French Drug Manufacturer Faces Class Action Over Birth Defects

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Birth defect claims have started to be filed against French manufacturer of Epilim, by parents whose unborn children were exposed to toxic chemicals in the womb.

Depakine was introduced into France in the 1960s as an anti-epilepsy drug. Eventually, it started to be introduced into Ireland under the trade name Epilim. The drug has also been prescribed to treat bipolar disorder, migraine and other chronic pain conditions. The active ingredient in the sodium valproate-GABA-stabilises electrical activity in the brain.

However, when taken by woman during pregnancy, the sodium valproate is broken down into valproic acid. When this molecule enters the bloodstream, it can cause serious health issues to unborn children. The birth defects, generally called “foetal valproate syndrome”, take the form of a range of congenital and development issues including autism and spina bifida.

The risks of foetal valproate syndrome due to taking Epilim during pregnancy were first identified by doctors in the 1980s. However, the evidence was considered not sufficiently conclusive of a link between the drug and the abnormalities, The link was allegedly hidden to prevent “fruitless anxiety” in parents who were taking the drug. Sanofi later informed the medical profession of the risks in 2006, but did not provide much information on the adverse health effects.

Only recently has France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the birth defect claims against Sanofi, and the agency has just published a report revealing that up to 4,100 children were born between 2007 and 2014 with “severe malformations” due to their mothers having taken the French version of Epilim. It also recognised that the drug caused hundreds of children to die in the womb.

The report has prompted the children´s parents to seek legal counsel. They formed a class action making birth defect claims against Sanofi on the grounds that the drug manufacturer failed to adequately advise the medical professional of the risks associated with Epilim or print warnings on the packets of the drugs. The French government has also got involved and is discussing a compensation package.

In Ireland, Epilim is still sold without a warning on the packet, and it is not known how many children have been diagnosed with foetal valproate syndrome due to being exposed to valproic acid in the womb. If a family member has been affected by this issue, and you would like to know more about birth defect claims against Sanofi, please do not hesitate to speak with a solicitor.