Law Commons^™

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Reflections On The Cost Of "Low-Cost" Whole Genome Sequencing: Framing The Health Policy Debate, Timothy Caulfield, Jim Evans, Amy Mcguire, Christopher Mccabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A. Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K. Cho, June C. Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jim Lee, Karen H. Rothenberg, Pamela Sankar, Michael J. Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J. Ungar, Brenda Wilson

Faculty Scholarship

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

Dynamic Expansion, Nicole Huberfeld

Faculty Scholarship

Nearly one in four Americans will have medical care and costs covered by the Medicaid program when it has been expanded pursuant to the Patient Protection and Affordable Care Act (the ACA). National media outlets have been reporting that only about half of the states are participating in the Medicaid expansion; if the reports were true, millions of Americans would be left without insurance coverage, and many of the nation’s medically fragile citizens would not have access to consistent healthcare. Contrary to these reports, most states will participate in the Medicaid expansion in the near future. This claim is not …

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

Approval And Withdrawal Of New Antibiotics And Other Antiinfectives In The U.S., 1980-2009, Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio, Aaron S. Kesselheim

Faculty Scholarship

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibioticsintroduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes. Adjusted for these withdrawals, the net introduction of NME antibiotics is not as troubling of a trend. The reduction in NME antibiotics was partially offset by a surge in the introduction of NME antiretrovirals for HIV/AIDS and other drug classes (such as cardiovascular drugs) posted similar declines.

These data …

Reverse Payments, Perverse Incentives, Murat C. Mungan

Faculty Scholarship

Issuing and enforcing prescription drug patents requires courts and legislatures to strike a delicate balance. A patent gives drug manufacturers a legal, if temporary, monopoly on sales of a drug; this encourages manufacturers to engage in costly research and development of new medicines. But not all patents issued by the Patent Office are ultimately deemed valid – generic drug manufacturers can infringe the patent, and, when sued, attack its validity in court on a variety of grounds, including obviousness. In recent years, patent holders have begun to settle these suits (which they initiated) by paying the alleged infringer. Not surprisingly, …

Limiting “Sugary Drinks” To Reduce Obesity — Who Decides?, Wendy K. Mariner, George J. Annas

Faculty Scholarship

When a judge struck down the New York City Board of Health's partial ban on selling “sugary drinks” in containers of more than 16 fluid ounces, the reaction was swift. The Portion Cap Rule was widely viewed as a signature accomplishment of Mayor Michael Bloomberg's third term as the “public health mayor,” and he vowed to appeal, saying, “I've got to defend my children, and yours, and do what's right to save lives. Obesity kills.” But the question before the judge was not about the health risks posed by obesity or even the relationship between obesity and access to large …

Enough About The Constitution: How States Can Regulate Health Insurance Under The Aca, Brendan S. Maher, Radha A. Pathak

Faculty Scholarship

Last term, the United States Supreme Court upheld the constitutionality of the Affordable Care Act in a landmark decision. It is a forceful reminder that America’s oldest question — how power should be shared between federal and state sovereigns — retains powerful political salience. Critics have reflexively attacked the decision as an assault on states’ rights, while supporters have celebrated the result. Regrettably, insufficient attention has been paid to how, in actuality, health care regulatory authority has been and will be divided between federal and state governments. In this Article, we fill that gap. To do so, we apply “federalism-in-fact,” …

"At The Hospital There Are No Human Rights": Reproductive And Sexual Rights Violations Of Women Living With Hiv In Namibia, Aziza Ahmed

Faculty Scholarship

This report documents the ongoing stigma and discrimination of women living with HIV in Namibia, building on prior findings and investigations on the subject, such as the 2008 research conducted by the International Community of Women Living with HIV/AIDS (ICW) and the Namibian Women’s Health Network (NWHN). The report, based upon both desk research and a field mission, examines the human rights situation related to sexual and reproductive health of women living with HIV, including the gravity and ongoing nature of forced and coerced sterilizations in Namibia. The report also provides evidence of violations of informed consent in the context …

Two Conflicts In Context: Lessons From The Schiavo And Bland Cases And The Role Of Best Interests Analysis In The United Kingdom, Barbara A. Noah

Faculty Scholarship

This Essay considers the different approaches to end of life decision making for incapacitated patients in the United States and in the United Kingdom. In the United States, individual patient autonomy is the primary guidepost for making end of life decisions for incapacitated patients. In the United Kingdom, patient preference is openly and deliberately supplemented with a careful consideration of the patient’s best interest. To contrast the two approaches, the Essay focuses on two cases involving patients in permanent vegetative states (PVS) for whom little was known about their respective individual preferences, and it analyzes the differences in conceptualization and …

In Denial: The Role Of Law In Preparing For Death, Barbara A. Noah

Faculty Scholarship

Only approximately 20% of Americans have engaged in any form of advance care planning and, even among older Americans, the process frequently is delayed until an acute illness provides sufficient pressure to act. End of life law, though flawed, offers some opportunity to express individual values and preferences via advance directives of various kinds in order to prepare for death before it is imminent. Yet many people avoid making these preparations because the thought of death is uncomfortable to confront. This Article considers the utility of existing law in preventing and resolving end of life disputes and avoiding over-utilization of …

Introduction: Wounds Of War: Meeting The Needs Of Active-Duty Military Personnel And Veterans With Post-Traumatic Stress Disorder, Kathy L. Cerminara

Faculty Scholarship

Kathy Cerminara, Introduction: Wounds of War: Meeting the Needs of Active-Duty Military Personnel and Veterans with Post-Traumatic Stress Disorder, 37 Nova Law Review 439 (2013).

Equality Standards For Health Insurance Coverage: Will The Mental Health Parity And Addiction Equity Act End The Discrimination?, Ellen M. Weber

Faculty Scholarship

Congress enacted the Mental Health Parity and Addiction Equity Act in 2008 to end discriminatory health insurance coverage for persons with mental health and substance use disorders in large employer health plans. Adopting a comprehensive regulatory approach akin to other civil rights laws, the Parity Act requires “equity” in all plan features, including cost-sharing, durational limits and, most critically, the plan management practices that are used to deny many families medically necessary behavioral health care. Beginning in 2014, all health plans regulated by the Affordable Care Act must also comply with parity standards, effectively ending the second-class insurance status of …

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Faculty Scholarship

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

More Law Than Politics: The Chief, The “Mandate,” Legality, And Statesmanship, Neil S. Siegel

Faculty Scholarship

This chapter in a forthcoming book on NFIB v. Sebelius asks whether the various parts of Chief Justice Roberts’s opinion on the minimum coverage provision are legally justifiable. I focus on what Roberts decided, not why he decided it that way.

Law is fully adequate to explain the Chief Justice’s vote to uphold the minimum coverage provision as within the scope of Congress’s tax power. Roberts embraced the soundest constitutional understanding of the Taxing Clause. He also showed fidelity to the law by applying—and not just giving lip service to—the deeply entrenched presumption of constitutionality that judges are supposed to …

The Impact Of Medical Liability Standards On Regional Variations In Physician Behavior: Evidence From The Adoption Of National-Standard Rules, Michael D. Frakes

Faculty Scholarship

I explore the association between regional variations in physician behavior and the geographical scope of malpractice standards of care. I estimate a 30–50 percent reduction in the gap between state and national utilization rates of various treatments and diagnostic procedures following the adoption of a rule requiring physicians to follow national, as opposed to local, standards. These findings suggest that standardization in malpractice law may lead to greater standardization in practices and, more generally, that physicians may indeed adhere to specific liability standards. In connection with the estimated convergence in practices, I observe no associated changes in patient health.

With Liberty And Access For Some: The Aca's Disconnectfor Women's Health, Nicole Huberfeld

Faculty Scholarship

The ACA denies to women the "basic security" of providing insurance for a procedure that statistics show one in three women will need during their reproductive lifetime. On one hand, the access-enhancing elements of the ACA are likely to help women, who earn lower wages, need more medical care, and live longer than men, to gain access to preventive and regular healthcare and to keep the insurance that they have. On the other hand, poor women and women of color will lose ground in access to abortion, because the ACA prevents insurance payment for abortions through both public and private …

Cutting The Cord To Private Cord Blood Banking: Encouraging Compensation For Public Cord Blood Donations After Flynn V. Holder, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Malpractice Mobs: Medical Dispute Resolution In China, Benjamin L. Liebman

Faculty Scholarship

China has experienced a surge in medical disputes in recent years, on the streets and in the courts. Many disputes result in violence. Quantitative and qualitative empirical evidence of medical malpractice litigation and medical disputes in China reveals a dynamic in which the formal legal system operates in the shadow of protest and violence. The threat of violence leads hospitals to settle claims for more money than would be available in court and also influences how judges handle cases that do wind up in court. The detailed evidence regarding medical disputes presented in this Essay adds depth to existing understanding …

“Rugged Vaginas” And “Vulnerable Rectums”: The Sexual Identity, Epidemiology, And Law Of The Global Hiv Epidemic, Aziza Ahmed

Faculty Scholarship

AIDS remains amongst the leading causes of death globally. Identity is the primary mode of understanding HIV and organizing in response to the HIV epidemic. In this Article, I examine how epidemiology and human rights activism co-produce ideas of identity and risk. I call this the "identity/risk narrative ": the commonsense understanding about an identity group's HIV risk. For example, epidemiology offers the biological narrative of risk: anal sex and the weak rectal lining make men who have sex with men more vulnerable to HIV; while the fragility of a woman's vaginal wall provides a biological foundation for women's vulnerability. …

Constitutional Uncertainty And The Design Of Social Insurance: Reflections On The Obamacare Case, Michael J. Graetz, Jerry L. Mashaw

Faculty Scholarship

In 2010, Barack Obama signed the Patient Protection and Affordable Care Act (the ACA), a complex statute of more than nine hundred pages that fulfilled his goal of extending health-insurance coverage to virtually all Americans – an objective that previous U.S. presidents had sought and failed to achieve for a century. This legislation was hotly contested in the Congress, passing with the support of very few Republicans in the Senate and none in the House.

To broaden access to health insurance, the ACA relies primarily on two devices: (1) an expansion to Medicaid – a joint federal-state health-insurance program for …

Distributions Of Industry Payments To Massachusetts Physicians, Christopher Robertson

Faculty Scholarship

Some states have mandated systematic public disclosure of payments made by drug- and device-makers to health care practitioners. We used Massachusetts data to characterize the distribution of payment types and the variation among medical specialties.

The 30 months’ of data included 32,227 reported payments to 11,734 Massachusetts physicians, for a total of $76.7 million. The most common form of payment was food. Compensation for bona fide services was the payment type with the highest value.

We found that 25% of currently licensed Massachusetts physicians received at least one payment during the study period. Prevalence ranged by specialties from pediatricians (12%) …

Plunging Into Endless Difficulties: Medicaid And Coercion In National Federation Of Independent Business V. Sebelius, Kevin Outterson, Nicole Huberfeld, Elizabeth Weeks Leonard

Faculty Scholarship

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes …

Health Care Cost Containment: No Longer An Option But A Mandate, Susan A. Channick

Faculty Scholarship

The growth in health care costs in the United States in the past two decades has been staggering and extraordinarily burdensome not only to the federal and state governments but also to employers and individuals who purchase their health insurance in the private market. According to a recent report by the Urban Institute Health Policy Center, four major and interrelated reasons are the significant drivers of the persistent rise in health care costs in excess of economic growth. The first is over-insurance due to the favorable tax treatment of employer-sponsored insurance to which approximately fifty-eight percent of non-elderly Americans have …

Where There Is A Right, There Must Be A Remedy (Even In Medicaid), Nicole Huberfeld

Faculty Scholarship

The anticipated growth of Medicaid under the ACA will likely aggravate an ongoing dispute surrounding private enforcement of the Medicaid Act. The Medicaid Act does not provide a private right of action except when a person who is eligible for Medicaid is denied entry into the program. Nevertheless, historically, both Medicaid providers and beneficiaries have been able to protect their rights through 42 U.S.C. § 1983, which allows individuals to seek redress against states in federal court for violations of statutory or constitutional rights, or through the Supremacy Clause, which prevents states from enacting laws that violate superseding federal laws. …

Grand Bargains For Big Data: The Emerging Law Of Health Information, Frank Pasquale

Faculty Scholarship

No abstract provided.

Did Legal Education Fail Health Reform? And How Health Law Can Help, Wendy K. Mariner

Faculty Scholarship

Arguments over the constitutionality of the Affordable Care Act illustrate the pervasiveness of health law issues in society. In court, arguments on both sides also demonstrated insufficient knowledge of the health care system and health insurance to identify and present useful arguments. Too many lawyers remained wedded to theories of constitutional law that have become disconnected from twenty-first century realities. Legal education may have something to answer for in this respect. This essay examines how legal education in health law may offer some valuable responses to ongoing critiques of legal education in general. The more law moves away from strict …