Opening of 97 St Stephen's Green

A redress scheme is needed for families affected by mis-prescribing of epilepsy drug Epilim during pregnancy, parents and legal experts have urged.

Just days ago a fourth High Court case on this issue concluded. Twelve-year-old Joshua Daly from Clonmel settled his High Court action with a €3.75m interim payment.

He has foetal valproate syndrome and the court heard Joshua will never take meaningful part in the workforce and will need lifelong support.

The European Medicines Agency and the HSE now advise women with epilepsy that they should not become pregnant while taking this medication. This is due to risks for the foetus from Epilim’s ingredient sodium valproate.

Advocacy group OACS Ireland (the Organisation for Anticonvulsant Syndromes Ireland) supported the Daly family and said the outcome is encouraging for other families.

“No family should have to seek justice through the court system,” they said.

“We are calling on [Health] Minister Stephen Donnelly to put in place a non-adversarial redress scheme for families who have been adversely impacted by this medication.”

Campaign for inquiry

OACS Ireland had successfully campaigned with Epilepsy Ireland for an inquiry.

“All families impacted by sodium valproate have endured considerable hurt, grief, and distress, which was foreseeable, preventable, and reportable,” they said.

They pointed to a HSE rapid assessment report in 2019 by then deputy chief medical officer Ronan Glynn, which found 3,126 babies potentially exposed to valproate in utero between 1975 and 2015.

Joshua’s mother Alison was satisfied, their solicitor Ciara McPhillips said, because the case will mean a big change for the family's life:

"Alison is very content with it, she was excited because hopefully it will mean a big change to them and their life.

“I know the clients don’t want to be in court. I do feel sorry when I see people like Alison at the back of the Four Courts, she’s not comfortable and she wants to be at home with her family.”

The case is settled for nine years, and will come back as an assessment of damages.

“When the case comes back before the court, it is an assessment of damages only which effectively means they are paying the full value of the case but without admitting fault,” she said.

Support for redress scheme

Ms McPhillips, partner at Michael Boylan LLP, supported the call for a redress scheme, saying more families are preparing for court.

“We’re just going over the same ground, time and time again,” she said. “ Has anybody got any sense of saying ‘maybe we should set up a redress scheme’?”

She also represented Alex Fahey who settled his case for €12m last year.

“When the Fahey case settled, the other families that were coming after them thought ‘oh great, this might mean we don’t have to go court’ yet here we are again,” she said.

In July an inquiry into historical licensing and use of sodium valproate in women of childbearing age was approved by Cabinet.

Redress beyond scope of inquiry

A Department of Health spokeswoman said “work is actively ongoing” to appoint a chair.

“The inquiry does not intend to address issues of redress or compensation. To engage on redress at this stage would be contrary to the aims of the enquiry,” she said.

“This inquiry is being established to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVSD) and their families.

"It will seek to document the regulation of sodium valproate and the control practices in place around prescribing and dispensing. The remit of the enquiry also seeks to examine the adequacy of existing services and supports.”

The Irish Examiner, November 2023