June 15, 2009

The Duty to Disclose
By Leonard Berlin, MD, FACR
Radiology Today
Vol. 10 No. 12 P. 22

Editor’s Note: Leonard Berlin, MD, FACR, is a professor of radiology at Rush University Medical College and the chairman of the department of radiology at Rush North Shore Medical Center in Skokie, Ill. He began writing on risk management and malpractice issues in a series of articles in the American Journal of Roentgenology. Those articles became the basis for his well-known book Malpractice Issues in Radiology.

The third edition of Malpractice Issues in Radiology is available from the American Roentgen Ray Society (www.arrs.org).

The Case
A 49-year-old man had a 6-week history of pain and numbness in his legs that apparently commenced with a fall at work. After a tentative diagnosis of nonspecific peripheral neuropathy, his family physician and a consulting neurologist ordered a myelogram. The patient weighed approximately 300 lbs (135 kg). The interpreting general diagnostic radiologist, after noting that the quality of the radiographs was “suboptimal, but adequate,” concluded that the myelogram had normal findings. However, the patient’s neurologic condition slowly deteriorated, and he visited another hospital 6 months later, where a neuroradiologist reinterpreted the original myelogram as showing an arteriovenous malformation of the spinal cord. Angiography confirmed the diagnosis, and surgery was performed, but the patient was left with permanent neurologic deficit.

The patient filed a malpractice lawsuit against the family physician, the neurologist, and the radiologist, alleging that their negligence in failing to correctly interpret the myelogram caused a delay in diagnosis and surgical treatment of the arteriovenous malformation that, in turn, led to serious, irreversible neurologic damage.

During discovery proceedings, a neuroradiology expert was retained by the plaintiff. The expert testified that the myelogram clearly revealed serpiginous filling defects characteristic of arteriovenous malformation and that the missing of this finding by the defendant radiologist constituted an obvious breach of the standard of care. When asked by the attorney who represented the defendant radiologist whether a general diagnostic radiologist who had not undergone neuroradiologic fellowship training should be expected to possess the same degree of knowledge of rare nervous system lesions such as spinal cord arteriovenous malformations as a well-trained, certificate-of-added-qualification-awarded neuroradiologist, the expert for the plaintiff responded affirmatively. “It is my opinion that the myelographic findings of arteriovenous malformation should be as recognizable to general radiologists as they are to neuroradiologists,” said the expert, “and if the general radiologist performing the myelogram feels unqualified to interpret the study, he should consult with a neuroradiologist.” When the defense attorney pointed out that the myelogram study was performed at a community hospital in which every member of the radiology department was a general diagnostic radiologist and no neuroradiologist was available for immediate consultation, the plaintiff’s expert replied that general radiologists, if they possess less knowledge than neuroradiologists, have a duty to either consult with a neuroradiologist or refer the patient to a neuroradiologist. The expert for the plaintiff then added that in his opinion the defendant radiologist should have included, when obtaining informed consent from the patient, a disclosure that he possessed limited knowledge of neuroradiology because he was a general radiologist rather than a neuroradiologist. “The patient should have been given that information before being asked to consent to the myelogram,” claimed the plaintiff’s expert, “and should have been told that he had a right to have the myelogram performed at another hospital where the radiologists had more knowledge and experience with myelography.”

In his deposition, the defendant radiologist testified that he possessed “basic” knowledge of neuroradiology, but acknowledged that he was not a neuroradiology expert. The radiologist said he had seen “several” arteriovenous malformations of the spinal cord in his residency but had not encountered any during his years in private practice. He went on to explain that the size of the hospital and the radiology department in which he practiced was such that both the number and the variety of radiologic examinations performed did not justify the cost of bringing a neuroradiologist into his group. The defendant radiologist testified that had he recognized an abnormality on the myelogram that was beyond his level of knowledge, he would have contacted a neuroradiologist at a nearby hospital for consultation. He did not believe, however, that he had a specific duty to obtain a consultation or to refer the patient to a neuroradiologic specialist to review a myelogram that he considered to have normal findings. When asked by the attorney for the plaintiff whether he had informed the patient that no neuroradiologist was available and that he had only limited knowledge of neuroradiology, the defendant radiologist answered no, because he did not believe he was under any obligation to do so.

A general diagnostic radiology expert retained by the defense stated that an arteriovenous malformation of the spinal cord is a very rare condition and that most diagnostic radiologists would not encounter even one during their entire professional careers. Although general diagnostic radiologists know what spinal cord vascular malformations are and are aware of their characteristic radiologic appearance, the expert for the defense continued, their level of familiarity with these lesions is usually significantly less than that of fully trained neuroradiologists who may have greater exposure to rare nervous system abnormalities. Furthermore, added the expert, the serpiginous filling defects on the myelogram were neither obvious nor readily apparent but were, rather, so subtle that they might remain undetected by many knowledgeable neuroradiologists as well.

Regarding whether a general radiologist had a duty to refer a rare or difficult case to a neuroradiologist or to explain to the patient that he was not a neuroradiologist, the defense expert testified that no such duties exist. If a general radiologist notes a suspicious abnormality in the spine or brain, he may elect to call a neuroradiologist for consultation, explained the expert for the defense, but certainly there is no obligation for him to do so if he does not see a radiologic abnormality in the first place.

Family practice and neurology experts retained by the plaintiff were extremely critical of the clinical conduct of the other two defendants in the case, but acknowledged that even they would not have been able to make the correct diagnosis on the myelogram study. They also expressed doubt that it was reasonable to expect any radiologist to reach the correct diagnosis only on the basis of the appearance of the patient’s myelogram.

Eventually, the malpractice case against the radiologist was dropped. The malpractice action against the other two physician defendants proceeded, however, and concluded in an out-of-court settlement.

Discussion
It is well established in the law and generally acknowledged by the radiology community that radiologists must obtain informed consent from patients before commencing certain diagnostic or therapeutic procedures. During the consent process, radiologists must divulge to the patient information regarding benefits and risks of the proposed procedure, alternative measures that might yield similar results, and the risks of not performing the procedure.1 Until the early 1970s, almost all American state courts required radiologists and other physicians to make such disclosures that comported with the prevailing standard of the medical community—that is, the disclosure of those risks that a reasonable physician in the community would customarily make in similar circumstances (Largey v Rothman, 1988, New Jersey). This was known as the prudent physician doctrine or the majority rule of informed consent.

In 1972, however, a movement that expanded the content and the nature of informed consent, called the prudent patient doctrine or the minority rule, was born as a result of a landmark federal court decision (Canterbury v Spence, 1972, Washington, D.C.). This new concept shifted the perspective of the consent process by removing it from the physician and placing it with the patient. It held that the scope of the physician’s duty to disclose information must be measured against the patient’s need to know facts that are material to making a decision relative to medical care, rather than against what the medical profession thinks the patient needs to be told (Canterbury v Spence). The prudent patient doctrine was enunciated quite clearly by the Hawaii Supreme Court (Carr v Strode et al, 1995).

The physician’s duty to disclose in an informed consent case… is not what the physician believes his or her patient needs to hear. … The focus should be on what a reasonable person objectively needs to hear from his or her physician to allow the patient to make an informed and intelligent decision regarding medical treatment.

Over the past quarter century, courts in an increasing number of states have departed from the prudent physician doctrine and converted to the prudent patient rule of informed consent, so much so that the states are currently divided evenly as to which of the two doctrines they adhere.1 As this patient-oriented trend continues to spread, the minority rule may well eventually become the majority rule.

How Much Should a Radiologist Disclose?
As the courts have been shifting the standards against which alleged informed consent violations are measured from what the physician should tell to what the patient should know, the courts have concurrently expanded the kind of information that physicians must disclose to their patients. For example, information regarding a physician’s own experience and expertise, heretofore not considered by physicians to be an important element of the informed consent process, may in certain instances be required. In one illustrative case, a suburban Chicago orthopedic surgeon was sued for malpractice by a patient who had sustained ulnar nerve damage after an endoscopic procedure for release of a carpal ligament. The patient claimed that she was not informed that the defendant orthopedic surgeon had received insufficient training before performing the endoscopic operation. The surgeon testified that it was true that he had performed only one similar endoscopic procedure on a cadaver as part of a training session, and he acknowledged that he had not disclosed either that or the fact that the plaintiff who was suing him was the first patient on whom he had done the endoscopic procedure independently. At the conclusion of the trial, the jury found the orthopedic surgeon liable for malpractice and awarded the patient $120,000 (Oldeen v Palutsis, 1997, Illinois).

A far more publicized case in which the court ruled that a physician must include as part of the informed consent a disclosure of his own experience and expertise, or as one legal observer referred to it, his “batting average,” occurred in Wisconsin.2 There, a $6.2 million settlement was reached between a patient who became quadriplegic after brain surgery for an aneurysm of the basilar artery and the neurosurgeon who performed the operation without first disclosing to the patient not only the extent of his own limited experience but also his outcomes in comparison with those of neurosurgeons at a nearby clinic. The patient, a 44-year-old woman, charged that the neurosurgeon had failed to disclose that his complication rate for such surgery was substantially higher than that of, and then failed to refer her to, the more experienced neurosurgeons at the Mayo Clinic that was only 90 miles (144 km) away. Because the ruling of the Wisconsin Supreme Court could have major impact on radiologic informed consent malpractice cases elsewhere in the nation, I shall review salient portions of the decision (Johnson v Kokemoor, 1996, Wisconsin). The court began by expanding the kind of information that should be included in the informed consent discussion:

A patient cannot make an informed, intelligent decision to consent to a physician’s suggested treatment unless the physician discloses what is material to the patient’s decision. ... In this case information regarding a physician’s experience in performing a particular procedure, a physician’s risk statistics as compared with those of other physicians who perform that procedure, and the availability of other centers and physicians better able to perform that procedure would have facilitated the plaintiff’s awareness of all of the viable alternatives available to her…

The court then pointed out the rather limited qualifications of the neurosurgeon defendant:

The defendant had relatively limited experience, [performing] thirty aneurysm surgeries during residency [all involving] anterior circulation aneurysms. ... Following residency, the defendant performed aneurysm surgery on six patients … [and] had operated on basilar bifurcation aneurysms only twice, and had never operated on a large basilar bifurcation aneurysm such as the plaintiff’s aneurysm...

The court then focused on what should constitute adequate informed consent:

The doctrine of informed consent focuses upon the reasonableness of a physician’s disclosure to a patient. ... Information regarding risk is material when a reasonable person would be likely to attach significance to [it] in deciding whether or not to forgo the proposed therapy. ... [A] reasonable physician in the defendant’s position would have advised the plaintiff of the availability of more experienced surgeons and would have referred her to them. ... The crux of the issue is the effect of the nondisclosure on the patient’s ability to make an intelligent choice. ... The standard to which a physician is held is determined not by what the particular patient being treated would want to know, but rather by what a reasonable person in the patient’s position would want to know. ... It is as much a part of the professional duty of a physician to give correct information as to the character of the disease from which his plaintiff is suffering … as it is to make a correct diagnosis or to prescribe the appropriate medicine...

The court then sharply responded to the neurosurgeon’s argument that he had no duty to disclose to the patient his experience:

[The neurosurgeon argues that informed consent only requires] disclosure of risks associated with particular treatments rather than the risks associated with particular physicians. ... We reject the defendant’s [argument] that it is error to admit evidence in an informed consent case that the physician failed to inform the patient regarding the physician’s experience. ... [We believe] that anything that is necessary for a reasonable person to arrive at an informed and reasonable consent is allowable evidence. ... The plaintiff introduced ample evidence that had a reasonable person in her position been aware of the defendant’s relative lack of experience in performing basilar bifurcation aneurysm surgery, that person would not have undergone surgery with him.
We therefore conclude that when different physicians have substantially different success rates with the same procedure and a reasonable person in the patient’s position would consider such information material, the … court may admit this statistical evidence (italics added). ... [The patient] should have been told that this was an extremely difficult, formidable lesion and that there are people in the immediate geographic vicinity that are very experienced … and that she should consider having at least a second opinion, if not going directly to one of these other physicians. ... “Doctors of good standing” would have referred her to a tertiary health care center better equipped and staffed by more experienced physicians. ... The plaintiff chose not to go elsewhere because the defendant gave her the impression that her surgery was routine and that it therefore made no difference who performed it.

Finally, the court turned to the question of whether physicians have a “duty to refer.” In Wisconsin there is no such recognized duty, said the court, but

…we merely hold that a physician’s failure to refer may, under some circumstances, be material to a patient’s exercise of an intelligent and informed consent. The question confronting a jury in an informed consent case is whether a reasonable person in the patient’s position would have arrived at a different decision about the treatment or surgery had he or she been fully informed. The defendant argues that if his duty to procure the patient’s informed consent includes the obligation to disclose that she consider seeking treatment elsewhere, then there will be no logical stopping point to what the doctrine of informed consent might encompass. We disagree with the defendant.

Commenting on the Wisconsin Supreme Court decision that held the neurosurgeon liable for malpractice even though there was no evidence to indicate that he had performed the aneurysm surgery negligently, a spokesperson for the American Medical Association said, “We’ve watched the law on informed consent evolve. The standard used to be what the average doctor thought his patient should know. But with the rise of medical consumerism, there’s been a shift to basing informed consent on what a reasonable person in the patient’s shoes would want to know. And the more information there is about physician performance, the more patients’ expectations will be raised.”3

What Should Patients Be Told About Radiologists’ Expertise?
The Wisconsin Supreme Court decision bears directly on issues raised in the malpractice case described at the beginning of this article. The radiologist who failed to diagnose an arteriovenous malformation on a myelogram admitted that, although he possessed less knowledge of unusual myelographic abnormalities than a neuroradiologist does, he nonetheless neither divulged that fact to the patient nor offered to refer the patient to a neuroradiologist. This brings us to the two questions that are the crux of this article—namely, just how much expertise is required of a radiologist who provides medical care to a patient, and to what extent is the radiologist required to disclose to the patient the degree of this expertise? Let us address these questions.

As to the level of expertise required, the law in every state in the United States recognizes that radiologists are not required to possess “the highest order of qualification, to which some men attain,” but nonetheless they must possess and exercise “that degree of skill which is ordinarily possessed by members of the profession.”4 The definition of “ordinarily” is, however, vague. Doctors are not required to be perfect, for perfection is a standard to which no profession can possibly adhere (Black v Gunderson Clinic, 1989, Wisconsin). Furthermore, the average radiologist cannot be expected to see all subtle abnormalities.5 Nevertheless, the performance of radiologists must match or exceed that which is considered minimally acceptable. By acknowledging that individual radiologists differ among themselves in their level of knowledge and experience, the courts seem to require all radiologists to practice at a level that is within a range of “normal,” a range that is more than minimally acceptable but less than extraordinary.4

Let us now address the second question, one that is far more perplexing: Given the fact that the knowledge and experience of a particular radiologist is within an acceptable range, does that radiologist owe a duty to the patient to disclose a comparison of this knowledge and experience with that of other radiologists whose knowledge and experience may be superior? From a legal point of view, the Wisconsin Supreme Court seems to answer this question in the affirmative, but that court decision is an isolated one and to what degree it may influence courts in other states is yet to be determined.

In this article, I have thus far discussed the issue of the duty to disclose strictly from a legal point of view. We must not forget, however, that our assessment of the importance of this duty is also impacted by ethical considerations. Indeed, the degree of physician-patient disclosure of information needed to satisfy a moral imperative may even far exceed that which is required by the law, for as Clever has written, “The law does not always establish duties to the extent that medical ethics does.”6 The distinction between what physicians must do because of legal dictates and what they should do because of moral mandates is often blurred. As we continue this discussion of what the courts set down as the minimal standards of disclosure to which radiologists must adhere, let us keep in mind that it may be morally virtuous for radiologists to adhere to an even higher standard of physician-patient disclosure.7

The trend toward more comprehensive physician-patient disclosure may require us to divulge an even greater amount of information and to address with the patient a myriad of other issues. For example, if a staff radiologist or a radiology resident or fellow is about to perform a procedure independently of a supervising radiologist for the first time, should the patient be told of that fact? Should a radiologist who possesses only basic but adequate expertise in a diagnostic technique or therapeutic procedure but who is aware that an associate who is on vacation has greater expertise inform the patient of that fact? The increasing use of teleradiology by the radiology community will bring to the forefront additional disclosure issues.8 For example, if teleradiology consultation is available and local radiologists choose not to avail themselves of that consultation, should the patient be informed of that fact? The manner in which radiologists practice their profession will undoubtedly be greatly impacted both medicolegally and practically by these disclosure issues.

The public call for the divulging of more medical information is also becoming more widespread. In a New York Times article published in 1996, a mother laments the fact that a sonographic study during her pregnancy revealed that her fetus had a clubfoot.9 Later, however, a healthy baby without a clubfoot was born. The mother writes that the process of informed consent must be taken far more seriously by the medical profession than it currently is and that women who undergo sonography should be told in detail about the limitations of screening and that clinical studies show that “no benefit to scanning occurs in a normal pregnancy.”9 A follow-up article pointed out that for the diagnosis of major and minor structural abnormalities of the fetus, sonography has a false-negative rate of 39% and a false-positive rate of 18%; the author concludes, “In the spirit of informed consent, women should be told that obstetrical ultrasound is a serious medical procedure designed to look for potentially devastating conditions, but there are no guarantees of the results.”10

The drive toward complete medical disclosure seems to be fueled by a combination of consumerism, feminism, and cynicism, according to the author of an article published in The New York Times.11 In decades past, the good patient was the docile patient and health care was characterized by “medical paternalism,” wrote the author, who then went on to write that it was feminism that changed that dynamic; if the underlying premise was that “it’s going to be a female patient and a male doctor, the patient had better become more educated. ... Doubts about the integrity and omniscience of doctors grew deeper as medicine became dominated by specialists, as housecalls and community hospitals disappeared, and as the media began covering medicine more aggressively.” But no trend has promoted patient activism as much as managed care, according to a professor of social medicine at Columbia University who is then quoted by the author as saying, “Now a loss of trust has turned into acute suspicion, because you’re no longer certain whether your physician is interested in your well-being or his reimbursement schedule. Better educated is better prepared and will be better served.”

The kind of information that should be included in a physician’s disclosure to a patient must continue to expand, according to a Texas attorney who has brought more than 30 medical malpractice lawsuits against psychiatrists alleging misdiagnoses of repressed memory and multiple personality syndromes. The attorney stated in a recent article that doctors “have a duty to be skeptical” about the existence of repressed memories and should “warn patients that delayed memories may be false.”12

Summary and Risk Management
Both the public at large and the courts are continuously imposing ethical and legal duties on radiologists and other physicians to expand the nature and the amount of information that must be disclosed to patients. The case described in this article focused in part on the issue of whether a general diagnostic radiologist should inform a patient that the radiologist possesses less expertise than, and should therefore refer the patient to, a neuroradiologist. In a recent malpractice trial in Illinois, a jury that found an orthopedic surgeon liable for malpractice was influenced by the fact that the surgeon had performed a procedure on a patient without having told the patient that he had no prior experience other than a practice session on a cadaver. In Wisconsin, the supreme court ruled that a neurosurgeon should have disclosed to the patient the fact that he had limited experience in cerebral aneurysm surgery and should have referred the patient to more experienced specialists in a nearby city. In an article dealing with how much patients ought to be told before undergoing radiologic procedures, Davidhizar et al points out that many of us were taught to give no information to patients, a stance that may have been easy in the past but is not justifiable today.13 These authors observe that patients today want and demand information and that, therefore, the dilemma of how much we tell patients is more substantial today than ever. These authors conclude that the amount of information that should be given to patients remains unclear because there are simply no succinct guidelines.

Risk management in radiology can lessen the likelihood of incurring a medical malpractice lawsuit and maximize the chances for a successful defense if a suit is filed while enhancing the quality of patient care. The following risk management pointers will help radiologists meet all three of these objectives and will assist them in determining how best to discharge the duty to disclose.

• In the process of obtaining informed consent, radiologists should adhere to standards of the radiology community that require, at the very least, disclosure regarding benefits and risks of the proposed procedure, alternative measures that might yield similar results, and the risks of not performing the procedure.

• Although there are currently no legal requirements or professional standards that compel radiologists to disclose to patients additional information beyond that previously described, it is nonetheless prudent for radiologists to anticipate as much as possible questions that a reasonable patient would want answered before granting consent to a diagnostic or therapeutic procedure, and then to offer appropriate information that answers those questions.

• In as much as there are as yet no written or unwritten standards that require physicians to voluntarily disclose to patients an accurate assessment of their own qualifications, radiologists must exercise their best judgment in determining the extent of personal and professional data that they divulge to patients. Radiologists should make special efforts to avoid misrepresenting, or give the appearance of misrepresenting, to patients their experience, expertise, or both. If a patient requests information about the radiologist’s credentials or qualifications in performing a diagnostic or therapeutic procedure, the radiologist should respond with complete honesty and candor.

• Although no state at this time legislatively or judicially           (with the possible exception of Wisconsin) imposes on radiologists the duty to seek consultation from or refer patients to better-qualified radiologists, radiologists should consider exercising such options in appropriate situations.

• Radiologists should document in the patient’s chart or radiology report the content of discussions held with patients relative to obtaining informed consent and disclosing additional information about the procedure itself or the radiologist performing it.

— This article appeared in its original form in the American Journal of Roentgenology. It is reprinted here with permission of the American Roentgen Ray Society.

 

References
1. Berlin L. Malpractice issues in radiology. Informed consent. Am J Roentgenol. 1997;169(1):15-18.

2. Wis. malpractice settlement based on MD’s inexperience. American Medical News. January 13, 1997:4.

3. Lowes RL. Informed consent will require more informing. Medical Economics. August 11, 1997:93-106.

4. Berlin L. Malpractice issues in radiology. Possessing ordinary knowledge. Am J Roentgenol. 1996;166(5):1027-1029.

5. Berlin L. Consequences of being accused of malpractice. Am J Roentgenol. 1997;169:1219-1223.

6. Clever LH. Obtain informed consent before publishing information about patients. JAMA. 1997;278(8):628-629.

7. Berlin L. Reporting the “missed” radiologic diagnosis: Medicolegal and ethical considerations. Radiology. 1994;192(1):183-187.

8. Berlin L. Malpractice issues in radiology. Teleradiology. Am J Roentgenol. 1998;170(6):1417-1422.

9. Angier N. Ultrasound and fury: One mother’s ordeal. New York Times. November 11, 1996:B7,B10.

10. Angier N. Doctors favor ultrasound use in right hands. New York Times. July 15, 1997:B9,B12.

11. Stolberg SG. Now, prescribing just what the patient ordered. New York Times. August 10, 1997:E3.

12. Klein SA. Memory recovered—or invented? American Medical News. December 8, 1997:3,24.

13. Davidhizar R, Dowd S. Should technologists tell everything they know? Radiol Manage. 1997:44-49.