France, Court of Cassation, 27 November 2019 18-16.537

Identification of the case

• Article 1245-3, paragraphs 1 and 2, of the Civil Code (Law n° 98-389 of 19 May 1998 transposing the Directive of 25 July 1985 and now codified in articles 1245 and following of the Civil Code)

• Articles 6 and 10 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products

Summary of the case

In this case, a woman suffering from epilepsy was being treated with Depakine, a medicine produced by Sanofi-Aventis France. Considering pregnancy, she had been advised to continue this treatment while taking another medicine. Later, she gave birth to a child with a general malformation syndrome. A panel of experts submitted a report which concluded that Depakine was teratogenic and that the child's malformations were caused by the medicine. The society was assigned in liability and compensation.

After noting that the teratogenic effects of an active ingredient in Depakine, and in particular the cases of malformations, had been regularly mentioned in the medical literature, the appeal judgment noted that the presentation of Depakin, in the patient package instructions didn’t contain the information that, among the possible adverse effects of the medicine, there was a particularly serious teratogenic risk. The Court of Appeal deduced that the product didn’t offer the safety that could legitimately be expected and that the medicine was defective.

• Civil judicial enforcement

In the absence of reasonable doubt as to the interpretation of European Union law and, in particular, of Articles 6 and 10 of Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, the Court of cassation had followed the reasoning of the Court of Appel and concluded that the medicine was found to be defective.

The Court précises that a product is defective when it does not offer the safety that can legitimately be expected. In assessing this, all circumstances must be taken into account, in particular the presentation of the product, the use to which it may reasonably be expected and the time at which it is put into circulation. In characterising the defectiveness of the medicinal product, the judges must focus on the content of the package instructions brought to the attention of the user of the product and its completeness with regard to the known risks of adverse effects.