Law Commons^™

Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz

Faculty Scholarship

No abstract provided.

Oy Canada! Trade's Non-Solution To "The Problem" Of U.S. Drug Prices, Daniel Gilman

Faculty Scholarship

Price disparities—price “differentiation” or “discrimination”—in pharmaceuticals markets have, in recent years, been the subject of much discussion. Price sensitivity should come as no surprise: Medicines play an increasingly important role in healthcare, while pharmaceuticals prices continue to rise. When prices vary greatly within markets or between neighboring markets, the pressure towards arbitrage is clear. This paper considers the question whether the re-importation of medicines from Canada or the EU is well advised and argues that it is not. First, we might reasonably question the extent to which we wish, as a matter of policy, to manage pharmaceuticals pricing; among other …

National Institutes Of Health State-Of-The-Science Conference Statement: Cesarean Delivery On Maternal Request, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Bridging The Relational-Regulatory Gap: A Pragmatic Information Policy For Patient Safety And Medical Malpractice, William M. Sage, Joshua Graff Zivin, Nathaniel B. Chase

Faculty Scholarship

The Article distinguishes and explores three categories of information use: Helping patients understand and participate in their care; Improving patient safety, including analyzing medical errors and identifying unsafe health care providers and practices; and Assessing the performance of the medical liability system in its many dimensions including deterrence, compensation, justice, administrative efficiency, and stability.

For each category, the Article comments on existing laws or programs for information reporting or disclosure, points out major tensions or ambiguities, and suggests pragmatic improvements.

The Scarlet Gene: Behavioral Genetics, Criminal Law, And Racial And Ethnic Stigma, Karen H. Rothenberg, Alice Wang

Faculty Scholarship

Imagine that a scientist from the state university asks you and your family to participate in a study on a particular gene variant associated with alcoholism. The project focuses on your ethnic group, the Tracy Islanders, who have a higher incidence of alcoholism, as well as a higher incidence of the gene variant, than the general population. You will not be informed whether you have the gene variant, but your participation in the study might help scientists develop drugs to help individuals control their addiction to alcohol. You have a family history of alcoholism, and you are concerned that your …

Autonomy Suspended: Using Female Patients To Teach Intimate Exams Without Their Consent, Robin Fretwell Wilson

Faculty Scholarship

Recent reports of medical students performing pelvic exams for training purposes on anesthetized women without their consent have produced a firestorm of controversy. Peter Ubel and colleagues found that 90% of medical students performed such exams during their obstetrics/gynecology rotations. A series of 2003 reports focused a white-hot spotlight on this teaching practice and resulted in Federal Trade Commission and Department of Justice hearings and action by the American Association of Medical Colleges and the American College of Obstetrics and Gynecology. In this article, Professor Wilson examines the merits of the defenses and justifications for using female patients for pelvic …

The Scapegoat: Emtala And Emergency Department Overcrowding, Laura Hermer

Faculty Scholarship

Part I of this article briefly discusses the Emergency Medical Treatment and Active Labor Act's salient provisions. Part II examines the history of emergency care and changes in healthcare organization and finance affecting the provision of charity care-topics which are significant in unraveling the alleged effects EMTALA has had on the healthcare system. Part III examines policy issues raised by EMTALA within our present system of health insurance and healthcare organization and finance.

This article reaches two conclusions. First, EMTALA, while a poor and archaic fit with our present system of healthcare delivery and finance, in fact has helped to …

The Role Of Religion In The Schiavo Controversy, Barbara A. Noah

Faculty Scholarship

The brief life of Theresa Marie Schiavo and the dispute over her end-of-life care captured public awareness in a way that few such cases have done. The reasons for the nearly unprecedented public attention to her case are two-fold. The decision by various religious groups and governmental entities to intervene in the dispute surrounding her care in order to promote conservative causes (some of them only tenuously related to her particular medical circumstances) prompted unusually intense media coverage. In addition, the ensuing publicity surrounding Theresa's tragic condition--an unexpected cardiac arrest left her in a permanent vegetative state at the age …

Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah

Faculty Scholarship

The Author reviews Michele Goodwin’s book BLACK MARKETS: THE SUPPLY AND DEMAND OF BODY PARTS, published by Cambridge University Press, 2006. The book discusses the shortage of cadaveric organs available for transplantation. It argues that the shortage disproportionately impacts racial minorities. It then analyzes existing organ procurement laws and proposed alternatives, with a focus on market solutions.

BLACK MARKETS is impeccably researched and persuasively argued, though some of its points are certainly controversial. The book is aimed at and very accessible to a general audience, but it will also prove interesting and informative to legal, medical and public health academic …

Book Review: Tom Baker's The Medical Malpractice Myth, Barbara A. Noah

Faculty Scholarship

The Author reviews THE MEDICAL MALPRACTICE MYTH by Tom Baker, published by University of Chicago Press, 2005. Baker’s book confronts the idea that medical malpractice litigation is exploding and underserving plaintiffs and that their attorneys receive unjustified rewards while physicians struggle under the burden of high costs. The book strives to debunk the various aspects of this myth and offers directions for reform. Throughout the book, Baker very effectively connects the legal arguments and the insurance and litigation data to his broader points about the politics of tort reform. Baker’s style is concise, lively, and very readable. He effectively weaves …

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.

Enhancing Access To Health Care And Eliminating Racial And Ethnic Disparities In Health Status: A Compelling Case For Health Professions Schools To Implement Race-Conscious Admissions Policies, Thomas E. Perez

Faculty Scholarship

No abstract provided.

Physicians As Researchers: Difficulties With The "Similarity Position", David Wasserman, Deborah Hellman, Robert Wachbroit

Faculty Scholarship

No abstract provided.

Resolving Medical Malpractice Claims In The Medicare Program: Can It Be Done?, Eleanor D. Kinney, William M. Sage

Faculty Scholarship

There is increasing interest in an integrated approach to patient safety and medical liability among policymakers. We have proposed Medicareled malpractice reform that would provide Medicare beneficiaries with better safety, improved communication in the event of error, preservation of therapeutic relationships, timely settlement, and fair compensation at a lower administrative cost. Disputes in the reformed system would be adjudicated by Medicare's existing administrative appeals system that would work together with Medicare's quality improvement regulation and payment policy to reduce errors and compensate injured patients.

Despite the laudable rationale for Medicare-led malpractice reform, important issues attend the constitutional and statutory authority …

Pay For Performance: Will It Work In Theory, William M. Sage

Faculty Scholarship

The title of my lecture about pay for performance in health care (often abbreviated as "P4P") echoes a French management saying: "It's all very well in practice, but it will never work in theory." There is no doubt that medical pay for performance is popular. P4P initiatives are everywhere; a search of online news reveals nearly 2,500 stories about pay for performance in the last two years alone. Folk legend Arlo Guthrie would have called P4P a movement-a "Pay for Performance Medical Quality Movement." But before you join in, you might want to know what you are joining. So let's …

Hunger Strikes At Guantanamo: Medical Ethics And Human Rights In A “Legal Black Hole”, George J. Annas

Faculty Scholarship

Being Human, a collection of readings assembled by President George W. Bush's Council on Bioethics, contains a powerful description of the force-feeding of Soviet political prisoner Vladimir Bukovsky, who was on a hunger strike to protest the refusal of prison authorities to provide a lawyer for a fellow inmate who was awaiting trial:

They started feeding me forcibly through the nostril. By a rather thick rubber tube with a metal end on it. . . . The procedure will be that four or five KGB guys will come to my cell, take me to a medical unit, put a straitjacket …

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Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller

Faculty Scholarship

Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). …

Rethinking Informed Consent: The Case For Shared Medical Decision-Making, Jaime S. King, Benjamin W. Moulton

Faculty Scholarship

No abstract provided.

Bioterror And “Bioart”: A Plague O' Both Your Houses, George J. Annas

Faculty Scholarship

Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind of war against non-state actors who use terror to intimidate populations has also made the creation of new ethical and legal rules for researchers seem critical. New laws have been passed, and there have been proposals for new codes of ethics for bioterrorism-related research. Almost five years after September 11, however, the outcome of the development of new research rules remains uncertain.

Intelligent Judging: Evolution In The Classroom And The Courtroom, George J. Annas

Faculty Scholarship

Religious arguments have permeated debates on the role of the law in medical practice at the beginning and the end of life. But nowhere has religion played so prominent a role as in the century-old quest to banish or marginalize the teaching of evolution in science classes. Nor has new genetics research that supports evolutionary theory at the molecular level dampened antievolution sentiment. Requiring public-school science teachers to teach specific religion-based alternatives to Darwin's theory of evolution is just as bad, in the words of political comedian Bill Maher, as requiring obstetricians to teach medical students the alternative theory that …

Contesting Anticompetitive Actions Taken In The Name Of The State: State Action Immunity And Health Care Markets, Clark C. Havighurst

Faculty Scholarship

The so-called state action doctrine is a judicially created formula for resolving conflicts between federal antitrust policy and state policies that seem to authorize conduct that antitrust law would prohibit. Against the background of recent commentaries by the federal antitrust agencies, this article reviews the doctrine and discusses it's application in the health care sector, focusing on the ability of states to immunize anticompetitive actions by state licensing and regulatory boards, hospital medical staffs, and public hospitals, as well as anticompetitive mergers and agreements. Although states are free, as sovereign governments, to restrict competition, the state action doctrine requires that …

The States "Race" With The Federal Government For Stem Cell Research, Joanna K. Sax

Faculty Scholarship

The goal of this paper is to analyze and explain the impact of state legislation and funding on the future of stem cell research. Without federal law regulating stem cell research, funding by states and private organizations may spur competition to attract and retain leading scientists and industry in individual states. Alternatively, state-funded stem cell research may incite the federal government to react either positively or negatively to pre-empt state and private action. Traditionally, most support for scientific research comes in the form of grants from the National Institutes of Health (NIH). Due to the practical ban on stem cell …

The Sympathetic Discriminator: Mental Illness, Hedonic Costs, And The Ada, Elizabeth F. Emens

Faculty Scholarship

Social discrimination against people with mental illness is widespread. Treating people differently on the basis of mental illness does not provoke the same moral outrage as that inspired by differential treatment on the basis of race, sex, or even physical disability. Indeed, many people would freely admit preferring someone who does not have a mental illness as a neighbor, dinner party guest, parent, partner, or person in the next seat on the subway. Moreover, more than ten years after the Americans with Disabilities Act (the "ADA" or "Act") expressly prohibited private employers from discriminating on the basis of mental, as …

Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- And Medium-Income Populations, Kevin Outterson

Faculty Scholarship

U.S. trade offi cials frequently employ the rhetoric of free riding and piracy when discussing intellectual property (IP) rights for medicines (Drahos with Braithwaite 2002; Benson 2005). The gentler term free rider is applied when developed country governments (OECD) use monopsony power to negotiate price discounts on patented pharmaceuticals (Outterson 2004, 2005b; U.S. Department of Commerce 2004; PhRMA 2005). Poorer governments usually lack suffi cient market power as a purchaser to negotiate discounts for their low- and middle-income populations. In these cases, governments and patients may resort to unlicensed generic drugs and compulsory licensing. In response, U.S. trade offi cials …

The New Biopolitics: Autonomy, Demography, And Nationhood, Jedediah S. Purdy

Faculty Scholarship

Political thinkers have long worried that freedom might be selfundermining, tending to erode the liberal rights and democratic politics that form its foundations. The argument has ancient and modern versions, versions of the political left and of the right. No doubt the only adequate answer is the sum of the answers to many particular questions: whether and when popular elections undermine liberal rights, how free markets enhance or undermine democracy, and so forth. In this article, I address an emerging problem in a central area of contemporary freedom: reproductive autonomy. I ask whether reproductive autonomy can undermine the political conditions …

The Ethical Health Lawyer: When Doing The Right Thing Means Breaking The Law - What Is The Role Of The Health Lawyer?, Robert L. Schwartz

Faculty Scholarship

No abstract provided.

The Role Of Medicare In Medical Malpractice Reform, William M. Sage

Faculty Scholarship

The medical malpractice crisis we think we are in is not the medical malpractice crisis we actually are in. Today's malpractice crisis is not an epidemic of lawsuits, impressionable juries, or even excessive insurance premiums. The real medical malpractice crisis is that the law has formed little connection between the malpractice system and the health care system.

Congress, Controlled Substances, And Physician-Assisted Suicide: Elephants In Mouseholes, George J. Annas

Faculty Scholarship

The U.S. Supreme Court's decision in Gonzales v. Oregon to reject the U.S. attorney general's authority to prohibit physicians in Oregon from prescribing Schedule II drugs for their terminally ill patients to commit suicide can seem paradoxical and confusing. How is it that California cannot permit the patients of physicians who recommend marijuana, a Schedule I drug, to possess legally and use marijuana that they may need to survive, but Oregon can legally permit physicians to prescribe Schedule II drugs and patients to possess and use such drugs to end their lives?

Dna Testing, Banking, And Genetic Privacy, George J. Annas

Faculty Scholarship

"Who am I?” has always been a fundamental philosophical question that may require decades of reflection to answer. With the advent of DNA analysis, there is a growing public impression that the answer may be found in our genes. Various Internet sites offer descriptions of our ancestral history on the basis of our DNA, as well as testing for specific “disease genes” or general profiles that are used to recommend lifestyle changes, such as foods to be eaten or avoided. Researchers have even suggested that although the scientific evidence is speculative and at best probabilistic, many people will want to …

The Patient's Right To Safety: Improving The Quality Of Care Through Litigation Against Hospitals, George J. Annas

Faculty Scholarship

It is the consensus of experts in the patient-safety field that little has changed to improve the safety of hospital care since the Institute of Medicine's 1999 report, To Err Is Human. The report noted that in order to be successful, “safety must be an explicit organizational goal that is demonstrated by clear organizational leadership. . . . This process begins when boards of directors demonstrate their commitment to this objective by regular, close oversight of the safety of the institutions they shepherd.” Leape and Berwick agree, noting that safety cannot become an institutional priority “without more sustained and …