On 30 September 2015, the French Senate adopted Article 45 of the Bill on the modernisation of the health system ("Bill on Public Health"), which provides for the introduction in French law of a mechanism of class actions against health products and cosmetics.

If you only had a few minutes to read this article, the essential points to remember are the following:

  • the text adopted by the French Senate corresponds to the text as amended by the Social Affairs Committee in July 2015;  
  • only associations representing users of the health system registered at a national level may initiate class actions;  
  • the deadline to join the group has been reduced: it would now be six months to three years after the end of the publicity measures;  
  • the court that will have to rule on the difficulties faced for individual compensations would be the court that will have ruled on liability;  
  • the introduction of new class actions relating to the same facts and the same breaches would be possible, so long as they do not seek compensation for the same losses;  
  • class actions in health-related matters would cover all losses (moral and material) which result from bodily injury;  
  • the French Senate did not go back on applicability of the provisions of class actions to breaches committed previous to its entry into force, which has previously been introduced by the French National Assembly;  
  • several members of Parliament have been very critical towards the regime of defective products liability;
  • the text will be debated once more by the Joint Committee (common to both Assemblies) and then, in the absence of a consensus, by the French National Assembly which will have the final vote;  
  • the law will be voted before the end of the year and Article 45 will enter into force at the latest on 1 July 2016, in the current state of the text.

Main changes made by the French Senate

  • Only associations registered at a national level will be allowed to initiate a class action.

The Social Affairs Committee had reserved the right to act to the sole associations representing users of the health system registered at a national level. An amendment had been filed in order to re-establish the opportunity for any registered association, be it at a national or local level, to initiate a class action. During the debates, the French Health Minister referred to medical accidents that occurred in some hospitals, in order to emphasise that associations registered at a local level should have the right to initiate class actions. The French Senate, however, did not wish to re‑establish the previous version of the text. The provision such as adopted enables to prevent several hundred of locally registered user associations from initiating class actions. The nationally registered associations are already around 140 (compared to the 15 associations that can initiate an action under consumer law).

  • The deadline to join the group now ranges from six months to three years after publicity measures.

This new drafting aims to "limit the duration of the situation of uncertainty inflicted on professionals liable to be sued"[1]. During the debate in the public session to re‑establish the five-year deadline, the French Health Minister indicated that a three‑year deadline was, in her opinion, too short, "in light of the legal proceedings initiated, the awareness and individual steps undertaken" and specified that she believed that the five-year deadline was "both reasonable and responsible". Her opinion was not followed.  

  • Substantial changes were made to the optional mediation phase.  
    • The court may order mediation, in agreement with the parties, in order to facilitate amicable settlements of disputes which "often allow a faster compensation of the victims"[2].
    • The compensation agreement will no longer need to be the object of a prior debate of the Committee in charge of assisting the mediator, before being proposed to the parties.
    • The approval decision of the agreement will be liable to appeal, the French Senate having considered that it could be in the interest of third parties (third party payers or public bodies, for example) to appeal the approval decision made by the court, should the agreement between the parties prejudice their interests. This amendment is against, in our view, the aim of appeasement and consensus that mediation strives for.
  • Unsuccessful compensation requests will have to be referred to the court having ruled on liability.

The previous version of the text only referred to the "court with jurisdiction". Depending on the size of the group, the action may have been referred to various courts because of different places of occurrence of the alleged damage. The amendment made by the Social Affairs Committee aims to reduce the "very high risk of difference of opinion from one court to another, to the detriment of the equality between litigants" and the "equally high risk that some courts would be embolised by a mass compensation litigation" without having sufficient resources at their disposal to cope with it[3]. Considering the second argument, it is regrettable that Article 45 does not provide that class actions in health-related matters should be initiated before some specialised courts, which would have both the necessary resources and thorough knowledge of medical liability cases and compensation for bodily injury.

  • Funds destined to compensation for losses sustained by users of the health system may, at the request of the association, be transferred to the CARPA account of the lawyer assisting them[4], rather than to an account opened with the French Deposits and Consignments Fund ("Caisse des Dépôts et Consignations").
  • The introduction of new class actions relating to the same facts and the same breaches will be possible, so long as these new actions do not aim to seek compensations for the same losses.

The Law Commission of the French Senate had noted that "sometimes some losses appear later, or even skip a generation. In this case, depriving the concerned persons of a remedy via a class action, under the pretext that the damage results from the same facts and the same breaches, without taking the difference in loss into account, is then not legitimate"[5].

The risk, however, is that it can open the door to a succession of class actions motivated by different losses, in a context which tends to increase the heads of losses.

Other debated subjects

  • The amendments that aimed to restrict class actions in health-related matters to the sole facts triggering liability that occurred after the entry into force of the law were not sustained. Thus, as the text voted by the French Senate stands, the retroactivity of the provisions of class actions is for the moment upheld.

In July 2015, the reporter of the Law Commission had indicated that "some persons have emphasised the retroactive nature of the measures, whilst the Government initially excluded compensation for the losses caused before the entry into force of the text. Members of the National Assembly were right to go back on this: it is a procedural law, which does not create a new ground of liability of the professional towards victims"[6]. The fact that class actions in health-related matters are available for breaches committed prior to the entry into force of the measures is nonetheless a source of legal uncertainty and will probably have financial consequences in terms of insurance coverage. The impact study of the Bill on Public Health noted in this regard that application of the measures over time (in the version of Article 45 proposed by the Government) purposefully took into account "the particular risks that may impact the insurance market of manufacturers and health professionals"[7].

  • Class actions in health-related matters would allow compensation for all losses (moral and material) which would result from a bodily injury.

The current wording of Article 45 provides that "the action can only concern compensation for the losses resulting from bodily injuries suffered by the users of the health system". Several amendments had been filed, which aimed for "the full and total compensation for any kind of losses, including moral losses resulting from bodily injuries suffered by the users of the health system"[8] or "bodily injuries, moral and material losses"[9]. The French Senate rejected these amendments, which seemed to stem from a misinterpretation of the text.

The French Health Minister and Mrs Catherine Deroche, co-reporter of the Social Affairs Committee, brought clarifications to the compensable heads of losses. The French Health Minister notably explained that it is important to "distinguish the observed damage that triggers the class action from the compensated losses of various kinds. The Dintilhac scale[10]will be applied to all individual situations".

The French Health Minister also referred to anxiety, which would be included in compensable losses. This should be nuanced in our view. The loss relating to anxiety is a relatively recent praetorian creation, which the French Supreme Court is refining little by little: whilst the social chamber of the French Supreme Court had dedicated a specific loss relating to anxiety in decisions concerning the exposure of workers to asbestos, a civil chamber of the French Supreme Court has for its part recently included anxiety to already existing heads of bodily injuries ("suffered pain" or "permanent functional deficit")[11].

The report drafted on behalf of the Social Affairs Committee indicated that the wording of Article 45 "excludes the compensation of the loss relating to anxiety suffered by people using a health product which would have proved to be defective but the effect of which would have not yet appeared at the time of the event"[12].

Considering all these different elements, it seems that anxiety felt as a result of the damage might be taken into consideration in the scope of a class action, whilst anxiety alleged on its own in the absence of a proven bodily injury should be dismissed, which is to be approved.  

  • Amendments aiming to offer users of the health system, as well as any person having an interest in acting, the possibility of initiating a class action without acting through a registered association have been rejected.

During the debates, the French Health Minister and Mrs Catherine Deroche expressed an unfavourable opinion on these amendments. They both respectively indicated that using a registered association was a "guarantee of soundness" and "a guarantee of success".

  • The French Senate rejected amendments that aimed to widen the scope of class actions. These amendments referred to certain failures in the health system about access to treatments, environmental origins, occupational accidents or professional illnesses. The French Senate also rejected amendments aiming to widen the scope of class actions to other possible defendants, such as health insurance bodies and healthcare authorities notably.

As the Bill stands, the only mentioned defendants remain the manufacturer of a health product or a cosmetic product, the supplier or the service provider using this product. Third party claims are not, however, to be excluded, provided that the court seized has jurisdiction.

  • The French Senate rejected amendments that would have changed the regime of defective products liability.

These amendments aimed to "facilitate the establishment of the causal link between the use of a health product and the damage suffered by the patient". The proof of imputability could have been brought through any available means and would have been presumed in certain cases, notably "whenepidemiological or pharmacovigilance studies sufficiently establish that the use of the product at stake triggers the risk of occurrence of the damage" or "when the manufacturer of the product notifies the risk on the packaging of the product"[13]. The rejection of these amendments must be approved. Indeed, these amendments would have resulted in changing the regime of liability of manufacturers, which would be against EU law.

What MPs said on this subject during the debate before the French Senate is proof of a certain state of mind about the current state of liability law: "Apart from the causal link, the defectiveness of the medication must be proven. It is a two stage latch! Either the side effect is mentioned in the packaging, and the user is supposed to be forewarned; or it was not and the causal link cannot be proven. […] Let us reverse the burden of proof".  

Next parliamentary steps

The text voted by the French Senate is therefore different from the one voted by the French National Assembly on 14 April 2015. It should therefore be debated shortly (end of October) by the Joint Committee[14]. In case of failure on the part of the Join Committee, the text will be re-examined by the Social Affairs Committee of the French National Assembly, then again in a public session, in view of a final adoption probably during the month of November.