Sanofi ordered to pay damages to a family whose daughter was born with congenital abnormalities
The court in Nanterre ruled Thursday that the French laboratory had known about the risk of autistic disorders associated with the antiepileptic drug since at least 2005 and was therefore obliged to mention it in the instructions for use.
On Thursday, May 12, the French company Sanofi was ordered by the court in Nanterre (Hauts-de-Seine) to pay 450,000 euros in damages to a family whose daughter was exposed to Depakine in the womb and was born with birth defects. The court ruled that the laboratory had known about the risk of autistic disorders associated with Depakine since at least 2005 and was therefore obliged to mention it in the instructions for use, according to the ruling, obtained by Agence France-Presse (AFP) on Saturday.
The mother, who was being treated for epileptic seizures, had been taking the drug since 1982. In 2004, she took four pills a day during her pregnancy. When her daughter was seven months old, she was hospitalized for bronchiolitis, and doctors diagnosed her with a "general learning delay." Subsequently, delays in psychomotor development were observed throughout childhood.
Risk of physical malformations
Sodium valproate, the active ingredient in Depakine, has been used since 1967 to treat epilepsy and bipolar disorders and increases the risk of physical malformations (absent spinal cord defects, cardiovascular anomalies, etc.) and neurodevelopmental disorders (e.g., language delays and autism spectrum disorders) in children exposed in the womb.
According to estimates - disputed by Sanofi - by the French Social Security and the ANSM (National Agency for Drug Safety), sodium valproate causes malformations in 2 150-4 100 children and neurodevelopmental disorders in 16 600-30 400 children.
"The decision to condemn the laboratory marks a turning point in the individual identification of each of the children exposed to Depakin," said the family's lawyer, Charles Joseph-Oudin, calling on the group to "change its behavior in all proceedings." The lab must now come to its senses and "treat with dignity" the families who have been severely harmed by the drug, he said.
Group actions
According to the ruling, the laboratory, which admitted that it had known of the risks, in particular for neurodevelopment, since 2003, was obliged to inform patients in the package leaflet. However, until 2006, Depakine's instruction leaflet did not recommend not using the drug during pregnancy and recommended consulting a doctor immediately if such a condition was detected, according to the ruling.
In Nader, this case is the first of many to be heard on the merits. In total, the court heard 23 cases, including one involving 272 applicants, according to a legal source.
A new procedure in French law introduced in 2014 - class actions - allows victims of the same injury to join together to file a lawsuit. The lawsuit against Sanofi, the first in the health sector, was brought in 2017 by the Association for the support of parents of children suffering from the anticonvulsant syndrome, Apesac, which has been fighting since 2011 on behalf of several thousand Depakine victims.
The class action was deemed admissible by a Paris court, which ruled on 5 January that Sanofi "wrongly failed to fulfill its duty of supervision and information". However, since the laboratory has announced its intention to appeal, it will have to wait for the ruling to be confirmed or annulled before launching the class action.
Comments
Post a Comment