New twist in the Dépakine file. 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” concerning the risks of its antiepileptic drug, for the fetus if taken during pregnancy.
The Paris court has also ruled “admissible” the group action presented by the association of victims of Dépakine against the laboratory. A decision that paves the way for a judicial first in the field of health. Sanofi has announced its intention to appeal the judgment.
A global period from 1984 to 2006
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.
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 neuro-developmental disorders, which took longer to be recognized, he reduced this period to 2001-2006.
Five years to come forward
Taking into account 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.