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Legal and Policy Considerations in Using Clinical Practice Guidelines
Legal and Policy Considerations in Using Clinical Practice Guidelines Peter D. Jacobson,
JD, MPH
The increased use of clinical practice guidelines has implications for both public policy and for litigation. Physicians are concerned that the introduction of practice guidelines will reduce their clinical decision-making authority and that the failure to follow clinical practice guidelines will lead to medical liability. Although practice guidelines are an increasing part of medical practice, there has been only limited litigation to determine the extent to which guidelines will be used to set the applicable standard of care. This article discusses the potential legal and public policy issues raised by the introduction and use of clinical practice guidelines. From a legal perspective, the primary issue is whether guidelines will be used to set the “standard of care” or will be
one piece of evidence that a jury would use to determine the outcome of medical liability litigation. Based on an assessment of the applicable legal and policy considerations, the article concludes that courts should admit guidelines into evidence, but that they should not be used as the sole determinant of the standard of care. Instead, guidelines should be treated as one piece of evidence to be weighed by the jury. This approach will facilitate physician acceptance of guidelines by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care. Q1997 by Excerpta Medica, Inc. Am J Cardiol 1997;80(8B):74H–79H
linical practice guidelines, although still in their infancy as a mechanism for clinical decision-makC ing, have already been both praised and vilified by
using practice guidelines, pressures from health plans, payers, and regulators suggest that they will be increasingly integral to medical practice. Indeed, in 1995, the Health Care Financing Administration (HCFA) issued a Notice of Proposed Rulemaking6 using professional society guidelines to define medical necessity in determining reimbursement for cataract surgery. Inevitably, the increased use of practice guidelines will lead to legal considerations and litigation. From a legal perspective, the primary concern is how the introduction of clinical practice guidelines will affect the standard of care. In addition, there are important antitrust questions involved in the development of clinical practice guidelines. These issues are beyond the scope of this article and will not be discussed. Some of the relevant questions are: (1) will physicians be insulated from liability if they adhere to clinical practice guidelines, or will they be exposed to liability for failure to follow specific guidelines; (2) how will the existence of multiple guidelines affect liability; (3) how will legislation authorizing the use of guidelines as a defense to a medical liability suit be interpreted; and (4) what role will physician discretion play in determining liability if a guideline is not followed. At this point, there is only limited litigation interpreting clinical practice guidelines. This short introduction to the legal considerations in using clinical practice guidelines will suggest how the courts are likely to incorporate guidelines into setting the standard of care and set forth the salient legal issues. For the reasons presented below, I anticipate that courts will treat clinical practice guidelines as one piece of evidence in establishing the standard of care, rather than as the primary determinant of the appropriate standard of care.7,8 The narrow question addressed in this article is the legal implications of clinical practice guidelines. This
physicians. Some physicians accept clinical practice guidelines as a measure of physician consensus. Others reject conventional wisdom, and fear the liability consequences of either relying on them or failing to use them.1 The general purpose for developing practice guidelines is to improve the quality of medical care by defining “best practices” based on scientific evidence. Clinical practice guidelines have been defined by the Institute of Medicine (IOM, 1992) as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” These circumstances can encompass many forms from clinical pathways to protocols, guidelines, and policies.2 In this sense, guidelines are used to define appropriate care and to eliminate inappropriate or wasteful medical interventions.3 Guidelines can be developed (1) by medical professional societies such as the American College of Cardiology (ACC); (2) from medical consensus panels such as the National Institutes of Health (NIH) and RAND consensus panels; (3) by healthcare institutions for local use; (4) by governmental agencies such as the Agency for Health Care Policy and Research (AHCPR); or (5) by private firms (such as utilization review firms). The contrast agent guidelines issued by the ACC4 and the American College of Radiology5 are examples of what constitutes appropriate clinical practice guidelines within this definition. Although not all physicians are enthusiastic about From the Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan. Address for reprints: Peter D. Jacobson, JD, MPH, School of Public Health, University of Michigan, 109 South Observatory, Ann Arbor, Michigan 48109-2029.
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issue is embedded within a much broader series of legal questions concerning relationships between patients, health plans, payers, and physicians in the new healthcare environment. Physicians no longer control the allocation of healthcare resources as they did before the advent of managed-care organizations and large integrated delivery systems. The development of legal doctrine on practice guidelines and the broader conflicts emerging between plans, physicians, and patients has generally lagged behind the rapid changes in healthcare delivery.
ESTABLISHING LIABILITY The purposes of tort law are to establish liability for civil wrongs, deter future harmful conduct, and compensate injured victims. Despite considerable dissatisfaction with the current tort system, efforts to reform it, so far, have not succeeded. Thus, the development and implementation of practice guidelines will be shaped, in part, by how courts interpret the guidelines as a matter of tort law. General negligence: To establish negligence generally, a plaintiff must show that the defendant owed a duty to the plaintiff, breached that duty, that the defendant’s actions caused the injury, and that the plaintiff suffered damages. In many instances, general custom in the industry establishes the duty of care owed to a third person. Courts are free, however, to rule that the established custom is inadequate, and thus the courts might hold defendants to higher standards than set by the industry. This is not the case for establishing the standard of care for physicians. Medical liability: To establish medical liability, an injured patient must show that the physician failed to exercise the appropriate standard of care owed to that patient and meet the other elements noted above. In medical liability cases, the medical profession sets its own standard of care based on what is customary and usual practice, as established through physician testimony and medical treatises. Courts are reluctant to substitute their judgment for that of the medical profession, even when a new, safer technology is being considered.9,10 Each physician must exercise the degree of skill ordinarily practiced under similar circumstances by members of the profession. Physicians with special knowledge, such as cardiologists, will be held to customary practices among those of similar skill and training. If, however, there is more than one recognized course of treatment, most courts allow some flexibility in what is regarded as customary; this is known as the respectable minority rule. Although the respectable minority rule is not often invoked as a defense to malpractice litigation, it could permit the use of competing guidelines as a respectable minority defense. The patient must also prove that the failure to maintain the standard of care caused the injury and that damages were incurred.
THE ROLE OF CLINICAL PRACTICE GUIDELINES IN ESTABLISHING THE STANDARD OF CARE The primary legal concern for practicing physicians is how courts will treat clinical practice guidelines in setting the standard of care. At issue is whether courts will hold physicians liable for failure to follow the guidelines and whether adherence to guidelines will provide a defense to liability. Specifically, the legal issue is whether courts will use guidelines to set the standard of care or will allow the use of guidelines as one piece of evidence for the trier of fact to consider. An important consideration is how courts will select among competing guidelines. Will there be a hierarchy of guidelines with professional society guidelines being given greater weight than locally derived guidelines? Some commentators, particularly Havighurst,11 have urged that guidelines can be an alternative to litigation if used as a contractual mechanism to determine the standard of care. Havighurst argues that guidelines incorporated in private contracts between patients and healthcare providers should be used to set the applicable standard of care. In this approach, individual contracts would determine the standard of care rather than the traditional tort approach. So far, this reform has not been adopted either by patients and providers or by the courts. Existing litigation: The answers to the above litigation questions are uncertain at this point. To date, there has been limited litigation involving practice guidelines and no clear patterns or trends have been established.12–14 The available cases, however, provide some guidance for how courts might begin to approach the evidentiary value of guidelines. The initial legal question in these cases has been whether guidelines are equivalent to a medical treatise, and hence admissible into evidence, or should be considered as inadmissible hearsay evidence. For example, in Davenport vs Ephraim McDowell Memorial Hospital,15 the court ruled that professional society guidelines were not considered to be a learned treatise but were nonetheless admissible because they might be “. . . helpful as a guide for measuring care.” On the other hand, in Quigley vs Jobe16 the court upheld the trial judge’s discretion not to admit private insurance guidelines. Neither of these cases, however, provides much guidance for physicians or other courts on the optimal way of introducing guidelines into evidence. In a recent review14 of reported litigation involving guidelines, several courts cited guidelines, especially professional society guidelines, in rejecting physicians’ motions to have the case dismissed. The authors also found that in seven cases, plaintiffs were unable to rely on guidelines to show a breach of the standard of care. In an additional six cases, the defendant physicians were successful in using guidelines to show that they had met the standard of care. Yet, in two more recent cases, defendants were unable to use compliance with guidelines as an affirmative defense (which effectively defeats the claim) to liability.17,18 A SYMPOSIUM: HEART DISEASE AND HEART FAILURE
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Evidentiary considerations: Although the existing litigation does not answer the questions posed, some of these recent cases suggest an approach that adequately balances the policy considerations behind the development and implementation of clinical practice guidelines. This approach is tempered with the legitimate concerns physicians have that their discretion and judgment will be eliminated by rigid adherence to the guidelines. In answering the above legal questions, two aspects of the process of introducing evidence during a trial must be considered. Courts make a distinction between the admission of evidence, and the weight of the evidence. The former is a matter for the judge to decide whereas the latter is usually a matter for the jury, often with general guidance from the judge. ADMISSIBILITY: The recent cases cited14 suggest the likelihood that judges will allow the admission of guidelines into evidence. This, however, was not always the case. Before the relaxation of the rules controlling the introduction of evidence beginning in the 1970s, courts were often reluctant to admit clinical practice guidelines into evidence to establish the standard of care. Guidelines were considered to be hearsay unless, as was usually not the case, the drafter of the guidelines was present for cross-examination.7,19 At that time, the standard of care was usually based on local practices. Guidelines not demonstrating evidence of local practices, they were deemed not relevant. In the 1970s, therefore, courts generally excluded guidelines from being admitted into evidence. Courts relied instead on the testimony of other physicians to determine the standard of care. With the relaxation of evidentiary rules and the shift to a national standard of care, it is unlikely that courts will exclude the admission of guidelines into evidence. As long as an expert is able to testify as to the nature and medical authority of the guideline, it is likely to be treated as relevant and admissible into evidence.12,20 Another important admissibility consideration is whether the guidelines can be used by both sides. In 1990, the Maine legislature enacted the Maine Medical Liability Demonstration Project21 to provide physicians with a defense to medical liability litigation if they adhere to certain specified guidelines. The problem is that the legislation also specified that only physicians could use the guidelines as exculpatory of liability. Plaintiffs may not use failure to adhere to the guidelines as inculpatory of liability. It is unlikely that courts will be receptive to a procedure where only one side can use the guidelines as evidence. WEIGHT: A second evidentiary consideration is the weight to be given by the trier of fact (usually, but not always, the jury) to the guidelines as evidence in establishing the standard of care. Although courts have not stated clearly how this will work, the most likely scenario is that the trier of fact will be able to draw an inference of liability from failure to adhere to the guidelines or an inference of proper care if the guidelines were followed based on expert testimony regarding the guidelines. The inference of below standard care may be rebutted by testimony from other 76H THE AMERICAN JOURNAL OF CARDIOLOGYT
physicians indicating that the failure to adhere to guidelines was appropriate in the individual case for justifiable clinical reasons. The judge will then instruct the jurors in how to weigh the conflicting evidence. In the absence of precedent on how guidelines should be interpreted, judges are most likely to issue instructions to jurors about the jury’s prerogatives in weighing the evidence. In this context, the authority of the guidelines developer will be an important consideration.8 The more respected the drafting authority, such as a national professional association, the more credibility the guidelines are likely to be accorded by the trier of fact. As Rosoff notes,8 guidelines may become the standard of care if widely adopted and followed by the medical community. The specificity of the guideline will also be an important determinant in the weight it is given by the trier of fact. The more specific the guideline the more likely it is to establish the standard of care. The more general the guideline the less likely that deviations from the guidelines will be treated as a breach of the standard of care. COMPETING GUIDELINES: A second issue is the existence of competing guidelines. In some instances, competing guidelines will offer only minimal distinctions. In others, the differences can be substantial. To demonstrate the challenge that the existence of competing guidelines can pose to physicians during litigation, consider the case of mammography for women under 50 years of age. Although a recent NIH consensus panel failed to recommend mammograms for women under 50, several prominent groups, including the American Cancer Society, vehemently disagree. A jury might thus be confronted with the difficulty of choosing between one professional society’s recommendation and an NIH consensus panel that failed to reach consensus. In determining whether to provide mammograms to women under 50, physicians will not be able to predict how courts will respond if sued by a patient for failure to detect cancer when a mammogram was not provided. LOCAL MODIFICATIONS: A third legal question may be how courts would rule if the guidelines were modified by an institution. Suppose, for instance, the ACC contrast agent guidelines were taken as a point of departure but modified by narrowly restricting what constitutes high risk. Then suppose further that a patient would be classified as low risk under the local guidelines but as high risk under the ACC guidelines. Presumably, a plaintiff would introduce the ACC guidelines to show liability whereas the physician would introduce the local modification to demonstrate compliance with an equally plausible standard of care. In that situation, a judge could instruct the jury to establish a hierarchy between professional society guidelines and the local modifications. More likely, the court will defer to the jury to decide between the two guidelines and treat both guidelines as evidence to be considered along with other testimony in the case. In this instance, physician testimony will most likely
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be the determining factor in shaping the litigation outcome. AN EXAMPLE: Many current guidelines, including the American College of Radiology (ACR) and ACC contrast agent guidelines, are lacking in clarity as to what is appropriate medical care. The ACC and ACR guidelines only suggest that it is acceptable to use high osmolar contrast agents for low-risk patients and low osmolar contrast agents for high-risk patients. Thus, the guidelines do not appear to establish a standard of care. Nevertheless, Jacobson and Rosenquist1 found that using low osmolar contrast agents for high-risk patients was sufficiently well established to constitute the applicable standard of care. However, there was no consensus on which contrast agents to use for low-risk patients. In any litigation by a low-risk patient where low osmolar contrast agents were not used, these guidelines are likely to be admitted into evidence. The guidelines will be an important piece of evidence in setting the standard of care but are unlikely to be sufficiently clear to establish the standard of care on their own. The jury will need to weigh the guidelines along with other testimony to determine whether the appropriate standard of care was met. SUMMARY: Considering this analysis, physicians must be prepared to defend why they chose to deviate from professional society guidelines. Plaintiffs’ attorneys are sure to introduce such failure as an indication of below standard care. In essence, this may shift the burden of persuasion from the plaintiff to the physician, requiring the defendant to justify failing to adhere to the guidelines. Policy considerations: There are several policy considerations supporting judicial doctrine to treat guidelines as one piece of evidence for the jury to consider rather than as establishing the standard of care. To begin with, most appropriateness guidelines provide a range of indications for when medical intervention might be considered desirable. For example, in RAND’s consensus statements, there are areas of inappropriateness and appropriateness, but also a middle ground where physician judgment and the patient’s presenting symptoms will determine the proper course of treatment. At the margin, guidelines are too blunt an instrument at this point to establish a clear standard of care. Even in the situation where guidelines are more precise, it is conceivable that two physicians would review the guidelines in relation to a particular patient and reach contrary results. Suppose, as Brennan7 notes, a breast cancer patient cites an NIH consensus guideline as the standard of care in alleging the physician’s liability for breach of care in not ordering a test. That same consensus panel result could be used by another physician to support the decision not to order the test. In both cases, more evidence than the guideline alone is needed to establish the appropriate standard of care for a particular patient. From the perspective of the practicing physician, moreover, there is a disconnect between how clinical decisions are made and how courts set the standard of care. Physicians think more in terms of a spectrum of
care, where clinical decisions are determined as a continuous variable, whereas the courts largely set standards of care as a binary variable— either yes or no. Since guidelines accord with the way many physicians actually make clinical decisions, courts should be reluctant to treat them as presenting yes or no alternatives. Finally, the legal system should encourage the use of practice guidelines without discouraging individual physician judgment. From a policy perspective, rationalizing medical care through practice guidelines is an important objective, but one that should not undermine the essential need to rely on physician judgment based on an individual patient’s presenting medical condition. If courts were to rely solely on guidelines to set the standard of care, physicians would be less likely to exercise their professional judgment because of the potential liability exposure. Guidelines represent a consensus of the best practices based on the best available information when they are developed. They are not and should not be expected to be a panacea for eliminating clinical variations. Scientific knowledge continues to evolve, and guidelines cannot always be amended to reflect the latest developments. Using guidelines to set the standard of care would, therefore, be inappropriate in most instances. PRACTICAL CONSIDERATIONS: One study by Hyams et al13 found that following guidelines deterred the initiation of litigation. Attorneys evidently felt that compliance with guidelines would present a strong defense of adhering to the appropriate standard of care. A further example is the decline of litigation against anesthesiologists following the widespread adoption of the Harvard Anesthesiology Practice Guidelines.22 Thus, although courts have not established the principle that adherence to clinical practice guidelines is a defense to medical liability litigation, it seems reasonable to conclude that physicians adhering to appropriate guidelines are likely to derive at least some legal benefit. Either attorneys for potential plaintiffs will be deterred from initiating litigation or the physician will be able to introduce the guideline into evidence as a defense to the litigation. The tradeoff is, of course, that some physicians distrust the conventional wisdom enshrined by the guidelines while others fear that modification of the guidelines based on physician judgment may expose them to greater liability than would otherwise be the case if guidelines were not available.1 The role of legislation: Aside from the judicial development of doctrine, legislators can impose their own view of how guidelines should be treated in litigation. As noted above, for example, legislation in Maine was enacted to encourage the use of practice guidelines. To date, the results of this project have not been evaluated, but there has been no reported litigation despite expected challenges by plaintiffs to the discrepancy in how the guidelines can be used.14 A SYMPOSIUM: HEART DISEASE AND HEART FAILURE
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CONCLUSIONS Clinical practice guidelines represent an important attempt by physicians to rationalize the practice of medicine based on scientific evidence. It is important for courts to interpret them in a way that will facilitate physician acceptance by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care. To be sure, the foregoing analysis leaves practicing physicians with considerable uncertainty about how guidelines will be treated. Unfortunately, legal doctrine has been slow to emerge in this area, with the consequence that how courts will respond can only be predicted based on a general understanding of how these issues will be presented for determination. It is unlikely that courts will rely solely on guidelines to set the standard of care. Given the physician judgment inherent in any clinical situation, the potential multiplicity of competing and conflicting guidelines, the usual lack of certainty inherent in the guidelines development process, and direct physician testimony, it is improbable that any guideline will suffice to set the standard of care. Failure to follow an established guideline will certainly constitute evidence of a breach of the standard of care, but this can be rebutted by testimony justifying the deviation from the guideline in the particular clinical setting. The best analysis at this point is that the use of clinical practice guidelines will not be an automatic defense to medical liability, but that the failure to impose clinical practice guidelines will not automatically result in liability. However, as Hyams et al13 found, the use of professional society guidelines may well deter the initiation of litigation. In addition, evidence that guidelines were developed and adhered to should be treated as strong evidence of meeting the applicable standard of care.
QUESTIONS AND ANSWERS
Sidney C. Smith, Jr., MD: Most guideline writers that are smart—and the College’s guideline writers certainly are—are very careful in that they can be hoisted on their on petard. They always choose language with the specific goal of not painting themselves into a corner. Rather, the guidelines indicate the very complex and individual nature of medical decision making. They provide a general map from which individuals may deviate for a whole host of reasons. So therefore, in using these guidelines in the courts, their interpretation becomes a contest of the so-called experts. Medical experts can be introduced by both sides that are credible only to the jury, the judge, and the legal system. These so-called experts are presented to the courts as if their opinions are comparable in significance to the ACC Guidelines which, in fact, they are not. Peter D. Jacobson, JD, MPH: You raise two issues. Allow me to briefly address the latter since I don’t want to get into an extended session on the use or misuse of experts. I think your point is absolutely correct. The legal system has major problems regarding expert witnesses, particularly in medical malprac-
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tice. That’s why I try to stress what weight the guidelines should have in terms of establishing the standard. Here, in a sense it is hard to have it both ways, and this really links into the first part of your question, because a well-drafted guideline helps avoid that very problem. A well-drafted guideline is what the professional society says and its experts have said is the standard of care. But, if you draft a guideline too loosely, then you’re opening it up to other experts for interpretation. There is a real trade-off between the specificity of the guideline, which constrains practice, and the expansiveness of the guideline, which leaves considerable individual discretion. I happen to prefer the latter but it still leaves one vulnerable to the expert witness. I think that over time the ability to shape the standard of care through guidelines will at least alleviate the worst excesses of the expert witness problem, but it’s never going to totally eliminate them unless we go to a no-fault based system. Thomas A. Pearson, MD, PhD: Do you think there are some special situations with prevention? For example, with a lot of treatments it is, Use this therapy or that therapy. For many preventive therapies, you are dealing with a person who has a medical event, and the results of clinical trials indicate that the person should be on therapy. That is why a lot of the early standards and report cards dealt with prevention. There weren’t any guidelines. In other words, I couldn’t write a guideline for the treatment of a complex arrhythmia, because it is so complicated. But, for prevention, a person has either had a myocardial infarction or they haven’t, and they should be on aspirin or they should not. Dr. Jacobson: That’s right, but all the pressures, it seems to me, are toward developing more guidelines and constraints. One of the problems is the limitation on physician autonomy in terms of the imposition of guidelines. The policy and the cost pressures are all moving in the direction of wanting to create more guidelines for increasingly complex situations. I agree with you, I wouldn’t want to begin to tell you how to treat any of the patients that you’ve all talked about today. If you’re going to have a system of accountability that involves medical malpractice, then you’re going to have to confront the situation of how the law works given the increase in pressure for guidelines. Dr. Smith: Briefly, could you address the physician’s liability, particularly when they are acting as policymaker in their position in their HMO or group practice as opposed to when they are making a decision just addressing a single patient’s care? Dr. Jacobson: The liability exposure would usually be with the HMO and the utilization review firm. In terms of the physician, the courts have been very much in flux in the sense that they have not understood how the system works and where to assign responsibility for inappropriate care. I think the use of practice guidelines is analogous to that of utilization management. The courts are going to have the same problem as they are with finding who is liable in the utilization management context. In the case of practice guidelines, the law is likely to evolve where the locus
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of responsibility is obviously on the physician. The question will be whether you can cite as a defense that the health plan or utilization firm imposed limits on your judgment forcing you to make a premature patient discharge which led to an adverse outcome. 1. Jacobson PD, Rosenquist CJ. The use of low-osmolar contrast agents: technological change and defensive medicine. J Health Politics, Policy and Law 1996;21:243–266. 2. Mittman BS, Tonesk X, Jacobson PD. Implementing clinical practice guidelines: social influence strategies and practitioner behavior change. Quality Review Bulletin 1992;18:413– 422. 3. Brook RH. Practice guidelines and practicing medicine: are they compatible? JAMA 1989;262:3017–3030. 4. Nissen SE, Douglas JS, Dreifus LS, Gibbons RJ, Higgins CB, Schelbert HR, Seward JB, Zaret BL, Ritchie JL. Use of nonionic or low osmolar contrast agents in cardiovascular procedures. J Am Coll Cardiol 1993;21:269 –273. 5. American College of Radiology (ACR). Current Criteria for the Use of Water Soluble Contrast Agents for Intravenous Injections. Reston, VA: American College of Radiology, 1990. 6. Federal Register, “Medicare program limits on Medicare coverage of cataract surgery”. Vol. 60, No. 194, October 6, 1995, 52396 –52402. 7. Brennan TA. Practice guidelines and malpractice litigation: collision or cohesion? Journal of Health Politics, Policy and Law 1991;16:67– 85. 8. Rosoff AJ. The role of clinical practice guidelines in health care reform. Health Matrix: Journal of Law-Medicine 1995;5;369 –396.
9. Jacobson PD, Rosenquist CJ. The introduction of low osmolar contrast agents in radiology: medical, economic, legal, and public policy issues. JAMA 1988; 260:1586 –1592. 10. Jacobson PD. Medical malpactice and the tort system. JAMA 1989;262: 2230 –2237. 11. Havighurst CC. Health care choices: private contracts as instruments of health reform. The AEI Press, Washington, DC, 1995. 12. West JC. The legal implications of medical practice guidelines. Journal of Health and Hospital Law 1994;27:97–103. 13. Hyams AL, Brandenburg JA, Lipsitz SR, Shapiro DW, Brennan TA. Practice guidelines and malpractice litigation: a two-way street. Ann Intern Med 1995; 122:450 – 455. 14. Hyams AL, Shapiro DW, Brennan TA. Medical malpractice guidelines in malpractice litigation: an early retrospective. J Health Politics, Policy and Law 1996;21:289 –313. 15. Davenport v. Ephraim McDowell Memorial Hospital. 769 S.W.2d 56 (Ky. App. 1990). 16. Quigley v. Jobe. 851 P.2d 236 (Colo.App. 1992). 17. United Blood Services v. Quintana. 827 P.2d 509 (Colo. 1992). 18. Jewett v. Our Lady of Mercy Hospital.612 N.E.2d 724 (Ohio Ct. App. 1992). 19. Anderson GF, Hall MF, Steinberg EP. Medical technology assessment and practice guidelines: their day in court. Am J Public Health 1993;83:1635– 1639. 20. West JC. Risk management and medical practice guidelines: what is risk management’s proper role? J Healthcare Risk Manage 1994;14:11–16. 21. 24 Me. Rev. Stat. Ann. § 2851 et seq. 22. Cheney FW, Posner K, Caplan RA, Ward RJ. Standard of care and anesthesia liability. JAMA 1989;261:1599 –1603.
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JD, MPH
The increased use of clinical practice guidelines has implications for both public policy and for litigation. Physicians are concerned that the introduction of practice guidelines will reduce their clinical decision-making authority and that the failure to follow clinical practice guidelines will lead to medical liability. Although practice guidelines are an increasing part of medical practice, there has been only limited litigation to determine the extent to which guidelines will be used to set the applicable standard of care. This article discusses the potential legal and public policy issues raised by the introduction and use of clinical practice guidelines. From a legal perspective, the primary issue is whether guidelines will be used to set the “standard of care” or will be
one piece of evidence that a jury would use to determine the outcome of medical liability litigation. Based on an assessment of the applicable legal and policy considerations, the article concludes that courts should admit guidelines into evidence, but that they should not be used as the sole determinant of the standard of care. Instead, guidelines should be treated as one piece of evidence to be weighed by the jury. This approach will facilitate physician acceptance of guidelines by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care. Q1997 by Excerpta Medica, Inc. Am J Cardiol 1997;80(8B):74H–79H
linical practice guidelines, although still in their infancy as a mechanism for clinical decision-makC ing, have already been both praised and vilified by
using practice guidelines, pressures from health plans, payers, and regulators suggest that they will be increasingly integral to medical practice. Indeed, in 1995, the Health Care Financing Administration (HCFA) issued a Notice of Proposed Rulemaking6 using professional society guidelines to define medical necessity in determining reimbursement for cataract surgery. Inevitably, the increased use of practice guidelines will lead to legal considerations and litigation. From a legal perspective, the primary concern is how the introduction of clinical practice guidelines will affect the standard of care. In addition, there are important antitrust questions involved in the development of clinical practice guidelines. These issues are beyond the scope of this article and will not be discussed. Some of the relevant questions are: (1) will physicians be insulated from liability if they adhere to clinical practice guidelines, or will they be exposed to liability for failure to follow specific guidelines; (2) how will the existence of multiple guidelines affect liability; (3) how will legislation authorizing the use of guidelines as a defense to a medical liability suit be interpreted; and (4) what role will physician discretion play in determining liability if a guideline is not followed. At this point, there is only limited litigation interpreting clinical practice guidelines. This short introduction to the legal considerations in using clinical practice guidelines will suggest how the courts are likely to incorporate guidelines into setting the standard of care and set forth the salient legal issues. For the reasons presented below, I anticipate that courts will treat clinical practice guidelines as one piece of evidence in establishing the standard of care, rather than as the primary determinant of the appropriate standard of care.7,8 The narrow question addressed in this article is the legal implications of clinical practice guidelines. This
physicians. Some physicians accept clinical practice guidelines as a measure of physician consensus. Others reject conventional wisdom, and fear the liability consequences of either relying on them or failing to use them.1 The general purpose for developing practice guidelines is to improve the quality of medical care by defining “best practices” based on scientific evidence. Clinical practice guidelines have been defined by the Institute of Medicine (IOM, 1992) as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” These circumstances can encompass many forms from clinical pathways to protocols, guidelines, and policies.2 In this sense, guidelines are used to define appropriate care and to eliminate inappropriate or wasteful medical interventions.3 Guidelines can be developed (1) by medical professional societies such as the American College of Cardiology (ACC); (2) from medical consensus panels such as the National Institutes of Health (NIH) and RAND consensus panels; (3) by healthcare institutions for local use; (4) by governmental agencies such as the Agency for Health Care Policy and Research (AHCPR); or (5) by private firms (such as utilization review firms). The contrast agent guidelines issued by the ACC4 and the American College of Radiology5 are examples of what constitutes appropriate clinical practice guidelines within this definition. Although not all physicians are enthusiastic about From the Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan. Address for reprints: Peter D. Jacobson, JD, MPH, School of Public Health, University of Michigan, 109 South Observatory, Ann Arbor, Michigan 48109-2029.
74H
©1997 by Excerpta Medica, Inc. All rights reserved.
0002-9149/97/$17.00 PII S002-9149(97)00826-6
issue is embedded within a much broader series of legal questions concerning relationships between patients, health plans, payers, and physicians in the new healthcare environment. Physicians no longer control the allocation of healthcare resources as they did before the advent of managed-care organizations and large integrated delivery systems. The development of legal doctrine on practice guidelines and the broader conflicts emerging between plans, physicians, and patients has generally lagged behind the rapid changes in healthcare delivery.
ESTABLISHING LIABILITY The purposes of tort law are to establish liability for civil wrongs, deter future harmful conduct, and compensate injured victims. Despite considerable dissatisfaction with the current tort system, efforts to reform it, so far, have not succeeded. Thus, the development and implementation of practice guidelines will be shaped, in part, by how courts interpret the guidelines as a matter of tort law. General negligence: To establish negligence generally, a plaintiff must show that the defendant owed a duty to the plaintiff, breached that duty, that the defendant’s actions caused the injury, and that the plaintiff suffered damages. In many instances, general custom in the industry establishes the duty of care owed to a third person. Courts are free, however, to rule that the established custom is inadequate, and thus the courts might hold defendants to higher standards than set by the industry. This is not the case for establishing the standard of care for physicians. Medical liability: To establish medical liability, an injured patient must show that the physician failed to exercise the appropriate standard of care owed to that patient and meet the other elements noted above. In medical liability cases, the medical profession sets its own standard of care based on what is customary and usual practice, as established through physician testimony and medical treatises. Courts are reluctant to substitute their judgment for that of the medical profession, even when a new, safer technology is being considered.9,10 Each physician must exercise the degree of skill ordinarily practiced under similar circumstances by members of the profession. Physicians with special knowledge, such as cardiologists, will be held to customary practices among those of similar skill and training. If, however, there is more than one recognized course of treatment, most courts allow some flexibility in what is regarded as customary; this is known as the respectable minority rule. Although the respectable minority rule is not often invoked as a defense to malpractice litigation, it could permit the use of competing guidelines as a respectable minority defense. The patient must also prove that the failure to maintain the standard of care caused the injury and that damages were incurred.
THE ROLE OF CLINICAL PRACTICE GUIDELINES IN ESTABLISHING THE STANDARD OF CARE The primary legal concern for practicing physicians is how courts will treat clinical practice guidelines in setting the standard of care. At issue is whether courts will hold physicians liable for failure to follow the guidelines and whether adherence to guidelines will provide a defense to liability. Specifically, the legal issue is whether courts will use guidelines to set the standard of care or will allow the use of guidelines as one piece of evidence for the trier of fact to consider. An important consideration is how courts will select among competing guidelines. Will there be a hierarchy of guidelines with professional society guidelines being given greater weight than locally derived guidelines? Some commentators, particularly Havighurst,11 have urged that guidelines can be an alternative to litigation if used as a contractual mechanism to determine the standard of care. Havighurst argues that guidelines incorporated in private contracts between patients and healthcare providers should be used to set the applicable standard of care. In this approach, individual contracts would determine the standard of care rather than the traditional tort approach. So far, this reform has not been adopted either by patients and providers or by the courts. Existing litigation: The answers to the above litigation questions are uncertain at this point. To date, there has been limited litigation involving practice guidelines and no clear patterns or trends have been established.12–14 The available cases, however, provide some guidance for how courts might begin to approach the evidentiary value of guidelines. The initial legal question in these cases has been whether guidelines are equivalent to a medical treatise, and hence admissible into evidence, or should be considered as inadmissible hearsay evidence. For example, in Davenport vs Ephraim McDowell Memorial Hospital,15 the court ruled that professional society guidelines were not considered to be a learned treatise but were nonetheless admissible because they might be “. . . helpful as a guide for measuring care.” On the other hand, in Quigley vs Jobe16 the court upheld the trial judge’s discretion not to admit private insurance guidelines. Neither of these cases, however, provides much guidance for physicians or other courts on the optimal way of introducing guidelines into evidence. In a recent review14 of reported litigation involving guidelines, several courts cited guidelines, especially professional society guidelines, in rejecting physicians’ motions to have the case dismissed. The authors also found that in seven cases, plaintiffs were unable to rely on guidelines to show a breach of the standard of care. In an additional six cases, the defendant physicians were successful in using guidelines to show that they had met the standard of care. Yet, in two more recent cases, defendants were unable to use compliance with guidelines as an affirmative defense (which effectively defeats the claim) to liability.17,18 A SYMPOSIUM: HEART DISEASE AND HEART FAILURE
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Evidentiary considerations: Although the existing litigation does not answer the questions posed, some of these recent cases suggest an approach that adequately balances the policy considerations behind the development and implementation of clinical practice guidelines. This approach is tempered with the legitimate concerns physicians have that their discretion and judgment will be eliminated by rigid adherence to the guidelines. In answering the above legal questions, two aspects of the process of introducing evidence during a trial must be considered. Courts make a distinction between the admission of evidence, and the weight of the evidence. The former is a matter for the judge to decide whereas the latter is usually a matter for the jury, often with general guidance from the judge. ADMISSIBILITY: The recent cases cited14 suggest the likelihood that judges will allow the admission of guidelines into evidence. This, however, was not always the case. Before the relaxation of the rules controlling the introduction of evidence beginning in the 1970s, courts were often reluctant to admit clinical practice guidelines into evidence to establish the standard of care. Guidelines were considered to be hearsay unless, as was usually not the case, the drafter of the guidelines was present for cross-examination.7,19 At that time, the standard of care was usually based on local practices. Guidelines not demonstrating evidence of local practices, they were deemed not relevant. In the 1970s, therefore, courts generally excluded guidelines from being admitted into evidence. Courts relied instead on the testimony of other physicians to determine the standard of care. With the relaxation of evidentiary rules and the shift to a national standard of care, it is unlikely that courts will exclude the admission of guidelines into evidence. As long as an expert is able to testify as to the nature and medical authority of the guideline, it is likely to be treated as relevant and admissible into evidence.12,20 Another important admissibility consideration is whether the guidelines can be used by both sides. In 1990, the Maine legislature enacted the Maine Medical Liability Demonstration Project21 to provide physicians with a defense to medical liability litigation if they adhere to certain specified guidelines. The problem is that the legislation also specified that only physicians could use the guidelines as exculpatory of liability. Plaintiffs may not use failure to adhere to the guidelines as inculpatory of liability. It is unlikely that courts will be receptive to a procedure where only one side can use the guidelines as evidence. WEIGHT: A second evidentiary consideration is the weight to be given by the trier of fact (usually, but not always, the jury) to the guidelines as evidence in establishing the standard of care. Although courts have not stated clearly how this will work, the most likely scenario is that the trier of fact will be able to draw an inference of liability from failure to adhere to the guidelines or an inference of proper care if the guidelines were followed based on expert testimony regarding the guidelines. The inference of below standard care may be rebutted by testimony from other 76H THE AMERICAN JOURNAL OF CARDIOLOGYT
physicians indicating that the failure to adhere to guidelines was appropriate in the individual case for justifiable clinical reasons. The judge will then instruct the jurors in how to weigh the conflicting evidence. In the absence of precedent on how guidelines should be interpreted, judges are most likely to issue instructions to jurors about the jury’s prerogatives in weighing the evidence. In this context, the authority of the guidelines developer will be an important consideration.8 The more respected the drafting authority, such as a national professional association, the more credibility the guidelines are likely to be accorded by the trier of fact. As Rosoff notes,8 guidelines may become the standard of care if widely adopted and followed by the medical community. The specificity of the guideline will also be an important determinant in the weight it is given by the trier of fact. The more specific the guideline the more likely it is to establish the standard of care. The more general the guideline the less likely that deviations from the guidelines will be treated as a breach of the standard of care. COMPETING GUIDELINES: A second issue is the existence of competing guidelines. In some instances, competing guidelines will offer only minimal distinctions. In others, the differences can be substantial. To demonstrate the challenge that the existence of competing guidelines can pose to physicians during litigation, consider the case of mammography for women under 50 years of age. Although a recent NIH consensus panel failed to recommend mammograms for women under 50, several prominent groups, including the American Cancer Society, vehemently disagree. A jury might thus be confronted with the difficulty of choosing between one professional society’s recommendation and an NIH consensus panel that failed to reach consensus. In determining whether to provide mammograms to women under 50, physicians will not be able to predict how courts will respond if sued by a patient for failure to detect cancer when a mammogram was not provided. LOCAL MODIFICATIONS: A third legal question may be how courts would rule if the guidelines were modified by an institution. Suppose, for instance, the ACC contrast agent guidelines were taken as a point of departure but modified by narrowly restricting what constitutes high risk. Then suppose further that a patient would be classified as low risk under the local guidelines but as high risk under the ACC guidelines. Presumably, a plaintiff would introduce the ACC guidelines to show liability whereas the physician would introduce the local modification to demonstrate compliance with an equally plausible standard of care. In that situation, a judge could instruct the jury to establish a hierarchy between professional society guidelines and the local modifications. More likely, the court will defer to the jury to decide between the two guidelines and treat both guidelines as evidence to be considered along with other testimony in the case. In this instance, physician testimony will most likely
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be the determining factor in shaping the litigation outcome. AN EXAMPLE: Many current guidelines, including the American College of Radiology (ACR) and ACC contrast agent guidelines, are lacking in clarity as to what is appropriate medical care. The ACC and ACR guidelines only suggest that it is acceptable to use high osmolar contrast agents for low-risk patients and low osmolar contrast agents for high-risk patients. Thus, the guidelines do not appear to establish a standard of care. Nevertheless, Jacobson and Rosenquist1 found that using low osmolar contrast agents for high-risk patients was sufficiently well established to constitute the applicable standard of care. However, there was no consensus on which contrast agents to use for low-risk patients. In any litigation by a low-risk patient where low osmolar contrast agents were not used, these guidelines are likely to be admitted into evidence. The guidelines will be an important piece of evidence in setting the standard of care but are unlikely to be sufficiently clear to establish the standard of care on their own. The jury will need to weigh the guidelines along with other testimony to determine whether the appropriate standard of care was met. SUMMARY: Considering this analysis, physicians must be prepared to defend why they chose to deviate from professional society guidelines. Plaintiffs’ attorneys are sure to introduce such failure as an indication of below standard care. In essence, this may shift the burden of persuasion from the plaintiff to the physician, requiring the defendant to justify failing to adhere to the guidelines. Policy considerations: There are several policy considerations supporting judicial doctrine to treat guidelines as one piece of evidence for the jury to consider rather than as establishing the standard of care. To begin with, most appropriateness guidelines provide a range of indications for when medical intervention might be considered desirable. For example, in RAND’s consensus statements, there are areas of inappropriateness and appropriateness, but also a middle ground where physician judgment and the patient’s presenting symptoms will determine the proper course of treatment. At the margin, guidelines are too blunt an instrument at this point to establish a clear standard of care. Even in the situation where guidelines are more precise, it is conceivable that two physicians would review the guidelines in relation to a particular patient and reach contrary results. Suppose, as Brennan7 notes, a breast cancer patient cites an NIH consensus guideline as the standard of care in alleging the physician’s liability for breach of care in not ordering a test. That same consensus panel result could be used by another physician to support the decision not to order the test. In both cases, more evidence than the guideline alone is needed to establish the appropriate standard of care for a particular patient. From the perspective of the practicing physician, moreover, there is a disconnect between how clinical decisions are made and how courts set the standard of care. Physicians think more in terms of a spectrum of
care, where clinical decisions are determined as a continuous variable, whereas the courts largely set standards of care as a binary variable— either yes or no. Since guidelines accord with the way many physicians actually make clinical decisions, courts should be reluctant to treat them as presenting yes or no alternatives. Finally, the legal system should encourage the use of practice guidelines without discouraging individual physician judgment. From a policy perspective, rationalizing medical care through practice guidelines is an important objective, but one that should not undermine the essential need to rely on physician judgment based on an individual patient’s presenting medical condition. If courts were to rely solely on guidelines to set the standard of care, physicians would be less likely to exercise their professional judgment because of the potential liability exposure. Guidelines represent a consensus of the best practices based on the best available information when they are developed. They are not and should not be expected to be a panacea for eliminating clinical variations. Scientific knowledge continues to evolve, and guidelines cannot always be amended to reflect the latest developments. Using guidelines to set the standard of care would, therefore, be inappropriate in most instances. PRACTICAL CONSIDERATIONS: One study by Hyams et al13 found that following guidelines deterred the initiation of litigation. Attorneys evidently felt that compliance with guidelines would present a strong defense of adhering to the appropriate standard of care. A further example is the decline of litigation against anesthesiologists following the widespread adoption of the Harvard Anesthesiology Practice Guidelines.22 Thus, although courts have not established the principle that adherence to clinical practice guidelines is a defense to medical liability litigation, it seems reasonable to conclude that physicians adhering to appropriate guidelines are likely to derive at least some legal benefit. Either attorneys for potential plaintiffs will be deterred from initiating litigation or the physician will be able to introduce the guideline into evidence as a defense to the litigation. The tradeoff is, of course, that some physicians distrust the conventional wisdom enshrined by the guidelines while others fear that modification of the guidelines based on physician judgment may expose them to greater liability than would otherwise be the case if guidelines were not available.1 The role of legislation: Aside from the judicial development of doctrine, legislators can impose their own view of how guidelines should be treated in litigation. As noted above, for example, legislation in Maine was enacted to encourage the use of practice guidelines. To date, the results of this project have not been evaluated, but there has been no reported litigation despite expected challenges by plaintiffs to the discrepancy in how the guidelines can be used.14 A SYMPOSIUM: HEART DISEASE AND HEART FAILURE
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CONCLUSIONS Clinical practice guidelines represent an important attempt by physicians to rationalize the practice of medicine based on scientific evidence. It is important for courts to interpret them in a way that will facilitate physician acceptance by not imposing liability for the failure to follow guidelines without additional evidence to determine the standard of care. To be sure, the foregoing analysis leaves practicing physicians with considerable uncertainty about how guidelines will be treated. Unfortunately, legal doctrine has been slow to emerge in this area, with the consequence that how courts will respond can only be predicted based on a general understanding of how these issues will be presented for determination. It is unlikely that courts will rely solely on guidelines to set the standard of care. Given the physician judgment inherent in any clinical situation, the potential multiplicity of competing and conflicting guidelines, the usual lack of certainty inherent in the guidelines development process, and direct physician testimony, it is improbable that any guideline will suffice to set the standard of care. Failure to follow an established guideline will certainly constitute evidence of a breach of the standard of care, but this can be rebutted by testimony justifying the deviation from the guideline in the particular clinical setting. The best analysis at this point is that the use of clinical practice guidelines will not be an automatic defense to medical liability, but that the failure to impose clinical practice guidelines will not automatically result in liability. However, as Hyams et al13 found, the use of professional society guidelines may well deter the initiation of litigation. In addition, evidence that guidelines were developed and adhered to should be treated as strong evidence of meeting the applicable standard of care.
QUESTIONS AND ANSWERS
Sidney C. Smith, Jr., MD: Most guideline writers that are smart—and the College’s guideline writers certainly are—are very careful in that they can be hoisted on their on petard. They always choose language with the specific goal of not painting themselves into a corner. Rather, the guidelines indicate the very complex and individual nature of medical decision making. They provide a general map from which individuals may deviate for a whole host of reasons. So therefore, in using these guidelines in the courts, their interpretation becomes a contest of the so-called experts. Medical experts can be introduced by both sides that are credible only to the jury, the judge, and the legal system. These so-called experts are presented to the courts as if their opinions are comparable in significance to the ACC Guidelines which, in fact, they are not. Peter D. Jacobson, JD, MPH: You raise two issues. Allow me to briefly address the latter since I don’t want to get into an extended session on the use or misuse of experts. I think your point is absolutely correct. The legal system has major problems regarding expert witnesses, particularly in medical malprac-
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tice. That’s why I try to stress what weight the guidelines should have in terms of establishing the standard. Here, in a sense it is hard to have it both ways, and this really links into the first part of your question, because a well-drafted guideline helps avoid that very problem. A well-drafted guideline is what the professional society says and its experts have said is the standard of care. But, if you draft a guideline too loosely, then you’re opening it up to other experts for interpretation. There is a real trade-off between the specificity of the guideline, which constrains practice, and the expansiveness of the guideline, which leaves considerable individual discretion. I happen to prefer the latter but it still leaves one vulnerable to the expert witness. I think that over time the ability to shape the standard of care through guidelines will at least alleviate the worst excesses of the expert witness problem, but it’s never going to totally eliminate them unless we go to a no-fault based system. Thomas A. Pearson, MD, PhD: Do you think there are some special situations with prevention? For example, with a lot of treatments it is, Use this therapy or that therapy. For many preventive therapies, you are dealing with a person who has a medical event, and the results of clinical trials indicate that the person should be on therapy. That is why a lot of the early standards and report cards dealt with prevention. There weren’t any guidelines. In other words, I couldn’t write a guideline for the treatment of a complex arrhythmia, because it is so complicated. But, for prevention, a person has either had a myocardial infarction or they haven’t, and they should be on aspirin or they should not. Dr. Jacobson: That’s right, but all the pressures, it seems to me, are toward developing more guidelines and constraints. One of the problems is the limitation on physician autonomy in terms of the imposition of guidelines. The policy and the cost pressures are all moving in the direction of wanting to create more guidelines for increasingly complex situations. I agree with you, I wouldn’t want to begin to tell you how to treat any of the patients that you’ve all talked about today. If you’re going to have a system of accountability that involves medical malpractice, then you’re going to have to confront the situation of how the law works given the increase in pressure for guidelines. Dr. Smith: Briefly, could you address the physician’s liability, particularly when they are acting as policymaker in their position in their HMO or group practice as opposed to when they are making a decision just addressing a single patient’s care? Dr. Jacobson: The liability exposure would usually be with the HMO and the utilization review firm. In terms of the physician, the courts have been very much in flux in the sense that they have not understood how the system works and where to assign responsibility for inappropriate care. I think the use of practice guidelines is analogous to that of utilization management. The courts are going to have the same problem as they are with finding who is liable in the utilization management context. In the case of practice guidelines, the law is likely to evolve where the locus
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of responsibility is obviously on the physician. The question will be whether you can cite as a defense that the health plan or utilization firm imposed limits on your judgment forcing you to make a premature patient discharge which led to an adverse outcome. 1. Jacobson PD, Rosenquist CJ. The use of low-osmolar contrast agents: technological change and defensive medicine. J Health Politics, Policy and Law 1996;21:243–266. 2. Mittman BS, Tonesk X, Jacobson PD. Implementing clinical practice guidelines: social influence strategies and practitioner behavior change. Quality Review Bulletin 1992;18:413– 422. 3. Brook RH. Practice guidelines and practicing medicine: are they compatible? JAMA 1989;262:3017–3030. 4. Nissen SE, Douglas JS, Dreifus LS, Gibbons RJ, Higgins CB, Schelbert HR, Seward JB, Zaret BL, Ritchie JL. Use of nonionic or low osmolar contrast agents in cardiovascular procedures. J Am Coll Cardiol 1993;21:269 –273. 5. American College of Radiology (ACR). Current Criteria for the Use of Water Soluble Contrast Agents for Intravenous Injections. Reston, VA: American College of Radiology, 1990. 6. Federal Register, “Medicare program limits on Medicare coverage of cataract surgery”. Vol. 60, No. 194, October 6, 1995, 52396 –52402. 7. Brennan TA. Practice guidelines and malpractice litigation: collision or cohesion? Journal of Health Politics, Policy and Law 1991;16:67– 85. 8. Rosoff AJ. The role of clinical practice guidelines in health care reform. Health Matrix: Journal of Law-Medicine 1995;5;369 –396.
9. Jacobson PD, Rosenquist CJ. The introduction of low osmolar contrast agents in radiology: medical, economic, legal, and public policy issues. JAMA 1988; 260:1586 –1592. 10. Jacobson PD. Medical malpactice and the tort system. JAMA 1989;262: 2230 –2237. 11. Havighurst CC. Health care choices: private contracts as instruments of health reform. The AEI Press, Washington, DC, 1995. 12. West JC. The legal implications of medical practice guidelines. Journal of Health and Hospital Law 1994;27:97–103. 13. Hyams AL, Brandenburg JA, Lipsitz SR, Shapiro DW, Brennan TA. Practice guidelines and malpractice litigation: a two-way street. Ann Intern Med 1995; 122:450 – 455. 14. Hyams AL, Shapiro DW, Brennan TA. Medical malpractice guidelines in malpractice litigation: an early retrospective. J Health Politics, Policy and Law 1996;21:289 –313. 15. Davenport v. Ephraim McDowell Memorial Hospital. 769 S.W.2d 56 (Ky. App. 1990). 16. Quigley v. Jobe. 851 P.2d 236 (Colo.App. 1992). 17. United Blood Services v. Quintana. 827 P.2d 509 (Colo. 1992). 18. Jewett v. Our Lady of Mercy Hospital.612 N.E.2d 724 (Ohio Ct. App. 1992). 19. Anderson GF, Hall MF, Steinberg EP. Medical technology assessment and practice guidelines: their day in court. Am J Public Health 1993;83:1635– 1639. 20. West JC. Risk management and medical practice guidelines: what is risk management’s proper role? J Healthcare Risk Manage 1994;14:11–16. 21. 24 Me. Rev. Stat. Ann. § 2851 et seq. 22. Cheney FW, Posner K, Caplan RA, Ward RJ. Standard of care and anesthesia liability. JAMA 1989;261:1599 –1603.
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