 In accordance with section 15(1) of the Act, the Minister must

154

Ramsden (2009), p. 5. Ibid, p. 5. 156 5. Ramsden states that, although ad hoc arbitration may be relatively informal, it is still much more formal than mediation or negotiation proceedings, while commercial arbitration is particularly formal and inflexible. 157 Cotton (2016), p. 593. 158 Ramsden (2009), pp. 6–7; Wiese (2016), pp. 127–128. 159 Ramsden (2009), pp. 6–7. 160 Wiese (2016), pp. 127–128. 161 Ramsden (2009), pp. 6–7; Wiese (2016), pp. 127–128. 162 Section 2 of the HPA. 155

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establish a professional board upon the recommendation of the HPCSA for each health profession in respect of which a register is kept under the Act.163 The professional boards, of which there are currently twelve, operate under the HPCSA’s jurisdiction.164 The professional boards have comprehensive powers under the Act and may remove and restore names from and to a register, and suspend a registered person from practicing his or her profession pending the institution of a formal enquiry. Indeed, these boards may perform any function and take the necessary steps to achieve the objects of the Act in relation to a profession falling within the ambit of the professional board.165 For instance, in terms of section 41(1) of the Act, these boards have the power to institute an inquiry into any complaint, charge or allegation of unprofessional conduct against medical practitioners registered under the Act, and, on finding the latter guilty of such conduct, the board may impose any of the penalties prescribed in section 42(1) of the Act. These penalties include (a) a caution or a reprimand (or both); (b) suspension for a specified period from practising or performing acts specially pertaining to his or her profession; (c) removal of his or her name from the register; (d) a prescribed fine; (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 or both. Any penalty imposed under this section is payable to the professional board and shall have the effect of a civil judgment of the magistrate’s court of the district in which the inquiry took place.166 A practitioner whose conduct is the subject of an inquiry under the HPA is afforded the opportunity, by himself or herself or through his or her legal representative, of answering the charge and of presenting a defence.167 The professional board may take evidence, summons witnesses and require any relevant information to be produced at the inquiry.168 Although it is not a requirement, the board is entitled to appoint someone with adequate experience in the administration of justice to be present as an assessor at such an inquiry and to advise the professional board or such committee, as the case may be, on matters of law, procedure or evidence.169 A patient may lodge a complaint with the HPCSA or any of the professional boards.170 Any complaint will be sent to the registrar, who will peruse, analyze and categorize them in accordance with their seriousness and significance.171 In

163

Section 15(1) of the HPA. Oosthuizen (2014), p. 14. 165 Section 15(B)(1)(g) of the Act. 166 Section 42(10) of the HPA. 167 Section 42(2) of the HPA. 168 Section 42(4)(a) of the HPA. 169 Section 42(5) of the HPA. 170 Regulation 2 of the Regulations Relating to the Conduct of Inquiries into Alleged Unprofessional Conduct under the HPA, 1974 (GN R102 in GG 31859 of 6 February 2009) (Professional Conduct Regulations). 171 Regulation 2(2)–(3) of the Professional Conduct Regulations. 164

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accordance with regulation 2(3) of the Regulations Relating to the Conduct of Inquiries into Alleged Unprofessional Conduct under the HPA172 (Professional Conduct Regulations), the registrar must refer complaints of minor transgressions and matters not falling under the jurisdiction of the HPCSA to the ombudsman for mediation. A “minor transgression” is defined as “conduct which, in the opinion of the registrar or preliminary committee of inquiry, on the basis of the documents submitted to the registrar or such committee, is unprofessional, but of a minor nature, and does not warrant the holding of a formal professional conduct inquiry”.173 The ombudsman must mediate such matters and refer matters that could not be resolved to the registrar for a so-called preliminary inquiry. If the matter falls outside the jurisdiction of the HPCSA, the ombudsman must refer it to the appropriate body and inform the complainant. Considering the wide jurisdiction and powers of the HPCSA, this will typically not occur where the complaint is concerned with medical malpractice. Regarding the mediation process, the ombudsman may call for further information in any manner he or she deems appropriate from any person who may assist in the resolution of the dispute.174 Information obtained in this regard is confidential and privileged.175 Once he has made a determination on the issue, the ombudsman will communicate it to the parties and require them to indicate whether or not they accept it.176 If they do, the ombudsman must confirm the decision in writing and it will then be binding on both parties as a final resolution of the matter.177 If either party does not agree to abide by the determination, the matter must be referred to the registrar for a preliminary inquiry.178 Preliminary inquiries into the conduct of a medical practitioner may be held by a preliminary committee of inquiry and in accordance with regulation 4 of the Professional Conduct Regulations. The preliminary committee of inquiry is established by a professional board in terms of section 15(5) of the HPA for the preliminary investigation of complaints to make a determination thereon and has wide discretionary powers.179 Among other things, it may decide that there are no grounds for taking further action on the matter;180 or that there are grounds for a professional conduct inquiry into the conduct of the practitioner (in which case it must direct that an inquiry be so held);181 or that the practitioner acted unprofessionally, but that the conduct in

172

GN R102 in GG 31859 of 6 February 2009. Regulation 1 of the Professional Conduct Regulations. 174 Regulation 3(2) of the Professional Conduct Regulations. 175 Regulation 3(6) of the Professional Conduct Regulations. 176 Regulation 3(3) of the Professional Conduct Regulations. 177 Regulation 3(4) of the Professional Conduct Regulations. 178 Regulation 3(5) of the Professional Conduct Regulations. 179 See regulation 4 of the Professional Conduct Regulations. 180 Regulation 4(7) of the Professional Conduct Regulations. 181 Regulation 4(8) of the Professional Conduct Regulations. 173

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question is found to constitute only a minor transgression (in which case it must determine a suitable penalty to be imposed).182 A professional conduct inquiry may be held in terms of the Professional Conduct Regulations read with the HPA.183 This inquiry, by a committee established by the professional board under section 15(5) of the HPA, investigates the conduct of a medical practitioner against whom a complaint has been made. The HPA defines “unprofessional conduct” as conduct that is essentially “improper or disgraceful or dishonourable or unworthy”. On finding a practitioner guilty of such conduct, the committee may impose any one or other of the penalties that are listed under section 42(1) of the HPA and mentioned above. Once again, a penalty imposed under this section is payable to the professional board and shall have the effect of a civil judgment of the magistrate’s court of the district in which the inquiry took place.184

The Legal Bases of the ADR Procedures There is no general statute that regulates mediation or negotiation proceedings in South Africa.185 As a result, matters such as the appointment of a mediator or negotiator, the mediation or negotiation process, confidentiality and the admissibility of evidence have to be regulated by the parties themselves.186 The law of arbitration in South Africa is based on common-law principles, which derive from Roman-Dutch law, as well as legislation.187 The most important statute in this context, the Arbitration Act 42 of 1965, consolidated and repealed all prior legislation,188 but did not expressly set aside the common law.189 The Act aims to provide for the settlement of disputes by arbitration tribunals in terms of written arbitration agreements and for the enforcement of the awards of such tribunals.190

182

Regulation 4(9) of the Professional Conduct Regulations. In this regard, this means a caution or one of the fines set out in the tariff published under the HPCSA. 183 Regulation 9 of the Professional Conduct Regulations. 184 Section 42(10) of the HPA. 185 Brand et al. (2012), p. 10. 186 Brand et al. (2012), p. 10. For a list of statutes that provide for mediation, see Wiese (2016), pp. 99–102; Broodryk (2015), pp. 667–692. 187 Wiese (2016), p. 130. 188 Wiese (2016), p. 130: Wiese states that the English Arbitration Act of 1889 formed the basis for the arbitration statutes adopted in the Cape (see also the Arbitration Act 29 of 1898 (Cape)), Natal (see also the Arbitration Act 24 of 1898 (Natal)) and Transvaal (the Arbitration Ordinance 24 of 1904 (Transvaal)). 189 Section 2 of the Arbitration Act. 190 Other notable statutes that impact on arbitration include the Companies Act 71 of 2008 which also provides for various ADR mechanisms to resolve commercial disputes, e.g. adjudication by the Companies Tribunal and filing a complaint with the Companies Commission. See Wiese (2016),

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Any dispute may be arbitrated in terms of the Act, other than matrimonial disputes and matters relating to status.191 The Act also applies to arbitrations where the state is a party, except where the dispute is between the state and another government.192 In accordance with section 40 of the Act, the Act applies to every arbitration under any law that refers to the resolution of disputes by way of arbitration.193 However, if such other law specifically provides otherwise, the Act will not apply.194 Because the Constitution is the supreme law of the country, all law, including the law relating to ADR methods, must be consistent therewith. Section 34 of the Constitution states that “[e]veryone has the right to have any dispute that can be resolved by the application of law decided in a fair public hearing before a court or, where appropriate, another independent and impartial tribunal or forum.” In Lufuno Mphaphule v Andrews195 the CC had to consider the effect of section 34 on the notion of private arbitration and held that it did not apply to a private arbitration because the parties may choose not to exercise their right to access a court to resolve their dispute.196 As indicated above, the mediation of minor transgressions in terms of the HPA, as well as the preliminary and professional conduct inquiries described above, are based on the HPA read together with the Professional Conduct Regulations.

The Nature of the ADR Procedures: Voluntary or Compulsory? One may distinguish between voluntary mediation and statutory mediation.197 Voluntary mediation refers to those instances where the parties have agreed of their own volition to mediate their dispute, typically also agreeing on the mediator’s identity as well as the process that will regulate the mediation.198 Parties may choose to do this out of their own accord, but may also attempt mediation on the basis of legislation. For example, section 70 of the CPA provides that a consumer may seek

p. 134; section 156 of the Companies Act 71 of 2008. Further, the Labour Relations Act 66 of 1995, which aims, inter alia, to promote effective resolution of labour disputes, provides for the resolution of such disputes by way of conciliation and arbitration by the Commission for Conciliation, Mediation and Arbitration. See section 1(d)(iv) of the Act as well as Wiese (2016), p. 104. 191 Section 2 of the Arbitration Act. 192 Section 39 of the Arbitration Act. 193 Wiese (2016), p. 132. 194 Ramsden (2009), pp. 14–15. 195 2009 (4) SA 529 (CC). 196 Para 188. 197 Wiese (2016), pp. 66–102. 198 Ibid, p. 67.

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to resolve any dispute in respect of a transaction or agreement with a supplier by inter alia referring the matter for mediation. On the other hand, statutory mediation, as Wiese maintains, takes place within a framework, “usually prescribed by legislation”,199 and is voluntary in most cases, but may also be compulsory.200 Arguably, it may only be regarded as compulsory insofar as legislation compels parties to refer their dispute to mediation, while the actual process itself remains voluntary. For example: regulation 2(3) of the Professional Conduct Regulations determines that the registrar “must” refer complaints of minor transgressions to the ombudsman for mediation. However, regulation 3 makes it clear that parties are not obliged to take part in the process or to abide by the ombudsman’s decision and the actual mediation process should therefore be regarded as voluntary. Wiese also lists court-referred mediation as an example of voluntary statutory mediation.201 In this regard, attention must be paid to Court-Annexed Mediation Rules that came into effect on 1 December 2014 (Mediation Rules). The Mediation Rules, which took the form of amendments to the Rules Regulating the Conduct of Proceedings of the Magistrates’ Courts (Magistrates’ Court Rules), provides for voluntary court-referred mediation in the Magistrates’ Courts.202 Rule 75(1) of the Magistrates’ Court Rules now states that parties may refer a dispute to mediation prior to the commencement of litigation, or after commencement of litigation but prior to judgment—provided that, where the trial has commenced, the parties must obtain the authorization of the court. Further, rule 75(2) stipulates that a judicial officer may at any time after the commencement of litigation, but before judgment, enquire into the possibility of mediation of a dispute and accord the parties an opportunity to refer the dispute to mediation. According to Claassen, court-referred mediation does not deny a party’s right to withdraw and enforce his or her right to litigate in court.203 Therefore, if a party feels aggrieved by the mediation process, he or she may withdraw at any stage.204 Where this occurs, the mediator would “usually ask for a private session with the aggrieved party to enquire the reason for his or her dissatisfaction in order to have an opportunity to remove any misunderstanding and hopefully convince that party to continue with the process.”205

199

Ibid, p. 88. For example, section 21(3) of the Children’s Act 38 of 2005, which states that, if there is a dispute between the biological father and the biological mother of the child regarding the biological father’s parental responsibilities, the matter must be referred for mediation to a family advocate, social worker, social services professional or other suitably qualified person. 201 Wiese (2016), pp. 88–93. 202 See Esplugues and Marquis (2015), pp. 667–692; Brand et al. (2012), pp. 44–49; Wiese (2016), pp. 88–93. 203 Claassen (2016), p. 9. 204 Ibid, p. 9. 205 Ibid, p. 9. 200

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The introduction of court-referred mediation is currently in its pilot phase,206 during which mediation is completely voluntary and the focus is limited to disputes that fall under the jurisdiction of the Magistrates’ Courts. Since its introduction, and up to August 2016, the pilot process has seen no fewer than 1280 cases in which parties have agreed to mediate.207 However, the Minister of Justice has indicated that, in future, “mediation could be compulsory and may extend to the disputes that fall within the jurisdiction of the High Courts”.208 Arbitration may be described as a voluntary procedure, i.e. it occurs when parties to a dispute agree to refer the dispute to arbitration for a binding decision.209 Such agreement may be taken on own initiative or based on recommendation set out in legislation. For example, section 166 of the Companies Act states that a person may refer a matter either to the Companies Tribunal or to an agency or person for resolution of the dispute by way of mediation. In Lufuno Mphaphule v Andrews210 the CC emphasized the basic principles underlying arbitration, namely that it is a “process built on consent in that parties agree that their disputes will be settled by an arbitrator.”211 Indeed, the court stated that the “hallmark of arbitration is that it is an adjudication, flowing from the consent of the parties to the arbitration agreement, who define the powers of adjudication, and are equally free to modify or withdraw that power at any time by way of further agreement.”212 In some cases, legislation may oblige parties to refer their dispute to arbitration.213 For instance, section 191(5) of the LRA requires that disputes concerning alleged unfair dismissals relating to the employee’s conduct or capacity must be referred to arbitration where conciliation has failed to resolve the dispute.214 Once again, however, it may be pointed out that arbitration under these circumstances can only be described as compulsory insofar as the referral of the dispute is concerned, and either party to the dispute may choose not to attend the arbitration or comply with the process. Lastly, attention may be drawn to rule 37(6)(d) of the Uniform Rules of Court, which states that the minutes of the pre-trial conference shall be prepared and signed by or on behalf of every party, indicating whether any issue has been referred by the parties for mediation, arbitration or decision by a third party and on what basis it has been so referred. Therefore, it may be said that, although the abovementioned ADR

206

In this phase, the rules are implemented in Gauteng and the North-West Province. However, in 2018 court-referred mediation services will be extended to the Regional Courts in Gauteng, Mpumalanga, Limpopo and the North-West. 207 Cameron (2017), p. 6. 208 Manyathi-Jele (2015), p. 11. 209 Wiese (2016), p. 128. 210 2009 (4) SA 529 (CC). 211 Para 195. 212 Para 195. 213 Wiese (2016), p. 128. 214 See Wiese (2016), p. 177. See further sections 21, 24, 74, 86, 191, 141 of the LRA.

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methods remain voluntary, this rule requires parties who intend litigation in the High Court “at least to consider the referral of the dispute [. . .] for resolution in terms of an ADR procedure.”215 The preliminary inquiry and professional conduct inquiry that may be launched under the auspices of the HPA read together with the Professional Conduct Regulations are compulsory. Regulation 4(1)(b)(ii) states that a failure to respond to the notification of a preliminary inquiry will constitute contempt of the HPCSA, which, under regulation 4(3) allows the committee to issue the practitioner a notice that instructs him or her to appear in person with a legal representative, (if any) to explain why he or she did not respond to the HPCSA correspondence. If the practitioner is found to be in contempt of the HPCSA it may provide the practitioner with a caution only or issue a prescribed fine.216 If a practitioner who was duly notified and indicated that he or she would attend fails to attend the preliminary inquiry, he or she may be similarly punished.217 Also, where a practitioner is not present at a professional conduct inquiry after being duly notified, the inquiry may nonetheless proceed in his or her absence and a practitioner may ultimately be found to have been guilty of professional misconduct.

The Aim and Philosophy of ADR Proceedings The aim and philosophy of the ADR proceedings may be understood better by identifying the shortcomings of court proceedings, which generally serves as a motivation for the use of these methods.218 Essentially, these shortcomings include the high cost of litigation and the lengthy delays associated therewith, which, in turn, restricts access to justice to a vast majority of the South African population.219 In comparison, the ADR mechanisms generally provide dispute resolution options that tend to be more time-efficient and affordable and which promotes the constitutional right to access to justice.220 To some extent it may therefore be said that the use of these ADR methods in the context of medical malpractice is based on cost-efficiency considerations, i.e. it is a response to the increased costs and lengthy time-lines associated with malpractice litigation.221 215

Wiese (2016), p. 90. See section 42(1)(a) and (d) and regulation 4(4) of the Professional Conduct Regulations. 217 Regulation 4(5) of the Professional Conduct Regulations. 218 Wiese (2016), p. 2. 219 Wiese (2016), p. 2; SALRC (1997), p. 17. 220 Claassen (2016), pp. 7–8; Wiese (2016), p. 2; SALRC (1997), pp. 17–18. 221 For instance, regarding mediation, Claassen (2016), pp. 8–9 writes: “Mediation is far less costly than litigation or arbitration. According to the Government Gazette mediation tariffs have been set, inter alia determining that a level 1 mediator may charge ZAR 4 500 and a level 2 mediator ZAR 6 000 as a maximum fee per day shared equally by both parties. [. . .] Mediation is far less time consuming than litigation or arbitration. It has been estimated that the largest portion of mediations 216

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However, the use of the ADR procedures is motivated also by other factors. For instance, they present opposing parties with an opportunity to reach an amicable settlement.222 Further, while court proceedings may lead to adverse publicity and could potentially ruin a successful professional career, ADR methods are arguably less likely to do so because they are private and confidential.223 Another underlying idea behind their use is that, unlike court proceedings, where the presiding officers may lack expertise regarding complex medical procedures that could potentially result in unjust decisions,224 parties may elect an arbitrator or mediator that is an expert in the relevant medical field as part of the ADR process, which may improve the likelihood of reaching a fair outcome.225 It may also be emphasized that parties involved in litigation often suffer from a lack of control during the proceedings because they are represented by legal representatives and others who make decisions on their behalf.226 In contrast, ADR processes, and mediation in particular, are regarded as bestowing on the parties a greater degree of control over the process in comparison to litigation, while engendering equality between the parties by the removal of any power imbalance between the ‘stronger professional’ and the ‘weaker lay patient’.227 Furthermore, whereas the adversarial nature of litigation may lead to a breakdown in relationships, ADR process offer a win-win outcome to a dispute.228 Regarding the effect that ADR processes may have on the improvement of healthcare standards and the potential preventive character, the following remarks may be made. It is conceivable that the use of ADR methods may contribute to a decline in the amount of medical malpractice litigation and that it could, indirectly, contribute to better healthcare. This is because such a decline could stifle the continuing increase of insurance premiums for doctors, which, in turn, may create more favorable and viable working conditions and may encourage practitioners to continue practicing in areas that are currently regarded as being exposed to a high risk of litigation.

are completed in less than a day. Mediating parties are also not subject to waiting time for trial dates, as in the courts. It is only the mediator and the parties who have to coordinate their diaries for a suitable date.” 222 Claassen (2016), pp. 7–8. 223 Ibid, pp. 7–8. 224 Ibid, pp. 7–8. 225 Ibid, pp. 7–8. 226 Ibid, p. 9. 227 Ibid, p. 9. 228 Ibid, p. 9: Claassen explains how mediation is a win-win arrangement: it is client-based, i.e. the interests or needs and not the rights of each party are paramount. It is not rights-based, as is the case in litigation or arbitration. The skilled mediator guides the parties to a mutual solution satisfactory to them irrespective of their legal rights. Thus, they arrive at a solution designed by their own needs leaving two winners instead of a loser and a winner. In arriving at a solution, the parties are not limited to their legal remedies. Often, a mere apology suffices to bring healing to broken relationships.

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There are no statistics to indicate whether the use of these ADR methods could have an impact on the prevention and deterrence of malpractice. The inquiries that may be launched under the HPA are essentially based on the idea to protect patients’ rights by ensuring the correct ethical and professional standards of conduct and rules and to discipline practitioners who fail to adhere to those standards.229 The aim of these proceedings is not to substitute court proceedings. As the HPCSA indicates: “The Professional Conduct Committee cannot order the healthcare professional to make financial restitution to the person (s) lodging the complaint. However, members of the public who lodge a complaint through HPCSA may also pursue civil litigation independently.”230

The Regulation of the Medical Health Profession by the HPCSA The HPA established the HPCSA as the statutory regulatory body responsible for exercising control over the healthcare profession and protecting patients’ rights.231 The HPCSA has a broad mandate that includes the promotion of healthcare, determination of the standards of professional education and training in the healthcare industry and the investigation of complaints concerning persons registered under the Act to ensure that appropriate disciplinary action is taken against them to protect the public interest.232 The health damages compensation procedures are not centralized in the HPCSA and parties interested in obtaining compensation would have to institute commonlaw claims against medical practitioners. Nevertheless, the HPA does provide for certain measures to safeguard the interests of victims of medical malpractice. The way in which this is done is by setting up professional boards that can oversee the professional conduct of healthcare practitioners, and discipline them, if necessary. Regarding the HPCSA’s efficiency, Still states as follows: “the increasing inefficiency of the HPCSA has ensured that this is no longer the preferred route for potential litigants. The grave state of the organisation is now official; a task team appointed by the Minister of Health reported its findings in November 2015, describing the HPCSA as suffering from ‘multi-system organisational dysfunction.”233

229

Section 15 read with chapter 4 of the HPA. HPCSA “Professional Conduct and Ethics” available at (accessed on 19 January 2017). 231 Section 2 of the HPA. 232 Sections 3–4 of the HPA; HPCSA “Overview” available at (accessed on 15 January 2018). 233 Still “So you want to sue your doctor” available at (accessed on 18 December 2018). 230

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Proposals for Reform of the Law Relating to the Compensation of Harm Arising from Medical Malpractice The Increased Use of ADR Procedures Generally, the standpoint of legal scholars, healthcare professionals and members of the Department of Justice is that they appear to be strongly in favor of limiting judicial proceedings and strengthening existing ADR mechanisms. Although the courts have not explicitly addressed the use of ADR mechanisms in the context of medical malpractice, reference has been made to the use of these methods in other contexts. In MB v NB234 the court highlighted the benefits of mediation in the context of marriage disputes, while the CC has also confirmed that the “benefit of arbitration over court adjudication has been shown in a number of international studies” (in the context of labour-related disputes).235 In Port Elizabeth Municipality v Various Occupiers236 the CC expressly endorsed the use of ADR methods as follows: [O]ne potentially dignified and effective mode of achieving sustainable reconciliations of the different interests involved is to encourage and require the parties to engage with each other in a proactive and honest endeavour to find mutually acceptable solutions. Wherever possible, respectful face-to-face engagement or mediation through a third party should replace arm’s-length combat by intransigent opponents. Compulsory mediation is an increasingly common feature of modern systems. It should be noted, however, that the compulsion lies in participating in the process, not in reaching a settlement [. . .] Not only can mediation reduce the expenses of litigation, it can help avoid the exacerbation of tensions that forensic combat produces. By bringing the parties together, narrowing the areas of dispute between them and facilitating mutual give-and-take, mediators can find ways round sticking-points in a manner that the adversarial judicial process might not be able to do. Money that otherwise might be spent on unpleasant and polarising litigation can be better used to facilitate an outcome that ends a stand-off, promotes respect for human dignity and underlines the fact that we all live in a shared society. In South African conditions, where communities have long been divided and placed in hostile camps, mediation has a particularly significant role to play. The process enables parties to relate to each other in pragmatic and sensible ways, building up prospects of respectful good neighbourliness for the future.

Furthermore, the high costs and protracted nature of civil litigation has also been highlighted by the highest court. In EFF v Speaker of the National Assembly; DA v Speaker of the National Assembly237 Mogoeng CJ recently emphasized the fact that “[l]itigation is prohibitively expensive and therefore not an easily exercisable constitutional option for an average citizen”. In other instances, courts have highlighted

234

2010 (3) SA 220 (GSJ). Cusa v Tao Ying Metal Industries 2009 (2) SA 204 (CC) para 63. 236 2005 (1) SA 217 (CC) paras 39–43. 237 2016 (5) BCLR 618 (CC) para 52. 235

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the importance of promoting the constitutional right to access to justice.238 Against this background, it may be said that courts would be in favor of strengthening ADR mechanisms in the context of medical malpractice.239

Potential Reform Options Outlined in the SALRC Report As remarked earlier, and seen against the background of excessive medical malpractice litigation, it is unsurprising that the Department of Health requested the SALRC to investigate the various issues related to the growing “medical malpractice crisis”240 and to table potential reform suggestions. The commission noted the escalation in medical malpractice litigation, and stated that there “is an urgent need to undertake reform of the law in order to regulate a system that will become paralysed if no action is taken.”241 The commission identified a list of potential reform opportunities. These suggestions vary in nature, with some aimed at innovating aspects of traditional civil litigation in courts while others are more far-reaching insofar as they promote the use of ADR mechanisms or the enactment of a statutory compensation scheme.242 A detailed analysis of each of the almost 25 proposals falls outside the scope of this chapter. However, the following general comments may be made. Broadly, it would appear that the suggestions contained in the SALRC Report may be divided into the following categories. First, some of the proposals seem to be linked to the development of the civil procedural system insofar as it envisages changing the process in terms of which law suits are brought in the medical malpractice context. For instance, the SALRC suggests that there should be an earlier exchange of information, expert notices, summaries and witness statements and that “early expert meetings” should be held.243 In addition, it recommends considering the introduction of pre-trial conferences between the affected parties.244 Another proposal is the introduction of a certificate of merit which would require a patient‘s lawyer to confirm, before the start of the case, that the case has merit.245

238

Areva NP Incorporated in France v Eskom Holdings SOC Ltd 2017 (6) SA 621 (CC) para 43. See also Cameron (2017), p. 7, who stated that the Mediation Rules “clearly signal that judges recognize the value of mediation in the civil justice system”. 240 SALRC Medico-legal Claims (2017), p. 47. 241 Ibid, p. 4. 242 See SALRC Medico-legal Claims (2017), pp. 55–56 for a full list of these proposals. 243 Ibid, p. 56. 244 Presumably the commission considers introducing compulsory pre-trial conferences, because parties are currently entitled to hold a voluntary pre-trial conferences—see Rule 37 of the Uniform Rules of Court. In any event, the main purpose of such conference would presumably be to minimise the issues in dispute. 245 SALRC (2017), p. 56. 239

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The commission also suggests making use of these procedures.246 The SALRC specifically noted the potential usefulness of compulsory mediation. Further, pre-litigation resolutions as a first step before litigation is also identified as potential reform options. On a related point, and perhaps similar to the way in which labour disputes are handled by the Commission for Conciliation Mediation and Arbitration and the labour courts, the commission furthermore suggests considering the establishment of a statutory body or tribunal to deal with medico-legal claims, either to screen and evaluate the viability of claims or to adjudicate them. Generally, these proposals, some of which are existing measures that apparently are not being applied in full, are aimed at providing quicker and cheaper ways to resolve medico-legal disputes. Secondly, some of the alternatives propose different methods of paying compensation. For example, the SALRC Report refers to the possibility of providing for structured settlements (including the making of periodic payments for future care and maintenance costs).247 This proposal also came under scrutiny in MEC for Health and Social Development (Gauteng) v DZ248 and found its way into the proposed State Liability Amendment Bill. Another suggestion is the provision of free treatment in state hospitals (in lieu of paying compensation), another proposal which was included in the State Liability Amendment Bill. The commission also identified the following potential alternatives: providing for the payment of annuities or staggered payments, providing for guarantees or undertakings towards paying future medical expenses, providing for a contingency deduction or reducing contingency fees and safeguarding payments made for the benefit of children and disabled claimants. Although not as drastic as some of the other proposals mentioned below, these suggestions would arguably also require statutory intervention of some kind. Several suggestions are also made about the potential limitation of damages. For instance, the capping of claims (especially claims for general damages in respect of pain and suffering and emotional shock), limiting the compensation for future care costs and loss of future earning and prescribing guidelines for the calculation of compensation (especially regarding the determination of life expectancy, future medical expenses, the cost of future care, treatment and therapy and the cost of assistive devices). Lastly, some of the proposals listed would amount to large-scale legislative reform of the law relating to medical malpractice. For example, the SALRC suggests the establishment of a compensation fund for harm arising from medical malpractice.249 It also proposes the implementation of a “no-fault system for the payment of compensation. This would also mean that (a) it would not be necessary to institute

246

Ibid, p. 55. Ibid, p. 56. 248 MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2018 1 SA 335 (CC); MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2016 ZASCA 185. 249 SALRC (2017), p. 56. 247

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medical malpractice claims; (b) the elements of delictual claim does not have to be proven; (c) payments are made in accordance with a fixed awards structure”.250 Intervention of this kind, which would allow victims of harm arising from medical malpractice to obtain compensation from a no-fault based compensation scheme by making use of administrative procedures (as opposed to instituting litigious proceedings against the wrongdoer responsible for causing harm), would amount to the profound legislative reform of the law relating to medical malpractice and it would therefore require justification. In this context, scholars have often raised their concern regarding the need for a justifiable basis for this kind of statutory development. Indeed, it has been pointed out that “the idea of selecting [a] group of injured and disabled people for special treatment is not easily defensible”.251 For this reason, academics have regularly emphasised a “fundamental problem”252 that confronts reformers of the law of delict/tort law in this context, which is that “it is difficult to find a satisfactory rationale for singling out [a specific category of] victims from other groups of unfortunates for special treatment by the state.”253 This particular problem was also identified by the SALRC when it considered the establishment of a statutory compensation scheme for harm that arises from crime in 2004.254 In that context, however, the commission stated that “the establishment of a compensation fund should not be abandoned but developed over time as a long term project within the broader objective of improved services for victims of crime”255 and that “developing a motivation for the establishment of a [statutory compensation fund] in SA remains incomplete, and must be completed if legislation is to be drafted, since no law should be passed without its objectives being clearly defined and costed.”256 This issue has received attention since then and, if the legislature indeed decides to pursue this option further, regard may be had to some of the policy considerations that could potentially provide a theoretical framework for the justifiable development of the law of delict by the enactment of a statutory compensation scheme for harm arising from medical malpractice.257

250

Ibid, pp. 55–56. Cane (2013), pp. 303–308. 252 South African Law Reform Commission (2004), pp. 182–183. See also Cane (2013), pp. 303–308. 253 SALRC (2004), p. 182. See also Cane (2013), pp. 303–308. 254 SALRC (2004). 255 SALRC (2004), p. 322. See also Wessels (2018). 256 SALRC (2004), pp. 318–319. 257 Wessels (2018), pp. 127–239. 251

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The Proposed State Liability Amendment Bill While SALRC’s investigation continues, the legislature has very recently had an opportunity to consider the State Liability Amendment Bill.258 The Bill aims to amend the State Liability Act of 1957 to provide for structured settlements for the satisfaction of claims against the State as a result of medical malpractice by servants of the State. Clause 1 of the Bill aims to introduce a new provision dealing with the structured settlement of claims. The proposed new section 2A(1) (if enacted) states that a court must, in a successful claim against the state that exceeds R1 million, order that compensation be paid to the creditor in terms of a structured settlement which may provide for past expenses and damages, necessary immediate expenses, the cost of assistive technology (or other aids or appliances), general damages for pain and suffering and loss of amenities in life as well as periodic payments for future costs referred to in the proposed new section 2A(2). The proposed section 2A(2)(a) requires that, insofar as the cost of future care, future medical treatment and future loss of earnings are concerned, the court must order that compensation for those costs be paid by way of periodic payments. Periodic payments may not occur less often than a year, must occur during the lifetime of the injured person and on the terms that the court considers necessary. In accordance with proposed section 2A(4), the state or creditor may apply to the court to vary the amount or frequency of the periodic payments (or both), if a substantial change in die condition or circumstances of the injured person necessitates it. Amounts paid in this manner must also increase on an annual basis and in accordance with the consumer price index. The proposed subsection 2(A)(b) states that, as a substitute for the amount of compensation that would have been paid for future medical treatment (or a reduced amount), a court may order the state to provide such treatment to the injured person at a public health establishment. Where this occurs, the relevant public health establishment must comply with the norms and standards set out by the Office of Health Standards Compliance under section 77 of the National Health Act of 2003. Proposed section 2A(d) states that “[i]n circumstances where future medical treatment has to be delivered in a private health establishment, the liability of the State shall be limited to the potential costs that would be incurred if such care was provided in a public health establishment.”

258

Government Gazette No. 41658 of 25 May 2018.

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Conclusion South Africa does not have a statutory compensation scheme for medical malpractice. Victims who suffer harm in this context must institute common-law delictual or contractual claims in a civil court in an attempt to obtain compensation. In doing so, they are not assisted by a reversal of the burden of proof and they must prove all of the elements of liability on a balance of probability. They may institute the claim against the person responsible for their harm or they may attempt to hold the latter’s employer vicariously liable. Most typically, victims institute delictual proceedings against the employer of the person who wrongfully and culpably caused their loss. In the last decade there has been a significant increase in medical malpractice litigation. More specifically, there has been a remarkable expansion of the state’s vicarious liability in delict for harm arising from medical malpractice in the public healthcare sector. Although there are a variety of ADR procedures that may be used within the context of medical malpractice, they are not readily used in practice. As a result of the rise in medical malpractice litigation, the SALRC has been tasked to investigate potential alternatives. The commission has identified a series of possible reform options, but has not made a definitive recommendation in this regard. In the interim, the State Liability Amendment Bill, which aims to introduce structured settlements, has been tabled in Parliament, but it has not yet been enacted.

References Books and Articles Bateman C (2011) Medical negligence pay-outs soar by 132%. SAMJ 216 Brand J, Steadman F, Todd C (2012) Commercial mediation: a user’s guide Broodryk T (2015) A developing mediation minnow: the South African perspective. In: Esplugues C, Marquis L (eds) New developments in civil and commercial mediation, pp 667–692 Cameron E (2017) Shaping the future of dispute resolution & improving access to justice, p 6 Cane P (2013) Atiyah’s accidents, compensation and the law, pp 303–308 Carstens PA, Howarth G (2014) Can private obstetric care be saved in South Africa? SAJBL 7 (2):69 Carstens PA, Pearmain D (2007) Foundational principles of South African medical law, p 283 Carstens PA, van den Heever P (2011) Res Ipsa Loquitur & medical negligence: a comparative survey, p 18 Claassen N (2016) Mediation as an alternative solution to medical malpractice court claims. SAJBL Coetzee LC, Carstens PA (2011) Medical malpractice and compensation in South Africa. ChicagoKent Law Rev 86(3):1268 Coetzee LC, Carstens PA (2013) Medical malpractice and compensation in South Africa. In: Oliphant K, Wright KW (eds) Tort and insurance law, vol 32, pp 397–437 at 403, 409 Cotton J (ed) (2016) The dispute resolution review, p 593 Dhai A (2015) Medico-legal litigation: balancing spiraling costs with fair compensation. SAJBL 8 (1):2

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Esplugues C, Marquis L (eds) (2015) New developments in civil and commercial mediation 667 Goldberg R (2013) United Kingdom. In: Oliphant K, Wright RW (eds) Medical malpractice and compensation in global perspective, p 456 Howarth G (2014) Public somnambulism: a general lack of awareness of the consequences of increasing medical negligence litigation. SAMJ 752 Hutchison D, Pretorius CJ (eds) (2012) The law of contract in South Africa, p 431 Loubser MM (2008) The South African law of delict. Oxford University Press, Cape Town Loubser MM, Midgley JR (eds) (2017) The law of delict in South Africa, p 327 Malherbe J (2013) Counting the cost: the consequences of increased medical malpractice litigation in South Africa. SAMJ, p 83 Manyathi-Jele N (2015) Court-annexed mediation officially launched. De Rebus DR 11 Midgley JR (2016) Delict. In: Joubert WA (ed) The law of South Africa, vol 15, 3rd edn. LexisNexis, Durban Neethling J, Potgieter JM (2015) Neethling-Visser-Potgieter law of delict Oliphant K, Wright R (eds) (2013) Medical malpractice and compensation in global perspective, p 456 Oosthuizen WT (2014) An analysis of healthcare and malpractice liability reform: aligning proposals to improve quality of care and patient safety. Unpublished LLM Thesis, University of Pretoria, p 14 Oosthuizen WT, Carstens PA (2015) Medical malpractice: the extent, consequences and causes of the problem. THRHR 273–275 Patel B (2008) Medical negligence and res ipsa loquitur in South Africa. SAJBL 57 Pepper M, Slabbert M (2011) Is South Africa on the verge of a medical malpractice litigation storm? SAJBL 29 Phahlane MO (2015) Office of the Chief Litigation Officer: Department of Health Medical Negligence Summit. Paper presented at the March 2015 Medico-Legal Summit, Pretoria Pienaar L (2016) Investigating the reasons behind the increase in medical negligence claims. PELJ, pp 10–11 Potgieter JM, Steynberg L, Floyd TB (2012) Visser & Potgieter: Law of damages, 3rd edn. Juta, Claremont Potgieter JM, Steynberg L, Floyd TB (2013) Visser & Potgieter law of damages, p 51 Ramsden PA (2009) The law of arbitration van den Heever P (2016) Medical malpractice: the other side. DR, 26 September 2016, pp 49–50 Wessels AB (2018) Developing the South African law of delict: the creation of a statutory compensation fund for crime victims. Unpublished LLD thesis for an analysis of a similar problem that has presented itself in the context of the state’s liability for harm arising from crime Wiese T (2016) Alternative dispute resolution in South Africa: negotiation, mediation, arbitration and ombudsmen

Cases Administrator, Natal v Edouard 1990 (3) SA 581 (A) Areva NP Incorporated in France v Eskom Holdings SOC Ltd 2017 (6) SA 621 (CC) Broude v McIntosh 1998 (3) SA 60 (SCA) Buthelezi 2002 (6) SA 21 (SCA) Buthelezi v Ndaba 2013 (5) SA 437 (SCA) Cape Metropolitan Council v Graham 2001 (1) SA 1197 (SCA) Castell v De Greeff 1994 (4) SA 408 (C) Country Cloud Trading CC v MEC, Department of Infrastructure Development 2015 (1) SA 1 (CC) Cusa v Tao Ying Metal Industries 2009 (2) SA 204 (CC) Economic Freedom Fighters v Speaker of the National Assembly 2016 (5) BCLR 618 (CC) Esterhuizen v Administrator, Transvaal 1957 (2) SA 710 (T)

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Fourway Haulage SA (Pty) Ltd v SA National Road Agency Ltd 2009 (2) SA 150 (SCA) Goliath v MEC for Health, Eastern Cape 2015 (2) SA 97 (SCA) International Shipping Co (Pty) Ltd v Bentley 1990 (1) SA 680 (A) 700 Khoza v MEC for Health and Social Development, Gauteng 2015 (3) SA 266 (GJ) Kruger v Coetzee 1966 (2) SA 428 (A) Le Roux v Dey 2011 (3) SA 274 (CC) Links v Department of Health, Northern Province 2016 (4) SA 414 (CC) Loureiro v iMvula Quality Protection (Pty) Ltd 2014 (3) SA 394 (CC) MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2016 ZASCA 185 MEC for Health and Social Development, Gauteng Provincial Government v DZ obo WZ 2018 1 SA 335 (CC) Medi-Clinic Ltd v Vermeulen 2015 (1) SA 241 (SCA) Minister of Safety and Security v Van Duivenboden 2002 (6) SA 431 (SCA) Mitchell v Dixon (1914) AD 519 Mokhethi v MEC for Health, Gauteng 2014 (1) SA 93 (GSJ) Naidoo v Birchwood Hotel 2012 (6) SA 170 (GSJ) Ngubane v South African Transport Services 1991 (1) SA 756 (A) Ntsele v MEC for Health, Gauteng Provincial Government [2013] 2 All SA 356 (GSJ) Nzimande v MEC for Health, Gauteng 2015 (6) SA 192 (GP) Oppelt v Department of Health, Western Cape 2016 (1) SA 325 (CC) Port Elizabeth Municipality v Various Occupiers 2005 (1) SA 217 (CC) Premier, Western Cape v Kiewitz 2017 4 SA 202 (SCA) Sea Harvest Corp v Duncan Dock Cold Storage 2000 (1) SA 827 (SCA) Standard Chartered Bank of Canada v Nedperm Bank Ltd 1994 (4) SA 747 (A) Van Wyk v Lewis (1924) AD 438

Legislation Academic Health Centres Act 86 of 1993 Arbitration Act 24 of 1898 (Natal) Arbitration Act 29 of 1898 (Cape) Arbitration Act of 1889 Children’s Act 38 of 2005 Chiropractors, Homeopaths and Allied Health Service Professions Act 63 of 1982 Choice of Termination of Pregnancy Act 92 of 1996 Companies Act 71 of 2008 Consumer Protection Act 68 of 2008 Dental Technicians Act 19 of 1979 Government Gazette No. 41658 of 25 May 2018 Health Professions Act 56 of 1974 Legal Practice Act 58 of 2014 Medical, Dental and Supplementary Health Service Professions Act 56 of 1974 Medical Schemes Act 131 of 1998 Mental Health Care Act 17 of 2002 Nursing Act 50 of 1978 Pharmacy Act 53 of 1974 South African Medical Research Council Act 58 of 1991 Transvaal (the Arbitration Ordinance 24 of 1904 (Transvaal))

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Reports Medical Protection Society Challenging the Cost of Medical Negligence (2015) South African Law Reform Commission Project 141: Medico-legal Claims (2017) South African Law Reform Commission Project 82: Sentencing (A Compensation Fund for Victims of Crime) (2004)

Internet Sources CCMA “Conciliation” available at (accessed on 14 December 2017) Health24 “SA’s shocking medical malpractice crisis” (10 March 2015) available at (accessed 17 January 2018) HPCSA “Professional Conduct and Ethics” available at (accessed on 19 January 2017) HPCSA “Overview” available at (accessed on 15 January 2018) T Kahn “Staggered medical negligence bill ‘unfair’ and may endanger patients” Business Day Online < https://www.businesslive.co.za/bd/national/health/2018-06-05-staggered-medicalnegligence-bill-unfair-and-may-endanger-patients/> (accessed on 13 August 2018) L Still “So you want to sue your doctor” available at (accessed on 18 December 2018)

Chapter 17

Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings National Report: Taiwan Hsiu-I Yang

Abstract Taiwan is renowned for her healthcare delivery system that provides all-inclusive comprehensive healthcare services (physician fee, hospitalization, prescription drugs, dental care, Chinese medicine) to the entire 23 million citizens through National Health Insurance since 1996. Taiwanese patients can easily access to needed care at any level of institutions, from clinic to medical center. Accordingly, physician shopping is not uncommon if the patient finds the physician not trustworthy or the medical outcome is not satisfactory. The severity and prevalence of medical injury is a rather under-discussed topic, while the main debate of medical malpractice has been directed by physician’s society and focused mainly on the decriminalization of physicians’ liability. This report first described the featured criminal-first legal culture to provide the backbone of understanding the whole medical malpractice scheme in Taiwan. Part 2 briefly discussed the conventional fault-based legal liability for medical injury and three no-fault compensation schemes in Taiwan. Part 3 introduced the procedural endeavors in the past 20 years to decriminalize medical malpractice by building up alternative dispute resolutions. To give the readers a truthful picture, this report is based on solid empirical studies, scholarly commentaries, and governmental statistics.

H.-I. Yang (*) National Yang Ming Chiao Tung University, School of Medicine, Institute of Public Health, Division of Law and Policy, Taipei, Taiwan e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_17

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Prelude: Overview of Taiwan’ Medical Malpractice Law: Walking Out of the Shadow of Criminal Liability With the implementation of National Health Insurance (全民健康保險, Quan Min Jian Kang Bao Xian) on March 1, 1996, medical malpractice law has ever since gradually developed into an important and independent sub discipline of personal injury law in Taiwan. More and more medical–legal programs or institutions are set up in Law schools and Public Health schools, which have attracted dozens of practicing physicians to study law, in particular, medical malpractice law annually. The core topic of Taiwan’s medical malpractice law is, however, about the efficiency and fairness of holding physicians criminally liable for medical injuries. In addition to the tort liability, physicians who negligently cause death or bodily injury to their patients may be held criminally responsible under Articles 276 and 284 of the Penal Code. Due to the distinct legal culture in Taiwan,1 most injured patients or patients’ families are used to utilize both the criminal and civil system to resolve medical malpractice disputes, and the popular strategy is criminal-first so that the claimants can get free help from prosecutors and access to expert opinions. Moreover, as in other civil law countries like France, Germany, the Netherlands, Sweden, and Switzerland, in Taiwan, the rules of procedure provide for the adjudication of tort damage claims by criminal courts.2 Accordingly, up to the date of 06/08/2019, it was estimated that nearly 63% of medical malpractice lawsuits were first filed in criminal procedure.3 Systematic empirical investigations have shown that such criminal-first practice is a grave misuse of criminal justice resource and lead to an “all loose” situation.4 Less than 10% of accused physicians were eventually prosecuted, among whom less than half were found guilty, and none of the convicted physicians were sentenced to jail. Without a clear distinction between criminal negligence and civil negligence, a not-guilty criminal verdict almost always leads to a civil decision in favor of the defendant doctors, and consequently most damages caused by healthcare were left uncompensated. The high winning rate of the physicians does not offset their emotional distress and suffering associated with the long litigation procedures. Moreover, the society as a whole pays the price not only on wasting precious criminal resource on civil cases, but also on defensive medicine resulted from an increasingly anxious and demoralized medical profession.

1 The apparent preference of Taiwanese patients for using criminal procedures is sometimes attributed to the traditional Chinese legal culture that emphasizes punishment and retribution. See Wang (1986), p. 135. 2 See Articles 487 to 512 of the Code of Criminal Procedure in Taiwan; for discussions about other countries, see Pfennigstorf and Gifford (1991), pp. 85–86. 3 See Ministry of Health and Welfare, Division of Health Affairs, Matters on Medical Dispute Resolution and Expert Assessment, Statistics of the Nature of Litigation (up to 2018) https://dep. mohw.gov.tw/DOMA/cp-2712-7681-106.html visited on 2020/04/14. 4 See Yang (2014), pp. 75–93.

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While most commentators agree that criminal procedure is not an appropriate platform for resolving medical malpractice disputes, there is no consensus on how to achieve the goal of decriminalization. Physician organizations have vigorously and persistently endeavored to seek legislative changes by introducing the concept of “gross negligence” into criminal liability. They argue that modern healthcare, a field where elements of risk are indispensable to everyday practice, should not be governed by penal law. In addition, they assert that physicians, a very precious human resource for the whole society, should not be locked behind bars simply because something went wrong and the patient got injured. Opponents to legal decriminalization, who tend to be consumer rights advocates, claim that the criminal liability imposed by Articles 276 and 284 of the Penal Code is not specifically designated for medical malpractice; rather, it is generally applied to any person who in performing his occupational duties negligently causes bodily injury or death to others. According to the basic principle of “equal application of law,” they argue, physicians should not be treated any differently from other professionals. In between, scholars advocate for a “de-facto” decriminalization by establishing a patient-friendly dispute resolution system, where patients’ needs in seeking truth and compensation are acknowledged and answered.5 It is under such background of pursuing a “de-facto” decriminalization of medical malpractice liability; various legislative reforms of the compensation schemes and policy proposals on alternatives to court proceedings are crafted in the past 20 years.

Compensation Schemes for Damages Caused by Healthcare A Combination of Fault-based and Cause-based Compensation Scheme In Taiwanese law, the civil liability of physicians is governed by the rules of contract and tort law, combined with the principle of vicarious liability and the general provisions of the civil code. Since claims for compensation are concurrent, medical malpractice actions are often based on either these theories. There are some important differences between the two theories.

Contractual Liability In general, medical treatment is given within a contract between doctor and patient. Taiwanese law distinguishes between contracts for work, which promise a specific result, and contracts for services, which promise skillful and careful performance. A medical contract is commonly deemed a contract for services (委任 Wei Ren, article 5

See Huang and Yang (2015), pp. 1845–1885.

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528 of Civil Code), rather than a contract for work (承攬 Cheng Lan, article 490 of Civil Code) because the physician does not owe a specific result or a cure.6 If contractual liability is given, a patient can claim compensation for all physical or financial loss and damage that is caused by the physician's negligent conduct. Also, under the contractual claim, vicarious liability can be invoked more easily,7 and the statute of limitations is longer8 than those in a tortious claim. However, compensation for personal pain and suffering, which is often the most important part of the damage, may only be granted on the ground of tortious liability (arts. 193, 195 of Civil Code).

Tort Liability The basis of tort liability is article 184 that provides that a person who intentionally or negligently violates the right of another is bound to make compensation for the damage resulting therefrom. For a tort to be established, the following requirements must be fulfilled: (a) fault or negligence; (b) damages; and (c) a causal nexus between act and damage: the physician is only liable if there is a causal relationship between the wrongful act and the damage. The general standard of liability in tort remains negligence, with comparative negligence also being applied.9 In addition to the general fault-based rules of compensation, three distinct types of injuries are compensated on an administrative no-fault base: vaccine injury, drug adverse reaction, and childbirth accident. Vaccine Injury Compensation Program (VICP) 198810 In response to the outcome in which a child received oral poliovirus vaccine and subsequently developed polio in 1986, the then Department of Health of the Executive Yuan (now known as Ministry of Health and Welfare) implemented the Vaccine Injury Compensation Program (VICP) and established a Compensation Relief Funds that pays for vaccine-injured individuals in June, 1988. The current legal framework for Taiwan Vaccine Injury Compensation Program is the “Disease Control Act” (Article 30) as well as the “Regulations Governing Collection and Review of Relief Fund for Victims of Immunization”. These laws regulate 6

E.g. The Supreme Court 53 Docket No. TAI-SHAN 2354 (1964) (最高法院五十三年台上字第 2354 號判決); The Supreme Court 70 Docket No. TAI-SHAN 1049 (1981) ( 七十年台上字第 1049 號判決). 7 See art. 224 of Civil Code compared to art. 188 where the principal has the possibility of exculpation. 8 The statute of limitations of filing a contractual claim is 15 years, while tort claim 2 years. See art. 125 of Civil Code compared to art. 197 of Civil Code. 9 Article 217 of Civil Code. 10 Detailed discussion of Taiwan’s VICP, see Wang (2015), pp. 149–158.

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administration, funding, eligibility, filing requirement, review committee, and types of compensation for the program. The Compensation Relief Fund is funded from the premium of NT1.5 dollars imposed on each vaccine purchased by the government. The premium is paid by vaccine manufacturers or importers after purchased vaccines are approved and certified by Taiwan Food and Drug Administration (TFDA). To file a VICP claim is simple and straightforward. All the claimant has to do is filling out a claim form and describing adverse events following vaccination to local health bureau, who then will collect a set of medical records dated at least 1 year before and after the injury for further processing. Claims are first reviewed by two members carefully chosen from VICP Working Group based on their expertise and types of adverse events. After reviewing the case thoroughly, the experts produce a primary review opinion and suggest amount of compensation awards if applicable. The cases are then brought to the VICP Working Group review meeting, which is held every other month, with a maximum interval of 60 days between two meetings, so as to ensure that the injury cases are solved in a timely fashion. During the meeting, the chairperson moderates discussions and determines if there is “causation” between the adverse event and the particular vaccine and amount of compensation award. The only criterion for compensation is “causation”, which is classified into three types: related, unable to exclude the relation, and unrelated. After a decision is made, the claimant is informed of whether or not the case is compensable. Until August 2014, a total of 1399 claims were reviewed and 560 claims had been determined as compensable. Moreover, 223 out of 839 dismissed claims, though not compensable, were given subsidies to cover funeral costs, medical expenses and fetal/embryo examination fee. The compensation awards and subsidies for claimants were paid from the Compensation Relief Funds and the amount had reached 95,599,487 NT dollars. Moreover, the program is able to resolve injury claims in a timely fashion. In the year 2013, 98 injuries cases were resolved with an average processing time of 155 days from the date of acceptance.

Drug Injury Relief Program (1999) Taiwan is one of the few countries with a specific scheme that serves to relief the drug related injury in terms of financial and social perspectives. In response to several social events related to the adverse reactions caused by terbinafine and itraconazole in 1997 in Taiwan, the Department of Health of the Executive Yuan (now known as Ministry of Health and Welfare) developed a drug injury relief program providing a timely relief to patients who suffered from adverse reactions in 1999, and Drug Relief Law was enacted in 2000. The government further established the Drug Hazard Relief Fund and the Taiwan Drug Relief Foundation (TDRF) in 2001 to operate the drug relief activities and levy the annual funding from the pharmaceutical industries. TDRF now receives patients’ applications for drug relief, educates people on drug safety, collects relief fund, releases subsidy, and establishes databases for Pharmacovigilance. The process to claim a drug relief is similar to that of vaccine-injury compensation mentioned above. All the claimant has

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Table 17.1 Reasons for unapproved cases of drug relief Reasons for unapproved cases from 1999–2014 (Table 17.2) Category Cases number Not related to drug usage 378 Off-label use 235 Common and foreseeable ADR 222 Faults resulted from people 89 Severity not meet the criteria for relief 50 Others 56 Total 1030

% 37% 23% 22% 9% 5% 5%

Source: Taiwan Drug Relief Foundation, Statistics visited on Feb. 1, 2018 http://www.tdrf.org.tw/ en/04_relief/rel_01main.asp?bull_id¼1034

to do is to fill out an application form to the local health bureau, and then the TDRF will be in charge of all the following data collection and fact investigation so as to decide whether or not the claim is qualified for compensation. Three positive requirements have to be met in order to qualify for drug injury relief: (1) proper usage; (2) legal medicine; and (3) causation. Furthermore, according to the 13th article of the Drug Injury Relief Act, following conditions are ineligible from relief actions: (1) Faults of individuals found in pharmaceutical manufacturers, importers, physicians, victims or others; (2) Adverse drug reactions occurred before Drug Injury Relief Act is enacted; (3) Victims have received subsidy from other relief programs such as vaccination injury relief program; (4) Victims have been compensated for the same event by means other than health insurance; (5) Severity of adverse drug reactions has not reach the level for subsidy; (6) The injury from drug overdose under the emergency medical care; (7) The injury from using investigational drugs; (8) Off label use of medicines; (9) Common and predicable adverse drug reactions; (10) Other situations that are announced by authority. Pursuant to these rules, Taiwanese drug injury relief program is a distorted “nofault” system in that it actually consider “fault”. As a matter of fact, it was not rare that the reviewing committee found fault in prescription or dispensing and then rejected the victim’s claim. From the statistics of 1999–2014, 89 of a total 1030 unapproved cases (9%) were due to fault found in cases (see Table 17.1). Scholars have criticized such stipulation as wrongfully punishing the innocent victims for other’s fault and urged for law revision.11

11

See Lee and Yang (2014), pp. 119–140.

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Childbirth Accident Relief Program (2012) Taiwanese physicians have long dissatisfied with the risk of being held criminal liable for medical injuries. The agony has piled up with the increasing workload and decreasing income following the global budget system adopted by the National Health Insurance in 2002. More and more young medical graduates choose to practice in low-risk specialty such as dermatology, rehabilitation, and cosmetic medicine. The National Health Research Institutes in Taiwan published an empirical investigation report in 2013, predicting that Taiwan will face a shortage of supply of doctors in general medicine, surgery, obstetrics and gynecology, pediatrics and emergency by 2022.12 A popular term “五大皆空” (Wu Da Jie Kong, the great five emptiness) was widely used in mass media to alarm the public of a near-future crisis in the health care delivery system. At the same time, the (extremely) low birth rate in Taiwan (ranked 222 among 224 countries)13 also forced the authority to take actions to respond to this national security issue. The Ministry of Health and Welfare started a pilot project on childbirth accident compensation in 2012, in which 90% of health care institution voluntarily participated and more than 300 families were compensated within 40 days of childbirth accident. The pilot project was funded by public budget from the Medical Development Fund. It has spent about 300 million NT dollars and decreased more than 70% of lawsuits within the period. The success of the project leads to the enactment of Childbirth Accident Emergency Relief Act in 2015. Other than establishing a no-fault compensation scheme for childbirth accident, the Act also incorporates various up-to-date patient safety mechanisms in the hope to create a patient-centered and care-oriented dispute resolution model. There are four legislative duties stipulated by the Act: C.A.R.E.- Care, Assist, Report, and Evaluation.14 (a) Duty of Care Volumes of studies have revealed that the foremost need for the patient or their families upon the occurrence of an unanticipated injury is to know the truth. Such need of information, if unanswered, often leads to following disputes and even formal accusations. However, it is a special knowledge and technique on how to communicate with upset and angry patients. To build up the institutional competency, article 4 of the Act requires that hospitals shall set up a childbirth accident “care group”, and clinics or midwifery agency shall designated a care specialist, to explain to and communicate with puerperae, their family, or representatives and to

h t t p : / / w w w . n h r i . o r g . t w / N H R I _ W E B / n h r i w 0 0 1 A c t i o n . d o ? s t a t u s ¼S h o w _ D t l & nid¼20141219679218210000&uid¼20081204954976470000, visited on 2018/02/02. 13 Central Intelligence Agency, Country Comparison: Total Fertility Rate (2017) https://www.cia. gov/library/publications/the-world-factbook/rankorder/2127rank.html, visited on 2018/02/03. 14 Childbirth Accident Emergency Relief Act Art. 1: To alleviate the risks to women during childbirth, a national relief mechanism is established to ensure timely relief for puerperae, fetuses, and newborns in case of accident during the childbirth process. This Act is enacted to reduce medical disputes, promote the partnership between puerperae and medical personnel, and enhance the health and safety of women during childbirth. 12

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provide assistance and care service within two working days after the occurrence of a childbirth accident. Members of the “care group” shall include professionals in law, medicine, psychology, and social work, etc. Moreover, the central competent authority shall set up funds to strengthen care personnel’s training in providing explanation, communication, and care, so that childbirth accident disputes may be resolved more efficiently. (b) Duty of Assist In addition to provide explanations, the “care group” or “care specialist” should assist the victims in collecting records and applying for childbirth accident relief. According to article 5, in the event of a childbirth accident dispute, the medical care institution or midwifery agency shall provide a copy of personal medical records, all examination reports, NHI medical orders, etc. within three working days upon the request; the information shall be provided within seven working days at the latest if the information is in a large amount. The childbirth accident relief is available only for cases that have causation with childbirth or such causation cannot be excluded. However, no relief will be given in any one of the following circumstances (article 11): 1. The adverse outcome suffered by the pregnant woman or puerpera and the fetus is caused by termination of pregnancy for non-medical causes; 2. Fetal death (including stillbirth) or adverse outcomes on a newborn caused by severe congenital malformation, gene defect, or premature birth at less than 33 weeks’ gestation; 3. Psychological or psychiatric disorders suffered by the pregnant woman or puerpera are caused by pregnancy or childbirth; 4. A childbirth accident for which a civil action, or private prosecution or accusation of a criminal case has already been filed. However, this does not apply to the following situations: (1) The civil litigation is withdrawn before the conclusion of the court trial hearing in the first instance; (2) For cases indictable only upon complaint, the accusation is withdrawn before the end of the investigation; or the private prosecution is withdrawn before the conclusion of the trial hearing in the first instance; (3) For cases indictable not upon complaint, written intent of non-pursuit is submitted before the end of investigation. 5. Availability for cases to apply for relief pursuant to drug hazards, vaccinations and other laws; 6. Fake or fraudulent information used in the application for relief; 7. Childbirth accidents that occurred before the implementation of this Act. (c) Duty of Report To prevent and reduce childbirth accident risks, medical care institutions and midwifery agencies shall develop in-house risk control and incident reporting mechanisms. They shall analyze the root causes of severe childbirth accidents and make proposals for improvements. They are required to report incidents and to be investigated as per the central competent authority’s request. The

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Table 17.2 Compensation scheme for damages caused by healthcare in Taiwan

Damages caused by healthcare

Principles Fault No-Fault

Types of Injuries/ compensation scheme

Vaccine-Injury/ Vaccine-injury compensation program 1988 Drug-induced injury/Drug Injury relief program 1999 Birth-related injuries/Childbirth accident relief program 2012

Legal bases Tort Law Contract Law Communicable Disease Act, article 30: Regulations Governing Collection and Review of Relief Fund for Victims of Immunization Drug Injury Relief Act 2000

Childbirth Accident Emergency Relief Act 2015

Forum Court Ministry of Health and Welfare via TWCDC Ministry of Health and Welfare via TDRF Ministry of Health and Welfare

competent authority shall monitor the implementation of the improvement proposals within one year after an incident is reported. The content of analysis for the root causes of severe childbirth accidents shall not be used as evidence in judicial cases (Art. 22). (d) Duty of Evaluation Art. 23: The competent authority shall perform statistical analyses and publish the results annually for the childbirth accident relief cases processed. The aforesaid publication of the results shall include analyses of cases in accordance with levels of medical care institution, region, and sex. Art. 24: For medical care institutions and midwifery agencies where childbirth accident disputes or childbirth accidents occur, the central competent authority may analyze the causes when necessary and order the institution/agency to conduct a review and make an improvement proposal. The institutions or organizations with credibility may be commissioned to perform the analyses mentioned in the previous paragraph, and regard shall have had to the principles of anonymity, confidentiality, and mutual learning. Also, the analyses shall not aim at punishment or attribution of responsibility. In sum, the overall compensation scheme for medical malpractice in Taiwan is organized within the court system, while three distinct types of injury are compensated by administrative no-fault system respectively (see Table 17.2).

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Normative Framework Defining and Determining the Existence of Fault, Standard of Care, and Accidental risk Both in tort and contract claim, plaintiffs in medical malpractice cases are required to prove negligence or fault. Since the Civil Code in Taiwan does not provide any definition of negligence, the description of Article 14 of Penal Code becomes the golden standard of defining negligence. It says that “a conduct is committed negligently if the actor fails, although not intentionally, to exercise his duty of care that he should and could have exercised in the circumstances.” Accordingly, all the legal scholars agree that the legal concept of negligence includes: (1) the existence of a duty of care; (2) capacity to exercise the duty of care, including foreseeability and preventability; and (3) breach of the duty of care. Because members of professional groups share a body of knowledge and expertise, and because the professions typically are self-regulating, the law generally allows the various professions to define their own “standards of care”. The standard of care for a professional is the degree of care customarily or ordinarily exercised by other members of the profession.15 In Taiwan, medical malpractice cases are routinely sent to the official Medical Review Board of the Ministry of Health and Welfare (hereinafter the “MRB”) for “professional assessment” (專業鑑定, Zhuan Yeh Jian Ding). The MRB was established in 1987 pursuant to Article 98 of the Medical Care Act. One of its missions is to provide professional assessment upon request from judicial organs.16 To better perform its statutory functions, the MRB is further divided into 3 working groups: the Medical Technology Group, the Medical Assessment Group, and the Medical Resource and Specialist Group. The Medical Assessment Group consists of 21–36 reviewing members; of which 2/3 are medical professionals from different specialties, and 1/3 are law-related experts. All the cases seeking assessment will be first sent to two individual doctors in different teaching hospitals for primary review, and then a Group meeting is regularly held to collectively decide if the alleged case is deemed “careless”(有疏失, Yo Shu-Sh), “not careless”(無疏失, Wu Shu-Sh), or “likely careless”(可能有疏失, Ke Neng Yu Shu-Sh). In the year of

15

Gifford and Richman (1991), pp. 15–16. Medical Care Act Art. 98: The central competent authority shall establish a medical review committee, which shall set up different working groups in accordance with the different missions, which are as follows: 16

1. 2. 3. 4. 5. 6. 7. 8.

Improvement of the medical care system; Review of medical technologies; Review of human trials; Assessment commissioned by the judiciary or procuratorial authority; Improvement of the specialist system; Promotion of medical ethics; Review of establishment or expansion of large hospitals exceeding a certain scale; Review of other medical affairs.

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2018, a total of 391 cases were assessed by the MRB, and of which 23 (5.88%) were found “careless”, 310 (79.28%) were found “not careless”, and 3 “likely careless”.17 Like many other jurisdictions,18 the Supreme Court in Taiwan has made it clear that the courts are the final arbiters and have the right to hold that a recognized professional practice is itself negligent.19 In the understanding that the ultimate issues of liability such as negligence and causation should be decided by the court, the MRB deliberately chooses the term “carelessness” (疏失, Shu-Sh) to be distinguished with the legal term “negligence”(過失, Guo-Sh). Ironically, the good intention brings about a confusing and even contradictory outcome for it is impossible to discern “carelessness” from “negligence”. Basically, the two terms are interchangeable in Chinese writing; both are evaluative in nature, denoting a blamable status. Though legally speaking, the MRB opinion, with no binding power, is only points of reference in court’s determination of negligence; the reality appears to be that in most cases Taiwanese courts conveniently rely upon the MRB’s finding of carelessness in making the final judgments of negligence. Studies have found that court decisions concurred with the MRB findings in more than 90% of cases. In few situations that the court disagreed with the MRB’s opinions, what it often did was to resent the case to a different professional institution (such as teaching hospitals) for a second assessment. It is obvious that a centralized expert review system providing “standard of care” to the court is advantageous in preventing “battle of experts” on trail and in saving time for judges in writing verdicts. Problems associated with such practice, however, are two folds: (1) for both the plaintiff and the defendant, their rights to trial might be violated because they are not allowed to present their views to and challenge the view taken by the MRB in the first place; and (2) for the court, its ability to hear and resolve medical malpractice is compromised by the overreaching concept of “carelessness”. With the development of health care law and accumulation of relating literatures, Taiwanese judges have been more and more willing to set the standard of care independent from the MRB’s opinion of carelessness. Pursuant to Article 83 of Medical Care Act,20 professional medical court was established in five district courts and four high court starting 2005. Continued education for the judges is offered annually to enhance their ability in hearing medical malpractice cases. Currently, the court typically inquires MRB’s professional assessment about “medical custom”,

17 Ministry of Health and Welfare, Division of Health Affairs, Matters on Medical Dispute Resolution and Expert Assessment, Statistics of the Assessment Outcome (up to 2018) 衛生福利部醫事 司,醫事爭議處理、鑑定等相關業務,鑑定結果統計表(至107年)https://dep.mohw.gov.tw/ DOMA/cp-2712-7681-106.html visited on 2020/04/14. 18 These jurisdictions include England, Ireland, New Zealand, Australia, Canada, the United States, and many other Civil Law countries. See Giesen (1989), pp. 117–120. 19 See the Supreme Court 79 Docket No. Tai-Shang 540 (1990), 最高法院七十九年台上字第 五 四○號判例. 20 Medical Care Act, Art. 83: The Judicial Yuan shall appoint courts to establish professional medical courts, in which a judge with related professional medical knowledge and trial experience shall handle medical disputes and litigation.

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“accepted medical standard”, “practice guideline”, “standard operational procedure”, etc. to determine what a reasonable physician should do in an argued situation. The Ministry of Health and Welfare issued Points of Operation for Medical Malpractice Assessment in 1997, indicating that the MRB’s assessment should be based on accepted medical knowledge and medical custom, taking into account local medical resource and local medical standard. Such locality rule has been incorporated into code language in the revision of Medical Care Act Article 82 in 2017. It stipulates in paragraph four that “in determination of the breach of duty of care and scope of professional discretion, one should comprehensively consider matters concerning the local medical custom, medical standard, medical facilities, working conditions, and emergency at the time.”

Determining the Burden of Proof According to the general principle of burden of proof in Taiwan, each party carries the burden of proof for the factual conditions of the statutory norm favorable to him or her (Article 277 of the Code of Civil Procedure). This principle also applies to the physician's liability in contract or tort. From this allocation of the burden of proof it follows that the plaintiff in a medical malpractice suit has the burden to prove that his injury was caused by a defective treatment for which the defendant is responsible. Thus, the plaintiff generally has to prove medical injury, negligence, and causation. The application of this rule has put the patient at a disadvantage because he may not know what treatment he received or how the injury he suffered came about. To alleviate the medical malpractice plaintiff’s burden so as to prevent his/her case from failing in limine, the German Federal Constitutional Court held that medical malpractice cases require flexible practice with regard to the law of evidence and that the burden of proof should fairly be shifted onto the shoulders of the physician or hospital whenever, in individual cases, this is demanded by considerations of justice.21 Following the German model, Taiwan amended the general rule of burden of proof by adding an exception to the Article 277 of Code of Civil Procedure in 2000. It says “A party bears the burden of proof with regard to the facts which he/she alleges in his/her favor, except either where the law provides otherwise or where the circumstances render it manifestly unfair.” The first medical malpractice case shifting the burden of proof to the defendant doctor and hospital was rendered by the Taipei District Court in 2001, in which the judge also cited the rule res ipsa loquitor to strengthen its application of the exception clause of Article 277.22 It is said that where the burden of proof lies, loses lies. An empirical study has found that the patient’s winning rate in medical malpractice cases increased from 19% to 41% when the burden of proof was shifted to the defendant doctor and

21

Giesen (1993), pp. 27–31; Lousanoff (1982), pp. 81–109. Taiwan Taipei District Court Civil Case 87 Docket No 1521, 2001 (臺灣臺北地方法院民事判 決87年度訴字第1521號). 22

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hospitals.23 However, it is up to the discretion of individual judge to allocate the burden of proof. In the period of 2000–2005, there was 173 medical malpractice cases were tried for compensation in the district court; the courts shifted burden of proof to the defendant in issue of negligence in 17 cases, and causation in 3 cases. Generally speaking, it is uncommon for the defendant doctors to shoulder the burden of proof in Taiwan.24 Nonetheless, because that the physicians and the hospitals have the statutory obligation to make and keep patient records,25 the court has alleviated the patient’s burden of proof in case that the records were missing or incomplete.26

Public and Private Hospitals There is no difference in regulation concerning compensation schemes for medical malpractice in public and private hospitals in Taiwan.

Efforts to Decrease the Frequency and Severity of Medical Litigation Cases Compared with the criminal liability risks, civil liability does not constitute special threat to health care providers in Taiwan. An empirical study has found that in the period of 2000/1/1–2008/6/3, the District Courts in Taiwan have heard a total of 372 medical malpractice cases for civil compensations, involving 531 individaul defendants (of which 469 are physicians) and 29 health institutions. The average time from the occurrence of alleged medical injury to the date of verdict is 4.2 years. The patient-plaintiff won in 69 cases (18.5%), and the highest award was NT 27,462,579 (equal to 0.91 million US dollars), while the lowest NT 56,325 (l878

23

See Shen (2005), pp. 28–49. Ibid. 25 See Physicians Act Art. 12: Practicing physicians shall keep signed or sealed medical records stating year, month and date. Medical Care Act Art. 67: Medical care institutions shall establish clear, accurate, and complete medical records. 26 See 臺灣高等法院台中分院93年度醫上易字3號民事判決。 Code of Civil Procedure Art. 282-1: Where a party intentionally destroys or hides a piece of evidence, or makes it difficult to use, for the purpose of obstructing the use of such evidence by the opposing party, the court may, in its discretion, take as the truth the opposing party’s allegation with regard to such evidence or the disputed fact to be proved by such evidence. In the case provided in the preceding paragraph, the parties shall be accorded an opportunity to present their arguments. 24

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US dollars). The average award was NT 3,723,172 (about 124,105 US dollars).27 Apparently, the number of litigation and amount of paid verdict was quite minimum in an international standard. Even though the filed cases of medical malpractice for civil compensation have steadily increased to around 300 cases per year in latest years, it is still a tiny portion of the total 78,000 medical injuries annually. Given the low frequency and severity of private litigation, it is no wonder that liability insurance is not popular in Taiwan. Currently, there are five types of liability insurance policy available in market provided by 16 insurance companies. In the year of 2015, the number of policy sold was reported as followed: (1) medical malpractice for physicians, Chinese Medicine doctors, and dentists: 13,538; (2) hospital comprehensive liability: 3172; (3) pharmacist liability: 2181; (4) nurses professional liability: 914; and (5) therapist liability: 103.28 Compared with the number of medical practitioners (including 43,961 physicians, 6288 Chinese Medicine doctors, and 13,502 dentists)29 and health care institutions (294 hospitals and 21,683 clinics, including 11,313 Western Medicine clinics, 3705 Chinese Medicine clinics, and 6665 dental clinics)30 in 2015, we can see that only 21.23% of healthcare providers chose the liability insurance as a risk management instrument (see Table 17.3). Therefore, there is no tendency to limit the number of medical litigation cases and neither any inclination to diminish the amount of financial compensation.

Alternatives to Court Proceedings As above-mentioned, the distinct issue of medical malpractice in Taiwan lies in the unproportionately use of criminal procedure. It is widely accepted that the most effective and efficient way to decriminalize medical malpractice is to create a patient-friendly system, which would attract the patient and their families, the dispute initiators, to voluntarily opt for alternatives to court proceedings. Generally speaking, Taiwanese are not litigious people. Folk belief teaches: “Lawsuit always ends in evil.” ( 訟終則凶,Song Zhong Tze Xiong) Six strategies have been identified in patients’ responding to suspicious medical injuries: (1) lump it; (2) exit; (3) claim; (4) seek for non-legal party; (5) consult lawyer; and (6) sue. The most comprehensive study of patients’ experience in 2015 has found that as much as 27% of

27

See Chang (2009). See Taiwan Insurance Institute, 2015 LOSS RATIOS FOR LIABILITY AND OTHER PROPERTY INSURANCE BY SUB-LINE OF BUSINESS (CALENDAR-YEAR BASIS) http://www. tii.org.tw/report_test/0102/69359454533500.pdf visited on 2018/08/02. 29 衛生福利部統計處, 表5歷年醫療院所執業醫事人員數, Ministry of Health and Welfare, Table 17.5 Number of Health Care Practitioners in Health Care Institutions Annually https://dep. mohw.gov.tw/DOS/cp-3052-12060-113.html visited on 2018/02/08. 30 衛生福利部統計處, 104年醫事機構現況及服務量統計分析, Ministry of Health and Welfare, 104 Statistics on Health Care Institutions and Service, 2015, see https://dep.mohw.gov.tw/DOS/lp3051-113.html, visited on 2018/02/08. 28

56,439,742

494 14.3%

22,446,902

13,502

207

6288

190

43,961 21.23%

Chinese Medicine 3705

22,177 Hospitals

63,751 Physicians Clinics Western Medicine 11,313

61,849

7382

Dentists

196,186,555

99,943,100

Chinese Medicine Doctors

Hospital comprehensive liability 3172

Medical malpractice liability 13,538

6665

Dental

215,351

2

13.6%

16,035

1975

4,307,508

Pharmacist liability 2181

59,258

3

0.8%

111,526

2162

1,975,915

Nurses professional liability 914

1,149,706

4

NA

NA

13,692

1,410,227

Therapist liability 103

Sources: Taiwan Insurance Institute, 2015 LOSS RATIOS FOR LIABILITY AND OTHER PROPERTY INSURANCE BY SUB-LINE OF BUSINESS (CALENDAR-YEAR BASIS) http://www.tii.org.tw/report_test/0102/69359454533500.pdf visited on 2/8/2018

Prevalence rate (a)/ (c) No. of Incurred Losses Amount paid

Types of Policy No. Of written policy (a) Amount of written premiums (b) Average premium per policy (a)/(b) No. of practicing professionals (c)

Table 17.3 Prevalence of medical liability insurance in Taiwan 2015 (in NT dollars)

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Table 17.4 Resolution of Medical Malpractice in Taiwan:1991 vs. 2005 Patient Withdrawn or Gave Up (without monetary payment) Settled/Mediated (with monetary payment) Litigations a

1991a 42.3% 42% 15.7%

2005b 42%

Civil 44.0% Criminal 82.3%

34.9% 23.1%

N/A N/A

Chen and Hsieh (1993), p. 50 Wu et al. (2009), p. 4

b

Taiwanese patients suspecting medical malpractice did not take any action. Among those who did take actions, more than half (54%) opted for “exit” and for “claim”. Less then one fourth (23.8%) consulted lawyers, and 18.3% sought for non-legal 3rd parties such as local representatives, NGO, or public media. Lawsuit was the least used strategy: 13.5% filed a civil and 7.9% a criminal litigation.31 This finding concurred with the studies of physicians’ experiences in medical malpractice. Wu and Chen’s investigations of physicians’ experiences of medical malpractice disputes in 1991 and 2005 respectively revealed that only a small part of disputes resorted to litigation, and most medical malpractice disputes were resolved outside the court (see Table 17.4).

Settlements As shown in many studies, in cases of adverse events, most patients or patient families would first ask the doctor or the hospital for explanations.32 Therefore, it is important for the healthcare institutions (hospitals and clinics) to develop an institutional on-site dispute resolution capacity. Few hospitals in Taiwan have risk management department. Social workers or persons in charge of public relations are the most common personnels in hospitals to deal with patients and their families in medical malpractice disputes. While these persons are poorly equipped with necessary knowledges and skills, claimants’ unsettled inquiries naturally evolved into stronger appeals. To enhance the capacity of local health athority in supervising individual healthcare institutions to establish the Care Group in providing care service to patients and their families in medial malpractice dispute, the Ministry of Health and Welfare launched a “Project to Guide the Implementation of Medical Malpractice Care in Healthcare Regions” (輔導醫療區域執行醫療糾紛關懷工作 計畫, Fu Dao Yi Liao Qu Yu Zh Xing Yi Liao Jiou Fen Gong Zuo Ji Hua) in 2015.

31 32

See Huang and Yang (2015). See Zhen (2003).

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Nowadays, all the 26 teaching hospitals and 84 regional hospitals has established the medical malpractice Care Group, but their actual function keeps unknown.

Mediation Administrative Mediation If the disputing parties cannot reach settlement by themselves, they may seek mediation from the Department of Health in local government. According to the Medical Care Act Article 99, municipal and county (city) competent authorities shall establish medical review committees (MRC), and one of MRC’s statutory missions is to provide mediation upon application. Members of the MRC shall include medical experts, legal experts, scholars, and social personages, excluding legislators/councilors and representatives of medical juridical persons, of which legal experts and social personages shall account for at least one-third of the number of members (Medical Care Act Article 100). Currently, there are total 20 local MRCs, and each has its own mediation style; some would assign a single member as mediator, chairing the mediation process with expert assistance from volunteers of the local physicians association; and some would hear and mediate the dispute collectively on member’s meeting. According to the self-reporting data, less than 1000 cases sought for MRC mediation annually, and the success rate was among 35–41% (see Table 17.5). Mediation is voluntary by nature. With the help of skilled mediators, disputing parties hopefully can communicate, negotiate, and eventually reach agreement in a non-adversial surrounding. In response to the strong pressure from the medical society associated with the crisis of diminishing young manpower in the five specialties (general medicine, surgery, obstetrics and gynecology, pediatrics and emergency), the Ministry of Health and Welfare (MOHW) has actively advocated for legislative reform to limit the criminal liability of medical malpractice to “gross negligence” since 2013. In addition, the MOHW proposed a draft act: “Medical Dispute Resolution and Medical Accident Compensation Act” (醫療糾紛處理及 Table 17.5 Number & Result of MRC Mediation: 2008–2016 No. Of Agreement Achieved No. Of Mediation Success Rate

2016 229

2015 217

2014 264

2013 NA

2012 NA

2011 NA

2010 NA

2009 NA

2008 NA

615 37.2%

622 34.89%

645 40.93

888 NA

944 NA

913 NA

839 NA

750 NA

614 NA

Sources: Ministry of Health and Welfare, Department of Health Affairs, Statistics of Medical Malpractice Mediation Nationwide 2014–2016; Statistics of Numbers Applying for Mediation Nationwide 2008–2014 (衛生福利部醫事司,全國各縣市103-105醫療調處案件統計; 全國各縣 市97-102醫療糾紛調處案件量統計) https://dep.mohw.gov.tw/DOMA/cp-2712-7681-106.html, visited on 02/12/2018

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醫療事故補償法, Yi Liao Jiou Fen Chu Li Ji Yi Liao Sh Gu Bu Chang Fa) as a complimentary scheme, in which mediation is designed as a prerequisite condition for civil lawsuit and an administrative no-fault compensation fund would cover all the medical accidents. The draft Act did not succeed in legislation because the huge opposition from the medical society against the establishment of a general no-fault compensation system. It was worried that the moral hazard of the no-fault compensation system will induce more malpractice disputes. However, there was a consensus about the fact that the institutional competence of the local MRC in mediation should be greatly enhanced. In preparation for the future enactment of a mandatory mediation system, the Ministry of Health and Welfare has started to systematically survey the operation of Local MRC and commissioned several working projects to empower the local MRC.

Court-Facilitated Mediation As a matter of law, it is not a new idea to require mediation before lawsuit in certain types of civil disputes. According to the Code of Civil Procedure Article 403I(7), medical disputes should be mediated by the court before an action is initiated. For a long time, this article did not have any substantial impact on real cases for the fact that most cases went to court after a failed MRC mediation. However, the situation started to change in 2012, when the Tai-chong District Court launched a “Pilot Project on Medical Malpractice Pre-trial Mediation, Consultation, and Professional Assessment” (台中地方法院醫療糾紛訴訟前調解,諮詢與鑑定試辦計畫, hereinafter the Pilot Project).33 With the cooperation of Tai-chong Physician Association, this Pilot Project recruited 10 legal mediators (including 5 retired judges, 1 present judges, and 4 judicial officers), 22 medical mediators, 60 medical consultants, and 4 teaching hospitals in Tai-chong region as assessment institutions. The Pilot Project took a co-chair approach for mediation; a legal mediator and a medical mediator worked together. The 22 medical mediators were recommended by the six professional associations in Tai-chong region, and most of them are senior physicians with rich experience in medical malpractice mediation. The Pilot Project did not accept individual application. All cases had to be referred either by the court or by the medical associations, local government, or teaching hospitals. The mediation was operated in three stages. (1) Collection of information stage: all relevant information including patients’ records, nursing notes, and medical images would be gathered in 5 days. (2) Identification of issues stage: based on the information collected, a judge assistant would help in classifying possible factual and legal issues and then informed both parties for opinions in paper. The medical mediator then examined and commented on the written response so that the legal mediator could identify the actual issues and give his/her legal opinions. (3) Mediation stage: if necessary, the two mediators would meet before the mediation date to have further discussion on

33

See Chen (2014), p. 31; Chen (2013), p. 15.

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suggested agreement proposal. The Tai-chong Pilot Project accepted its first case on October 2012 and a total of 45 mediations were conducted by the end of July 2013. Among the 32 closed cases, agreement was reached in 17 cases; the success rate was 53.1%, higher than that of the MRC mediation (40.93%).34 Encouraged by the Tai-zhong experience, Kao-xiong district court, Zhang-hua district court, and Tainan district court have adopted a similar system since 2013. More courts plan to follow in the near future.

Arbitration Taiwanese physicians were once enthusiastic about the idea of arbitration. In 2004, the Chinese Arbitration Association Taipei (中華民國仲裁協會 Zhong Hua Ming Kuo Zhong Chai Xie Huei) trained 37 physicians as medical arbitrators, but no medical malpractice dispute has ever yet resorted to arbitration. As a result, there are currently only 13 arbitrators listing their specialty in medical malpractice, and only two of them have medical background.35 Even though Taiwan has been promoting medical tourism lately, there is no discussion about utilizing international arbitration as a means of resolving claims in cross-border healthcare.

Taiwan Healthcare Reform Foundation (醫療改革基金會) The only organization in Taiwan striving to protect patients’ right in medical malpractice is the Taiwan Healthcare Reform Foundation (THRF). THRF, founded in 2001 by university professors, is an independent, non-governmental organization that aims to improve the healthcare quality and patient’s rights in Taiwan. Its job is to address various healthcare concerns in Taiwan through advocacies, public education, and publications.36 THRF has been providing medical dispute consulting services to the public from the very first beginning. Being the first and only policy advocating grass-root group, THRF insists on no government neither hospital donation policy to assure its neutrality. As a result, THRF is mainly operated by volunteers from the academic society with limited funding from small amount donation. THRF does not provide direct medical or legal assistances; rather, they offer information and advices on where and how to get helps. The public is able to contact the THRF and discuss their cases through email or phone. THRF also

34

See Lin (2014), p. 11. See Chinese Arbitration Association Taipei, Arbitrator, http://www.arbitration.org.tw/ ArbitratorResults.php visited on 2018/02/12. 36 See Taiwan Health Care Reform Foundation, http://www.thrf.org.tw/page/488, visited on 2020/ 04/13. 35

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provide free leaflet: “Medical Dispute Guidelines” to the public. The leaflet includes guidelines on how to prepare a medical litigation, how to seek various consultants, and much other information regards to the medical dispute. In 2001, the Taiwan Healthcare Reform Foundation helped establish a community for the patient and family members who suffered from medical malpractice disputes. Those who joined the community could share their experiences and help each others. “The Taiwan Care Association of Medical Malpractice Dispute” (TCAMMD) was founded in 2007. However, while the THRF is still active in all kinds of healthcare policy issues, the TCAMMD is rarely heard in public.

Proposals De Lege Ferenda As mentioned in above section, the medical society in Taiwan has long been dissatisfied with the criminal resolution of medical malpractice. The crisis of diminishing young manpower in the five specialties (general medicine, surgery, obstetrics and gynecology, pediatrics and emergency) added fuels to the campaign for statutory decriminalization. The Ministry of Health and Welfare (MOHW) has actively advocated for legislative reform to limit the criminal liability of medical malpractice to “gross negligence” since 2013. In addition, the MOHW proposed a draft act: “Medical Dispute Resolution and Medical Accident Compensation Act” (醫療糾紛處理及醫療事故補償法, Yi Liao Jiou Fen Chu Li Ji Yi Liao Sh Gu Bu Chang Fa) as a complimentary scheme, in which it requires all hospital with 100+ beds should establish a special “Medical Malpractice Care Group” to help the patients and the patient families. Furthermore, mediation is designed in the draft act as a prerequisite condition for civil lawsuit and an administrative no-fault compensation fund would cover all the medical accidents. The draft Act did not succeed in legislation because the huge opposition from the medical society against the establishment of a general no-fault compensation system. It was worried that the moral hazard of the no-fault compensation system will induce more malpractice disputes. As discussed in above sections, despite the failure of legislation, a lot of reform projects such as setting Care Group within hospitals and strengthen the capacity of mediation, have been put into force to prepare for the future passage of the Medical Dispute Resolution Act.

Systemic Remarks The National Health Insurance has provided an universal coverage of comprehensive medical service, including hospitalization, prescription drugs, dental care, and Chinese Medicine to all Taiwanese since 1996. The system is internationally renown for its low cost and high accessibility. Comparatively speaking, there is no problem

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in waiting lists or lack of healthcare. Therefore, there is no claim ever raised on those issues.

References Chang Y-T (2009) An Empirical Study of the Civil Lawsuits of Medical Malpractice in the District Court in Taiwan, Master Thesis, Institute of Public Health, National Yang Ming University, 2009) 張耘慈,臺灣地方法院民事醫療糾紛判決之實證研究,國立陽明大學,公共衛生研究 所碩士論文 Chen R-J, Hsieh C-R (1993) Impacts of Medical Malpractice on Health Care Cost, Table 17.5, p. 50, Research Report of the Department of Health (1993) 陳榮基、謝啟瑞,醫療糾紛對醫療 成本之影響,行政院衛生署八十年委託研究計畫研究報告,頁50 表五 Chen XD (2013) Dealing with medical risks and dispute resolution – on the pilot program of Tai-chung District Court. In: Chun-Fu C (ed) A new way of thinking medical malpractice dispute resolution – centered on the pilot program of Tai-chung District Court:15; 陳學德 (2013),h醫療風險與糾紛解決之道――從臺灣臺中地方法院試辦醫療制度談起i,收於:陳 聰富(編)(2014),hh醫療糾紛處理之新思維(一)―以臺中地院醫療試辦制度為中心ii,頁15。 Chen XD (ed) (2014) Lessons and experiences of Tai-chung District Court in medical malpractice mediation, Consultation and Expert Review 陳學德(編)(2014),hh臺中地院醫療調解、諮詢、 鑑定制度經驗分享ii Giesen D (1989) International Medical Malpractice Law: A Comparative Law Study of Civil Liability Arising from Medical Care Giesen D (1993) Civil Liability in the Field of Medicine, 27–31, Eleventh Conference on the Law of the World, Cairo, Egypt, September 25–30, 1993 Gifford DG, Richman WM (eds) (1991) A Comparative Study of Liability Law and Compensation Schemes in Ten Countries and the United States, 15–16 Huang Y-Y, Yang H-I (2015) Why do patients sue their doctors: a patient-centered empirical legal study. Natl Taiwan Univ Law Rev 44:4, pp 1845–1885 黃鈺媖、楊秀儀,病人為何要告醫師? 以糾紛發動者為中心之法實證研究,台大法學論叢44卷4期,頁1845-1885 Lee M-R, Yang H-I (2014) Does no-fault compensation equal to non-blame? A critical re-flection on the Article 13 of drug injury relief act. Taiwan Law Rev 228:119–140 李明蓉,楊秀儀,「無 過失補償」就是不究責嗎?–從藥害救濟法第十三條第一款談起,月旦法學228期,頁119140 Lin Y-L (2014) On the law and judicial practice of medical malpractice: ADR Tai-chung experience. J Law Med 21:1, p 11 林義龍,論醫療糾紛處理之法制與實務–ADR台中經驗,醫事法 學21卷第1期,頁11(2014年6月) Lousanoff O (1982) Facilitations of Proof in Medical Malpractice Cases: A Comparative Analysis of American and German Law Pfennigstorf W, Gifford DG (1991) A Comparative Study of Liability Law and Compensation Schemes in Ten Countries and the United States Shen G (2005) On the application of the equal weapon rule in medical malpractice litigations. Taiwan Law Rev 17, 沈冠伶,武器平等原則於醫療訴訟之適用,月旦法學雜誌17期,頁28-49 (2005) Wang P-C (2015) Updates on vaccine injury compensation program in Taiwan and program evaluation. Taiwan Epidemiol Bull 31(18):149–158 Wang T-J (1986) The legal aspect of medical compensation--civil liabil-ity of medical malpractice. Med Legal Study 1:134–139 (王澤鑑 ,「賠償醫學的法律觀-醫事衛生案件的民事責任」, 醫事法學第一卷第五、六、七期合刊本:134-139(七十五年一到六月)

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Wu J-Y, Huei-Zhen L, Rong-Ji C (2009) Status Quo of medical malpractice in Taiwan. Formosa Med Rev 13:1, Table 17.2, p 4 (2009) 吳俊穎、賴惠蓁、陳榮基,台灣的醫療糾紛狀況,台灣 醫學13卷1期,頁4表二 Yang H-I (2014) Myths and realities of medical malpractice in Taiwan: fifteen years after. CrossStrait Law Rev 45:75–93 楊秀儀,台灣醫療糾紛之迷思與真相–十五回顧與展望,月旦民商 法雜誌45期,頁75-93 Zhen Z-Z (2003) A study of medical malpractice resolution: focusing on the cases from Taiwan medical revolution foundation, Master Thesis, Taipei Medical University, Institute of Health Care Management (2003) 鄭志忠(2003),hh醫療糾紛案件處理之探討-以台灣醫療改革基會 收案對象為例ii,台北醫學大學醫務管理學研究所碩士論文,台北

Chapter 18

Alternative Compensation Schemes for Medical Malpractice in the United Kingdom Colm Peter McGrath

Abstract This chapter examines the state of law and regulation concerning medical malpractice in the UK in the context of alternative compensation or redress schemes available for patients who find themselves injured in the course of a healthcare interaction. A reader will find that the overwhelming majority of such injuries are left to be dealt with by more or less unaltered private law rules. It is characteristic of the English common law that there is little by way of a lex specialis that deals with such injuries. Indeed, suggestions of generally implementing anything akin to many continental-style no-fault compensation or redress schemes have been rejected on grounds of the likely cost of doing so. Nevertheless, there are a number of small scale, specific schemes, along with a redress scheme for relatively low-level injuries now in operation in Wales, and a number of specific procedural requirements in the context of malpractice litigation generally that are worth considering as relevant in this space.

The Shape of Compensation for Medical Malpractice in the UK The overall framework for the recovery of compensation for medical malpractice is provided for by the positive law administered by the regular civil court system within the UK. The constitutional architecture within the United Kingdom (UK) does not recognise the institutional division between the civil law and administrative law familiar to many other European systems. This may be unpacked further. The relevant law is almost entirely non-statutory, that is to say it is part of the common law, the body of formal rules drawn from and developed by court practice in the UK. As a matter of legal doctrine, within that body of rules, the relationship between doctor and patient is ordinarily governed by tort C. P. McGrath (*) Dickson Poon School of Law, King’s College London, London, UK e-mail: [email protected] © Springer Nature Switzerland AG 2021 D. Bach-Golecka (ed.), Compensation Schemes for Damages Caused by Healthcare and Alternatives to Court Proceedings, Ius Comparatum - Global Studies in Comparative Law 53, https://doi.org/10.1007/978-3-030-67000-9_18

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law, which imposes a direct extra-contractual civil law obligation on those providing healthcare to avoid intentional and, more importantly, negligent harm to patients. Where a practitioner is employed by a healthcare provider, that provider may be held liable according to general principles of vicarious liability. In practice, as the overwhelming majority of healthcare in the UK is provided by the National Health Service (NHS), this is the most common form of ultimate liability for medical malpractice. An aggrieved claimant may feel motivated to forgo a vicarious action, suing the relevant practitioner personally and indeed this may be the only option where healthcare is provided outside of the National Health Service. Less frequently, tort liability may also operate, in appropriate circumstances, directly against the healthcare institution themselves rather than vicariously. Here, the nature of the claim is, necessarily, more obviously focused on organisational failures rather than the personal error of a particular member of the medical staff.

The Relevance of Tort Law Within tort law, two individual torts are particularly relevant in the healthcare context: The tort of trespass protects the patient’s bodily integrity against intentional, direct interreference, and requires the patient to demonstrate they did not consent to this interference. Trespass is a tort which is actionable per se, meaning that the patient (the claimant) does not have to demonstrate any damage resulting from non-consensual bodily interference. They will be compensated, albeit, nominally if there is nothing more than mere touching, for the interference alone. Trespass thus aims to vindicate and, where there is harm, compensate the violation of a patient’s bodily interest. However, trespass is seldom used in the medical malpractice context as the courts are satisfied with the patient being informed of the risks associated with medical treatment in broad rather than specific terms in order to meet the bar for defeating a claim in trespass.1 The overwhelming majority of medical malpractice actions therefore concern the tort of negligence, which requires both proof of the defendant's fault, and that the patient suffered an actionable form of harm. This requirement of harm, and the ultimate calculation of the loss suffered by the patient in terms of the monetary damages that are awarded, lends the tort of negligence it’s characteristic feature as a primarily compensatory legal tool. The English common law allows for exceptional circumstances where a claimant may recover more than the value of their harm despite the action being rooted in the tort of negligence. The courts have made clear that such damages are inappropriate as a potential consequences of negligence in the healthcare context, albeit that behaviour by the defendant that causes a particularly

1

Chatterton v Gerson [1981] QB 432.

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acute degree of distress may be accounted for in the process of calculating the compensatory award.2 The primary interest of the tort of negligence in this context is protection of the patient’s bodily and psychiatric integrity and direct, which is to say, consequential economic losses. The law does not ordinarily protect the patient’s economic interests beyond those immediately connected to their physical injury, although this includes reduced capacity to earn throughout their remaining life.3 Damages awarded in a successful negligence action also routinely include the award of non-pecuniary losses to represent the patient’s pain, suffering and loss of amenity and, in all cases, must be proven by each individual claimant.4 Tort’s zealous emphasis only on the relationship between doctor and patient may be seen in the fact that the law only exceptionally provides a third party with a claim, particularly with regard to causation of economic loss.5

The Relevance of Contract Law Away from tort, whilst it is not impossible, in principle, to conclude a contract with a healthcare practitioner, this relies on healthcare being provided in a private capacity as care provided by the NHS is not provided on the basis of any sort of contractual relationship between the patient and practitioner or institution. Due to the organisation of healthcare provision within the UK such cases account for a relatively small proportion of both care, and, in practice, of compensation claims, and it may be assumed that all situations discussed below involve public rather than private healthcare, unless otherwise stated. Even then, the courts have been unwilling to allow a mere doctrinal difference in the method of creating a private law obligation to impose a different abstract duty on the defendant or to lead to a different standard of care,6 or, finally, to protect a broader range of interests than would ordinarily be the case in the tort of negligence. Thus, even in situations where a patient is receiving care under a contract, the obligation imposed will be one of reasonable care to achieve the agreed goal (obligation de moyen) which then, necessarily, requires proof of fault to be actionable, and proving fault will be approached in an identical fashion to the tort of negligence.

2

Kralj v McGrath and St Theresa’s Hospital [1986] 1 All ER 54. Pickett v British Rail Engineering Ltd [1980] AC 136. 4 H West & Son Ltd v Shephard [1964] AC 326. 5 West Bromwich Albion Football Club Ltd v El-Safty [2006] EWCA Civ 1299; [2007] PIQR P7. 6 Thake v Maurice [1986] QB 644. 3

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Recovery and Regulation Conventionally compensation is recovered vicariously from the institution employing or relying on a healthcare practitioner to supply the level of care that meets the institution’s statutory requirement. This vicarious liability is regarded as very broad in the healthcare context, and a formal employment relationship between the practitioner and an institution is not required.7 Since 1996, a separate institutional body within the structure of the NHS, NHS Resolution (NHSR—known from 1996–2017 as the NHS Litigation Authority (NHSLA)) has satisfied judgments against medical practitioners within the NHS.8 It is possible to sue any practitioner in their private capacity although the vicarious action will, almost inevitably, provide access to deeper pockets and many leading cases have involved actions against private practitioners in this fashion.9 Medical practitioners and institutions are, separately, regulated by a number of professional disciplinary bodies. Central to this system is the role of the General Medical Council (GMC), whose main role is to maintain and police a register of those qualified to practice medicine in the UK, a right which they can withdraw following appropriate disciplinary action, although other lesser sanctions are also available.10 A complaint may be made by a private person, but compensation is not available through this route.11 There is no formal relationship between the scheme overseen by the GMC and the protection offered by an action before the courts, and courts are, traditionally, unwilling to interfere with properly undertaken decisions of the GMC.12 Thus, the courts cannot withdraw a practitioner’s right to practice themselves and the GMC has emphasised that conduct which is regarded as negligent by a court, will not ordinarily—particularly where the conduct complained off is a one-off incident and not part of a broader pattern of behaviour on the part of the practitioner concerned—attract sanction under the GMC’s regulatory regime.13 Although if such negligence is of a sufficiently serious nature, then the fact that it took place as a single incident represents no impediment to regulatory sanction.14

7 Roe v Ministry of Health [1954] 2 QB 66; Various Claimants v Catholic Child Welfare Society [2013] 2 AC 1. 8 It should be noted that this scheme does not extend to primary healthcare services such as General Practitioners, who, other than in emergency situations, form the gateway to accessing secondary services such as hospital treatment under the NHS. 9 Notable examples include Chester v Afshar [2004] UKHL 41; [2005] 1 AC 134 and Thake v Maurice [1986] QB 644. 10 Glynn and Gomez (2012), pp. 116, 2-047f. 11 Glynn and Gomez (2012), pp. 88–89. 12 Allinson v General Council of Medical Education and Registration [1894] 1 QB 750. For a developmental overview of this system see Smith (1994); Quick (2017), p. 88ff. 13 Treverton-Jones et al. (2017) para 2.56ff. 14 Glynn and Gomez (2012), pp 857–860; Treverton-Jones et al. (2017) para 2.56ff.

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Criticisms of the Overall Framework for Recovery It is generally accepted in academic writing that providing compensation through the system of tort law administered by the courts in the UK is both a slow and expensive process which contains considerable disincentives for litigants.15 The court-based system of recovering compensation for medical injury has repeatedly been criticised on these grounds.16 In recent years, changes to the potential public funding of tort claims have made it harder for aggrieved patients to bring an action for fear of having to pay the defendant healthcare institutions’ litigation costs if unsuccessful.17 Indeed, such is the force of the criticism here that senior academic commentators have forcibly argued in favour of abolishing large parts of tort law as it is customarily understood and administered in the UK, and replacing it with a no-fault accident compensation scheme.18 Doubts have even been expressed, albeit extra-judicially, by those at the highest levels of the judiciary, about whether personal injury law as a whole in the UK is fit for purpose.19 Despite these well-known drawbacks, the last independent review of the continued suitability of tort law generally and as a means for dealing with compensation for victims of medical malpractice within the United Kingdom, the so-called Pearson Commission, which reported in 1978, concluded that the system ought generally to be maintained, and, notably rejected the adoption of a no-fault compensation scheme for medical malpractice. Yet, the subject has been a regular, if intermittent,20 feature of political debate in the decades since 2000 there have been a number of attempts to consult on or enact statutory redress schemes aimed at allowing for faster resolution of claims for medical malpractice, particularly where the sum being claimed is relatively small. The resurgence of debate here is evidenced and has been driven, in part, by a series of highly public scandals in healthcare within the UK, best exemplified by the Bristol Royal Infirmary scandal, where repeated serious failures in management and staffing led to the deaths of 29 children. The subsequent report into this scandal, led by Sir Ian Kennedy QC, a highly respected medical lawyer, noted that the existing system of litigation-centric, fault-based compensation for clinical harm served, perversely, to disincentivise openness and resolution of problems in the healthcare system.21 Indeed, recommendation 119 of his report was:22 In order to remove the disincentive to open reporting and the discussion of sentinel events represented by the clinical negligence system, this system should be abolished. It should be

15

Cane (2013), p. 199ff. Morgan (2018). 17 Goldberg (2013), p. 469. 18 The two most trenchant invectives can be found in: Atiyah (1997) and Cane (2013). 19 Sumption (2018). 20 Lunney et al. (2017), p. 998. 21 Department of Health (2001), pp. 365–366. 22 Department of Health (2001), p. 451. 16

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replaced by an alternative system for compensating those patients who suffer harm arising out of treatment from the NHS.

Although a subsequent seminal report by the Chief Medical Officer for England—in effect the Government’s senior medical adviser—into the functioning and potential reform of the clinical negligence system recognised the potential contribution that a less adversarial system of recovering compensation could make to strengthen the deterrent effect of awarding compensation for sub-standard practice resulting in injury,23 this path was rejected by the Government. Both the necessary reduction in the extent of damages that would, as in other systems around the world that were considered as models,24 be required, as well as the overall increase in the cost burden to the public purse from the likely increased number of claims and, finally, the general difficulty in distinguishing qualifying harm from the natural progression of a disease were given as the reasons why such a scheme was rejected.25 But the Chief Medical Officer did recommend the creation of a system of medical redress that would be established in principle by the NHS Redress Act 2006, in England and Wales and which would have created a system of extra-judicial medical redress for hospital-based malpractice.26 Although passed into legislation by the UK Parliament, this scheme has remained, in the argot of the British constitution, un-commenced under successive Governments as it relates to England and, is, perhaps, now best assumed to be ‘dead in the water’ in England. It is also important to note that, whilst this scheme would have enacted a number of novel features such as the provision of both an explanation of what happened and an apology,27 the scheme retained the requirement that the health provider was or was likely to be liable in tort (the so-called ‘qualifying liability’) as the trigger for qualifying under the scheme. Thus, whilst it was intended to reduce costs and inefficiency by removing proceedings from court and encouraging applicants to settle for an agreed package of care provided by the NHS, it did not represent any challenge to the dominance of fault-liability as the method of identifying liability in relation to medical malpractice. Another factor behind the resurgence of discussion surrounding alternative compensation schemes for medical malpractice, is the devolution of legislative competence for both regional organisation of NHS services and the potential provision of a localised redress scheme within any one of the four ‘home nations’ of the UK (England, Scotland, Wales and Northern Ireland). This permits, in principle, a degree

23

Chief Medical Office (2003), p. 108. Sweden, Finland, Denmark, Norway, France and New Zealand; Chief Medical Office (2003), p. 96f. 25 Chief Medical Office (2003), pp. 111–112. Whether this would necessarily lead to a spike in claims, as feared, is unclear. See Taylor (2015), p. 87, noting that one Welsh Health Board reported a two-thirds increase in complaints (rather than claims) following the introduction of Putting Things Right. 26 NHS Redress Act 2006, see generally Cave (2011). 27 NHS Redress Act 2006, s 3(2) c. 24

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of difference to emerge between the constituent parts of the UK and the creation of a limited and regional rather than a national scheme. Thus, the Scottish Executive has recently concluded a large-scale consultation process, beginning in 2009, on whether to enact an extra-judicial, no-fault compensation scheme.28 Despite initial suggestions in a report from April 2014 that a Swedish-style no-fault scheme would be further investigated with a view to implementing some version of such a scheme,29 a further report from the Scottish Executive in 2016 has now retreated from that earlier position, re-emphasising the role of ‘reasonable care’ (and, thus, fault) in defining the borders of compensation for medical injury, and instead seeking to implement what it calls a ‘no-blame’ scheme.30 We await further details. In Wales, the system of redress set out in the NHS Redress Act 2006 was brought into operation in 2011 under the name Putting Things Right.31 As such, qualifying claimants in Wales may now be dealt with under the redress scheme as long as the value of the claim is under £25,000.32

Related Redress Schemes in the Medical Context Away from the idea of a generalised system of medical redress, in the sense of a system that would cover the majority of injuries that a patient might suffer as a result of a healthcare interaction, there are a number of interlinked compensation schemes limited to those NHS patients who were exposed to contaminated blood products in the period before heat-treatment of blood was available to kill the viruses present in donated blood, and, as a result, contracted Human Immunodeficiency Virus (HIV) and/or Hepatitis C.33 Between them these provide a mixture of non-discretionary one-off lump sum payments, ongoing payments and discretionary support in various different forms.

28

Jones (2018a), pp. 38–41. Consultation on Recommendations for No-Fault Compensation in Scotland for injuries resulting from clinical treatment (2014). 30 No-Blame’ Redress Scheme: A Public Consultation on Draft Proposals for a ‘No-blame’ Redress Scheme in Scotland for Harm Resulting from Clinical Treatment (2016). 31 The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011, 2011 No 704 (W 108); as amended by The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) (Amendment) Regulations 2011, 2011 No 1706 (W 192). It should be noted that the explanatory note to the regulations makes clear that this scheme does not apply to either primary care providers (such as General Practitioners) or, obviously, private practitioners outside the NHS. 32 The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011, 2011 No 704 (W 108) r 44(1). 33 Macleod and Hodges (2017), p. 557ff. In the case of infection with Hepatitis C, since 1st November 2017 this has been shifted from a central UK-wide fund, the Skipton Fund, to regional bodies for each of the constituent parts of the UK. 29

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In addition, there is a no-fault scheme established under the Vaccine Damage Payments Act 1979 that now awards a one-off, tax-free payment, un-related to the harm actually suffered, of £120,000 to those who suffer severe disablement following vaccination against a statutorily fixed list of diseases.34 Severe disablement was originally defined as 80%, but, since 2002,35 has been lowered to 60%.36 With minor exceptions, the scheme only covers those who claim before their 21st birthday,37 although it does cover persons who suffer injury as a result of their mother receiving vaccination for one of the relevant diseases whilst pregnant.38 As noted in Making Amends, 910 awards were made between 1979 and 2003.39 In general, successful claims are rare, and founder on the requirement that a claimant under the scheme must demonstrate that the vaccination caused the disability.40 In any case, the sum recoverable under the scheme pales in comparison to what a child whose disablement has come about as the result of a tort might recover from a negligent defendant.41 Finally, it is relevant to note that the comprehensive social security system in the UK, funded from central taxation, provides, in effect a system of no-fault compensation for disabled citizens who satisfy the appropriate threshold. Whilst this is not intended to provide compensation for financial losses (payments focus on enabling affected citizens to purchase the extra daily assistance they require and on mobility issues), the cause of the disability is irrelevant in assessing whether payment is made.42

Conclusion As a consequence, the basic position in the UK as it concerns extra-judicial alternatives for damage caused by healthcare is that such schemes are limited in number and scope. As one leading author, writing in 2018, summed it up: There are currently few examples of no-fault compensation schemes in the UK.43

34

The sum has varied over time with the original payment being £10,000. See Jones (2018b), p. 36, n162. 35 The Regulatory Reform (Vaccine Damage Payments Act 1979) Order 2002 (SI 2002/1592) art 2. 36 Vaccine Damage Payments Act 1979 s 1(4). 37 Vaccine Damage Payments Act 1979 s 3(1) c(i). 38 Vaccine Damage Payments Act 1979 s 1(3). 39 Chief Medical Office (2003), p. 104, para 48. 40 Jones (2018b), p. 36, para 1-049. 41 Cane (2013), p. 107. 42 Jones (2018b), p. 35, para 1-048. 43 Jones (2018b), p. 34, para 1-047.

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Thus, whilst there are examples of no-fault and redress schemes for injury caused by medical treatment, the overwhelming centre of gravity remains the fault-centered tort of negligence. As noted above, even where, as in Wales, there is now a redress scheme in operation, access to this scheme hinges on the same requirements as the tort of negligence and the aim is, thus, clearly not to destabilise the centrality of fault, but rather to speed up settlement of low-value claims. The tort of negligence thus acts as the central gateway to compensation in the vast majority of claims relating injury caused by medical treatment, and, as such, any claim that the presence of a small number of extra-judicial schemes allows one to characterise the UK as a ‘hybrid’ must be treated with caution. Equally, whilst the tort system has been the target of repeated and sustained criticism over the monetary costs, delays and psychological costs involved, particularly for non-repeat players such as claimants in medical malpractice cases, there has, clearly, only been limited effort towards reforming this system and whether limited to the subject at hand, or viewed more broadly, there is currently little likelihood that recovery of compensation for personal injury in the UK will undergo the sort of root and branch reform that would move it closer to some of its continental European neighbours, or antipodean cousins.

Unpacking the Relevant Legal Rules Understanding Fault in the Context of Medical Malpractice Fault, as required by the tort of negligence lacks a statutory definition in this context but is customarily defined, judicially, in the following terms:44 Negligence is the omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do; or doing something which a prudent and reasonable man would not do.

Fault is thus objective and does not take account of the subjective characteristics possessed by the defendant medical practitioner or institution. Fault may also be identified either in the defendant’s negligent act, or, their omission, that is to say, negligence may be identified in, say, misdiagnosing the relevant condition, ordering the wrongful treatment or carrying out the correct treatment in a negligent fashion, but it may also be found in the defendant’s failure or omission to undertake a particular test or procedure. Where a claim concerns the exercise of medical expertise and skill, then whether a defendant practitioner or institution has been at fault is commonly assessed by taking into account expert evidence as to the expected behaviour on the facts of any given case. As will be explained below, there is considerable account taken of

44

Blyth v Birmingham Waterworks Co (1856) 11 Ex 781.

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customary accepted practice where the claim is one that relates to the exercise of medical skill and expertise. Equally, as will be set out below, where a claim does not concern medical expertise and skill then evidence of customary accepted practice is irrelevant. The key category where this distinction matters is claims concerning the failure to inform a patient about the risks inherent in a properly undertaken medical treatment, which are not, since 2015, regarded as involving questions of medical skill and expertise.45 Importantly, however, where a risk that manifests in harm to the patient is unforeseeable at the time at which the defendant took it, the defendant will not have acted negligently. For instance, in a decision from 1954, the Court of Appeal held that the fact that at the time the claimant-patient underwent anaesthesia in 1947, subsequently suffering paralysis as a result of the anaesthetic being contaminated with disinfectant, the fact that it was unknown that invisible cracks in the storage bottle for anaesthetic could allow disinfectant to seep in and cause contamination, was sufficient to defeat the claim. As Lord Justice Denning famously put it, ‘We must not look at the 1947 accident with 1954 spectacles’.46 Simply because a risk is foreseeable, however, is not enough to render the defendant negligent when a knowingly taken, or foreseeable risk results in harm. Particularly in the context of medical treatment, such an approach would, in effect, import a strict liability into what remains, at heart, a fault-based liability. As such, a range of other factors are taken into account in assessing whether a particular defendant has been negligent. These include considerations of the likelihood of the harm,47 the potential gravity of the harm considering the characteristics of the foreseeably injured claimant,48 the availability and cost of protection against the risk materialising,49 and, with increasing emphasis over the last 20 years, the social utility of the defendant’s activity, or, rather, what would have to be banned in order to avoid the particular risk.50 This does not mean, however, that a defendant medical practitioner may simply rely on the general social utility of healthcare to justify taking a risk, although where a patient is facing death without medical intervention, riskier treatment may be justified if that is, at that point, the only option available.51 Particularly in the context of healthcare, courts are willing to take account of the setting in which care is delivered. In essence, in asking whether the defendant has satisfied the required standard of care the court is prepared to take account of whether treatment was being undertaken in a well-provisioned, calm hospital, or, in the

45

Montgomery v Lanarkshire Health Board [2015] UKSC 1; [2015] AC 1430, see below. Roe v Ministry of Health [1954] 2 QB 66 at 84. 47 Warren v Greig (1935) The Lancet 1, which concerned a very remote possibility of the patient bleeding to death following the removal of teeth. 48 Paris v Stepney Borough Council [1951] A.C. 367. 49 Hucks v Cole [1993] 4 Med LR 393. 50 Compensation Act 2006 s 1; Tomlinson v Congleton Borough Council [2003] UKHL 47; [2004] 1 AC 46. 51 Jones (2018b), p. 304, para 3-087. 46

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colourful language of the Court of Appeal, took place in ‘battle conditions’. As Mustill LJ put it: An emergency may overburden the available resources, and, if an individual is forced by circumstances to do too many things at once, the fact that he does one of them incorrectly should not lightly be taken as negligence.52

Again, however, given many difficult medical treatments regularly descend into more challenging, immediately threatening situations than were predicted, it is not enough to simply rely on this to defeat a claim in negligence. Where it is foreseeable that an emergency may arise, the failure to have appropriate resources or abilities in place for dealing with it may well ground a finding of negligence.53

Applying the Fault Concept in the Context of Medical Malpractice The relevant standard of care depends on whether the nature of the claim is one for failure to disclose risk or for failure to correctly diagnose or correctly implement a medical intervention. In the case of the former, establishing the standard of care relies heavily on the accepted standard of practice within the relevant part of the medical profession itself. A practitioner will be judged against the standards in practice as they were at the time the alleged negligence occurred.54 As noted above, the obligation owed is one to take reasonable care, not to reach a specified result. The foundational case in this area is Bolam v. Friern Hospital Management Committee55 where McNair J confirmed the relevant abstract standard:56 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 well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art.

Furthermore, and in light of the well-known fact that the practice of medicine does not always settle upon merely one potential method of treatment in a given situation, Bolam confirmed that:57 . . .a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view. At the same time, that does not

52

Wilsher v Essex Area Health Authority [1987] QB 730 at 749, although that case, which involved injury suffered by a premature child who was injured when a junior doctor inserted a catheter into the wrong vein, did not fall in that category. 53 Bull v Devon Area Health Authority [1993] 4 Med LR 117. 54 Jones (2018b), p. 301, para 3-080. 55 [1957] 1 WLR 582. 56 [1957] 1 WLR 582, 586. 57 [1957] 1 WLR 582, 587.

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mean that a medical man can obstinately and pig-headedly carry on with some old technique if it has been proved to be contrary to what is really substantially the whole of informed medical opinion.

This framework has applied since 1957 and, rightly, has been seen as deferential to the standard of practice adopted in the medical profession, handing medical practitioners the advantage of an essentially sociological standard or care rather than an external, ethical one. The resulting appearance of shifting legal judgment of potentially negligent medical practice from judges assessing said conduct to a matter of whether a defendant can demonstrate that a reasonable body of medical opinion would have done the same in the situation has, however, been checked in recent decades, and in limited circumstances the court may disregard accepted practice. The House of Lords confirmed this in 1997 noting that:58 . . . .the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable or respectable, will need to be satisfied that, in forming their views, the experts have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter.

Obviously, a practitioner must remain conscious of the standard of care accepted in the profession at a given moment, it is no defence simply to practice as one was taught however many decades ago. International developments may be relevant in assessing what standard of care ought to have been adopted, particularly where dealing with the alleged negligence of a specialist, who may more readily be expected to be up to date with such international developments, or where there are no available comparator practices within the UK.59 In cases concerning the disclosure of information, an issue particularly relevant in the context of securing the patient’s consent to a proposed medical intervention although, as noted above, this is a matter considered as going to the quality of the advice rather than the presence or absence of the patient’s consent, the standard is markedly different. As made clear in Montgomery v Lanarkshire Health Board, the now leading decision on this point, the standard of information that a patient can be expected to receive is not judged against the accepted medical view of what information should be disclosed in a given situation.60 Rather, as the court put it in Montgomery:61 The social and legal developments which we have mentioned point away from a model of the relationship between the doctor and the patient based on medical paternalism. They also point away from a model based on a view of the patient as being entirely dependent on information provided by the doctor. What they point towards is an approach to the law which, instead of treating patients as placing themselves in the hands of their doctors (and

58

Bolitho v City and Hackney Health Authority Respondents [1998] AC 232, at 241–242. Ndri v Moorfields Eye Hosptial NHS Trust [2006] EWHC 3652. 60 Montgomery v Lanarkshire Health Board [2015] UKSC 1; [2015] AC 1430. 61 Montgomery v Lanarkshire Health Board [2015] UKSC 1, at [81]. 59

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then being prone to sue their doctors in the event of a disappointing outcome), treats them so far as possible as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.

As such, the test that a court will apply in assessing whether a patient has been provided with the appropriate amount of information demands disclosure of all material risks connected with the proposed treatment and of any reasonable alternative or variant treatments.62 As to what constitutes a material risk, this test demands a mixed objective and quasi-subjective assessment: The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.

The assessment of what a person in the position of the reasonable patient would consider a risk cannot depend on what practitioners ordinarily disclose in that situation. Given the recent nature of this decision the law here is developing but it appears that a number of courts have considered a risk of the order of 1:1000 to fall below the threshold of materiality.63 In consenting to undergo medical treatment, the patient undertakes to bear the risk of suffering harm from risks that are inherent within that treatment (so long as they are, or should be aware of them before they agree to undergo treatment) or of a non-negligent error on the part of the medical practitioner or institution providing the treatment. In this sense, the tests for fault outlined above operate to demarcate the scope of recovery for injury suffered from accidental risks that are related to a physician’s performance within the tort of negligence and the medical redress scheme currently in operation in Wales. Thus English law does not recognise either the manner in which the term ‘aléa thérapeutique’ is understood in French jurisprudence, as referring to those harms caused by non-negligent healthcare for which one may, nevertheless, be held liable, nor does it honour the concept itself in another fashion; fault remains the keystone to liability.

Burdens and Standards of Proof in the Context of Medical Malpractice The initial burden of proof for both questions of fault, causation and both the existence and scope of any resulting damage rests with the claimant in all cases. The English courts have been heavily set against altering this position to make it easier for aggrieved patients to claim compensation by forcing a healthcare 62

Montgomery v Lanarkshire Health Board [2015] UKSC 1, at [87]. A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038; [2015] Med LR 262. 63

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practitioner to demonstrate that their negligence was not to blame for the injuries incurred.64 Whilst rare, there are a very small number of cases where the court has been forced to decide the outcome of the case simply on the basis of the burden of proof.65 The court is permitted to draw inferences from proven facts but cannot rest their judgment on pure conjecture. In particular, the principle of res ipsa loquitur allows the court to make an inference of negligence from the defendant’s conduct. This does not involve a formal reversal of the burden of proof, but rather the application of the principle creates a prima facie inference of negligence.66 It, thus, allows a patient who lacks precise knowledge about how the accident that has affected them occurred, to point to the accident itself as evidence of the defendant’s negligence. The principle is limited to situations where there has been an accident which ordinarily does not happen in the absence of negligence in circumstances which the defendant has entire control over; it cannot apply where all the facts surrounding the accident are actually known.67 In the healthcare context, there are cases in which this principle has been applied,68 but it certainly cannot apply where there is another possible party beyond the defendant, or those under the defendant’s control, who had a degree of control over the situation the claimant complains of,69 nor is it sufficient to suggest that the mere fact that the patient has suffered harm is indicative of the defendant’s negligence.70 In practice, as the Court of Appeal has now acknowledged, the presence of expert evidence narrows the useful scope of the principle, focusing matters on whether a court is justified in making an inference from the corpus of evidence as a whole.71

The (Ir)relevance of the Public or Private Status of an Institution A largely identical scheme governs both, although in private hospitals the legal relationship between the institution, the relevant practitioner and the patient is likely to be contractual rather than tort-based. In any case, a duty of care is concurrently

64

See the discussion in the Court of Appeal in Wilsher v Essex Area Health Authority [1987] QB 730. 65 Barnett v Medway NHS Foundation Trust [2017] EWCA Civ 235; [2017] Med LR 217. 66 Jones (2018b), p. 358, para 3-171. 67 Scott v London & St Katherine Docks [1861-73] All ER Rep 248. 68 Mahon v Osbourne [1939] 2 KB 14; Cassidy v Ministry of Health [1951] 2 KB 343; Thomas v Curley [2013] EWCA Civ 117; [2013] Med LR 141. 69 Morris v Winsbury-White [1937] 4 All ER 494. 70 Fletcher v Bench (1973) 4 BMJ 17. 71 Ratcliffe v Plymouth and Torbay Health Authority [1998] PIQR P170.

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owed in tort.72 As concerns the civil law regime, courts are unwilling to allow a medical malpractice claim framed in contract to impose a higher standard of care than would be the case in the tort of negligence.73 This may be explained by an emphasis on ensuring that patients who are better off and thus can access private healthcare, should not be able to buy a higher degree of protection than those who must rely on public healthcare mechanisms.74 The only key difference lies in that access to the redress scheme outlined in Putting Things Right hinges on treatment being undertaken within the structures of the NHS (i.e. public healthcare) and so a private patient, unless they suffer harm that qualifies them for one of the limited disability/disease-related schemes outlined above, can only rely on the civil law mechanisms as a route to compensation.

Procedural Requirements in the Context of Medical Malpractice There is certainly no formal pre-trial requirement, as in some other systems, that a prospective claim must meet with the approval of a neutral medical expert or body of medical experts. Indeed, as set out above, there are well established categories of cases—such as disclosure and cases where, following the decision in Bolitho, the customary approach amongst medical practitioners is not logically defensible—in which the presence or content of expert evidence is, in practice, irrelevant. In reality, however, and certainly in ‘core’ clinical negligence cases, if a claimant was entirely unable to secure expert support for their case then they would be ill-advised to bring it. Indeed, courts in the UK are generally unwilling, although this is not a fixed principle, to find a professional defendant such as a doctor, to have been negligent unless there is some expert evidence as to what the proper approach on the relevant facts ought to have been.75 This has recently been affirmed in one of the senior most courts within the judicial architecture of the UK.76 Yet the very nature of assessing negligence, as set out above, allied to the naturally adversarial nature of the English trial system ensures that this is often readily available.77 If any relevant procedural trend may be identified it lies in the emphasis, following the Woolf Reforms, on

72

Roe v Ministry of Health [1954] 2 QB 66; Horton Rogers (2011), pp. 186–187; Jones (2018b), p. 80, para 2-012. 73 Thake v Maurice [1986] QB 644. 74 A concern equally apparent in other areas of medical malpractice law, see Montgomery v Lanarkshire Health Board [2015] UKSC 1 at [55]. 75 Jones (2018a), p. 646, para 10-043; Pantelli Associates Ltd v Corporate City Developments Number Two Ltd [2010] EWHC 3189 (TCC); ACD (Landscape Architects) Ltd v Overall [2012] EWHC 100 (TCC). 76 Caribbean Steel Co Ltd v Price Waterhouse [2013] UKPC 18. 77 Goldberg (2013), p. 452f.

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expert evidence only being relied on with the court’s permission,78 and increased use, where possible, of a single joint expert rather than competing expert opinions.79 In practice, a significant informal limitation exists in the form of actually funding litigation. Over the last 20 years legal aid, which was historically a ‘significant source of funding for medical negligence claims’80 in that it allowed those who could not otherwise afford it access to court proceedings, has been withdrawn from nearly all cases of medical malpractice, with the exception of claims concerning those who, as a result of medical malpractice, suffer neurological injury in utero or during the process of birth.81 Furthermore as a consequence of the Jackson Reforms, a set of reforms to the funding of civil litigation that came into effect April 2013 under the guidance of Lord Justice Jackson, there has been widespread use of conditional fee arrangements (in essence a ‘no win no fee’ agreement with one’s solicitor) as a means of funding actions for medical malpractice. This is often coupled with the need for After the Event (ATE) insurance so as to protect the litigant against paying the defendant’s litigation costs. Given this requires litigation firms to make an upfront assessment of the chances of success, a notoriously difficult assessment to make in medical malpractice cases, this risks a general chilling effect on claimants’ ability to secure legal representation at a reasonable initial cost, particularly where a claim is assessed as having a 50:50 chance of success.82 Where a claimant is exceptionally slow in bringing their action, a claim may, of course, be time-barred on limitation grounds. As set out in the Limitation Act 1980, claims for personal injury must be brought within a three year period measure from either the date on which the cause of action accrued, or (b) the date of knowledge (if later) of the person injured.83 Personal injury as defined in the relevant part of the Act includes both claims in the tort of negligence and, following a decision of the House of Lords in 2008, the tort of trespass,84 the two most relevant torts in the case of medical malpractice, as well as where personal injury results from breach of a duty imposed by contract. Thus, there is, in effect, no distinction between private and public healthcare on this point. This three-year limitation period here is subject to an unfettered discretion for the court to extend the limitation period where it feels it is equitable to do so, taking into account the extent to which the initial three-year period prejudiced the claimant and the extent to which exercising the discretion would prejudice the defendant. Where the patient has died then an action may be brought by their personal representative on behalf of the patient’s estate under the

78

Civil Procedure Rules, SI 1998/3132 (L17) r 35.4. Civil Procedure Rules, SI 1998/3132 (L17) r 35.7(1). 80 Jones (2018b), p. 1271, para 13-020. 81 Legal Aid, Sentencing and Punishment of Offenders Act 2012 Sch 1, Pt 1 para 23. It is important to note that, even where this requirement is satisfied there is a further assessment of the merits of the claim and a cost/benefit analysis of bringing it, see Jones (2018b), pp. 1271–1272. 82 Goldberg (2013), p. 470. 83 Limitation Act 1980 s 11(4). 84 A v Hoare [2008] UKHL 6; [2008] 1 AC 844, interpreting s 11(1) of the 1980 Act. 79

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Law Reform (Miscellaneous Provisions) Act 1934. If death occurs before the end of the initial three-year period, then a fresh three-year period commences from the date of death or the date of the personal representative’s knowledge, whichever is later.85

Damage Caps and Limitations on Recoverable Harm The key principle in calculating compensatory damages in medical malpractice cases is full compensation of the loss suffered, intended to restore the claimant to the position they would have been in had the harm not occurred.86 As one leading commentator puts it: ‘The tort system is the only compensation system that professes to provide “full compensation”’.87 All pecuniary losses, past and future and non-pecuniary losses are recoverable in cases of medical malpractice. Nevertheless, there is evidence to suggest that English courts undervalue the calculation of what full compensation actually means, certainly in comparison to their US counterparts whose awards were found to be ‘significantly higher in relative terms’.88 There is no hypothetical cap on the amount of damages that may be recovered.89 A recent Government consultation on capping the recoverable fees in low-level claims (i.e. in the range £1000 to £25,000) was met with negative feedback from relevant stakeholders (58% of respondents were against the proposal) and has been postponed following the election of a new Government in June 2017.90 Since 1984 actuarial tables have been available to help more accurately estimate future losses and, since 1992 there has been guidance on the award of non-pecuniary damages in personal injury cases which, whilst not binding upon a court is designed to ensure that like injuries are compensated alike and, over time, has come, in effect, to be used as a starting point in calculating such damages.91 Thus, there is an informal upper limit on the recoverable damages for non-pecuniary losses, but no upper limit on recoverable pecuniary losses.92As a result, certainly in the medical malpractice context, the amount of damages recoverable by the claimant can reach into the tens of millions of pounds where they are injured at birth and, thus, require

85

Limitation Act 1980 s 11(5). Jones (2018b), p. 1168, para 12-002; Wells v Wells [1999] AC 345. 87 Cane (2013), p. 142. 88 Cane (2013), p. 157. 89 Horton Rogers (2011), p. 192, noting, however, that in practice there may be limits set by precedent on recovery for non-pecuniary losses. 90 See the documents available on the website of the Department of Health and Social Care: https:// assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/ 681387/2018_FRC_Consultation_response_.pdf. (last accessed March 2020). 91 Cane (2013), p. 167, referring to the Guidelines for the Assessment of Damages in Personal Injury Cases. 92 Cane (2013), p. 171. 86

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compensation not only for lost future income and amenity, but also the cost of a lifetime of care.93 As to how damages are awarded in practice in the sorts of personal injury cases that make up medical malpractice litigation, the traditional rule remains the one-time award of a lump-sum.94 Where litigation is slow enough to allow the claimant to have recovered by the time damages were assessed, assessment is, obviously, less problematic. Where, as is often the case in medical malpractice cases, an extended and uncertain recover lies ahead, then damages are awarded taking into account the chances of the claimant recovering, which is obviously an uncertain, and unprovable art. As it was eloquently put by Lord Scarman in the House of Lords during a medical malpractice decision in which the court called for ‘radical’ reform of the process by which damages were awarded in the calculation and award of damages for personal injury:95 The award, which covers past, present, and future injury and loss, must, under our law, be of a lump sum assessed at the conclusion of the legal process. The award is final; it is not susceptible to review as the future unfolds, substituting fact for estimate. Knowledge of the future being denied to mankind, so much of the award as is to be attributed to future loss and suffering - in many cases the major part of the award - will almost surely be wrong. There is really only one certainty: the future will prove the award to be either too high or too low.

Despite this call, it was not until 2003 that legislative machinery was put in place to enable the courts to award periodical payments in lieu of a lump sum for losses in personal injury cases.96 Indeed, the court must now consider adopting this approach,97 and such an award may be made (in respect of pecuniary losses only) against the wishes of the parties, although such cases are, in practice, rare.98 Further legislative intervention in 2005 permitted the potential to vary a periodical payments order (PPO) to be made clear in the grant of the initial PPO.99 Given the fact that the award of a PPO shifts the burden of meeting the payment to the defendant, places the risk that the claimant lives longer than expected on the defendant,100 eases the weight of the claimant’s task in calculating what is needed on a more immediate, annual basis rather than grasping blindly for the future, and was strongly supported by claimants’ groups,101 it may generally be seen as a positive step for injured

93

Cane (2013), p. 172, n 141, stressing the proportion of such awards that goes to long-term care. Variance after the fact is possible, but, in practice severely limited by tying any such application to the period of time within which, after trial, an appeal would have been possible. This allows, in principle, for new evidence to be considered on appeal, but, in practice, the window is, at most, a matter of weeks, see CPR R.52.4, r. 52.5. See also Horton Rogers (2011), pp. 191–192. 95 Lim Poh Choo v Camden and Islington AHA [1980] AC 174, at 183. 96 Damages Act 1996 (amended by the Courts Act 2003 s100). 97 Damages Act 1996 s 2(1)b. 98 Cane (2013), p. 140, n 33. 99 See also the 2005 regulations. 100 Cane (2013), p. 141. 101 Lunney et al. (2017), pp. 899–900. 94

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patients rather than heralding any sort of limitation on what they can recover from a negligent defendant. Indeed, even if the award of PPO changes how damages are awarded, the underlying principle of full compensation, i.e. what damages should be calculated remains undisturbed. Particularly in the medical malpractice context, the shift was, in fact, welcomed, if not, as one leading expert suggest in fact ultimately driven,102 by the NHS given the shift allowed NHS Redress (and, in its previous iteration, the NHS Litigation Authority) a method of satisfying awards for compensation that better suited them and lessened, at least in the short term, the impact of liability awards on their budget, which is to say, PPOs allow payment to be folded into the organisation’s regular annual income, and, necessarily, to spread payment of PPOs over time.103 That said, the fact that a large majority of claims involving medical malpractice settle without seeing court means that, in practice, PPOs are only made in a tiny minority of cases and lump sums, whether paid in a single payment or structured over time, likely remain the norm in settlement agreements.104

Particular Rules and Institutions Regarding Medical Malpractice in the UK Procedural Protocols As set out above, there are a limited number of extra-judicial procedures, often specific to a particular form of injury, which a patient may avail themselves of. The broadest of these is the redress scheme for low-quantum injuries established as Putting Things Right in Wales. None of these schemes is, at present, mandatory and, given the reluctance to adopt a broader no-fault scheme in Scotland,105 and the absence of even the modest medical redress scheme envisaged under the unenacted legislative scheme in England, it is unlikely that there would be sufficient political will to implement a scheme that would, in substance, both appear to reduce the amount of compensation available to injured patients, and, concurrently, to potentially increase the liability of the NHS under the scheme. Following the report by Lord Woolf, Access to Justice, in 1996 a number of reforms to civil procedure generally, including in clinical negligence cases, were undertaken,106 as set out in the Civil Procedure Rules (CPR).107 These set out a framework governed by the so-called ‘overriding objective’ of ‘. . .enabling the court 102

Lewis (2006), p. 418. Cane (2013), p. 141. 104 Ibid. 105 Jones notes that the proposals for an additional scheme in Scotland now amount to little more than a fast-track element of the existing claims model, Jones (2018b), p. 41. 106 Civil Procedure Act 1997. 107 SI 1998/3132 (L17). 103

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to deal with cases justly and at proportionate cost.’108 In addition, there is a Pre-Action Protocol for Resolution of Clinical Disputes, a part of the CPR setting out the conduct normally expected of parties prior to commencing litigation and applicable to claims against both public and private healthcare practitioners.109 This sets out a number of further objectives which underlie that Protocol, which can be said to have, as their aim, the speeding up of resolution and, where possible, the avoidance of litigation.110 It seeks to achieve this by emphasising the following:111 The specific objectives are– (a) to encourage openness, transparency and early communication of the perceived problem between patients and healthcare providers; (b) to provide an opportunity for healthcare providers to identify whether notification of a notifiable safety incident has been, or should be, sent to the claimant in accordance with the duty of candour imposed by section 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014; (c) to ensure that sufficient medical and other information is disclosed promptly by both parties to enable each to understand the other’s perspective and case, and to encourage early resolution or a narrowing of the issues in dispute; (d) to provide an early opportunity for healthcare providers to identify cases where an investigation is required and to carry out that investigation promptly; (e) to encourage healthcare providers to involve the National Health Service Litigation Authority (NHSLA) or their defence organisations or insurers at an early stage; (f) to enable the parties to avoid litigation by agreeing a resolution of the dispute; (g) to enable the parties to explore the use of mediation or to narrow the issues in dispute before proceedings are commenced; (h) to enable parties to identify any issues that may require a separate or preliminary hearing, such as a dispute as to limitation; (i) to support the efficient management of proceedings where litigation cannot be avoided; (j) to discourage the prolonged pursuit of unmeritorious claims and the prolonged defence of meritorious claims; (k) to promote the provision of medical or rehabilitation treatment to address the needs of the claimant at the earliest opportunity; and (l) to encourage the defendant to make an early apology to the claimant if appropriate.

In addition, the Protocol emphasises that parties should consider alternative dispute resolution, such as it is within the UK, rather than racing to litigation and notes, non-exhaustively, that this may take the form of discussion and negotiation between the parties with the aim of offering a settlement of any potential claim; non-binding mediation by a third party or using a third party to provide a neutral expert opinion on the strength of their respective cases; binding arbitration by a third party, and reliance on the complaints procedures available within the NHS or relevant part of the medical profession.112

108

Civil Procedure Rules, SI 1998/3132 (L17) r 1.1 (1). Horton Rogers (2011), p. 194. 110 Pre-Action Protocol r 2.1; r 2.2. 111 Pre-Action Protocol r 2.2. 112 Pre-Action Protocol, r 5. 109

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As noted above, an emphasis within the CPR on the use of joint expert reports is intended to reduce some measure of the adversarial in these proceedings. Although the Court may, under the CPR, direct that evidence is given by a single joint expert,113 this does not, where it is reasonable given the nature and value of the claim and, at the further discretion of the court, prevent a party from adducing their own expert report on the available evidence.114 As noted by one reputable academic commentator, given the contested nature of the test for fault as envisaged under the Bolam test and the inherently adversarial nature of court proceedings in the UK, it will be rare in practice to be able to rely on this mechanism rather than individual experts.115 To the limited extent that there are true extra-judicial alternatives, these are schemes rooted in particular, often very narrowly compassed, forms of medical harm and appear to be intended to avoid the time and evidential difficulties which in the UK, are inherent in litigation concerning clinical negligence. Based on the Making Amends report, the currently-only-partly-enacted medical redress scheme for England and Wales cannot be said to have had strengthening patients’ rights as a central aim,116 given the requirement of ‘qualifying liability’ in tort with its consequent retention of the fault requirement that so dominates and distorts court proceedings in the UK. The reform set out in the Medical Redress Act 2006, and the accompanying Regulations putting that scheme into action in Wales, was more obviously intended to reduce the overall costs to the public purse of the clinical negligence system by speeding up resolution or settlement of potential claims whilst emphasising the uptake of a care package from the NHS as part of that settlement. The fact that a concurrent suggestion for a no-fault compensation scheme for seriously brain-damaged babies was not taken up, likely as a result of the potentially high cost of such a scheme,117 again suggests that costs management for the public purse is a primary motivation for any move, however, small, away from the prevailing tort system overseen by the courts. The true deterrent effect of tort litigation on sub-standard practice by individual practitioners in the UK is a matter of speculation,118 but was doubted in Making Amends on the basis that so many cases are, in practice, settled out of court.119 On the other hand, as there is a clear picture of the rather alarming size of the annual bill due for clinical negligence within the NHS, it is clearly an incentive to improve

113

Civil Procedure Rules, SI 1998/3132 (L17) r 35.7(1). Daniels v Walker [2000] 1 WLR 1382. 115 Jones (2018b), p. 1317, para 13-108. 116 Ibid, 59–60, para 1-094, discussing Making Amends. 117 Ibid, 57 para 1-088. 118 Jones notes, sagely, that it may be said that tort litigation has not obviously slowed the ‘staggering numbers of adverse clinical incidents’ but that, equally, these may well have prompted the institutional reflection and discussion over potential other models for compensating medical injury within the NHS that have been discussed here, Jones (2018b), pp. 20–24; Morgan (2018). 119 Chief Medical Office (2003), p. 117. 114

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practice on, at least, an institutional scale, in order to reduce that cost.120 Making Amends did stress that in the interests of increasing patient safety more effort ought to be taken to more obviously learn from errors.121 To that end, Putting Things Right does include a system of serious incident reporting covering a list of defined events including unexpected or avoidable death or severe harm of one or more patients.122

Public Protection Agencies As should be clear from the foregoing, there is not a public agency that deals with medical malpractice per se. Nor is there such an agency (unless the courts can be considered as such) in which assessing and awarding damages for injury caused by healthcare are centralised. As noted above, as it concerns public healthcare, NHS Redress, administering the NHS Indemnity scheme, stands to satisfy successful claims against the NHS in court and, in practice, to settle them where appropriate, but does not award them. There are number of charitable or voluntary organisations that provide help with advocacy and complaints often, but not exclusively,123 on a regional basis,124 but, again, these do not award damages. As set out above, to the extent that there is a general impression in the relevant literature, the state of the law in the UK, along with the nature of legal proceedings themselves, is thought to make clinical negligence claims stressful, drawn-out and expensive experiences for all the parties concerned.125 That is not to say that there are not important functions beyond compensation of harm that are served by the availability of an action in tort, however out of reach for many people it is in reality.126

120

As Jones suggests, it is hard to see what would be an incentive to improve practice if this is not understood as an incentive, Jones (2018b), p. 52, para 1-078. 121 Chief Medical Office (2003), p. 117. The report noted the world-wide impetus on open recognition of medical errors and putting in place systems to learn from them. 122 Putting Things Right: Guidance on dealing with concerns about the NHS from 1 April 2011, 80. 123 One prominent charitable body (amongst others) is Action against Medical Accidents, see https://www.avma.org.uk. See generally Quick (2017). Quick assesses the broad contribution of myriad regulatory bodies internal and external to medical practice as contributing to efforts to improve patient safety overall. 124 For example, see the work of the Care Forum in the South West of the UK: https://www. thecareforum.org. 125 See the general criticisms set out above. 126 Morgan (2018) arguing, in part, that the vindicatory function of personal injury law generally is an important feature of this discussion.

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Statutory Apology Rules There are a number of regulatory and legal incentives to proffer information about errors that have occurred in the course of medical treatment. Firstly as a matter of professional regulatory guidance, the General Medical Council is clear that when there has been an error:127 You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should: (a) put matters right (if that is possible); (b) offer an apology; (c) explain fully and promptly what has happened and the likely short-term and long-term effects.

This does not have binding force for a civil law claim but is strongly indicative of appropriate behavior. Needless to say, there can be no claim in and of itself based on the failure to apologise for an error. Any claim must be for a legally recognised harm, and the failure to apologise is not recognised as such in the UK.128 In practice, of course, apologising may draw a practitioner’s previously unnoticed error to the attention of the patient, but, again, where this concerns an error that has not caused, or will not go on to cause a legally recognised form of harm then there can be no claim in the tort of negligence.129 Nevertheless it remains the case that failure to comply with this may be relevant as a matter of professional misconduct. As a matter of common law, and particularly following the decision in Montgomery v Lanarkshire Health Board discussed above, information about errors and failures in treatment is likely to now be considered as part of the general duty regarding disclosure of information.130 Although, again, this is only likely to be relevant to constructing a successful claim where the failure to inform leads to the patient suffering further harm that, had they been properly informed, they would have avoided. A separate, statutory, so-called ‘duty of candour’ came into affect on 1st April 2015 and applies to those providing health and social care services in England.131 Where an notifiable safety incident—which is defined as ‘. . .any unintended or unexpected incident that [. . .], in the reasonable opinion of a health care professional, could result in, or appears to have resulted in’, death, severe harm, moderate harm or prolonged psychological harm (all terms defined in the relevant regulation)—has occurred, then the patient themselves or, where the patient has died or is underage, their relative or guardian should be notified that this is the case and given

127

General Medical Council (2013) para 55. Indeed in the Compensation Act 2006 s 2, it is made clear that an apology cannot be taken as an admission of negligence or a breach of statutory duty. 129 Jones (2018b), p. 408, para 4-053. 130 See also the related dicta in Naylor v Preston Area Health Authority [1987] 1 WLR 958. 131 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. 128

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reasonable support in relation to the incident. The process of notification is one that must take place in person, truthfully recount all the known facts at that point, advise what further enquiries may be required, and include an apology.132 It is a criminal offence committed by the relevant institution and punishable by a fine if notification is not made or the requirements for the content of notification are not followed.133 A written apology is also envisaged as part of providing redress under the Putting Things Right scheme in Wales alongside or in place of financial compensation, the giving of an explanation, and a report on the action that has or will be taken to prevent similar incidents.134

Disclosure in the Litigation Context As it refers to the disclosure of information between parties to potential litigation, whilst this was, traditionally, an area where there was little cooperation between the parties, modern custom is to, as Professor Jones neatly puts it, ‘conduct litigation with ‘cards on the table’ so that parties can assess the relative strengths and weaknesses of their respective cases and where appropriate, settle the action.’135 Disclosure of the relevant medical records to the claimant (or their lawyers) may be made voluntarily by the potential defendant or may be ordered by the court under a statutory power.136 The Pre-Action Protocol for Resolution of Clinical Disputes provides a template Letter of Notification which a claimant may use to contact the potential defendant. By contrast a claimant must serve a so-called Letter of Claim. The letter should contain information concerning the following matters:137 This letter should contain— (a) a clear summary of the facts on which the claim is based, including the alleged adverse outcome, and the main allegations of negligence; (b) a description of the claimant’s injuries, and present condition and prognosis; (c) an outline of the financial loss incurred by the claimant, with an indication of the heads of damage to be claimed and the scale of the loss, unless this is impracticable; (d) confirmation of the method of funding [. . .]; and (e) the discipline of any expert from whom evidence has already been obtained.

132

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 reg 20 (3). Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 reg 22. 134 The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011 reg 27. 135 Jones (2018b), p. 1284, para 13-052. 136 Senior Courts Act 1981 s 33(2) as it concerns the High Court; County Courts Act 1984 s 52(2). 137 Pre-Action Protocol for Resolution of Clinical Disputes r 3.16. 133

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The intention is to allow a focused exchange between the parties, which although it may potentially lead to litigation, may also prompt the timely settlement of the issue where the matter is clear and conceded by the defendant.

References Cases A v East Kent Hospitals University NHS Foundation Trust [2015] EWHC 1038; [2015] Med LR 262 A v Hoare [2008] UKHL 6; [2008] 1 AC 844 ACD (Landscape Architects) Ltd v Overall [2012] EWHC 100 (TCC) Allinson v General Council of Medical Education and Registration [1894] 1 QB 750 Barnett v Medway NHS Foundation Trust [2017] EWCA Civ 235; [2017] Med LR 217 Blyth v Birmingham Waterworks Co (1856) 11 Ex 781 Bolitho v City and Hackney Health Authority Respondents [1998] AC 232 Bull v Devon Area Health Authority [1993] 4 Med LR 117 Caribbean Steel Co Ltd v Price Waterhouse [2013] UKPC 18 Cassidy v Ministry of Health [1951] 2 KB 343 Chatterton v Gerson [1981] QB 432 Chester v Afshar [2004] UKHL 41; [2005] 1 AC 134 Daniels v Walker [2000] 1 WLR 1382 Fletcher v Bench (1973) 4 BMJ 17 Hucks v Cole [1993] 4 Med LR 393 Kralj v McGrath and St Theresa’s Hospital [1986] 1 All ER 54 Lim Poh Choo v Camden and Islington AHA [1980] AC 174 Mahon v Osbourne [1939] 2 KB 14 Montgomery v Lanarkshire Health Board [2015] UKSC 1; [2015] AC 1430 Morris v Winsbury-White [1937] 4 All ER 494 Naylor v Preston Area Health Authority [1987] 1 WLR 958 Ndri v Moorfields Eye Hosptial NHS Trust [2006] EWHC 3652 Pantelli Associates Ltd v Corporate City Developments Number Two Ltd [2010] EWHC 3189 (TCC) Paris v Stepney Borough Council [1951] AC 367 Pickett v British Rail Engineering Ltd [1980] AC 136 Ratcliffe v Plymouth and Torbay Health Authority [1998] PIQR P170 Roe v Ministry of Health [1954] 2 QB 66 Scott v London & St Katherine Docks [1861-73] All ER Rep 248 Thake v Maurice [1986] QB 644 Thomas v Curley [2013] EWCA Civ 117; [2013] Med LR 141 Tomlinson v Congleton Borough Council [2003] UKHL 47; [2004] 1 AC 46 Various Claimants v Catholic Child Welfare Society [2013] 2 AC 1 Warren v Greig (1935) The Lancet 1 Wells v Wells [1999] AC 345 West Bromwich Albion Football Club Ltd v El-Safty [2006] EWCA Civ 1299; [2007] PIQR P7 H West & Son Ltd v Shephard [1964] AC 326 Wilsher v Essex Area Health Authority [1987] QB 730

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Statutes and Statutory Instruments Vaccine Damage Payments Act 1979 The Regulatory Reform (Vaccine Damage Payments Act 1979) Order 2002 (SI 2002/1592) Limitation Act 1980 Senior Courts Act 1981 County Courts Act 1984 Damages Act 1996 Civil Procedure Rules, SI 1998/3132 (L17) Courts Act 2003 s100 Compensation Act 2006 s 1 NHS Redress Act 2006 The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) Regulations 2011, 2011 No 704 (W 108) The National Health Service (Concerns, Complaints and Redress Arrangements) (Wales) (Amendment) Regulations 2011, 2011 No 1706 (W 192) Legal Aid, Sentencing and Punishment of Offenders Act 2012 Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 Ministry of Justice. Pre-Action Protocol for the Resolution of Clinical Disputes Available at https:// www.justice.gov.uk/courts/procedure-rules/civil/protocol/prot_rcd#aims. Accessed March 2020

Books, Articles, Chapters Atiyah P (1997) The damages lottery. Hart, Oxford Cane P (2013) Atiyah’s accidents, compensation and the law. CUP, Cambridge, see now Cane P, Goudkamp J (2018) Atiyah’s accidents, compensation and the law. CUP, Cambridge Cave E (2011) Redress in the NHS. J Prof Negl 27:138–158 Chief Medical Office (2003) Making Amends: A Consultation Paper Department of Health (2001) Learning from Bristol. Command Paper 5207(I) Glynn J, Gomez D (eds) (2012) The regulation of healthcare professional: law, principle and process. Sweet & Maxwell, London Goldberg R (2013) Medical malpractice and compensation in the UK. In: Oliphant K, Wright R (eds) Medical malpractice and compensation in global perspective. De Gruyter, Berlin, pp 439–472 Horton Rogers WV (2011) Medical liability in England. In: Koch BA (ed) Medical liability in Europe. De Gruyter, Berlin, pp 165–206 Jones M (ed) (2018a) Clerk & Lindsell on Torts. Sweet & Maxwell, London Jones M (2018b) Medical Negligence. Sweet & Maxwell, London Lewis R (2006) The politics and economics of tort law. Mod Law Rev 69:418–442 Lunney M, Nolan D, Oliphant K (2017) Tort law. OUP, Oxford Macleod S, Hodges C (eds) (2017) Redress schemes for personal injuries. Hart, Oxford Morgan J (2018) Abolishing Personal Injuries Law? A response to Lord Sumption. J Prof Negl 34:133–154 Quick O (2017) Regulating patient safety: the end of professional dominance? CUP, Cambridge Smith RG (1994) Medical discipline. OUP, Oxford Sumption J (2018) Abolishing personal injury law-a project. J Prof Negl 34:124–132 Taylor S (2015) Medical accident liability and redress in English and French law. CUP, Cambridge Treverton-Jones G, Foster A, Hanif S (eds) (2017) Disciplinary and regulatory proceedings. Lexis Nexis, London

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Reports Putting Things Right: Guidance on dealing with concerns about the NHS from 1 April 2011. Available at http://www.wales.nhs.uk/sitesplus/documents/861/Healthcare%20Quality%20-% 20Guidance%20-%20Dealing%20with%20concerns%20about%20the%20NHS%20-%20Ver sion%203%20-%20CLEAN%20VERSION%20%20-%2020140122.pdf. Accessed March 2020 General Medical Council (2013) Good Medical Practice. Available at https://www.gmc-uk.org/ ethical-guidance/ethical-guidance-for-doctors/good-medical-practice. Accessed March 2020 Consultation on Recommendations for No-Fault Compensation in Scotland for injuries resulting from clinical treatment (2014). Available at https://www.gov.scot/publications/consultationrecommendations-fault-compensation-scotland-injuries-resulting-clinical-treatment/. Accessed March 2020 No-Blame’ Redress Scheme: A Public Consultation on Draft Proposals for a ‘No-blame’ Redress Scheme in Scotland for Harm Resulting from Clinical Treatment (2016). Available at https:// www.gov.scot/publications/blame-redress-scheme/pages/7/. Accessed March 2020 Department of Health and Social Care (2018) Consultation on Introducing Fixed Recoverable Costs in Lower Value Clinical Negligence Claims. Available at https://assets.publishing.service.gov. uk/government/uploads/system/uploads/attachment_data/file/681387/2018_FRC_Consulta tion_response_.pdf. Accessed March 2020