Law Commons^™

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 …

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 …

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 …

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 …

Embracing The New Geography Of Health Care: A Novel Way To Cover Those Left Out Of Health Reform, Nathan Cortez

Faculty Journal Articles and Book Chapters

Even after landmark health reform in 2010, our health care system will not achieve universal coverage. The Patient Protection and Affordable Care Act is expected to leave 23 million uninsured after a decade. And until several major provisions take effect in 2014, 50 million will remain uninsured. This Article argues that cross-border health insurance plans that utilize foreign medical providers are a surprisingly feasible alternative for the residually uninsured. Cross-border plans can be much less expensive than traditional, domestic-only plans. And they might appeal to immigrants and others that are neither eligible for public plans nor able to afford private …

The Elusive Ideal Of Market Competition In U.S. Health Care, Nathan Cortez

Faculty Journal Articles and Book Chapters

This chapter, in the book Health Care and EU Law (TMC Asser Press 2011), explores how market competition has both driven and (somewhat ironically) undermined U.S. health reform efforts over the past few decades. More than its peers, the U.S. health care system looks to market-inspired theories and policy instruments, even in public programs like Medicare. But decades of promoting market ideals has not given Americans the health care system we desire. Still, the market question remains the basic dividing line in U.S. health policy.

This chapter explores how the U.S. health care system remains an international outlier, exploring American …

Recalibrating The Legal Risks Of Cross-Border Health Care, Nathan Cortez

Faculty Journal Articles and Book Chapters

The nascent scholarship surrounding "medical tourism" assumes, without much scrutiny, that foreign jurisdictions provide few legal remedies to patients, instead focusing on whether U.S. patients can sue in U.S. courts. This article tests that assumption by examining whether patients might recover adequate compensation not only in the United States, but in four common destinations: India, Thailand, Singapore, and Mexico. I analyze how each jurisdiction handles medical malpractice complaints and discuss the unique obstacles patients might face when navigating each of these systems. I conclude that U.S. patients will struggle to recover remotely adequate compensation in each of these jurisdictions. This …

Three Ways Of Looking At A Health Law And Literature Class, Jennifer S. Bard, Thomas Wm. Mayo, Stacey A. Tovino

Faculty Journal Articles and Book Chapters

The authors of this Article participated in a panel at the American Society of Law, Ethics & Medicine Conference in 2008 that discussed the use of literary materials in law school to teach medical ethics (and related matters) in a law school setting. Each author comes at the topic from a different perspective based on his or her own experience and background. This Article and the panel on which it was based reflect views on how literature can play a valuable role in helping law students, as well as medical students, understand important legal and ethical issues and concepts in …

International Health Care Convergence: The Benefits And Burdens Of Market-Driven Standardization, Nathan Cortez

Faculty Journal Articles and Book Chapters

For over thirty years, health scholars have debated whether health care policies are converging, or becoming more alike, internationally. Convergence theories have always been particularly appealing in health care. Most countries generally struggle with the same challenges: how to provide quality care, to as many people as possible, for a reasonable price. Moreover, modern scientific medicine has not only influenced how countries around the world provide and regulate health care, but has also driven rising patient expectations. These commonalities invite theories of convergence: If policymakers in different jurisdictions face similar challenges, why wouldn't they adopt roughly similar solutions?

In this …

The Baby Doe Rules And Texas’S 'Futility Law' In The Nicu, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

The applicability in the NICU of the futility provision of Texas's Advance Directives Act and its relationship to the Baby Doe rules are reasonably straightforward. Nonetheless, many comments have been written about Texas's so-called “futility law,” some of them complimentary and others, not so much. The most serious critiques of the Texas futility provision, however, are based upon assumptions that result from a fundamental misreading of the law. After a brief discussion of the futility provision and its principal features, this Essay examines the misunderstandings that plague many critiques of the law and then offers a list of proposed amendments …

Patients Without Borders: The Emerging Global Market For Patients And The Evolution Of Modern Health Care, Nathan Cortez

Faculty Journal Articles and Book Chapters

This article addresses the unique legal, policy, and ethical questions that arise when patients travel to foreign jurisdictions for medical care. A growing number of patients are leaving the United States, and employers, insurers, and even government payors are beginning to explore whether they can reduce spending by utilizing hospitals and physicians in developing countries. Because this is a dramatic leap, it has generated countless media stories, and has drawn attention from the WHO, WTO, World Bank, and U.S. Senate - many of which believe so-called medical tourism may transform health care here and abroad.

Despite this attention, the market …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Sex, Marriage, Medicine, And Law: 'What Hope Of Harmony?', Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

This essay offers a critique of the Kansas Supreme Court's decision in In re Estate of Gardiner, 42 P.3d 120 (Kan. 2002), and similar cases that hold that for purposes of the opposite-sex marriage rule, an individual's sex is determined at birth, is genetically fixed, and cannot be changed through surgery or hormone therapy. The result for transgendered individuals is a legal regime that is hostile to medical care that brings external sex characteristics into line with sexual identity. The result for society is a legal rule that is at odds with scientific opinion. Finally, the result for the opposite-sex …

The First Fifty Years: Health Law's Greatest Hit, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

In honor of the Syracuse Law Review's 50th Anniversary, this article considers various developments in health law and concludes that the passage of the Medicare amendments to the Social Security Act has had the most significant impact on the field. The article discusses the impact of Medicare on the culture of hospitals and their medical staffs, on the development and dissemination of new technologies, and on restructuring and reforming the industry in key areas, including fraud and abuse, patient dumping, organ donation, advance directives, patients' rights, and other agencies' regulation of health care providers.

Texas' New Advance Directives Act, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

No abstract provided.

Treatment Alternatives For The Dying Patient: Medical Ethics And The Law, Thomas Wm. Mayo, Robert L. Fine

Faculty Journal Articles and Book Chapters

No abstract provided.

Foreword: Nonfinancial Barriers To Health Care, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

Health care policy traditionally has been seen as a three-legged stool. Three interdependent variables-cost, quality, and access-have largely defined the domain of health policy. Ignore one of the variables, and the stool topples. It is not surprising, therefore, that health care policymakers have tended to view the problem of access to health care resources primarily in economic terms. Economic analysis of the access problem is useful because it gives policymakers a common methodology, vocabulary, and set of analytical tools that provide insights into the related problems of cost containment and quality, as well as the access issue. This in turn …

The Mixture And Derived-From Rules Under Rcra: Once A Hazardous Waste Always A Hazardous Waste, Jeffrey M. Gaba

Faculty Journal Articles and Book Chapters

No abstract provided.

Constitutionalizing The 'Right To Die', Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

Following the Supreme Court’s unprecedented acceptance of three abortion cases, and for the first time a case involving the withdrawal of life-sustaining medical treatment in the upcoming 1989 Term, this article addresses the so-called right to die. Specifically, as in Cruzan v. Director, Missouri Department of Health, whether the federal constitutional right of privacy extends to decisions, made on behalf of permanently unconscious patients, to have life-sustaining medical treatment discontinued and, if so, whether a state’s interest in the sanctity of life can override the patient’s privacy right? This article argues that on doctrinal as well as policy grounds, no …

Medical Decision Making During A Surrogate Pregnancy, Thomas Wm. Mayo

Faculty Journal Articles and Book Chapters

This article is concerned with a tradition of paternalism within the medical and legal professions toward pregnant women, their children, and the medical decisions that pregnant women make affecting both. In most surrogacy contracts, the surrogate mother agrees not to have an abortion and to refrain from certain types of harmful conduct, including the consumption of alcoholic beverages, smoking, and the use of illegal drugs. This article will consider the implications these provisions have for medical decision making during pregnancy, and for the concepts of individual autonomy, informed consent and the developing doctrine of fetal rights.

Considering the nature of …