Controversy surrounding Roe v. Wade has grown steadily in the nearly two decades since the case was decided. Supreme Court appointments by two administrations openly hostile to Roe may finally have presented Roe's original dissenting Justices with the votes needed to overrule or substantially revise the decision. With the prospect of Roe's demise at hand, it is no longer clear what protections, if any, will be afforded the right to abortion, as a matter of federal constitutional law.
Michelle Friedland argues in this note that the Americans with Disabilities Act fails to adequately distinguish between the separate goals of preventing pure discrimination and providing affirmative accommodation. The Act's conflation of these two different objectives, and its reliance on a single definition of disability for both, hinders its effectiveness in improving the status of individuals with disabilities in the employment setting. To illustrate this, she points to the counterintuitive results reached in recent court decisions. Friedland further traces the legislative origins of the Act's definition of disability and the ambiguity it leaves as to Congress's goals for the Act's employment provisions. She posits three possible goals the Act might be designed to achieve and recommends basic reforms for accomplishing each. Her ultimate conclusion is that provisions dealing with accommodation and discrimination need to be divided so that each can have its own definition of disability. In addition, she believes funding mechanisms for providing accommodation should be altered to ameliorate inequalities in burdens borne by employers and to avoid improper incentives to circumvent the Act.
Medical devices marketed in the United States must satisfy FDA standards of safety and effectiveness. Many observers have criticized the FDA medical device review process as both time consuming and unpredictable. In this note, Lawrence Makow examines the Agency's treatment of two novel medical technologies, magnetic resonance spectroscopy and biliary extracorporeal shockwave lithotripsy. He concludes that the outcomes of these cases exemplify the mismatch between clinical utility and FDA approval status that has prompted concerns about lack of predictability. Mr. Makow asserts that this mismatch results from the FDA's implementation of the medical device statute rather than from the statute itself. He proposes an asymmetric standard for evaluating the safety and efficacy of new medical devices. While the safety showing would always require a high burden of proof, the efficacy standard would vary depending on the relationship between the device's safety and efficacy. Under this asymmetric standard, the FDA could better manage its workload and achieve more predictable results without sacrificing the public interest in avoiding injury from unproven medical devices.
Throughout this century in the United States, four approaches to law have vied for dominance among legal scholars. While there have been many more than four "schools" of law or "movements," many of these, I think, have represented a variant, a particular form or specific application, of one of these four underlying points of view. In other instances, the particular school or movement has merged elements of more than one of my approaches. (And, in such cases, the school was usually criticized for its vagueness and lack of coherence, but more on that later.) Each of these approaches is very much alive and influential today—and each is so in a relatively recent form or manifestation. In this Article, I would like to describe briefly the four points of view, indicate how the current manifestations of each relate to earlier versions, and finally suggest how each would analyze an issue that is, and will become ever more, pressing in the law, namely, whether we own our bodies and their parts or whether, instead, they belong, at least in some instances, to those who need them.
The emergency rooms of American hospitals have frequently become the principal suppliers of nonurgent primary care to the under- and uninsured. Canvassing published reports and using original data obtained from a representative urban hospital, Erik Olson examines the demographics of the American emergency room and analyzes its finances. The costs of providing primary care are shifted, to the extent possible, to those who can pay. The result is escalating health care costs and a deterioration of quality of care due to overcrowding, leading some hospitals to close their emergency rooms and others to turn away ambulances or "dump" patients who still require critical care. Mr. Olson explains that state antidumping laws and the federal COBRA statute have been ineffective at stemming these practices in the face of severe economic pressure to continue them. Pointing out that emergency rooms are an excessively expensive method of treating uninsured nonemergency patients, he proposes a system of primary care clinics created through a public/private partnership between municipalities and existing private health care providers. The partnership is designed to maintain a high standard of care at the clinics. As an incentive to stimulate the appearance of such clinics, a tax would be imposed on private health care providers; the tax on a given provider would be reduced to the extent that provider subsidizes a local primary care clinic that offers universal coverage, regardless of insurance status. Because the existence of such clinics would reduce inefficient use of hospital emergency rooms, in the long run hospitals should find it less expensive to finance local primary care clinics than to continue to sustain unreimbursed expenses due to improper use of their emergency departments.
Whatever else I might own in this world, it would seem intuitively obvious that I own the cells of my body. Where else could the notion of ownership begin, other than with the components of the tangible corpus that all would recognize as "me"? The law, however, does not view the issue so neatly and clearly, particularly when cells are no longer in my body. As so often happens in law, we have reached this point, not by design, but by the piecemeal development of disparate notions that, when gathered together, form a strange and disconcerting picture. This Article examines both property and intellectual property doctrines in relation to human cells that are no longer within the body. In particular, the Article discusses the Bilski decision, in the context of life science process patents, and the Molecular Pathology case, in the context of gene patents. For patent law, the Article concludes that the problem lies not with the fact that genes constitute patentable subject matter, but rather with the extent of the rights that are granted. For both property and intellectual property law, the Article concludes that a more careful application of basic legal principles would better reflect the interests of society as a whole and the interests of individual human subjects, as well as the interests of those who innovate.
The long-anticipated decision in Bilski v. Kappos was supposed to end uncertainty regarding the patentability of process claims (or, at the least, business method claims). Instead, the opinion featured a series of anomalies: The Court emphasized strict construction of the Patent Act, but acknowledged three judge-made exceptions to patentability. It disapproved State Street, the Federal Circuit case that had upheld business method patents, but could muster only four votes for the proposition that business methods are in fact unpatentable. But even though the Court upheld business method patents, it invalidated all of Bilski's hedging claims. And while the Justices agreed on one thing - a patent that "preempts" something (a mathematical formula, an approach, a commonly used idea, a wide swath of technological developments, the public's access) is bad - they failed to operationalize the concept. That problem had plagued the law prior to State Street; in the interest of preventing the same set of problems from recurring, this Article uses recent empirical studies on gene patents to tease out indicia ("clues") to supplement the machine-or-transformation test for determining when a claim is preemptive and therefore invalid. Chief among these clues is the inability to invent around claims that cover broad prospects.
Physician-assisted suicide (PAE) is an emotionally charged issue that state legislators struggle with more and more each year. In this note, David Sloss examines whether the right to voluntary PAE is protected by the Due Process Clause of the Fourteenth Amendment. Mr. Sloss argues that all competent, terminally ill patients have a fundamental right to die with dignity. He concludes that no state should place a substantial obstacle, or undue burden, in the path of a competent patient with an objectively rational desire to die.
In this note, Catherine Paytash examines the validity of the learned intermediary doctrine as it is applied in the context of prescription drug therapy. She explores and analyzes the rationales advanced to support the rule and the criticisms that have been leveled against its application to prescription drugs. Paytash identifies two roles that the learned intermediary doctrine is intended to play in relation to prescription drugs: 1) a role that provides a reasonable and efficient legal system of warning about side effects and appropriate use, and 2) a role that encompasses a system for informing patients. Paytash concludes that the learned intermediary doctrine, though justified as a legal standard of liability for warnings provided by prescription drug manufacturers, is inadequate as a system for informing patients about the prescription medications they use. She proposes that the most efficient way of preventing prescription drug related injury is a hybrid solution comprised of the learned intermediary doctrine as the legal standard for liability for product warnings and an FDA-mandated system of patient package inserts as a supplemental means of providing prescription drug users with information.
For eighteen years, a majority of the Supreme Court has upheld abortion rights without deciding whether or when a fetus may be regarded as an independent person. Today, another set of Justices would deny those rights on the ground that the fetus's status is an issue for state legislators to resolve. These mirror-image strategies share a common aim: Each allows the Court to evade the single question that, in every discourse but the judicial one, is by now synonymous with the abortion debate itself—the question of when human life begins. The policy of avoidance began at the outset of the Court's abortion jurisprudence. In Roe v. Wade, the Court expressly refused to "speculate" about "this most sensitive and difficult question."' Instead, the Roe Court predicated governmental power to forbid abortion on the putative state interest in "protecting the potentiality of human life." It was this interest in "potentiality" that the Court held to become "compelling" when the fetus reaches viability.
In this note, Katherine A. White explores the conflict between religious health care providers who provide care in accordance with their religious beliefs and the patients who want access to medical care that these religious providers find objectionable. Specifically, she examines Roman Catholic health care institutions and HMOs that follow the Ethical and Religious Directives for Catholic Health Care Services and considers other religious providers with similar beliefs. In accordance with the Directives, these institutions maintain policies that restrict access to "sensitive" services like abortion, family planning, HIV counseling, infertility treatment, and termination of life-support. White explains how most state laws protecting providers' right to refuse treatments in conflict with religious principles do not cover this wide range of services. Furthermore, many state and federal laws and some court decisions guarantee patients the right to receive this care. The constitutional complication inherent in this provider-patient conflict emerges in White's analysis of the interaction of the Free Exercise and Establishment Clauses of the First Amendment and patients' right to privacy. White concludes her note by exploring the success of both provider-initiated and legislatively mandated compromise strategies. She first describes the strategies adopted by four different religious HMOs which vary in how they increase or restrict access to sensitive services. She then turns her focus to state and federal "bypass" legislation, ultimately concluding that increased state supervision might help these laws become more viable solutions to provider-patient conflicts.
Critics of American tort law often question the ability of lay jurors to make factual determinations in trials involving complex scientific evidence. In this article, Professor Sanders attempts to refocus tort reform debate by studying how trial procedures themselves contribute to jurors' inability to properly assess scientific evidence. Professor Sanders' analysis centers on trials involving Bendectin, a drug which plaintiffs have claimed caused birth defects in the children of mothers who took it during pregnancy. After noting that the weight of scientific and federal judicial opinion concludes that plaintiffs cannot establish a causal link between Bendectin use and birth defects by a preponderance of the evidence, Professor Sanders analyzes the transcripts of six Bendectin trials to determine why jury verdicts do not comport with the weight of scientific and judicial opinion. Based on his conclusion that trials are incapable of adequately conveying the weight of scientific opinion to a lay jury, he evaluates the ability of various trial reform proposals to ameliorate this problem. Finally he recommends adopting proposals that would facilitate jurors' understanding of scientific evidence and lead to verdicts consistent with the weight of scientific opinion.
In health care law, as in other regulatory spheres, many rules are meant to promote trustworthiness. Market-oriented scholars have long urged that parties be permitted to contract out of such rules. They have argued, on efficiency grounds, for contractual enjoining of clinical decisionmaking authority; relationships among providers and health care payers; and physicians' conflicting obligations to patients, payers, and other third parties. To a large degree, courts and regulators accommodated, clearing a path in the 1980s and 1990s for the rise of managed care. But a growing body of research on the psychology of trust, altruism, and health risk raises doubts about contractual departure from rules meant to reinforce trustworthiness. Rising consumer hostility to managed care cost control methods has lent urgency to these doubts. While some contractarian scholars dismiss these doubts, others, most notably Mark Hall, take them seriously. Drawing upon some of the same empirical studies that have led others to question contractarian prescriptions, Hall argues that consumer trust is robust, indeed often present in excess, and that regulation on trust-related grounds is mostly unnecessary, even counterproductive. I contend in this essay that contractarian prescriptions for health law pose large risks for our health system's trustworthiness. Hall's case to the contrary misreads both the psychological evidence and the import and irony of Americans' backlash against managed care. Because people are uncomfortable, to the point of denial, with health care's cost-benefit tradeoffs, the medical marketplace delivers evasion and euphemism about how these tradeoffs are made. But there is also a thriving market for the exposure of evasion. Regulatory and legal deference to contractual arrangements that ration covertly thus engenders consumer anger and distrust. Rather than tolerating such arrangements, the law should demand contractual honesty as the price for deference to contractual freedom.
At the intersection of tort reform and biodefense, both proponents and critics of the tort system face a unique quandary: How to protect the country from potentially catastrophic biological threats without abandoning the principles of individualized justice that the tort system embodies. The resolution of that quandary is still evolving, and may indicate a transformed future for tort reform. Instead of a grand, decisive battle that reshapes the rules for the entire tort system, the fight could move issue-by-issue - with biodefense an important test case. On December 30, 2005, President Bush signed into law the Public Readiness and Emergency Preparedness (PREP) Act. The legislation provides sweeping protection from tort liability, on a case-by-case basis, to drug manufacturers, hospitals, doctors, and other entities involved in preparing for or responding to a pandemic or bioterrorist attack. The Act empowers the Secretary of Health and Human Services to issue Declarations designating covered persons and covered countermeasures for immunity from suit. The immunity is airtight, allowing injured plaintiffs to access the tort system only in the unlikely event that the defendant committed willful misconduct or blatantly failed to follow the parameters of the Declaration. In place of tort, the Act creates a government-funded administrative compensation scheme that would pay only very modest benefits to successful claimants. Whereas tort reform was a hot political topic in the 2004 presidential election, other matters have since eclipsed it. Second, bioterrorism and pandemic flu have dropped out of the media headlines. No one has committed an act of bioterrorism on U.S. soil since the 2001 anthrax attacks, and public scares over Severe Acute Respiratory Syndrome (SARS) and avian flu have subsided. These threats remain constant and serious, however, whether or not in the limelight, and America's response to them deserves careful scrutiny.
The ownership of preexisting genes and other biochemicals raises important questions about the scope and purpose of patent law - what it is designed to accomplish and how biotechnology fits within that design. More fundamentally, whether patent law is properly applied to products not independently created by a patent applicant implicates questions about the limits of intellectual property ownership, policy decisions about whether natural substances and processes should reside in the public or private sphere, choices about the value placed upon publicly available knowledge, and the microeconomic effects of limiting patents to some kinds of biotechnological innovations while excluding patents on others. Are patents on naturally occurring phenomena, such as discovered DNA sequences, proteins, plasmids, and other biological chemicals, truly as uncontroversial and "simply necessary" as a matter of public policy as many legal commentators, the biotechnology industry, and the Patent and Trademark Office Director himself have argued? Are patents on naturally occurring substances of any kind authorized by the relevant legislation and case law? The answers are far from obvious, and their importance merits a more careful and detailed examination of the legal and policy underpinnings of the patenting of genes and other biotechnological innovations than has so far been undertaken. This Article provides the first comprehensive examination of this issue. The authors argue that the strong recent trend in the case law and literature toward viewing gene patents as uniformly desirable and legally proper rests upon a prevalent misinterpretation of a triad of key patent law concepts.
Recent medical studies have indicated that synthesized human growth hormone (hGH) may cosmetically enhance short, but otherwise perfectly healthy, individuals by adding inches to their final predicted height. In this note, Curtis Kin examines the legal and ethical implications of such a discovery, arguing that nontherapeutic hGH treatment is likely the first of many biotechnology and gene therapy enhancements that may be available to the public in a "genetic supermarket" of enhancement products. Mr. Kin finds that the current regulatory framework for biotechnology and gene therapy inadequately regulates unapproved uses of hGH and fails to address properly its implications for a genetic "race to perfection." He proposes changes to the current regulatory framework that will enforce a strict distinction between therapeutic and enhancement applications of biotechnology and gene therapy. These changes in the law, Mr. Kin reasons, will help to solve the social and ethical problems posed by these emerging developments in technology.
Asexuality is an emerging identity category that challenges the common assumption that everyone is defined by some type of sexual attraction. Asexuals--those who report feeling no sexual attraction to others--constitute one percent of the population, according to one prominent study. In recent years, some individuals have begun to identify as asexual and to connect around their experiences interacting with a sexual society. Asexuality has also become a protected classification under the antidiscrimination law of one state and several localities, but legal scholarship has thus far neglected the subject. This Article introduces asexuality to the legal literature as a category of analysis, an object of empirical study, and a phenomenon of medical science. It then offers a close examination of the growing community of self-identified asexuals. Asexual identity has revealing intersections with the more familiar categories of gender, sexual orientation, and disability, and inspires new models for understanding sexuality. Thinking about asexuality also sheds light on our legal system. Ours is arguably a sexual law, predicated on the assumption that sex is important. This Article uses asexuality to develop a framework for identifying the ways that law privileges sexuality. Across various fields, these interactions include legal requirements of sexual activity, special carve-outs to shield sexuality from law, legal protections from others' sexuality, and legal protections for sexual identity. Applying this framework, the Article traces several ways that our sexual law burdens, and occasionally benefits, asexuals. This Article concludes by closely examining asexuality's prospects for broader inclusion into federal, state, and local antidiscrimination laws.
As with phrenology and the polygraph, society is again confronted with a device that the media claims is capable of reading our minds. Functional magnetic resonance imaging ("fMRI"), along with other types of functional brain imaging technologies, is currently being introduced at various stages of a criminal trial as evidence of a defendant's past mental state. This Article demonstrates that functional brain images should not currently be admitted as evidence into courts for this purpose. Using the analytical framework provided by Federal Rule of Evidence 403 as a threshold to a Daubert/Frye analysis, we demonstrate that, when fMRI methodology is properly understood, brain images are only minimally probative of a defendant's past mental states and are almost certainly more unfairly prejudicial than probative on balance. Careful and detailed explanation of the underlying science separates this Article from others, which have tended to paint fMRI with a gloss of credibility and certainty for all courtroom-relevant applications. Instead, we argue that this technology may present a particularly strong form of unfair prejudice in addition to its potential to mislead jurors and waste the court's resources. Finally, since fMRI methodology may one day improve such that its probative value is no longer eclipsed by its extreme potential for unfair prejudice, we offer a nonexhaustive checklist that judges and counsel can use to authenticate functional brain images and assess the weight these images are to be accorded by fact finders.
Law relies on a well-developed and constantly evolving iconography to tell its stories. Like lawyers and judges, legal scholars typically rely upon official legal sources to flesh out the implicit meaning of the law’s language. But “official law,” with its stress on statutory language, legislative intent, and case precedent, is quite plainly an insufficient source for understanding the texture and nuance of legal language. To better understand law’s implicit meaning, readers of law need to mine unofficial as well as official sources of law. These unofficial sources often provide insight into, and occasionally substance for, law’s official meaning. Popular culture is one important source of legal meaning. In a myriad of ways, popular culture influences the making, interpretation, and application of law. By illuminating and contextualizing problems, creating certain types of narrative, or favoring some narrative constructions over others, popular culture frequently determines what kind of law is made. My primary interest in this paper revolves around the iconography of crime, mental illness, and insanity. These concepts not only go to the heart of the legal understanding of human responsibility, they also have long provided an unending well of narratives to feed the human hunger for meaning-making stories. This Article attempts to trace the iconography of criminal madness in popular cinema and to link it with the law’s development over the same span. Part I provides some prefatory observations about the relation of film and culture to law. Part II explores the depiction of criminal madness in the 1930s, primarily through the monster movies of the era. Part III describes the growing embrace of psychological and psychiatric theories in midcentury cinema, which occurred precisely during a period in which the insanity defense was liberalized and constitutional checks on the state’s power to institutionalize mad criminals were recognized. Finally, Part IV examines dramatic post-1970s changes in cinematic portrayals of criminals, the criminal justice system, and mad criminals, and explores ways in which the new iconography of criminal madness contributed to a dramatic shrinkage of the rights of mentally ill offenders.