France's Sanofi faces class action suit over epilepsy drug

An association of French women who took an epilepsy drug during pregnancy said Tuesday they would launch a class action against its maker, Sanofi.

In the first such case since class action suits in health cases were authorised in September, the French pharmaceutical giant is accused of failing to inform pregnant women using the Depakine drug of the risk of birth defects.

Around 14,000 pregnant women took Depakine in France between 2007 and 2014.

It contains sodium valproate, a key substance for treating some forms of epilepsy as well as bipolar disorders.

But a foetus exposed to the drug faces a risk of having birth defects or developing autism or learning difficulties.

The association's lawyer Charles Joseph-Oudin told AFP he had taken the "first amicable step" by writing to Sanofi to ask the company to admit its responsibility and compensate the victims.

Some 2,000 families are represented by the group, whose acronym is Apesac, of whom 14 have established dossiers to support the case.

Sanofi has four months to respond, after which Apesac can take the group to court to "make it recognise (its) responsibility over the delay in informing the users of sodium valproate", Joseph-Oudin said, adding that the company had known of the risks since the early 1980s.

Sanofi also faces around 20 individual lawsuits.

Paris prosecutors opened an investigation into the case in September.