French Minister of Health Marisol Touraine has recently proposed a new National Health Bill that, among other sweeping changes, would extend the availability of class actions to  claims involving injuries to health. Companies that might be targeted by such claims are well advised not only to learn about this new law, but to become  engaged in this policy debate.

Background

In March 2014, France adopted a new Consumer Law, which includes a class action procedure that is  limited to consumer protection and antitrust claims. The proce- dure is only available for  recovering material damages and cannot be used for claims based on damages to one’s health. The law  takes effect on October 1, 2014.

At the time of adoption, however, the government stated that it will review the new law within 30  months to determine whether to extend the model to health and environmental claims. Min. Touraine  has accelerated this plan by inserting a variation of the class action procedure found in the new  Consumer Law into her proposed National Health Bill.

Current Proposal

  • Scope: The scope of the proposed health class action is quite broad. It would allow patient  associations to seek redress for personal injuries caused by specific health products listed in  Article L. 5311-1 of the Code of Public Health. Potential defendants would include the  manufacturers and suppliers of these products, if the injury is caused by a defect in those  products, or health professionals, if the injury is caused by the professional’s negligent use of  those products.

The list of products in Article L. 5311-1 is extensive and includes: all manner of drugs,  contraceptives, medical devices, diagnostic tests, blood and cellular products, organs and tissues, compounded products, therapeutic products, oils and herbal medicines, certain disinfectants, contact lenses and non-corrective lenses, cosmetic products, breast milk conserved by milk banks, insecticides, certain  micro-organisms and toxins, tattooing products, and even software used in medical laboratories.

  • Standing: The delegation of standing to patient associations differs from the Consumer Law,  which permits only those consumer associations that are officially recognized as representative on  a national level. Presently, there are  15 such consumer associations. In contrast, the National  Health Bill would allow even local patient groups to file a claim.
  • Jurisdiction/Venue: Whereas the Consumer Law only permitted class actions in civil courts, the  National Health Bill would permit them in either civil or adminis- trative court, depending on the  defendant.
  • Decision on Liability + Certification: Like the Consumer Law, in the first phase, the patient  association files a claim based on several exemplary individual cases. The civil court then decides  the defendant’s general liability toward the class based on these exemplary cases. Unlike the  Consumer Law, however, there is no requirement for the court to examine whether the claim may be  admitted as a class action and no certification criteria for that analysis aside from the presence  of a similar or identical issue. The court defines the class and the claims to be compensated. The  defendant may appeal this decision immediately.
  • Opt-in to Enforce: In the second phase, once the appeals are exhausted, notice is provided to  the absent class members as defined in the judgment, who are given between two months and two years  to join the case and enforce their claim (the Consumer Law limits the opt-in period to six months).  The court sets the terms and conditions for opting in and may appoint an expert to assess the  individual’s membership in the class, including an assessment of causation. The opt-in period is  suspended until the expert’s report is filed.

The use of the expert appears to be an effort to sidestep the likely predomi- nance of individual  issues in health claims and related manageability challenges. Moreover, depending on the weight  given to the expert’s report, this may result in a shifting of the burden to the defendant to  counter the expert’s conclusions regarding the claims of the individual class members.

  • Simplified Procedure: If the necessary information about the impacted class of consumers is  clearly identifiable (i.e., their names, the number in the class, the total damages suffered) and  the damages are “identical or similar,” then  the judge has the authority to order the defendant to  compensate each of the consumers directly and individually. 

Timeline

The draft Heath Bill is currently under review by the Council of State. The Council of Ministers  may consider it during fall 2014, and it could be examined in Parliament by early 2015.