Product Liability and Safety_2026

FRANCE Law and Practice Contributed by: Diane Bandon-Tourret and Agathe Clarac, LexCase

ments in respect of the healthcare products they use (a regime established by the CJEU in its decision of 21 December 2011, CHU de Besançon v Thomas D ..., CPAM du Jura , Case C-495/10) and subsequent war - ranty claims (depending on the nature of the contracts between the establishments and the producers). In criminal matters, special courts have jurisdiction. Finally, in the case of health products, the alternative methods introduced via the Commissions de con- ciliation et d ’ indemnisation des accidents médicaux (CCI) or Office national d ’ indemnisation des accidents médicaux , des affections iatrogènes et des infections nosocomiales (ONIAM) are also likely to apply. 2.11 Appeal Mechanisms for Product Liability Claims In civil cases, the appeal procedure is governed by the CPC. The time limit for appeal is: • one month for contentious judgments (CPC, Article 538); and • 15 days for orders including summary orders (CPC, Article 490) or those of the pre-trial judge (CPC, Article 795) as well as for decisions of the enforce - ment judge (CPC, Articles R. 121-20 and R. 311-7). Appeals against criminal judgments are governed by specific rules set out in the Code of Criminal Proce - dure. 2.12 Defences to Product Liability Claims In the case of defective products, the producer is automatically liable unless he/she can prove: • that he/she did not put the product into circulation; • that the defect causing the damage did not exist at the time when the product was put into circulation by him/her or that this defect arose subsequently; • that the product was not intended for sale or for any other form of distribution; and • that the state of scientific and technical knowledge at the time he/she put the product into circula - tion did not allow the existence of the defect to be detected, except where the damage was caused

by an element of the human body or by products derived from it. On that aspect, the Court of Cassation has decided to refer a question to the Conseil constitutionnel con - cerning whether, in order to exonerate the liability of the manufacturer of a defective product on the basis of the risk of development, the difference in treatment existing between the victims of bodily injury result - ing from a health product, depending on whether or not this product is derived from the human body, is contrary to the principle of equality before the law (Civil Division, First Chamber, 5 January 2023, FS-B, No 22-17.439) – which was confirmed by the Consti - tutional Council (Decision No 2023-1036 QPC of 10 March 2023). On that matter, in a case involving Mediator, a drug used to treat diabetes, the Court of Cassation recent - ly ruled that the producer’s knowledge of the prod - uct’s safety defect precluded the development risk exemption from being invoked (First Civil Chamber, 6 December 2023, F-D, No 22-21.238). Regarding a case involving alleged damages due to Depakine, the Nanterre judicial court has also recently ruled out the liability exemptions for risk of development, establish - ing that, even if the scientific studies were not defini - tive, a scientific signal already existed before the time of the drug prescription. Therefore, the risk was not undetectable (Nanterre judicial court, 25 September 2025, No 19/09925). Otherwise, the defect is due to the product’s compli - ance with mandatory legislative or regulatory rules. The producer of the component part is also not liable if he/she establishes that the defect is attributable to the design of the product in which that part has been incorporated or to the instructions given by the pro - ducer of that product. The producer’s liability may be reduced or eliminat - ed, having regard to all the circumstances, where the damage is caused jointly by a defect in the product and by the fault of the victim or of a person for whom the victim is responsible. In a serial case concerning PIP prostheses, it was held that the certifying body could be held liable, insofar as

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