In a decision made on Wednesday, the Paris court believes that the laboratory did not inform pregnant women of the risks of malformations and neuro-developmental disorders that this antiepileptic was running to their future children. Sanofi appealed.
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Sanofi has a fault, lacking his obligation of vigilance and his obligation of information “on the risks for the fetus that implied by depalant taking in pregnant women. For several years, with this antiepileptic drug with recognized efficiency, the laboratory has “produces and marketed a defective product”, in the sense that it does not offer “the security to which one can legitimately expect”.
Never the responsibility of Sanofi in the case of the Depakine had also been clearly stated by the Justice and in the decision made Wednesday, January 5 by the e section of the Re Civilian Chamber of the Judicial Court of Paris, specialized in the treatment of group actions.
Recent procedure (2014) in French law, group action allows victims of the same damage to regroup to act in court. The one against Sanofi, the first in the field of health, had been brought in 2017 by the Association of Assistance to parents with anti-convulsant syndrome (APESAC), which has been aimed at the fight of several thousand Victims of the Depakine.
It is now established that this medicine, marketed since 1967, increases the risk of congenital malformations (heart, kidneys, members, fingers, facial, etc.) and neuro-developmental disorders (delay Language, autism spectrum disorders, etc.) in children of women who have consumed during their pregnancy. According to estimates – contested by sanofi – health insurance and the national drug safety agency (ANSM), the sodium valproate, the active principle of the Depakine, would be responsible for malformations in 2,150 to 4,100 children, and neuro-developmental disorders in 16,600 to 30,400.
In his judgment, the court considers that malformation and neuro-developmental disorders caused by the sodium valproate were “regularly mentioned in the medical literature from 1984” for the first “and from 2001” for the second. The laboratory should have, “Upon knowledge of adverse effects, have the information for patients and information for health professionals in this direction”. However, it was not until January 2006 that the descakine, in his leaflet, was formally advised to pregnant women.
Half of the victims apart
The Tribunal declared “admissible” group action brought by APESAC, and specified that could join the 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 children exposed in utero over the same period; For neuro-developmental disorders, the same population, but only over the period between 2001 and January 2006 “.
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