Sanofi has “Committed a fault by failing to fulfill its obligation of vigilance and its obligation to inform” on the risks to the fetus of taking Depakine in pregnant women. For several years, with this antiepileptic drug with recognized effectiveness, the laboratory has “Produced and marketed a defective product”, in the sense that he did not offer “The security one can legitimately expect”. Never had the responsibility of Sanofi in the Dépakine affair been so clearly stated by the courts as in the decision rendered on Wednesday January 5 by the 7e section of the 1D Civil Chamber of the Paris Court of Justice, specializing in the processing of class actions.
A recent procedure (2014) in French law, group action allows victims of the same damage to come together to take legal action. The one against Sanofi, the first in health, was brought in 2017 by the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which since 2011 has been fighting several thousand victims of Dépakine.
It is now established that this drug, marketed since 1967, increases the risk of congenital malformations (of the heart, kidneys, limbs, fingers, face, etc.) and neuro-developmental disorders (language delay, autism spectrum disorders, etc.) in the children of women who have used it during their pregnancy. According to estimates – disputed by Sanofi – from the Health Insurance and the National Medicines Safety Agency (ANSM), sodium valproate, the active principle of Depakine, is responsible for malformations in 2,150 to 4,100 children, and neurodevelopmental disorders in 16,600 to 30,400.
In its judgment, the court found that malformations and neurodevelopmental disorders caused by sodium valproate were “Regularly mentioned in the medical literature from 1984” for the first ones “And from 2001” for the latter. The laboratory should have, “As soon as you become aware of undesirable effects, have the information intended for patients and the information intended for healthcare professionals amended accordingly”. However, it was not until January 2006 that Dépakine, in its instructions, was formally discouraged for pregnant women.
Half of the victims dismissed
The court declared “Admissible” the class action brought by Apesac, and specifying who could join the said action: for malformations, all women who have been pregnant “Between 1984 and January 2006” and having consumed the drug during their pregnancy, as well as all the children exposed in utero over the same period; for neuro-developmental disorders, the same population, but only over the period included “Between 2001 and January 2006”.
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