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Written on 20th January 2021 by Susan Brown

In a recent update to Parliament on the government’s response to the recommendations of the Cumberlege Review, the Minister for Patient Safety, Suicide Prevention and Mental Health, Nadine Dorries, confirmed that the government has no plans to set up an independent redress agency. In July 2020, the Cumberlege Review called for an independent redress agency to provide a way of compensating those harmed by valproate (and other medicines and medical devices) without the need for litigation. The government’s update currently provides no alternative means of financial redress for injured victims of negligent valproate treatment. Those with serious injury who are entitled to compensation should seek specialist legal advice about making a claim.

Boyes Turner’s clinical negligence team are already helping families claim the compensation they deserve after their children suffered severe physical and neurological disability from valproate as a result of negligent medical care. 

The government’s response to the IMMDS Review’s recommendations

In 2020 the IMMDS (Independent Medicines and Medical Devices Safety) Review, chaired by Baroness Julia Cumberlege, reviewed three controversial treatments, including the use of sodium valproate in pregnancy. Its report, First Do No Harm, condemned the healthcare system’s treatment of women who were prescribed the drug, which was known to cause severe physical and neurological injury to unborn babies. It is estimated that over 20,000 babies suffered harm as a result of exposure to the drug during their mother’s pregnancy.

In her recent update to Parliament, Mrs Dorries set out the government’s response so far to the Review’s recommendations. In relation to valproate, this included:

  • that the government had immediately made an unreserved apology on behalf of the healthcare system to the affected women, children and their families, for the time the system had taken to listen and respond to their concerns; 
  • a statutory Patient Safety Commissioner is to be appointed to promote patient safety and act as an independent advocate for patients;
  • the Medicines and Healthcare products Regulatory Agency (MHRA), is working to improve its engagement with patients, reform systems for reporting adverse incidents with medicines and medical devices, and strengthen the evidence base for its regulatory decisions;
  • a Valproate Safety Implementation Group will work on reducing harm from valproate by:
    • taking action to reduce the number of women prescribed valproate;
    • improving patient safety for women for whom there is no alternative medication, such as by increasing adherence to the Valproate Pregnancy Prevention Programme, which mandates that every girl or woman:
      • knows about the risks of valproate in pregnancy;
      • is on effective contraception, if appropriate;
      • and has a specialist review at least once a year at which she and her specialist prescriber discuss and both sign a risk acknowledgement form. 
    • working with patients to understand how women can be supported to make informed decisions about their health care.
  • a new Valproate Registry is being developed which will help monitor adherence to the Valproate Pregnancy Prevention Programme and allow for long-term, individual patient follow up.

However, the government made clear that it has no current plans to establish an independent redress agency. Redress schemes for valproate (and the other treatments) ‘remain under consideration’.

Can I claim compensation for injuries caused by valproate exposure in pregnancy?

The government’s refusal to set up a redress agency for valproate victims has not affected their existing right to claim compensation for injuries suffered from valproate exposure as a result of negligent medical care. Our experienced clinical negligence team are already helping families whose children have suffered negligent valproate injury to claim the compensation they deserve.

We can help clients recover compensation as long as we can prove that our client’s injuries arose from valproate exposure during their mother’s pregnancy as a result of negligent GP or hospital advice or medical care.  Compensation can help pay for essential care, specialist equipment, therapies and medical treatment, home adaptations and special educational support arising from the child’s disability. It also provides the family with the peace of mind that comes from knowing that money will be available to ensure their disabled child’s long-term needs are met.

If you or a member of your family have suffered serious injury as a result of valproate negligence and you would like to find out more about making a claim, contact us by email on