At the helm, the Depakine victims association asked Sanofi to shoulder its responsibility.
The victims denounce "a major human disaster" and ask the court to recognize the malformations and developmental delays in children whose mothers have followed this antiepileptic treatment.
This group action, the first in the health sector, was launched in May 2017 at the initiative of the Association for the Assistance of Parents of Children Suffering from Anticonvulsant Syndrome (Apesac), which represents 4 000 people, half of sick children.
The procedure, carried out in parallel with a criminal investigation, is illustrated by fourteen cases of mothers who received Dépakine during their pregnancy between 1977 and 2015. “Today we are talking about a considerable human tragedy which, for dozens of years, has affected thousands of children, ”Apesac's lawyer, Mr. Charles Joseph-Oudin, testified in a one-and-a-half-hour plea.
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The lawyer intends to recognize the civil liability of Sanofi in the deformities or developmental disorders occurring in children whose mothers had received this treatment based on sodium valproate, considered essential for some patients.
Sanofi still disputes the direct causal link between Dépakine and the disorders mentioned
Since 1967, this product has been responsible for malformations in 2,150 to 4,100 children and neurodevelopmental disorders in 16,600 to 30,400 children, according to estimates from the Health Insurance and the ANSM.
According to Apesac, these risks had been described since the 1980s but were only brought to the attention of women in 2015.
"The laboratory did not try to find out, while signals were accumulating," said Joseph-Oudin.
“However, these create an obligation of vigilance.
As soon as a signal appears, the laboratory must inform practitioners and patients.
When did this signal date?
From 1982 for malformations and 1984 for neurodevelopmental disorders, ”he continued.
The laboratory subsequently assured in a press release that “from the beginning of the 1980s, Sanofi conscientiously informed the health authorities as scientific knowledge developed on the risks that may be associated with exposure to in utero with sodium valproate, regularly making requests for changes to information documents intended for healthcare professionals and patients ”.
At the hearing, Sanofi pleaded the inadmissibility of the class action.
Me Armand Aviges, lawyer for the French pharmaceutical giant, assured that “families are not in an identical situation, as required by the texts.
There are very disparate situations, whether it be the dates of pregnancies or damage, ”insisted the defender.
Depakine still on the market
He also maintained that "not a single report retains a certain and direct causal link between sodium valproate and the disorders mentioned".
"There is a statistical association but no physical or biological explanation", defended Me Aviges, adding: "there is neither malice nor strategy with us."
Present in the room, the president of Apesac, Marine Martin, sighs.
While the lawyer evokes her particular case, she takes it up on the date of birth, in 1999 and 2002, of her children while she was being treated at the Dépakine.
In 2012, she was the first woman to take legal action.
"He acts as if the laboratory cares about the victims, but it does not deceive anyone," she said at the end of the hearing.
During his pleadings, Sanofi's lawyer also recalled that "Dépakine is still marketed", while being contraindicated for several years for women of childbearing age and pregnant women.
As part of the criminal investigation, the Sanofi group, accused by families of victims of having delayed too long in informing about the risks of taking this drug during pregnancy, was indicted in August 2020 for “involuntary homicides”.
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In July 2020, the administrative justice recognized for the first time the responsibility of the State, as well as that of Sanofi and doctors, ordering the State to compensate the families of severely disabled children. The deliberation of the civil section will be made on December 15. If Sanofi's responsibility were recognized, the judge would then define the group of victims who could claim compensation.
