Health Law and Policy Commons^™

Dobbs And The Destabilization Of Clinical Trials, Allison M. Whelan

Vanderbilt Law Review

This Article explores an important yet overlooked collateral consequence of the U.S. Supreme Court’s elimination of the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization: the destabilization of clinical research. Specifically, this Article focuses on the harms to pregnant persons, persons capable of pregnancy, and persons of color that may transpire as a result of new barriers to clinical research in the aftermath of Dobbs. By hindering clinical research, these new obstacles will exacerbate existing health disparities experienced by these populations, which have historically been excluded from or exploited by the American healthcare and research systems.

This …

The States' Hodgepodge Of Physician Licensure Regulations, Tara Sklar, Christopher Robertson

Faculty Scholarship

The end of the federal COVID-19 public health emergency (PHE) on May 11, 2023, marked a pivotal shift in the landscape of telehealth regulation in the US. Kwan, Jolin, and Shachar analyze the implications of this transition by exposing inconsistencies in access to care. We agree that we now face a “convoluted patchwork of permanent and temporary changes to telehealth law and policy.”

Perspectives On The Constitution Of The War On Drugs: A Collection Of Posts From The Balkinization Blog, Douglas A. Berman, Rachel Barkow, Louis Michael Seidman, Kimani Paul-Emile, Jennifer D. Oliva, Shaun Ossei-Owusu, Katherine Shaw, Paul Butler, David E. Pozen

Faculty Scholarship

This collection of essays provides extended commentary from multiple law professors on David Pozen’s 2024 book, The Constitution of the War on Drugs. Pozen’s book provides a rich and astute perspective on a wide array of dynamic legal, political, and social stories at the intersection of constitutional jurisprudence and drug policy. The work is the first book in Oxford University Press’s Inalienable Rights series to be fully open access. Yale Law Professor Jack Balkin, recognizing the book engaged many historical and cutting-edge issues in the fields of constitutional law, criminal law and health law, invited professors in these fields …

Lending A Hand: The Use Of The Mississippi Products Liability Act And Mississippi's Blood Shield Statute In Palermo V. Lifelink Found., Inc., Taylor Price

MC Law Review

The experience of undergoing a surgical procedure is one of the most vulnerable positions an average individual finds themselves in during his or her lifetime. The overall risk associated with this process is even greater when the surgery involves the removal or transfer of one or more of the body's organs or tissues. The principal event that concerned Palermo v. LifeLink Found., Inc. was a botched surgical operation featuring a human tissue implant performed in March 2005 on Richard Palermo. The tissue implant surgically inserted into Palermo's knee became bacterially infected shortly after the operation and required further injury, causing …

"I'M Sorry, Mississippi": An Argument For Enactment Of A Physician Apology Statute By The Mississippi Legislature, Brittany Brooks Frankel

MC Law Review

Imagine this: you are a dedicated orthopedic surgeon who loves her work. You perform a total knee replacement, albeit on a high-risk patient. The patient does not heal properly and complains of an unsteady gait. Upon further analysis, you begin to become concerned that his inability to heal may be due to an improperly placed implant. A corrective surgery will be required. You are distraught by the unanticipated outcome and wish to express your deepest apologies to the patient and his family. Not so fast! Be aware that your moral compass could be leading you into expressing an apology that …

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

The Persistent Public Health Emergency, Yael Zakai Cannon

Georgetown Law Faculty Publications and Other Works

May 11, 2023 was ostensibly a day of celebration. With infections and deaths from COVID-19 down, the federal government announced the end of the official Public Health Emergency three years after its initial declaration. But the conclusion of the Public Health Emergency also signaled the termination of unprecedented health protection measures—outside the realm of healthcare—such as eviction and utility shutoff moratoria and emergency rental and utility assistance. These COVID-era measures successfully cut eviction filings nationally by more than half and provided people in many jurisdictions with the protections and assistance needed to maintain their electricity, heat, water, and gas. Now …

Brief For Amici Curiae Legal Scholars Supporting Respondent, Nicole Huberfeld, Timothy S. Jost, Linda C. Mcclain, Wendy E. Parmet, Erwin Chemerinsky, Elizabeth Mccuskey, Danielle Pelfrey Duryea, Gabriel Scheffler, George J. Annas

Faculty Scholarship

QUESTION PRESENTED: Whether the Emergency Medical Treatment and Labor Act, 42 U.S.C. § 1395dd, preempts Idaho law in the narrow but important circumstance where terminating a pregnancy is required to stabilize an emergency medical condition that would otherwise threaten serious harm to the pregnant woman’s health but the State prohibits an emergency-room physician from providing that care.

The Socioeconomic Gap Of Infertility: Medicaid Coverage Of Infertility Treatments In West Virginia, Samantha Wilson

West Virginia Law Review

Infertility treatments have become more accessible and widely used in the last 20 years. As more couples look to these treatments in their struggle to start a family, health insurers are lagging behind in coverage for these options. For the majority of women in the country, paying for infertility treatment out-ofpocket is unrealistic. Not all states have approached this issue but those who have vary in their approach. Some are utilizing either mandate-to-cover for private insurers or Medicaid coverage to attempt to make treatments and diagnosis more accessible. Without policy solutions, the inequality of access between socioeconomic statuses will remain. …

Against Bankruptcy: Public Litigation Values Versus The Endless Quest For Global Peace In Mass Litigation, Abbe Gluck, Elizabeth Chamblee Burch, Adam Zimmerman

Scholarly Works

Can bankruptcy court solve a public health crisis? Should the goal of “global peace” in complex lawsuits trump traditional litigation values in a system grounded in public participation and jurisdictional redundancy? How much leeway do courts have to innovate civil procedure?

These questions have finally reached the Supreme Court in Harrington v. Purdue Pharma L.P., the $6 billion bankruptcy that purports to achieve global resolution of all current and future opioids suits against the company and its former family owners, the Sacklers. The case provides a critical opportunity to reflect on what is lost when parties in mass torts find …

Patients Versus Profits, Isaac ("Zack") D. Buck

Scholarly Works

Private equity (PE) has come to health care. With it: layoffs, cuts, and new pressures for providers, higher prices for payers, and questions from patients about quality and excessive care. PE firms, driven solely by a profit motive, take over health care entities, “lean” them down, load them with debt, and hope to extract a profit for their investors when they sell the hospital, physician group, or nursing home. Their entry into health care has been stealthy but dramatic: upwards of a third of all for-profit hospitals in the United States, and 40 percent of America’s emergency rooms, are now …

The Thinning Blue Line: Ptsd Benefits For Law Enforcement In Minnesota, Caleb Wootan

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Health Law And Bigotry Distractions, Daniel G. Aaron, Leslie Francis

Utah Law Faculty Scholarship

Bigotry distractions are strategic invocations of racism, transphobia, or negative stigma toward other marginalized groups to shape political discourse. Although the vast majority of Americans agree on large policy issues ranging from reducing air pollution to prosecuting corporate crime, bigotry distractions divert attention from areas of agreement toward divisive identity issues. This article explores how the nefarious targeting of identity groups through bigotry distractions may be the tallest barrier to health reform, and social change more broadly. The discussion extends the literature on dog whistles, strategic racism, and scapegoating.

Naloxone And Methadone Access In Tribal Communities, Philomena Kebec

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Death, Bankruptcy, And The Public Hospital, Michael A. Francus

Journal Articles

From the Article

This Article expands the purview of bankruptcy scholarship to those government businesses, assessing how Chapter 9 operates for them. It does so by taking public hospitals as a case study, offering a comprehensive look at every public-hospital bankruptcy between 1988 and 2021.

Designing Designer Bankruptcy, Michael A. Francus

Journal Articles

Today's mass torts are headed to bankruptcy. Be it Purdue Pharma 's opioids, United States of America (USA) Gymnastics' sexual abuse, Pacific Gas and Electric Company's (PG&E) wildfires, or Johnson & Johnson 's talc, masstort defendants have determined that bankruptcy-not class actions, multi district litigation, or one-off state suits-is the way to manage their mass-tort liability. But today's mass-tort bankruptcy is not the mass-tort bankruptcy of yesteryear, when the whole business filed for bankruptcy. Instead, these modern mass-tort bankruptcies are designer bankruptcies, where the defendant uses its corporate structure to choose which assets and which liabilities enter bankruptcy. To take …

Certificates Of Public Advantage: A Valuable Tool Or Diminishing Allure?, Abdur Rahman Amin

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Autism And Access To Healthcare, Amanda Forbes

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Taiwan's Medical Injury Law In Action, Chih-Ming Liang, Robert B Leflar, Chih-Cheng Wu

Emory International Law Review

Taiwan’s healthcare system, lauded internationally for its universal insurance coverage, moderate costs, and high quality of care, has one significant group of detractors: its physicians. Overworked, squeezed financially by the nation’s global budgeting system’s annual payment restrictions, and oppressed by both criminal prosecutions and civil malpractice actions, doctors and hospitals raised criticisms that culminated in legislative reforms enacted in 2017 and 2022. Are the reforms making any difference?

This Article offers the first comprehensive examination in English of how Taiwan’s medical injury law works. The Article is based on interviews with judges, attorneys, physicians, scholars, and other citizens, literature reviews, …

A Health Justice Approach To Abortion, Maya Manian

Scholarly Articles in Law Reviews & Journals

The Supreme Court’s watershed decision in Dobbs v. Jackson Women’s Health Organization, overturning fifty years of precedent protecting abortion rights, has led to chaos in both the legal and public health landscapes. With Roe v. Wade eliminated, reproductive rights and justice advocates urgently need new frameworks to help regain access to comprehensive reproductive health care in the long term. Recently, a number of legal scholars have argued in favor of medicalizing civil rights—adopting the framework of health justice to talk about civil rights issues. Scholars argue that the health justice framework could be used to advance civil rights in the …

Human Rights In Hospitals: An End To Routine Shackling, Neil Singh Bedi, Nisha Mathur, Judy D. Wang, Avital Rech, Nancy Gaden, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Medical students (NSB, NM, JDW) spearheaded revision of the policy and clinical practice for shackling incarcerated patients at Boston Medical Center (BMC), the largest safety net hospital in New England. In American hospitals, routine shackling of incarcerated patients with metal restraints is widespread—except for perinatal patients—regardless of consciousness, mobility, illness severity, or age. The modified policy includes individualized assessments and allows incarcerated patients to be unshackled if they meet defined criteria. The students also formed the Stop Shackling Patients Coalition (SSP Coalition) of clinicians, public health practitioners, human rights advocates, and community members determined to humanize the inpatient treatment of …

Defining Health Affordability, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Affordable health care, insurance, and prescription drugs are priorities for the public and for policymakers. Yet the lack of a consensus definition of health affordability is increasingly recognized as a roadblock to health reform efforts. This Article explains how and why American health law invokes health affordability and attempts, or fails, to define the concept. It then evaluates potential affordability definitions and proposes strategies for defining affordability more clearly and consistently in health law.

Part I examines the role health affordability plays in American health policy, in part by contrasting the United States’s health system with systems elsewhere. Part II …

The New Over-The-Counter Oral Contraceptive Pill—Assessing Financial Barriers To Access, Christopher Robertson, Anna Braman

Faculty Scholarship

In July 2023, the Food and Drug Administration (FDA) approved Opill (norgestrel), the first over-the-counter (OTC) daily oral contraceptive pill in the United States, a move that could dramatically improve practical access to family planning. Opill’s price, however, hasn’t been made public and may not be revealed until the drug enters the market in early 2024. Although contraceptive pills generally cost between $10 and $50 per month without insurance, there’s no indication that Opill’s price will fall within this range. In addition, although the manufacturer (Perrigo) has expressed interest in a consumer-assistance program, it hasn’t released details regarding eligibility for …

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …

Panel: Fraud And Abuse, Ellen Mcintyre, Lisa Rivera, Amy Leopard, Tony Hullender

Belmont Health Law Journal

No abstract provided.

Privacy Issues With Healthcare Technology, Professor Charlotte Tschider

Belmont Health Law Journal

No abstract provided.

Dosing Discrimination: Regulating Pdmp Risk Scores, Professor Jennifer Oliva

Belmont Health Law Journal

No abstract provided.

Innovator Liability And Prescription Medication: A Stopgap Measure Patients Deserve, Will True

Belmont Health Law Journal

This Note argues that in the absence of an updated statute and FDA regulation, states should permit plaintiffs to recover under the theory of innovator liability. Despite the theory’s arguable contravention of “traditional common law tort principles” and potentially unfair results against brand-name manufacturers, victims of defective drugs and inadequate warnings should have an avenue for recourse. Forfeiting one’s ability to recover potentially hundreds of thousands of dollars in damages in exchange for paying a cheaper price for medication is not a fair trade. Indeed, the Supreme Court in PLIVA, Inc. v. Mensing (discussed in Section II and arguably the …

An Update Is Required To Continue Using This Regulation: Why The Hipaa Privacy Rule Should Be Modified To Protect A Broader Range Of Health Data, Lauren Caverly Pratt

Belmont Health Law Journal

While there is no constitutional right to privacy of information, general public sentiment leans in favor of keeping personal health data private. More precisely, individuals would like information known only to the individual and other parties to whom he or she chooses to disclose the information. This is because public knowledge of sensitive personal data may harm the individual economically, socially, or in other intangible ways. The benefits of public knowledge of such individually identifiable health data do not outweigh these potential harms. Privacy should be the default.

To achieve this, HIPAA must be expanded to protect private health data …

Independent Freestanding Emergency Centers: The Face Of An Alternative Model To Healthcare In Rural America, Alisha Patel

Belmont Health Law Journal

This Note will attempt to provide a background of rural healthcare disparities and the issues facing these regions. This Note will also explore the history of IFECs in the United States to better understand the context of the issues and reasons as to why emergency regulations such as EMTALA do not already extend to IFECs. Part 1 of this Note will examine the origin of IFECs and their role in the healthcare landscape today. Part II will discuss EMTALA and the challenges associated with IFECs during a public health emergency. Lastly, Part III of this Note will highlight the advantages …