Court Nixes Litigation Standards Set by Pathologists

What if a truck drivers’ union tried to set standards for when juries could conclude that a driver was negligent in causing a motor vehicle wreck? Or what if a trucking company could defend its driver falling asleep at the wheel by showing that its other drivers had impeccable driving records?

That’s about the situation the courts face with litigation guidelines set by two pathologists’ groups about when misreadings of Pap smears by members of these groups should be judged negligent.

A recent ruling by the 11th Circuit Court of Appeals, the federal appeals court for the southeastern-most states, found the pathologists were wrong in trying to enforce their litigation standards. And it reinstated a lawsuit brought by a patient which had been thrown out by a trial judge because the plaintiff’s expert had not followed the litigation guidelines promulgated by the College of American Pathologists (CAP) and the American Society of Cytopathology (ASC).

Here’s a quotation from the 11th Circuit’s decision in Adams v. LabCorp that shows the judges saw the difference between clinical practice guidelines promulgated for better patient care versus these litigation guidelines:

As an initial matter, it is important to put these guidelines in context. Both sets of them focus not on how cytotechnologists should go about their duties in examining slides, but instead on how courts should go about their duty to adjudicate claims against cytotechnologists and similar professionals. In the words of the guidelines, they are to be used in assessing Pap smear slides “in conjunction with litigation or potential litigation.” They are not objective, scientific findings; they are not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells; they are policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.

As far as we are aware, this is the first time that an industry group has promulgated a set of guidelines that attempts to define and limit the evidence courts should accept when the group’s members are sued. The members of the CAP and ASC have a substantial interest in making it more difficult for plaintiffs to sue based on alleged negligence in their Pap smear screening, and their guidelines do just that.

The guidelines, if enforced, would have made it not just difficult, but VERY difficult to impossible, to prove that a laboratory had been careless or negligent in reading a patient’s Pap smear. Here’s an excerpt from the ASC’s guidelines:

A violation of a reasonable prudent practitioner standard of practice based on how specific Pap tests were screened and interpreted can only be established through an unbiased blinded rescreening review process that includes the contested case as one of a number of normal and abnormal GYN cytology samples representing a variety of disease states. Focused review or review with knowledge of subsequent development of carcinoma inevitably biases the objectivity of the review against the laboratory and does not reflect standard practice.

Hindsight bias is an issue, and every honest expert witness I’ve dealt with tries to make sure to keep that in mind and not let it unduly influence his or her view of a case. But these guidelines essentially use an elephant gun to go after a flea.

In practical terms, the ASC guidelines would require the plaintiff to hire an independent pathologist to go to the defendant laboratory, whereupon the pathologist would be put to a test devised by the defendant: the specimens at issue would be salted in with a group of other specimens, some normal, some not, and the pathologist would then study the specimens under the microscope as if they were specimens seen in the ordinary course of lab work.

(Except, of course, that most labs, LabCorp included, use “cytotechnologists,” non-doctors, to first screen the specimens and point out potential abnormalities for the pathologists to then study more closely. And the issue in this case was that the cytotechnologists at LabCorp had not even flagged this patient’s smears as possibly worrisome.)

And what if the independent pathologist passes the test devised by the defendant lab and correctly diagnoses the mix of normal and abnormal specimens? The test of the plaintiff’s expert is still not over, because the ASC guidelines go on to say:

Courts and experts should recognize that a false‐negative result by itself is not sufficient proof of negligence. Rather, the courts should evaluate whether the overall Pap‐test practices of the laboratory meet the standard of care and whether unbiased blinded rescreening consistently detects significant abnormalities not initially identified by the laboratory.

I’ve italicized two key pieces. First, “overall practices of the laboratory” seems to mean that as long as the lab overall has a good track record, it shouldn’t be found negligent for messing up on one patient’s specimen, even if it was wrong that one time. This would be like a trucking company saying, “Never mind that our driver fell asleep at the wheel; we have a nearly spotless driving record other than this one time.”

A fundamental aspect of American tort law is that the defendant’s conduct is judged on the specific case, and it’s not relevant to prosecute or defend a case based on what happened on some other occasions (with a few exceptions when the allegation of wrongful conduct is that the defendant had failed to detect a pattern in the prior events). This prevents plaintiffs from using prior bad events unfairly, and it prevents defendants from using prior good events unfairly.

The second italics is on the word “consistently.” That means the pathology groups want their members to be found guilty ONLY if no experts can be found to defend their reading on a particular occasion. So only the most egregious cases could go forward, since it’s child’s play to find an expert who will give a pass to conduct that other experts will criticize.

In the Adams case, the plaintiff had hired an expert of sterling credentials, Dr. Dorothy Rosenthal of Johns Hopkins Hospital. She had not only spent 40 years training cytotechnologists how to read Pap smears, she also had worked on the pathologists’ committee that set the medical standards for when cells on a Pap smear look cancerous, when they look borderline, and when they are benign.

The lab had criticized Dr. Rosenthal for doing a non-blinded review of Ms. Adams’ Pap smears, but as the 11th Circuit pointed out, the lab’s own expert witness did exactly the same non-blinded review. And the 11th Circuit was troubled by the one-sided nature of the litigation guidelines:

…the ASC’s guidelines condemn non-blinded review because it “biases the objectivity of the review against the laboratory,” but express no concern about non-blinded review biasing the assessment of defense experts against plaintiffs. Clearly, the purpose of the guidelines is to raise the bar only on the plaintiffs’ side of the courtroom.

The litigation guidelines go way too far on hindsight bias, as the court observed:

…both sets of guidelines treat the mere risk of review bias as intolerable. They do not specify the frequency or degree to which review bias actually affects reviewers’ judgments. Nor do they cite any empirical evidence supporting their assertion that knowing the outcome “inevitably biases” the reviewer. Yet they insist that a court should exclude expert testimony unless the expert has eliminated entirely the possibility of any review bias. That would be a radical reworking of [Federal Evidence] Rule 702, which requires courts to determine that the expert’s method is reliable, not that it is free of any possibility of bias.

The lab also claimed that Dr. Rosenthal’s opinions were “Ipse Dixit” — Latin for, “because I say so” — but the Court said that was wrong too, since the expert had used the same atlas showing what abnormal cervical cells look like that the defendant’s employees had used:

Dr. Rosenthal used a well-established classification system to assess the cells: the same Bethesda System that LabCorp’s cytotechnologists use. In her deposition testimony she went picture-by-picture, pointing to specific places in each one where Ms. Adams’s cells showed abnormalities and classifying those abnormalities using the same Bethesda classification system that is used by LabCorp’s cytotechnologists and nearly every other professional in the field of cytopathology. And the Bethesda Atlas, which is maintained by the ASC, provides numerous examples of each abnormality that Dr. Rosenthal identified, including “classic examples” of abnormal cells as well as “borderline” cells. As Dr. Rosenthal explained in her deposition, the images in the Atlas could be used to assess whether her opinion was in step with the established standards in the field. The fact that Dr. Rosenthal applied an established diagnostic system in which she was well versed contributed to the reliability of her methodology.

One puzzle remains: these guidelines have been around since at least 2000, in the case of ASC, but only now in 2014 reached the attention of a federal appeals court. Maybe that’s because trial courts before the one that was reversed here by the 11th Circuit could see so plainly that the “litigation guidelines” were an improper attempt by a self-interested professional group to stack the deck of lawsuits against its members.

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