The French group Sanofi was condemned Thursday by the court of Nanterre (Hauts-de-Seine). It must 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 in connection with Depakine was known to the laboratory and that it therefore had a duty to mention it in the notice, according to the judgment consulted this Saturday by AFP.

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The mother who obtained the conviction, followed for epileptic seizures, has taken this drug since 1982. In 2004, during her pregnancy, she took four tablets a day. At the age of seven months, her daughter was hospitalized with bronchiolitis. An “overall delay in acquisitions” was then noted. Delays in psychomotor development were then observed throughout his childhood. In 2016, his parents took Sanofi to court.

“This conviction marks a turning point”

Used since 1967 in the treatment of epilepsy and bipolar disorders, sodium valproate (active ingredient of Depakine) increases the risk of physical malformations (lack of closure of the spine, cardiovascular abnormalities, etc.) neuro-developmental (language delay, autism spectrum disorders, etc.) in children exposed in their mother's womb.

"This decision to condemn the laboratory marks a turning point for the individual recognition of each of the children exposed to Dépakine", reacted 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.

According to the judgment, the laboratory recognized that from 2003 it was aware of the risks, in particular neuro-developmental. He therefore had a duty to inform patients in the package leaflet. It was only in 2006 that the leaflet advised against Depakine during pregnancy and recommended prompt consultation with a doctor in the event of the discovery of such a condition, specifies the judgment.

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 plaintiffs. A class action launched in 2017 by the Apesac victims' association was deemed admissible by the Paris court, which ruled on January 5 that Sanofi "committed a fault by failing in its obligation of vigilance and its obligation to 'information ". The lab announced a call.