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What is Valporate?

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 in pregnancy as it can cause serious long-term injury to the unborn baby. Since its introduction in 1974, the manufacturers’ product information for doctors has warned that valproate carries a risk of causing birth defects.

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 warn them of the risks.

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 must be prescribed in compliance with strict safeguards set out in the valproate licensing regulations and NICE summary guidelines.  These include processes for warning the patient of the risks of valproate in pregnancy, and mandatory contraception via a pregnancy prevention programme (PPP).

Fetal Anti-Convulsant Syndrome (FACS) is a serious condition in which a baby suffers physical and/or developmental disability from his mother taking sodium valproate medication in pregnancy.

Babies who are exposed to valproate drugs, such as Epilim and Epival, have up to 40% risk of injuries which range from minor physical malformations to severe disability from spina bifida, organ defects, learning disability and autism.

Prescription of sodium valproate drugs to women of childbearing age is currently banned in most circumstances, owing to the high risk of serious injury to the unborn baby. In exceptional circumstances where no other treatment is available to the woman, hospital doctors, GPs and pharmacists must comply with strict rules for warning the woman of the serious risks of pregnancy and protecting her from pregnancy whilst she is taking the drug.

Where 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 substantial compensation for their injury.

Boyes Turner’s experienced birth injury lawyers can help

Boyes Turner’s experienced birth injury lawyers have helped countless children recover their full entitlement to compensation for serious disability caused by negligent medical treatment. 

We understand the devastating impact that a child’s severe disability has upon the child and their family. Where that disability was caused by medical mistakes our focussed approach enables us to secure early interim payments, so that whilst we work towards valuation of the claim and eventual settlement, the family can begin meeting the child’s needs straight away.

What is the Independent Medicines and Medical Devices Safety Review (IMMDS)?

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 aim of the IMMDS review was to examine all the evidence surrounding the use of valproate, including:

  • what was known about sodium valproate;
  • what decisions/actions were taken by the drug’s manufacturers, regulators, medical clinicians and policy makers;
  • whether informed consent was taken from patients;
  • whether there has been a satisfactory response to patients’ and other campaigners’ safety concerns;
  • the licensing of valproate and use of the drug for women of childbearing age having regard to the known association with harm to the unborn baby/fetus (teratogenicity);
  • how the knowledge of valproate’s harmful effect on the unborn baby was/should have been communicated between the drug’s manufacturers, regulators, health practitioners and patients, and what action was taken.  

The IMMDS review also intended to:

  • set out clearly the characteristics and implications of fetal valproate spectrum disorders (such as FACS) so that those who have been affected by sodium valproate are diagnosed correctly and their needs are assessed properly;
  • make recommendations for further action.

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 lengthy report, First Do No Harm, was published in July 2020.

In relation to the use of sodium valproate in pregnancy, the review concluded:

  • At the time of licensing, sodium valproate was known to be teratogenic to animals but there was no long-term follow-up of those taking the drug at that time.
  • The healthcare system as a whole took too long to respond to emerging information about the effects of the drug, with warnings, regulatory action or by further research. The system was too slow to take action to make sure that women were aware of the risks and were being properly advised.
  • There was a time lag between doctors becoming aware of the risks of congenital malformations and neurodevelopmental effects on unborn babies from valproate and warnings being given to patients.
  • Many women were not given enough information about the risks and benefits of their epilepsy treatment and family planning options to make informed choices. 
  • Doctors often dismissed patients’ concerns or reassured them that valproate was safe or that if their babies had problems they could be ‘fixed’.
  • The healthcare system took more than 40 years to put in place measures to make sure that women were properly informed of the risks of valproate before they became pregnant.
  • Even since the Pregnancy Prevention Programme (PPP) has been in place, hundreds of women on valproate are still becoming pregnant without being aware of the risks.
  • Those who have suffered avoidable harm should receive support and an apology. They are not currently receiving adequate support.
  • Families affected by teratogenic medicines should receive integrated expert medical and social care in specialist centres where they can access the services all the services they need in one place.
  • NHS England and NHS Improvement (NHS E&I) should now write to all women and girls of childbearing age who are on valproate and ask them to see their GP or specialist doctor to make sure their treatment complies with the Pregnancy Prevention Programme (PPP).
  • An ex gratia payment scheme, funded by the government and the drug manufacturer, should be set up to make payments to those affected, according to their need. A redress agency should be set up by the government from which those who have suffered avoidable harm can claim compensation. Litigation (claiming compensation through the courts) is still an available option.

What is Fetal Anti-Convulsant Syndrome (FACS)

Fetal Anti-Convulsant Syndrome (FACS) is a serious condition in which a baby suffers physical and/or developmental disability from his mother taking sodium valproate medication in pregnancy.

Babies who are exposed to valproate drugs, such as Epilim and Epival, have up to 40% risk of injuries which range from minor physical malformations to severe disability from spina bifida, organ defects, learning disability and autism.

Prescription of sodium valproate drugs to women of childbearing age is currently banned in most circumstances, owing to the high risk of serious injury to the unborn baby. In exceptional circumstances where no other treatment is available to the woman, hospital doctors, GPs and pharmacists must comply with strict rules for warning the woman of the serious risks of pregnancy and protecting her from pregnancy whilst she is taking the drug.

Where 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 substantial compensation for their injury.

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What types of injury are caused to babies by negligent valproate prescription in pregnancy?

Negligent prescription of valproate to a woman before or during pregnancy can cause severe injuries to her unborn baby, including:

  • minor malformations, (for example, such as small fingers and toes);
  • major malformations:
    • spinal malformations (for example, spina bifida);
    • face and skull malformations, (for example, cleft palate)
    • malformed limbs;
    • malformation of the organs, (for example, the heart, kidneys and sexual organs);
       
  • learning and developmental disability, such as:
    • fetal valproate syndrome, fetal anti-convulsant syndrome (FACS), or fetal valproate spectrum disorder;
    • delayed walking and talking;
    • problems with speech and language;
    • memory problems;
    • low intelligence for their age;
    • autism spectrum disorder (ASD).
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What type of negligence can lead to a valproate injury claim?

Claims for compensation may arise where a baby was seriously injured from being exposed to valproate after:

  • a GP or hospital doctor prescribed valproate:
    • to a pregnant woman;
    • to a woman of childbearing age who was not using contraception;
    • without properly warning the woman of the risks of taking valproate in pregnancy;
    • without checking that the woman understood the risks of valproate in pregnancy;
    • without first ruling out all alternative effective treatments;
    • without ensuring that the woman is regularly reviewed by a specialist;
       
  • a pharmacist dispensed valproate:
    • to a pregnant woman;
    • to a woman of childbearing age who was not using contraception;
    • without properly warning the woman of the risks of taking valproate in pregnancy;
    • without correctly labelling the packaging in accordance with the guidelines.
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What compensation can be claimed for valproate injury?

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:

  • pain, suffering and disability;
  • costs of care;
  • case management;
  • therapies;
  • specialist aids and equipment;
  • prosthetics;
  • home adaptations;
  • medical treatment;
  • special educational needs;
  • loss of earnings;
  • psychological counselling;
  • additional costs of holidays and other activities.

Boyes Turner’s experienced birth injury lawyers can help

Boyes Turner’s experienced birth injury lawyers have helped countless children recover their full entitlement to compensation for serious disability caused by negligent medical treatment. We understand the devastating impact that a child’s severe disability has upon the child and their family. Where that disability was caused by medical mistakes our focussed approach enables us to secure early interim payments, so that whilst we work towards valuation of the claim and eventual settlement, the family can begin meeting the child’s needs straight away.

What is the Independent Medicines and Medical Devices Safety Review (IMMDS)?

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 aim of the  IMMDS review is to examine all the evidence surrounding the use of valproate. This is expected to include:

  • what was known about sodium valproate;
  • what decisions/actions were taken by the drug’s manufacturers, regulators, medical clinicians and policy makers;
  • whether informed consent was taken from patients;
  • whether there has been a satisfactory response to patients’ and other campaigners’ safety concerns;
  • the licensing of valproate and use of the drug for women of childbearing age having regard to the known association with harm to the unborn baby/fetus (teratogenicity);
  • how the knowledge of valproate’s harmful effect on the unborn baby was/should have been communicated between the drug’s manufacturers, regulators, health practitioners and patients, and what action was taken.  

The IMMDS review will also:

  • set out clearly the characteristics and implications of fetal valproate spectrum disorders (such as FACS) so that those who have been affected by sodium valproate are diagnosed correctly and their needs are assessed properly;
  • make recommendations for further action.

The review is intended to be completely independent from the government, the DHSC, the NHS, the pharmaceutical industry, and other regulatory bodies. Baroness Julia Cumberlege leads the review. Its report is due to be published in July 2020.

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Susan Brown

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Richard Money-Kyrle

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Julie Marsh

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Vanessa Wand

Senior associate - solicitor

Nicola Anderson

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Rachel Makore

Associate - solicitor

Alpa Rana

Associate - solicitor

Fran Rothwell

Associate solicitor

Sita Soni

Associate - solicitor

Tara Byrne

Solicitor

Ben Ireland

Solicitor

Audrey Elmore

Medical records coordinator

Nicky Melville

Professional support assistant

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