Law Commons^™

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Kevin Outterson, Christine Årdal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …

Informed Consent And The First Amendment, Wendy K. Mariner, George J. Annas

Faculty Scholarship

For more than two decades, states have been adding to the things that physicians must say and do to obtain “informed consent” — and thereby testing the constitutional limits of states' power to regulate medical practice. In 1992, the Supreme Court upheld states' authority to require physicians to provide truthful information that might encourage a woman to reconsider her decision to have an abortion, finding that such a requirement did not place an “undue burden” on the woman.

The Space Between Two Worlds: Forward To The Health Law, Elizabeth Mccuskey

Faculty Scholarship

This year's Law Review Symposium explored the modem state of health law under the heading, From Scalpel to Gavel. By situating its discussion in the space between the health sciences and law, this symposium embodied the inherently interdisciplinary nature of health law. The gathering of scholars, physicians, counsel, enforcers, and community groups bridged the spaces among numerous disciplines, promoting the exchange of empiricism, ideas, and experiences that have come to define health law.

Medical Evidence And Expertise In Abortion Jurisprudence, Aziza Ahmed

Faculty Scholarship

Medical literature on abortion largely supports pro-choice legal claims. In turn, progressive lawyers often call for “evidence-based approaches” to lawmaking on the assumption that it will produce pro-choice legal and regulatory outcomes. This article argues that the evidence-based approach is no longer a reliable or stable strategy for pro-choice lawyering given transformations in judicial treatment of medical knowledge and a shifting evidentiary base.

Drawing on landmark cases from 1973 to 2012, this article demonstrates how the Supreme Court and lower courts selectively utilize medical expertise and evidence to liberalize or constrain abortion access. With Roe v. Wade, 4 the Supreme …

The Argument That Wasn't' And 'King, Chevron, And The Age Of Textualism, Abigail Moncrieff

Faculty Scholarship

In these two short essays, I examine the somewhat bizarre — and potentially harmful — ways that Chief Justice John Roberts escaped the tension between legalism and realism in King v. Burwell, the Court’s latest Obamacare case. King presented a close legalistic case but a slam-dunk realist case in favor of an IRS interpretation of Obamacare. Roberts opted for the realistic result, but he got there through a bizarre combination of legalistic maneuvers. In “The Argument that Wasn’t,” I note that Roberts refused to make the full legalistic argument in the government’s favor, ignoring an invocation of the constitutional avoidance …

The Impact Of Law On The Right To Water And Adding Normative Change To The Global Agenda, Michael Ulrich

Faculty Scholarship

A resolution was passed at the United Nations Water Conference in 1977 to achieve universal access to sufficient water by 1990. This bar was lowered significantly as part of the Millennium Development Goals (MDGs). However, as the MDGs come to an end this year, even this reduced benchmark will not be reached. Water is inescapably intertwined with every other MDG, as well as the ability to exercise any human right. Consequently, the failure to achieve this goal implores an exploration of its causes. As the global community embarks on setting a new post-MDG agenda, one currently overlooked aspect is the …

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 …

Reframing Federalism — The Affordable Care Act (And Broccoli) In The Supreme Court, Wendy K. Mariner, George J. Annas, Leonard H. Glantz

Faculty Scholarship

The U.S. Supreme Court decision to uphold most of the Affordable Care Act (ACA), including the insurance-coverage requirement, allows historic reforms in the health care system to move forward. Because the justices were split four to four on whether the ACA was constitutional, Chief Justice John Roberts was able to write the lead opinion that commanded five votes for whatever outcome he determined was constitutional. The chief justice's leadership in upholding almost all of the ACA was unanticipated, as was much of his legal reasoning. It was widely assumed that the interpretation of the Commerce Clause by the Court would …

Safeguarding The Safeguards: The Aca Litigation And The Extension Of Structural Protection To Non-Fundamental Liberties, Abigail Moncrieff

Faculty Scholarship

As the lawsuits challenging the Patient Protection and Affordable Care Act (ACA) have evolved, one feature of the litigation has proven especially rankling to the legal academy: the incorporation of substantive libertarian concerns into structural federalism analysis. The breadth and depth of scholarly criticism on this point is surprising, however, given that judges today frequently choose indirect methods for protecting substantive constitutional values, including structural and process-based methods of the kinds at issue in the ACA litigation. Indeed, indirection in the protection of constitutional liberties is a well-known and well-theorized strategy, which one scholar recently termed “semisubstantive review” and another …

The Affordable Care Act And Health Promotion: The Role Of Insurance In Defining Responsibility For Health Risks And Costs, Wendy K. Mariner

Faculty Scholarship

This article examines whether insurance is an appropriate mechanism for improving individual health or reducing the cost of health care for payers. The Affordable Care Act contains implicit standards for allocating responsibility for health, especially in provisions encouraging health promotion and wellness programs. A summary of the accumulating evidence of the effects of such programs suggests that wellness programs have been somewhat more effective in making people feel better than in reducing costs. Health promotion should be encouraged, because health is valuable for its own sake. Insurance is not well suited to improve health or manage behavioral risks to health; …

Obamacare's (3) Day(S) In Court, Abigail Moncrieff

Faculty Scholarship

Before the oral arguments in late March, the vast majority of legal scholars felt confident that the Supreme Court of the United States would uphold the individual mandate against the constitutional challenge that twenty-six states have levied against it. Since the oral argument, that confidence has been severely shaken. This article asks why legal scholars were so confident before the argument and what has made us so concerned since the argument. The article posits that certain fundamental characteristics of health insurance - particularly its unusual role in steering healthcare consumption decisions, which distinguishes health insurance from standard kinds of indemnity …

Cost-Benefit Federalism: Reconciling Collective Action Federalism And Libertarian Federalism In The Obamacare Litigation And Beyond, Abigail Moncrieff

Faculty Scholarship

The lawsuits challenging Obamacare's individual mandate have exposed a rift in federalism theory. On one side of the divide is a view that the national government ought to intervene - and ought to be constitutionally permitted to intervene - whenever the states are "separately incompetent" to regulate. This is the view that Robert Cooter and Neil Siegel recently theorized as "collective action federalism." On the other side of the divide is a view that federalism exists for reasons other than efficiency of regulation and particularly that the Founders created the federal structure for the protection of individual liberty. According to …

Women And Children Last — The Predictable Effects Of Proposed Federal Funding Cuts, Wendy K. Mariner, George J. Annas

Faculty Scholarship

"Women and children last” might as well be the refrain of the current U.S. Congress's new health care budget cutters. We have seen similar efforts before. In the mid-1990s, managed care organizations tried to save money by limiting hospitalization benefits for new mothers and their infants to 24 hours after a vaginal delivery and 48 hours after a cesarean section. As with current Congressional proposals, financial savings were seen as more important than the health of women and children. Because only women get pregnant and give birth, restricting access to reproductive health care is discriminatory on its face and undermines …

The Freedom Of Health, Abigail Moncrieff

Faculty Scholarship

What would have happened if the Patient Protection and Affordable Care Act (PPACA) really had authorized government “death panels” that would decide whether an elderly patient could get treatment? Leaving aside commerce clause and other constraints particular to Congress, would that kind of direct healthcare rationing be a constitutional exercise of governmental power in the United States? I think not. I argue here that an emergent substantive due process constraint would invalidate such an exercise; direct rationing of that kind would violate a constitutional “freedom of health” that is nascent in Supreme Court jurisprudence. Based on that logic, I argue …

Health Reform: What's Insurance Got To Do With It? Recognizing Health Insurance As A Separate Species Of Insurance, Wendy K. Mariner

Faculty Scholarship

Health insurance can be, and to a large extent already is, a separate species of insurance. This article describes the different views of insurance that made health reform contentious. It argues that the goals of health reform are incompatible with conventional views of insurance. Nonetheless, reforming health insurance to achieve those goals does not require as dramatic shift as some might think, because health insurance has already become primarily a means of paying for health care, rather than a simple risk spreading device for specified losses.

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

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 …

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 …

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 …

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 …

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.

Imagining A New Era Of Neuroimaging, Neuroethics, And Neurolaw, George J. Annas

Faculty Scholarship

The human brain has been at the center of medicolegal debates since the late 1960s, when efforts began to develop an alternative definition of death: one centered on brain function instead of heart and lung function. Technological developments and new surgical techniques made this new definition of death, sometimes called "brain death," seem necessary. Mechanical ventilation, a technology that allows respiration and therefore heartbeat to continue after the brain ceases functioning, and heart transplantation, which requires a corpse with a beating heart as a donor, necessitated the definitional alternative. Irreversible cessation of all functions of the brain has been accepted …

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.

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 …}

Law And Public Health: Beyond Emergency Preparedness, Wendy K. Mariner

Faculty Scholarship

This Article examines three questions: What is public health? What is public health law? What roles can lawyers play in public health? It first describes the breadth of public health, highlighting six trends shaping its future: social determinants of health; synergy between medicine and public health; shifts in focus from external (e.g., environmental and social) to internal (behavioral) risks to health; federalization of public health law; globalization of health risks and responses; and bioterrorism. Because the domains of law that apply to public health are equally broad, the Article next offers a conceptual framework for identifying the types of laws …