Medical Jurisprudence Commons^™

Patient Decision Aids Improve Patient Safety And Reduce Medical Liability Risk, Thaddeus Pope

Faculty Scholarship

Tort-based doctrines of informed consent have utterly failed to assure that patients understand the risks, benefits, and alternatives to the healthcare they receive. Fifty years of experience with the doctrine of informed consent have shown it to be an abject catastrophe. Most patients lack an even minimal understanding of their treatment options. But there is hope. Substantial evidence shows that patient decision aids (PDAs) and shared decision making can bridge the gap between the theory and practice of informed consent. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than clinician-patient discussions …

Towards Racial Justice: The Role Of Medical-Legal Partnerships, Medha D. Makhlouf

Faculty Scholarly Works

Medical-legal partnerships (MLPs) integrate knowledge and practices from law and health care in pursuit of health equity. However, the MLP movement has not reached its full potential to address racial health inequities, in part because its original framing was not explicitly race conscious. This article aims to stimulate discussion of the role of MLPs in racial justice. It calls for MLPs to name racism as a social determinant of health and to examine how racism may operate in the field. This work sets the stage for the next step: operationalizing racial justice in the MLP model, research, and practice.

Stemming The Shadow Pandemic: Integrating Sociolegal Services In Contact Tracing And Beyond, Medha D. Makhlouf

Faculty Scholarly Works

The COVID-19 pandemic has shed light on the challenges of complying with public health guidance to isolate or quarantine without access to adequate income, housing, food, and other resources. When people cannot safely isolate or quarantine during an outbreak of infectious disease, a critical public health strategy fails. This article proposes integrating sociolegal needs screening and services into contact tracing as a way to mitigate public health harms and pandemic-related health inequities.

Digital Home Health During The Covid-19 Pandemic Challenges To Safety, Liability, And Informed Consent, And The Way To Move Forward, Sara Gerke

Faculty Contributions to Books

In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID-19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

When Is A Change Significant? The Update Problem Of Apps In Medical And Behavioral Research, Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer

Faculty Scholarly Works

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be …

Ethical Malpractice, Nadia N. Sawicki

Faculty Publications & Other Works

Traditional claims of medical malpractice arise from deviations from medical standards of care regarding knowledge, professional decision-making, or technical skill. While many standards of ethical behavior are just as firmly rooted in medical custom as these more technical standards, U.S. courts have typically been unwilling to acknowledge ethical violations as compensable breaches of legal duty. This Article poses a question that should be at the forefront of discussions about medical liability in the 21st century – whether malpractice law should evolve to recognize violations of professional ethical norms as a basis for tort liability. In evaluating this question, it draws …

Tort Law Implications Of Compelled Physician Speech, Nadia N. Sawicki

Faculty Publications & Other Works

Abortion-specific informed consent laws in many states compel physicians to communicate state-mandated information that is arguably inaccurate, immaterial, and inconsistent with their professional obligations. These laws face ongoing First Amendment challenges as violations of the constitutional right against compelled speech. This Article argues that laws compelling physician speech also pose significant problems that should concern scholars of tort law.

State laws that impose tort liability on physicians who refuse to communicate a state-mandated message often do so by deviating from foundational principles of tort law. Not only do they change the substantive disclosure duties of physicians under informed consent law, …

Apparent Authority: Minnesota Finally Rejects Categorical Exemption For Independent Contractors In Hospital Emergency Rooms And Signifies Potential For Nondelegable Duty Doctrine—Popovich V. Allina Health Sys., 946 N.W.2d 885 (Minn. 2020)., Dana Ohman

Mitchell Hamline Law Review

No abstract provided.

Unlimited Medical Liability?, Jessica L. Roberts, Leah R. Fowler, Paul S. Appelbaum

Emory Law Journal Online

No abstract provided.

Joplin V. Cassin, 252 A.3d 271 (R.I. 2021), Julyssa Tavares

Roger Williams University Law Review

No abstract provided.

Antibody Claims And The Evolution Of The Written Description/Enablement Requirement, S Sean Tu, Christopher M. Holman

Faculty Works

No abstract provided.

Fertility Care: Essential Or Non-Essential? Lessons From The Covid-19 Pandemic, Rebecca S. Feinberg

Scholarly Works

At the beginning of the COVID-19 pandemic, in an effort to allocate medical resources towards the anticipated influx of patients infected with the novel virus, many non-essential healthcare services were temporarily paused. The American Society of Reproductive Medicine led the move to halt infertility care in all but the most extreme cases. This cessation of infertility care, compounded by the unknown duration of this recommendation, added to the already high level of stress and anxiety that fertility patients experience and in cases of advanced maternal age or diminished ovarian reserve potentially resulted in suboptimal clinical outcomes. There was vocal disagreement …

Assistance In Dying: A Comparative Look At Legal Definitions, Jocelyn Downie, Mona Gupta, Stefano Cavalli, Samuel Blouin

Articles, Book Chapters, & Popular Press

Euthanasia, assisted suicide, medical assistance in dying, death with dignity: these and many other different terms are used around the world to capture various types of assistance in dying. This diversity in terminology can create confusion both in academic debates and in policy-making if it is unclear what type of action or inaction is intended to be captured, by whom, and under what circumstances. By defining and contrasting several terms and legal status of assistance in dying in jurisdictions authorizing it, this comparative glossary aims to lay a foundation that prevents linguistic and conceptual confusion.

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

Abortion Rights Beyond The Medico-Legal Paradigm, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

Abortion rights in international law have historically been framed within a medico-legal paradigm, the belief that regulated systems of legal and medical control guarantee safe abortion. However, a growing worldwide practice of self-managed abortion (SMA) supported by feminist activism challenges key precepts of this paradigm. SMA activism has shown that more than medical service delivery matters to safe abortion and has called into question the legal regulation of abortion beyond criminal prohibitions. This article explores how abortion rights have begun to depart from the medico-legal paradigm and to support the novel norms and practices of SMA activism in a transformation …

Non-Consensual Disclosures, Nina Varsava

BYU Law Review

In the course of biomedical research on humans — for example, flu, imaging, and genomic studies — researchers often uncover information about participants that is important to their health and wellbeing. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the "Common Rule." I argue that human subjects researchers will often have strong ethical reason s to disclose results even when participants did not consent to the disclosure in advance. I also …

Paging Doctor Robot: Medical Artificial Intelligence, Tort Liability, And Why Personhood May Be The Answer, Benedict See

Brooklyn Law Review

Artificial intelligence (AI) is a part of everyday life. From our phones, to social media accounts, to online shopping, AI is present and enhances our daily experiences. One area where AI has a heavy (and an increasing) presence is the medical industry. Just as humans make mistakes, so does AI. However, when a human doctor makes a mistake, they can be sued for malpractice, but when AI makes a mistake, who is to be held responsible? Because tort law was designed with humans in mind, it may be hard to apply to medical AI, who’s “black box” algorithms make their …

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …

Pain Is Enough: Chronic Pain As Disability, Katherine L. Moore

Buffalo Law Review

States have historically failed to recognize chronic pain as a disability. In medicine, chronic pain has gained increasing recognition as a disability in and of itself, even absent a current, medically determinable physical impairment. The law, however, has been slow to catch up. This Article argues that chronic pain is a disability, even without medical evidence of an underlying impairment, because of pain’s significant functional impact on the body and mind. In the 2018 case of Saunders v. Wilkie, the United States Court of Appeals for the Federal Circuit recognized that “pain is enough” for a veteran to be …