The 2010 federal health insurance reform act includes an individual mandate that will require Americans to carry health insurance. This article argues that even if the mandate were to catalyze universal health insurance coverage, it will fall short on some of the policy objectives many hope to achieve through a mandate if implemented in a fragmented insurance market. To uncover this problem, this article sets forth a novel framework that disentangles three different policy objectives the individual mandate can serve. Namely, supporters of the mandate might hope for it to: (1) facilitate greater health and financial security for the uninsured (“paternalism”); (2) eliminate inefficiencies in health care delivery and financing (“efficiency”); and/or (3) require the healthy to buy insurance to help fund medical care for the sick (“health redistribution”). Health redistribution — the primary focus of this article — is a shifting of wealth from the healthy to the sick through the mechanism of risk pooling. Many see health redistribution as a means to enable all Americans to more equitably access medical care on the basis of need, rather than on the basis of ability or willingness to pay.

Drawing on evidence from the implementation of an individual mandate in Massachusetts's health reform in 2006, this article reveals that the fragmented American health insurance market will thwart the mandate's ability to achieve these objectives— in particular the goal of health redistribution. Fragmentation is an atomization of the insurance market into numerous risk pools that has been driven by market competition and regulation. It prevents Americans from sharing broadly in the risk of poor health and, in doing so, entrenches a system where access to medical care remains tied to ability to pay and individualized characteristics. The final section of this article examines how various policies, including some in the new law (e.g., insurance regulation and exchanges) and others not (e.g., expanded public insurance), can reduce fragmentation so that the mandate can successfully serve all desired objectives and in the process gain greater legitimacy over time.

The social movement surrounding autism in the U.S. has been rightly defined a ray of light in the history of social progress. The movement is inspired by a true understanding of neuro-diversity and is capable of bringing about desirable change in political discourse. At several points along the way, however, the legal reforms prompted by the autism movement have been grafted onto preexisting patterns of inequality in the allocation of welfare, education, and medical services. In a context most recently complicated by economic recession, autism-driven change bears the mark of political and legal fragmentation. Distributively, it yields ambivalent results that have not yet received systemic attention. This article aims to fill this analytical vacuum by offering, first, a synoptic view of the several legal transformations brought about or advocated for by the autism movement and, second, a framework for investigating their distributive consequences.

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. People can be maintained on life-support even after permanently losing the ability to breathe spontaneously and remaining unconscious and unable to interact meaningfully with others. In part because this group of people could help fulfill the growing need for organ donation, there has been a great deal of pressure on the way we determine death. The determination of death has been modified from the old way of understanding death as occurring when a person stops breathing, her heart stops beating, and she is cold to the touch. Today, physicians determine death by relying on a diagnosis of total brain failure or by waiting a short while after circulation stops. Evidence has emerged that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from our biological and common-sense understandings of death.

We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. However, the considerable debate over the determination of death in the medical and scientific literature has not informed the public of the fact that our current determinations of death do not adequately establish that a person has died. It seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution of acknowledging the legal fictions involved in determining death. This move in the direction of greater transparency may someday result in allowing us to face squarely these issues and effect the legal changes necessary to permit ethically appropriate vital organ transplantation. Finally, this paper also provides the beginnings of a taxonomy of legal fictions, concluding that a more systematic theoretical treatment of legal fictions is warranted to understand their advantages and disadvantages across a variety of legal domains.

Ten years ago, Jesse Gelsinger died while participating in a human genetherapy trial at the University of Pennsylvania (“Penn”). His death came to signify the corrosive influence of financial interests in human subjects research. After Jesse's death, the media reported that one researcher, Dr. James Wilson, held shares in a biotech company, Genovo, which stood to gain from the research's outcome—shares that The Wall Street Journal later valued at $13.5 million, although Wilson maintains he did not make nearly this much. At the time Penn authorized Wilson's deal, internal Penn documents implicitly valued Wilson's stake in Genovo at approximately $28.5 to $33 million.

Jesse's death sparked two separate lawsuits: one by the family, who sued in tort, and one by the federal government, which framed alleged errors in the research trial as a civil False Claims Act violation.

For years, commentators have debated how to most appropriately allocate scarce medical resources over large populations. In this paper, I abstract the major rationing schema into three general approaches: rationing by price, quantity, and prioritization. Each has both normative appeal and considerable weakness. After exploring them, I present what some commentators have termed the “moral paradigm” as an alternative to broader philosophies designed to encapsulate the universe of options available to allocators (often termed the market, professional, and political paradigms). While not itself an abstraction of any specific viable rationing scheme, it provides a strong basis for the development of a new scheme that offers considerable moral and political appeal often absent from traditionally employed rationing schema.

As I explain, the moral paradigm, in its strong, absolute, and uncompromising version, is economically untenable. This paper articulates a modified version of the moral paradigm that is pluralist in nature rather than absolute. It appeals to the moral, emotional, and irrational sensibilities of each individual person. The moral paradigm, so articulated, can complement any health care delivery system that policy-makers adopt. It functions by granting individuals the ability to appeal to an administrative adjudicatory board designated for this purpose. The adjudicatory board would have the expertise and power to act in response to the complaints of individual aggrieved patients, including those complaints that stem from the moral, religious, ethical, emotional, irrational, or other subjective positions of the patient, and would have plenary power to affirm the denial of access to medical care or to mandate the provision of such care. The board must be designed to facilitate its intended function while creating structural limitations on abuse of power and other excess. I make some specific suggestions on matters of structure and function in the hope of demonstrating both that this adjudicatory model can function and that it can do so immediately, regardless of the underlying health care delivery system or its theoretical underpinnings.

Changes in technology sometimes raise important public policy choices and require that we clarify key values and reexamine legal concepts. Such is the case with the development of electronic medical records (EMRs), which facilitate obtaining patient data from provider and insurer records. EMRs expand our ability to tap patient data and thereby create great potential benefits as well as risks. This new technology requires that we clarify the ambiguous property interests in patient data. How the law defines ownership of patient data will shape whether its benefits can be developed and also affects patient confidentiality.

EMRs make it feasible to collect aggregate patient data that can be used to vastly improve medical knowledge, patient safety and public health. Researchers have long used patient data from clinical trials to evaluate the benefits and risks of drugs and medical therapy, compare their relative effectiveness, and analyze health care cost and quality.

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.

The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

Throughout the world, complex mutually-dependent relationships exist between physicians and pharmaceutical and medical device companies. This article focuses on one particular aspect of these relationships—payments made by drug and device companies to physicians and their organizations and institutions to market drugs and devices. It is widely believed that drug and device company marketing to physicians creates conflicts of interest that corrupt physician judgment and increase the cost of medical care. This article examines first the economic basis of physician/industry relationships that causes conflicts to arise. It next considers the measures that a number of developed countries have taken to respond to these relationships. Finally, it proposes an approach that would comprehensively address the problems caused by drug and device company marketing to physicians.

Critics of the current medical malpractice tort system claim that adjudication of malpractice claims before generalist judges and lay juries contributes to rising costs of medical malpractice insurance premiums and medical care. They claim that properly deciding issues in this realm requires specialized knowledge of medicine and medical technology that juries, and even judges of general jurisdiction, do not possess. One lobbying group alleges there is a continuing medical malpractice litigation crisis in the United States, evidenced by increasing medical costs, deaths from needless medical errors, departure of physicians from the practice of medicine due to increasing medical malpractice insurance premiums, and random medical justice in medical malpractice cases. Whether there is a direct, causal correlation between the increasing cost of medical malpractice insurance premiums and medical malpractice litigation is debatable.

If nature has made any one thing less susceptible than all others of exclusive property, it is the action of the thinking power called an idea, which an individual may exclusively possess as long as he keeps it to himself; but the moment it is divulged, it forces itself into the possession of every one, and the receiver cannot dispossess himself of it.

I suspect that our collective search for villains — for someone to blame — has distracted us and our political leaders from addressing the fundamental causes of our nation's health-care crisis. All of the actors in health care — from doctors to insurers to pharmaceutical companies — work in a heavily regulated, massively subsidized industry full of structural distortions. They all want to serve patients well. But they also all behave rationally in response to the economic incentives those distortions create. Accidentally, but relentlessly, America has built a health-care system with incentives that inexorably generate terrible and perverse results. Incentives that emphasize health care over any other aspect of health and well-being. That emphasize treatment over prevention. That disguise true costs. That favor complexity and discourage transparent competition based on price or quality.

Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle – an iconic emblem of compounding – have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy – to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. In one impressive example of successful early compounding, God commanded Moses to “compoundeth” a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus. Not generally one to shrink from a challenge, Moses followed God’s recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.

It would be naïve to argue that money isn't the driving force motivating health care delivery in 2010. At nearly 17% of GDP, health care delivery is a large and growing industrial enterprise that is the largest employer in many communities. Save for free clinics, generating revenue is fundamental to every aspect of the delivery system. From insurance reimbursement rates to the cost of purchasing the latest technology, the surest explanation for understanding changes in the health care system and concomitant development of legal doctrine is, indeed, to “follow the money.”

Determining who controls the money flows usually explains who the dominant players are, and how they are able to organize and change the delivery system. Unquestionably, the most straightforward way to understand how the system functions, where its vulnerabilities lie, and why it is so difficult to institute significant reforms is to identify who controls the money.

In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.

Since the demise of the last major health reform initiative in 1994, health coverage for the American people has deteriorated. Private insurance costs have risen, and coverage under private insurance became less comprehensive, with higher deductibles and copayments. Many new treatments for serious diseases and associated provider compensation have become more and more unaffordable, even for those with health insurance coverage. Recent reports document the challenges for cancer patients faced with the soaring cost of cancer treatment. Public programs, such as Medicare and Medicaid, have picked up some slack and have grown in numbers. But gaps remain. Approximately 16 percent of the U.S. population is uninsured. Annual U.S. spending for health care was $2 trillion in 2005, and is estimated to reach $4 trillion by 2015.