Health Law and Policy Commons^™

Covid-19 And The Conundrum Of Mask Requirements, Robert Gatter, Seema Mohapatra

All Faculty Scholarship

As states begin to loosen their COVID-19 restrictions, public debate is underway about what public health measures are appropriate. Many states have some form of mask-wearing orders to prevent the spread of COVID-19 infection. Public health guidance from the Centers for Disease Control and Prevention and the World Health Organization has conflicted. From a public health point of view, it is not clear what the right answer is. In the absence of directives, individuals are also making their own choices about mask use. At a time when public health measures, like shelter-in-place orders and social distancing, are being used to …

The Mosaic Of Coronavirus Vaccine Development: Systemic Failures In Vaccine Innovation, Ana Santos Rutschman

All Faculty Scholarship

Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.

Knowledge Of Practicing Physicians About Their Legal Obligations When Caring For Patients With Disability, Nicole Agaronnik, Elizabeth Pendo, Julie Ressalam, Eric G. Campbell, Lisa Iezzoni

All Faculty Scholarship

doi: 10.1377/hlthaff.2018.05060 HEALTH AFFAIRS 38, NO. 4 (2019): 545–553

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

Permitted Incentives For Workplace Wellness Plans Under The Ada And Gina: The Regulatory Gap, Elizabeth Pendo, Brandon Hall

All Faculty Scholarship

Although workplace wellness plans have been around for decades, they have flourished under the Patient Protection and Affordable Care Act (“PPACA”) into a $6 billion-dollar industry. Under PPACA, a “wellness plan” is a program of health promotion or disease prevention offered by an employer that is designed to promote health or prevent disease and which meets the other applicable requirements of that subsection. Employers look to these programs to promote healthy lifestyles, improve the overall health of employees and beneficiaries, and reduce rising healthcare costs. PPACA’s amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) permit employers to offer …

On The Judicialization Of Health, Ana Santos Rutschman

All Faculty Scholarship

The provision of health care has long been at the forefront of domestic and international debates, philosophical inquiries, and political agendas. A growing body of legal scholarship has added to the debate by examining the role of judicial review in the context of health-related litigation. What role, if any, should courts play in compelling the provision of health care or in furthering access to potentially life-saving medicines?

This question intersects with multiple strands of the law. For instance, it has an institutional component that interrogates the function(s) of courts within systems of checks and balances. It ties into constitutional design …

Medical Malpractice Cuts Not The Answer, Ruqaiijah A. Yearby

All Faculty Scholarship

Tort reform--legislation that aims to reduce medical malpractice suits --will not cut medical costs and improve health care unless the government addresses the proliferation of unnecessary medical errors that victimize hundreds of thousands of patients every year.

Yearby's research considers how laws enacted to grant equal access to quality health care actually can pose barriers to the disenfranchised, and she is critical of health care reform efforts that do not address the far-reaching problem of medical errors. Finding ways to curb what she calls the "alarming rate of these medical errors," not only will reduce medical malpractice suits, but save …

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Healthcare Blockchain Infrastructure: A Comparative Approach, Ana Santos Rutschman

All Faculty Scholarship

Blockchain has been hailed as the most disruptive technology of the next decade. One of the areas of immediate application is healthcare, where different types of blockchain applications could help streamline data sharing, protect patient privacy, and assist in the monitoring of drug shipments. This Article explores the first steps taken by healthcare companies in the United States to incorporate blockchain solutions into their business models. It then contrasts them to ongoing experiments in the European Union, with a focus on Sweden’s adoption of CareChain (a national, interoperable blockchain health data platform) and Estonia’s digitization of 95% of the country’s …

Ip Preparedness For Outbreak Diseases, Ana Santos Rutschman

All Faculty Scholarship

Outbreaks of infectious diseases will worsen, as illustrated by the recent back-to-back Ebola and Zika epidemics. The development of innovative drugs, especially in the form of vaccines, is key to minimizing future outbreaks, yet current intellectual property (IP) regimes are ineffective in supporting this goal.

IP scholarship has not adequately addressed the role of IP in the development of vaccines for outbreak diseases. This Article fills that void. Through case studies on the recent Ebola and Zika outbreaks, it provides the first descriptive analysis of the role of IP from the pre- to the post-outbreak stages, specifically identifying IP inefficiencies. …

Segregation In St. Louis: Dismantling The Divide, For The Sake Of All [In Collaboration With], Thomas Harvey, John Mcannar, Michael-John Voss, Ascend Stl Inc., Community Builders Network Of Metro St. Louis, Metropolitan St. Louis Equal Housing And Opportunity Council (Ehoc), Team Tif

All Faculty Scholarship

Place matters. Where people live in St. Louis has been shaped by an extensive history of segregation that was driven by policies at multiple levels of government and practices across multiple sectors of society. The effect of segregation has been to systematically exclude African American families from areas opportunity that support economic, educational, and health outcomes.

Accessibility Of Medical Diagnostic Equipment - Implications For People With Disability, Lisa Iezzoni, Elizabeth Pendo

All Faculty Scholarship

Under Attorney General Jeff Sessions, the U.S. Department of Justice (DOJ) has inactivated or rescinded numerous rules and guidelines issued by prior administrations, sometimes attracting considerable public attention in the process. Little noticed, however, was a decision by the DOJ on December 26, 2017, to formally withdraw four Advance Notices of Proposed Rulemaking related to Titles II and III of the Americans with Disabilities Act (ADA), including rulemaking that addressed making medical diagnostic equipment accessible to people with disability. For now, this step halts efforts on a national level to ensure accessibility of such equipment, which includes exam tables, weight …

Editor, "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

All Faculty Scholarship

August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the …

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby

All Faculty Scholarship

For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their “bad blood,” …

Special Issue "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo, Guest Editor

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho, Alexander Rovzar

All Faculty Scholarship

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are …

Medicaid Maximization And Diversion: Illusory State Practices That Convert Federal Aid Into General State Revenue, Daniel L. Hatcher

All Faculty Scholarship

For years, states have been using illusory schemes to maximize federal aid intended for Medicaid services-and then often diverting some or all of the resulting funds to other use. And states have help. Private revenue maximization consultants are hired by states to increase Medicaid claims, often for a contingency fee. We do not know the exact amount of federal Medicaid funds that has been diverted to state revenue and private profit each year, but it is in the billions.

The states' revenue strategies take advantage of the matching-grant structure of the Medicaid program. When state funds are spent on eligible …

The Health Exception, Monica E. Eppinger

All Faculty Scholarship

The abortion doctrine laid out in Roe v. Wade permits a procedure necessary to preserve the life or the health of the pregnant woman, setting out what has come to be called the “life exception” and the “health exception.” This Article investigates the background and antecedents of the health exception, identifying three periods of formation and change up to the drafting of the Model Penal Code in 1959. It argues that theories of health lie at the heart of legal doctrine, shaping common-law treatment of abortion and persisting in nineteenth- and twentieth-century statutes. This account reveals origins of a health …

Race Based Medicine, Color Blind Disease: How Racial Preferences In Violation Of The 14th Amendment Are Killing Us All, Ruqaiijah Yearby

All Faculty Scholarship

Disease is color blind, but medicine is not. For example, sickle cell disease is often discussed in terms of a Black disease; however, people of all different races suffer from sickle cell. Moreover, sickle cell is found in a number of places that have little to no Blacks, such as Afghanistan, Bangladesh, Burma, and Honduras. Nevertheless, health care providers often provide people of different races different levels of care justifying their disparate treatment based on scientific claims. However, not only are these scientific claims baseless, but also the explicit use of race to determine what medical treatment is provided patients …

Collecting New Data On Disability Health Inequities, Elizabeth Pendo

All Faculty Scholarship

Prior to the Affordable Care Act, disability was marginalized in data collection efforts, limiting our ability to understand and address significant health inequities experienced by millions of Americans. Now, for the first time, we can use these tools to collect valuable new data on the nature and extent of health inequities experienced by people with disabilities across the country.

This article argues that standardized health collection data is critical to health equity, and because of the ACA’s groundbreaking requirements for data collection of disability status and treatment of patients with disabilities, we now have the potential to identify, track, and …

Missing The 'Target': Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah Yearby

All Faculty Scholarship

The central purpose of medical research on children is to generate new knowledge that can improve children’s health, subject to ethical standards that promote justice. Incorporated in U.S. law, international law, and European Union law, the Justice Principle prohibits targeting in medical research, which is the selection of research subjects because of their manipulability and compromised position, rather than for reasons directly related to the problem being studied. Unfortunately, medical research studies involving children have too often violated the Justice Principle, by targeting children in a compromised position due to their health status and vulnerable to manipulability because of their …

Substantial Confusion About "Substantial Burdens", Chad Flanders

All Faculty Scholarship

As the Supreme Court rev1s1ts the clash between religious belief and the Affordable Care Act (ACA) in the Zubik¹ case, it is worth mulling over a key phrase in the law that governs that clash: '·substantial burden." According to the Religious Freedom Restoration Act (RFRA), the government must-provided it does not meet certain other conditions, such as showing a compelling interest-make an accommodation if it places a ''substantial burden'' on a person's religious exercise.² If the question in the Hobby Lobby case was whether a for-profit corporation could be a ''person" that ''exercised religion,"³ the question the …

Involuntary Consent: Conditioning Access To Health Care On Participation In Clinical Trials, Ruqaiijah A. Yearby

All Faculty Scholarship

Although the controversy over the lack of consent in fetal-tissue clinical trials is relatively new, history is replete with instances of medical researchers who have conducted clinical trials with minorities and the economically disadvantaged without their consent.1 Traditionally, American bioethics has served as a safety net for the rich and powerful (for they are not forced to act as research subjects to obtain access to health care for themselves or their children) while failing to protect the vulnerable, which includes minorities and the economically disadvantaged. Without access to health care, minorities and the economically disadvantaged are unduly influenced to participate …

Missing The “Target”: Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah A. Yearby

All Faculty Scholarship

Nearly everyone has experienced a burn and the resulting pain. Now imagine that you suffer a third-degree radiation burn that injures all the layers of your skin as well as the tissue, causing you extreme pain. . The burn turns your skin white, cherry red, or black and may produce blisters that are dry, hard, and leathery-looking. The burn can also be seen on the surface of your lungs and gastrointestinal tract. If the burn is big enough you will need skin grafts and surgery to replace the skin and tissue that will never grow back, as well as treatment …

En-Gendering Economic Inequality, Michele E. Gilman

All Faculty Scholarship

We live in an era of growing economic inequality. Luminaries ranging from the President to the Pope to economist Thomas Piketty in his bestselling book Capital in the Twenty- First Century have raised alarms about the disparity between the haves and the have-nots. Overlooked, however, in these important discussions is the reality that economic inequality is not a uniform experience; rather, its effects fall more harshly on women and minorities. With regard to gender, American women have higher rates of poverty and get paid less than comparable men, and their workplace participation rates are falling. Yet economic inequality is neither …

Book Review: Body Banking From The Bench To The Bedside, Natalie Ram

All Faculty Scholarship

How much is a kidney worth? An ounce of breast milk? Genetic material from an individual facing a Parkinson's diagnosis? In today's America, it depends on who is selling. One might think that such body products are beyond value or that their value depends on the individual characteristics of the supplier. But under existing American law and practices, what matters more is whether the seller is also the supplier of that body product, or whether the seller is another entity, such as a pharmaceutical company, hospital, or biobanker.

A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch

All Faculty Scholarship

No abstract provided.

Sick And Tired Of Being Sick And Tired: Putting An End To Separate And Unequal Health Care In The United States 50 Years After The Civil Rights Act Of 1964, Ruqaiijah A. Yearby

All Faculty Scholarship

Since the end of the Civil War in 1865, the U.S. health care system has been structured to be racially separate and unequal. Ninety-nine years later, the enactment of Title VI of the Civil Rights Act of 1964 (Title VI) was supposed to put an end to this racially separate and unequal health care system by mandating equal access to health care for all races. However, fifty years later, African Americans continue to receive separate and unequal treatment compared to Caucasians, in hospitals, nursing homes, and physician offices. As a result, racial disparities in health status and access to health …