The American health care system has undergone tremendous transformation over the past few decades. The fee-for-service (FFS) health care system in which physicians enjoyed a great deal of autonomy has become a managed care system in which cost and utilization considerations play a larger role in physician decision making. Although physicians and other health care professionals are still patient advocates, this role often results in a conflict between their own economic interests and their duties to their patients.

Rather than depending on self-sacrificing health care professionals to advocate for them, patients need to assert their own power in the managed care arena. One way to gain such power is to use the class action device in litigation aimed at improving medical care quality, cost and access. Class actions, in fact, are likely to proliferate as managed care organizations (MCOs) grow and affect more patients’ lives. There are well-recognized dangers to using the class action device, but if used properly, it could prove a valuable remedy for patients.

One of the most frequently expressed concerns about new scientific discoveries resulting from the Human Genome Project is the potential for genetic discrimination in insurance and employment. The issue of discrimination in insurance, primarily health insurance, has justifiably received widespread attention in the scholarly literature. Among other research, there has been a special task force on insurance of the Joint Working Group on Ethical, Legal, and Social Implications of the Human Genome Project, a special committee report of the National Action Plan on Breast Cancer, a special report of the American Council of Life Insurance and the Health Insurance Association of America and numerous reports and scholarly articles.

The ethical, legal and social implications of genetic discrimination in employment, although widely recognized as being very important, have received somewhat less attention than genetic discrimination in health insurance. Undoubtedly, much of the concern about genetic discrimination in employment arises from the relationship between employment and group health insurance. However, there are other problems. The disclosure of sensitive genetic information may result in invasions of privacy and breaches of confidentiality in obtaining the information and the loss of employment means denial of the opportunity to earn a livelihood for individuals determined to be at genetic risk. As a result, many at-risk individuals forego genetic testing because they fear these consequences.

Henry Fan, owner of T.I. Drugstores, one of the city's largest pharmacies, just walked into your office for legal advice. He sits down across from your desk and holds his head in his hands. With a worried look on his face, he tells you that his pharmacy has just been sued by one of its customers, Elaine Jones. A year ago, T.I. Drugstores received a prescription for Jones from Dr. Kenneth Brown for Bendectin, a prescription drug used for the treatment of nausea and vomiting during the early stages of pregnancy. After reviewing the prescription for errors, the pharmacist filled the prescription according to its directions and sold it to Jones.

Approximately eight months later, Jones gave birth to a baby girl with severe deformities as a result of the ingested Bendectin. Sadly, her child will never be able to sit or walk properly. Jones is suing T.I. Drugstores for negligently failing to advise her of the potential hazards associated with ingesting Bendectin. Additionally, Jones claims that T.I. Drugstores is strictly liable for failing to warn her of the fact that ingesting Bendectin causes birth defects in children.

Fan informs you that the pharmacist assumed that Brown had forewarned Jones of the risks associated with Bendectin. Outraged, Fan insists that neither his drugstore nor his pharmacist acted incorrectly. They simply did what they were supposed to do: fill the prescription according to its specifications.

Because the health care industry comprises over thirteen percent of the American economy, law enforcers increasingly apply antitrust law to all aspects of health care delivery and financing. Through antitrust enforcement, consumers receive the benefits of lower health care costs and improved health care services. To achieve further cost savings, health care providers are forming, as well as joining, many different types of provider network joint ventures. Providers form networks, expect ing “them to generate efficiencies, reduce excess capacity, improve utilization, permit greater specialization and enhance quality.” However, because they organize competing physicians and enable them to collaborate on prices and set fee schedules, provider networks raise serious antitrust concerns. Consequently, the federal government and courts are increasingly focusing their antitrust enforcement efforts on the formation and anticompetitive activities of provider networks.

In Part I, this Note addresses the degree to which network providers must be economically and financially integrated to legally collaborate and set prices. Part II briefly explains the procedures one may use to enforce the federal antitrust laws. Following this explanation of antitrust enforcement procedures, Part III discusses the relevant statutory and case law applicable to health care provider networks.

The voluntary consent of the human subject is absolutely essential.

Contrary to the first principle of the Nuremberg Code, the voluntary consent of the human subject is neither necessary nor sufficient for ethically and legally responsible research in the United States. That it is not sufficient has been well argued by Robert Burt and others. We would not say that the central problem of the Nazi experiments was their failure to obtain informed consent. Nor would the presentation of signed and witnessed consent forms change anyone's view on the moral justification for the experiments. For related reasons, institutional review boards (IRBs) sometimes reject or defer protocols for paternalistic or various other reasons, arguing that clinicians should not allow patients to consent to be subjects in a study.

The Human Genome Project (HGP) provides information about the human genome that will forever alter society and the way we view ourselves. The genetic age offers great potential, including a future where gene and germ-cell therapy may virtually eliminate genetic disease. However, genetic information may also result in a world characterized by genetic discrimination and genetic determinism. Although genetic information will be used to develop revolutionary treatments, such as gene therapy and other molecular medicine, it will also bring genetic discrimination and heretofore unrealized invasions into the privacy of our genetic codes.

Despite education campaigns about the health hazards associated with smoking and the use of smokeless tobacco, teenage use of tobacco products has reached epidemic proportions. Recent studies indicate that adolescent smoking is on the rise, and that children are beginning to smoke at progressively earlier ages. “Nearly 3,000 young people start smoking each day,” accounting for more than one million new smokers each year. In addition, ninety percent of all new smokers are under the age of eighteen.

Although young people are generally aware of the serious, long-term health risks associated with tobacco use, studies suggest that those who smoke do not usually view those risks as applying to them personally. Furthermore, evidence shows that young people who begin to smoke know about the addictive properties of nicotine, but do not believe that they will become addicted. For these reasons, in August 1995, the Food and Drug Administration (FDA) proposed strict regulations aimed at reducing the number of children and adolescents who smoke. Several of these provisions target cigarette advertisements aimed at minors.

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.

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.

In the United States we have very mixed feelings about research with human subjects. The Nuremberg Code (the Code), which provides a foundation for the protection of human subjects, was written by American judges in the context of trying Nazi doctors who committed atrocious acts of human experimentation on concentration camp inmates. The Code provides ten common-sense guidelines controlling research. For example, a researcher may not conduct research on human subjects without that subject's informed consent, or if there is an a priori reason to believe that the research will cause death or disabling injury to the subject. What is remarkable about the creation of the Code is that it was thought to be necessary to document and impose the most fundamental moral principles on researchers. The Code demonstrates a remarkable suspicion of research with human subjects and those who perform such research.

This could be the world's largest friendly fire incident.

In his classic treatise On War, Karl von Clausewitz emphasizes that courage is the “first quality of a warrior.” He defines two types of courage: “courage in the presence of danger to the person; next, moral courage, or courage in the presence of responsibility, whether before the judgment seat of an external authority or before that of the internal authority of conscience.“ Both were involved in the U.S. military's decision to seek a waiver of informed consent requirements for the use of investigational drugs and vaccines on U.S. troops in the Persian Gulf War. The danger of chemical and biological attack was seen as demanding this waiver; while the Nuremberg Code, medical ethics, and respect for the human rights and dignity of American soldiers cautioned against it. The legal maneuvering to revise consent regulations for wartime conditions provides a case study illustrating how the boundary line between therapy and experimentation can become hopelessly blurred, the differences between law and ethics, and the ethical obligations of military physicians.