Health Law and Policy Commons^™

Presumptively Awful: How The Federal Government Is Failing To Protect The Constitutional Rights Of Those Adjudicated As Mentally Ill, As Illustrated By The 18 U.S.C. § 922(G)(4) Circuit Split, Kaitlyn M. Rubcich

Pepperdine Law Review

The Third, Sixth, and Ninth Circuits are split as to whether the 18 U.S.C. § 922(g)(4) federal firearms ban violates the Second Amendment rights of those who were once adjudicated as mentally ill but have since returned to good mental health. In Beers v. Attorney General, the Third Circuit applied its own unique framework and held that § 922(g)(4) is constitutional. Meanwhile, the Sixth Circuit applied intermediate scrutiny in Tyler v. Hillsdale County Sheriff’s Department and deemed the statute unconstitutional, while in Mai v. United States, the Ninth Circuit also applied intermediate scrutiny but held that § 922(g)(4) is constitutional. …

The Federal Global Migration And Quarantine Network: A Report From The National Academies Of Sciences, Engineering, And Medicine, Lawrence O. Gostin, Georges C. Benjamin, Tequam Worku

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic thrust the US Centers for Disease Control and Prevention (CDC) Division of Global Migration and Quarantine (DGMQ) into the epicenter of the national response. DGMQ is charged with preventing the importation of infectious diseases at land and sea borders and the spread of those diseases within the US. For more than 50 years, the agency’s comprehensive quarantine system, its regulatory powers, and scientific guidance has placed DGMQ at the forefront of emergency response. CDC requested the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the performance of the DGMQ during the COVID-19 pandemic, covering 5 …

Physical Losses, Invisible Damages: Finding Coverage For Business Interruption Insurance Claims Sustained During The Covid-19 Pandemic, Mason Medeiros

Minnesota Journal of Law, Science & Technology

No abstract provided.

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello

University of Miami Law Review

Concentrated Animal Feeding Operations (“CAFO’s”) are largely unregulated by State or Federal Laws in the United States. As a result of this lack of oversight, they are a breeding ground for deadly infectious diseases. The COVID-19 epidemic has demonstrated the threat that diseases pose to the United State like H1N1, SARS, and Ebola.
The USDA needs to regulate CAFOs under the mandate given to them by congress in the AHPA to ensure that they are not the epicenter of the next wave of deadly infectious diseases. Scientists have been warning about the disease potential of CAFOs for the last decade, …

The Implication Of Texas Abortion Law Sb8 On At-Risk Populations In Texas And Other States, Kelly Zielinski

DePaul Journal of Health Care Law

When the United States Supreme Court didn’t strike down, SB8, Texas’ anti-abortion law, there was a shift in the legal landscape for women’s reproductive rights. The novel structure of the bill would undeniably lead to copycat bills being enacted by other states looking to restrict access to abortion and disproportionately affect at-risk populations in those states. To protect the most vulnerable populations, the government needs to enact laws that recognize abortion as healthcare. Roe v. Wade has been precedent for fifty and any limitations on the established law will have lasting impacts on generations to come. This comment summarizes the …

Manipulating The Prescription Drug Market: Spiking Prices, Inducing Demand, And Costs To The Public, Katherine Drabiak, J.D.

DePaul Journal of Health Care Law

In 2016, Mylan made headlines when it spiked the price of its EpiPen AutoInjector by 400%, raising the price from an average of $57 to $500. Critics called the price hike “outrageous, “brutal” and “corrupt.” Public outcries fueled a demand for a Congressional investigation, and Mylan negotiated a settlement with the United States Department of Justice over alleged violations of the False Claims Act. Although competition self-corrected and similar products entered the marketplace, this case – and other similar cases involving generic drugs and insulin – highlighted the skyrocketing costs of prescription drugs in the United States. In 2019, United …

Dental Support Organizations And The Corporate Practice Of Dentistry: Will Streamlining Create Legal Violations?, Angelina Campin

DePaul Journal of Health Care Law

The increased use of technology when searching for health care providers means that consumers of dental care are more concerned with efficiency in making appointments and paying bills, immediate access to information, clear pricing, and transparency when it comes to choosing a provider and a facility to visit. Keeping up with the increased demands for efficiency and technological advances presents a challenge to sole practitioner dentists, which is the standard dental practice model. Dental support organizations (“DSOs”) have seen an increase in popularity recently, especially over the last five to ten years, in part to meet both the needs of …

Artificial Intelligence/ Machine Learning-Based Medical Devices: Regulatory And Patentability Challenges, May Lee

Penn State Journal of Law & International Affairs (2012 - Present)

No abstract provided.

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Penn State Journal of Law & International Affairs (2012 - Present)

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to (1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory …

A New Architecture For Global Health Emergency Preparedness And Response—The Imperative Of Equity, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Even before COVID-19 emerged in Wuhan, China, in December 2019, the prevailing global narrative was inequity—in health, income, race, and socioeconomic status. COVID-19 amplified all these inequities. Early in the pandemic, low-income countries were left without key medical resources, such as diagnostic tests, personal protective equipment, and ventilators. By 2021, inequitable vaccine distribution captured global attention and outrage. This year, high-income countries have bought the lion’s share of Paxlovid, a highly effective antiviral treatment. Vaccine inequities remain with only 16% of people in low-income countries having received at least 1 vaccine dose vs 80% of people across high-income countries. This …

The Post-Pandemic Order: A Blueprint For Balancing Health And Ip Interests In The Age Of Covid Variants, Arjun Padmanabhan, Tanner J. Wadsworth

Student Scholarship

In December 2021, the World Health Assembly (“WHA”) convened to develop a pandemic response treaty for future pandemics. Unfortunately, as presently envisioned, the resulting pandemic response framework will suffer from many of the same inadequacies that prevented existing frameworks from responding effectively to COVID-19. The threat of new pandemics emerging in the future—and new variants developing in the present—call for a more integrated, robust, comprehensive solution.

This Article lays a blueprint for that solution: a global multilateral Council empowered to(1) investigate developing pandemics; (2) incentivize pharmaceutical companies to rapidly-produce vaccines and share them through voluntary licenses or TRIPS compulsory licensing …

From Healthcare To Hiring: Impacts Of Social And Public Policy On Disabled Veterans In The United States, Benjamin Michael Stoflet

Student Scholarship

The United States Government is struggling to fulfill commitments it has made to service members suffering from disabilities incurred during honorable service to the country. The Department of Veterans Affairs (VA) disability compensation structure, job training programs, and methods of alternative dispute resolution is a patchwork resulting from decades of legislation creating a system where veterans often become locked in a complicated and often combative process to obtain benefits they have earned. Employers, advocacy groups, academics, and federal officials agree that there are systematic issues within the VA negatively impacting disabled veterans. These include a lack of patient-centered care, divergent …

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely affordable …

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and, second, an indirect sex …

Cost-Effectiveness Comes To America: The Promise And Perils Of Cost-Effective Analysis In Medication Coverage Decisions, Carl Coleman

Georgia State University Law Review

In an effort to control rising drug costs, some health insurers have begun experimenting with methods to link decisions about coverage to the value added by medicines, including through the use of formal cost-effectiveness analysis (CEA). Increased interest in subjecting new drugs to rigorous economic analysis is a welcome development, as it offers the potential to minimize wasteful spending on drugs whose high prices are not justified by evidence of additional benefits produced. At the same time, CEA raises significant ethical issues, particularly when payers use it to limit access to drugs deemed to provide insufficient value for money. For …

Does Size Matter? Nanoscale Particle Size As An Indicator Of Inherency In Nanopharmaceutical Patent Validity, Kirsten Fehlan

Georgia State University Law Review

Scientific and technological advances in nanopharmaceuticals bring the doctrine of inherent obviousness to a head. On the one hand, nanotechnology promises to offer novel ways to target and treat traditionally incurable diseases by operating at a scale that is comparable to the scales that most biological systems use. On the other hand, nanotechnology inventions that result in improved pharmacokinetic properties are susceptible to validity challenges based on inherent obviousness.

Inherency and obviousness are two independently recognized and well-understood principles in United States patent law. Inherency refers to a claimed limitation or feature that is either necessarily present in, or the …

Statement From Columbia Law School’S Center For Gender And Sexuality Law On The Supreme Court Decision Overruling The Constitutional Right To Abortion, Center For Gender And Sexuality Law

Center for Gender & Sexuality Law

The Supreme Court opinion in Dobbs v. Jackson Women’s Health Organization signals a major break with at least three generations of constitutional law. This opinion eliminates not only constitutional protections for abortion, but well-settled legal principles on which fundamental rights have rested for over 60 years. “Within a 24-hour period the Supreme Court ruled on the one hand that abortion rights are a local issue to be decided by each state independently, while on the other, states are barred from making local decisions about how to regulate guns,” said Katherine Franke, James L. Dohr Professor of Law and Director of …

404 Provider Not Found: Contributions And Solutions To Inadequate Provider Networks For Behavioral Health Care, Travis Williams

Georgia State University Law Review

Despite the efforts of policymakers, access to in-network behavioral health care services has continued to lag relative to other types of health care. Many psychiatrists, for example, do not accept insurance, limiting access to their services to only those individuals who can afford to pay out of pocket. Several factors contribute to insurance networks’ paucity of behavioral health care providers, including low insurance reimbursement for behavioral health care services, inadequate regulation and enforcement, provider shortages, and a lack of access to telehealth services. To maximize the utility of existing regulatory structures, states should take an outcome-oriented enforcement approach that principally …

The Mda Public Education Campaign: An X-Ray View, James Pond, Matt Maguy

The Journal of the Michigan Dental Association

The MDA Public Education Campaign has achieved significant engagement, surpassing previous milestones in video views and Find-a-Dentist searches. The article delves into the campaign's success, emphasizing its educational focus and strategic use of digital platforms. It explores the campaign's structure, target audience, and the integration of the Find-a-Dentist tool. With a shift from traditional TV commercials to digital advertising, the campaign's adaptability and real-time metrics are highlighted. The piece concludes by providing insights into the campaign's funding, oversight, and the content of the 2022 initiatives.