French lab Sanofi ordered to pay €450,000 in latest epilepsy drug case

French pharmaceutical lab Sanofi has been ordered to pay €450,000 compensation to a family whose child was born with deformations and disorders linked to epilepsy medication taken by his mother.

A court in Nanterre ordered the lab to pay the compensation after it found that the baby girl had been exposed to the drug Depakine while in utero.

The mother had been taking the medication for her epilepsy since 1982. When she was pregnant in 2004, she was taking four tablets per day.

At the age of seven months, the baby girl was hospitalised for bronchiolitis, and it was then noticed that she had “general development delays”. Developmental delays were then observed during the rest of her childhood.

In 2016, her parents took Sanofi to court.

The court found that the lab had known that the medication risked causing development delays and autism-style difficulties at least since 2003. It said that the lab had a responsibility to mention this on the drug notice.

Depakine, whose active ingredient is sodium valproate, has been used to treat epilepsy and bipolar difficulties since 1967.

It is also sold under the brand names Dépakote and Dépamide for bipolar disorder (and also under generic names), and is also sometimes used to treat severe migraines.

Yet, it carries risks of severe side effects for unborn babies when taken during pregnancy. It can cause physical deformity (cardiovascular and spinal column issues) and neurodevelopmental issues (autism spectrum, slow language learning) in the developing foetus.

The family’s lawyer, Charles Joseph-Oudin, told the AFP: “This decision from the court marks a turning point for individual acknowledgement of every child exposed to Depakine.”

He called on Sanofi to “change its behaviour in all procedures” and said that the lab “must now see sense and take charge, with dignity, of all the families severely affected” by the drug.

The court judgement, given on May 12, said that Sanofi has known of the risks of the medication since at least 2003, and should have told patients from that point. The drug notice only discouraged its use during pregnancy, and warned patients to consult a doctor as soon as possible if they became pregnant, in 2006.

This is the first of a long series of cases set to be judged in Nanterre. The court has been asked to consider 23 files across 272 plaintiffs.

It comes after a court in Paris also accepted a case brought by victims’ association Apesac, which was launched in 2017. It found on January 5 that Sanofi had “committed an error and failed in its obligation of care and its obligation of information.”

The lab has launched an appeal against this judgement.

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