Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers.

In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

The politics of reproduction dominate the political landscape now more than ever. One area of controversy has been informed consent statutes for abortion, which have been praised by the pro-life movement but derided by the pro-choice movement. More recently, legislatures have begun to enact informed consent statutes with respect to end-of-life decision making, an area almost as politically controversial as abortion. Like many abortion disclosure laws, some of these have been entitled “Right to Know” statutes. Yet, the supporters and opponents of each set of statutes tend not to be the same, aligning to a large extent based on their place in the culture wars over life and death.

In this Article, I strive not only to show the remarkably similar critiques each side marshals but also to use these concerns to think in more nuanced ways about the goals of informed consent and whether the disclosure mandates achieve those goals. I first argue in favor of the aspirational goals of informed consent as a process that allows patients to participate in their medical decision making. While conceding the inherently political nature of abortion and end-of-life care, I also contend that the significance of decisions regarding those matters warrants, at least in theory, legislative efforts to ensure that patients have the opportunity to engage in deliberative and informed decision making.

In describing and responding to the similar critiques of both sets of laws—the political bias of the statutes; the efforts to persuade, especially with non-medical information; the potential vulnerability of the targeted audience; and the interference with physician discretion—I uncover and challenge some of the presumptions about informed consent inherent in those critiques. Although information that persuades or influences is not per se problematic, I argue that disclosure of information that is inaccurate, untrue, or emotionally inflammatory harms informed consent. Even well-crafted informed consent mandates, however, are insufficient to promote truly deliberative decision making because they oversimplify the complexity of these decisions and fail to respond to the fact that informed consent is a process that requires more than simply the delivery of information; it also requires dialogue and discussion. This Article ends with suggestions for ways to try to promote such a dialogue.

Cases concerning the regulation of tobacco have long existed within the World Trade Organization (WTO) and its predecessor, the General Agreement on Tariffs and Trade 1947 (GATT 1947), although often these cases have not centered on the detrimental health impact of tobacco products. With the 2012 circulation of the Report of the WTO Appellate Body in U.S.—Clove Cigarettes, the potential friction between international trade law and tobacco regulation in the context of public health has come to the fore. In that Report, the Appellate Body found in part against the United States’ flavored cigarette ban. Combined with the ongoing WTO challenges to mandatory plain tobacco packaging in Australia—Tobacco Plain Packaging, governments might begin to fear that the WTO agreements represent an insurmountable barrier to ambitious tobacco control measures. However, careful examination of the Clove Cigarettes case alongside the two other recent Appellate Body Reports (U.S.—Tuna II (Mexico)5 and U.S.—COOL6) on the WTO's Agreement on Technical Barriers to Trade (TBT Agreement)7 demonstrates that the TBT Agreement has ample flexibility to accommodate health objectives underlying tobacco regulation.

In November 2011, U.S. District Court Judge Richard Leon ruled that the U.S. Food and Drug Administration's (FDA’s) proposed graphic health warnings for cigarette packages violated tobacco companies’ First Amendment rights. In doing so, he pointedly refused to consider the experiences of Canada, the United Kingdom, and the more than thirty other countries that had adopted similar graphic warnings in the past decade. Rather, he swatted away all references to those other countries’ experiences by stating (first at oral argument and then in his decision) that “none of [those countries] afford First Amendment protections like those found in our Constitution.”

While it is true that no other country uses the First Amendment per se, many other countries do offer constitutional protection to freedom of speech and/or freedom of expression. Indeed, several other countries apply “strikingly similar” legal tests when reviewing restrictions on speech (and on commercial speech in particular). Thus, the statement that other countries do not “afford First Amendment protections like those found in our Constitution” is an oversimplification.

Even though most American retirees benefit from Medicare coverage, a mounting body of research predicts that many will face large and increasing out-of-pocket expenditures for healthcare costs in retirement and that many already struggle to finance these costs. It is unclear, however, whether the general population understands the likely magnitude of these out-of-pocket expenditures well enough to plan for them effectively. This study is the first comprehensive examination of Americans' expectations regarding their out-of-pocket spending on healthcare in retirement. We surveyed over 1700 near retirees and retirees to assess their expectations regarding their own spending and then compared their responses to experts' estimates. Our main findings are twofold. First, overall expectations of out-of-pocket spending are mixed. While a significant proportion of respondents estimated out-of-pocket costs in retirement at or above expert estimates of what the typical retiree will spend, a disproportionate number estimated their future spending substantially below what experts view as likely. Estimates by members of some demographic subgroups, including women and younger respondents, deviated relatively further from the experts' estimates. Second, respondents consistently misjudged spending uncertainty. In particular, respondents significantly underestimated how much individual health experience and changes in government policy can affect individual out-of-pocket spending. We discuss possible policy responses, including efforts to improve financial planning and ways to reduce unanticipated financial risk through reform of health insurance regulation.

There was an argument that the Obama Administration's lawyers could have made—but didn't—in defending Obamacare's individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals' healthcare savings and consumption decisions. Because consumer-directed healthcare, which reaches its apex when individuals self-insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the healthcare market that arise from individual decisions to self-insure. This argument would done a better job than the Obama Administration's of aligning the individual mandate with existing Commerce Clause and Necessary and Proper Clause precedent, and it would have done a better job of addressing the conservative Justices' primary concerns with upholding the mandate. This Article lays out this forgone defense of the individual mandate.

Proponents of the Trans-Pacific Partnership agreement (TPPA) describe it as a twenty-first century agreement that will reach further behind the border than any previous free trade or investment agreement. As the chief executive of Business New Zealand said during the round of TPPA negotiations in Auckland in December 2012:

More specifically, the TPPA aims to frame how governments make their domestic policy and regulatory decisions as a complement to more extensive rules that constrain the substance of those decisions. These “disciplines” aim to empower commercial players and advance their interests, and to marginalize competing priorities, advocates, and agencies; including democratic political institutions.

In 2008, an amendment was proposed to the Colorado Constitution that sought to attach the rights and protections associated with legal “personhood” to any human being from the moment of fertilization. Although the initiative was defeated, it sparked a nation-wide Personhood Movement that has spurred similar efforts at the federal level and in over a dozen states. Personhood advocates choose terms like “fertilization,” or phrases such as “human being at any stage of development,” to identify the “person”-defining moment in the reproductive process, and these designations have profound implications for reproductive choice. Proponents are outspoken in their desire to outlaw abortion, but they are less transparent about their intent with respect to other aspects of reproductive choice, such as contraception and infertility treatments.

This paper describes the background of the Personhood Movement and its attempt to achieve legal protection of the preborn from the earliest moments of biological development. Following the late 2011 failure of the personhood measure in Mississippi, the language used within the Movement was dramatically changed in an attempt to address some of the concerns raised regarding implications for reproductive choice. Putting abortion to one side, this paper identifies why the personhood framework that is contemplated by the proposed changes does not eliminate the potential for restrictions on contraception and in vitro fertilization (IVF) that put the lives of these newly recognized persons at risk; nor should it if proponents intend to remain consistent with their position. The paper goes on to suggest what those restrictions might look like based on recent efforts being proposed at the state level and frameworks that have already been adopted in other countries.

Current estimates approximate that the population over sixty-five years of age will increase from 40 million in 2010 to 72.1 million by 2030. As society ages, the number of elderly with cognitive deficits that impair decision-making abilities will also increase. This will place additional burdens on families and probate courts seeking to balance individual autonomy with necessary protections. A legal determination of incompetency is a prerequisite to a judicial order appointing a guardianship or other protective mechanism. The current legal-medical model for competency determinations fails to reflect the complexities of declining capacity in an aging population. A global structure for competency determinations leaves a critical gap between competent and incompetent. The gap between competence and incompetence not only raises concerns about how to classify those that fall between the two, but also highlights the lack of legal protections for those within the gap. A revised model is needed to provide protections to individuals who do not yet meet the threshold for incompetence but require additional protections for their personal or financial welfare. This Article provides an unprecedented examination of the legal model for determining competence through a comparison of the medical model for evaluating capacity. While a number of legal scholars have examined the appointment and oversight of guardians, fewer articles have critically examined the process by which individuals are declared incompetent. This Article presents a comprehensive overview of competency and clinical capacity determination procedures, legal mechanisms available to protect individuals with declining capacity, and policy recommendations for improving legal protections in light of inefficiencies related to legal competency determinations.

The modern food environment is considered a primary driver of obesity and other nutrition-related chronic diseases. A significant contribution to this environment is the proliferation of claims on food packaging that provides a misleading picture of a product's healthfulness. The Food and Drug Administration (FDA) is the agency responsible for food labels but it lacks the regulatory authority and adequate resources to address the majority of questionable labeling practices. The FDA's current system of enforcement is thus essentially based on voluntary compliance and consumer- and manufacturer-initiated litigation has not successfully filled the regulatory gap. This manuscript reviews the current state of food labeling claims and the FDA's inadequate authority over misbranded food products. It analyzes competing views on regulatory compliance strategies and argues that a regulatory overhaul consistent with the best science and the First Amendment is necessary. With increased resources and authority, the FDA can meet current public health challenges and adequately ensure that labels are clear and consumers are properly informed and protected.

The Federal False Claims Act (FCA) creates civil liability for entities that falsely or fraudulently contract with the government to provide services or goods in exchange for federal funds. FCA cases often arise in healthcare contexts in which the government pays entities for providing products and services to eligible beneficiaries. With the growth of Medicare and Medicaid funding for healthcare services, there has been a corresponding increase of false claims and FCA cases, in the healthcare context. For instance, of the over 30 billion recovered by the government for FCA cases in the last fifteen years, recoveries from Health and Human Services constitutes over 20 billion.

An FCA case may involve a false representation that a service has been provided when in fact it has not. Such a case may also involve a false representation of compliance with underlying governmental requirements for payment. Recently, there has been growing confusion as to how to address cases in which the defendant is not the party actually submitting the allegedly false claim, but the party that caused the false claim to be filed.

As implementation of the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) accelerates and states seek to address risk factors for non-communicable disease more broadly, tension has increased between the law of the World Trade Organization (WTO) and public health. For example, Indonesia recently brought a successful claim against a U.S. law that prohibits cigarettes with a characterizing flavor other than menthol or tobacco. Indonesia succeeded in arguing that the regulation discriminates against clove-flavored cigarettes of Indonesian origin in favor of menthol-flavored cigarettes of U.S. origin.

Also in the WTO context, the Dominican Republic, Honduras, and Ukraine have challenged an Australian law prohibiting the presence of branding on tobacco packaging other than product and variant names in a standardized location, font size, and style. This regulation, commonly referred to as “plain packaging,” is the first of its kind and may represent a turning point in the regulation of tobacco packaging.

Cigarettes result in over 400,000 preventable American deaths each year. In 2011, fewer than twenty percent of adults smoked. Since the publication of the first U.S. Surgeon General's Report on Smoking and Health nearly fifty years ago, when smoking prevalence was around forty percent, policies such as smoke-free laws, large tax increases, and litigation have collectively contributed to cut smoking prevalence in half. Unfortunately, no one expects the mix of policies currently proposed, which includes further tax increases, spatial smoking restrictions, somewhat higher minimum age restrictions, adverse publicity, and quitting assistance, to reduce U.S. smoking prevalence below fifteen percent in the foreseeable future.

The rule adopted by the U.S. Food and Drug Administration (FDA) to require hard-hitting graphic warnings on cigarette packages, as is currently done in dozens of other countries, has thus far been rejected by federal judges who have found that warnings designed to arouse negative emotions violate cigarette manufacturers’ First Amendment rights.

Many states have enacted medical malpractice reforms, recognizing that their tort systems result in protracted litigation, high costs, and a large number of uncompensated victims. One proposed reform, an “early offer” system, allows a medical provider to make a financial offer covering an injured patient’s economic damages, which, if the patient accepts, precludes litigation. However, if a patient rejects an offer, he will face a higher burden of proof at trial. The early offer system seeks both to assure claimants receive prompt compensation for their economic damages, and to save insurers and providers litigation expenses and unreasonable damage payments.

At the turn of the last century, allies of industry on the Supreme Court deployed a novel constitutional doctrine to thwart government regulations aimed at improving public health and safety. During the Lochner v. New York era, the Supreme Court discovered a right to “freedom of contract” in the Due Process Clause of the Fourteenth Amendment that advanced the “economic liberty” of businesses to conduct their affairs without government oversight. The newfound freedom of contract forbade, for example, public policies aimed at improving factory conditions by setting maximum working hours, forbidding child labor, or setting a minimum wage. The Court later somewhat abashedly changed course, finding that government in fact had great leeway to implement economic regulations protecting and promoting general welfare.

Today, seventy-five years after the Supreme Court repudiated the doctrine of economic substantive due process, the Court has backtracked to the notion that the Constitution significantly impedes the government's ability to safeguard public health and safety by regulating commercial activities.

A bustling, non-profit hospital bills an elderly patient more than $2,000 for a magnetic resonance imaging (MRI) scan ordered by his physician. Despite the enormous profits the hospital will accrue during the year, its total revenue stream will be tax-exempt because it qualifies as a § 501(c)(3) organization under the Internal Revenue Code (IRC). A hospital’s ability to navigate the tax system without serious ramifications presents potential issues, particularly as the healthcare market is undergoing gradual changes in the wake of the Affordable Care Act (ACA). An organization’s ability to obtain preferential § 501(c)(3) tax status by showing that it is “organized and operated exclusively” for one of the exempt purposes under the statute is a root cause of many problems. This involves fulfilling a two-prong test under IRC § 501(c)(3), which includes both an organizational and an operational component. Both tests have to be satisfied or the organization in question loses its tax-exempt status under § 501(c)(3).

It has been estimated that the use of tobacco kills nearly 6 million people each year, with most deaths occurring in low- and middle-income countries. This disparity is expected to increase over the next few decades. On the basis of current trends, tobacco use will kill more than 8 million people worldwide per annum by 2030, with eighty percent of those premature deaths occurring in low- and middle-income countries. The significant burden of morbidity and mortality associated with tobacco use is well documented and proven and will not be repeated here.

The evidence base for addressing the tobacco epidemic domestically, regionally, and globally has developed in a systematic fashion over the past five decades. Effective measures for tobacco control are now well known and have been canvassed widely in the published literature.