Multi-national pharmaceutical company Sanofi has been charged with manslaughter in France due to congenital disorders linked to its drug for epilepsy. According to a Jurist report, the indictment filed this week arose from four infants’ deaths from 1990 to 2014. The infants died 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.
The National Fund for Compensation of Medical Accidents has also proposed a €6.5m 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.
The group maintains that it has always complied with its information obligations and warned the health authorities from the start of the 1980s on the risks of fetal malformation, and from 2003 on the neurodevelopmental risks, but without immediate reaction from the authorities.
Depakine and its derivatives have caused serious congenital malformations since 1967 in 2,150 to 4,100 children, according to an evaluation by the ANSM and Health Insurance. Epidemiologist Catherine Hill puts forward the figure of 14,000 victims, including children with developmental delays.
[link url="https://www.jurist.org/news/2020/08/france-prosecutors-charge-sanofi-with-manslaughter-over-birth-deformities-linked-to-epilepsy-drug/"]Full Jurist report[/link]