Digital Commons Network^™

Estimating The Need For Additional Bankruptcy Judges In Light Of The Covid-19 Pandemic, Benjamin Iverson, Jared A. Ellias, Mark Roe

Faculty Scholarship

In this Article, we present the first effort to use an empirical approach to bolster the capacity of the bankruptcy system during a national crisis—here, the COVID-19 crisis. We provide two analyses, one using data from May 2020, very early on in the crisis, and another using data from September 2020, closer to the publication of this Article. Our analysis is based on an empirical observation: Historically, an increase in the unemployment rate has been a leading indicator of a rise in bankruptcy filings. If this historical trend continues to hold, the May 2020 unemployment rate of 13.3% would have …

The Incentives Of Private Prisons, John F. Pfaff

Faculty Scholarship

No abstract provided.

Public Health Law Tools: A Brief Guide, Kristen Underhill

Faculty Scholarship

The COVID-19 pandemic offers a threat with few precedents in modern times and tests the tools of modern surveillance and public health law. The goal of this chapter is to provide a brief overview of the types of measures that state and federal governments can invoke to treat and prevent the spread of infectious disease. The following sections will provide an orientation to domestic public health law followed by the types of measures available to state and federal public health authorities.

Although this chapter does not consider international institutions, treaties, or norms that affect public health, these are also essential …

Linked Fate: Justice And The Criminal Legal System During The Covid-19 Pandemic, Susan P. Sturm, Faiz Pirani, Hyun Kim, Natalie Behr, Zachary D. Hardwick

Faculty Scholarship

The concept of “linked fate” has taken on new meaning in the face of the COVID-19 pandemic. People all over the world – from every walk of life, spanning class, race, gender, and nationality – face a potentially deadly threat requiring cooperation and sacrifice. The plight of the most vulnerable among us affects the capacity of the larger community to cope with, recover, and learn from COVID-19’s devastating impact. COVID-19 makes visible and urgent the need to embrace our linked fate, “develop a sense of commonality and shared circumstances,” and unstick dysfunctional and inequitable political and legal systems.

Nowhere is …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

Nations And Markets, Harlan G. Cohen

Faculty Scholarship

Economics and security seem increasingly intertwined. Citing national security, states subject foreign investments to new scrutiny, even unwinding mergers like the purchase of Grindr or the creation of TikTok. The provision of 5G has become a diplomatic battleground – Huawei at its center. Meanwhile, states invoke national security to excuse trade wars. The U.S. invoked the GATT national security exception to impose steel and aluminum tariffs, threatening more on automotive parts. Russia invoked that provision to justify its blockade of Ukraine, as did Saudi Arabia and the UAE to excuse theirs of Qatar. And with the spread of COVID-19, states …

Social, Cultural And Economic Aspects Of Antimicrobial Resistance, Timo Minssen, Kevin Outterson, Susan Rogers Van Katwyk, Pedro Henrique D Batista, Clare I. R. Chandler, Francesco Ciabuschi, Stephan Harbarth, Aaron Kesselheim, Ramanan Laxminarayan, Kathleen Liddell, Michael T. Osterholm, Lance Price, Steven J. Hoffman

Faculty Scholarship

Although often considered only a medical problem, antimicrobial resistance is an evolutionary challenge accelerated by social, cultural and economic factors that lead to the misuse, overuse and abuse of life-saving antimicrobial medicines. The antimicrobial resistance challenge is compounded by inadequate attention to disease prevention and response, global circulation of people and products, differences in industry and market regulations across countries, and a fragile pipeline of new antibiotics and their alternatives. While the discovery of new antimicrobials will provide temporary solutions, sustainable success requires rigorous social science research that explores the drivers of antimicrobial resistance. These solutions should promote balance between …

Understanding Violent-Crime Recidivism, J. J. Prescott, Benjamin David Pyle, Sonja B. Starr

Faculty Scholarship

People convicted of violent crimes constitute a majority of the imprisoned population but are generally ignored by existing policies aimed at reducing mass incarceration. Serious efforts to shrink the large footprint of the prison system will need to recognize this fact. This point is especially pressing at the time of this writing, as states and the federal system consider large-scale prison releases motivated by the COVID-19 pandemic. Those convicted of violent crimes constitute a large majority of older prisoners, who are extremely vulnerable to the spread of the virus behind bars. Excluding them from protective measures will deeply undermine those …

Antibiotic Development — Economic, Regulatory And Societal Challenges, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, Kevin Outterson, John H. Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

When Are Vaccine Mandates Appropriate?, Dorit R. Reiss, Carmel Shachar

Faculty Scholarship

Vaccine refusal is a serious public health problem, especially in the context of diseases with potential to spark global pandemics, such as Ebola virus disease in the Democratic Republic of the Congo. This article examines whether and when compelling vaccination through mandates and criminalization, for example, are appropriate. It argues that some legal approaches are ethical when they preserve social stability, trust in government, therapeutic research opportunities, or when they diminish disease severity.

The Cancer Curse: Regulatory Failure By Success, Robin C. Feldman

Faculty Scholarship

Since the turn of the millennium, a series of regulatory decisions—unrelated in time and design—has shifted the focus of the pharmaceutical industry toward cancer research and treatment. Regulation, of course, is designed to drive public and private behavior, but the sum of these regulatory actions is driving behavior well beyond governmental design. This phenomenon represents a peculiar form of regulatory failure that cannot be sufficiently explained without contemplating a new form of regulatory failure—failure by success.

As with any great epic tale, the modern saga is full of celebrities and drama, framed by truly heart-wrenching stories. However, with 89 percent …

The Covid-19 Vaccine Dilemma, Dorit R. Reiss

Faculty Scholarship

COVID-19 continues to lead to large numbers of deaths, harms, and financial costs. Without an effective vaccine, those will continue. The pressure to find a vaccine is high; and that pressure places a risk on the safeguards in place to assure that vaccines are safe and effective will be ignored. The United States has an extensive apparatus to oversee vaccine safety before and after licensing, including multiple federal committees and several monitoring systems, and that apparatus gave us, in 2020, an extraordinarily safe vaccine supply. This Article explains the different pressures that push for and against using the same apparatus …

Institutionalizing The Centers For Disease Control And Prevention's Independence, Dorit R. Reiss

Faculty Scholarship

The United States' response to the COVID-19 pandemic was sub­ optimal. One problem in it was the politicization of the public health response. One aspect of that politicization was aggressive political intervention in the Centers for Disease Control and Prevention ( CDC) efforts to provide guidance and help pandemic response. The concern was strong enough that four previous CDC Directors, in an unusual step, published an op-ed calling out political intervention in the CDC. This article proposes two changes to strengthen the CDC's institutional independence: codifying the CDC's role in preventing diseases and reducing harms in a statute, and restructuring …

Digging The Rabbit Hole, Covid-19 Edition: Anti-Vaccine Themes And The Discourse Around Covid-19, Tara C. Smith, Dorit R. Reiss

Faculty Scholarship

This article draws on a broadcast popular among the anti-vaccine community to map out six themes used by the broadcast to mislead viewers about COVID-19. The themes are the claim that “they” e government and pharma e are lying to you, claims that COVID-19 is an excuse to remove civil liberties, viewing everyone as an expert, claiming that science cannot save us, skewing the science, and a claim that “they” are out to harm the viewers. The article points out that similar themes are used to mislead followers with anti-vaccine information. It highlights the concern that these themes will not …

How Congress Can Help Raise Vaccine Rates, Dorit R. Reiss, Y. Tony Yang

Faculty Scholarship

2019 saw an unusually high number of measles cases, and other preventable disease outbreaks, at least in part linked to vaccines refusal. States are considering legislative responses. This Essay examines what role the federal government can fill in increasing vaccines rates. The Essay suggests that the federal government has an important role to fill in funding research, coordination, and local efforts. It also suggests that a federal school vaccine mandate is likely not the solution: first, such mandates can run into plausible constitutional challenges, and second, there are policy arguments against it. The policy contentions include the unfairness of imposing …

Providing Adolescents With Independent And Confidential Access To Childhood Vaccines: A Proposal To Lower The Age Of Consent, Lois A. Weithorn, Dorit R. Reiss

Faculty Scholarship

The recent rise in rates of nonvaccination and vaccine-preventable diseases and the attendant risks to the public’s health require that lawmakers consider new policy solutions. This Article proposes one such solution. We recommend creation of a limited exception to parental decisionmaking authority by permitting certain older minors to provide legally binding consent for childhood vaccinations and protecting the confidentiality of minors who request vaccination. We analogize this proposed policy to other statutory exceptions that permit certain minors independent access to services relating to contraception, pregnancy, sexually transmitted diseases, mental health and substance abuse, and sexual assault. In this interdisciplinary paper, …

The Zooming Of Federal Civil Litigation, Scott Dodson, Lee Rosenthal, Christopher Dodson

Faculty Scholarship

No abstract provided.

Risk Factors And Mortality Rates Associated With Invasive Group B Streptococcus Infections Among Patients In The Us Veterans Health Administration, Robin L.P. Jump, Brigid Wilson, Daniel Baechle, Sunah Song, Federico Perez

Faculty Scholarship

IMPORTANCE The incidence of invasive infections caused by group B Streptococcus (GBS) continues to increase in the United States. Although diabetes is a key risk factor for invasive GBS, the influence of long-term glycemic control is not well characterized; other risk factors and mortality rates associated with specific types of invasive GBS infections are unknown. OBJECTIVE To investigate risk factors and mortality rates associated with specific invasive GBS infectious syndromes. DESIGN, SETTING, AND PARTICIPANTS This cohort study used US Veterans Health Administration data to assess active users of the Veterans Affairs health care system between January 1, 2008, and December …

Designing Development Programs For Non-Traditional Antibacterial Agents, John H. Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan J. Darrow, Kevin Outterson

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

Key Inflammatory Pathway Activations In The Mci Stage Of Alzheimer’S Disease, Jagan A. Pillai, Sean Maxwell, Lynn M. Bekris, Stephen M. Rao, Mark R. Chance, James B. Leverenz

Faculty Scholarship

Objective: To determine the key inflammatory pathways that are activated in the peripheral and CNS compartments at the mild cognitive impairment (MCI) stage of Alzheimer’s disease (AD). Methods: A cross-sectional study of patients with clinical and biomarker characteristics consistent with MCI-AD in a discovery cohort, with replication in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. Inflammatory analytes were measured in the CSF and plasma with the same validated multiplex analyte platform in both cohorts and correlated with AD biomarkers (CSF Aβ42, total tau (t-tau), phosphorylated tau (p-tau) to identify key inflammatory pathway activations. The pathways were additionally validated by evaluating …

Betting On Climate Policy: Using Prediction Markets To Address Global Warming, Gary M. Lucas Jr, Felix Mormann

Faculty Scholarship

Global warming, sea level rise, and extreme weather events have made climate change a top priority for policymakers across the globe. But which policies are best suited to tackle the enormous challenges presented by our changing climate? This Article proposes that policymakers turn to prediction markets to answer that crucial question. Prediction markets have a strong track record of outperforming other forecasting mechanisms across a wide range of contexts — from predicting election outcomes and economic trends to guessing Oscar winners. In the context of climate change, market participants could, for example, bet on important climate outcomes conditioned on the …

Lead Us Not Into Temptation: A Response To Barbara Fedders's Opioid Policing, Anna Roberts

Faculty Scholarship

No abstract provided.

Using And Misusing Legal Decisions: Why Antivaccine Claims About Nvicp Cases Are Wrong, Dorit Rubinstein Reiss, Rachel Heap

Faculty Scholarship

No abstract provided.

Measles And Misrepresentation In Minnesota: Can There Be Liability For Anti Vaccine Misinformation That Causes Bodily Harm?, Dorit Rubinstein Reiss, John L. Diamond

Faculty Scholarship

No abstract provided.

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Tamar F. Barlam, Jake R. Morgan, Warren A. Kaplan, Kevin Outterson, Stephen I. Pelton

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.

The Global Preclinical Antibacterial Pipeline, Ursula Theuretzbacher, Kevin Outterson, Aleks Engel, Anders Karlén

Faculty Scholarship

Antibacterial resistance is a great concern and requires global action. A critical question is whether enough new antibacterial drugs are being discovered and developed. A review of the clinical antibacterial drug pipeline was recently published, but comprehensive information about the global preclinical pipeline is unavailable. This Review focuses on discovery and preclinical development projects and has found, as of 1 May 2019, 407 antibacterial projects from 314 institutions. The focus is on Gram-negative pathogens, particularly bacteria on the WHO priority bacteria list. The preclinical pipeline is characterized by high levels of diversity and interesting scientific concepts, with 135 projects on …

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

Legal And Policy Responses To Vaccine-Preventable Disease Outbreaks, Leila Barraza, Dorit R. Reiss, Patricia Freeman

Faculty Scholarship

No abstract provided.

Concurrent Atlantoaxial Septic Arthritis And Septic Thrombosis Of The Ophthalmic Vein Due To Staphylococcus Aureus: A Case Report And Review Of The Literature, Robin L.P. Jump

Faculty Scholarship

Atlantoaxial joint septic arthritis and superior ophthalmic vein thrombosis are uncommon manifestations of Staphylococcus aureus infection. A 68-year-old man presented with acute-onset neck pain and diplopia. Imaging studies revealed atlantoaxial septic arthritis and right superior ophthalmic vein thrombosis. Blood cultures grew methicillin-susceptible S. aureus. We review the literature describing these 2 uncommon manifestations of a common pathogen.