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Content ArticleMaternity costs make up the largest cost to the NHS in value of claims. The Early Notification Scheme provides a faster and more caring response to families whose babies may have suffered severe harm. 'The second report: The evolution of the Early Notification Scheme' provides an overview of progress made since the report into the first year of the scheme, which was published in 2019. The report updates on the progress of the key recommendations which were made in the first report and reflects on modifications and improvements made to the scheme since its launch five years ago. It provides an analysis of the main clinical themes, based on a small cohort of cases, and makes recommendations to further improve outcomes for affected families.
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Content ArticleDrugwatch is a US consumer advocacy organisation that works with certified medical and legal experts to educate the public on dangerous drugs and medical devices and to empower consumers to assert their legal rights. In this article, Terry Turner, writer for Drugwatch, examines the history of the medical tech company C.R. Bard, which specialises in vascular, urology, surgery and oncology devices. Bard manufactures thousands of medical devices and sells them worldwide. The article looks at how the company was established and then examines several legal issues Bard has faced, including criminal charges stemming from medical fraud and accusations of selling defective devices that have killed patients or caused serious complications. The author looks at criminal charges concerning heart catheters to which Bard pleaded guilty. They also highlight problems with Bard's transvaginal and hernia mesh products and inferior vena cava (IVC) filters—devices designed to catch blood clots before they reach the lungs or the heart.
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Content ArticleThis article outlines how the first trials relating to harm caused by the LifeCell Strattice biologic patch will proceed. The Strattice patch is a form of surgical mesh used to treat hernias, but unlike other polypropylene mesh devices, it is composed of pig skin preserved in a solution that chemically links together proteins in the tissue. Patients involved in the US litigation complain that they suffered painful injuries from the Strattice patch. They claim that the manufacturer knew it had problems following multiple reports from patients, but failed to act to stop its use. The US Food and Drug Administration (FDA) received at least 450 adverse event reports on Strattice from September 1990 until September 2020. Among those reports were six patient deaths and 340 patient injuries, and many patients have had to undergo mesh removal.
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Content ArticleVaginal mesh implants were introduced in the late 1990s as a routine treatment for stress urinary incontinence and pelvic organ prolapse, common complications following childbirth. However, these flexible plastic scaffolds have led to life-altering complications for many women including nerve damage, chronic pain, and several reported deaths. This blog outlines the story of vaginal mesh, from the 1990s to the present day.
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Content ArticleSlides from a Bevan Brittan webinar reviewing recent case law and practice developments.
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News Article
Former trust CEO and medical director cleared over surgery scandal
Patient Safety Learning posted a news article in News
A major trust’s former chief executive and medical director have been cleared, after being accused of failing to protect breast patients from a rogue surgeon. The Medical Practitioners Tribunal Service has ruled neither Mark Goldman nor Ian Cunliffe’s fitness to practise was impaired, in a case brought by the General Medical Council. Mr Goldman was chief executive of the Heart of England Foundation Trust from 2001 until 2010, while Dr Cunliffe served as HEFT medical director between 2006 and 2010. Both held roles at HEFT while Ian Paterson was there. Mr Paterson was jailed for 20 years in 2017 after being convicted of 17 offences of wounding with intent while being employed at HEFT, while a later inquiry concluded he may have conducted up to 1,000 botched and unnecessary operations over a 14-year period. Mr Goldman and Dr Cunliffe are now pursuing the GMC for the costs of the case, which is expected to be heard over five days in January 2023. Read full story (paywalled) Source: HSJ, 18 October 2022 -
News Article
Family hit a 'brick wall' seeking justice for baby
Patient Safety Learning posted a news article in News
The grandfather of a baby who died at a hospital that was fined over failings in the delivery has spoken of his five-year fight for justice. Derek Richford was speaking as an independent report into baby deaths at the East Kent Hospitals Trust will be released this week. He said he "came up against a brick wall" while searching for answers over the death of grandson Harry Richford. An inquest into Harry's death at Margate's Queen Elizabeth the Queen Mother Hospital in 2017 found it was wholly avoidable and contributed to by neglect. Coroner Christopher Sutton-Mattocks said the inquest, which was finally held in 2020, was only ordered due to the family's persistence. The following year the trust was fined £733,000 after admitting failing to provide safe care and treatment for mother Sarah Richford and her son following a prosecution by the Care Quality Commission (CQC). Mr Richford said: "To start with we felt fairly alone and we felt like we were coming up against a brick wall. "The trust were refusing at that time to call the coroner. They were reporting Harry's death as 'expected'. "We didn't contact anyone other than the CQC just to say 'look there's been a problem here'." He said at a meeting with the trust, more than five months later, "we suddenly realised that there were a huge [number] of errors". Mr Richford told the BBC: "It took me about a year to come up with all the detail I needed and to speak to all the right people." He said the family then spoke to the Health Safety Investigation Branch who found there were issues. Mr Richford also tracked down a "damming" report by the Royal College of Obstetricians and Gynaecologists (RCOG). "In the end it was like peeling back the layers of an onion, and the more you took off, the more you found," he said. Read full story Source: BBC News, 18 October 2022 -
News ArticlePeter Duffy warned that there is a growing risk of electronic patient records and NHS staff communications being exposed to tampering efforts in disputes with managers and executives. The surgeon, who now practices on the Isle of Man, made the comments during talks given in September – to the Association for Perioperative Practice (AfPP) and at the Royal College of Surgeons Ireland (RCSI) in Dublin. He told audiences that “there is increasing potential for electronic tampering” of NHS IT records, holding serious implications for patient safety reporting and disputes with government and health service bodies. The consultant medic, who says he was driven out of UHMBT in 2016 after blowing the whistle on dangerous practices and uninvestigated cases of harm within the trust’s urology services, won a constructive dismissal claim against his ex-employer in 2018. Duffy now alleges that emails concerning the care of a patient at the centre of his whistleblowing were forged and backdated by senior UHMBT staff, several years after his employment claim against the trust had ended. The emails were not disclosed during the tribunal – despite a court order having been issued to release all communications concerning the care of the patient in question, the late Peter Read, who died in early 2015 – and are understood to have surfaced during the course of an external review into UHMBT’s urology services carried out between late 2019 and 2021. Niche Consult, a private firm commissioned by NHS England/Improvement (NHSE/I) to investigate Duffy’s patient safety disclosures alongside broader concerns regarding the trust’s urology department, determined that the emails in question were not fakes. Duffy told the AfPP and RCSI audiences that, during the Niche review of UHMBT’s urology services in 2020, he was “abruptly told that two entirely new, never-seen-before emails had suddenly, unexpectedly appeared”. The emails appear to partly implicate him in the series of clinical errors and missed care opportunities that contributed to Read’s death. Duffy described the allegedly falsified emails as being part of “an executive vendetta” waged against him in retaliation for his whistleblowing activity and negative publicity surrounding it, as UHMBT was seeking to cultivate the image of a “turnaround” trust in the years following a major maternity scandal between 2004 and 2013. Read full story Source: Computer Weekly, 28 September 2022
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News Article
Buffer zone to be set up outside Bournemouth abortion clinic
Patient Safety Learning posted a news article in News
An extensive buffer zone is being put in place around a clinic in Dorset in order to prevent anti-abortion campaigners harassing service users and staff. The zone will cover six streets around the British Pregnancy Advice Service clinic in Bournemouth and will be in force for 12 hours a day, five days a week for the next three years. Anyone caught protesting, harassing, intimidating or photographing visitors or staff could incur a fixed penalty notice of £100 or be liable for conviction at a magistrates court. Women have complained of being followed into the clinic or accosted when they leave. They have reported being told “the baby loves them” or asked whether they know they “murder babies” inside the building. One worker told the Guardian she has witnessed “many distressed clients”, including one who injured herself trying to climb a wall to avoid walking past the protesters. In another serious incident, an individual dressed in a monk’s cassock followed a staff member along the street in the dark while recording her. One service user said: “It was really intimidating. You’re in a really vulnerable situation and you have all these people shouting at you and saying you’re going to hell.” Read full story Source: The Guardian, 11 October 2022 -
Content ArticlePreventable harm, from the systems of care intended to improve health, continues to occur at an unacceptable rate in the United States. Healthcare systems have an opportunity to learn and improve from each episode of preventable harm. Accordingly, every preventable patient death or injury must energise our efforts to prevent future patient harm. The Anesthesia Patient Safety Foundation (APSF) believes that criminal prosecution of healthcare providers will make the work of preventing harm more difficult since it continues to shift the focus away from system improvements. They have released a position and policy statement outlining the rationale for opposing criminal prosecution and, equally important, recommends that all healthcare systems and organisations aggressively act, now, to improve their culture, processes, and training to reduce errors of all kinds and, specifically in light of recent events, medication errors. Some specific actions are recommended as examples of what can be done. Individual healthcare professionals should be mindful of their role in preventing errors and reporting errors that occur as well as taking action to encourage and enable their organization to improve the flaws in the systems in which they work that lead to harm to patients.
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News Article
Lucy Letby was ‘constant malevolent’ presence on neonatal ward, court hears
Patient Safety Learning posted a news article in News
A nurse murdered seven babies and attempted to kill 10 others by poisoning them on a hospital neonatal unit where she was a “constant malevolent presence”, a court has heard. Lucy Letby, 32, fatally injected newborns with insulin, air or milk during night shifts when she knew their parents would not be present, a jury was told. One of the babies was just 24 hours old when Letby allegedly injected him with air, killing him just 90 minutes after she came on shift. The nurse tried to kill his twin sister the next day, it is alleged. The court was told that Letby, who was trained to care for the most seriously ill babies, developed an “unusual interest” in the parents of some of her 17 alleged victims and in some cases tracked them on Facebook. Jurors were told that she was the only “common denominator” that connected the deaths of seven infants and the “catastrophic” collapses of 10 others at the Countess of Chester hospital between June 2015 and June 2016. She allegedly tried to kill some babies more than once – in one case, three times – using various methods. Nick Johnson KC, prosecuting, told the jury: “We say the collapses and deaths of the 17 children named on the indictment were not normally occurring tragedies. They were all the work, we say, of the woman in the dock who we say was a constant malevolent presence when things took a turn for the worse for these children.” Read full story Source: The Guardian, 10 October 2022 -
Content Article
AvMA case study: Chloe's story
Patient-Safety-Learning posted an article in Risk management and legal issues
This article tells the story of two-year-old Chloe, who died after hospital staff failed to recognise that she had meningitis, sending her home after her parents first took her to A&E. The NHS Trust carried out an internal investigation which identified many areas where care should have been better and set out a range of recommendations for improving care of children in A&E in the future. The Trust only apologised to the family after an out-of-court settlement was made. -
News Article
How 175 British children were infected with HIV
Patient Safety Learning posted a news article in News
At least 175 children with the blood disorder haemophilia were infected with HIV in the 1980s, according to documents from the national archives seen by BBC News. Some of the families affected are giving evidence at a public inquiry into what has been called the worst treatment disaster in the history of the NHS. It was almost 36 years ago - in late October 1986 - but Linda will never forget the day she was told her son had been infected. She had been called into a consulting room in Birmingham Children's Hospital, with 16-year-old Michael. As a toddler, he had been diagnosed with haemophilia, a genetic disorder that stopped his blood clotting properly. Linda assumed the meeting was to discuss moving his care to the main Queen Elizabeth Hospital in the city. "It was so routine that my husband stayed in the car outside," she says. "Then, all of a sudden, the doctor said, 'Of course, Michael is HIV positive,' and he came out with it like he was talking about the weather outside. My stomach just fell." Between 1970 and 1991, 1,250 people with blood disorders were infected with HIV in the UK after taking Factor VIII - a new treatment that replaced the clotting protein missing from their blood. About half of those infected with HIV died of an Aids-related illness before life-saving antiretroviral drugs became available. Almost three decades later, Linda is giving evidence to the long-running public inquiry into the treatment disaster. She will appear alongside other parents, in a special session about the experiences of families whose children were infected in the 1970s and 80s. "I felt as though I needed to do it because I want to help get to the bottom of it," she says. "We all want to know why it was allowed to happen and to keep on happening as well." Read full story Source: BBC News, 6 October 2022 -
Content ArticleMr B was 71 years' old and was undergoing treatment for cancer of the oesophagus. During surgery, a nasogastric tube that had been inserted became dislodged and was put back into place by medical staff, despite guidelines against this. The family realised that something had gone wrong in the operation and Mr B became very seriously ill, dying five months later. When the family asked the hospital for an investigation, they revealed that a hole had been made in Mr B’s stomach when the nasogastric tube was replaced. There was no assurance given that steps would be taken to prevent similar errors in the future, and no apology from the hospital. The family sought legal advice and came to an out of court settlement with the hospital.
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Content Article
AvMA case study: Lyndsey's story
Patient-Safety-Learning posted an article in Risk management and legal issues
This article tells the story of Lyndsey, who was 36 years' old and expecting her third child when she died of shock and haemorrhage, and a perforated gastric ulcer. Sadly, her baby also died as a result of Lyndsey's condition. In her narrative report, the Coroner raised concerns that Lyndsey had been prescribed methadone with no face-to-face consultation, and that she had received a prescription with no planned medical review. She also raised concerns about the reliability of the ambulance pre-alert system due the absence of systems for auditing the effectiveness and reliability of the pre-alert system and the lack of knowledge and training of staff in control. -
News Article
Tribunal told of 'failure' over girl's blood tests
Patient Safety Learning posted a news article in News
If doctors had tested a nine-year-old girl's blood sooner they may have changed the treatment she received before her death, an expert witness has confirmed to a medical tribunal. The hearing was told this was a "significant failure" in the care of Claire Roberts. Claire died at the Royal Belfast Hospital for Sick Children in 1996. In 2018 a public inquiry concluded she died from an overdose of fluids and medication caused by negligent care. At the time, her parents were told a viral infection had spread from her stomach to her brain. The General Medical Council (GMC) said one of the doctors involved in Claire's care, Dr Heather Steen, acted dishonestly in trying to conceal the circumstances of her death. Dr Steen denied allegations that she acted dishonestly and engaged in a cover-up. The Medical Practitioners Tribunal Service (MPTS) heard from a defence expert witness on Monday who said doctors not checking the sodium levels in Claire's blood earlier was a "significant failure" in her care. Dr Nicholas Mann told the tribunal he would have ordered more blood tests on Claire on the morning after she was admitted to hospital but he said he did not know if this would have prevented her death. "There should have been more attention to her fluids and electrolytes on the day after admission. Whether that would have altered the final outcome I don't know but certainly it would have been sensible to do that," he said. The tribunal also heard that Claire's death was not referred to a coroner, despite this being something all of the doctors caring for her would have had a duty to do. It was also told that a letter sent to Claire's parents from the hospital in 2005 contained inaccuracies. During questioning of Dr Mann, a barrister for the GMC highlighted the involvement of Dr Steen in compiling the letter which was signed by another doctor. Tom Forster KC said it was the GMC's case that Claire's family were given incorrect information about potential causes of her death despite these not being definitively diagnosed. Read full story Source: BBC News, 3 October 2022 -
News Article
Covid inquiry first preliminary hearing to begin
Patient Safety Learning posted a news article in News
The first preliminary hearing of the UK Covid public inquiry will begin today. The session, in London, will focus on the UK's pandemic preparedness before 2020. It will be largely procedural, involving lawyers and an announcement about who will be giving evidence. Public hearings where witnesses are called will not start until the spring. The inquiry formally started in the summer, with a listening exercise. But this first preliminary hearing is still being seen as an important milestone for the families who lost loved ones. Lindsay Jackson's mother, Sylvia, 87, died from Covid during the first lockdown, after contracting it at a care home. Ms Jackson, of the Covid-19 Bereaved Families for Justice campaign group, said it was essential lessons were learned. She was "really pleased" the inquiry was finally starting but it had taken too long to reach this stage. "It's two-and-a-half years since the pandemic started," she said. "We lost so many people. If people have done things wrong, they need to be held accountable. "For me, my family and the others who lost loved ones, it's important that answers are found to the questions that we have." Read full story Source: BBC News, 4 October 2022 -
Content ArticleThis guidance from the Department of Health and Social Care is for NHS hospitals and independent hospitals (providing NHS-funded care) in England, and police forces in England and Wales. It outlines how to comply with the requirements of the Mental Health Units (Use of Force) Act 2018.
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News Article
Mother given substantial damages over baby's care
Patient Safety Learning posted a news article in News
A mother from County Down will receive "substantial" undisclosed damages over alleged hospital treatment failures and care given to her daughter. Christina Campbell from Ballygowan brought medical negligence lawsuits over treatment she received at the Ulster Hospital in Dundonald after her daughter, Jessica, died in 2017 with a rare genetic disorder. The claim said that failure to test Ms Campbell during her pregnancy meant the condition went undetected. Damages were also sought for an alleged "ineffective" end of life care plan for the four month old. Jessica was diagnosed with trisomy 13 shortly after her birth in December 2016. She experienced feeding and respiratory difficulties, as well as a congenital heart defect and a bilateral cleft lip and palate. She was discharged from hospital with a home-based end-of-life care plan, including community and respite referral to the hospice, but a few months later. The claims said a failure to provide Ms Campbell with a amniocentesis test, which checks for genetic or chromosomal conditions, meant Jessica's condition was not discovered sooner. The lawsuit also highlighted concerns about Jessica's hospice treatment. It includes alleged uncertainty about the provision of humidified oxygen, a defective feeding pump and delays in a specific feeding plan and saline nebuliser being provided for the family. The family's solicitor said the awarding of damages "signifies the importance of lessons learned" as a result of Ms Campbell's campaign. "It is hoped that lessons can now be learned to ensure no other family has to go through a similar experience," he said. Read full story Source: BBC News, 29 September 2022 -
Content Article
AvMA case study: Heather's story
Patient-Safety-Learning posted an article in Risk management and legal issues
This video summarises the story of Heather, who has cauda equina syndrome and suffered permanent damage as a result of negligent hospital treatment. -
News Article
CQC triggers two reviews into whistleblowing concerns
Patient Safety Learning posted a news article in News
The Care Quality Commission (CQC) has commissioned an independent review into handling of a high-profile whistleblower case, and a wider internal review of how it responds when it is given “information of concern”. The independent review will be led by Zoë Leventhal KC of Matrix Chambers and will consider how the regulator handled “protected disclosures” from University Hospitals of Morecambe Bay Foundation Trust surgeon Shyam Kumar, alongside “a sample of other information of concern shared with us”. Mr Kumar won a tribunal against the CQC earlier this month, which found he was unfairly dismissed as a special advisor on hospital inspections after raising serious patient safety concerns. Between 2015 and his dismissal in 2019 Mr Kumar wrote to senior colleagues at the CQC with a number of concerns within his trust around bullying, patient harm and the quality of CQC hospital inspections. The tribunal drew particular attention to the two whistleblowing disclosures made by Mr Kumar about the CQC itself, which it found “clearly had a material influence on the decision to dismiss”. The CQC said in an announcement today that the independent review would aim to determine whether it took “appropriate action” in response to the information disclosed in Mr Kumar’s case and others. It will include consideration of whether the ethnicity of the people raising concerns impacted on decision making or outcome and is expected to conclude by the end of the year. Read full story (paywalled) Source: HSJ, 28 September 2022 -
Content ArticleThis is the story of the avoidable death of Glyn Davies, as told by his sister Anne. Glyn had an obstruction of the small bowel caused by adhesions from previous surgery and died from aspiration pneumonia after two weeks in intensive care at The Royal Lancaster Infirmary. Glyn's family felt that the investigation following his death had not been dealt with well, with evidence being withheld from the Coroner. This included information in Glyn's medical notes that indicated he had caught the hard-to-treat bacterial infection Stenotrophomonas Maltophilia, from either the ventilator or tubes whilst in intensive care. The family then took legal action against The University Hospitals of Morecambe Bay NHS Foundation Trust and the case was settled out of court in March 2020.
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Content Article
AvMA case study: George's story
Patient-Safety-Learning posted an article in Medication
This article tells to story of the events that led to the death of a patient named George from an avoidable medication error in December 2012. George slipped and fell in his garden in October 2012, badly hitting his head. He was taken to hospital where he was diagnosed with a subdural haematoma–when blood collects between the skull and the surface of the brain. After successful life-saving surgery at King’s College Hospital, George was moved to a ward to recover. George suffered from osteoarthritis and had been taking the anti-inflammatory medication naproxen to manage this for some time, accompanied by omeprazole to protect the stomach lining. As he recovered in hospital, he was prescribed his normal naproxen, but was not given the omeprazole to go with it. By the time the hospital stopped the medication, approximately one month later, George had developed severe bleeding and ulcers in his stomach. George’s condition worsened and he died on 4th December 2012. -
News ArticleMany pharmacies and physicians are forced to deny patients access to drugs, such as methotrexate, that can be used to help induce an abortion A few weeks after the supreme court’s 24 June decision to overturn the nationwide abortion rights established by Roe v Wade, the pharmacy chain Walgreens sent Annie England Noblin a message, informing her that her monthly prescription of methotrexate was held up. Noblin, a 40-year-old college instructor in rural Missouri, never had trouble getting her monthly prescription of methotrexate for her rheumatoid arthritis. So she went to her local Walgreens to figure out why, standing in line with other customers as she waited for an explanation. When it was finally her turn, a pharmacist informed Noblin – in front of the other customers behind her – that she could not release the medication until she received confirmation from Noblin’s doctor that Noblin would not use it to have an abortion. Since the supreme court’s elimination of federal abortion rights, many states have been enacting laws which highly restrict access to abortion, affecting not only pregnant women but also other patients as well as healthcare providers. As a result, many pharmacies and physicians have been forced to deny and delay patients’ access to essential medications – such as methotrexate – that can be used to help induce an abortion. Noblin is one of the 5 million methotrexate users across the US and one of the country’s many autoimmune patients. Although she was eventually given her prescription, Noblin and other patients are now forced to grapple both with a monthly invasion of privacy at pharmacies that ask them about their reproductive choices as well as the possibility of being wholly denied the medication in the future due to restrictive laws. Read full story Source: The Guardian, 26 September 2022
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Content ArticleAn open letter to Brandon Lewis, the justice secretary, and the Sentencing Council for England and Wales warns that pregnant women in jail suffer severe stress and highlights evidence suggesting they are more likely to have a stillbirth. The signatories include the Royal College of Midwives and Liberty.
