“The agency responsible for the safety of medicines failed in its obligations and committed an error involving the responsibility of the State,” states a press release from the court.
The Paris Administrative Court of Appeal confirmed this Tuesday that the State had a share of responsibility in the“insufficient information” given to patients and doctors on the risks of the anti-epileptic Dépakine taken during pregnancy.
The court judges that in “not modifying the marketing authorization of the Dépakine so that patients are sufficiently informed of the risks for the fetus (…), the agency responsible for the safety of the medicine failed in its obligations and committed an error entailing the responsibility of the State”according to a press release from this body. She confirms, “for children born between 1999 and 2009, that the State must partially repair the consequences of the insufficient 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.
“Very big victory”
This decision, which concerns five cases, shows that “this scandal is progressing from a legal point of view. It now remains to compensate the victims.told AFP Me Charles Joseph-Oudin, the lawyer in these five cases including that of the president of the association of victims of Dépakine (Apesac), Marine Martin. It is “a very big additional victory”she reacted to AFP.
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 Dépakine affair, which broke out in 2015, is at the heart of numerous legal proceedings in France, still ongoing but having already given rise to several decisions unfavorable to the French laboratory Sanofi. An amicable compensation scheme is open to the National Medical Accident Compensation Office (Oniam).
“We are continuing compensation procedures against the State in other cases. And we are continuing compensation procedures against Sanofi”added Me Joseph-Oudin. For him, “There are two responsible parties, the industrialist and the State. The responsibility of one does not make the responsibility of the other disappear.
-“Loss of luck”
Seizure of several appeals against judgments of the administrative court of Montreuil, “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” .
She recalls that the seriousness of the risks for the unborn child was gradually documented from the 1980s for congenital malformations, and from the 2000s for neurodevelopmental disorders.
She 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 to make the decision to change treatment, when such a possibility existed, or to abandon a pregnancy”. “The State is, however, only responsible for part of the damage suffered,” underlines the court, considering that “mistakes” committed by the laboratory or by the prescribing doctors “are likely to exempt the State from all or part of the obligation to repair the damage suffered by children and their relatives”.
However, the court does not hold “no fault of the laboratory which 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”.
Contacted by AFP, Sanofi affirms that “since the end of the 1980s, the laboratory has continually requested changes to the information documents, which have not been accepted by the health authority”.
