Legal Liability for Medical Innovation
Files
Description
Many of the major issues of health care today revolve about two familiar questions to students of tort and regulation. What are the proper institutional arrangements to minimize the level of risk associated with the delivery of products and services, and what level of compensation, if any, should be provided to those persons who are injured when the remaining risks materialize in losses? These questions are especially difficult in cases of medical innovation, where both risks and rewards are frequently great. The enormous complexity of issues is revealed by the range of institutional responses. Deterrence and compensation can be approached under the tort law, specifically through suits for medical malpractice and products liability. They can be handled by various forms of direct legislative and administrative overview, from Food and Drug Administration control over drugs to institutional review boards in local hospitals and medical centers. They also can be handled by private contracts amongst the various parties. Each system of controls works in a different way. The tort remedies tend to operate by indirection: there is no direct supervision over the behavior of the various parties, who (it is hoped) nonetheless are induced to perform properly by the threat of damage actions. The administrative controls, adopted in part out of the fear that some defendants may prove insolvent or some harms (death, serious disabilities) will prove irreparable, represent direct public controls that deploy a mixture of fines, inspections, licensing, and approvals to prevent most losses from occurring. The private contractual element is designed to preserve for patients and consumers some measure of autonomy and choice, at least within the constraints of tort and direct regulation. The hardest problems arise over the mix of remedies. I will start with the tort approach to these questions, specifically medical malpractice and products liability, and then consider how regulation complements or substitutes for it. Although I refer to the issue from time to time, I do not stress an argument that I have made elsewhere, which is that contractual solutions for all the flaws are better than the regulatory and tort alternatives that are so much in vogue today. Instead, I want to address the various methods for the public control of medical innovation, and indeed medical practice generally. That inquiry begins with a discussion of the connections between medical malpractice and products liability law; thereafter, it addresses the integration of tort remedies with direct public control. One central theme is that more need not be merrier. Throughout this essay I want to stress the importance of the coordination between the tort and the regulatory sides of the issue, and to emphasize the great benefits that follow from the adoption of clear rules to handle complex problems. Much of what I have to say is a plea for a return to safe harbors, whether by custom or by statute, for new therapies or products introduced into the marketplace. The sheer number of concrete situations influenced by possible private actions makes it imperative that there be some known and observable standard to guide parties who must act under the applicable legal rules. The present system tends to offer injured persons repeated bites at the apple, wherein it is commonplace to examine medical or manufacturing practices under different standards, first in administrative and then in judicial settings. In my view the duplication of supervision is the source of conflict, cost, and contradiction, all of which should be controlled to help medical innovation, indeed medical treatment, proceed on rational lines. This essay is organized as follows. The first section argues that the rules of product liability and medical malpractice should be understood as an integrated whole: that is, they are best understood if their interactions with each other are taken into account. The second section then examines the way in which these rules should be applied to three distinct contexts: routine cases and known risks, experimental treatment, and routine treatment that reveals an unknowable risk. In each case the key objective of the liability system is to insure the proper transmission of information. Where the information to be transmitted is standardized in form, an official, uniform determination of its adequacy should be made before it is disseminated, not afterwards. As in so many areas of law, the greatest mistake in the current liability rules is their excess of ambition. Certain major risks can be controlled at low price, but in the effort to endow the system with a certainty that it cannot possess, the limited, but vital, gains that are possible are systematically undone. The best again becomes the enemy of the good.
Source Publication
Medical Innovation and Bad Outcomes: Legal, Social, and Ethical Responses
Source Editors/Authors
Mark Siegler
Publication Date
1987
Recommended Citation
Epstein, Richard A., "Legal Liability for Medical Innovation" (1987). Faculty Chapters. 2088.
https://gretchen.law.nyu.edu/fac-chapt/2088
