Law Commons^™

Life Sciences & Health Law, Carly Toepke, Katrin Hanschitz, Yevgeniya Ocheretko, Danny Shebaclo

The Year in Review

No abstract provided.

Equal Protection And Scarce Therapies: The Role Of Race, Sex, And Other Protected Classifications, Govind Persad

SMU Law Review Forum

The allocation of scarce medical treatments, such as antivirals and antibody therapies for COVID-19 patients, has important legal dimensions. This Essay examines a currently debated issue: how will courts view the consideration of characteristics shielded by equal protection law, such as race, sex, age, health, and even vaccination status, in allocation? Part II explains the application of strict scrutiny to allocation criteria that consider individual race, which have been recently debated, and concludes that such criteria are unlikely to succeed under present Supreme Court precedent. Part III analyzes the use of sex-based therapy allocation criteria, which are also in current …

Video Advance Directives: Growth And Benefits Of Audiovisual Recording, Thaddeus Mason Pope

SMU Law Review

No abstract provided.

First Man And Second Woman: Reflections On The Anniversaries Of Apollo 11 And Cruzan, George J. Annas

SMU Law Review

No abstract provided.

Crispr And The Future Of Fertility Innovation, June R. Carbone

SMU Science and Technology Law Review

No abstract provided.

Consumer Protections In The Context Of Holistic Healthcare, Rachel Pauerstein

SMU Science and Technology Law Review

No abstract provided.

In Re Zhu: Implied Consent To Posthumous Sperm Retrieval, Mary Kathryn Sapp

SMU Science and Technology Law Review

No abstract provided.

Cruzan And The “Right To Die”, Thomas Wm. Mayo

SMU Law Review

No abstract provided.

Cruzan’S Legacy In Autonomy, Kathy L. Cerminara

SMU Law Review

No abstract provided.

Remaking The “Right To Die”: Give Me Liberty But Do Not Give Me Death, Janet L. Dolgin

SMU Law Review

No abstract provided.

Beyond Cruzan: Dementia And The Best Interests Standard, Rebecca Susan Dresser

SMU Law Review

No abstract provided.

Cruzan And The Other Evidentiary Standard: A Reconsideration Of A Landmark Case Given Advances In The Classification Of Disorders Of Consciousness And The Evolution Of Disability Law, Joseph J. Fins

SMU Law Review

No abstract provided.

A History Of The Law Of Assisted Dying In The United States, Alan Meisel

SMU Law Review

No abstract provided.

Cruzan And Surrogate Decision-Making, David Orentlicher

SMU Law Review

No abstract provided.

The Legacy Of Cruzan: Balancing The Moral Agency Of Surrogates And The State, Margie Hodges Shaw, Timothy E. Quill, Bernard L. Sussman

SMU Law Review

No abstract provided.

Digital Health And Regulatory Experimentation At The Fda, Nathan Cortez

Faculty Journal Articles and Book Chapters

For well over a decade the U.S. Food and Drug Administration (FDA) has been told that its framework for regulating traditional medical devices is not modern or flexible enough to address increasingly novel digital health technologies. Very recently, however, the FDA introduced a series of digital health initiatives that represent important experiments in medical product regulation, departing from longstanding precedents applied to therapeutic products like drugs and devices. The FDA will experiment with shifting its scrutiny from the pre-market to the post-market phase, shifting the locus of regulation from products to firms, and shifting from centralized government review to decentralized …

A Black Box For Patient Safety?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Technology now makes it possible to record surgical procedures with striking granularity. And new methods of artificial intelligence (A.I.) and machine learning allow data from surgeries to be used to identify and predict errors. These technologies are now being deployed, on a research basis, in hospitals around the world, including in U.S. hospitals. This Article evaluates whether such recordings – and whether subsequent software analyses of such recordings – are discoverable and admissible in U.S. courts in medical malpractice actions. I then argue for reformulating traditional "information policy" to accommodate the use of these new technologies without losing sight of …

Patent Eligibility Of Predictive Algorithm In Second Generation Personalized Medicine, Jerry I-H Hsiao

SMU Science and Technology Law Review

No abstract provided.

Investigating Potentially Unlawful Death Under International Law: The 2016 Minnesota Protocol, Christof Heyns, Stuart Casey-Maslen, Toby Fisher, Sarah Knuckey, Thomas Probert, Morris Tidball-Binz

The International Lawyer

No abstract provided.

Germline Editing: Two Steps Forward, One Step Back?, Kristina Smith

SMU Science and Technology Law Review

No abstract provided.

The Faa’S Mental Health Standards: Are They Reasonable?, Katie Manworren

Journal of Air Law and Commerce

No abstract provided.

Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck

SMU Science and Technology Law Review

No abstract provided.

Quarantine And The Federal Role In Epidemics, Michael R. Ulrich, Wendy K. Mariner

SMU Law Review

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

“Heal Thyself.”—An Argument For Granting Asylum To Healthcare Workers Persecuted During The 2014 West African Ebola Crisis, Bethany Echols

SMU Law Review

This article argues for a change in United States asylum policy at a time when change is needed most. Those seeking asylum must prove that they fear persecution in their home country based on one of five protected categories and that their government is the persecutor or is unable to control the actions of the persecutors. Multiple articles have recognized that the “particular social group” is the most difficult category of asylum seeker to analyze. Not only do the standards for particular social groups (PSGs) vary among circuit courts, but judicial consistency is lacking.

This article focuses on a particular …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

New Forms Of Dialects Between Intellectual Property And Public Health: Pharmaceutical Patent-Related Investment Disputes, Valentina Vadi

The International Lawyer

No abstract provided.

The Mobile Health Revolution?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

Health Care Law, Mary Jean Geroulo

SMU Law Review

No abstract provided.

A Medical Malpractice Model For Developing Countries?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article, written for the symposium "Reforming Medical Liability: Global Perspectives," evaluates the unique plight of developing countries in crafting medical liability regimes. Many developing countries struggle to maintain workable systems for adjudicating physician negligence. This is due to a variety of factors, such as widespread poverty, more pressing public health priorities that demand attention, a scarcity of physicians, immature health care systems, large informal health sectors, regulatory deficits, and weak civil societies, among others. Patients in these countries are also less able than their counterparts in well-developed countries to evaluate and challenge the care they receive and thus serve …