The world relies largely on private firms for the development of new medicine, and the system is efficient. Driven by the incentive to profit from sales of new pharmaceuticals, drug companies risk millions of dollars and years of work to shepherd basic scientific discoveries through laboratory and human testing in the hope of developing a marketable drug. For example, it is estimated that in 2002 alone, pharmaceutical companies invested $45 billion the development of new medicine worldwide.

While the profit incentive generates such enormous private investment in human drug development, it also encourages firms to pose inappropriate risks to the safety of human subjects when speeding a new drug to the market. The risks posed by financial conflicts of interest associated with human subjects research on new pharmaceutical products are notable examples, both in the U.S. and internationally.

Picture this: a party to a lawsuit proposes to show jurors images of a human brain to support its claim or defense. The other party objects, and the trial judge must make a ruling. What determines how the judge will rule? That is the question I attempt to address.

I begin in Part II by describing very briefly some existing methods of brain imaging—how they work and what they try to do—and cataloging some possible uses of these methods in courtrooms. Part III discusses current legal standards of admissibility of scientific evidence under the Federal Rules of Evidence (FRE). Part IV examines the particular problem of scientific evidence offered to establish that a person was or was not telling the truth. Part V provides a brief history of some past attempts to introduce brain-imaging evidence into courtrooms. The article concludes with some general comments on the issues facing judges when parties to lawsuits offer brain-imaging evidence.

The United States is currently entering a period in which the demand for longterm care services is growing at a particularly rapid rate; it is projected that the inflation-adjusted expenditures for long-term care will double between 1993 and 2018. As the population continues to age and become more chronically ill and disabled, the need to expand our long-term care capacity, and the long-term care options available, has become self-evident. The question is how we can meet this need in a cost-effective manner that is satisfactory to the consumer of services.

With the opening of the new Supreme Court term and three new cases, each with the potential of eroding or overruling Roe v. Wade, discussions of Webster v. Reproductive Health Services, the most anticipated case of the 1989 term, are seemingly out of fashion. But Webster is significant and noteworthy as the first case of this decade which directly presented the high Court an opportunity to overrule Roe, the 1973 landmark case which afforded women the right to make intimate decisions about abortion free of governmental interference. The Court, flooded with amici curiae on both sides of the issue and an avalanche of political activism unparalleled in this decade, left Roe intact, albeit slightly modified. Because there are no longer five solid votes on the Court to uphold Roe, Webster has left its mark on American politics and has radically changed the tenor of the abortion debate for years to come.

In the absence of capable government services, a railroad company in Texas and multiple cotton mills in North Carolina successfully prevented malaria in the early twentieth century. This Article looks through the lens of economics to understand how and why people had the incentive to privately coordinate malaria prevention during this time, but not after. These firms, motivated by increases in productivity and profit, implemented extensive anti-malaria programs and used their hierarchical organizational structures to monitor performance. The factors underlying the decline of private prevention include a fall in the overall rate of malaria, the increasing presence of the federal government, and technological innovations that lowered exposure to mosquitoes. Understanding how, why, and when firms can prevent diseases has important implications for current disease policy, especially where governments, international organizations, and technologies are not enough.

The rise and fall of the pain-killer Vioxx is one of the most remarkable marketing stories in pharmaceutical history. A true riches to rags tale, its events unfolded with lightning speed in an industry defined by lethargy.

On May 20, 1999, the Merck Company secured FDA approval of Vioxx for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis. From that date through August 2004, 105 million Vioxx prescriptions were filled in the US and an undetermined number were filled outside the US. In 2003 alone, Merck's worldwide Vioxx sales totaled $2.5 billion.

The fall happened even more quickly than the rise. In March 2000, Merck published a study raising the specter of cardiovascular problems associated with taking Vioxx. In November 2000, The New England Journal of Medicine published a study raising similar concerns. In February 2001, an FDA advisory panel became sufficiently concerned about the association of Vioxx and cardiovascular events that it advised the FDA to require a label warning about the possible link.

Physicians have struggled to defeat alternative medicine, and to obtain a monopoly over the health care of their patients, since physicians began systematically organizing in the United States. They claim to oppose alternative medicine because it lacks efficacy, may waste precious health care dollars and may harm patients. Part II of this Article examines the ongoing debate about alternative medicine and the arguments that may wedge the door of Western medicine open to alternative treatment methods. Alternative medicine's successful entry into Western practice depends on convincing conventional medicine of the efficacy of alternative treatments, a task that remains largely undone. Part III explains why the debate about unproven alternative therapies differs from previous discussions about human research, and therefore merits independent consideration. Part IV argues that it is not ethically appropriate for physicians to offer or agree to provide alternative therapies whose efficacy remain unproven or are of dubious potential.

With tobacco trade, the past is prologue. In the 1980s, the U.S. government used domestic trade remedies (“Super 301”) to pry open markets for U.S. tobacco companies. The targets included Japan, South Korea, Taiwan, and Thailand. A grateful tobacco industry donated a renovation of the Treaty Room in the U.S. Department of State, declaring at the dedication: “Tobacco is intimately and historically associated with American diplomacy.”

Thailand responded by banning imported cigarettes on grounds that the imports were more addictive and marketing of imports was driving up consumption. The United States then challenged Thailand for violating the General Agreement on Tariffs and Trade (GATT). The GATT panel ruled against Thailand, finding that the import ban failed to satisfy the health exception of GATT Article XX.

By the end of 2013, almost 122,000 organ transplant candidates in the United States remained active on the national waiting list. The current number of candidates exceeds 123,000. To address this overwhelming need, researchers have been exploring methods to supplement traditional organ donations. At the forefront of this research is regenerative medicine, the field of regenerating or replacing tissue and organ function by studying the body’s own healing mechanisms. Regenerative medicine is quickly fulfilling its promise of producing vascularized, functioning organs in vitro by combining two other areas of research: the replication of cell lines in vitro and the recent adaptation of three-dimensional printing for the health care industry. Today, physicians armed with the latest generation of bioprinters and imaging equipment are creating high-resolution airway splints and personalized bone replacements for human use. These techniques have even achieved success with more complicated structures, including human kidneys and livers.

Alarm about the adverse effects of transferring emergency patients for economic reasons has resulted in federal legislation aimed at curbing the practice. We review the history of common law hospital liability for denial of emergency care and analyze the federal legislation designed to restrict the transfer of medically indigent patients with emergency problems. We conclude that the currently proposed solutions to patient dumping will have limited effectiveness without more specific incentives for the provision of health care to the medically indigent.

On January 23, 1996, thirty-five-year-old Sandra Jensen became a pioneer in medical history as the first person with Down's Syndrome to undergo heart and lungs transplants. Based on her mental retardation, Stanford University and the University of California at San Diego initially rejected Jensen's candidacy for the procedure. The surgeons believed that a person with Down's Syndrome lacked the mental capacity to navigate through possible complications that could occur after the transplantation, even though Jensen, a disabilities activist, had lived on her own since the age of twenty. Eventually, overwhelming pressure from community members, advocacy groups, family and friends forced the hospitals to reconsider and, after closer inquiry, Stanford surgeons admitted to misjudging Jensen's ability to comprehend her condition and to handle her own care. A month after surgery, Jensen took her first trip outside Stanford Medical Center to begin her journey toward recovery.

Jensen expressed the hope that her story would “open doors for others with disabilities who are in need of transplants.” In fact, her experience prompted local politicians to consider legislation barring discrimination against mentally disabled individuals in need of transplants.

This Article examines the question of civil liability arising, both in tort and in contract, as a result of the “wrongful birth” of a child following an unsuccessful sterilization operation. After a general overview of the concept and background of wrongful birth, the Article deals with tort liability in a sterilization-wrongful-birth action, suggesting in particular that there are four stages in the sterilization process at which a physician's conduct may fall below the standard required by law, and discussing the effect of negligence at each of the four stages. The alternative claim for breach of warranty is then examined, with emphasis on the practical difficulties involved in establishing contractual liability in this type of case. Finally, the Article discusses public policy and assessment of damages issues involved in the wrongful birth action, and evaluates the merits of some of the arguments that have been advanced under these headings—particularly the “overriding benefit” theory—to defeat claims for wrongful birth.

The governance of reproductive science is fraught with controversy in nearly every jurisdiction across the globe. Worldwide, legislators and policy makers have struggled to craft meaningful and ethical parameters for the regulation of this new and evolving area of biotechnology. In most countries, it is agreed that some form of regulatory oversight over reproductive technologies is necessary. There is far less consensus, however, as to the type of regulatory structure that should be established. Recent debates over reproductive science have focused on two of the most controversial practices in this area: embryonic stem cell research and cloning technology. Specifically, interested parties have struggled over whether these practices are so egregious that they should be altogether prohibited, or whether they ought to be permitted, but subject to particular legislative limits and regulatory oversight.

The difficulties that most countries have experienced in devising legislation pertaining to embryonic stem cell and cloning research emanate from the moral ambiguity that characterizes this area of science.

Proposals to ration health care in the United States meet a number of objections, symbolic and literal. Nonetheless, an acceptance of the idea of rationing is a necessary first step toward universal health insurance. It must be understood that universal health care requires an acceptance of rationing, and that such an acceptance must precede enactment of a program, if it is to be economically sound and politically feasible. Commentators have argued that reform of the health care system should come before any effort to ration. On the contrary, rationing and reform cannot be separated. The former is the key to the latter, just as rationing is the key to universal health insurance.

The authors present a case study to illustrate how a mentally impaired but socially intact nursing home resident, who had no one to act as an advocate for her, was denied appropriate treatment for an acute illness which ultimately resulted in her death. The case raises important questions about advocacy for the mentally-impaired, acutely-ill institutionalized patient. This Article explores the role of the advocate, how advocates are selected, what qualities and talents they should possess, and what responsibilities should be assigned to them. The authors suggest that nursing home residents should be encouraged to engage in self-advocacy to the greatest extent possible. The competent elderly should be urged to name their preferred advocates. Individuals who serve in advocacy roles should be advised to seek information regarding the patient's wishes from those who know the patient well. Furthermore, there is a need for quality education and training of those who serve in advocacy roles on behalf of nursing home residents, and state laws need to specify the responsibilities of persons who serve as advocates.

Current state laws regulating the licensure of dentists place severe restrictions upon the freedom of movement of practitioners. Most state laws were enacted during a period when a strong rationale for regulating public health and welfare existed. Today, these laws hamper the free movement of dentists and are anachronisms in an era of national standards and practices. The authors contend that the extant laws rest upon outdated assumptions and serve economic and protectionist goals rather than public health and safety.

This Article examines the history and application of the traditional justifications for state licensure and their present ramifications. The authors suggest that replacing the current regulatory system with a national clinical examination and a national licensure program will best serve the interests of the public and the dental profession.

In December 1998, Iceland's Parliament, the Althing, passed the Act on a Health Sector Database (the Database Act or Act), a highly controversial law authorizing the development of a Health Sector Database (the Database) to collect genetic and medical information already contained in various locations around Iceland as part of Iceland's national health system. As a result of the Database Act, Iceland is the only country in the world with laws authorizing collection and storage of the genetic heritage of an entire population by a private biotechnology corporation with rights to exploit the data as a commercial commodity. Many databases now exist in Iceland as individual and segregated entities that contain detailed medical information about every Icelandic person, both living and dead, dating back to 1915 when the recording commenced.

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.