The sodium valproate scandal nine months from Hughes Report – where are we now?

In February 2024, The Patient Safety Commissioner (PSC) published the ‘Hughes Report’ on options for redress for those affected by the sodium valproate scandal.

At the time my colleague Sally Simpson published a blog welcoming and outlining the proposed redress scheme, but also addressing its limitations and outlining how people could alternatively bring a compensation claim to secure damages and interim payments. A link to her blog can be found here.

I’ve had the privilege of working with Sally on sodium valproate compensation claims during the first seat of my training contract. Six months later, having now completed this part of my training, I thought it was a good time to reflect on the progress which has been made on the redress scheme. It’s important this issue receives adequate coverage and the media buzz in February does not die out as this could leave room for the Government to delay further action.

What is the sodium valproate scandal?

Sodium valproate is a drug is prescribed to treat epilepsy or bipolar disorder. Sodium valproate has known risks for pregnant women and, if taken, a baby can suffer birth defects and developmental disorders, described as foetal valproate syndrome.

Despite problems with sodium valproate being first identified in the 1970s, the restrictions on its use only came in 2018. An estimated 20,000 babies in the UK have been affected since then.

What’s the update?

Unfortunately for those affected by the scandal, we are in the same position as we were in February – waiting to see what Government action will be taken to implement the recommendations set out in the report.

In Hansard dated 25th March 2024, Lord Markham, Parliamentary Under Secretary of State at the Department of Health and Social Care, provided the following update on Government action following publication of the Hughes Report which, frankly, doesn’t tell us anything new.

He said: “The Government commissioned the Patient Safety Commissioner to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the commissioner and her team for completing this report and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government are now carefully considering the PSC’s recommendations and will respond substantively, hopefully in the coming months.”

Since March 2024 we’ve had the general election, pausing progress. And now, with a new Government, many sodium valproate victims have been left wondering where they stand.

The epilepsy community has written and lobbied the new Government to ensure all progress is not lost. Epilepsy Action has put together a manifesto of key issues affecting people with epilepsy and called on the new Government to implement a compensation scheme.

In July 2024, the new Labour Parliamentary Under Secretary of State at the Department of Health and Social Care, Baroness Merron, met with the PSC who published the Hughes Report. She wrote to the PSC in August 2024 to provide assurance that she is “looking at this important issue”.

She referenced the measures implemented in January 2024 that means valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply.

Where does that leave us and what options are available to you?

Disappointingly, there has been little to no progress being made for a Government redress scheme. The Government’s assurances in March 2024 that a substantive response would follow “in the coming months” now feels like a distant cry.

I am not convinced this can be entirely excused by the general election given problems with sodium valproate were first identified in the Seventies and it is only in recent years that advancement has been made on a redress scheme.

It remains to be seen whether the new Government will follow through on the recommendations published in the Hughes Report and it is crucial pressure is maintained on the Government to stop delays.

In the meantime, a civil claim remains the most effective route to compensation. If you or anyone you know were prescribed sodium valproate during pregnancy and there is reason to believe this has caused harm, please get in touch with the specialist solicitors in the Child Brain Injury team at Bolt Burdon Kemp.