“The Independent Medicines and Medical Devices Safety Review” led by Baroness Cumberlege, commonly known as the Cumberlege Review, has issued a long-awaited report on 8 July 2020.
IBB Solicitors represents a number of families who have been left devastated by the apparent harmful side-effects of Sodium Valproate, a medication usually prescribed to treat epilepsy and bipolar disorder. It has been suspected for decades that Sodium Valproate was causing developmental problems and birth defects in newly born children. It was also closely associated with autism. Despite the concern of patients, Sodium Valproate was continuing to be regularly prescribed to pregnant women until 2018.
Why was the Cumberlege Review started?
The level of concern reached a point in 2018 that led to Jeremy Hunt, then Secretary of State for Health, to initiate a review into the suspected harmful side effects of three forms of treatment used by the NHS, including Sodium Valproate. The other two treatments were Primidos, a hormone-based pregnancy test, and vaginal mesh implants.
One of the key aims of the Cumberlege Review in relation to Sodium Valproate was to investigate what was known about the side effects of the drug while it was being prescribed to pregnant mothers, and what steps were taken (and should have been taken) in light of the known scientific information. The Review has also looked at the role played by the pharmaceutical manufacturers and those licenced to sell the Sodium Valproate, together with the actions of the regulatory authorities, government, healthcare providers and clinicians. The fundamental question considered in respect of all these parties is whether appropriate action could have been taken sooner and why concerns were not promptly acted upon.
The Review has also looked at whether patients using Sodium Valproate were being properly informed about the known risks and benefits of continuing on the medication during pregnancy to enable them to make an informed decision on whether to continue taking it.
What was the outcome of the Review?
Following more than two years of speaking to affected patients and gathering medical evidence, the Cumberlege Review has resulted in a report that will make for very uncomfortable reading for the health services and those responsible for the healthcare service.
In her letter attached to the report, addressed to the Secretary of State for Health, Baroness Cumberlege states:
“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.
“The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities. We met with people, more often than not women, whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel as the result of Primodos, sodium valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better.
What are the report’s main recommendations?
Baroness Cumberlege concludes that there was a failure on the part of the health system over many years to respond to the concerns expressed by patients. In response she has made 9 major recommendations. They are:
- That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
- Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
- A Redress Agency for those harmed by medicines and medical devices in future should be established.
- The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
- The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
- That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
- That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
- Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.
What next for those affected by Sodium Valproate?
Since April 2018, Sodium Valproate has not been prescribed to women of childbearing potential unless they are on a pregnancy prevention plan. However, there are many families left devastated by the side-effects of Sodium Valproate and understandably some have sought legal representation with a view to seeking compensation for the harm caused to their child. The Cumberlege Review does recommend the setting up of a Scheme to meet costs of care and support for those who have been avoidably harmed. It is too early to assess the extent of this Scheme and whether it will meet all the financial consequences suffered by families as a result of the complex medical conditions now suffered unnecessarily as a result of Sodium Valproate.
In December 2020, the media reported that the Government was now prepared to contemplate the appointment of an Independent Patients Commissioner to act as a champion for those affected by sodium valproate. This is the second of the nine recommendations proposed by Baroness Cumberlege that has been addressed by the government, following the governments apology in July 2020 on behalf of the healthcare system to the patients and families affected.
Baroness Cumberlege has welcomed this development but is quoted in the press as saying “Had there been a patient safety commissioner before now, much of the suffering we have witnessed could have been avoided.”
The latest government update on the government’s response to Baroness Cumberlege’s report was published on 11 January 2021 by Nadine Dorries, the Minister for Patient Safety, Suicide Prevention and Mental Health. The update included confirmation that the government is intending to amend the Medicines and Medical Devices Bill to establish the role of an independent Patient Safety Commissioner. The government has stated that “The commissioner will act as an independent advocate for patients, and strengthen the ability of our health services to listen to the voice of patients”.
Disappointingly, the government update provides no further insight into their thinking on the recommendation by Baroness Cumberlege to set up a redress scheme for those affatced by for sodium valproate. The update simply states that this recommendation remains under consideration.
Speak to our clinical negligence experts today
IBB Law’s team of expert clinical negligence solicitors are already representing many families in relation to the wrongful prescribing of Sodium Valproate. We offer No Win, No Fee representation for our clients, meaning no matter your financial situation, we can help you secure the access to the expert legal advice you need.
If you or your family have been effected by Sodium Valproate and would like to discuss whether you may be entitled to compensation, without any commitment or cost, call 0333 123 9099, email firstname.lastname@example.org or use the enquiry form to request a call back.