But it does not matter to a man whether he acts at his own peril or not, unless harm comes of it, and there must always be some one within reach of the consequences of the act before any harm can be done.

—Oliver Wendell Holmes

[Scientists must be certain of their interpretation of the facts, that their priorities are correct, and that they are not bringing unnecessary and unjustified anxiety to many by over-statement or by expression of cancer risks in terms incomprehensible to the lay public.

—John Higginson, Director, International Agency for Research on Cancer

In March of 1998, a Connecticut jury awarded $400,000 under a claim for Negligent Infliction of Emotional Distress (“N.I.E.D”) to an employee who had only lost his job. The employee had been subject to unnecessary internal investigation, and his employment was terminated as a result of this investigation. In December of 1992, a North Carolina jury awarded only $100,000 for N.I.E.D. damages to parents who had lost their nine month-old infant. The parents actually witnessed the death of their infant, who died from swelling of the brain caused by improper administration of intravenous fluids. Both of these awards were meant to compensate plaintiffs for the mental distress caused by the defendants' negligent conduct. Yet considering the circumstances of these two cases, one wonders whether the jurors were really able to evaluate the nature and extent of the plaintiffs' mental distress and, more importantly, what kind of evidence the jurors considered to make their determination.

Can private law litigation serve as a tool for advancing public health objectives? With this contentious and oft-asked question in mind, we tackle Canada's recent tobacco litigation. This Article first presents critical commentary regarding various lawsuits waged against Canadian cigarette manufacturers by citizens acting as individuals or as parties to class action lawsuits. We then turn to analyze how Canada's provincial governments rely on targeted legislation to facilitate private law recourses for recouping the healthcare costs of treating tobacco-related diseases. We address challenges to the constitutionality of this type of legislation, as well as attempts by manufacturers to transfer responsibility to the federal government.

Canadian litigation in this field is nothing like that of the United States with regards to both the volume and variety of its individual and class action litigation claims. This is also true with regard to the stage of advancement of governmental claims in Canada. Nevertheless, particularities of the Canadian context may provide interesting contrast with the situation in the United States.

The Supreme Court of the United States and other courts currently are considering the question of the extent to which the health care field should be subject to antitrust rules. This Article explores the special characteristics of the health care field, and the problems they create for antitrust analysis. Two current cases—Arizona v. Maricopa County Medical Society (awaiting decision by the Supreme Court) and Kartell v. Blue Shield of Massachusetts, Inc. (pending in the District of Massachusetts)—illustrate the issues raised by efforts to contain health care costs through the setting of maximum fees. This Article suggests that traditional antitrust principles should and will prevail over arguments that such restraints are in the public interest.

Victoria, a pregnant inmate housed in a Louisiana state prison, brought a civil rights action challenging the prison’s policy of requiring her to obtain a court order to receive an elective abortion. Although Louisiana state law purported to allow Victoria to obtain an elective abortion, Victoria was unable to obtain her abortion because of procedural delays. Victoria was released from prison before she gave birth but her pregnancy was too far along for her to legally obtain an abortion. She was therefore forced to carry her pregnancy to term and forced to place her newborn child with adoptive parents. Had she given birth in prison, she would have been shackled to her hospital bed, as Louisiana policies require.

Little information regarding pregnancy, prenatal care, perinatal outcomes, and access to elective abortions for female inmates exists. We know, however, that between six and ten percent of the women entering jail or prison are pregnant and that more women may become impregnated in prison as a result of rape by prison guards.

“Fetal vulnerability programs,” which are employer attempts to protect employees' unborn fetuses from harm caused by the mothers' exposure to hazardous material in the workplace, have been challenged as a form of employment discrimination. This Note analyzes the recent judicial application of the Pregnancy Discrimination Act (PDA) and the disparate impact theory to fetal vulnerability cases. The Note also examines the business necessity defense's accommodation of legitimate employer interests. The Note concludes that a more potent business necessity defense, a stricter standard for evaluating alternative protective measures, and a judicial interpretation of the PDA which is more consistent with congressional intent are necessary for fair and reasonable resolution of these cases.

Despite overwhelming epidemiological evidence that cigarette smoking causes cancer, and that addictive nicotine in tobacco keeps smokers smoking, our legal system has yet to allow a recovery against the tobacco industry for the massive harms it knowingly causes. Plaintiff smokers have sought recovery, only to be thwarted by affirmative defenses of assumption of the risk and contributory negligence, preemption of their claims by federal cigarette labeling laws, the difficulty of proving that cigarette smoking causes cancer, and the enormous resources of the $45 billion per year tobacco industry.

After forty years of unsuccessful lawsuits against the tobacco industry, a new plaintiff has come forward. In 1994, Florida and Massachusetts passed legislation enabling the states to bring suit against the tobacco industry to recover Medicaid costs of treating smoking-related illnesses.

Increasingly, health is recognized as a major force for economic development; and because economic development is central to political and social stability, health is being looked at as the great hope for the future of the world, as population sizes and disparities among them increase. This perspective has been growing ever since the 1993 World Development Report was released by the World Bank, and it has fueled an intensive scrutiny of health care around the world, focusing on systems and health care delivery on the one hand, and equitable access to the products of research on the other hand. In the middle of all of is this is a concern about how health care (which must include both the training of personnel from the basic low level health care worker to the physician), and research and development (which must include the financing of research in academia and the development of products primarily in the private sector) are organized, and how they do or do not address inequities between and within populations and nations.

A federal requirement that donor blood be labelled as either “paid” or “volunteer” took effect on May 15, 1978. A major rationale for requiring such labelling is that physicians, now that they can distinguish between categories of blood, will fear liability for post-transfusion hepatitis resulting from the use of paid blood. Thus, supporters of the labelling requirement hope that it will deter the use of high-risk commercial blood. Some paid blood, however, is not commercial blood and in fact may be safer than volunteer blood. The labelling strategy for hepatitis control, therefore, has negative as well as positive attributes. This Article considers the efficacy of blood labelling as a hepatitis control measure and proposes an alternative strategy—the periodic publicizing of hepatitis rates of facilities that perform transfusions—that, if practiced responsibly, could significantly decrease hepatitis transmission rates.

As enacted, the Affordable Care Act (ACA) directed states to provide Medicaid coverage to most nonelderly adults with incomes up to 138% of the Federal Poverty Level (the “Medicaid expansion group”) beginning in 2014. The Medicaid expansion provision of the ACA is an integral component of fulfilling the ACA’s primary objective to achieve near-universal health insurance coverage rates across the United States.

Title XIX of the Social Security Act (Title XIX) is Medicaid’s enabling statute. Medicaid is a medical assistance program for certain low-income individuals, jointly funded and administered by federal and state governments. Certain features of the Medicaid program provide a framework within which the ACA and subsequent Supreme Court decision National Federation of Independent Business (NFIB) v. Sebelius can be understood.

Peer Review Committees (PRCs) that aid insurance companies in evaluating chiropractic treatments and fees have been the focus of recent court challenges. Some practitioners have argued that PRC activities constitute price fixing in violation of the Sherman Antitrust Act. PRCs have been successful thus far in claiming an exemption from antitrust scrutiny as a “business of insurance” within the meaning of the McCarran-Ferguson Act. This Note contends that PRCs are not exempt from antitrust regulation; since PRCs do not spread risks and are involved in inter-rather than intra-industry agreements, their activities do not fall within the narrowly defined “business of insurance” exemption.

The Note then analyzes the merits of the price fixing allegations under both the “per se” standard and the “rule of reason.” First, the Note concludes that the unique nature of the health care market and the legitimate functions served by peer review make the application of a per se standard inappropriate. Second, under the rule of reason, the Note indicates that peer review encourages efficient and innovative health care practices while it deters the escalation of health care costs. The Note concludes that the net effect of peer review is not anticompetitive, especially since PRCs lack the coercive power to compel compliance with the recommendations.

As more same-sex couples enter into civil unions and domestic partnerships, the courts and other institutions are beginning to consider the implications of these partnerships in several areas of the law. A Georgia appeals court, for example, recently published the first opinion addressing this issue, ruling that a civil union of two women, obtained in Vermont, was not equivalent to a marriage for the purposes of interpreting a child custody agreement entered into in Georgia. As many observers predicted, the enactment of legislation recognizing same-sex partnerships has profound implications on the practice of family law, trust and estate law and healthcare law.

This Article focuses on an area of healthcare law in which the legal status of a civil union or domestic partnership could have significant consequences—organ donations. In particular, it explores whether a civil union or domestic partner is an appropriate party to consent to an organ donation.

Despite modern medical advances, births of genetically defective children still occur. The author outlines the problem of genetic disease, and describes the medical and legal advances that now make possible a reduction in its incidence. Then she cites—and briefly comments upon— some court cases brought by parents of genetically defective children against their physicians for allegedly failing to predict or to diagnose genetic defects in those children in time for the parents to exercise any procreative options such as sterilization, contraception, or abortion. In addition, the author speculates on various questions that may arise in future litigation in this area—among them, the question of whether or not courts someday will endow genetically defective children with a cause of action against their parents for bringing them into the world.

This article provides an overview of how the constitutional protections for commercial speech affect the Food and Drug Administration's (FDA) regulation of drugs, and the emerging issues about the scope of these protections. A federal district court has already found that commercial speech allows manufacturers to distribute reprints of medical articles about a new off-label use of a drug as long as it contains disclosures to prevent deception and to inform readers about the lack of FDA review. This paper summarizes the current agency guidance that accepts the manufacturer's distribution of reprints with disclosures.

Allergan, the maker of Botox, recently maintained in a lawsuit that the First Amendment permits drug companies to provide “truthful information” to doctors about “widely accepted” off-label uses of a drug. While the case was settled as part of a fraud and abuse case on other grounds, extending constitutional protections generally to “widely accepted” uses is not warranted, especially if it covers the use of a drug for a new purpose that needs more proof of efficacy, and that can involve substantial risks.

A health law academic pointed out in an article examining a fraud and abuse case that off-label use of drugs is common, and that practitioners may lack adequate dosage information about the off-label uses. Drug companies may obtain approval of a drug for a narrow use, such as for a specific type of pain, but practitioners use the drug for similar uses based on their experience. The writer maintained that a controlled study may not be necessary to establish efficacy for an expanded use of a drug for pain. Even if this is the case, as discussed below in this paper, added safety risks may exist if the expansion covers a longer period of time and use by a wider number of patients. The protections for commercial speech should not be extended to allow manufacturers to distribute information about practitioner use with a disclosure about the lack of FDA approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies.

The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

Intense local opposition has frequently frustrated efforts to site hazardous waste facilities. This Note examines states' attempts to balance the increasing need for such facilities with growing community opposition. The Note focuses on the Massachusetts response to this problem, and argues that the Massachusetts program has failed to adequately preempt a locality's power to block facility siting. The Note proposes an alternative model, based on the National Environmental Policy Act, which addresses local concerns while achieving its purpose of siting safe containment facilities for toxic substances.

This Article analogizes early semiconductor technology and its surrounding economics with isolated genes, stem cells, and related bioproducts, and their surrounding economics, to make the case for sui generis (of its own class) intellectual property protection for isolated bioproducts. Just as early semiconductors failed to meet the patent social bargain requiring novelty and non-obviousness in the 1980s, isolated genes and stem cells currently fail to meet the patent bargain requirements of non-obviousness and eligible subject matter that entitle them to traditional intellectual property protection. Like early semiconductor chip designs, nevertheless, the high cost of upstream bioproduct research and development, coupled with the need to sustain continued economic growth of the biotechnology industry, mandates that Congress provide some level of exclusive rights to ensure continued funding for this research. Sui generis intellectual property protection for isolated bioproducts would preserve the incentive to continue innovation in the field. As illustrated by the semiconductor industry, however, such sui generis protection for this technology must include limitations that address the need to provide an appropriate level of public access to facilitate downstream product development and enrich the public domain.