Health Law and Policy Commons^™

Nothing Generic About It: Promoting Therapeutic Access By Overcoming Regulatory And Legal Barriers To A Robust Generic Medical Device Market, Megan S. Wright, Zachary Shapiro, Adam Pan, Keturah James, Joseph Fins

Faculty Scholarship

This Article addresses a paradox in American healthcare technology: a thriving market for generic drugs but a paucity of generic medical devices. Despite the success of generic pharmaceuticals in reducing healthcare costs, no analogous market exists for generic medical devices. This plays a part in keeping prices high while limiting access to affordable therapies. In this Article, we highlight the regulatory and legal barriers currently impeding the development of a generic medical device market in the United States. We explore differences between generic drugs and generic devices in FDA regulation, products liability, and patentability, all of which contribute to the …

Prescription Restriction: Why Birth Control Must Be Over-The-Counter In The United States, Susannah Iles

Michigan Journal of Gender & Law

This Note argues that it is harmful and unnecessary to require women to obtain prescriptions for access to hormonal birth control. Requiring a prescription is necessarily a barrier to access which hurts women and hamstrings the ability to dictate their own reproductive plans. It is also an irrational regulation in light of the relative safety of hormonal birth control pills, particularly progestin-only formulations, compared to other drugs readily available on the shelves.

Leading medical organizations, including the American College of Obstetrics and Gynecologists, advocate for over-the-counter access to hormonal birth control. While acknowledging that not every woman will have positive …

When Food Is A Weapon: Parental Liability For Food Allergy Bullying, D'Andra Millsap Shu

Marquette Law Review

Food allergies in children are rising at an alarming pace. Increasingly, these children face an added threat: bullies targeting them because of their allergies. This bullying can take a life-threatening turn when the bully exposes the victim to the allergen. This Article is the first major legal analysis of food allergy bullying. It explores the legal system’s failure to adequately address the problem of food allergy bullying and makes the case for focusing on the potential tort liability of the bully’s parents. Parents who become aware of their child’s bullying behavior and fail to take adequate steps to stop it …

State Liability For A Mishandled Response: Strategic Remedies On The Heels Of Covid-19, Captain Matthew H. Ormsbee Usaf

Marquette Law Review

In early 2020, as the novel coronavirus (COVID-19) shocked many health experts and world leaders with its ease of transmission and slow but unyielding spread from Wuhan, China, the initial state response centered on how to contain an epidemic and help those who are infected. Many months later, as some states enjoy a flattened curve following austere social distancing measures, many states may turn their attention from health response to legal response for China’s initial mishandling of the COVID-19 outbreak. China is certainly not alone in implementing containment measures that were not maximally prompt or effective. Still, China occupies a …

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

Kidney Donation And The Consent Of The Poor, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

In "Consentability," Nancy Kim tackles an important and current topic—in an age of increasing options about how to live, die, and procreate, what limits, if any, should the law place on those choices? "Consentability" is a valuable resource for scholars and policymakers alike, summarizing the arguments for and against government intrusion on the choices of consenting adults with encyclopedic thoroughness. After weighing the arguments, Kim proposes that “bodily integrity exchanges” be permitted, subject to limitations. Although we agree with the general conclusion that bodily integrity exchanges should be permitted, we disagree with the specific limitations that treat the decisions of …

Of Mosquitoes And "Moral Convictions" In The Age Of Zika: How The Trump Administration's Gutting Of The Affordable Care Act's Contraceptive Mandate Jeopardizes Women's And Children's Health, Linda C. Fentiman

Health Matrix: The Journal of Law-Medicine

The Trump Administration’s efforts to undo the contraceptive mandate, a key component of the Affordable Care Act (ACA), threaten a major public health emergency, as well as the rule of law and separation of powers. The Trump Administration’s Rules greatly expand the grounds for exemption from the contraceptive mandate: they allow even publicly traded corporations to assert religious beliefs as a ground for exemption and exempt all employers except publicly traded corporations from compliance with the contraceptive mandate if they hold “moral convictions” in opposition to contraception. By denying women access to effective, affordable contraception, these Rules increase the odds …

Medical Aid In Dying By Telehealth, Konstantin Tretyakov

Health Matrix: The Journal of Law-Medicine

Medical aid in dying is a form of medical treatment recognized in several states and the District of Columbia and available to adult residents of those states who are competent and suffer from a terminal disease. Timely access to it is critical for qualifying patients. The article explores the possibility of facilitating access to medical aid in dying via telehealth—a method of providing health care remotely by means of electronic communication. Specifically, I analyze the feasibility of medical aid in dying by telehealth from clinical and legal perspectives. I also examine a relevant normative issue of the nature of in-person …

Protecting Participants In Genomic Research: Understanding The "Web Of Protections" Afforded By Federal And State Law, Leslie E. Wolf, Catherine M. Hammack, Erin Fuse Brown, Kathleen M. Brelsford, Laura M. Beskow

Law Faculty Scholarship

Advances in genomic research increasingly rely on large-scale datasets combining biospecimens, electronic health records, and behavioral data. This article examines the complex legal framework governing privacy and confidentiality protections for participants in genomic research in the United States. Through a combination of qualitative interviews with national thought leaders and systematic legal analysis of federal and state statutes, the authors assess how existing legal protections operate in practice. The study evaluates several hypothetical research scenarios—including the return of individual results, data breaches, and legal demands for data access—to illustrate how laws such as the Common Rule, HIPAA, the Genetic Information Nondiscrimination …

Dementia, Autonomy, And Supported Healthcare Decision Making, Megan S. Wright

Maryland Law Review

No abstract provided.

Covid-19 And Public Accommodations Under The Americans With Disabilities Act: Getting Americans Safely Back To Restaurants, Theaters, Gyms, And “Normal”, Frank Griffin M.D., J.D.

SLU Law Journal Online

THIS IS A PRELIMINARY EXPEDITED VERSION OF THE OFFICIAL ARTICLE TO BE ORIGINALLY PUBLISHED IN SAINT LOUIS UNIVERSITY LAW JOURNAL VOLUME 65 NUMBER 2

COVID-19 permanently changed the way places of public accommodation like restaurants, theaters, medical facilities, arenas, gyms, and many other proprietors of mainstream American activities must operate in order to accommodate people with newly-defined, COVID-19-related disabilities under Title III of the Americans with Disabilities Act (ADA). The required modifications will affect all patrons and employees of these establishments. Under the ADA, places of public accommodation are barred from discriminating against people with disabilities in the full and …

Executive Power And The Aca, Nicholas Bagley

Book Chapters

As with any law of its complexity and ambition, the Affordable Care Act (ACA) vests in the sitting president broad implementation discretion. The law is not a blank check: in many ways both large and small, the ACA shapes and constrains the exercise of executive power. But Congress has neither the institutional resources nor the attention span to micromanage the rollout of a massive health program. It has no choice but to delegate.

Naturally, both President Obama and President Trump have drawn on their authority to tailor the ACA to their policy preferences. Neither president, however, has been able to …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Texas Landfills: The Need For Administrative Reform Of The Texas Commission On Environmental Quality’S Permitting Process, William Todd Keller Jr.

St. Mary's Law Journal

Abstract forthcoming

Brief Of Amicus Curiae The Washington And Lee University School Of Law Black Lung Clinic In Support Of Petitioners: California V. Texas, Timothy C. Macdonnell

Scholarly Articles

Section 1556 of the Patient Protection and Affordable Care Act (PPACA) makes two major changes to the Black Lung Benefits Act. These changes remove limiting language to make it simpler for disabled miners and their families to establish that they are entitled to federal benefits. First, § 1556(a) reinstates the fifteen-year rebuttable presumption, which presumptively entitles former coal miners to benefits if they have worked over fifteen years underground and have a totally disabling pulmonary disease. The second, § 1556(b), reinstates a continuation of benefits for surviving spouses whose coal-mining spouse was receiving benefits at the time of their death. …

Prevention And Surveillance Of Violence Against Minnesota Healthcare Workers, Nicole Dailey

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Introduction, Ruqaiijah Yearby

Saint Louis University Journal of Health Law & Policy

No abstract provided.