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Malpractice Issues in Radiology |
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 July 27, 2000;
accepted after revision August 7, 2000.
Case summaries are based on actual events and lawsuits, although certain
facts have been omitted or modified by the author, who has supplied and
obtained authorization for the reproduction of the radiographic image. 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.
The Case
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Over the next 2 months, the woman experienced increasing pain in the right ankle. Although the woman spoke by telephone with her family physician regarding the ankle discomfort and pain, she did not return to the physician until 8 weeks after the automobile collision. Radiographs obtained at this time revealed a fracture of the neck of the talus that appeared to be healing. The patient was referred to an orthopedic surgeon who applied a short leg cast. Eventually the fracture healed, but subsequent CT and MR imaging revealed areas of aseptic necrosis and minimal misalignment of the subtalar joint. The patient continued to complain of pain, especially while walking.
Eleven months after the initial accident, the patient filed a medical malpractice lawsuit against the hospital, the emergency department physician, and the radiologist. The lawsuit alleged that the pain and suffering the woman had experienced and "would likely experience for the remainder of her life" was the direct result of negligence on the part of the defendants in failing to diagnose a talar neck fracture promptly so that corrective surgery could have been undertaken.
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Although the attorney for the plaintiff offered to negotiate an out-of-court settlement of the lawsuit, the defense team refused. The case thus proceeded to trial [1].
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Q: I take it that you would agree with me that the fact that a radiologist does not diagnose a fracture or an abnormality on an X-ray, even though it's there, doesn't in and of itself mean that the radiologist has departed from the standard of care.A: Yes. The question isn't, can it be seen? The question is, should it be seen?
Q: How do you determine whether it should have been seen or not?
A: Several ways. There are two major factors. One is how obvious it is—the obvious factor. What is in the background. A little tiny nodule in a basically fatty breast, no one should miss. A little tiny nodule in a very dense breast you can hardly pick out. It can't be seen. An incidental little bony abnormality on the corner of a film in a patient with major trauma in the acute setting and it turns into an osteogenic sarcoma, you are going to miss. A lesion in the middle of a bone in a patient without trauma that comes in with bone pain, you shouldn't miss.
The defense attorney then asked the plaintiff's expert how many legal cases the expert reviews every year and whether those reviews are at the request of a plaintiff's attorney or a defense attorney. The expert responded that he sees approximately 20 cases per year, all sent by plaintiff's attorneys.
Q: Of the 20 or so cases sent to you in the last year by plaintiff's attorneys, on how many occasions have you said the X-rays are stone-cold normal—there is absolutely nothing here diagnostic that I could find?A: Probably 10 to 20% of the time, I tell the attorney I would not have expected the abnormality to be seen by the radiologist.
Q: So 80 to 90% of the time you find that there is an abnormality that you believe should have been diagnosed by the radiologist in the exercise of reasonable care?
A: That would be fairly accurate.
The second radiology expert called to the witness stand by the attorney for the plaintiff also stated that the talar fracture was clearly visualized and should have been diagnosed by the defendant radiologist. During cross-examination, the defense attorney focused on the expert witness's opinion about subtlety of the radiographic finding and whether radiologists could miss subtle findings and still not be negligent:
Q: Would you agree with me, where a fracture is very subtle, a radiologist can be exercising good medical care and judgment and still miss the fracture?A: It depends on the radiologist's level of expertise.
Q: Well, if we are talking about a competent, general diagnostic radiologist, does it seem plausible to you that where there was a subtle fracture, radiologists may exercise good standard of care and still miss the diagnosis?
A: If the fracture is very subtle, sure.
Q: It all depends on how you define very subtle.
A: Right.
Q: You do not find this case as being very subtle?
A: That's correct.
Q: Would you agree with me that the fact that a fracture can be seen in retrospect on a film does not necessarily mean that the radiologist who interpreted the film as normal at the time deviated from the standard of care?
A: I would not agree with that.
Q: So the fact that you can see it in retrospect means that there was a deviation from the standard of care at the time the radiologist called the film normal?
A: In this particular case.
Q: Have you ever had the experience of calling a particular study normal, only to be asked to re-review it later and find something that you had missed?
A: It depends whether you mean something that was overtly missed. It is not a common occurrence but it happens from time to time.
Q: How many times would you say that's happened in the last 6 or 7 years?
A: Fortunately never with anything serious, but some minor things.
Q: Whether it is serious or not, how many times in the last 6 or 7 years would you say you have had the experience of having initially read a study as normal only to look at that study at a subsequent date and find out that you missed something?
A: I can't remember a specific occasion where that occurred.
Q: You can't recall that ever happening?
A: Not with anything significant.
Q: What about with something insignificant?
A: From time to time. I can't put a number on it because it's not a common occurrence.
Q: Once a year?
A: Maybe.
After the plaintiff's attorney rested his case, the defense attorney called his first radiology expert to the stand. The defense expert disagreed with the plaintiff's experts, testifying that in his opinion the talar neck fracture was quite subtle. During cross-examination, the attorney for the plaintiff questioned the expert about standard of radiologic care.
Q: How is it, Doctor, that we know a fracture of the talar neck was there and that it was not diagnosed on these films by the defendant radiologist, and yet you say the radiologist met the standard of care?A: Well, you really have to put yourself into the shoes and position of that radiologist. The definition of standard of care is how a radiologist acting in a reasonable manner would interpret those films. In this particular case, when you have something that is very subtle, it's very likely that a reasonable radiologist can miss it. It is a common misperception that if you are wrong, it must be malpractice. It has been shown in this case that the original diagnosis was wrong—the MRI shows there is a fracture of the talus. So how can you possibly not have committed malpractice if you are wrong? I think the first thing you have to realize is that X-rays and the people who interpret them will not always be right. A prudent radiologist, a well-trained reasonable radiologist, a board-certified radiologist, will not always be able to see the finding if the finding is subtle enough. When a radiologist has to spend a significant amount of time on a finding and you can't see it, and even when you are pointed to the general area you can't see it, and you have a question about it but you are not quite sure if it really is a problem, I think that that is significantly subtle enough that that radiologist would be within the standard of care to have not called it.
The next and last radiology expert called to the witness stand also testified on behalf of the defense. During direct examination, the defense attorney introduced into evidence an article published in a radiology journal in 1976 [2] and asked the expert witness to summarize it. The witness stated that the article reported the results of a study dealing with radiologic errors that had been conducted at the University of Missouri. The study disclosed that radiologists at the university committed an average error rate of 31% when interpreting extremity radiographs. The radiologists' error rate was not influenced by experience, because the percentage of errors was essentially the same among staff radiologists, third- and fourth-year residents, and second-year residents. In the group of radiographs that were subjectively determined by the participants to be "difficult," the error rate was 53%, whereas in the group of radiographs that were considered "easy," the error rate was 28%. The defense attorney asked the radiology expert witness whether a report published in 1976 still has validity in 2000. "Yes," the expert replied, "Numerous studies published before and after 1976, even extending through the summer of 2000, report similar error rates in diagnostic radiology."
The defense's radiology expert was then cross-examined by the attorney for the plaintiff. The attorney began by asking how the expert witness determines whether a missed diagnosis is indicative of negligence:
A: I look at the study. I try to answer questions in my own mind as to how obvious or subtle the abnormality is, whether the abnormality, which we can now perceive in retrospect, could be confused with normal structures. The standard of care calls for a reasonable evaluation of the film; the radiologist has to conduct himself or herself in a reasonable fashion. Ultimately, I have to answer for myself not the question of whether the interpretation was correct or not, but rather do I believe the interpretation was a reasonable interpretation of the findings, even if that interpretation is incorrect.Q: Let's talk about fractures. You're looking at a film, and in retrospect you see a fracture that was not seen initially, and you see that it's there. And the question is, was it obvious enough so that it was medical negligence to miss it, or the converse, is it so subtle that it is not medical negligence to miss it. What are your definitions of "obvious" and "subtle?"
A: If something is seen with great difficulty, if the fracture line can very well be mimicked by a normal finding, such as a prominent trabecular pattern, or if the projection of the film is such that the fracture line is very difficult to discern, to me the finding is subtle. In other words, the question is how easily we can see the fracture, how easy it is to discern, and how it manifests itself relative to normal findings.
Q: Is it relevant to you whether the radiologist was supposed to look specifically for a fracture of a particular area or whether the film was taken for a completely different purpose and this was an incidental finding?
A: It's relevant, but not controlling. It's the duty of the radiologist to look at every corner of the film. On the other hand, there are many studies published in the radiology literature that show that accuracy of interpretation is improved if one knows the patient's history. In the case of fractures, if one knows where the pain or the findings are, the accuracy will be improved.
Q: Do you agree that the defendant radiologist in this case was indeed focused on the question of whether there was a fracture of the foot, as distinguished from a situation where the film was taken for an entirely different purpose?
A: Yes.
Q: His job, then, basically was to rule out a fracture of the ankle?
A: That's correct.
Q: So his job, to put it down right to the nitty-gritty, was to find out whether there was or was not a fracture of the talus. He was supposed to look at the talus and determine whether it was fractured or not. Wasn't that his job?
A: Well, I would put it in somewhat broader terms. His job was to examine and interpret all films presented to him in a reasonable fashion to the best of his ability.
Q: But wasn't he also supposed to rule out a fracture of the ankle?
A: Yes that's part of his duty.
Q: So the defendant radiologist had a duty to look at the talus bone on the film?
A: Yes.
Q: When you look at the film today, do you see a fracture?
A: Today, as I look at the film, yes, I do.
Q: Then tell me and the jury again what is subtle about this particular film that leads you to state that there was no departure from the accepted standard of care?
A: When I first looked at the film, I will tell you that I did not see the fracture. On learning the history and then seeing subsequent films, I knew there was a fracture. In retrospect, I can see what I think is the fracture. But even today in retrospect, I believe the fracture is extremely subtle and can be seen only with difficulty. I think I can see the radiolucent line that represents the fracture, but I have seen similar radiolucent lines in normal ankles. As I sit here today, I believe that what I see on this ankle film is not totally dissimilar to what I can see on other normal ankle films.
The attorney for the plaintiff then turned to the University of Missouri article [2] regarding error rates among radiologists:
Q: Doctor, are you telling the jury and me that radiologists misread 30% of all X-rays?A: Not necessarily. What these studies show is that when radiologists are given X-rays preselected because they are all known to be abnormal, without any clinical information and without any opportunity to discuss the films with colleagues or referring physicians, 30% of the abnormalities will not be seen by the radiologist. These are artificially controlled studies, which is not the way radiologists practice radiology on a day-to-day basis. In the real world, we do have clinical information, and we have dialogue with colleagues and referring physicians. In addition, some of the things we miss have no clinical significance, and furthermore, some of the things we miss initially we may find on reviewing the same X-rays, or on subsequent X-rays obtained, either later the same day or several days later. Lastly, many X-rays are normal, and our error rate on those is much lower.
Q: Well, Doctor, if you're saying radiologists miss 30% of abnormalities, do you inform all the patients of that fact?
A: No.
Q: Do you reduce your fees 30%?
A: No.
As might be expected, during other portions of the trial the attorneys for the plaintiff and for the defendant each produced expert orthopedic witnesses who gave conflicting testimony: the plaintiff's expert stated un-equivocally that immediate diagnosis would have prevented the complications sustained and the lingering foot pain experienced by the patient, and the defense expert asserted with equal assurance that even if the fracture had been diagnosed immediately, neither the treatment nor eventual sequelae would likely have been different.
The defense expert quoted an authoritative source [3] who stated that because the blood supply of the talus is tenuous, aseptic necrosis often occurs after a talar neck fracture regardless of the timing of diagnosis and treatment. After the respective attorneys gave their closing arguments, the jury began its deliberation. Three hours later, the jury returned a verdict in favor of the defendant radiologist, ruling that no negligence had been committed.
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Medical and Radiologic Errors
An Institute of Medicine report
[4] issued at the end of 1999
that stated that medical errors cause from 44,000 to 98,000 deaths every year
in American hospitals mesmerized, indeed shocked, the American public
[5]. The earth-shattering
revelation that doctors' mistakes "kill" 98,000 Americans each
year commandeered the headlines of newspapers and front covers of magazines,
captured the imagination of political cartoonists, and became the lead story
on television news broadcasts. Medical errors became the subject matter of
television and radio talk shows throughout the nation. The Institute of
Medicine report galvanized the government into action. President Clinton
called for a new Patient Safety Center and for the federal government to
conduct research on reducing medical errors
[6], and senators and
congressional representatives introduced legislation to study and curb such
errors [7].
Although the accuracy of the Institute of Medicine study [4] has been questioned because it includes in its data many patients who were so ill that they would have died whether or not errors were committed [8], the validity of the study has been defended by others [9]. Although the government, the medical community, and the public-at-large have all proclaimed their determination to eradicate medical errors, various commentators have cautioned that a major reduction in errors will not come easily or quickly [5, 10, 11]. To begin with, write these commentators, in order to reduce medical errors there must be public reporting of such errors. The commentators point out that medical errors and malpractice litigation are inextricably linked, and therefore it is unrealistic to expect that the medical community will be willing to publicly report errors until there are major reforms in the medical malpractice litigation process.
That adverse events and medical errors occur with and without negligence is far from a new revelation. In 1991, Harvard medical practice study investigators reported that adverse events occurred in 3.7% of hospitalizations in New York and that 28% of these were due to negligence [12]. Just last year, researchers reported that adverse events occurred in 2.9% of hospitalizations in Utah and Colorado and 28-33% were due to negligence [13]. A recent Mayo Clinic study of autopsies comparing clinical diagnoses with postmortem diagnoses revealed that in 26% of cases a major diagnosis was missed clinically [14]. The Mayo Clinic researchers concluded that "The number of missed major diagnoses remains high, and despite the introduction of more modern diagnostic techniques and of intensive and invasive monitoring, the number of missed major diagnoses has not essentially changed in the past 20 to 30 years."
A study comparing clinical and autopsy findings conducted by researchers at University Hospital in Zurich, Switzerland, also published in 2000, found that the rate of minor diagnostic errors increased from 23% in 1972 to 46% in 1992 [15]. However, the frequency of major diagnostic errors was halved over the same 20-year period, mainly through a reduction in missed diagnoses of cardiovascular diseases. According to the researchers, this improvement was apparently the result of new technical diagnostic procedures and improved clinical skills. Neither of the autopsy studies addressed the issue of negligence.
The frequency and nature of radiologic errors have been the subject of numerous studies published in radiology journals for more than a half century. Researchers over the years have not only repeatedly confirmed the University of Missouri findings of an error rate that hovers in the 30%-plus range [2], but have also reported even higher miss rates in relation to cancer diagnoses—up to 75% in mammography [16] and 90% in chest radiography [17]. Comprehensive reviews of many of these studies can be found else-where [18, 19].
As one of the radiology expert witnesses in the case described in this article pointed out in his testimony, retrospective miss rates as determined by carefully controlled retrospective studies in which radiologists, without any clinical information or interaction with other physicians, blindly render interpretations of radiographs containing abnormalities, do not reflect actual error rates committed by radiologists in their day-to-day practice. A University of Texas study published in 1998 reviewed imaging interpretations, most of which were normal, rendered in the radiology departments of six community hospitals and found a 4.4% mean rate of interpretation errors [20]. This figure seems more in keeping with the reported frequency of adverse events found in hospitalizations.
Radiologic errors are of two types: cognitive, in which an abnormality is seen but its nature is misinterpreted, and perceptual or the "miss," in which a radiologic abnormality is simply not seen by the radiologist on initial interpretation. The perceptual variety accounts for approximately 80% of all radiologic errors [21]. Because radiologic errors are common and allegations that a diagnostic error has been committed account for 70% of all medical malpractice lawsuits filed against radiologists [19], it is no wonder that radiologists are being forced into the courtroom as defendants in malpractice actions with disconcertingly high frequency.
How successfully can radiologic errors or misses be defended? To arrive at an answer to this question, let us first examine the nature of the standard of care to which a radiologist is measured.
Standard of Radiologic Care
In a recent decision, the Illinois Supreme Court addressed the concept of
standard of care as it applies to professionals
[22]:
"Profession" is commonly defined as a vocation or occupation that requires advanced education and training and involves intellectual skills, such as medicine, law, theology, engineering, teaching, etc.... The term "standard of care" in common law is generally understood to mean a measure or rule against which a defendant's conduct is to be measured.... Professionals are expected to possess a higher degree of skill, care, and learning than the average person.... [and] to possess and exercise a standard minimum of special knowledge and ability.The established standard of care for all professionals is stated as the use of the same degree of knowledge, skill and ability as an ordinarily careful professional would exercise under similar circumstances.... In professional negligence cases, unlike negligent actions in general, the plaintiff bears a burden to establish the standard of care through expert witness testimony.... In instances, however, where the professional's conduct is so grossly negligent or the treatment so common that a lay-person could readily appraise it, no professional expert testimony or other such relevant evidence is required.
The Illinois court discussed professional errors in general, [22] but a recent state of Wisconsin Court of Appeals decision addressed radiologic perceptual errors specifically [23]:
Physicians too often have a tendency to encourage the aura of an infallibility they do not possess. Theirs is not an exact science, and even the very best of them can be wrong in diagnosis or procedure. The question, however, is not whether a physician has made a mistake; rather, the question is whether he was negligent. Unless the untoward result was caused by the failure to conform to the accepted standard of care, he is not liable....A radiologist may review an X-ray using the degree of care of a reasonable radiologist, but fail to detect an abnormality that, on average, would have been found.... Radiologists simply cannot detect all abnormalities on all X-rays.... The phenomena of "errors in perception"...occur when a radiologist diligently reviews an X-ray, follows all the proper procedures, and uses all the proper techniques, and fails to perceive an abnormality, which, in retrospect, is apparent.... Errors in perception by radiologists viewing X-rays occur in the absence of negligence.
The Jury
In the midst of the myriad often-conflicting facts and figures concerning
the frequency and nature of medical and radiologic errors that are introduced
into a trial through expert witnesses, exhibits, defendants, and the attorneys
them-selves, the jury is charged with deciding one, and only one, question:
Did or did not the defendant physician breach the standard of care? Jurors are
instructed by the judge about the legal aspects of a specific case that
include admonitions that jurors should base their decisions solely on evidence
that was submitted during the trial. Nonetheless, according to one poll, 75%
of persons eligible to serve on a jury say they would act on their own beliefs
regardless of legal instructions from a judge
[24]. These beliefs are to a
great extent influenced, if not actually formulated, by what jurors read in
the print media and hear and see on radio and television. It is therefore not
surprising that the jury trial has been called "one of the most
standardless operations" in our entire judicial system
[25].
The jury in this case found in favor of the defendant radiologist, seemingly agreeing with the testimony of the defense's expert radiology witnesses and the defense attorney that the missing of the fracture of the talar neck, although admittedly an error, was nonetheless an error that did not breach the standard of care. Lest there develop among radiologist readers the belief that this trial means that from this day forward all radiologists sued for malpractice for missing a "subtle" radiographic abnormality will be exonerated, I must caution that another jury hearing the same evidence and confronted with the same facts could well reach an opposite verdict.
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Contrary to many opinions expressed by state appeals courts, much of the public seems to believe that every radiologic error represents a negligent act. Most radiologists, nonradiologist physicians, lawyers, and lay people alike tend to take the position that if a radiologist has missed a diagnosis that was in retrospect present on radiographs, the miss cannot be considered anything but malpractice. To counteract this common perception (or misperception) among judges or jurors in a court of law, a defendant radiologist accused of negligence for missing a radiographic diagnosis, along with his or her attorney and supporting expert witnesses, must present a strong and convincing argument. The likelihood of such a defense argument succeeding is not known. Statistically, plaintiffs prevail in medical malpractice lawsuits less than 24% of the time [25], but most malpractice lawsuits are settled out of court under terms often not publicly disclosed. Therefore, accurate statistics addressing the question of how often indemnification is paid to plaintiffs when radiologists who commit radiologic errors are sued for malpractice is simply not available.
It is difficult to defend in the courtroom a radiologist who has failed to perceive a radiographic abnormality that in retrospect can be perceived. Nevertheless, data that include statistics regarding the frequency of errors committed by radiologists during the course of ordinary everyday practice, explanations of what makes certain radiographic abnormalities subtle, expert opinions that it is not possible for any radiologist or other professional to adhere to a standard of perfection, and evidence that the conduct of the defendant radiologist has been careful and prudent, can at times, as illustrated in the case described in this article, be sufficiently persuasive so as to effect a jury verdict in favor of the defendant radiologist.
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