Wrongful birth actions aim to compensate litigants who are negligently deprived by health professionals of their right to reproductive choice. Access to safe and legal abortion is integral to the action and wrongful birth claims in the United Kingdom have been facilitated by the Abortion Act 1967 (as amended). The recent Australian case CES v Superclinics (1995) 38 NSWLR 47 shows how judicial confusion about the legality of abortion can result in judges condoning medical negligence. The Superclinics case (...) also suggests that doctors are not required to provide pregnant women with the same standard of care as other patients. These developments show that law can become incoherent and health professionals can act negligently with impunity when reproductive choice does not have a secure legal foundation. (shrink)

This article considers the issue of expanded access to innovative treatments in the context of recent legislative initiatives in the United Kingdom and the United States. In the United Kingdom, the supporters of legislative change argued that the common law principles governing medical negligence are a barrier to innovation. In an attempt to remove this perceived impediment, two bills proposed that innovating doctors sued for negligence should be able to rely in their defence on the fact that (...) their decision to innovate was “responsible.” A decision to innovate would be regarded as responsible if it followed a specified process. Although these changes to the law of medical negligence were not passed, this article argues that the idea of a process-based approach was sound. In the United States, a number of states have passed “Right to Try” laws that permit doctors to prescribe and companies to provide investigational products without the need for FDA approval. These laws do not purport to and nor are they able to alter the obligations of individuals and companies under federal law. They are consequently unlikely to achieve their stated aim of expanding access to investigational products. This article argues that they nevertheless have a cogent rationale in so far as they highlight the need for rights-based reform to federal regulations governing access. (shrink)

'The law imposes the duty of care: but the standard of care is a matter of medical judgment'. So says Lord Scarman, outlining the hitherto accepted 'Bolam' standard, in his recent speech in the House of Lords decision of Sidaway v Bethlem Royal Hospital, reflecting earlier judicial dicta suggesting that it is for the medical profession rather than the courts to determine whether or not a medical practitioner has achieved the required standard of care (1). It is (...) suggested here that this concept is bad in principle, and that the weight of judicial authority is against it. (shrink)

First Published in 1988. Routledge is an imprint of Taylor & Francis, an informa company.

Historically, the standard of care in medical negligence provided considerable scope for external evaluation of clinical judgment. Under the Bolam test, however, determining the standard was seen by the courts as essentially a matter for the medical profession, to be resolved by expert testimony with minimal court scrutiny. In recent years, courts have become more willing to probe such testimony and challenge the credibility of medical experts, although they would very rarely override clinical judgment. The House (...) of Lords' decision in Bolitho may be construed as inviting courts to reach their own conclusions on the reasonableness of clinical conduct, along standard risk–benefit lines, after having made their own assessment of the expert opinion. Closer scrutiny of such opinion is the more welcome in the light of current concerns about partisanship in expert testimony. (shrink)

In modern law medical paternalism no longer rules. Respect for patient autonomy is now a fundamental principle of both medical law and bioethics. As a result of these developments, and cases such as Rees v Darlington Memorial NHS Trust and Chester v Afshar, there have been suggestions that the law of clinical negligence should be developed so as to recognise diminished autonomy as a form of actionable damage in this area of tort law. Yet in order for (...) the tort of negligence to recognise this new interest, it is first necessary to determine how autonomy should be understood in this context. The purpose of this article is to shed light on this issue and arrive at a suitable definition of the concept. After outlining the different theories of autonomy it is argued that the traditional liberal (current desire) definition is the most philosophically and legally coherent. (shrink)

In this paper, I examine the rhetoric employed by court judgements, with a particular emphasis on the narrative construct of the ‘passive patient’. This construction advances and reinforces paternalistic values, which have scant regard for the patients’ preferences, values, or choices within the legal context. Further, I critique the rhetoric employed and argue that the use of this rhetoric is the basis for a precedent that limits the understanding and respect of patients. Through this paper, I present the contemporary use (...) of the ‘passive patient’ construct in the context of the Indian legal system and describe how such constructions have become a source of normative justification for legal reasoning that jeopardizes the patient’s agency. I argue for the primacy of ‘respect for persons’ within Indian law and the need to treat each patient as a person who has agency, preferences, and values during clinical interactions. I conclude by suggesting that laws that adopt narratives that acknowledging the significance of patient engagement and the relevance of effective communication during clinical encounters would help cultivate a culture of patient-centred care, by moving beyond the rhetoric of ‘passive patient’ and the ‘health/choice’ dichotomy. (shrink)

Background Professional communities such as the medical community are acutely concerned with negligence: the category of misconduct where a professional does not live up to the standards expected of a professional of similar qualifications. Since science is currently strengthening its structures of self-regulation in parallel to the professions, this raises the question to what extent the scientific community is concerned with negligence, and if not, whether it should be. By means of comparative analysis of medical and (...) scientific codes of conduct, we aim to highlight the role of negligence provisions in codes of conduct for scientists, and to discuss the normative consequences for future codes of conduct. -/- Methods We collected scientific and medical codes of conduct in a selection of OECD countries, and submitted each code of conduct to comparative textual analysis. -/- Results Negligence is invariably listed as an infraction of the norms of integrity in medical codes of conduct, but only rarely so in the scientific codes. When the latter list negligence, they typically do not provide any detail on the meaning of ‘negligence’. -/- Discussion Unlike codes of conduct for professionals, current codes of conduct for scientists are largely silent on the issue of negligence, or explicitly exclude negligence as a type of misconduct. In the few cases where negligence is stipulated to constitute misconduct, no responsibilities are identified that would help prevent negligence. While we caution against unreasonable negligence provisions as well as disproportionate sanctioning systems, we do argue that negligence provisions are crucial for justified trust in the scientific community, and hence that there is a very strong rationale for including negligence provisions in codes of conduct. (shrink)

This article explores medical responsibility and negligence from an ethical and legal perspective within the Colombian context. It highlights causes of negligence such as deficiencies in professional training and organizational problems. The article emphasizes "objective imputation as key to determining the criminal responsibility of the physician" (Alvarado D. 2019). The objectives include analyzing the current legal framework in Colombia and assessing the link between medical ethics and legal responsibility. The methodology builds upon a thorough examination of (...) specialized literature, including peer-reviewed scientific articles in medicine and law, as well as legal documents and ethical regulations. A targeted search was conducted across various bibliographic databases including Google Scholar, Redalyc, Scielo, Dialnet, Biomed Central, Miguel De Cervantes Virtual Library, and BVS virtual health library. (shrink)

The legal framework governing claims of medical negligence is extensively documented within South African (SA) jurisprudence, with a predominant focus on the liability of medical practitioners. In contrast, the liability of pharmacists has received comparatively scant attention. This issue was recently highlighted by a case in which a woman from the Western Cape initiated legal action against Clicks, a leading health, beauty and wellness retailer and SA’s largest retail pharmacy chain, alleging that the provision of incorrect medication (...) nearly cost her life. At the time of writing, the case has yet to advance to trial. This article explores the legal and ethical dimensions of medical negligence attributed to pharmacists within the context of their professional duties. Additionally, it investigates how similar cases are adjudicated in foreign jurisdictions, with a specific focus on the US. (shrink)

The Court of Appeals of Indiana upheld the trial court's judgment and refused to create a new tort for “wrongful prolongation of life” because existing law offers a remedy to those who do not wish to be kept alive through artificial measures. Specifically, the court affirmed the trial court's dismissal in favor of Muncie Medical Investors, LP, the operator of Woodlands Nursing Home since the plaintiffs could have sought relief under I.C. § 16-36-1-8 which provides for court resolution of (...) disputes regarding an individual's treatment at the end of life.In 1992, Rebecca Taylor suffered a stroke that left her paralyzed on her left side and confined to a wheelchair. Taylor executed a living will in late 1993 directing that if she was suffering from a terminal illness with “no reasonable possibility of recovery,’’ then no “extraordinary means” to prolong her life should be used. (shrink)

Two professionals who treated Jack Adcock before his death were convicted of gross negligence manslaughter, receiving 24-month suspended sentences. His nurse, Isabel Amaro, was erased from the nursing register; but after reviews in the High Court and Court of Appeal, his doctor, Hadiza Bawa-Garba, was merely suspended. This article explores the proposition that nurses are at greater risk of erasure than doctors after gross negligence manslaughter through a close reading of the guidance for medical and nursing tribunals (...) informed by analysis from the High Court and Court of Appeal in the Bawa-Garba cases. Examination of the relevant sections of the guidance for medical and nursing tribunals reveals no significant differences. An outline of the conduct that amounted to breach of duty of care by Amaro and Bawa-Garba shows that their conduct could satisfy the thresholds for erasure given in their professions’ respective guidelines for tribunals. Both presented similar mitigating evidence, although this cannot be weighed heavily in a professional tribunal setting. Thus, Amaro was treated more harshly than Bawa-Garba without a simple explanation. However, I suggest that the Nursing and Midwifery Council’s Conduct and Competence Committee made a mistaken ‘presumption of erasure’ for gross negligence manslaughter and misinterpreted the sway that sentencing remarks should hold over tribunals. Both of these types of error were criticised by the Court of Appeal in Bawa-Garba. Furthermore, the Conduct and Competence Committee did not flesh out its analysis of ‘public confidence’ or acknowledge Lord Hoffmann’s caution against ending ‘useful’ careers for the sake of public confidence, but Bawa-Garba’s legal team ensured these arguments were taken into account by the Medical Professional Tribunal. The Conduct and Competence Committee’s failures are not inherent to Nursing and Midwifery Council procedure or policy. Rather Amaro’s self-representation appears to have impaired her access to justice. Tribunals must accept their right, and responsibility, to reach their own conclusions. (shrink)

Purpose Medical students receive a varying amount of training in medical ethics and are expected to navigate clinical ethical dilemmas innately. There is little literature on attempts to navigate ethical dilemmas experienced during early clinical experiences and whether current curricula prepare students for these dilemmas. This study explores the different ethical dilemmas experienced by medical students on their third-year clerkships and analyzes the factors, sources, and resolutions proposed by them.Methods From 2016 to 2018, third-year medical students (...) completed a written assignment to describe, analyze, and reflect on a clinical situation in which they experienced an ethical dilemma. They identified specific ethical dilemmas present, potential preventative and aftermath solutions, and reflected on their professional development from their experience. The research team utilized applied thematic analysis to identify themes and patterns in the data. A thematic matrix was utilized to examine similarities and differences across medical students.Results Of the 162 reflections, 144 (88.9%) students indicated an ethical dilemma that included issues related to autonomy and beneficence. Of these, 116 (71.6%) students found the two ethical principles in direct conflict. Students identified three common sources of this conflict: lack of communication; unclear understanding of clinical policies regarding family authority and psychiatric capacity; and medical negligence. Lastly, students suggested different solutions for dealing with and preventing this conflict.Conclusion Our findings suggest that an overwhelming number of students face ethical challenges when confronted with medical situations that raise conflicts between autonomy and beneficence. Their recommended solutions reveal an appeal among students to have tools and strategies in place to ease the need to make difficult decisions. Medical students might be better served by learning about the complexities of ethical decision-making and the likelihood of experiencing moral distress when they feel an inability to implement what they envision as the best solution. (shrink)

Dr Bawa-Garba, a senior paediatric trainee who had been involved in the care of a child who died shortly after admission to hospital, was convicted of gross negligence manslaughter and subsequently erased from the medical register. We argue that criminalisation of doctors in this way is fraught with ethical tensions at levels of individual blameworthiness, systemic failures, professionalism, patient safety and at the interface of the regulator and doctor. The current response to alleged manslaughter during clinical care is (...) not fit for purpose because of its narrow focus on criminalisation and punishment of individual doctors. The justice system fails to take into account systemic issues in a sufficiently proper and informed way particularly in respect of human factors involved in decision-making. It is easier to convict individual doctors for gross negligence manslaughter than it is to effect legal accountability upon organisations. If educational reflections are used to apportion blame, then this could impact detrimentally on honesty and the duty of candour, with negative implications for patient safety. Regulatory processes should not be deployed without consideration of context. There is an urgent need for a fresh and open evaluation of professional and societal expectations from the regulator that should include positive action as well as those that are proportionately punitive. Justice and patient safety would be served better by more sophisticated contextualisation through an approach that balances accountability in healthcare with failures that can occur within complex systems, and by working to a radical shift towards a just culture. (shrink)

On January 11, 2024, the United Kingdom (U.K.) Supreme Court rendered its judgment in _Paul v Royal Wolverhampton NHS Trust_, restricting the circumstances in which “secondary victims” can successfully claim for damages in clinical negligence cases. This ruling has provided welcome clarity regarding the scope of negligently caused “pure” psychiatric illness claims, but the judgment may well prove controversial. In this article, I trace the facts and opinion from the majority and also discuss an important dissenting opinion. I then (...) reflect on what the ruling means for psychiatric illness claims by secondary victims, and more broadly on the implications for clinical negligence law. I suggest that while much-needed clarity has been injected in this area of the law, it is difficult, reading the majority of the Supreme Court’s emphasis on the restricted scope of a medical practitioner’s duty, to envision a scenario in which secondary victim could ever succeed in a clinical negligence context. (shrink)

The precipitous and medically contraindicated reduction or “tapering” of opioids for patients with chronic pain due to serious medical conditions has caused needless suffering and, increasingly, suicide. Physicians could be liable for wrongful death based on negligent tapering of opioids.

Although the teaching of medical ethics and law in medical education is an old story that has been told many times in medical literature, recent studies show that medical students and physicians lack confidence when faced with ethical dilemmas and medico-legal issues. The adverse events rates and medical lawsuits are on the rise whereas many medical errors are mostly due to negligence or malpractices which are preventable. While it is true that many (...) class='Hi'>medical schools teach their students medical law and ethics, there are wide variations in what is being taught because there is no universally agreed syllabus. Yet the knowledge of medical law and ethics is closely relevant to the medical profession and that failure in abiding the law may result in serious civil or even criminal consequences. While this paper does not propose to lay detailed analysis of the relevant areas of law or ethics, it proposes to cover some legal areas so as to highlight and bring to attention the need for a medical law and ethics course. This article also considers the problems faced and recommendation as to future directions to be taken with respect to teaching medical law and ethics. It concludes with a suggested course outline for the teaching of medical law and ethics. (shrink)

Criminalizing unintentional mistakes in medicine as the offence of gross negligence manslaughter has always been a contentious issue. The threshold of prosecution is not well-defined, and even less clear when faced with a situation in which an intern doctor is held liable. This commentary attempts to review the current legal position of holding an intern doctor liable for gross negligence medical manslaughter.

Medical indemnity is not usually the stuff of high political and social drama in Australia. When the biggest medical defense organization went into voluntary liquidation in 2002, this all changed. Newspapers carried stories on an almost daily basis about the actual or possible negative impact of the “crisis” on doctors, hospitals, and communities. Doctors became increasingly vocal in their criticisms and expansive in their claims. Their political organization, the Australian Medical Association, lobbied powerfully and successfully for government (...) intervention to address the problem of dramatically escalating premiums for some doctors. This, combined with a broader public relations campaign about public liability insurance, resulted in significant changes in the law at both the federal and state level - not just in the area of medical negligence but in relation to most personal injury litigation.The genesis of and reasons for current medical indemnity problems in Australia have been the subject of much speculation and little rigorous analysis. (shrink)

In the context of clinical and non-clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system (...) failures in a health system, but is proposed in this paper as a more pervasive kind of neglect. Several non-medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good. (shrink)

The problem of undermedication of pain in health care is widely recognized and acknowledged; however, there is an obvious lack of exploration of this problem from an ethical perspective. When undermedication is raised as a moral concern, the underlying premise is that a patient may experience harm or not benefit from ineffective pain management practices. I will argue that the harm is of a particular type, that is, moral negligence. My intention is to increase nurses’ awareness of both the (...) type of moral harm they are causing, and their professional and moral duties to provide appropriate medication, more particularly to avoid undermedication. I hope that this heightened awareness will be incorporated into practice. As a nurse, I chose to focus on nursing for this article, but my claims are applicable to other health professions, such as medicine. (shrink)

이 글은 의료 행위의 중요한 경우에서 합리적인 의사결정을 내리기 위해서는 법적 판단과 함께 도덕적 판단 또한 반드시 고려되어야 하는 이유를 논증한다. 이러한 목적을 이루기 위해 먼저 한 사고실험을 통해 의료 행위에서 초래될 수 있는 업무상 과실치사상죄 적용에 대한 법적 판단을 분석함으로써 행위자의 법적 책임을 최소화할 수 있는 결정이 무엇인지 논증한다. 다음으로 도덕의 관점에서 그 문제를 분석할 경우 법적 판단과 다른 결론을 도출할 수 있음을 논증함으로써 중요한 의료적 결정을 내릴 때 법적 판단과 함께 도덕적 판단을 함께 고찰해야 하는 이유를 논증한다. 우리가 (...) 가진 도덕 감정은 일반적으로 도덕적으로 선하거나 옳은 행위를 권장하고 도덕적으로 악하거나 그른 행위를 금지한다. 하지만 우리가 몸담고 있는 현실 세계에서 일어나는 다양한 사건들 중에는 도덕적으로 최선의 행위를 선택하는 것이 아닌, 도덕적인 ‘차악’의 행위를 선택해야 할 처지에 놓이기도 한다. 이러한 경우는 ‘나를 보호하기 위한 실천적 선택’의 기로에 놓인 경우로 나타난다. 즉 우리는 그러한 순간에 자신의 현실적인 이익에는 부합하지만 도덕적인 부담을 감수해야 하는 선택을 하거나, 반대로 도덕적인 부담으로부터 벗어나기 위해 자신의 현실적인 이익을 포기해야 할 수 있다. 그리고 행위자가 행한 행위를 오직 법과 도덕에 의해서만 평가한다면, 그 행위자가 중대한 결정을 내려야 하는 경우는 법적 판단과 도덕적 판단이 충돌하는 경우라고 할 수 있다. 즉 그 행위자는 도덕적으로 문제될 것은 없지만 법적으로 처벌을 받을 수 있는 경우, 반대로 도덕적으로 비난받을 수 있지만 법적으로 문제가 없는 경우 중에서 한 행위를 선택해야 할 경우 중대한 결정을 내려야 한다. 법적 책임을 최소화하는 결정이 도덕적으로는 정당화될 수 없는 비판적인 사례를 분석함으로써 의료 행위에서 윤리적 분석과 숙고가 요청되는 이유를 강조할 수 있다. (shrink)

“That’s Africa”, or words to that effect, have been directed at me a number of times recently as some form of justification of things not working. Africa is broken and we have to work with what we have got, is the idea. Is this acceptance of the way things are a way of surviving and working in difficult environments or is it actually wrong and medically negligent to accept substandard practice? In many ways, this dilemma can be applied to any (...) part of the world, both developing and developed, but it is most acute in Africa.While observing medical ward rounds in a public hospital in Malawi, I came across two kinds of doctor. One kind would accept the way things were and work within the constraints; the other kind would always be battling against the constraints. I was told that “we can’t give an intravenous infusion because the nurses cannot count the number of drops …” Really? Why can’t they count the number of drops? I see no reason, aside from a complete lack of time . This attitude included everything from delivering blood samples to the laboratory to accessing drugs. …. (shrink)

The extent to which English law remedies injury to autonomy as a stand-alone actionable damage in negligence is disputed. In this article I argue that the remedy available is not only partial and inconsistent but also gendered and discriminatory against women. I first situate the argument within the broader feminist critique of tort law as failing to appropriately remedy gendered harms, and of law more broadly as undervaluing women’s interest in reproductive autonomy. I then show by reference to English (...) remedies law’s first principles how imposed motherhood cases—Rees v Darlington and its predecessor McFarlane v Tayside Health Board—result in gender injustice when compared with other autonomy cases such as Chester v Afshar and Yearworth v North Bristol NHS Trust: A minor gender-neutral ITA is better remedied than the significant gendered harm of imposing motherhood on the claimant; men’s reproductive autonomy is protected to a greater extent than women’s; women’s reproductive autonomy is protected by an exceptional, derisory award. Worst of all, courts refuse to recognise imposed motherhood as detriment; and the deemed, mansplained, nonpecuniary joys of motherhood are used to offset pecuniary upkeep costs, forcing the claimant into a position she sought to avoid and thus further undermining her autonomy. The recent Singaporean case ACB v Thomson Medical Pte Ltd, awarding compensation for undermining the claimant’s genetic affinity in an IVF wrong-sperm-mix-up demonstrates some improvement in comparison to English law, and some shared gender injustices in the context of reproductive autonomy. ACB’s analysis is oblivious to the nature of reproductive autonomy harm as gendered; and prioritises the father’s interest in having genetic affinity with the baby over a woman’s interest in not having motherhood imposed upon her. (shrink)

Faith healing deaths occur infrequently in Canada, but when they do they pose a considerable challenge for criminal justice. Similar to caregivers who absent-mindedly and fatally forget a child in a hot vehicle, faith healers do not intentionally harm their children. It can seem legally excessive and unjust to prosecute achingly bereaved parents. But unlike ‘hot-car’ deaths, faith healing parents are not absent minded in the deaths they cause. Rather, significant deliberation and strength of will is necessary to treat their (...) child’s ailment with faith alone. Two different Criminal Code provisions can be brought to bear upon these deaths, namely, s. 215 ‘Failing to provide the necessaries of life’ and s. 219 ‘Criminal negligence’. From a public, medical, and scientific perspective treating potentially fatal ailments with ‘faith’ and ‘prayer’ seems like reckless endangerment, giving apparent justification to the more serious criminal negligence charge. But, the fault element in the criminal negligence offence continues to be a vexing issue in Canadian jurisprudence. People accused of negligence-based offences are commonly held to the standard of what a reasonable person might predictably have done in similar circumstances. While it is unnecessary for the impartial trier of fact to conceive of faith healing as ‘reasonable’, it is an open question whether faith healers are sufficiently unreasonable to warrant serious criminal condemnation and possible incarceration when their course of action causes death. Is it justifiable to think of faith healers who cause death as criminally unreasonable? That is, do they depart markedly enough from the standard that criminal negligence is rightly attributed to them? Public attitudes toward religion, religious fundamentalism, and healthcare must be considered when trying to discern what a reasonable person does when treating an ailing child at risk of death. (shrink)

Few subjects provoke as much controversy or debate as that of medical care, and the law that governs such an emotive area finds itself with the near-impossible task of simultaneously trying to regulate the medical profession and healthcare provision whilst upholding the rights of the millions of people who use those services every year. Medical Law combines an accessible explanation of the complex and challenging legal rules of medical care in England and Wales with a stimulating (...) examination of the social, political and ethical arguments such care provokes. It examines a broad range of issues, from the structure and organisation of the NHS, through the rules of clinical negligence, as well as focussing on the legal and ethical concerns around such deeply contentious areas as surrogacy, organ donation, abortion and euthanasia. Written very much with newcomers to the area in mind, Leanne Bell lucidly outlines not just what the law is, but how it has developed over time and also provides insights as to how advances in medical technology and techniques may call for it to evolve in the future. (shrink)

In Barrett v. Danbury Hospital ), the Supreme Court of Connecticut held that the fear of contracting or transmitting HIV or any other blood-borne pathogens is not a compensable injury and does not give rise to a negligence or a medical malpractice claim. The court's decision affirmed the holding of a Connecticut trial court.In June 1990, Allen Barrett was admitted to Danbury Hospital complaining of abdominal pain. He had a history of gall bladder trouble. Barrett was placed on (...) a stretcher in the emergency room. The attending physician diagnosed Barrett's pain as a gallstone condition. During the course of his examination, the doctor noticed that Barrett was sitting in blood. The physician subsequently performed a rectal examination of Barrett to locate the source of the blood. The physician determined that the patient was not bleeding, but that the blood was in fact coming from two slits in the vinyl pad that covered the stretcher on which Barrett sat. (shrink)

Traditionally, mechanistic reasoning has been assigned a negligible role in standard EBM literature, although some recent authors have argued for an upgrade. Even so, the mechanistic reasoning that has received attention has almost exclusively been positive—both in an epistemic sense of claiming that there is a mechanistic chain and in a health-related sense of there being claimed benefits for the patient. Negative mechanistic reasoning has been neglected, both in the epistemic and in the health-related sense. I distinguish three main types (...) of negative mechanistic reasoning and subsume them under a new definition of mechanistic reasoning in the context of assessing medical interventions. This definition is wider than a previous suggestion in the literature. Each negative type corresponds to a range of evidential strengths, and it is argued that there are differences with respect to typical evidential strengths. The variety of negative mechanistic reasoning should be acknowledged in EBM, and it presents a serious challenge to proponents of so-called medical hierarchies of evidence. (shrink)

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision (...) in the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. (shrink)

OBJECTIVES: To study and report the attitudes and practices of physicians in a former Soviet republic regarding issues pertaining to patients' rights, physician negligence and the acceptance of gratuities from patients. DESIGN: Survey questionnaire administered to physicians in 1991 at the time of the Soviet breakup. SETTING: Estonia, formerly a Soviet republic, now an independent state. SURVEY SAMPLE: A stratified, random sample of 1,000 physicians, representing approximately 20 per cent of practicing physicians under the age of 65. RESULTS: Most (...) physicians shared information with patients about treatment risks and alternatives, with the exception of cancer patients: only a third of physicians tell the patient when cancer is suspected. Current practice at the time of the survey left patients few options when physician negligence occurred; most physicians feel that under a reformed system physician negligence should be handled within the local facility rather than by the government. It was common practice for physicians to receive gifts, tips, or preferential access to scarce consumer goods from their patients. Responses varied somewhat by facility and physician nationality. CONCLUSION: The ethics of Soviet medical practice were different in a number of ways from generally accepted norms in Western countries. Physicians' attitudes about the need for ethical reform suggest that there will be movement in Estonia towards a system of medical ethics that more closely approximates those in the West. (shrink)

In 2014, Lord Saatchi launched his ultimately unsuccessful Medical Innovation Bill in the UK. Its laudable aim was to free doctors from the shackles that prevented them from providing responsible innovative treatment. Lord Saatchi’s principal contention was that current law was the unsurmountable barrier that prevented clinicians from delivering innovative treatments to cancer patients when conventional options had failed. This was because doctors feared that they might be sued or tried and convicted of gross negligence manslaughter if they (...) deviated from standard practice. Concerns about fear of the law and potential negative effects on medical practice are not new. Fear of litigation has been suggested as the reason for doctors practising “defensive medicine,” by opting for treatments regarded as “grievance-resistant,” rather than clinically indicated, for example, by ordering diagnostic tests or performing certain procedures, which are not strictly medically necessary. Whilst this claim is plausible and apparently accepted by the courts, there is limited empirical evidence in support of it so far as practitioners in the UK are concerned. In this paper, we report on our empirical research which provides a snapshot of medical opinion to begin to rectify this gap. We ran focus groups of different medical specialties, asking what these medical practitioners thought the barriers to medical innovation to be. We found that fear of the law was not the principal barrier to be lowered, and that the answer was far more multifaceted. (shrink)

Background There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence. Methods Informants were 12 Israelis, aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon (...) discharge. Results Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity. Discussion Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons. Conclusions Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent. (shrink)

A doctor who lapses and injures her patient, and a driver who lapses and causes an accident, are liable under negligence law for the harm done. But lapse is not necessarily negligence, since reasonable people lapse from time to time. We show that tort liability for “reasonable” lapses distorts doctors’, drivers’, and manufacturers’ incentives to take care. Furthermore, such liability provides potential injurers with incentives to substitute activities which are less prone to lapses with activities which are more (...) prone to lapses, even if such substitution is inefficient. We propose several solutions to the inefficiencies that result from liability for lapses, and argue that under certain circumstances injurers should be entitled to invoke a “lapse defense.”. (shrink)

The rules governing recovery for negligently inflicted psychiatric injury are among the most criticized of all of tort law. However, one area which, to date, has escaped with a minimum of judicial or academic scrutiny concerns the very threshold requirement for these actions: proof of a ‘recognized psychiatric illness’. This article critiques that longstanding requirement of English law from two perspectives. First, it is argued that the international classifications of psychiatric disorders (ICD-10 and DSM-IV) are being misapplied and misconstrued in (...) the English medico-legal context and that the role (and limitations) of these classifications are worthy of far greater judicial examination and critical scrutiny than has typically been the case to date. Secondly, it is contended that the insistence upon a recognized psychiatric illness, as a threshold requirement, is giving rise to inconsistencies and distortions in the law and that the requirement is neither legally nor medically supportable in the modern era. Instead, it is argued that the stage has been reached whereby something lesser than a recognized psychiatric illness should be sufficient to trigger a compensable injury in law. The article concludes by suggesting various legal avenues by which to feasibly and robustly ‘ring-fence’ the number of potential claims in negligence, should the reform-oriented approach of this article be adopted. (shrink)

Over fifteen years after first reporting to the State of New York, the Harvard Medical Practice Study continues to have a significant impact in medical malpractice policy debates. In those debates the HMPS has come to stand for four main propositions. First, “medical injury… accounts for more deaths than all other kinds of accidents combined” and “more than a quarter of those were caused by substandard care.” Second, the vast majority of people who are injured as result (...) of substandard care do not file a claim. Third, “a substantial majority of malpractice claims filed are not based on provider carelessness or even iatrogenic injury.” Fourth, “whether negligence or a medical injury had occurred… bore little relation to the outcome of the claims.”Medical malpractice researchers have long known that the HMPS provides far stronger support for the first two of these propositions than for the last two; the HMPS was not designed or powered to reach strong conclusions about the validity of medical malpractice claims. (shrink)

In this paper, by applying a feminist bioethical perspective, we identify a new form of medical paternalism that still shapes contemporary legal policies on human egg cryopreservation performed without medical reasons. The fear of negligent, careless women who opt to delay their pregnancy for mere convenience is a widely known gender biased stereotype. Nevertheless, the opinions and judgments of medical professionals on this issue have not yet been sufficiently explored by in-depth research. In this essay, therefore, first (...) we look at the broader bioethical, legal, and social aspects of human egg cryopreservation. In the second part of the paper we discuss a unique qualitative study conducted with professionals working at Hungarian IVF clinics. We argue, based on a bioethical analysis of the collected data, that when new reproduction technologies provide opportunities for women to widen their range of reproductive choices, the traditional forms of medical paternalism can be reinforced by gendered paternalism, as well. We identify several elements of gendered paternalism that characterized the attitudes of the IVF staff and discuss the professionals’ resistance to elective egg freezing and vitrification of eggs for the future. We conclude by suggesting directions for future policy. Although we focus on the Hungarian case in this paper, we are aware that similar attitudes can be observed in some other countries where this technology has become available and requested by women, but where they also face difficulties in their access to it. (shrink)

ABSTRACT The UK Supreme Court ruling of Montgomery v Lanarkshire clarified that in obtaining informed consent to treatment, practitioners are under a duty to inform patients of material risks. Traditionally such risk has pertained to the clinical risks inherent to treatment. In examining empirical and judicial evidence, this paper makes the case for disclosure of potent financial interests; with potency relating to those interests likely to have greatest influence over practice. The paper explores how financial interests may detrimentally influence practice (...) patterns and how non-disclosure of such interests may be linked to the erosion of patient trust and subsequent disinclination to consent to treatment. Judicial notions of material risk are explored, and the conclusion reached that they offer a broader interpretation of disclosable risk compared to current UK GMC guidance. It is anticipated that empirical evidence could be used by the courts in determining questions of both materiality and causation in cases of negligent non-disclosure of potent financial interests. The paper concludes that there is sufficient reason to surmise that a test case could successfully apply the principles identified therein to establish the materiality of conflict of interest in informed consent to medical treatment. (shrink)

There can be no disputing the proposition that doctors and nurses should be held accountable for their professional activities. In most circumstances this accountability should be achieved through appropriate and effective complaints and disciplinary procedures, but there will be cases where the criminal law should become involved. The criminal law, however, is a serious weapon, and should only be used to punish those whose conduct is truly criminal; it should not be used against those who have merely made a human (...) error. The task of the law should therefore be to identify those situations where a doctor or nurse has behaved in a way which demonstrates a criminally culpable state of mind. In NZ recently the law has failed to do this and has been used as a weapon against those who may be in no sense morally blameworthy. -/- In New Zealand recently the law has failed to do this and has been used as a weapon against those who may be in no sense morally blameworthy. In this respect, NZ has been out of step with other comparable jurisdictions and has demonstrably failed to distinguish between cases where death is caused accidentally (through the making of an ordinary human error) and cases where it is caused criminally (through recklessness or culpable negligence). This is a surprising situation in a jurisdiction which has prided itself on its willingness to adopt a reformist legal agenda. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The (...) role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

Background: We described the prevalence of anxiety and depression related to COVID-19 pandemic among different types of population and examined their potential risk factors.Methods: A cross-sectional survey was conducted to collect demographic characteristics, exposure histories, and many other concerns about COVID-19. The Zung's self-rating anxiety scale and self-rating depression scale, followed by a four-step multiple logistic regression analysis was performed to identify factors associated with mental health outcomes.Results: Out of 3,303 participants, the quarantined people, community workstation staffs-policemen-volunteers and general public (...) reported higher percentages of depression than the general medical staff. Moreover, the quarantined people also showed higher prevalence of anxiety than the general public and the general medical staff. The quarantined people had the highest risk of anxiety and depression, whereas the self-rated health was negatively associated with the risks of anxiety and depression. Younger age group showed higher risks of anxiety and depression. People who had exposure history or contact from Hubei province after December 1, 2019, had family or friends engaged in front-line health care work, had confirmed case nearby were all more likely to suffer from anxiety. Moreover, the negligence or overindulgence toward the epidemic information was associated with a higher risk of depression and anxiety.Conclusions: Our findings show that the CPV and quarantined people were most at-risk population. We have identified that the young people, people with exposure histories and negligence or overindulgence toward epidemic information are in grave need of attention. (shrink)