Reflections on The Hughes Report: Pelvic mesh, sodium valproate, hormone pregnancy tests and options for redress (a blog from Patient Safety Learning)

Summary

On the 7 February 2024, the Patient Safety Commissioner for England published a report considering options for redress for those who have been harmed by two of the interventions covered by the Independent Medicines and Medical Devices Safety Review: sodium valproate and pelvic mesh. In this blog, Patient Safety Learning sets out the background to this report, outlines responses from patient groups and campaigners, and reflects on how this work will be taken forward.

Content

The Independent Medicines and Medical Devices Safety (IMMDS) Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests (HPTs), sodium valproate and pelvic mesh.

Published in July 2020, the IMMDS Review’s report, First Do No Harm, outlined how these interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades. It made nine recommendations as part of this, two of which specifically concerned redress options for patients:

“Recommendation 3: A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

Recommendation 4: Separate schemes should be set up for each intervention – HPTs, 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.”[1]

In its initial response to the report, the Government rejected both these recommendations. Considering the proposal to create a new independent Redress Agency, they stated that this was not necessary as the Government could already establish redress schemes without this, and said that they did not believe that this “would necessarily make products safer or drive the right incentives for industry”.[2] On the recommendation to establish separate redress schemes for the three medical interventions, their response pointed towards patients instead having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability.

Despite this response, patients and family members harmed by these medical interventions have continued to tirelessly campaign for appropriate redress.[3-6] In a change of approach last year, the Minister for Mental Health and the Women’s Health Strategy, Maria Caulfield MP, signalled that the Government would now be willing to look again at the issue of redress.[7] Subsequently she commissioned the Patient Safety Commissioner for England, Dr Henrietta Hughes, to explore redress options for those who have been harmed by two of the interventions covered by the IMMDS Review: sodium valproate and pelvic mesh.[8]

The Hughes Report

The outcome of this work by the Patient Safety Commissioner was a new report published on the 7 February 2024 on options for redress for those harmed by pelvic mesh and sodium valproate. In this, the Commissioner argues that there is a clear case for redress and makes ten recommendations on how the Government should approach this.

At the core of these recommendations is a proposal to create a two-stage financial redress scheme, comprised an Interim Scheme and a Main Scheme. The report summarises this as follows:

“The Interim Scheme will be easily accessible for claimants and will result in the award of an interim payment to those directly harmed. The purpose of the Interim Scheme is to offer patients an initial, fixed sum in recognition of the avoidable harm they have suffered as a result of system-wide healthcare and regulatory failures.

The Main Scheme will involve an individualised approach with more stringent evidential requirements that will require time to develop. Payments from the Main Scheme should be more comprehensive and designed to help meet the needs of those who have been harmed. There should also be scope within the Main Scheme to award redress to those indirectly harmed, which is another issue that requires careful consideration. The purpose of the Main Scheme is to recognise that the system-wide healthcare and regulatory failures caused different levels of harm to each patient.”[9]

The Patient Safety Commissioner also suggests that an amount of £25,000 should be paid via the Interim Scheme, which is the median figure from the survey she undertook asking patients about how much an interim payment should be. The report also states that the Interim Scheme “should be able to make payments to patients in 2025, so they do not have to wait long for some financial support”.[9]

Responses from patient groups and campaigners

One of the groups present at the launch of The Hughes Report in Parliament was INFACT (Independent Fetal Anti-Convulsant Trust). They are a charity whose purpose is to give relief and assistance to all persons whose disabilities were caused by the fact that their mother took an anticonvulsant drug (such as sodium valproate) during pregnancy to treat her condition. Responding to the report, Emma Murphy, Co-Founder of INFACT, told us:

“The report itself is very thorough and detailed and we can see a lot of thought has been put into it and we are pleased with her supporting the families calls for Redress. It is a huge step forward. 

The report outlines a number of options and ways the Government could now implement redress but this does mean our families are again having to wait for the Government to decide what to do. 

INFACT strongly urge the Government to act upon this report that they requested and deliver justice to Britain’s Valproate Children just like they did with Thalidomide babies.” 

Also present at the Parliamentary launch event was Sling the Mesh, a patient-led group which helps support people harmed by mesh implants. Speaking to us about the report’s recommendations, Sling the Mesh founder Kath Sansom said:

“While we are pleased that this report validates the suffering of thousands of women many who have lost jobs, pensions, homes, partners, and live in constant pain, there are also concerning elements to it. Most notably, the initial sum of £20,000 to £25,000 for mesh is disappointingly low. We hope second stage payments for women directly harmed will compensate for that and our members will not have to jump through hoops to receive it. 

All women harmed by pelvic mesh trusted they were having a gold standard surgery, with little to no warning of risks from their surgeon, and as a result experienced irreversible, life altering complications. Many were then gaslit and deceived for years, and, just like the Post Office scandal, told they were the only one suffering, forcing them to suffer in silence.”

You can read Sling the Mesh’s full response to this report here.

Our reflections

Patient Safety Learning believes, like many individual patients and patient groups, that there must be redress options for patients harmed by the interventions covered by the IMMDS Review. There is considerable evidence that for many patients the clinical negligence route is simply not viable and, in the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need.

We therefore broadly welcome and support the recommendations in the Patient Safety Commissioner’s report. Given we are now over three and half years on from redress schemes first being recommended by the IMMDS Review, it is vital that the Government responds to this report promptly and begin implementing its recommendations with urgency.

Considering how this will be taken forward, we believe that careful thought needs to be given to the following issues:

• How to ensure the equitable treatment of patients harmed by sodium valproate and pelvic mesh across the United Kingdom. While the Patient Safety Commissioner’s remit is limited to England, there are obviously many patients and families also affected by these issues in Scotland, Northern Ireland and Wales who have an equally strong case for redress.
• Appointing an appropriate administrator of these redress schemes that has the confidence of patients. As The Hughes Report makes clear, there would be significant patient concerns if this task was assigned either to the Department of Health and Social Care (DHSC) itself or an existing arm’s length body.
• What can be done to make the Main Scheme as simple as possible for patients and family members. Many of those harmed by sodium valproate and pelvic mesh have been fighting for justice and recognition for many years and should not now have to face a complex and difficult to navigate system for redress.

Sling the Mesh have highlighted with us some specific points around the eligibility criteria for the proposed schemes that will also need to be addressed:

• Whether those who have had a successful medical negligence claim will be able to access redress, either as part of the Initial Scheme or the Main Scheme.
• How eligibility for pelvic mesh payments will be determined for the Initial Scheme, or whether this will apply to simply to all patients who have had a pelvic mesh implant.
• Questions around the fairness of the proposed cut-off date for trans-vaginally inserted mesh for the treatment of stress urinary incontinence (SUI). It is proposed in the report that this should be 11 July 2018 after which all SUI mesh inserted “should have been under a high vigilance regime”.[9] This would rule out a small but not insignificant number of harmed patients from access to redress.
• Providing clarity concerning the cut-off dates relating to trans-abdominally inserted pelvic mesh for pelvic organ prolapse. In the report this is left open for a decision by the Government, with multiple options being presented.

Sling the Mesh have also told us of their concerns relating to how individuals will be assessed, and funding determined for the Main Scheme. Patients have lived for many years with the denial that mesh has caused harm. Assessment processes could potentially present significant difficulties if patients are required to prove pain and harm caused because of implanted mesh, such as evidencing complex conditions such a fibromyalgia and chronic pain.

The IMMDS Review evidenced many patients having their concerns and symptoms ignored and dismissed. It is vital that any assessment processes for redress do not replicate and compound this harm.

Hormone pregnancy tests

Despite welcome recommendations regarding redress for patients harmed by sodium valproate and pelvic mesh, the glaring omission in this process is the absence of any consideration of patients and family members affected by hormone pregnancy tests. Explaining the reason for this in her report, the Patient Safety Commissioner states that:

“Our terms of reference did not include the issue of hormone pregnancy tests. This was a decision taken by DHSC and should not be interpreted as representing the views of the Commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this. The Patient Safety Commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.”[9]

Commenting on this exclusion of hormone pregnancy tests from this process, the DHSC have said that “the government's position remains that the available evidence does not support a causal association between the use of hormone pregnancy tests and adverse outcomes in pregnancy”.[10]

Patient Safety Learning does not believe that the decision to exclude patients and family members affected by hormone pregnancy tests from redress considerations is acceptable or sustainable. It is also not in keeping with the spirit of the IMMDS Review’s recommendations, which made clear the strong case for redress even in light of questions around causal association, stating:

“In the case of hormone pregnancy tests, casual association has not been established, however in view of the stress, anxiety, psychological harm, and toll of fighting for recognition, we feel that it would be appropriate for a discretionary scheme to be set up to provide redress.”[1]

Response from patient campaigners

We approached Marie Lyon, Chair of the Association for Children Damaged by Hormone Pregnancy Tests, for their views on the decision to omit hormone pregnancy tests from this process, who said:

“The Patient Safety Commissioner (PSC) betrayed our families by accepting the dictates of the DHSC and excluding our families from discussions. The PSC failed to contact even one of our families to ensure their patient safety needs had been met. Instead, our families have had to take sole responsibility for the safety of their children, whilst meeting the burden of costs for medication and medical equipment necessary to prevent physical and mental health deterioration.

We were also betrayed by the IMMDS Review who failed to add their voice in support of our inclusion. The IMMDS update report published in 2023 contained not one mention of our Primodos families and the ongoing financial and physical stress they have had to deal with for over 5 decades. It seemed to have been forgotten that former Prime Minister Theresa May commissioned the IMMDS Review specifically to review historical evidence of harm for Primodos families.

The final betrayal is by the Secretary of State for Health who has failed to honour the recommendation for Redress, documented in the Government ordered IMMDS Review. However, the Secretary of State did not fail to demand our families sign a legal document agreeing never to initiate further legal action or face a penalty of £10 million pounds plus in costs which would be enforced by the Courts.

All three have betrayed our families for expediency and a public pat on the back for how generous they were being. This is not accepting responsibility for avoidable harm; it is taking the easy way out by focussing on Valproate and Mesh where they are unable to refute a causal association to avoid Redress.”

You can read more about the work being done by the Association for Children Damaged by Hormone Pregnancy Tests to fight for justice and improve patient safety in the below articles:

• Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests
• Wellcome Collection: Primodos, paternalism and the fight to be heard
• Primodos 2023: Fighting Against the Odds - A Denied Opportunity for Justice (Sharon Hartles) 

Your views

Are you a patient or family member who has been affected by harm from hormone pregnancy tests, sodium valproate and pelvic mesh implants? We would welcome your views on issues discussed in this blog, please do comment below (you will need to be a hub member to comment; it's free and easy to register) or contact us directly at content@pslhub.org.

References

1. The IMMDS Review, First Do No Harm, 8 July 2020.
2. DHSC, Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021.
3. Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023.
4. Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.
5. A joint letter to Maria Caulfield MP from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2023.
6. Paula Goss, When will the Government take responsibility and meet the needs of all mesh patients? A blog by Paula Goss, 17 October 2023.
7. Patient Safety Learning, Response to Select Committee report on the IMMDS Review, 20 January 2023.
8. Patient Safety Commissioner for England, PSC Redress Project, Last Accessed 10 January 2024.
9. Patient Safety Commissioner for England, The Hughes Report: options for redress for those harmed by valproate and pelvic mesh, 7 February 2024.
10. BBC News, Primodos victims ‘airbrushed’ from financial help, 8 February 2024.