Course Authors
Maxwell J. Mehlman, J.D.
Mr. Mehlman reports no commercial conflict of interest.
Estimated course time: 1 hour(s).
Albert Einstein College of Medicine – Montefiore Medical Center designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
In support of improving patient care, this activity has been planned and implemented by Albert Einstein College of Medicine-Montefiore Medical Center and InterMDnet. Albert Einstein College of Medicine – Montefiore Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Upon completion of this Cyberounds®, you should be able to:
Discuss the potential role of practice guidelines in medical malpractice cases
Describe the legal objection to "hearsay" evidence and the "learned treatise" exception
Discuss a new development that may undermine the ability of practice guidelines to establish the appropriate legal standard of care.
In a previous Cyberounds®, I discussed a rule of evidence pertaining to the admissibility of apologies to prove negligence. While we're on the subject of evidence, I'd like to bring your attention to a novel development with potentially profound consequences for the use of practice guidelines as evidence of the standard of care in medical malpractice cases.
First, a bit of background.
Many people have long thought that one way to reform the medical malpractice system, as well as to improve health care quality, is to rely more on professionally-created practice guidelines to establish standards of reasonable care. Much of this enthusiasm stems from the development of sophisticated, severity-adjusted outcome measurement techniques to evaluate the quality of medical interventions. Let's find out which processes really improve patient outcomes, it is urged, and then embody this knowledge in practice guidelines.
Outcome-based practice guidelines may be the gold standard, but many if not most practice guidelines are of the "consensus"-type -- that is, based primarily on the opinions and anecdotal experience of experts in the field, such as members of prestigious medical societies or faculty members at major medical schools. Still, advocates of practice guidelines assert that physicians who follow these guidelines should be assumed to have acted reasonably, while physicians who fail to follow the guidelines without good reason should be deemed negligent.
Guidelines: Use and Abuse
Of course, practice guidelines have their limitations. They can be too rigid, restricting the ability of the physician to try something new or to tailor treatment to the specifics of an individual patient's case. Guidelines can be out-of-date if they are not frequently revised in light of new information. Moreover, it sometimes is difficult to tell whether a guideline promotes the quality of care or is being used primarily to block competition from other health care providers. (A recent example is the rival guidelines issued by the American Academy of Ophthalmology and the American Optometric Association on the proper role of optometrists in providing laser eye surgery or Lasik® to patients.(1))
Guidelines also can be misused in the law. A notorious example is legislation enacted by the Maine legislature in 1991, which permitted certain practice guidelines created by Maine specialty societies to serve as conclusive evidence of the appropriate standard of care, but only when introduced by malpractice defendants. In other words, while a physician could introduce the fact that she complied with a guideline as conclusive evidence that she was not negligent, a plaintiff in Maine could not introduce the fact that a physician failed to comply with a guideline as any evidence that the physician was negligent.
But guidelines that are properly crafted and evenly applied seem to have a positive role to play in the filed of medical malpractice. They could encourage parties to drop claims or settle cases by providing a benchmark against which physician behavior could be assessed. They could help us get away from the current situation in which lay juries are left to determine the standard of care based on a battle of experts in the courtroom, with the result that the jury's verdict may be based more on the cross-examination skills of the attorneys than on a sound appreciation of medical science. Guidelines even could assist physicians and other health care professionals in resisting efforts by managed care plans to withhold medically necessary services to enrollees.
Rules of Evidence
Now we come to the rules of evidence. The law doesn't like "hearsay." Hearsay basically is when someone testifies that something is true because someone else told him so. The problem with hearsay is that the way juries are presumed to be able to evaluate when someone is telling the truth is by listening to that person's testimony, especially to what they say under cross-examination. When A testifies that something is true because B told him so, the jury theoretically can determine if A is telling the truth. But that only shows that B really did tell A what A says B told him; it doesn't mean that what B told A is true. The only way to do that is to drag B into the court room and make him testify, including making him give the jury a description of why he thinks that what he says is true is in fact true.
Here, then, is the problem with using a practice guideline as evidence of reasonable care. Suppose an expert witness in a medical malpractice case testifies that the defendant was not negligent because the defendant followed a practice guideline put out by some prestigious body, say the American College of Cardiology. Except in the rare instance in which the witness knows and can testify about the information that the College relied on in establishing the guideline, for example, by having been a member of the committee that issued the guideline, the guideline is hearsay: the jury has little way of ascertaining if the guideline is an accurate and reliable depiction of the appropriate standard of care.
The Hearsay Exception
The saving grace for practice guidelines is that the Federal Rules of Evidence, and many states, recognize an exception to the hearsay rule for so-called "learned treatises."(2) Judges permit expert medical witnesses to base their views on or bolster them by reference to publications like the Physicians Desk Reference or classic medical textbooks, without having written the textbooks or having served as consultants to the FDA when it reviewed the drug labeling claims reprinted in the PDR.
Many proponents of practice guidelines argue that courts should regard them as learned treatises. After all, the American College of Cardiology, or the Harvard Medical School (which issued one of the first practice guidelines in 1986 in the form of anesthesia standards(3)) certainly are prestigious, learned bodies. When they, or a group of their members, get together and opine on the proper way to care for a patient, their views should count as weighty evidence of what is or is not reasonable. Some courts have agreed,(4) and proponents of practice guidelines hope that others will follow suit.
The Daubert Challenge
Now we come to the recent development. In 1993, the US Supreme Court decided a case called Daubert v. Merrill Dow Pharmaceuticals, Inc.(5) That case concerned how the courts should decide whether scientific evidence on which an expert basis his opinion -- in Daubert, whether the drug Bendectin® causes birth defects -- is reliable and therefore should be allowed to be presented to the jury. The Court promulgated a test in the form of a series of considerations: whether the theory or technique in question can be and has been tested; whether it has been subjected to peer review and publication; its known or potential error rate; the existence and maintenance of standards controlling its operation; and whether it has attracted widespread acceptance within a relevant scientific community.
Until now, no one has sought to apply this test to practice guidelines. But there is a case pending in Chicago, having to do with proper immunization practices, in which a defendant who allegedly violated a practice guideline is arguing that the guideline doesn't meet the Daubert test. Why? Because like many if not most practice guidelines, it apparently is based on clinical judgment and anecdotal experience rather than on outcome-based, peer-reviewed, published studies.
If courts accept this challenge and exclude expert testimony based on consensus-type practice guidelines, they will set back the prospects for using practice guidelines in medical malpractice cases, possibly fatally in the case of "consensus"-type guidelines that form the bulk of those currently in existence.
Stay tuned.