Epilepsy drug makers sent 'clear message' after court ruling

British valproate campaigners say the makers of the antiepileptic drug have been sent a “clear message” after a manufacturer was ordered to pay more than a quarter of a million euros to a French mother whose children were damaged in the womb.

Sodium valproate was sold under brand names such as Epilim in the UK, in France it is better known as Dépakine.

Marketed since 1967, it has been found the drug “can cause problems for a baby’s development, including birth defects and lifelong learning difficulties,” according to the latest advice on the NHS website. However, in the UK, a legal challenge was discontinued in 2010 after funding was terminated by the legal services commission.

The Paris case was brought by Marine Martin whose eldest child, Salomé, was born with facial malformations and suffers from dyspraxia. Florent, the youngest, was born with malformations which required two surgical interventions and was also diagnosed with Asperger’s autism.

Sanofi was ordered to pay €280,000 (£236,539) and Mdm Martin’s victory could lead to hundreds of other French challenges.

According to French newspaper Le Monde, the court declared Sanofi “responsible for a lack of information on the malformative and neurodevelopmental risks of Dépakine, which it marketed, for maintaining in circulation a product that it knew to be defective, and of a lack of vigilance during the pregnancies of Mdm Marine Martin, between 1998 and 2002.”

British campaigner Emma Friedmann, whose son Andy was part of the failed test case in the UK, said: “The judgment sends a clear message that Sanofi could and should have acted in a way to prevent harm. My son wouldn’t be able to pursue similar action in the UK due to the inadequacies in UK law and access to justice.

“Marine’s children are a similar age to my son. Information was available and I could have been alerted to the extent of the risk.”

Ms Friedmann who runs campaign group FACSaware says of Mdm Martin, “We campaigned together to get warnings issued, a pictogram on the outside of the packaging and restrictions of prescribing, so the judgment in France feels like a victory for all of us.”

Drug caused ‘avoidable harm’

In July 2020, in the UK, the Cumberlege review into valproate, along with pregnancy test drug, Primodos, and the medical implant vaginal mesh found that they had all caused “avoidable harm” to patients and it recommended the government set up a fund of redress to help victims.

The British government, thus far, has not introduced a fund. But, across the Channel, France created the National Office for Compensation for Medical Accidents in 2017. According the Le Monde, it has paid out nearly €58m to 1,120 sodium valproate victims.

While Mdm Martin’s children have already received funds from the French government, she went to court against the manufacturer after refusing her own state payment of €16,000 because it did not nearly cover her costs.

Mdm Martin told Sky News: “It’s a great victory. I’ve been waiting 12 years for my case to go to trial. Sanofi did everything it could to prevent it. They know I have 8,000 victims behind me ready to follow.”

Her message to British campaigners is “you must not give up. You must multiply the proceedings – civil, criminal, administrative, class action”.

Sanofi to challenge judgment

Sanofi argues that it is the health authority, and not the pharmaceutical company, that decides on the content of information documents relating to medicinal products, and it is up to doctors to assess whether the treatment is appropriate for the patient’s individual situation and explain the risks.

Furthermore, it claims the company’s efforts to warn regulators were not acted on. A Sanofi spokesperson said, regarding sodium valproate in France: “The regulations did not allow pharmaceutical companies to communicate information to doctors and patients without prior authorisation from the French Health Authority.”

“In the case of sodium valproate, Sanofi has complied with its obligations by informing the French Health Authority and requesting changes to its information documents as scientific knowledge of the risks associated with the treatment evolves.

“The risks of foetal malformation have been mentioned for over 40 years in documents intended for doctors. At the time, the French Health Authority decided that this information should only be communicated to patients by healthcare professionals. This logic led the Health Authorities to refuse Sanofi’s requests, made as early as the early 80s, to also mention this information in the patient leaflet.”

The company says it also informed the health authority about the risk of neurodevelopmental problems in the early 2000s and made several requests to amend its information documents but says the health authority only informed doctors in 2006 and it was only in 2010 that it decided to include malformative and neurodevelopmental risks in the patient information leaflet.

Sanofi says it therefore intends to challenge the judgment.

The findings of the Cumberlege review point to similar failings by UK regulators although it recommends a redress scheme funded by both state and manufacturer. Earlier this year, the patient safety commissioner, Henrietta Hughes, recommended that people affected by valproate should get an interim payout of £100,000 per patient from the government, followed by additional funds based on their needs.

Ms Hughes says the new government is considering her proposal.

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