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Editorials |
1 From the Avon Foundation Comprehensive Breast Evaluation Center, Wang Ambulatory Care Center, Suite 240, 15 Parkman St, Boston, MA 02114. Received February 26, 2004; accepted February 27. Address correspondence to the author (e-mail: kopans.daniel@mgh.harvard.edu).
Index terms: Breast radiography, quality assurance • Editorial • Medicolegal problems • Screening
I appreciate Leonard Berlin’s astute comments (1) with regard to the concerns that I raised over the medical-legal situation surrounding breast cancer screening (2). His insightful observations reinforce a number of the points that I was trying to make. I believe, however, that he provides a somewhat idealized view of the legal system. The fact that the system usually vindicates the defendant does not nullify the toll that the process can take on physicians who are wrongfully accused of negligence. When I suggested that physicians are being held to impossible standards, I was not implying that physicians were, necessarily, losing suits for this reason, but, rather, that such standards were the reason physicians were being accused in the first place. The fact that 70% of suits are won by the defendant may be a reassuring outcome, but it does not take into account the devastating effects that the accusation of negligence has on physicians as they wait, often years, to be vindicated.
Furthermore, the success at trial does not take into account the cases that are settled out of court, in which the physician may not have been negligent at all, but the physician and/or the insurance company decided not to risk the vagaries of a jury trial. Finally, we do not know what percentage of the cases that are lost by physicians were based on truly negligent actions rather than on the whim of a jury.
I know of one case in which the jury, before they even heard the case, had agreed, having seen the plaintiff who was dying of breast cancer, that they were going to find in her favor. When the judge learned of this, the case was settled before the trial began. There had actually been no negligence involved, but the defense was unwilling to risk trying to convince jurors who had already made up their minds. The plaintiff was given $250,000.
Clearly, anecdotes should not be used to condemn a system, but we should also view the realities of systems and not just the idealized vision of how the system is supposed to work. Certainly, the legal system does not always work well, as we have seen in some high-profile trials. I believe that reducing the physician’s exposure to court proceedings is an important goal. Just as women need to be informed beyond the idealized claims about how mammography really works, physicians also need to be aware of the realities of the legal system.
Berlin is concerned that my observations might detract from the important effort to try to educate women as to the facts surrounding mammographic screening. This was certainly not my intention. As I noted in the article, I fully support such efforts. I am, however, skeptical that these efforts will be successful. I do not mean to be argumentative, but a quick search of PubMed revealed at least 16 articles that, in one way or another, discussed the false-negative rates of mammography (3–18). A Google search reveals multiple Web sites that warn women about false-negative mammograms (19–26). There have been a number of articles written that specifically highlight the risk of false reassurance from a negative mammogram, both for diagnosis (27–30) and for screening (31,32). Opponents of screening for women aged 40–49 years have written article after article describing the harms of screening, including the false-negative rates, as well as the potential for false reassurance. The limitations of mammography have not been kept a closely guarded secret.
Unfortunately, as Berlin points out, health advocacy groups have used hyperbole to try to convince women to be screened. Radiologists who advertise their services have been able to make claims that are not substantiated by science. Nevertheless, accurate information has been available for decades. It is also obvious that there is no way to control what the media decide to print. I personally state in virtually every interview that I have had with reporters, "It is important for women to realize that mammography is far from perfect. It does not find all cancers and does not find all cancers early enough to result in a cure. A negative mammogram does not mean that a woman does not have breast cancer, and she should immediately bring any change in her breast to her doctor’s attention, even if she just had a negative mammogram." Of course, the decision to report such statements is in the hands of the reporters, editors, and producers.
I completely agree that it behooves us all to try to provide accurate assessments of the benefits and limitations of mammography screening. That said, I believe that we also have an ethical responsibility to promote mammographic screening because the scientific data clearly show that mammography can save lives. Information should be provided that is based on scientific facts, and this information should be realistic and not exaggerated. Explaining the limitations of mammography is important, but the focus should remain on the benefits of the test. In an effort to explain the fact that mammography is far from perfect, we need to exercise caution that the message is not misinterpreted, thereby, inappropriately, discouraging women from being screened.
I doubt, however, that lawsuits will diminish by just explaining this to women who are frightened and angry about the fact that their cancer was not detected, mainly because all radiologists, no matter how skilled, periodically fail to see a cancer that is visible in retrospect. Why would we expect the patient to accept this when our own colleagues, as experts for the plaintiff, routinely ignore the fact that they, themselves, have overlooked a cancer that is visible in retrospect—yet they are willing to fault another for the same perceptual problem? Why would we expect the patient to be more understanding? I will be delighted if a major educational effort is successful and, as I have stated, will support the effort, but I am skeptical that it will be a success.
The main thrust of my article was not, as Berlin suggested, the expectation that we can reform the judicial system. I am not so naïve. My hope, however, is that science can be injected directly into a particular problem. As I wrote, it is my understanding that the huge volume of litigation that swirled around the relationship between silicone gel implants and systemic disease was brought to an abrupt halt when Judge Porter commissioned a scientific review of the data by an independent panel. That panel concluded that there was no evidence that implants contributed to systemic illness. Since this type of analysis, ordered by a judge, is admissible in all courts, it effectively brought the litigation to an end based on the lack of scientific evidence to support the claims of the litigants.
It is my hope that a similar review can be done to evaluate the ability of radiologists to perceive abnormalities during imaging studies. There are ample data providing evidence that there is an immutable perceptual problem and that all radiologists, no matter how skilled, periodically fail to see specific abnormalities that are visible in retrospect.
Despite the scientific evidence, it is my understanding, in discussing this problem with lawyers, that this is a very difficult argument to make in front of a jury when the jurors are staring at the "obvious" cancer. As I pointed out in my article, most cases that go to trial are decided for the defendant, but that is not the main point. The fear among radiologists is the suit itself. If, however, there is a scientific review that is sanctioned by and admissible in all courts and that confirms the vagaries of human perception, then these suits would not be initiated in the first place.
Berlin was concerned about several other points. He suggests that radiologists are not being held to unreasonable standards and cited an appellate court decision that addressed the fact that "radiologists simply cannot detect all abnormalities on all X-rays... . Errors in perception by radiologists viewing x-rays occur in the absence of negligence." This sounds like a very positive, clear definition of the facts, but Berlin ends by citing the real problem: "How their guidelines are interpreted by physicians, lawyers, and jurors, however, is an another matter." As I noted earlier, the problem is that the system permits accusations that hold physicians to an impossible standard, thereby requiring the defendant to convince a jury that he or she was not negligent. In effect, a physician who is accused of negligence feels guilty until proven innocent. Physicians who go before a jury are vindicated more often than not, but this vindication does not mean that the accusation and the process to get to the truth do not already presuppose that physicians operate at an impossible level. When a trial is concluded, it may be that the jury did understand that the radiologist was not negligent, and, ultimately, the radiologist is not held to an impossible standard. Nonetheless, the system is set up, in many cases, with an initial expectation that is often impossible to attain, and the hope is that the jury will understand.
Another unrecognized problem is that appellate court decisions do not apply to the cases that are settled out of court. I have seen several cases in which there was clearly no negligence involved, but the insurance companies were not willing to risk losing a larger sum of money on the vagaries of a jury trial, and so they agreed to settle for a lower sum. Nevertheless, radiologists accused of negligence who settle out of court are still entered into a national database and must explain the reasons why they are listed in this database every time they change jobs or renew their license. It is fine to defend our legal system, which is probably one of the best such systems in the world; however, just as with the limitations of mammography, the limitations of the judicial system must be recognized, or changes will never be made. Radiologists should at least be aware of the limitations of the system. I still meet physicians who are stunned because the system did not seem to take "truth" into account. Idealized declarations about how the legal system is supposed to work are fine, but physicians face real-life courts and juries. As lawyers have reminded me, our legal system is adversarial and designed to "see who wins." They would argue that this is probably the best way to get at the truth, but the system is not designed, specifically, to seek the truth.
Berlin’s defense of the standard of care ignores the reality. It is impossible to argue that there is a standard of care if the decision of one jury has no influence on the next case that revolves around the same question. An example from an actual case was the question, "Should ultrasound have been used to evaluate a palpable mass in 1992?" One jury might decide that it was the standard of care in 1992, while another jury might decide that it was not. How can one argue that there is a standard of care when completely opposite standards can be, simultaneously, correct? The only conclusion is that it is at the discretion of the jury to decide what the standard of care should have been at the time the event for which you are now being sued took place. There can be no real standard if one jury can decide one way and another jury can decide the other, with both decisions being correct. The fact that juries frequently arrive at the correct decision does not negate the fact that the system is capricious and unpredictable. If this were not the situation, then cases would never be settled out of court.
In the ideal world, radiologists would find all breast cancers and save the lives of everyone who develops breast cancer. Berlin goes further suggest that, in the ideal world, experts are reasonable, and there are effective rules that govern each expert’s involvement and testimony. In my experience, however, experts who lack expertise are very common. I have personally been involved in cases in which experts have made statements that were totally unsupportable scientifically, yet these statements were permitted by the court. The most egregious was the expert who insisted that he could see the cancer in the medial portion of the left breast on a previous mammogram. His testimony was allowed, despite the fact that the cancer was ultimately diagnosed in the other side of the breast in its lateral portion—nowhere near the normal tissue to which he was pointing. Fortunately, the jury decided in favor of the defendant, but why should the radiologist have been sued in the first place based on such erroneous expert testimony?
The apologist for the legal system would point out that it is up to the defendant’s lawyer to discredit such testimony and that the radiologist won, but this argument ignores the fact that the radiologist never should have been accused in the first place. Truth does not always prevail. In another case, the expert convinced a jury that a cancer had moved from the upper outer breast, where he pointed on an earlier mammogram, to the periareolar area at diagnosis. In this case, the jury believed him and awarded the plaintiff a multi–million-dollar settlement.
I am intrigued by Berlin’s defense of the expert witness given that two of his own articles were disparaging of the system (33,34). I certainly did not mean to imply that all expert witnesses lack true expertise. The point is that the system does not differentiate between true experts and those who claim expertise. The fact that the legal interpretation of an expert allows for anyone who has viewed a mammogram to claim expertise certainly denigrates the title "expert," but this does not invalidate my concerns. Unfortunately, the financial rewards of testifying can certainly encourage the nonexpert "expert." As to the standards to which experts are held, a quote from Berlin’s own article reinforces my point (33):
The thought of penalizing an expert witness for providing false testimony in a legal proceeding is generally viewed by the courts as abhorrent. Courts have consistently held that the expert witness should be immune to judicially administered penalties, repeatedly ruling that if experts are subjected to such action, qualified physicians and scientists will refuse to participate and assist in the administration of justice.
I hope that the cases I have cited are the exception rather than the rule, but the system is considerably flawed, and Berlin’s rationalizations do not correct this. I have no illusions that the system will be reformed, but it is also important that radiologists realize and understand the situation. Trying to rationalize the problems do not make them disappear.
I will say once more that I fully support the effort to provide women and their physicians with all of the information possible so that both can have an accurate understanding of the benefits and shortcomings of mammographic screening. At the same time, radiologists should be aware of the strengths and shortcomings of our legal system. I still hope that a judge might be convinced to commission a review of the perception literature so that such a review might be used to quickly reduce the exposure of radiologists to scientifically unjustified lawsuits. This would reduce the fear that radiologists have of mammographic screening, thereby allowing radiologists to continue to participate in the major decrease in breast cancer deaths that has occurred since large-scale mammographic screening began.
FOOTNOTES
Author stated no financial relationship to disclose.
See also the editorial by Berlin in this issue.
REFERENCES
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  J. Raymond and I. Trop The Practice of Ethics in the Era of Evidence-based Radiology Radiology, September 1, 2007; 244(3): 643 - 649. [Abstract] [Full Text] [PDF]
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