British campaigners advocating for valproate victims have said a significant message was sent to the drug’s manufacturer after a French court ordered Sanofi to pay over a quarter of a million euros to a mother whose children were harmed in the womb. The case involved sodium valproate, sold in the UK under the brand name Epilim and as Dépakine in France.

Emma Friedmann, a British campaigner whose son was part of a failed legal case in the UK, expressed that the ruling highlighted how Sanofi should have acted to prevent harm. She lamented that her son could not pursue similar legal action in the UK due to shortcomings in the country’s laws and barriers to justice. She noted that had proper information been made available, she could have been warned about the risks of the drug during pregnancy.

Friedmann, who leads the campaign group FACSaware, worked with Marine Martin, the French woman who won the recent case, to push for stricter warnings, including a pictogram on packaging and tighter prescription regulations. Friedmann sees the French court’s judgment as a victory for all who fought for greater awareness of the risks associated with sodium valproate.

In 2020, the UK's Cumberlege Review investigated the harm caused by sodium valproate, the pregnancy test drug Primodos, and vaginal mesh implants, concluding that all three had caused avoidable harm. The review recommended a government compensation fund for affected patients, but no such fund has been established in the UK. Meanwhile, France set up the National Office for Compensation for Medical Accidents in 2017, which has since paid nearly €58 million to 1,120 victims of sodium valproate.

Sodium valproate, in use since 1967, has been linked to birth defects and lifelong learning difficulties, according to the latest advice on the NHS website. However, in the UK, a legal challenge related to the drug was discontinued in 2010 when legal aid was withdrawn.

Marine Martin’s case, which was brought before a French court, involved her two children. Her eldest, Salomé, was born with facial malformations and dyspraxia, while her younger child, Florent, required surgeries for malformations and was diagnosed with Asperger’s autism. The court ruled that Sanofi failed to properly inform about the malformative and neurodevelopmental risks of Dépakine, which it continued to sell despite knowing the product was defective. Sanofi was ordered to pay €280,000 (£236,539) in damages, and this decision may pave the way for hundreds of similar cases in France.

Martin had already received financial support from the French government but chose to sue Sanofi after rejecting a state payment of €16,000, as it did not cover her costs. She celebrated her victory, stating that it marked the culmination of a 12-year battle.

Sanofi plans to appeal the judgment, arguing that it was not the company’s responsibility to communicate risks directly to patients, as such decisions rested with the health authorities. The company claims it complied with regulations by informing the French Health Authority about the risks of fetal malformation, which had been mentioned in medical documents for over 40 years. Sanofi also said it requested updates to patient information leaflets as scientific knowledge of the risks developed but was blocked by the health authority until 2010.

Martin urged British campaigners not to give up, calling for multiple legal actions. The findings of the Cumberlege Review also pointed to regulatory failures in the UK. Earlier in 2024, Henrietta Hughes, the UK’s patient safety commissioner, recommended interim payments of £100,000 per affected patient, with additional compensation to be determined based on their needs. Hughes added that the UK government is currently considering her proposal.

Reference :

1. Farrell, J. (2024, September 14). Makers of sodium valproate sent 'clear message' after Sanofi ordered to pay €280,000 to mother whose children were harmed. Sky News. https://news.sky.com/story/makers-of-sodium-valproate-sent-clear-message-after-sanofi-ordered-to-pay-280-000-to-mother-whose-children-were-harmed-13214382

(Input from various sources)

(Rehash/Yash Kamble/MSM)