Health Law and Policy Commons^™

Nih Guidelines On Human Stem Cell Research In Context: Clarity Or Confusion?, Karen H. Rothenberg, Michael Ulrich

Faculty Scholarship

Restrictions on federal funding for human embryonic stem cell (hESC) research under President Bush stimulated a number of states and the private sector to fund stem cell research, resulting in a patchwork of varying guidelines throughout the country. The National Institutes of Health’s (NIH) guidelines were expected to change all of this.With President Obama following through on his assurance to remove restrictions, stem cell researchers assumed they would find clarity when the new NIH Guidelines on Human Embryonic Stem Cell Research were promulgated to outline an ethical framework to determine which research was eligible for federal funding. As part of …

Medical Malpractice Liability Crisis Or Patient Compensation Crisis?, Kathryn Zeiler

Faculty Scholarship

Tort reform has been a hot topic among those interested in assessing whether and how well the tort system aids injured plaintiffs in achieving civil justice. The debate has been especially heated when it comes to medical malpractice liability. Until recently, rhetoric about the liability system and its relationship to insurance markets and physician supply dominated tort reform debates. While claims made by both proponents and opponents can seem intuitive, they are often unsubstantiated. In recent years, however, academics and others have acquired or created datasets to perform analyses to enhance our understanding of the relationship between the tort system …

Pregnant Man: A Conversation, Darren Rosenblum, Noa Ben-Asher, Mary Anne Case, Elizabeth Emens, Berta E. Hernandez-Truyol,, Vivian M. Gutierrez, Lisa C. Ikemoto, Angela Onwuachi-Willig, Jacob Willig-Onwuachi, Kimberly Mutcherson, Peter Siegelman, Beth Jones

Faculty Scholarship

I'm a law professor who works on gender, sexuality, and culture in the international and comparative context. That's my head working. In "real" life, my partner, Howard, and I have been engaged in having a baby together for several years, a project that came to fruition with the birth of our daughter Melina. Of course, such a project evokes intensely complex feelings and thoughts. Beyond a simple transposition of the personal onto the political, I feel so fortunate to have engaged in myriad conversations with a variety of friends and colleagues who think much more carefully about the family and …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Faculty Scholarship

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness. Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories, and provides an early empirical test of these models, using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models, and …

Human Rights And American Bioethics: Resistance Is Futile, George J. Annas

Faculty Scholarship

The Borg are always confident that humans will be assimilated into their collective hive and therefore that, as they say, “resistance is futile.” In Star Trek, of course, the humans always successfully resist. Elizabeth Fenton and John Arras, like the Borg, resist the idea that humans are uniquely special as well as the utility of the human rights framework for global bioethics. I believe their resistance to human rights is futile, and I explain why in this essay. Let me begin with their subtitle, because we do seem to agree that popular culture is a powerful aid to understanding human …

Pandemic Preparedness: A Return To The Rule Of Law, Wendy K. Mariner, George J. Annas, Wendy E. Parmet

Faculty Scholarship

Current discussions of pandemic influenza and emergency preparedness would do well to heed the lessons of US Airways flight 1549, which landed in the Hudson River in January 2009. This article examines what past emergencies teach us about how to prevent or control epidemics and argues that it is time for a return to the rule of law in pandemic preparedness. The most important resource in emergency preparedness is a healthy, resilient population, which depends importantly on sustainable systems of medical care and public health. Preparedness thus requires more money than law. After September 11, 2001, however, federal emergency preparedness …

Enhancing The Fighting Force: Medical Research On American Soldiers, Catherine L. Annas, George J. Annas

Faculty Scholarship

During President Barack Obama's first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post's Michael Fletcher:

Question: What is your reaction to Alex Rodriguez's admission that he used steroids as a member of the Texas Rangers?

Obama: You know, I think it's depressing news.... And if you're a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it's unfortunate, because I think there are a lot of ballplayers who played it …

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 …

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 …

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 …

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 …

Answering The Millennium Call For The Right To Maternal Health: The Need To Eliminate User Fees, Margaux J. Hall, Aziza Ahmed, Stephanie E. Swanson

Faculty Scholarship

Complications during childbirth and pregnancy are a main source of death and disability among women of reproductive age. Approximately 536,000 women die from pregnancy-related complications each year. Developing countries suffer most profoundly, accounting for 99% of deaths. The world's nations, by endorsing U.N. Millennium Development Goals, recognized that most deaths are preventable; they have pledged to reduce maternal mortality by 75% by 2015. This Article assesses the barriers presented by user fees - formal charges for health services still charged by many countries - to the attainment of MDGs. It shows that user fees hamper healthcare access, particularly in emergency …

Virginity Testing And South Africa's Hiv/Aids Crisis: Beyond Rights Universalism And Cultural Relativism Toward Health Capabilities, Erika George

Faculty Scholarship

In this Article, I explore the tension between the politics of culture and the rights of women and girls to equality, privacy, and sexual autonomy in the context of epidemic disease. Specifically, this Article examines the political debate surrounding the resurgence of virginity testing, its widespread popular support in certain communities, and the South African government's recent efforts to prohibit the practice. This Article argues that the current debate over virginity testing, which focuses on abolition or accommodation of the practice, is misguided and polarizing. It argues that these perspectives on the debate increase the likelihood that the problem causing …

The Changing Face Of Family Law: Global Consequences Of Embedding Physicians And Biotechnology In The Parent-Child Relationship, George J. Annas

Faculty Scholarship

Sexual reproduction, also known as making babies the old-fashioned way, has always brought with it significant challenges for family law, especially regarding protecting the best interests of children, and the identification of parents with the right and responsibility to rear them. But these challenges often seem mundane in the face of what has evolved since physicians have been injected into baby making and thus into novel parent-child relationships. The addition of physicians and their "new" medical technologies, sometimes called Assisted Reproductive Technology (ART), have forced the law to reconsider the very definition of motherhood and have radically altered society's view …

Social Solidarity And Personal Responsibility In Health Reform, Wendy K. Mariner

Faculty Scholarship

In the United States, calls to expand access to health care, when not simply ignored, typically result in bills or legislation to reform health insurance. We are in the midst of just such a cycle today. Several states have adopted reform laws to make insurance available to most of their residents. Presidential candidates are offering their own proposals for the nation's health care system. Former Treasury Secretary Paul O'Neill even declared that health care should be a right, adding that wealthier people should help pay for those who will never be able to afford their own care. Most Americans cannot …

Rules For Donations To Tissue Banks: What Next?, George J. Annas

Faculty Scholarship

Michael Crichton's Next is a fictional creation of multiple catastrophes emanating from the real-life case of John Moore, in which the California Supreme Court ruled in 1990 that Moore did not own his cells after they were removed from his body. As human tissue has become commercially useful, and as tissue banks storing and providing samples for research have flourished, the question of who owns the tissue has become more vital. Next got mixed reviews, but even many scientists, such as Michael Goldman, who reviewed the book in Nature, agree with Crichton that it is imperative that we “establish clear …

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

Faculty Scholarship

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, …

Reviews In Medical Ethics: Stumbling On Options: A Review Of Readings In Comparative Health Law & Ethics, Frances H. Miller

Faculty Scholarship

Thanks to a series of storms sweeping up the eastern seaboard for three days, I found myself with four fivehour flight delays and two completely unrelated books in my briefcase. One of the books was the second edition of Professor Tim Jost's Readings in Comparative Health Law & Ethics,' which I was reviewing for this publication. The second was Daniel Gilbert's Stumbling on Happiness,² which someone - no doubt thinking I could use a little wisdom on the subject - had given me for my birthday. I did not mind the delays, for they gave me time …

Market-Based Licensing For Hpv Vaccines In Developing Countries, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Human papillomavirus (HPV) vaccines hold great promise for preventing cervical cancer, but 93 percent of mortality worldwide occurs in low- and middle-income countries, where high vaccine costs can restrict dissemination. Current models for promoting international access to health care innovations include differential pricing, advance market commitments, and voluntary and compulsory licensing. Some of these mechanisms have been effective, but much room for improvement remains. We discuss the usefulness of a new type of license that uses market forces to lower prices through generic competition in low- and middle-income countries while ensuring that pharmaceutical companies are appropriately reimbursed for their research …

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

Faculty Scholarship

The first two terms of the Roberts Court signal a willingness to revisit precedent, and the Court appears poised 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. Federal courts have inconsistently and confusingly applied the Gonzaga framework, but the Rehnquist Court would not revisit the rule. Last term, the Roberts Court granted a petition for certiorari that would have required reconsidering Gonzaga. Before it could be heard on the merits, the respondents mooted the …

Clear Notice For Conditions On Spending, Unclear Implications For States In Federal Healthcare Programs, Nicole Huberfeld

Faculty Scholarship

This article explores an important case from the 2005-06 Supreme Court term, Arlington Central School District Board of Education v. Murphy. Murphy is a benchmark for Spending Clause jurisprudence, as the new Roberts Court adopted what was the dissenting view for years, but its significance has gone largely unnoticed. Additionally, Murphy may have critical implications for the federalism revolution and for the country's largest healthcare programs. These broad observations are focused in this article by the example of the Clawback Provision, a new Medicaid requirement that has been challenged by New Jersey, Texas, Maine, Missouri, and Kentucky. The Supreme Court …

The Legacy Of The Nuremberg Doctors' Trial To American Bioethics And Human Rights, George J. Annas

Faculty Scholarship

In this lecture I argue that modern bioethics was born at the Nuremberg Doctors' Trial, a health law trial that produced one of the first major human rights documents: the Nuremberg Code. Accepting this conclusion has significant consequences for contemporary American bioethics generally, and specifically in the context of our continuing global war on terror in which the United States uses physicians to help in interrogations, torture, and force-feeding hunger strikers.

The primary force shaping the agenda, development, and current state of American bioethics has not been either medicine or philosophy, but law, best described as health law. Like bioethics, …

Health Care Reform In America: Beyond Ideology, George J. Annas

Faculty Scholarship

The inspiration for the following keynote address was drawn from an article authored by Professor Annas in 1995 which appeared in the New England Journal of Medicine.² In that article, Professor Annas sought to explain the Clinton healthcare plan's failure by analyzing the power and importance of the healthcare reform metaphors used in promoting the plan. In his remarks here, Professor Annas extends his analysis of healthcare related metaphors to those common in current healthcare reform parlance, theorizing that current efforts at healthcare reform have been unsuccessful, in part, because the metaphors used fail to frame the issues involved …

Medical Judgment In Court And In Congress - Abortion, Refusing Treatment, And Drug Regulation, George J. Annas

Faculty Scholarship

Over the past four decades, the courts and Congress have consistently granted almost unqualified deference to physicians (and medical ethics), at least for treatment decisions made in the context of a consensual physician-patient relationship. The primary exception to this harmonious deference is the 2007 abortion decision of Gonzales v. Carhart, 127 S. Ct. 1610 (2007), and it is reasonable to review our continuing and seemingly intractable legal debate over abortion and the physician's role in it to determine if it could erode judicial and congressional deference to medical judgment in other areas of medical practice and medical ethics.

Imaging The Mind, Minding The Image: An Historical Introduction To Brain Imaging And The Law, Laura Stephens, Shahram Khoshbin

Faculty Scholarship

Since ancient times, people have yearned to attribute human behaviors to a physical source within the head. Recently, neuroimaging technologies have given us the technical ability to look at the living brain, its structures, and some of its functions without the need for invasive procedures. However, the science has a long way to go before these technologies can allow us fully to appreciate the anatomical and physiologic underpinnings of human thoughts, states of mind, motives, will, or behaviors.

In this Article, we use an historical overview to introduce the various new technologies for imaging the brain. Today, the goal of …

Mission Creep: Public Health Surveillance And Medical Privacy, Wendy K. Mariner

Faculty Scholarship

The National Security Agency's domestic surveillance program has parallels in the growth of disease surveillance for public health purposes. This article explores whether laws requiring health providers to report to government names and identifiable information about patients with infectious or chronic diseases may be vulnerable to challenge as an invasion of privacy. A shift in the use of disease surveillance data from investigating disease outbreaks to data mining and analysis for research, budgeting, and policy planning, as well as bioterrorism, tests the boundaries of liberty and privacy. The Supreme Court has not reviewed a disease reporting law. Its few related …

Medicine And Public Health: Crossing Legal Boundaries, Wendy K. Mariner

Faculty Scholarship

In 2006, New York City began a mandatory reporting system for laboratories to submit blood sugar (A1c) test results (primarily for diabetes) to the city's Department of Health and Mental Hygiene without the patient's consent. This article examines whether this new program is an innovative way to improve New Yorkers' health, an invasion of medical privacy, or usurpation of the physician's role. The registry is an example of public health initiatives in chronic diseases, which challenge the limits of laws governing medicine care and public health programs by blurring the historical boundaries between them.

Pharma On The Hot Seat, Nicole Huberfeld

Faculty Scholarship

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act’s statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital …