Paris (AFP)
The Court of Cassation on Wednesday overturned a decision condemning the pharmaceutical group Sanofi to pay more than three million euros to a family whose mother took the antiepileptic Dépakine and whose child was born with a malformation, according to a decision consulted by AFP.
"In concrete, the family will not be able to touch the 3 million euros", commented to AFP Marine Martin, president of the association of victims Apesac.
At the end of 2017, the Orleans Court of Appeal had ordered the pharmaceutical group to pay two million euros to this family, including a life annuity for the youngest daughter who has a general malformation syndrome, with an abnormality of the upper limbs. Sanofi had also been ordered to reimburse all costs paid by the primary health insurance fund (more than one million euros) for health expenses.
Sanofi said on Wednesday evening "has always been transparent, alerted the authorities and repeatedly requested changes to information documents for patients and health professionals on sodium valproate (the active molecule of Dépakine) ".
The laboratory told AFP that it had asked the Medicines Agency to modify the information leaflets for patients from 2004, and intends to make its arguments in this respect on appeal.
"The Court of Cassation has taken the measure of the seriousness of our arguments concerning the role of the Health Authority in the drafting of information documents including the patient record.Sanofi will have the opportunity to make its case before the Court of reference, "said the group.
If it is "a return to square one" for the family, Wednesday's decision is however considered a "half-hearted victory" for Apesac, because it sweeps the arguments invoked by the laboratory, including the prescription .
The laboratory "will not be able to say that their product is not defective and it will not be able to constantly oppose the prescription of the facts," said Martin, which could be used for other civil proceedings in this case.
Sodium valproate, marketed by Sanofi in particular under the name Dépakine and Dépakote, as well as in generic form, is at the center of a health scandal related to its prescription to pregnant women while its dangers for the fetus (congenital malformations). and neurodevelopmental disorders) were known.
The prescription conditions and the package leaflet were modified in 2015. This medicine has been responsible since 1967 for malformations in 2,150 to 4,100 children, and neurodevelopmental disorders in 16,600 to 30,400 children, according to the Health Insurance and the Medicines Agency. (ANSM).
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