Dépakine: Sanofi found responsible for a lack of vigilance and information on the risks of the drug


Thibaud Hue, with AFP
, modified at

4:57 p.m., 05 January 2022

The Paris court ruled on Wednesday that Sanofi had “committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” on the risks of its drug Depakine for the fetus if taken during pregnancy.

The Paris court ruled on Wednesday that Sanofi had “committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” on the risks of its drug Depakine for the fetus if taken during pregnancy. He 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 France in the field of health. Sanofi has announced its intention to appeal the judgment.

This 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 took too long to inform patients of the risks. deformities or developmental delays in children whose mothers received this treatment during pregnancy.

Congenital malformations and neurodevelopmental disorders

In its judgment, the court fixes between 1984 and 2006 the period of time during which the risk of congenital malformations was not sufficiently taken into account. For neurodevelopmental disorders, which took longer to be recognized, he reduced this period to 2001-2006.

Given the scientific information available at the time, the court considers that Sanofi “produced and marketed a defective product between May 22, 1998 and January 2006 for congenital malformations and between 2001 and January 2006 for neurodevelopmental disorders”.

He also 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 born between 1984 and January 2006 for congenital malformations and between 2001 and January 2006 for developmental and cognitive disorders have five years to do so.

“Very important for families”

In the show Europe Midi Wednesday, the victims’ lawyer, Charles Joseph-Oudin, recalls that “the court writes and retains for the first time that Sanofi committed a fault and marketed a defective drug. For families, it is very important, they are relieved to know that the responsibility of the company is acquired. It is a very symbolic advance “, he adds on Europe 1.

The lawyer also specifies that “the fight is not yet over”, stressing that Sanofi has already appealed against the decision of the Paris court. He adds: “The Apesac association and I will continue to fight to obtain compensation”.



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