Health Law and Policy Commons^™

The Costs Of Having (Too) Many Choices: Reshaping The Doctrine Of Informed Consent, Maytal Gilboa, Omer Y. Pelled

Brooklyn Law Review

This article suggests a reshaping of the doctrine of informed consent to accommodate the potential costs of choices vis-à-vis patients’ well-being. Applying insights from psychology and behavioral economics, it makes four main claims. First, the current doctrine imposes a broad duty of disclosure on physicians toward their patients, based on the premise that patients want and need to know all the alternative treatments for their ailment. We argue that this premise is misguided. The process of choice making is not cost free. Since patients incur costs when they must choose a treatment from too many alternatives, the current duty should …

Law In The Time Of Zika: Disability Rights And Reproductive Justice Collide, Seema Mohapatra

Brooklyn Law Review

This article focuses on finding common ground between those seeking to ensure abortion access and those advocating for disability rights, using the reaction to the Zika virus as a case study. Although the symptoms of Zika in women were often mild, the correlation of Zika infection in pregnant women to microcephaly affecting their newborns led to travel advisories and alarm bells for pregnant women in areas where the Zika virus was prevalent. Although the rise of microcephaly and its connection to Zika was a cause for concern and investigation, the condition itself is not a death sentence, as headlines suggested. …

Purchasing Health? The Promise And Limits Of Public Health Insurance, Kristen Underhill

Faculty Scholarship

The 2010s have been a momentous decade for Medicaid. With enrollment of over seventy-two million people (19% of the country’s population), Medicaid is the nation’s largest public health insurance program, and it is the primary or sole source of health insurance for vulnerable groups such as low-income children and pregnant women, adults with disabilities, and people in need of long-term care. Since 2014, the pendulum of Medicaid policy has swung from an unprecedented expansion of coverage under the Affordable Care Act (ACA), toward more recent federal regulations and state policy innovations that are instead predicted to limit uptake of benefits. …

Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii

Other Publications

Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create AI systems to take on these tasks, several risks and challenges emerge, including the risk of injuries to patients from AI system errors, the risk to patient privacy of data acquisition and AI inference, and more. Potential solutions are complex but involve investment in infrastructure for high-quality, representative data; collaborative oversight by both the Food and Drug Administration and other health-care actors; and changes to medical education that will prepare …

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

Articles, Book Chapters, & Popular Press

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

The Gender Injustice Of Abortion Laws, Joanna Erdman

Articles, Book Chapters, & Popular Press

This commentary is a response to Katarzyna Sękowska-Kozłowska’s article on the treatment of criminal abortion laws as a form of sex discrimination under international human rights law through a study of the communications, Mellet v. Ireland and Whelan v. Ireland. The commentary offers a reading of these communications, and specifically the sex discrimination analysis premised on inequalities of treatment among women, as an engagement with the structural discrimination that characterises abortion laws, and asa radical vision for gender justice under international human rights law.

The Intersection Of Indigenous Public Health With Law And Policy In Canada, Constance Macintosh

Articles, Book Chapters, & Popular Press

This chapter presents an overview of the law, policy and governance practices that are most directly implicated in the population health of Indigenous people who reside in Canada. The first section provides a general description of the socio-legal categories that are drawn upon in health policy, programming and legislation regarding Indigenous peoples. It briefly describes roles in funding and delivering community health services and programming, as well as disputes about responsibilities and some shortcomings.

The second section provides an overview of the population health status of Indigenous peoples. Epidemiological data is presented, and select social determinants of health are also …

Refusing Care As A Legal Pathway To Medical Assistance In Dying, Jocelyn Downie, Matthew J. Bowes

Articles, Book Chapters, & Popular Press

Can a competent individual refuse care in order to make their natural death reasonably foreseeable in order to qualify for medical assistance in dying (MAiD)? Consider a competent patient with left-side paralysis following a right-brain stroke who is not expected to die for many years; normally his cause of death would not be predictable. However, he refuses regular turning, so his physician can predict that pressure ulcers will develop, leading to infection for which he will refuse treatment and consequently die. Is he now eligible for MAiD? Consider a competent patient with spinal stenosis (a non-fatal condition) who refuses food …

Incarceration In Canada: Risks To And Opportunities For Public Health, Adelina Iftene

Articles, Book Chapters, & Popular Press

In their introduction to the latest edition of Public Health Law and Policy in Canada, the editors are unequivocal about the importance of this area of growing interest and scholarship. This text, they explain, “explores a range of perspectives that examine how law, in many forms and contexts, plays a critical role in protecting the public from known and emerging threats and promoting conditions for health.”

Written and edited by leading health law scholars and featuring contributions from legal and health experts from across the country, this book provides a comprehensive overview of our Canadian public health law and policy …

Open Science Precision Medicine In Canada: Points To Consider, Palmira Granados Moreno, Sarah E. Ali-Khan, Benjamin Capps, Timothy Caulfield, Damien Chalaud, Aled Edwards, E. Richard Gold, Vasiliki Rahimzadeh, Adrian Thorogood, Daniel Auld, Gabrielle Bertier, Felix Breden, Roxanne Caron, Priscilla M.D.G. César, Robert Cook-Deegan, Megan Doerr, Ros Duncan, Amalia M. Issa, Jerome Reichman, Jacques Simard, Derek So, Sandeep Vanamala, Yann Joly

Faculty Scholarship

Open science can significantly influence the development and translational process of precision medicine in Canada. Precision medicine presents a unique opportunity to improve disease prevention and healthcare, as well as to reduce health-related expenditures. However, the development of precision medicine also brings about economic challenges, such as costly development, high failure rates, and reduced market size in comparison with the traditional blockbuster drug development model. Open science, characterized by principles of open data sharing, fast dissemination of knowledge, cumulative research, and cooperation, presents a unique opportunity to address these economic challenges while also promoting the public good.

The Centre of …

Powerful Speakers And Their Listeners, Helen Norton

Publications

In certain settings, law sometimes puts listeners first when their First Amendment interests collide with speakers’. And collide they often do. Sometimes speakers prefer to tell lies when their listeners thirst for the truth. Sometimes listeners hope that speakers will reveal their secrets, while those speakers resist disclosure. And at still other times, speakers seek to address certain listeners when those listeners long to be left alone. When speakers’ and listeners’ First Amendment interests collide, whose interests should prevail? Law sometimes – but not always – puts listeners’ interests first in settings outside of public discourse where those listeners have …

Pregnancy And The First Amendment, Helen Norton

Publications

Suppose that you are pregnant and seated in the waiting room of a Planned Parenthood clinic, or maybe in a facility that advertises “Pregnant? We Can Help You.” This Essay discusses the First Amendment rules that apply to the government’s control of what you are about to hear.

If the government funds your clinic’s program, the U.S. Supreme Court has held that it does not violate the First Amendment’s Free Speech Clause when it forbids your health-care provider from offering you information about available abortion services. Nor does the government violate the Free Speech Clause, the Court has held, when …

Unjust Timing Limitations In Genetic Malpractice Cases, Lauren E. Clatch

Law Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

Keynote: The Protection Of Lgbt Youth, Craig Konnoth

Publications

This keynote contains three parts. Part I addresses the intersection of two metaphors: medicine and childhood in LGBT Rights. Part II addresses the state regulation of LGBT youth. Part III offers Professor Konnoth's concluding remarks on the protection of LGBT youth.

Financial Impact Of The Opioid Crisis On Local Government: Quantifying Costs For Litigation And Policymaking, Elizabeth Weeks

Scholarly Works

The opioids epidemic has had a significant impact on individuals and communities, including local governments responsible for serving and protecting those affected individuals. This is the first study of its kind to consider whether those local government costs are quantifiable, a question that has salience both for pending opioid litigation in federal and state courts and for local planning and budgeting decisions. This article first provides a detailed description of the opioid litigation landscape, including the federal multidistrict litigation (MDL) in Ohio, the Native American tribes’ actions, and various procedural and other hurdles that local government plaintiffs face in seeking …

Teaching Tomorrow’S Lawyers Through A (Semi-) Generalist, (Mostly-) Individual Client Poverty Law Clinic: Reflections On Five Years Of The Community Health Law Partnership, Jason A. Cade

Scholarly Works

Design options when starting a live-client clinic from scratch can be somewhat overwhelming. Should the clinic focus on systemic impact or individual representation? Appellate work or hearings? Should the clinic specialize or cover multiple legal issues? Another set of issues concerns how the clinic should find and accept its clients, and whether students should have a role in the intake process. The list of choices goes on. In this Essay, written for the Georgia Law Review’s Online Issue celebrating 50 years of clinics at the University of Georgia School of Law, I describe how I have navigated these and other …

Healthism In Tort Law, Elizabeth Weeks

Scholarly Works

This article draws on the author's recently published book, Healthism: Health Status Discrimination and the Law (with Jessica L. Roberts) (Cambridge University Press 2018), examining tort law doctrine and policy for examples of differential treatment of health status or behaviors. Just as scholars previously have drawn attention to discrimination based on race, sex, age, and other protected categories in tort law, the article urges similar examination of tort law's potential to discriminate against the unhealthy. The article discusses the potential for healthism in the reasonably prudent person standard of care, contributory negligence, assumption of the risk, noneconomic damages caps, impaired …

Manufactured Emergencies, Robert L. Tsai

Faculty Scholarship

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Tamar F. Barlam, Jake R. Morgan, Warren A. Kaplan, Kevin Outterson, Stephen I. Pelton

Faculty Scholarship

We compared antibiotic prescribing for children with and those without an underlying chronic condition associated with increased risk for invasive pneumococcal disease. Children with a chronic condition had significantly greater cumulative exposure to antibiotics and higher rates of prescriptions per person-year than those without a chronic condition; this population is at increased risk for the emergence of multidrug-resistant pathogens.

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

Big Waiver Under Statutory Sabotage, Elizabeth Mccuskey

Faculty Scholarship

The Affordable Care Act's State Innovation waiver allows federal agencies to suspend the most controversial parts of the statute for states to pursue alternative paths, while keeping the federal funding provided by the statute. This "big waiver" provision has the potential to enable states to pursue transformative health reforms, while preserving the affordability and universal coverage aims of the federal statute. Big waivers like this one carry theoretical promise, which largely depends on the strength of the federal statute's baseline infrastructure. This Essay considers early implementation of the State Innovation waiver as a test for big waiver theory - and …

Us Military Medical Ethics In The War On Terror, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Military medical ethics has been challenged by the post-11 September 2001 ‘War on Terror’. Two recurrent questions are whether military physicians are officers first or physicians first, and whether military physicians need a separate code of ethics. In this article, we focus on how the War on Terror has affected the way we have addressed these questions since 2001. Two examples frame this discussion: the use of military physicians to force-feed hunger strikers held in Guantanamo Bay prison camp, and the uncertain fate of the Department of Defense’s report on ‘Ethical Guidelines and Practices for US Military …