Solicitor calls for redress scheme to avoid ‘perpetual litigation’ over anti-epilepsy drug

There will be “perpetual litigation” on the prescription of an anti-epilepsy drug to pregnant women over the next decade if some form of redress scheme is not established, a medical negligence solicitor representing several cases has said.

On Thursday, a 13-year-old boy with autism who sued a neurologist alleging there was a failure to properly inform his mother about the risks of taking sodium valproate (Epilim) during pregnancy settled his High Court action for €15 million. His brother also secured €2.65 million settlement, while their sister has also sued and has a case pending before the High Court.

Valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take such medicines during pregnancy, and sodium valproate has been the subject of two recent reviews by the European Medicines Agency, in 2014 and 2017.

It is now accepted that babies exposed to valproate in the womb have a 10 per cent risk of birth defects and a 30-40 per cent risk of neurodevelopmental disabilities which can be permanent.

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A 2018 report by the Health Service Executive said it is possible that up to 1,250 children, born between 1975 and 2015, inclusive, experienced some form of neurodevelopmental delay as a result of exposure to valproate in utero in Ireland.

Michael Boylan, the solicitor who took Thursday’s case, said his firm had about 30 cases at various stages of preparation.

“We had one late last year, which was the first one. We’ve had two today. We’ve a case listed for later in the year. I know there are other lawyers who are processing cases as well. There’s a lot of affected people out there,” he said. “It’s an absolute no-no for use in pregnancy. Every effort should be made to counsel the parents and the mother in particular about the risks of taking it. That’s what the essence of these cases are about.”

Mr Boylan said ultimately it was the State which was footing the bill of these settlements, due to the indemnity arrangements of consultants with public appointments.

“This really should be dealt with by an admission of responsibility by the State here. There should be a form of redress scheme set up, like the CervicalCheck tribunal. Each family shouldn’t have to go through the litigation process on an individual basis,” he said.

“They really should set it up so the stress can be minimised and there can be saving of legal costs as well. Otherwise, there’s going to be perpetual litigation for several years, if not a decade.”

In 2020, Minister for Health Stephen Donnelly announced his commitment to holding an inquiry into the historical licensing and use of Epilim in Ireland. Terms of reference were accepted by families late last year.

Asked about the timeline of an inquiry, a spokeswoman said: “Work is under way in the Department of Health to finalise policy documentation prior to bringing forward a memo for Government with the aim of establishing the inquiry in 2023.”

Inquiries on the drug have already taken place in other countries, including in France and in the UK.