Multinational pharmaceutical company Sanofi has been charged with manslaughter in France due to congenital disorders linked to its drug for epilepsy.
The indictment filed Monday arose from four infants’ deaths from 1990 to 2014. The infants passed away after their mothers had taken the drug during their pregnancies. The court will now undertake an investigation to ascertain the company’s responsibility for these deaths.
Sodium valproate has been marketed by the company as Depakine since 1967 for the treatment of epilepsy, bipolar disorder, and migraine. According to studies, it has been found to carry an elevated risk of causing congenital disorders if taken by pregnant women, and has caused disabilities such as malformations, autism, and learning difficulties in approximately 15,000-30,000 children. Sanofi has denied responsibility for these conditions.
Marine Martin, whose organization Association for the Assistance of Parents of Children Suffering from Anti-Convulsant Syndrome (APESAC) initiated the inquiry that led to the investigation, said on Twitter that the investigation is “a great victory” for the victims’ families.
Sanofi was also charged with “aggravated deception” and “unintentional injuries” in February after three years of investigation, for “deception on the risks inherent in the use of the product and the precautions to be taken which had the consequence of making its use dangerous for the health of the being human [sic].”
Last month, a French court ordered the state to pay thousands of Euros in compensation to three families on account of inaction by officials to ensure the drug was not taken by pregnant women. The National Fund for Compensation of Medical Accidents (ONIAM) has also proposed a 6.5 million Euro ($ 7.7 million) compensation for the 500 victims who had filed complaints with it. Sanofi has maintained that it does not intend to compensate or participate in a state-backed compensation mechanism.