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The responsibility of the laboratory in the malformations and developmental delays in the unborn child caused by the antiepileptic that it has marketed since 1967 was recognized on January 5 by the Paris court.
This Wednesday, the Paris court ruled: it ruled that the Sanofi laboratory had “committed a fault by failing in its obligation of vigilance and its obligation to inform” on the risks of his drug Depakinean antiepileptic responsible for malformations and neurodevelopmental disorders in thousands of children whose mothers had received this treatment during pregnancy.
Dépakine: a group action launched
The court also considered “admissible” the class action presented by the association for helping parents of children suffering from anti-convulsant syndrome (Apesac), victims in particular of Dépakine. This action, the first in France in the field of health, was launched in May 2017 and pointed to the delay in information from Sanofi on the risks of its drug. The laboratory has announced that it will appeal the judgment.
A judgment whichfixed between 1984 and 2006 the period of time during which the risk of birth defects has not been sufficiently taken into accountreports AFP. For the neurodevelopmental disorderswhich took longer to be recognized, it reduces this period to 2001-2006.” The court also requests that a “wide publicity is given to the possibility open to patients and their children to participate” to the Apesac group action. They have 5 years to do so.
Dépakine: Sanofi indicted for “involuntary homicides”
According to figures put forward in 2017 by Health Insurance and the National Medicines Agency (ANSM), since the start of its marketing in 1967, Depakine has been responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children. At the same time, as part of the criminal investigation, the Sanofi laboratory was indicted in 2020 for “manslaughter”.