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Depakine: Sanofi held responsible for a lack of vigilance and information

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The judgment had been awaited by many families of victims for several years. On Wednesday January 5, 2022, the Paris court ruled that Sanofi had “committed a fault by failing in its duty of care and its obligation to provide information” on the risks caused by its medicine Depakine (sodium valproate) on the fetus in case of taken during pregnancy to fight against epilepsy.

In addition, the justice considered “admissible”, group action presented by the association of victims of Dépakine against the laboratory. This decision paves the way for a judicial first in France. For its part, the Sanofi laboratory has announced its intention to appeal this decision. In July 2020, the administrative court of Montreuil recognized for the first time the State responsibility in the Dépakine affair.

Inform the families

In view of the scientific data available at the time, the court found that Sanofi “produced and marketed a defective product between May 22, 1998 and January 2006 for birth defects and between 2001 and January 2006 for neurodevelopmental disorders”. Serious side effects noted in the leaflet only in the 2000s.

This procedure was launched in May 2017 at the initiative of the Association to help parents of children suffering from anticonvulsant syndrome (Apesac). Justice wants wide publicity to be made for massively inform families of the existence of this group action. Today, patients suffer from various disorders like malformations, autistic disorders, ENT problems, etc. Specifically, the women concerned and their children (born between 1984 and January 2006) for congenital malformations and between 2001 and January 2006 for developmental and cognitive disorders have five years to make themselves known. Depakine has been marketed by Sanofi since 1967.

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