Medical Jurisprudence Commons^™

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 …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

If You Build It, Will They Come? An Empirical Study Of The Voluntary Use Of Mediation And Its Implications, Dwight Golann

Cardozo Journal of Conflict Resolution

A generation ago, American litigants did not often go to mediation voluntarily. Advocates of the process predicted, however, that as lawyers and parties became more familiar with mediation, they would opt to use it more often. But, is this true? Virtually no data exists about how often litigants voluntarily choose to mediate legal disputes, whether use varies in different kinds of cases, and what motivates litigants' decisions whether to mediate or not. This Article presents data about each of these issues and analyzes its meaning.

Social Rights And The Welfare State: A Necessary Relation, Mario Santiago Juarez

Cardozo International & Comparative Law Review

The article argues that the welfare state is indispensable for fulfilling social rights, emphasizing that mere recognition of these rights is insufficient without robust state commitment to public policies and systems. It traces the historical development of social rights from the industrial revolution to modern times, highlighting the role of key reforms and international frameworks. The analysis critiques the limitations of judicial enforcement and advocates for structural policies, such as progressive taxation and full employment, to ensure equitable access to essential services like education, healthcare, and housing.

India's Aadhaar Card - A Violation Of Indian Citizen's Right To Privacy, Sonal Chhugani

Cardozo International & Comparative Law Review

The article examines the implications of India's Aadhaar Card program, arguing that while it may comply with Indian law, it violates the right to privacy under Article 17 of the International Covenant on Civil and Political Rights (ICCPR). The Aadhaar Card, a mandatory biometric identification system, centralizes vast amounts of citizen data, posing significant risks to privacy and security. Despite the Indian Supreme Court's ruling that the program does not violate domestic privacy rights, the article contends that it fails to meet international privacy standards, necessitating reforms to align with global human rights obligations.

Applicability Of International Schemes Of Legal Safeguards In Physician Assisted Suicide To Future United States Policy, Annie M. Bonazzi

Cardozo International & Comparative Law Review

The note argues that the United States can draw from international models, particularly those in Switzerland, Colombia, and Australia, to develop a more cohesive and effective policy on physician-assisted suicide (PAS). By combining existing U.S. state safeguards with international approaches, such as Colombia's panel-based system and Switzerland's nonprofit mechanism, the U.S. could address ethical, legal, and practical challenges more comprehensively.

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 …

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 …

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.

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 …

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 …

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 …

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 …

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, …