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Depakine: Sanofi condemned for lack of information on the leaflet

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Sanofi, a French group, was ordered 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 in connection with Depakine were known to the laboratory, at least in 2005, and that consequently it had the duty to mention it in the notice, according to the judgment consulted on Saturday by the AFP. The mother, followed for epileptic seizures, took this medicine since 1982. In 2004, during her pregnancy, she took 4 tablets a day.

Sanofi taken to court in 2016

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. In 2016, his parents took Sanofi to court.

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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.

A turning point for individual recognition

“This decision to condemn the laboratory marks a turning point for the individual recognition of each of the children exposed to Dépakine”, reacted to AFP, 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, so it therefore had a duty to inform patients in the instructions.

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It was only in 2006 that the instructions 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.

The court seized of 23 cases

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 found on January 5 that Sanofi had “committed a fault by failing in its obligation of vigilance and its obligation to ‘information”. The lab announced a call.

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