Law Commons^™

Scope Of Duty, Counterfactual Analysis And Birth Defects: The Challenging Case Of Khan V Meadows, Kee Yang Low, Jordan Ting Xuan Chia

Research Collection Yong Pung How School Of Law

The tort of negligence has evolved into a sophisticated and calibrated framework. Even then, aspects of this elaborate structure are constantly being tweaked and, sometimes, challenged. Most recently, in the UKSC decision of Khan v Meadows, the spotlight is thrown on scope of duty analysis against the challenging backdrop of medical negligence and unwanted birth defects. The judgment of the majority suggests there is more that needs to be considered at the stage of damages, and that the sequential framework of negligence may benefit from some rearrangement.

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

On The Cusp Of The Next Medical Malpractice Insurance Crisis, Philip G. Peters Jr.

Faculty Publications

Medical malpractice claims are dwindling. Total payouts are far lower than during the 2002 crisis. Yet, insurance industry profits have been sinking for a decade and are nearly in the red. After a dozen years with a “soft” insurance market, we are now on the cusp of yet another malpractice insurance crisis.

How can profits be in peril if claims have dwindled and payouts are historically low?
Answering that question requires an understanding of the insurance cycle. The cycle periodically transforms gradual increases in costs and gradual decreases in revenue into explosive increases in premiums.

The industry’s financial statistics today …

Periods For Profit And The Rise Of Menstrual Surveillance, Michele E. Gilman

All Faculty Scholarship

Menstruation is being monetized and surveilled, with the voluntary participation of millions of women. Thousands of downloadable apps promise to help women monitor their periods and manage their fertility. These apps are part of the broader, multi-billion dollar, Femtech industry, which sells technology to help women understand and improve their health. Femtech is marketed with the language of female autonomy and feminist empowerment. Despite this rhetoric, Femtech is part of a broader business strategy of data extraction, in which companies are extracting people’s personal data for profit, typically without their knowledge or meaningful consent. Femtech can oppress menstruators in several …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

When Justice Should Precede Generosity: The Case Against Charitable Immunity In Arkansas, Courtney Jane Baltz

Arkansas Law Notes

This Comment discusses various aspects of the modern hospital and examines charitable immunity’s incompatibility with modern law.

First, Part II explains the historical justifications for immunity and presents the doctrine’s landscape in the United States. Part III examines the role precedent plays in continuing to adhere to the rule of immunity. Part IV takes an in-depth approach of the big business of hospitals by evaluating various financial aspects of charitable hospitals. Part V explores the reality of charitable immunity falling out of touch with concepts of modern law. Part VI takes a more specific look at the application of the …

California V. Texas: The Role Of Congressional Procedure In Severability Doctrine, Mary Leto Pareja

Faculty Scholarship

The United States Supreme Court is once again considering a case that challenges the constitutionality of the Affordable Care Act (“ACA”). In this round of litigation, plaintiffs argue that because Congress lowered the individual mandate tax penalty to zero in the 2017 Tax Act that makes the individual mandate itself unconstitutional and that, furthermore, the individual mandate cannot be severed from the rest of the ACA. The District Court agreed with the plaintiffs and struck down the entire ACA, and the Supreme Court granted cert to hear this momentous question. A decision is expected by summer of 2021.

The ACA …

Unilateral Burdens And Third-Party Harms: Abortion Conscience Laws As Policy Outliers, Nadia N. Sawicki

Faculty Publications & Other Works

Most conscience laws establish nearly absolute protections for health care providers unwilling to participate in abortion. Providers' rights to refuse-- and relatedly, their immunity from civil liability, employment discrimination, and other adverse consequences--are often unqualified, even in situations where patients are likely to be harmed. These laws impose unilateral burdens on third parties in an effort to protect the rights of conscientious refusers. As such, they are outliers in the universe of federal and state anti-discrimination and religious freedom statutes, all of which strike a more even balance between individual rights and the prevention of harm to third parties. This …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

A Malpractice-Based Duty To Disclose The Risk Of Stillbirth: A Response To Lens, Nadia N. Sawicki

Faculty Publications & Other Works

In Medical Paternalism, Stillbirth, & Blindsided Mothers, Lens argues that physicians who fail to disclose the risk of stillbirth to pregnant patients should be liable under the doctrine of informed consent. In this Response, I suggest that courts might be hesitant to expand informed consent in the way Lens proposes. Instead, I offer an alternative avenue for imposing liability, via traditional theories of medical malpractice.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

State Peer Review Laws As A Tool To Incentivize Reporting To Medical Boards, Nadia N. Sawicki

Faculty Publications & Other Works

State medical boards have been stymied in their ability to take disciplinary action against physicians who engage in serious misconduct, in part because hospitals and other health care organizations rarely report such misconduct. This Article offers a proposal for incentivizing hospital reporting of physician misconduct, inspired by an existing but flawed model in the federal Health Care Quality Improvement Act. This Article proposes that state legislatures link state medical practice act reporting requirements with state laws establishing an evidentiary privilege for peer review activities.

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Social Determinants Of Health And Slippery Slopes In Assisted Dying Debates: Lessons From Canada, Jocelyn Downie, Udo Schuklenk

Articles, Book Chapters, & Popular Press

The question of whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying has recently come to the fore in debates about the legalization of assisted dying. For example, it was central to critiques of the 2021 amendments made to Canada’s assisted dying law. The question of whether changes to a country’s assisted dying legislation lead to descents down slippery slopes has also come to the fore—as it does any time a jurisdiction changes its laws. We explore these two questions through the lens of Canada’s experience both to inform Canada’s ongoing …

Attitudes Toward Withholding Antibiotics From People With Dementia Lacking Decisional Capacity: Findings From A Survey Of Canadian Stakeholders, Gina Bravo, Lieve Van Den Block, Jocelyn Downie, Marcel Arcand, Lise Trottier

Articles, Book Chapters, & Popular Press

Background

Healthcare professionals and surrogate decision-makers often face the difficult decision of whether to initiate or withhold antibiotics from people with dementia who have developed a life-threatening infection after losing decisional capacity.

Methods

We conducted a vignette-based survey among 1050 Quebec stakeholders (senior citizens, family caregivers, nurses and physicians; response rate 49.4%) to (1) assess their attitudes toward withholding antibiotics from people with dementia lacking decisional capacity; (2) compare attitudes between dementia stages and stakeholder groups; and (3) investigate other correlates of attitudes, including support for continuous deep sedation (CDS) and medical assistance in dying (MAID). The vignettes feature a …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

The Need For A System View To Regulate Artificial Intelligence/Machine Learning-Based Software As Medical Devices, Sara Gerke, Boris Babic, Theodoros Evgeniou, I. Glenn Cohen

Faculty Scholarly Works

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug …

Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …

"As Long As I'M Me": From Personhood To Personal Identity In Dementia And Decision-Making, James Toomey

Elisabeth Haub School of Law Faculty Publications

As people, especially older people, begin to develop dementia, we confront ethical questions about when and how to intervene in their increasingly compromised decision-making. The prevailing approach in philosophically-inclined bioethics to tackling this challenge has been to develop theories of “decision-making capacity” based on the same characteristics that entitle the decisions of moral persons to respect in general. This Article argues that this way of thinking about the problem has missed the point. Because the disposition of property is an identity-dependent right, what matters in dementia and decision-making is an individual’s personal identity with their prior self, not their moral …

Second-Trimester Abortion Dangertalk, Greer Donley, Jill Wieber Lens

Articles

Abortion rights are more vulnerable now than they have been in decades. This Article focuses specifically on the most assailable subset of those rights: the right to a pre-viability, second-trimester abortion. Building on Carhart v. Gonzales, where the Supreme Court upheld a federal ban on a safe and effective second-trimester abortion procedure, states have passed new second-trimester abortion restrictions that rely heavily on the woman-protective rationale—the idea that the restrictions will benefit women. These newer second-trimester abortion restrictions include bans on the Dilation & Evacuation (D&E) procedure, bans on disability-selective abortions, and mandatory perinatal hospice and palliative care counseling …

Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke

Faculty Scholarly Works

Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S. that ensures that such devices are reasonably safe and effective when placed on the market and will remain so throughout their life cycle. I advocate for U.S. Food and Drug Administration (FDA) and congressional actions. I focus on how the FDA could - with additional statutory authority - regulate AI-based medical devices. I show that …

Prisons, Nursing Homes, And Medicaid: A Covid-19 Case Study In Health Injustice, Mary Crossley

Articles

The unevenly distributed pain and suffering from the COVID-19 pandemic present a remarkable case study. Considering why the coronavirus has devastated some groups more than others offers a concrete example of abstract concepts like “structural discrimination” and “institutional racism,” an example measured in lives lost, families shattered, and unremitting anxiety. This essay highlights the experiences of Black people and disabled people, and how societal choices have caused them to experience the brunt of the pandemic. It focuses on prisons and nursing homes—institutions that emerged as COVID-19 hotspots –and on the Medicaid program.

Black and disabled people are disproportionately represented in …

Courts Beyond Judging, Michael C. Pollack

Articles

Across all fifty states, a woefully understudied institution of government is responsible for a broad range of administrative, legislative, law enforcement, and judicial functions. That important institution is the state courts. While the literature has examined the federal courts and federal judges from innumerable angles, study of the state courts as institutions of state government — and not merely as sources of doctrine and resolvers of disputes — has languished. This Article remedies that oversight by drawing attention for the first time to the wide array of roles state courts serve, and by evaluating the suitability of both the allocation …

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these …

Diversity In Mdl Leadership: A Field Guide, Elizabeth Chamblee Burch

Scholarly Works

Multidistrict litigation (MDL) includes some of the most high-profile torts of our day—opioids, talc, RoundUp, to name a few—but the attorneys who spearhead these proceedings often look a lot like they did fifty years ago: predominately white and predominately male.

A debate has emerged over whether attorneys best positioned to fill MDL leadership roles are the grizzled repeat players who appear time and again—and who are largely white, older, and male—or newcomers with fresh ideas and energy who may not always look like their predecessors. And if diversity is important, what kind of diversity matters?

In this short essay, I …

Mdl Revolution, Elizabeth Chamblee Burch, Abbe Gluck

Scholarly Works

Over the past 50 years, multidistrict litigation (MDL) has quietly revolutionized civil procedure. MDLs include the largest tort cases in U.S. history, but without the authority of the class-action rule, MDL judges—who formally have only pretrial jurisdiction over individual cases—have resorted to extraordinary procedural exceptionalism to settle cases on a national scale. Substantive state laws, personal jurisdiction, transparency, impartiality, reviewability, federalism, and adequate representation must all yield if doing so fulfills that one goal.

Somehow, until now, this has remained below the surface to everyone but MDL insiders. Thanks to the sprawling MDL over the opioid crisis—and unprecedented opposition to …

Information For The Common Good In Mass Torts, Elizabeth Chamblee Burch, Alexandra D. Lahav

Scholarly Works

In recent years, judges have privileged confidentiality over transparency in discovery, especially in large scale multidistrict litigation such as the Opiate litigation. By uncovering the assumptions underlying our current regime, this Article sheds light on the process that got us here as a first step towards re-envisioning the rules governing information in litigation. We investigate an untold history of discovery’s publicity to show that many of our assumptions about what is public and what is private is historically contingent, even accidental. So too are our assumptions about the best way to arrive at truth.

Accordingly, we suggest that courts ought …