The Paris Administrative Court of Appeal confirmed this Tuesday, January 14 that the State had a share of responsibility in the“insufficient information” given to patients and doctors about the risks of taking Dépakine during pregnancy, an antiepileptic drug marketed by Sanofi. In “not modifying the marketing authorization for Dépakine so that patients are sufficiently informed of the risks for the fetus […]the agency responsible for the safety of medicines failed in its obligations and committed an error entailing the responsibility of the State”, the court decides in a press release.
She therefore maintains that “for children born between 1999 and 2009, […] the State must partially repair the consequences the insufficiency of information given to doctors and patients” on the risks of malformations for the fetus or developmental disorders in the children of women treated during pregnancy.
Seizure of several appeals against judgments of the administrative court of Montreuil (Seine-Saint-Denis), “the court confirms that the State health authorities were not responsive enough in updating, depending on the period, all or part of these documents, taking into account the serious suspicions highlighted by existing studies” .
It has been established that Dépakine, given since the end of the 1960s, frequently causes malformations or developmental disorders in the children of women treated during pregnancy. The drug is at the heart of numerous legal proceedings in France, which are still ongoing but have already given rise to several decisions unfavorable to the manufacturer, Sanofi.
-“No fault of the laboratory”
The court recalls that the seriousness of the risks for the unborn child has been gradually documented since the 1980s for congenital malformations, and from the 2000s for neurodevelopmental disorders. She also considers that “this lack of information is not the direct cause of the problems experienced by children”, but that she has “resulting, for mothers, in a loss of chance of making the decision to change treatment, when such a possibility existed, or to abandon a pregnancy”.
Unlike the court, the court “However, it is not the fault of the laboratory” French Sanofi, “who had unsuccessfully proposed modifications to the information contained in the documents, for pregnancies carried out in 2006, 2008 and 2009”. She doesn’t hold back either “except in special cases due to the fault of doctors”.
