AROUND THE WORLD

How different countries have treated families affected by valproate-linked birth defects

UK

UK families brought a civil action against sodium valproate manufacturers in 2010, but it was halted after legal aid was withdrawn three weeks before the case was to begin.

The drug firm being sued waived millions in legal costs in return for those litigants agreeing not to sue in future. In 2018, the MHRA medical watchdog issued tougher guidelines restricting sodium valproate for child-bearing age women, but it continues to be prescribed for some as long as they are made aware of all the risks.

A small group of women are unable to take any other drug than sodium valproate. Users are informed not to suddenly stop the medication because of pregnancy as the risk of seizure may be more damaging than the risk of birth defects.

FRANCE

The French equivalent of the MHRA faces criminal prosecution for failing to protect pregnant women and children against the risk of birth defects and learning difficulties.

In May, a French court awarded the family of one child affected by the drug in the womb around £400,000 in damages concluding the drug maker knew about the risk of malformations. The manufacturer said it will appeal.

France believes up to 4,000 children have suffered birth defects and up to 30,400 have suffered developmental problems. The French government is understood to have laid aside millions to compensate families.

US

Medical watchdog, the FDA, warned clinicians in 2009 about its concerns over exposure to sodium valproate in the womb. Hundreds of civil actions are waiting to be heard in civil courts with potential settlements from drug firms climbing into the millions.