The Paris court on Wednesday found the French laboratory Sanofi responsible for a lack of vigilance and information on the risks of the drug Dépakine.
The judges ruled that the pharmaceutical group had “committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” concerning the risks of its drug for the fetus if taken during pregnancy.
The court also ruled “admissible” the group action presented by the association of victims of Dépakine against the laboratory, paving the way for a first judicial in the field of health in France.
After the Mediator, the Dépakine is one of the most resounding health scandals that France has known in recent years.
Sodium valproate has been marketed since 1967 under the brands Dépakine (for patients with epilepsy), Dépakote and Dépamide (for bipolar patients), as well as under generic brands. But this molecule would be responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children, according to estimates from the Health Insurance and the Medicines Agency (ANSM).