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The Missed Breast Cancer Redux

Time for Educating the Public About the Limitations of Mammography?

¹ Department of Radiology, Rush Medical College, Chicago, IL 60612, and Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076.

Received October 31, 2000; accepted after revision November 16, 2000.

 
Case summaries are based on actual events and lawsuits, although certain facts have been omitted or modified by the author. All opinions expressed herein are those of the author and do not necessarily reflect those of the American Journal of Roentgenology or the American Roentgen Ray Society.

Address correspondence to L. Berlin.

Introduction

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 

A season is set for everything, a time for every experience under heaven:

A time for being born and a time for dying,

A time for planting and a time for uprooting the planted;

A time for slaying and a time for healing,

A time for tearing down and a time for building up;....

A time for silence and a time for speaking;

A time for loving and a time for hating;

A time for war and a time for peace.

Ecclesiastes 3:1-8 [1]

And may this author respectfully add:

A time for educating the public about the benefits of mammography

And a time for educating the public about the limitations of mammography.

The Case

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
A screening mammogram obtained in a 45-year-old woman was interpreted by a radiologist as showing normal findings. Eleven months later, the woman returned to the radiology facility for follow-up mammography. The new study disclosed a lesion in the right breast suggestive of carcinoma. Surgery confirmed infiltrating ductal carcinoma with involvement of many lymph nodes. The patient underwent mastectomy and chemotherapy.

Two years later, the patient filed a medical malpractice lawsuit against her primary care physician, the radiologist, and the radiology facility at which mammography had been performed. The lawsuit alleged that the defendants had acted negligently by causing an 11-month delay in the diagnosis of the woman's breast cancer, and that this delay had seriously impaired her chance for survival. Attempts to settle the lawsuit were not successful. By the time the case proceeded to trial, the woman was undergoing treatment for diffuse metastatic disease.

At the trial, an expert radiology witness for the plaintiff testified that the defendant radiologist had breached the standard of care by missing a suspicious lesion on the initial mammograms. The plaintiff's expert was a board-certified radiologist but was no longer in active practice; on cross-examination he admitted that he had not been a regular interpreter of mammography for approximately 11 years.

An expert radiology witness for the defense supported the interpretation of the defendant radiologist, testifying that he was unable to see any abnormality on the initial mammograms. The defense expert was a nationally known and highly regarded researcher and teacher whose radiology practice was active and dedicated solely to mammography.

At the conclusion of the trial, the jury, perhaps swayed by sympathy for the patient who was terminally ill during the proceedings, ruled that the defendant radiologist was liable for malpractice and awarded the patient $4.5 million. The jury found no liability on the part of the family physician or the radiology facility [2].

Medical-Legal Issues: Proximate Cause

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
To resolve a medical malpractice case alleging delay in the diagnosis of breast cancer, two questions must be addressed: was the defendant radiologist negligent in missing a carcinoma on mammography, and did the delay in diagnosis cause injury to the patient; or, in legal terms, did the alleged negligence proximately cause damage to the patient? The question of whether the missing of a lesion constitutes negligence has been covered in previous American Journal of Roentgenology (AJR) articles [3,4,5] and need not be discussed here. However, the question of proximate cause—that is, the extent to which, if at all, a delayed diagnosis of breast cancer adversely affects treatment and prognosis—is an issue on which this article will focus.

Review of the vast body of scientific literature and the extensive statistical data dealing with screening mammography and survival rates for breast cancer can help to identify general trends and to define probabilities. In the courtroom, however, issues are case-specific. In front of a jury, a particular woman will appear in whom breast cancer of a certain histologic type and stage has been diagnosed, and for whom a diagnosis allegedly could have been made some months, or years, earlier. The question of the extent that treatment and prognosis have been altered will be debated by attorneys and expert witnesses and answered by a jury. There is never a single "correct" answer to this question, and only rarely is there even a semblance of agreement among the expert witnesses. The public's lack of understanding can be illustrated by a recent Wall Street Journal article that portrayed a woman with a family history of breast cancer who had to wait 2 months to undergo screening mammography as "really uncomfortable" because "I know that cancer can spread extremely fast, and the space of a couple of months can make a difference" [6].

The widely divergent scientific opinion about the degree to which a delay in diagnosis influences the survival of patients with breast cancer is illustrated by two articles that were published in the same issue of Lancet in April 1999. One group of researchers found that delays of even 3-6 months were associated with lower survival rates [7]. The second group of researchers disclosed that delays in the diagnosis of breast cancer of 3 months or more did not seem to be associated with decreased survival rates in patients with breast cancer [8]. The second group of researchers explained their findings:

Many breast cancers detected at screening have been present for some time. These breast cancers lead to average or higher than average survival, which suggests long doubling times and a nonaggressive phenotype. On the other hand, some aggressive cancers undoubtedly metastasize early, for which early detection would probably contribute little to long-term survival. It is hardly surprising, therefore, that data on delay are confusing. A systematic overview of the literature commissioned by the National Health Service suggests that delays of longer than 3 to 6 months have an adverse influence [7]. Much of the data reviewed in the study are, however, old and the study may have a substantial publication bias.... Our results suggest that delays of more than 90 days are unlikely to have an impact on survival.

With such wide divergence of opinion among researchers who are presumably well-intended, fair, and objective, it should be no surprise that there usually exists an even greater divergence of opinion among radiology expert witnesses in the courtroom who, because they are retained by legal counsel who are adversaries, may not always be so well-intended, fair, and objective.

That radiology expert witnesses who are well versed with up-to-date radiology literature may arrive at contradictory conclusions can be expected. Other "experts," however, render opinions without possessing adequate knowledge of contemporary scientific literature. One such opinion that has little basis in fact is illustrated by the letter written by a defense attorney to a radiologist's insurance company in a malpractice case that alleged a 1-year delay in diagnosis of breast cancer:

On June 30, 1997, [the plaintiff] underwent mastectomy. It was confirmed that there were four positive lymph nodes, and chemotherapy was recommended. She then underwent extensive chemotherapy. At present, plaintiff is taking Tamoxifen. She currently sees her oncologist every 4 months and so far, in July 2000, is cancer free. However, she has been advised that her prognosis is bleak.

Doctor [a nationally known and respected radiologist] was very pessimistic about the plaintiff's prognosis. We advised him that she has testified she is cancer free at this time, but he stated most likely she will not survive. He stated that he could not tell the extent of the cancer by the 1996 films, but "it's not trivial." He also believes that if the defendant radiologist had discovered the cancer in 1996, treatment would not have been so extensive. Therefore, he could not help us on causation.

One wonders whether this "expert" would have rendered the same opinion if he had been more familiar with the radiology literature cited in this article.

Damages

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
Generally, to show that a patient has sustained injury as a result of medical malpractice, the injury to the patient must be objective—either so physical that it is visible to the eye, or so physical that it is documented in terms of the need for additional treatment or loss of chance for survival. Compensation for emotional injury or pain, or mental anguish, is awarded only if physical injury is proven. However, in breast cancer, general legal rules can change. What constitutes patient injury when breast cancer is involved seems to have been greatly liberalized in a recent decision of the Supreme Court of the state of Colorado [9]. In that case, a 32-year-old woman sued a physician for emotional distress caused by his failure to diagnose her breast malignancy 3 months earlier. No testimony regarding additional treatment or decreased prognosis as a result of the 92-day delay was offered at trial. The jury awarded the patient $220,000 in compensatory damages, and the physician filed an appeal. The Appellate Court overturned the verdict, but the Colorado Supreme Court reinstated it, stating:

We note that [the patient] sought damages for "emotional distress, including fear of an increased risk of recurrence of cancer." Similarly, the [patient's] case at trial focused more on emotional distress brought on by the increased risk caused by [the doctor's] misdiagnosis than the risk itself.... Although surgery removed [the patient's] cancerous mass as well as her lymph nodes, medical evidence suggests that a delay in treatment which leads to the growth of a cancerous tumor "invariably results in a more serious prognosis" for long-term survival.... [It is true that] where the plaintiff demonstrates that her cancerous condition physically worsened as a result of the delayed diagnosis, the plaintiff has demonstrated a sufficient physical injury to permit the recovery of emotional distress damages. [But] the usual reservations courts have concerning speculation and conjecture in cases involving plaintiff's seeking purely emotional damages are inapplicable in a case such as this.... The reasonableness of the plaintiff's fears are sufficient [to deserve compensation].

Whether the Colorado Supreme Court's expanded definition of damages applicable in missed breast cancer cases is adopted by other states remains to be seen.

Public Perceptions

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
The public's perception of the importance of mammography and early detection of breast cancer comes from many sources: newspapers, magazines, television, advertisements, and, of course, one's own physician [10]. In the past decade, mammography has been promoted as constituting the best, if not the only, means of detecting breast cancer early and effecting an improved cure rate. Unquestionably, this kind of promotion has been in the public interest, because it has led to more women undergoing mammography than could ever have been achieved without such promotion. On the other hand, has the pendulum swung too far—that is, has mammography been overpromoted? Jurors, judges, attorneys, patients, and even doctors, as members of the public, are exposed to the same barrage of information regarding breast cancer and mammography as is the general public. Has possible overpromotion made it too difficult—disproportionately difficult—for a defendant radiologist to prevail in a malpractice lawsuit in which he or she is accused of missing breast cancer on mammography? The answer may be affirmative, because 48% of malpractice claims that allege errors in diagnosing breast cancer now result in indemnification payments, a figure considerably higher than the 29% indemnification rate of malpractice claims involving all physician groups as a whole (Physician Insurers Association of America, unpublished data).

The news media seem to have backpedaled to a small degree in their message that mammography always reveals breast cancer in its earliest stages and therefore assures patients of increased survival. Here are examples. In a New York Times article in November 1999, science writer Jane Brody [11] emphasized that "the diagnosis and treatment of a tiny cancer is not a guarantee of cure." An article in a Chicago newspaper stated [12]:

Women have come to expect too much from their yearly mammogram...they now mistakenly believe the tests are infallible, failing only when people fail. The truth is that what's flawed are the tests themselves.

The article concluded:

Mammograms are lifesavers. All women older than 40 should be getting yearly breast x-rays.... the tests are incredible success stories, but you'll benefit if you realize they are not perfect. They are simply the best we have.

A front page article in USA Today in December 1999 by science writer Rita Rubin [13] also emphasized that with regard to mammography and breast cancer "early detection doesn't necessarily save lives." An article by the same writer [14] published in February 2000 in a Chicago newspaper added, "Mammography has been oversold."

Considerable news media coverage was given to the Canadian report of Miller et al. [15] questioning the efficacy of mammography in decreasing breast cancer mortality. A USA Today article from September 2000 quoted the associate director of the National Cancer Institute's Biomedical Imaging Program: "The data aren't as clear-cut as people would like them to be. Everything we know about the biology of cancer suggests to us that early detection should be beneficial" [16]. The article went on to quote one of the researchers from the Canadian study:

[W]e expected emotional responses, because that is what you get if you go against the stream and there are huge vested interests in this area.... Our study doesn't say you shouldn't do screening mammography. All we're saying is there's an alternative.

Can the Courtroom Atmosphere in Cases of Missed Breast Cancer Be Changed?

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
The question of whether early detection does or does not reduce breast cancer mortality rate commands considerable attention in an article appearing elsewhere in this issue of the AJR [17]. The major thrust of the present article is not the efficacy of mammography, but rather the malpractice-litigation aspect of breast cancer and mammography. The reason for reviewing the myriad and often contradictory reports concerning the value of mammography is not to cast aspersions on mammography. Virtually the entire radiology community in the United States believes that mammography is the best tool available today to detect breast cancer in its early stages and that early detection will offer women the opportunity to achieve the best chance of cure. Thousands of radiologists have dedicated and will continue to dedicate their careers and professional lives to elevating the quality of mammography. It is not the purpose of this article to detract in any way from their achievements. It is not the purpose of this article to argue against fair compensation for women who have been injured as a result of professional negligence committed by radiologists or other physicians. It is not the purpose of this article to argue against the current legal system by which compensation is awarded.

This article does have two purposes, however. The first is to suggest that radiology organizations and nonradiology public interest groups examine all sides of the efficacy issue as they relate to mammography and encourage the news media to do the same, with the ultimate goal of better educating the American public by presenting a more balanced view of the relationship between early detection of breast cancer and survival with breast cancer. This more balanced view, in turn, will hopefully modify the public's perceptions and misperceptions about missed mammographic diagnoses and malpractice.

The other purpose of this article, along with others dealing with missed breast cancer published in the AJR [17, 18], is to provide reference material that may assist parties contemplating or already involved in breast cancer malpractice litigation. As has been pointed out, much evidence exists in the radiology literature that provides sound bases to argue that a delay in the diagnosis of breast cancer may not necessarily diminish the patient's chance of survival or reduce the patient's chance for cure.

Summary and Conclusion

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 
The allegation of a delay in the diagnosis of breast cancer remains the most prevalent cause for which radiologists are sued for medical malpractice. Although some data indicate that the absolute number of malpractice lawsuits alleging missed mammographic diagnoses has stabilized or may be slightly decreasing, the average indemnification paid in such cases is rising. However, with the number of mammographic examinations performed annually in the United States likely to increase, it is probable that the number of related malpractice lawsuits will begin to rise accordingly.

The two issues at stake in lawsuits alleging delay in the diagnosis of breast cancer are whether the radiologist has been negligent in his or her interpretation of mammography, and whether the alleged delay in diagnosis has adversely affected the patient's treatment or prognosis. At trial, these issues are decided by a jury; in settlement discussions, these issues are decided by attorneys representing the plaintiff and defendants, and by claims managers of professional liability insurance companies. In either event, the testimony of radiologists retained as expert witnesses by the various parties in the lawsuit heavily influences final resolution. Jurors, attorneys, insurance claims managers, patients, and doctors are all members of the public at large, and thus all are influenced in varying degrees by the voluminous medical information to which the public is exposed by the print and broadcast news media. In this way perceptions—and misperceptions—are formed. It is likely that medical malpractice lawsuits alleging delay in the diagnosis of breast cancer are more frequent and result in disproportionately greater indemnification because the public perceives mammography to be unrealistically accurate and effective in improving prognosis. Perhaps the material presented in this and similar articles can assist patients who believe they have been subjected to malpractice and their attorneys, radiologists who believe they are unfairly accused of malpractice for misinterpreting mammography and their legal counsel, and radiology experts who may testify in malpractice cases. Perhaps the resource material presented in these articles can help guide all parties into reaching a fair and equitable resolution of these kinds of lawsuits.

Perhaps radiology organizations such as the American College of Radiology, the Radiological Society of North America, and the American Roentgen Ray Society, and public interest organizations such as the American Cancer Society should consider undertaking efforts that would educate the public to the fact that mammography may not be as accurate as initially thought, that early diagnosis of breast cancer does not necessarily guarantee a cure, and that failure to diagnose breast cancer earlier does not necessarily result in a poorer prognosis.

The time to educate the public about the benefits of screening mammography has been well spent. Is it now time to educate the public about the limitations of mammography?

References

Top Introduction The Case Medical-Legal Issues: Proximate... Damages Public Perceptions Can the Courtroom Atmosphere... Summary and Conclusion References

 

1. Ecclesiastes 3:1-8. The writings: a new translation of the Holy Scriptures according to the Masoretic text. Philadelphia: The Jewish Publication Society of America, 1985: 386-387
2. Crain v Miller, 94-3031 (Middlesex Division, Mass 1999)
3. Berlin L. Perceptual errors. AJR 1996;167:587 -590[Free Full Text]
4. Berlin L, Hendrix RW. Perceptual errors and negligence. AJR 1998;170:863 -867[Abstract/Free Full Text]
5. Berlin L. Defending the "missed" radiographic diagnosis. AJR 2001;176:317 -322[Free Full Text]
6. Martinez B. As more women seek mammograms, many have to wait months. Wall Street Journal. October 30, 2000: A1, A17
7. Richard MA, Westcombe AM, Love SB, Littlejohns P, Ramirez AJ. Influence of delay on survival in patients with breast cancer: a systematic review. Lancet 1999;353:1119 -1126[Medline]
8. Sainsbury R, Johnston C, Haward B. Effect on survival of delays in referral of patients with breast-cancer symptoms: a retrospective analysis. Lancet 1999;353:1132 -1135[Medline]
9. Boryla v Pash, 960 P2d 123 (Colo 1998)
10. Johnson T. Shattuck Lecture: medicine and the media. N Engl J Med 1998;339:87 -92[Free Full Text]
11. Brody JE. How good can mammograms be? Suits seek to set a standard. New York Times. Nov 2, 1999:D7
12. Breen M. Mammograms, Pap tests aren't perfect. Chicago Sun-Times. Nov 21, 1999:48A
13. Rubin R. Do mammograms pass the test? USA Today. Dec 21, 1999:1A
14. Rubin R. Not a foolproof test. Chicago Sun-Times. Feb 28, 2000:42
15. Miller AB, To T, Baines CJ, Wall C. Canadian National Breast Screening Study-2: 13-year results of a randomized trial in women aged 50-59 years. J Natl Cancer Inst 2000;92:1490 -1499[Abstract/Free Full Text]
16. Rubin R. Questioning mammography. USA Today. Sep 26, 2000:1D
17. Berlin L. Dot size, lead time, fallibility, and impact on survival: continuing controversies in mammography. AJR 2001;176:1123 -1130[Free Full Text]
18. Berlin L. The missed breast cancer: perceptions and realities. AJR 1999;173:1161 -1167[Free Full Text]

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