British ministers are facing a backlash after families affected by the hormone pregnancy test Primodos were excluded from a review into compensation for victims of health scandals.
A report from the Patient Safety Commissioner says there is a “clear case for redress” for thousands of women and children affected by epilepsy treatment with sodium valproate and vaginal mesh implants.
The commissioner, Dr Henrietta Hughes, wanted to include in her review patients who had suffered avoidable harm as a result of hormonal pregnancy tests, including Primodos, but was told by the Department of Health and Social Care (DHSC) that they would not be included.
Marie Lyon, chair of the Association For Children Damaged by Hormone Pregnancy Tests, said families who took hormone pregnancy tests between 1958 and 1978 felt “betrayed”.
She said many were never told about the risks of Primodos and were told by their GP to take the drug – which is 40 times as strong as an oral contraceptive pill – to find out whether or not they were pregnant.
Hormone pregnancy tests were taken off the market in the late 1970s, and manufacturers faced claims that such tests led to a number of adverse outcomes, including birth defects and miscarriages.
Lyon said families felt like they were “left out in the cold”, adding: “I feel betrayed by the Patient Safety Commissioner, by the IMMDS (Independent Medicines and Medical Devices Safety Review) review and by the Secretary of State of Public Health – all three of them betrayed our families, because they basically just forgot about us. It’s a case of ‘it’s too hard, so we’ll just focus on valproate and mesh’.”
Labor MP Yasmin Qureshi, a long-time campaigner on the issue, said: “It is deeply disappointing that the Government has ensured that families affected by Primodos are left out of this report.
“Many of those who would benefit from compensation are on borrowed time, they don’t have the luxury of waiting for the government to do the right thing. They urgently need financial support.”
The new report from the Patient Safety Commissioner states: “Our terms of reference did not include the issue of hormonal pregnancy tests. This was a decision taken by the DHSC and should not be interpreted as reflecting the Commissioner’s view on the avoidable harm suffered in relation to hormonal pregnancy testing or the action required to address it.
“The Patient Safety Commissioner wanted them included in the scope but nevertheless agreed to take on the work as defined by DHSC ministers.”
A group of 172 plaintiffs tried to take legal action against the makers of Primodos and the government in an attempt to obtain compensation, but their claims were dismissed by a high court last year.
The report highlights how thousands of women’s lives have been “destroyed” by pelvic mesh, and thousands of children will “never be able to lead independent lives” after being exposed to sodium valproate.
Treatment of epilepsy Sodium valproate has been linked to physical deformities, autism and developmental delay in some children when taken by their mothers during pregnancy.
Vaginal mesh implants have been used to treat urinary and gynecological conditions but have caused disabling damage in some women.
The report says that “there is a clear case for redress based on systemic healthcare and regulatory failures” for women and children affected by the problems in England.
It says the government should create a two-stage financial recovery scheme: an interim scheme and a main scheme.
An interim award of £25,000 was the “average amount that patients said would be appropriate”, the commissioner said.
This would be followed by a master schedule of payouts based on each patient’s individual needs.
Hughes said: “My report could not be clearer – the case for redress has been made. It highlights in detail the everyday issues that impact those who have been harmed, who have seen their lives destroyed by pelvic networks, and the children who will never be able to lead independent lives.”
Kath Sansom, founder of the Sling The Mesh campaign group, said: “While we are pleased that this report confirms the suffering of thousands of women, many who have lost their jobs, pensions, homes and partners and are living in constant pain, there are also with regard to its elements.
“Most notably, the initial figure of £25,000 for mesh is disappointingly low. We hope that payments in the second phase for women directly affected will compensate for this. All of the women who suffered damage from pelvic mesh relied on undergoing gold standard surgery, with little to no warning from the surgeon of the risks, and as a result experienced irreversible, life-changing complications.
“Many were then gaslighted for years and told, as in the Post Office scandal, that they were the only ones suffering, leaving them to suffer in silence.
“Finally, our thoughts go out to the Primodos families who have been campaigning since the 1960s and 1970s and who have no positive news at all on financial recovery in this report.”
CEO of the Epilepsy Society, added: “The recommendations in the Hughes report are frank, honest and long overdue.”