Health Law and Policy Commons^™

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Understandings Of Self-Managed Abortion As Health Inequity, Harm Reduction And Social Change, Joanna Erdman, Kinga Jelinska, Susan Yanow

Articles, Book Chapters, & Popular Press

This commentary explores how self-managed abortion (SMA) has transformed understandings of and discourses on safe abortion and associated health inequities through an intersection of harm reduction, human rights and collective activism. The article examines three primary understandings of the relationship between SMA and safe abortion: first SMA as health inequity, second SMA as harm reduction, and third SMA as social change, including health system innovation and reform. A more dynamic understanding of the relationship between SMA, safe abortion and health inequities can both improve the design of interventions in the field, and more radically reset reform goals for health systems …

Constitutionalizing Abortion Rights In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article endeavours to understand the feminist activism from which constitutional abortion rights in Canada were born in the landmark Supreme Court case of R v Morgentaler 1988, and the influence of these rights on continued feminist activism for reproductive justice. Part I reviews abortion practice in the ‘back-alley’ prior to and immediately after the 1969 criminal reform with attention to the direct service activism of liberation feminists in their campaign to repeal the abortion law as a matter of constitutional justice. Part II turns to adjudication in the courts to study how judicial reasoning channelled these constitutional claims, exploring …

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles, Book Chapters, & Popular Press

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of their …

Social Science Evidence In Charter Litigation: Lessons From Carter V Canada (Attorney General), Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, I offer the reflections of an academic who wandered well out of her wheelhouse. While I have graduate training in both philosophy and law, I am not an expert on the use of social science and humanities evidence in litigation. But, through the course of working on Carter v Canada (Attorney General), I had the opportunity to participate directly in the process of marshalling, preparing, analyzing, and critiquing the evidence. My hope is that, through this paper, I can bring a perspective that may be useful both for practitioners who might (or, I would say, should) be …

Template Policy Re: Access To Medical Assistance In Dying In Publicly-Funded Institutions, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Patients are being denied access to assessments for, and provision of, medical assistance in dying (MAiD) in publicly-funded institutions in Canada. Health authorities should implement policies that prohibit forced transfer for MAiD (assessments and provision) unless it can be achieved without undue delay or harm to the patient (as determined by the MAiD Program, not the institution). This is a template policy that health authorities could adopt to ensure access to a legal health service in all publicly-funded institutions (including faith-based institutions) under their authority.

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

Articles, Book Chapters, & Popular Press

Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

The Legal Status Of Deep And Continuous Palliative Sedation Without Artificial Nutrition And Hydration, Jocelyn Downie, Richard Liu

Articles, Book Chapters, & Popular Press

Deep and continuous palliative sedation combined with the withholding or withdrawal of artificial nutrition and hydration (collectively termed “PSs̄ANH”) is an important aspect of high-quality end-of-life care. It is one means of alleviating suffering. Unfortunately, the legality of this practice has been under-researched and PSs̄ANH is not yet appropriately regulated in Canada. In this paper, we explore the legal status of PSs̄ANH where it (1) will not hasten death (Type 1 PSs̄ANH); (2) might, but is not certain to, hasten death (Type 2 PSs̄ANH); or (3) is certain to hasten death (Type 3 PSs̄ANH). It is clear that Type 1 …

A Critique Of Canadian Jurisprudence On The Therapeutic Privilege Exception To Informed Consent, Michael Hadskis

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada’s landmark decisions in Hopp v Lepp and Reibl v Hughes furnished a general analytical framework for informed consent actions that remains fully intact today. This article sets its gaze on a specific aspect of the framework, dubbed “therapeutic privilege,” that permits physicians to deviate from their general duty to disclose material, treatment-related risks to competent patients. Specifically, the privilege allows information about material risks to be withheld or generalized if physicians believe their patients are “unable to cope” with receiving such information. It is argued that the Supreme Court’s terse and vaguely-articulated exception to truth …

Improving Outcomes In Child Poverty And Wellness In Appalachia In The "New Normal" Era: Infusing Empathy Into Law, Jill C. Engle

Faculty Scholarship

No abstract provided.

Quarantine And The Federal Role In Epidemics, Michael R. Ulrich, Wendy K. Mariner

SMU Law Review

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

Bearing Faith: The Limits Of Catholic Health Care For Women Of Color, Kira Shepherd, Elizabeth Reiner Platt, Katherine M. Franke, Elizabeth Boylan

Faculty Scholarship

This study finds that in nineteen out of the thirty-four states/territories that we studied, women of color are more likely than white women to give birth at hospitals bound by the ERDs. Women of color’s disproportionate reliance on Catholic hospitals in these states increases their exposure to restrictions that place religious ideology over best medical practices.

To determine whether women of color disproportionately give birth at hospitals operating under the ERDs, we compared the percentage of births to women of color at Catholic and non-Catholic hospitals. In over half of the states we studied (19 out of 33 states plus …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

Countering Pay-For-Performance's Unintended Consequences By Rethinking The Physician's Duty To Disclose, Mariah Dick

Health Matrix: The Journal of Law-Medicine

The article highlights the features of the U.S. Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and identify those attributes that make it vulnerable to the same types of unintended behaviors that have plagued pay-for-performance models in other industries. Topics discussed include unintended consequences associated with pay-for-performance in non-health care industries; physician disclosure standards; and need of laws for patient-centered care and patient autonomy.

Witch Doctors, Zombies, And Oracles: Rethinking Health In America, Ali S. Khan

Health Matrix: The Journal of Law-Medicine

To the extent we can even refer to an American healthcare "system," it functions brilliantly ... to make money. The system is designed to reward executives or major shareholders of pharmaceutical & health insurance companies, healthcare facilities, and related entities. With a rapidly aging population, healthcare will soon surpass a fifth of our economy. Of course, the American healthcare system does not function brilliantly when one considers the perspective of patients and over-extended primary care providers. Prices are growing faster than inflation or wages, healthcare is twice as costly as other comparable nations, and one third is a result of …

Institutionalising An Evidence-Informed Approach To Guideline Development: Progress And Challenges At The World Health Organization, Unni Gopinathan, Steven Hoffman

Articles & Book Chapters

This study explored experiences, perceptions and views among World Health Organization (WHO) staff about the changes, progress and challenges brought by the guideline development reforms initiated in 2007. Thirty-five semistructured interviews were conducted with senior WHO staff. Sixteen of the interviewees had in-depth experience with WHO’s formal guideline development process. Thematic analysis was conducted to identify key themes in the qualitative data, and these were interpreted in the context of the existing literature on WHO’s guideline development processes. First, the reforms were seen to have transformed and improved the quality of WHO’s guidelines. Second, independent evaluation and feedback by the …

The Development Of Emergency Planning For People With Disabilities Through Ada Litigation, 51 J. Marshall L. Rev. 819 (2018), Barry Taylor

UIC Law Review

No abstract provided.

When Trade Secrecy Goes Too Far: Public Health And Safety Should Trump Corporate Profits, Julie E. Zink

Vanderbilt Journal of Entertainment & Technology Law

This Article addresses the historical and ongoing use of trade secrets to withhold critical information from the public. Through its text and footnotes, the Article discusses the positives and negatives of trade secret protection; addresses historical and current examples of trade secret abuse; analyzes the inadequate solutions that have been tried and proposed; and, ultimately, recommends changing trade secret law by incorporating the precautionary principle into the definition of a trade secret to ensure that protection will no longer be available for information that endangers public health.

This Article is both timely and necessary, as the public is continually bombarded …

The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley

Health Matrix: The Journal of Law-Medicine

The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …