Duke Law Journal最新文献

Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

This Note identifies a discrepancy in the law governing the decisionmaking that directs patient care. Seeking treatment that a third party will pay for, a patient needs not only a physician-prescribed course of treatment but also an insurer's verification that the cost is medically necessary or otherwise covered by the patient's plan. Both of these decisions directly impact the ultimate care delivered to the patient, but are governed by two very different liability regimes. A patient who suffers an adverse outcome may sue his physician in tort, while a patient who suffers from a lack of coverage may generally sue his insurer only under contract. In other words, when a patient suffers from inadequate care, his potential remedies vary considerably depending on whether the physician or the insurer is the defendant. This discrepancy in liability is the consequence of the federal law governing the administration of employer-sponsored health plans, and its extensive preemption of related state law. Many commentators have called for legal reform to address the distortion of managed care liability that results, arguing that managed care liability must be consistent or that wronged beneficiaries must have access to meaningful remedies. This Note argues that the federal law governing managed care organizations is problematic for a different reason and that the first step toward reform may be more elementary than previously suggested. Specifically, it suggests that the law governing insurers' coverage decisions is inconsistent with the law governing treatment recommendations. Patients suffer the same harm from error in both contexts-but because they can recover substantially more from treating physicians, doctors are named as defendants even when the insurers make errors. Further, this Note argues that simply aligning these two standards might offer a gateway to reform.

Fetal homicide laws criminalize killing a fetus largely to the same extent as killing any other human being. Historically, the common law did not generally recognize feticide as a crime, but this was because of the evidentiary "born-alive" rule, not because of the substantive understanding of the term "human being." As medicine and science have advanced, states have become increasingly willing to abandon this evidentiary rule and to criminalize feticide as homicide. Although most states have recognized the crime of fetal homicide, fourteen have not. This is largely the result of two independent obstacles: (judicial) adherence to the born-alive rule and (legislative) concern that fetal homicide laws could erode constitutionally protected reproductive rights. This Note explores a variety of fetal homicide laws that states have adopted, demonstrating that popular opinion has shifted toward recognizing this crime. It then directly confronts the objections that have prevented other states from adopting such laws: it first reviews the literature suggesting that the born-alive rule should be abandoned, as it is an obsolete evidentiary standard; it then argues that constitutionally protected reproductive liberties can be reconciled with, and in fact augmented by, punishing the killing of a fetus as a homicide.

A growing scientific literature supports the existence of placebo effects from a wide range of health interventions and for a range of medical conditions. This Article reviews this literature, examines the implications for law and policy, and suggests future areas for research on placebo effects. In particular, it makes the case for altering the drug approval process to account for, if not credit, placebo effects. It recommends that evidence of placebo effects be permitted as a defense in cases alleging violations of informed consent or false advertising. Finally, it finds that tort law already has doctrines such as joint and several liability to account for placebo effects. Future research on placebo effects should focus on whether awareness of placebo effects can disable these effects and whether subjects can control their own placebo effects.