First sodium valproate injury case opens next month

The first court case taken by an Irish family affected by the prescribing of sodium valproate during pregnancy opens in late November.

A total of 20 cases are at different stages of preparation, including one family whose child was born as recently as 2018.

The anti-epileptic drug was first prescribed in Ireland in 1975, with a British inquiry finding that data had begun to emerge in the 1980s around the risks of taking valproate during pregnancy.

The HSE has estimated up to 1,500 babies were affected in Ireland, with impacts including lower intellectual ability, memory problems, difficulty with speech, and delayed walking and talking.

Read more on the Sodium Valproate Scandal.

Ciara McPhillips, the solicitor for the families, said the children and their families have suffered.

“There is a case coming before the courts at the end of November, this case is just one family,” she said. “There are two more listed for February, and there are more that I expect for next summer.”

In 2014, the European Medicines Agency (EMA) strengthened its previous warnings on the drug. However, the cases being taken are on behalf of children born between 2004 and 2018, according to Ms McPhillips, partner with Michael Boylan Litigation.

“I find it astounding that, despite the EMA warning in 2014, I have a family who conceived their third child by IVF and nobody said, in 2018, stop taking Epilim,” she said.

Warning not heeded

Briefings prepared for Health Minister Stephen Donnelly indicate warnings were not acted on.

One document says: “These patient groups have stated that many of the women they represent received little or no information, either before or during pregnancy, on the potential effects on their children, even when such information should have been known to prescribers and pharmacists.”

Documents released under the Freedom of Information Act show HSE estimates of babies affected up to 2015 include 153 to 341 who may have experienced a major congenital malformation, and up to 1,250 who may have experienced a neurodevelopmental delay.

Mr Donnelly first committed to an inquiry in November 2020, with options submitted in early 2021, the documents show, with a second set of terms of reference now under discussion.

The Department of Health wrote to the manufacturer Sanofi on April 22 this year asking if they would be available for an inquiry.

However, the inquiry will be non-statutory, meaning witnesses cannot be compelled to appear, according to minutes of a meeting on August 30 between fepartment officials and advocacy groups, Organisation Anticonvulsant Syndromes Ireland and Epilepsy Ireland.

“The patient groups expressed their frustrations and concerns with the current TORs [terms of reference], stating they felt they don’t meet their objectives and that the 'review phase' is not comprehensive,” the minutes show.

A spokesman for the advocacy groups said: “Following a recent meeting with our families to discuss the most recent terms of reference, we are reflecting on what they said and are in ongoing contact with the Department.”

Original article published on the Irish Examiner