Health Law and Policy Commons^™

The 800 Pound Gorilla Sleeps: The Federal Government's Lackadaisical Liability And Compensation Policies In The Context Of Pre-Event Vaccine Immunization Programs, Michael Greenberger

Faculty Scholarship

On July 21, 2004, President Bush signed the Project Bioshield Act, which authorizes the spending of $5.6 billion to advance the development and acquisition of vaccines and other countermeasures to biological agents. While the funding and progress are welcome signs for our national biodefense strategy, the failure of the federal Phase I smallpox vaccination program demonstrated that other serious obstacles remain to the implementation of a successful pre-event vaccine immunization program. Specifically, as demonstrated by a field study of several states' health departments, performed at the ANSER Institute for Homeland Security, the federal government's inability to provide both sufficient liability …

A Defense Of Paid Family Leave, Gillian Lester

Faculty Scholarship

The problem of combining work and family life is perhaps the central challenge for the contemporary American family. In this Article, I evaluate and defend government provision of paid family leave, a benefit that would allow workers to take compensated time off from work for purposes of family caregiving.

A legal intervention in the arena of work-family accommodation can only build on some prior normative understanding of the family, and embedded within that, contested value choices about women's identities and entitlements in workplace, family, and society. I am not the first legal scholar to advocate paid family leave of some …

The New Censorship: Institutional Review Boards, Philip A. Hamburger

Faculty Scholarship

Do federal regulations on Institutional Review Boards violate the First Amendment? Do these regulations establish a new sort of censorship? And what does this reveal about the role of the Supreme Court?

Medical Malpractice Insurance And The Emperor's Clothes, William M. Sage

Faculty Scholarship

Tom Baker and Mark Geistfeld's contributions to this Symposium offer detailed and persuasive analyses of medical malpractice insurance. Their principal contribution to the malpractice reform debate, however, is simple: confirming that liability insurers should not be left to their own devices between malpractice crises or appeased during crisis periods. Instead, liability insurance must be consciously designed to help the health care system work toward its core goals of high quality, broad access, and affordable cost.

In 2000, the IOM issued a follow-up report to its earlier indictment of medical error, calling upon the health care system to become safe, effective, …

Public Medical Malpractice Insurance: An Analysis Of State-Operated Patient Compensation Funds, Frank A. Sloan, Carrie A. Mathews, Christopher J. Conover, William M. Sage

Faculty Scholarship

Compared to major tort and insurance reforms, PCFs have received virtually no attention by scholars. With an exception or two, they are not a major focus of public policy debate either. Because they are small organizations and there have been lengthy periods in which medical malpractice markets are quiescent, they have not attracted much scrutiny. Given a lack of quantitative evidence, our evaluation depended on qualitative evidence. Yet PCFs address the fundamental issues of medical malpractice that have led to reoccurring crises in the availability of medical malpractice insurance coverage and in its premiums for such coverage. As such, PCFs …

The Threat Of Smallpox: Eradicated But Not Erased: A Review Of The Fiscal, Logistical And Legal Obstacles Impacting The Phase I Vaccination Program, Holly L. Myers, Elin Gursky, Georges C. Benjamin, Christopher Gozdor, Michael Greenberger

Faculty Scholarship

Fears that terrorists may have the capabilities and intent to disseminate a variety of biologic agents has once again brought smallpox into the American consciousness. On December 13, 2002, recognizing that the global discontinuation of routine smallpox vaccination over two decades ago had left most Americans unprotected and vulnerable to the ravaging effects of the virus, the President announced a precautionary measure to begin vaccinating teams of emergency responders. The program commenced January 24, 2003. In the ensuing months, public health departments scrambled to meet the goal of vaccinating approximately 500,000 first responders, a protected phalanx that could quickly and …

The Supreme Court's Limitation Of Managed-Care Liability, Wendy K. Mariner

Faculty Scholarship

This article summarizes and critiques the U.S. Supreme Court's decision in Aetna Health Inc. v. Davila, which limited managed care organizations' liability for negligent decisions about the care of patients in private employer-sponsored health plans governed by ERISA. It contrasts the Court's dichotomous view of health benefit plans, in which insurers administer contracts and treating physicians make medical judgments, with the more complicated relationships that affect decisions about both coverage and treatment.

Why Don’T Doctors & Lawyers (Strangers In The Night) Get Their Act Together?, Frances H. Miller

Faculty Scholarship

Health care in America is an expensive, complicated, inefficient, tangled mess – everybody says so. Patients decry its complexity, health care executives bemoan its lack of coherence, physicians plead for universal coverage to simplify their lives so they can just get on with taking care of patients, and everyone complains about health care costs. The best health care in the world is theoretically available here, but we deliver and pay for it in some of the world’s worst ways. Occam’s razor (“Among competing hypotheses, favor the simplest one”) is of little help here. There are no simple hypotheses – everything …

The Jekyll And Hyde Story Of International Trade: The Supreme Court In Phrma V. Walsh And The Trips Agreement, Srividhya Ragavan

Faculty Scholarship

The paper analyses the international impact of the approval by the United States Supreme Court to use indirect price control mechanisms to tackle public health and Medicaid issues. It traces similarities in policies implemented by the United States and those it opposed within developing nations. For example, the recent use by the developed nations of compulsory licensing and price control mechanisms, which they opposed as violating TRIPS when used by developing nations, underlines a poverty penalty suffered by developing nation signatories of TRIPS. In effect, TRIPS exempts developed nations from fulfilling obligations developing nations were forced to fulfill and thus …

Medical Malpractice And Contract Disclosure: An Equilibrium Model Of The Effects Of Legal Rules On Behavior In Health Care Markets, Kathryn Zeiler

Faculty Scholarship

This paper develops a theoretical model of how specific legal rules affect the types of contracts managed care organizations ("MCOs") use to compensate physicians. In addition, the analysis provides insights into how physician treatment decisions and the rate of medical malpractice lawsuits react to different legal rules. In particular, the model predicts that outcomes in jurisdictions forcing MCOs to disclose physician contract terms to patients differ from those that do not. Contracts vary depending on the disclosure rule and how treatment costs relate to expected damages and litigation costs. Moreover, the model predicts that jurisdictions forcing contract disclosure observe higher …

Politics, Power, And Public Health: A Comment On Public Health’S New World Order, Laurence R. Helfer

Faculty Scholarship

No abstract provided.

Divorcing Marriage From Procreation – Goodridge V. Department Of Public Health Case, Jamal Greene

Faculty Scholarship

Public debate about same-sex marriage has spectacularly intensified in the wake of the Massachusetts Supreme Judicial Court's decision in Goodridge v. Department of Public Health. But amid the twisted faces, shouts, and murmurs surrounding that decision, a bit of old-fashioned common-lawmaking has been lost. Some have criticized the Goodridge court for its apparently result-oriented approach to the question of whether, consistent with the Massachusetts Constitution, the commonwealth may deny marriage licenses to same-sex couples. Others have defended the decision, both on the court's own rational basis terms and on other grounds, including sex discrimination and substantive due process. This …

Bioethical Malpractice: Risk And Responsibility In Human Research, Barbara A. Noah

Faculty Scholarship

This Article provides an overview of Institutional Review Board (IRB) operations, reviews the sources of regulatory guidance, and examines the weaknesses of the existing system for the protection of human research subjects. It then discusses the scant case law relating to IRB negligence in the protection of human research subjects and explores some hypothetical circumstances under which it may be appropriate to hold a board accountable for injuries to clinical trial participants. Finally, this Article considers the potential consequences of expanded IRB liability, concluding that tort lawsometimes may serve an important function as a catalyst to regulatory reform when professional …

Politicizing The End Of Life: Lessons From The Schiavo Controversy, Barbara A. Noah

Faculty Scholarship

The case of Theresa Marie Schiavo raises challenging legal and ethical issues, although the events of the case are not entirely novel. It is a well-settled principle under Florida law that individuals have a right to refuse life-sustaining medical treatment. After years of litigation, numerous courts have confirmed that removal of life support is legally appropriate under the facts of this case. Nevertheless, six days after Theresa's feeding tube was removed, the Florida legislature
opted to intervene in the final judicial decision by granting the Governor the authority to overrule the court's decision and to order the tube reinserted. These …

Can Consumer-Choice Plans Satisfy Patients? Problems With Theory And Practice In Health Insurance Contracts, Wendy K. Mariner

Faculty Scholarship

Much scholarship has considered whether health care - and insurance - should be distributed by voluntary contract or subject to government standards or regulation. Contracts will likely play a key distributive role in any future health care system. Yet we do not fully understand where private contracting does and does not work to further the goals of equitable access to affordable care. This article examines the role of health insurance policies in defining and enforcing access to medical care, focusing on private employment-based group health benefit plans. It describes models of consumer choice health plans and critiques their capacity for …

Parks As Gyms? Recreational Paradigms And Public Health In The National Parks, Jay D. Wexler

Faculty Scholarship

When scholars and policymakers think about the relationship between public health and environmental law and policy, they likely think first about controlling pollution and other toxic substances. As other articles have amply demonstrated, water pollution, air pollution, and other environmental toxins can have significant deleterious effects on the public's health. Scholars rightly pay serious attention to these relationships, and policymakers wisely devise methods and strategies to ameliorate the public health risks posed by these polluting substances.

Although pollution control might be the most obvious and important intersection between environmental policy and public health, legal and policy decisions regarding the management …

Free Trade Against Free Riders?, Kevin Outterson

Faculty Scholarship

The US is using free trade agreements to address the global free rider problem in pharmaceutical R&D. This brief article outlines several objections to that approach.

Extremely Preterm Birth And Parental Authority To Refuse Treatment: The Case Of Sidney Miller, George J. Annas

Faculty Scholarship

Disputes between physicians and patients over medical care have tended toward resolution in both the courts and ethics committees, with each of these bodies ultimately deciding that the informed, competent patient must be the final decision maker. Parents, too, have the authority to make medical decisions for their children, but these decisions can be challenged if physicians do not believe they are medically reasonable. One bioethical issue, however, is as intractable today as it was 30 years ago, when it began to be publicly discussed: the extent of parental authority to refuse life-sustaining medical treatment for an extremely premature infant. …

Forcible Medication For Courtroom Competence: The Case Of Charles Sell, George J. Annas

Faculty Scholarship

The right to refuse treatment is firmly recognized in U.S. law. Competent persons have the legal right to refuse treatment, even life-sustaining treatment, and incompetent patients can also refuse treatment through an advance directive, by naming a health care agent to make decisions for them or by having a person who knows their wishes express them.

Politics, Morals And Embryos, George J. Annas, Sherman Elias

Faculty Scholarship

Bioethics in the United States reflects US culture and tends to be pragmatic, market-oriented and insular. Add embryo politics to this mix and, over the past few years, the result has been a bioethics that has become so narrow and selfabsorbed as to be virtually irrelevant to the rest of the world. Not all the blame for this can be placed on President George W. Bush’s political agenda for his President’s Council on Bioethics, now in its third year of operation, but much can. The council has made public bioethics the servant of politics by pursuing a narrow, embryo-centric agenda. …

Access To Health Care In Texas: A Patient-Centered Perspective, Laura Hermer, William J. Winslade

Faculty Scholarship

Access to health coverage in Texas is, and continues to be, an urgent policy issue. This article provides an overview and evaluation of the primary state- or local-based and private financial means through which Texans gain access to health care, and offers suggestions to the Texas Legislature to help improve coverage access.

How A Drug Becomes ‘Ethnic’: Law, Commerce, And The Production Of Racial Categories In Medicine, Jonathan Kahn

Faculty Scholarship

A drug called BiDil is poised to become the first drug ever approved by the Food and Drug Administration (FDA) to treat heart failure in African Americans - and only African Americans. This article explores the story of BiDil and considers some of its broader implications for the use of racial categories in law, medicine, and science. It argues that BiDil is an ethnic drug today as much, if not more because of the interventions of law and commerce as because of any biomedical considerations. The article is, first, a retrospective analysis of how law, commerce, science, and medicine interacted …

Where Is Health Law Going?: Follow The Money, Robert L. Schwartz

Faculty Scholarship

Where has health law come from? Where will it be going? To follow the development of this discipline, follow the money. Where substantial financial interests entered the health care enterprise, lawyers have been sure to follow--or, sometimes, to lead. Where we can predict there will be concentrations of money, we can predict there will be concentrations of lawyers, and, not too far behind, legal academics. The very birth of "health law" (or, at least, its transformation out of "medical law") was a consequence of a newly developing medical economy. Since the term "Health Law" was first used as a casebook …

Monopsony As An Agency And Regulatory Problem In Health Care, Peter J. Hammer, William M. Sage

Faculty Scholarship

The article is organized as follows. Part I returns to the source, explaining the controversy in Kartell, examining Breyer's opinion, and summarizing its impact on other courts. Part II looks at Kartell through the lens of classic monopsony theory involving suppliers, producers, and consumers, and focuses on the opinion's oversimplification of the relationship between health insurers and insured individuals. It further considers whether lower input prices result in lower consumer prices in the endproduct market, and, therefore, whether monopsony power can be welfare-enhancing. Part III evaluates Kartell's disregard of other important principal-agent problems in health care that arguably influence the …

Introduction: The New Economy And The Unraveling Social Safety Net, Elizabeth M. Schneider

Faculty Scholarship

No abstract provided.

American Bioethics And Human Rights: The End Of All Our Exploring, George J. Annas

Faculty Scholarship

In his compelling novel Blindness, José Saramago tells us about victims stricken by a contagious form of blindness who were quarantined and came to see themselves as pigs, dogs, and “lame crabs.” Of course, they were all human beings - although unable to perceive themselves, or others, as members of the human community. The disciplines of bioethics, health law, and human rights are likewise all members of the broad human rights community, although at times none of them may be able to see the homologies, even when responding to a specific health challenge.

The boundaries between bioethics, health law, and …

Regulating Teenage Abortion In The United States: Politics And Policy, Carol Sanger

Faculty Scholarship

Thirty-four US states currently require pregnant minors either to notify their parents or get their consent before having a legal abortion. The Supreme Court has upheld the constitutionality of theses statutes provided that minors are also given an alternative mechanism for abortion approval that does not involve parents. The mechanism used is the 'judicial bypass hearing' at which minors persuade judges that they are mature and informed enough to make the abortion decision themselves. While most minors receive judicial approval, the hearings intrude into the most personal aspects of a young woman's life. The hearings, while formally civil in nature, …

Finding Cures For Tropical Diseases: Is Open Source An Answer?, Stephen M. Maurer, Arti K. Rai, Andrej Sali

Faculty Scholarship

Only about 1% of newly developed drugs are for tropical diseases, such as African sleeping sickness and dengue fever. While patent incentives and commercial pharmaceutical companies have made Western health care the envy of the world, the commercial model works only if companies can sell enough patented products to cover their R&D costs. The model thus fails for diseases found largely in the developing world, where markets for patented products are tiny. Any solution to the problem of tropical diseases must recognize the need for rigid cost-containment. An open source approach to identifying promising drug candidates would keep costs down …

Finding Cures For Tropical Diseases: Is Open Source An Answer?, Stephen M. Maurer, Arti K. Rai, Andrej Sali

Faculty Scholarship

No abstract provided.

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 …