NHS Compensation claims for epilepsy medication
15 April 2025
Sodium valproate has appeared in news articles with varying frequencies over the last few years. It is an anti-seizure medication (ASM) which has been used to control epileptic seizures since the 1970s. It was also occasionally used to treat migraines. It has several brand names, the most common of which appears to be Epilem, Episenta and Depakote
A possible side effect, that the drug was known to be harmful to a developing fetus (ie teratogenic) in animals was known and a warning was given explaining that it should only be used in severe and resistant cases of epilepsy. However, the choice of ASMs would have been limited at that time and the impact upon the developing fetus during pregnancy has only become better understood from the early 2000s, although “fetal valproate syndrome” (now known as fetal valproate spectrum disorder or FVSD) was described in 1984.
As always, it is not possible to litigate with the benefit of hindsight. The use of sodium valproate was in line with a responsible body of medical opinion at the time but in any event, the risk would have been balanced against uncontrolled seizures and the attendant risk on the mother and unborn child.
With medical advancement, the choice of ASMs has broadened and the true extent of the risk posed to the fetus by sodium valproate is better understood, but doctors have continued to prescribe sodium valproate without any discussion of the side effects.
In 2004, the National Institute for Health and Care Excellence (NICE) produced guidance that it was the responsibility of the treating clinician to give accurate information regarding the risks to a fetus,so that patients could make informed decisions. The risk of birth defects is contained within the small print of accompanying literature, which is provided with every prescription, but it was not enough to rely on patients to read it.
As late as 2022 the Times published an article that sodium valproate was still being prescribed to pregnant women and women who may get pregnant without any discussion of the inherent risks.
Further, it is now known that the unborn foetus is at risk of developing learning or behavioural problems if the father takes sodium valproate in the three months before conception, and so alternative ASMs must be discussed with that section of the population.
Following a review led by Baroness Julia Cumberledge a report “First Do No Harm” was published in July 2020. It covered a range of concerns including sodium valproate use in pregnancy, It recommended compensation for affected families
Estimates are that approximately 20,000 babies were exposed to sodium valproate in the womb, yet when Professor Henrietta Hughes published her report (the Hughes Report) on 7 February 2024, she identified that no compensation had been paid in spite of Baroness Cumberledge’s report. The Hughes report set out recommendations for an interim scheme and main scheme. Professor Hughes stated that some victims should receive an initial payment of £100,000 with further compensation thereafter. The Hughes report also recommended an awareness campaign.
As a result of these reports, claims against the NHS can be conducted via a solicitor and/or by sending a questionnaire to a dedicated NHS email address, which will then be investigated. Further information can be found on the NHS website https://resolution.nhs.uk/sodium-valproate
It goes without saying that anyone who suspects they may have a claim (for themselves or on behalf of their child(ren)) should take legal advice.
This article was written by Redkite Solicitors, Julie Long. To find out more about Julie and the support that she can provide to you, visit her website profile here: https://www.redkitesolicitors.co.uk/team/julie-long/
The contents of this article are intended for general information purposes only and shall not be deemed to be, or constitute legal advice. We cannot accept responsibility for any loss as a result of acts or omissions taken in respect of this article.