In a ruling handed down Wednesday, the Paris court found that the pharmaceutical company had failed to inform pregnant women of the risks of birth defects and neurodevelopmental disorders that this antiepileptic drug posed to their unborn children. Sanofi has appealed the decision.
By Henri Seckel
Sanofi «acted negligently by failing to fulfill its duty of care and its duty to inform» regarding the risks to the fetus posed by Depakine use in pregnant women. For several years, with this anti-epileptic drug—whose effectiveness is well established—the company «manufactured and marketed a defective product,» in the sense that it did not offer the «safety that one can legitimately expect.».
Never before had Sanofi’s liability in the Depakine case been so clearly established by the courts as in the ruling handed down on Wednesday, January 5, by the 7th Section of the 1st Civil Chamber of the Paris Judicial Court, which specializes in handling class-action lawsuits.
Recent case—2014—Under French law, class-action lawsuits allow victims of the same harm to join forces to take legal action. The lawsuit against Sanofi, the first of its kind in the healthcare sector, was filed in 2017 by the Association for Assistance to Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which has been advocating on behalf of several thousand victims of Depakine since 2011.
It is now well established that this medication, which has been on the market since 1967, increases the risk of congenital malformations (heart, kidneys, limbs, fingers, face, etc.) and neurodevelopmental disorders (language delay, autism spectrum disorder, etc.) in the children of women who took it during pregnancy. According to estimates—contested by Sanofi—from the French National Health Insurance system and the French National Agency for Medicines and Health Products Safety (ANSM), sodium valproate, the active ingredient in Depakine, is believed to be responsible for birth defects in 2,150 to 4,100 children and for neurodevelopmental disorders in 16,600 to 30,400 of them.
In its ruling, the court found that birth defects and neurodevelopmental disorders caused by sodium valproate were «consistently mentioned in the medical literature beginning in 1984» for the former «and beginning in 2001» for the latter. The pharmaceutical company should have, «as soon as it became aware of these adverse effects, updated the patient information and the information for healthcare professionals accordingly.» However, it was not until January 2006 that the package insert for Depakine formally advised against its use by pregnant women.
Half of the victims were excluded
The court ruled that the class-action lawsuit filed by Apesac was «admissible» and specified who could join the lawsuit: for birth defects, all women who were pregnant «between 1984 and January 2006» and who took the medication during their pregnancy, as well as all children exposed in utero during the same period; for neurodevelopmental disorders, the same population, but only for the period «between 2001 and January 2006.».
Marine Martin, founder of Apesac, hailed this as a «major victory,» while expressing regret that the time periods selected «exclude half of the Depakine victims.» These dates are «too restrictive,» according to Charles Joseph-Oudin, the association’s attorney, who notes that the risk of birth defects was known as early as 1982, the risk of neurodevelopmental disorders as early as 1984, and that the lack of information persisted beyond 2006.
The lawyer nevertheless welcomed the «immense symbolic significance» of a decision that «condemns Sanofi’s philosophy and strategy of denying liability,» while acknowledging that, for the time being, it had «relatively limited practical consequences,» particularly because the pharmaceutical company has announced its intention to appeal, and the appeal has suspensive effect. We will therefore have to wait for a second ruling—at the earliest in 2023—to confirm or overturn Wednesday’s decision before knowing whether the class-action lawsuit, the path to compensation, can proceed or not.
Sanofi responded in a press release: «The position taken by the Paris Court of Justice is not consistent with earlier court rulings, which either do not hold the company liable or find that the primary liability rests with other actors in the healthcare system,» notably the ANSM, the government’s health regulator, on which Sanofi places the blame.
Also charged with «involuntary manslaughter»
The company states that it has «always been transparent in alerting health authorities and repeatedly requesting changes to the Depakine patient and healthcare professional information materials.» It asserts that «the patient information materials were updated in accordance with the evolving state of scientific knowledge and the decisions of the health authorities at the time.».
In addition to this class-action lawsuit, Sanofi is under investigation in the criminal aspect of the case—as is the ANSM—for «aggravated fraud,» «unintentional injury,» and «involuntary manslaughter.» In addition, more than 3,000 claims have been filed with the National Office for Compensation of Medical Accidents, which, as of July 2021, had already approved more than 800, totaling 28.5 million euros—public funds that Sanofi, in theory, will have to partially reimburse if its liability is ultimately established. Finally, dozens of individual civil lawsuits are pending—several trials are scheduled for 2022. APESAC hopes that the ruling in the class-action lawsuit, even if it is suspended by the appeal, will lend weight to the plaintiffs’ claims in all these parallel proceedings.
It’s not all bad news for Sanofi: it was reported on Wednesday that, in the criminal aspect of the case, the investigating judge had been compelled by the investigating chamber to commission a second expert analysis of the drug, in addition to the first one that had led to the company being placed under investigation. It was specifically this first expert analysis, dated January 2020—which Sanofi strongly contested and had demanded be replaced—that the Paris Judicial Court relied on to render its decision in the class-action lawsuit. If the second expert report reaches conclusions that differ from the first, it could be a game-changer. The legal battle over Depakine is far from over.
Henri Seckel
