(D) Legislative intervention in 2002

Following some 30 years of pressure for change and a growing concern that the courts were too free in their imposition of liability without fault on medical practitioners and hospitals, in March 2002 important legislation governing health care was enacted.¹⁵⁵ It had three main relevant aspects: it provided for the basis of the liabilities of medical practitioners and establishments, whether public or private; it required all those providing medical services, whether private or public, and the producers or suppliers of medical products, to insure against their liability, with the exception of the State itself;¹⁵⁶ and it set up a special fund for the compensation of those suffering very (p.152) serious harm as a result of contracting a ‘nosocomial infection’ or a medical accident where liability was not established.¹⁵⁷ It also dealt with an number of other important medico-legal issues and of more particular problems: so, for example, it created retroactively a presumption of causation between the supply of blood infected with Hepatitis C and a patients own infection.¹⁵⁸

(I) The basis of liability and its relationship to liability for products

The legislation’s key provision governing liability states that:

Outside the case where their liability is incurred by reason of a defect in a medical product [produit de santé], [doctors, dental surgeons and midwives], and any establishment, service or bodies in which individual acts of prevention, diagnosis or care take place are liable for the harmful consequences of acts of prevention, diagnosis or care only in the case of fault. The above establishments, services or bodies are liable for harm resulting from nosocomial infections, unless they establish the existence of a cause étrangère.¹⁵⁹

The purpose of this provision was to clarify and to unify the rules (but not the jurisdictions) governing medical liability in public and private law, which was seen as unstable and uncertain and as discriminating unfairly between patients in the public and private sectors.¹⁶⁰ In parliament, it was recognised that there was a tension between the rights of patients to compensation and the need to avoid unsupportable and uninsurable liabilities in doctors and hospitals and defensive medicine à l’Americaine.¹⁶¹ The legislation also provided for a special prescription period for actions for damages against medical practitioners and establishments of ten years from the time of ‘consolidation’ of a claimant’s harm.¹⁶² Nevertheless, a number of uncertainties remain.

First, while the legislation states as a general principle that the liabilities of both individuals and institutions in respect of health care are based only on fault, it is not clear whether this refers to proven fault or may also include presumed fault.¹⁶³ As has been seen, in their earlier jurisprudence both the Cour de cassation and the Conseil d’Etat had recourse to presumptions of fault in some situations of medical liability, though these did not coincide.¹⁶⁴ In this respect, the legislation’s travaux préparatoires are ambiguous as an earlier draft referred to the ability of the courts to find fault, whether proved or presumed, but this was later simply omitted.¹⁶⁵ Commentators on the legislation have argued for either position.¹⁶⁶

(p.153) Secondly, though, the loi of March 2002 provides that the general rule of liability for fault does not apply to liability in respect of defects in ‘medical products’.¹⁶⁷ In the travaux préparatoires this provision was said to have been included so as to ensure compatibility with the Product Liability Directive and the legislation which implemented it in France,¹⁶⁸ though at the time the French legislative extension of the Directives provisions so as to impose liability on all business suppliers of products on the same terms which the Directive required for producers and importers meant that its significance appeared much larger than it will be after amendment of the implementing legislation so as to conform to the Directive.¹⁶⁹ On the other hand, it has been said that the provision in the 2002 legislation concerning the liability of hospitals and doctors in respect of defective medical products is broad enough to cover cases where products are used in the course of treatment and not merely where they are supplied,¹⁷⁰ thereby preserving earlier jurisprudence of the Cour de cassation and the Conseil d’Etat where liability without fault was imposed. This view would retain a liability without fault where a provider of health care is neither the producer nor the supplier of a product in the ordinary sense as, for example, in the case of anesthetic apparatus.¹⁷¹ Finally, the exclusion of liability for medical products from the general rule leaves the possibility of liability (whether under the Product Liability Directive or under the previous jurisprudence) in respect of harm caused by products other than ‘medical products’, for example, food cooked and supplied to patients containing salmonella or a chair which breaks when used.

Thirdly, the loi provides exceptionally that institutional (but not individual) providers of health care are to be liable in respect of harm caused by ‘nosocomial infections’, their only defence being cause étrangère.¹⁷² While the loi does not define ‘nosocomial infections’, the courts may well use the definition in a ministerial circular of 2000 which refers to them as any infection contracted in a health care establishment;¹⁷³ if so, they could include infections which are transmitted via medical products, for example, through use of an aseptic needle, prothesis or implant or even blood infected with a virus. Liability is indeed strict here, modelled on the obligation de sécurité de résultat developed by the Cour de cassation, but to be used by administrative courts as well.¹⁷⁴ But this liability would certainly go further than the Product Liability Directive’s provisions as to the liability of those who merely supply products and could be vulnerable to challenge on this ground.¹⁷⁵