Victims face court fights on epilepsy drug as the State ‘drags its heels’

Original article published on The Irish Independent

Last December, a case revolving around the prescription of a seizure-controlling drug to a pregnant woman was settled for €12m without admission of liability.

The settlement was made in favour of a Co Carlow teenager who suffered neurological damage due to his mother taking sodium valproate during her pregnancy.

In an action against two doctors, the woman claimed she was not fully informed of dangers of taking the drug, which has the brand name Epilim, while she was expecting her child.

Her now-16-year-old son was diagnosed with autism and foetal valproate syndrome disorder. He requires constant monitoring and his difficulties will prevent him from gaining employment as an adult. Read our piece on the sodium valproate scandal.

The settlement came on the second day of what was scheduled to be a six-week trial in the High Court. Up to that point, the claim was being fully defended.

The manner in which the case was resolved followed an all-too-familiar pattern.

For years, the parents of children with claims against health authorities have complained of being dragged through the courts when they have a valid case, with settlements being agreed only on the steps of the court or soon after the start of an action. Families are often left wondering why cases such as these are so hard fought when, to their mind, they should be resolved much sooner and without the need to see the inside of a courtroom.

While the State Claims Agency says it acts fairly and ethically in dealing with claimants, it is also mandated by legislation to manage claims so that the liability of the State is contained at the lowest achievable level.

The Carlow lawsuit was the first of its kind but many more Epilim cases are in the pipeline, including one involving two brothers that is due to go before the High Court later this month.

A third lawsuit, involving a boy from Co Tipperary, is scheduled for next November.

The State Claims Agency told the Irish Independent it had received 16 claims in relation to the prescribing of sodium valproate and described 13 of these as “active”. The real number of lawsuits the State is likely to face is much higher.

Ciara McPhillips, a solicitor with medical negligence firm Michael Boylan LLP, said it had 20 other Epilim cases that had yet to be filed but were in various stages of preparation.

The lack of a class action system in Ireland means cases have to be filed and fought individually.

The lawsuits involve claims that although risks associated with taking Epilim while pregnant were known in the medical community, women were not informed.

Used mainly for epilepsy and bipolar disorder, evidence of links with physical malformations in babies, such as cleft palate, spina bifida and neural tube defects, emerged soon after the drug was licensed in 1975. By the 2000s it became clear cognitive issues and developmental delay were also associated with exposure to the drug in utero.

Despite the growing number of cases, the State has been dragging its heels over the setting up of an inquiry into the historical licensing and use of the drug. Health Minister Stephen Donnelly promised a “fair and fast inquiry” in 2020 but has yet to bring a memo on it to Cabinet.

In a statement, his department said all documentation required to progress the proposed inquiry was being finalised by officials. However, it was silent on when the inquiry might finally  be launched.

The delay has sparked anger in the Organisation for Anticonvulsant Syndromes (OACS) Ireland, a group of families affected by sodium valproate.

“After a long and frustrating process following the minister’s commitment to an inquiry in 2020, terms of reference for the inquiry were agreed towards the end of 2022,” a spokesman said.

“Repeated assurances were given by the Department of Health that these would be presented to Cabinet before the Christmas recess. This did not happen.

“Once again, families who are desperately awaiting the establishment of this inquiry have been let down, with no explanation as to why the agreed terms of reference have yet to be placed on the Cabinet agenda.

“Families impacted by this drug have waited decades for answers and it is long past time this inquiry be established. Anger among families affected at the failure to establish an inquiry is at an all-time high. Families deserve answers,” he said.

The need for an inquiry in Ireland is clear following a public inquiry in the UK that determined an estimated 20,000 children could have been affected by the drug there.

An HSE “rapid assessment” report estimated that from 1975 to 2015 between 153 and 341 children exposed to valproate in the womb experienced a major congenital malformation and up to 1,250 children experienced some form of neurodevelopmental delay.

The failure to get an inquiry up and running has lessened the prospect of a non-adversarial redress scheme any time soon, which means claims for compensation and for future care will inevitably end up in the courts unless another solution is found.

Asked whether it intended to contest other sodium valproate cases in light of the Carlow settlement, the State Claims Agency said it did not comment on individual cases and that each was “considered according to its particular facts and whether or not there is third- party involvement”.

It also said the question of a redress scheme was a policy matter for the Government.

The lawsuit scheduled to be heard in November involves a boy called Josh, an 11-year-old with autism, who is suing the HSE. He has an older sister who was also affected but she is not part of the case.

According to his mother Alison, Josh had breathing problems not long after he was born and had to be monitored for sleep apnoea.

She noticed he cried all the time and wasn’t hitting his developmental milestones.

After years of looking for answers, a geneticist at Children’s Health Ireland in Crumlin found on balance of probabilities that Josh’s autism and development concerns were attributed to exposure to sodium valproate in utero.

The boy has a variety of issues to contend with. He has to constantly wear ear defenders due to being sensitive to noise. The curtains are kept drawn at the family home in Co Tipperary because he is terrified of wind and rain. He also doesn’t feel pain when he injures himself.

Alison admits the prospect of having to go to court is “terrifying”. “If a scheme was to be put in place, it would be brilliant. No one would have to be dragged through court.

“It shouldn’t be like this. Something should be in place for the children. We have been through enough over the years,” she said.

Alison had been taking Epilim for seizures while she was pregnant with Josh and said had she been informed of the potential effects she would have come off it.

Ms McPhillips pointed to a report last November by Dr Gabriel Scally on the implementation of recommendations from his 2018 scoping inquiry into Cervical Check. In the report, Dr Scally said the “court system is not the right place to achieve a resolution that is imbued with grace and compassion”.

Ms McPhillips said the same principle applied to Epilim cases but people seeking redress and funding for future care had no other option.
“Here we are ignoring the fact Dr Scally said the courts aren’t suitable and there is over-reliance on them for dealing with clinical negligence issues,” she said.

February 2023