Support for sodium valproate scandal victims proposed – but does it go far enough? | Bolt Burdon Kemp Support for sodium valproate scandal victims proposed – but does it go far enough? | Bolt Burdon Kemp

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Support for sodium valproate scandal victims proposed – but does it go far enough?

An estimated 20,000 people could potentially access compensation following a report on the sodium valproate scandal.

Options for a redress scheme, aimed at compensating children harmed by epilepsy drugs taken by their mothers while pregnant, have been set out in the Hughes Report.

Dr Henrietta Hughes, the Patient Safety Commissioner, released the report on 7th February and while it is welcome news, as a specialist child brain injury solicitor I believe the suggested options don’t fully address the lifelong needs of affected children.

What’s the scandal?

The sodium valproate scandal centres around the fact that approximately 20,000 babies in the UK have suffered harm due to this antiepileptic drug. Despite being aware of the risks for over 40 years, both the drug manufacturer (Sanofi, which markets the drug as Epilim in the UK) and medicine regulators (the predecessor of the Medicines and Healthcare Regulatory Agency) failed to consistently communicate the dangers of taking this medication during pregnancy.

Proposed redress scheme

A redress scheme would recognise the harm caused to children born with birth defects and developmental disorders resulting from their mothers’ use of sodium valproate during pregnancy.

By providing financial support, the scheme could help families cope with the additional needs and challenges associated with these conditions. It is also argued that implementing a redress scheme could potentially prevent lengthy and costly legal battles by providing an alternative avenue for compensation.

I explain what’s included in the proposal in more detail further in this blog.

As a specialist child brain solicitor, I welcome Government recognition of the harm caused to so many families, and the recognition that this harm could have been avoided if the correct information had been widely shared with patients.

But, I don’t think the scheme goes far enough. To understand why we need to consider the challenges faced by these children and the resources required to address them, before examining how the suggested redress scheme would operate.

What problems can sodium valproate during pregnancy cause?

In my blog of June 2022 I described how sodium valproate, if taken during pregnancy,  can cause serious birth defects and developmental disorders, described as Foetal Valproate Spectrum Disorder (FVSD)

Birth defects seen include:

  • Spina Bifida (where the bones of the spine do not develop properly)
  • Facial and skull malformations (including cleft lip and palate, where the upper lip or facial bones are split)
  • Malformations of the limbs, heart, kidney, urinary tract and sexual organs.

The effects on development can include:

  • Being late in learning to walk and talk
  • Lower intelligence than other children of the same age
  • Poor speech and language skills
  • Memory problems.

Children exposed to valproate in the womb are also more likely to have autism or autistic spectrum disorders.  There is also some evidence that children may be more at risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).

The consequence of serious birth defects and developmental disorders

The harm caused by sodium valproate taken in pregnancy is highly variable. Most children exposed to sodium valproate in the womb are born healthy. But for those affected, if there are multiple congenital anomalies or significant intellectual disabilities the child’s needs are extremely high.

The costs of meeting these needs

Each child and their family are unique, as is the harm caused by sodium valproate, so there is never a “one size fits all” answer to the question of how much it costs to meet the needs of a child in this situation.

However, to give an idea of the costs involved, our specialist child brain injury team often obtains multimillion pound financial settlements for children born with brain injuries caused by medical negligence, the sum depending on the severity of the injury and the extent of the child’s needs.

In these situations, there may well be a lifelong need for care and supervision. A huge worry for parents is what will happen when they are no longer there to provide care for their children.

Paying for therapies such as occupational therapy, physiotherapy, speech and language therapy, or treatment such as orthopaedics and neurology soon adds up. There is also often a need for educational support in school and employment support beyond.

All this needs to be coordinated. Care staff will need to be recruited, trained and managed. And there will be a need to constantly review, assess and address the child’s changing needs as they grow and develop. Support for the parents and siblings is also crucial for managing the stresses and strains of coping with a child with severe disabilities.

What redress scheme is being suggested?

The Hughes Report suggests both financial and non-financial redress.

The report recommends two-stage financial redress: an Interim Scheme and a Main Scheme. The Interim Scheme would offer patients an initial, fixed sum in recognition of the avoidable harm they have suffered because of system-wide healthcare and regulatory failures. The Main Scheme would involve an individualised approach that would recognise the different levels of harm caused to each patient and help meet their specific needs.

According to the Hughes report, £100,000 was the median sum suggested by a survey of patients as appropriate for a payment under the interim scheme. The report does not suggest what financial redress would be included under the Main Scheme nor how it would be quantified. It does, however, endorse the principle that the redress should “represent broadly fair, proportionate compensation for the injury and loss suffered…, with due consideration of, but without being bound by, the boundaries of entitlement to damages in law.”

The suggestions in the report for the non-financial aspects of the redress scheme are key to understanding how this “broad” principle could play out in practice.

Suggestions for the non-financial aspects include:

  • Link workers to signpost patients to available support, including support with finding suitable employment and training opportunities, and to offer an advocacy service to access public services, including welfare benefits.
  • A housing support fund to which patients and their families could apply for support with home adaptations tailored to their type of housing.
  • A national multidisciplinary diagnostic and treatment support service to provide healthcare where currently there is variation and inequitable access to such services.
  • An improved service from the Department for Work and Pensions with better assessment processes, “soft touch” reviews, the involvement of the Severe Disability Group as well as clearer pensions information, including how to make up for lost national insurance contributions.
  • National guidance, training, and support on the issue of FVSD for local authorities to improve awareness and recognition of the special educational needs of children harmed by valproate.

In other words, the redress scheme envisaged would make “link workers” available to direct families to existing services and benefits, require families to apply for grants for housing adaptions (in much the same way as they can already), attempt to plug gaps in existing healthcare services, and would tell the DWP to improve its service.

This sticking plaster approach comprising the non-financial elements of the redress scheme suggested by the report would inevitably limit the financial element to costs necessary to top up care available through the NHS and social care system.

While in theory the non-financial aspects of the redress seem like a good idea, it would force the victims of the sodium valproate scandal to rely on already overstretched and woefully underfunded state-funded health, housing, education and social care.

Criticisms of the compensation claims process

The Hughes Report’s criticisms of the compensation claims process are used to support the introduction of a redress scheme. Some of the criticisms – the lengthy nature of the process, for example – have some weight. But there are potential mechanisms that could be adopted by the courts, as they have done in mesothelioma cases for example, to speed up the process.

Other criticisms demonstrate a poor understanding of how a claim for compensation, if handled by specialist solicitors, works. For example, the report argues for a redress scheme on the basis that a court is generally limited to an award of financial damages or costs at the end of the proceedings and that the patient survey respondents (over 90%) believed that effective redress extends beyond financial compensation.

This is not accurate. Courts are always able to order the defendant to make an interim payment of compensation, if certain criteria are met, at an early stage in the claim and specialist solicitors will always seek an interim payment of compensation at the earliest possible opportunity.

These interim payments, unlike the fixed initial payment envisaged under the Interim Scheme proposed for redress, is an individualised payment. It is used to repay the family’s past and ongoing out-of-pocket expenses and losses, providing much-needed financial support.

Even more importantly, it is used to pay for the practical and therapeutic support that the family and the child need while the process of valuing the claim goes on.

Early rehabilitation and support are crucial because the sooner a child can take advantage of, say, therapies to improve speech and language, or teaching assistance to fully access education, or equipment to improve quality of life, the more likely it is they will be able to fulfil their full potential and the better the long-term outlook.

Time limits

To qualify for a payment under the Interim Scheme redress proposals, an individual would have to be directly harmed, (not just negatively affected, such as family members) and would have to have received treatment by a specific cutoff date. Two cutoff dates are suggested:  a date of birth before 23 June 2019 or a date of birth before 22 May 2021. This suggests that a redress scheme may be helpful in cases where the prospects of overcoming the strict time limits for bringing a medical negligence claim through the courts are thought to be poor.

The law relating to time limits for bringing a claim through the courts is complex. For example, for a person injured at birth or during childhood, the time limit to bring a compensation claim generally expires on their 21st birthday. However, the time limit may not apply at all if it can be established that the person lacks mental capacity to conduct legal proceedings. It is therefore worth consulting with a specialist solicitor in such cases.

Where does that leave us?

The purpose of the Hughes Report is to explain what the Government should do to meet the needs of individual patients who have suffered “avoidable harm” because of the healthcare and regulatory failures in the prescribing of sodium valproate. In its own words, “it should lead to Government action”.

Whether it does lead to Government action and, what that action might be, remains to be seen.

In the meantime, I would encourage anyone who believes they or their children may have been harmed by sodium valproate to get in touch. If a doctor prescribed sodium valproate without fully explaining the risks or considering alternatives, to girls or women who could have children or who were pregnant, and their baby suffered harm as a result, there may be a claim for compensation.

We will listen to your story and, if we think there is a claim, investigate and fight for your right to compensation.

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