On behalf of the team

On 5 January 2022, for the first time in French history, the Paris Court ruled against a professional entity in a class action. The grounds of the class action were based on the Public Health Code. The Association d’aide aux parents d’enfants souffrant du syndrome de l’anticonvulsivant (“APESAC”) is the association to act as plaintiff in this class action. This association represented families in which the mother took medication (including Depakine and its derivatives) for epilepsy during her pregnancy. It was later discovered that the use of this medication during pregnancy led to malformations and disorders of children exposed to the medication. The APESAC filed the class action against Sanofi-Aventis France (the manufacturer), which was followed by Sanofi-Aventis France summoning the ONIAM (the National Office for Compensation for Medical Accidents) and its insurer Allianz.

The French judges drew a few important conclusions: first, Sanofi-Aventis France had a duty of care towards children exposed to the medication. According to the Paris Court, Sanofi failed to comply with its duty of care, and therefore its duty of information. The fact that the medication works very well for the treatment of epilepsy does not detract from this. Already in 1984, Sanofi should have requested the national drug safety agency for a modification of the package insert for the medication Depakine (and its derivatives). This would have ensured that health professionals had the necessary information, which could have prevented pregnant women taking the medication. Until 2006, the possibilities of these malfunctions and disorders were not presented properly in the package insert of the medication. Accordingly, the product was not in line with the expected safety guidelines. Secondly, the Court concluded that Sanofi produced and marketed a defective product.

With respect to the participants in the class action, the Court sets out the criteria to be eligible to take part in the class action. The Court also ruled that plaintiffs can opt in to the class action within five years. APESAC will, on behalf of the plaintiffs, negotiate the amount of compensation. It is up to the Court to approve the settled compensation. The Court of Paris further ruled that the plaintiffs are entitled to a 95% loss of opportunity to choose a less dangerous therapeutic alternative and ordered both Sanofi and Allianz to pay a provision of € 120.000 to cover the future costs of the class action procedure.