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News ArticleA study cited at the infected blood inquiry as evidence that the devastating consequences of blood products contaminated with hepatitis could not have been foreseen, misrepresented the results of a trial in making its case, according to the Guardian. Up to 6,520 people are believed to have been infected with hepatitis C through imported factor VIII blood products in the 1970s and 80s, while a further 26,800 are estimated to have been infected with the virus though blood transfusions. About 2,000 people are estimated to have died as a result. The inquiry, which publishes its final report on 20 May, heard that the medical profession considered non-A and non-B hepatitis (later known as hepatitis C) as “relatively benign” at the time, with Pier Mannuccio Mannucci’s 2003 paper, 'Aids, hepatitis and haemophilia in the 1980s: memoirs from an insider', quoted in support of this proposition. Mannucci’s 2003 paper argued that the view held by “the great majority of haemophilia treaters was that the problem of hepatitis was a tolerable one, because the benefits of concentrates seemed to outweigh risks”. In making his argument, Mannucci cited his own work, writing: “A prospective biopsy study was undertaken by me … in 10 haemophiliacs with non-A, non-B chronic hepatitis followed up for more than six years. The study, published in 1982, demonstrated no case of progression towards cirrhosis or haepatocellular carcinoma.” However, the original 1982 report says that there were actually 11–not 10–people included in the study and “one patient with active cirrhosis died of liver failure during the follow-up period”. Who knew what about the risks and when is a key plank of the inquiry. Read full story Source: Guardian, 2 May 2024
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Content ArticleThis systematic review of qualitative evidence aimed to improve understanding of the processes and outcomes of redress and reconciliation following a life-changing event, from the perspectives of individuals experiencing the event and their families. The authors searched six bibliographic databases for primary qualitative evidence exploring the views of individuals who have experienced a life-changing event, and/or their family or carers, of redress or reconciliation processes. This was supplemented with targeted database searches, forward and backward citation chasing and searches of Google Scholar and relevant websites. The review identified three themes identified by patients and families that represent procedural elements required to support a fair and objective process: transparency, person-centred and trustworthy. A further theme identified—restorative justice—is about how a fair process feels to those who have experienced a life-changing event. It highlights the importance of an empathic relationship between the different parties involved in the process and the significance of being able to engage in meaningful action. Theses findings provide insights on how to conduct a fair review into instances of medical harm.
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News ArticleIn 2009, Emma Murphy took a phone call from her sister that changed her life. “At first, I couldn’t make out what she was saying; she was crying so much,” Murphy says. “All I could hear was ‘Epilim’.” This was a brand name for sodium valproate, the medication Murphy had been taking since she was 12 to manage her epilepsy. Her sister explained that a woman, Janet Williams, on the local news had claimed that taking the drug during her pregnancies had harmed her children. She was appealing for other women who might have experienced this to come forward. Murphy found the news segment that evening and watched it. “I was just stunned,” she says. “Watching that, I knew. I knew there and then that my children had been affected.” At that point, Murphy was a mother to five children, all under six, and married to Joe, a taxi driver in Manchester. “My kids are fabulous, all of them, but I’d known for years that something was wrong,” she says. “They weren’t meeting milestones. There was delayed speech, slowness to crawl, not walking. There was a lot of drooling – that was really apparent. They were poorly, with constant infections. I was always at the doctors with one of them." A call between Murphy and Janet Williams was the start of an incredible partnership. It led to the report published this month by England’s patient safety commissioner, Dr Henrietta Hughes, which recommended a compensation scheme for families of children harmed by valproate taken in pregnancy. Hughes has suggested initial payments of £100,000 and described the damage caused by the drug as “a bigger scandal than thalidomide”. It is estimated that 20,000 British children have been exposed to the drug while in the womb. Williams and Murphy have campaigned relentlessly to reach this point. It is by no means the endpoint – even now, an estimated three babies are born each month having been exposed to the drug. Together, the women formed In-Fact (the Independent Fetal Anti Convulsant Trust) to find and support families like theirs. They were instrumental in the creation of an all-party parliamentary group to raise awareness in government. Read full story Source: The Guardian, 22 February 2024
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Content ArticleOn 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.
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Content ArticleThe recent Hughes Report outlined the options for redress for those harmed by valproate and pelvic mesh In this blog, AvMa's Chief Executive, Paul Whiteing, discusses the trade-off of redress schemes.
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News Article
Pelvic mesh compensation disappointingly low, says victim
Patient Safety Learning posted a news article in News
A woman who described the time in her life after a pelvic mesh implant as "soul destroying" said proposed government compensation was "disappointingly low". Claire Cooper, from Uckfield, is one of around 100,000 women across the UK who had transvaginal mesh implants. England's patient safety commissioner suggested compensation could start at around £20,000. Ms Cooper, 49, was originally given the mesh implant as a treatment for incontinence after childbirth. However, after struggling with pain following the operation, Ms Cooper claimed doctors treated her as if she were "psychotic" and "a nuisance". She said her experience was one of being "mocked". "It was just soul destroying," Ms Cooper told BBC Radio Sussex. "I lost my fight because I was met at every turn with resistance so I just lost the ability to advocate for myself." Ms Cooper eventually had surgery to remove the mesh, which she said one doctor compared to "cheese cutting wire". She is still living with chronic pain. Read full story Source: BBC News, 15 February 2024 Further reading on the hub: Doctors shocking comments to women harmed by mesh- Posted
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News ArticleCampaigners have accused the UK government of betraying them after a review of redress for victims of health scandals excluded families who may have been affected by the hormone pregnancy test Primodos. A report published on Wednesday by the patient safety commissioner, Dr Henrietta Hughes, found a “clear case for redress” for thousands of women and children who suffered “avoidable harm” from the epilepsy treatment sodium valproate and from vaginal mesh implants. But despite the commissioner wanting to include families affected by hormone pregnancy tests in her review, the Department of Health and Social Care (DHSC) told her they would not be included. Primodos was an oral hormonal drug used between the 1950s and 70s for regulating menstrual cycles, and as a pregnancy test. Hormone pregnancy tests stopped being sold in the late 1970s and manufacturers have faced claims that such tests led to birth defects and miscarriages. Last year, the high court dismissed a case brought by more than 100 families to seek legal compensation owing to insufficient new evidence. The Hughes report states: “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.” Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, said the families of those who took the tests felt “left out in the cold” and betrayed that they were not included in the commissioner’s review. “I feel betrayed by the patient safety commissioner, by the IMMDS [Independent Medicines and Medical Devices Safety] review and by the secretary of state for health – all three have betrayed our families because, basically, they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’,” Lyon said. Prof Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, who led a systematic review of Primodos in 2018, said: “It’s unclear to me how the commissioner can keep patients safe if they are blocked and don’t have the power to go to areas where patient safety matters.” Read full story Source: The Guardian, 7 February 2024
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News Article
Mesh and sodium valproate scandal victims need payouts soon, report says
Patient Safety Learning posted a news article in News
Families of children left disabled by an epilepsy drug and women injured by pelvic mesh implants should be given urgent financial help, England's patient safety commissioner has said. Dr Henrietta Hughes has called on the government to act quickly to help victims of the two health scandals. It follows a review which found lives had been ruined because concerns about some treatments were not listened to. It is estimated that, since the early 1970s, about 20,000 babies have been born with disabilities after foetal exposure to sodium valproate, which can harm unborn babies if taken in pregnancy. Scientific papers from as early as the 1980s suggested valproate medicines were dangerous to developing babies, yet warnings about the potential effects were not added to some packaging until 2016. Some families affected have been campaigning for decades to raise awareness of the potential effects of the drug, with some calling for compensation and a public inquiry. Dr Hughes was asked by the government to look into a potential compensation scheme for those affected by that scandal, as well as the one involving some 10,000 women who were injured by their pelvic mesh implants - a treatment for pelvic organ prolapse (POP) and incontinence. Read full story Source: BBC News, 7 February 2024- Posted
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Content ArticleIn late 2023, the Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, asked the Patient Safety Commissioner for England to explore redress options for those who have been harmed by pelvic mesh and sodium valproate. This report sets out the outcome of this project and is designed to help the government understand the options available for providing redress to those patients harmed by pelvic mesh and valproate.
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News Article
‘Get on with it’: patient champion demands epilepsy drug redress
Patient Safety Learning posted a news article in News
Ministers must begin paying compensation to the families of children disabled by the epilepsy drug sodium valproate by next year, a report will say this week. The report’s author, Dr Henrietta Hughes, England’s patient safety commissioner, says valproate is “a bigger scandal than thalidomide, in terms of the numbers of people affected”. She will back calls for financial redress for the thousands of children left physically and mentally disabled. Every month, three babies are still being born who have been exposed to the drug. Speaking before the report’s launch, Hughes, 54, a GP, said the state had failed pregnant women by not telling them about key information regarding the drug’s risks. “These families have already been betrayed, because they weren’t given the right information to be able to make decisions to keep themselves and their family safe,” she said. “There are senior politicians of every stripe who have expressed their sincere sympathy and support for patients who have been harmed. I take the view that people who seek high office need to also accept the responsibility that comes with that high office. “The time for redress is now. The government is responsible. I’ve been asked to give them options for redress and I’ve done that. They have the recommendations, they have the advice, they have everything they need. Get on with it.” Read full story (paywalled) Source: The Times, February 2024- Posted
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Content ArticleIn this blog by Sling The Mesh, the author reflects on the recent case of a mother left in debilitating pain and faecally incontinent from vaginal mesh being awarded a record settlement of at least £1 million. She highlights that in reality many cases are thrown out before they get to court, some never get off the ground owing to being out of the legal time frame and many more women don’t even attempt a medical negligence claim as the process feels too stressful, triggering PTSD and anxiety.
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Content ArticlePaula Goss had surgery to implant rectopexy and vaginal meshes which left her with severe pain and other serious complications. In this blog, Paula talks about why she set up Rectopexy Mesh Victims and Support to campaign for adequate treatment, redress and justice for people injured by surgical mesh. She outlines the need for greater awareness of mesh injuries amongst both healthcare professionals and the public and talks about what still needs to be done to enable people to access the treatment and support they need.
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News Article
Blood-inquiry families heckle PM over compensation
Patient Safety Learning posted a news article in News
Rishi Sunak says the government will wait for the Infected Blood Inquiry's final report before responding to questions around victim compensation. Bereaved families heckled the prime minister when he told the inquiry the government would act as "quickly as possible". Mr Sunak told the inquiry people infected and affected by the scandal had "suffered for decades" and he wanted a resolution to "this appalling tragedy". But although policy work was progressing and the government in a position to move quickly, the work had "not been concluded". He indicated there was a range of complicated issues to work through. "If it was a simple matter, no-one would have called for an inquiry," Mr Sunak said. Campaign group Factor 8 said Mr Sunak had offered "neither new information not commitments" to the victims and bereaved families, which felt "like a betrayal". Haemophilia Society chief executive Kate Burt said: "This final delay is demeaning, insulting and immensely damaging. "We urge the prime minister to find the will to do the right thing and finally deliver compensation which recognises the suffering that has been caused." Read full story Source: BBC News, 26 July 2023- Posted
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News ArticleA scheme handing payments to those affected by the contaminated blood scandal will be announced this week, as ministers scramble to help those harmed by the “historic wrong”. Whitehall sources confirmed that a programme handing interim payments will be confirmed in the coming days, once officials have ironed out issues to ensure that victims are not taxed on the payments or have their benefits affected by them. It is thought that ministers accept recent recommendations that infected people and bereaved partners should get “payments of no less than £100,000”. More than 4,000 people are in line for the payment. Kit Malthouse, the cabinet office minister, has been prioritising the scheme in the last week to ensure payments are made as soon as possible. “The infected blood scandal was a tragedy for everyone involved, and the prime minister strongly believes that all those who suffered so terribly as a result of this injustice should receive compensation as quickly as possible,” said a No 10 source. “He has tasked ministers with resolving this issue so that interim payments can be made to all those infected as soon as possible, and we will set out the full details later this week.” Read full story Source: The Guardian, 6 August 2022
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News Article
Epilepsy drug that harms babies may damage their children too
Patient Safety Learning posted a news article in News
An epilepsy drug that caused disabilities in thousands of babies after being prescribed to pregnant women could be more dangerous than previously thought. Sodium valproate could be triggering genetic changes that mean disabilities are being passed on to second and even third generations, according to the UK’s medicines regulator. The Medicines and Healthcare Products Regulatory Agency (MHRA) has also raised concerns that the drug can affect male sperm and fertility, and may be linked to miscarriages and stillbirths. Ministers are already under pressure after it emerged in April that valproate was still being prescribed to women without the legally required warnings. Six babies a month are being born after having been exposed to the drug, the MHRA has said. It can cause deformities, autism and learning disabilities. Cat Smith, the Labour chairwoman of the all-party parliamentary group on sodium valproate, said: “This transgenerational risk is very concerning. There have been rumours that this was a possibility, but I had never heard it was accepted until last week by the MHRA." “The harm from sodium valproate was caused by successive failures of regulators and governments, and this news means it could be an order of magnitude worse than we first thought. It underlines the need for the Treasury to step up to their responsibilities around financial redress to those families.” Read full story (paywalled) Source: Sunday Times, 19 June 2022- Posted
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News Article
Infighting delays valproate compensation
Patient Safety Learning posted a news article in News
Source: The Times. 5 March Shared on Twitter @ShaunLintern- Posted
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No timetable for infected blood victims' compensation
Patient Safety Learning posted a news article in News
There is a "moral case" for compensation to be paid to people affected by the contaminated blood scandal, the government has said. But Paymaster General Jeremy Quin told MPs he could not commit to a timetable. In August, the government announced that 4,000 UK victims would receive interim payments of £100,000. Tens of thousands of people contracted HIV or hepatitis C in the 1970s and 80s after being given infected blood. In September, modelling by a group of academics commissioned by the public inquiry estimated that 26,800 people were infected after being given contaminated transfusions between 1970 and 1991. The study calculated that 1,820 of those died as a result, but that the number could be as high as 3,320. The inquiry, chaired by retired High Court judge Sir Brian Langstaff, began taking evidence in 2018. The interim compensation announcement in August came after Sir Brian argued there was a compelling case to make payments quickly - saying victims were on borrowed time because of their failing health. Payments have been made to those whose health is failing after developing hepatitis C and HIV, and partners of people who have died. But families have complained that many people affected, such as bereaved parents, missed out. Read full story Source: BBC News, 15 December 2022- Posted
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News ArticleThe family of a man who died after being given infected blood have called on the UK government to pay their compensation immediately. Randolph Peter Gordon-Smith, who had haemophilia, learned in 1994 that he had been infected with hepatitis C. His daughter said the family were "abandoned" to care for him without support before his death in 2018. The chairman of the UK infected blood inquiry has said parents and children of victims should receive compensation. Sir Brian Langstaff wants to see a final compensation framework set up by the end of the year. Ms Gordon-Smith, who lives in Edinburgh, says compensation would provide an acknowledgement of "what they did to our family" as his daughters cared for him when he was dying. "I think the government needs to get their chequebook out, do the right thing and pay [the compensation]," she added. "Not when the inquiry rules, but now." Read full story Source: BBC News, 22 June 2023
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Ayrshire MSP Katy Clark wants ban on surgical mesh use in hernia ops
Patient Safety Learning posted a news article in News
AN Ayrshire MSP has called for an end to surgical mesh being implanted in hernia patients in Scotland. A Freedom of Information request by Labour's Katy Clark has revealed that one in 12 of all hernia patients in NHS Ayrshire and Arran who have been implanted with surgical mesh since 2015 have been readmitted to hospital due to complications. And the West of Scotland MSP has backed a petition by constituents calling for the suspension of the use of surgical mesh until an independent review has been carried out. It follows the recent public health scandal over the pain and suffering endured by many women across Scotland implanted with transvaginal mesh. It took years of tireless campaigning by affected women before the Scottish Government took action, last year creating a mesh removal reimbursement scheme. Read full story Source: Irvine Times, 9 June 2023- Posted
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Judge says parents and children should receive infected blood payments
Patient-Safety-Learning posted a news article in News
The parents and children of victims of the contaminated blood scandal should receive government compensation, a judge has said. The chairman of the infected blood public inquiry, Sir Brian Langstaff, said it was time to "recognise deaths which have so far gone unrecognised". More than 3,000 people died after contracting HIV or hepatitis C via NHS treatments in the 1970s and 80s. The government must now respond to the recommendations. In August 2022, the government agreed to make the first interim compensation payments of £100,000 each to about 4,000 surviving victims, and bereaved widows. Sir Brian said, "It is a fact that around 380 children with bleeding disorders were infected with HIV. Some of them died in childhood. But their parents have never received compensation. Children who were orphaned as a result of infections transmitted by blood transfusions and blood products have never had their losses recognised. It's time to put that right." Read full story Source: BBC News -
Content Article
A bitter pill: Primodos (Sky News, 3 January 2023)
Patient-Safety-Learning posted an article in Medication
This Sky News investigation looks at one of the pharmaceutical industry's biggest scandals—the hormone pregnancy test Primodos which was prescribed to pregnant mothers in the UK between 1958 and 1978. Primodos was found to lead to birth defects, miscarriages and stillbirth, and regulatory failings led to avoidable harm to thousands of babies.- Posted
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Content ArticleThe Health and Social Care Select Committee have published a new report reviewing the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This blog sets out Patient Safety Learning’s reflections on this report.
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Content ArticleThis Health and Social Care Select Committee report reviews the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. You can read Patient Safety Learning’s reflections on this report here.
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Content ArticleIn this opinion piece, Kath Sansom, founder of campaign group Sling the Mesh, looks at flaws in the Government’s approach to women harmed by pelvic mesh surgery receiving financial redress. She highlights the unsuccessful case of Sarah*, who attempted to bring a clinical negligence case after suffering multiple complications as a result of pelvic mesh, to demonstrate that the national Redress Agency recommended by the Cumberlege Review is still very necessary.
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Content ArticleOn the 20 January 2023 the Health and Social Care Select Committee published a reported with reviewed the progress that the UK Government has made in implementing the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. This paper sets out the UK Government’s response to the recommendations set out in this report. Related reading: Health and Social Care Select Committee: Follow-up on the IMMDS report and the Government’s response (20 January 2023) Patient Safety Learning: Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (20 January 2023)
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