French justice on Wednesday authorized families of victims of Dépakine, an anti-epileptic drug responsible for physical deformities and neurodevelopmental disorders in children exposed in utero, to join a group action against the Sanofi laboratory.
In its decision, the civil chamber dedicated to group actions of the Judicial Court of Paris responded favorably to the request of the Association for assistance to parents of children suffering from anti-convulsant syndrome (Apesac), which accompanies 7,500 families, a first in medical-legal history in France.
According to the estimates of the Health Insurance and the Medicines Agency (ANSM), sodium valproate, the active principle of Depakine marketed since 1967, is responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children, which is one of the biggest scandals linked to the pharmaceutical industry in France.
"It's a very big victory," Apesac president Marine Martin told Reuters. "With this decision, justice recognizes the responsibility of the laboratory, it is now high time for it to change its attitude and stop looking down on families."
Sanofi, indicted since 2020 in this case for "aggravated deception" and "unintentional injuries" after complaints from 42 families, and for "manslaughter" following a complaint from Apesac, announced to appeal the decision rendered Wednesday.
"The laboratory will appeal this decision. It is based in particular on the objectionable conclusions of an expert report filed in the context of criminal proceedings," said the pharmaceutical company in a statement sent to Reuters.
Ensuring that it has always followed the instructions of the health authorities, Sanofi recalls that the courts last month ordered: "a second opinion in order to guarantee respect for the right to a fair trial and the rights of the defense".
Apesac should also appeal part of the decision, said Marine Martin, the justice having stopped in 2001 the date on which the responsibility of Sanofi can be engaged for the neuro-developmental disorders caused in children by the. administration of its anticonvulsant treatment to pregnant women.
A date which would de facto exclude very many families represented by Apesac from the compensation claim. "It is intriguing as a date when the amicable compensation fund adopted that of 1984", the year of publication of the first scientific paper pointing to neurodevelopmental disorders in children exposed in utero to sodium valproate, a-t- she pointed out.
If the question of taking into account neuro-developmental disorders is debated, that of physical malformations is, however, "no doubt", recalled Marine Martin.
Denouncing "repeated lies" from Sanofi , the president of Apesac seeks proof of the indictment of Sanofi for "manslaughter", the investigation now having to determine whether Depakine caused the death of four babies aged a few. weeks or months, between 1990 and 2014.
In his order, the investigating judge imposed on Sanofi to pay eight million euros in security "mainly intended to guarantee the payment of the fines incurred and the repair of damages" for the four families concerned, as well as a bank guarantee of 80 million euros to guarantee the rights of victims.
According to Apesac, the total amount of compensation that families could claim in the context of the class action could amount to hundreds of millions of euros, if the date of 1984 is retained.
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