PARIS, Nov 20 (Reuters) – The mother of two autistic children in France has lodged a legal complaint for endangering life after she suspected she was exposed to airborne emissions from Sanofi’s (SASY.PA) Depakine epilepsy drug plant, the Le Monde newspaper reported on Monday.
Melanie S., whose children showed neuro-developmental disorders similar to those observed in children whose mothers took Depakine during pregnancy, has never used the drug but since 2011 she has worked in an office located some 50 metres from the plant in Mourenx, southwest France, the paper said.
Her children were born in 2014 and 2016, according to Le Monde.
She filed the complaint on Nov. 15 “against unknown persons” in connection with emissions from the Sanofi plant, the newspaper said.
Sanofi said it was not aware of the complaint and judicial authorities could not be immediately reached for comment.
Sanofi said in an email to Reuters that the production process of sodium valproate at the Mourenx plant generates airborne emissions for which there was no set threshold until April 2018.
Since that date the Mourenx site operates “in compliance with regulations to produce a treatment essential to many patients”.
Sanofi also specified that in 2017 an independent company specializing in health and environmental impact research reviewed emissions tied to the sodium valproate production process and did not find “specific risk tied to emissions”.
In May 2022, a French court ordered Sanofi to pay more than 400,000 euros ($436,280.00) in damages to a family whose child suffered from a form of autism caused by its epilepsy drug Valproate, sold under the name Depakine in France, saying the drugmaker failed to inform about known side effects.
French health authorities have estimated the drug was responsible for deformities in between 2,150 and 4,100 children and neuro-developmental defects in up to 30,400.
Sanofi was placed under formal investigation in 2020 on charges of manslaughter, but rejected those charges at the time and said it would challenge the findings of the investigation.
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Reporting by Dominique Vidalon; Editing by Susan Fenton
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