Law Commons^™

When Is Medical Care “Futile”? The Institutional Competence Of The Medical Profession Regarding The Provision Of Life-Sustaining Medical Care, Meir Katz

Meir Katz

“Medical futility,” the doctrine by which hospital ethics boards have assumed the right to authorize medical providers to unilaterally withdraw or decline to provide aggressive life sustaining medical care, has swelled in popularity in recent years and has affected the lives of countless terminal patients. The case law governing medical futility is inconsistent and appears to provide medical providers and patients alike little guidance in this extremely sensitive area of health law. Lost in the confusion created by the case and statutory law is due consideration of the normative case behind “medical futility.” “Futility,” by definition, is preceded by an …

Vaccine Liability In The Supreme Court: Forging A Social Compact, John D. Kraemer, Lawrence O. Gostin

John D Kraemer

In its decision in Bruesewitz v. Wyeth LLC, the Supreme Court ruled that state products liability suits that allege design defects in vaccines are preempted by the National Childhood Vaccine Injury Act. This decision, the third in a trilogy of Supreme Court preemption cases that deal with products liability suits for health commodities, preserves the Vaccine Injury Compensation Program and the delicate balance between ensuring the vaccine supply and compensating injuries that it enables. Failing to preempt state product liability suits would have exposed vaccine manufacturers to substantial litigation costs defending unfounded claims about autism.

Moving Upstream: The Merits Of A Public Health Law Approach To Human Trafficking, Jonathan Todres

Jonathan Todres

Human trafficking, a gross violation of human rights and human dignity, has been identified by numerous government leaders as one of the priority issues of our time. Legislative efforts over the past decade have produced a patchwork of criminal laws and some assistance programs for victims. There is no evidence, however, that these efforts have reduced the incidence of trafficking. This lack of meaningful progress prompts questions as to what the best framework is for addressing human trafficking. This Article begins with a discussion of the limitations inherent in the current law-enforcement-centric approach to the problem. It then explores the …

A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

An Ad Hoc Inquiry Into The Feasibilities And Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users, Margarita Rubin

Margarita Rubin

ABSTRACT Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a viable target for state tort claims. In February, 2008 the Supreme Court handed down a crucial decision in Riegel v. Medtronic, Inc., involving medical devices regulated by the FDA. In Riegel, the Court reaffirmed the distinction between the exhaustive "federal requirements" of the PMA process and the looser scrutiny of 510(k) notification. This means that 510(k) devices—which vastly outnumber PMA devices—remain fully exposed to mass-tort liability. Medical …

Towards A New Moral Paradigm In Health Care Delivery: Accounting For Individuals, Meir Katz

Meir Katz

For years, commentators have debated how to most appropriately allocate scarce medical resources over large populations. In this paper, I abstract the major rationing schema into three general approaches: rationing by price, quantity, and prioritization. Each has both normative appeal and considerable weakness. After exploring them, I present what some commentators have termed the “moral paradigm” as an alternative to broader philosophies designed to encapsulate the universe of options available to allocators (often termed the market, professional, and political paradigms). While not itself an abstraction of any specific viable rationing scheme, it provides a strong basis for the development of …

Responding, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

The Nigerian Social Health Insurance System And The Challenges Of Access To Health Care: An Antidote Or A White Elephant?, Obiajulu Nnamuchi

Obiajulu Nnamuchi

This paper is an excursion into the operation of the recently launched National Health Insurance Scheme of Nigeria. Its primary task is to determine whether social health insurance in Nigeria, as expressed in the statute establishing the scheme, has prospects for actualizing its promise of, inter alia, ensuring access to affordable health care for every Nigerian. To make this determination, the paper critically analyzes key components of the scheme, focusing on the different actors and issues, the interplay of which is crucial to the scheme's successful implementation. Regrettably, the depth and breadth of the analysis are somewhat constrained by the …

"Let's Do The Time Warp Again": Assessing The Competence Of Counsel In Mental Health Conservatorship Proceedings, Grant H. Morris

Grant H Morris

Thirty years ago, I wrote an article on mental health conservatorships in California and the role of counsel for persons for whom a conservatorship has been proposed. Data was gathered on the performance of attorneys in court hearings conducted in San Diego County Superior Court. The data revealed that lawyers representing proposed conservatees were inactive and ineffective in representing their clients’ interests. The lawyers did not consider themselves advocates in an adversary process in which conservatorship was to be avoided. A year after the article was published, the California Supreme Court, citing that article as authority for the “paternalistic attitude” …

An Empirical Examination Of The Factors Associated With The Commutation Of State Death Row Prisoners’ Sentences Between 1986 And 2005, John D. Kraemer

John D Kraemer

Commutation is usually a death row prisoner’s last hope of evading his or her capital sentence. However, unlike many other stages of the death penalty process, little research focuses on the factors that affect decisions to commute or allow a death sentence to go forward, and that which has been conducted utilizes data which is now nearly a decade old. This paper seeks to examine personal and demographic factors associated with commutation decisions and to resolve incon- sistent findings in the prior research. Using the statistical method of multiple logistic regression, this paper finds statistically significant disparities in the odds …

Screening Of Prisoners For Hiv: Public Health, Legal, And Ethical Implications, John D. Kraemer

John D Kraemer

Inmates are disproportionately impacted by HIV/AIDS in the United States. As a result, correctional health systems have often screened prisoners -- either at entry or while incarcerated -- for HIV. This paper assesses the likely public health impact of such programs and concludes that they can be beneficial so long as screening programs are linked with adequate prevention and treatment. It also assesses the conditions under which screening programs comply with or violate United States constitutional law and ethical norms.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Who Owns Your Body? A Study In Literature And Law, Lori B. Andrews

Lori B. Andrews

No abstract provided.

Influenza Genetic Sequence Patents: Where Intellectual Property Clashes With Public Health Needs, Lori B. Andrews, Laura A. Shackelton

Lori B. Andrews

Biomedical Research And The Law:--Embryonic Stem Cells, Clones And Genes: Science, Law, Politics, And Values, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

The Right To Die With Dignity: An Argument In Ethics And Law, Raphael Cohen-Almagor

raphael cohen-almagor

We face a dilemma. Suppose there is a person who suffers great pain and wants to die. Those who believe life is intrinsically valuable object to taking life and to taking any action on the person’s desire because the end of life is something granted only to nature, and is not a decision that is incumbent on human beings. However, this objection ignores the autonomy of the agent’s concerns, because she might say: “I would like to die. I would rather die in these circumstances because I don’t feel that I am adding anything just by surviving.” Can life be …

Built In Obsolescence: The Coming End To The Abortion Debate, Vernellia R. Randall, Tshaka C. Randall

Vernellia R. Randall

The current legal and political dispute is grounded in the misconception that the decision to have an abortion is one decision, a decision to terminate a fetus. In fact, in choosing an abortion, a woman is actually making two distinct choices: first, she is choosing to terminate her pregnancy, that is, remove the fetus from her body; and, second, she is choosing to terminate the fetus. Currently, a woman’s decision to remove the fetus from her body (the “autonomy decision”) is necessarily a medical decision to terminate the fetus (the “reproductive decision”). The current argument in favor of legalized abortion …

The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

Over a quarter of a century has passed since health care ethics committees (HCECs) in the United States received legal recognition as alternatives to the courts in resolving conflicts related to patient end-of-life care. By the mid to late 1980s HCECs had been established in over half of U.S. hospitals and had received a certain legitimacy in the health care system. Given their age and growth one could characterize them developmentally as emerging from adolescence and establishing themselves in young adult-hood. As a result, we might expect that they would have resolved the identify crisis characterizing the adolescent years. Yet, …

Diabetes Treatments And Moral Hazard, Jonathan Klick, Thomas Stratmann

All Faculty Scholarship

In the face of rising rates of diabetes, many states have passed laws requiring health insurance plans to cover medical treatments for the disease. Although supporters of the mandates expect them to improve the health of diabetics, the mandates have the potential to generate a moral hazard to the extent that medical treatments might displace individual behavioral improvements. Another possibility is that the mandates do little to improve insurance coverage for most individuals, as previous research on benefit mandates has suggested that mandates often duplicate what plans already cover. To examine the effects of these mandates, we employ a triple-differences …

Mandatory Waiting Periods For Abortions And Female Mental Health, Jonathan Klick

All Faculty Scholarship

Proponents of laws requiring a waiting period before a woman can receive an abortion argue that these cooling off periods protect against rash decisions on the part of women in the event of unplanned pregnancies. Opponents claim, at best, waiting periods have no effect on decision-making and, at worst, they subject women to additional mental anguish and stress. In this article, I examine these competing claims using adult female suicide rates at the state level as a proxy for mental health. Panel data analyses suggest that the adoption of mandatory waiting periods reduce suicide rates by about 10 percent, and …

Medical Malpractice And The Insurance Underwriting Cycle, Tom Baker

All Faculty Scholarship

No abstract provided.

Atypical Pneumonia And Ambivalent Law And Politics: Sars And The Response To Sars In China, Jacques Delisle

All Faculty Scholarship

No abstract provided.

The Effect Of Abortion Legalization On Sexual Behavior: Evidence From Sexually Transmitted Diseases, Jonathan Klick, Thomas Stratmann

All Faculty Scholarship

Unwanted pregnancy represents a major cost of sexual activity. When abortion was legalized in a number of states in 1969 and 1970 (and nationally in 1973), this cost was reduced. We predict that abortion legalization generated incentives leading to an increase in sexual activity, accompanied by an increase in sexually transmitted diseases (STDs). Using Centers for Disease Control data on the incidence of gonorrhea and syphilis by state, we test the hypothesis that abortion legalization led to an increase in sexually transmitted diseases. We find that gonorrhea and syphilis incidences are significantly and positively correlated with abortion legalization. Further, we …

The Exclusion Of Pregnant, Pregnable, And Once-Pregnable People (A.K.A. Women) From Biomedical Research, Vanessa Merton

Elisabeth Haub School of Law Faculty Publications

The barriers to women's participation as subjects in biomedical research are currently being challenged as a matter of legislative policy, medicine, and law. This Article catalogs the ways in which women have been disadvantaged by their exclusion and recent developments to redress them, and goes on to dissect the underlying rationales for excluding women from clinical trials. The author reveals the 'fundamental misconception' behind exclusionary rationales, and argues that research sponsors in fact have more to fear in the way of potential liability from the exclusion of women, even pregnant women and women of child-bearing capacity, than from their inclusion. …