Law Commons^™

The Use Of Placebos In Clinical Trials: Responsible Research Or Unethical Practice?, Sharona Hoffman

Faculty Publications

Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also …

Health Care Fraud And Abuse: A Tale Of Behavior Induced By Payment Structure, Arti K. Rai

Faculty Scholarship

The campaign to curtail "fraud and abuse" in the Medicare and Medicaid programs represents an attempt by regulators to evade more fundamental and difficult questions regarding cost and quality control. In the Medicare arena, tackling these larger questions will require dismantling the program's fee-for-service structure and imposing on providers financial incentives to evaluate carefully health care costs and benefits. Commentary on, David A. Hyman, Health Care Fraud and Abuse: Market Change, Social Norms and the Trust "Reposed in Workmen," 30 Journal of Legal Studies 531 (2001)

Health Care Ethics Experts In Canadian Courts, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, I will first describe the traditional approach to the use of experts in Canadian courts. Then I will consider whether, on this approach, health care ethics experts should be permitted to testify in Canadian courts. I will argue that they should be permitted to testify but caution should be exercised by the courts, the parties, and the experts themselves. The objective of the paper is to highlight the strengths and raise some concerns about the weaknesses of a practice that appears to be growing, so that the potential harmful consequences might be anticipated, problems with the practice …

Genetic And Metabolic Screening Of Newborns: Must Health Care Providers Seek Explicit Parental Consent?, Sheila Wildeman, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, we provide some background on the history of newborn screening and the legal context within which questions regarding consent must be answered, and then turn to the various arguments that can be made for and against the current approach to parental consent to genetic and metabolic tests administered as part of provincial/territorial newborn screening programs. In the end, we conclude that either practice should be changed to align it with current law such that explicit parental consent is sought for the established tests, or that advocates for maintaining current practices should lobby for legislation permitting newborn screening …

Book Review. Gostin On Public Health Law, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Testing Poor Pregnant Women For Cocaine: Physicians As Police Investigators, George J. Annas

Faculty Scholarship

In 1989, Supreme Court Justice Thurgood Marshall surmised that “declaring a war on illegal drugs is good public policy . . . [but] the first, and worst, casualty of war will be the precious liberties of our citizens.” The same year, in the midst of President George Bush's “war on drugs,” the Medical University of South Carolina initiated a program to screen selected pregnant patients for cocaine and to provide positive test results to the police. At a time of high public concern about “cocaine babies,” this program seemed reasonable to the university and local public officials. Drug-screening programs in …

Conjoined Twins: The Limits Of Law At The Limits Of Life, George J. Annas

Faculty Scholarship

Conjoined twins have been the subject of scientific exhibits, medical study, human curiosity, and even entertainment, but until the year 2000, conjoined twins had never been the subject of a courtroom battle. A unique case that was the subject of two British court decisions deserves study.1 The case illustrates the difficulty of applying legal principles to unprecedented life-and-death decisions involving proposed medical interventions for children — particularly when parents and physicians disagree about what should be done.

Placebo-Controlled Trials Of New Drugs: Ethical Considerations, David Orentlicher

Scholarly Works

No abstract provided.

Student Scholarship, In One Place, But Not Another: When The Law Encourages Breastfeeding In Public While Simultaneously Discouraging It At Work, Emily F. Suski

Faculty Publications By Year

In this Essay, the author takes a novel approach to the topic of breastfeeding and work by exploring the trend among states to exempt breastfeeding from criminal indecent exposure laws and comparing this trend to the support, or lack thereof, in laws and policy for breastfeeding at work. The author's comparison reveals that while there is a trend to support breastfeeding in public, there is no such trend in the law to support breastfeeding in the relatively more private work environment.

The author argues that this disparity is both counterintuitive and serves to limit women's choices regarding breastfeeding and work. …

"Geographical Morality" Revisited: International Relations, International Law, And The Controversy Over Placebo-Controlled Hiv Clinical Trials In Developing Countries, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

The Merger Between Public Health And Health Law – The Us Situation, Wendy K. Mariner

Faculty Scholarship

Law is an essential tool for protecting the public’s health. It is often the law that turns public health science into public health action. Sanitation, clean air and water, universal vaccination, injury prevention, tobacco control, drug policy, and a vast array of other interventions are achieved through a complex web of local, provincial and national statutes, regulations and judicial cases. The Institute of Medicine in the United States defines public health as “what we, as a society, do collectively to ensure the conditions in which people can be healthy.” And society acts collectively most often through law.

Thus, the merging …

“Partial-Birth Abortion” And The Supreme Court, George J. Annas

Faculty Scholarship

Aortion has long been, and remains, the most politicized medical procedure in the United States. It has been the subject of more state and federal legislation than all other medical procedures combined. The U.S. Supreme Court, which almost never hears cases about medical procedures, has regularly heard cases over the past 25 years concerning the constitutionality of various state laws designed to limit abortion. Thus, it was only a matter of time before the Court would hear a case on the constitutionality of laws restricting so-called partial-birth abortion. When the Court heard a challenge to Nebraska's law, statutes relating to …

Quality Control, Enterprise Liability, And Disintermediation In Managed Care, Nicole Huberfeld

Faculty Scholarship

The authors examine the potential of enterprise liability for managed care organizations in light of current health-care finance realities. They conclude that, despite the recent trend toward more loosely structured managed care organizations, such as disintermediated or patient-directed plans, plan-based enterprise liability best serves the goal of reducing medical injury by permitting a focus on entities with sufficient scope to translate liability pressure into support for systemic risk-reduction measures. Advancing plan-based enterprise liability in an era of disengaged managed care organizations will require an extension of tort liability to firms with little control but much influence over their business partners.

The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?

Curing Conflicts Of Interest In Clinical Research: Impossible Dreams And Harsh Realities, Patricia C. Kuszler

Articles

This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, …

Slouching Toward Managed Care Liability: Reflections On Doctrinal Boundaries, Paradigm Shifts, And Incremental Reform, Wendy K. Mariner

Faculty Scholarship

Following the seemingly endless debate over managed care liability, I cannot suppress thoughts of Yeats’s poem, “The Second Coming.” It is not the wellknown phrase, “Things fall apart; the centre cannot hold,” that comes to mind; although that could describe the feeling of a health-care system unraveling. The poem’s depiction of lost innocence — “The best lack all conviction, while the worst/Are full of passionate intensity” — does not allude to the legislature, the industry, the public, or the medical or legal profession. What resonates is the poem’s evocation of humanity’s cyclical history of expectation and disappointment, with ideas as …

Poverty, Welfare Reform, And The Meaning Of Disability, Jennifer Pokempner, Dorothy E. Roberts

All Faculty Scholarship

No abstract provided.

The Rights Of The Adolescent: The Mature Minor, Roxanne Mykitiuk, Victoria J. Davis

Articles & Book Chapters

Health care providers who treat adolescents may also be required to diagnose and treat the reproductive health conditions of minor patients and to facilitate health prevention measures, including contraception and testing for sexually transmitted diseases. Teens who do not want their parents to know about their sexual behaviour may consult a health care provider for reproductive or sexual health care services and treatment without parental knowledge or consent. This may present legal and ethical dilemmas for health care providers. Common law recognizes that adolescents under the legal age of majority who are sufficiently mature (the mature minor) may have the …

Surrogacy From The Perspectives Of Economic And Civil Liberties, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The field of law and economics, of which Judge Posner is the leading theorist, has offered a rich and sophisticated framework for thinking about a wide variety of problems at the interface of law and society. The theory, based on economic principles for understanding behavioral incentives and disincentives, is widely taught in law schools and is influential in scholarship. I have not always agreed with the application of the theory to complex problems of individual and group behavior, yet I constantly have been impressed with the elegance of the writing and analysis.

Judge Posner thinks about surrogacy arrangements in terms …

Race And Discretion In American Medicine, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The author’s focus in this article is on racial disparities in medical care provision--that is, on differences in the services that clinically similar patients receive when they present to the health care system. Racial disparities in health status, which is not greatly influenced (on a population-wide basis) by medical care, are beyond his scope here. Disparities in medical care access-potential patients' ability, financial and otherwise, to gain entry to the health care system in the first place, are also outside his focus. The author begins this article by putting the problem of racial disparities in medical care provision within the …

Gang Aft Agley, Carl E. Schneider

Articles

In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …

Caretakers And Collaborators, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

A chilling subplot in the twentieth-century saga of state-sponsored mass murder, torture, and other atrocities was the widespread incidence of medical complicity. Nazi doctors’ human “experiments” and assistance in genocidal killing are the most oft-cited exemplar, but wartime Japanese physicians’ human vivisection and other grotesque practices rivaled the Nazi medical horrors. Measured by these standards, Soviet psychiatrists’ role in repressing dissent, Latin American and Turkish military doctors’ complicity in torture, and even the South African medical profession’s systematic involvement in apartheid may seem, to some, almost prosaic. Yet these and other reported cases of medical complicity in human rights abuse …

Handling Cases Of Willful Exposure Through Hiv Partner Counseling And Referral Services, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Cases of willful exposure reveal the existing and future risks to the public health (especially women) which may be presented by individuals who willfully expose others to HIV through unsafe sexual or needle-sharing behaviors. In response to a documented case of willful exposure, a PCRS counselor or other public health official may, in his or her professional judgment, decide to act to avert a legitimate public health threat to known or unknown persons in the community. Yet handling such cases raises difficult issues in law, ethics, and public health practice. Public health authorities may be unable or ill-equipped to successfully …

The Limits Of Law At The Limits Of Life: Lessons From Cannibalism, Euthanasia, Abortion, And The Court-Ordered Killing Of One Conjoined Twin To Save The Other, George J. Annas

Faculty Scholarship

The subject is law at the beginning and end of life. Most of my work is in the area of general health law: law and medicine, public health law, and health and human rights. But this is my favorite subject area, and I expect you to ask me the hardest questions you can. I am not saying I can answer them, but if I cannot that is my fault, not yours. I am going to make a pretty broad argument today about law and medicine; specifically about how new medical technology and medical practice standards have eclipsed religion (and sometimes …

The Limits Of State Laws To Protect Genetic Information, George J. Annas

Faculty Scholarship

During the 2000 presidential campaign, Al Gore characterized the DNA code as a secret code like that of the Nazis. In his words, “with the completion of the Human Genome, we are on the verge of cracking another enemy's secret code. When we intercept and decipher the coded messages that cancer sends from cell to cell, we will turn the tide, and win the war against cancer.” Gore was expanding the metaphor of the war on cancer, and commandeering the DNA code in the service of that metaphor. At about the same time, then president Bill Clinton called the DNA …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Health Care, Technology And Federalism, Kevin Outterson

Faculty Scholarship

The regulation of health care has traditionally been the province of the states, most often grounded in the police power. In Colonial times, this division of responsibility was a rational response to the technological level of the eighteenth century, although even in the youth of the Republic some health and safety regulation required national and international action. With the growth of distancecompression technology, the increase in mobility of goods and services, and a significant federal financial role in health care, the grip of the police power on the regulation of health care has been weakened. Discussion of the police power …

Unemployment Insurance And Wealth Redistribution, Gillian Lester

Faculty Scholarship

This Article evaluates the merit of liberalizing unemployment insurance eligibility as a means to achieve progressive wealth redistribution-an idea that has recently gained popularity among policymakers and legal scholars. Unemployment insurance (UI) provides temporary, partial wage replacement to workers who suffer unexpected job loss, but it tends to exclude workers who have very low wages or hours of work, or who quit for reasons considered "personal" (for example, to accommodate family demands). Professor Lester argues that while redistribution to workers who are poor or who have caregiving obligations is a desirable goal, expanding UI is a poor way to do …

A Vision Of Health And Human Rights For The 21st Century: A Continuing Discussion With Stephen P. Marks, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Professor Marks offers an eloquent vision of health and human rights in the 21st Century. As the Director of the Francois-Xavier Bagnoud Center for Health and Human Rights, Professor Marks ably carries the torch that Jonathan Mann lit in the field until his tragic death on September 2, 1998. Professor Marks stands along with the leading figures in health and human rights - e.g., Audrey Chapman, Sofia Gruskin, Michael Kirby, Daniel Tarantola, Brigit Toebes, Katarina Tomasevski, and Virginia Leary.

Public Health, Ethics, And Human Rights: A Tribute To The Late Jonathan Mann, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The late Jonathan Mann famously theorized that public health, ethics, and human rights are complementary fields motivated by the paramount value of human well-being. He felt that people could not be healthy if governments did not respect their rights and dignity as well as engage in health policies guided by sound ethical values. Nor could people have their rights and dignity if they were not healthy. Mann and his colleagues argued that public health and human rights are integrally connected: Human rights violations adversely affect the community's health, coercive public health policies violate human rights, and advancement of human rights …