Clinical practice guidelines and medical malpractice: Guidelines gaining credibility in courtrooms, may eliminate expert testimony - Doctors, Lawyers and Lawsuits - preventing defensive medicine - Statistical Data Included

Physician Executive, March, 2002 by Albert Tzeel

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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)