Sanofi ordered to compensate French family for epilepsy drug side effects

PARIS (Reuters) – A French courtroom has ordered Sanofi to pay greater than 400,000 euros ($416,440) in damages to a household whose little one suffered from a type of autism brought on by its epilepsy drug Valproate, saying the drugmaker failed to tell about recognized uncomfortable side effects.

The hyperlink, alongside bodily malformation, had additionally been recognised in a landmark class motion ruling in January, which may doubtlessly result in lots of of tens of millions of euros in compensation, although Sanofi mentioned it will file an enchantment.

The most recent ruling, made final week and seen by Reuters on Saturday, states that Sanofi will need to have recognized the chance that the drug, if taken by pregnant girls, may trigger malformations and “neuro-behavioural issues” in youngsters, which ought to have been talked about in its connected leaflet.

Sanofi mentioned in an announcement it will enchantment the choice, including the drug’s general risk-benefit ratio is optimistic.

The courtroom in Nanterre on Thursday ordered the corporate to compensate the mother and father of the lady for the assorted bodily and psychological damages suffered, and ensuing prices similar to particular care and education wants.

The decision is the primary in France to state a hyperlink between Valproate, bought beneath the identify Depakine in France, and issues generally known as autism, in a person case, mentioned Marine Martin, who heads sufferer affiliation APESAC.

“I hope that Sanofi will change its place and begin compensating the victims now that increasingly more courtroom choices are being rendered”, Martin, herself the mom of a kid affected by Depakine uncomfortable side effects, instructed Reuters on Saturday.

French well being authorities have estimated the drug was chargeable for deformities in between 2,150 and 4,100 youngsters and neuro-developmental defects in as much as 30,400.

Sanofi was positioned beneath formal investigation in 2020 on fees of manslaughter, however rebutted these fees on the time and mentioned it will problem the deserves of the investigation.

($1 = 0.9605 euros)

(Reporting by Tassilo Hummel; Modifying by David Holmes)