Health Law and Policy Commons^™

Healthy Planet, Healthy People: Integrating Global Health Into The International Response To Climate Change, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

The potentially groundbreaking negotiations currently underway on the international response to climate change and national implementation of commitments under the United Nations Framework Convention on Climate Change (UNFCCC) include a number of hotly contested issues: (1) what degree of climate change is acceptable as a basis for emissions targets, (2) to what extent and in what ways climate change mitigation should incorporate emissions reductions or increased sinks for developing countries, (3) whether the legal regime governing mitigation can take advantage of the huge mitigation potential of changed practices in the land use and agricultural sectors, (4) how adaptation should be …

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

Bizarre Love Triangle: The Spending Clause, Section 1983, And Medicaid Entitlements, Nicole Huberfeld

Law Faculty Scholarly Articles

The first two terms of the Roberts Court signal a willingness to revisit precedent, even decisions that have been considered long-settled, and the United States Supreme Court may be ready to reinterpret another area of jurisprudence: the private enforcement of conditions on federal spending against states through actions under 42 U.S.C. § 1983. The most recent pre-Roberts Court precedent is Gonzaga University v. Doe, a 2002 decision that made it more difficult for individuals harmed by violations of federal laws to enforce rights through § 1983 actions. Federal courts have inconsistently and confusingly applied the Gonzaga framework, but the …

Newsletter, Fall 2008

Newsletter

No abstract provided.

The Case Against Tax Incentives For Organ Transfers, Lisa Milot

Scholarly Works

Each year some 6,700 Americans die while awaiting an organ transplant. On its face, this fact seems almost inconsequential, representing less than 3% of American deaths annually. However, for the nearly 100,000 patients on the transplant wait list (and their families), nothing could be more consequential. What is more, the demand for transplantable organs is sure to rise as (1) more diseases become subject to prevention or cure, making organ failure the first sign of medical problems; (2) the success rate for transplants increases, leading to wider use; and (3) barriers to inclusion on the wait list are removed.

In …

Non-Beneficial Pediatric Research And The Best Interest Standard: A Reconciliation, Paul J. Litton

Faculty Publications

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children …

Newsletter, Winter/Spring 2008

Newsletter

No abstract provided.

Disability, Equipment Barriers, And Women’S Health: Using The Ada To Provide Meaningful Access, Elizabeth Pendo

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Has Erisa Closed Our Laboratories? Options For State Health Reform, Terrence Burek

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Health Courts?, Philip G. Peters Jr.

Faculty Publications

This article undertakes the first detailed critique of the proposal from Common Good and the Harvard School of Public Health to replace medical malpractice jury trials with adjudication before specialized health courts. Professor Peters concludes that the modest benefits likely to be produced by the current health court proposal are matched by the risks of bias and overreaching that these courts would also present. Missing from the plan is the doctrinal change mostly likely to improve patient safety - hospital enterprise liability. Without enterprise liability, the health court proposal is unlikely to achieve its patient safety goals and, as a …

Constructing 'Health', Defining 'Choice': Legal And Policy Perspetives On The Post-Pgd Embryo In Four Jurisdictions, Estair Van Wagner, Roxanne Mykitiuk, Jeff Nisker

Articles & Book Chapters

Through Preimplantation Genetic Diagnosis, embryos created by IVF are selected for transfer to a woman based on particular characterisations, including the presence of genetic markers or a tissue match for a sibling. In this paper we examine the precise language used in the recent policy and regulatory documents of four jurisdictions (the United Kingdom, Australia, Canada and New Zealand) that in any way characterises the post-PGD embryo. We then explore the mutually constructed relationship between how that embryo is characterised and the purposes for which PGD is applied, as well as the types of uses to which the post-PGD embryo …

Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, Lindsay Wiley, James G. Hodge Jr., Erin Fuse Brown, Dhrubajyoti Bhattacharya

Scholarly Articles in Law Reviews & Journals

No abstract provided.

The New Massachusetts Health Law: Preemption And Experimentation, Edward A. Zelinsky

Articles

The Employee Retirement Income Security Act of 1974 (ERISA) preempts major features of the new Massachusetts health law. Although regrettable, this conclusion is mandated by ERISA's statutory terminology and the controlling case law. Other states, in fashioning their health care policies, are looking at elements of the new Massachusetts law. Just as ERISA preempts the individual and business contribution mandates of the Massachusetts statute, ERISA will preempt any similar provisions adopted by other states.

Because state experimentation with health care is particularly desirable today, Congress should, at a minimum, amend ERISA to validate the new Massachusetts health law. More comprehensively, …

Newsletter, Summer 2007

Newsletter

No abstract provided.

The Three Faces Of Retainer Care: Crafting A Tailored Regulatory Response, Frank Pasquale

Faculty Scholarship

Retainer care arrangements allow patients to pay a fee directly to a physician's office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as boutique medicine. Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most …

Newsletter, Winter 2006-2007

Newsletter

No abstract provided.

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.

Tackling The “Evils” Of Interlocking Directorates In Healthcare Nonprofits, Nicole Huberfeld

Law Faculty Scholarly Articles

The nonprofit sector and matters of nonprofit governance have been in the national spotlight much of late. One area of heightened interest is directors of healthcare entities regularly serving on the board of more than one healthcare organization. Even when board membership of related entities is relatively independent, one corporation's business plan frequently is affected (or even controlled) by the business needs of a separately incorporated parent, affiliate, or other related organization. Very little case law addresses "interlocking" directorates for nonprofit board members, and the case law that does exist tends to address narrow, fact-based state law interpretive issues rather …

Striving For Equality, But Settling For The Status Quo: Is Title Vi More Illusory Than Real?, Ruqaiijah Yearby

All Faculty Scholarship

A plethora of empirical studies, such as the Institute of Medicine’s Unequal Treatment report, have shown that racial inequities in health care continue at the same level as in the Jim Crow Era. Innumerable reasons have been offered to explain the continuation of these health inequities, including racial discrimination. Congress enacted Title VI of the Civil Rights Act of 1964 to put an end to racial discrimination in health care, but it still persists. Given the regulation and enforcement mechanisms established under Title VI explicitly aimed at remedying racial discrimination such as that directed at elderly African-Americans it is unbelievable …

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 …

Newsletter, Winter 2006

Newsletter

No abstract provided.

Common Ground: Exploring Policy Approaches To Addressing Racial Disparities From The Left And The Right, M. C. Gibbons

Journal of Health Care Law and Policy

No abstract provided.

A Right To No Meaningful Review Under The Due Process Clause: The Aftermath Of Judicial Deference To The Federal Administrative Agencies, Ruqaiijah Yearby

Faculty Publications

The Due Process Clause of the Fifth Amendment has been perverted in the federal administrative system. For example, federal agencies, such as the U.S. Department of Health and Human Services (HHS), regularly deprive individuals of liberty and property with little to no review. In its regulation of the health care industry through the Medicare program, HHS often turns a blind eye to procedural Due Process protections, such as providing individuals an opportunity to challenge the deprivation of property at a hearing, even though the Constitution, the Administrative Procedure Act, and the Medicare Act grant these protections. The Medicare compliance hearing …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Tragedy & Remedy: Black Reparations For Racial Disparities In Health, Kevin Outterson

ExpressO

This Article makes unique and powerful contributions to Black reparations, health care law, biomedical and social science research into racial disparities in health, and critical race theory.

The starting point is the tragedy of Black health in America, with dramatically higher death rates and shorter life expectancies. Current research is ill-equipped to consider the deeper historical roots of Black health disparities; while the development of racially-specific therapies (such as the FDA’s approval in July 2005 of BiDil, a heart drug for Blacks) actually contributes to racial profiling in medicine. Biomedical research has a race problem.

The Black reparations movement suffers …

Newsletter, Spring 2005

Newsletter

No abstract provided.

Punishing Tobacco Industry Misconduct: The Case For Exceeding A Single Digit Ratio Between Punitive And Compensatory Damages, Sara D. Guardino, Richard A. Daynard

ExpressO

This article addresses large punitive damages awards that juries have granted to plaintiffs in recent cases against the tobacco industry, and demonstrates why such high awards are a warranted and necessary incentive for the companies to change their dangerous course of conduct.

In State Farm v. Campbell, the United States Supreme Court announced that “few awards exceeding a single-digit ratio between punitive and compensatory damages” will be constitutional. In a subsequent smoking and health case brought against Philip Morris, however, a state appeals court allowed a punitive damages award that was almost 97 times the compensatory damages award. This decision …

Is It Too Late For Title Vi Enforcement?: Seeking Redemption Of The Unequal United States‟ Long Term Care System Through International Means, Ruqaiijah Yearby

Faculty Publications

Legal and medical experts have noted continued racism in the health care system that prevents the equal distribution of quality care. Initially most racism was intentional and expressed through de jure segregation, as evidenced by federal funding of the construction of racial segregated health care facilities. Now most racism, expressed through de facto segregation, is subtly incorporated into the daily practices of institutions causing an adverse disparate impact on African-Americans. This institutional racism establishes separate and independent barriers through the neutral denial of opportunities and equal rights to individuals and groups that results from the normal operations of the institutions …

Raich, Health Care, And The Commerce Clause, Alex Kreit, Aaron Marcus

William Mitchell Law Review

This article considers to what extent health care may be viewed as a traditional area of state concern in the context of the Supreme Court’s revival of federalism principles, in particular limits on Congress’ Commerce Clause power, and what effect Raich v. Ashcroft, heard by the Court in the fall 2004 term, might have on these issues. Addressing these questions will necessarily involve exploration of medical marijuana policy as well as the role of the “traditional state interest” principle within the Commerce Clause. However, the central focus of this article is not what impact Raich may have on the Commerce …

Hospital Chaplaincy Under The Hipaa Privacy Rule: Health Care Or "Just Visiting The Sick?", Stacey A. Tovino

Scholarly Works

Approximately seventy-nine percent of Americans believe that praying can help people recover from illness, injury or disease, and nearly seventy-seven percent of American patients would like spiritual issues discussed as part of their care. Despite Americans' strong beliefs in the health-related benefits of religious and spiritual practices and traditions, the preamble to the federal Department of Health and Human Services' ("HHS") health information privacy rule (the "Privacy Rule") explains that health care "does not include methods of healing that are solely spiritual" (the "preamble"). The preamble concludes that, "clergy or other religious practitioners that provide solely religious healing services are …