PARIS: French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug, the company said Monday, in a long-running case that has also seen it charged with fraud.
Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families, but insists it had warned health authorities of the drug’s risks already in the 1980s. But in a statement sent to AFP it insisted it had “fulfilled its obligation” of providing information on the drug and its side effects, and said it “contests the validity of these proceedings.”Under the French legal system, charges do not automatically result in a trial as prosecutors can decide not to proceed based on a lack of evidence.
The court found that health officials knew about the risk of birth defects from Depakine already in 1983, and of learning disabilities and autism from 2004.
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