France must pay damages over birth defects linked to epilepsy drug

A French court on Thursday ordered the state to compensate three families whose children suffered grave disabilities linked to an anti-epileptic drug taken during pregnancy.

The Montreuil Administrative Court said that the disabilities must be presumed to be linked to sodium valproate, marketed in France as Depakine, since no other cause had been identified.

The three women had become pregnant five times between 1981 and 2008 and had continued to take sodium valproate during their pregnancies.

Their children had been born with physical deformities and developmental difficulties, while one died eight days after birth.

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The court noted that by the time of the second pregnancy concerned, in 1984, the risks of physical malformation when the drug was taken in pregnancy were known.

By the time of the third, in 2005, it was also known to be linked to neuro-developmental disorders.

“The state had committed no fault in 1981, as the danger was not yet established, but it had failed to make doctors and patients aware of the risks in 1984,’’ the court ruled.

For the later pregnancies, the court ruled that the information leaflet provided with the medicine was not adequate, even though it warned against taking it during pregnancy.

The court held that the doctors who prescribed the drug and its manufacturers were also partly responsible.

It ordered the state to pay the various members of the families involved a total of 497,502.31 Euros (561,576.37 dollars) in compensation.

It also ordered an expert report on the damages due to one of the children.


Vanguard News Nigeria


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