Stephen Donnelly, the Health Minister, stated that the government must definitely consider the creation of a compensation scheme, pending the outcomes of a probe into historical licensing and utilisation of a drug for epilepsy among expectant mothers that could reveal systematic failings. The inquiry set to begin in a few weeks is focused on the use of sodium valproate, also known as Epilim, among fertile women. Bríd O’Flaherty BL was appointed as the head of the inquiry on Wednesday.
Valproate-related medicines have been known to result in developmental disorders and birth defects in children whose mothers were on these medications during their pregnancy. As a result, there have been demands from impacted mothers for a probe into the lack of warning about the potential risks.
A study by the Health Service Executive from 2018 suggested approximately 1,250 children, born from 1975 to 2015, may have been affected by some neurodevelopmental delay due to their in utero exposure to valproate in Ireland. In his remarks after the announcement of the inquiry’s chair, Mr Donnelly stated that the creation of an official timeline displaying the growth of scientific understanding around the drug’s potential impact on foetal development should be the inquiry’s primary objective.
He added that if such timeline was to reveal systematic failures, court actions should be avoided, and a non-confrontational method to provide compensation and support should be found.
The Department of Health established the inquiry to offer a platform to those suffering from a foetal valproate spectrum disorder (FVSD) diagnosis, and to evaluate the adequacy of the assistive services and supports provided to patients and their caregivers.
Michael Boylan Solicitors’ Ciara McPhillips, who represents a large number of affected families, has emphasised that these families are seeking answers. Important questions about who knew about the drug’s issues, the timing and nature of these known issues, and the apparent failure to pass on this information to patients demand resolving.
Ms McPhillips, whose firm is representing 40 families in individual High Court actions, said the initiation of a compensation scheme should be prioritised to prevent future legal battles. She further highlighted that if this is not done, there is a possibility of more court cases. Four successful High Court cases have already been dealt with in relation to the usage of Epilim during pregnancy, and four additional cases are ongoing.