Law Commons^™

Abortion Disorientation, Greer Donley, Caroline M. Kelly

Articles

The word “abortion” pervades public discourse in the wake of Dobbs v. Jackson Women’s Health Organization. But do we know what it means? Not only do law and medicine define it differently; state legislatures have codified wildly different definitions of abortion across jurisdictions. Our analysis exposes inherent ambiguities at the boundaries of the term, particularly as abortion intersects with other categories that we often think of as distinct: pregnancy loss, ectopic pregnancy, and other forms of medically necessary care. By juxtaposing statutory text next to real people’s experiences of being denied care in states with abortion bans, we reveal …

Are Embryos Or Fetuses Brain Dead? Implications For The Abortion Debate, Greer Donley

Articles

Most state abortion definitions exclude the removal of a dead fetus, attempting to distinguish miscarriage and abortion care. But what does “dead” mean at the earliest stages of potential life? There is a consensus at the end of life that death not only encompasses the cessation of cardiac activity, but also brain death. This symposium essay considers whether life can exist before brain life begins and how that might impact the abortion debate. The most rudimentary brain waves cannot be detected in an embryo before roughly the eighth week of pregnancy; the capacity for feeling and consciousness begin much later. …

Making The World Safer And Fairer In Pandemics, Lawrence O. Gostin, Kevin A. Klock, Alexandra Finch

Georgetown Law Faculty Publications and Other Works

Global health has long been characterized by injustice, with certain populations marginalized and made vulnerable by social, economic, and health disparities within and among countries. The pandemic only amplified inequalities. In response to it, the World Health Organization and the United Nations have embarked on transformative normative and financial reforms that could reimagine pandemic prevention, preparedness, and response (PPPR). These reforms include a new strategy to sustainably finance the WHO, a UN political declaration on PPPR, a fundamental revision to the International Health Regulations, and negotiation of a new, legally binding pandemic agreement (popularly called the “Pandemic Treaty”). We revisit …

Property's Boundaries, James Toomey

Elisabeth Haub School of Law Faculty Publications

Property law has a boundary problem. Courts are routinely called upon to decide whether certain kinds of things can be owned--cells, genes, organs, gametes, embryos, corpses, personal data, and more. Under prevailing contemporary theories of property law, questions like these have no justiciable answers. Because property has no conceptual essence, they maintain, its boundaries are arbitrary--a flexible normative choice more properly legislative than judicial.

This Article instead offers a straightforward descriptive theory of property's boundaries. The common law of property is legitimated by its basis in the concept of ownership, a descriptive relationship of absolute control that exists outside of …

Indiana Law Fertility Fraud Expert Participates In Washington, Dc Roundtable, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Professor Jody Madeira, an internationally recognized expert in fertility fraud, bioethics, and law and medicine, participated this morning (January 26) in a bipartisan roundtable discussion with victims of fertility fraud. The event was facilitated by U.S. Representatives Stephanie Bice (R-OK), Mikie Sherrill (D-NJ), Julia Letlow (R-LA), and Chrissy Houlahan (D-PA) following the January 23 introduction of their Protecting Families From Fertility Fraud Act, which would—for the first time—make it a federal crime to knowingly misrepresent the source of DNA used in any procedure that involves assisted reproduction.

A Guide To Mireille Delmas-Marty's “Compass”, Diane Marie Amann

Scholarly Works

This essay appears as the Afterword (pp. 55-64) to a volume featuring an important work by the late Mireille Delmas-Marty (1941-2022) titled A Compass of Possibilities: Global Governance and Legal Humanism. A Collège de France de Paris law professor and one of the pre-eminent legal thinkers of her generation, Delmas-Marty and the essay’s author were longtime colleagues and collaborators. The volume contains an English translation of a 2011 lecture by Delmas-Marty, originally titled “Une boussole des possibles: Gouvernance mondiale et humanismes juridiques.” Amann’s essay surveys that writing, in a manner designed to acquaint non-francophone lawyers and academics with Delmas-Marty’s …

Fair Allocation Of Scarce Therapies For Coronavirus Disease 2019 (Covid-19), Govind C. Persad, Monica E. Peek, Seema K. Shah

Sturm College of Law: Faculty Scholarship

The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (e.g., the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (i.e., benefiting people and preventing harm, equal concern, and mitigating health inequities) …

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

The Lived Experience Of Health Insurance: An Analysis And Proposal For Reform, Jacqueline R. Fox

Faculty Publications

People are carrying tens of billions of dollars of medical debt, much of it in collections. We delay going to the Emergency Department while having a heart attack because it may cost too much. Doctors try to help insured patients find the best coupon to offset the high copayment for a necessary prescription drug. For inexpensive drugs, insurers make a profit by clawing back copayments that exceed what the drug costs. People who are already arbitrarily disadvantaged because of race, gender, health status, LGBTQ status, obesity, etc. are disproportionately burdened by all of this.

No one would design a system …

Madeira Serves As Legal Commentator In Netflix’S “Our Father”, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

No abstract provided.

Narrative Capacity, James Toomey

Elisabeth Haub School of Law Faculty Publications

The doctrine of capacity is a fundamental threshold to the protections of private law. The law only recognizes private decision-making—from exercising the right to transfer or bequeath property and entering into a contract to getting married or divorced—made with the level of cognitive functioning that the capacity doctrine demands. When the doctrine goes wrong, it denies individuals, particularly older adults, access to basic private-law rights on the one hand and ratifies decision-making that may tear apart families and tarnish legacies on the other.

The capacity doctrine in private law is built on a fundamental philosophical mismatch. It is grounded in …

Resuciating Consent, Megan S. Wright

Journal Articles

The scholarly focus on autonomy in healthcare decision making largely has been on information about, rather than consent to, medical treatment. There is an assumption that if a patient has complete information and understanding about a proposed medical intervention, then they will choose the treatment their physician thinks is best. True respect for patient autonomy means that treatment refusal, whether informed or not, should always be an option. But there is evidence that healthcare providers sometimes ignore treatment refusals and resort to force to treat patients over their contemporaneous objection, which may be facilitated by the incapacity exception to informed …

Righting Health Policy: Bioethics, Political Philosophy, And The Normative Justification Of Health Law And Policy, D. Robert Macdougall

Publications and Research

In Righting Health Policy, D. Robert MacDougall argues that bioethics needs but does not have adequate tools for justifying law and policy. Bioethics’ tools are mostly theories about what we owe each other. But justifying laws and policies requires more; at a minimum, it requires tools for explaining the legitimacy of actions intended to control or influence others. It consequently requires political, rather than moral, philosophy. After showing how bioethicists have consistently failed to use tools suitable for achieving their political aims, MacDougall develops an interpretation of Kant’s political philosophy. On this account the legitimacy of health laws does …

Errors In Converting Principles To Protocols: Where The Bioethics Of Us Covid‐19 Vaccine Allocation Went Wrong, William F. Parker, Govind C. Persad, Monica E. Peek

Sturm College of Law: Faculty Scholarship

For much of 2021, allocating the scarce supply of Covid-19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy-five …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

Social Justice, Civil Rights, And Bioethics, Kathy Cerminara

Faculty Scholarship

A stunning confluence of events in the United States in the first few months of 2020 have illustrated pervasive systemic prejudice against vulnerable people resulting in increased risk of death. Combined and situated among other, similar incidents too numerous to mention here, they present an opportunity for bioethicists to help change the impact of implicit bias, white privilege, and prejudice in shaping the very ability to live a healthy life in America. The current lack of care and even outright cruelty rendering a variety of vulnerable populations susceptible to early death illustrate why there must be more attention paid to …

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

"As Long As I'M Me": From Personhood To Personal Identity In Dementia And Decision-Making, James Toomey

Elisabeth Haub School of Law Faculty Publications

As people, especially older people, begin to develop dementia, we confront ethical questions about when and how to intervene in their increasingly compromised decision-making. The prevailing approach in philosophically-inclined bioethics to tackling this challenge has been to develop theories of “decision-making capacity” based on the same characteristics that entitle the decisions of moral persons to respect in general. This Article argues that this way of thinking about the problem has missed the point. Because the disposition of property is an identity-dependent right, what matters in dementia and decision-making is an individual’s personal identity with their prior self, not their moral …

Geneva Statement On Heritable Human Genome Editing: The Need For Course Correction, Roberto Andorno, Francoise Baylis, Marcy Darnovsky, Donna Dickenson, Hille Haker, Katie Hasson, Leah Lowthorp, George J. Annas, Catherine Bourgain, Katherine Drabiak, Sigrid Graumann, Katrin Grüber, Matthias Kaiser, David King, Regine Kollek, Calum Mackellar, Jing-Bao Nie, Osagie K. Obasogie, Mirriam Tyebally Fang, Gabriele Werner-Felmayer, Jana Zuscinova

Faculty Scholarship

As public interest advocates, policy experts, bioethicists, and scientists, we call for a course correction in public discussions about heritable human genome editing. Clarifying misrepresentations, centering societal consequences and concerns, and fostering public empowerment will support robust, global public engagement and meaningful deliberation about altering the genes of future generations.

Medical Civil Rights As A Site Of Activism: A Reply To Critics, Craig Konnoth

Publications

See Craig Konnoth, Medicalization and the New Civil Rights, 72 Stan. L. Rev. 1165 (2020).

See also Rabia Belt & Doron Dorfman, Response, Reweighing Medical Civil Rights, 72 Stan. L. Rev. Online 176 (2020), https://www.stanfordlawreview.org/online/reweighing-medical-civil-rights/; Allison K. Hoffman, Response, How Medicalization of Civil Rights Could Disappoint, 72 Stan. L. Rev. Online 165 (2020), https://www.stanfordlawreview.org/online/how-medicalization-of-civil-rights-could-disappoint/.

Constitutionalizing Nature's Law: Dignity And The Regulation Of Biotechnology In Switzerland, James Toomey

Elisabeth Haub School of Law Faculty Publications

The Swiss Constitution was amended by referendum in 1992 to include two unique provisions: Article 119, which imposes strict limits on genetic and reproductive technologies in humans in order to protect ‘human dignity’, and Article 120, which commits the Swiss federal government to limiting genetic technologies in non-human species on the basis of the ‘dignity of the creature’. This article analyzes the role of ‘dignity’ as a limit on biotechnologies in the Swiss constitutional order. It concludes that the understanding of dignity the constitution embraces codifies a contestable metaphysical theory of value at the constitutional level. Specifically, the Swiss constitutional …

Parental Autonomy Over Prenatal End-Of-Life Decisions, Greer Donley

Articles

When parents learn that their potential child has a life-limiting, often devastating, prenatal diagnosis, they are faced with the first (and perhaps, only) healthcare decisions they will make for their child. Many choose to terminate the pregnancy because they believe it is in their potential child’s best interest to avoid a short and painful life. I argue that these decisions should be protected in the same way that parental healthcare decisions are constitutionally protected after birth—including a parent’s refusal or withdrawal of life-saving treatment for an infant or child who is very sick or dying. Parental autonomy ensures that parents …

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …

The Ethics Of Dna Testing At The Border, Medha D. Makhlouf

Faculty Scholarly Works

From 2018 to 2020, the U.S. government dramatically expanded DNA surveillance of immigrants. The most recent expansion, finalized in March 2020, effectively requires the collection of DNA from all immigration detainees and storage of their genetic information in the Federal Bureau of Investigation’s (“FBI”) Combined DNA Index System (“CODIS”) database for criminal forensic investigation. This new policy is ethically troubling because it fails to address the potential privacy harms it creates; shifts the application of DNA analysis for criminal investigation from retrospective to prospective assessment of criminality; and disparately impacts racial and ethnic minorities. In this time of extreme immigration …

Ethical And Regulatory Issues For Embedded Pragmatic Trials Involving People Living With Dementia, Emily A. Largent, Spencer Phillips Hey, Kristin Harkins, Allison K. Hoffman, Steven Joffe, Julie C. Lima, Alex John London, Jason Karlawish

All Faculty Scholarship

Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration …

Medicalization And The New Civil Rights, Craig Konnoth

Publications

In the last several decades, individuals have advanced civil rights claims that rely on the language of medicine. This Article is the first to define and defend these “medical civil rights” as a unified phenomenon.

Individuals have increasingly used the language of medicine to seek rights and benefits, often for conditions that would not have been cognizable even a few years ago. For example, litigants have claimed that discrimination against transgender individuals constitutes illegal disability discrimination. Others have argued that their fatigue constitutes chronic fatigue syndrome (which was, until recently, a novel and contested diagnosis) to obtain Social Security disability …

Transparency Trade-Offs Priority Setting, Scarcity, And Health Fairness, Govind Persad

Sturm College of Law: Faculty Scholarship

This chapter argues that rather than viewing transparency as a right, we should regard it as a finite resource whose allocation involves tradeoffs. It then argues that those tradeoffs should be resolved by using a multi-principle approach to distributive justice. The relevant principles include maximizing welfare, maximizing autonomy, and giving priority to the worst off. Finally, it examines some of the implications for law of recognizing the tradeoffs presented by transparency proposals.

Law & Health Care Newsletter, Spring 2019

Law & Health Care Newsletter

No abstract provided.

Contraceptive Equity: Curing The Sex Discrimination In The Aca's Mandate, Greer Donley

Articles

Birth control is typically viewed as a woman’s problem despite the fact that men and women are equally capable of using contraception. The Affordable Care Act’s contraceptive mandate (Mandate), which requires insurers to cover all female methods of birth control without cost, promotes this assumption and reinforces contraceptive inequity between the sexes. By excluding men, the Mandate burdens women in four ways: it fails to financially support a quarter to a third of women that rely on male birth control to prevent pregnancy; it incentivizes women to endure the risks and side effects of birth control when safer options exist …