Clinical practice guidelines and medical malpractice: Guidelines gaining credibility in courtrooms, may eliminate expert testimony. (Doctors, Lawyers and Lawsuits).

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IN 1787, 11 YEARS after penning the Declaration of Independence, Thomas Jefferson wrote, "without health there is no happiness. An attention to health, then, should take the place of every other object." (1)

Jefferson's words ring even more true today. As a society, Americans attend to health in ever increasing amounts. Health care spending accounts for nearly 15 percent of the U.S. gross domestic product.

Multiple factors account for this:

* Technological innovation

* Physician-induced demand

* Insurance-generated consumer price insensitivity

* Governmental regulation

Some maintain that the fear of medical malpractice litigation plays a significant role as well. This fear of liability, also called defensive medicine, is defined as "objective measures taken to document clinical judgment in case there is a lawsuit." (2)

Indirect costs to the health care system secondary to defensive medicine are estimated to run $15 billion to $35 billion per year. (2,3)

Many researchers and policy analysts, like Wennberg and Eddy, (4,5) recommend analyzing physician practice patterns and small area variations in practice to promote cost-effective, high quality clinical policies. They advocate development of clinical practice guidelines to assist and standardize practitioner treatment of particular medical conditions.

As the movement toward guidelines gains momentum, questions arise about the role guidelines will play in medical malpractice litigation. How will they affect the current status of a malpractice tort? What will the implications for public policy be?

What are clinical practice guidelines?

Clinical practice guidelines - also known as practice parameters, clinical protocols, critical pathways and treatment algorithms - serve five major purposes in medicine, according to the Institute of Medicine.

1. Assist patients and practitioners in clinical decision-making

2. Educate individuals or groups

3. Assess and ensure quality of care

4. Allocate health care resources

5. Reduce the risk of legal liability for negligent care (6)

The very explicit guideline development that emerged in the 1990s weighs potential benefits, harms and costs of treatment for each individual treatment option with the patient preferences for outcomes. (7)

"Guidelines are intended generally to improve the outcomes of medical care by increasing adherence to standards of care.... In this regard, guidelines relate to malpractice litigation which, like other areas of tort law, is intended to bring about better care by visiting sanctions on those who injure patients while using substandard techniques. (8)

The promulgation of guidelines will establish a national standard of care. The advent of telemedicine, computerized databases and online consultations created access to information about a nationwide standard of care against which to judge physicians in all areas. (9)

How will this affect the need for expert testimony on the standards of care in malpractice cases?

Will guidelines replace need for expert testimony?

"The normal method of proving professional negligence and the one usually required, is to establish by expert testimony the appropriate standard of care and prove its breach." (10)

Additionally, "authoritative, published works on the general and specific subjects in issue may be admitted and argued from." (11) That means, to be effective, clinical practice guidelines must be acknowledged as "authoritative, published works."

However, some written documents, like practice parameters, may constitute hearsay. Hearsay consists of statements made by individuals who are not testifying before the jury. Hearsay, when introduced to resolve matters in dispute, is considered too unreliable for admission unless it falls within certain exceptions.

One exception is the learned treatise. Learned treatises consist of publications on a subject of science or the arts including medicine. These are established as reliable authorities by the testimony of a qualified witness or by judicial notice. (12, 13)

Note that learned treatises, however, do not obviate the need for expert testimony in and of themselves. "In most cases, admitting institutional rules and professional guidelines as evidence, there was also expert testimony on the standard of care." (14)

Yet, just as a plaintiffs expert may introduce a clinical practice guideline, a defendant's expert can attack its admissibility.

So under our current system of malpractice litigation, the role of guidelines is still uncertain. They can help define the standard of care but only as part of a larger armamentarium. By themselves, they do not constitute a predetermined standard of care that a court is obligated to apply. (15)

But, just as medical diagnosis and treatment is a dynamic process, so too, is the interpretation of the law.

Guidelines gaining acceptance

Clinical practice guidelines, especially those given rigorous scientific analyses by the experts, are gaining acceptance in malpractice cases.

In a recent survey of attorneys from across the U.S. who categorized themselves as medical malpractice specialists, researchers found that the overwhelming proportion of respondents thought that the use of guidelines in litigation is increasing. (16)

Interestingly, the concept of guidelines is spreading evenly throughout the legal profession, led by the experienced attorney. And it's expected that guidelines will be used more often in future litigation. (16)

A survey by Hyams, Shapiro and Brennan also found that 28 percent of malpractice litigation attorneys reported at least one case settled because of the influence of clinical practice guidelines.

Meanwhile, 31 percent reported refusing to take at least one case within the previous three years because the physician-defendant followed established professional guidelines in caring for the patient-plaintiff. (17)

Clinical practice guidelines affect public policy

Any change within our current tort system is bound to have a dramatic impact on public policy. This is especially true of medical malpractice where costs and litigation fees amount to about $9 billion per year. (18)

A guideline-based national standard of care will help establish justice and equity. "Nationwide, guidelines and standards are a classic 'public good,' one from which everyone should benefit." (19)

In addition, "practice guidelines should somewhat improve the ability of the legal system and liability insurers to determine when actionable negligence has occurred." (20)

Since physicians, patients, attorneys and the reviewing authorities will have access to the same information, guidelines will level the playing field for all participants. As a result, guidelines may be used to both indict and exonerate a physician

Since guidelines will bear proscriptive standards of care, they will minimize, if not eliminate, the need for expert witnesses. "Clear guidelines would thus help rationalize litigation by providing standards for courts which now have to rely on less-than-objective battles of experts." (8)

Eliminating the battles of experts could reduce litigation costs and even lead to lower insurance premiums. Attorney fees, along with the cost of administering liability insurance, account for at least two-thirds of each dollar paid for malpractice professional liability insurance. (22)

These cost savings, as one aspect of tort reform, will occur if guidelines replace the need for expert testimony. But, ultimately, the only way to eliminate experts is to give guidelines the potential of becoming law. (23)

Adopting guidelines into the law

For guidelines to develop independent legal standing as the prescriptive standard of care, several tort reforms need to occur. Some states have already passed laws dealing with guidelines and others are contemplating them.

First, state legislatures must unify the medical standard of care and the legal standard of care. A legislature can unify these two standards through statutes affirming that the courts recognize guidelines as defining the appropriate standard of care without the need for expert testimony.

This, in turn, would facilitate the use of guidelines by ensuring that both courts and physicians alike would follow them. This presupposes that state officials and representatives from the medical, legal and lay public communities approve, adopt and announce the guidelines that would govern medical practice.

To facilitate acceptance of guidelines and enhance their use, state legislatures also should allow a phase-in period where guidelines could only be used as an "affirmative defense."

The affirmative defense, first outlined in the Maine Liability Demonstration Project, allows physicians who follow a guideline to be exculpated outright. (24) However, if a physician does not adhere to a given guideline, the plaintiff cannot use the parameter to incriminate.

This ensures buy-in or compliance by physicians. It also allows a slower transition as the public prefers that health care reform occur incrementally rather than as a complete overhaul. (25)

Some states are making progress with guidelines. Maine, Minnesota, Vermont and Florida, for example, have already enacted legislation allowing for an affirmative defense for physicians following designated protocols. (26,27,28,29)

Even with new laws about guidelines, it's important for physicians to realize that the duty they owe to the patient overrides the duty to blindly follow guidelines. In some cases, an exemption from the guideline should be obtained from the proper authorities.

This ostensibly pre-empts situations like Wickline v. State of California (1986) (30) where the physicians disregarded good medical judgment by following guidelines that adversely affected the patient's outcome.

Guidelines help maximize happiness

Although guidelines cannot guarantee a medical outcome with certainty, their usage can most certainly guarantee the most cost-effective, quality-intensive medical care available.

In the economic sense, this notion of overall quality maximizes individual utility. And the notion of cost effectiveness in both the medical and legal spheres maximizes society's utility.

Ultimately, the more individuals and society can maximize their common utility, the better their chances to pursue and maximize their happiness.

And that, as Jefferson wrote, is our right.

References

(1.) Lee, P.R. "Advancing America's Health." JAMA. 1995, 273(3):248-249.

(2.) Todd, J.S. "Reform of the Health care System and Professional liability." New England Journal of Medicine. 1993, 329(23):1733-1735.

(3.) Costello, M.M. and Murphy, K.M. "Clinical Guidelines: A Defense in Medical Malpractice. Suits." The Physician Executive. 1995, 21(8):10-12.

(4.) Wennberg, J.E., Freeman, J.L. and Culp, W.J. "Are Hospital Services Rationed in New Haven or Over-Utilised in Boston?" Lancet. May 23, 1987, 1185-1188.

(5.) Eddy, D. "Clinical Policies and the Quality of clinical Practice." New England Journal of Medicine. 1982, 307(6):343-347.

(6.) Field, M. and Lohr, K. (ed.). Guidelines for Clinical Practice: From Development to Use. Washington, D.C., Institute of Medicine, National Academy Press, 1992.

(7.) Woolf, S.H. "Practice Guidelines, a New Reality in Medicine. II. Methods of Developing Guidelines." Archives of Internal Medicine. 1992, 152(5):946-952. (Note: This development strategy includes the use of experts who provide impartial recommendations for medical practice based upon the scientific evidence.)

(8.) Burroughs, C.E. "The Use of Practice Guidelines in Wisconsin for Liability Protection." Wisconsin Medical Journal. 1994, 93(2):69-75.

(9.) Furrow, B.R. "Quality Control in Health Care: Developments in the Law of Medical Malpractice." The Journal of Law, Medicine and Ethics. 1993, 21(2):173-192.

(10.) Slee, D.A. "Negligence, in Southwick AF: The Law of Hospital and Health Care Administration. Ann Arbor, Mich., Health Administration Press, 1988, p. 61.

(11.) Michigan Compiled Laws, Annotated, 600.5050(5)

(12.) Hirshfeld, E.B. "Practice Parameters and the Malpractice Liability of Physicians." JAMA. 1990, 263(11):1556-1562.

(13.) Federal Rules of Evidence, 803 (18)

(14.) King, Jr., J. The Law of Medical Malpractice in a Nutshell. St. Paul, Minn., West Publishing Co. 1986, p. 109.

(15.) Hirshfeld, E.B. "Should Practice Parameters Be the Standard of Care in Malpractice Litigation?" JAMA. 1991, 266(20):2886-2891.

(16.) Hyams, A.L., Brandenburg, J.A. and Lipsitz, D.R. "Practice Guidelines and Malpractice Litigation: A Two-Way Street." Annals of Internal Medicine. 1995, 122 (6):450-55.

(17.) Hyams, A.L., Shapiro, D.W. and Brennan, T.A. "Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective." Journal of Health Politics, Policy and Law. 1996, 21(2):289-313.

(18.) Merz, S.M. "Clinical Practice Guidelines: Policy Issues and Legal Implications." The Joint Commission Journal on Quality improvement. 1993, 19 (8):306-312.

(19.) Leape, L. "Practice Guidelines and Standards: An Overview," QRB. 1990, 16(2):42-49.

(20.) Havighurst, C.C. "Practice Guidelines as Legal Standards Governing Physician liability." Law and Contemporary Problems 1991, 54(1-2):87-117.

(21.) Brennan, T.A. "Practice Guidelines and Malpractice Litigation: Collision or Cohesion?" Journal of Health Politics, Policy and Law. 1991, 16(1):67-85.

(22.) King, Jr., J. The Law of Medical Malpractice in a Nutshell. St. Paul, Minn., West Publishing Co., 1986, p. 325.

(23.) Smith, G.H. A Case Study in Progress: Practice Guidelines and the Affirmative Defense in Maine. The Joint Commission Journal on Quality Improvement 1993, 19(8):355-362.

(24.) Smith, G.H. "Maine's Liability Demonstration Project: Relating Liability to Practice Parameters." American Medical Association State Health Legislation Report. 1990, 1-5.

(25.) Brodie, M. and Blendon, R.J. "The Public's Contribution to Congressional Gridlock on Healthcare Reform. Journal of Health Politics, Policy and Law. 1995, 20(2):403-410.

(26.) Maine Liability Demonstration Project: Me. Rev. Stat. Ann. tit. 24,[section] 2971-2978.

(27.) Minnesota's 1993 Health Care Cost Containment Law: Minn. Stat. Ann. [section] 62J [West 1993].

(28.) Vermont Health Care Reform Law: 1991 Vt. Acts 160 [adjourned session] [section] 46.

(29.) Florida 1993 Health Insurance Reform Act, Fla. Stat. Ann. [section] 408.02 [West 1994].

(30.) Wickline v. State of California, Cal App 2d, 228 Cal Rptr 661, 1986.

RELATED ARTICLES:

ACPE Resources

Several books about clinical practice guidelines are available from ACPE.

They include: Measuring Clinical Care, Managing Quality of Care in a Cost-Focused Environment, Clinical Resource and Quality Management, and Tools for the Task: The Role of Clinical Guidelines.

To order, visit our bookstore at www.acpe.org or call 800-562-8088.

Albert Tzeel, MD is chief medical officer at Humana Inc. in Milwaukee, Wis. Previously, he served as associate medical director of the Health Alliance Plan of Michigan in Detroit, Mich. Tzeel earned his medical degree from the University of Michigan Medical School in Ann Arbor, MI, and his masters in health services administration from the University of Michigan School of Public Health, also in Ann Arbor. He can be reached by phone at 414/223-0207 or by e-mail at [e-mail].