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Sodium valproate is a recognised, effective treatment for epilepsy but can cause severe, permanent injury to an unborn baby if taken in pregnancy. Doctors and pharmacists have always been required to take extreme care in prescribing valproate drugs to women of childbearing age, but there is extensive evidence of women being prescribed valproate without adequate steps being taken to ensure they do not become pregnant or warnings of the risks.
If a child is physically or developmentally disabled because their mother was negligently prescribed valproate drugs before or during pregnancy, or allowed to become pregnant whilst on the drug, they may be able to claim compensation.
Speak to our medical negligence solicitors
For more than 30 years, Boyes Turner's medical negligence solicitors have guided injured patients and their families through the claims process to secure the compensation and specialist support that they need to manage their disability and rebuild their lives.
You can contact us by telephone or email for free, confidential advice from a medical negligence solicitor. We will ask you to tell us briefly about your child’s injury and your medical care, and advise you about any time limits which may apply and whether we can help you investigate your claim. Once our investigations confirm you have grounds for a claim, we will notify the defendant healthcare provider (usually represented by NHS Resolution) on your behalf and invite them to respond, giving them an opportunity to admit liability (responsibility for the injury) before court proceedings are issued.
If liability is admitted, we will obtain a judgment from the court and apply for a substantial interim payment to meet your needs arising from the injury and disability. If NHS Resolution deny liability, we will advise you about the best way to proceed with your claim. This may involve issuing court proceedings or inviting NHS Resolution to enter into settlement negotiations or mediation.
Partner, Medical negligence
We strongly recommend that families considering a valproate injury compensation claim seek independent advice from medical negligence solicitors who specialise in representing severely injured patients in claims against NHS Resolution.
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In what can only be described as a stressful process dealing with Birth Negligence for your child, Boyes Turner, specifically Richard Money Kyrle and Tara Byrne made the process as smooth, efficient, and with a high level of understanding and empathy as possible. Each part of the process was explained clearly in layman's terms so I had a clear idea of what to expect and also a timeline of how long each process would take. Both Richard and Tara were always an email or phone call away and having to divulge such past traumatic events was done with the utmost respect and empathy. My son's case has now settled and thanks to all the hard work and fighting for justice we are able to move towards a bright future.
Thoroughly professional, knowledgable and approachable with communication and updates as and when needed, in what can be a drawn out process, I was always comfortable asking questions and always received answers which were clear and understandable. Highly recommend
Sodium valproate is an anti-convulsant drug which is used to reduce fits or seizures in people with epilepsy. It has many trade names, including Epival and Epilim. Valproate is also prescribed to stabilise people who suffer from bipolar disorder.
Valproate is known to be dangerous if taken during pregnancy, as it can cause serious, long-term injury and disability to the unborn baby.
Babies who are exposed before birth to valproate drugs, such as Epilim and Epival, have up to a 40% of risk of injuries which range from minor physical malformations to severe disability from spina bifida, organ defects, learning disability and autism.
In 2018, doctors were banned from prescribing sodium valproate to women of childbearing age. In exceptional cases, where no other equivalent drug is effective in managing the woman’s epilepsy, valproate may be prescribed but only in compliance with strict safeguards set out in the valproate licensing regulations and NICE summary guidelines. These regulations and guidelines require hospital doctors, GPs and pharmacists to follow processes for warning the woman of the risks of taking valproate in pregnancy, regularly reviewing her medication needs, and ensuring she has mandatory contraception via a pregnancy prevention programme (PPP).
Fetal valproate spectrum disorder (FVSD) is a serious condition in which a baby suffers physical and/or learning and developmental disability as a result of their mother taking sodium valproate medication during pregnancy. Children who were exposed to sodium valproate in their mother’s womb before birth can have one or more of a range of injuries which include malformations of the spine, limbs, organs or face, and difficulties with learning and intelligence, speech and communication, or autism spectrum disorder (ASD).
Other names for these valproate-related physical and neurodevelopmental injuries include fetal valproate syndrome (FVS) and fetal anti-convulsant syndrome (FACS).
Negligent prescription of valproate to a woman before or during pregnancy can result in severe injuries to her baby. Sodium valproate compensation claims often relate to one or more of the following avoidable injuries:
Children with valproate-related disabilities are sometimes described as having fetal valproate spectrum disorder (FVSD) or fetal valproate syndrome (FVS) or fetal anti-convulsant syndrome (FACS).
A child or young adult with valproate-related disability may be entitled to make a sodium valproate compensation claim if their injuries were caused by in-utero exposure to valproate after:
Permanent physical and/or neurological disability from valproate exposure will have severe, lifelong consequences for the child, many of which are not fully apparent to the family in the early years of the child’s life.
Our highly experienced medical negligence solicitors work with a multi-disciplinary team of experts to understand the child’s condition and assess their lifelong needs for support with care, therapies, education, specialist equipment and adapted accommodation. Our client’s claim is carefully valued to ensure that their compensation provides for these needs, whilst also compensating them for the financial impact of being left unable to learn, work or participate fully in all aspects of life.
The amount of compensation that a child can claim for their valproate injury depends on the severity of their disability and its impact on their life.
Claims may include compensation for:
In 2018, the Department of Health and Social Care (DHSC) called for The Independent Medicines and Medical Devices Safety (IMMDS) Review to investigate how the NHS responded to emerging information and complaints about valproate and two other NHS treatments. The review was led by Baroness Julia Cumberlege and was carried out independently from the government, the DHSC, the NHS, the pharmaceutical industry, and other regulatory bodies. Its report, First Do No Harm, was published in July 2020.
In relation to safety concerns about sodium valproate in pregnancy, the review found that valproate has been known to be teratogenic ever since it was licensed in the 1970s. Amongst its findings, the review criticised the healthcare system for:
The review found that even since the Pregnancy Prevention Programme (PPP) has been in place, there is evidence that hundreds of women on valproate are still becoming pregnant without being aware of the risks.
The review’s call for an ex gratia payment scheme to make ‘no fault’ payments to those injured by valproate was rejected by the government. Despite more recent calls by the Patient Safety Commissioner for a valproate compensation scheme, the only way to obtain compensation for valproate-related injury is by making a medical negligence claim.
We strongly recommend that families considering a valproate injury compensation claim seek independent advice from medical negligence solicitors who specialise in representing severely injured patients in claims against NHS Resolution
The NHS’s legal defence team, NHS Resolution, claims to offer families of valproate-injured children an alternative process for making a valproate injury claim via their valproate claims ‘gateway’. This is not a redress scheme and does not provide easy or unchallenged access to compensation for valproate injury. It is a direct link which enables NHS Resolution to investigate and defend the injured person’s claim, without the injured person being advised or represented by their own claimant-specialist solicitor.
By applying to NHS Resolution for compensation via this gateway, families of valproate-injured victims are risking their child’s claim by managing their child’s legal claim themselves for their child as a litigant-in-person. They are telling their story, making their case and giving their evidence to the NHS’s legal defence team without support from their own legal or independent medical experts.
Our clients who have experienced this process tell us that, in some cases, NHS Resolution are also subjecting the child and their family to genetic testing to search for any possible alternative cause for the injury, which is then used to deny their claim. To date, we are unaware of any valproate-injured claimants whose claims have been accepted and compensated via NHS Resolution’s valproate gateway. We are not alone in our concerns about the biased and misleading nature of NHS Resolution’s valproate gateway, many of which have been echoed by the Patient Safety Commissioner.
Parents and families should be aware that they may be putting their child’s claim for compensation at risk by applying directly to NHS Resolution before seeking advice from an independent, claimant-specialist solicitor.
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