Health Law and Policy Commons^™

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

Unbefriended And Unrepresented: Better Medical Decision Making For Incapacitated Patients Without Healthcare Surrogates, Thaddeus Pope

Faculty Scholarship

How should we make medical decisions for incapacitated patients who have no available legally-authorized surrogate decision maker? Because these patients lack decision making capacity, they cannot authorize treatment themselves. Because they lack a surrogate, nobody else can authorize treatment either. Clinicians and researchers have referred to these individuals as “adult orphans” or as “unbefriended,” “isolated,” or “unrepresented” patients. Clinicians and researchers have also described them as “unimaginably helpless,” “highly vulnerable,” and as the “most vulnerable,” because “no one cares deeply if they live or die.”

The persistent challenges involved in obtaining consent for medical treatment on behalf of these individuals …

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis

Law Faculty Articles and Essays

This Article is divided into four parts. Part I discusses the history and evolution of the "right to die movement" in the United States. The current legal landscape in the United States is examined in Part II. In Part III, I analyze some of the relevant ethical concerns caused by the availability of physician-assisted suicide. My analysis primarily focuses on the Oregon statutes because it is the oldest physician-assisted suicide law in the United States and has served as a model for laws in the United States and abroad. For example, Lord Falconer's Bill, which was defeated by the British …

Health Law, Public Law, And Social Justice, Sidney D. Watson

Saint Louis University Law Journal

I have taught Health Law for almost three decades. In the early years, the course was primarily about private law, the application of contract and tort principles in the context of health insurance coverage and medical care. Federal law of Medicare, Medicaid, EMTALA, and federal civil rights laws always made an appearance. Other federal statutes were added as they came along: HIPAA, the Americans with Disabilities Act, and GINA. Over the years, the course focused more and more on federal statutes until the passage of the Affordable Care Act (“ACA”) in 2010 completed the transition

Health law is now a …

Remedying Stigma-Driven Health Disparities In Sexual Minorities, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres

Faculty Publications By Year

There is growing recognition and evidence that health care professionals regularly encounter - though they may not identify - victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to …

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Faculty Publications By Year

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Transparency, Leslie P. Francis

Utah Law Faculty Scholarship

Transparency is one of the key concepts of privacy protection. Transparency means openness about data collection, use, and retention. Individuals need to know what information about them is being collected, how it is being collected, how it is to be used and shared, how it is protected, what has been learned from data use, how what has been learned might benefit them, and how they can seek correction or redress for security breaches or other unjustified uses or disclosures of data. This chapter begins with a highly salient recent example of transparency in action: the principled commitment to transparency in …

Mitchell's Story: A Cautionary Tale Of Underlying Cardiovascular Disease And The Call For Increased Pre-Participation Sports Physicals At The Intercollegiate Level, Jessica M. Goldstein

Marquette Sports Law Review

None

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 …

End-Of-Life In Prison Symposium Report, Adelina Iftene, Crystal Dieleman, Hanna Garson

Articles, Book Chapters, & Popular Press

In 2016, the Canadian Parliament passed “An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying)” (S.C. 2016, c. 3). This statute decriminalized providing medical assistance to the dying in a defined set of circumstances. The Corrections and Conditional Release Act (CCRA) was also amended: section 19 now reads “(1.1) Subsection (1) does not apply to a death that results from an inmate receiving medical assistance in dying, as defined in section 241.1 that Act.”

Pursuant to these amendments, this meeting focused on issues that may arise in implementing MAiD in …

Theorizing Time In Abortion Law And Human Rights, Joanna Erdman

Articles, Book Chapters, & Popular Press

The legal regulation of abortion by gestational age, or length of pregnancy, is a relatively undertheorized dimension of abortion and human rights. Yet struggles over time in abortion law, and its competing representations and meanings, are ultimately struggles over ethical and political values, authority and power, the very stakes that human rights on abortion engage. This article focuses on three struggles over time in abortion and human rights law: those related to morality, health, and justice. With respect to morality, the article concludes that collective faith and trust should be placed in the moral judgment of those most affected by …

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

Human Rights Education In Patient Care, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores how human rights education in the health professions can build knowledge, change culture, and empower advocacy. Through a study of educational initiatives in the field, the article analyzes different methods by which health professionals come to see the relevance of human rights norms for their work, to habituate these norms in everyday practice, and to espouse these norms in advocacy for social justice. The article seeks to show the transformative potential of education for human rights in patient care.

A Constitutional Future For Abortion Rights In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

In 2015, Abortion Access Now PEI legally challenged the restrictive abortion policy of Prince Edward Island. This article studies their challenge as a unique case in the building of a constitutional future for abortion rights in Canada. The article tracks how AAN PEI drew on classic rule of law arguments of transparency, accountability, and constitutional justice to shape and claim abortion rights as democratic rights, an entitlement to fully and equally participate in and benefit from the health care system as a fundamental social institution of the state.

Next Up: A Proposal For Values-Based Law Reform On Unilateral Withholding And Withdrawal Of Potentially Life-Sustaining Treatment, Jocelyn Downie, Lindy Willmott, Ben White

Articles, Book Chapters, & Popular Press

As the legalization of assisted dying shifts from a project for law reform to one of implementation, the gaze for Canadian end of life law and policy academics and practitioners should be turned quickly to another pressing issue – the unilateral withholding and withdrawal of potentially life-sustaining treatment. What should happen when the health care team believes that treatment should not be provided and the patient’s loved ones believe that it should? While the future of end of life law and policy no doubt includes many other issues, this is an urgent and immediate horizon issue for Canada as well …

A Test For Freedom Of Conscience Under The Canadian Charter Of Rights And Freedoms: Regulating And Litigating Conscientious Refusals In Health Care, Jocelyn Downie, Francoise Baylis

Articles, Book Chapters, & Popular Press

Conscientious refusal to provide insured health care services is a significant point of controversy in Canada, especially in reproductive medicine and end-of-life care. Some provincial and territorial legislatures have developed legislation or regulations, and some professional regulatory bodies have developed policies or guidelines, to better reconcile tensions between health care professionals’ conscience and patients’ access to health care services. As other groups attempt to draft standards and as challenges to existing standards head to court, the fact that the meaning of “freedom of conscience” under the Canadian Charter of Rights and Freedoms is not yet settled will become ever more …

Should Medical Assistance In Dying Be Extended To Incompetent Patients With Dementia? Research Protocol Of A Survey Among Four Groups Of Stakeholders From Quebec, Canada, Gina Bravo, Claudie Rodrigue, Vincent Thériault, Marcel Arcand, Jocelyn Downie, Marie-France Dubois, Sharon Kaasalainen, Cees M. Hertogh, Sophie Pautex, Lieve Van Den Block

Articles, Book Chapters, & Popular Press

Background: Alzheimer’s disease and related disorders affect a growing number of people worldwide. Quality of life is generally good in the early stages of these diseases. However, many individuals fear living through the advanced stages. Such fears are triggering requests for medical assistance in dying (MAiD) by patients with dementia. Legislation was recently passed in Canada and the province of Quebec allowing MAiD at the explicit request of a patient who meets a set of eligibility criteria, including competence. Some commentators have argued that MAiD should be accessible to incompetent patients as well, provided appropriate safeguards are in place. Governments …

The Rules Of Maternity, Dara Purvis

Faculty Scholarship

A diverse body of laws and regulations speaking to reproductive rights, healthcare, criminal punishment of drug use, termination of parental rights, and more creates the rules of maternity. These rules are guidance provided both obliquely and explicitly by the law's coercive power telling women both how to and who should mother. Rule one begins in pregnancy, with the message that "your body is your child's vessel." During pregnancy, women are counselled that doctor knows best. After the child's birth, the mother remains responsible for the people who enter a child's life, leading to rule 3: "mothers must always protect." …

Federalism And Health Care In Canada: A Troubled Romance?, Colleen M. M. Flood, William Lahey Prof., Bryan P. Thomas

Articles, Book Chapters, & Popular Press

Canadian federalism fragments health system governance. Although the Constitution has been interpreted as providing shared jurisdiction over health generally, with respect to health care, the courts have interpreted it as giving direct jurisdiction to the provinces. The federal role in health care is therefore indirect, but nevertheless potentially powerful. For example, the federal government has used its spending powers to establish the Canada Health Act (CHA), which commits funding to provinces on condition they provide first-dollar public coverage of hospital and physician services. However, in recent times, as federal contributions have declined, the CHA has been weakly enforced. …

How Assuming Autonomy May Undermine Wellness Programs, Jessica L. Roberts, Leah R. Fowler

Health Matrix: The Journal of Law-Medicine

In recent years, corporate wellness programs have become a routine aspect of the employer-provided health-insurance system. While they vary tremendously in their requirements and incentives, what these programs share is the common goal of modifying employee behavior to improve health and, as a result, to lower costs. However, the effectiveness of wellness programs has been called into question.

Sex Education: Funding Facts, Not Fear, Rachel Rubenstein

Health Matrix: The Journal of Law-Medicine

The article offers information on the funding sex education programs enacted by the government for teaching about abstinence as the best method for avoiding sexually transmitted diseases and unintended pregnancy and risks factors associated with it in the U.S. Topics discussed include analysis of California Healthy Youth Act as a model for adequate sex education; different forms of sex education; and enactment of Abstinence Education Grant Program for the same.

Public Policy And The Legislative Process, Sheila A. Leander, David F. Walz

Book Chapters

No abstract provided.

Contemporary Practice Of The United States Relating To International Law, January 2017, Daugirdas Kristina, Julian Davis Mortenson

Articles

In this section: • Congress Overrides Obama’s Veto to Pass Justice Against Sponsors of Terrorism Act • U.S. Federal Court of Appeals Upholds United Nations’ Immunity in Case Related to Cholera in Haiti • U.S.-Russian Agreements on Syria Break Down as the Syrian Conflict Continues • Russia Suspends Bilateral Agreement with United States on Disposal of Weapons-Grade Plutonium • The United States Makes Payment to Family of Italian Killed in CIA Air Strike • United States Ratifies Hague Convention on the International Recovery of Child Support and Other Forms of Family Maintenance

Controlling Excessive Off-Label Medicare Drug Costs Through The False Claims Act, David Kwok

Health Matrix: The Journal of Law-Medicine

High prescription drug prices are driving ever-increasing United States healthcare costs, and the federal government is following this alarming trend …

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

Faculty Publications & Other Works

No abstract provided.

Health Care Is Not A Typical Consumer Good And We Should Not Rely On Incentivized Consumers To Allocate It, Lawrence E. Singer

Faculty Publications & Other Works

No abstract provided.