Health Law and Policy Commons^™

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

Physician Peer Review Immunity: Time To Euthanize A Fatally Flawed Policy, Charles R. Koepke M.D.

Journal of Law and Health

Dr. X is a young, charismatic, board-certified surgeon at the local hospital. While popular among her patients and non-surgical colleagues, to the established surgical "Old Guard," she appears somewhat of a threat. Her training in new advanced techniques, coupled with splendid bedside manner, has caused her practice to become quite busy. However, disruption in some well-established referral patterns has occurred, and business has been siphoned away from her older colleagues. . . . This hypothetical - but not uncommonly recurring - fact pattern demonstrates the destruction of a promising medical career, elimination of competition, promotion of status quo cronyism, and …

Dying To Wait: How The Abigail Court Got It Wrong, Juan Joel Tovanche

Journal of Law and Health

At age twenty-one, Abigail Kathleen Burroughs met a fate usually reserved for aged men who have spent much of their lives drinking and smoking. Diagnosed with cancer at nineteen, Abigail battled the squamous cell carcinoma that invaded her body even as she struggled to maintain her characteristic optimism. Abigail struggled with more than her illness, however. In the last years of her life, Abigail and her family also wrestled with Food and Drug Administration (FDA) regulations that denied her access to medication that could have saved her life. The policy at issue was the FDA's practice of progressive testing, which …

The Neglect Of The Umbilical Cord: Ohio's Failure To Adequately Promote Banking Of Umbilical Cord Blood Stem Cells And The Need For New Legislation, Shannon Folger

Journal of Law and Health

Because current legislation, including OH H.B. 237, is insufficient in that it does not have the potential to significantly increase the number of cord blood donations, it will be necessary to enact legislation that is more demanding. Such legislation should be modeled after current "required request" organ donation laws, which mandate that health professionals actively pursue organ donations by expressly asking the family to consent to donation. Modeled after these laws, better legislation will not only require that state health departments generate information about donation opportunities, but also that health professionals then provide each maternity patient with materials about cord …

Discretion To Follow The Law: The Collision Of Ohio's Nursing Home Bill Of Rights With Ohio's Political Subdivision Tort Liability Act, Peter Traska Elk & Elk Co., Ltd., Katherine Knouff

Journal of Law and Health

The Ohio Political Subdivision Tort Liability Act confers general immunity on political subdivisions. Therefore, government owned homes seek to avoid liability by raising the defenses provided by the Ohio Political Subdivision Tort Liability Act, despite the resident's rights under the Nursing Home Bill of Rights. The result is that residents of government owned nursing homes have inferior remedies for the tortious acts of a county home's employees. The disparate treatment meted out to residents of county owned homes opens the Political Subdivision Act to another challenge: equal protection. The law formerly recognized that government actors taking part in the marketplace …

Germs On A Plane: Legal Protections Afforded To International Air Travelers And Governments In The Event Of A Suspected Or Actual Contagious Passenger And Proposals To Strengthen Them, Alexandra R. Harrington

Journal of Law and Health

This article calls for the creation of an international public health do-not-fly list akin to those used by Interpol and the United States government as a stop-gap measure to ensure that passengers who have been diagnosed with infectious diseases or have been exposed to infectious diseases are unable to travel until it is established that it is medically safe for them to do so. This article has also called for amendments to the IHR and the Vienna Conventions to clarify the rights and obligations of travelers and states in the event of a suspected or established case of infectious disease …

Reverse Pre-Empting The Federal Arbitration Act: Alleviating The Arbitration Crisis In Nursing Homes, Jana Pavlic

Journal of Law and Health

In Casarotto, the Supreme Court enunciated that Montana's notice requirement conflicted with the "goals and policies of the FAA." The inequities associated with the process of pre-dispute arbitration agreements in nursing homes, however, confirm that the FAA's "goals and policies"' conflict with "accepted principles of contract law"' in this context. Long standing principles of contract law that predate the FAA, as well as basic human morality, should supersede the interests of efficiency and convenience purportedly served by the general enforceability of the statute. State case law as well as attempted state legislation already evince an underlying public policy to protect …

The Deficit Reduction Act Of 2005 - Reducing The Number Of Recipients And Applicants Eligible To Receive Medicaid Benefits, Christal Contini

Journal of Law and Health

Medically impaired individuals such as George, as well as disaster victims, mentally handicapped persons, homeless persons, and foster children, will be adversely affected by the new citizenship documentation requirements imposed upon the states by the Act. States will also be adversely affected by the increased administrative costs of implementing the Act's requirements. This note asserts that aspects of the citizenship verification requirements treat citizen applicants worse than immigrant applicants, which violates the Due Process Clause of the Fifth Amendment. Amendments should be made to the United States Code and the Code of Federal Regulations to ease the burden on individuals …

Ten Fingers, Ten Toes: Newborn Screening For Untreatable Disorders, Ellen Wright Clayton

Vanderbilt Law School Faculty Publications

This movie makes two important points despite its admitted unreality. The first, which the screen writer probably did not fully appreciate at the time, is that genetic testing cannot now and probably will never be able to predict with complete certainty the occurrence and course of complex diseases. It is not true that "Genes-R-Us." Rather, we are the products of complex interactions of our genes, the genomes of other organisms (many of which we live in relation with), and the environment, broadly understood to include the air we breathe, the water we drink, the food we eat, the drugs we …

Can Clinical Genetics Laboratories Be Sued For Medical Malpractice?, Ellen Wright Clayton, Alexandra L. Foulkes, Jessica L. Roberts, Et Al.

Vanderbilt Law School Faculty Publications

From a legal perspective, is a clinical laboratory a healthcare provider? Physicians are clearly healthcare providers who owe their patients the associated fiduciary duties. It is less clear, however, which-if any-legal duties genetic testing labs owe to the individuals who seek their services.

The question of whether clinical genetics laboratories are healthcare providers for legal purposes may be thornier than it could initially appear. Clinical genetics laboratories perform multiple tasks. Most significantly, they sequence genetic samples and then interpret the results. As "next generation sequencing" has become more accessible,' labs can generate and interpret more sequence data for a growing …

Social Factoring The Numbers With Assisted Reproduction, Bridget J. Crawford, Lolita Buckner Inniss

Publications

In early 2009 the airwaves came alive with sensational stories about Nadya Suleman, the California mother who gave birth to octuplets conceived via assisted reproductive technology. Nadya Suleman and her octuplets are vehicles through which Americans express their anxiety about race, class and gender. Expressions of concern for the health of children, the mother's well-being, the future of reproductive medicine or the financial drain on taxpayers barely conceal deep impulses towards racism, sexism and classism. It is true that the public has had a longstanding fascination with multiple births and with large families. This is evidenced by a long history …

Toward An Architecture Of Health Law, Wendy K. Mariner

Faculty Scholarship

This article examines 3 questions: What is an academic field of law? Is health law such a field? If it is, how can or should it be described? The first question may have no answer; scholars and practicing lawyers have fashioned their owns spheres of expertise. Describing health law faces particular challenges, including the breadth of applicable doctrines and the decline of unique medically-oriented adaptations of general principles. The article offers a blueprint based on the health and human rights framework as a functional description of the eclectic and translegal field of health law. This approach can identify the principles …

Protecting Hiv Positive Women’S Human’S Rights: Recommendations For The Obama Administration, Aziza Ahmed, Catherine Hanssens, Brook Kelly

Faculty Scholarship

To bring the United States in line with prevailing human rights standards, its National HIV/AIDS Strategy will need to explicitly commit to a human rights framework when developing programmes and policies that serve the unaddressed needs of women. This paper focuses on two aspects of the institutionalized mistreatment of people with HIV: 1) the criminalization of their consensual sexual conduct; and 2) the elimination of informed and documented consensual participation in their diagnosis through reliance on mandatory and opt-out testing policies. More than half of US states have HIV-specific laws criminalizing the consensual sexual activity of people with HIV, regardless …

Defining Health Law Or The Edgewood Syndrome, Paula Lobato De Faria, Wendy K. Mariner, George J. Annas

Faculty Scholarship

The authors' main purpose is to present ideas on defining Health Law by highlighting the particularities of the field of Health Law as well as of the teaching of this legal branch, hoping to contribute to the maturity and academic recognition of Health Law, not only as a very rich legal field but also as a powerful social instrument in the fulfillment of fundamental human rights. The authors defend that Health Law has several characteristics that distinguish it from traditional branches of law such as its complexity and multidisciplinary nature. The study of Health Law normally covers issues such as …

International Health Care Convergence: The Benefits And Burdens Of Market-Driven Standardization, Nathan Cortez

Faculty Journal Articles and Book Chapters

For over thirty years, health scholars have debated whether health care policies are converging, or becoming more alike, internationally. Convergence theories have always been particularly appealing in health care. Most countries generally struggle with the same challenges: how to provide quality care, to as many people as possible, for a reasonable price. Moreover, modern scientific medicine has not only influenced how countries around the world provide and regulate health care, but has also driven rising patient expectations. These commonalities invite theories of convergence: If policymakers in different jurisdictions face similar challenges, why wouldn't they adopt roughly similar solutions?

In this …

The Baby Doe Rules And Texas’S 'Futility Law' In The Nicu, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

The applicability in the NICU of the futility provision of Texas's Advance Directives Act and its relationship to the Baby Doe rules are reasonably straightforward. Nonetheless, many comments have been written about Texas's so-called “futility law,” some of them complimentary and others, not so much. The most serious critiques of the Texas futility provision, however, are based upon assumptions that result from a fundamental misreading of the law. After a brief discussion of the futility provision and its principal features, this Essay examines the misunderstandings that plague many critiques of the law and then offers a list of proposed amendments …

Three Ways Of Looking At A Health Law And Literature Class, Jennifer S. Bard, Thomas Wm. Mayo, Stacey A. Tovino

Faculty Journal Articles and Book Chapters

The authors of this Article participated in a panel at the American Society of Law, Ethics & Medicine Conference in 2008 that discussed the use of literary materials in law school to teach medical ethics (and related matters) in a law school setting. Each author comes at the topic from a different perspective based on his or her own experience and background. This Article and the panel on which it was based reflect views on how literature can play a valuable role in helping law students, as well as medical students, understand important legal and ethical issues and concepts in …

How Medicare Could Get Better Prices On Prescription Drugs, Kevin Outterson

Faculty Scholarship

Congress may reform drug pricing policies under Medicare Part D as part of a larger health reform effort. Currently, the "noninterference" provision prevents the government from negotiating drug prices on behalf of Medicare Part D prescription drug plans. Commonly considered reform proposals borrow ideas from Medicaid, either through returning dual eligibles to Medicaid drug pricing or by imposing mandatory rebates across the Part D population. We examine a menu of other options, including value-based pricing; expansion of generic and therapeutically equivalent substitution; increased formulary diversity; importation; and limited antitrust waivers. These latter options may reduce federal spending without direct government …

Death From The Public Domain?, Kevin Outterson

Faculty Scholarship

In his recent article in the Texas Law Review, Ben Roin advances the claim that pharmaceutical innovation and the public’s health are harmed by the doctrines of non-obviousness and novelty. He does not mince words, labeling the nonobvious requirement as “perversity” with a “pernicious” effect on drug development. In his view, these standards pose an insurmountable barrier for drug companies seeking to commercialize inventions already in the public domain. He claims that valuable, life-saving drug ideas languish in the public domain because the companies face high barriers to entry from the FDA, but potential free riders are encouraged through the …

Federalization Snowballs: The Need For National Action In Medical Malpractice Reform, Abigail Moncrieff

Faculty Scholarship

Because tort law generally and healthcare regulation specifically are traditional state functions and because medical, legal, and insurance practices are highly localized, legal scholars have long believed that medical malpractice falls within the states' exclusive jurisdiction and sovereignty. Indeed, this view is so widely held that modern legal scholarship takes it for granted. Articles on general federalism issues use medical malpractice as an easy example of a policy in which federal intervention lacks functional justification, and articles that focus on federalization of other tort reforms use medical malpractice as an easy foil, pointing out that the uniformity interest that justifies …

Dirty Business: Legal Prophylaxis For Nosocomial Infections, Robert Steinbuch

Kentucky Law Journal

No abstract provided.

What The Doctor Ordered: Balancing Religion And Patient Rights In U.S. Pharmacies, Rachel T. Caudel

Kentucky Law Journal

No abstract provided.

The Difficult Road To Compelling Vaccination For Sexually Transmitted Diseases--How Gardasil And Those To Follow Will Change The Way That States Require Inoculation, Jonathan T. Scott

Kentucky Law Journal

No abstract provided.

The Burden Of Knowledge, Christian Turner

Scholarly Works

Sometimes we are better off not knowing things. While we often hear that "ignorance is bliss," there has not been a comprehensive consideration in the legal academy of the virtues of ignorance and its regulation. Though the distribution of knowledge, like the distribution of other goods, is affected both directly and indirectly by law, several characteristics of knowledge distinguish it from other kinds of property. Much has been written about the impact of the nonrival and nonexclusive nature of knowledge on its production and distribution. This Article centers around two other attributes of knowledge that combine to create a special …

Towards Achieving Lasting Healthcare Reform: Rethinking The American Social Contract, Fazal Khan

Scholarly Works

The famous preamble to the United States Declaration of Independence reflects a concise and eloquent understanding of the Lockean social contract theory that underpinned the foundation of the original American government: that free people will naturally find it in their self-interest to leave the state of nature (and the tyranny of foreign rule) and join a society where a legitimate sovereign power and the rule of law protect the citizens' fundamental rights. As of the writing of this essay, a new decade approaches and both the U.S. Senate and House have passed historic healthcare reform bills. The two legislative bodies, …

Public Bioethics And The Bush Presidency, O. Carter Snead

Journal Articles

Public bioethics figured prominently during the tenure of President George W. Bush. This Article explores the Bush legacy in this domain. It begins by articulating and examining the grounding norms of President Bush’s approach to public bioethics. Next, it analyzes how these norms were applied to concrete areas of concern. Building on this analysis, the next section reflects on what the President’s actions illustrate about the capacity of the Executive Branch to shape public bioethics. The Article concludes with a brief discussion of the possible metrics by which the Bush Administration’s efforts might be judged, and then offers several assessments …

The Public’S Right To Health: When Patient Rights Threaten The Commons, Elizabeth Weeks Leonard

Scholarly Works

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a "public health right" that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection--empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges--practical, methodological, and political.

The purpose of this Article is to survey the current state of the field by describing commonly used methods, analyzing enabling and …

The Elderly And Health Care Rationing, George P. Smith Ii

Scholarly Articles

This Monograph derives from research undertaken during my appointment as a Visiting Scholar at The Poynter Center for The Study of Ethics and American Institutions, Indiana University, Bloomington in July-August, 2000. The thesis of this Monograph is that before contemporary society can confront the issue of health care rationing for the elderly, it must seek to integrate the disciplines of moral and ethical reasoning with the qualitative formulations of needs and resources. Until such a point is reached, however, the greatest danger to avoid is the perpetuation of non-decisions regarding health care treatment. Such "decisions" all too frequently result in …

Advertising Obesity: Can The U.S. Follow The Lead Of The Uk In Limiting Television Marketing Of Unhealthy Foods To Children?, David Darwin

Vanderbilt Journal of Transnational Law

Childhood obesity has tripled in the U.S. since the 1970s, and television advertisement of unhealthy foods has been linked to the unhealthy eating habits of children. The United Kingdom, facing a similar problem, promulgated regulations in 2007 banning the advertisement of foods high in fat, sodium, and sugar during programming directed at children below age 16.

In the U.S., industry representatives, public policy advocates, and government officials are debating whether to rely on self-regulation efforts or to implement government-established guidelines. Industry representatives argue that government guidelines would do little to solve the childhood obesity problem and that the UK regulations …