Victims face court battles over epilepsy drugs as state ‘drags its heels’

In a lawsuit against two doctors, the woman claimed she was not fully informed of the dangers of taking the drug, brand-name Epilim, while she was expecting her child.

Her son, now 16, was diagnosed with autism and a fetal valproate syndrome disorder. He needs constant supervision and his difficulties will prevent him from finding employment as an adult.

The settlement came on the second day of a six-week trial in the High Court. Up to this point the claim has been fully defended.

The way the case was solved followed an all too familiar pattern.

For years, parents of children with claims against health authorities have complained that they are dragged through the courts on legitimate cases, with settlements only being reached at the court stages or shortly after the complaint is filed. Families often wonder why cases like this are so hotly contested when they believe they should be resolved much sooner and away from a courtroom.

While the State Claims Agency says it is fair and ethical in dealing with claimants, it also has a legal obligation to administer claims in a manner that limits state liability to the lowest possible level.

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

A third lawsuit involving a Co Tipperary boy is planned for next November.

This was announced by the State Claims Agency Irish Independent It had received 16 applications related to the prescription of sodium valproate and called 13 of them “active”. The actual number of lawsuits the state is likely to face is much higher.

Ciara McPhillips, a medical negligence attorney for the law firm Michael Boylan LLP, said she has 20 other Epilim cases that have yet to be filed but are at various stages of preparation.

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

The lawsuits include claims that while risks associated with taking Epilim during pregnancy were well known in the medical community, women were not informed.

Shortly after the drug’s approval in 1975, evidence of links with physical deformities in babies emerged, primarily used for epilepsy and bipolar disorder, such as cleft palate, spina bifida, and neural tube defects. In the 2000s, cognitive problems and developmental delays became apparent and were also associated with exposure to the drug in utero.

Despite the growing number of cases, the state has been reluctant to establish an investigation into the drug’s historic licensing and use. Health Secretary Stephen Donnelly promised a “fair and speedy inquiry” in 2020 but has yet to submit a memo to Cabinet.

In a statement, his department said all paperwork needed for the proposed investigation to progress was being finalized by officials. However, there is no word on when the investigation could finally begin be started.

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

“Following a long and frustrating process following the minister’s commitment to an inquiry in 2020, the mandate for the inquiry towards the end of 2022 has been agreed,” a spokesman said.

“The Department of Health has repeatedly given assurances that these will be presented to Cabinet before the Christmas break. This didn’t happen.

“Once again, families desperate for this inquiry to be set up have been left in the lurch, with no explanation as to why the agreed tasks have not yet been placed on the Cabinet agenda.

“Families affected by this drug have waited decades for answers, and this inquiry is long overdue for this to happen. Anger among affected families at the failure to open an investigation is at an all-time high. Families deserve answers,” he said.

The need for an investigation in Ireland is clear after a public inquiry in the UK found that an estimated 20,000 children there could be affected by the drug.

An HSE Rapid Assessment report estimated that between 1975 and 2015 between 153 and 341 children exposed to valproate in utero developed a serious congenital malformation and up to 1,250 children developed some form of neurodevelopmental delay.

The failure to launch an investigation has reduced the prospect of a non-adversarial redress system for the foreseeable future, meaning that claims for compensation and future care will inevitably end up in court unless another solution is found.

When asked whether it intended to challenge other sodium valproate cases in light of the Carlow settlement, the State Claims Agency said it had not commented on individual cases and that each “was considered on its own particular facts and whether there were third party participation”.

It also said that the issue of a reparation system is a political matter for the government.

The lawsuit, due to be heard in November, involves a boy named 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, shortly after he was born, Josh had trouble breathing and needed to be monitored for sleep apnea.

She noted that he cried all the time and didn’t meet his developmental milestones.

After years of searching for answers, a geneticist from Children’s Health Ireland in Crumlin weighed the probabilities and found that Josh’s autism and developmental problems were due to exposure to sodium valproate in utero.

The boy faces many problems. Due to his sensitivity to noise, he must wear hearing protection at all times. The curtains are kept drawn at the family home in Co Tipperary for fear of the wind and rain. He also doesn’t feel any pain when he hurts himself.

Alison admits the prospect of going to court is “terrifying”. “If a scheme were to be introduced it would be brilliant. Nobody would have to be taken to court.

“It shouldn’t be like that. There should be something for the kids. We’ve been through enough over the years,” she said.

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

Ms McPhillips referred to a report by Dr. Gabriel Scally last November on the implementation of recommendations from his 2018 cervical check scoping study. In the report, Dr. Scally that “the court system is not the place to seek a resolution imbued with grace and compassion.”

Ms McPhillips said the same principle applies to Epilim cases, but that people seeking redress and funding for future care have little choice.
“Here we ignore the fact that Dr. Scally said the courts are inadequate and over-reliant when it comes to clinical negligence,” she said.