Depakine scandal: Paris court orders Sanofi to compensate whistleblower Marine Martin

Marine Matin had filed a complaint in 2012. Midi Libre – MICHAEL ESDOURRUBAILH

In a decision rendered on Monday, September 9, the Paris judicial court ordered Sanofi to compensate Marine Martin for a "failure to inform about the malformation and neurodevelopmental risks of Depakine" and "lack of vigilance" at the time of the pregnancies, in the years 1998-2002. Mother of two handicapped children "born under Depakine", Marine Martin, who lives in Pollestres, in the Pyrénées-Orientales, had filed a complaint in 2012.

In the long and painful case of Depakine, an antiepileptic prescribed to thousands of women during their pregnancy, causing irreversible disabilities in children (congenital malformations, cognitive disorders), Marine Martin has just won a decisive round: in a decision rendered on Monday, September 9, the Paris judicial court ordered Sanofi to pay the whistleblower €285,000 in compensation for “failure to inform about the malformation and neurodevelopmental risks of Depakine” and “lack of vigilance” at the time of the pregnancies, in the years 1998-2002. Depakine is described as a “defective product”.

“We won and I can't believe it. I'm still in shock”, reacted Marine Martin on Tuesday, engaged in a fierce legal battle against the industrialist, convicted of negligence, the court did not retain the ten-year limitation period invoked by the pharmaceutical giant.

This court decision marks a significant step forward for the thousands of victims and their families, by acknowledging the laboratory's liability well before previous judgments: on May 12, 2022, the Nanterre court ordered Sanofi to pay €450,000 in compensation to the family of a disabled girl born under Depakine in 2004.

The court then considered that the laboratory had been aware of the risks since 2003, five years after Marine Martin's first pregnancy.

“Alarming studies well before birth of my children"

In 2012, faced with the unexplained disabilities of her two children Salomé and Nathan, now aged 25 and 22 respectively, the mother, living in Pollestres (Pyrénées-Orientales), headquarters of Apesac (Association for assistance to parents of children suffering from anticonvulsant syndrome), had filed a complaint against Sanofi. A year earlier, in 2011, she had created Apesac.

In an alert issued in June 2018, the French National Agency for the Safety of Medicines (ANSM) estimated that sodium valproate, the active ingredient in Depakine, causes a high rate of malformations, more than 10%, and/or neurodevelopmental disorders of 30% to 40% in children exposed during pregnancy. Three years earlier, the ANSM had urged doctors to stop prescribing the drug to women of childbearing age, before formally banning it in June 2018. But "the first alarming studies came out well before my children were born, in the early 80s", Marine Martin recalled to Midi Libre, on October 15, 2023.

“Physical malformations and neurodevelopmental disorders were described in the 1970s”, and confirmed by numerous studies in 1987/1988, pointed out Me Oudin, Marine Martin's lawyer, in his argument, which specifies : “Thus, 14 years before Salomé's pregnancy and 17 years before Nathan's pregnancy, a study already described a link between in utero exposure to sodium valproate and neurodevelopmental disorders”.

Awaiting criminal trial

In At the hearing of April 22, 2024, postponed by six months at the request of Sanofi, Me Charles Oudin, lawyer for Marine Martin, asked Sanofi for compensation of 411,066 euros for “loss of professional earnings” and “anxiety damage”.

Mr. Oudin requested compensation in light of the liability of Sanofi for the defective products and the lack of vigilance of the laboratory. He was heard. Contacted on Tuesday, September 10, Sanofi indicated that it was still studying the follow-up to this court decision. On the file, the laboratory continues to refer responsibility to the health authorities: “Sanofi has respected its obligations by informing the health authority and requesting changes to the information documents as scientific knowledge on the risks associated with the treatment evolved”, the prescription of sodium valproate to pregnant women.

“It has always been the responsibility of the health authority to assess these requests and to act on them or not. The risks of foetal malformation have been mentioned for over forty years in documents intended for doctors", but "the health authority had at the time decided that this information should be communicated to patients only by health professionals" and "this logic led the health authorities to refuse Sanofi's requests, made from the early 1980s, to also mention this information in the patient information leaflet", adds the laboratory.

On the criminal case, which brings together around a hundred complaints from families, The investigation “should be closed by the end of the year”, Marine Martin hopes. In 2020, Sanofi was indicted for "involuntary manslaughter", "involuntary injury" and "aggravated deception".

In this health scandal, estimates from the Health Insurance and the National Agency for the Safety of Medicines report malformations for 2,150 to 4,100 children, and neurodevelopmental disorders for 16,600 to 30,400 children.