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Cardozo Law Review

Abstract

Uncertainty pervades medicine. It is particularly acute when a physician deliberately deviates from generally accepted practices in an attempt to improve patient care. Unlike innovative drug and device manufacturers, treating physicians are not subject to mandatory ex ante public regulation. The question of how to constrain physician behavior thus largely falls to the tort system. Innovation by definition involves a departure from custom, so adherence to customary standards of care essentially requires physicians to solely bear the liability costs of innovative treatment. This regime, of course, protects patients from unnecessary risks associated with untested therapies, but may also unduly deter physicians from tailoring individualized treatment plans that address patients' particular needs and preferences.

There are several possible alternatives to regulating physician innovation, ranging from the highly paternalistic to the highly libertarian. The public regulatory regime could be revised to require that all untested medical interventions undergo formal testing before physicians are permitted to use them in the treatment setting. But turning an individual from a patient in a treatment setting into a subject in a research setting fundamentally transforms her role in the medical decisionmaking process and the goals of the intervention. At the other extreme, we could adopt a contract-based model of physician liability that allows for more robust and coherent adherence to principles of patient autonomy. But physicians' superior knowledge and patient vulnerabilities caution against treating a medical encounter as an arms-length negotiation.

This Article proposes a fiduciary framework to regulate physician innovation under conditions of endogenous uncertainty. The proposed approach could be described as a "libertarian paternalism" model of medical decisionmaking. It mandates close scrutiny of the decisionmaking process but deference to the substance of medical decisions. Under this framework, the physician should be held liable for failing to act in the patient's best interests, taking into account the patient's unique clinical condition and value preferences. Within these constraints, however, patients should have the freedom to choose - and assume the associated risks and uncertainties - from among a range of clinically acceptable alternatives. Properly applied, fiduciary principles can strike a desirable balance that respects patient autonomy, deters unreasonable risks, and encourages beneficial innovation.

Disciplines

Law | Medical Jurisprudence

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