According to information unveiled by France Inter, Apesac (the association helping parents of children suffering from the anticonvulsant Depakine syndrome) has officially appealed to the Paris Tribunal de Grande Instance in order to have the laboratory recognized the responsibility for the disorders from which their children suffer. children, born under Dépakine. This is the first French group action in health, as the association had announced it last December.
In France, according to the National Medicines Safety Agency, between 2,150 and 4,100 children now have birth defects because they were exposed during pregnancy to Depakine, a medicine for epilepsy and the bipolar disorders.
For its part, the Sanofi laboratory denies any responsibility. Amel Benkritly, head of pharmacovigilance, affirms that his laboratory alerted the drug agency in 2003: “As soon as we became aware of a certain number of medical publications which warned of other undesirable effects” he told France Inter.
A mode of defense refuted by the lawyer for the APESAC association, Maître Charles Joseph-Oudin (also defender of the victims of the Mediator): “laboratories cannot be exempted from their responsibility on the grounds that they are subject to the control of an administrative authority”. And this, even if the responsibility of the latter was retained.
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