Medicine and Law

This article is about the information relevant to decision-making capacity in refusal of life-prolonging medical treatment cases. We examine the degree to which the phenomenology of the options available to the agent—what the relevant states of affairs will feel like for them—forms part of the capacity-relevant information in the law of England and Wales, and how this informational basis varies across adolescent and adult medical treatment cases. We identify an important doctrinal phenomenon. In the leading authorities, the courts appear to (...) count the first-personal phenomenology of the available options among the information that adolescents seeking to refuse life-prolonging treatment must understand and appreciate in order to possess capacity; adults are not held to this (higher) standard. We evaluate this differential treatment in light of philosophical work on transformative choice—decisions involving options whose sensory character, and effect on our values and preferences, are grasped only through experience itself. (shrink)

In response to the spread of COVID-19, governments across the world have, with very few exceptions, enacted sweeping restrictive lockdown policies that impede citizens’ freedom to move, work, and assemble. This paper critically responds to the central arguments for restrictive lockdown legislation. We build our critique on the following assumption: public policy that enjoys virtually unanimous support worldwide should be justified by uncontroversial moral principles. We argue that that the virtually unanimous support in favor of restrictive lockdowns is not adequately (...) justified by the arguments given in favor of them. Importantly, this is not to say that states ought not impose restrictive lockdown measures, but rather that the extent of the acceptance of these measures is not proportionate to the strength of the arguments for lockdowns. -/- We begin by exploring the case for restrictive lockdowns. We first argue that several of the principles that are used to justify the lockdowns yield unexpectedly revisionary implications for other political problems that many would be unwilling to accept. We then outline what we consider the strongest argument for a lockdown—namely, that its net welfare benefits are great enough to defeat the moral presumption against restricting citizens’ civil liberties to move, work, and assemble. However, we give a number of reasons for doubting that the lockdown’s net welfare benefits are, in fact, sufficiently high to defeat the presumption against it. (shrink)

Informed consent, when given by proxy, has limitations: chiefly, it must be made in the interest of the patient. Here we critique the standard approach to parental consent, as present in Canada and the UK. Parents are often asked for consent, but are not given the authority to refuse medically beneficial treatment in many situations. This prompts the question of whether it is possible for someone to consent if they cannot refuse. We present two alternative and philosophically more consistent frameworks (...) for paediatric proxy consent. The first allows meaningful consent (parents may say ‘yes’ or ‘no’ to treatment), provided that parents are medically informed/competent and intend the health and well-being of their child. In the second solution, medical practitioners or the state consent for treatment, with parents only being consulted to help give insight to the child’s circumstances. While we contend that either of these two options is superior to the insincerity of the present paradigm, we suggest that the first solution is preferable. (shrink)

Since 1968, a brain-based criterion of death has been adopted in medical practice and passed into law or national guidelines in most countries worldwide. In some countries, such as Australia, Spain, and the United States, death can be determined by either the circulatory and respiratory criterion or by the neurological criterion. This practice corresponds to recommendations by the World Health Organization and the World Medical Association. In the USA, the Uniform Determination of Death Act (UDDA) provides that “an individual who (...) has sustained either (1) irreversible cessation of circulatory and respiratory functions or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead.” We show that the UDDA contains two conflicting interpretations of the phrase “cessation of functions”. By one interpretation, what matters for the determination of death is the cessation of spontaneous functions only, regardless of their generation by artificial means. By the other, what matters is the cessation of both spontaneous and artificially supported functions. Because each UDDA criterion uses a different interpretation, the law is conceptually inconsistent. A single consistent interpretation would lead to the conclusion that conscious individuals whose respiratory and circulatory functions are artificially supported are actually dead, or that individuals whose brain is entirely and irreversibly destroyed may be alive. We explore solutions to mitigate the inconsistency. (shrink)

Under the current Mental Health Act of England and Wales, it is lawful to perform deep brain stimulation in the absence of consent and independent approval. We argue against the Care Quality Commission's preferred strategy of addressing this problematic issue, and offer recommendations for deep brain stimulation-specific provisions in a revised Mental Health Act.

The increasing use of opioid treatment agreements has prompted debate within the medical community about ethical challenges with respect to their implementation. The focus of debate is usually on the efficacy of OTAs at reducing opioid misuse, how OTAs may undermine trust between physicians and patients and the potential coercive nature of requiring patients to sign such agreements as a condition for receiving pain care. An important consideration missing from these conversations is the potential for racial bias in the current (...) way that OTAs are incorporated into clinical practice and in the amount of physician discretion that current opioid guidelines support. While the use of OTAs has become mandatory in some states for certain classes of patients, physicians are still afforded great leeway in how these OTAs are implemented in clinical practice and how their terms should be enforced. This paper uses the guidelines provided for OTA implementation by the states of Indiana and Pennsylvania as case studies in order to argue that giving physicians certain kinds of discretion may exacerbate racial health disparities. This problem cannot simply be addressed by minimising physician discretion in general, but rather by providing mechanisms to hold physicians accountable for how they treat patients on long-term opioid therapy to ensure that such treatment is equitable. There are no data in this work. (shrink)

UK maternity policy makes great fanfare about providing person-centered care, built around what the pregnant woman or birthing person needs. Maternity Voices Partnerships involving healthcare professionals and women are supposed to guide policy and practice at the local level. UK consent law prioritizes the pregnant person's own conception of the risks and factors that are material to her care. The COVID-19 pandemic has shown how tenuous a hold these laudable principles actually have when the going gets tough.

Some people oppose abortion on the grounds that fetuses have full moral status and thus a right to not be killed. We argue that special obligations that hold between mother and fetus also hold between parents and their children. We argue that if these special obligations necessitate the sacrifice of bodily autonomy in the case of abortion, then they also necessitate the sacrifice of bodily autonomy in the case of organ donation. If we accept the argument that it is obligatory (...) to override a woman’s bodily autonomy for the sake of an unborn child’s survival, we must continue to override the bodily autonomy of parents to ensure the survival of their living children, until the parent no longer has a special obligation to their child to the same degree as their special obligation to the fetus. And if the life of a child is truly more important than the bodily autonomy of its parents, as must be the case to force women to carry unwanted pregnancies to term, this should remain true until such a time that their children are no longer considered their responsibility. Thus, parity of reasoning suggests that policies compelling the gestation of a fetus should be accompanied by policies compelling organ donation. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation (...) of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

The pelvic exam is used to assess the health of female reproductive organs and so involves digital penetration by a physician. However, it is common practice for medical students to acquire experience in administering pelvic exams by performing them on unconscious patients without prior authorization. In this article, we argue that such unauthorized pelvic exams (UPEs) are sexual assault. Our argument is simple: in any other circumstance, unauthorized digital penetration amounts to sexual assault. Since there are no morally significant differences (...) between UPEs and other instances of digital penetration, UPEs are sexual assault. So, insofar as one is against sexual assault, one should be against UPEs. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

In Righting Health Policy, MacDougall argues that bioethics has not developed the tools best suited for justifying health law and policy. Using Kant’s practical philosophy as an example, he explores the promise of political philosophy for making normatively justified recommendations about health law and policy.

The COVID-19 pandemic has been overwhelming public health-care systems around the world. With demand exceeding the availability of medical resources in several regions, hospitals have been forced to invoke triage. To ensure that this difficult task proceeds in a fair and organised manner, governments scrambled experts to draft triage guidelines under enormous time pressure. Although there are similarities between the documents, they vary considerably in how much weight their respective authors place on the different criteria that they propose. Since most (...) of the recommendations do not come with ethical justifications, analysing them requires that one traces back these criteria to their underlying theories of distributive justice. In the literature, COVID-19 triage has been portrayed as a value conflict solely between utilitarian and egalitarian elements. While these two accounts are indeed the main antipodes, I shall show that in fact all four classic theories of distributive justice are involved: utilitarianism, egalitarianism, libertarianism, and communitarianism. Detecting these in the documents and classifying the suggested criteria accordingly enables one to understand the balancing between the different approaches to distributive justice—which is crucial for both managing the current pandemic and in preparation for the next global health crisis. (shrink)

Goal: To assess public knowledge and attitudes towards the family’s role in deceased organ donation in Europe. -/- Methods: A systematic search was conducted in CINHAL, MEDLINE, PAIS Index, Scopus, PsycINFO, and Web of Science on December 15th, 2017. Eligibility criteria were socio-empirical studies conducted in Europe from 2008 to 2017 addressing either knowledge or attitudes by the public towards the consent system, including the involvement of the family in the decision-making process, for post-mortem organ retrieval. Screening and data collection (...) were performed by two or more independent reviewers for each record. -/- Results: Of the 1482 results, 467 studies were assessed in full-text form, and 33 were included in this synthesis. When the deceased has not expressed any preference, a majority of the public support the family's role as a surrogate decision-maker. When the deceased expressly consented, the respondents' answers depend on whether they see themselves as potential donors or as a deceased's next-of-kin. Answers also depend on the relationship between the deceased and the decision-maker(s) within the family, and on their ethnic or cultural background. -/- Conclusions: Public views on the authority of the family in organ donation decision-making require further research. A common conceptual framework and validated well-designed questionnaires are needed for future studies. The findings should be considered in the development of Government policy and guidance regarding the role of families in deceased organ donation. (shrink)

Objectives To increase postmortem organ donation rates, several countries are adopting an opt-out (presumed consent) policy, meaning that individuals are deemed donors unless they expressly refused so. Although opt-out countries tend to have higher donation rates, there is no conclusive evidence that this is caused by the policy itself. The main objective of this study is to better assess the direct impact of consent policy defaults per se on deceased organ recovery rates when considering the role of the family in (...) the decision-making process. This study does not take into account any indirect effects of defaults, such as potential psychological and behavioural effects on individuals and their relatives. -/- Design Based on previous work regarding consent policies, we created a conceptual model of the decision-making process for deceased organ recovery that included any scenario that could be directly influenced by opt-in or opt-out policies. We then applied this model to internationally published data of the consent process to determine how frequently policy defaults could apply. -/- Main outcome measures We measure the direct impact that opt-in and opt-out policies have per se on deceased organ recovery. -/- Results Our analysis shows that opt-in and opt-out have strictly identical outcomes in eight out of nine situations. They only differ when neither the deceased nor the family have expressed a preference and defaults therefore apply. The direct impact of consent policy defaults is typically circumscribed to a range of 0%–5% of all opportunities for organ recovery. Our study also shows that the intervention of the family improves organ retrieval under opt-in but hinders it under opt-out. -/- Conclusions This study may warn policy makers that, by emphasising the need to introduce presumed consent to increase organ recovery rates, they might be overestimating the influence of the default and underestimating the power granted to families. (shrink)

In his ‘When conscientious objection runs amok: A physician refusing human immunodeficiency virus preventative to a bisexual patient’, Brummett has argued that Catholic physicians should not be able to raise conscientious objections to HIV pre-exposure prophylaxis for bisexual patients, as this constitutes discrimination. Brummett argues that such a conscientious objection represents an instance of conscience creep, which he argues is undesirable. Here I re-analyse the case presented by Brummett using a teleological framework and making reference to Catholic teaching on cooperation (...) with evil. While I agree with Brummett that in this case the physician should not have had the right to conscientiously object, I argue that the teleological framework offers advantages over the argument Brummett has presented. I also comment on why only considering empirically measurable harm as a publicly defensible reason for one to hold a conscientious objection is problematic, as well as on the difficulties associated with cases of discrimination in a pluralistic society. (shrink)

The case of Alta Fixsler, where a judge ruled that withdrawing life sustaining care was in her best interest rather than transferring her to Israel, as her parents wanted, is the latest in a series of controversial paediatric best interest decisions. Using this case, as well as some other recent cases, I argue that the UK exhibits a high degree of medico-legal paternalism in best interest decisions, even though paternalism seems to be ubiquitously negatively perceived in medical ethics. Firstly, I (...) explain what I mean by medico-legal paternalism and defend my claim that this phenomenon is present in the UK. I then argue that at least philosophically (rather than legally) such a situation is impossible to justify in a secular state and that how we treat paediatric best interest decisions is very different from other areas of medical law. Lastly, I discuss proposals that aim to rectify this situation. (shrink)

Organ trafficking in all its various forms is an international crime which could be entirely eliminated if healthcare professionals refused to participate in or be complicit with it. Types of organ trafficking are defined and principal international declarations and resolutions concerning it are discussed. The evidence for the involvement of healthcare professionals is illustrated with examples from South Africa and China. The ways in which healthcare professionals directly or indirectly perpetuate illegal organ transplantation are then considered, including lack of awareness, (...) the paucity of both undergraduate and postgraduate education on organ trafficking, turning a blind eye, advocacy of organ commercialism, and the lure of financial gain. (shrink)

El consentimiento informado del paciente se inserta en el ámbito de su autonomía decisoria. Aunque presenta un sustrato corporal, este aparece combinado con elementos de índole moral que presuponen una noción concreta de persona como libre y autónoma. Tanto de las definiciones doctrinales como del material normativo se desprende que se trata de una posición jurídica subjetiva del paciente, alternativamente calificada como una “pretensión” o “derecho subjetivo en sentido estricto”, en términos hohfeldianos; un “derecho negativo de defensa”, o una “inmunidad”. (...) En España, el Tribunal Constitucional ha vinculado el consentimiento informado del paciente al derecho fundamental a la integridad física y moral (15 CE), lo cual permite plantear el análisis en clave iusfundamental. Con todo, se advierten dudas e incompatibilidades entre la explicación habitual del consentimiento informado, su fundamento constitucional y su regulación jurídica. El objetivo del presente libro consiste en proporcionar una definición integral del consentimiento informado como derecho subjetivo del paciente y como manifestación de un derecho fundamental, a partir de una óptica poliédrica que aporta certeza en la práctica asistencial y jurídica. // The patient's right to informed consent is inserted within the scope of his decisional autonomy. Although it has a bodily background, it is combined with features of moral nature, which presupposes a concrete notion of the person as free and autonomous. Both, doctrinal approaches and normative legal material show that it is a subjective legal position of the patient, being alternatively qualified as a Hohfeldian “claim” or a “subjective right in a strict sense”; a "negative right" or an "immunity." The Spanish Constitutional Court has linked the informed consent of the patient to the fundamental right to physical and moral integrity (15 CE), which allows us to propose a fundamental rights-based analysis. Nonetheless, doubts and inconsistencies are perceived between the customary explanation of informed consent, its constitutional foundation and its legal regulation. The aim of this book is to provide a comprehensive definition of informed consent as subjective right of the patient and expression of a fundamental right, from a multi-fold perspective that provides certainty in both legal and health care practice. (shrink)

In this paper, I argue that medical school admissions should be limited to statistically relevant factors. My argument rests primarily on three assumptions. A state professional school should maximize production. If a state professional school should maximize production, then it should maximize production per student. If a state professional school should maximize production per student, then, within the optimum budget, a state medical school should maximize quality-adjusted medical services per graduate. I put forth a tentative equation for ranking applicants as (...) a way of maximizing quality-adjusted medical services per graduate. This way of ranking is cheaper than the way admissions is currently done. Hence, the proposal is practically as well as theoretically appealing. (shrink)

According to the High Court in England and Wales, the primary purpose of legal interventions into the lives of vulnerable adults with mental capacity should be to allow the individuals concerned to regain their autonomy of decision making. However, recent cases of clinical decision making involving capacitous vulnerable adults have shown that, when it comes to medical law, medical ethics and clinical practice, vulnerability is typically conceived as opposed to autonomy. The first aim of this paper is to detail the (...) problems that arise when the courts and health care practitioners respond to the vulnerability of capacitous adults on the basis of such an opposition. It will be shown that not only does the common law approach to vulnerability fail to adequately capture the autonomy of capacitous vulnerable adults, the conception of vulnerability and autonomy in oppositional terms leads to objectionably paternalistic health care responses that undermine the autonomy of vulnerable patients as well as clinical and legal interventions that violate their autonomy. In response, the second aim of this paper is to show that the concepts of autonomy and vulnerability are necessarily entwined and, on that basis, the focus should be on promoting the autonomy of capacitous vulnerable adults where possible. In order to make this case, the paper explains the limitations of standard approaches to the autonomy of vulnerable adults and, in their place, offers a conception of legitimate, self-authorised autonomy that is fundamentally dependent on intersubjective practices of recognition. (shrink)

The High Court continues to exercise its inherent jurisdiction to make declarations about interventions into the lives of situationally vulnerable adults with mental capacity. In light of protective responses of health care providers and the courts to decision-making situations involving capacitous vulnerable adults, this paper has two aims. The first is diagnostic. The second is normative. The first aim is to identify the harms to a capacitous vulnerable adult’s autonomy that arise on the basis of the characterisation of situational vulnerability (...) and autonomy as fundamentally opposed concepts or the failure to adequately acknowledge the conceptual relationship between them at common law. The second part of this aim is to draw upon developments in analytic feminist philosophy to illustrate how standard approaches to autonomy are ill-equipped to capture the autonomy issues of capacitous vulnerable adults when their decisions regarding care and treatment are at stake. The second (normative) aim is to develop an account of self-authorised, intersubjective autonomy on the basis of analytic feminist insights into the relational practices of recognition. This account not only attempts to capture the autonomy of capacitous vulnerable adults and account for the necessary harms to their autonomy that arise from standard common law responses to their situational vulnerability, it is also predicated on the distinctions between mental capacity, the satisfaction of conditions for informed consent and the exercise of autonomy, meaning that it is better placed to fulfil the primary aim of the inherent jurisdiction – to facilitate the autonomy of vulnerable adults with capacity. (shrink)

Several European countries are approving legislative reforms moving to a presumed consent system in order to increase organ donation rates. Nevertheless, irrespective of the consent system in force, family's decisional capacity probably causes a greater impact on such rates. In this contribution we have developed a systematic methodology in order to analyse and compare European organ procurement laws, and we clarify the weight given by each European law to relatives' decisional capacity over individual's preferences (expressed or not while alive) regarding (...) the destination of his or her organs after death. In this sense, the results constitute the first comprehensive and comparative legislative mapping on European transplantation laws. (shrink)

This paper analyses the arguments for and against what we have called automatic organ procurement model in relation to the organs of the deceased. For this purpose, this work provides empirical evidence to assess the potential impact of this model on donation rates and on public opinion. Specifically, we examine first the reasons supporting this model, with special reference to utilitarian and justice arguments. On the other hand, we analyse both the approaches based on the violation of pre mortem and (...) post mortem interests opposing this theoretical model and the rejection the model would generate in the population. Finally, we point out the aspects that, in our opinion, should be exhaustively regulated if this model were implemented. In particular, we refer to the legal status of the human body, the treatments for end-of-life patients, the incentives for health professionals and the recognition of the right to conscientious objection. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

Focusing on a matter of continuing contemporary significance, this book is the first work to offer an in-depth exploration of exploitation in the doctor-patient relationship. It provides a theoretical analysis of the concept of exploitation, setting out exploitation's essential elements within the authors' account of wrongful exploitation. It then presents a contextual analysis of exploitation in the doctor-patient relationship, considering the dynamics of this fiduciary relationship, the significance of vulnerability, and the reasons why exploitation in this relationship is particularly wrongful. (...) Two case studies - sexual exploitation and assisted dying - are employed to assess what the appropriate legal, ethical and regulatory responses to exploitation should be, to identify common themes regarding the doctor's behaviour, and to illustrate the effects of exploitation on patients. A recurring question addressed is how exploitation in the doctor-patient relationship is and should be dealt with by ethics, regulators and the law, and whether exploitation in this relationship is a special case. The book provides a critical, inter-disciplinary evaluation of exploitation in the doctor-patient relationship that will be of interest to health care lawyers, bioethicists, legal academics and practitioners, health care professionals, and policy makers. (shrink)

America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who (...) have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue that, to pass muster under current law, policymaking in this area must recognize a crucial distinction: prioritizing minority communities, such as hard-hit neighborhoods, without regard to individual race is typically legal, but prioritizing individuals on the basis of their racial identity faces is likely not. I also explain how prioritization on the basis of Native American status is allowable and legally distinct from prioritization on the basis of individual race. -/- In Part II, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part III, I argue that randomly allocating scarce medical interventions, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part IV, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require focusing on factors other than race, or potentially considering race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part V, I examine two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in hard-hit occupations, potentially alongside race-sensitive aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in education, would narrow disparities without classifying individuals by race. The other strategy would address the starkly disparate racial impact of deaths early in life by limiting the use of age-based exclusions from vaccine or treatment access that explicitly deprioritize the prevention of early deaths and so disparately exclude minorities, and by considering policies that prioritize the prevention of early deaths. (shrink)

In this Correspondence, I argue that given that scarcity has existed both for critical care resources and for vaccines, allocating critical care resources to prioritize the prevention of early COVID-19 deaths (i.e. COVID-19 deaths among younger patients) could valuably counterbalance the disproportionate exclusion of minority patients and those with life shortening disabilities that age-based vaccine allocation produces. -/- Covid-19 deaths early in life have overwhelmingly befallen minorities and people with life-shortening disabilities. Policies preventing early deaths prevent an outcome widely recognized (...) as worse—dying earlier in one’s life rather than later—while counteracting intersecting forms of injustice. Ultimately, prohibiting the use of age as a tiebreaker in critical care allocation, as Brown et al. propose, will worsen disparities and is not mandated by law. (shrink)

In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies. In Part II, I identify two types of tailored policies--activity-based and (...) group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19. In Part III, I consider the public health law grounding of tailored policies in the principles of “least restrictive means” and “well-targeting.” I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted. In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones. (shrink)

We argue that the universal recommendations against “off-label” pediatric use of approved COVID-19 issued by the FDA, CDC, and AAP are overbroad. Especially for higher-risk children, vaccination can be ethically justified even before FDA authorization or approval – and similar reasoning is relevant for even younger patients. Legal risks can also be managed, although the FDA, CDC, and Department of Health and Human Services (HHS) should move quickly to provide clarity.

This chapter argues that adequately facing and responding to medical error requires making space for blame. In vindicating blame as a response to medical error, this essay does not advocate a return to a “bad apple” blame culture in which unlucky practitioners are unfairly scapegoated. It does, however, defend the targeted feeling and expression of angry, and even resentful, blaming attitudes toward health-care providers who make at least certain kinds of mistakes. The chapter makes the case that the angry and (...) resentful feelings associated with blame reflect a conception of oneself as a person worthy of consideration, and that expressing these feelings allows victims and families to fight for their dignity and self-respect. Along the way, it distinguishes between shaming and blaming, explaining that blaming, unlike shaming, characteristically aims to draw offenders into a moral dialogue. As a result, a good blaming practice can provide a logic within which providers who make costly errors may seek forgiveness, reconciliation, and healing. (shrink)

Background Consent policies for post-mortem organ procurement (OP) vary throughout Europe, and yet no studies have empirically evaluated the ethical implications of contrasting consent models. To fill this gap, we introduce a novel indicator of governance quality based on the ideal of informed support, and examine national differences on this measure through a quantitative survey of OP policy informedness and preferences in seven European countries. -/- Methods Between 2017–2019, we conducted a convenience sample survey of students (n = 2006) in (...) Austria (AT), Belgium (BE), Denmark (DK), Germany (DE), Greece (GR), Slovenia (SI) and Spain (ES), asking participants about their donation preferences, as well as their beliefs and views about the policy in place. From these measures, we computed indices of informedness, policy support, and fulfilment of unexpressed preferences, which we compared across countries and consent systems. -/- Results Our study introduces a tool for analyzing policy governance in the context of OP. Wide variation in policy awareness was observed: Most respondents in DK, DE, AT and BE correctly identified the policy in place, while those in SI, GR and ES did not. Respondents in opt-out countries (AT, BE, ES and GR) tended to support the policy in place (with one exception, i.e., SI), whereas those in opt-in countries (DE and DK) overwhelmingly opposed it. These results reveal stark differences in governance quality across countries and consent policies: We found a preponderance of informed opposition in opt-in countries and a general tendency towards support–either informed or uninformed–in opt-out countries. We also found informed divergence in opt-in countries and a tendency for convergence–either informed or uninformed–among opt-out countries. -/- Conclusion Our study offers a novel tool for analyzing governance quality and illustrates, in the context of OP, how the strengths and weaknesses of different policy implementations can be estimated and compared using quantitative survey data. (shrink)

Adolescents are routinely treated differently to adults, even when they possess similar capacities. In this article, we explore the justification for one case of differential treatment of adolescents. We attempt to make philosophical sense of the concurrent consents doctrine in law: adolescents found to have decision-making capacity have the power to consent to—and thereby, all else being equal, permit—their own medical treatment, but they lack the power always to refuse treatment and so render it impermissible. Other parties, that is, individuals (...) who exercise parental responsibility or a court, retain the authority to consent on an adolescent’s behalf. We explore four defences of the doctrine. We reject two attempts to defend the asymmetry in the power to consent to and refuse medical treatment by reference to transitional paternalism. We then consider and reject a stage of life justification. Finally, we articulate a justification based on the distinctiveness of adolescent well-being. (shrink)

This essay experiments with Kant’s writings on rational religion distilled through the Strange Case of Dr Jekyll and Mr Hyde as canonical confrontations with primal problems of evil. It suggests boundaries between Stevenson’s characters and their occupations comparable to the those conflicted in the Kantian university, namely, law, medicine, theology, and philosophy (which makes a short anticipatory appearance in his earlier text on rational religion). With various faculties it investigates diffuse comprehensions—respectively, legal crime, biogenetic transmission, and original sin—of key ethical (...) modes: will, inheritance, incorporation, freedom, duty, obligation, love, living, and killing to conclude on the possible logic of evil (or evils of logic) collateral and possibly innate to Kant’s comprehension of radical evil. (shrink)

This book examines the relationship between law and scientific advancement, with a particular focus on the theory of evolution and medical innovation. Historically, the law has struggled to keep pace with modern medical advances. The authors demonstrate that the laws that govern human behaviour must evolve in response to such advances."--Provided by publisher.

El consentimiento informado del paciente se inserta en el ámbito de su autonomía decisoria. Aunque presenta un sustrato corporal, este aparece combinado con elementos de índole moral que presuponen una noción concreta de persona como libre y autónoma. Tanto de las definiciones doctrinales como del material normativo se desprende que se trata de una posición jurídica subjetiva del paciente, alternativamente calificada como una “pretensión” o “derecho subjetivo en sentido estricto”, en términos hohfeldianos; un “derecho negativo de defensa”, o una “inmunidad”. (...) En España, el Tribunal Constitucional ha vinculado el consentimiento informado del paciente al derecho fundamental a la integridad física y moral (15 CE), lo cual permite plantear el análisis en clave iusfundamental. Con todo, se advierten dudas e incompatibilidades entre la explicación habitual del consentimiento informado, su fundamento constitucional y su regulación jurídica. El objetivo de la presente tesis doctoral consiste en proporcionar una definición integral del consentimiento informado como derecho subjetivo del paciente y como manifestación de un derecho fundamental, a partir de una óptica poliédrica que aporta certeza en la práctica asistencial y jurídica. // The patient's right to informed consent is inserted within the scope of his decision-making autonomy. Although it has a bodily background, it is combined with features of moral nature, which presupposes a concrete notion of person as free and autonomous. Both, doctrinal approaches and normative legal material show that it is a subjective legal position of the patient, being alternatively qualified as a Hohfeldian “claim” or a “subjective right in a strict sense”; a "negative right" or an "immunity." The Spanish Constitutional Court has linked the informed consent of the patient to the fundamental right to physical and moral integrity (15 CE), which allows us to propose a fundamental rights-based analysis. Nonetheless, doubts and inconsistencies are perceived between the customary explanation of informed consent, its constitutional foundation and its legal regulation. The aim of this doctoral thesis is to provide a comprehensive definition of informed consent as subjective right of the patient and expression of a fundamental right, from a multi-fold perspective that provides certainty in both legal and health care practice. (shrink)

If medical complicity is understood as compliance with a directive to act against the professional's best medical judgment, the question arises whether it can ever be justified. This paper will trace the contours of what would legitimate a directive to act against a professional's best medical judgment (and in possible contravention of her oath) using Joseph Raz's service conception of authority. The service conception is useful for basing the legitimacy of authoritative directives on the ability of the putative authority to (...) enable subjects to comply better with reasons that already apply to them. Hence, the service conception bases the legitimacy of practical authority on a certain kind of greater knowledge or expertise. This helps to focus the conundrum regarding complicity on the clash of expertise between the medical expert and the governing body tasked with coordinating behaviour and otherwise devising rules for the social good. The ethical dilemma presented by a hypothetically legitimate directive to act against a professional's best medical judgment also serves to highlight the moral dimension of one's duty to obey a legitimate authority. (shrink)

This timely Research Handbook offers significant insights into an understudied subject, bringing together a broad range of socio-legal studies of medicine to help answer complex and interdisciplinary questions about global health - a major challenge of our time. Interdisciplinary chapters explore both how the terrain of medicine can generate new questions about law, regulation and the state, and how the law intersects with health and medicine at every level. Bringing together leading international scholars, the Research Handbook assembles concrete case studies (...) to suggest avenues for further research on socio-legal inquiries, such as the construction of disorders by law, the reparation of injuries, and how race and gender impact justice. The Research Handbook for Socio-Legal Studies of Medicine and Health will be an inspiring read for researchers, academics and graduate students in the fields of health law, socio-legal studies, and gender and sexuality. (shrink)

Aryeh Goldberg compellingly argues for a Narrative Coherence Standard (NCS) to bolster existing methods of assessing patients' mental capacity. But his account fails to distinguish between the cognitive abilities of children and adults; consequently, worries may be raised about the scope of the NCS, in particular when we consider child patients. In this article, I argue the NCS cannot plausibly apply to children. Since children's self-conception does not arrive fully formed — but rather is a product of both incomplete cognitive (...) development and socializing factors — I claim children may not possess a sufficiently intimate knowledge of self, and therefore a sufficiently coherent sense of self, as Goldberg demands. Therefore, we should either revise the NCS to accommodate children, adopt an incremental view of consent, or revert to the relevant form of the MacArthur competence criteria to establish children’s capacity to consent. (shrink)

Shared Decision Making (‘SDM’) is one of the most significant developments in Western health care practices in recent years. Whereas traditional models of care operate on the basis of the physician as the primary medical decision maker, SDM requires patients to be supported to consider options in order to achieve informed preferences by mutually sharing the best available evidence. According to its proponents, SDM is the right way to interpret the clinician-patient relationship because it fulfils the ethical imperative of respecting (...) patient autonomy. However, there is no consensus about how decisions in SDM contexts relate to the principle of respect for autonomy. In response, I demonstrate that in order to make decisions about what treatment they will or will not receive, patients will be required to meet different conditions depending on the approach proponents of SDM take to understanding personal autonomy. Due to the fact that different conceptions of autonomy yield different obligations, I argue that if physicians and patients satisfied all the conditions described in standard accounts of SDM, then SDM would undermine patient autonomy. (shrink)

El análisis de la protección jurídica del consentimiento informado del paciente en los Estados Unidos de América pasa ante todo por considerar las soluciones proporcionadas por el common law, sin perjuicio de las previsiones establecidas en las diversas legislaciones estatales en la materia y la posible vía de protección constitucional, aun cuando se constatan ciertas dificultades que no han de ser consideradas insalvables. El presente artículo se propone ofrecer una revisión pormenorizada acerca del origen, la evolución y los fundamentos de (...) la protección jurídica del consentimiento informado en el ámbito asistencial ofrecida por el ordenamiento jurídico norteamericano, para posteriormente realizar un somero estudio comparativo con la regulación española. (shrink)

We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

This Essay explains why model policies proposed or adopted in response to the COVID-19 pandemic that allocate scarce medical resources by using medical evidence to pursue two core goals—saving more lives and saving more years of life—are compatible and consonant with disability law. Disability law, properly understood, permits considering medical evidence about patients’ probability of surviving treatment and the quantity of scarce treatments they will likely use. It also permits prioritizing health workers, and considering patients’ post-treatment life expectancy. These factors, (...) when based on medical evidence and not inaccurate stereotypes, are legal to consider even if they disadvantage some patients with specific disabilities. It then discusses the ethical advantages of triage policies that use medical evidence to save more lives and years of life, which I call “evidence-based triage,” focusing on the benefits of these policies for patients with disabilities. In doing so, I explain why recent critiques err by treating people with disabilities as a monolith, overlooking the political disadvantages of less-visible victims, and treating the social origins of scarcity as a justification for saving fewer lives. Evidence-based triage parallels other policy responses to the COVID-19 pandemic, like physical distancing and postponement of medical procedures, which may burden patients with specific disabilities or medical conditions but are nevertheless justified because they save more patients. (shrink)