Health Law and Policy Commons^™

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 …

Relational Duties, Regulatory Duties, And The Widening Gap Between Individual Health Law And Collective Health Policy, William M. Sage

Faculty Scholarship

In response to a prominent editorial by Dr. Jeffrey M. Drazen, Professor Sage explains how a relational approach has impeded health law's ability to effectively govern the American health care system, arguing that health law has traditionally focused on the physician-patient encounter rather than on achieving collective objectives (which he calls regulatory duties). Professor Sage traces health law's relational emphasis to private and public law, professional ethics and bioethics, budgetary and general politics, and health care consumerism. He concludes that four areas of health policy-conflicts of interest in biomedical research, managed care and pay-for-performance, health care transparency and education, and …

Duty To The Unborn: A Response To Smolensky, Jaime S. King

Faculty Scholarship

No abstract provided.

Predicting Probability: Regulating The Future Of Preimplantation Genetic Screening, Jaime S. King

Faculty Scholarship

No abstract provided.

A Prescription For Racial Equality In Medicine, Barbara A. Noah

Faculty Scholarship

A significant body of evidence suggests that minority race adversely affects the quantity and quality of health care provided to minority patients. Although no one has documented systemic overt racism among health care providers, persistent inequities in the delivery of health care services pose serious problems for patients of color. Ultimately, the medical establishment must confront the reality that African Americans and other racial minorities often do not receive equal treatment in the health care system.

The continued implementation of affirmative action programs as part of the medical school admissions process plays a key role in improving health care delivery …

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 …

The Law School Clinic As A Partner In A Medical-Legal Partnership, Jane R. Wettach

Faculty Scholarship

No abstract provided.

Does Being A Repeat Player Make A Difference? The Impact Of Attorney Experience And Case-Picking On The Outcome Of Medical Malpractice Lawsuits, Catherine T. Harris, Ralph Peeples, Thomas B. Metzloff

Faculty Scholarship

We begin with Galanter's suggestion that attorneys who are "repeat players" in a specific area of litigation have an advantage over those who are not. Using a combination of data sources we analyze the impact of attorney experience and case characteristics on case outcome of 348 North Carolina medical malpractice lawsuits. We add the insurers' evaluation of liability to the analysis in a limited number of cases (n=72). While plaintiffs' attorney's medical malpractice case experience had an impact, we argue that this must be understood in the context of the plaintiffs' attorney's ability to pick cases in which the insurers' …

Integrating Accommodation, Elizabeth F. Emens

Faculty Scholarship

Courts and agencies interpreting the Americans with Disabilities Act (ADA) generally assume that workplace accommodations benefit individual employees with disabilities and impose costs on employers and, at times, coworkers. This belief reflects a failure to recognize a key feature of ADA accommodations: their benefits to third parties. Numerous accommodations – from ramps to ergonomic furniture to telecommuting initiatives – can create benefits for coworkers, both disabled and nondisabled, as well as for the growing group of employees with impairments that are not limiting enough to constitute disabilities under the ADA. Much attention has been paid to how the integration of …

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 …

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.

Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …

Who Is To Shame? Narratives Of Neonaticide, Susan Ayres

Faculty Scholarship

In seventeenth-century England, single women who killed their newborns were believed to have acted to hide their shame. They were prosecuted under the 1624 Concealment Law and punished by death. This harsh response eventually evolved into a more humane and sympathetic one, as shown by the increasing number of acquittals in the late eighteenth century and by the sharp drop of prosecutions in the late nineteenth century. Then, in 1922, England passed the Infanticide Act, amended in 1938, which provided that a mother who killed her child would be prosecuted for manslaughter, not murder. Today, the great majority of women …

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 …

Might The Fact That 90% Of Americans Live Within 15 Miles Of A Wal-Mart Help Achieve Universal Health Care?, William M. Sage

Faculty Scholarship

The subject of this Essay is the retail medical clinic movement. Retail medical clinics-a few hundred exist at the time of this publication-are typically located in national or regional chains of discount stores, pharmacies, and supermarkets. 1 News articles describing this new phenomenon in American health care tend to examine its viability as a business. The symposium for which this Essay was prepared is devoted to the "Massachusetts Health Plan," that state's pioneering effort (in the current political cycle) to achieve near-universal health insurance for its residents. Accordingly, this Essay situates the retail medical clinic movement in overall "health policy," …

Some Principles Require Principals: Why Banning “Conflicts Of Interest” Won’T Solve Incentive Problems In Biomedical Research, William M. Sage

Faculty Scholarship

This Article seeks to bring greater discipline to the analysis of conflicts of interest in biomedical research, and by doing so to reveal trends and tensions in the research enterprise that require a more deliberate and longer term response. By comparing tensions in biomedical research to those affecting indisputably "relational" professionals such as lawyers, this Article concludes that "conflict of interest" is the wrong language to describe most of these situations, and leads to the wrong solutions. Conflict of interest analysis in law derives from an image of professional obligation running directly from expert agent to dependent principal. Because a …

Child Welfare Interventions For Drug-Dependent Pregnant Women: Limitations Of A Non-Public Health Response, Ellen M. Weber

Faculty Scholarship

National drug policy, medical practice and the child welfare system have not kept pace with scientific research that points to effective health interventions to address alcoholism and drug dependence among pregnant women. In its 2003 amendments to the Child Abuse Prevention and Treatment Act, Congress adopted a policy requiring physicians to report to child protective services all patients who give birth to an infant affected by illicit drug use. Drawing on epidemiological, medical and social science research, this Article critiques Congress’s decision to require health professionals to engage in a surveillance role instead of a therapeutic intervention. In seeking to …

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 …

Why Are Demonstrations Of Comprehensive Malpractice Reform So (At All) Controversial, William M. Sage

Faculty Scholarship

We are currently coming to the end of what I have described as the first malpractice crisis of the 21st century. Malpractice crises, which are defined by shrinking liability coverage and/or rising premiums, occur periodically. The insurance crisis that now seems to be ebbing was different in certain ways from its 20th century predecessors, but will almost certainly not be the last such period to arise. As interest in "solving" this crisis wanes for various reasons, we have to ask what we have learned from the last five years. In my opinion, this crisis has produced strong arguments for testing …

Do Defendants Pay What Juries Award? Post-Verdict Haircuts In Texas Medical Malpractice Cases, 1988–2003, David A. Hyman, Bernard Black, Kathryn Zeiler, Charles Silver, William M. Sage

Faculty Scholarship

Legal scholars, legislators, policy advocates, and the news media frequently use jury verdicts to draw conclusions about the performance of the tort system. However, actual payouts can differ greatly from verdicts. We report evidence on post-verdict payouts from the most comprehensive longitudinal study of matched jury verdicts and payouts. Using data on all insured medical malpractice claims in Texas from 1988–2003 in which the plaintiff received at least $25,000 (in 1988 dollars) following a jury trial, we find that most jury awards received “haircuts.” Seventy-five percent of plaintiffs received a payout less than the adjusted verdict (jury verdict plus prejudgment …

Collateral Damage: The Aftermath Of The Political Culture Wars In Schiavo, Kathy L. Cerminara

Faculty Scholarship

Kathy Cerminara, Collateral Damage: The Aftermath of the Political Culture Wars in Schiavo, 29 Western New England Law Review 279 (2007). Theresa Marie Schiavo died a celebrity at the age of 42 in Pinellas Park, Florida, in early 2005. She never sought the public spotlight; she never even knew she was a celebrity. She became a celebrity, one of the best-known figures in bioethics, because of politics. This Article examines the politics surrounding her death and draws some conclusions about the aftermath for those left behind in the America Ms. Schiavo departed. The lessons of Schiavo are mixed. It …

Introduction To The Tenth Anniversary Issue Of The Journal Of Health Care Law & Policy , Karen H. Rothenberg, Diane E. Hoffmann

Faculty Scholarship

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 …

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

Faculty Scholarship

No abstract provided.

Pain Detection And The Privacy Of Subjective Experience, Adam Kolber

Faculty Scholarship

No abstract provided.

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 …

Foreword: The Politics Of Health Law: Any Tipping Points In View?, Frances H. Miller

Faculty Scholarship

Malcolm Gladwell explored the way certain ideas and behaviors can proliferate "just like viruses do" once they achieve a critical mass in The Tipping Point,' his best-seller about the sorts of widespread and rapidly adopted social phenomena he labels epidemics. Gladwell's subtitle, "How Little Things Can Make a Big Difference," indicates that he thinks it need not take much to get one of these social epidemics rolling. He does believe, however, that three factors are essential: getting "people with a particular and rare set of social gifts" involved,² packaging the ideas so they are "irresistible" under the circumstances, ^{3 …}