Law Commons^™

The Shared Ethical Framework To Allocate Scarce Medical Resources: A Lesson From Covid-19, Ezekiel J. Emanuel, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, …

The Human Role In Artificial Intelligence, Christopher J. Smiley Dds

The Journal of the Michigan Dental Association

The success of AI requires human involvement to ensure that it is used safely and effectively. Transparency, collaboration, and standardization are necessary.

Protect Your Patients And Yourself: The Complete And Honest Medical History, Mitchell Gardiner Dmd

The Journal of the Michigan Dental Association

This feature article emphasizes the critical role of obtaining a complete and honest medical history in dental practice. Reflecting on the evolution of clinicians' diligence since dental school, the article underscores the potential risks associated with inadequate medical histories. The legal and ethical responsibilities in gathering comprehensive patient information are highlighted, emphasizing the impact on patient well-being and the dentist's vulnerability to legal challenges. The complexities of patients' truthfulness, especially regarding sensitive topics, are discussed, urging clinicians to establish trust for accurate disclosures. The article concludes with practical recommendations, stressing the ongoing need for thorough medical history reviews and the …

Risk Tradeoffs And Equitable Decision-Making In The Covid-19 Pandemic, Lawrence O. Gostin, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Since the start of the Covid-19 pandemic, societies have faced agonizing decisions about whether to close schools, shutter businesses, delay nonemergency health care, restrict travel, and authorize the use of emergency Covid-19 countermeasures under limited scientific understanding. Measures to control the spread of COVID-19 have disrupted our health, educational, and economic systems, tarnished our mental health, and took away our cherished time with family and friends. Conflicting advice from health agencies on the utility of public health measures left us wondering, was it all worth it? We still do not have all the answers to guide us through difficult risk-risk …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

The Ethics Of Research That May Disadvantage Others, Christopher Robertson

Faculty Scholarship

In prospective interventional research, a treatment may provide an advantage for the recipient over other humans not receiving it. If the intervention proves successful, the treated are better able to compete for a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of non-treated persons. The concerns for “bystanders” have typically focused on direct harms (e.g., infecting them with a virus), unlike the mere competition for rivalrous goods at issue here.

After broadly scoping this problem, analysis reveals several reasons that such research is typically permissible, notwithstanding the potential setbacks to the interests …

Bioethics: Ethical Considerations Of Ventilator Triage During A Pandemic, Susannah J. Gleason, William J. Keegan

Georgia State University Law Review

In the midst of the COVID-19 pandemic, hospitals across the country faced unprecedented volumes of patients seeking treatment related to the respiratory complications of the virus. As a result, states were forced to reassess existing scarce resource allocation guidelines to appropriately accommodate the high demand. This Peach Sheet analyzes the ethical considerations implicated in enacting and following these guidelines when treating patients, specifically in the context of ventilator triage in response to the COVID-19 pandemic.

Equitable Allocation Of Covid-19 Vaccines: An Analysis Of The Initial Allocation Plans Of Cdc's Jurisdictions With Implications For Disparate Impact Monitoring, Harald Schmidt, Rebecca Weintraub, Michelle A. Williams, Alison Buttenheim, Emily Sadecki, Helen Wu, Lawrence O. Gostin, Angela A. Shen

Georgetown Law Faculty Publications and Other Works

Major global and national vaccine allocation guidelines urge planners to allocate vaccines in ways that recognize, and ideally reduce, existing societal inequities within countries. However, allocation plans of the US will be determined individually by each of the CDC’s 64 jurisdictions (states, the District of Columbia, five cities, and territories). We analyzed whether jurisdictions have incorporated novel approaches to reduce inequity, based on plans published by the CDC in early November 2020 (63 summaries [98% of all jurisdictions] and 47 full guidance documents [73% of all, including all 50 states]).

Eighteen states adopted a novel proposal to use a disadvantage …

Video; Health Law & Ethics 2020, Kathy Cerminara, Jonathan Kroner Law Office, Mcdermott Will & Emery Llp, Lubell & Rosen, Gerald M. Morris

NSU Law Seminar Series

This program will focus on the current climate of health law and the necessary steps used through federal practice to adjust to the ever-changing atmosphere of new legislation. Attendees will learn about the various paths within the practice, about emerging new laws, outreach and training, and how to become involved in the federal practice of health law. The presenters will explain what you need to get started, what different types of experiences and exposure might be helpful in entering the field and instruct you on maintaining ethics by knowing and following the Federal Rules of Civil Procedure and Model Rules …

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

Setting Priorities Fairly In Response To Covid-19: Identifying Overlapping Consensus And Reasonable Disagreement, David Wasserman, Govind C. Persad, Joseph Millum

Sturm College of Law: Faculty Scholarship

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; …

Regulating Care Robots, Valarie K. Blake

Law Faculty Scholarship

Care robots already assist the elderly in some nursing homes around the globe and could be in widespread use in hospitals and private homes sooner than we think. These robots promise great hope for patients: robots can provide increased independence, assistance with daily living, comfort and distraction during procedures, education, and companionship during vulnerable and lonely times in patients' lives. Despite these promising features, there are a number of concerns; care robots, designed with the aim of winning patient trust and affection, have unprecedented access to personal lives as well as recording and sensory capabilities beyond any human. They pose …

Meat Processing Workers And The Covid-19 Pandemic: The Subrogation Of People, Public Health, And Ethics To Profits And A Path Forward, Kelly K. Dineen

Saint Louis University Journal of Health Law & Policy

The COVID-19 pandemic has highlighted and exacerbated existing health injustices. People who are Latino/Latinx, Black, Indigenous or members of other minority groups have disproportionately paid with their very lives. The pandemic has also exposed the complex interdependence of worker health and well-being, community health, and economic security. Industries like meat processing facilities—with congregate and high-density workplaces staffed by workers who are already disadvantaged by structural discrimination—must reckon with decades of subrogation and exploitation of workers. During this pandemic, the industry has pushed that exploitation to a point of no return. Policies to protect workers need a reset to an orientation …

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

Articles

Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. …

The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health ethics is a distinct and established field, and it is important that its approaches and rationales are understood widely in the public health community. Such understanding includes the capacity to identify and combine principled and practical concerns in public health. In this paper, we present a background to the ideas that motivate public health ethics as a field of research and practice, and rationalize these through a critical ethico-legal approach to analysis. Two essential points of inquiry are identified and formulated to allow philosophical and practical agendas regarding public health to be combined. These come through asking the …

Mid-Atlantic Ethics Committee Newsletter, Summer 2019

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus

Arkansas Law Review

Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking a …

Ethical Cannabis Lawyering In California, Francis J. Mootz Iii

St. Mary's Journal on Legal Malpractice & Ethics

Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …

Legalization Of Physician-Assisted Suicide For Increased Patient Autonomy, Morgan Mcenroe

Religion: Student Scholarship & Creative Works

This essay features an assessment of the various factors which play into the argument for legalization of physician-assisted suicide (PAS) in the United States for increased patient autonomy. Arguments for legalization of PAS as a means of end-of-life care remain separate from voluntary euthanasia. National legalization of PAS, for this fundamental principle of hospice care, is necessary to allow a choice to those in their final stages of life of how they wish to leave. If the values of PAS advocates are maximization of autonomy and minimization of suffering, then it follows that the chronically depressed, as well as patients …

Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe

All Faculty Scholarship

In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,” informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is — or ought to be — responsible for obtaining a patient’s consent? Must the treating physician personally provide all the necessary disclosures, or can the consent process, like other aspects of modern medicine, take advantage of specialization and division of labor? Analysis of Shinal v. Toms, …

Mid-Atlantic Ethics Committee Newsletter, Spring 2018

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Euthanasia By Organ Donation, Michael Shapiro

Dalhousie Law Journal

Euthanasia, the administration of therapy designed to hasten death, particularly in patients with intolerable suffering, has been gaining in acceptance in countries around the world, most recently in Canada. Organ donation from deceased organ donors has always been performed under the strictures of the dead donor rule, the requirement that donors be declared dead prior to any organ recovery. Recent scientific and ethical investigations, however, have questioned whether all donors, whether pronounced based on neurologic (brain death) or circulatory criteria are, in fact, dead. One potential approach to this quandary would be to abandon the fiction imposed by the dead …

Physicians' Attitudes, Concerns, And Procedural Understanding Of Medical Aid-In-Dying In Vermont, Teresa Ditommaso, Ari P. Kirshenbaum, Brendan Parent

Dalhousie Law Journal

The general purpose of the current study was to collect data on physicians' attitudes towards Act 39, the medical aid-in-dying act that was legislatively approved in 2013. Given the recent nature of the implementation of Act 39, this is the first such study to be conducted in the State of Vermont. The survey was quantitative in nature and addressed three distinct aspects of legalized prescribing of life-ending medication, these being physicians': (I) attitudes regarding ethics and legality of Act 39, (11)understandings of the policies and procedural requirements under the law, including their belief in legal immunity from penalty, and (I1) …

Questioning Polst: Practical And Religious Issues, Lloyd Steffen

Dalhousie Law Journal

The Physician Orders for Life Sustaining Treatment (POLST) is a one-page transferrable medical chart insert designed to facilitate physician-patient communication about a patient's wishes at the end of life. The document as a chart addition is in widespread use today, but various criticisms have been leveled at POLST, the most serious being that POLST creates a slippery slope to illicit active euthanasia. This article examines the criticisms and finds that they fit two categories, the first being practical implementation problems. These problems are correctable given more and better training of medical care staff. The second and more serious ethical charge …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …