The Paris judicial court ruled on Wednesday on the admissibility of the group action of the association of victims of Dépakine against Sanofi, as well as on the responsibility of the laboratory in the malformations or developmental delays occurring in children whose the mothers had received this treatment for epilepsy.
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Responsible. The Paris court ruled on Wednesday January 5 that the Sanofi group had “committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” concerning the risks of the drug Depakine, an antiepileptic agent responsible for malformations and neurodevelopmental disorders in thousands of children. He also estimated “admissible” the group action presented by the association of victims of Depakine against the laboratory. Sanofi has announced its intention to appeal the judgment.
This group action, the first in the health sector, was launched in May 2017 at the initiative of the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), founded by Marine Martin, who believes that Sanofi took too long to inform patients about the risks of taking this drug during pregnancy. The procedure, carried out in parallel with a criminal investigation, is illustrated by 14 cases of mothers who received sodium valproate (the active ingredient in Depakine) during their pregnancy between 1977 and 2015.
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. This molecule is 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). Sanofi was also indicted in 2020 for “manslaughter” in the criminal investigation into this case.