French state found liable for birth defects linked to epilepsy drug

A French court on Thursday ordered the state to pay thousands of euros in damages over birth defects linked to an anti-epilepsy drug, saying officials should have ensured that it was not taken by pregnant women.

The court also ruled that pharma giant Sanofi, which makes the drug Depakine, and doctors who prescribed it were responsible as well, in a scandal that has affected 15,000 to 30,000 children in France.

“The state has neglected its duties to monitor (drugs),” the court said in its ruling, adding that health authorities should have required information on the risks to pregnant women in the instructions that came with the medicine.

It ordered payment of 20,000 to 200,000 euros ($22,500-$327,000) to the three families who filed the case, depending on the date of birth of five children now aged between 11 and 35.

The children were born with serious congenital malformations, autism or learning difficulties.

Depakine is Sanofi’s brand name for sodium valproate, a drug now made by several companies worldwide and has been in use since the 1960s.

Besides epilepsy, it is also used to treat migraines and bipolar disorder.

During a hearing last Wednesday, the court’s advisory expert said the health officials knew about the risks regarding birth defects from using Depakine starting in 1983, and the risks of learning disabilities and autism from 2004.

But the court ruled that for one of the children, born in 1985, only the risk of physical defects could be taken into account, rejecting the claim of autism risks as well.

As a result, the three families are appealing the court’s ruling, their lawyer Charles Joseph-Oudin told AFP.

Marine Martin, president of the APESAC association that represents around 7,500 victims’ families, also said the court’s ruling fell short of what families deserved.

“I welcome the conviction of the state,” she said.

“But I’m angry because 80 percent of the children born before 2004 are excluded from compensation,” even though she said authorities had been alerted to autism cases as early as 1984.

-‘Denial of responsibility’-

“The state failed in the implementation of its health policy,” Joseph-Oudin said.

He also called on Sanofi to end a “denial of responsibility,” accusing it of waging a legal war of attrition in a bid to avoid paying compensation.

Contacted by AFP, Sanofi did not immediately respond to a request for comment.

Sanofi is facing separate charges of aggravated fraud and unintentionally causing injury in 42 cases filed by families.

Under the French legal system, the charges do not automatically mean the case will reach a courtroom, since prosecutors could decide not to move to trial.

Another 500 complaints have been lodged with France’s national compensation agency for medical accidents, which has already proposed a 6.5 million euro package for Depakine victims.

Sanofi has denied any wrongdoing, saying it warned health authorities of the drug’s risks beginning in the 1980s.

France’s other ongoing pharmaceutical scandal concerns the diabetes drug Mediator, prescribed for weight-loss but which could cause fatal heart problems.

The landmark trial that opened in September wraps up on Monday, and a ruling is expected early July.

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