The texts published are drafted in their original language and are not subject to any translation.

The adoption of a class action mechanism in the field of health had become necessary, in light of a series of health scandals that resulted in bodily harm caused by health products (such as Mediator and PIP breast implants), coupled with the absence of a permanent mechanism (which led to serial accidents being addressed through ad hoc mechanisms (i.e. the Office national d’indemnisation des accidents médicaux, des affections iatrogènes et des infections nosocomiales (ONIAM))).

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Codified in Articles L. 1143-1 et seq. of the Public Health Code, the class action aims at the compensation of individual bodily harm linked to a health product.

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Unlike other class actions, the “health” class action seeks compensation for “damage resulting from bodily injury.” It does not therefore aim at the withdrawal of defective products or the cessation of unlawful practices. While harm to physical and psychological integrity, and even anxiety-related harm, fall within the scope of the class action, non-pecuniary moral damage does not. Material damage is not expressly mentioned, although it generally accompanies bodily injury. Issues of coordination may arise between the “health” and “consumer” class action regimes and the special regime for defective products (C. civ., art. 1245 et s.), particularly where the producer has not been identified.

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Bodily harm must have been caused by products listed under (art. L. 5311-1 du CSP), including products for health purposes intended for human use and cosmetic products subject to control by the ANSM, such as medicinal products, medical devices, labile blood products, cells, organs and tissues. The users concerned must be placed in a similar or identical situation.

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Standing to bring the action is reserved for accredited users’ associations at national or regional level, provided they do not market certain health products. Thus, the first class action in this field was introduced in 2017 by APESAC, an association of victims of Dépakine, seeking liability of the pharmaceutical group in relation to malformations or developmental delays suffered by children exposed in utero to valproate. Since the adoption of a common framework in the Code of Civil Procedure, associations registered for at least five years, where permitted by their statutory purpose, should also be granted standing in accordance with the common framework (Article 63 of the Law on the Modernisation of Justice in the 21st Century).

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Harm may result from a violation or breach of a statutory or contractual obligation relating to the listed products, committed by the “producer,” such as pharmaceutical laboratories; the “supplier,” such as pharmacies and wholesalers; or the “provider using” a health product, such as healthcare institutions and physicians. All such liable parties may be held jointly and severally liable (in solidum). Furthermore, the class action may be brought directly against the insurer of the liable party (direct action).

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Specific rules derogate from the general regime of class actions. In particular, the initiation of a “health” class action is not subject to a prior formal notice.

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The judgment on liability is rendered on the basis of the individual cases presented in support of the action. It determines the categories of bodily harm eligible for compensation for the users constituting the group defined by the court, any investigative measures and/or interim payments, as well as the time limit for joining the group, which ranges from six months to five years.

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Where the claim is well-founded, adhesion (opt-in) or a claim for compensation is addressed to the person recognised as liable, either directly by the user or by the claimant association, which thereby receives a mandate for compensation purposes.

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Enforcement of the judgment takes place within the framework of the individual compensation procedure, if necessary with the assistance of a third party – a lawyer or judicial officer. The defendant proceeds with individual compensation of harm suffered by members who meet the eligibility criteria and have joined the procedure. If their claim is not satisfied, members may refer the matter to the court for compensation. Where enforcement of the judgment is necessary, the claimant association having received a mandate is deemed to be the creditor.

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Mediation occupies a central role. With the agreement of the parties, the court may entrust a mediator with a specific mission, assisted by a Mediation Commission (composed of eight members representing health experts, specialists in bodily injury compensation, experts in the relevant pathology, insurers, the ONIAM, and social security bodies), all bound by professional secrecy. Within a period of three months (renewable once), the mediator proposes to the parties an agreement setting out the conditions for amicable compensation of the harm covered by the action.

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The amicable compensation agreement must be accepted by the claimant association and at least one of the defendants in the class action and approved by the class action judge. It must contain specific information, including the types of bodily harm concerned, the arrangements for adversarial individual expert assessments and their funding, the conditions of settlement offers made to victims and to third-party payers who have borne costs related to the harm suffered by users, as well as the publicity measures implemented by the defendants to inform users of the existence of the agreement and of the possibility of seeking compensation under the conditions and within the time limits set therein.

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To date, three class actions have been brought in this field:
– an action brought by the Association d’aide aux parents d’enfants souffrant du syndrome de l’anticonvulsivant (APESAC), filed on 13 December 2016 against the Sanofi laboratory for malformations in children exposed in utero to valproate (Dépakine);
– an action brought by the Réseau d’entraide, soutien et information sur la stérilisation tubulaire (RESIST), filed on 24 March 2018 against the Bayer laboratory for side effects related to contraceptive implants;
– and an action brought by the Association d’aide aux victimes des accidents des médicaments (AAAVAM), filed on 7 June 2019 against the Bayer laboratory, concerning the marketing of Androcur.