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.

Until recently, physicians have been the primary health care providers in the United States. In response to the rising health care costs and public demand of the past decade, allied health care providers have challenged this orthodox structure of health care delivery. Among these allied health care providers are nurse practitioners, who have attempted to expand traditional roles of the registered nurse.

This article focuses on the legal issues raised by several major obstacles to the expansion of nurse practitioner services: licensing restrictions, third party reimbursement policies, and denial of access to medical facilities and physician back-up services. The successful judicial challenges to discriminatory practices against other allied health care providers will be explored as a solution to the nurse practitioners’ dilemma.

In recent years, many states have attempted to address the cost and access problems that face their health care systems. Such efforts, however, are significantly impeded by a variety of federalism doctrines that limit the ability of states to regulate the health care market. This Article surveys some of those federalism barriers, including the constitutional restraints imposed by the Commerce Clause, the Privileges and Immunities Clause, and the Fourteenth Amendment, and the statutory hurdles created by ERISA, the Social Security Act, and the Americans with Disabilities Act of 1990. This Article concludes that the restraints that these doctrines and statutes place on states reflect not only federalism concerns, but also deeper ambivalence about governmental regulation of the health care market. Only when that ambivalence is resolved can a proper division of labor between the states and federal government be determined.

Between 1.7 and 4% of the world population is born with intersex conditions, having primary and secondary sexual characteristics that are neither clearly male nor female. The current recommended treatment for an infant born with an intersex condition is genital reconstruction surgery to render the child as clearly sexed either male or female. Every day in the United States, five children are subjected to genital reconstruction surgery that may leave them with permanent physical and emotional scars. Despite efforts by intersexed people to educate the medical community about their rejection of infant genital reconstruction surgery, the American medical community has not yet accepted the fact that differences in genital size and shape do not necessarily require surgical correction.

Genital reconstruction surgery may involve removing part or all of the penis and scrotum or clitoris and labia of a child, remodeling a penis or creating a vaginal opening. While the initial surgery is typically performed in the first month of a child's life, genital reconstruction surgery is not only performed on infants.

Policy debates over medical malpractice in the United States involve a complex amalgam of legal doctrine, public demands to address the problem of medical errors, and the interests of various stakeholder groups. Most parties can agree, however, that the current system for compensating medical injury performs poorly. It falls short of achieving its two main goals: compensation and deterrence. The current system of tort liability is “neither sensitive nor specific in its distribution of compensation:” the vast majority of patients injured by negligent medical care do not receive compensation, yet the system compensates some cases that do not appear to involve negligence. Sometimes, it awards more in noneconomic damages than seems reasonable to many observers. Ultimately, tort liability appears to do little to improve health care quality and safety, yet it spurs costly defensive medicine. Physicians and health care organizations face burdensome insurance and legal costs, leading some to threaten to curtail their services. These concerns about the burden of medical injury and the malpractice “crisis” have sharpened calls for reform.

There is a great deal of misinformation surrounding the economics of pharmaceutical importation and price regulation. Among economists, the principles governing the relationships between prices, innovation, and pharmaceutical research and development (R&D) investment are incontrovertible. Unfortunately, faulty, non-economic analyses abound on these fundamental relationships, reinforcing economic illiteracy and leading to unfounded U.S. public policy.

Effective public policy debate requires that all parties to the debate be informed and aware of the potential costs and benefits associated with new policies, or changes in existing policies. This has not yet occurred for pharmaceutical importation and price regulation policy. Therefore, the purpose of this paper is to provide a positive (in contrast to a normative) economic analysis of pharmaceutical importation and price regulation.

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.

The emerging king of the new health care order is capitation. “Whoever controls the capitated revenue stream will be poised to dominate the emerging health care delivery system— and to reap an enormous windfall that could total hundreds of billions of dollars.” Accordingly, we are witnessing a tremendous struggle over the locus of capitation. Once firmly ensconced in the insurance and HMO industry, capitation is now spreading to organizations controlled by doctors and hospitals.

In a world littered with countless acronyms and organizational types—HMO, IDS, MCO, EPO, PHO, IPA, PSN, OWA—we are most reluctant to introduce yet another. But we must. None of the existing terms describes an important aspect common to all of them that is the subject of this article—providers bearing financial risk for medical expenses. We call these Risk-Bearing Provider Groups (RBPGs). The most prominent example of an RBPG is a physician-hospital organization (PHO), which consists of at least one hospital and one physician practice group that accepts partial or full capitation for at least some of its patients. Accepting capitation risk is not essential to being a PHO, but is a common characteristic. PHOs seek to maintain the financial center of gravity in a provider organization as insurers and employers increasingly come to dominate health care delivery. PHOs can do this by contracting directly with employers on a fully or partially capitated basis, thereby by-passing insurance companies. They can also subcontract with insurance companies or HMOs—so-called “downstream” capitation. Accepting treatment obligations under financial risk helps providers maintain their professional and institutional autonomy and offers the prospect of capturing some of the financial rewards created by the market restructuring that is presently sweeping the country.

Electronic fetal monitoring (EFM) has been criticized as ineffective, unsafe and costly. Despite existing controversy regarding the risks involved in using EFM, this monitoring procedure continues to be widely employed. In many jurisdictions, in fact, the use of EFM during labor may be considered the customary practice. This Article analyzes the medical and legal issues arising from a physician's use of or failure to use EFM. The Author argues that EFM subjects the mother and the fetus to risks which may be avoided if auscultation, a less intrusive monitoring technique, is employed. The ‘customary practice’ standard of care, the ordinary negligence standard of care, and the ‘best judgment’ and ‘duty to keep abreast’ standards of care are compared and applied to the physician's decision to use EFM. The Author contends that physicians who employ auscultation may not be liable for failing to use EFM; however, physicians who use EFM despite the evidence of its risks may be liable for failing to ‘keep abreast’ or to use their ‘best judgment’ or for negligence. Finally, the Author contends that both physicians and their patients are best protected when the physician elicits the mother's informed consent to employ a particular monitoring technique during labor.

In its amendments to the Child Abuse Prevention and Treatment Act, Congress set forth a strict standard for treatment of impaired infants. The statute, shaped by right-to-life groups and certain medical organizations, calls for aggressive treatment in virtually all cases, regardless of the degree of suffering imposed and the burdens and risks involved. The federal rule evidences deep distrust of parental decisionmaking, relegating most parents to a nonparticipatory bystander role.

Congress did not make its rule binding on the states. Rather, it conditioned the receipt of federal funds upon incorporation of the rule into each state's law. Most states have accepted the condition, largely through rulemaking by state child abuse agencies.

This article challenges the authority of state administrators to promulgate these rules, and argues that state constitutions, little mentioned in the Baby Doe debate thus far, may prohibit many states from adopting the federal standard. Ordering medical interventions that perpetuate extreme conditions of physical and mental devastation, subjecting infants to grave suffering for uncertain benefits, and depriving parents of virtually all decisionmaking power violates the norm of governments constitutionally committed to individual liberty, human dignity and family autonomy. A constitutionally sound approach to this issue would permit careful, ethical deliberation, attention to the individual circumstances of each infant Doe and a reasonable degree of parental control.

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword.

This article evaluates consumerism and the regulatory mechanism of which it is essentially an example — legally mandated disclosure of information. We do so by assessing the crucial assumptions about human nature on which consumerism and mandated disclosure depend. Consumerism operates in a variety of contexts in a variety of ways with a variety of aims. To assess so protean a thing, we ask what a patient's life would really be like in a consumerist world The literature abounds in theories about how medical consumers should behave. We look for empirical evidence about how real people actually buy health plans, choose providers, and select treatments.

We conclude that consumerism, and thus mandated disclosure generally, are unlikely to accomplish the goals imagined for them. Consumerism's prerequisites are too many and too demanding. First, consumers must have choices that include the coverage, care-takers, and care they want. Second, reliable information about those choices must be available. Third, information must be put before consumers, especially by doctors. Fourth, consumers must receive the information. Fifth, the information must be complete and comprehensible enough for consumers to use it. Sixth, consumers must understand what they are told. Seventh, consumers must be willing to analyze the information. Eighth, consumers must actually analyze the information and do so well enough to make good choices.

Our review of the empirical evidence concludes that these prerequisites cannot be met reliably most of the time. At every stage people encounter daunting hurdles. Like so many other dreams of controlling costs and giving patients control, consumerism is doomed to disappoint. This does not mean that consumerist tools should never be used. It means they should not be used unadvisedly or lightly, but discreetly, advisedly, soberly, and in the fear of error.

The backlash against managed care, in general, and Health Maintenance Organizations (“HMOs”), in particular, is a major health policy issue. It has led to the formation of major commissions at the national and state levels, and to a great outpouring of legislative activity. The U.S. Congress has been deadlocked over various versions of a Patients’ Bill of Rights for the past two years. As a nation, we are far from resolving the many problems consumers report experiencing with their HMOs. However, to prescribe an effective solution to the problem, it is important to understand the root causes of the consumer backlash. It is, after all, possible that a Patients’ Bill of Rights will do little if it is not targeted to correct what is really bothering people about HMOs.

While science does advance steadily over time, occasionally a scientific breakthrough occurs that does not merely augment current scientific explanations and understandings, but instead radically redirects the focus of the scientific inquiry, fundamentally reconfigures our conception of our world and community, and threatens our existing social and moral conventions. We are currently experiencing such a scientific revolution, precipitated by advances in decoding our genetic makeup. While the revolution began at least by 1952 with the discovery by James Watson and Francis Crick of the structure of the DNA molecule–the molecule that contains our genetic information–the pace of the revolution has accelerated most rapidly in the last ten years. The engine for this change is the Human Genome Project.

Scholars of differing political affiliation and the President's Council on Bioethics have called for regulation of assisted reproductive technology (ART) that would emulate many aspects of the regulatory system of the United Kingdom, in particular that of the Human Fertilisation and Embryology Authority. Specifically, scholars and the Council have argued that research in the U.S. involving gametes and human embryos lacks consistent oversight. While the Centers for Disease Control and Prevention (CDC) produces an annual ART success rate report, submission of data is guaranteed only by the promise that non-responders will be noted as such in the appendix of CDC's report, and most ART clinics publish success rates on the Internet in a much more recognized forum: website advertising. Moreover, U.S. law does not require licensing or accreditation of infertility programs and few regulations govern embryo research. While the large majority of clinics report their success rate data, and many follow practice standards and apply for accreditation from private agencies, these practices are strictly voluntary. Clinics failing to report their success rates face no legal consequence.

Nursing homes perform a vital function in the long-term care continuum by providing nursing care around the clock to the elderly and disabled. By entrusting these institutions with society's frailest members, the general population relies on government agencies and their regulations to ensure that the elderly receive quality care. States expect quality care, but providers often lack the financial support and regulatory guidance.

Recently, the conflict between reimbursement and quality care received national attention. Vencor, the U.S.'s second largest nursing home chain, attempted to terminate its Medicaid contracts and evict all its Medicaid residents. Executives explained that the contract terminations and resident evictions were strategies to make room for higher paying private pay residents. Faced with state, and potentially federal, fines, as well as a district court injunction and public outrage over the patient dumping, the company quickly abandoned its policy and apologized.

Epidemics are among the greatest threats to humanity, and the International Health Regulations are the world's key legal instrument for addressing this threat. Since their revision in 2005, the IHR have faced two big tests: the 2009 H1N1 influenza pandemic and the 2014 Ebola epidemic in West Africa. Both exposed major shortcomings of the IHR, and both offered profound lessons for the future.

The objective of this Article is twofold. First, we seek to compare the lessons learned from H1N1 and Ebola for reforming the IHR in order to test the hypothesis that they are similar. Second, we seek to examine the barriers to implementing these lessons and to identify strategies for overcoming those barriers.

We find that the lessons from H1N1 and Ebola are indeed similar, and that opportunities to act on lessons from H1N1 were woefully missed. We identify many political barriers to global collective action and implementation of lessons for the IHR. On that basis, we describe strategies to overcome these barriers, which will hopefully be deployed now to reform the IHR before the policy window following Ebola closes, and before the inevitable next epidemic comes. The emerging threat of the Zika virus underscores that we have no time to waste.

Signed into law in 2016, the landmark 21st Century Cures Act is as complex as it is divisive. For some stakeholders, including patient groups and representatives of regulated industries, the Act represented a major leap forward in pharmaceutical innovation, human subjects protections, and numerous other provisions. For other observers, this legislation was characterized as a major rollback in important regulations, which would leave patients worse off and the payers holding the bag. The one element of the Act that was relatively uncontroversial covered a number of provisions related to addressing the opioid crisis.

This was by design. Provisions related to this issue were not part of the original legislation and were added to win over additional members of Congress who needed to be brought along to support the legislation. Many of the statute's provisions were intertwined with the Comprehensive Addiction Recovery Act (“CARA”) passed previously, but that legislation was stripped of much of its funding for opioid crisis response.

The Internet offers pharmaceutical companies and medical device manufacturers a dynamic new medium for promoting their products—a medium that might actually be better suited for health care product promotion than print or television. On the Internet's World Wide Web (Web) pages, drug and device makers can produce interactive marketing and advertising material that more easily complies with current Food and Drug Administration (FDA) and Federal Trade Commission (FTC) disclosure requirements. Navigation buttons and hypertext links can facilitate compliance with such information disclosure requirements by allowing drug and device makers to “hide” the brief summaries or labels until interested viewers “click” on them.

Despite the appropriateness of the medium, however, a Web search today will turn up less drug and medical device promotion than one might expect. In fact, the Web, which represented $7 billion in commerce in 1997 and is expected to account for $20 billion in 1998, is strangely quiet on this front.

The creation of new vaccines is one of the key challenges in the battle against global infectious diseases. Therefore, creating the optimal conditions for innovation in vaccines is one of the most important roles law may undertake in this battle. In relation to pharmaceuticals, the economic theory of patent protection is commonly cited by industry and in the academic literature to justify the patenting of life-saving medicines and vaccines. The economic theory of patent protection holds that innovation occurs due to patents protecting the research and development investment made by the innovator. Proponents of this theory claim that without patents such innovation in medicines and vaccines would occur at a significantly reduced rate. This Article considers the applicability of the economic theory of patent protection to pandemic influenza vaccines. This Article examines a number of factors relevant to patent law, theory, and innovation including: the patent landscape for pandemic influenza vaccines; the market dominance enjoyed by manufacturers; the actual risk posed by imitators making generic vaccines if patent protection were not in place; and, the licensing and regulatory provisions for creating generic vaccines.

According to the economic theory of patent protection, a patent incentivizes innovation by providing an innovator with a temporary monopoly regarding their innovation, and by protecting them from the threat posed by imitators who wish to make a cheap replica of the product. However, even without a patent, pandemic influenza vaccine manufacturers are in this position. Due to economies of scale and the complicated regulatory and licensing frameworks relevant to bringing a pandemic influenza vaccine to market, manufacturers are at little to no risk from generic imitators. Moreover, there is a very strong incentive to innovate because pandemic influenza vaccine manufacturers are selling a product for which demand exceeds supply to a captive market of nations and organizations, each of which is hoping to secure as much vaccine as possible. The unique conditions associated with pandemic influenza vaccines appear to provide more of an incentive to innovate and research in this field than the fact that the innovations can be patented.