Health Law and Policy Commons^™

Immigration Detention And Illusory Alternatives To Habeas, Fatma Marouf

Faculty Scholarship

The Supreme Court has never directly addressed whether, or under what circumstances, a writ of habeas corpus may be used to challenge the conditions of detention, as opposed to the fact or duration of detention. Consequently, a circuit split exists on habeas jurisdiction over conditions claims. The COVID-19 pandemic brought this issue into the spotlight as detained individuals fearing infection, serious illness, and death requested release through habeas petitions around the country. One of the factors that courts considered in deciding whether to exercise habeas jurisdiction was whether alternative remedies exist, through a civil rights or tort-based action. This Article …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Agencies, Polarization, And The States, Gillian E. Metzger

Faculty Scholarship

Political polarization is all the rage. Yet administrative agencies are strikingly absent from leading accounts of contemporary polarization. To the extent they appear, it is largely as acted-upon entities that bear the fallout from the congressional-presidential confrontations that polarization fuels, or as the tools of presidential unilateralism. This failure to incorporate administrative agencies into polarization accounts is a major omission. Agencies possess broad grants of preexisting authority that they can use to reshape governing policy and law, often at presidential instigation, thereby putting pressure on Congress to respond. In the process, they can construct new alliances and arrangements that have …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

Brand New Law! The Need To Market Health Care Reform, William M. Sage

Faculty Scholarship

The most serious problem with the Patient Protection and Affordable Care Act (ACA) is not its contents but its packaging. Because it requires significant departures from business as usual in health insurance, health care delivery, and health behavior, the ACA is unlikely to succeed unless Americans feel a shared stake in its success. Unfortunately, the new law has been branded only by its opponents. Neither the Obama administration nor its congressional allies have effectively communicated the law’s key elements to the public. Most surprisingly, the groundbreaking program of near-universal health coverage the ACA creates does not even have a name. …

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 …

Theorizing And Generalizing About Risk Assessment And Regulation Through Comparative Nested Analysis Of Representative Cases, Jonathan B. Wiener, Brendon Swedlow, Denise Kall, Zheng Zhou, James K. Hammitt

Faculty Scholarship

This article provides a framework and offers strategies for theorizing and generalizing about risk assessment and regulation developed in the context of an on-going comparative study of regulatory behavior. Construction of a universe of nearly 3,000 risks and study of a random sample of 100 of these risks allowed us to estimate relative U.S. and European regulatory precaution over a thirty-five-year period. Comparative nested analysis of cases selected from this universe of ecological, health, safety, and other risks or its eighteen categories or ninety-two subcategories of risk sources or causes will allow theory-testing and -building and many further descriptive and …

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 …

Abortion, Equality, And Administrative Regulation, Gillian E. Metzger

Faculty Scholarship

Abortion and equality are a common pairing; courts as well as legal scholars have noted the importance of abortion and a woman's ability to control whether and when she has children to her ability to participate fully and equally in society. Abortion and administrative regulation, on the other hand, are a more unusual combination. Most restrictions on abortion are legislatively imposed, while guarantees of reproductive freedom are constitutionally derived, so administrative law does not frequently figure in debates about access to abortion.

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.

Against “Individual Risk”: A Sympathetic Critique Of Risk Assessment, Matthew D. Adler

Faculty Scholarship

No abstract provided.

Managed Care’S Crimea: Medical Necessity, Therapeutic Benefit, And The Goals Of Administrative Process In Health Insurance, William M. Sage

Faculty Scholarship

This Essay explores the concept of medical necessity as it has evolved in the judicial and administrative oversight of managed care. The goals of the Essay are to illustrate the range of plausible rationales for establishing administrative procedures to govern medical necessity disputes, and to demonstrate the difficulty of incorporating into those procedures the most important professional and social responsibilities of managed care in today’s health care system. Part I of the Essay explains the ideological and practical significance of medical necessity as managed care has evolved. Part II examines medical necessity as a legal problem, and questions whether current …

Regulating Through Information: Disclosure Laws And American Health Care, William M. Sage

Faculty Scholarship

Efforts to reform the American health care system through direct government action have failed repeatedly. Nonetheless, an alternative strategy has emerged from these experiences: requiring insurance organizations and health care providers to disclose information to the public. In this Article, Professor Sage assesses the justifications for this type of regulation and its prospects. In particular, he identifies and analyzes four distinct rationales for disclosure. He finds that the most commonly articulated goal of mandatory disclosure laws-improving the efficiency of private purchasing decisions by giving purchasers complete information about price and quality- is the most complicated operationally. The other justifications-which he …

Nicotine Withdrawal: Assessing The Fda's Effort To Regulate Tobacco Products, Lars Noah, Barbara A. Noah

Faculty Scholarship

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a "pediatric disease," FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to …

Aids And Government: A Plan Of Action, Taunya L. Banks

Faculty Scholarship

No abstract provided.