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Showing results for tags 'Legal issue'.
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Content ArticleNHS Resolution received 172 claims relating to anti-infective medications between 1 April 2015 until 31 March 2020. Anti-infective medications include antibiotics, antivirals and antifungals. The analysis in this leaflet focuses on closed claims that have been settled with damages paid and concern an element of the prescribing process: prescribing, transcribing, dispensing, administering and monitoring. Claims concerning a failure to recognise that an anti-infective was indicated have not been included within the analysis.
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- Medication - related
- Medication
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Content ArticleIn this British Journal of Nursing article, John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses some recent reports on the duty of candour and shared decision-making.
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- Duty of Candour
- Communication
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Content ArticleIn response to the COVID-19 pandemic, the Department for Health and Social Care (The Department) began an unprecedented programme of Personal Protective Equipment (PPE) procurement buying items such as gowns, gloves and masks. It eventually purchased 37.9 billion items at a cost of just over £13 billion. Two years on from that initial procurement activity the Department is still having to manage many of the contracts that it signed. It has now received nearly all of the PPE that it ordered but it is in dispute with many suppliers over the quality of the PPE that has been supplied and is also looking at whether fraud was committed on certain contracts. Much of the PPE still resides in storage locations, both around the UK and in China, and the Department is looking at options for how it might now dispose of some of the stock that it deems to be excess. Responsibility for management of the PPE programme has now largely been transferred back to Supply Chain Co-ordination Limited, the NHS’s main procurement partner prior to the pandemic. This report makes a series of recommendations.
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- PPE (personal Protective Equipment)
- Legal issue
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Content Article
The NHS whistleblowing crisis (8 February 2022)
Patient Safety Learning posted an article in Whistle blowing
Tommy Greene and David Hencke report on a number of worrying NHS dismissal cases in this Byline Times article.- Posted
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- Whistleblowing
- Speaking up
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Content ArticleThis guidance is for Integrated Care Boards, NHS trusts, foundation trusts and NHS England. It supports effectively partnership working with people and communities to improve services and meet the public involvement legal duties.
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- Integrated Care System (ICS)
- Collaboration
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Content ArticleThis annual report sets out how NHS Resolution's dispute resolution strategy has continued to drive down litigation against the NHS in England in 2021-22. 77% of claims made by patients were resolved in 2021/22 without court proceedings, continuing the year-on-year reduction for the last five years, and in line with the organisation's strategy to keep patients and healthcare staff out of court. NHS Resolution achieved this reduction through a range of dispute resolution approaches and continued cooperation across the legal market. It emphasises that the reduction in litigation has not been at the expense of a rigorous approach to investigation.
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- Legal issue
- Complaint
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Content ArticleAfter the US Food and Drug Administration (FDA) first warned in 2008 of serious complications associated with transvaginal mesh, thousands of lawsuits have been filed, most of which were compiled into seven federal multidistrict litigation cases against the major manufacturers. This blog by Meghann Cuniff for Forbes Advisor provides an update on the progress of these law suits. It also advises on how to file a vaginal mesh lawsuit and joining a class action lawsuit.
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- Medical device
- Womens health
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Content ArticleThis article in Computer Weekly outlines the tribunal proceedings and judgement in high-profile case brought by whistleblower Chris Day. Dr Day claimed that Lewisham and Greenwich NHS Foundation Trust had concealed evidence when a director deleted up to 90,000 emails before he was due to testify at an earlier tribunal, concerning allegedly false and detrimental public statements about Dr Day made by the Trust. Dr Day’s lengthy legal battle first began when he was a junior doctor working at Queen Elizabeth Hospital Woolwich’s intensive care unit in 2013, where he spoke up about under-staffing at the ICU.
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- Whistleblowing
- Legal issue
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Content ArticleDavid Hencke in this issue of Westminster Confidential discusses the avoidable death scandal at Epsom and St Helier University Health Trust that has led to another relative coming forward and queries about a former senior staff member in Jersey.
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- Whistleblowing
- Patient harmed
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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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- Medication
- Pharma / Life sciences
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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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- Womens health
- Medical device
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Content ArticleThe investigation and tribunal hearing of Dr Manjula Arora generated significant anger and anxiety among the medical profession. The case raised once again the perception of a regulatory process lacking in fairness; of a system in which the stakes seem much higher if you are a black and minority ethnic doctor. The General Medical Council (GMC) acknowledged that strength of feeling, making clear it would not oppose Dr Arora’s appeal against the sanction and commissioning a review of the case to understand lessons to be learned for future cases.
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- Investigation
- Regulatory issue
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Content ArticleIn 1999, the pivotal report “To Err is Human” by the Institute of Medicine led to sweeping changes in healthcare. This report outlined how blaming individuals does not change the underlying factors that contribute to medical errors. It also stated that blaming an individual does little to make the system safer – or prevent someone else from similar errors. It is unusual for a nurse to be charged criminally, when there is no intent to harm a patient. However, the recent trial in America of nurse RaDonda Vaught could set a precedent for future medical errors to be treated as criminal cases. The case may ensure that for every step that has been taken forward in patient safety, we have now taken two steps backwards. This article from Human Factors 101 looks at the case of RaDonda Vaught, the criminal trial and conviction, and discusses the impact this will have on healthcare.
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- Legal issue
- Criminal behaviour
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Content ArticleLocum GP Manjula Arora was given a month’s suspension by the Medical Practitioners Tribunal Service (MTPS) in May 2022 after a complaint to the General Medical Council (GMC) that centred on whether or not she had been promised a laptop by her employer. The ruling was overturned and the GMC conducted a review of the case that found that a legal test around dishonesty was incorrectly applied. The two co-chairs of the GMC review highlight some of its recommendations in this opinion piece in the BMJ. They argue that while the NHS is very diverse, it is not very inclusive and that structural racism affects the treatment of and opportunities available to staff from different cultural backgrounds. They call for greater compassion and cultural competency in the GMC, and for healthcare services to manage concerns on a local level before referring cases to the GMC.
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- Organisational culture
- Racism
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Content Article
Blog - Is human error a crime? (2 November 2022)
Patient-Safety-Learning posted an article in Legal matters
Martin Anderson, author of the Human Factors 101 blog, looks at the case of US nurse RaDonda Vaught, who was found guilty of criminally negligent homicide and abuse of an impaired adult following a medication error that led to a patient death in 2017. He provides a timeline of the events that occurred in the run up to the criminal trial and highlights concerns that the case will set a precedent in bringing criminal charges against nurses when there is no intent to harm a patient. He then looks at the system factors that may have contributed to the medication error, asking a number of questions about the circumstances under which Vaught made the error. The blog goes on to outline the serious impact the case could have on healthcare professionals' willingness to report errors, take on complex cases and use innovative treatments—it may even put people off taking on a career in the healthcare sector in the first place.- Posted
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- Human error
- Human factors
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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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- Risk management
- Patient / family involvement
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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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- Mental health
- Restrictive practice
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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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- Surgery - General
- Medical device
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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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- Cancer
- Human error
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Content ArticleThis article tells the story of Ruth, whose baby son was left with severe cerebral palsy and several other injuries following oxygen starvation during his birth. Ruth's labour was badly mismanaged and she found gaps, omissions and additions to her medical notes when she requested copies. Following a lengthy legal case, Kate received compensation that allowed her family to pay for her son's medical and care needs and adapt their home.
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- Maternity
- Patient harmed
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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.- Posted
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- Paediatrics
- Legal issue
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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.- Posted
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- Maternity
- Legal issue
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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.- Posted
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- Legal issue
- Surgery - Trauma and orthopaedic
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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.- Posted
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- Patient death
- Medication
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