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Over the decades we have witnessed legal cases influencing the government to develop the statutory duty of candour (DoC) in the medical profession. A duty that for a long time existed only in tort (civil) law. The purpose of the statutory DoC is understandingly important. For the public it simply reinforces an ethical duty already enforced by most professional regulators. For the medical profession, it is rather complex in ways that the courts can interpret and use it leaving uncertain legal ramifications for doctors. In this chapter, we explore the law in relevance with DoC in the United Kingdom, and the limitations and controversies around it for a better clarification and understanding. For organizations, we advocate the avoidance of bureaucracy in the DoC process and consideration of human factors before a regulatory response that avoids the fear of penalties, litigation and defensive practice among doctors undermining the development of culture of DoC. For the legal profession, is it time to change their outlook, where they are most able to support process of DoC and avoid the use of open disclosures to support a case of clinical negligence and its legal ramifications for doctors?

A year after its launch, the results of the Department of Health & Social Care’s (DHSC) consultation on ‘appropriate clinical negligence cover’ are still widely anticipated. In this article, we explore the benefits and disadvantages of regulated and discretionary indemnity cover as understood by the DHSC, the medical defence organisations (MDOs), insurance brokers and underwriters. We also turn to surgeons and clinicians with private practices to ask what they think about the current arrangements. Reforms to medical indemnity insurance forecast the passing of the UK's long-established medical defence and protection organisations.

Medical litigation in spine surgery is a serious concern today, with a high volume of clinical negligence claims, substantial financial cost and significant burden, who is threatening the future of this surgery. Classical spinal surgery should be performed with very well documented indication, in order to improve the expected results, with clear aims: decompression of the neural elements of the spine from tightness, stabilizing the spine to protect the nerves, eliminate the pain resulting from abnormal loading from the different movements. Spinal surgery today means a wide analysis, understanding and realization of spinal decompression, also osteosynthesis and fusions, using high-performance gestures, with increased addressability especially in the elderly, for a varied pathology, which involves anaesthetic-surgical risks, complications. In such a context, surgical damage does not necessarily result from an error or from surgical misconduct and the surgeon is not always responsible for the damage in the absence of a proven fault in the legal sense. The paper aims to briefly review the main problems, but also useful recommendations to meet various challenges, expectations, maintaining the quality of life of each patient, reducing risks of getting sued, also to increase the odds of a successful defence. In conclusion: education, vigilance, improved patient-safety strategies, investigation, implementation and sharing of lessons learned from litigation claims remain important components of spinal surgeons training, to reduce future cases of negligence and improve patient care, quality of life, as many of the cases of successful litigation had a preventable cause.

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of “failure to warn”, i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on “failure to warn” and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550–555.

Obstetrics and gynaecology is ranked the most litigious of all the medical specialties with 85% of clinicians in the specialty likely to face a malpractice suit by the age of 65. The defence organisations (NHS Litigation Authority, MDU, MPS etc) receive several thousand of claims per year but only 1–2% ever reach court and most are settled in the pre-trial phase. In many instances cases are successfully defended (70%) however this may be after arduous legal procedures and lengthy discussion. The main reasons for successful litigation relate to accountability, the need for an explanation, concerns with standards of care and compensation. Poor communication leads to a breakdown of the patient-doctor relationship and further increases the risks of litigation. The aim of this article is to raise awareness of the common causes of clinical negligence claims to help clinicians avoid common pitfalls leading to litigation, prepare doctors to deal with potential negligence claims when they arise and understand the civil law and basic acts governing clinical negligence in a medicolegal claim.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses several reports looking at how our clinical negligence compensation system operates, and possible reform of this

Clinical negligence claims are on the rise, with lawyers often playing a leading part in ascertaining what went wrong, why it went wrong and what lessons can be learned. I present a schema which may help lawyers better understand what goes wrong in clinical negligence cases.

There are some dento-legal mantras that have, by default, come to be understood as the truth, for example: “If it ain't in the notes, it didn't happen” and “Good records, good defence; poor records, poor defence; no records, no defence.” The opposite view was offered by the trial judge in a dental clinical negligence case in recent years. The judge's view can be summed up as: “If you don't make a note of something that has happened, you leave yourself at risk of proceedings like these.”

According to NHS Resolution, the cost of harm from clinical activity in the last year was £8.3 billion. The steady increase in litigation within the National Health Service (NHS) has led to concerns being raised regarding the sustainability of the NHS, the increasing practice of defensive medicine, and the psychological impact on healthcare professionals. To our knowledge, litigation within oral and maxillofacial surgery has not been investigated in the UK since 2010, therefore our aims were to identify the trends within our specialty and the common reasons for negligence claims over the last 10 years. A freedom of information request was made to NHS Resolution for all clinical negligence claims from 2010 to 2020. A total of 1,122 claims were registered and the total for damages paid was £32,631,131. The claims were categorised by the primary injury and further divided into groups of cause codes. Four types of primary injury comprised 65.4% (n = 734) of all negligence claims and were as follows: additional or unnecessary operations (n = 313, 27.9%), unnecessary pain (n = 156, 13.9%), nerve damage (n = 139, 12.4%), and dental damage (n = 126, 11.2%). The damages associated with nerve damage were the costliest, with a total of £8,033,737 being paid. The significant increase in the number and cost of clinical negligence claims is concerning. The lessons from these claims must be shared and implemented to reduce the burden on the NHS, and ensure that we are providing a high quality of care with improved patient outcomes.

Cauda equina syndrome (CES) is a condition where early identification and treatment is crucial to avoid potentially devastating effects. There is a high number of litigation cases linked with CES given it is a relatively rare condition. This scoping review protocol proposes to explore the extent and process of CES litigation in UK healthcare context cases amongst UK physiotherapists.The methodological framework recommended by Arksey and O'Malley, Levac et al. and the Joanna Briggs Institute will be used throughout this review to aid reporting and transparency. A patient and public involvement (PPI) group meeting was convened at the beginning of the review process in order to provide knowledge exchange to inform the search strategy and propose resources to be used during the scoping review. Two reviewers will independently review the literature in order to apply the inclusion and exclusion criteria. Once the studies to be included have been identified, the data from these studies will be extracted and charted. Results will show quantitative data of the studies included in the review and a narrative synthesis of the literature.This scoping review will evaluate the existing knowledge relating to CES and litigation and will map the key concepts around this topic. Results will be disseminated to practitioners and policy-makers through peer-reviewed publications, conferences, reports and social media. This method may prove helpful to others who are investigating extent and processes relating to medicolegal cases involving healthcare practitioners.The current paper is registered with OSF registries (DOI 10.17605/OSF.IO/MP6Y3).

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, considers the two opposing viewpoints on the need for change in the clinical negligence litigation system

Objective Identify organizational factors associated with high clinical litigation rates among acute National Health Service (NHS) trusts in England. Design Cross-sectional analysis using routine data. Setting NHS trusts in England. Participants A total of 235 NHS trusts used the NHS Clinical Negligence Scheme in 2016–17. Ninety-seven trusts (41.3%) with no maternity services, 2 (0.9%) providing specialized services and 3 (1.2%) without clinical negligence claims were excluded. Hence, the remaining 133 trusts (56.6%) were included. Intervention(s) None. Main Outcome Measures Rate of clinical litigation by trust per 100 000 occupied bed days. Results The mean rate of clinical litigation was 25.4 per 100 000 occupied bed days. In univariable analyses, higher values of summary hospital-level mortality indictor, staff sickness, written complaints, patient safety incidents and being in the North of England led to increased clinical litigation rates. Conversely, higher patient admissions, NHS Staff Survey overall engagement score and occupied bed days led to decreased clinical litigation rates. In the multivariable model, factors associated with increased clinical litigation rates were as follows: summary mortality hospital-level indicator (SHMI) (0.9 increase in litigation rate per 0.05 increase in SHMI; P = 0.012); new written complaints (0.62 increase per 50 complaints higher; P Conclusions This study identified organizational factors associated with clinical litigation, which will be of interest to clinicians and the NHS. This research also highlights areas for further investigation.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses the benefit of patient safety learning from clinical negligence claims, complaints reports and CQC investigations

Healthcare professionals are expected to deliver care that is consistent with clinical guidelines. In this article, we show that the English courts are increasingly willing to be persuaded by written guidelines when determining the standard of care in cases of alleged clinical negligence. This reflects a wider shift in the approach taken by courts in a number of common law jurisdictions around the world. However, we argue that written guidelines are still only one element that courts should consider when determining the standard of care. It is possible to deliver perfect care that deviates from professional guidelines and even to deliver negligent care by uncritically following a guideline that is flawed. We further argue that written guidelines are relevant beyond defining the accepted standard of care. This is because the decision to deviate from a guideline suggests the existence of multiple approaches that should be discussed with patients as part of ensuring informed consent. It is therefore likely that written guidelines will become an even more prominent feature of the medicolegal landscape in future years.

John Tingle, Lecturer in Law, Birmingham Law School, University of Birmingham, discusses how the Courts may view clinical negligence claims brought by families who have lost loved ones during the pandemic

Suppose that a doctor carrying out a treatment or advising on a treatment or acting as an expert in litigation or writing or lecturing about a treatment is in a minority so far as contemporary medical opinion is concerned. It may be a matter of choice for the doctor between treatment A (the majority practice) or treatment B (the minority practice), and the minority treatment may be of an innovative character. Unfortunately, things went badly wrong, the patient suffered harm and the doctor finds him/herself a defendant in a case for clinical negligence. What is the legal duty of the doctor? Is it sufficient that he/she acted in good faith? Or that he/she was a competent doctor? Or that he/she was a doctor following the practice of a substantial number of doctors, albeit a minority? Or that he/she was in effect acting ‘on his/her own’? The legal test is: Was the doctor following the practice of a responsible body of medical clinical opinion, albeit a minority opinion? Medicine has made huge advances over the years – one of the great achievements. But many advances have come about because of the initiative of one individual or a small group of individuals, often in the face of strong disbelief or opposition. The medical profession is a conservative profession, understandably so in view of the obvious inherent risks. Original ideas may not be well received. Therefore, the minority innovative doctor must proceed carefully because he/she runs the risk of a medical mishap, criticism and litigation.

Introduction: Litigation against the National Health Service (NHS) in England is rising, costing £2.4 billion in 2018/19. The aim of this study was to determine the incidence and characteristics of otolaryngology clinical negligence claims in England. Methods: A retrospective review was undertaken of all clinical negligence claims in England held by NHS Resolution relating to otolaryngology between April 2013 and April 2018. Analysis was performed using information for cause, patient injury and claim cost. Where claim information was adequately detailed, the authors categorised claims by subspecialty, diagnosis and operation. Results: A total of 727 claims were identified with an estimated potential cost of £108 million. From these, 463 were closed claims. Including open claim reserves, the mean cost of a claim was £148,923. Head and neck surgery was the subspecialty with the highest number of claims (n=313, 43%) and highest cost (£51.5 million) followed by otology (n=171, £24.5 million) and rhinology (n=171, £13.6 million). Over half of claims were associated with an operation (n=429, 59%) where mastoid surgery (n=46) and endoscopic sinus surgery (n=46) were equally associated with the greatest number of claims. The most frequent reasons for litigation included failure or delay to diagnose (n=178, 25%) failure or delay to treat (n=136, 19%), intra-operative complications (n=130, 18%) and failure of the consent process (n=107, 15%). Discussion: Clinical negligence claims in otolaryngology are related to several different components of patient management and is not limited to post-operative complications. This study highlights the importance of robust pathways in outpatient diagnostics and the consenting process, especially in the high-risk speciality of head and neck surgery, in order to deliver better patient care and reduce the impact of litigation.

Purpose Groin hernia repair is the most frequently performed general surgical operation in the UK. Complications from laparoscopic and open repair are well recognised; however, potential differences are yet to be considered in relation to litigation. Methods Administrative data were obtained and analysed from the NHS Litigation Authority for inguinal hernia-related claims from 1995 to 2016. Claims identified as using an open or laparoscopic approach were compared. Results 880 claims were made, 760 had been settled. 88 laparoscopic and 241 open procedures were identified; 65% laparoscopic and 63% open hernia claims were found to be in favour of the claimant. Payouts totalled to 4.1GBP/4.8EUR/5.3USD million and 9.4GBP/11.0EUR/12.1USD million for laparoscopic (mean 82,824GBP/96,579EUR/106,453USD) and open (mean 66,796GBP/77,892EUR/85,852USD) approaches, respectively. The most common reasons for claim initiation were visceral/vascular injury (54%) in the laparoscopic group, and testicular complications or chronic pain (35%) in the open group. Additional procedures were necessary for 48% and 44% of laparoscopic and open claims, respectively. The highest average payouts were associated with visceral injury, (laparoscopic 116,482GBP/135,820EUR/149,715USD; open 199,103GBP/232,246EUR/255,905USD) and vascular injury (laparoscopic 88,624GBP/103,369EUR/113,892USD; open 64,460GBP/75,163EUR/82,870USD). Additional procedures resulted in an average payout of 93,352GBP/108,917EUR/120,008USD (laparoscopic) and 60,408GBP/70,506EUR/77,657USD (open). The most common additional procedures were corrective visceral/vascular repairs, orchidectomy and recurrent hernia repair. Conclusions The rate of litigation for clinical negligence in inguinal hernia surgery in the UK is increasing. Whilst there has been a recent increase in laparoscopic hernia repair claims, the volume and burden of claims related to open procedures remain greater.

The NHS cannot afford to divert more and more money to litigation, and we need to tackle the problem at source. Tim Draycott and colleagues set out four principles to reduce avoidable harm

The treatment of sepsis is a significant cause of clinical negligence. Determining causation is a key aspect to successful litigation. We have reviewed the use of medical evidence in establishing legal causation.

A GP who was found liable for a serious spinal injury sustained by a patient whom he had failed to refer to hospital for tests has applied for permission to take the case to the Court of Appeal. The High Court ruled that GP Majella Okeahialam was liable for the injury to Tahir Younas, then aged 43, who fell and hit his head after fainting while crossing a car park in January 2014.1 In October 2013 Younas had had an electrocardiogram at the GP’s surgery that showed electrical abnormalities, but the doctor failed to refer him to a hospital cardiology department. The GP admitted negligence, but a claimant in a clinical negligence case must also prove that the negligence caused the injury. Younas’s lawyers argued …

Recent notable changes in the legal landscape have resulted in a significant evolution of the expert witness role and created unique challenges. The number of clinical negligence cases continues to rise, with a greater public awareness of the litigation process, and additional clinical risk associated with an increased complexity of diagnoses/treatment and changes in clinical pathways. Many cases are high value and/or complex and following the Jackson reforms, urgent deadlines are more commonplace. Experts are now asked to provide a broader level of opinion and support to increasingly overworked and time pressured solicitors. To maintain high-quality opinion, experts are having to further professionalise their practices and work more closely and proactively with instructing parties while at the same time protecting their independence. Increased pressure to cut costs, the post-Jackson need for speed of response, changes in data protection laws and IT processes and loss of immunity have all led to a more resource intensive role. The challenge for experts is to develop sufficient medico-legal experience with adequate administrative support, alongside clinical work, to provide higher quality services and ultimately improved outcome for patients, doctors and Trusts. Through the opinion of an oncology expert, current and future challenges for the medico-legal expert are highlighted along with potential implications for patients, relatives, doctors and health care providers.

The General Medical Council clearly states that a doctor must offer help when off-duty, if an emergency arises. However, despite an English doctor’s professional duty to offer their assistance, this duty does not exist as a legal duty. Therefore, a doctor would not be held negligent for failing to offer help, outside of their clinical setting. This article will critically analyse the reasons behind this lack of legal duty, comparing the law to other jurisdictions.

Objective To explore different models of clinical–insurer engagement around maternity safety and to understand how state insurers could and should engage with clinical staff to improve outcomes and reduce harm. Design Semi-structured interviews and focus groups were conducted with senior representatives from state insurers. Transcripts were analysed to identify different models of engagement. Themes were also elicited from the transcripts. A further one-day focus group allowed for clarification and elaboration of these themes. Participants Senior representatives from state insurers in England, Scotland, Wales, Republic of Ireland, Sweden and Victoria, Australia. Results A variety of clinical engagement activities were undertaken by the insurers. These included training on claims and risk management, hospital site visits, facilitating multi-professional network meetings and working with clinical experts to develop best practice recommendations. Some insurers engaged with frontline clinical staff through collaborative patient safety programmes. The themes (identity and size, data and research, incentivising improvement and system integration) were important for considering the role of state insurers within health systems and how insurers could engage with clinical teams. Conclusions This study identified different examples of clinical–insurer engagement. Whilst this was encouraging, the relationships between insurers and clinical teams could be developed further. Insurers and clinical staff could still collaborate more closely and work together in improving patient outcomes. Whilst not specifically their domain, insurers do have a role in patient safety. Closer clinical collaboration may strengthen this contribution.

In this case concerning a hypoxic birth injury, the High Court awarded damages for Post Traumatic Stress Disorder to two “secondary victims” (the mother and grandmother) caused by the events in questions. This is one of only very few reported clinical negligence cases where such claims have succeeded.

In a British hospital that is not too distant, a 6-year-old boy who had been diagnosed from birth with Down's syndrome, died in tragic circumstances. The child, Jack, who had been very unwell, had ...

This article looks at the new clinical negligence scheme for general practice and what the changes will mean for indemnity