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MEDICOLEGAL ASPECTS OF NEURODIAGNOSTIC TESTS
DIAGNOSTIC TESTING IN NEUROLOGY
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MEDICOLEGAL ASPECTS OF NEURODIAGNOSTIC TESTS H. Richard Beresford, MD, JD
The benefits of advances in neurodiagnostic testing are plain to see. Quick and precise diagnoses enable early, appropriate treatments for patients. Even if timely diagnoses open no therapeutic windows, the information gleaned may enhance prognostication and counseling. Clinicians can be more efficient and productive when they have ready access to reliable tests performed by technicians or nonclinical specialists. And biomedical researchers can use newer technologies to systematically monitor effectiveness of experimental therapies and to gain insights into pathophysiology of disease. Against this roseate backdrop, it may seem overly downbeat to raise legal concerns. Yet these concerns are unavoidable. Some test methodologies are invasive and therefore potentially harmful. Others that are not physically dangerous may be misapplied or misinterpreted in ways that produce psychosocial or economic harms. In a legal system like ours that entitles injured persons to recover monetary damages from wrongdoers, claims for test-related harms are predictable. Claimants may assert that a test itself caused harm, either because of significant intrinsic danger or because it was carelessly conducted. Or they may assert that choice of a particular test was inappropriate, or that clinicians mishandled test data in detrimental ways. Legal second guessing of a decision to perform a particular test is improbable unless there is a plausible link between the test and an adverse outcome. Failure to order a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) for a patient with a history of increasing headache, for example, will generate a plausible malpractice claim if the patient is later found to have a lesion that was treatable when the test allegedly should have been ordered. Other claims may allege negligent performance of a test itself, failure to obtain informed consent to testing, or negligent misapplication of data obtained through testing. This article briefly reviews legal issues that may arise with respect to neurodiagnostic testing. It focuses on applications of malpractice law. The considerable imFrom the Cornell Law School, Ithaca, and Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York
NEUROLOGIC CLINICS VOLUME 14 NUMBER 1
FEBRUARY 1996
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pact of the doctrine of informed consent also is explored. The article closes with a short exposition on “enterprise liability,” a concept that has special relevance to test-related claims arising in the framework of managed care. NEGLIGENCE IN TESTING Negligence Doctrine In law, negligence implies a careless breach of a lawful duty. The breach can take the form of nonfeasance, the failure to act when one should have acted, or misfeasance, the failure to act carefully enough. But before liability will attach, a claimant must establish that the breach of duty caused measurable harm. In other words, nonfeasance or misfeasance ordinarily is not actionable unless it results in provable injury. Thus, even if a physician carelessly fails to inform a patient that stroke is a risk of angiography, the physician would be chargeable with negligence only if the angiogram indeed caused a stroke. The physician, in theory, would be vulnerable to a charge of battery (unlawful touching) for not disclosing a significant risk before testing. But the costs of litigating such a claim ordinarily would far outstrip what a claimant could recover in damages. When the core of a negligence claim is medical malpractice, a claimant must produce medical expert testimony to establish standard of care, breach of duty, and a causal relationship between breach of duty and harm. Although the large volume of medical malpractice litigation may lead physicians to believe otherwise, the requirement of substantiating expert testimony offers considerable protection against medically baseless charges. Before an expert’s opinion is admissible into evidence in a malpractice case, the expert must testify that, “with reasonable medical certainty” or words to that effect, a defendant physician acted negligently. A less definite opinion will be excluded, or can be grounds for reversal on appeal if it is admitted. Moreover, even i f a court hears an expert’s opinion that lacks medical or scientific support, a defendant can attack it on cross-examination or produce other experts to refute it. Compelling claimants to substantiate their cases with testimony from medical professionals obviously does not assure a just outcome in every case. Some experts will testi ignorantly or unconscionably, and some courts will misinterpret what they hear. But the requirement averts the welter that could emerge if courts decided malpractice cases without benefit of informed opinions from medical professionals.
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Negligent Failure to Test As more and better neurodiagnostic tests come on line, it is foreseeable that some clinicians will fail to use them to an optimal degree. They may not know the tests exist, what they can achieve, or the proper indications for ordering them. They may view the tests as insufficiently precise or too costly in light of expected benefits. Or they may respond to pressures to contain health care costs by withholding testing they otherwise might choose. In any of these circumstances, claims may arise in which physicians are charged with negligent failure to conduct medically indicated testing. Few such claims will raise novel legal issues, no matter how exotic the test. The focus will remain on whether a physician violated accepted standards of medical practice by not testing. That a particular new diagnostic technology is complex, extraordinarily powerful, or very costly, in itself, is not legally significant. What is significant is the existing state of medical practice with respect to conducting the
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t e ~ t .If~ the , ~ average practitioner in the relevant specialty would have ordered the test in clinical circumstances at issue, then a defendant who failed to order the test would be at legal risk. But if the test is only used at large academic medical centers or seldom is ordered by most clinical practitioners, the legal risk of withholding it is considerably less, even if the test clearly is useful. Tests that gain general acceptance only slowly or haltingly may be especially problematic. During the ”shakedown” period in which knowledge about the utility of a new test is accumulating, some clinicians may eschew ordering it because of honest uncertainty about its value. But suppose the test ultimately proves highly reliable for diagnosing a treatable disorder and a patient of one of these physicians had that disorder at a time when the physician chose to forego the test. In an ensuing malpractice suit, the claimant could argue that the physician was negligent in not performing testing that the claimant’s experts testify was medically indicated. The defendant then would have to overcome the inference, deriving from hindsight, that it was careless to omit what is now regarded as a clinically valuable test. In this circumstance, the most fruitfui tactic would be to locate experts who are willing to testify that, at the relevant time, it was uncertain whether the test was medically indicated. The defendant then could argue that omitting the test did not violate the temporally relevant standard of care. The preceding hypothetical example underscores why it is important for clinicians to inform themselves about new diagnostic tests, especially those that may enable early detection of treatable disorders. Foregoing tests of this sort may have substantial adverse consequences for some patients, leading inexorably to lawsuits. Moreover, physicians’ reputations and, perhaps, referrals may suffer if it becomes widely known that they lack current knowledge about diagnostic technologies. Obvious as these pitfalls of incomplete knowledge are, the fact remains that it may be difficult for physicians to achieve fully up-to-date knowledge about new modalities of testing. This is especially true for physicians with large practices that include patients with a wide range of diagnoses and problems. Even specialists in neurology may be hard put to stay informed about technologies as diverse as functional neuroimaging, transcranial Doppler, magnetoencephalography, immunologic tests for autoimmune neurologic disorders, and molecular genetic diagnostic tests, despite the fact that technologies may be quite relevant for evaluating some patients in their practices. Of course, law does not require physicians to know everything about all tests that may pertain to their patients. It requires only that physicians know what the average or “reasonable” practitioner in a comparable environment knows about such tests: This means that if failure to perform functional neuroimaging is at issue, for example, the relevant standard of care is that of similarly situated practitioners, not that of the university-based specialist in functional neuroimaging. A claimant’s lawyer might produce such a specialist as an expert witness because he or she has impressive credentials and may-so the lawyer hopes-awe the jury. Nevertheless, a defendant neurologist is not chargeable with the knowledge of such a specialist unless the claimant can prove that the defendant’s clinical peers possess such knowledge as well.
Negligent Choice of Test Rather than failing to test, a clinician allegedly may choose the wrong test. Suppose a neurologist orders an MRI of the cervical and thoracic spine for a patient with lower limb weakness, spasticity and hyperreflexia, for example, and then tells the patient, after the MRI is found to be normal, that she probably has a degenerative or demyelinating spinal cord disease. If the patient subsequently is found to
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have a parasagittal meningioma after further progression of spastic paraparesis and appearance of severe headache, the stage would be set for a lawsuit alleging negligent misdiagnosis. The hypothesized claimant would have little difficulty finding expert witnesses to support two linked theories of liability. One theory would be that the initial evaluation should have included brain imaging because the differential diagnosis of lower limb weakness with corticospinal signs includes parasagittal or bifrontal lesions, regardless of the fact that the claimant did not complain of headaches when evaluated by the defendant. The second theory is that the defendant should have ordered brain imaging when MRI of the spine was found to be normal, rather than presuming that the claimant had an untreatable myelopathy. In other words, the defendant arguably either chose the wrong test initially or, even if the initial choice of test was reasonable, negligently failed to order additional testing. The defendant clinician might try to just@ the alleged misfeasance or nonfeasance by emphasizing that a spinal cord disorder was a more likely cause of claimant’s presenting signs than a brain tumor, and the spine MRI was the most appropriate and reliable way to exclude spinal cord disease. Although the defendant probably could secure expert witnesses who would support those propositions, they might be reluctant to support the choice not to do brain imaging, especially after the spine images were normal. They might be willing to testify that the decision not to do brain imaging was reasonable under the clinical circumstances, however, even though it turned out be an unwise choice in retrospect. They also might be willing to weigh in with something about the probabilistic nature of medical diagnoses and the unfeasibility of performing every available test when confronting certain categories of problems. Cases of this sort accent the more general question of the extent to which clinicians should try to be discriminating in their use of costly diagnostic technologies. One might conclude that the easy answer is that they should not try. Inevitably, it might be argued, a highly selective approach to testing will result in missing a few improbable but important diagnoses. Equally inevitably, this would result in lawsuits. The contrapuntal view is that the social costs of nonselective testing outweigh the benefits of a few more correct diagnoses and a few less malpractice suits. Adjusting these conflicting viewpoints ultimately is a political problem, one society eventually will have to confront as more and more diagnostic technologies become available. In the meantime, individual clinicians need to balance their desire to achieve as much diagnostic certainty as possible against the practical constraints on employing the panoply of available diagnostic technology. Negligent Performance of Testing Some neurologic clinicians conduct their own diagnostic tests (e.g., electromyography, muscle biopsy, lumbar puncture, carotid and transcranial Doppler). In this role, they are vulnerable to claims that they performed the tests negligently. There are two variants of such claims. One is that the claimant sustained direct physical injury because the test was performed carelessly (eg., excessive bleeding from muscle biopsy, spinal nerve root injury during lumbar puncture). The other variant is that the unskillful performance of the test produced inaccurate or misleading data, to the detriment of the patient (e.g., failure to detect a high-grade carotid stenosis on an ultrasonic study). Proof of negligence in these cases would require testimony from medical experts with experience in performing the procedures in question. The role of these experts would be to define an acceptable standard of technical compe-
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tence and express an opinion as to whether a defendant met that standard while testing the claimant. Mere proof that a claimant sustained a complication or that the test yielded inaccurate or misleading data would not sustain a claim of negligence. There must be a preponderance of evidence both that the testing procedure was performed carelessly and that carelessness caused the asserted harm, whether direct physical injury or generation of harmfully wrong information. For the tests neurologists commonly perform, the legal risks seem small. Significant direct harms from the minimally invasive tests most neurologists conduct must be rare. The greater risk would seem to lie in the generation of inaccurate data. A carelessly done carotid Doppler study could result in missing or delaying an opportunity to perform a protective carotid endarterectomy, for example. Given the emerging evidence of the efficacy of carotid endarterectomy for significant carotid stenosis, even in asymptomatic patients, it is easy to envision a claim by a patient with stroke attributable to carotid disease against a neurologist whose carotid Doppler study had failed to identify the carotid lesion. Negligent Interpretation
Assuming a test yields valid data, a physician may misinterpret the data. A neurologist, for example, might erroneously interpret localized spiking on an electroencephalographic recording as artifact when, in fact, it is a focal epileptiform discharge, or might incorrectly conclude that a nonenhancing cerebral lesion is an infarct rather than a neoplasm. Errors of this sort may or may not be negligent, but if they prove consequential, they may fuel malpractice claims. The outcome of such claims ordinarily would hinge on the testimony of neurologic expert witnesses. For claimants to prevail, the preponderance of expert opinion must be that the defendants violated accepted or prevailing standards of neurologic practice in interpreting the data in question. More subtle questions about interpretation of tests may arise with respect to data that have important psychosocial dimensions. Neurologists may elect to perform molecular genetic testing to diagnose a suspected hereditary disorder (e.g., Huntington’s disease) or to determine whether a patient is at heightened risk for developing a neurologic disorder because of a particular genotype (e.g., apoE4), for example. The information gleaned from such testing can have a powerful impact on patients. Unless they have been informed appropriately about the implications of testing or counseled appropriately about the significance of test results, considerable harm may result. This could include suicide triggered by learning one has or is at significant risk for an incurable neurologic disease, and stigmatization and loss of employment or insurance if test results are disseminated wrongfully or thoughtlessly. Neurologists who fail to anticipate such outcomes, or who fail to assure appropriate genetic testing, may be vulnerable to a charge of negligent nonfeasance. The argument might run that they have a duty to prepare their patients for the foreseeable consequences of testing, and that failure to provide or assure medically appropriate genetic counseling violates this duty. Claimants might find it difficult to sustain such an argument in court. One barrier may be proving that appropriate counseling would have averted an adverse outcome. Also, a defendant might argue that genetic tests are qualitatively similar to other tests that may yield diagnoses of lethal or untreatable diseases, and that physicians cannot reasonably be expected to shield patients from the psychological suffering undesired test results may inflict. Legal nuances aside, however, the potential for claims of this sort should encourage neurologists and other physicians who order genetic testing to try carefully to pre-
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pare their patients for the possibility of a result that confirms or foretells a terrible disease. CONSENT-BASED LIABILITY The Informed Consent Doctrine Most claims that allege failure by physicians to obtain informed consent to testing, in reality, are malpractice claims. The core of the claim is that a physician violated a professional duty to tell the patient enough. Defining what is enough virtually always requires expert medical testimony to describe the test and its indications, risks, benefits, and alternatives. Medical testimony also is needed to determine whether a claimant sustained measurable injury as a result of an allegedly inadequate disclosure. Moreover, the law in some states tests adequacy of disclosure on the basis of what the average or reasonable physician tells patients, not by reference to what average or reasonable patients expect to hear. Focus on the question of whether a physician violated a lawful professional duty protects physicians in an important way. Claimants cannot establish lack of informed consent simply by proving that physicians failed to disclose certain facts about tests. They also must show that the nondisclosure violated prevailing professional standards, largely as defined by physicians. Suppose a neurologist admittedly failed to tell a patient who underwent a medically appropriate lumbar puncture that diplopia caused by nerve VI palsy is a rare complication of the procedure, for example. If the patient then charges the physician with failure to obtain informed consent, he does not win a lawsuit merely by proving that the neurologist did not tell him about a rare complication that materialized. The claimant also must prove that the nondisclosure of this remote risk violated professional standards, as depicted by his medical experts. Assuming the claimant could find physicians who would testify that the defendant should have disclosed the remote risk of diplopia, this testimony would be subject to rebuttal by testimony from other neurologists to the effect that disclosure of such remote risks is not standard practice. Even if this claimant satisfies a legal decision maker that the risk of diplopia was so material that the neurologist should have disclosed it, the claimant does not necessarily win. He or she also must prove that, had the remote risk of diplopia been disclosed, he or she would have refused lumbar puncture. In other words, he or she must show somehow that the miniscule risk of transient diplopia would have led him to decline a test that was medically indicated. The law of most states would require such a claimant to show that the average or reasonable patient Standing alone, a claimant's would have declined the test in those circurnstan~es.3,~ hindsight-based assertion of what he or she would have done if told of the remote risk would not suffice. Indeed, the legal requirement that claimants prove that they would have declined testing if an omitted disclosure had been made does much to explain why claimants seldom win suits against physicians based on lack of informed consent. Consent to Newly Developed Tests When a new diagnostic technology is introduced, a measure of uncertainty may exist about both its safety and utility. To the extent the technology has been subject to regulatory oversight (as with new medical devices that require premarketing approval by the FDA), the most important safety issues will have been resolved, as well as many issues relating to validity and reliability. Physicians who
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use the technology nevertheless have a legal obligation to secure informed consent to its use. Suppose, for example, that the new technology is an arterial catheter that facilitates angiographic study of intracranial vascular occlusive disease. As with any potentially risky diagnostic test, a neurologist who employs the new catheter must explain the technology to the patient or lawful surrogate, describe the indications for its use, and disclose expected benefits, risks, and alternatives. Because it is new technology, however, its full risk profile may not be known. In this instance, the legally prudent approach is to be overinclusive rather than underinclusive in disclosing potential risks and to stress that unforeseen risks may materialize. This sort of broad disclosure will alert patients to the fact that the test is new and that an unexpected adverse event is possible.
Testing in Research Clinical investigators may employ generally accepted diagnostic technologies in their studies of human subjects, or they may use human subjects to study the safety and efficacy of new diagnostic technologies. In either context, they must obtain informed consent to testing. In many instances, the requirements for securing informed consent will be spelled out in Institutional Review Board (IRB)-approved research protocols that, in turn, are subject to federal or state regulations pertaining to human re~earch.~ Generally speaking, experimental protocols of this sort mandate expansive disclosures. Moreover, where the research offers little or no prospect of directly benefiting the experimental subjects, clinical investigators should be especially sensitive to the need for exhaustive disclosure of potential risks and for disabusing subjects of beliefs that the research might somehow benefit them. In other words, clinical investigators ought to view themselves as fiduciaries with respect to research subjects, invariably placing the well-being of experimental subjects ahead of their own interests in gaining scientific knowledge. At times the line between clinical testing and research may be indistinct. In one sense, this is immaterial because testers must obtain informed consent to testing in both circumstances. Nonetheless, how the test is characterized may be significant. Suppose, for example, that a patient with parkinsonism who has had little response to levodopa is asked by his attending neurologist to undergo positron emission tomography (PET). Suppose, further, that the neurologist also is engaged in a study of dopamine metabolism in "Parkinson look-alike" disorders. The PET study may be useful in clarifying why the patient has not responded to levodopa and suggesting alternative therapeutic strategies, but it also will yield data for the neurologist's scientific study. If the neurologist fully explains and discloses the risks of PET, as well as the potential utility of the study in explaining the poor response to levodopa, the patient arguably has enough information to decide about PET. Nevertheless, if a disclosed risk of PET materializes (e.g., vascular thrombosis), the patient might claim that the neurologist did not disclose her conflict of interest with respect to the PET study and that, if he or she had, the patient would have declined the test. How this claim would play out might depend on whether the claimant could persuade a legal decision maker that a reasonable person would have declined the test if the neurologist had disclosed her conflict of interest. Obviously the neurologist easily could have avoided such a claim by honoring an ethical obligation to disclose the conflict. When a test is the focus of research, experimenters should be aware of a potential obligation to disclose more than the foreseeable risks of the test itself. They also
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should consider disclosing any financial or other gains they anticipate realizing if the test proves valid and useful. Thus, the California Supreme Court recently decided that investigators who seek cells and tissues of research subjects for developing biotechnology products must inform the research subjects of their commercial expectations7One rationale for this decision is that experimental subjects should be given the opportunity to bargain with researchers for a share of the profits that might be realized from use of their cells and tissues. As more and more clinical investigators establish links with biotechnology companies, issues of this sort may become more than rare curiosities. Unavoidably Dangerous Technologies Under the law of product liability, manufacturers of certain products may be held liable even if claimants injured by the products do not prove that the products are defective. If a product is useful but unavoidably dangerous despite careful manufacture (e.g., some prescription drugs), therefore, the makers can be held liable if they do not provide adequate warnings to users of the products. When such products are prescribed or utilized by physicians, however, manufacturers can shift the liability for injuries caused by the products to the physicians if they can establish that they adequately warned physicians of materialized risks, even if the manufacturers did not warn patients or the public directly. A simple example relates to penicillin. Manufacturers of various forms of this antibiotic agent are careful to advise physicians that penicillins may trigger anaphylactic reactions. If a patient incurs such a reaction after receiving the drug from a physician who did not warn him or her of that risk, the liability is that of the physician, not the manufacturer. An exception to this ”learned intermediary” doctrinelowould be when the claimant can show that the penicillin itself was made defectively. One impact of the “learned intermediary” doctrine is to reinforce the obligation of physicians to disclose risks of medical products or devices that they employ for diagnostic purposes. Physicians can escape liability by showing that manufacturers, in fact, did not warn them about materialized risks. But, as any careful reader of package inserts for pharmaceutical agents or of materials that accompany medical devices knows, manufacturers’ disclosures of risks tend to be exhaustive, covering some risks that may be so remote as to be improbable. Although a physician might try to argue that such disclosures are more obfuscatory than substantive, if a risk of a testing device or product is clearly stated and the physician did not communicate it to an injured patient, the manufacturer is likely to be off the liability hook. The physician might still prevail by showing that the risk in question was so remote that virtually no physicians disclose it to their patients or that, even if they do, patients generally accept it. ENTERPRISE LIABILITY AND DIAGNOSTIC TESTS The Concept of Enterprise Liability Calls for medical malpractice reform have grown in recent years, and many states have enacted laws that aim to reduce the financial and social costs of medical liability litigation. By and large, the reforms have been more in the nature of tinkering with existing tort laws than bold strokes. Shifts to a no-fault system or an administrative system akin to workers’ compensation have been rejected. One concept that has attracted growing attention, however, is that of “enterprise liability.”’ The
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concept takes into account the increasingly corporate nature of medical practice in which physicians and hospitals are banding together to cope with the cost-containing and other demands of managed care. The essence of ”enterprise liability” is to shift liability for medical maloccurrences from individual physicians to the corporate entities to which they are linked. In such a paradigm, the presumption is that the corporate entity will have a powerful incentive to oversee the performance of its physicians, and that this oversight will compensate for the loss of negligence-detemng influences that flow from insulating physicians from personal liability. In short, if an entity must pay for harms to patients, it will deploy managerial techniques to prevent those harms. The micromanagement that may result from this could be considerable, and some physicians may find the tradeoff intolerable. But as more and more physicians become enmeshed in corporate medicine, their collective antipathy to bureaucratic oversight may wane. Diagnostic Testing in Managed Care A gnawing concern of many physicians is that pressures to contain health care costs in the managed care model will force underutilization of diagnostic testing. It is hard to deny that some tests, notably neuroimaging and electrophysiologic studies, have been overutilized in the past. But, in itself, that does not justify blanket efforts to limit use of certain costly but valuable tests, be they existing technologies such as MRI or evolving new technologies. Such tests may be eminently cost-effective in the long run when used by knowledgeable clinicians. Rules that inflexibly restrict their use neither save money nor enhance quality of care. In the context of managed care, the challenge is to assure that corporate entities are held accountable for policies or conduct that compel physicians to forego potentially beneficial testing. Accountability of this sort should lead managers to adapt policies about testing to the needs of patients rather than to fiscal concerns. On the other hand, in itself, it would not relieve physicians of their obligation to advocate for testing in the face of constraining rules. Existing legal precedents suggest that physicians cannot successfully invoke managed care policies to just@ their own failures to actively promote the best interests of their patients.”
Enterprise Liability and Diagnostic Tests If enterprise liability were to become the dominant model for processing medical infiry claims, targets of most claims would be organizations that hold managerial or regulatory power over the physicians whose conduct generated the claims. In the realm of diagnostic tests, this would mean that claims based on allegedly wrongful selection, performance, interpretation, or omission of diagnostic tests for patients covered by the enterprise would be brought against the enterprise rather than offending physicians. Presumably, claims based on lack of informed consent to testing also would be brought against the enterprise, even though it might be argued that informed consent claims should be treated differently because of the “personal” nature of the transactions involved. Because most informed consent claims are treated by courts as malpractice claims, however, the rationale for enterprise liability applies to them as well. A corporate entity might attempt to defeat enterprise liability claims by asserting that the conduct of wrongdoing physicians violated binding rules of the enterprise and that, in this circumstance, the physicians themselves should bear legal responsibility for resulting harms to patients. Whether this type of defense succeeds,
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in part, would depend on the nature of the contract between physician and enterprise. If, for example, the contract provided that physicians must obtain informed consent (as defined in the contract) before performing risky diagnostic tests, and the physician failed to disclose a known and materialized risk of a test, the enterprise might escape liability. But, unless a physician is in clear violation of enterprise rules, the logic of the enterprise liability doctrine is that ambiguities of contract or circumstances should be resolved in favor of targeting the enterprise. The case for enterprise liability is particularly strong when a claimant asserts that indicated testing was omitted because of a corporate entity's inappropriate cost-containment policies. This is arguably a form of corporate negligence, a doctrine that courts have invoked to hold hospitals liable for some actions of physicians who hold staff privileges but are not employees.' The rationale is that a hospital corporation that has assumed responsibilities for issuing credentials to physicians should take reasonable steps to determine their competence and to oversee their clinical activities in the hospital, including the conduct of diagnostic testing. Similarly, a managed care organization that has undertaken to issue credentials and manage physicians should bear legal responsibility for test-related acts or omissions occurring within the framework of its managed care contracts with physicians. Formal acceptance of the enterprise liability principle would eliminate the need for directly involving physicians in claims stemming from these acts or omissions.
References 1. Abraham KS, Weiler PC: Enterprise medical liability and the evolution of the American health care system. Harvard Law Rev 108:381-436,1994 2. Beresford H R Neurologist as expert witness. Neurol Clin 10:1059-1071,1992 3. Canterbury v Spence, 464 Fed 2d 772 [DC Circuit 19721, cert den 93 Sup Ct 560 4. Cobbs v Grant, 502 P 2d 1 [Sup Ct CA 19721 5. Code Fed Regs 45,46:405-407, (1983) 6. Hall v Hilbun, 466 So 2d 856 [Sup Ct MS 19851 7. Moore v Regents of Univ of California, 271 CA Rptr 146,793 Pac 2d 479 (1990) 8. Richter v Northwestern Memorial Hosp, 177 I11 App 3d 247,532 NE 2d 269 (1988) 9. Siliciano J: Wealth, equity, and the Unitary Medical Malpractice Standard. Virginia Law Rev 77439-484,1991 10. Terhune v A.H. Robins Co, 90 WN 2d 9,577 Pac 2d 975 (1978) 11. Wickline v State of California, 228 CA Rptr 662 [CA App 19861, petition for review dismissed, 741 Pac 2d 613 (1987)
Address reprint requests to H. Richard Beresford, MD, JD Cornell Law School Myron Taylor Hall Ithaca. NY 14853-4901
0733-8619/96 $0.00 + .20
MEDICOLEGAL ASPECTS OF NEURODIAGNOSTIC TESTS H. Richard Beresford, MD, JD
The benefits of advances in neurodiagnostic testing are plain to see. Quick and precise diagnoses enable early, appropriate treatments for patients. Even if timely diagnoses open no therapeutic windows, the information gleaned may enhance prognostication and counseling. Clinicians can be more efficient and productive when they have ready access to reliable tests performed by technicians or nonclinical specialists. And biomedical researchers can use newer technologies to systematically monitor effectiveness of experimental therapies and to gain insights into pathophysiology of disease. Against this roseate backdrop, it may seem overly downbeat to raise legal concerns. Yet these concerns are unavoidable. Some test methodologies are invasive and therefore potentially harmful. Others that are not physically dangerous may be misapplied or misinterpreted in ways that produce psychosocial or economic harms. In a legal system like ours that entitles injured persons to recover monetary damages from wrongdoers, claims for test-related harms are predictable. Claimants may assert that a test itself caused harm, either because of significant intrinsic danger or because it was carelessly conducted. Or they may assert that choice of a particular test was inappropriate, or that clinicians mishandled test data in detrimental ways. Legal second guessing of a decision to perform a particular test is improbable unless there is a plausible link between the test and an adverse outcome. Failure to order a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) for a patient with a history of increasing headache, for example, will generate a plausible malpractice claim if the patient is later found to have a lesion that was treatable when the test allegedly should have been ordered. Other claims may allege negligent performance of a test itself, failure to obtain informed consent to testing, or negligent misapplication of data obtained through testing. This article briefly reviews legal issues that may arise with respect to neurodiagnostic testing. It focuses on applications of malpractice law. The considerable imFrom the Cornell Law School, Ithaca, and Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York
NEUROLOGIC CLINICS VOLUME 14 NUMBER 1
FEBRUARY 1996
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pact of the doctrine of informed consent also is explored. The article closes with a short exposition on “enterprise liability,” a concept that has special relevance to test-related claims arising in the framework of managed care. NEGLIGENCE IN TESTING Negligence Doctrine In law, negligence implies a careless breach of a lawful duty. The breach can take the form of nonfeasance, the failure to act when one should have acted, or misfeasance, the failure to act carefully enough. But before liability will attach, a claimant must establish that the breach of duty caused measurable harm. In other words, nonfeasance or misfeasance ordinarily is not actionable unless it results in provable injury. Thus, even if a physician carelessly fails to inform a patient that stroke is a risk of angiography, the physician would be chargeable with negligence only if the angiogram indeed caused a stroke. The physician, in theory, would be vulnerable to a charge of battery (unlawful touching) for not disclosing a significant risk before testing. But the costs of litigating such a claim ordinarily would far outstrip what a claimant could recover in damages. When the core of a negligence claim is medical malpractice, a claimant must produce medical expert testimony to establish standard of care, breach of duty, and a causal relationship between breach of duty and harm. Although the large volume of medical malpractice litigation may lead physicians to believe otherwise, the requirement of substantiating expert testimony offers considerable protection against medically baseless charges. Before an expert’s opinion is admissible into evidence in a malpractice case, the expert must testify that, “with reasonable medical certainty” or words to that effect, a defendant physician acted negligently. A less definite opinion will be excluded, or can be grounds for reversal on appeal if it is admitted. Moreover, even i f a court hears an expert’s opinion that lacks medical or scientific support, a defendant can attack it on cross-examination or produce other experts to refute it. Compelling claimants to substantiate their cases with testimony from medical professionals obviously does not assure a just outcome in every case. Some experts will testi ignorantly or unconscionably, and some courts will misinterpret what they hear. But the requirement averts the welter that could emerge if courts decided malpractice cases without benefit of informed opinions from medical professionals.
v
Negligent Failure to Test As more and better neurodiagnostic tests come on line, it is foreseeable that some clinicians will fail to use them to an optimal degree. They may not know the tests exist, what they can achieve, or the proper indications for ordering them. They may view the tests as insufficiently precise or too costly in light of expected benefits. Or they may respond to pressures to contain health care costs by withholding testing they otherwise might choose. In any of these circumstances, claims may arise in which physicians are charged with negligent failure to conduct medically indicated testing. Few such claims will raise novel legal issues, no matter how exotic the test. The focus will remain on whether a physician violated accepted standards of medical practice by not testing. That a particular new diagnostic technology is complex, extraordinarily powerful, or very costly, in itself, is not legally significant. What is significant is the existing state of medical practice with respect to conducting the
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t e ~ t .If~ the , ~ average practitioner in the relevant specialty would have ordered the test in clinical circumstances at issue, then a defendant who failed to order the test would be at legal risk. But if the test is only used at large academic medical centers or seldom is ordered by most clinical practitioners, the legal risk of withholding it is considerably less, even if the test clearly is useful. Tests that gain general acceptance only slowly or haltingly may be especially problematic. During the ”shakedown” period in which knowledge about the utility of a new test is accumulating, some clinicians may eschew ordering it because of honest uncertainty about its value. But suppose the test ultimately proves highly reliable for diagnosing a treatable disorder and a patient of one of these physicians had that disorder at a time when the physician chose to forego the test. In an ensuing malpractice suit, the claimant could argue that the physician was negligent in not performing testing that the claimant’s experts testify was medically indicated. The defendant then would have to overcome the inference, deriving from hindsight, that it was careless to omit what is now regarded as a clinically valuable test. In this circumstance, the most fruitfui tactic would be to locate experts who are willing to testify that, at the relevant time, it was uncertain whether the test was medically indicated. The defendant then could argue that omitting the test did not violate the temporally relevant standard of care. The preceding hypothetical example underscores why it is important for clinicians to inform themselves about new diagnostic tests, especially those that may enable early detection of treatable disorders. Foregoing tests of this sort may have substantial adverse consequences for some patients, leading inexorably to lawsuits. Moreover, physicians’ reputations and, perhaps, referrals may suffer if it becomes widely known that they lack current knowledge about diagnostic technologies. Obvious as these pitfalls of incomplete knowledge are, the fact remains that it may be difficult for physicians to achieve fully up-to-date knowledge about new modalities of testing. This is especially true for physicians with large practices that include patients with a wide range of diagnoses and problems. Even specialists in neurology may be hard put to stay informed about technologies as diverse as functional neuroimaging, transcranial Doppler, magnetoencephalography, immunologic tests for autoimmune neurologic disorders, and molecular genetic diagnostic tests, despite the fact that technologies may be quite relevant for evaluating some patients in their practices. Of course, law does not require physicians to know everything about all tests that may pertain to their patients. It requires only that physicians know what the average or “reasonable” practitioner in a comparable environment knows about such tests: This means that if failure to perform functional neuroimaging is at issue, for example, the relevant standard of care is that of similarly situated practitioners, not that of the university-based specialist in functional neuroimaging. A claimant’s lawyer might produce such a specialist as an expert witness because he or she has impressive credentials and may-so the lawyer hopes-awe the jury. Nevertheless, a defendant neurologist is not chargeable with the knowledge of such a specialist unless the claimant can prove that the defendant’s clinical peers possess such knowledge as well.
Negligent Choice of Test Rather than failing to test, a clinician allegedly may choose the wrong test. Suppose a neurologist orders an MRI of the cervical and thoracic spine for a patient with lower limb weakness, spasticity and hyperreflexia, for example, and then tells the patient, after the MRI is found to be normal, that she probably has a degenerative or demyelinating spinal cord disease. If the patient subsequently is found to
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have a parasagittal meningioma after further progression of spastic paraparesis and appearance of severe headache, the stage would be set for a lawsuit alleging negligent misdiagnosis. The hypothesized claimant would have little difficulty finding expert witnesses to support two linked theories of liability. One theory would be that the initial evaluation should have included brain imaging because the differential diagnosis of lower limb weakness with corticospinal signs includes parasagittal or bifrontal lesions, regardless of the fact that the claimant did not complain of headaches when evaluated by the defendant. The second theory is that the defendant should have ordered brain imaging when MRI of the spine was found to be normal, rather than presuming that the claimant had an untreatable myelopathy. In other words, the defendant arguably either chose the wrong test initially or, even if the initial choice of test was reasonable, negligently failed to order additional testing. The defendant clinician might try to just@ the alleged misfeasance or nonfeasance by emphasizing that a spinal cord disorder was a more likely cause of claimant’s presenting signs than a brain tumor, and the spine MRI was the most appropriate and reliable way to exclude spinal cord disease. Although the defendant probably could secure expert witnesses who would support those propositions, they might be reluctant to support the choice not to do brain imaging, especially after the spine images were normal. They might be willing to testify that the decision not to do brain imaging was reasonable under the clinical circumstances, however, even though it turned out be an unwise choice in retrospect. They also might be willing to weigh in with something about the probabilistic nature of medical diagnoses and the unfeasibility of performing every available test when confronting certain categories of problems. Cases of this sort accent the more general question of the extent to which clinicians should try to be discriminating in their use of costly diagnostic technologies. One might conclude that the easy answer is that they should not try. Inevitably, it might be argued, a highly selective approach to testing will result in missing a few improbable but important diagnoses. Equally inevitably, this would result in lawsuits. The contrapuntal view is that the social costs of nonselective testing outweigh the benefits of a few more correct diagnoses and a few less malpractice suits. Adjusting these conflicting viewpoints ultimately is a political problem, one society eventually will have to confront as more and more diagnostic technologies become available. In the meantime, individual clinicians need to balance their desire to achieve as much diagnostic certainty as possible against the practical constraints on employing the panoply of available diagnostic technology. Negligent Performance of Testing Some neurologic clinicians conduct their own diagnostic tests (e.g., electromyography, muscle biopsy, lumbar puncture, carotid and transcranial Doppler). In this role, they are vulnerable to claims that they performed the tests negligently. There are two variants of such claims. One is that the claimant sustained direct physical injury because the test was performed carelessly (eg., excessive bleeding from muscle biopsy, spinal nerve root injury during lumbar puncture). The other variant is that the unskillful performance of the test produced inaccurate or misleading data, to the detriment of the patient (e.g., failure to detect a high-grade carotid stenosis on an ultrasonic study). Proof of negligence in these cases would require testimony from medical experts with experience in performing the procedures in question. The role of these experts would be to define an acceptable standard of technical compe-
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tence and express an opinion as to whether a defendant met that standard while testing the claimant. Mere proof that a claimant sustained a complication or that the test yielded inaccurate or misleading data would not sustain a claim of negligence. There must be a preponderance of evidence both that the testing procedure was performed carelessly and that carelessness caused the asserted harm, whether direct physical injury or generation of harmfully wrong information. For the tests neurologists commonly perform, the legal risks seem small. Significant direct harms from the minimally invasive tests most neurologists conduct must be rare. The greater risk would seem to lie in the generation of inaccurate data. A carelessly done carotid Doppler study could result in missing or delaying an opportunity to perform a protective carotid endarterectomy, for example. Given the emerging evidence of the efficacy of carotid endarterectomy for significant carotid stenosis, even in asymptomatic patients, it is easy to envision a claim by a patient with stroke attributable to carotid disease against a neurologist whose carotid Doppler study had failed to identify the carotid lesion. Negligent Interpretation
Assuming a test yields valid data, a physician may misinterpret the data. A neurologist, for example, might erroneously interpret localized spiking on an electroencephalographic recording as artifact when, in fact, it is a focal epileptiform discharge, or might incorrectly conclude that a nonenhancing cerebral lesion is an infarct rather than a neoplasm. Errors of this sort may or may not be negligent, but if they prove consequential, they may fuel malpractice claims. The outcome of such claims ordinarily would hinge on the testimony of neurologic expert witnesses. For claimants to prevail, the preponderance of expert opinion must be that the defendants violated accepted or prevailing standards of neurologic practice in interpreting the data in question. More subtle questions about interpretation of tests may arise with respect to data that have important psychosocial dimensions. Neurologists may elect to perform molecular genetic testing to diagnose a suspected hereditary disorder (e.g., Huntington’s disease) or to determine whether a patient is at heightened risk for developing a neurologic disorder because of a particular genotype (e.g., apoE4), for example. The information gleaned from such testing can have a powerful impact on patients. Unless they have been informed appropriately about the implications of testing or counseled appropriately about the significance of test results, considerable harm may result. This could include suicide triggered by learning one has or is at significant risk for an incurable neurologic disease, and stigmatization and loss of employment or insurance if test results are disseminated wrongfully or thoughtlessly. Neurologists who fail to anticipate such outcomes, or who fail to assure appropriate genetic testing, may be vulnerable to a charge of negligent nonfeasance. The argument might run that they have a duty to prepare their patients for the foreseeable consequences of testing, and that failure to provide or assure medically appropriate genetic counseling violates this duty. Claimants might find it difficult to sustain such an argument in court. One barrier may be proving that appropriate counseling would have averted an adverse outcome. Also, a defendant might argue that genetic tests are qualitatively similar to other tests that may yield diagnoses of lethal or untreatable diseases, and that physicians cannot reasonably be expected to shield patients from the psychological suffering undesired test results may inflict. Legal nuances aside, however, the potential for claims of this sort should encourage neurologists and other physicians who order genetic testing to try carefully to pre-
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pare their patients for the possibility of a result that confirms or foretells a terrible disease. CONSENT-BASED LIABILITY The Informed Consent Doctrine Most claims that allege failure by physicians to obtain informed consent to testing, in reality, are malpractice claims. The core of the claim is that a physician violated a professional duty to tell the patient enough. Defining what is enough virtually always requires expert medical testimony to describe the test and its indications, risks, benefits, and alternatives. Medical testimony also is needed to determine whether a claimant sustained measurable injury as a result of an allegedly inadequate disclosure. Moreover, the law in some states tests adequacy of disclosure on the basis of what the average or reasonable physician tells patients, not by reference to what average or reasonable patients expect to hear. Focus on the question of whether a physician violated a lawful professional duty protects physicians in an important way. Claimants cannot establish lack of informed consent simply by proving that physicians failed to disclose certain facts about tests. They also must show that the nondisclosure violated prevailing professional standards, largely as defined by physicians. Suppose a neurologist admittedly failed to tell a patient who underwent a medically appropriate lumbar puncture that diplopia caused by nerve VI palsy is a rare complication of the procedure, for example. If the patient then charges the physician with failure to obtain informed consent, he does not win a lawsuit merely by proving that the neurologist did not tell him about a rare complication that materialized. The claimant also must prove that the nondisclosure of this remote risk violated professional standards, as depicted by his medical experts. Assuming the claimant could find physicians who would testify that the defendant should have disclosed the remote risk of diplopia, this testimony would be subject to rebuttal by testimony from other neurologists to the effect that disclosure of such remote risks is not standard practice. Even if this claimant satisfies a legal decision maker that the risk of diplopia was so material that the neurologist should have disclosed it, the claimant does not necessarily win. He or she also must prove that, had the remote risk of diplopia been disclosed, he or she would have refused lumbar puncture. In other words, he or she must show somehow that the miniscule risk of transient diplopia would have led him to decline a test that was medically indicated. The law of most states would require such a claimant to show that the average or reasonable patient Standing alone, a claimant's would have declined the test in those circurnstan~es.3,~ hindsight-based assertion of what he or she would have done if told of the remote risk would not suffice. Indeed, the legal requirement that claimants prove that they would have declined testing if an omitted disclosure had been made does much to explain why claimants seldom win suits against physicians based on lack of informed consent. Consent to Newly Developed Tests When a new diagnostic technology is introduced, a measure of uncertainty may exist about both its safety and utility. To the extent the technology has been subject to regulatory oversight (as with new medical devices that require premarketing approval by the FDA), the most important safety issues will have been resolved, as well as many issues relating to validity and reliability. Physicians who
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use the technology nevertheless have a legal obligation to secure informed consent to its use. Suppose, for example, that the new technology is an arterial catheter that facilitates angiographic study of intracranial vascular occlusive disease. As with any potentially risky diagnostic test, a neurologist who employs the new catheter must explain the technology to the patient or lawful surrogate, describe the indications for its use, and disclose expected benefits, risks, and alternatives. Because it is new technology, however, its full risk profile may not be known. In this instance, the legally prudent approach is to be overinclusive rather than underinclusive in disclosing potential risks and to stress that unforeseen risks may materialize. This sort of broad disclosure will alert patients to the fact that the test is new and that an unexpected adverse event is possible.
Testing in Research Clinical investigators may employ generally accepted diagnostic technologies in their studies of human subjects, or they may use human subjects to study the safety and efficacy of new diagnostic technologies. In either context, they must obtain informed consent to testing. In many instances, the requirements for securing informed consent will be spelled out in Institutional Review Board (IRB)-approved research protocols that, in turn, are subject to federal or state regulations pertaining to human re~earch.~ Generally speaking, experimental protocols of this sort mandate expansive disclosures. Moreover, where the research offers little or no prospect of directly benefiting the experimental subjects, clinical investigators should be especially sensitive to the need for exhaustive disclosure of potential risks and for disabusing subjects of beliefs that the research might somehow benefit them. In other words, clinical investigators ought to view themselves as fiduciaries with respect to research subjects, invariably placing the well-being of experimental subjects ahead of their own interests in gaining scientific knowledge. At times the line between clinical testing and research may be indistinct. In one sense, this is immaterial because testers must obtain informed consent to testing in both circumstances. Nonetheless, how the test is characterized may be significant. Suppose, for example, that a patient with parkinsonism who has had little response to levodopa is asked by his attending neurologist to undergo positron emission tomography (PET). Suppose, further, that the neurologist also is engaged in a study of dopamine metabolism in "Parkinson look-alike" disorders. The PET study may be useful in clarifying why the patient has not responded to levodopa and suggesting alternative therapeutic strategies, but it also will yield data for the neurologist's scientific study. If the neurologist fully explains and discloses the risks of PET, as well as the potential utility of the study in explaining the poor response to levodopa, the patient arguably has enough information to decide about PET. Nevertheless, if a disclosed risk of PET materializes (e.g., vascular thrombosis), the patient might claim that the neurologist did not disclose her conflict of interest with respect to the PET study and that, if he or she had, the patient would have declined the test. How this claim would play out might depend on whether the claimant could persuade a legal decision maker that a reasonable person would have declined the test if the neurologist had disclosed her conflict of interest. Obviously the neurologist easily could have avoided such a claim by honoring an ethical obligation to disclose the conflict. When a test is the focus of research, experimenters should be aware of a potential obligation to disclose more than the foreseeable risks of the test itself. They also
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should consider disclosing any financial or other gains they anticipate realizing if the test proves valid and useful. Thus, the California Supreme Court recently decided that investigators who seek cells and tissues of research subjects for developing biotechnology products must inform the research subjects of their commercial expectations7One rationale for this decision is that experimental subjects should be given the opportunity to bargain with researchers for a share of the profits that might be realized from use of their cells and tissues. As more and more clinical investigators establish links with biotechnology companies, issues of this sort may become more than rare curiosities. Unavoidably Dangerous Technologies Under the law of product liability, manufacturers of certain products may be held liable even if claimants injured by the products do not prove that the products are defective. If a product is useful but unavoidably dangerous despite careful manufacture (e.g., some prescription drugs), therefore, the makers can be held liable if they do not provide adequate warnings to users of the products. When such products are prescribed or utilized by physicians, however, manufacturers can shift the liability for injuries caused by the products to the physicians if they can establish that they adequately warned physicians of materialized risks, even if the manufacturers did not warn patients or the public directly. A simple example relates to penicillin. Manufacturers of various forms of this antibiotic agent are careful to advise physicians that penicillins may trigger anaphylactic reactions. If a patient incurs such a reaction after receiving the drug from a physician who did not warn him or her of that risk, the liability is that of the physician, not the manufacturer. An exception to this ”learned intermediary” doctrinelowould be when the claimant can show that the penicillin itself was made defectively. One impact of the “learned intermediary” doctrine is to reinforce the obligation of physicians to disclose risks of medical products or devices that they employ for diagnostic purposes. Physicians can escape liability by showing that manufacturers, in fact, did not warn them about materialized risks. But, as any careful reader of package inserts for pharmaceutical agents or of materials that accompany medical devices knows, manufacturers’ disclosures of risks tend to be exhaustive, covering some risks that may be so remote as to be improbable. Although a physician might try to argue that such disclosures are more obfuscatory than substantive, if a risk of a testing device or product is clearly stated and the physician did not communicate it to an injured patient, the manufacturer is likely to be off the liability hook. The physician might still prevail by showing that the risk in question was so remote that virtually no physicians disclose it to their patients or that, even if they do, patients generally accept it. ENTERPRISE LIABILITY AND DIAGNOSTIC TESTS The Concept of Enterprise Liability Calls for medical malpractice reform have grown in recent years, and many states have enacted laws that aim to reduce the financial and social costs of medical liability litigation. By and large, the reforms have been more in the nature of tinkering with existing tort laws than bold strokes. Shifts to a no-fault system or an administrative system akin to workers’ compensation have been rejected. One concept that has attracted growing attention, however, is that of “enterprise liability.”’ The
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concept takes into account the increasingly corporate nature of medical practice in which physicians and hospitals are banding together to cope with the cost-containing and other demands of managed care. The essence of ”enterprise liability” is to shift liability for medical maloccurrences from individual physicians to the corporate entities to which they are linked. In such a paradigm, the presumption is that the corporate entity will have a powerful incentive to oversee the performance of its physicians, and that this oversight will compensate for the loss of negligence-detemng influences that flow from insulating physicians from personal liability. In short, if an entity must pay for harms to patients, it will deploy managerial techniques to prevent those harms. The micromanagement that may result from this could be considerable, and some physicians may find the tradeoff intolerable. But as more and more physicians become enmeshed in corporate medicine, their collective antipathy to bureaucratic oversight may wane. Diagnostic Testing in Managed Care A gnawing concern of many physicians is that pressures to contain health care costs in the managed care model will force underutilization of diagnostic testing. It is hard to deny that some tests, notably neuroimaging and electrophysiologic studies, have been overutilized in the past. But, in itself, that does not justify blanket efforts to limit use of certain costly but valuable tests, be they existing technologies such as MRI or evolving new technologies. Such tests may be eminently cost-effective in the long run when used by knowledgeable clinicians. Rules that inflexibly restrict their use neither save money nor enhance quality of care. In the context of managed care, the challenge is to assure that corporate entities are held accountable for policies or conduct that compel physicians to forego potentially beneficial testing. Accountability of this sort should lead managers to adapt policies about testing to the needs of patients rather than to fiscal concerns. On the other hand, in itself, it would not relieve physicians of their obligation to advocate for testing in the face of constraining rules. Existing legal precedents suggest that physicians cannot successfully invoke managed care policies to just@ their own failures to actively promote the best interests of their patients.”
Enterprise Liability and Diagnostic Tests If enterprise liability were to become the dominant model for processing medical infiry claims, targets of most claims would be organizations that hold managerial or regulatory power over the physicians whose conduct generated the claims. In the realm of diagnostic tests, this would mean that claims based on allegedly wrongful selection, performance, interpretation, or omission of diagnostic tests for patients covered by the enterprise would be brought against the enterprise rather than offending physicians. Presumably, claims based on lack of informed consent to testing also would be brought against the enterprise, even though it might be argued that informed consent claims should be treated differently because of the “personal” nature of the transactions involved. Because most informed consent claims are treated by courts as malpractice claims, however, the rationale for enterprise liability applies to them as well. A corporate entity might attempt to defeat enterprise liability claims by asserting that the conduct of wrongdoing physicians violated binding rules of the enterprise and that, in this circumstance, the physicians themselves should bear legal responsibility for resulting harms to patients. Whether this type of defense succeeds,
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in part, would depend on the nature of the contract between physician and enterprise. If, for example, the contract provided that physicians must obtain informed consent (as defined in the contract) before performing risky diagnostic tests, and the physician failed to disclose a known and materialized risk of a test, the enterprise might escape liability. But, unless a physician is in clear violation of enterprise rules, the logic of the enterprise liability doctrine is that ambiguities of contract or circumstances should be resolved in favor of targeting the enterprise. The case for enterprise liability is particularly strong when a claimant asserts that indicated testing was omitted because of a corporate entity's inappropriate cost-containment policies. This is arguably a form of corporate negligence, a doctrine that courts have invoked to hold hospitals liable for some actions of physicians who hold staff privileges but are not employees.' The rationale is that a hospital corporation that has assumed responsibilities for issuing credentials to physicians should take reasonable steps to determine their competence and to oversee their clinical activities in the hospital, including the conduct of diagnostic testing. Similarly, a managed care organization that has undertaken to issue credentials and manage physicians should bear legal responsibility for test-related acts or omissions occurring within the framework of its managed care contracts with physicians. Formal acceptance of the enterprise liability principle would eliminate the need for directly involving physicians in claims stemming from these acts or omissions.
References 1. Abraham KS, Weiler PC: Enterprise medical liability and the evolution of the American health care system. Harvard Law Rev 108:381-436,1994 2. Beresford H R Neurologist as expert witness. Neurol Clin 10:1059-1071,1992 3. Canterbury v Spence, 464 Fed 2d 772 [DC Circuit 19721, cert den 93 Sup Ct 560 4. Cobbs v Grant, 502 P 2d 1 [Sup Ct CA 19721 5. Code Fed Regs 45,46:405-407, (1983) 6. Hall v Hilbun, 466 So 2d 856 [Sup Ct MS 19851 7. Moore v Regents of Univ of California, 271 CA Rptr 146,793 Pac 2d 479 (1990) 8. Richter v Northwestern Memorial Hosp, 177 I11 App 3d 247,532 NE 2d 269 (1988) 9. Siliciano J: Wealth, equity, and the Unitary Medical Malpractice Standard. Virginia Law Rev 77439-484,1991 10. Terhune v A.H. Robins Co, 90 WN 2d 9,577 Pac 2d 975 (1978) 11. Wickline v State of California, 228 CA Rptr 662 [CA App 19861, petition for review dismissed, 741 Pac 2d 613 (1987)
Address reprint requests to H. Richard Beresford, MD, JD Cornell Law School Myron Taylor Hall Ithaca. NY 14853-4901