Product liability for health products

Liability for health products refers to the set of regimes under which the victim of damage caused by a medicinal product, a medical device or another health product can obtain compensation. The central regime is liability for defective products, provided for in Articles 1245 et seq. of the Civil Code, which transpose Directive 85/374/EEC. It coexists with the fault-based liability of healthcare professionals and institutions and with compensation mechanisms based on national solidarity, entrusted to the National Office for Compensation of Medical Accidents.

The defective products regime

The producer is strictly liable for damage caused by a defect in its product, whether or not it is bound by a contract with the victim. A product is defective when it does not provide the safety that a person is entitled to expect, taking into account in particular its presentation, the use to which it could reasonably be expected to be put and the time when it was put into circulation. The victim must prove the damage, the defect and the causal link, and the Court of Justice accepts that this proof may result from serious, specific and consistent presumptions, even in the absence of scientific consensus. The action is time-barred three years from the date on which the victim became aware, or should have become aware, of the damage, the defect and the identity of the producer, and liability is extinguished ten years after the product was put into circulation, unless proceedings have been brought within that period.

Grounds for exemption

The producer may escape liability by proving, in particular, that the state of scientific and technical knowledge at the time the product was put into circulation did not enable the existence of the defect to be discovered. French law excludes this development risk defence where the damage is caused by an element of the human body or by products derived from it. The presentation of the product, and in particular the content of the package leaflet and of the summary of product characteristics, plays a decisive role, since failure to mention a known adverse effect may constitute the defect.

Liable producers and intellectual property

Any person who presents itself as the producer by putting its name, trade mark or other distinguishing feature on the product is treated as the producer, as is the importer into the Union. The proprietor of a trade mark used by a licensee under a licence may thus, where the product bears its mark, be pursued as the apparent producer, hence the value of warranty and insurance clauses in contracts. Directive (EU) 2024/2853, which replaces the 1985 Directive and must be transposed by the end of 2026, notably extends the regime to software and eases the proof of defectiveness.

Key points

The victim of a defective health product has a strict liability claim against the producer, subject to a three-year limitation period and a ten-year long-stop period. Proof of defect and causation may rest on presumptions, and the information in the package leaflet weighs heavily in the assessment of defectiveness. In licence, manufacturing and distribution agreements, the allocation of liability and insurance should be checked, and the transposition of the 2024 Directive should be monitored.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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