Siblings' family take cases over prescribing of valproate during pregnancy

Two more court cases in relation to the prescribing of medication containing valproate during pregnancy open in the High Court today.
The cases are being taken on behalf of two brothers living in Dublin, Jack Clarke born in 2009 and Tom Clarke born in 2013.

Click to read our Sodium Valproate Scandal news article.

In a similar case in November, a settlement of €12m was made for Alex Fahey, 16, in Carlow. The teenager was diagnosed with autism and fetal valproate syndrome disorder (FVSD), which is associated with exposure to sodium valproate during pregnancy.

Valproate or sodium valproate is an ingredient in a drug sold as Epilim manufactured by Sanofi which is used for the treatment of epilepsy and also for bi-polar disorder and other conditions.

The HSE said about one in 10 children exposed to valproate in the womb are at high risk of congenital malformations and up to 30%-40% are at high risk of serious developmental disorders.

A UK inquiry, in 2020, of academic literature found "this suggested an association between sodium valproate exposure in utero, and physical malformations, with the ‘Foetal Valproate Syndrome’ being described in 1984”.

Health Minister Stephen Donnelly committed to holding an inquiry in November 2020, but terms of reference for this have not yet been presented to Cabinet for discussion.

Families represented by OACS Ireland and supported by Epilepsy Ireland accepted the terms in August. However a Department of Health spokesman said earlier this month the paperwork continues to be worked on.

In Ireland this medication should now carry warnings. Doctors and pharmacists should discuss risks with women taking this medication. However, a study led by the Royal College of Surgeons Ireland in 2021 found “most specialists under-estimated this risk” of developmental disorders.

A spokesman for the State Claims Agency said in relation to these latest cases: “The SCA, as a matter of respect for plaintiffs and their families, and the confidentiality attaching to litigation, does not comment on individual cases or groups of cases.”

The SCA, he said, acts on behalf of non-consultant hospital doctors in respect of sodium valproate cases around care provided since 2002, and for hospital consultants since February 2004.

Solicitor for Jack and Tom Clarke is Ciara McPhillips with Michael Boylan LLP.

Irish Examiner

February 2023