Health Law and Policy Commons^™

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

Federalized Corporate Governance: The Dream Of William O. Douglas As Sarbanes-Oxley Turns 20, Joan Macleod Heminway

Brooklyn Journal of Corporate, Financial & Commercial Law

The federalization of U.S. corporate governance has been a topic of conversation among policymakers from the very beginning of federal securities law in the New Deal era. Among the early proponents of a federalized system of corporate governance oversight was William O. Douglas—perhaps best known as the longest-serving U.S. Supreme Court justice, but who also was a former commissioner and chair of the U.S. Securities and Exchange Commission. Reflecting on Douglas’s federal corporate governance ideas, Professor Roberta Karmel wrote a law review article for the Delaware Journal of Corporate Law, published in 2005, commenting on the extent and nature of …

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

Shifting Antitrust Laws And Regulations In The Wake Of Hospital Mergers: Taking The Focus Off Of Elective Markets And Centering Health Care, Maya Inka Ureño-Dembar

Brooklyn Law Review

Access to health care requires access to a care center and access to comprehensive health care services. Rampant hospital mergers are uniquely poised to reduce both the number of hospitals, requiring patients to travel further, and the services provided within a newly merged hospital, namely reproductive health services. This phenomenon is clearly seen through the merging of secular and nonsecular hospitals, which often result in patients being forced to travel much further for reproductive health care. In the United States’ current model, health care is not a right, but is treated as a commodity. As such, it is governed by …

Medical Error Disclosure: A Content Analysis Of State Legislation, Teresa Kathleen Sparks

Graduate Theses and Dissertations

Medical error is a public health problem in the United States (U.S.), causing approximately 250,000 hospital deaths per year. Health care leaders and policy-makers have identified medical error disclosure as one of many viable evidence-based solutions to address the problem of medical error – leading to increased transparency in health care, improved patient outcomes, potential medical malpractice cost reduction, and decreased health care provider distress and turnover. Unfortunately, health care providers are often hesitant to practice disclosure and are not required to do so in most U.S. jurisdictions. A qualitative inquiry using content analysis was conducted to understand the language …

Fighting The Ftca: Medical Malpractice, Veterans, And The Va, Taylor C. Spillers

Arkansas Law Review

Dr. Levy, who served as the Chief of Pathology at the Fayetteville Veterans Health Care System of the Ozarks (“Fayetteville VA”) from 2005 to 2018, diagnosed veterans with an error rate of 10%. The “pathology practice average is 0.7%.” Of the more than 3,000 cases Dr. Levy misdiagnosed, 589 were classified as “Level 3 (major) errors” which should always “trigger an [internal] investigation.” Unfortunately, no investigations ensued until Dr. Levy’s ultimate arrest, although the Fayetteville VA addressed Dr. Levy’s behavior repeatedly throughout his employment.

Getting Away With Murder: How California State Law Determined Recovery In First Roundup Cancer Case Johnson V. Monsato Co., Eliza L. Quattlebaum

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Periods For Profit And The Rise Of Menstrual Surveillance, Michele E. Gilman

All Faculty Scholarship

Menstruation is being monetized and surveilled, with the voluntary participation of millions of women. Thousands of downloadable apps promise to help women monitor their periods and manage their fertility. These apps are part of the broader, multi-billion dollar, Femtech industry, which sells technology to help women understand and improve their health. Femtech is marketed with the language of female autonomy and feminist empowerment. Despite this rhetoric, Femtech is part of a broader business strategy of data extraction, in which companies are extracting people’s personal data for profit, typically without their knowledge or meaningful consent. Femtech can oppress menstruators in several …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Abortion Delayed Is Abortion Denied: Why The Hyde Amendment's Rescission Of Federal Funding For Medically Necessary Abortions Harms Low-Income Women, Aliza Shatzman

Cardozo Journal of Equal Rights & Social Justice

The article argues that the Hyde Amendment, which restricts federal funding for abortions except in cases of life endangerment, rape, or incest, violates the constitutional rights established by Roe v. Wade. It contends that the amendment disproportionately harms low-income women by denying them access to medically necessary abortions, thereby undermining their health and autonomy. The author asserts that the Hyde Amendment conflicts with the "reliance interest" doctrine outlined in Planned Parenthood v. Casey, where women have come to depend on the availability of abortion services.

When Justice Should Precede Generosity: The Case Against Charitable Immunity In Arkansas, Courtney Jane Baltz

Arkansas Law Notes

This Comment discusses various aspects of the modern hospital and examines charitable immunity’s incompatibility with modern law.

First, Part II explains the historical justifications for immunity and presents the doctrine’s landscape in the United States. Part III examines the role precedent plays in continuing to adhere to the rule of immunity. Part IV takes an in-depth approach of the big business of hospitals by evaluating various financial aspects of charitable hospitals. Part V explores the reality of charitable immunity falling out of touch with concepts of modern law. Part VI takes a more specific look at the application of the …

Applying The Health Justice Framework To Address Health And Health Care Inequities Experienced By People With Disabilities During And After Covid-19, Robyn M. Powell

Washington Law Review

The COVID-19 pandemic has been especially devastating for people with disabilities, as well as other socially marginalized communities. Indeed, an emerging body of scholarship has revealed that people with disabilities are experiencing striking disparities. In particular, scholars have shined a light on state and hospital triage policies that allow hospitals to ration critical health care and resources, such as ventilators, for people with disabilities if resources become limited and they cannot treat all patients during the pandemic. These injustices deserve extensive consideration from policymakers, legal professionals, and scholars.

Elucidating how the inequities that people with disabilities experience during the COVID-19 …

Utilitarian Triage In Disasters, Alyssa Nielsen

BYU Law Review

No abstract provided.

California V. Texas: The Role Of Congressional Procedure In Severability Doctrine, Mary Leto Pareja

Faculty Scholarship

The United States Supreme Court is once again considering a case that challenges the constitutionality of the Affordable Care Act (“ACA”). In this round of litigation, plaintiffs argue that because Congress lowered the individual mandate tax penalty to zero in the 2017 Tax Act that makes the individual mandate itself unconstitutional and that, furthermore, the individual mandate cannot be severed from the rest of the ACA. The District Court agreed with the plaintiffs and struck down the entire ACA, and the Supreme Court granted cert to hear this momentous question. A decision is expected by summer of 2021.

The ACA …

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

"As Long As I'M Me": From Personhood To Personal Identity In Dementia And Decision-Making, James Toomey

Elisabeth Haub School of Law Faculty Publications

As people, especially older people, begin to develop dementia, we confront ethical questions about when and how to intervene in their increasingly compromised decision-making. The prevailing approach in philosophically-inclined bioethics to tackling this challenge has been to develop theories of “decision-making capacity” based on the same characteristics that entitle the decisions of moral persons to respect in general. This Article argues that this way of thinking about the problem has missed the point. Because the disposition of property is an identity-dependent right, what matters in dementia and decision-making is an individual’s personal identity with their prior self, not their moral …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Social Determinants Of Health And Slippery Slopes In Assisted Dying Debates: Lessons From Canada, Jocelyn Downie, Udo Schuklenk

Articles, Book Chapters, & Popular Press

The question of whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying has recently come to the fore in debates about the legalization of assisted dying. For example, it was central to critiques of the 2021 amendments made to Canada’s assisted dying law. The question of whether changes to a country’s assisted dying legislation lead to descents down slippery slopes has also come to the fore—as it does any time a jurisdiction changes its laws. We explore these two questions through the lens of Canada’s experience both to inform Canada’s ongoing …

Attitudes Toward Withholding Antibiotics From People With Dementia Lacking Decisional Capacity: Findings From A Survey Of Canadian Stakeholders, Gina Bravo, Lieve Van Den Block, Jocelyn Downie, Marcel Arcand, Lise Trottier

Articles, Book Chapters, & Popular Press

Background

Healthcare professionals and surrogate decision-makers often face the difficult decision of whether to initiate or withhold antibiotics from people with dementia who have developed a life-threatening infection after losing decisional capacity.

Methods

We conducted a vignette-based survey among 1050 Quebec stakeholders (senior citizens, family caregivers, nurses and physicians; response rate 49.4%) to (1) assess their attitudes toward withholding antibiotics from people with dementia lacking decisional capacity; (2) compare attitudes between dementia stages and stakeholder groups; and (3) investigate other correlates of attitudes, including support for continuous deep sedation (CDS) and medical assistance in dying (MAID). The vignettes feature a …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Playing God: Faulty Decision-Making In Medical Futility Disputes, C. Scott Sergeant

Mitchell Hamline Law Review

No abstract provided.

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …