A 12-YEAR-OLD boy with autism who sued the HSE over the alleged failure to properly inform his mother of the risks of taking an epilepsy drug while pregnant has settled his case for €3.75 million.

Joshua Daly, of Clonmel, Tipperary, claimed that he was diagnosed with autism spectrum disorder as a result of his mother, Alison Daly, taking sodium valproate (under the brand name Epilim).

He was subsequently diagnosed with foetal valproate syndrome (FVS) in 2021.

He claimed that had his mother been warned about the known risks of autism from taking Epilim, she would have opted for alternative treatment.

Sodium valproate can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.

The drug was prescribed in Ireland and elsewhere for years after the danger was discovered and many countries are now investigating its use.

Joshua sued the Health Service Executive (HSE) through his mother, Alison Daly, who is also his full-time carer. 

At the High Court today, Aongus O’Brolchain SC, instructed by Ciara McPhillips, a partner in Michael Boylan Litigation, told Mr Justice Paul Coffey that Alison was born on 24 November 1979. 

He claimed that when she was 11 years old, she suffered a fall and had a seizure. He claimed that doctors were not entirely sure whether she had a seizure and fell, or fell and had a seizure. 

The cause was thought to be epilepsy and Alison was treated by a consultant neurologist in Cork University Hospital. 

O’Brolchain told the court that from 1990, Alison was on different medication but shortly afterwards, was prescribed Epilim along with other drugs. 

She had her first child, Shauna, on 28 December 1998. She was subsequently referred to another consultant in the hospital upon the retirement of the first consultant.

The court heard that from 2001, she was under the care of the same consultant and the same neurological team at Cork University Hospital.

Between 2001 and 2009, Alison was brought in to the hospital on a number of occasions to have telemetry tests in an effort to identity what was causing seizures as she was continuing to have falls that led to injuries, the court heard.

The hospital was never able to identify precisely that she had epilepsy.

The court heard that she had a “spontaneous miscarriage which would have been advised to the team during course of her treatment”.

In 2010, she became pregnant with Joshua. He was born on 20 July 2011. 

The court heard that it was Joshua’s case that at no stage did the consultant or team discuss the medication that Alison was on – in particular, sodium valproate – as to what the dosage was or what the risks associated with Epilim were other than neutral risks, including cleft palate, thought to be counteracted by taking folic acid.

O’Brolchain told the court that Joshua became quite difficult at home and in 2016, he was diagnosed with autism spectrum disorder (ASP).

He was later diagnosed with foetal valproate syndrome.

The court heard that as a result, Joshua has had “great difficulties in the course of his life”.

Some of a report, conducted by the defendant’s expert clinical neuropsychologist, was read out in court by O’Brolchain. 

It stated that “in the examiner’s view, the young man will require lifelong support”.

It also stated that he will require ongoing support from dedicated individuals and will not be able to participate in the open workforce in any way. 

The court heard that Joshua is now in a class of five in a special school and “getting on well”.

O’Brolchain told the court that both parties participated in mediation on 3 November of this year. Causation and negligence had been denied by the defendant prior to this. 

Following mediation, the matter of liability in the case was removed subject to an agreement reached by both parties. 

A settlement of €3.75 million will be paid over the next nine years. The case will then return before the courts on 23 November 2032, when Joshua’s needs will be further assessed. 

Judge Coffey told the court he was satisfied that the case is best dealt with by way of a compromised agreement to Josh’s 21 birthday, “where there will be greater visibility of his needs to the future”. 

He also told the court that he was satisfied that what had been achieved by the interim settlement is “fair and reasonable” and he approved the settlement. 

Joshua’s mother Alison and sister, Shauna were present in court for the ruling.

Judge Coffey welcomed them and said: “I convey to you and Joshua my very best wishes.”