This Article explores the antitrust and other implications of private credentialing and accrediting programs in the health care industry. Although such programs are usually sponsored by powerful competitor groups, they serve the procompetitive purpose of providing useful information and authoritative advice to independent decision makers. Part One examines the risk that credentialing will sometimes be unfair to competitors and deceive consumers. Its survey of common-law, antitrust, and regulatory interventions to correct such unfairness and deception seeks to determine the degree of oversight to which credentialing and similar activities have been and should be subjected. In recommending that judicial or regulatory scrutiny should be limited to discovering whether standards and practices have a rational relation to a procompetitive purpose, the Article argues that greater intrusion into credentialing schemes would be inconsistent with market theory and first amendment values and would discourage line-drawing efforts that stimulate competition and facilitate consumer choice. By emphasizing throughout that personnel certification and institutional accreditation embody ideology and opinion as well as factual information, Part One sets the stage for the argument in Part Two that antitrust law can and should be used to contest the dominance of a single ideology of health care and to facilitate the development of alternative sources of consumer information. The Article’s overall thesis is that, whereas the quality of advice given to the public about health care personnel and similar matters should not be closely regulated, neither should the supply of competing information and opinion be artificially curtailed.

The age of empirical jurisprudence appears to be upon us. At both trial and appellate levels, empirical data are playing ever more prominent roles in civil and criminal adjudication. Expert witnesses were once confined to a narrow class of forensic scientists. Today psychologists, sociologists, statisticians, and other empirical researchers regularly testify in court. Lawyers aware of the value of using empirical argument hire expert witnesses to discuss and dispute vast bodies of data often generated precisely for the purpose of influencing legal decision-makers.

Courts are continually being asked to settle broad issues of social policy, many of which turn on empirical analyses of the effects of actual and proposed statutes, regulations, and judicially-generated rules. As a result, the use of data-oriented arguments continues to grow. Scholars are looking for change in the traditional structures for regulating the introduction of data into evidence, and have proposed innovative procedures that recognize the potential contributions of empirical results.

More than twenty-four million people in the United States are considered limited English proficient (LEP), and numerous studies have documented the consequences of communication barriers in healthcare. These consequences include: patients’ inability to become engaged and involved in their care; the absence of crucial information—including cultural information—essential to healthcare quality; risks to patient safety arising from the misunderstanding of physician instructions; and ethical and legal lapses stemming from the absence of informed consent. Addressing healthcare rights necessarily entails coming to grips with how to facilitate communication and the exchange of information between the healthcare system and an increasingly diverse patient population.

The history of language access services in healthcare is grounded in two distinct bodies of law: the law of informed consent and civil rights law. Modern notions of informed consent law—which have their roots in the Nuremberg trials of the late 1940s—would recognize a cause of action in tort where a lack of adequate communication creates a barrier to an LEP patient's ability to consent to care. In modern healthcare law, the ability of patients to affirmatively give informed consent to treatment is considered a fundamental element of healthcare quality.

The most publicized finding of the Institute of Medicine (IOM) report is that between 44,000 and 98,000 patients die each year as a result of “adverse events” in medical care. The core concern of the report is to argue that a "systems" approach to medical practice holds out considerable promise for the elimination of the subset of those “adverse events” which are the result of medical error. The report outlines the “systems” approach and proposes various public policies which might encourage the adoption of that approach, enhance its effectiveness and protect it from potentially undermining legal assaults.

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.

Corporate influence is one of the most pressing issues in public health. It cuts across many of our most intractable problems—from obesity to the opioid epidemic. Companies develop close relationships with public health agencies, research universities, academic medical centers, professional societies, and patient advocacy organizations—often funding medical research and public health interventions intended to address the very challenges these corporations are creating or exacerbating. How we view relationships with industry, including how these relationships are framed in ethical discourse, shapes our legal and policy responses to them. In recent years, fueled in part by the opioid epidemic, the ethical framing of industry relationships has begun to evolve in significant ways. But legal and policy responses have not yet caught up. In this article, I develop a temporal account of corporate influence, and legal and policy responses to corporate influence. This account clarifies the limitations and adverse effects of conflicts of interest disclosure, especially when implemented as the sole legal or policy response. Disclosure can illuminate corporate influence—but policymakers cannot and should not rely on disclosure to eliminate corporate influence or its effects. Nor should we allow disclosure to crowd out structural and systemic responses to corporate influence—including sequestration of and separation from private-sector entities.

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (“WIPO”) recently approved a historic “Development Agenda” – a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (“WHO”) has launched its own development agenda of sorts – an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) that is tasked with preparing “a global strategy and plan of action” aimed at “securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

Disparities in health outcomes and access to the essential medicines that affect health outcomes are two of the most pressing issues facing the world today. The lack of adequate health care in developing countries is rooted in a number of systemic problems, including insufficient health infrastructure, lack of medical personnel, government corruption and incompetence, and the high price of pharmaceuticals. These problems are not mutually exclusive. Instead, they are mutually reinforcing, particularly in least developed and developing countries.

The high cost of drugs and vaccines is undoubtedly one of the driving forces in disparate health outcomes, and partial solutions to poor health in the developing world rightly focus on lowering the cost of health products, while preserving the financial incentive for innovation. The high cost of many medicines is largely due to the international patent system, codified by the Trade Related Intellectual Property Rights (TRIPS) Agreement, which grants a monopoly to the innovator and allows it to completely control pricing for a period of years. The result is an access gap, whereby patients in low- and middle-income countries (LMI) cannot afford expensive patented drugs, while patients in wealthy countries can afford and do have access to such treatments.

California is not alone in turning its back on the severely mentally ill. Because of financial incentives from the federal government, every state continues to close state-run psychiatric hospitals, leaving those who are poor and severely mentally ill with no treatment or care. Many cities have areas similar to San Francisco where the mentally ill suffer in public because it is cheaper to abandon the mentally ill to an open-air asylum than it is to build and fund psychiatric hospitals.

The author of this Article, an internationally recognized coroner perhaps best known among laymen for his incisive and tenacious criticism of the Warren Commission report on the Kennedy assassination, turns his attention to the federal government's 1976-1977 Swine Flu Immunization Program. Dr. Wecht contends that although this program may have been viewed by its key proponents as having great public health importance, or perhaps even political value, its creation and continuation nevertheless were scientifically unjustified. Furthermore, he contends, the federal government failed to inform the public adequately of important facts about the program's origins and progress, and it mismanaged the program in several important respects. Among the topics he discusses are swine flu's epidemiological history (including the 1976 Fort Dix outbreak that propelled swine flu into the national consciousness); the key elements leading to the government's decision to immunize; the government's failure to reevaluate the program seriously as problems arose; the shortcomings of the federal swine flu statute; the inadequacy of the government's investigation of the deaths of three persons in Pittsburgh within a few hours after being vaccinated (a matter that was of immediate concern to the author in his role as Coroner of Allegheny County, Pennsylvania); the long-delayed termination of the program following the emergence of a possible statistical link between the immunizations and an increase in the incidence of the Guillain-Barré Syndrome; the financial and human costs of the program; and the need for calmer, more objective decision making in future situations where immunization of the general populace is being considered.

There is little quarrel that access by medical and health policy researchers to medical records and claims data has spurred advances in quality and access to medical treatment. Nevertheless, dissatisfaction lingers with the regime used to regulate access to that information. The American regulatory regime on medical record access has politely been characterized as “fragmented” and less politely as a “black hole.” U.S. Senator Edward M. Kennedy asserts, “[t]oday, video rental records have greater protection than sensitive medical information.” At the center of this dissatisfaction is the question of how much say an individual should have in letting others—even those with legitimate need—look at and use an individual's records.

Currently the number of AIDS-related deaths in the United States has reached 311,000 and at least one million more Americans are infected with HIV. Of those one million or more infected, many spread the virus unknowingly as approximately forty percent of those infected have never been tested. More than eighty-five percent of the U.S. population has never been tested for HIV. No cure or vaccine for HIV currently exists.

The federal and state governments have set up a patchwork of free and confidential HIV testing at local clinics. States have enacted a variety of legislation concerning HIV testing and test results. Most states have enacted statutes that require informed consent for an HIV test to be conducted. All states require the reporting of AIDS cases, and many also require the reporting of HIV-positive status to state public health departments. Furthermore, many states mandate certain requirements for HIV counseling.

Pleas for reform of the legal system are common. One area of the legal system which has drawn considerable scholarly attention is the jury system. Courts often employ juries as fact-finders in civil cases according to the Seventh Amendment of the Constitution: “In Suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved … .” The general theory behind the use of juries is that they are the most capable fact-finders and the bestsuited tribunal for arriving at the most accurate and just outcomes. This idea, however, has been under attack, particularly by those who claim that cases involving certain difficult issues or types of evidence are an inappropriate province for lay jurors who typically have no special background or experience from which to make informed, fair decisions.

The legal system uses expert witnesses to assist triers of fact in understanding issues which are beyond their common knowledge or difficult to comprehend.

My experience and reflections concerning tobacco litigation stem from representing the American Cancer Society in November of 1998,' when the State of Oregon asked Judge Anna Brown of the Circuit Court of Multnomah County in Portland to approve the settlement agreement reached between Oregon and the major tobacco manufacturers. The American Cancer Society inteivened in opposition. The agreement was a part of a multi-state settlement reached by forty-six state Attorneys Generals and the tobacco industry proposed to state courts during that same week and the ensuing weeks around the country. By October of 1999, the Master-Settlement Agreement (MSA) was approved by enough states that it was effectuated. Distributions pursuant to the agreement will begin in 2000 or 2001. Total disbursements over twenty years will exceed $240 billion, a huge amount of money by anyone's standards.

The possibility of cloning human beings, although widely contemplated for several decades, became scientifically feasible in 1997 when the first mammal created through cloning procedures was born. Although the scientists who created the sheep named Dolly did not intend to apply cloning techniques to human beings, news media worldwide began predicting such an application.

In the United States, public and political outcry against the possibility of cloning human beings was loud and swift. Almost immediately, President Clinton announced a ban on federal funding of cloning research and requested the National Bioethics Advisory Commission to prepare a report evaluating the technology and making recommendations concerning its use. Several bills were introduced in Congress which prohibited federal funding and/or banned cloning in both the public and private sectors. As of yet, none of these bills have been passed.

In Jefferson v. Griffin Spalding County Hospital Authority, the Supreme Court of Georgia affirmed a lower court order requiring a pregnant woman to submit to a cesarian section and other medical procedures necessary to save her unborn child’s life. The court found that the state’s interest in protecting the viable fetus outweighed the pregnant mother’s right to religious practice, right to refuse medical treatment, and parental autonomy. Jefferson appears to stand for the proposition that fetuses have rights that attach at viability and that mothers have a corresponding duty to ensure live births. The decision foreshadows substantial conflict between fetal and maternal rights.

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.

In 1965 Congress, through amendments to the Social Security Act, established the Medicare and Medicaid programs and mandated that hospitals participating in those programs be reimbursed for the “reasonable cost” of providing inpatient services to Medicare and Medicaid patients. In this Article, the Chairman of the Massachusetts Rate Setting Commission contends that HEW—which, like Congress, was anxious to stimulate the voluntary participation of hospitals in the Medicare and Medicaid programs—interpreted “reasonable cost” with excessive liberality toward participating hospitals and created a fiscally burdensome and inflationary reimbursement system lacking principles of efficiency and planning. The author then describes a series of attempts—varying in scope and success—to reformulate “reasonable cost,” as applied to Medicare and Medicaid reimbursement, in a manner more consistent with the author's concept of sound public policy. The culmination of these attempts to date, he states, was Public Law 92-603 (Social Security Amendments of 1972), which introduced to the reimbursement system the concepts of (1) tough evaluation of the reasonableness of hospital costs, with emphasis on efficiency, utilization, and planning; (2) shifting de facto power over reimbursement rates away from the hospitals and into the hands of the agencies that purchase their services; and (3) increased public scrutiny of hospital operations. The author contends that this law, and the philosophy which underlies it, represents a healthy balancing of the needs of hospitals and the needs of the public; that the trend toward cost control and public control which the law embodies has been substantially furthered in those states which have statutorily established hospital budget or charge review programs; and that such trend will continue and profoundly affect any national health insurance plan enacted in the future.

The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), i.e., groups of primary care clinicians and practices in all 50 states working to improve clinical care and translate research findings into practice. This symposium contribution seeks to (1) describe some of the common shortcomings of clinical trials, (2) explore the opportunities and challenges posed by use of real-world evidence as a basis for drug and device regulation, (3) briefly describe the history and evolution of PBRNs, and (4) articulate the challenges and opportunities for using PBRNs to fulfill the 21st Century Cures Act mandate for real-world evidence.

Of the over 100 types of human papillomavirus (HPV), more than 40 can be sexually transmitted. Genital HPV infection is very common, with a point prevalence among women worldwide of approximately 10 percent. In most cases, HPV infection is either cleared or becomes undetectable and causes no disease; however, persistent HPV infection is causally related to all cervical cancers and genital warts. In addition, a large proportion of other cancers, such as vaginal, vulvar, anal, and penile cancers as well as many cancers of the head and neck, are associated with HPV infection. Moreover, recurrent respiratory papillomatosis (RRP) is a potentially serious disease caused by HPV types typically responsible for genital warts. RRP can lead to severe airways obstructions and may require repeated surgical interventions. HPV types are typically divided into high-risk types, most often associated with cancers, and low-risk types, typically associated with warts. High-risk types 16 and 18 are responsible for approximately 70 percent of cervical cancers worldwide, whereas low-risk types 6 and 11 are responsible for approximately 90 percent of genital warts.