New Medical Devices Invention, Development, and Use (1988) / Chapter Skim
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Product Liability and Medical Device Regulation: Proposal for Reform
Product Liability and Medical Device Regulation: Proposal for Reform
Pages 73-92
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Both systems have been controversial and have generated heated debate, and proposals for reform have proliferated in recent years. This paper presents an analytical framework from which the strengths and weaknesses of product liability and regulation, as they affect medical devices, can be appraised.
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For example, if product liability suits raise the costs of particular products, this result must be evaluated against the public's demands for widespread access to advanced medical technology and the real cost constraints that government and third-party payers face. Effective policy reform requires an understanding of the individual and social functions underlying product liability and regulation generally, and in relation to medical devices specifically.
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In the context of medical devices, the goal is to prevent the production of unsafe products that cause harm (Sugarman, 19851. This goal benefits society generally, not injured individuals.
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Tort law, however, fails to meet these goals generally, and fails to meet them in relation to medical devices specifically. Admittedly, this conclusion is drawn on what is generally recognized to be limited statistical data (American Bar Association, 19871.
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For example, the California appellate courts have been inconsistent in regard to medical devices. In the most recent case involving the drug diethylstilbestrol (DES)
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Much of the costs of medical devices will be borne by public payers, private insurers, of- employers. Moreover, it is frequently impossible to assign, and therefore internalize, accident costs to a specific product.
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In theory, there is no conflict between the goals of product liability and regulation generally, or in relationship to medical devices specifically. Although their institutional structures and mandates are quite different, both tort and regulation seek to deter the production or use of unsafe products.
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.~° Courts may draw these conclusions even if the FDA has mandated the precise language in the warning labels and has determined that the product is safe and effective. Even where states have interpreted case law to mean that a medical product that meets FDA requirements is not defective for purposes of strict liability, one trial lawyer asserted that "an effective presentation can be made in court that the FDA's standards for medical devices do not preclude recovery since they are so ineffectual as to be virtually meaningless" (Ramsey, 19861.
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MEDICAL DEVICES AS A SPECIAL KIND OF CONSUMER PRODUCT: A FRAMEWORK FOR APPROACHING REFORM At present, medical device regulation and product liability rules have inefficiently and ineffectively addressed both the individual goal of compensation and the social goals of deterrence and punishment. Realignment of the responsibilities of regulation and product liability will lead to a better fit between the desired goals and the processes by which they can be achieved.
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Ignoring the interface between medical devices and medical care is short-sighted and, in the long run, may reduce innovation and be destructive to values of access and equity. A second justification for realignment is the presence of the FDA.
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The following proposal incorporates the fundamental principle essential to rational reform: Individual and social functions need to be decoupled in a framework that treats medical devices as a special kind of product. Within this boundary, the discussion will identify the areas in which further debate must take place.
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FDA would thereby retain its important social function of protecting the public health by regulating all medical devices.
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Thus, companies would benefit from fully cooperating with FDA. The public also would benefit from more timely and complete information on medical device hazards.
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The goal would be to provide some monetary recompense for injuries caused by medical devices. Debate will center on whether the system should be no-fault, like workers compensation, or fault-based, like negligence law.
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Remedies FIGURE 2 Proposed Compensation Board, shifting compensation decisions from the Courts to an administrative federal agency. not based on fault, the award could be for economic losses only (i.e., medical costs, lost wages, etc.)
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This would spread the costs of unexpected adverse reactions as widely as possible across the medical devices industry. An alternative would be to establish a public fund, perhaps supplemented with private money, for unintended, unexpected adverse reactions (in effect, a public-private partnership)
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Elimination of unnecessary procedures, development of rules of compensation and schedules for multiple claims, and streamlining and simplifying the process are all important. The overall need is to develop a compensation system that can satisfy the public's need for compensation for harm without compromising the important values of medical device innovation and health care access and distributional equity.
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This can only be accomplished if medical devices are considered separate from other consumer products and are viewed as an integral part of the health care system. If we do not address the significant limitations of the present tort and regulatory policies in the near future, we may find ourselves making health care compromises that obstruct the values that we intend to protect.
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1986. Coexistence, conflict and cooperation: Public policies toward medical devices.
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1983. Medical Device Regulation: The FDA's Neglected Child.
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