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France: Sanofi charged with manslaughter in criminal case over birth defects linked to epilepsy medication

"France's Sanofi charged with manslaughter in birth defects case", 3 August 2020.

French prosecutors have indicted pharma giant Sanofi for manslaughter over birth defects linked to an epilepsy drug in a long-running case that has also seen it charged with fraud. The charges relate to the drug valproate, marketed as Depakine among other trade names, which studies say has caused disabilities in about 15,000-30,000 children whose mothers took the medicine while pregnant...research found that when pregnant women took the drug, their children had an elevated risk - between 10 to 40 percent - of congenital malformations, autism and learning difficulties.

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...Sanofi said it has filed a legal challenge to the indictment. 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.

Last month, a French court ordered the state to pay thousands of euros in damages over the scandal, saying officials should have ensured the drug was not taken by pregnant women...