Health Law and Policy Commons^™

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 …

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.

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 …

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.

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.

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 …

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

Faculty Scholarship

No abstract provided.

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 …

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 …

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 Role Of The Federal Government In Response To Catastrophic Health Emergencies: Lessons Learned From Hurricane Katrina, Michael Greenberger

Faculty Scholarship

In much of the recent thought devoted to the role of states in responding to catastrophic public health emergencies, as most clearly evidenced by the commentary surrounding the Centers for Disease Control and Prevention- sponsored Model State Emergency Health Powers Act (Model Act), there is a focus on state governments being viewed as the exclusive controlling governmental agent supervising the governmental response. Much of that thinking is premised on a view of limitations placed on Congress’ power to act in public health emergencies emanating from Commerce Clause restrictions in the Supreme Court decisions of U.S. v. Lopez, 514 U.S. 549 …

When Should Judges Admit Or Compel Genetic Tests?, Diane E. Hoffmann, Karen H. Rothenberg

Faculty Scholarship

No abstract provided.

Malpractice Reform As A Health Policy Problem, William M. Sage

Faculty Scholarship

Calling malpractice reform a "health policy problem" means that we should analyze it in terms of the quality of health care, access to health care, and the cost of health care-the basic health policy triad with which we all are familiar. We immediately recognize patient safety as a health policy problem because it is obviously about quality. We may believe there is so much slack in the health care system that we can make major improvements in patient safety without excessive cost. But ultimately, there are going to be cost-safety tradeoffs, which are also health policy concerns. We tend not …

Dying In America - An Examination Of Policies That Deter Adequate End-Of-Life Care In Nursing Homes, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

This article examines current health care policies and government practices that deter appropriate end-of-life care, focusing on the use of hospice services for dying nursing home patients. The authors conclude that hospice and nursing home regulations, reimbursement for hospice and nursing homes, and enforcement of the fraud and abuse rules collude to “chill” utilization of hospice by nursing homes and result in inadequate end-of-life care for many nursing home patients. They argue that these policies and practices have at their roots a number of questionable assumptions and call for a shift in existing paradigms affecting care to this group and …

Law And Public Health: Beyond Emergency Preparedness, Wendy K. Mariner

Faculty Scholarship

This Article examines three questions: What is public health? What is public health law? What roles can lawyers play in public health? It first describes the breadth of public health, highlighting six trends shaping its future: social determinants of health; synergy between medicine and public health; shifts in focus from external (e.g., environmental and social) to internal (behavioral) risks to health; federalization of public health law; globalization of health risks and responses; and bioterrorism. Because the domains of law that apply to public health are equally broad, the Article next offers a conceptual framework for identifying the types of laws …

Induced Autism The Legal And Ethical Implications Of Inoculating Vaccine Manufacturers From Liability, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

Against “Individual Risk”: A Sympathetic Critique Of Risk Assessment, Matthew D. Adler

Faculty Scholarship

No abstract provided.

The Bustle Of Horses On A Ship: Drug Control In New York City Public Housing, Jeffrey Fagan, Garth Davies, Jan Holland, Tamara Dumanovsky

Faculty Scholarship

For decades, violence, drugs and public housing have been closely linked in political culture and popular imagination. In 1990, the Department of Housing and Urban Development (HUD) made funds available to public housing authorities to combat drug and crime problems. This program, the Drug Elimination Program (DEP) combined several strategies under one administrative umbrella: police enforcement, drug treatment, drug prevention, youth and gang outreach, community organizing, integrated health and social service agencies, and tenant mobilization projects. In New York, the Housing Authority spent $165 million on DEP in its 330 public housing sites between 1990 and 1996. Yet there has …

Pharmaceutical Arbitrage: Balancing Access And Innovation In International Prescription Drug Markets, Kevin Outterson

Faculty Scholarship

While neoclassical economic theory suggests that arbitrage will undermine global differential pricing of pharmaceuticals, the empirical results are more complex. Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. Counterfeiting is demonstrated to be the more serious threat. These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement.

A more fundamental question, however, is whether pharmaceutical differential pricing is appropriate for …

I Want To Live: Medicine Betrayed By Ideology In The Political Debate Over Terri Schaivo, George J. Annas

Faculty Scholarship

The public's view of the political intrusion into the medical care of Theresa Marie Schiavo is well illustrated by two political cartoons. The first, by Tony Auth, reprinted in the Boston Globe shortly after Congress passed a law authorizing intervention by the federal courts, pictures a horde of congressmen charging mindlessly out of the Capitol, all dressed as physicians-one carrying a saw, another an I.V. pole-with the caption, "Coming Soon to a Sickbed Near You . .. [tihe United States Congress." The second, by Tom Toles, published in the Washington Post shortly after the results of the autopsy report were …

Family Privacy And Death: Antigone, War, And Medical Research, George J. Annas

Faculty Scholarship

Death ends the doctor–patient relationship, and legally the patient's right of privacy dies with the patient. Other privacy interests survive, the most central of which are those of the patient's family to bury the body and to prevent the disclosure of some personal information, such as medical information, about the deceased relative. Just what privacy interests encompass and when they can be overridden by other interests — such as freedom of speech or the claims of public policy or medical research — are evolving.1 Family privacy concerning a family member who has died is at the forefront of a …

“Culture Of Life” Politics At The Bedside: The Case Of Terri Schiavo, George J. Annas

Faculty Scholarship

For the first time in the history of the United States, Congress met in a special emergency session on Sunday, March 20, to pass legislation aimed at the medical care of one patient — Terri Schiavo. President George W. Bush encouraged the legislation and flew back to Washington, D.C., from his vacation in Crawford, Texas, so that he could be on hand to sign it immediately. In a statement issued three days earlier, he said: “The case of Terri Schiavo raises complex issues. . . . Those who live at the mercy of others deserve our special care and concern. …

Unspeakably Cruel: Torture, Medical Ethics, And The Law, George J. Annas

Faculty Scholarship

Torture is a particularly horrible crime, and any participation of physicians in torture has always been difficult to comprehend. As General Telford Taylor explained to the American judges at the trial of the Nazi doctors in Nuremberg, Germany (called the “Doctors' Trial”), “To kill, to maim, and to torture is criminal under all modern systems of law . . . yet these [physician] defendants, all of whom were fully able to comprehend the nature of their acts . . . are responsible for wholesale murder and unspeakably cruel tortures.” Taylor told the judges that it was the obligation of the …

Jumping Frogs, Endangered Toads, And California's Medical-Marijuana Law, George J. Annas

Faculty Scholarship

Mark Twain wasn't thinking about federalism or the structure of American government when he wrote “The Celebrated Jumping Frog of Calaveras County.” Nonetheless, he would be amused to know that today, almost 150 years later, the Calaveras County Fair and Jumping Frog Jubilee not only has a jumping-frog contest but also has its own Frog Welfare Policy. The policy includes a provision for the “Care of Sick or Injured Frogs” and a limitation entitled “Frogs Not Permitted to Participate,” which stipulates that “under no circumstances will a frog listed on the endangered species list be permitted to participate in the …

Reforming Child Protection: A Public Health Perspective, Marsha Garrison

Faculty Scholarship

No abstract provided.

Causation By Presumption? Why The Supreme Court Should Reject Phantom Losses And Reverse Broudo, John C. Coffee Jr.

Faculty Scholarship

Over a quarter of a century ago, Judge Henry Friendly coined the term "fraud by hindsight" in upholding the dismissal of a proposed securities class action. As he explained, it was too simple to look backward with full knowledge of actual events and allege what should have been earlier disclosed by a public corporation in its Security and Exchange Commission (SEC) filings. Because hindsight has twenty/twenty vision, plaintiffs could not fairly "seize [] upon disclosures" in later reports, he ruled, to show what defendants should have disclosed earlier.

Today, a parallel concept – "causation by presumption" – is before the …