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Malpractice Issues in Radiology |
1 Department of Radiology, Rush North Shore Medical Center, 9600 Gross Point Rd., Skokie, IL 60076, and Rush Medical College, Chicago, IL 60612.
Received June 5, 2003;
accepted after revision June 6, 2003.
Address correspondence to L. Berlin
(lberlin{at}rsh.net).
Introduction
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O! be some other name:What's in a name? That which we call a rose
By any other name would smell as sweet.
Shakespeare, Romeo and Juliet [1]
Suffering from bilateral pneumonia, a 58-year-old woman was admitted to the intensive care unit of a local hospital. Determining that prolonged IV administration of antibiotics would be required, the patient's internist contacted an anesthesiologist to insert a central venous catheter. Immediately after accomplishing the catheter placement, the anesthesiologist ordered a portable chest radiograph to verify the position of the catheter tip, requesting that the radiologist interpreting the radiograph call him if any problems with the placement were seen.
A radiology technologist obtained the chest radiograph at 10:00 A.M. After the radiograph was developed, the technologist attempted to find a radiologist to interpret the study but was unable to do so. Following hospital policy, the technologist took the chest radiograph to the emergency department, where an emergency department physician was asked to render an interpretation as to whether the central venous catheter had been properly placed. The emergency department physician determined that the placement of the catheter was appropriate and asked the radiology technologist to call a nurse in the intensive care unit and report the finding. After receiving the report, the nurse noted it and the name of the interpreting emergency department physician in the patient's chart, and then began to infuse medications and fluids into the catheter.
In the meantime, the technologist hung the chest radiograph on a multiviewer so that it would be officially interpreted by a radiologist. For reasons never explained, however, a radiologist did not see the radiograph until 9:00 P.M., 11 hr after it had been obtained. The radiologist reported that the catheter was "a little more to the left than is usually seen when it is in the superior vena cava." The radiologist dictated her report into a dictation system that could be accessed by telephone by any appropriate physician or nurse but did not attempt to directly communicate the interpretation to a nurse or the patient's physician.
A second chest radiograph was obtained at 6:00 the following morning and was promptly interpreted by the same radiologist. The radiologist included in her report the statement, "Central venous catheter remains." At 10:30 A.M., the patient's nurse noted that the patient's right arm was cold and without a detectable pulse. A new chest radiograph was obtained and interpreted at 11:30 A.M. by the same radiologist as follows: "The tip of the central venous catheter is in the midline at approximately the T7 level, and I cannot exclude this being in the aorta." With the permission of the patient's physician, the radiologist then injected contrast medium into the patient's central venous catheter. At this point the radiologist concluded that the catheter tip was in the ascending aorta.
The central venous catheter was removed immediately, but by this time the patient had already developed a thrombosis in her right axillary artery. Eventually the patient's right arm below the elbow was amputated.
Six months later the patient filed a medical malpractice lawsuit against the radiologist, alleging that the patient's right arm amputation was caused by the radiologist's negligence for failing to promptly communicate to the treating physician the findings on the chest radiograph. The lawsuit proceeded to trial, at the conclusion of which a jury found in favor of the patient, awarding her a total compensation of $2.5 million. The defendant radiologist appealed the jury verdict, claiming, among other things, that the plaintiff's expert radiology witness had not properly established the standard of radiologic care. The appeal eventually reached the Supreme Court of Alabama, which affirmed the verdict [2].
The Alabama Supreme Court Decision
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[The radiologist] argues that [the plaintiff's expert witness] did not testify to the applicable standard of care. [The expert] did testify to the applicable standard of care. Here is his testimony:Q: Doctor, based on your training and experience and background and education, are you familiar with the standard of care of a board-certified radiologist?
A: Yes, I am. The role of a radiologist is a consultant. A referring physician usually orders an X-ray, and it's the job of the radiologist to interpret those films accurately, on a timely basis, and then also provide a report back to the referring physician on a timely basis as was deemed necessary.... If it's a stat report from an intensive care unit looking for a question, that means immediate. The radiograph should be interpreted immediately and the report conveyed back in a timely manner.
Q: Doctor, if a particular radiologist's policy or practice of reading in a timely and accurate fashion and reporting in a timely and accurate fashion, is different from what you said, can that still be the standard of care?
A: No, if an individual doctor has her own standard, certainly it does not supersede the national standard of care.
Q: The national standard would top that?
A: That's correct.
Q: And you have to adhere to that?
A: Yes, you should.
Q: Okay. And, doctor, the standard that you have alluded to is not written down out there anywhere, is it?
A: There isn't anything that's hard and fast that's written saying this is what you must do, but there are guidelines that are published to tell you this is how you should do it.
Q: Doctor, did you bring those with you?
A: Yes, I did.
Q: Let me show you what I've marked as plaintiff's exhibit number nine. Is that a document you brought with you?
A: Yes, it is.
Q: Okay. Doctor, what is that document?
A: Well, it's the ACR, which is the American College of Radiology, Standard for Communication in Diagnostic Radiology.
Q: And did you bring that as evidence of showing what the standard is for a board-certified radiologist?
A: Yes.
Q: And doing what you said a while ago was the standard of care?
A: Yes.
Q: And what's written down here is not the actual standard, correct?
A: That's correct.
Q: But some guidelines, and I'm sure that there are others out there, aren't there?
A: No, not put out by the American College of Radiology.
Q: Okay. What is the American College of Radiology?
A: It's sort of the governing group for all the radiologists in the United States.
Q: Judge, at this time we would offer plaintiff's exhibit number nine.
The Court: Admitted.
Q: Doctor, based on your training and experience, and your review of the record, X-rays, and reports in this particular case, have you formed any opinions as to the conduct of [the defendant radiologist]? And if so, please tell the jury those opinions.
A: The opinion is that the radiographs were not interpreted on a timely basis and...even though she saw an abnormality, she did not realize the significance of it and did not convey the results to the treating physician in a timely manner.
Q: And do you have an opinion as to whether that would breach the standard of care?
A: Yes, I believe it is a breach of the standard of care.
Q: You criticize the failure to communicate. What should have happened with that report?
A: Well, this report was dictated. But I didn't see any notation in the chart which said that the radiologist, after she interpreted the film, notified the ICU nurse or any of the physicians involved in the case of her findings that questioned the abnormal location of the catheter on the chest radiograph.
Q: Okay. And are you saying that it was the standard of care for her to have done so?
A: Yes.
Q: Do you think she breached the standard of care?
A: Yes, I do.
The Alabama Supreme Court concluded that the plaintiff did present sufficient evidence to justify the jury's determination that the defendant radiologist's delay in recognizing the misplacement of the central venous catheter and in communicating that finding in timely fashion to the treating physician did indeed breach the standard of radiologic care and cause the patient to lose her arm.
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In order to establish medical malpractice, it must be shown...that [the patient's] injury was caused by the doing of some particular thing that a physician of ordinary skill, care, and diligence would not have done under like or similar conditions or circumstances, or by the failure or omission to do some particular thing that such a physician would have done under like or similar conditions or circumstances... The standard of care for the physician in the practice of a board-certified medical specialty should be that of a reasonable specialist practicing medicine in that same specialty.
It has been long established in American courtrooms that evidence identifying the applicable standard of medical care is offered by expert witnesses whose special knowledge, skill, experience, training, or education permits them to testify to an opinion that will aid the judge or jury in resolving questions that are beyond the understanding or competence of laypersons [6]. Until approximately a decade and a half ago, medical expert witnesses had few if any objective measures of medical standards on which they, or the courts, could rely. The situation changed, however, in the late 1980s when various medical organizations and specialty societies began creating and codifying practice guidelines or standards [7]. The American College of Radiology (ACR) Standard for Communication: Diagnostic Radiology, on which the lawsuit described in this article focused, was first implemented in 1991 [8].
How various state appeals courts have viewed written professional guidelines and standards and the degree to which these guidelines and standards have been used to help determine the standard of medical care have been studied by medical–legal scholars and have been the subject of a variety of articles published in the legal [9–11] and medical [12, 13] literature. Until recently, however, no article has analyzed or addressed any appeals court decisions that have directly dealt with ACR standards.
The Courts Turn Their Attention To ACR Standards
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The first instance in which a state supreme court specifically analyzed a standard promulgated by the ACR occurred in Kansas [15]. In that case, a patient sued a radiologist for failing to diagnose on chest radiographs findings that later proved to be non-Hodgkin's lymphoma. During the trial of the lawsuit, an expert radiology witness retained by the plaintiff's attorney testified that:
Radiology standards promulgated by the American College of Radiology include the following sentence: "Comparison with previous...examinations and reports when possible is a part of the radiologic consultation and report."
The radiology expert went on to testify that the report rendered by the defendant radiologist on the chest radiographs in question "did not show that comparison had been made," and that therefore "the report did not comply with the applicable standard of care." The radiology expert concluded his testimony by stating, "Reading the current film without comparing with previous films would be deviating below an acceptable standard of care."
At the conclusion of the trial, the jury decided in favor of the plaintiff. The defendant appealed and the case found its way to the state supreme court.
In its decision, the Kansas Supreme Court did not specifically state that the ACR standard was equivalent to the standard of medical care, but nevertheless the court let stand the jury's hearing testimony about the ACR standard as evidence of the standard of radiologic care [15]. The court for other technical reasons remanded the case for a new trial, but before that happened the defendant radiologist settled the lawsuit for an undisclosed sum.
In the Alabama case discussed at the beginning of this article, that state's supreme court, too, allowed the plaintiff's expert radiology witness to testify about the ACR standard of communication as evidence of the radiologic standard of care [2]. However, the Alabama court went further. The court allowed the expert to offer the printed ACR standard as an exhibit, meaning that the jurors would be allowed to take the written standard with them into the jury room in which they were to conduct their deliberations. Although the courts in general readily acknowledge that jurors recognize that many expert witnesses testify untruthfully as well as truthfully [16], it seems highly unlikely that jurors would question the validity, credibility, or authoritativeness of published ACR standards. It is true that all ACR standards presently contain a disclaimer that states [17]:
The standards of the American College of Radiology...are not intended to establish a legal standard of care or conduct, and deviation from a standard does not, in and of itself, indicate or imply that such medical practice is below an acceptable level of care.
Nonetheless, it is unlikely that this legalistic type of disclaimer would move jurors to invalidate the importance of the printed standard, especially if not instructed to do so by a judge (Ginsberg MD, personal communication).
The ACR standards were again the focus of judicial attention in a recent case decided by New York State's highest court [18]. In that case, a hospital was sued by a patient who had been sexually assaulted by a male technologist while she was undergoing transvaginal sonography. A radiology expert witness retained by the plaintiff patient testified that the hospital had deviated from the appropriate standard of care by not requiring the presence of a female staff member when a male technologist was performing transvaginal sonography. The plaintiff's expert referred to the ACR Standard for the Performance of an Ultrasound Examination of the Female Pelvis, pointing specifically to a sentence it contained: "It is recommended that a woman be present in the examining room during a transvaginal sonogram, either as an examiner or a chaperone" [19].
The New York Supreme Court rejected the argument of the plaintiff's expert witness, holding that, "The materials from the American College of Radiology clearly state that its guidelines `are not rules.'" The court also added [18]:
The guidelines relied on by plaintiff's expert failed to establish an industry standard, and the expert proffered no evidence to support the existence of an actual practice or custom in the radiological community requiring the presence of a chaperone during vaginal ultrasounds.
The most recent appeals court decision centering on an ACR standard was delivered by an Arizona appellate court earlier this year [20]. The matter involved a woman who had undergone preemployment chest radiography. The defendant radiologist interpreted the radiograph as disclosing a "nodular density overlying the right sixth rib anteriorly." The patient was not informed of the findings until 10 months later, when a diagnosis of lung carcinoma was established. The patient then filed a malpractice lawsuit against the radiologist for failing to communicate the findings directly to her. A trial court judge dismissed the lawsuit on the basis that the radiologist did not have a duty to communicate the radiographic abnormalities directly to the patient. The Arizona appellate court, however, reversed the lower court decision and reinstated the lawsuit. In doing so, the court carefully traced the evolution of a radiologist's communication duty. The court began its decision by stating [20]:
The issue presented is whether a radiologist, to whom a person is referred...who detects a medical condition for which further inquiry or treatment is appropriate, has a duty to inform that person. We conclude that the radiologist does have such a duty.
The court then reviewed how other state appeals courts have addressed the issue of whether radiologists should report directly to patients. The court pointed out that courts in some jurisdictions have declined to impose on radiologists a duty to communicate abnormal radiologic findings directly to patients. These include the states of New Jersey, California, Georgia, and Michigan [20]. Other state courts have taken an opposite tack, holding that radiologists do have the duty to communicate directly to patients. These include Washington, Louisiana, and Mississippi.
The Arizona appellate court then focused on a New Jersey case in which a patient underwent a preemployment physical examination that included chest radiography [21]. The radiologist interpreted the study as disclosing findings suspicious for Hodgkin's disease and informed the examining physician of that fact. The examining physician reported the abnormality to the employer but failed to inform the patient of the finding, and as a result the diagnosis was delayed for 6 months. The patient later died, after which the patient's widow filed a malpractice lawsuit against both the examining physician and the radiologist for failing to communicate the radiographic abnormalities directly to the patient. Influenced by instructions from the trial court judge indicating that the examining physician did not have a duty to inform the patient of the abnormality because the physician had been retained by the patient's employer only for the purpose of performing a preemployment physical, the jury found the physicians not liable. The plaintiff appealed and the matter eventually reached the New Jersey Supreme Court. In a ruling published just this past year, the court held that the examining physician did indeed have a duty to directly communicate abnormalities to the patient, and remanded the lawsuit for a new trial. However, of great importance to radiologists, the court added the following qualifying statement [21]:
Nothing in this opinion should be viewed as requiring a physician to whom a patient has been referred by an examining physician for diagnostic tests (for example, a pathologist or radiologist) to convey the test results directly to the patient.
Noting the position of the New Jersey Supreme Court regarding communication duties of radiologists, the Arizona appellate court pointed to other state courts that took opposing positions. A federal court in Washington State [22] ruled that a radiologist had the duty to notify a patient of an abnormality that appeared on the patient's chest radiograph. Another federal court in the District of Columbia ruled similarly [23]. The Arizona court then quoted a passage from the American Medical Association's Council on Ethical and Judicial Affairs: "The physician has a responsibility to inform the patient about important health information or abnormalities that he or she discovers during the course of the examination" [24].
The Arizona court then focused its attention on the standards of the ACR, identifying (incorrectly) the college as a "national organization that tests and certifies radiologists as specialists in diagnostic radiology and other subspecialty practices within the general field of radiology" [20].
The Arizona court examined the disclaimer that appears on every ACR standard and then that portion of the communication standard that relates to communication of urgent findings such as pneumothorax. The court singled out and placed in italics the sentence that admonished radiologists to communicate urgent findings directly to patients when a referring physician is not readily available.
The Arizona court then referred to the ACR Standard for the Performance of Screening Mammography, emphasizing its mandate that radiologists should "communicate the results of the screening mammogram directly to the patient when the patient is self-referred, that is, that no physician or comparable health care provider sent the patient for the examination." Specifically, the court highlighted, in italics, this excerpt from that standard [25]:
Reports in the categories of...suspicious abnormality...should be communicated to the self-referred patient in a manner that ensures receipt and documentation of the report. The report should indicate a need for further consultation with a physician, and a followup contact with the patient should be made to determine that she has consulted a physician for follow-up care.
The Arizona court concluded [20]:
We do not hold that the [ACR] standards in and of themselves establish a standard of care, but published standards or guidelines of specialty medical organizations are useful in determining the duty owed or the standard of care applicable to a given situation.This is the approach we are persuaded to follow: It is reasonable to expect that the patient's primary physician would obtain the results of the various diagnostic studies ordered, correlate these results with his own findings, and evaluate to what degree the patient needed to be advised of the results. However, the physician to whom the referral was made and who performed the diagnostic tests bears no such duty with regard to advising the patient of the results unless there is no referring physician or the referring physician is unavailable, in which case the duty shifts to the testing physician. The point is to ensure that a physician such as the radiologist contacts a responsible person to alert that person to the presence of the matter of concern or abnormality. The "responsible person" may well be the referring physician, but, if there is no referring physician [available]...the radiologist bears the duty of direct communication with the patient.
We thus conclude that...a physician has a duty to exercise reasonable care in conducting the examination, and this duty includes communicating about the examination directly to the person examined. This imposition of responsibility protects the person being examined, who reasonably and foreseeably relies on the physician conducting the examination to disclose potentially serious threats to the person's health. Given the benefit to the person being examined, any burden imposed on the physician as a result of this duty to inform is slight, an appropriate balance particularly in light of the stronger position of the physician in terms of knowledge.
The degree to which this February 2003 Arizona appellate court decision will influence appellate and supreme courts in other states remains to be determined. What is noteworthy, however, is that the Arizona court's written decision is far from superficial or flippant; on the contrary, it is one that goes into minute detail and uses numerous authoritative sources to justify its outright rejection of an earlier New Jersey Supreme Court decision that exempted radiologists from the duty of directly communicating to patients any radiologic abnormality. Because of its depth and analytic perspective, the Arizona court decision may turn out to be a watershed that once and for all widely expands the radiologist's duty to communicate. Appeals courts in other states may well adopt similar policies in future decisions.
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The Council based its vote on recommendations of a report issued by the college's Task Force on Standards Name and Construct. The members of the task force arrived at their recommendation after they had received and discussed opinions from an independent legal consultant and two semanticists, as well as results of surveys from other medical specialty organizations.
The legal consultant had noted that guidelines "carry a more permissive and less mandatory connotation than standards" and that "deviation from guidelines may be more justifiable than deviation from standards" (Bierig J, personal communication). The consultant further observed that juries are more apt to believe that a physician who has not followed a written standard has violated the standard of medical care more than a physician who has not followed a practice guideline. The opinion concluded with the recommendation that the college change the name Standards to Guidelines.
One of the semanticists stated that the term "standard" is defined as something considered to be an authority and is often used as a basis of comparison, such as in "standard deviation" or "standard of living." The term "guideline," on the other hand, implies an "urging" rather than a "firm directive" (Hoffman C, personal communication). The semanticist went on to explain that a guideline is something that gives parameters by which a person can then determine his or her own behavior, whereas a standard prescribes or proscribes behavior to which a person must or must not conform. In other words, concluded the semanticist, the general perception is that guidelines are suggestions of conduct, whereas standards are more likely to be perceived as mandatory prescriptions of conduct.
A second semanticist agreed, stating that standards are considered "an authoritative or recognized exemplar of correctness and perfection," and that "standard" is more likely to be confused by jurors with standard of care (Kretzschmar WA Jr, personal communication). This semanticist concluded that in his opinion jurors would be more likely to confuse the word "standards" than the word "guidelines" with standard of care.
The task force also polled 12 medical specialty societies and found that eight called their practice recommendations "guidelines" and one called them "standards and guidelines." None called them by the single word "standards."
The opinions of the consultants surveyed by the task force—an attorney, two semanticists, and leaders of other medical specialty organizations—were unanimous that jurors would equate the legal term "standard of care" with the ACR compendium of practice recommendations called Standards more than if the recommendations were called Guidelines. The members of the task force, and then an overwhelming majority of the Council of the ACR, agreed with this assessment, even though this hypothesis could not be objectively proven.
Although there is little reason to doubt that laypersons who serve on juries may not be able to distinguish between "standard of care" and "standards," such lack of clarity does not seem to extend to judges who sit on appellate and supreme courts. Of the four appeals courts decisions discussed in this article [2, 15, 18, 20] that specifically mention ACR standards, none contains any indication that any of the justices equated the ACR standards with the legal standard of radiologic care. In two of the decisions—the New York [18] and Arizona [20] cases—the courts use the words "standards" and "guidelines" interchangeably. Perhaps one can conclude from these court decisions that Shakespeare's observation in Romeo and Juliet about names and words applicable to roses [1] applies equally well to practice recommendations promulgated by the ACR.
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In recent months, the ACR standards have been discussed at trial by expert witnesses, and in some cases the written standards themselves have been admitted into evidence, giving jurors the opportunity to consult the standards directly while deliberating how to resolve a malpractice lawsuit. As a result, the ACR standards are playing an increasingly important role in influencing jurors and appeals court justices in their determination of whether a defendant radiologist in a given situation has met the standard of care. A trend toward more widespread use of ACR standards by the courts is likely to continue.
In part because authoritative consultants have suggested that jurors are likely to confuse radiology standards with the legal term "standard of care," the ACR is in the process of changing the names of most of its current standards to guidelines. Although this name change will probably benefit defendant radiologists at the trial court level, it is unlikely to have any impact on judges who serve on state appellate and supreme court panels.
Law professor–author Ginsberg has written [14]:
The purpose of the ACR standards may be advisory, and may not include defining a legal standard of care; however, it would be naïve to believe that practice standards will not creep into medical–legal litigation as evidence of the applicable standard of care.... If courts continue to admit ACR standards into evidence, as in the Alabama case [2], a jury might consider the ACR standards tantamount to the standard of care.... This truly places radiologists in peril.... The ACR standards will continue to have legal implications for radiologists.... Radiologists must realize that ACR standard[s]...will likely generate claims against radiologists.
Indeed, a rose by any other name smells the same. In similar fashion, ACR guidelines and standards, by either or any other name, can subject radiologists to allegations of medical malpractice that not infrequently result in liability being imposed on them.
Acknowledgments
I acknowledge with gratitude Milton J. Guiberteau, chairman, and the other
members of the American College of Radiology Task Force on Standards Name and
Construct, whose analyses, insights, and wisdom regarding the distinction
between the terms "standards" and "guidelines"
provided a substantial contribution to the preparation of this article.
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