Drugmaker Sanofi is facing a class action suit brought by French parents who allege their children suffered birth defects because their mothers took the company’s anticonvulsant drug Depakine during pregnancy. The drug has been on the market since 1967.

The first French class action suit to deal with a health issue was made possible by a new law that took effect in September of this year. The plaintiffs charge the drugmaker failed to inform users of the risks. Around 14,000 pregnant women are estimated to have taken Depakine in France between 2007 and 2014.

In its suit, APESAC contends that Sanofi failed to properly inform users about the potential risks to fetuses from the drug that contains sodium valproate and is usually prescribed to treat epilepsy and sometimes bipolar disorders. Exposure to the drug is said to present a risk of birth defects, autism or learning difficulties.

Marine Martin, president of the advocacy organization, told news agencies that Sanofi has four months to acknowledge its responsibility before the case goes to trial. "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."

APESAC hopes the class action suit seeking financial compensation will benefit families that have filed individual lawsuits – the number is believed to be around 20. The state prosecutor in Paris opened a preliminary investigation in September.

A lawyer for APESAC, Charles Joseph-Oudin, told Agence France Press he had taken the "first amicable step" by writing to Sanofi to ask it to admit responsibility and compensate the victims. He said the company has known of the risks since the early 1980s.