The Paris court ruled on Wednesday January 5 that the French pharmaceutical group Sanofi had “Committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” concerning the risks of its drug Depakine for the fetus if taken during pregnancy.
He also estimated “Admissible” the group action presented by the association of victims of Depakine once morest the laboratory, paving the way for a first judicial in the field of health. Sanofi has already announced its intention to appeal the judgment.
Indictment for “manslaughter” in 2020
The procedure was launched in May 2017 at the initiative of the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which considers that Sanofi was too late in informing patients of the risks of malformations. or developmental delays in children whose mothers received this treatment during their pregnancy.
The court ordered that wide publicity be made to the possibility open to patients and their children to participate in this group action. The women concerned and their children have five years to do so.
According to the estimates of the Health Insurance and the National Agency for Medicines and Health Products Safety (ANSM), sodium valproate, the active principle of Depakine marketed since 1967, is responsible for malformations in 2,150 in 4,100 children, and neurodevelopmental disorders in 16,600 to 30,400 children. Target of legal proceedings in this case since 2011, Sanofi was indicted in 2020 for “aggravated deception” and “unintentional injuries”, then for “manslaughter” following a complaint from Apesac.
