Sodium Valproate – the future of claims and compensation

Sodium valproate (brand names include Epilim and Depakote) is a drug to treat epilepsy, bipolar disorder and migraines which, if taken in pregnancy, is associated with a significant risk of birth defects and developmental disorders often known as Fetal Valproate Syndrome (FVS).

Given the breadth of the symptoms of FVS, it may be many years in some instances before it is clear that a person is suffering from this. Unsurprisingly, longstanding concerns about this medication have resulted in comparisons with the Thalidomide scandal.

A 2022 investigation by the Times reported that doctors knew in 1973 that the drug posed a risk to unborn babies and said that some 50 years and an estimated 20,000 disabled babies later, it was still being prescribed to pregnant women.

Recent evidence also reveals that, since April 2018, 315 females on a register of valproate users under the age of 54 have been prescribed the drug during their pregnancy. Here I look at the situation as it stands now and the future for obtaining compensation for those who have been harmed.

The facts are harsh – if sodium valproate is taken in pregnancy, up to four in 10 babies are at risk of developmental disorders and approximately one in nine are at risk of birth defects. These can include spina bifida, malformation of the limbs and facial and skull malformations.

The Hughes Report

Patient Safety Commissioner Henrietta Hughes has this month published a report recommending a publicly-funded redress scheme for those affected. This follows a report from the Independent Medicines and Medical Devices Safety Review in 2020 called ‘First Do No Harm‘. This detailed that there had been inadequacies involving healthcare providers, regulators, professional bodies and pharmaceutical manufacturers. The report concluded that it had taken far too long for serious action to be instigated to reduce the number of women who take valproate during pregnancy while being unaware of the risks.

Problems have continued despite increasing guidance and regulations over the years. For example, the National Institute for Health and Care Excellence (NICE) published guidelines in 2004 on informing patients of ‘childbearing potential’ about the risks. Also, prescription requirements were tightened by the Medicines and Healthcare Products Regulatory Agency (MRHA) in 2018 when it set out that valproate should not be used by a woman able to have children without there being a Pregnancy Prevention Programme (PPP) in place.

The Hughes report found that thousands of children who were exposed to valproate now have learning and physical disabilities with many being unable to live independent lives. Ms Hughes suggests that under a redress scheme, there should be interim payments to eligible people – followed by potential further payouts under a ‘Main Scheme’.

New Regulations

The MRHA have now produced a public assessment report in which they set out advice that no one under the age of 55 should be started on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Rules were also introduced in 2023 to ensure patients receive their medication in the manufacturer’s original full packs which display all relevant warnings.

Legal claims

A legal claim by a group of affected families against the drug manufacturer, Sanofi, issued in 2004, was discontinued in 2010 after funding was terminated by the Legal Services Commission. This left many uncompensated for very significant injuries.

The Hughes report refers to there being some progress in France about a class action against Sanofi. However, the report states that (also about pelvic mesh) ‘it seems unlikely that for either product we will see large scale group actions in England’.

Medical Negligence Claims

Medical negligence claims – those relating to failures in medical care rather than actions against product manufacturers – will remain possible for some, including potentially where there has been a failure by a doctor either to provide proper information or to prescribe valproate appropriately. Claims may also be possible against pharmacists, for example, if correct warnings were not in place on the medication box or the correct leaflet was not enclosed with the medication.

Ms Hughes says in her report that limitation periods have been a hurdle to some trying to bring legal action. I would strongly advise anyone who considers that they may have a claim but are outside the standard limitation period for a clinical negligence case to seek advice from a specialist solicitor since there might still be a way forward.

Ms Hughes also points out that a new ‘claims gateway’ has been set up on NHS Resolution’s (NHSR) website about valproate clinical negligence claims. NHSR is the body which deals with claims against the NHS. The site sets out an alternative procedure to a standard legal claim, whereby cases are assessed by solicitors acting for NHSR. If they consider that the legal test for clinical negligence has been met then an offer may be made without the need for Court involvement.

As an experienced clinical negligence solicitor acting exclusively for claimants, I have concerns about reliance on such an alternative ‘gateway’. Clearly, NHSR-appointed solicitors do not have a duty of care to act in the best interests of unrepresented Claimants.  NHSR-appointed lawyers only have a duty to their clients and to the court. Only a solicitor appointed by the family / the injured party can properly advise the injured party on all appropriate issues, including the value of their claim. A specialist Claimant solicitor will obtain all of the expert evidence needed to reach the best outcome and also be able to reduce the stress for claimants by advising them clearly and supporting them throughout the process of a legal claim.

Reflections on a redress scheme

Ultimately, Ms Hughes does not have the necessary authority to set up a redress scheme. The decision is one for the Government. There are large numbers in need of compensation. However, the Hughes report recognises that such a scheme may result in awards of less financial value than those which could be awarded by the Court in a successful legal action.

A scheme which contributes to the losses that people have suffered is not equivalent to an award of damages in a successful legal claim whereby the Court will endeavour to put an injured person, so far as possible, in the position they would have been in without the negligence. In my view, a redress scheme would nonetheless provide some much-needed help for those with no apparent legal options.