PARIS (AP) — A French association of people affected by an epilepsy drug that caused birth defects launched a class action against pharmaceutical company Sanofi on Tuesday.
APESAC President Marine Martin told The Associated Press that Sanofi now has four months to acknowledge its responsibility before a judge takes up the case.
The global drug company has been selling Depakine, the anticonvulsant drug at the center of the class action, in France since 1967.
Depakine, which contains sodium valproate, is usually prescribed to treat epilepsy.
Sanofi said in an email to the AP that it had received notification of the proceedings. The company declined to comment further.
A study revealed by Le Canard Enchaine newspaper found that Depakine was prescribed to more than 10,000 pregnant women in France between 2007 and 2014. Another report published in February estimated that around 450 children in France who were exposed to the drug while in the womb were born with congenital defects.
The class action alleges that Sanofi failed to properly inform users about the drug's potential risks for developing fetuses, said Martin, whose association represents about 2,900 families.
"We want Sanofi to be condemned because it will be very important for the victims' families," she said. "It would be recognition that they suffered harm."
Martin added she is hopeful the class action, which seeks financial compensation, will help the cases of several families who also have filed individual lawsuits against the company. Paris prosecutors opened a preliminary investigation in September.
The Depakine case is the first class action to be brought in France dealing with a health issue, a milestone made possible by a new health law that took effect in September.