The Patient Safety Commissioner (PSC), Dr Henrietta Hughes OBE, has called for urgent action by the government to provide redress to meet the needs of thousands of children and families who suffered avoidable harm from the epilepsy drug, sodium valproate. The Hughes Report sets out her findings from her review and makes recommendations for redress for those harmed by valproate and pelvic mesh. In this update we focus on the recommendations which relate to those injured by sodium valproate. Unborn babies who are exposed to their mother’s valproate anti-epileptic medication in pregnancy are known to have a high risk of congenital malformations (11%) and neurodevelopmental disorders (30 to 40%), which can lead to permanent disability. For decades, women have been prescribed sodium valproate to help control their symptoms of epilepsy, too often without being made fully aware of the risks during pregnancy to their unborn child. The Patient Safety Commissioner’s report challenges the government to heed the warning that Dr Hughes gave them when she agreed to carry out this review, against causing further harm by “putting patients through an emotional rollercoaster by raising their expectations, only to see them dashed again with further delays in agreeing to implement a redress scheme”. She emphasises the immense suffering and challenges faced by these patients and warns that confidence in the government to do the right thing is eroding. She says the government now has a responsibility to provide a restorative redress scheme to begin the process of putting right what has gone wrong. Why is the Patient Safety Commissioner calling for redress for valproate injury? The first Patient Safety Commissioner (PSC), Dr Henrietta Hughes OBE, was appointed in September 2022 to promote patients’ safety and their views in relation to medicines and medical devices in England. The PSC is a new role which was created in response to the recommendations of Baroness Cumberlege’s review and First Do No Harm report into the healthcare system’s appalling response to the harm caused to women and their children from the epilepsy drug sodium valproate, as well as two other treatments (pelvic mesh and Primodos). The PSC’s report concludes that valproate-harmed patients have a clear case for redress based on the systemic healthcare and regulatory failures that were revealed by the First Do No Harm review in 2020, which had been commissioned by the government in February 2018. Following publication of the First Do No Harm report in July 2020, the government apologised to those who had been harmed by these failings, saying “we need to take action”. The PSC points out that any genuine and meaningful apology must involve regret, responsibility, redress and reform. Instead, the government’s apology was generic and appeared forced and was followed by repeated rejections of the review’s recommendation for a Redress Agency. This increased rather than reduced the harm that was suffered by valproate-injured patients. The PSC believes that for this apology to become meaningful to patients, any government ‘action’ must include taking action to provide valproate victims with redress. Dr Hughes’ report defines redress as a scheme of financial and non-financial support designed to help meet the needs of harmed patients. The PSC is calling for flexible, holistic redress which understands and addresses the substantive, procedural and psychological needs of harmed patients, made on an ex-gratia basis which does not depend on apportioning blame or liability. PSC says not enough action has been taken for valproate-injured patients The PSC’s report acknowledges that various actions have been taken since the criticisms raised by the First Do No Harm review, but remains concerned about lack of progress and lack of redress. The Medicines and Healthcare products Regulatory Agency (MHRA) and NHS Digital have developed a national Medicines in Pregnancy Registry to track valproate use in girls and women up to the age of 54 in England since April 2018. This has shown that 18,235 female patients in this age group were prescribed valproate in the month of March 2023, (down 33% from 27,441 in April 2018) but 315 women were prescribed valproate during their pregnancy, including 30 who were prescribed valproate for the first time in pregnancy, having never taken it before. The PSC expressed concern about whether these women were given sufficient information to provide informed consent, given the risks of serious injury from valproate to their unborn baby. Failure to provide women with sufficient information to make an informed decision about whether to take valproate was one of the key failures identified by the First Do No Harm review. All girls and women of childbearing potential who are prescribed valproate must be managed with a Pregnancy Prevention Programme (PPP), but the August 2022 valproate audit showed mixed compliance. Of the 12,068 patients who took part in the audit: 5.6% were not given correct advice and information about the potential impact of valproate on an unborn child; 10.6% did not have the patient guide information booklet; 11.1% did not have the patient card; and only 73.3% had discussed their valproate medication and the need for effective contraception with a GP or specialist in the last 12 months. In December 2022, MHRA acknowledged that safety requirements were not being followed consistently. In November 2023, the MHRA published a National Patient Safety Alert setting out the Independent Commission on Human Medicines’ advice on additional measures required to reduce the serious harms from valproate. The healthcare system across the UK was asked to develop an action and improvement plan to implement these measures by 31 January 2024. In addition, PSC reports that she has heard and seen evidence of ongoing issues, including: women being starting on valproate when already pregnant; patients not receiving full information about the risks of valproate to the unborn baby; the Annual Risk Acknowledgement Form omitting the type of contraception used or simply being sent to patients by post with a stamped addressed envelope, resulting in only 50% returned; lack of staff who are trained to advise and fit highly effective contraception in specialist hospital clinics, with patients being directed to make their own contraceptive arrangements via their GP or community contraception clinics; inconsistencies between NHS England’s and MHRA’s definition of ‘highly effective’ contraception for women on valproate; lack of communication between contraceptive clinics, GPs, hospitals or community pharmacists about the patient’s anti-epileptic medication or contraception; patients not having annual reviews or being lost to follow-up by their neurologist or psychiatrist; 70-week-long waits for a neurology appointments, which are needed for annual reviews and completion of Annual Risk Acknowledgement Forms for patients taking valproate. Understanding the cost of harm from valproate injury The Hughes Report highlights the personal impact of physical and neurological disability from valproate, as well as the wider emotional, educational, vocational and financial effects. Valproate injury can cause learning disability, ASD/ADHD, problems with mental health, memory, speech and language, and family and social relationships. Physical disability from valproate injury can include conditions such as scoliosis (abnormal curvature of the spine), abnormal development of feet and ears (including deafness), and severely reduced mobility. Many valproate-injured children will need round-the-clock care for the rest of their lives. This represents a double disability for the child’s mother, whose ability to care for her children may be affected by her own epilepsy or bipolar disorder, which she must manage alongside the disability suffered by her child. In addition, PSC pointed to Office of Health Economics/Epilepsy Society research which estimates the financial cost per case of harm (to the family, the NHS, the education system, the welfare system and wider society) as ranging from £2.5 million in severe cases of Autism Spectrum Disorder (ASD), £927,000 for spina bifida and £124,000 for a child born with Attention Deficit Hyperactivity Disorder (ADHD). PSC says NHS Resolution’s valproate claims gateway does not provide adequate redress The PSC dismisses the government’s suggestion that NHS Resolution’s claims gateway process provides an adequate alternative means to redress for children and families affected by valproate injury. Dr Hughes refers to government figures suggesting that 16 claims had been made directly to NHS Resolution via the valproate and pelvic mesh gateways, but, as at April 2023, no compensation had been paid. Whilst acknowledging the information provided to patients without access to legal representation she stated: “…we think that the term ‘claims gateway’ is misleading. It suggests that the government has created new, easier legal frameworks or routes to litigation. This is not the case, as the government itself acknowledges.” In addition, she notes that “NHS Resolution is not independent from the claims that it is assessing.” She concludes that it is inappropriate for the government to point to this work as an example of how it is progressing the cause of redress for patients as it completely overlooks the experiences of patients who have struggled with traditional adversarial legal processes. She says that NHS Resolution’s gateways do not provide a substantial change nor benefit to those seeking to bring claims. We expressed our own serious concerns about the misleading nature of NHS Resolution’s valproate claims gateway process in our previous article. Recommendations from the Hughes Report The Patient Safety Commissioner makes recommendations in her report which, if implemented, could begin to provide redress for thousands of families affected by avoidable harm from sodium valproate. Her recommendations reiterate that the government has a responsibility to create a redress scheme which provides financial and non-financial redress for those harmed by valproate. In addition to financial redress, the PSC recommends that all valproate-injured patients should have access to non-financial redress, such as signposting and help with access to public services, housing, healthcare needs, education, welfare benefits, along with individual apologies and answering previously unaddressed questions. She recommends that the government creates a two-stage financial redress scheme. Starting in 2025 an Interim Scheme should make initial, fixed sum interim payments to patients who have been directly harmed by valproate exposure during their mother’s pregnancy. This will acknowledge the avoidable harm they have suffered as a result of system-wide healthcare and regulatory failures and also enable the government to identify the number of people harmed, which remains unclear owing to a lack of healthcare data. The Cumberlege Review estimated that 20,000 people may have been avoidably injured as a result of valproate exposure. The PSC said that valproate-injured families had indicated that Interim Scheme payments should be in the range of £100,000 (median average) to £340,907 (mean average), representing redress for past harm that they had suffered. The Interim Scheme would be followed by a Main Scheme which would provide personalised financial support to patients who have been directly harmed by valproate, based on their individual circumstances, as well as to family members who had been indirectly harmed by the child’s valproate injury. Government would need to decide on the types of losses that would be compensated and how to quantify those losses. The PSC noted that a tariff redress scheme would pay out less than a court would award to a successful claimant in a traditional medical negligence claim but would provide an easier, less stressful and non-adversarial route for patients. She suggested that redress via the Main Scheme could be paid fully as a lump sum or over time in periodic payments to meet ongoing needs. She made it clear that redress scheme payments must not affect patients’ entitlement to social security benefits. The PSC emphasised the importance of both the Interim and Main Schemes being non-adversarial, straightforward and accessible for patients. To achieve this, she recommended that a ‘presumption of truth’ should be applied during eligibility assessments, preserving the patient’s dignity and for ease of proof. She recommended that both schemes should be administered by an independent body which has the confidence of patients. On that basis she ruled out the Department of Health and Social Care (DHSC) or any organisation that it sponsors, the NHS, or NHS Resolution which defends claims against the NHS and has an inherent conflict of interest. Patients with neurodevelopmental disorders from Fetal Valproate Spectrum Disorder (FVSD) often lack mental capacity to make their own claim. Dr Hughes advised that the government would need to ensure that provision was made for the necessary involvement and costs of Court of Protection deputyship through the schemes. The PSC recommended that the government must ensure that the Interim and Main Schemes are launched alongside a national awareness campaign to reach all eligible valproate-injured patients, including those from marginalised and disadvantaged groups. In her words, “a redress scheme is only worthwhile if people actually know about it.” If you or a family member have suffered severe injury as a result of medical negligence or have been contacted by HSSIB/MNSI or NHS Resolution you can talk to a solicitor, free and confidentially, for advice about how to respond or make a claim by contacting us.
