The antiepileptic drug would be responsible for malformations and delays in development among children whose mothers have received treatment during pregnancy. Sanofi was indicted in 2020 for “involuntary homicides”.
Le Monde with AFP
The Judicial Court of Paris estimated, Wednesday, January 5, that the French Pharmaceutical Group Sanofi had “committed a fault, lacking its obligation of vigilance and its obligation of information” concerning the risks of its drug depakin for the fetus in case of taking during pregnancy.
He also considered “admissible” group action presented by the Association of Victims of Depakine against the laboratory, paving the way for a first judiciary in the field of health. Sanofi has already announced its intention to appeal judgment.
Industifying for “involuntary homicides” in 2020
The procedure was launched in May 2017 on the initiative of the Association of Parents of Children with Anticonvulsant Syndrome (APESAC), which believes that Sanofi has too long to inform the patients of the Risks of malformations or developmental delays in children whose mothers had received this treatment during their pregnancy.
The Tribunal orders that broad advertising is 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 it.
According to health insurance estimates and the National Medicines and Health Products Safety Agency (ANSM), the sodium valproate, the active principle of the depalant marketed since 1967, is responsible for malformations In 2,150 to 4,100 children, and neurodevelopmental disorders in 16,600 to 30,400 children. Target of legal proceedings In this case since 2011, Sanofi has been indicted in 2020 for “aggravated deception” and “involuntary injuries”, then for “involuntary homicides” after a complaint of APESAC.