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Abstract:
The role of hospitals in managing the informed consent process for hospital-based treatments has expanded substantially over the last several decades. Most recently, many hospitals have installed multi-media platforms designed to provide a patient with basic information about a recommended procedure, including its associated risks, and to record the patient’s consent to or rejection of the procedure. Yet, despite the substantial control that hospitals exercise over the informed consent process, state courts routinely dismiss informed consent claims brought against hospitals, holding that only physicians have the training and expertise to satisfy informed consent obligations and therefore that only physicians may be held liable for a breach of those obligations. While there is good reason to overturn the policy against imposing informed consent liability on hospitals, history suggests that it is unlikely to happen. Current law imposing such liability on physicians only has proven its staying power, persisting despite several developments in both health care and law that justify institutional liability. This Article argues that the survival of the policy against imposing informed consent liability on hospitals is both remarkable and mysterious. It then attempts to resolve the mystery by offering a trust-based explanation for the reluctance of courts to act.

Informed Consent, Hospital, Institutional Liability, Trust

Abstract:
Courts and commentators have forgotten that embedded in the duty of physicians to obtain a patient's informed consent is a prior obligation for physicians to get to know that patient. This is most clear in jurisdictions employing the reasonable person standard of disclosure. That standard requires physicians to disclose to a patient information that a reasonable person would want to know if that person were in the patient's position or, more precisely, if that person were "in what the physician should know to be the patient's position." Thus, a physician must learn some minimal information about each patient's "position." An examination of common law reveals that, with rare exception, courts interpret the patient's position to mean nothing more than the patient's medical condition. This article argues that such an understanding of each patient is insufficient for the purposes of achieving efficient use of clinical time, healthy outcomes, and patient autonomy. Instead, the law should require physicians to make a reasonable inquiry about each patient's treatment goals. Such an inquiry will dispel incorrect assumptions that can result from a mere medical assessment of each patient. Under a reasonable inquiry rule, patients would be less likely to receive unnecessary treatment, more likely to play a role in planning their own treatments, more likely to comply with treatment plans and more likely to perceive their physicians as caring professionals. The article concludes that the rule of reasonable inquiry about patients' treatment goals strikes an appropriate balance between the need for autonomy and the need for clinical efficiency.

Abstract:
This Article responds to the work of Professor Mark A. Hall, who has written an accompanying essay in reply, published in the same issue of the Wake Forest Law Review.

This Article identifies an emerging medical trust movement and challenges its normative claim that, as a matter of policy, the law should be used to preserve, if not promote, trust in medicine. Key to this challenge is the fact that the emerging movement defines medical trust in emotional terms as a kind of faith that goes beyond rationally based confidence. First, because the movement defines medical trust as faith, it mistakenly assumes that public perception of our health care system must attain an emotional pedigree before health care can be maximally effective or efficient. Yet, this is inconsistent with evidence that the public relies on our health care delivery system despite its highly institutionalized and impersonal nature that undermines the very faith in medicine that the emerging movement claims to be necessary. Second, pursuing faith in medicine as a matter of policy, as suggested by the emerging movement, would conflict with decades of work designed to make savvy health care consumers out of patients. Patients displaying the emotional kind of trust espoused by the emerging movement are compliant and unlikely to question medical authority, and so a policy of encouraging such trust through law effectively encourages a more docile patient. This could undercut the ability of patients to protect themselves in today's medical marketplace. Third, the emerging trust movement teaches that once emotional trust in health care is lost, it is difficult if not impossible to regain. Consequently, a policy of encouraging faith in medicine will likely abandon those who have lost their faith. In light of recent studies indicating that racial and ethnic minorities are less trusting of physicians and health care institutions, the burden of the movement's proposed policy to encourage faith in medicine could fall disproportionately on racial and ethnic minorities. Finally, a policy of pursuing faith in medicine through law would limit lawmakers to styles of regulation that defer to health care industry insiders to regulate themselves. This is because self-regulation most clearly signals that faith in health care providers is warranted while command-and-control regulations signal that such faith is unjustified. Thus, if law is to encourage faith in medicine, then lawmakers must presume to rely on self-regulation to oversee health care delivery and must generally avoid command-and-control regulation. As a result, the proposed policy of the emerging medical trust movement will limit the ability of lawmakers to protect consumers from dangers associated with our market-based health care delivery system. Given inconclusive evidence of the necessity of faith to good health care and given the risks of promoting faith in medicine through law, this Article concludes that the law should not attempt to promote faith in medicine, but instead should encourage rational confidence in health care. A shift from faith to confidence is a shift from promoting emotional dependence on the good will of health care providers to promoting rational observation of the competence and interests of those providers. By orienting health policy toward consider confidence, the law may be able to achieve the advantages of faith-oriented health policy while also avoiding its drawbacks.

Abstract:
Professor Gatter estimates that institutional ethics consultation processes are used to resolve as many as 13,500 end-of-life treatment (EOLT) disputes each year. Despite this sizable case load, the law has largely ignored the method of dispute resolution used to address EOLT disagreements. This article argues that, at the stage when an ethics consultation is requested in an EOLT dispute, mediation is the most appropriate method for attempting to resolve that dispute. This article challenges current wisdom that mediation is inappropriate for addressing disputes between physicians and patients. The challenge is based on four key points. First, EOLT disputes between physicians and patients (or their decision-makers) involve disputants in an ongoing, trust relationship. Second, a primary goal in resolving disputes between those in a trust relationship should be to preserve that trust as much as possible. Third, mediation is the most likely of dispute resolution methods to preserve trust between disputants. Fourth, techniques exist to minimize, if not eliminate, the risks of mediating disputes between physicians and patients, such as the risk of preserving a power imbalance between the parties. As a result, Professor Gatter recommends changes in the law to assure that patients and their decision-makers are provided with the option of mediating EOLT disputes.

Abstract:
The problem of financial conflicts of interest in human subjects research is international in scope as drug manufacturers conduct trials in countries outside of the U.S., Japan, and the European Union, thereby side-stepping domestic regulation of conflicts of interest. Because such out-sourcing of human drug trials results in exporting risks associated with financial conflicts of interest, this essay examines the primary international sources for regulating those conflicts. These sources include the World Health Organization’s Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products, the Guidelines for Good Clinical Practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects adopted by the Council for International Organizations of Medical Sciences. Each source fails to adequately guard against the harm that financial conflicts of interest can do, and there is reason to believe this inadequacy results from the interest that drug manufacturers in the three largest drug-manufacturing and drug-consuming markets have to keep conflict of interest regulation to a minimum. Strategies for improving international standards are discussed.

Human Research, Conflict of Interest, International Law, Pharmaceutical

Abstract:
There has been a call for more stringent regulation of financial conflicts of interest in human subjects research following the deaths of several individuals who volunteered to participate in human subjects research, which deaths were linked to the financial conflicts of interest of participating researchers and research institutions. Each proposal argues that regulation is necessary to restore trust in medical research. This Article examines whether proposed strategies for regulating financial conflicts of interest are likely to achieve the goal of a trustworthy human research enterprise. It does not question whether enhancing trustworthiness is an appropriate goal; rather, it assumes that such a goal is worth pursuing. Instead, it argues that adopting trustworthiness as a regulatory goal has significant implications for the style of regulation that the law must employ. The Article then questions whether regulatory strategies proposed to date are consistent with a trust-promoting style and, thus, whether those strategies are likely to result in a more trustworthy human research enterprise.

Human Research, Pharmaceuticals, Conflict of Interest, Trust