Health Law and Policy Commons^™

Sanitation: Reducing The Administrative State’S Control Over Public Health, Lauren R. Roth

Scholarly Works

On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and …

Disappropriation, Matthew Lawrence

Matthew B. Lawrence

Reforming Regenerative Medicine Regulation, Sarah Duranske

Georgia State University Law Review

Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …

What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler

All Faculty Scholarship

Major legislative actions during the early part of the 115th Congress have undermined the central argument for regulatory reform measures such as the REINS Act, a bill that would require congressional approval of all new major regulations. Proponents of the REINS Act argue that it would make the federal regulatory system more democratic by shifting responsibility for regulatory decisions away from unelected bureaucrats and toward the people’s representatives in Congress. But separate legislative actions in the opening of the 115th Congress only call this argument into question. Congress’s most significant initiatives during this period — its derailed attempts to repeal …

Wage Theft As Public Larceny, Elizabeth J. Kennedy

Brooklyn Law Review

Home care for the elderly and disabled is a rapidly expanding industry in which structural and regulatory factors contribute to worker vulnerability and exploitation. Systemic exclusion from core federal employment and labor laws, as well as many state and local regulations, results in minimal consequences for employers who violate standards. Despite recent movement at the federal level to create a “new mindset” of rights and regulations, home care workers must be equipped with creative ways to enforce these new rights and to challenge existing gaps in enforcement. With the understanding that two-thirds of the home care industry is financed by …

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

"How's My Doctoring?" Patient Feedback's Role In Physician Assessment, Ann Marie Marciarille

Ann Marie Marciarille

A society-wide consumer revolution is underway with the rise of online user-generated review websites such as Yelp, Angie’s List, and Zagat. Service provider reviews are now available with an intensity and scope that attracts increasing numbers of reviewers and readers. Health care providers are not exempt from this new consumer generated scrutiny though they have arrived relatively late to the party and as somewhat unwilling guests.

The thesis of this article is that online patient feedback on physicians is relevant and valuable even though it is also uncomfortable for health care providers. This is because the modern physician-patient relationship is …

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 …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

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 …