Paris (AFP)
Sanofi was indicted for "manslaughter" in the scandal of the anti-epileptic Dépakine, following an investigation initiated by families of victims accusing the pharmaceutical group of having delayed informing of the risks of the drug for pregnant women.
This is a supplementary indictment, the group having already been prosecuted since February for "aggravated deception" and "unintentional injuries" in this case.
It was in 2016 that an investigation was opened at the Paris judicial tribunal, following a procedure initiated by the Association for the Assistance of Parents of Children Suffering from Anti- convulsant (Apesac): representing 4,000 people including half of sick children, it 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 Dépakine by Sanofi, but also under generic brands.
It is prescribed for people with bipolar disorder, but has a high risk of birth defects in the fetus if taken by a pregnant woman. Malformations, autism, ENT disorders: the effects can be devastating for some children who have been exposed in utero.
"Sanofi Aventis France has complied with its information obligations and disputes the merits of these proceedings," the group reacted on Monday in a communication to AFP.
He indicates that he "seized the investigative chamber in order to contest his indictment" and highlights the fact that "all of these elements in no way prejudge the responsibility of the laboratory".
No other information is given by Sanofi on the elements which led to this new indictment, revealed this weekend by Le Monde. According to the daily, "the legal information now aims to determine whether the laboratory can be held responsible for the death in 1990, 1996, 2011 and 2014, of four babies aged a few weeks or a few months, including mothers, during their pregnancies, had taken Depakine ".
For Apesac, "Sanofi must assume its share of responsibility," lawyer for the association Me Charles Joseph-Oudin told AFP on Monday.
- Recognized State responsibility -
According to the lawyer for Apesac, "the next procedural step should be the indictment of the drug agency for injuries and manslaughter".
He says a total of 1,402 families - or around 2,500 children - have contacted the association.
In July, justice had for the first time recognized the responsibility of the State, as well as that of Sanofi and doctors, in the devastating effects of the anti-epileptic Dépakine, ordering it to compensate families of severely disabled children. .
According to this decision taken by the administrative court of Montreuil (Seine-Saint-Denis), the state had been ordered to compensate the three applicant families, including five children today aged 11 to 35, severely disabled. Their mothers had continued to take this anti-epileptic during their pregnancy without suspecting the irreversible effects on their babies.
In total, the number of children disabled because of sodium valproate is estimated at between 15,000 and 30,000, according to studies.
In addition to other ongoing legal proceedings on this scandal, 516 cases of direct victims have been filed with Oniam (National Office for Compensation for Medical Accidents), and 952 cases as indirect victims, namely parents, brothers and sisters.
With the Mediator - whose trial-river ended in July, for a judgment expected in March - the Dépakine is one of the most resounding health scandals in France in recent years.
© 2020 AFP