Law Commons^™

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Optimizing Cybersecurity Risk In Medical Cyber-Physical Devices, Christopher S. Yoo, Bethany Lee

All Faculty Scholarship

Medical devices are increasingly connected, both to cyber networks and to sensors collecting data from physical stimuli. These cyber-physical systems pose a new host of deadly security risks that traditional notions of cybersecurity struggle to take into account. Previously, we could predict how algorithms would function as they drew on defined inputs. But cyber-physical systems draw on unbounded inputs from the real world. Moreover, with wide networks of cyber-physical medical devices, a single cybersecurity breach could pose lethal dangers to masses of patients.

The U.S. Food and Drug Administration (FDA) is tasked with regulating medical devices to ensure safety and …

The Ethics Of Research That May Disadvantage Others, Christopher Robertson

Faculty Scholarship

In prospective interventional research, a treatment may provide an advantage for the recipient over other humans not receiving it. If the intervention proves successful, the treated are better able to compete for a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of non-treated persons. The concerns for “bystanders” have typically focused on direct harms (e.g., infecting them with a virus), unlike the mere competition for rivalrous goods at issue here.

After broadly scoping this problem, analysis reveals several reasons that such research is typically permissible, notwithstanding the potential setbacks to the interests …

Law School News: Rwu Law Professors Win Release For Two Immigrants At Risk For Covid-19 04-24-2020, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

Law School News: Rwu Law Professors File Emergency Covid-19 Lawsuit 04-12-2020, Michael M. Bowden

Life of the Law School (1993- )

No abstract provided.

The Paradox Of Insurance, Gideon Parchomovsky, Peter Siegelman

All Faculty Scholarship

In this Article, we uncover a paradoxical phenomenon that has hitherto largely escaped the attention of legal scholars and economists, yet it has far-reaching implications for insurance law: loss-creation by uninsured parties caused by the presence of insurance. Contrary to the conventional wisdom, we show that insurance can create significant negative externalities by inducing third parties to engage in antisocial, illegal and unethical activities in order to extract money from insureds or insurers. Moreover, as the amount and scope of insurance grows, so does its distortionary effect on third parties. We term this phenomenon the paradox of insurance. The risk …

Saving Money On Health Insurance Just Got A Lot Easier . . . Or Did It?: The Preserving Employee Wellness Programs Act And Its Impact On The Future Of Employee Health, Zachary Maciejewski

Indiana Law Journal

This Note addresses the growing use of employer-sponsored wellness programs in the American workplace and the concomitant harms and risks these programs impose on employee privacy and insurance costs. Specifically, this Note analyzes the Preserving Employee Wellness Programs Act (PEWPA)—a proposed law that would allow employers to require employees to disclose genetic information to qualify for an employer-sponsored wellness program (and the program’s associated insurance premium benefits). This Note ultimately argues that employees and employee advocacy groups must work to thwart PEWPA to preserve employee privacy in the face of mounting corporate pressure to alter the structure of employer-sponsored health …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Kevin Outterson

Faculty Scholarship

We compared antibiotic prescribing for children with and those without an underlying chronic condition associated with increased risk for invasive pneumococcal disease. Children with a chronic condition had significantly greater cumulative exposure to antibiotics and higher rates of prescriptions per person-year than those without a chronic condition; this population is at increased risk for the emergence of multidrug-resistant pathogens.

Managing Cumulative Risk, Lauren R. Roth

Mitchell Hamline Law Review

No abstract provided.

If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

Ethicists who oppose compensating kidney donors claim they do so because kidney donation is risky for the donor’s health, donors may not appreciate the risks and may be cognitively biased in other ways, and donors may come from disadvantaged groups and thus could be exploited. However, few ethical qualms are raised about professional football players, who face much greater health risks than kidney donors, have much less counseling and screening concerning that risk, and who often come from racial and economic groups deemed disadvantaged. It thus seems that either ethicists—and the law—should ban both professional football and compensated organ donation, …

Human Survival, Risk, And Law: Considering Risk Filters To Replace Cost-Benefit Analysis, John William Draper

Librarian Scholarship at Penn Law

Selfish utilitarianism, neo-classical economics, the directive of short-term income maximization, and the decision tool of cost-benefit analysis fail to protect our species from the significant risks of too much consumption, pollution, or population. For a longer-term survival, humanity needs to employ more than cost-justified precaution.

This article argues that, at the global level, and by extension at all levels of government, we need to replace neo-classical economics with filters for safety and feasibility to regulate against significant risk. For significant risks, especially those that are irreversible, we need decision tools that will protect humanity at all scales. This article describes …

Prep And Our Youth: Implications In Law And Policy, Jason Potter Burda

Faculty Publications

Truvada®, an antiretroviral medication originally approved to treat HIV, is the first drug to receive FDA approval for use by HIV-negative individuals to actually prevent infection. The prophylactic use of an antiretroviral such as Truvada is a pharmacological prevention method called “HIV pre-exposure prophylaxis” (or “PrEP”). With an efficacy of over ninety percent when used as prescribed, Truvada as PrEP has been embraced by the public health community, and implementation is under way across the United States. Truvada as PrEP is currently indicated for adult use only, but it may also be prescribed off-label to at-risk youth. In this Article, …

Reimagining The Risk Of Long-Term Care, Allison K. Hoffman

All Faculty Scholarship

U.S. law and policy on long-term care fail to address the insecurity American families face due to prolonged illness and disability — a problem that grows more serious as the population ages and rates of disability rise. This Article argues that, even worse, we have focused on only part of the problem. It illuminates two ways that prolonged disability or illness can create insecurity. The first arises from the risk of becoming disabled or sick and needing long-term care, which could be called “care-recipient” risk. The second arises out of the risk of becoming responsible for someone else’s care, which …

Law And Politics, An Emerging Epidemic: A Call For Evidence-Based Public Health Law, Michael Ulrich

Faculty Scholarship

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be …

Environmental Law, Big Data, And The Torrent Of Singularities, William Boyd

Publications

How will big data impact environmental law in the near future? This Essay imagines one possible future for environmental law in 2030 that focuses on the implications of big data for the protection of public health from risks associated with pollution and industrial chemicals. It assumes the perspective of an historian looking back from the end of the twenty-first century at the evolution of environmental law during the late twentieth and early twenty-first centuries. The premise of the Essay is that big data will drive a major shift in the underlying knowledge practices of environmental law (along with other areas …

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …

"Toiling In The Danger And In The Morals Of Despair": Risk, Security, Danger, The Constitution, And The Clinician's Dilemma, Michael L. Perlin, Alison Julia Lynch

Michael L Perlin

Abstract: Persons institutionalized in psychiatric hospitals and “state schools” for those with intellectual disabilities have always been hidden from view. Such facilities were often constructed far from major urban centers, availability of transportation to such institutions was often limited, and those who were locked up were, to the public, faceless and often seen as less than human.

Although there has been regular litigation in the area of psychiatric (and intellectual disability) institutional rights for 40 years, much of this case law entirely ignores forensic patients – mostly those awaiting incompetency-to-stand trial determinations, those found permanently incompetent to stand trial, those …

Are Mothers Hazardous To Their Children’S Health?: Law, Culture, And The Framing Of Risk, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This Article examines the psychosocial processes of risk construction and explores how these processes intersect with core principles of Anglo-American law. It does so by critiquing current cultural and legal perceptions that mothers, especially pregnant women, pose a risk to their children’s health. The Article’s core argument is that during the last four decades, both American society and American law have increasingly come to view mothers as a primary source of risk to children. This intense focus on the threat of maternal harm ignores significant environmental sources of injury, including fathers and other men, as well as exposure to toxic …

Health Insurance Is Dead; Long Live Health Insurance, Wendy K. Mariner

Faculty Scholarship

Today, health insurance is no longer simply a class of insurance that covers risks to health, and it has not been so for many years. Health insurance has become a unique form of insurance — a mechanism to pay for healthcare that uses risk spreading as one of several pricing methods. The Affordable Care Act builds on this important payment function to create a complex social insurance system to finance healthcare for (almost) everyone. This article examines how the ACA draws on various conceptions of insurance to produce a quasi-social insurance system. This system poses new challenges to laws governing …

Liability Cure-All For Insidious Disease Claims, Susan Frankewich

Pepperdine Law Review

Recent decisions handed down in various circuits have created virtual chaos in predicting the liability and damage amounts of insidious disease claims. At least three substantially divergent theories have been adopted to impute liability to the manufacturers of the disease catalysts. Additionally, a new trust fund concept has been used on a limited basis to reconcile differences in court decisions. The trust fund approach is relatively flexible and simple to apply in apportioning damages for insidious disease claims. The author examines and analyzes these three liability theories. In conclusion, the adoption of the trust fund concept is recommended.

Abortion And Informed Consent: How Biased Counseling Laws Mandate Violations Of Medical Ethics, Ian Vandewalker

Michigan Journal of Gender & Law

If we slightly change the facts of the story about the discouraging doctor, it becomes a story that happens every day. Abortion patients face attempts to discourage them from terminating their pregnancies like those the imaginary doctor used, as well as others-and state laws mandate these attempts. While the law of every state requires health care professionals to secure the informed consent of the patient before any medical intervention, over half of the states place additional requirements on legally effective informed consent for abortion. These laws sometimes include features that have ethical problems, such as giving patients deceptive information. Unique …

Genealogies Of Risk: Searching For Safety, 1930s-1970s, William Boyd

Publications

Health, safety, and environmental regulation in the United States are saturated with risk thinking. It was not always so, and it may not be so in the future. But today, the formal, quantitative approach to risk provides much of the basis for regulation in these fields, a development that seems quite natural, even necessary. This particular approach, while it drew on conceptual and technical developments that had been underway for decades, achieved prominence during a relatively short timeframe; roughly, between the mid-1970s and the early 1980s--a time of hard looks and regulatory reform. Prior to this time, formal conceptions of …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Choosing One: Resolving The Epidemic Of Multiples In Assisted Reproduction, Theresa Glennon

Villanova Law Review

No abstract provided.

Tontines For The Invincibles: Enticing Low Risks Into The Health-Insurance Pool With An Idea From Insurance History And Behavioral Economics, Tom Baker, Peter Siegelman

All Faculty Scholarship

Over one third of the uninsured adults in the U.S. below retirement age are between 19 and 29 years old. Young adults, especially men, often go without insurance, even when buying it is mandatory and sometimes even when it is a low cost employment benefit. This paper proposes a new form of health insurance targeted at this group—the “Young Invincibles”—those who (wrongly) believe that they don’t need health insurance because they won’t get sick. Our proposal offers a cash bonus to those who turn out to be right in their belief that they did not really need health insurance. The …

Preserving Human Potential As Freedom: A Framework For Regulating Epigenetic Harms, Fazal Khan

Scholarly Works

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

Risk Equity: A New Proposal, Matthew D. Adler

All Faculty Scholarship

What does distributive justice require of risk regulators? Various executive orders enjoin health and safety regulators to take account of “distributive impacts,” “equity,” or “environmental justice,” and many scholars endorse these requirements. But concrete methodologies for evaluating the equity effects of risk regulation policies remain undeveloped. The contrast with cost-benefit analysis--now a very well developed set of techniques --is stark. Equity analysis by governmental agencies that regulate health and safety risks, at least in the United States, lacks rigor and structure. This Article proposes a rigorous framework for risk-equity analysis, which I term “probabilistic population profile analysis” (PPPA). PPPA is …

Mris And The Perception Of Risk, Steven Goldberg

Georgetown Law Faculty Publications and Other Works

The most important safety decision concerning MRIs was to change the name of the procedure. In the late 1970s, the procedure known as nuclear magnetic resonance (NMR) became magnetic resonance imaging (MRI) because of the negative connotations the word “nuclear” invited. The change was understandable since MRIs do not expose patients to dangerous radiation: “nuclear” was in the original name because basic research on the atomic nucleus led to the development of MRIs. The main cost of the name change was to obscure the important link between basic research and useful medical technologies.

In recent years, however, MRIs, a generally …

Qalys And Policy Evaluation: A New Perspective, Matthew D. Adler

All Faculty Scholarship

“QALYs” (Quality-Adjusted Life Years) are a metric for health and longevity very widely employed by health researchers. Surveys are used to assign health states a quality ranking on zero-one scale, with zero representing a health state no better than death and one perfect health. The total QALY value of a health profile is calculated as the time spent in its component health states, each weighted by its quality. Until a few years ago, despite the huge academic literature on QALY measurement, this approach was seldom used by policymakers in the U.S. But there have been recent signs of governmental interest …