Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation.

• Author: Mello, Michelle M.

INTRODUCTION

For several decades, state legislatures and courts have struggled with the question of how to rationalize the system of tort liability as it relates to medical malpractice. It has become commonplace to speak of the costs of malpractice litigation as having reached "crisis" levels, with profound impacts on physicians' professional lives, the quality and quantity of health care delivered in this country, and the nation's fisc. Indeed, both the direct and the indirect costs of malpractice litigation take a heavy toll on litigants and their insurers. Direct costs accrue in the form of litigation expenses and damages paid by malpractice liability insurers to successful plaintiffs.(1) Indirect costs arise in the form of "defensive medicine," that is, "physicians' ordering of tests and procedures ... primarily [for the purpose of reducing] their exposure to malpractice risk."(2) Researchers have encountered difficulties in ascertaining the precise magnitude of these costs,(3) but there is general agreement that they are significant. According to one estimate, the cost of defensive medicine is nearly $7 billion, and the total cost of the medical malpractice system (including damage awards, malpractice insurance premiums, and defensive medicine) is over $22 billion per year.(4)

Not all of this cost is socially inefficient. To be sure, it is desirable to have in place a medical malpractice system that channels reasonable compensation to the victims of medical negligence, even if it involves some transaction costs in the form of litigation expenses. However, there is little doubt that a portion of these costs are "excessive" in the sense that they are unrelated to this goal. Defensive medicine costs are "excessive" if they are incurred to pay for health services that contribute nothing to the health and well-being of the patients for which they are ordered. Litigation expenses may be "excessive" in two ways: First, the costs associated with achieving the "correct" outcome in a malpractice case(5) may be higher than necessary (for example, because too much discovery was conducted or an excessive number of high-priced medical experts was employed). Second, all costs incurred in cases in which an "incorrect" result is reached are socially inefficient. That is, an award of damages to a plaintiff who was not, in fact, the victim of medical negligence is an "excessive" cost of the medical malpractice system. The expense of litigation that does not result in compensation for an authentic malpractice victim is also inefficient. Efforts to reduce costs in the medical malpractice system should thus be aimed at three targets: discouraging defensive medicine, lowering the costs of producing accurate outcomes, and decreasing the incidence of incorrect outcomes.

In the last ten years, there has been increasing attention paid to the possibility of using clinical practice guidelines ("CPGs") to accomplish these goals. CPGs are consensus statements developed by various bodies--public and private--about what constitutes appropriate treatment for a specific condition, set of symptoms, or preventive care goal. The Institute of Medicine has defined CPGs as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances."(6) Because they derive from the consensus of experts, CPGs are thought to represent the prevailing standard of care in the medical profession. It is not surprising, then, that would-be tort reformers have suggested using CPGs as evidence of the legal standard of care in medical malpractice cases.(7)

At first blush, this proposal is attractive. The reformers point out that at present, the medical malpractice system is pervaded by uncertainty: uncertainty as to what constitutes the legal standard of care, uncertainty as to what evidence will be sufficient to prove a breach of that standard, and uncertainty as to the magnitude of the damages a jury will award if it is convinced by that evidence. This uncertainty is manifested in physicians' pursuit of defensive medicine.(8) Unsure about exactly what is required of them, and averse to the risk of being sued, physicians protect themselves by ordering tests and other services that may be medically unnecessary but that will create a "paper trail" that they can later invoke in defense of the care rendered. If physicians knew ex ante that the standard of care to which they had a legal duty to conform was inscribed in black and white in a compendium of CPGs, it is argued, two benefits would be reaped. Physicians would operate under less uncertainty, and consequently would practice medicine less defensively. Additionally, physicians would have an incentive to comply with CPGs, which represent our best estimate of what constitutes good quality care.

This Article attempts to evaluate these arguments in light of the existing empirical evidence concerning the use of CPGs in medical practice and as the legal standard of care. It is proposed that while there may be certain efficiencies associated with the use of CPGs as the legal standard of care, their use is deeply problematic. The argument proceeds as follows: Courts, state legislatures, and academic commentators have suggested a variety of ways in which CPGs could be incorporated into malpractice litigation.(9) While empirical evidence indicates that CPGs currently are being used both as exculpatory evidence (by physician defendants) and as inculpatory evidence (by plaintiffs), statutory reforms enacted to date provide for the one-way, "shield-only" use of CPGs.(10) Indeed, there are good reasons to disallow their inculpatory use. Chief among these is that CPGs do not, in fact, appear to represent prevailing medical practice in most instances. But permitting physicians to use CPGs as an affirmative defense in malpractice litigation while denying plaintiffs the right to use this evidence to prove their own case would also be problematic. Restricting one party's access to relevant, probative, and otherwise admissible evidence on a key element of a legal claim is an anomaly in the law(11) and requires strong justification. There is no such justification for restricting the use of CPGs. Thus, CPGs should either be available to all parties or to none. Because of the problems associated with the inculpatory use of CPGs, the best course of action is to restrict their use by both plaintiffs and defendants.

This Article proceeds in four parts. Part I provides background information about the evolution and purpose of CPGs, the standard of care in medical malpractice cases, current uses of CPGs in malpractice litigation, and reform proposals. Part II presents arguments against the use of CPGs to prove that the defendant physician breached the standard of care. Part III discusses the problems with allowing the one-way exculpatory use of CPGs by defendants. Part IV presents some concluding thoughts on the role CPGs should play in malpractice litigation in the future.

1. BACKGROUND

   1. Evolution and Purpose of Clinical Practice Guidelines

      CPGs have been a part of medical practice for more than half a century.(12) Interest in the possibilities of using CPGs to improve medical practice grew in the 1970s and 1980s after health services researchers discovered wide variations in care processes between different geographic locations within the United States.(13) Practice variation is thought to imply an overuse of medical procedures in some geographic areas, and/or an underuse in other areas, that is attributable to physicians' uncertainty regarding appropriate indications for particular treatments.(14) In response to these empirical findings, health economists such as Alain Enthoven began advocating the use of cost-effectiveness analysis to root out socially inefficient medical practices.(15) Cost-effectiveness analysis and a related method of evaluating clinical interventions, outcomes research,(16) have produced a large body of findings concerning the efficacy of various health services, upon which clinical practice guidelines can be based.

      A number of different parties have involved themselves in composing and disseminating CPGs. The promulgators can be grouped into three categories: professional societies, government bodies, and health care payers (that is, HMOs and insurance companies). The American Medical Association ("AMA") and more than fifty physician specialty boards have been involved in the development of CPGs.(17) CPGs developed by professional medical societies are regarded as highly authoritative,(18) due to both physicians' expertise and the fact that, unlike insurers, physicians' financial incentives traditionally have been aligned with providing top-quality care to their patients. Guidelines developed by professional societies tend to be broad and flexible in nature, leaving substantial room for physicians to exercise clinical judgment. The AMA refers to its CPGs as "parameters" to connote that the guidelines are meant merely to identify "floors" and "ceilings" of appropriate care, defining a range of acceptable practices from which physicians can select according to their training and judgment.(19)

      Medical professional societies have two motivations for developing CPGs. First, they seek to reduce the incidence of avoidable medical injuries and improve the quality of care by reducing overuse of certain services. The AMA has stated:

      In essence, it is hoped that practice parameters will enable physicians to provide high-quality medical care more effectively and efficiently, thereby responding to society's need to control health care expenditures without sacrificing the quality of care. It is expected that practice parameters will help physicians reduce the amount of unnecessary or inappropriate care for patients [and] reduce the incidence of avoidable injuries caused by substandard care and the amount of defensive medicine....(20)...