The Government must “absolutely be open” to establishing a redress scheme if an inquiry into the historical licensing and use of an anti-epilepsy drug among pregnant women finds “systemic issues”, Minister for Health Stephen Donnelly has said.
On Wednesday Mr Donnelly announced the appointment of Bríd O’Flaherty BL as chairwoman of the inquiry into the use of sodium valproate, also known as Epilim, among women of childbearing age.
The inquiry was to “get up and running in a matter of weeks”, he said.
Valproate-containing medicines can cause birth defects and developmental disorders in children whose mothers take them during pregnancy. Affected mothers have called for an inquiry into why they were not warned of the risks.
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A 2018 report by the Health Service Executive said it was possible that up to 1,250 children born between 1975 and 2015 experienced some form of neurodevelopmental delay as a result of exposure to valproate in utero in Ireland.
[ Mothers of children with foetal valproate syndrome demand public inquiryOpens in new window ]
Speaking following the announcement of the chairwoman, Mr Donnelly said the “first thing” the inquiry should do was establish an official timeline of developments in scientific knowledge about the potential impact of the drug on foetal development.
“If the timeline finds there were systemic failures, then my strong preference would be families should not have to go to court and we should find a non-adversarial process of providing supports and compensation,” he said.
The Department of Health said the inquiry had been set up to give a voice to those affected by a diagnosis of foetal valproate spectrum disorder (FVSD) and would assess the adequacy of services and supports in place for patients and their caregivers.
Ciara McPhillips, of Michael Boylan solicitors, which represents many of the families affected, said they wanted answers.
“There are key questions of who knew the issues with the drug, when did they know those issues, what issues did they know about and why was that information not passed on to patients,” she said.
There have been four successful High Court cases to date regarding the use of Epilim in pregnancy and there are four more cases under way.
Ms McPhillips, whose firm represents 40 families in individual High Court actions, said there should be a redress scheme. If there was not, she said, there was a risk “there will be further court cases”.
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