Law Commons^™

Commentary On Reynolds V. Mcnichols, Aziza Ahmed

Faculty Scholarship

The 1973 case Reynolds v McNichols concerns a woman who was repeatedly arrested on suspicion of and for “prostitution.” During these arrests, Roxanne Reynolds, the defendant, was subject to forced examination and treatment. The arrests and examinations were authorized by Section 735 of the Revised Municipal Code of the City and County of Denver, which directed the Department of Health and Hospitals “to use every available means to ascertain the existence of and investigate all suspected cases of communicable venereal disease, and to determine the sources of such infections.” Reynolds argued that the ordinance was unconstitutional because it was irrational, …

When Desperate Patients Go To Court For Unproven Treatments - The Battle For Hospital Independence, Christopher Robertson, Margaret Houtz

Faculty Scholarship

As the Covid-19 pandemic wears on, patients have asked courts to compel hospitals to administer unproven therapies, with mixed legal results. Although talk radio hosts, politicians, and social media users have promoted various treatment approaches, they have given particular attention to ivermectin. The Food and Drug Administration (FDA) has approved ivermectin for use in humans for treating onchocerciasis (river blindness), intestinal strongyloidiasis, certain other parasitic worms, head lice, and skin conditions such as rosacea. Although this approval facilitates legal offlabel use for prophylaxis against or treatment of other conditions, both the FDA and the Centers for Disease Control and Prevention …

Race, Risk, And Personal Responsibility In The Response To Covid-19, Aziza Ahmed, Jason Jackson

Faculty Scholarship

The COVID-19 crisis has tragically revealed the depth of racial inequities in the United States. This Piece argues that the disproportion­ate impact of the pandemic on racial minorities is a symptom of a failing approach to public health, one that privileges individual behaviors over the structural conditions that generate vulnerability and inequitable health outcomes. Despite clear racial disparities in illness and deaths, the neoliberal ideology of personal responsibility shifts the onus for mitigation of risk away from the social and legal determinants of health and onto the individual. To understand how and why these disparate racial outcomes arise, this Piece …

Antibiotic Development & Economic, Regulatory And Societal Challenges, Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, John Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

A Perspective On Incentives For Novel Inpatient Antibiotics: No One-Size-Fits-All, Kevin Outterson

Faculty Scholarship

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

An International Legal Framework To Address Antimicrobial Resistance, Kevin Outterson, Steven J. Hoffman, John-Arne Rottingen, Otto Cars, Charles Clift, Fiona Rotberg, Göran Tomson, Anna Zorzet, Zain Rizvi

Faculty Scholarship

Antimicrobial resistance is a growing threat to global health. Currently it accounts for approximately 700,000 deaths annually, but is predicted to cause as many as 10,000,000 deaths by 2050 if nothing is done to address it. To effectively deal with this problem three areas must be addressed simultaneously: access, conservation, and innovation. However, solving issues of access, conservation and innovation at the same time requires new coordination and financing mechanisms, some of which must be organized globally. This bulletin outlines the possible role that a binding international legal framework can play in the fight against antimicrobial resistance.

Adjudicating Risk: Aids, Crime, And Culpability, Aziza Ahmed

Faculty Scholarship

The AIDS epidemic continues to pose significant public health challenges, especially given that the spread of the virus outpaces the AIDS response.¹ Importantly, HIV continues to disproportionately impact socially and economically marginalized communities. In countries with concentrated epidemics,² it is racial minorities, sex workers, men who have sex with men, and drug users who face the brunt of the epidemic.³ In the United States, the data is startling⁴ : 44% of new infections were among African-Americans, and among African-Americans contracting HIV, 57% were among gay and bisexual men.⁵ In 2016, the CDC found that one …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Trafficked? Aids, Criminal Law And The Politics Of Measurement, Aziza Ahmed

Faculty Scholarship

Since early in the HIV epidemic, epidemiologists identified individuals who transact sex as a high-risk group for contracting HIV. Where the issue of transacting sex has been framed as sex work, harm-reduction advocates and scholars call for decriminalization as a primary legal solution to address HIV. Where the issue is defined as trafficking, advocates known as abolitionists argue instead for the criminalization of the purchase of sex.

Global health governance institutions are porous to these competing ideas and ideologies. This article first historicizes the contestation between harm-reduction and abolition in global governance on health. The paper then turns to a …

Challenges For People With Disabilities Within The Health Care Safety Net, Michael Ulrich

Faculty Scholarship

Medicare and Medicaid were passed to serve as safety nets for the country's most vulnerable populations, yet, the disabled community continues to be one whose health care needs are not being met. This group is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that covers the population as a whole and their acute and long-term needs.

“Rugged Vaginas” And “Vulnerable Rectums”: The Sexual Identity, Epidemiology, And Law Of The Global Hiv Epidemic, Aziza Ahmed

Faculty Scholarship

AIDS remains amongst the leading causes of death globally. Identity is the primary mode of understanding HIV and organizing in response to the HIV epidemic. In this Article, I examine how epidemiology and human rights activism co-produce ideas of identity and risk. I call this the "identity/risk narrative ": the commonsense understanding about an identity group's HIV risk. For example, epidemiology offers the biological narrative of risk: anal sex and the weak rectal lining make men who have sex with men more vulnerable to HIV; while the fragility of a woman's vaginal wall provides a biological foundation for women's vulnerability. …

With Liberty And Access For Some: The Aca's Disconnectfor Women's Health, Nicole Huberfeld

Faculty Scholarship

The ACA denies to women the "basic security" of providing insurance for a procedure that statistics show one in three women will need during their reproductive lifetime. On one hand, the access-enhancing elements of the ACA are likely to help women, who earn lower wages, need more medical care, and live longer than men, to gain access to preventive and regular healthcare and to keep the insurance that they have. On the other hand, poor women and women of color will lose ground in access to abortion, because the ACA prevents insurance payment for abortions through both public and private …

Feminism, Power, And Sex Work In The Context Of Hiv/Aids: Consequences For Women's Health, Aziza Ahmed

Faculty Scholarship

This paper examines the involvement of feminists in approaches to sex work in the context of HIV/AIDS. The paper focuses on two moments where feminist disagreement produced results in favor of an "anti-trafficking" approach to addressing the vulnerability of sex workers in the context of HIV. The first is the UNAIDS Guidance Note on Sex Work and the second is the "anti-prostitution pledge" found in the Presidents Emergency Plan for AIDS Relief. This article also examines the anti-sex work position articulated by abolitionist feminists and demonstrates the unintended consequences of the abolitionist position on women's health. By examining the actual …

Smoking And The First Amendment, Kevin Outterson

Faculty Scholarship

On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law. For the first time, Congress had given the Food and Drug Administration (FDA) authority to directly regulate tobacco products, with the aim of improving public health. And indeed, effective tobacco control would be a remarkable public health achievement — and might be possible if the law is allowed to stand. But on November 7, 2011, a federal judge in Washington, D.C., issued a preliminary injunction blocking some of its key provisions as unconstitutional restrictions on commercial speech, and the battle seems likely …

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.

The Supreme Court And Abortion Rights, George J. Annas

Faculty Scholarship

Since the Supreme Court's landmark 1973 abortion-rights decision in Roe v. Wade, the law has taken the lead in defining the contours of the continuing public debate over reproductive liberty. Ever since then, abortion opponents have tried to make abortion more burdensome by limiting Roe, and these continuing challenges are the reason there have been so many Supreme Court decisions about abortion, including the Court's 1992 decision in Planned Parenthood of Southeastern Pennsylvania v. Casey, which unexpectedly reaffirmed the core of Roe.

Be Not Afraid Of Change: Time To Eliminate The Corporate Practice Of Medicine Doctrine, Nicole Huberfeld

Faculty Scholarship

This article argues that the corporate practice of medicine doctrine is a physician-centric, guild type doctrine that is misplaced in the present incarnation of the American healthcare system and that does nothing to improve quality, efficiency, or accountability. The paper focuses on three key reasons that the corporate practice of medicine doctrine should be laid to rest. First, the motives for creating the corporate practice of medicine doctrine are long gone, as physicians have not been able to operate as a guild of autonomous providers of healthcare for quite some time. Second, it is disingenuous to pretend that physicians are …

The Right To Health And The Nevirapine Case In South Africa, George J. Annas

Faculty Scholarship

Thanks to activists in South Africa, the right to health as a human right has returned to the international stage, just as it was being displaced by economists who see health through the prism of a globalized economy and by politicians who see it as an issue of national security or charity. The current post-apartheid debate in South Africa is not about race but about health, and in this context, the court victory by AIDS activists in the nevirapine case has been termed not only, as stated in one British newspaper, “the greatest defeat for [President Thabo] Mbeki's government” but …

Genetic Testing For Susceptability To Disease From Exposure To Toxic Chemicals: Implications For Public And Worker Health Policies, Michael S. Baram

Faculty Scholarship

The Environmental Genome Program intends to identify "susceptibility genes" that would indicate if a person is more vulnerable to cancer or other disease as a result of exposure to certain chemicals in the workplace, the environment, foods, or other products. Research findings and the capability to test persons for such genes are likely to impugn and challenge health policies and regulatory programs that do not take genetic susceptibility into account when conferring health benefits and restricting chemical exposures. This article focuses on the Occupational Safety and Health Administration (OSHA) and discusses four options available to this agency for protecting genetically …

Tobacco, The Food And Drug Administration, And Congress, George J. Annas

Faculty Scholarship

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices.”1 The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. …

Burden Of Proof: Judging Science And Protecting Public Health In (And Out Of) The Courtroom, George J. Annas

Faculty Scholarship

The breast implant cases alleging systemic disease would in all likelihood have been lost had recipients been properly warned of potential dangers by the manufacturer or their surgeons.

Partial-Birth Abortion, Congress, And The Constitution, George J. Annas

Faculty Scholarship

The political debate over abortion during the past 25 years has shifted among various dichotomous views of the world: life versus choice, fetus versus woman, fetus versus baby, constitutional right versus states' rights, government versus physician, physician and patient versus state legislature. Hundreds of statutes and almost two dozen Supreme Court decisions on abortion later, the core aspects of Roe v. Wade, 1 the most controversial health-related decision by the Court ever, remain substantially the same as they were in 1973. Attempts to overturn Roe in both the courtroom and the legislature have failed. Pregnant women still have a constitutional …

A National Bill Of Patients' Rights, George J. Annas

Faculty Scholarship

In one of the most enthusiastically received proposals in his January State of the Union address, President Bill Clinton called on Congress to enact a national bill of rights in health care. The President said, “You have the right to know all your medical options, not just the cheapest. You have the right to choose the doctor you want for the care you need. You have the right to emergency room care, wherever and whenever you need it. You have the right to keep your medical records confidential.”

Women And Children First, George J. Annas

Faculty Scholarship

In the lore of the sea there are few events that have so exemplified heroism and self-sacrifice as the acts of the soldiers and sailors of the British ship Birkenhead when it sank in 1852. The soldiers of the 74th Highland Regiment stood at attention on deck (with the band playing) “while the women and children were saved and the captain very properly went down with his ship.” More than 450 lives were lost, and the phrase “women and children first” was introduced into the language as part of the “Birkenhead drill.” As Kipling put it in his poem …

Reframing The Debate On Health Care Reform By Replacing Our Metaphors, George J. Annas

Faculty Scholarship

Metaphors matter, as our sterile debate on the fi-nancing of health insurance demonstrates so well. In that debate the traditional metaphor of American medicine, the military metaphor, was displaced by the market metaphor in public discourse. Metaphors, which entice us to understand and experience “one kind of thing in terms of another . . . play a central role in the construction of social and political reality.” The market metaphor proved virtually irresistible in the public arena and led Congress to defer to market forces to “reform” the financing of health insurance in the United States.

Health Warnings, Smoking, And Cancer - The Cipollone Case, George J. Annas

Faculty Scholarship

The figures have become familiar. Tobacco use has been declared "the single most important preventable cause of [premature] death in the United States, accounting for one of every six deaths, or some 390,000 deaths annually. "The health goals of the nation for the year 2000 call for reducing the prevalence of cigarette smoking to 15 percent among adults (a 48 percent decrease from the current 29 percent) and reducing the rate of beginning smoking among teenagers to 15 percent (a 50 percent decrease from the current rate of 30 percent). The goal of reducing smoking in the United States is …

The Law And Economics Of Organ Procurement, Keith N. Hylton

Faculty Scholarship

This paper presents an economic analysis of the organ procurement system in the U.S. and examines proposals to alleviate the shortage of transplantable organs. The paper's principal conclusions are: (1) Although non-market solutions deserve the highest priority, demand increases fueled by improvements in transplant technology will probably make some market-based solution necessary in the future. (2) Quality deterioration and coercion will not necessarily be worrisome problems under a market-based procurement system.