Depakine: Sanofi condemned for lack of information on the leaflet

The French group Sanofi was sentenced Thursday, May 12 by the court of Nanterre to compensate up to 450,000 euros a family whose daughter, exposed to Dépakine in utero, was born with malformations.

The court considered that the risk of autistic disorders linked to Depakine was known to the laboratory, at least in 2005, and that it therefore had a duty to mention it in the instructions.

The mother, followed for epileptic seizures, took this drug since 1982. In 2004, during her pregnancy, she took four tablets a day.

When she was seven months old, her daughter was hospitalized with bronchiolitis. It was then noted an “overall delay in acquisitions”. Delays in psychomotor development were then observed throughout his childhood. It was in 2016 that the family decided to take Sanofi to court.

A conviction that marks a turning point

“This decision to condemn the laboratory marks a turning point for the individual recognition of each of the children exposed to Dépakine”, declared the family lawyer, Me Charles Joseph-Oudin, calling on the group to “change behavior in all procedures”.

According to him, the laboratory “must now line up with reason and take care of the families hard hit with dignity” by the drug.

Three years before informing patients

The laboratory recognized that as early as 2003 it was aware of the risks, in particular neurodevelopmental, and therefore had a duty to inform patients in the instructions. It was only in 2006 that the instructions advised against Depakine during pregnancy and recommended prompt consultation with a doctor in the event of such a state being discovered.

In Nanterre, this file is the first of a long series to be judged on the merits. In all, the court is seized of 23 cases, including one involving 272 claimants, according to a judicial source.

A class action launched in 2017 by the victims’ association Apesac was deemed admissible by the Paris court, which ruled on January 5, 2022 that Sanofi had “committed a fault by failing in its duty of vigilance and its obligation of information”. The laboratory announced that it had appealed the decision.

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