why this judgment is particularly important, especially for victims

The Paris judicial court on Monday declared the pharmaceutical group “responsible for a failure to provide information on the malformation and neurodevelopmental risks” of this antiepileptic prescribed to pregnant women.

This is one of the most important legal cases related to public health in recent years in France. The case of Depakine, the antiepileptic drug responsible, according to national health authorities, for malformations and neurodevelopmental disorders in thousands of children, took a new turn on Monday, September 9. The pharmaceutical group Sanofi was declared “responsible for a lack of risk information” by the Paris judicial court and ordered to pay nearly 300,000 euros to Marine Martin, president of the association for Aid to Parents of Children Suffering from Anticonvulsant Syndrome (Apesac). Franceinfo explains why this judgment is particularly important.

The ruling comes on top of other setbacks for Sanofi.

Since 2015, numerous proceedings have targeted the pharmaceutical giant that produces Depakine, based on a molecule, sodium valproate. This antiepileptic treatment has been prescribed since the end of the 1960s, including to pregnant women. The laboratory is mainly accused of having misinformed patients about the risks of the drug. Sanofi is being prosecuted both criminally – it has been indicted since 2020 for “involuntary manslaughter” – and civilly, with individual actions such as those of Marine Martin, and group actions, which bring together a large number of patients.

Monday’s decision is not the first to implicate the group’s liability. In 2022, the laboratory was already ordered to pay 450,000 euros to a patient whose daughter, exposed to Depakine, was born with malformations. In January 2024, the class action launched in 2017 was deemed admissible by the Paris court, which considered that Sanofi had “committed an error by failing in his duty of care and his duty to provide information”The lab announced it would appeal. In August, the Nanterre court declared 40 families – representing 170 people – eligible to claim compensation related to the fear of developing neurodevelopmental disorders.

Monday’s decision “reinforces the successes already achieved by the victims in their various actions initiated against Sanofi”Charles Joseph-Oudin, the lawyer for Marine Martin and many other families, reacted to franceinfo. “It is urgent that the company abandons its attitude of contemptuous denial towards the victims of Depakine and finally assumes its responsibility towards the families affected by this drug.”he added.

This judgment is a major victory for whistleblower Marine Martin.

Marine Martin is the main face of the Depakine victims. By creating the association Apesac in 2011, she helped to give media and legal coverage to this affair. It has been twelve years since this whistleblower initiated civil proceedings against the pharmaceutical group. “It’s a fight of extraordinary toughness”the mother of two children born in 1999 and 2002 confided on franceinfo on Tuesday. They suffer from malformations and have developed neurological disorders.

“Clearly, I suffered, Sanofi is trying by all means to stop my procedures. I became an expert patient at the drug agency and they tried to fire me from this position”she testified in 2021 to France 3 Occitanie.

“They know that I am the spearhead of all this action and that I motivate the families.”

Marine Martin, whistleblower in the Depakine case

to France 3 Occitanie in 2021

As recalled The Worldit was Marine Martin who enabled the victims of Depakine to access, from 2017, compensation from the National Office for Compensation of Medical Accidents (Oniam). According to the daily, which consulted the organization’s 2023 activity reportnearly 58 million euros were paid to the 1,120 victims who accepted Oniam’s proposals, including Marine Martin’s children and husband. The latter, however, refused the offer and preferred to continue the legal fight: “I was offered 16,000 euros, barely the price of a car”she told the newspaper.

She got almost 18 times more with Monday’s conviction (284,000 euros in compensation). According to her lawyer Charles Joseph-Oudin, “This decision justifies and salutes the fight of whistleblower Marine Martin since the creation of the Apesac association”. Marine Martin is all the more pleased with this victory as the laboratory does not participate in the victims’ compensation fund managed by Oniam (National Office for Compensation of Medical Accidents). “It’s absolutely scandalous”she commented to franceinfo on Tuesday.

However, the whistleblower remains vigilant and combative, believing that Sanofi will appeal. “It’s a war of nerves. We’re getting into the hard stuff. The money I earned is blocked. They’re wearing the victims down. That’s why it’s important that other victims join me in the legal proceedings.”

This judgment extends the period for which the laboratory is liable to be condemned.

The previous convictions concerned children born after Marine Martin’s. This legal victory “opens the door to thousands of victims”by showing them that the ten-year limitation period, an argument invoked by Sanofi, is not “impassable”assures Marine Martin. This new judgment therefore implies that the laboratory’s liability was already engaged in the state of scientific knowledge at the time. Enough to extend, in terms of case law, the period for which Sanofi is likely to be ordered to compensate patients.

Asked by AFP, the group said it was studying “the follow-up” to this decision and, more broadly, reiterated its position on Depakine. Sanofi believes that it asked the French health authorities early enough to modify the drug’s leaflet, and places the blame on them for not following up on this request.