Health Law and Policy Commons^™

Patents On Dna Sequences: Molecules And Information, Rebecca S. Eisenberg

Book Chapters

As public and private sector initiatives raced to complete the sequence of the human genome, patent issues played a prominent role in speculations about the significance of this achievement. How much of the genome would be subject to the control of patent holders, and what would this mean for future research and the development of products for the improvement of human health in a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claim, to the genome on behalf or the many sequential innovators who elucidate its sequence and …

Standards Of Review In Texas., W. Wendell Hall

St. Mary's Law Journal

Abstract Forthcoming.

Doctrine Of Equivalents: Is Festo The Right Decision For The Biomedical Industry., Faith S. Fillman

St. Mary's Law Journal

The doctrine of equivalents, which Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. threatens to overturn, is an equitable doctrine and should therefore provide patentees and competitors equal and fair protection. Prior to Festo, the Federal Circuit used two approaches: the complete bar rule and the flexible bar rule. Under the complete bar rule, the author must completely copy the patented art for infringement to occur, this is otherwise known as literal infringement. In contrast, under the flexible bar rule, infringement can occur if the product is closely related to the prior art. Federal Circuits have officially adopted the complete …

Conflict In Health Care Organizations, Mary Etta C. Mills

Journal of Health Care Law and Policy

No abstract provided.

Are You My Parent? Are You My Child? The Role Of Genetics And Race In Defining Relationships After Reproductive Technological Mistakes, 5 Depaul J. Health Care L. 15 (2002), Raizel Liebler

UIC Law Open Access Faculty Scholarship

Imagine that you are a married woman who wants to have a genetically related child with your husband. Your doctor tells you that you are infertile, and therefore you and your husband go to XYZ fertility clinic to receive in vitro treatment. You have your eggs harvested, your husband supplies sperm, and ten embryos are created. Five embryos are implanted in your uterus and five are frozen and kept by the fertility clinic for your later use. You successfully conceive and give birth to twins. You notice that the children you give birth to are of a different race than …

Apparent Authority And Healthcare In Illinois, 22 N. Ill. U. L. Rev. 475 (2002), Marc Ginsberg

UIC Law Open Access Faculty Scholarship

No abstract provided.

Personal Privacy And Common Goods: A Framework For Balancing Under The National Health Information Privacy Rule, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

In this Article, we discuss how these principles for balancing apply in a number of important contexts where individually identifiable health data are shared. In Part I, we analyze the modern view favoring autonomy and privacy. In the last several decades, individual autonomy has been used as a justification for preventing sharing of information irrespective of the good to be achieved. Although respect for privacy can sometimes be important for achieving public purposes (e.g., fostering the physician/patient relationship), it can also impair the achievement of goals that are necessary for any healthy and prosperous society. A framework for balancing that …

Public Health Law: A Renaissance, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health seeks to assure the conditions for people to be healthy. Public health can be distinguished from health care in several critical respects. Public health focuses on: (1) the health and safety of populations rather than the health of individual patients; (2) prevention of injury and disease rather than treatment and care; (3) relationships between the government and the community rather than the physician and patient; and (4) population based services grounded on the scientific methodologies of public health (e.g., biostatistics and epidemiology) rather than personal medical services. These critical features - populations, prevention, government and communities, and epidemiological …

Foreword: Phase Ii Of The Genetics Revolution: Sophisticated Issues For Home And Abroad, Frances H. Miller

Faculty Scholarship

The distinguished health law and policy scholars we invite to contribute to the American Journal of Law & Medicine's annual symposium issue are given carte blanche to write about any aspect of the designated topic that appeals to them. The authors in this year's genetics symposium, The Genetic Revolution: Conflicts, Challenges and Conundra, are already well known for their work in the field-in fact three of them have just co-authored the only casebook specifically dedicated to the law, policy and ethics of geneticsl-and we deliberately asked them for relatively short pieces on the theory that taken together their articles would …

Bioterrorism, Public Health, And Civil Liberties, George J. Annas

Faculty Scholarship

The prospect of having to deal with a bioterrorist attack, especially one involving smallpox, has local, state, and federal officials rightly concerned. Before September 11, most procedures for dealing with a bioterrorist attack against the United States were based on fiction. Former President Bill Clinton became engaged in the bioterrorism issue in 1997, after reading Richard Preston's novel The Cobra Event. In Tom Clancy's 1996 Executive Orders, the United States is attacked by terrorists using a strain of Ebola virus that is transmissible through the air. To contain the epidemic, the President declares a state of emergency, orders that …

Cloning And The U.S. Congress, George J. Annas

Faculty Scholarship

In the immediate aftermath of the birth of Dolly the sheep, the national debate over the banning of human cloning focused almost exclusively on the issue of safety. President Bill Clinton's National Bioethics Advisory Commission, for example, recommended in 1997 that Congress impose a five-year moratorium on attempts to clone a human because of the likely physical harm to the cloned infant. Congress did not act on this suggestion, but even if it had, that moratorium would already be almost over. Cloning is now back on the congressional agenda, with a new focal point: the creation of cloned embryos for …

Financing Public Health Through Nonprofit Conversion Foundations, Christopher W. Frost

Kentucky Law Journal

No abstract provided.

A Perfect Storm On The Sea Of Doubt: Physicians, Professionalism And Antitrust, Thomas L. Greaney

Loyola Consumer Law Review

No abstract provided.

The Role Of Jury In Modern Malpractice Law, Philip G. Peters Jr.

Faculty Publications

This article explores the policy issues raised by the choice between a custom-based standard of care and a jury-determined reasonability standard. The author examines not only traditional legal arguments but also the recent findings of cognitive psychology, jury performance studies, and health industry research. Not surprisingly, this analysis reveals that both options are imperfect. However, the author cautiously recommends the reasonable physician standard. The revolutionary transformation of the health care industry in last quarter of a century has transferred considerable power from physicians to the health insurance industry, an industry that has not yet earned the privilege of self-regulation. Unlike …

In (Or Out Of) The Marketplace Of Ideas: Warf V. Geron And Lessons For Canada, Matthew Herder

Dalhousie Journal of Legal Studies

Four days after President George W. Bush addressed America regarding human embryonic stem cell ("hESC") research in August 2001, a lawsuit was filed by the Wisconsin Alumni Research Foundation (“WARF”) against Geron Corporation ("Geron"). WARF holds patents in respect of hESC technologies pioneered by James Thomson. The parties were unable to negotiate licences for additional hESC types. In January 2002, WARF and Geron announced that a new agreement had been reached. This paper examines the antecedent question: should the hESC technologies have been patentable in the first place? The reason for pursuing hESC research appears to be the possibility to …

Antitrust, Health Care Quality, And The Courts, Peter J. Hammer, William M. Sage

Law Faculty Research Publications

Antitrust law represents the principal legal tool that the United States employs to police private markets, yet it often relegates quality and nonprice considerations to a secondary position. While antitrust law espouses the belief that vigorous competition will enhance quality as well as price, little evidence exists of the practical ability of courts to deliver on that promise. In this Article, Professors Hammer and Sage examine American health care as a vehicle for advancing understanding of the nexus among competition, quality, and antitrust law. The Article reports the results of a comprehensive empirical review of judicial opinions in health care …

Making Sense Of Pretext: An Analysis Of Evidentiary Requirements For Summary Judgment Litigants In The Fifth Circuit In Light Of Reeves V. Sanderson Plumbing Prodcuts, And A Proposal For Clarification., Eric S. Riester

St. Mary's Law Journal

Although the United States Supreme Court in Reeves v. Sanderson Plumbing Products, Inc. attempted to clarify the summary judgment landscape of Title VII employment discrimination cases, lower courts in the Fifth Circuit are still without guidance. Under Reeves, direct proof of discrimination is not required to defeat a motion for summary judgment as long as the circumstantial evidence allows a reasonable inference of discrimination. The required strength of the circumstantial evidence, however, remains a major issue in the Fifth Circuit. Since Reeves, the Fifth Circuit has not stated a uniform summary judgment standard, nor has it answered how much circumstantial …

Principles For Protecting Privacy, Fred H. Cate

Articles by Maurer Faculty

This article addresses health privacy in the broader context of other areas of recent privacy activity, in an effort to discover what people should have learned in trying to identify those principles that should undergrid regulatory efforts to protect privacy. Increasingly, the dominant trend in recent and pending privacy legislation is to invest consumers with near absolute control over information in the marketplace. - irrespective of whether the information is, or could be, used to cause harm. The Health Insurance Portability and Accountability Act privacy rules wholly ignore the concept of harm and the constitutional requirement of targeting restriction on …

Introduction To Written Symposium On Public Health And International Law, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Bioterrorism, Public Health, And International Law, David P. Fidler

Articles by Maurer Faculty

No abstract provided.

Genetic Interventions: (Yet) Another Challenge To Allocating Health Care, Arti K. Rai

San Diego Law Review

Much of the existing literature on genetic intervention addresses questions of discrimination or reproductive decisionmaking. Although this book discusses those questions,

it takes as its major focus an issue that is perhaps even more vexing—the issue of how we should, from the standpoint of distributive justice, allocate genetic interventions. In other words, given the wide range of genetic interventions that may become available, how should we divide such interventions? Implicit in this problem is the reality that scarcity will prevent individuals from having access to all genetic interventions that would be of benefit to them. In this brief Essay, I …

Genetic Enhancement, Distributive Justice, And The Goals Of Medicine, Mark A. Hall

San Diego Law Review

In this brief Essay, I focus on chapter 4 of the book’s discussion of the distinction between treatment and enhancement.

This distinction is at the core of many of the most challenging problems of ethics and public policy raised by genetics. This is also the place where there appears to be disagreement or ambivalence among these authors

and where fault

lines appear in their otherwise remarkably united front.

Punishing Reproductive Choices In The Name Of Liberal Genetics, Alexander Morgan Capron

San Diego Law Review

When the four American moral philosophers who individually have already made the most significant contributions to the ethical analysis of contemporary health care and medicine collaborate, it should come as no surprise that their joint effort is a lucid and powerful analysis of the principles that a just and humane society would employ in setting policies about how the new tools of molecular genetics should be used for human betterment. In From Chance to Choice: Genetics and Justice, Allen Buchanan, Dan W. Brock, Norman Daniels, and Daniel Wikler aimed to steer a middle course between two extreme models. The first …

How Not To End Disability, Janet Radcliffe Richards

San Diego Law Review

When advances in genetic technology offer the chance of preventing or curing disease and disability, it is one thing to recommend caution on the grounds that these obvious benefits may be outweighed by associated harms. It is quite another to deny even that there are benefits to be outweighed, and that attempts to prevent disability by these means should be resisted outright. That, however, is a view that is increasingly widespread in the disability rights movement.

Is Moral Theory Perplexed By New Genetic Technology?, Richard J. Arneson

San Diego Law Review

From Chance to Choice: Genetics and Justice

intelligently addresses difficult issues at the intersection of medical ethics and the theory of justice. The authors Allen Buchanan, Dan W. Brock, Norman Daniels, and Daniel Wikler repeatedly emphasized their opinion that advances in genetic technology force upon us entirely new ethical questions that previous moral theories lack the resources to resolve.

The claim that

new scientific discoveries render previous moral theories obsolete should be regarded with suspicion. Suspicion should be further aroused when readers note another feature of the authors’ theorizing that neatly fits the claim that we stand at the dawn …

The Ethics Of Genetic Intervention: Human Research And Blurred Species Boundaries, Rebecca Dresser

San Diego Law Review

From Chance to Choice: Genetics and Justice1

is a well-written and tightly argued analysis. This Essay addresses two topics meriting more attention than they received from these authors. First, this Essay considers in greater detail a topic the book briefly addresses—the human research necessary to support clinical use of genetic interventions. What appears as simply a step along the way to clinical benefits may actually present serious impediments. Second, this Essay expands on a point the authors mentioned only in passing. They noted that developments in

genetics are blurring traditional species boundaries. Blurred boundaries between humans and other species raise …

A Rawlsian Approach To Solving The Problem Of Genetic Discrimination In Toxic Workplaces, Robert A. Bohrer

San Diego Law Review

The Human Genome Project (HGP) may well be the beginning of a technological leap that rivals the advent of the Industrial Age.2 The principal goal of the project is to map and fully sequence3

the twenty- four chromosomes that contain the complete genetic contents of a

normal human cell. The human genome consists of twenty-two pairs of chromosomes plus the X and Y chromosomes that determine gender.4 As would be expected for such a technologically adventurous undertaking, the HGP has been accompanied by a substantial outpouring of concern about the ethical, legal, and social issues that will arise from this …

Does Technological Enhancement Of Human Traits Threaten Human Equality And Democracy?, Michael H. Shapiro

San Diego Law Review

This Article outlines some of the moral, legal, and general policy difficulties that societies and individuals will face if technological enhancements via germ line and somatic mechanisms become possible. It identifies and analyzes some of the conceptual structures necessary to explain the nature of these difficulties, suggests some alternative basic scenarios—such as greater or lesser scarcity of technological enhancement resources, impacts on how we perceive each other, and different remediation patterns—and then maps and reverse maps the projected technological developments against the value and legal structures. This Article also describes and comments on what may seem to be, from our …

Deconstructing Binary Race And Sex Categories: A Comparison Of The Multiracial And Transgendered Experience, Julie A. Greenberg

San Diego Law Review

Millions of people are transgendered

and cannot easily be categorized as either male or female. Similarly, millions of people are multiracial and cannot be classified as being of one distinct race. Race classification systems have existed for centuries and have been the subject of extensive commentary and critique for decades. Sex and gender classification systems, on the other hand, have just started to become the subject of litigation in the last half of the twentieth century

and it is only during the last decade that sex classification systems have become the topic of extensive scholarly discussion.

Women, Poverty, Access To Health Care, And The Perils Of Symbolic Reform, Mary Anne Bobinski, Phyllis Griffin Epps

Faculty Articles

This article looks at health care through gendered eyes. We sift though available data on access to health care, health status, and health treatments to determine whether men and women experience health care differently in the United States. While we do not doubt that overt gender-based discrimination occasionally occurs in health care, this article focuses on the importance of unintended consequences and unconscious bias. We also explore the impact of symbolism about women's roles on the process of health care reform. The results have important implications for policy makers, advocates, and health care providers.

The United States has a large …