Product liability | Snapshot of health-related class actions in France
Recent high-profile public health scandals have led to the introduction of health-related class actions (actions de groupe) into French law, with the aim of better compensating claimants and deterring wrongdoing in health-related matters.
More than a year after the Hamon Law provided for the first French class actions limited to consumer protection and antitrust claims, the 2016 National Health Law (the "Health Law"), enacted on 26 January 2016, introduced class actions in health-related cases to redress bodily injuries caused by health and cosmetic products. The new health class action system entered into force on 28 September 2016 pursuant to Ministerial Order No. 2016-1249 enacted on 26 September 2016. The key features of this new system are now available and are set out below.
Who may bring such class actions?
Only registered associations representing users of the health system, at both national and local levels, can bring actions on behalf of users before the civil and administrative courts. Previously, these associations could only bring criminal actions in the collective interest of the users of the health system without representing individuals as such and for personal injuries.
Moreover, to be authorized to bring class actions, an association must meet certain criteria and must not, for instance, have side activities involving the marketing of health products. There are currently just over 500 registered associations, as compared to only 15 consumer associations entitled to launch class actions in consumer and antitrust-related matters.
On behalf of whom?
Registered associations are mandated by users of the health system placed in a similar or identical situation to seek compensation for individual damages for the physical injury users allegedly suffered.
Potential defendants include manufacturers and suppliers of health and cosmetics products; entities prescribing these products (such as hospitals or healthcare professionals); and such entities’ civil liability insurers. Any relevant natural or legal person, whether private or public, such as pharmaceutical companies, medical device manufacturers, pharmacists, wholesalers, healthcare facilities and healthcare professionals, may therefore be liable under the framework for health class actions.
One of the distinctive features of health class actions is that claimants may bring an action directly against the defendant’s insurer. This is because one specific aim of the new system is to facilitate access to compensation for victims of similar injuries.
The aim of the new health class actions is to provide compensation for physical injuries caused to users of the healthcare system by products within the competence of the French National Agency for Medicines and Health Products, which are referred to in a non-exhaustive list in Article L.5311-1 II of the French Public Health Code. The list includes medicinal products, raw materials for pharmaceutical purposes, contraceptives, medical devices, products derived from human blood, cellular products, organs and tissues, in vitro diagnostics, software, non-corrective lenses, tattoo products and cosmetics.
The scope of French health class actions is broad and allows users of the health system to seek redress for personal injury claims, when placed in identical or at least similar situations.
There are no specific rules as to territorial jurisdiction, which may increase the risk of forum shopping. Relevant registered associations may bring class actions on behalf of users of the health system before civil or administrative courts, depending on the private or public nature of the defendants.
Health-related class actions relate to all relevant products, whether commercialized before or after the entry into force of the Health Law.
The time allotted to join the claimant class, as defined by the relevant court, ranges from six months to five years from the date of completion of the publicity measures.
What are the main steps of the procedure?
The Health Law provides for a two-step opt-in procedure with an optional mediation phase.
To initiate the first step, the association must file a claim on behalf of at least two users of the health system, detailing each user’s claiming order to avoid any lack of representation.
The court then reviews the admissibility of the action and proceeds to examine the liability of the defendant towards the claimants.
The court may appoint experts to consider scientific and medical issues, including reviewing users’ medical records and relevant scientific literature, as well as regulatory assessment of the product.
Subject to the parties’ approval, the court may also appoint a mediator. In such cases, a mediation committee of at least nine individuals appointed by a court order can assist the mediator. The mediator is appointed for three months – renewable once – to help the parties reach a settlement agreement specifying, in particular, the type of bodily damages, the method and funding for providing opposing expert witnesses, the conditions for submitting individual settlement offers and for carrying out advertising.
The court defines the proposed class of users of the health system who may seek to impose liability on the defendant, sets out the criteria that the users must meet to be included into the claimant class and determines what damages resulting from physical injuries may be indemnified. This judgment may be subject to appeal.
Once there is no longer any appeal available and the judgment becomes final, the criteria for joining the class and other prescribed information are made public under the conditions ordered by the court. The court defines the time allotted to join the class as well as the conditions that the claimants must meet and the nature of the damages to be redressed.
The second step of the procedure is the implementation of the judgment in the form of compensation for individual damages.
Claimants may either attempt to obtain compensation directly from the defendants or through the relevant association. If the defendant refuses to compensate any victim, such victims may each file an individual claim to obtain compensation with the court initially assigned to the case.
What about other actions?
Besides class actions, the victims may use other mechanisms, such as individual civil cases, criminal cases or alternative dispute resolution processes.
Moreover, several class actions may be introduced in relation to the same products, provided that they do not relate to the same facts, breaches or damages.