Sanofi has been ordered by a French court to pay more than 400,000 euros ($416,440) in damages to a family whose child was diagnosed with a form of autism caused by epilepsy drug valproate, sold under the name Depakine in France. The family says the drugmaker failed to inform consumers about known side effects.
The court concluded the drugmaker must have known about the risk that the drug could cause malformations and “neuro-behavioral disorders” in children if taken by pregnant women, Reuters reports. The risk should have been mentioned in the drug's attached leaflet, the court found. It’s the first ruling in France to make a link between the drug and autism in an individual patient's case.
Sanofi said it will appeal the decision. The company says it made several demands of the country's health authority to modify the information documents and leaflet. However, in its decision the court “did not take into consideration the refusal of the health authorities at the time to take into account the requested changes,” Sanofi said in an emailed statement.
“The effectiveness of sodium valproate—which is on the list of essential medicines of the World Health Organization—has never been called into question,” a Sanofi spokesperson said. “Moreover, the Court emphasizes that the benefit/risk ratio is positive. This drug remains essential for millions of patients with epilepsy.”
The decision comes after a class-action lawsuit launched in September placed Sanofi under formal investigation. At the time, the drugmaker said it had no intention to compensate patients and their families.
In the US, risks from the drug have been flagged since 2011. The FDA reviewed studies showing children born to women who took Depakine during pregnancy performed worse on cognitive tests and added its conclusion to the drug's label and medication guides. In 2009, the agency warned doctors about the risk of neural tube birth defects from exposure to Depakine and related drugs.
French authorities have estimated the drug was at fault for physical deformities in between 2,150 and 4,100 children and neuro-developmental defects in up to 30,400 babies.