Health Law and Policy Commons^™

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Faculty Scholarship

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness. Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories, and provides an early empirical test of these models, using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models, and …

Human Rights And American Bioethics: Resistance Is Futile, George J. Annas

Faculty Scholarship

The Borg are always confident that humans will be assimilated into their collective hive and therefore that, as they say, “resistance is futile.” In Star Trek, of course, the humans always successfully resist. Elizabeth Fenton and John Arras, like the Borg, resist the idea that humans are uniquely special as well as the utility of the human rights framework for global bioethics. I believe their resistance to human rights is futile, and I explain why in this essay. Let me begin with their subtitle, because we do seem to agree that popular culture is a powerful aid to understanding human …

Recalibrating The Legal Risks Of Cross-Border Health Care, Nathan Cortez

Faculty Journal Articles and Book Chapters

The nascent scholarship surrounding "medical tourism" assumes, without much scrutiny, that foreign jurisdictions provide few legal remedies to patients, instead focusing on whether U.S. patients can sue in U.S. courts. This article tests that assumption by examining whether patients might recover adequate compensation not only in the United States, but in four common destinations: India, Thailand, Singapore, and Mexico. I analyze how each jurisdiction handles medical malpractice complaints and discuss the unique obstacles patients might face when navigating each of these systems. I conclude that U.S. patients will struggle to recover remotely adequate compensation in each of these jurisdictions. This …

Nih Guidelines On Human Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael Ulrich

Faculty Scholarship

Restrictions on federal funding for human embryonic stem cell (hESC) research under President Bush stimulated a number of states and the private sector to fund stem cell research, resulting in a patchwork of varying guidelines throughout the country. The National Institutes of Health’s (NIH) guidelines were expected to change all of this.With President Obama following through on his assurance to remove restrictions, stem cell researchers assumed they would find clarity when the new NIH Guidelines on Human Embryonic Stem Cell Research were promulgated to outline an ethical framework to determine which research was eligible for federal funding. As part of …

Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, "integrated" strategy. This would increase reimbursement for the appropriate, …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

Physician-Assisted Suicide And Dementia: The Impossibility Of A Workable Regulatory Regime, John B. Mitchell

Faculty Articles

Currently, four-and-a-half million Americans are afflicted with Alzheimer’s Disease, accounting for roughly half the cases of adult dementia, and fourteen million cases are projected by mid-century. With the coalescence of the baby boomers, managed health care, and increasingly scarce health care resources, our society must brace to face a social and legal policy challenge of enormous importance and complexity. In this circumstance, the inevitable call for access to physician-assisted suicide, likely triggered through some form of living will, will need to be considered within a context far different than the current focus of the assisted-suicide debate on terminal illness. Asserting …

Reconstructing The Individual Mandate As An Escrow Account, Gregg Polsky

Scholarly Works

This short essay in Michigan Law Review First Impressions describes how the individual mandate could be reconstructed as an escrow account. Such a restructuring would ameliorate policy concerns regarding the mandate while still deterring the opportunistic behavior that would otherwise occur as a result of the nondiscrimination rules imposed on insurers.

What I Talk About When I Talk About Health Law, Elizabeth Weeks

Scholarly Works

Invited contribution celebrating the 25th Anniversary of the Beazley Institute for Health Law & Policy.

Preserving Human Potential As Freedom: A Framework For Regulating Epigenetic Harms, Fazal Khan

Scholarly Works

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the …

Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead

Journal Articles

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square.

This Article examines the question of how scientific methods and …

Reauthorizing Schip: Only A Starting Point, Pamela Newell

Journal Articles

No abstract provided.

Second Class Citizens: The Case Against Unequal Military Healthcare Benefits For Puerto Rican Veterans, Mónica Matos-Desa

Cardozo Journal of Equal Rights & Social Justice

The note argues that Puerto Rican veterans and their families face unequal treatment under the TRICARE healthcare system due to Puerto Rico's status as an unincorporated territory. This inequality stems from historical legal frameworks that have perpetuated the notion of Puerto Ricans as second-class citizens, despite their significant contributions to the U.S. military. The note advocates for legislative changes to extend equal TRICARE Prime benefits to Puerto Rico, ensuring first-class citizenship for its residents.

In The Manner Prescribed By The State: Potential Challenges To State-Enforced Hospital Limitations On Childbirth Options, Krista Stone-Manista

Cardozo Journal of Equal Rights & Social Justice

The article argues that hospital bans on vaginal births after cesarean (VBAC) infringe upon women's legal and constitutional rights, violating principles of autonomy and equality. These bans are not only medically unnecessary but also undermine international human rights standards that protect women's decisional autonomy in healthcare. The analysis posits that such bans discriminate against women and set a dangerous precedent for state and medical control over women's bodies during pregnancy.

Cutting The Fat Out Of Health-Care Costs: Why Medicare And Medicaid Write-Offs Should Not Be Recoverable Under Oklahoma’S Collateral Source Rule, Michael W. Cromwell

Oklahoma Law Review

No abstract provided.

Pursuing Health As Foreign Policy: The Case Of China, Yanzhong Huang

Indiana Journal of Global Legal Studies

Eastphalia Emerging?: Asia, International Law, and Global Governance, Symposium. Indiana University Maurer School of Law, Bloomington, Indiana, 2009

The President’S Global Health Initiative, Lawrence O. Gostin, Emily A. Mok

Georgetown Law Faculty Publications and Other Works

The U.S. Global Health Initiative (GHI) represents the Obama administration’s new strategy for international development assistance in health. With a pledge of $63 billion over six years, GHI aims to fund PEPFAR and a set of broader global health issues (e.g., maternal and child health, nutrition, and neglected tropical diseases). GHI is also being framed as “smart power” whereby health would serve as a critical tool for U.S. foreign policy.

However, as the U.S. enters a period of severe budgetary restraint and as domestic crises rise to the fore, the promise of global health reform could become illusory. The lack …

The National Individual Health Insurance Mandate: Ethics And The Constitution, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Within weeks, after signing the nation’s first comprehensive health insurance reform, twenty states filed lawsuits challenging the constitutionality of the Bill’s most politically charged feature—an individual purchase mandate. If anything, the tax penalty is too low compared with the cost of insurance, so it may not sufficiently incentivize healthy individuals. But it remains deeply controversial because it compels individuals to purchase coverage they choose not to have, raising the question whether Congress can lawfully and ethically require individuals to contract with, and transfer money to, a private party. To be sure, the individual mandate lacks a clear American precedent. (It …

Redressing The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Consider two children—one born in sub-Saharan Africa and the other in the United States. The African child is twenty-five times more likely to die in the first five years of life; if she lives to child-bearing age, she is a two hundred times more likely to die in labor; and overall, she will die thirty years earlier than the American child. The international community is deeply resistant to taking bold remedial action—more concerned with their geostrategic interests than the health of the poor. The scale of foreign aid is both insufficient and unsustainable and fails to address the key determinants …

The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

International norms recognize the special value of health. The WHO Constitution states that “the enjoyment of the highest attainable standard of health” is a fundamental human right. The right to health, moreover, is a treaty obligation with clear obligations. Despite robust international norms, unconscionable health disparities exist between the world’s rich and poor, causing enormous suffering. The WHO urges “closing the health gap in a generation” through action on the social determinants of health. As the Marmot Commission observed: “the social conditions in which people are born, live, and work are the single most important determinant of good or ill …

Reducing Distracted Driving: Regulation And Education To Avert Traffic Injuries And Fatalities, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we consider the legal and policy implications of distracted driving (the tendency of people to use electronic devices while operating a motor vehicle). After reviewing the empirical evidence showing that distracted driving has serious adverse consequences, we discuss the legal basis for governmental interventions to reduce distracted driving. These interventions include laws restricting the use of electronic devices while driving, especially sending text messages. Since drivers have at best a reduced expectation of privacy, these restrictions should easily survive legal challenges. At the same time, it is important to consider the responsibility of automobile manufacturers to improve …

Restoring Health To Health Reform, Lawrence O. Gostin, Peter D. Jacobson

Georgetown Law Faculty Publications and Other Works

In this article, we discuss the public health provisions of the Patient Protection and Affordable Care Act (PPACA--P.L. 111-148). We first set forth a framework to identify the key reforms that are needed for a robust public health system. These include workforce and infrastructure investments. We then assess the PPACA against these criteria. We conclude that although the act would make significant investment in public health (especially in wellness and prevention programs), it does little to improve the existing structural deficiencies that the public health system must overcome if it is to be effective in improving the population’s health.

The O’Neill Institute For National And Global Health Law: Discovering Innovative Solutions For The Most Pressing Health Problems Facing The Nation And The World, Lawrence O. Gostin, Oscar A. Cabrera, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

The connection between health and an individual’s ability to function in society, as well as the importance of health to a society’s economic, political, and social wellbeing necessitates finding innovative solutions to the world’s most pressing health problems. The O’Neill Institute for National and Global Health Law at Georgetown University seeks to demonstrate the role that academia can play in addressing complex national and global health problems in a comprehensive, evidence-based, intellectually-rigorous, and nonpartisan manner. The O’Neill Institute currently has three research programs: global health law, national health law, and the center for disease prevention and outcomes. Projects within these …

Health Care Reform — A Historic Moment In Us Social Policy, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

On March 23, 2010, President Obama signed into law the first U.S. comprehensive health care reform bill, the Patient Protection and Affordable Care Act (PPACA). After almost a century of failed attempts, the U.S. now has a national health care system which promises to increase access to care, increase consumer choice, and ban insurance discrimination for individuals with preexisting medical conditions. The PPACA is expected to expand insurance coverage to 32 million individuals by 2019 through a variety of measures. At a cost of $938 billion over 10 years, the PPACA is projected to reduce the deficit by $143 billion …

High Crimes, Not Misdemeanors: Deterring The Production Of Unsafe Food, Rena I. Steinzor

Faculty Scholarship

In the fall of 2008, Minnesota public health officials became alarmed by an unusually high number of illnesses and deaths caused by salmonella poisoning. Federal and state regulators and the news media eventually traced the outbreak back to products supplied by the Peanut Corporation of America (PCA). Employees shipped batches that tested positive for salmonella from a plant with a leaking roof, mold growing on ceilings and walls, rodent infestation, filthy processing receptacles, and feathers and feces in the air filtration system. Under an agreement with the Food and Drug Administration (FDA), Georgia state inspectors visited the PCA plant nine …

Nih Guidelines On Human Embryonic Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael R. Ulrich

Faculty Scholarship

No abstract provided.

Does Twenty-Five Years Make A Difference In “Unequal Treatment”?: The Persistence Of Racial Disparities In Health Care Then And Now, Ruqaiijah A. Yearby

All Faculty Scholarship

In 1985, the Secretary of the U.S. Department of Health and Services (HHS) issued a landmark report that exposed the persistence of racial disparities in the U.S. healthcare system. Unfortunately, twenty-five years later, racial disparities in healthcare continue to persist. For example, since 1985, more African-Americans have died from coronary disease, breast cancer, and diabetes than Caucasians, even though more Caucasians suffer from these diseases than African-Americans. Notwithstanding their increased mortality rates, African Americans “have a statistically significantly lower mean number of annual ambulatory [walk-in] visits and are less likely to have seen a physician in [any given] year.” Studies …

Race, Sex And Genes At Work: Uncovering The Lessons Of Norman-Bloodsaw, Elizabeth Pendo

All Faculty Scholarship

The Genetic Information Nondiscrimination Act of 2008 (“GINA”) is the first federal, uniform protection against the use of genetic information in both the workplace and health insurance. Signed into law on May 21, 2008, GINA prohibits an employer or health insurer from acquiring or using an individual’s genetic information, with some exceptions. One of the goals of GINA is to eradicate actual, or perceived, discrimination based on genetic information in the workplace and in health insurance. Although the threat of genetic discrimination is often discussed in universal terms - as something that could happen to any of us - the …

The Eminence Of Imminence And The Myopia Of Markets, Teneille R. Brown

Utah Law Faculty Scholarship

This article questions the privileging of disaster, or imminent threat, over more distant threats to public health. In many cases, this privileging makes sense as we do not have time to evaluate the threat under traditional frameworks. But in some cases, we privilege disaster in ways that may be ethically and legally unsound. Here I am interested in a particular type of public health threat – the negative consequences that stem from climate change. In this article I view the climate change discussion through the lens of distributive justice. I analyze the ethical as well as legal arguments for encouraging …

Scientific Understandings Of Postpartum Illness: Improving Health Law And Policy?, Stacey A. Tovino

Scholarly Works

In its broadest sense, the Article examines the relationship between science and the law in the context of postpartum illness. From classical antiquity to the present day, physicians and scientists have investigated the causes, correlates, and consequences of the depressions and psychoses that develop in some women following their transition to motherhood. The scientific investigation of postpartum illness has been characterized by an open-ended search for knowledge with the recgonition that scientific findings published one day are subject to revision the next. Legislators and judges also have sought to understand postpartum illness as necessary to make laws that affect and …