Health Law and Policy Commons^™

Global Health Law Governance, Lawrence O. Gostin

O'Neill Institute Papers

The field of public health law traditionally focuses on law at the national and sub-national level. National legal systems, however, are inadequate to deal with major threats to humans. Despite the inadequacies of national governance, there are fundamental questions that need resolution in the field of global health law: Why should governments care about the health of people far away? Are profound health disparities just and, if not, is there a corresponding obligation to redress the injustice? Can international law effectively bind governments, foundations, and corporations to act for the global good? This article, based on a lecture at Emory …

A Theory And Definition Of Public Health Law, Lawrence O. Gostin

O'Neill Institute Papers

The literature, both academic and judicial, on the intersection of law and health is pervasive. The subject of law and health is widely taught, practiced, and analyzed. The fields that characterize these branches of study are called health law, health care law, law and medicine, forensic medicine, and public health law. Do these names imply different disciplines, each with a coherent theory, structure, and method that sets it apart? Notably absent from the extant literature is a theory of the discipline of public health law, an exploration of its doctrinal boundaries, and an assessment of its analytical methodology.

Public health …

The International Migration And Recruitment Of Nurses: Human Rights And Global Justice, Lawrence O. Gostin

O'Neill Institute Papers

The international migration of health workers – physicians, nurses, midwives, and pharmacists – leaves the world’s poorest countries with severe human resource shortages, seriously jeopardizing the achievement of the U.N. health Millennium Development Goals (MDGs). Advocates for global health call active recruitment in low-income countries a crime. Despite the pronounced international concern, there is little research and few solutions. This commentary focuses on the international recruitment of internationally educated nurses (IENs) from the perspective of human rights and global justice. It explains the complex reasons for nurse shortages in rich and poor countries; the duties of source and host countries; …

Ensuring Effective Pain Treatment: A National And Global Perspective, Allyn L. Taylor, Lawrence O. Gostin, Katrina A. Pagonis

O'Neill Institute Papers

Medical availability of effective pain medication is vitally important domestically and globally. Medical advances have substantially improved the technical capacity to control pain and diminish its consequences. Worldwide, millions of persons with chronic, acute, and terminal conditions have found relief from excruciating pain through medical intervention. However, richer countries have disproportionately benefited from improvements in access to and use of pain medication. The tragedy is that for most of the world's population, particularly persons in poorer countries, effective pain control is entirely unavailable.

The "Fetal Protection" Wars: Why America Has Made The Wrong Choice In Addressing Maternal Substance Abuse - A Comparative Legal Analysis, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

No abstract provided.

The Duty Of States To Assist Other States In Need: Ethics, Human Rights, And International Law, Lawrence O. Gostin, Robert Archer

O'Neill Institute Papers

This article deals with a foreign policy question of extraordinary importance: What responsibilities do States have to provide economic and technical assistance to other states that have high levels of need affecting the health and life of their citizens? The question is important for a variety of reasons. There exist massive inequalities in health globally, with the result that poorer countries shoulder a disproportionate burden of disease and premature death. While poor countries have by far the greatest ongoing health needs, they also have the least capacity to meet those needs. In addition to the pervasive and debilitating effects of …

Readability Studies: How Technocentrism Can Compromise Research And Legal Determinations, Louis J. Sirico Jr.

Working Paper Series

One way to determine whether consumers understand a document is to use a readability formula to assign it a score. These formulas calculate readability by counting such variables as the number of words and syllables in a passage or document. The idea of readability formulas has been defined as “an equation which combines those text features that best predict text difficulty. The equation is usually developed by studying the relationship between text features (e.g., words, sentences) and text difficulty (e.g., reading comprehension, reading rate, and expert judgment of difficulty).” Even though readability formulas are mechanical and imperfect, they are easy …

Addressing The Global Tragedy Of Needless Pain: Rethinking The United Nations Single Convention On Narcotic Drugs, Allyn L. Taylor

O'Neill Institute Papers

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

Over a quarter of a century has passed since health care ethics committees (HCECs) in the United States received legal recognition as alternatives to the courts in resolving conflicts related to patient end-of-life care. By the mid to late 1980s HCECs had been established in over half of U.S. hospitals and had received a certain legitimacy in the health care system. Given their age and growth one could characterize them developmentally as emerging from adolescence and establishing themselves in young adult-hood. As a result, we might expect that they would have resolved the identify crisis characterizing the adolescent years. Yet, …

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Climate Change, Human Health, And The Post-Cautionary Principle, Lisa Heinzerling

O'Neill Institute Papers

In this Article, I suggest two different but related ways of reframing the public discourse on climate change. First, I propose that we move further in the direction of characterizing climate change as a public health threat and not only as an environmental threat. Second, I argue that we should stop thinking of responses to climate change in terms of the precautionary principle, which counsels action even in the absence of scientific consensus about a threat. We should speak instead in terms of a ?post-cautionary? principle for a post-cautionary world, in which some very bad effects of climate change are …

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …

What Do Nonprofits Maximize? Hospital Service Provision And Market Ownership Mix, Jill R. Horwitz, Austin Nichols

Law & Economics Working Papers Archive: 2003-2009

Conflicting theories of the nonprofit firm have existed for several decades yet empirical research has not resolved these debates, partly because the theories are not easily testable but also because empirical research generally considers organizations in isolation rather than in markets. Here we examine three types of hospitals – nonprofit, for-profit, and government – and their spillover effects. We look at the effect of for-profit ownership share within markets in two ways, on the provision of medical services and on operating margins at the three types of hospitals. We find that nonprofit hospitals’ medical service provision systematically varies by market …

Integrating The Complexity Of Mental Disability Into The Criminal Law Course, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

No abstract provided.

Cold Comfort Pharmacy: Pharmacist Tort Liability For Conscientious Refusals To Dispense Emergency Contraception, Kristen Marttila Gast

ExpressO

The past several years have seen an increasing number of pharmacists refuse to dispense emergency contraception, an effective, post-coital form of contraception, on the grounds that the drug violates their personal beliefs. This Article addresses the impact of those pharmacist refusals under existing principles of tort law. The Article draws on existing pharmacy case law, state-specific refusal clauses, and ethics statements promulgated by professional pharmacy associations to investigate whether pharmacists have a legal duty to dispense emergency contraception, notwithstanding religious or ethical objections. Concluding that in most states, such a legal duty does exist, the Article develops a “wrongful conception” …

Accessing Reproductive Technologies: Invisible Barriers, Indelible Harms, Judith F. Daar

ExpressO

The use and success of assisted reproductive technologies (ART) over the past decade has contributed perceptibly to family formation nationwide. Today, 3 of every 100 children born owe their existence to some form of assisted conception. Despite, or perhaps because of, its technical successes, a growing body of evidence suggests that barriers to ART are being constructed to prevent procreation among select populations. The article’s theme is one of harm, specifically the harm that befalls patients, physicians, offspring and society when fertility treatments are denied on the basis of personal characteristics, including race, marital status and sexual orientation. While ART …

Brave New Babies, Lori B. Andrews

All Faculty Scholarship

No abstract provided.

Overriding Mental Health Treatment Refusals: How Much Process Is "Due"?, Samuel Jan Brakel

ExpressO

No abstract provided.

Of Elephants And Embryos: A Proposed Framework For Legal Personhood, Jessica Berg

ExpressO

No abstract provided.

Doomsday: A Look At The Ethical Issues Behind The Government's Coercive Powers In Response To A Public Health Nightmare., Jacob M. Chapman

ExpressO

This article posits a hypothetical scenario in which a deadly pandemic is unleashed upon the United States and the several individuals whom appear to have a natural immunity refuse to participate in necessary research. The article then examines the possible legal and ethical approaches available for reacting to the pandemic.

The hypothetical scenario addressed in this article highlights a gap in current public health law. While various states have laws and procedures relating to quarantine and forced inoculation, these laws and procedures do not suggest whether the state may or may not coerce non-threatening individuals into participating in potentially dangerous …

New Differences Between Negligence And Strict Liability And Their Implications On Medical Malpractice Reform, Noam Sher

ExpressO

The present article seeks to explore previously undiscussed differences between the negligence and strict liability rules and thereby examine the required medical liability reform, if such reform is indeed required. Our main thesis is that negligence as a basis for liability entails a unique mechanism, which is essentially different than the strict liability mechanism, and is more efficient for several reasons, related to the legal function of resolving partial information problems which cause partial failure in the healthcare market. Among other things, the negligence mechanism (1) motivates the parties to a potential damages claim to invest in information gathering; (2) …

Patent Political Economy - Indian Lessons On Pharmaceutical Patent, Julien L. Chaisse, Samira Guennif

ExpressO

The Intellectual Property Rights (IPR) regime adopted by any country is essentially a tool that strives to ensure both the growth of the domestic pharmaceutical industry and people’s access to medicines. But, contrary to the very easily advanced theory, there is no paradox between the two. From this perspective, the Indian experience has shown that it is precisely the relaxation of its national IPR regime that promoted the growth of its domestic industry, thereby ensuring a better patient access to medicines. However, the globalisation process does not overlook any sector, which means that medicines too are submitted to the new …

Hepatitis C In Prisons: Evolving Toward Decency Through Adequate Medical Care And Public Health Reform, Andrew Brunsden

Articles & Chapters

Hepatitis C (HCV) in prisons is a public health crisis tied to current drug policy's emphasis on the mass incarceration of drug users. Prison policy acts as a barrier to HCV care by limiting medical care for the infected, especially drug users, and by inhibiting public health measures addressing the epidemic. This Comment argues that courts mistakenly limit prisoners' Eighth Amendment right to basic medical care when they defer to prisons that apply HCV policies as categorical rules of treatment. Where current standards of care mandate individualized patient evaluation for treatment, prison policies that eschew this principle exhibit deliberate indifference …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Medical Self-Defense, Prohibited Experimental Therapies, And Payment For Organs, Eugene Volokh

ExpressO

Three sisters lie in adjoining hospital rooms. A fourth lives a block away. All are in deadly peril.

Alice is seven months pregnant, and the pregnancy threatens her life. Her fetus has long been viable, so she no longer has the Roe/Casey right to abortion on demand. But because her life is in jeopardy, she has a constitutional right to save her life by hiring a doctor to perform a post-viability abortion, though it means the death of a viable fetus. She would even have such a right if the pregnancy were only posing a serious threat to her health, …

The Brain-Disordered Defendant: Neuroscience And Legal Insanity In The Twenty-First Century, Richard E. Redding

Working Paper Series

Brain-damaged defendants are seen everyday in American courtrooms, and in many cases, their criminal behavior appears to be the product of extremely poor judgment and self-control. Some have a disorder in the frontal lobes, the area of the brain responsible for judgment and impulse control. Yet because defendants suffering from frontal lobe dysfunction usually understand the difference between right and wrong, they are unable to avail themselves of the only insanity defense available in many states, a defense based on the narrow McNaghten test. “Irresistible impulse” (or “control”) tests, on the other hand, provide an insanity defense to those who …

Plan B Contraceptive And The Role Of Politics In Medicine: A Comparative Analysis Of The "Switch" Of Emergency Contraception From Prescription To Non-Prescription In The United States, France, The United Kingdom, And Canada, Mary E. Armstrong

ExpressO

Of the approximately 6 million pregnancies in the United States each year, almost half are unintended. Of these unintended pregnancies, approximately four in ten will end in abortion. Plan B emergency contraception is a drug that has the potential to reduce the number of abortions performed each year in half. Despite contentions from various religious and political sects, Plan B is not an abortifacient. It acts by preventing a pregnancy from starting rather than terminating a pregnancy that is already established. On December 16, 2003, a panel of medical and scientific experts gathered by the Food and Drug Administration (FDA), …

Brain Imaging And Privacy: How Recent Advances In Neuroimaging Implicate Privacy Concerns , David P. Finn

ExpressO

This paper deals with recent advances in neuroimaging technologies which could begin to implicate privacy concerns in the near future.

Biopolitics At The Bedside: Proxy Wars And Feeding Tubes, Joshua E. Perry

ExpressO

In the aftermath of Terri Schiavo’s dramatic final weeks of life, George Annas speculated that proponents of “culture of life” politics might “now view [themselves] as strong enough to generate new laws . . . to require that incompetent patients be kept alive with artificially delivered fluids and nutrition.” Indeed, Professor Annas’ prescience has been demonstrated by the post-Schiavo introduction in two dozen state legislatures of over fifty different bills making it more onerous to remove a patient’s artificial nutrition and hydration (ANH). With minor exception, however, most of the proposed legislation has either stalled or been watered down, prompting …