The investigation into the group, French pharmaceutical Sanofi in the scandal of Depakine continues. Last February, the company announced it was already be prosecuted for “aggravated tort of deceit” and “unintentional injuries” in the survey on the marketing of the anti-epileptic Depakine. She said, this Monday, have also been under investigation for ” involuntary homicide “. The investigation had been initiated in 2016 with the judicial court of Paris, following a procedure at the initiative of the Association of assistance to parents of children suffering from the syndrome of the anticonvulsant (Apesac), representing 4 000 people, half of the sick children, and that was based on 14 cases of mothers who received Depakine during their pregnancy.
The molecule in question, sodium valproate, has been marketed since 1967 under the brand name Depakine by Sanofi, but also under generic brands, and is prescribed for individuals suffering from a bipolar disorder. It presents a high risk of birth defects on the fetus if taken by a pregnant woman. In February 2020, the judges in charge of the investigation on the commercialization of Depakine had put in to review the pharmaceutical group, French for “aggravated tort of deceit” and ” involuntary injury “.
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Sanofi challenges the review
on Monday, the group told the Agence France-Press have also been under investigation recently for involuntary homicide “, confirming information of the daily Le Monde which referred to the date of 20 July. The group, in a communication submitted to the Agence France-Presse, claiming to have ” complied with its disclosure obligations and disputes the merits of these proceedings “. “The laboratory has entered the chamber of the instruction in order to challenge his indictment. All of these elements does not prejudge the responsibility of the laboratory “, does it before.
No other information is given by Sanofi on the elements that have led to this new review. According to The World, ” the judicial inquiry should aim to determine if the laboratory can be held responsible for the death in 1990, 1996, 2011 and 2014 of four babies aged between a few weeks or a few months, whose mothers, during their pregnancy, were taking Depakine “. For the Apesac, “Sanofi must assume its share of responsibility,” said, Monday, the Agence France-Presse the lawyer of the association, Charles Joseph Oudin.
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the responsibility of The State, recognized
According to the lawyer of the Apesac, ” the next procedural step should be examination of the Agency of the drug for injuries and manslaughter “. He said that a total of 1 402 families – or approximately 2 500 children – have contacted the association. Last July, the justice had for the first time recognised the responsibility of the State, as well as Sanofi and doctors, in the devastating effects of the antiepileptic drugs Depakine, condemning him to indemnify the families of severely disabled children.
According to the decision taken by the administrative court of Montreuil (Seine-Saint-Denis), the State was ordered to compensate three families applicants, including five children now ages 11 to 35 years, with severe disabilities. Their mothers had continued to take this antiepileptic drug during their pregnancy, unaware of the irreversible effects on their babies. In total, the number of children with disabilities due to the sodium valproate is estimated to be between 15 000 and 30 000, according to the studies. At the same time to other legal proceedings in the course of this scandal, 516 folders of the direct victims have been deposited at the Oniam (Office national d’indemnisation des accidents médicaux), and 952 records as indirect victims, the parents, brothers and sisters. With the Mediator – in which the trial river ended in July, for a trial expected in march, the Depakine is the one of the most sensational scandals to health in France in recent years.
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