Health Law and Policy Commons^™

Prioritizing Abortion Access Over Abortion Safety In Pennsylvania, Randy Beck

Scholarly Works

This conference was prompted by the prosecution of Dr. Kermit Gosnell, who ran an abortion clinic in Philadelphia, Pennsylvania. Dr. Gosnell was convicted in May of 2013 of charges arising from the killing of viable infants born in his clinic, the negligent death of an adult patient, and the systematic disregard of regulations governing the performance of abortions in Pennsylvania. One question proposed for our consideration is whether Dr. Gosnell is an “outlier,” a description offered by the National Abortion Federation following Gosnell’s indictment.

Presumably, one might want to know whether Gosnell was typical of abortion providers because it could …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Trips And Bits: An Essay On Compulsory Licenses, Expropriation, And International Arbitration, Peter B. Rutledge

Scholarly Works

This essay examines the potential for arbitration to resolve disputes between private companies and developing countries over the propriety of compulsory licenses. At bottom, my thesis is that arbitration supplies the medium through which to mediate the tension between the profit-seeking goals of private multinational companies and the development goals of foreign nations, especially in the developing world. The compulsory license debate raises a clash of fundamental interests between the patent holder, the patent holder’s state, and the host state. Arbitration can play an important role in balancing those interests, albeit a highly unusual one. Arbitration provides an essential forum …

Gene Patents No More? Deciphering The Meaning Of Prometheus, Fazal Khan, Lindsay Kessler

Scholarly Works

When Congress enacted the United States Patent Act in 1952, it specified that patentable subject matter included anything “under the sun that is made by man.” Three decades ago the United States Patent and Trademark Office (USPTO) issued the first gene patent and ushered in a brave new gold rush. Some genes are associated with specific diseases, so being able to identify these sequences is an essential first step for developing genomic diagnostic tests and therapies. The problem with gene patents is that they allow modern-day prospectors to cordon off access to naturally occurring DNA sequences and exclude others from …

Sustainability & Ethics Of Animal Farming Practices, Joyce Tischler, Bruce Myers, Mark Risse, Terence Centner

Working in the Public Interest Conferences

High-density farming practices in the production of eggs, meat, dairy, and poultry make these products more affordable and more widely accessible— but at what cost? Panelists will discuss the ethics of these practices, as well as the impact on the environment and human health.

An Essay On Originalism And The 'Individual Mandate': Rounding Out The Government’S Case For Constitutionality, Dan T. Coenen

Scholarly Works

The Supreme Court now has under advisement the landmark federal health care law case. Much attention has focused on the law’s minimum coverage provision—or so-called “individual mandate” — and, in particular, its constitutionality under the Commerce Clause and the Necessary and Proper Clause. In a separate and much lengthier article, I offer two main observations about the arguments made to the Court on that issue. First, I show that the challengers of the minimum coverage provision emphasized originalist reasoning in their briefs and oral arguments, while the federal government did not. Second, I explain why — contrary to the impression …

The Rhetoric Hits The Road: State Resistance To Affordable Care Act Implementation, Elizabeth Weeks Leonard

Scholarly Works

This paper provides an update and reanalysis of my previously published article, Rhetorical Federalism: The Value of State-Based Dissent to Federal Health Reform, 93 Hofstra Law Review 111 (2010). In Rhetorical Federalism, I made an affirmative case for the widespread trend of state resistance to the then-recently enacted Patient Protection and Affordable Care Act of 2010 (ACA). Before and immediately after ACA’s enactment, a significant number of states engaged in various forms of objection to the new federal Act, including but not limited to lawsuits challenging the constitutionality of the individual insurance mandate. My article focused on five targets of …

Affordable Care Act Litigation: The Standing Paradox, Elizabeth Weeks Leonard

Scholarly Works

The Patient Protection and Affordable Care Act (ACA) litigation presents a standing paradox. In the current posture, it appears that states lack standing to challenge the federal law on behalf of individuals, while individuals possess standing to challenge the federal law on behalf of states. This Article contends that there is no principled reason for this asymmetry and argues that standing doctrine should apply as liberally to states as individuals, assuming states allege the constitutional minimum requirements for standing and especially where the legal challenge turns on allocation of power between the federal government and states. The Article proceeds by …

Getting Past The Politics: How The Healthcare Reform Affects You, Fazal Khan, Sylvia Caley, David Howard, Glenn Pearson

Working in the Public Interest Conferences

Discusses the anticipated implications of the Patient Protection and Affordable Care Act on Georgia residents with particular focus on specific demographic groups.

Can You Really Keep Your Health Care Plan? The Limits Of Grandfathering Under The Affordable Care Act, Elizabeth Weeks Leonard

Scholarly Works

This article examines the rhetoric and reality of President Obama's repeated hallmark promise during federal health reform that "you can keep your health plan," as one example of the Administration's equivocal stance toward deregulation. Although rhetorically supporting the popular preference for decreased government involvement in health care, the Obama Administration, in several instances, has achieved significant re-regulation through the intricacies of executive branch rule-making. The Affordable Care Act's "grandfather rule" (Section 1251, "Preservation of Right to Maintain Existing Coverage") purports to uphold the "you can keep your health plan" promise. But the regulatory requirements for plans to retain grandfathered status …

The Impact Of The Patient Protection And Affordable Health Care Act Of 2010 On State Workers’ Compensation Systems, Thomas A. Eaton

Presentations and Speeches

The relationship between national health care reform and workers’ compensation is not a new issue. Whenever there is a serious discussion about some form of national involvement in the delivery or financing of general health care, the question arises: how does workers’ compensation fit in to this plan? The question is a logical one for state workers’ compensation and federal health care reform share a number of common concerns. Both strive to provide meaningful access to care; both aim to stem the tide of rising costs; and each is concerned about how to coordinate with the other. But, the devil …

Rhetorical Federalism: The Value Of State-Based Dissent To Federal Health Reform, Elizabeth Weeks Leonard

Scholarly Works

This Article makes the affirmative case for the widespread trend of state resistance to the recently enacted, comprehensive federal health reform law, the Patient Protection and Affordable Care Act of 2010, or ACA. A significant number of states have engaged in various forms of objection to the new federal laws, including filing lawsuits against the federal government, enacting laws providing that ACA will not apply to residents of the state, and refusing to cooperate with implementing the new laws. This Article identifies reasons why those actions should not be disregarded simply as Tea Party antics or election-year gamesmanship but instead …

Ensuring Government Accountability During Public Health Emergencies, Fazal Khan

Scholarly Works

The main argument of this Article is that the gravest threat to civil liberties during a public health emergency (PHE) stems from federal powers premised on post-9/11 national security justifications, not putative state powers under the Model State Emergency Health Powers Act (MSEHPA). While I concur with earlier assessments that the MSEHPA is seriously flawed and that PHEs should be construed as primarily federal issues, going forward, more critical attention needs to be focused on the federal role during PHEs as the initially alarming MSEHPA appears to be more of a paper tiger. First, as the responses to Hurricane Katrina …

State Constitutionalism And The Right To Health Care, Elizabeth Weeks Leonard

Scholarly Works

This Article examines state constitutions and health care rights. Notably, close to a third of states’ constitutions recognize health while the U.S. Constitution contains no reference. Ample scholarly commentary exists on the absence of a right to health care under the U.S. Constitution but little attention has been paid to state constitutional law. This Article begins by explaining the absence of a federal right and the rationale for looking to state constitutional protections for health. The Article then provides a comprehensive survey of state constitutional provisions and judicial decisions enforcing or interpreting them. The survey reveals certain common themes and …

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.

Putting The Community Back Into The "Community Benefit" Standard, Jessica Berg

Georgia Law Review

Disputes about tax exemption for hospitals are occurring all over the country. Local tax authorities have revoked tax- exempt status for some hospitals. State governments are considering whether to require minimum amounts of charity care in exchange for tax exemption. Congress is debating whether hospitals should remain a part of the nonprofit sector at all. At the same time, uninsured individuals are suing hospitals for unfair billing and collection practices. Creative accounting and expansive definitions of "free" care have led to a variety of non ideal practices by hospitals in order to balance their bottom line, while maintaining tax-exempt status. …

The Parity Cure: Solving Unequal Treatment Of Mental Illness Health Insurance Through Federal Legislation, Christopher J. Churchill

Georgia Law Review

American health care reform has drawn both impassioned critics and vociferous supporters. Although underinsured and uninsured Americans face a dire plight, the mentally ill-even those with private health insurance-confront even greater hurdles. While drawing substantially less outcry, many insurance plans place limits on mental illness coverage that do not apply to physical illnesses. Though Congress recently passed the Mental Health Parity and Addiction Equity Act of 2008 (the MHPAEA), it did not solve the problem. The MHPAEA eliminates some disparity-such as higher deductibles for mental health treatment-but still allows insurers to impose unequal annual coverage limits. Furthermore,the MHPAEA shares the …

Phase Six Pandemic: A Call To Re-Evaluate Federal Quarantine Authority Before The Next Catastrophic Outbreak, John T. Clarkson

Georgia Law Review

At some point in the future, the United States will confront a deadly pandemic. One potential response to blunt the impact of an outbreak may be the use of a large-scale quarantine. The current statutory framework governing federal quarantine authority, however, is outdated and in need of revision. Any reform must acknowledge that the federal government may be best positioned to respond to national health threats and must simultaneously create limits on federal power to ensure a proper balance of power remains between the states and the federal government. This Note proposes that Congress focus its reform efforts on adding …

State Of Emergency: Why Georgia's Standard Of Care In Emergency Rooms Is Harmful To Your Health, Jason R. Graves

Georgia Law Review

Patients injured by medical negligence have historically
been able to recover for the injuries they sustained. In
2005, however, the Georgia General Assembly passed
Georgia Senate Bill 3, which gave virtual immunity to
emergency room doctors and those practicing in obstetrics
wards. The Bill requires a showing of gross negligence by
clear and convincing evidence to prevail on a medical
malpractice claim against those protected by the statute.
The law prevents injured patients who cannot meet this
standard from recovering any damages, even
compensation for medical bills arising from the negligent
act. The legislature enacted the Bill in an effort …

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 …

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

Book Review Of “Populations, Public Health, And The Law,” Wendy E. Parmet (Georgetown University Press, Washington, D.C., 2009), Elizabeth Weeks Leonard

Scholarly Works

Wendy Parmet's new book, Populations, Public Health, and the Law, is a provocative, milestone contribution to the growing body of public health law scholarship. This article reviews this scholarly work.

Sustainable Commerce: Public Health Law And Environmental Law Provide Tools For Industry And Government To Construct Globally-Competitive Green Economies, T. Rick Irvin, Peter A. Appel

Scholarly Works

This Article examines the legal mechanics underlying the sustainable commerce private/public governance paradigm whereby industry and government create sustainable commerce initiatives which coordinately grow local/state economies and employment, enhance local/state competitiveness in the global marketplace, and at the same time substantially improve local/state public health and environmental infrastructure. This includes an examination of the legal foundation for state/local sustainable commerce initiatives drawn from existing public health and environmental law and a review of two specific local/state sustainable commerce initiatives which have followed this paradigm with impressive results over a two-to-four year timeframe. Part II of this Article examines how public …

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. …

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, …

Teaching Sicko, Elizabeth Weeks

Scholarly Works

This article provides insights in how to make up cancelled law classes to ensure compliance with American Bar Association accreditation instructional hours requirements. How to cover the missed course content. How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students. Faced with the prospect of having to make up two hours each of my Health Care Financing and Regulation course and my Public Health Law seminar, I turned to the teacher's little helper: the DVD player

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 …

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 …

Remembrance Of Lives Past: The Challenge Of Addressing Epigenetic Risk In Society, Fazal Khan

Popular Media

Do our ancestors’ experiences from several generations ago play a role in our current health? Could a famine or a period of food abundance experienced by our grandfathers affect whether we are currently obese or likely to develop diabetes? Can being the grandchildren of those who suffered through genocide or intense racial discrimination affect levels of certain chemicals in our brains even if we are not exposed to the same social stresses? In other words, do we biologically inherit the “memories” of past generations independent of changes to our ancestors’ genetic code or DNA? Assistant Professor Fazal Khan explores how …