€12m epilepsy drug settlement in High Court could open floodgates to dozens more cases

€12m epilepsy drug settlement in High Court could open floodgates to dozens more cases

The HSE estimates that up to 1,250 children may have experienced neurodevelopmental delay after their mothers took the epilepsy drug sodium valproate/Epilim during pregnancy. Stock picture: iStock

A €12m High Court settlement with a teenager whose mother took sodium valproate while pregnant could open the floodgates to dozens more cases.

The settlement was made with Alex Fahey, 16, from Co Carlow, who claimed he suffered neurological damage as a baby after his mother, Helen Maher Fahey, took sodium valproate under the brand name Epilim while pregnant.

The HSE has estimated that up to 341 children may have experienced a major congenital malformation, and up to 1,250 may have experienced some form of neurodevelopmental delay after their mothers took epilepsy medication containing the substance.

Alex’s case was the first to be heard of the 20 cases being taken by families represented by one solicitor, Ciara McPhillips, a partner with Michael Boylan Litigation.

It emerged yesterday that a number of similarly affected families have now agreed terms of reference with the Department of Health for a State inquiry into the prescribing of medication containing sodium valproate during pregnancy.

Those terms are expected to be put forward for Cabinet approval by the end of the year. The inquiry had first been promised by Health Minister Stephen Donnelly back in 2020.

Alex Fahey’s settlement came after Helen Fahey sued two doctors on behalf of her son. She said she hopes her family’s case shows other parents whose children have been affected like Alex they can “take the same path to get justice” to ensure their children are looked after.

Addressing the court, she said she was happy the case had “turned out like this” but she wished it did not have to happen.

“It is a very difficult thing to accept,” she said. “But I know Alex will have the best life he can have and be looked after, because we are not always going to be here, obviously.”

The court heard Alex requires constant watching and his difficulties will prevent him from ever working, having been diagnosed with fetal valproate syndrome disorder (FVSD).

He has also been diagnosed with autism.

The case opened on Wednesday and had been expected to last six weeks. However, yesterday Mr Justice Paul Coffey was told the case had settled, without any admission of liability, for €12m against both defendants, plus the plaintiff’s legal costs.

Ms McPhillips, a partner at Michael Boylan Litigation, says she hopes the outcome will bring security and peace of mind for her clients.

“Echoing what his mother said in court, it is regrettable that Alex sustained any injury, given now it is very clear that the neurology community in the early 2000s knew of the risks of sodium valproate,” she said.

“It appears to us, on behalf of the families we act [for], that this information was not passed onto mothers.

Reflecting on Ms Fahey’s comments regarding justice, Ms McPhillips said: “In cases such as this where a vulnerable child has been injured, it is very regrettable that they and their families must pursue an adversarial court process.

“Today’s outcome ought to herald the establishment of a non-adversarial redress scheme for all those affected — up to 1,200 children, by the HSE’s own estimates.”

The settlement was welcomed by advocacy group the Organisation for Anticonvulsant Syndromes Ireland (OACS) who support affected families.

OACS founder Karen Keely: '[W]e are continuing our search for answers on why this experience happened to ... 1,250 families across Ireland.' Picture: Moya Nolan
OACS founder Karen Keely: '[W]e are continuing our search for answers on why this experience happened to ... 1,250 families across Ireland.' Picture: Moya Nolan

“We are pleased the settlement highlights the scale of disabilities that a person with FVSD experiences, and the challenges which can face the families who support them,” said OACS founder Karen Keely.

“As representatives of the families affected, we are continuing our search for answers on why this experience happened to — as the HSE currently estimates — 1,250 families across Ireland and have campaigned for the establishment of an independent inquiry so all can get justice they deserve."

A spokesman for the Department of Health said officials are completing the details of the proposed inquiry into the historical licensing and use of sodium valproate.

“A memo to government will be brought as soon as this work is completed,” he said.

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