Calls for redress scheme for children affected by drug that caused birth defects

Sodium Valproate

TWO MEDICAL NEGLIGENCE solicitors have called for a redress scheme to be established for children who were born with birth defects as a result of their mothers being prescribed an anti-epilepsy drug while pregnant.

Michael Boylan told The Journal there will be “at least a decade” of litigation over sodium valproate, sold in Ireland under the brand name Epilim, unless a redress scheme is set up.

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.

Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy.

Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).

Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay.

The drug’s risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it “could give rise to fruitless anxiety”.

A HSE report published in 2018 estimated that 1,250 children have been affected by valproate since 1975 in Ireland.

In 2021, an investigation by Noteworthy found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.

Boylan’s litigation firm has taken a number of cases for families affected by the drug.

Last week, 13-year old Jack Clarke settled his case for €13 million after suing a neurologist who he alleged failed to properly inform his mother of the risks of taking Epilim while pregnant.

Jack claimed that he was diagnosed with autism spectrum disorder and has moderate global development delay as a result of his mother, Elizabeth Elliot Clarke, taking Epilim, and that had she been warned about the known risks of autism from taking the drug, she would have sought alternative treatment.

His nine-year-old brother, Tom Clarke, also settled a case for €2.65 million, to be paid over the next seven years until a further assessment of his needs will be carried out. The boys’ sister, Hannah, also has a case pending before the High Court.

Last December, 16-year-old Alex Fahey, whose mother took sodium valproate while pregnant, also settled a case for €12 million. His case was the first to be heard of the families represented by Ciara McPhillips, a partner with Boylan’s firm.

The next case involving Epilim will be heard in November, and McPhillips told The Journal that the firm has approximately 30 other cases waiting to go to court.

She said that alongside caring for their children, it takes a huge toll on parents to “go through the stress of a legal case, and a legal case in which at present, the State is fighting”.

“I’m sure the results in the cases to date will hearten and strengthen the resolve of other families and they will hope that they will achieve similar outcomes, but as things stand, without a redress scheme, every one of those families is taking the risk that their case will not succeed,” she said.

“They are taking on that their children will have to be subjected to assessments both organised by our offices on their behalf, also by the defendants. That’s very disruptive. It’d be disruptive in any household where mum and dad have a job, a good school routine, etc, nevermind where there’s a house where there’s also other factors be taken into account.

I know at the latter stages, it can be all very, very overwhelming for the families involved. It would seem cruel to me to continue down that path.

“I think the definition of insanity is to repeat the same things and expect a different result, and it would seem that that is what’s happening. We’re repeating the same cases based on similar facts and, is it expected that there’s going to be different outcomes? But that’s obviously a decision for the State and their legal teams to make.”

Redress scheme

Boylan said a redress scheme should be set up that would be similar to the Cervical Check tribunal.

“It should be set up. Otherwise, there’s going to be at least a decade, I would predict, of litigation over it with an absolutely huge amount of extra stress caused to the families, and expense,” he said.

There’s hundreds of potential cases out there in Ireland alone.

He said his firm are taking individual cases as quickly as possible, but that it can take years for the case to come before the courts.

“Doing it as quickly as we can do it? You’re talking about three to four years from start to finish so that you can prove it chapter and verse.”

McPhillips said a redress scheme would be the more sensible approach in terms of saving families from facing going to court, as well as saving money.

“Obviously as litigators, if no redress scheme is put in place, we will continue to litigate these cases. These people can’t be left without access to justice and restitution,” she said.

“But it would seem nonsensical to us – and on a personal level, as parents, as taxpayers – to put families through this and to incur all the additional cost that comes with this when we now have an admission of liability in one case, full settlement in two other cases, it would be nonsensical as to why the State would persist to pursuing litigation.”

In 2018, the HSE established a dedicated service in the National Children’s Hospital Group, based in Crumlin Hospital, where a child can undergo tests to determine whether they have fetal valproate syndrome (FVS).

Doctors can rule out other causes of developmental delay and autism and then issue a formal diagnosis of FVS, which someone can only have if they have been exposed in-utero to sodium valproate.

But McPhillips said that despite children having a diagnosis of FVS, the State “at the 11th hour” have raised the query of conducting more diagnostic tests on the children her firm have represented.

“We obviously feel these children have already been through these tests to the satisfaction of the State. These tests weren’t arranged by us, they weren’t carried out by us, they were carried out by completely independent doctors going through the normal course of treating these children, and I have to say, it’s not an approach we would normally see.

“If we have a case, for example, where an individual alleges that they have a delayed diagnosis of cancer, the State never, in my experience, have turned around and said: ‘Actually we don’t know if the treating doctors are actually correct on that, we want to retest this person to see if there’s cancer at all’. And that’s the equivalent here.

The treating doctors have said this child has this diagnosis, and then this red herring, in my mind, of suggesting that perhaps they don’t is being raised as part of the litigation process.

“I fully accept and I know that the State would argue that every case turns on its own facts, but there is certainly a point in time here where all of the guidelines were telling doctors that there were specific issues with this drug, and in the cases in which we act, it appears that that information was ignored, unacknowledged, and at the very least, not passed to the mothers.”

Promised inquiry

In November 2020, Health Minister Stephen Donnelly committed to holding an inquiry into the historical licencing and use of sodium valproate in Ireland.

It came months after a two-year inquiry in the UK published a review that criticised failures by manufacturers, regulators, clinicians and policymakers to uphold patient safety and to take action on the risks the drug poses.

A similar inquiry was conducted in France, and last year, a French court allowed affected families to join a class action against manufacturer Sanofi.

However, over two years later, Donnelly’s promised inquiry has yet to commence.

In a statement to The Journal, chairperson of the Organisation for Anticonvulsant Syndromes (OACS) Ireland Karen Keely said that while the group welcome the recent court settlements, “not all of our members will have the ability or the resources to take legal action through the Courts in respect of the harm caused to them by valproate”.

“We once again urge the Minister for Health to confirm when he intends delivering on his 2020 commitment to holding an inquiry into the historical licensing and use of sodium valproate,” Keely said.

“In November 2020, the Minister promised a ‘fair and fast’ inquiry and our members still do not know when the inquiry will commence nor have we received clarity from the Minister on the version of the terms of reference meant to be governing the proposed inquiry.

Our members want the inquiry to investigate urgently, as the Minister had promised, the use of Epilim since it was first licensed in Ireland.

Keely added that an inquiry is “necessary and urgent to restore our members confidence and the general public’s confidence in the health care and regulatory system here”.

“It is very important to OACS Ireland members that the historical licensing of valproate be investigated thoroughly by the proposed inquiry, not only to ascertain how OACS Ireland members came to be harmed by this drug, but also from a wider public interest perspective to ensure that the lessons learnt from this inquiry based on a proper historical lookback would prevent any other drug causing the same devastating consequences as this drug did occurring again.”

Boylan said the Department of Health and Donnelly have been “foot-dragging” on getting the promised inquiry started.

“That is a shame. Families have been waiting for a couple of years now at this stage for the promised inquiry. It was promised after the UK inquiry published and that was a couple of years ago at this stage.

“That’s what should happen, so that the facts surrounding this disaster can be clearly established and who knew what, when. That’s important.”

McPhillips said an inquiry would ensure that lessons were learned, but it would also ensure transparency and make the finer details of the cases known to the wider public.

“We know that there was an inquiry in the UK, and we have had ample opportunity at this juncture to review that report and consider the content of it.

Certainly, there are issues and actions that occurred in the UK that if replicated here, would require accountability.

“We know that the manufacturer told the UK regulator a number of years before the warnings were increased in respect of the medication that there was an issue with the medication, and the UK regulator took the view – and this is a direct quote – that it would cause ‘fruitless anxiety’, and they decided not to up the levels on warnings around medication. I would like to know did the Irish regulator get the same warning.”

In a statement to The Journal, a spokesperson for the Department of Health said it is currently in the process of “finalising supporting policy documents in order to progress establishing an inquiry into the historical licensing and prescribing of sodium valproate”.

“A Memo for Government to commence the inquiry will be brought to Cabinet as soon as this work is completed,” the spokesperson said.

“The inquiry is being designed to provide a safe and supportive environment in which affected patients and their families can provide personal testimony about their lives and experiences.”

McPhillips said she plans to use the time between now and her next case in November to progress and launch all of the other 30 cases that she is representing.

“We are dedicated to this. I will continue through FOI, we will make discovery requests if it’s necessary, but I feel very passionately about this and the more families I meet, the more my resolve strengthens,” she said.

“We are not going away. These families are not going away. The representative organisation that supports these families, OACS Ireland, are not going away. They are continuing to hammer the drum.

“I see it all the time myself through the media and social media that that organisation is really hammering the drum to ensure that the inquiry gets set up, and we will continue to litigate these cases until such time as a redress scheme or proper restitution for these families is put in place.”

The Journal

March 2023