Clinical Guidelines in Court: It's a Tug of War

Organizations such as the AAFP create clinical practice guidelines to assist clinicians in their decision making. The guidelines follow the best available evidence to support care practices.

But the guidelines may be used as evidence in malpractice lawsuits.

This concerns some physicians, who believe jurors may misunderstand evidence-based guidelines and how they're developed.

"Juries are ill-equipped to understand (evidence-based medicine)," says Eric Wall, M.D., of Portland, Ore., a member of the AAFP Commission on Clinical Policies and Research. "They do not have the critical appraisal skills to evaluate studies."

AAFP guidelines delve into a number of topics, including blood glucose levels in patients with type 2 diabetes mellitus, newly detected atrial fibrillation, migraine headache, minor closed head injuries in children, otitis media and trial of labor versus elective repeat Caesarean section.

In the practice of medicine, there are three types of recommendations, says Wall. In one classification, there are clinical options in which evidence is based on "expert" opinion and published evidence is of poor quality or nonexistent. Often, community standards of care are grounded in such expert opinion. On the opposite end, says Wall, are evidence-based practice standards such as immunization recommendations that are almost universally accepted. In between are clinical guidelines developed by researchers who summarize the evidence surrounding a clinical situation and propose guidelines based on studies published in the medical literature. Such guidelines do allow for flexible interpretation based on individual patient considerations.

One family physician with firsthand knowledge of the use of guidelines in litigation is Dan Merenstein, M.D., of Washington, D.C. As a third-year resident trained in a shared decision-making model, in 1999 he discussed the risks and benefits of prostate cancer screening with a 53-year-old male patient who subsequently declined to have a prostate-specific antigen test. Merenstein didn't see the patient again until four years later, when the patient became a plaintiff in a lawsuit, seeking damages from Merenstein and his residency. The patient had been diagnosed with prostate cancer in the years following his physical exam with Merenstein.

"What I didn't anticipate was that the plaintiff's attorney was going to argue that I should have never discussed the risks and benefits and should have just ordered the PSA," says Merenstein. In June 2003, jurors exonerated Merenstein but found his residency program liable for $1 million.

AAFP policy says there is insufficient evidence to recommend for or against prostate cancer screening, in keeping with findings of the U.S. Preventive Services Task Force.

Merenstein says evidence-based medicine got a bad rap in the courtroom: "Lawyers portrayed it as a cost-saving measure used to deny tests to patients." Meanwhile, jurors had 15 separate guidelines to evaluate regarding PSA testing, further clouding the issue.

It's unfortunate the medical profession hasn't done more to regulate guidelines, says Merenstein. "In my trial, (guidelines) got thrown around. A lot of people who make guidelines have a questionable self-interest in them."

Wall notes that not all professional organizations are as rigorous as the AAFP in reviewing studies that will be included in evidence supporting clinical recommendations. The Academy is careful to use clear terminology that describes the quality of evidence supporting a recommendation, he adds.

Herbert Young, M.D., director of the AAFP Scientific Activities Division, says guidelines can also be used to defend a physician. "The legal system grabs everything (as evidence)," he says. "We believe that guidelines will be more beneficial than harmful because they point out that the science is not certain, while some expert witnesses state things with certainty."

A Harvard School of Public Health study in the mid-1990s showed that plaintiffs were more likely to use guidelines as evidence of a physician deviating from the standard of care than the reverse.

"That's because a lot of doctors don't follow guidelines," says Richard Roberts, M.D., J.D., of Madison, Wis., an AAFP former president.

"If you only think of guidelines as being applied defensively, you've missed the point," Roberts said. "When done well, guidelines represent an effort by a number of people to synthesize the best available evidence and weave that into a succinct set of clinical recommendations."

Practicing FPs should proceed carefully. Merenstein, now a fellow at Johns Hopkins University, Baltimore, in the Robert Wood Johnson Clinical Scholars Program, at one point questioned whether he would return to practice medicine. He currently sees only urgent-care patients and admits, "I order more tests now, am more nervous around patients; I am not the doctor I should be."

But Merenstein says he still believes in evidence-based medicine.

"I hope I'll go back to the way I should practice, but I'm not sure," he says. "I don't want to go through that again."

Roberts, with degrees in law and medicine, has advice for physicians tempted to practice defensive medicine: "If physicians spend their time running down the hall looking over their shoulder for the lawyer they think is chasing them, they'll run into the wall. My advice is to practice the best medicine they know how."