Pharma giant Sanofi charged with manslaughter in birth defects drug scandal
Sanofi stands accused of “involuntary manslaughter” over the devastating effects of its epilepsy drug Depakine, suspected of causing birth defects in thousands of children whose mothers took the medicine while pregnant. The French group has said it will appeal.
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Already charged with aggravated fraud and unintentionally causing injury, Sanofi's legal woes looked set to worsen on Monday after it was put under investigation for manslaughter.
The charges relate to the Sanofi drug valproate, marketed in France under the trade name Depakine and other generic versions since 1967. It is commonly prescribed to people suffering from epilepsy, migraines and bipolar disorder.
However, when taken by mothers-to-be it can increase the chances of their children having birth defects, autism and learning difficulties.
Health authorities say the French company failed to warn pregnant mothers about the risks.
Sanofi insists it “fulfilled its obligation” of providing information on the drug and its side-effects, and said it “contests the validity of these proceedings”.
Undeniable link
The investigation will determine whether the pharmaceutical company can be held responsible for the deaths of four babies in the late 90s and early 2000s, whose mothers took Depakine during their pregnancies.
"It is undeniable that the link between the dose (of Depakine) and the damage observed among the young victims is scientifically proven," investigating judges told Le Monde newspaper.
The investigation comes on the heels of legal action launched in 2016 by victims and their families.
Marine Martin, president of an association which helps the families of children damaged by the drug, said today's announcement was "a great victory for the families of victims of Depakine”.
🇫🇷#Sanofi inculpé pour homicides involontaires dans le scandale de l'anti-épileptique #Depakine.
— RFI (@RFI) August 4, 2020
🎧Ecoutez @_MarineMartin, lanceuse d'alerte, mère de deux enfants touchés et présidente de l'@APESAC1, association de victimes de la Dépakine.
👉https://t.co/S8J7UQ4IBx#RFIMatin pic.twitter.com/znPxwIWD8J
"For years, I've been receiving calls from mothers who lost their babies shortly after giving birth because their child died from the defects.
"We forget very often that Depakine kills," Martin told RFI.
The French drugs agency (ANSM) estimates that Depakine may have caused disabilities in as many as 30,000 children whose mothers took the medicine while pregnant.
Millions in compensation
Victims are seeking millions in damages.
"We're hoping for a major trial like this year's Mediator trial," Martin said, in reference to the diabetes drug scandal that was irresponsibly prescribed as a weight loss pill with deadly consequences.
"We must move quickly, children desperately need treatment."
Last month, a French court ordered the government to pay thousands of euros in compensation, saying officials should have ensured the drug was not taken by pregnant women.
In the criminal proceedings against Sanofi, judges are calling on the company to provide substantial financial guarantees, including depositing 8 million euros in bail money immediately and an 80 million euro bank guarantee if the case goes to trial.
No responsibility
The money will go towards a compensation package for Depakine victims.
For now, Sanofi has refused to pay any compensation.
Under the French legal system, charges do not automatically result in a trial and the group insists that its indictment "does not in any way prejudge the responsibility of the laboratory". It has filed a legal challenge appealing the charges.
Valproate remains the primary drug for the treatment of many forms of epilepsy and continues to be sold.
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