Three siblings settle actions against HSE over epilepsy drug during pregnancy

The settlement against the HSE, which was reached after mediation in each case, is without an admission of liability.

Three children from the same family who sued claiming there was a failure to adequately inform their mother of the risks associated with taking an epilepsy drug while pregnant have settled their High Court actions with interim payouts totalling €3.6m.

It was claimed there was a failure to assess or investigate the risks associated with prescribing the epilepsy medicine sodium valproate for their mother during pregnancy.

The settlement against the HSE, which was reached after mediation in each case, is without an admission of liability.

The children, who are all from the same family, cannot be identified by order of the court.

Aongus O’Brolchain, for the family, told the court that each of the children was diagnosed with fetal valproate spectrum disorder which is associated with the use of the drug in pregnant women. The children were also later diagnosed as being on the autism spectrum.

He said the children’s mother in her late teens had seizures and developed juvenile absence epilepsy. She was prescribed sodium valproate which is also known as Epilim, which is an anticonvulsant medication.

Counsel said after the woman was married and wanted to start a family, she was advised that there was a 3% risk in pregnancy in relation to taking the medication, but if she took folic acid that would neutralise the risk.

Counsel said the doctor who was involved in the woman’s care of her epilepsy would say it was his practice to explain the risks of taking sodium valproate in pregnancy but the woman would say that was not correct.

The woman’s first child was born in 2011 and she had two other children in 2013 and 2015 while she was still taking the epilepsy drug.

In the proceedings by all three children who had sued the HSE through their mother, it was claimed that if the mother had been advised of the alleged risks to her of taking sodium valproate during her pregnancies, she would have opted for alternative treatment.

It was further claimed that there was a failure to have due regard to the significant evidence available at the time of the mother’s pregnancies that exposure to sodium valproate in utero increased the risk of major congenital malformations, developmental delay, and autism.

It was also contended there was a failure to adequately assess and investigate any alternative treatments that carried less risk or were suitable for use during the pregnancy and in particular since the mother had been seizure free for many years.

All of the claims were denied.

Ms Justice Leonie Reynolds, who approved three separate interim settlements for the next eight years, said it was a remarkable outcome to the case.

She congratulated the legal teams and the mediator for reaching the settlement, which she said “was a very good outcome for the children".

The case will come back before the court in eight years when the future care needs of the children will be assessed.