Article | 22/12/15 | Alexandra Cohen-Jonathan
On December 17, 2015, the French National Assembly finally adopted the Bill relating to the modernization of the French health system, despite strong opposition from the Senate over certain of its key provisions. The opposition has already announced that it will seize the Constitutional Council, which shall render its decision within one month. Article 45 of the Bill provides for the introduction of a class action regarding health products, whose implementation may profoundly impact the situation of operators in the health sector. The main features of class actions in health-related matters are detailed below, it being specified that an implementing decree has yet to be published.
A monopoly entrusted to approved associations of healthcare system users
The class action procedure is only open to approved associations of healthcare system users (without any requirement of representativeness at a national level). To date, there are 141 approved associations of healthcare system users at a national level and 345 at a regional level. Thus 486 different associations of healthcare system users will have standing to bring class actions in health-related matters, against only 15 associations of consumers in the procedure established by the Hamon Act (March 17, 2014). The risk of misuse of the procedure is increased, especially as disputes involving public health are particularly sensitive and their media coverage is already high.
A broad scope of application
This class action relates to health products referred to in Article L. 5311-1 of the Public Health Code, namely medication, medical devices, blood products, but also cosmetics and contact lenses, etc.
Phase 1: a single judgment on liability, group definition and publicity measures
The purpose of the class action is to obtain compensation for the individual injuries sustained by users of the healthcare system who are placed in a “similar or identical position” and for which the common cause lies in a breach committed by a manufacturer or supplier of health products or by a service provider using one such product.
The class action will allow claimants to seek the liability of these professionals on the basis of preexisting liability regimes. Producers (pharmaceutical companies, medical device manufacturers) could be held liable inter alia in respect of liability for defective products.
Health professionals may be liable notably if they have committed a breach while using a health product, especially when using a medical device without regard for its conditions of use.
Class actions will be brought before the civil or administrative courts depending on the professional who will be summoned (public or private hospital, pharmaceutical laboratory, etc.).
The class action shall be based on “individual cases” which are supposedly representative of the group of alleged victims. No minimum number is required: a class action could be initiated merely on the basis of a description in the writ of summons of the situation of a few individuals (as was the case in the previously filed class actions in the consumer field).
All pecuniary and non-pecuniary losses resulting from bodily injuries can be compensated (e.g., health costs, lost wages, pain and suffering, etc.). For this purpose, the appointment by the Court of an expert to determine whether a causal link exists between the alleged loss and the allegedly defective health product will be common (especially when medication is involved). To that extent, the first phase of the class action will therefore be drawn out and could take several years before a judgment is rendered on liability.
If it recognizes the liability of the professional, the (judicial or administrative) court will, in the same decision, fix the criteria for opting into the class and determine the appropriate publicity measures. Once the ruling can no longer be appealed (before ordinary courts or before the French Supreme Court), the publicity measures will be implemented (when appropriate, TV advertisements may be used) and then the compensation phase will begin.
Phase 2: compensation by the professional or, failing that, individual lawsuits
Once informed of the judgment, the users concerned may choose to join the class (late opt-in system). The limitation period for joining the class will be determined by the judge but cannot be inferior to 6 months or superior to 5 years. The justification for this period of 5 years lies in the consideration of the possible occurrence of bodily injuries.
The second phase of the class action in health-related matters differs from the one established by the Hamon Act. Indeed, users who, after having joined the class, are faced with the professional’s refusal to compensate will have to bring an individual legal action before the court which ruled on the professional’s liability. It might therefore take several years before a decision is rendered in these individual cases.
Given the length of a class-action procedure, the question of the effectiveness of such proceedings may arise, unless one considers that the real goal is above all to pressure professionals by encouraging them to compromise, in particular because of the risk of prolonged media exposure.
Class actions may relate to facts prior to the entry into force of the law
The final adopted text allows the introduction of class actions relating to health products which are no longer on the market and/or for breaches that had already ceased at the time of entry into force of the law (subject to the applicable statute of limitations). This feature of class actions in health-related matters is a source of great legal uncertainty for professionals. It therefore appears essential that these professionals prepare themselves, in particular by conducting a risk-mapping process to identify the risks related to their business.
Insurance-related issues will be particularly present in these class actions
The text provides that class actions may be initiated directly against the relevant professional’s liability insurer. It is therefore likely that the insurer will be summoned at the very beginning of the class-action procedure. The specific features of the proceedings (including the associated reputational damage and the late identification of the victims) will lead to appreciating the respective roles of insurers and their policyholders in entirely different perspectives, particularly with regard to issues of supervision of the proceedings and of guarantee caps.
Alexandra Cohen-Jonathan, partner