The pharmaceutical group Sanofi announced Monday evening its indictment for " aggravated deception " and " unintentional injuries " in the case of the marketing of the reference anti-epileptic agent Dépakine, an investigation opened in September 2016. The molecule at issue , sodium valproate, has been marketed since 1967 under the brand name Depakine by Sanofi, but also under generic brands, and is prescribed for people suffering from bipolar disorder, but presents a high risk of birth defects on the fetus if it is taken by a pregnant woman.
Read also: Sanofi's plan to come back in force
" This measure allows [the group] to assert all of its defenses and will be an opportunity to demonstrate that it has complied with its obligation to inform, " said Sanofi in a press release. The group also ensures that it "will continue to cooperate fully with the judicial authorities and has every confidence in the outcome of the procedure ".
A "reversal of the file"
" This is a reversal of the file, which so far has not advanced much, " rejoiced Me Charles Joseph-Oudin, the lawyer of the Association of assistance to parents of children suffering from the syndrome anti-convulsant (Apesac), at the origin of the procedure, contacted by AFP. " Sanofi is bragging about a position of denial of responsibility which is more and more difficult to maintain, " added the lawyer. According to him, around forty people have filed a criminal complaint in this case " of extreme gravity and which in reality concerns thousands of victims ".
The Paris public prosecutor's office had opened in September 2016 a judicial inquiry for involuntary injuries and aggravated deception which consists of “ deception on the risks inherent in the use of the product and the precautions to be taken having resulted in making its use dangerous for the health of the human being ”, carrying out their investigations over the period from 1990 to April 2015. The opening of the investigation followed a preliminary investigation carried out under the authority of the public prosecutor's office since September 2015, after the first complaints of victim.
In a report from February 2015, the General Inspectorate for Social Affairs (Igas) estimated that Sanofi had shown a “ low reactivity ”, adding that the company had not sufficiently informed of the known risks for pregnant patients. When a pregnant woman takes this medication, her child is at a high risk - of the order of 10% - of congenital malformations, but also an increased risk of autism and intellectual and / or delayed walking, up to '' to 40% of exposed children. In late August 2016, the Ministry of Health recognized that more than 14,000 pregnant women had been “ exposed ” between 2007 and 2014, during the presentation of a study conducted by the National Agency for the Safety of Medicines and Health Products (ANSM).
See also - Dépakine: the testimony of a victim (12/14/2016)
