The Hughes Report one year on: Still no justice for victims of sodium valproate scandal

It’s been one year since The Hughes Report was published, yet families affected by sodium valproate are still no closer to redress for the suffering they and their children have endured.

As a solicitor specialising in child brain injury claims, I’ve had the privilege of working with many families whose lives have been turned upside down by medical negligence. For families of children born with Foetal Valproate Syndrome (FVS), the battle for justice is deeply personal. It’s not just about financial support; it’s about recognition, accountability, and ensuring no one else goes through the same avoidable tragedy.

On 7 February 2025, we mark the first anniversary of the publication of the Hughes Report: “Options for Redress for Those Harmed by Valproate and Pelvic Mesh.” The report was a glimmer of hope for families who’ve spent years fighting for acknowledgment of the harm caused by sodium valproate.

As I summarised in a blog then, the report calls for the establishment of an independent two-stage redress scheme to provide both financial and non-financial compensation for affected patients. Yet, a year on, the Government has still not responded to the report, leaving affected individuals without a straightforward path to compensation.

I want to take this opportunity to reflect on why this issue is so important, the history of the sodium valproate scandal, and why families urgently need a redress scheme.

The devastating impact of sodium valproate

Sodium valproate has been used since the 1970s to treat epilepsy, bipolar disorder, and migraines. While it’s a highly effective medication, it has catastrophic consequences when taken during pregnancy. The drug is known to cause severe birth defects and developmental disorders, leaving children with lifelong disabilities, described as Foetal Valproate Syndrome (FVS).

Many of the families I work with tell me the same heartbreaking story: they were not adequately warned about the risks. They trusted their doctors and took the medication, unaware of the potential harm to their unborn children.

The financial and emotional impact is enormous. These families face the cost of providing therapies and specialist equipment, while navigating the challenges of caring for a child with complex needs. Many parents are unable to work due to their caring responsibilities, placing additional strain on household finances.

Why a redress scheme is essential

The Hughes Report recognised the unique challenges faced by families affected by sodium valproate and recommended a statutory compensation scheme to provide financial and non-financial support. This is particularly important for families who cannot bring a clinical negligence claim.

Clinical negligence claims require evidence that a healthcare provider failed in their duty of care. For many families, this can be difficult to prove, especially if they were prescribed sodium valproate in accordance with the guidelines at the time. A redress scheme would ensure these families are not excluded from receiving the support they desperately need.

The report also recommended non-financial measures, including access to counselling, respite care and specialist services. This integrated approach would make a meaningful difference to families, addressing both the practical and emotional challenges they face.

A long history of inaction

Research in the 1980s began to link prenatal exposure to sodium valproate with congenital malformations and neurodevelopmental disorders but, despite accumulating evidence during the 1990s and 2000s, regulatory bodies and the medical community were slow to respond.

Women affected by sodium valproate and pelvic mesh implants have campaigned tirelessly for change, forming grassroots organisations to raise awareness and demand action. Their efforts led then-Health Secretary Jeremy Hunt to launch a review in 2018 into the use of sodium valproate, with the subsequent report, “First Do No Harm – The Independent Medicines & Medical Devices Safety Review” chaired by Baroness Julia Cumberlege, published in 2020.

This made nine key recommendations, one of which was for a redress scheme for those harmed by sodium valproate.

The Hughes Report followed up on this recommendation by providing detailed recommendations for the redress scheme, including financial and non-financial support, emphasising the need for a co-designed, independent, and straightforward compensation scheme.

Where are we now?

While new measures have been introduced to ensure valproate is not started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply, there has been no progress on a redress scheme.

Writing in August 2024 to the patient safety commissioner Henrietta Hughes, the Minister for Patient Safety and Women’s Health, Baroness Merron, said:

“I wanted to write to assure you that I am looking at [the recommendations of your report] and I will write with an update on progress at the earliest opportunity”.

What needs to happen

The failure to act on the Hughes Report is a betrayal of the families it promised to support. A statutory compensation scheme must be introduced as a matter of urgency.

Such a scheme would:

• Provide financial relief to cover the cost of care and support;
• Offer non-financial support, such as counselling and respite care;
• Acknowledge the harm caused and provide a sense of justice to affected families.

The scheme must be accessible, efficient, and inclusive, ensuring no family is left behind.

Families affected by sodium valproate have waited long enough.

A personal reflection

In my role as a clinical negligence solicitor, I’ve seen first-hand the resilience and determination of families caring for children with Foetal Valproate Syndrome. These families have been let down repeatedly by a healthcare system that failed to protect them and governments that have delayed meaningful action.

The Hughes Report offered a pathway to justice, but without implementation, it is nothing more than words on paper.

On this anniversary, we must renew our calls for action. Families affected by sodium valproate deserve not only financial support but also acknowledgment of the harm they have endured.

It’s time to turn recommendations into reality and give these families the support and justice they deserve.

In the meantime, the only route to compensation is through a clinical negligence claim.

We recommend contacting specialist clinical negligence solicitors as soon as possible if your child or your family has been affected by Foetal Valproate Syndrome. Our friendly and approachable team would be happy to chat and let you know if we can help.