In 1999 the Institute of Medicine reported that most medical injuries relate to unavoidable human error in a context of system failure. Patient safety improves when healthcare providers facilitate blame-free reporting and organisational learning. This is at odds with fault-based civil liability law, which discourages a more open (doctor-patient) communication on medical injuries. The absence of a clear-cut definition of ‘medical error’ complicates litigation and hence swift, appropriate patient compensation. No-fault systems perform better in this respect. A dual track liability system for medical malpractice is challenging to implement and operate, yet may be the only option for Pan-European harmonisation of medical liability.
1.1 Doctor-patient Relationship, Healthcare Quality and Patient Safety
The doctor-patient relationship is shaped by the quality and manner of information exchange. This is a delicate process with case-specific relational and communication elements,1which all affect deliberation and decision-making on the most appropriate course of care. Despite greater patient access to medical information clinical practice is still characterised by considerable physician-patient information asymmetry.2Conscientious efforts for more effective implementation of the informed consent doctrine3as codified in the European Convention on Human Rights & Biomedicine,4the Charter of Fundamental Rights of the European Union (
There is no difference in quality of care involved.12A recent literature review on the role of shared decision-making in reducing medical litigation supports this observation. Professional arrogance and failure to diagnose or respect patient preferences put clinicians at higher risk of litigation, in particular when they also make little effort to enhance patient understanding of possible treatment harms and benefits.13Statistics show only a small minority of doctors is complaint/claim-prone. Yet they account for a disproportionally large number of malpractice lawsuits.14Prospective identification and proactive peer counselling and/or monitoring of these ‘bad apples’ might result in less litigation and better healthcare.15
This is important in the context of (improving) patient safety and patient satisfaction, as the volume and complexity of medical interventions steadily increase and patients become less risk-tolerant and more aware of their rights.16Physicians experience growing pressure to perform according to professional standards/guidelines and to meet best practices in patient-centred care.17Medical progress raises patient expectations of treatment success. Failure is not an option. This ambiance fosters their belief that medical accidents result from individual carelessness, negligence or substandard care rather than from coincidental events or system errors.18This is however, a fallacy. In 1999, the Institute of Medicine (
1.2 How to Compensate Medical Injuries?
When suffering an injury or experiencing an adverse outcome during medical treatment, a patient may sue his doctor for malpractice and seek compensation. His country of residence determines whether his claim is handled within a contractual or tort liability system or a no-fault system. In the first situation, he is financially compensated when it is proven that negligence caused his injury. This implies his treatment was not in line with the required and generally accepted professional standard.30Contractual and tort liability root in the assumption, that the defendant’s culpable fault underlies the injury of the claimant31and demands monetary compensation. In a no-fault system evidence of a causal relationship between treatment and injury constitutes the basis for compensation.32There is broad agreement in the medicolegal literature that contractual and tort liability systems do not engage physicians in improving healthcare. No-fault systems however enhance their participation in institutional efforts to address system errors/failures and increase patient safety.33The following paragraphs discuss key elements of both systems.
2 Medical Error and Legal Remedies for Damages: Tradition or Innovation?
In general terms tort law is organised around corrective justice,34distributive justice35and prevention or deterrence. The latter plays a prominent role in how physicians interact with patients. As only doctors are in the position to take (additional) precautionary measures to reduce the probability and/or severity of injury, most medical accidents are unilateral from a legal perspective.36Usually the patient has no influence on suffering injury, and plays a negligible role.37In a vast majority of medical malpractice cases the claimant is a patient and the defendant a doctor. Hence medical malpractice is probably the area of tort law in which empirical evidence best supports the role of tort liability in providing economic incentives (for measures) to prevent medical injuries. Most relevant data on this subject relate to the
The inconsistent definition of medical error in the medicolegal literature complicates correct interpretation of
Although apparently there are different liability rules applicable according to the place of accident, case law shows that these differences have no practical effect. Courts base their decisions on the evidence of negligence; even if the injury took place in a public hospital a strict liability rule will not be applied.74
Even so, the number of actions before administrative courts is growing faster than the number of litigations at civil courts.75This is also the trend in France.76Civil Code provisions are the basis for German medical malpractice law;77just like in Poland78and the Netherlands.79The number of malpractice claims in Germany is among the highest in Europe. During the past decade, however, only 8% resulted in litigation involving breach of contract. ‘The rest are settled by the doctor/hospital’s liability insurer or abandoned, in some cases following adjudication by an arbitration board’.80Overall most European countries address medical malpractice primarily via fault-based contract and/or tort law.81Also in Europe the legal focus is primarily on doctors’ duties and less on patients’ rights. Compensation of injured patients depends on proving the doctor’s negligence and its causal relationship with their personal injury: a (medically) complex and daunting task.
3 Compensation via No-fault Systems: A Mixed Bag
Compared to contract and tort litigation, no-fault systems appear to result in more quick, more fair and more reliable compensation of injured patients.82They operate independently of courts. Proof of negligence is not required. Facilitation of blame-free reporting and evaluation of medical errors by healthcare providers is considered their most compelling advantage. This is essential to improve organisational learning, healthcare quality and patient safety.83Critics dispute these observations and are concerned about their (potential) undermining of tort law’s deterrence and damage-preventive effect.84Erosion of physician accountability may expose patients to more rather than less risk of harm. Health-economists argue that no-fault systems may be associated with significantly more claims and hence even higher healthcare costs; unless compensation is capped at a lower level than current tort awards.85They doubt whether this serves the interests of injured patients.86Finally legal scholars question the compatibility of a fully-fledged no-fault system with (positive obligations of) the European Convention of Human Rights (
In 1975 Sweden was the first Scandinavian country to adopt a ‘no-fault’ system.89Initially it involved a patient insurance scheme with a voluntary and private character.90In 1997 the Patient Injury Act (
Until 2002, French patients had to sue their healthcare provider(s) to obtain compensation for treatment-related injuries. Proof of fault was indispensable for success.101Administrative courts handled claims for injuries in state-run public hospitals. Civil courts judged cases involving private practitioners or institutions.102Disparities in their handling of similar claims were common, led to manifest injustice and in the end also contributed to a ‘national crisis’ involving patients, physicians, institutions, insurers and even the Conseil d’Etat and the Cour de Cassation.103In 2002 the French Parliament enacted major reforms via legislation (i.e. the Kouchner Act),104clarified and harmonised existing medical malpractice liability rules,105and created a complementary legal route to get compensation ‘quickly’ and more easily.106Its provisions were incorporated in the French Code de la santé publique (
To start a procedure under the no-fault scheme a seriously injured patient114must submit his case to a Commission Régionale de Conciliation et d’Indemnisation [
In 2010 Belgium introduced a similar dual track liability system for medical malpractice.134Its legal basis, structure and operation resemble the French system. Its no-fault scheme involves a Fund for Medical Accidents (
E.J. Emanuel et al., ‘Four models of the physician-patient relationship’,
D.L. Frosch et al., ‘Authoritarian Physicians and Patients’ Fear of Being Labeled ‘Difficult’ among Key Obstacles to Shared Decision Making’, Health Affairs 31 (2012) 1030-1038.
C. Grady, ‘Enduring and emerging challenges of informed consent’, New England Journal of Medicine 372 (2015) 855-862; E.S. Spatz, ‘The New Era of Informed Consent’,
See Arts. 5, 8, 9 and 10.
See Art. 3.
See e.g. Arts. 7:448-449 Medical Treatment Agreements Act (
S.F. Birkeland, ‘Informed Consent Obtainment, Malpractice Litigation, and the Potential Role of Shared Decision-making Approaches’, European Journal of Health Law 24 (2017) 264-282.
R. Heywood et al., ‘Patient perceptions of the consent process: qualitative inquiry and legal reflection’, Journal of Professional Negligence 24 (2008) 104. Patients perceive information disclosure by doctors as an effort to dodge liability rather than as sincere facilitation of their well-informed, genuine consent to their treatment. The Supreme Court’s landmark ruling in Montgomery v. Lanarkshire Board (2015) reinforced patients’ rights in the
C. Vincent et al., ‘Why do people sue doctors? A study of patients and relatives taking legal action’, Lancet 343 (1994) 1609-1613; H.T. Stelfox et al., ‘The relation of patient satisfaction with complaints against physicians and malpractice lawsuits’, American Journal of Medicine 118 (2005) 1126-1133; D. Roter, ‘The patient-physician relationship and its implication for malpractice litigation’, Journal of Health Care Law & Policy 9 (2006) 304-314.
R. Heywood et al., ‘Informed consent in hospital practice: health professionals’ perspectives and legal reflections’, Medical Law Review 18 (2010) 152.
N.C. Meruelo, ‘Mediation & Medical Malpractice’, Journal of Legal Medicine 29 (2008) 289.
W. Levinson et al., ‘Physician-patient communication. The relationship with malpractice claims among primary care physicians and surgeons’,
M. Durand et al., ‘Can shared decision-making reduce medical malpractice litigation? A systematic review’,
D.M. Studdert et al., ‘Prevalence and Characteristics of Physicians Prone to Malpractice Claims’, New England Journal of Medicine 374 (2016) 354-362. ‘Approximately 1% of all physicians accounted for 32% of paid claims’; M.M. Bismark et al., ‘Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia’,
T.H. Gallagher et al., ‘Physicians with multiple patient complaints: ending our silence’,
H.M. Krumholz, ‘Informed consent to promote patient-centered care’,
D.H. Sohn, ‘Negligence, genuine error and litigation’, International Journal of General Medicine 6 (2013) 49-56. ‘Negligence is failure to meet a standard level of care. It is an incorrect decision. (…) A system error, on the other hand is an occasional, simple human error. Deterrents cannot reduce these errors, because they are made unintentionally’.
L.T. Kohn et al., To Err is Human: Building a Safer Health System (Washington,
L. Leape, ‘Non-Punitive Approach to Prevention of Medical Errors’, Journal of Oral & Maxillofacial Surgery 63 (8, Supplement) (2005) 16.
D.G. Stevenson et al., ‘Does litigation increase or decrease health care quality? A national study of negligence claims against nursing homes’, Medical Care 51 (2013) 430-436.
M.M. Mello et al., ‘National costs of the medical liability system’, Health Affairs 29 (2010) 1569-1577; H. Nys, ‘The Factual Situation of Medical Liability in the Member States of the Council of Europe’ in: Report to the 2008 Council of Europe Conference ‘The Ever-Growing Challenge of Medical Liability: National and European Responses’ (Strasbourg: Council of Europe, 2009) pp. 17-41.
H. Scherz et al., ‘Defensive Medicine: A Cure Worse Than The Disease’, Forbes Magazine, 27 August 2013.
A.B. Jena et al., ‘Physician spending and subsequent risk of malpractice claims’,
O. Ortashi et al., ‘The practice of defensive medicine among hospital doctors in the United Kingdom’,
A. O’Dowd, ‘Doctors increasingly practice “defensive” medicine for fear of litigation, says regulator’,
P. Bertoli, Medical Malpractice in Public Healthcare Systems (Rotterdam: Erasmus University Rotterdam, 2014) pp. 39-45; V. Di Gregorio et al., ‘Defensive medicine in Europe: which solutions?’, European Journal of Public Health 25 (Supplement 3) (2015) 145.
Supra note 18, p. 49.
However, doctors remain professionably accountable. Supra note 7, p. 6; see also K. Wallis et al., ‘New Zealand’s 2005 ‘no-fault’ compensation reforms and medical professional accountability for harm’, The New Zealand Medical Journal 126 (2013) 33-44.
D.M. Studdert et al., ‘No-Fault Compensation for Medical Injuries. The Prospect for Error Prevention’,
Corrective justice is based on the concept that ‘individuals who are responsible for the wrongful losses of others have a duty to repair the losses’; see A. Beever, ‘Corrective Justice and Personal Responsibility in Tort Law’, Oxford Journal of Legal Studies 28 (2008) 477.
Distributive justice relates to (financial) compensation, which the injurer (defendant) provides to the victim (claimant) for any damage the victim suffered as a consequence of the injurer’s unduly risky behaviour.
B.C.J. van Velthoven et al., ‘Medical liability: do doctors care?’, Recht der Werkelijkheid 33 (2012) 28-30. In a bilateral accident both parties can be held accountable for their role in causing damage.
Ibid. Exceptions may involve situations in which patients do not take their medication as prescribed or refuse to faithfully comply with life style rules in line with their doctor’s instruction.
Mello et al., supra note 33.
The institutional context involves amongst others medical liability insurance, the structure and financial management of healthcare (institutes), codes of professional conduct for medical practitioners and national regulation of quality & safety standards.
T.A. Brennan et al., ‘Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I’, New England Journal of Medicine 324 (1991) 370-376. A doctor often precribes an antibiotic in case of a serious bacterial infection. This may cause an unforeseeable allergic reaction with the patient and subsequent kidney failure. If so, the kidney failure constitutes an adverse event. This is by definition not negligence.
Google Scholar reports around 5000 hits (26 January 2017). It is considered ‘the best-known study of the epidemiology of medical injury and malpractice claiming’; see D.M. Studdert et al., ‘When Tort Resolutions Are “Wrong” Predictors of Discordant Outcomes in Medical Malpractice Litigation’, The Journal of Legal Studies 36 (S2) (2007) S47-S78.
A.R. Localio et al., ‘Relation between malpractice claims and adverse events due to negligence’, New England Journal of Medicine 325 (1991) 429; see also A. Kachalia et al., ‘New Directions in Medical Liability Reform’, New England Journal of Medicine 364 (2011) 1564-1565. ‘The best estimates are that only 2-3% of patients injured by negligence file claims, only about half of claimants recover money, and litigation is resolved discordantly with the merit of of the claim (i.e. money is awarded in nonmeritorious cases or no money is awarded in meritorious cases) about a quarter of the time’.
Supra note 22, p. 435; see also infra note 84.
Supra note 18, p. 51.
A.B. Jena et al., ‘Outcomes of medical malpractice litigation against
Mello et al., supra note 24.
D.P. Kessler, ‘Evaluating the Medical Malpractice System and Options for Reform’, Journal of Economic Perspectives 25 (2011) 93-110; see also supra note 18, p. 51.
D.A. Hyman et al., ‘Medical Malpractice and Compensation in Global Perspective: How Does The US Do It?’, Chicago-Kent Law Review 87 (2012) 163-198; M.M. Mello et al., ‘The Medical Liability Climate and Prospects for Reform’,
S. Amaral-Garcia, Quantifying the Economics of Medical Malpractice. A View from a Civil Law Perspective, Doctoral Dissertation, Erasmus University Rotterdam, The Netherlands, 2011; chapter 3; see also Kachalia et al., supra note 42, p. 1566.
S.J. Szamania et al., ‘Alternative dispute resolution in medical malpractice. A survey of emerging trends and practices’, Conflict Resolution Quarterly 26 (2008) 71-96.
D. Shieh, ‘Unintended Side Effects: Arbitration and The Deterrence of Medical Error’, New York University Law Review 89 (2014) 1806-1835.
A.B. Kachalia et al., ‘Beyond negligence: Avoidability and medical injury compensation’, Social Science & Medicine 66 (2008) 387-402; M.M. Mello et al., ‘“Health Courts” and accountability for patient safety’, The Milbank Quarterly 84 (2006) 459-492.
H.R. Clinton et al., ‘Making patient safety the centerpiece of medical liability reform’, New England Journal of Medicine 354 (2006) 2205-2208; see also Mello et al., supra note 49 and infra notes 57 and 58.
U. Magnus, ‘Why is US Tort Law so Different?’, Journal of European Tort Law 1 (2010) 102-124; see also K. Oliphant, ‘Medical Malpractice and Compensation: Comparative Observations’, in K. Oliphant et al. (eds.), Medical Malpractice and Compensation in Global Perspective (Berlin: De Gruyter, 2013) p. 514. ‘… liability law in the United States has a number of special features that make it somewhat untypical, and limit its utility as a comparator in cross-jurisdictional investigation, amongst them the role of the jury in deciding upon liability and assessing the damages, the availability of punitive damages, the rule that each party should bear its own legal costs, win or lose, the largest role played by contingency fees, and the availability of extensive pre-trial procedures to require the disclosure of documents and the taking of witness statements’.
Kachalia et al., supra note 53, p. 388. ‘Each of the Nordic countries (…) have abandoned their negligence-based compensation systems (…). The shifts were motivated largely by perceptions that the tort system’s adversarialism, combined with the highly specialized knowledge and fact-finding needed in medical injury claims, made the resolution process too long and expensive. A related impetus was concern that the tort system’s cumbersome nature impaired patients’ access to due compensation’.
K. Essinger, ‘Medical liability: alternative ways to court procedures’, in: Report to the 2008 Council of Europe Conference ‘The Ever-Growing Challenge of Medical Liability: National and European Responses’ (Strasbourg: Council of Europe, 2009) pp. 42-57 ‘The percentage of claims solved by courts is less than 1% in Scandinavian countries, 2% for
Ibid., p. 48. ‘Administrative countries or systems are based on special patient right legislation regarding medical injuries. They use administrative procedures out of court for claims handling to a very low cost and probably much shorter median times for decisions. They solve 98%-99% of claims out of court’.
V. Ulfbeck et al., ‘Malpractice in Scandinavia’, Chicago-Kent Law Review 87 (2012) 111-129; see also supra note 57.
G. Helleringer, ‘Medical Malpractive and Compensation in France. Part II: Compensation Based on National Solidarity’, Chicago-Kent Law Review 86 (2011) 1126; L. Ancelot et al., ‘Physician-patient relationship and medical accident victim compensation: some insights into the French regulatory system’, European Journal of Health Economics 16 (2015) 529-542; and S. Taylor, Medical Accident Liability and Redress in English and French Law (Cambridge: Cambridge University Press, 2015) chapters 2 and 5.
Ibid., Taylor, pp. 27-28; see also supra note 57.
The Conseil d’Etat (Council of State) is the highest administrative court in France.
The Cour de Cassation (Court of Cassation) is the highest civil court in the French judiciary.
S. Taylor, ‘The development of medical liability and accident compensation in France’, in: E. Hondius (ed.), The Development of Medical Liability (Cambridge: Cambridge University Press, 2010) pp. 70-107.
T. Vandersteegen et al., ‘Physician Specialists’ Perceptions of the Medical Malpractice System in Belgium’, European Journal of Health Law 22 (2015) 481-491.
Taylor, supra note 60, p. 14. ‘Redress would ordinarily comprise compensation and/or a package of care or treatment, the provision of an explanation, an apology, and providing the patient with a report on the action which had been, or would be taken to prevent similar cases arising in the future. Damages under the scheme would be likely to be limited to £ 20,000’.
Taylor, supra note 60, p. 15. The
Taylor, ibid., pp. 10-11. These measures involved (1) the introduction of an obligatory protocol to promote out-of-court settlements of claims and avoiding litigation, and (2) the withdrawal of legal aid for the majority of medical negligence claims.
Ibid. In England the National Health Service Litigation Authority (
Bertoli, supra note 29, pp. 45-50. In 2011 the Italian Association of Insurance Companies (
Bertoli, supra note 29, pp. 34-38; see also A. Feola et al., ‘Medical Liability: The Current State of Italian Legislation’, European Journal of Health Law 22 (2015) 347-358.
S. Amaral-Garcia et al., ‘Do Administrative Courts Favour the Government? Evidence from Medical Malpractice in Spain’, Journal of European Tort Law 6 (2015) 246-248; see also M.P. Garcia Rubio et al., ‘The Development of Medical Liability in Spain’, in: E. Hondius (ed.), The Development of Medical Liability (Cambridge: Cambridge University Press, 2010) pp. 160-187.
Amaral-Garcia, supra note 72, p. 247.
M. Castellano Arroyo et al., ‘Medical Responsibility and Liability in Spain’, in: S.D. Ferrara et al. (eds.), Malpractice and Medical Liability. European State of the Art and Guidelines (Berlin/Heidelberg: Springer Verlag, 2013) pp. 161-187; P. Giraldo et al., ‘A retrospective review of medical errors adjudicated in court between 2002 and 2012 in Spain’, International Journal for Quality in Health Care 27 (2015) 1-7; see also supra note 72.
Infra notes 126, 129.
M.S. Stauch, ‘Medical Malpractice and Compensation in Germany’, Chicago-Kent Law Review 86 (2011) 1143: ‘Under the Bürgerliches Gesetzbuch [
K. Baczyk-Rozwadowska, ‘Medical Malpractice and Compensation in Poland’, Chicago-Kent Law Review 86 (2011) 1217-1261. Injured parties in Poland prefer the tort liability regime.
E. Hondius, ‘Medical Liability in The Netherlands’, in: E. Hondius (ed.), The Development of Medical Liability (Cambridge: Cambridge University Press, 2010) p. 137 ‘The Dutch legislature has opted for the private law solution and within this for contract and not tort as a basis’.
Stauch 2011, supra note 77, p. 1162; see also Law Library of Congress, Medical Malpractice Liability: Germany, June 2009; last updated 6 June 2015. ‘Medical malpractice claims are mostly settled with the liability insurers, often after mediation services of the medical associations or the social health insurers have given expert opinions. (…) German awards for tangible damages are low because most of the losses resulting from personal injury are borne by the social security system’.
Supra note 57, p. 43; see also C.M. Romeo-Casabona, ‘The legal approach to medical liability. Negligence and breach of patient’s autonomy’, in: Report to the 2008 Council of Europe Conference ‘The Ever-Growing Challenge of Medical Liability: National and European Responses’ (Strasbourg: Council of Europe, 2009) pp. 109-119.
J. Dute, ‘Medical Malpractice Liability: No Easy Solutions’, European Journal of Health Law 1 (2003) 85-90; Kachalia et al., supra note 53.
Studdert et al., supra note 33. For specific (dis)advantages of ‘no-fault’ systems see A.M. Farrell, No-Fault Compensation Schemes for Medical Injury: A Review (Scottish Government Social Research, 2010).
B.R. Furrow, ‘The Patient Injury Epidemic: Medical Malpractice Litigation As A Curative Tool’, Drexel Law Review 4 (2011) 41-107.
T. Vandersteegen et al., ‘The impact of no-fault compensation on health care expenditures: An empirical study of OECD countries’, Health Policy 119 (2015) 367-374.
Supra note 48, p. 104.
S.A.M. McClean, No-Fault Compensation Review Group. Report and Recommendations. Volume I (Edinburgh: The Scottish Government, 2011) chapters 4 and 5. This concerned Articles 2, 6, 8, 13
Ulfbeck et al., supra note 59, p. 116. Denmark is the exception among the Scandinavian countries. For information on France see Helleringer, supra note 60. For information on Belgium see supra, note 65.
Finland followed in 1987, Denmark in 1988 and Norway in 1992.
Farrell, supra note 83, p. 32. Swedish hospitals established an insurance company for medical injuries to avoid court procedures and to compensate patients more satisfactorily.
Ulfbeck et al., supra note 59, p. 114. Originally Patientskadelag (Svensk författningssamling [
Under the Health and Medical Services Act (1982) 17 county councils and 4 regional bodies are responsible for most medical services. Their common insurer, Landstingens Ömsesidiga Försäkringsbolag (
Farrell, supra note 83, p. 40.
This is known as ‘the alternative rule’.
Supra note 59, p. 116. This applies to all Scandinavian systems except for the Danish system.
Ibid. ‘The few malpractice cases that do go to court, therefore most often concern injuries that the patient insurance does not cover’.
Farrell, supra note 83, p. 35; see also Di Gregorio, supra note 29: ‘In countries where a no-fault system (…) is in force, most of the litigations are disputed out of the court of law: the claims resolved in court are 0.1% in Sweden, 0.3% in Finland, 0.5% in Denmark (…)’.
Still there are mechanisms to deter medical malpractice. Supra notes 32, 59 (Ulfbeck et al., p. 113), 82 (Dute, pp. 88-89) and 92 (Anell, pp. 45-47).
World Bank, supra note 94.
Supra note 87, p. 32; see also M. Erichsen, ‘The Danish Patient Insurance System’, Medicine & Law 20 (2001) 355-369.
For review of medical liability in France before 2002 see Taylor, supra note 64, pp. 77-92.
Taylor, supra note 60, pp. 28-30. The French secondary healthcare sector consists of public, private non-profit and private profit-oriented hospitals. In 2011 there were 938 public hospitals with 255,758 beds and 1,747 private clinics, providing 156,239 beds. Primary care is private. The relationship between patient and primary care doctor or private clinic is contractual.
Taylor, supra note 60, chapters 2, 5. The Cour de Cassation and the Conseil d’Etat did not (fully) respect each other’s case law. Liability costs for insurers skyrocketed after the Perruche case. Insurance premiums for ‘high-risk physicians’ (e.g. obstetricians and surgeons) exploded. Patients lamented about excessively high litigation costs and the long lag time between filing a claim and obtaining a court decision. Politicians felt, that the rules for medical liability had become unfair and too complex. France was copying the American litigation culture; see also D. Thouvenin, ‘French Medical Malpractice Compensation since the Act of March 4, 2002: Liability Rules Combined with Indemnification Rules and Correlated with Several Kinds of Proceedings’, Drexel Law Review 4 (2011) 166-167; J. Barbot et al., ‘ “No-fault” compensation for victims of medical injuries. Ten years of implementing the French model’, Health Policy 114 (2014) 237-245.
The legislation involved 1) Loi no. 2002-203 du 4 mars 2002 ‘relative aux droits des malades et à la qualité du système de santé’ (Loi Kouchner) [Law nr. 2002-203 of March 4 2002 on Patients’ Rights and Quality of the Health System Act’ (Kouchner Act)] and 2) Loi no. 2002-1577 du 30 décembre 2002 ‘relative à la responsabilité civile médicale’ (Loi About) [Law nr. 2002-1577 of December 30, 2002 on Medical Civil Liability (Law About)]. The latter law became known as the Revised Kouchner Act.
F. G’Sell-Macrez, ‘Medical Malpractice and Compensation in France. Part I: The French Rules of Medical Liability since the Patients’ Rights Law of March 4, 2002’, Chicago-Kent Law Review 86 (2011) 1095.
This route fits the French socio-legal tradition to facilitate the compensation of accident victims as a mechanism of social solidarity and loss distribution. Nevertheless it only compensates harm, that was the consequence of ‘the occurence of an accidental risk inherent to the medical procedure and which occurred without any fault of the practitioner and could not be controlled’. This includes claims for so-called ‘aléa thérapeutique’; see supra notes 60 (Helleringer), 60 (Taylor, p. 25; pp. 61-63) and 103 (Thouvenin; pp. 176-186).
Supra note 105, p. 1097. ‘The Patients’ Right Law of March 4, 2002, modifies the legal basis for medical liability, which is now regarded as a “legal regime” that is neither contractual nor tortious. This change has been very recently confirmed in an important decision of the Cour de Cassation on January 28, 2010, which merely mentions Article L 1142-1 of the
According to Art. 1382 of the (French) Civil Code one is liable for the harm caused to another by one’s fault.
The list of health professionals includes amongst others doctors, dentists, midwives, pharmacists and nurses.
Supra note 64, pp. 27, 29-30, 37-42. This article, however, also provides for exceptions to fault liability for harm (e.g. accidents, caused by a defective medical product or a hospital-acquired infection) to shield health professionals and liability insurers from excessive liability that was established in previous case law from the Conseil d’Etat and the Cour de Cassation; see also supra note 105, pp. 1098-1099.
Until 2002 this was not compulsory. The new rule ‘forced’ insurers to also cover ‘high-risk physicians’. Articles L 1142-25 and 26
This is in accordance with Art. 6
Barbot et al., supra note 103, pp. 238-241.
If the medical accident caused the patient’s death, this can be done by a relative or legal representative. Patients with ‘minor’ injuries cannot start this procedure. They have to sue for damages in court.
In line with Art. L 1142-6
Harm, which may be in line with the natural progression of a patient’s illness, does not constitute a medical accident; see Taylor, supra note 60, pp. 99-100.
Art. D 1142-1
Taylor, supra note 60, pp. 58, 104, 110-112. For 2013 37% of cases was rejected. In 62% of those the harm was judged to be not sufficiently serious. The decision’s validity is questionable. Most claims are poorly documented.
Taylor, supra note 60, pp. 101-104.
Ex Arts. L 1142-11 and 12
Ibid. Ex Art. L 1142-14
Ex Art. L. 1142-17
In this situation
Thouvenin, supra note 103, p. 184. The Conseil d’Etat (in 2007) and the Cour de Cassation (in 2010) ruled that
Art. L 1142-20
This relates to legal unclarity about the access criteria for the no-fault scheme; see supra notes 60 (Taylor, chapter 5) and 103 (Barbot et al., p. 244).
The existence of separate administrative and civil courts and their legally unrestricted application of different rules to different patient categories is in itself a source of legal uncertainty.
Taylor, supra note 60, pp. 81-82, 85-87.
S. Taylor, ‘Providing Redress for Medical Accidents in France: Conflicting Aims, Effective Solutions?’, Journal of European Tort Law 2 (2011) 57-76.
K. Chevreuil et al., ‘France: Health System Review’, Health Systems in Transition 12 (2010) 42. ‘(…) 80% of patients were satisfied with the current organization and funding basis of the health care system (…)’; see also L Degos et al., ‘Can France keep its patients happy?’,
Supra note 65; infra note 136.
Ibid.; see also Taylor, supra note 60, p. 103. The Belgian criteria for ‘seriousness’ apply to entitlement for no-fault compensation and not for access to the no-fault scheme itself as in France.
T. Vandersteegen, Essays on the Medical Malpractice Reform in Belgium. A Law and Economics Analysis (Hasselt: University of Hasselt, 2016).
Council of the European Union, Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare-associated infections, Official Journal of the European Union 52 (2009) 1-6, Notice No 2009/C 151/01; see also European Commission, Patient Safety and Healthcare Associated Infections. Report of the Commission to the Council [
Council of the European Union, Council conclusions on patient safety and quality of care, including the prevention and control of healthcare associated infections and antimicrobial care, Official Journal of the European Union 57 (2014) 8 Notice No 2014/C 438/05.
O. Quick, ‘Patient safety and the problem and potential of law’, Journal of Professional Negligence 28 (2012) 82.
A.W. Wu et al., ‘Disclosing medical errors to patients: It’s not what you say, it’s what they hear’, Journal of General Internal Medicine 24 (2009) 1012-1017.
D.M. Studdert et al., ‘Disclosure of Medical Injury to Patients: An Improbable Risk Management Strategy’, Health Affairs 26 (2007) 215-226.
Taylor, supra note 60, pp. 152-156.
Supra note 87, p. 32. The promotion of safety and quality of care by learning from medical error and moving away from attributing blame are among the legal and social goals of the Swedish system.
Ibid. Health practitioners facilitate 60-80% of all claims.
This also applies to other Scandinavian countries and New-Zealand.
V. Paskalia, ‘Cross-border Healthcare in the EU: And What if Something Goes Wrong?’, European Journal of Health Law 23 (2016) 1-16.