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.
On the market since 1967, the drug is used to treat epilepsy, migraines and bipolar disorder.
But 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.
On Monday, the company confirmed a report in Le Monde newspaper that prosecutors have now also charged it with manslaughter.
But in a statement sent to the AFP news agency, it insisted it had “fulfilled its obligation” of providing information on the drug and its side-effects, and that it “contests the validity of these proceedings”.
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.
The court found that health officials knew about the risk of birth defects posed by Depakine as early as 1983, and of learning disabilities and autism since 2004.
Another 500 complaints have been lodged with France’s national compensation agency for medical accidents, which has already proposed a 6.5-million-euro ($7.6m) package for Depakine victims.
Sanofi, a France-based multinational, is working on a candidate vaccine against the novel coronavirus with the United Kingdom’s GSK, for which it will receive up to $2.1bn from the US government.