Paris (AFP)

After more than three years of investigation, the judges in charge of the investigation into the marketing of the antiepileptic depakine put Sanofi under investigation for "aggravated deception and" involuntary injuries ", announced the pharmaceutical group on Monday evening.

The investigation, opened in September 2016, aimed to establish whether there had been "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 "and covered the period from 1990 to April 2015.

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 people suffering from bipolar disorder. However, it is at high risk of birth defects on the fetus if it is taken by a pregnant woman.

The investigation followed a procedure launched in May 2016 on the initiative of the Association for parents of children suffering from anti-convulsant syndrome (Apesac), which represents 4,000 people, half of whom are children patients, and relying on 14 cases of mothers who received Depakine during their pregnancy.

"This is a reversal of the file, which so far has not advanced much," rejoiced Me Charles Joseph-Oudin, the lawyer of Apesac, joined 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, about forty people have filed a criminal complaint in this case "of extreme gravity and which actually concerns thousands of victims".

Sanofi, for its part, estimated in a press release that this indictment would allow it "to assert all its defenses and will be an opportunity to demonstrate that it has respected its obligation to inform and has demonstrated transparency" .

- Criticism of "low reactivity" -

Sanofi also assured that it "will continue to cooperate fully with the judicial authorities and has every confidence in the outcome of the procedure".

The opening of the investigation followed a preliminary investigation carried out under the authority of the prosecution since September 2015, after the first complaints of victims.

In a February 2015 report, the General Inspectorate of Social Affairs (Igas) estimated that Sanofi, but also the Medicines Agency (ANSM) had shown "low reactivity" and had not sufficiently informed of the known risks for pregnant patients.

When a pregnant woman takes this drug, her child is at a high risk - around 10% - of birth defects, as well as an increased risk of autism and intellectual and / or delayed walking, which can reach up to 40% of children exposed.

The group claims to have always complied with its information obligations and to have warned the health authorities from the early 1980s on the risks of fetal malformation, and from 2003 on the neurodevelopmental risks, but without immediate reaction from the authorities.

Dépakine and its derivatives have caused serious birth defects since 2,150 to 4,100 children since 1967, according to an evaluation by ANSM and Health Insurance. Epidemiologist Catherine Hill puts forward the figure of 14,000 victims, taking into account children suffering from developmental delays.

Sanofi found itself at the heart of another scandal related to Dépakine, environmental this one, while its chemical factory of Mourenx (Pyrénées-Atlantiques), where the drug was produced in particular, was questioned in 2018 for non-standard emissions of toxic discharges.

According to the France Nature Environment (FNE) association, the site released "hazardous materials at astronomical rates", including bromopropane, which is part of the composition of sodium valproate.

The group then decided to stop production in order to make the technical improvements necessary for a return to normal.

© 2020 AFP