Law Commons^™

Doubts About Daubert: Psychiatric Anecdata As A Case Study, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In Daubert v. Merrell Dow Pharmaceuticals Inc., the Supreme Court sensibly held that testimony purporting to be scientific is admissible only if it possesses sufficient indicia of scientific validity. In Kumho Tire Co. v. Carmichael, the Court more questionably held that opinion evidence based on "technical" and "specialized" knowledge must meet the same admissibility threshold as scientific testimony. This Article addresses the implications of these two decisions for opinion evidence presented by mental health professionals in criminal trials.

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

Articles

This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Catholic Health Care And The Diocesan Bishop, John J. Coughlin

Journal Articles

Over the course of the last decade, the provision of health care in the United States has been undergoing a radical transformation. The days when an insurer, such as Blue Cross and Blue Shield, paid a standard fee to a physician who provided a specified service to an individual patient are passing rapidly. This fee-for-service concept, which characterized American health care from the end of World War II until the 1990s, is being supplanted by a variety of arrangements that fall under the general rubric of "managed care." The fundamental approach of managed care is to provide the patient with …

Recent Case Developments, Jeffrey W. Stempel

Scholarly Works

Recent case developments in Insurance Law in the years 1999 and 2000.

The Implementation Of Oregon’S Death With Dignity Act: Reassuring, But More Data Are Needed, David Orentlicher

Scholarly Works

Undoubtedly, empirical data from Oregon will play a key role for academics, legislators, judges, and the public as debate over the legalization of physician-assisted suicide continues. A central issue in the debate is whether a right to assisted suicide can be limited to only the truly compelling cases, or whether it will in practice be provided to patients who choose it out of depression, coercion, or misunderstanding. Empirical research can provide critical insights into this question.

Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz

Faculty Scholarship

Is meat with its high fat content the real culprit, or is it the FDA-approved growth hormones, the same hormones that have been rejected in Europe, that should bear the blame? Why is eating less meat associated with a lower incidence of many types of cancer? Could it be chemical overload? American women are about five times more likely to develop breast cancer than are women in less developed countries.

Health Care Reform In The Year 2000: The View From The Front Of The Classroom, Ken Wing

Faculty Articles

This article looks at the implications of the evolution of health care reform from the perspectives of teaching health law in the United States. U.S. on Congress' adoption of important limits on federal welfare programs, the direct role of government in financing health care, and the practical and theoretical problems in attempting to move forward to a more government controlled health care systems.

Egregious Inaction: Five Years After 'Of Life And Death', Jocelyn Downie

Articles, Book Chapters, & Popular Press

In November 1999, the Standing Senate Committee on Social Affairs, Science and Technology was authorized to examine and report upon developments since the release of Of Life and Death, the final report of the Special Senate Committee on Euthanasia and Assisted Suicide. A subcommittee to update Of Life and Death was therefore established. On February 14, 2000, I participated in the first panel of witnesses before this subcommittee. In light of the subcommittee's mandate, I set myself the following two tasks: first, to update the legal status sections of Of Life and Death by reporting on any changes to the …

An End To Insanity: Recasting The Role Of Mental Disability In Criminal Cases, Christopher Slobogin

Vanderbilt Law School Faculty Publications

This article argues that mental illness should no longer be the basis for a special defense of insanity. Instead, mental disorder should be considered in criminal cases only if relevant to other excuse doctrines, such as lack of mens rea, self-defense and duress, as those defenses have been defined under modern subjectively-oriented codes. With the advent of these subjectively defined doctrines (a development which, ironically, took place during the same period that insanity formulations expanded), the insanity defense has outlived its usefulness, normatively and practically. Modern official formulations of the defense are overbroad because, fairly construed, they exculpate the vast …

The Criminal Defense Lawyer's Fiduciary Duty To Clients With Mental Disability, Christopher Slobogin, Amy Mashburn

Vanderbilt Law School Faculty Publications

This Article has argued that the defense attorney has a multifaceted fiduciary duty toward the client with mental disability. That duty requires, first and foremost, respect for the autonomy of the client. The lawyer shows that respect not only by heeding the wishes of the competent client but by refusing to heed the wishes of the incompetent client. A coherent approach to the competency construct is therefore important. Following the lead of Professor Bonnie, this Article has broken competency into two components: assistance competency and decisional competency. It has defined the former concept in traditional terms, as an understanding of …

Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Rules For Research On Human Genetic Variation: Lessons From Iceland, George J. Annas

Faculty Scholarship

Research on genetic variation aims to understand how genes function and requires the comparison of DNA samples from groups of individuals to identify variations that might have importance for health or disease. This work is easier if the samples are linked to accurate medical records and genealogic information. Iceland has medical records for all its citizens going back to World War I and detailed genealogic information going back even further. Because Iceland's small population (270,000) has long been isolated and homogeneous, it is thought by many to be an ideal place to search for disease-related genes. Journalists have cavalierly labeled …

The Contested Lessons Of Euthanasia In The Netherlands, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, while I will conclude that the Dutch experience should give us some concern about a slippery slope, I will, more importantly, also conclude that it should not give us the level of concern suggested by some commentators. I will argue that it does not provide a basis on which to conclude that assisted suicide and voluntary active euthanasia should not be decriminalized in Canada. Rather, it provides a basis for proceeding with caution and developing a permissive regime that places barriers on the slope and contains mechanisms by which slippage down the slope can be detected (and, …

Ulysses And The Fate Of Frozen Embryos - Reproduction, Research, Or Destruction?, George J. Annas

Faculty Scholarship

On his 10-year voyage back to Ithaca from the Trojan War, Ulysses was warned by Circe to take precautions if he wanted to hear the Sirens' transfixing song, or there would be “no sailing home for him, no wife rising to meet him, /no happy children beaming up at their father's face.” Ulysses accordingly ordered his men to stop their ears with beeswax and bind him firmly to the mast and instructed them that if he gestured to be set free, they should stick to the original agreement and bind him tighter still. Making an agreement that has as a …

Becoming Visible: The Ada's Impact On Healthcare For Persons With Disabilities, Mary Crossley

Articles

This Article will adopt the perspective of individuals with disabilities in their encounters with the health care finance and delivery system in the United States, and will pose the question of what the past decade has shown the ADA to mean (or not mean) for those individuals' ability to seek, receive, and pay for effective health care services. To that end, this Article will provide an overview of three broad areas on which the ADA has had varying degrees of impact.

Part II of the Article will examine how the ADA has affected the rights of an individual with a …

Beyond Cloning: Expanding Reproductive Options For Same-Sex Couples, David Orentlicher

Scholarly Works

No abstract provided.

Medical Malpractice: Treating The Causes Instead Of The Symptoms, David Orentlicher

Scholarly Works

No abstract provided.

Social Risk And The Transformation Of Public Health Law: Lessons From The Plague Years, Elizabeth B. Cooper

Faculty Scholarship

Acquired Immune Deficiency Syndrome (AIDS) was the wake-up call that disturbed America from its mid-twentieth century slumber concerning the dangers of communicable diseases. Until AIDS was identified in 1981, most Americans felt largely impervious to health threats posed by viruses or bacteria. Polio, smallpox, and tuberculosis had been brought under control by the "magic bullets" of antibiotics and vaccines." We felt more susceptible to the ravages of cancer or the debilitation of heart disease. But, over the last twenty years, the (re)emergence of serious or life-threatening microbial- based conditions such as Ebola, hantavirus, Lyme disease, West Nile virus, and even …

The Public Health Improvement Process In Alaska: Toward A Model Public Health Law, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

In this Article, we present the findings of our study on the improvement of public health law in Alaska. We examine and analyze the public health laws supporting the state's public health system. The fact that Alaska has attained statehood comparatively recently, and has a governing structure involving state, municipal, rural, and tribal entities presents unique opportunities for the State to improve its public health system and its supporting legal infrastructure

Health Care Divided: Race And Healing A Nation, Sidney D. Watson

All Faculty Scholarship

Race matters. Race—particularly racial segregation—casts a pervasive shadow over the organization of American health care. It influences the ownership and governance of institutional providers. It helps account for the high cost of health care in the United States. It contributes to America’s abysmal health status, among the worst of the industrialized world. It is reflected, in part, in the lack of national health insurance. So David Barton Smith begins this book, a book he describes as the story of “a divided nation, a divided health care system, and the uncompleted journey to heal both.”[1]

Most of us are not comfortable …

Are Ethics Committee Members Competent To Consult?, Diane E. Hoffmann, Anita J. Tarzian, J. Anne O'Neil

Faculty Scholarship

No abstract provided.

Tobacco, The Food And Drug Administration, And Congress, George J. Annas

Faculty Scholarship

Smoking has been the number-one target of public health professionals in the United States for more than a decade because it is the leading cause of premature death. Nonetheless, no unified public health strategy has been developed. In 1995, with the strong endorsement of President Bill Clinton and Vice President Al Gore, the commissioner of the Food and Drug Administration (FDA), Dr. David Kessler, announced that the agency had jurisdiction over tobacco and would regulate cigarettes as “drug-delivery devices.”1 The tobacco companies objected and sued the FDA, arguing that Congress had not given the FDA jurisdiction over their product. …

Political Questions, Judicial Questions, And The Problem Of Washington V. Glucksberg, Carl E. Schneider

Other Publications

Over a century and a half ago, Alexis de Tocqueville famously said, "Scarcely any political question arises in the United States that is not resolved, sooner or later, into a judicial question." Physician-assisted suicide superbly illustrates Tocqueville's acute observation. For a number of years, assisted suicide was the prototype of a (nonpartisan) political question. Interest groups brought it to public attention. Public discussion of it flourished. Legislatures debated it. Citizens in several states decided in referenda whether to make it legal. Almost suddenly, however, this classic political process was transformed into a judicial one by the startling and strongly stated …

Informed Consent Law And The Forgotten Duty Of Physician Inquiry, Robert Gatter

All Faculty Scholarship

Courts and commentators have forgotten that embedded in the duty of physicians to obtain a patient's informed consent is a prior obligation for physicians to get to know that patient. This is most clear in jurisdictions employing the reasonable person standard of disclosure. That standard requires physicians to disclose to a patient information that a reasonable person would want to know if that person were in the patient's position or, more precisely, if that person were "in what the physician should know to be the patient's position." Thus, a physician must learn some minimal information about each patient's "position." An …

Concluding Thoughts: Bioethics In The Language Of The Law, Carl E. Schneider

Book Chapters

What happens when the language of the law becomes a vulgar tongue? What happens, more particularly, when parties to bioethical disputes are obliged to borrow in their daily controversies, the ideas, and even the language, peculiar to judicial proceedings? How suited are the habits and tastes and thus the language of the judicial magistrate to the political, and more particularly, the bioethical, questions of our time? We must ask these questions because, as the incomparable Tocqueville foresaw, it has become American practice to resolve political—and moral—questions into judicial questions. We now reverently refer to the Supreme Court as the great …

Information, Decisions, And The Limits Of Informed Consent, Carl E. Scheider, Michael H. Farrell

Book Chapters

For many years, the heart's wish of bioethics has been to confide medical decisions to patients and not to doctors. The favoured key to doing so has been the doctrine of informed consent. The theory of and hopes for that doctrine are well captured in the influential case of Caterbury v. Spence: '[t]rue consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knoledgeably the options available and the risks attendant upon each'.

The Road To Glucksberg, Carl E. Scheider

Book Chapters

No abstract provided.

Making Biomedical Policy Through Constitutional Adjudication:The Example Of Physician-Assisted Suicide, Carl E. Scheider

Book Chapters

Throughout most of American history no one would have supposed biomedical policy could or should be made through constitutional adjudication. No one would have thought that the Constitution spoke to biomedical issues, that those issues were questions of federal policy, or that judges were competent to handle them. Today, however, the resurgence of substantive due process has swollen the scope of the Fourteenth Amendment, the distinction between federal and state spheres is tattered, and few statutes escape judicial vetting. Furthermore, Abraham Lincoln's wish that the Constitution should "become the political religion of the nation" has been granted. "We now reverently …

Drug Treatment Courts And Emergent Experimentalist Government, Michael C. Dorf, Charles F. Sabel

Faculty Scholarship

Despite the continuing "war on drugs," the last decade has witnessed the creation and nationwide spread of a remarkable set of institutions, drug treatment courts. In drug treatment court, a criminal defendant pleads guilty or otherwise accepts responsibility for a charged offense and accepts placement in a court-mandated program of drug treatment. The judge and court personnel closely monitor the defendant's performance in the program and the program's capacity to serve the mandated client. The federal government and national associations in turn monitor the local drug treatment courts and disseminate successful practices. The ensemble of institutions, monitoring, and pooling exemplifies …

Symposium: Regulatory And Liability Considerations, Michael S. Baram, Ellen Flannery, Patricia Davis, Gary Marchant

Faculty Scholarship

You can tell from remarks by prior speakers that regulatory approvals and liability prevention are of critical importance to progress in biomaterials. Gene therapy trials and the tragic outcomes of some of those trials have raised the specter of government suspension of clinical studies, termination of funding, and potential liability for personal injury under malpractice or products liability doctrines. Regulatory requirements and the terms of research grants and contracts have to be very carefully addressed by organizations testing, developing, making, selling and using biomaterials, biotechnology, and medical devices. However, many regulatory requirements are incomplete, ambiguous and confusing because the agencies …