France’s Sanofi charged over drug linked to birth defects

French pharmaceutical giant Sanofi said late Monday it has been formally charged for causing harm and failing to inform about the risks of an epilepsy drug linked to birth defects when taken during pregnancy.

Sanofi said French prosecutors decided to move ahead on charges of aggravated fraud and unintentionally causing injury after a three-year preliminary probe into the company's response to concerns over the drug Depakine.

Victims and family members filed a lawsuit in September 2016 after French regulator IGAS criticised the slow response of the company and of France's health safety agency ANSM to the risks related to valproate, the drug's active molecule.

Studies found babies of women who took the drug during pregnancy increased the risk of congenital malformations by 10 percent and autism and learning difficulties of up to 40 percent.

“Sanofi will have to deal with the tens of thousands of poisoned victims, out of which more than a hundred died,” said Marine Martin, president of victims association Apesac, adding she was “extremely satisfied to see the criminal proceedings launched in 2016 reach an important threshold”.

Sanofi welcomes formal investigation
Sanofi became aware of the risk of foetus malformation in the 1980s and the risks of autism and learning difficulties around 2003. It claims it always respected its obligation to inform the ANSM about the risks.

The company said it welcomed the advancement of the case as “the occasion to demonstrate that it respected its obligation to inform” patients about the drug and to “prove it has always complied with its duty to inform and been transparent”.

The charges do not mean the case will automatically reach a courtroom as prosecutors could decide not to move to trial.

Thousands of victims
Sodium valproate has been used to treat epilepsy and bipolar disorder since 1967 and is included on the World Health Organization's list of “essential medicines”. Depakine is prescribed in more than 100 countries and is also sold under the trade names Depakote, Epilim and Stavzor.

The ANSM estimates Depakine and its derivatives caused serious congenital malformations in 2,150 to 4,100 children since 1967. An epidemiologist, Catherine Hill, has estimated there were 14,000 victims when including those with neurological deficiencies.

The IGAS estimated that 425 to 450 babies suffered congenital birth defects or were stillborn following exposure to Depakine between 2006 and 2014.

Chemical plant
Depakine was at the heart of an environmental scandal for Sanofi in 2018, when a chemical plant producing the drug in southwestern France was closed over toxic waste emissions.

Conservation group France Nature Environnement said “astronomical levels of dangerous materials” were coming from the site, at the town of Mourenx in France's Pyrénées-Atlantiques department.

The gasses included bromopropane, part of the sodium valproate composition.

Sanofi decided to stop production until it installed the equipment needed to properly treat the chemical waste.