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DOI: 10.1148/radiol.2291030227
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(Radiology 2003;229:288-289.)


Letters to the Editor

Missed Mammographic Abnormalities, Malpractice, and Expert Witnesses: Does Majority Rule in the Courtroom? [letter]

Leonard Berlin, MD

Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Road, Skokie, IL 60076, e-mail: lberlin@rsh.net

Editor:

In the February 2003 issue of Radiology, Dr Ikeda and colleagues (1) concluded their highly detailed article on the analysis of 172 missed breast cancers with the statement that because a majority of five experienced radiologists were not able to retrospectively detect subtle abnormalities on mammograms originally interpreted as normal, failure to identify these findings in the initial interpretations does not constitute diagnostic error or conduct below a reasonable standard of care. I would like to believe that their conclusion is correct, for it would clearly diminish the level of anxiety possessed by most radiologists regarding malpractice litigation. However, I fear that whatever sense of comfort radiologists may be enjoying from this article is not warranted.

Dr Ikeda and colleagues found that all five of the blinded radiologists who conducted the mammography review rated 47% of the cases as normal. What the data also disclosed, however, is that in 53% of the cases, at least one of these highly credentialed and experienced mammographers on blinded review noted findings suspicious enough to warrant calling back the patient for additional studies. The authors based their conclusion regarding whether negligence occurred on the determination by a majority of the five reviewing radiologists, a legitimate approach for scientific research. It is not, however, an approach that works in the courtroom in which a medical malpractice trial is being conducted. There, a plaintiff’s single expert witness gives an opinion that a defendant radiologist breached the standard of care, testimony that is usually countered with a defense expert’s opinion that the defendant’s actions complied with the standard.

"The standard of care becomes whatever a contest of experts can persuade a jury is the most appropriate standard for the case at hand," Potchen and Bisesi (2) wrote. The persuasion is attempted through testimony of individual experts. Judges and jurors in court proceedings do not care about majority votes of groups of expert witnesses as to whether a defendant radiologist did or did not breach the standard.

In fact, if any of the members of Dr Ikeda’s research group who found recallable findings on these mammograms were available and willing to testify as an expert in a malpractice lawsuit focusing on one of the mammographic studies that he or she found to be suspicious, the researcher might well have to acknowledge that the defendant radiologist who initially interpreted the mammogram as normal indeed breached the standard of care. The authors themselves stated, "If prior findings are sufficiently specific and suspicious to prompt recall, failure to do so may fall below a recognized standard of care" (1). Such testimony would very likely sway a jury into rendering a verdict in favor of the plaintiff and awarding compensatory damages.

An article similar in certain respects to that of Dr Ikeda and colleagues was published in 1996 in the New England Journal of Medicine. In that report, Brennan et al (3) reviewed more than 31,000 records of hospitalized patients with the objective of determining the relationship among adverse events, the percentage of those events attributable to negligent conduct, and outcomes of malpractice litigation. A panel consisting of board-certified internists and surgeons had previously analyzed in detail each record and determined that adverse events occurred in 3.7% of the hospitalizations and that 27.6% of these events were due to negligence (4). Those adverse event cases that evolved into malpractice lawsuits were followed to their final resolution. It was found that the indemnification paid to injured patients was directly related to the severity of the damage sustained by patients and was totally independent of whether the panel itself had judged the injury to be due to negligence.

The analogy between the studies of Brennan et al and Dr Ikeda and colleagues is obvious: Notwithstanding the judgment by a majority vote of an educated, highly credentialed, and independent panel of experts that no negligence occurred, a plaintiff who sustains injury and on whose behalf an expert witness (whether the witness is as qualified as or less qualified than any of the panelists) testifies that negligent conduct has occurred will likely be awarded compensation. A woman whose diagnosis of breast cancer is identified on a subsequent mammogram but missed on an earlier mammogram certainly falls into this category.

Majority does indeed rule in committees and panels of physician researchers or judges who sit on appellate or supreme courts. Majority does not rule, however, among expert witnesses who give testimony in the trial court. Such are the vagaries of malpractice litigation as it is played out in our justice system, circa 2003.

REFERENCES

  1. Ikeda DM, Birdwell RL, O’Shaughnessy KF, Brenner RJ, Sickles EA. Analysis of 172 subtle findings on prior normal mammograms in women with breast cancer detected at follow-up screening. Radiology 2003; 226:494-503.[Abstract/Free Full Text]
  2. Potchen EJ, Bisesi MA. When is it malpractice to miss lung cancer on chest radiographs? Radiology 1990; 175:29-32.[Free Full Text]
  3. Brennan TA, Sox CM, Burstein HR. Relation between negligent adverse events and the outcomes of medical-malpractice litigation. N Engl J Med 1996; 335:1963-1967.[Abstract/Free Full Text]
  4. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324:370-376.[Abstract]

Dr Ikeda and colleagues respond:

Debra M. Ikeda, MD,*, Robyn L. Birdwell, MD,*, Kathryn F. O’Shaughnessy, PhD,{dagger}, R. James Brenner, MD,{ddagger} and Edward A. Sickles, MD§

Department of Radiology, Stanford University Medical Center, 300 Pasteur Drive, Room S-068A, Route 1, Stanford, CA 94305-5105*.
R2 Technology, Sunnyvale, Calif{dagger}
Tower–St Johns Imaging Eisenberg Keefer Breast Center, John Wayne Cancer Institute, St John’s Health Center, Santa Monica, Calif{ddagger}
Department of Radiology, University of California, San Francisco.§

We read with interest Dr Berlin’s comments on our article (1) and his editorial comments regarding expert witness testimony and standard of care in mammography interpretation. He comments that judgments on malpractice litigation regarding diagnostic error on prior mammograms involve single expert witness testimony for plaintiff and defendant. That judgment is based on whether the expert agrees that a well-trained radiologist in standard clinical practice would act similarly to the radiologist defendant with regard to mammographic findings in the case.

In our article, we do not imply that the judgment of a majority vote of five blinded radiologists would be used in the courtroom, nor that such a panel replaces an expert witness testimony. The purpose of the panel of five blinded radiologists in our study was to identify a population of mammographic findings that were not obvious cancers. The panel was used to determine which mammographic findings were sufficiently below the threshold for intervention that most radiologists would not take action (recommend recall for additional imaging). Once this population of findings was identified, we conducted an unblinded review by two expert radiologists to determine which of these subtle findings, if any, would still be dismissed, simulating the standard clinical practice of well-trained radiologists in conforming to the standard of care. Thus, in our article, we provide objective evidence that there is a population of mammographic findings that are visible but that would not be acted on in standard clinical practice. At issue in a medicolegal context is forseeability, and our analysis of such abnormalities from this perspective shows that while some subtle findings are actionable in retrospect (cases reevaluated by the two experts as Breast Imaging Reporting and Data System, or BI-RADS, category 0 or 4), the majority are not actionable in standard clinical practice, requiring only the recommendation for routine screening mammography (cases reevaluated by the two experts as BI-RADS category 1 or 2, despite the fact that cancer developed at the same site within 14 months).

The key point is that just because "something" is visible where cancer develops subsequently does not mean that a defendant radiologist was negligent in choosing not to recommend recall for additional imaging. Our results show that failure to act on every subtle mammographic finding at a site where cancer develops later does not necessarily imply failure to conform to the standard of care. Expert witnesses who provide advice and testimony in medicolegal reviews should recognize this when making judgments on specific cases.

The studies of Brennan et al (2,3) on the medical records of 31,000 patients cited by Dr Berlin, while interesting, are not directly comparable to ours. The study of Brennan et al would be comparable to ours if the panel of clinicians in that study saw the actual patients, not just their records. We reviewed the actual mammograms, just as expert witnesses review actual mammograms for deposition and testimony in court. At the time of expert testimony, the expert explains if the findings on the mammogram were suspicious or not, and the actual mammograms may be displayed in the courtroom for the jury. At issue, again, is forseeability and whether the finding was suspicious enough to be recalled by a well-trained radiologist in normal clinical circumstances. Our findings show that on review of the actual mammograms, there are some findings that are not suspicious enough to be recalled, even if they were located where cancer developed subsequently.

Our article is not applicable to every malpractice case. There are some suspicious findings that are not recalled in which the radiologist’s interpretation falls below reasonable clinical practice. On the other hand, our article elucidates a population of findings that are within the standard of care to return to screening.

Dr Berlin’s stated perspective, intended or not, infers an advantage for the plaintiff testimony if a case is tried before a jury. We do not accept this contention. Most cases that proceed to trial result in verdicts in favor of the defendant (L. Bartholomew, written communication, May 2003). Our work adds objective and credible evidence—supported by independent expert corroboration—that needs to be reconciled to testimony presented either before or during trial and that may be cited to support various opinions, regardless of which "side" uses the data.

In this manner, resolution of cases may be predicated to a greater degree on the basis of science rather than emotion.

REFERENCES

  1. Ikeda DM, Birdwell RL, O’Shauhnessy KF, Brenner RJ, Sickles EA. Analysis of 172 subtle findings on prior normal mammograms in women with breast cancer detected at follow-up screening. Radiology 2003; 226:494-503.
  2. Brennan TA, Sox CM, Burstein HR. Relation between negligent adverse events and the outcomes of medical-malpractice litigation. N Engl J Med 1996; 335:1963-1967.
  3. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study 1. N Engl J Med 1991; 324:370-376.




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