Pap test litigation—
Not backing off: CAP retains call for blinded review

Nevertheless, the data show gynecologic cytology is still in a small group that accounts for the majority of claims, and Pap tests are one of the areas likely to result in litigation, Dr. Austin notes. “So it’s gone down, but it’s still in that high-risk category.”
Telling a jury the truth about Pap tests is not always simple, Dr. Austin notes. “Although I’m primarily a defense expert, I’ve done some cases for plaintiffs, but I’ve always insisted that I would have to show that slides would be repeatedly misread in a blinded review type of exercise. We’ve done that as a first step in cases I’ve testified in, but of course other experts have avoided that because it takes some additional time and effort.”

The appeals court said that Dr. Rosenthal—whose testimony was excluded by the Georgia trial court—could testify without a blinded review, Dr. Austin points out. “It doesn’t say that blinded review is not a good method, just that experts like Dr. Rosenthal may testify without it and it’s up to the jury to sort it out.”

The standard of practice requires professional judgment, Dr. Austin points out. “And if professional societies can’t provide insight into that, then I don’t know who is supposed to do it. I think it’s intuitive that professional organizations in charge of training and accreditation programs will have special knowledge of standards of practice, and people who don’t understand that are very misguided.”

Bierig, who represents the American Medical Association, the American Board of Medical Specialties, and several certifying boards, agrees that the CAP and the ASC, in issuing the guidelines, acted completely within their proper scope. “All specialty societies that I know of have put out practice guidelines for how physicians in that specialty should diagnose, treat, or report various conditions. What’s different about the College’s guidelines is that they address how expert witnesses in a certain kind of case, cytopathology malpractice cases, should review slides they’re called upon to review. But there is nothing wrong with that. The College is simply expressing its opinion on an important issue on which its members have expertise.”

The court certainly does not have to accept the College’s viewpoint, Bierig adds. “The court is not bound by what the College or ASC says. A court that disagrees with the College’s proposed approach is free to reject it. What is most troubling in this case is how the court attributes bad motives, malevolence, or bad faith to the College, and says that these guidelines were really biased and clearly designed to protect members of the College.” A medical society, just like a natural person, has a First Amendment right to express its views, he says.

The CAP guidelines are no different from an amicus brief, Bierig says. “The way the process works is that an entity sets forth its position to a court either in the form of an amicus brief or in some other way, such as a practice guideline. The court either agrees with that position or it doesn’t. But the notion that the entity is condemned for expressing its good faith position where the court disagrees with that position flies in the face of this country’s commitment to freedom of expression.”

Whether or not a court agrees with the position taken by the College on expert testimony in cytopathology cases, there can be no doubt that the guidelines were adopted in good faith, Bierig says.

“Testimony that doesn’t meet basic fairness guidelines can skew the adjudicative process. You can have a very sympathetic plaintiff, a woman who died or is dying of cervical cancer because her positive Pap test was missed, and the judge and jury can’t help but feel very sorry for that person,” Bierig says. “But the question is, was the pathologist or cytotechnologist negligent? Dr. Austin would say we want to have a fair evaluation of that question. To have a reviewer come in knowing that the slides were of a person who had cervical cancer, and say, ‘well, this should have been spotted’—that’s not the position the cytotechnologist or pathologist was in at the time of the review.”

“If you talk to cytopathologists, they will tell you that a cytotechnologist or a cytopathologist who is doing a very good job will still, from time to time, miss calling cases,” Bierig adds. “That doesn’t necessarily mean they are negligent, but that there is a certain irreducible number of false-negatives that will occur. And the issue is not unique to pathology. Situations in which there has been a tragic result, but not through the negligence of the physician, come up frequently in malpractice cases. The courts should be asking whether the physician is at fault. But often they ask who is in the best position to pay.”

Bierig offers this analogy to blinded review of slides in cytopathology malpractice cases: Where the police want a witness to identify a suspected perpetrator, they don’t just show the suspect to the witness and ask whether that suspect committed the crime. Rather, they place the suspect in a lineup with several other persons to see whether the witness can make the identification. Similarly, “an expert witness shouldn’t be given a slide that he or she knows has been misread and then asked to opine whether it has been misread. Instead,” Bierig says, “the expert witness should be given numerous slides, most of which are negative, and then asked to identify which of them, if any, are positive.”

Medical practitioners view things differently than lawyers and courts do, Dr. Crothers points out. “Speaking as a pathologist and a scientist, we wanted to provide a framework in which both opposing parties could make a decision as to whether a test was worth going to court over. It can benefit both parties, actually.”
“If you had a case under consideration for litigation in your lab and all the observers came back and called it high-grade epithelial lesion, then I think your defense attorney is going to have a different approach to that case than if it showed there were answers all over the field or most people called it normal,” Dr. Crothers says.

The court seemed to think the College was forcing a guideline on the court process. But that wasn’t the intent, she contends. “The intent was to inject a bit of reality into the whole process and raise awareness of the subjectivity of Pap test interpretation. Expert witnesses are biased through prior knowledge of the outcome and have an inherent conflict of interest if they are paid for their answers.”

In the appeals record, she notes, there are some interesting facts. “Under normal circumstances a cytotechnologist would take at most 10 minutes to screen a slide, but expert witnesses often will take two or three times that long. In this case, there were four slides but the expert took 90 minutes to review them. Now some photography might have accounted for some of that, but we don’t know that. It may mean that the cells perhaps weren’t so easy to find and you really had to scrutinize the slides to find them.”

Where a conscientious individual is doing his or her job and going at a routine clip, would that person reasonably be expected to find the one or two cells? “I don’t know, but that’s kind of where the question lies from a scientific point of view,” Dr. Crothers says.

Since the 1990s, the malpractice litigation environment has changed substantially, she notes. “The primary reasons are that we’ve introduced a lot of automation, and we’ve essentially cleaned up the procurement and preparation process.” About 95 percent of laboratories now use liquid-based cytology, which prevents the air-drying artifact and some of the preparation problems that used to arise, she says. “It allows for a more monolayer, even distribution of cells across the slides so they’re a little easier to interpret.” However, she adds, blood or inflammation are among factors that can still cause a problem.

Automated screening instruments help greatly. “It’s very common in large labs now to have an instrument preselect the fields of view, the potentially abnormal areas on a slide for the first observer, then the cytotechnologist reviews those to decide whether the slide is abnormal and needs complete screening, or lacks anything significant and can be signed out as negative.” Those instruments are finely tuned to high-grade epithelial lesions, “and that helps for those cases where there may be very few cells that are characteristic.”

The introduction of HPV testing has wrought other improvements in identifying high-risk patients, Dr. Crothers points out. “It has allowed cytology to take this big atypical squamous cell category that we’ve had and use an additional test, HPV testing, to triage those patients either to colposcopy or a repeat test in a year. And that’s been helpful because in the past, clinicians weren’t always sure what to do with that atypical squamous cell category, and patients might be over-screened and end up with multiple Paps, multiple biopsies and excisions, or they might get under-screened and possibly lost for follow-up.”

There are still so many other factors that the false-negative rate may not have decreased at all, however. “In fact, it probably hasn’t, but now we are able to more effectively get patients in the system with a clinical algorithm that outlines how they should be properly followed. With clinicians following that, we have a lot less opportunity to miss somebody who has a significant lesion.”

Bierig envisions three steps that the College might take in the wake of the Adams v. LabCorp decision. “First the guidelines should be basically neutral, and not suggest that there be a different approach for defendants than for plaintiffs. The College needs to make clear that whatever it believes to be the right approach to review of cytopathology slides in connection with litigation applies equally to experts for all parties to the case. I think that that was the intent, but it may not have been expressed as clearly as it could have been.”

Second, the College may want to include an explanation of the reasons for the guidelines. “If a court concludes, as this court did, that particular guidelines are nothing more than an effort to protect negligent physicians from liability, then the court will, of course, completely discount that effort. On the other hand, if the entity that issues guidelines explains what it is trying to do and why, I think the guidelines have a much better chance of being accepted by the court. It is, of course, impossible to know, but one wonders what this court would have done had the College’s guideline included a thoughtful explanation for the positions taken therein.”

Third, in general, any medical society guidelines should be reviewed no less often than every three years to ensure that the entity that issued them still agrees with them, and to modify them to reflect changes in science or medicine that may have occurred, Bierig recommends. “You want to make sure your guidelines reflect advances in the state of the art—as well as what the medical society thinks is right.”
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Anne Paxton is a writer in Seattle.