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 a duty to mention it in the instructions.
The mother, followed for epileptic seizures, took this medicine since 1982. In 2004, during her pregnancy, she took 4 tablets a day.
“A global acquisition delay”
When she was seven months old, 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.
Used since 1967 in the treatment of epilepsy and bipolar disorders, sodium valproate, the active ingredient of Depakine, increases the risk of physical malformations and neurodevelopmental disorders in children exposed in their mother’s womb.
Risks known to the laboratory since 2003
“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 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.
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.