A French court ruled that Sanofi (NASDAQ: SNY) (OTCPK: SNYNF) failed to inform the known side effects of its epilepsy drug Depakine, which orders the drug giant to pay over € 400,000 ($ 416,440) in compensation to a family whose child developed some form of autism as a result.
The court in Nanterre said in its ruling Thursday that the company must have known that the drug, if taken during pregnancy, could lead to malformations and “neuro-behavioral disorders” in children and should have listed the risk in an attached leaflet.
Sanofi (SNY) intends to appeal the decision, saying that the overall risk-benefit profile of the drug is positive, Reuters reported Saturday, citing a statement from the company.
The link between Depakine and side effects, including birth defects, was documented in a class action lawsuit filed in January that could result in potentially hundreds of millions of euros in damages, a decision that Sanofi (SNY) said it would appeal.
French health authorities have estimated that Depakine is associated with malformations in 2,150 – 4,100 children and neurodevelopmental defects in up to 30,400 children.
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