Law Commons^™

Hospital Mergers And Public Accountability: Tennessee And Virginia Employ A Certificate Of Public Advantage, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres

Faculty Publications By Year

There is growing recognition and evidence that health care professionals regularly encounter - though they may not identify - victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

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The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Faculty Publications By Year

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …

The Double-Edged Sword Of Health Care Integration: Consolidation And Cost Control, Erin C. Fuse Brown, Jaime S. King

Faculty Publications By Year

The average family of four in the United States spends $25,826 per year on health care. American health care costs so much because we both overuse and overpay for health care goods and services. The Affordable Care Act's cost control policies focus on curbing overutilization by encouraging health care providers to integrate to promote efficiency and eliminate waste, but the the cost control policies largely ignore prices. This article examines this overlooked half of health care cost control policy: rising prices and the policy levers held by the states to address them. We challenge the conventional wisdom that reducing overutilization …

Resurrecting Health Care Rate Regulation, Erin C. Fuse Brown

Faculty Publications By Year

Our excess health care spending in the United States is driven largely by our high health care prices. Our prices are so high because they are undisciplined by market forces, in a health care system rife with market failures, which include information asymmetries, noncompetitive levels of provider market concentration, moral hazard created by health insurance, multiple principal-agent relationships with misaligned incentives, and externalities from unwarranted price variation and discrimination. These health care market failures invite a regulatory solution. An array of legal and policy solutions are typically advanced to control our health care prices and spending, including: (1) market solutions …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

The Impact Of Disability: A Comparative Approach To Medical Resource Allocation In Public Health Emergencies, Katie Hanschke, Leslie E. Wolf, Wendy F. Hensel

Faculty Publications By Year

It is a matter of time before the next widespread pandemic or natural disaster hits the United States (U.S.). The international response to the 2009 H1N1 influenza stands as a cautionary tale about how prepared the world is for such an emergency. Although the pandemic fortunately proved to be less severe than initially anticipated, it nevertheless resulted in shortages of medical equipment, overburdened hospitals, and preventable patient deaths, particularly among young people.

A pandemic will inevitably lead to difficult decisions about the allocation of medical resources, such as who will have priority access to ventilators and critical care beds when …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

When Harvard Said No To Eugenics: The J. Ewing Mears Bequest, 1927, Paul A. Lombardo

Faculty Publications By Year

James Ewing Mears (1838-1919) was a founding member of the Philadelphia Academy of Surgery. His 1910 book, The Problem of Race Betterment, laid the groundwork for later authors to explore the uses of surgical sterilization as a eugenic measure. Mears left $60,000 in his will to Harvard University to support the teaching of eugenics. Although numerous eugenic activists were on the Harvard faculty, and who of its Presidents were also associated with the eugenics movement, Harvard refused the Mears gift. The bequest was eventually awarded to Jefferson Medical College in Philadelphia. This article explains why Harvard turned its back …

Health And Human Rights, Jonathan Todres

Faculty Publications By Year

No abstract provided.

Ethics Consultations And Conflict Engagement In Health Care, Charity Scott

Faculty Publications By Year

This article explores the intersection of two professional fields - bioethics and clinical ethics consultation in health care on one hand, and alternative dispute resolution ("ADR") and conflict management on the other - which until recent years remained relatively unknown to each other. It marries the literatures and lessons of these two fields in order to promote the quality of ethics consultations in hospitals and other health care organizations. * Increasingly, health care ethics committees and consultants acknowledge the need to employ the frameworks, approaches, and tools of good conflict management to do their work effectively. Similarly, conflict specialists and …

North Carolina's Bold Model For Eugenics Compensation, Peter Hardin, Paul Lombardo

Faculty Publications By Year

No abstract provided.

A Public Health Approach To Human Trafficking, Jonathan Todres

Faculty Publications By Year

Trafficked individuals experience physical, sexual and emotional violence at the hands of traffickers, pimps, employers, among others, and are exposed to various workplace, health and environmental hazards. The breadth of the harm suggests a role for a currently underutilized approach: public health methodologies. The field of public health offers vital skills and expertise in the fight against human trafficking.

Developing A Durable Right To Health Care, Erin C. Fuse Brown

Faculty Publications By Year

The Patient Protection and Affordable Care Act’s (ACA) signature accomplishment was the creation of a statutory right to health care for the uninsured. This is a momentous change in policy, addressing one of the most vexing social issues of our time and affecting millions of people and billions of dollars of the U.S. economy. This ambition and the degree of societal and political debate leading up to the Act’s passage suggests that it is a “superstatute,” a rare breed of statute that can, among other things, create rights and institutions more typically thought to be the province of constitutional undertaking. …

Collaborating With The Real World: Opportunities For Developing Skills And Values In Law Teaching, Charity Scott

Faculty Publications By Year

This article describes a broad range of teaching innovations and opportunities that classroom law professors can take advantage of in their own backyards. It presents examples of real-world engagement by faculty who help their students learn the skills, values, and attributes of good professional practice by supplementing what they already are teaching well with opportunities to learn the law in real-world contexts. Classroom professors do not need to become clinical professors or start teaching lawyering skills courses. Instead, they can collaborate with clinical professors, practicing lawyers, and other professionals outside their classrooms in settings that relate to their doctrinal fields. …

Temporary Insanity: The Strange Life And Times Of The Perfect Defense, Russell D. Covey

Faculty Publications By Year

The temporary insanity defense has a prominent place in the mythology of criminal law. Because it seems to permit factually guilty defendants to escape both punishment and institutionalization, some imagine it as the “perfect defense.” In fact, the defense has been invoked in a dizzying variety of contexts and, at times, has proven highly successful. Successful or not, the temporary insanity defense has always been accompanied by a storm of controversy, in part because it is often most successful in cases where the defendant’s basic claim is that honor, revenge, or tragic circumstance – not mental illness in its more …

Looking At The Initial Client Meeting Through An Interdisciplinary Lens: Applying Lessons From The Medical Profession To Law Teaching And Practice, Lisa Radtke Bliss

Faculty Publications By Year

In this essay a clinical law professor observes similarities in the way that physicians and lawyers interact with patients and clients during the initial consult/interview, based upon her experiences teaching in a medical legal partnership clinic.

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.

Rights Relationships And The Experience Of Children Orphaned By Aids, Jonathan Todres

Faculty Publications By Year

The global AIDS pandemic has left more than fifteen million children orphaned. These children constitute one of the most vulnerable populations, yet their situation has received relatively little scrutiny from legal scholars. This Article intends to fill that void by explicating the experience of children orphaned by AIDS, situating it in the broader context of the HIV/AIDS pandemic, and evaluating protections available under international human rights law. Analyzing human rights law as applied to children orphaned by AIDS exposes the extent to which rights are interrelated, particularly for marginalized populations.

In current scholarship, the interrelationship among rights, for the most …

Toward Healing And Restoration For All: Reframing Medical Malpractice Reform, Jonathan Todres

Faculty Publications By Year

The medical malpractice liability system is blamed for everything from the high cost of health care to quality assurance issues. This Article suggests that that one of the problems with the current approach to medical malpractice is that legal remedies for medical error are not viewed as part of the continuum of care. Thus, a new model - driven by the principle of care and the goal of healing - is needed to address medical errors more effectively. Building from these core principles of care and healing, the author develops a new healing-centered framework which provides a better assessment of …

"Sufficient" Capacity: The Contrasting Capacity Requirements For Different Documents, Mary F. Radford, Lawrence A. Frolik

Faculty Publications By Year

In Anglo-American law, the concept of mental "capacity" is used to measure the degree to which an individual has the "mental ability to understand the nature and effects of one's acts" as determined by a medical or cognitive assessment of an individual's mental ability. Based on an individual's mental capacity, the law decides whether the individual had sufficient capacity to engage in the action in question. The legal concept of mental capacity, therefore, is the basis for "when a state legitimately may take action to limit an individual's rights to make decisions about his or her own person or property." …

Familiar Battles For Bioethics: Facing Off Over Transplantation, Paul A. Lombardo

Faculty Publications By Year

No abstract provided.

Student Scholarship, In One Place, But Not Another: When The Law Encourages Breastfeeding In Public While Simultaneously Discouraging It At Work, Emily F. Suski

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In this Essay, the author takes a novel approach to the topic of breastfeeding and work by exploring the trend among states to exempt breastfeeding from criminal indecent exposure laws and comparing this trend to the support, or lack thereof, in laws and policy for breastfeeding at work. The author's comparison reveals that while there is a trend to support breastfeeding in public, there is no such trend in the law to support breastfeeding in the relatively more private work environment.

The author argues that this disparity is both counterintuitive and serves to limit women's choices regarding breastfeeding and work. …

Eugenic Laws Restricting Immigration, Paul A. Lombardo

Faculty Publications By Year

No abstract provided.