The Paris Administrative Court of Appeal confirmed on January 14, 2025 that the State had a share of responsibility in the "lack of information » given to patients and doctors on the risks of the anti-epileptic Depakine, marketed by Sanofi, taken during pregnancy.
The court ruled that in " By failing to amend the marketing authorisation for Depakine so that patients are adequately informed of the risks to the foetus (…), the agency responsible for the safety of medicines failed in its obligations and committed an error engaging the liability 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 inadequacy of the information given to doctors and patients » on the risks of malformations for the fetus or developmental disorders in the children of women treated during their pregnancy.
"A very big victory"
This decision, which concerns five cases, shows that " This scandal is moving forward from a legal point of view. Now it remains to compensate the victims", Charles Joseph-Oudin, the lawyer in these five cases including that of the president of the association of victims of Depakine (Apesac), Marine Martin, told AFP. It is " a very big additional victory" she responded to AFP.
It has been established that Depakine, given since the end of the 1960s, frequently causes malformations or developmental disorders in the children of women treated during pregnancy. The Depakine 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 mechanism is open to the National Office for Compensation of Medical Accidents (Oniam). We are continuing compensation proceedings against the State in other cases. And we are continuing compensation proceedings against Sanofi.", added Me Joseph-Oudin. For him, " There are two parties responsible, the industrialist and the State. The responsibility of one does not eliminate the responsibility of the other.“.
Read alsoWhat is this Depakine that is causing a “scandal”?
"Loss of chance"
Seizure of several appeals against judgments of the administrative court of Montreuil, " The court confirms that the state health authorities have not been sufficiently responsive 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 progressively 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 children experience", but that she has " resulted in a loss of opportunity for mothers to make the decision to change treatment, when such a possibility existed, or to abandon a pregnancy“.
“ The State is, however, only liable for part of the damage suffered.", the court emphasizes, considering that " mistakes "committed by the laboratory or by the prescribing physicians" are such as 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 retain " no fault of the laboratory which had unsuccessfully proposed changes 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 of fault of doctors" Contacted by AFP, Sanofi states 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.“.
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