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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 March 29, 2002;
accepted after revision March 29, 2002.
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.
Case 1
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The patient later filed a medical malpractice lawsuit against the gynecologist, alleging negligence for failure to order mammography. At the jury trial that followed, the plaintiff patient testified that she had informed the gynecologist of the right nipple discoloration and inversion during both office visits, but that the gynecologist had ignored her complaints. A gynecology expert witness retained by the plaintiff's attorney testified that the defendant gynecologist had been negligent for failing to order a mammogram every year after the patient reached her 50th birthday, as "prescribed" by the American Cancer Society. The expert further asserted that if the woman had informed the gynecologist of the symptoms relating to her right breast, the gynecologist "had all the more reason" to order mammography as well as additional tests.
The defendant gynecologist testified that the patient had never informed him of her breast symptoms, and he had found no abnormalities on physical examination. The patient's medical chart supported the gynecologist's recollections. As for his decisions not to order screening mammography, the gynecologist contended that he had followed the recommendations of the American College of Obstetrics and Gynecology, which at the time held that "regular," as opposed to "yearly," mammograms were required. The defendant gynecologist explained that he interpreted "regular" to mean "within the physician's discretion." An expert gynecology witness retained by the defense attorney supported the defendant gynecologist's position. At the conclusion of the trial, the jury found the defendant gynecologist not liable for malpractice. The plaintiff patient proceeded to appeal the jury's verdict.
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A physician may rightfully choose to practice his profession in accordance with a school of thought which differs in its concept and procedures from another school of thought. Even though the school that he follows is a minority one, he will not be deemed to be negligent or practice improperly, so long as it is reputable and respected by reasonable medical experts.
On the basis of that instruction, contended the plaintiff's attorney, the jury erroneously found the defendant gynecologist not liable because the gynecologist had followed the American College of Obstetrics and Gynecology guidelines calling for "regular" mammography, instead of the more "generally accepted" guidelines of the American Cancer Society that call for "annual" mammography. The appellate court ruled that the trial judge's instruction concerning the two schools of thought doctrine was correct, although the court reversed the jury verdict and ordered a new trial on other grounds that are not germane to the issues discussed in this article.
The defendant gynecologist then appealed to the Pennsylvania Supreme Court. That court affirmed the appellate court's ruling related to the two schools of thought doctrine, stating [1]:
The "two schools of thought" doctrine provides a complete defense to a malpractice claim when the prescribed medical treatment or procedure has been approved by one group of medical experts, even though an alternate group recommends another approach.... Where competent medical authority is divided, a physician will not be held responsible if in the exercise of his judgment he followed a course of treatment advocated by a considerable number of recognized and respected professionals in the given areas of expertise.
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Nine months after the diagnosis of prostate carcinoma was established, the patient filed a medical malpractice lawsuit against the internist, alleging that the internist had been negligent in failing to order tests of PSA levels at the times of the patient's two physical examinations.
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At trial the patient testified that at the time of both physical examinations he had asked his internist to order a PSA test but was told by the internist that the test was "not important" for him to have. The patient went on to say that at the time the internist was refusing to order the PSA, urologists in the internist's own group practice were advertising to provide free PSA tests to men in his age bracket. According to the patient, these advertisements claimed that "early detection meant cure," and "prostate cancer could be cured if caught early." During further questioning by his attorney, the patient asserted that had the internist not discouraged him from having a PSA, and had he been adequately informed about both sides of the PSA screening controversy, he would "definitely" have made the choice to be screened.
An internal medicine expert witness retained by the attorney for the plaintiff testified that the standard of care required physicians to recommend PSA screening to all men older than 50 years. If in fact the defendant internist had not ordered the PSA test on the patient on the occasions of the routine physical examinations, then the defendant was "clearly negligent," contended the plaintiff's expert. On cross-examination by the defense attorney, the plaintiff's expert acknowledged that if the defendant internist had offered the PSA tests to the patient and the patient had declined them, then the standard of care would have been met.
In his testimony, the defendant internist acknowledged that he did not specifically recommend that the patient undergo PSA screening because he believed that, on the basis of his careful and extensive review of all available data, PSA screening was of questionable value. The defendant explained that he had discussed with the patient evidence both for and against PSA screening and then left the ultimate choice for screening up to the patient. The internist insisted that he had been "entirely knowledgeable" about the value of PSA testing, had been diligent in his search for information about it, and had "over the years" carried on professional discussions on the subject with both colleagues and other male patients.
When he was cross-examined by the plaintiff's attorney, the defendant internist acknowledged that he did let his patients know that he was not a "strong believer" in the PSA test because of lack of evidence that it had proven benefits in reducing morbidity and mortality of prostate cancer. In response to a question from the plaintiff's attorney, the internist admitted that he did not emphasize that the test might save lives, but he countered that neither did he emphasize the potential risks of the test, which included the complications of biopsy and unnecessary prostatectomy. The defendant internist denied that he ever refused to order any test that a patient felt strongly about, and indeed, the medical record of the plaintiff patient contained numerous examples of tests that were ordered because of the patient's concerns. One example the internist described at trial was an exercise tolerance test he had ordered when the plaintiff patient was worried about chest discomfort, even though the internist believed the discomfort was noncardiac in origin.
The defendant internist stated that he had ordered the stress test simply because the patient wanted reassurance that he did not have a cardiac problem. In answer to the plaintiff attorney's final question on cross-examination, the defendant internist acknowledged that he had not documented in writing in the patient's chart that he had discussed with the patient the "pros and cons" of the PSA test and had told the patient to "make up your own mind about whether to have it."
An expert internal medicine witness retained by the defense attorney testified that at the time the patient had been under the care of the defendant internist, the American Academy of Family Physicians and the United States Preventive Services Task Force, which develop national guidelines for preventive health care, did not recommend PSA screening. The defense witness contended that the defendant internist had acted "completely within the standard of medical care" by simply explaining the "pros and cons" about PSA testing to the patient and then letting the patient "decide for himself."
The final witness for the defense was an oncologist who, after pointing out that the patient was presently free of disease, testified that he believed that the 2-year delay in the diagnosis of the patient's prostate cancer had not significantly lowered the patient's chance for survival.
At the conclusion of the trial and after lengthy deliberation, the jury reached a verdict in favor of the plaintiff, awarding him $1.5 million.
When interviewed by the defense attorney after rendering their verdict in the case, several jurors explained that they did not believe that the PSA test should have been ordered automatically or that the standard of care required the defendant internist to make a specific recommendation in favor of obtaining the PSA.
The jurors affirmed the patient's right to make an informed choice about his health care, and they regarded the defendant internist as a good and honest physician. However, they explained, they were faced with a discrepancy between what the physician recalled telling the patient about PSA testing and what the patient recalled being told. Without documentation of discussions held between the internist and the patient, or evidence of printed material confirming that the internist had transmitted to the patient PSA information, the jurors said they had no choice but to believe the patient's account that he had not received a balanced overview of the pros and cons of PSA testing. The jurors continued that they believed that had the patient been given more information, he would have had the test at the earliest opportunity and more likely than not would have had a longer life, if not a cure. They also said that they found unconvincing the defendant oncologist's opinion that the patient's prognosis had not been worsened by the delay in diagnosis of the cancer.
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PSA Testing and Prostate Cancer
PSA testing has been widely used as a guide to initiate prostate biopsies
and to monitor men 50 years old and older, with and without prostate cancer,
since its introduction in 1987
[3]. Because an elevated PSA
level is frequently the earliest sign of prostate cancer, it was initially
thought that widespread use of the test would lead to earlier diagnosis and
treatment of prostate cancer that would, in turn, lower mortality from this
disease. However, the use of PSA as a screening test has been, and remains,
controversial because no randomized controlled trials have ever been completed
that show that the diagnosis of early prostate cancer achieved by routine PSA
screening decreases the death rate of patients with this disease
[4,
5.] Although it is intuitive to
believe that early intervention for prostate cancer can cure this potentially
deadly disease, some evidence suggests that this approach may not improve
survival and quality of life, and in fact may result in adverse effects
[6]. A recently published study
conducted by a group of investigators in Quebec
[7] found that PSA screening
was not associated with a decline in prostate cancer mortality. Those
researchers confirmed that the death rate due to prostate cancer had
decreased, but they attributed this reduction solely to changes in disease
management and hormonal treatment of advanced disease.
Other problems are associated with PSA screening. The specificity of the PSA test is poor. Approximately 75% of men who undergo prostate biopsy because of elevated PSA levels (4-10 ng/mL) do not have cancer [8], and approximately 27% of radical prostatectomies performed at the Johns Hopkins Hospital on men whose cancers were initially suspected because of abnormal PSA levels contained potentially insignificant tumors [3].
Physicians who deal with prostate cancer on a clinical basis tend to prefer routine PSA testing, whereas epidemiologists and other scientists seem to remain unconvinced about the benefits of such screening [9]. Many epidemiologists assert that widespread PSA testing leads to overdiagnoses and unnecessary treatment while doing little to lower the death rate. They point out that as many as one third of autopsies performed on men who have died from other causes reveal the presence of occult and often even large prostate cancers that had never assumed clinical importance.
At present, it is virtually impossible to prove or disprove the value of PSA screening in prostate cancer [10]. The current status of PSA testing can perhaps be summed up by one urologist's succinct comment, "I think there is enough tantalizing evidence to believe that routine PSA screening saves lives, but not enough to be sure" [11].
The divergence of individual opinions regarding the usefulness of PSA testing is reflected by the variance in the recommendations concerning PSA testing promulgated by professional organizations. Vastag [9] summarized the recommendations of 10 professional and patient-advocate organizations regarding PSA testing. Only one, the American Cancer Society, recommends routine PSA testing annually for men 50 years old and older and for men 45 years and older who are considered at high risk. Three organizations, the American Academy of Family Physicians, the American College of Physicians, and the American College of Preventive Medicine, recommend counseling men about the risks and possible, but unknown, benefits of PSA testing. The American Medical Association holds that "launching of mass screening programs for the early detection of prostate cancer is premature," and the Canadian Task Force on Preventive Health Care states that there is "fair evidence" to exclude routine PSA testing in asymptomatic men older than 50 years [9]. The American Society of Clinical Oncology states that its policy panel "has found insufficient evidence to warrant any recommendation," and the American Urological Association states simply, "The use of PSA screening...remains controversial" [9]. The National Cancer Institute's outside peer review panel has found that "there is insufficient evidence to determine if decreasing mortality occurs with PSA screening" [9]. Finally, although it does not make recommendations regarding screening, Medicare does include annual PSA testing as a standard benefit [9].
Although clearly the consensus of these organizations is that the value of PSA screening remains in doubt, little doubt exists that physicians have the responsibility to counsel patients regarding the advantages and disadvantages of the test. A strong feeling exists among some that PSA testing is definitely recommended for men who ask their clinicians to make the decisions about screening on their behalf [8]. The American Cancer Society specifically recommends that "men who ask the clinician to make the testing decision on their behalf should be tested," according to Robert Smith, director of the society's cancer screening program, and his colleagues [12]. Those researchers also believe that a clinical policy of not offering testing, or of discouraging testing in men who request early prostate cancer detection tests, is inappropriate. On the other hand, The Canadian Urological Association and many health authorities in Europe discourage the practice of prostate cancer screening [13].
It can be concluded from this brief discussion that although apparently no standard of medical care requires physicians to recommend PSA testing, nonetheless the standard would seem to call for a discussion between physician and patient regarding the advantages and disadvantages of the test.
Mammography and Cancer of the Breast
The efficacy of mammography in reducing mortality from breast cancer is not
free of controversy
[14,15,16];
nevertheless, a substantial degree of agreement exists in the medical
community that women older than 40 years should undergo screening mammography
annually. Notwithstanding the fact that over recent years sporadic reports
have questioned whether mammography saves lives of women with breast cancer
[17] and, if so, to what
extent [18,
19], mammography remains one
of the most widely accepted screening procedures in preventive medicine. In
February 2002, the United States Preventive Services Task Force, which is an
independent panel of experts that reviews research on a wide range of
preventive services, issued new guidelines for breast cancer screening that
strongly recommend mammography for women 40 years old and older
[20]. This report was
announced at a national press conference held by United States Secretary of
Health and Human Services, Tommy Thompson, and has been well publicized in the
news media [21,
22].
Talking with Patients About the Pros and Cons of Screening Tests
Let us return to the second question with which the juries in the cases
described in this article were confronted—namely, what is the extent of
the duty imposed on physicians to inform patients about the advantages and
disadvantages of screening tests? As has already been mentioned, most
professional organizations and researchers recommend that physicians discuss
with their male patients the benefits and risks of PSA screening. Similarly,
informational discussions between physicians—nonradiologists and
radiologists alike—and their female patients regarding the value of
screening mammography are also encouraged
[23]. In both situations, the
goal is to educate the patient to a sufficient degree to allow the patient to
make an informed decision as to whether the screening test should be
performed. However, accomplishing this goal is not easy. Gilbert Welch of
Dartmouth Medical School has succinctly crystallized the problems inherent in
attempting to educate patients about screening tests
[24]:
Shared decision making sounds great, but there is much to balance. Physicians want to provide a comprehensive picture of the decision without providing so much detail that our patients are overloaded. Physicians want to communicate the probabilities for various end points without being overly precise.... We also want to communicate the downsides of various therapies without scaring patients.... Physicians want to try to really assure the decision, not simply step aside...and advocate the responsibility as advisor.
Welch goes on to point out that no matter how it is expressed, the benefit of screening will seem small to patients. If the efficacy of a screening test is such that 1000 people need to be screened to avoid one death, individual patients will come to realize that most people will get no benefit at all but a few may benefit tremendously. Even with such a low likelihood of individual benefit, however, there would be no need to make a decision regarding screening if there were no risks. Therein lines the rub, for the risks of screening are rarely discussed. As Welch pointed out, the prevailing medical culture has tended to downplay the risks of screening, not only in physician's offices, but also in the news media [24]. A recent survey of articles about screening mammography published between 1990 and 1997 in six of the 10 newspapers with the greatest (United States) circulation revealed that newspapers tended to overrepresent support for screening mammography [25]. Twice as many articles were found that support rather than express reservations about mammography. Disadvantages of screening tests are further minimized or even ignored by the many physicians and nonphysician entrepreneurs currently marketing high-technology radiologic screening tests directly to consumers—perhaps even bombarding them with radio, print media, and Internet messages, all of which exaggerate the value of screening [26].
Robert Stanley [27] and others [28] have summarized those disadvantages of screening tests that are not adequately divulged to the public. The downsides include the fact that patients may undergo unnecessary and sometimes dangerous testing because of false-positive results and may in fact receive unnecessary treatment for the same reason. Patients can be lulled into a false sense of security with negative screening findings, because screening tends to miss the most aggressive cancers. Interval cancers, those not usually diagnosed on screening tests, are the fastest growing tumors and therefore more deadly than those detected by screening [24]. Furthermore, the attention given by physicians to ordering and interpreting screening tests may distract both physician and patient from other issues that are more important to patients. Finally, screening tests such as those obtained by CT can be erroneously interpreted and result in a serious finding being missed [29].
A comprehensive discussion between physician and patient regarding the attributes and downsides of a given screening test can present additional problems for the physician. Screening discussions with patients are time-consuming. One researcher [6] has observed that physicians often have insufficient time available during office visits to clearly explain to patients the choices regarding screening studies. Also, according to this researcher, many physicians frequently underestimate a patient's desire for or ability to cope with screening information, and other physicians may simply not be prepared for "discussions of uncertainty."
Other obstacles exist. Such discussions should be documented in the patient's chart, but even with documentation patients could later allege that the discussion either never took place or did not contain adequate information to properly inform them about the importance of the test. Under such a scenario, a patient could then file a malpractice lawsuit, possibly successfully, against the physician if the patient developed carcinoma of a type the screening test was designed to discover at an early stage. Faced with these myriad potential problems, most physicians may well opt to simply order the screening test, regardless of whether they personally believe it to be efficacious.
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The timely ordering of certain screening tests is considered mandatory to comply with the standard of medical care, and thus a physician's failure to order the test can constitute conduct that deviates from the standard. In the two cases described in this article, physicians were sued for failing to order screening tests, a mammogram in one, a PSA test in the other. In the latter case the jury rendered a sizable verdict in favor of the patient. Although abundant scientific literature raises concerns about the efficacy of, and in some cases suggests risks to obtaining, certain screening tests, the public is generally exposed at a disproportionately greater degree to the benefits of these tests. As a result, juries confronted with a plaintiff patient who develops cancer or other serious disease for which a screening test was available but not ordered by the patient's physician, tend to find that the physician's failure to order the test was negligent.
Traditionally, diagnostic radiologists are consulting rather than primary care physicians and thus have not been placed in the position of ordering screening tests. However, in recent years patients have, with increasing frequency, referred themselves to radiologists for screening tests such as mammography, CT of the lungs, CT of the heart, and CT of the total body, often as a result of overzealous news media coverage or direct advertising by the radiologist. Patients may well question radiologists, not only about the advisability of undergoing, and repeating in the future, the screening tests that led to the inquiry, but also about other screening tests. The radiologist thereby establishes a physician—patient relationship with the patient. Once this relationship exists, the law will impose on the radiologist the duty to ensure that any advice given by the radiologist complies with the standard of radiologic care. In its latest revision of the Standard for Communication: Diagnostic Radiology that became effective January 1, 2002, the American College of Radiology for the first time documented the responsibilities to self-referred patients that are imposed on radiologists [30]:
Radiologists should recognize the potential obligations of assuming the care and treatment of patients who present themselves for imaging studies on a self-referred basis. Such obligations may include communicating the results of imaging studies to the patient and the necessity of appropriate follow-up.
Risk management in radiology can lessen the likelihood of incurring a medical malpractice lawsuit and maximize the chance for a successful defense if a suit is filed, while at the same time enhancing good patient care. The following risk management pointers will help meet all three of these objectives with respect to potential liability resulting from failure to order a screening test.
Acknowledgments
I acknowledge with gratitude the assistance of Matson Sewell in the
preparation of this article.
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