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The radiologist and informed consent: A review, comments and proposals
THE RADIOLOGIST AND INFORMED CONSENT: A REVIEW, COMMENTS AND PROPOSALS BURTON A. JOHNSON, M.D., J.D. A. EVERETTEJAMES, JR., M.D., J.D.
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0363-0188/79/06001-19505.00 9 1979 Year Book Medical Publishers, Inc.
TABLE OF CONTENTS THE PURPOSE OF THIS DISCUSSION . . . . . . . . . . . .
ACKNOWLEDGMENTS
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practices radiology in a 13-man group with Fairfax Radiology Consultants, Inc., in Fairfax, Virginia. He received his M.D. from Howard University Medical School, completed his residency at Georgetown University, and took a two-year fellowship in pediatric radiology at Johns Hopkins. Dr. Johnson graduated from the American University School of Law in 1978 and is a member of the Maryland Bar. He has lectured on medical-legal topics at Vanderbilt, Johns Hopkins and Georgetown Universities.
is Professor and Chairman of Radiological Sciences, and Professor of Medical Administration, Vanderbilt University. His publications include over 200 manuscripts, 34 book chapters and 7 medical texts on a variety of topics including cerebrospinal fluid physiology, biomedical engineering, biological burden of medical studies and legal medicine. Dr. James was educated at the University of North Carolina, Duke, Harvard, Johns Hopkins and Vanderbilt.
T HE PURPOSE OF THIS DISCUSSION is to outline the legal responsibilities and pitfalls radiologists encounter in t hei r dut y to inform th eir patients of the risks involved in diagnostic and therapeutic procedures. There is certainly no shortage of comm en t on this topic in the medical literature. The Index Medicus has been providing those interested with more t h a n 300 references on this topic since 1972; most of t h e m have been published in the past 5 years. These articles are preponderantly fulminations against the unfairness of t he minority rule and implications representing judicial overreactions and intrusion into the practice of medicine. In this monograph we will discuss the minority 3
rule and its m a n y implications, some of which reach beyond the geographic confines of the jurisdictions where the rule is followed. More important, we will discuss the possibility t h a t the physician can lose an informed consent case in a jurisdiction where the minority rule is not followed or in the instance where neither the minority nor the majority rule have been firmly established by the courts. Physicians must be aware of the legal atmosphere in which their practice resides, for to do otherwise is inviting legal risks t h a t are not compatible with the care with which they conduct their practices. The topic of informed consent both in abstract theory and in the reality- of the practice of medicine continues to fascinate physicians, but at the same time, it also invariably invokes feelings of frustration, inadequacy, hopelessness and, at times, h o s t i l i t y . The more one analyzes the informed consent issue, the more one will be impressed t h a t much more is involved in it t h a n the outlining of risks, benefits and alternate choices to a patient concerning a proposed course of t r e a t m e n t or diagnostic procedure. The informed consent problem is a microcosm of the forces and changes which are shaping society and very definitely the medical profession. The development of the minority rule, as we shall subsequently demonstrate, has had a reasonably logical judicial progression and is a strange hybrid of the unintentional tort of negligence and the intentional tort of battery. At the same time, however, the minority rule shows the undeniable influence of welfarism, as well as t h a t of "no fault" and the "deepest pocket" theories of recoveries for injuries. There is also an emphasis on consumerism mixed with those other influences. Although medical malpractice cases based solely on an informed consent issue are relatively uncommon, it is our opinion t h a t there is a potential viable informed consent issue in most malpractice disputes. We can, therefore, expect to see more cases brought containing a charge of failure to adequately disclose as one of the plaintiff's assertions. Probably the most important and least understood factor of informed consent is t h a t it focuses the sharp differences in the frames of reference in which the physician, patient, lawyer and courts find themselves when presented with an identical set of facts. The words '~informed consent" imply a meeting of the minds between physician and patient, which is another way of saying adequate communication. Every case t h a t comes into the courtroom with an informed consent issue represents in some m a n n e r a failure of communication. Every failure of communication has its origin in the parties involved being unable and/or unwilling to appreciate and understand the frame of reference of the other. This inability to understand the basic philosophical approach of another person is based on cultural, intellectual, educational, 4
class and economic differences, and these considerations are beneath the surface of every malpractice litigation. The best defense in a n y jurisdiction against the charge of inadequate informing is, simply, to inform the patient in a calm, clear and direct manner of the benefits and risks of the anticipated procedure and then properly to document this exchange. This is as near as one can approach a complete and perfect defense in this imperfect world. This communication will define the majority and minority rule and will list the jurisdictions where the minority rule is in effect and how one may come to accommodation with implications of this interpretation. In outlining the development of the minority rule and exploring the sources of physicians' attitudes and resistance, we hope to provide the readers with not only an understanding of the problem but also a reasonable approach in reducing their liability. The majority rule is also called the ~community standard rule." As this appellation would imply, the physician must inform his patient of the risks and benefits of a particular treatment or procedure to the same extent as a physician would who is practicing in similar circumstances in the community. In jurisdictions that follow the majority rule, the plaintiff must show by expert testimony that the physician failed in that duty. Similarly, the physician defendants may offer in testimony their expert witness to establish the propriety of the physician's conduct. This standard is well known to all physicians and needs no expansive comment except to say that the "community" of physicians is for practical consideration at present nationwide. The expansion of the community of physicians is logical, in that ease of travel and communication of medical knowledge has obviated most of these community norms of practice. To illustrate this point, expert witnesses from England have been allowed to testify as to medical standards of care in Maryland. Therefore, the community standard is not so impervious a shield as physicians would believe. Additionally, there are a number of expert witnesses available on a nationwide basis to testify on medical subjects at any time. Therefore, it follows both logically and in actual fact that there is little comfort or protection in practicing in a majority rule state because the plaintiff can readily produce an expert to testify to the inadequacy of the physician's risk disclosure. The majority rule simply means that the plaintiffs must bear the expense and difficulty of finding an expert witness to support their allegations and the defendant physician may elect to do the same. In general, irrespective of the testimony of the expert witness from either side, while these witnesses are testifying the jury is observing the victim of an undisclosed risk and will seek to find compensation for that unfortunate person. Therefore, the best defense is not an expert witness of community standard, but 5
well-documented evidence of disclosure and assumption of risk by the injured party. The minority rule was first established in 1962 in a New Mexico case, Woods vs. Brumlop. The rule can be summarized by stating t h a t the physician's duty to inform is measured by what the patient needs to know in order to make a decision as to assumption of the risk. This has been termed a '~consumerist" concept. The effect of the minority rule is t h a t the patient does not need to provide expert testimony as to the standard of adequate disclosure, because the patient's need to know is the measure of the adequacy of the physician's disclosure. (One cannot help but wonder whether the minority rule places the burden on the physician of"reading patients' minds" as to their needs.) Similarly, the physician defendant in such jurisdictions is barred from bringing in expert testimony in his defense. This latter circumstance has caused much of the consternation and confusion over the minority rule in the medical community. Many physicians faced with the minority rule feel t h a t the courts have set the standard of medical performance for which the legal profession has no training or experience to do so, while, conversely, they have denied physicians the defense of standard of practice of their medical peers. Nearly all of the large volume of articles in the medical literature and the response to them in the letters columns of those various medical journals have in one form or another expressed this underlying concern. This conceptual incongruity again illustrates the basic differences in frames of reference between physicians, patients and courts. In Cobbs vs. Grant, the California Supreme Court very perceptively addressed this issue. The court simply stated the risk was the patient's, not the doctor's; the physicians' duty did not include m a k i n g the patients' decisions in their behalf. The physician's duty was discharged by diagnosing and proposing the treatment. After doing so, the physician was no longer obligated to an active role until the patient decided on accepting or refusing the t r e a t m e n t or procedure recommended: A medical doctor, being the expert, appreciates the risks inherent in the procedure he is prescribing, the risks of not to undergo the treatment, and the probability of successful outcome of treatment. But once this information has been disclosed, that aspect of the doctor's expert function has been performed. The weighing of these ~risks against the undisclosed subjective fears and hopes of the patient is not an expert skill. Such evaluation and decision is a nonmedical judgement reserved to the patient alone. A patient should be denied the opportunity to weigh the risks only where it is evident he cannot evaluate the data, as for example, where there is an emergency or the patient is a child or incompetent. 6
Most physicians would regard the court's reasoning as somewhat theoretical and simplistic, for they know by experience t h a t patients' decisions are almost never made in such a detached fashion. But the court was correct in its observation t h a t the risk was not the doctor's but the patient's to assume. Physicians in their compulsion and zeal to heal often lose sight of the basic fact t h a t the untoward results or complications of the t r e a t m e n t or diagnostic procedure fall on the patient, not the doctor. These informed consent cases and the controversy they cause m a y often be reduced to these very basic and unavoidable premises: is there risk, and if so, who will suffer as a result of its occurrence? When viewed from this frame of reference, the answer should be clear as to disclosure of risk. For patients there is the physical and emotional suffering in addition to the economic loss if the risk is realized, so they should make the decisions as to assuming the risks. The obvious exception, of course, which is recognized by all courts, is t h a t of extreme emergencies or where the patient is legally incompetent. Therefore, regardless of the rule followed by the legal jurisdiction in which one practices, is it not basically fair and moral t h a t the patient should be the one to make the decision? The corollary of t h a t is t h a t the doctor should provide adequate information about the risks involved so the patient can make an intelligent and ~informed" decision. The minority rule had a fascinating development, which should be traced in order to give the reader a better understanding of its implications and the overall problems encountered in informing patients. The late Supreme Court Justice Cardoza had a remarkable affinity for coining phrases and summarizing legal concepts in a m a n n e r t h a t facilitates our understanding and recall. While a justice of the New York Court of Appeals, he made the famous statement defining battery in regards to medical practice: "Every human being of adult years and sound mind has a right to determine what should be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable for damages." Cardoza, J. Schloendorff vs. Society of N e w York Hospital 211 N.Y. 125,103 N.E. 92 (1914) Battery is an intentional tort. That is, it is an intentional, unconsented touching (which m a y be either harmful or beneficial) of one person by another. All physicians are familiar with this concept, but the lesson to be learned is not from Cardoza's quote, but in the facts of the case t h a t provided the basis for the quotation. The appellate review is sketchy, but it seems t h a t the patient, 7
Mrs. Schloendorff, had a pelvic mass. The doctor, evidently an employee of the New York Hospital, examined her and told her he thought it was a leiomyoma (fibroid), but he wanted to examine her under anesthesia to be more complete in his study and certain of his diagnosis (this occurred in 1914; now one might request a pelvic sonogram). Mrs. Schloendorff agreed, but stipulated that, ~'nom a t t e r what you find you are not to operate on me." He performed the examination under anesthesia, confirming what he thought was a large fibroid and proceeded to do a hysterectomy! The record does not preserve his testimony, but we are willing to speculate t h a t his reasoning, which was and is typical of m a n y physicians', went as follows: "Mrs. Schloendorff has this big fibroid which needs to come out. She is unconscious now and it will be easy to do the procedure. Despite what she told me, ! am sure she will be glad t h a t it is done when she wakes up and will agree t h a t I knew what was best for her under these circumstances." Mrs. Schloendorff was not pleased and sued and won a judgement against the doctor on a battery charge. Note there was no allegation by her of fraud, deceit or improper diagnosis or treatment. She sued because her body was touched in a m a n n e r against her consent. Schloendorff is a classic example of a physician assuming to know what is best for a patient, which he m a y well have, and also assuming the patient would agree with his presumption. The essence here is not whether the physician knows best; rather, it is t h a t the patient has the choice. It is the patient's body or domain t h a t is to be ~violated." The patient bears the physical and emotional risk and thus should make this decision. Another medical case, Mohr vs. Williams from Minnesota (1905), has been used in legal texts for years to illustrate t h a t an unconsented touching, even when it is intended to benefit, not to h a r m the one touched, is still an act of battery. Mrs. Mohr gave Dr. Williams permission to do a stapedectomy on her right ear. When he examined her under anesthesia, he found her left ear to be the more severely damaged and after consulting with her family physician, who was in the room, Dr. Williams operated on the left ear. Mrs. Mohr lost hearing in the ear subsequent to surgery, a risk of which she had been warned and consented to assume on the right ear. She sued on a battery theory and won a substantial judgement. Again, as in the Schloendorff case, the p l a i n t i f did not allege incompetence or malpractice, fraud or deceit. Thus, this represents another situation where a doctor was sued for battery where he had no intent to do a n y t h i n g but benefit his patient. Once more, although the record does not tell us about the conversation between Dr. Williams and the primary care physician in the operating room after the left ear was found to be the more seriously involved, we might attempt to speculate t h a t both 8
physicians were in complete agreement as to the advisability of operating on the patient's left ear without the further delay of requesting specific consent again. Mrs. Mohr did not agree, brought suit on the charge of battery and won a judgement. The principle underlying these cases, which Mrs. Schloendortfs and Mrs. Mohr's physicians (and all of us too often) failed to grasp, to their dismay, is the basic concept t h a t was to be learned from the California Supreme Court in Cobbs 60 years later, namely, t h a t the risk was the patient's and not the doctor's to assume. Legal entanglements in any jurisdiction can be avoided if t h a t simple principle is used as the foundation of activity. The battery theory has worked well for recovery in cases such as Schloendorff and Mohr, where there was no consent to treatment. But cases appeared more frequently in which there was consent based on inadequate disclosure of risk. In such cases the courts followed the battery theory by reasoning t h a t a consent based on inadequate disclosure was no consent at all and, therefore, the touching was a battery. This theory was unwieldy and the courts did not like to apply it because it carried the stigma of socially unacceptable behavior. The courts freely admitted t h a t the physicians in virtually all such cases had acted in good faith and in what they thought were the patient's best interests. These conflicts were given some resolution by the Kansas case of Natanson vs. Kline in 1960, in which the Kansas Supreme Court stated t h a t failure to inform adequately was just another facet of medical negligence and should be treated by the courts as such. Furthermore, the standard should be established by expert testimony as in any other allegation of medical malpractice. This decision shifted failure to inform adequately from the tort of battery and into t h a t of negligence. (Interestingly, both torts in the medical malpractice situation arise out of an implied service contract. Physicians are almost always sued on a tort, but not on contract theories. There has been a growing overlap of tort and contract actions and considerations in the past 100 years.) It was not until 1968, however, t h a t the minority rule, as currently interpreted, was formulated by the New Mexico Supreme Court in Woods vs. Brumlop. The definition of the minority rule by t h a t court was clear and succinct: A physician has a duty to make a full and frank disclosure to the patient of all pertinent facts relative to the illness, treatment, surgery or therapy prescribed or recommended therefore. If a physician fails to so advise the patient, and afterwards the patient would have refused the treatment, surgery or therapy performed, the physician has committed an act of malpractice and is liable for all harmful consequences which follow proximate cause of the failure to disclose. Because of the relationship that exists between a phy-
sician and patient, expert medical testimony is not necessary to show what a reasonable medical practitioner would disclose under the same or similar circumstances in a community. Dr. Collins, a d i s t i n g u i s h e d r a d i o l o g i s t / a t t o r n e y , perceived the significance of t h e m i n o r i t y r u l e and r e p o r t e d it in Radiology long before m a n y legal scholars b e c a m e a w a r e of it. Dr. Collins' observations b e a r r e p e a t i n g : With this it becomes evident that a new type of action for malpractice is evolving. In addition to the battery that concerned Judge Cardozo and to negligence, there is a third type, failure to inform. This differs from ordinary negligence in that no question of skill, competence, or deviation from standard of medical care is involved. It differs from both in the matter of causation. In the case of battery or negligence, the act must be shown to have caused injury. It cannot be said that failure to inform caused the injury complained of. This form of malpractice is based upon the right of the patient to know the risks involved in treatment which is carried out or even recommended, and upon the duty of the physician to offer this information. The reason for consent here is not to excuse a battery but to acknowledge warning. N o t e t h a t plaintiffs m u s t show not only a lack of disclosure of risk and proof t h a t t h e i r i n j u r y was caused by the m a t e r i a l i z a t i o n of t h a t risk, b u t also t h a t t h e y would h a v e refused the procedure h a d t h e y b e e n a d e q u a t e l y informed. This existence of probable refusal is a h u r d l e t h a t all plaintiffs m u s t cross before t h e y can recover a j u d g e m e n t in a n informed consent suit. In d e t e r m i n i n g w h e t h e r the p a t i e n t would h a v e refused t h e a s s u m p t i o n of the risk, most courts use the objective test, or the " r e a s o n a b l e m a n " rule, i.e., would a r e a s o n a b l e m a n h a v e refused the procedure a f t e r b e i n g given such disclosure u n d e r similar circumstances? T h e m i n o r i t y r u l e did not gain w i d e s p r e a d application until 1972, w h e n t h e U.S. District C o u r t of Appeals in W a s h i n g t o n , D.C., in Canterbury vs. Spence and the California S u p r e m e C o u r t decision in Cobbs vs. Grant established t h e m i n o r i t y r u l e in those jurisdictions. T h e r e are now 14 jurisdictions w h e r e t h e m i n o r i t y r u l e is in effect (table). The rule was established in N e w York by Zelesnik vs. Jewish Chronic Disease Hospital, in 1975. It was, however, s t r u c k down and the m a j o r i t y r u l e was reestablished by the l e g i s l a t u r e t h a t y e a r as p a r t of a legislative response to t h e t h r e a t of a physicians' s t r i k e p r e c i p i t a t e d by t h e t h e n c u r r e n t m a l p r a c t i c e i n s u r a n c e crisis. T h e legislative r e v e r s a l of the rule in N e w York was in response to a v e r y u n i q u e j u x t a position of c i r c u m s t a n c e s at the time. However, if one p r e s e n t l y is practicing in a s t a t e w h e r e t h e m i n o r i t y rule is followed, it is probably unrealistic to a n t i c i p a t e t h a t a s i m i l a r legislative re10
JURISDICTIONS FOLLOWING THE MINORITY RULE AS OF AUGUST, 1978 California Colorado Louisiana
Cobbs vs. Grant 8 Cal. 3d 229, 502 P 2d, 1 (1972) Hamilton vs. H a r d y 549 P 2d, 1099 (1976) Percle vs. St. Paul Fire and Marine Insurance Company
Maryland New Mexico New York*
S a r d vs. Hardy 281 Md. 432 (1977) Woods vs. Brumlop 1 N.M. 221,377 P 2d, 520 (1962) Zelesnik vs. J e w i s h Chronic Disease Hospital
349 So. 2d 1289 (1977)
Ohio Oregon
Pennsylvania Rhode Island Vermont
Washington Wisconsin District of Columbia
47 Ap 2d 99, 366 N.Y.S. 2d, 163 (1975) 37 Ohio Misc. 95 308 N.E. 2d, 765 (1973) GetcheU vs. Mansfield 260 Or. 174, 489 P 2d, 953 (1971) Holland vs. Sisters o f St. Joseph Peace 522 P 2d, 208 (1974) confirmed and followed Getchell. Cooper vs. Roberts 220 Pa. Sup. 260, 286 A 2d, 647 (1971) Wilkinson vs. Vesey 295 A 2d, 676 (1972) S m a l l vs. Gifford Memorial Hospital 349 A 2d, 703 (1975) Holt vs. Nelson 523 P 2d, 211 (1974) Miller vs. Kennedy 522 P 2d, 852 (1974) Shier vs. Freedman 206 N.W. 2d, 166 (1973) Canterbury vs. Spence 464 F 2d, 772 (D.C. Circ. 1972) Congrove vs. Holmes
*The minority rule was abolished and the majority rule reestablished by the New York State Legislature in July, 1975, in response to a threatened doctors' strike over the malpractice insurance crises of that time.
sponse would be forthcoming in the present atmosphere of consumerism. The supreme courts of 10 jurisdictions have decided to continue to use the majority rule.t Three state supreme courts have had the issue presented but have not decided because it was not sufficiently framed by the case reviewed. The courts deferred commitment on establishing or refusing to establish the minority rule until an appropriate case with that issue was brought before them.$ However, the courts seem to be posturing themselves to look favorably on establishing the minority rule if presented with an appropriate case. In hearing nonconstitutional, nonfederal question cases, the federal courts are bound by the precedent of the state in which the court sits. If there is no precedent to follow as to which rule of informed consent has been established in that jurisdiction, which is the case in about one half of the states, then the federal court is free to go outside the jurisdiction for precedent. In this tArizona, Maine, Montana, Carolina, Oklahoma, Kansas, Illinois, Texas, U t a h and Virginia. SAlaska, Iowa and Massachusetts. 11
mobile society, and with many of our largest metropolitan areas actually continuing across state borders, there are m a n y malpractice cases that will be heard in federal courts because of federal jurisdiction being conferred by the diversity of citizenship of the parties. As an example, in Riedinger vs. Collburn (1973) the 6th Circuit Federal Court in Idaho followed Cobbs and applied the minority rule, but in the 8th Circuit Court in Arkansas in Pegram vs. Cisco, the majority rule was followed. As mentioned, approximately one half of the state supreme courts have not firmly decided which rule is to be followed in their jurisdiction. Consequently, in those jurisdictions, physicians bear the risk of being the party, in the precedent case in which the minority rule was first established in their jurisdiction. In analyzing the jurisdictions where this issue has been adjudicated, the chances of the rule being established are slightly better than 5 0 - 50. Thus, the best defense in any jurisdiction is a calm, clear, complete and well-documented disclosure of risk, rather than the existence or nonexistence of the majority rule. The majority and minority rules have been discussed in sufficient detail to be familiar to the reader. Also, the concept that the risk is not the doctor's but the patient's to bear should have been established. Assuming that most physicians agree at least to the concept of properly informing their patients, why is the resistance to completely informing in general and to the minority rule in particular? It is our position that, as in any complex issue involving rather sophisticated concepts, there is more than one answer. Among the most common reasons expressed by physicians for failing to inform their patients adequately of all of the risks are: (1) fear of patient refusal for a clinically necessary procedure; (2) fear of precipitating an untoward psychological or even physical reaction or diminished response to the therapy proposed; (3) frame of reference problems (i.e., "they would not understand it anyway"); (4) physician time and the logistics of providing the information; and (5) a sense of futility on the part of the physician CI will be sued anyway if there is a serious complication and it will just be my word against the patient's. The jury will render a sympathy verdict so my precautions will not protect me sufficiently to justify the effort."). The fear of refusal or of precipitating untoward reactions is more apparent than real when analyzed. Alfidi found that informing patients of the complications of radiographic special procedures did not lead to an increase of unwise refusals. Lankton et al. discovered that fully explaining an anesthetic risk to patients preoperatively did not increase the patient anxiety or refusals and even seemed to have a calming effect on some patients. They also found, however, that on interviewing the same patients after the operation, about one-half would not want to be fully informed 12
before going through subsequent surgical procedures. Lalli, however, found mild and moderate contrast reactions were increased by fully disclosing the possibility of risks to patients. One caveat might be offered here regarding studies in which the observation is an increase in minor reactions. Elaborate and overly thorough warnings of psychosomatic reactions offer no more than psychic sensitization and become self-fulfilling prophecies. It has been the experience of the first author that full disclosure made in a calm, simple and direct manner does not increase refusals or untoward reactions and, in fact, establishes a better rapport between physician and patient. To physicians, refusal by a patient means a constraint on doing what they believe is best for the patient under the circumstances. Therefore, with every good intention and in what they deem is the patient's best interest, they will often not inform for fear of refusal. This is a pitfall in which physicians continually fall with sometimes disastrous legal results, as illustrated by the Schloendorffand Mohr cases. As physicians, our frame of reference enables us to understand and sympathize with those feelings, but in laymen's minds and in their frame of reference, this attitude is interpreted as arrogance, paternalism or even the fear of losing the opportunity of income. The minority decisions in Cobbs and Canterbury discuss this problem at length and afford the physician, as do all the minority jurisdictions, the "therapeutic privilege" of withholding information if in the opinion of the physician that information would have deleterious psychological effects on the patient. This operates on the theory that the information should preclude a rational decision being made by the patient. The "therapeutic privilege," however, is not a loophole and will be very strictly defined by the courts. In general, one should not fear an unwise refusal or adverse psychological reaction from a patient who has been approached and informed in a calm, open and direct manner. In this age of consumerism it is unrealistic to believe that the courts or the public will look favorably on a physician's failure to inform because he feared unwise refusal. There is belief by physicians regarding the disclosure of risks or discussion of medical topics that "the patient would not understand it anyway." There is some truth to that assertion as we know from daily experience, and it is also, to a certain extent, documented in literature. In a long-term genetic counseling study involving 155 couples, Leonard et al. found 50% of the subjects had a good understanding of what was explained, 35% "gained something" and 25% learned very little. Epstein and Lasagne found that 8% of their patients, who were clearly told orally and in print that fatal reactions could result from the proposed procedure, did not comprehend or remember that fact. Epstein and Lasagne also discovered that the longer the form and time used in 13
explanation, the less the patient's comprehension and the less likely a forthcoming consent. All of these facts lead us to believe that the patient's frame of reference will have small likelihood of being the same as the physician's, so that we must not only communicate the information material to the patient's decision making, but also document our disclosure. The problem of futility is closely related to that of frame of reference. As stated above, patients will often fail to comprehend or remember what is explained. This probably is due more to the basic h u m a n characteristic of selective listening and denial rather than lack of education, of intelligence, or disinterest. An interesting observation of this point was made by Robinson and Marov who tested 20 patients for recall of significant points of their informed consent interviews, 4 - 1 5 months after they had had open heart surgery. These patients had received multiple, meticulous explanations of their diagnosis, proposed treatment, potential risks and benefits as well as alternative therapy. All 20 patients failed to recall accurately what had been documented at the interview. This comes as little surprise to most physicians, but it will not provide a viable defense in the courtroom to a charge of failure to inform adequately. These studies, and the intuitive knowledge we have regarding informed consent from the daily practice of medicine, indicate that courtroom examinations of adequacy of disclosure do not have a very large reality factor. Nevertheless, physicians still must in some w a y meet the duty to inform the patient and, if the disclosure is properly documented, then the patient's failure of memory in a courtroom can be successfully rebutted. In radiology we might use the patient's chart for consultation notes. These have a more personal impact and greater credibility than standard consent forms. Finally, on the topic of physician resistance, probably the most important causes of resistance to full disclosure are the logistical problems and time involved in disclosure. A number of courts have concurred with the medical community in this regard by refusing to establish the minority rule, as typified by the North Carolina Supreme Court in Butler vs. Berkley: " . . . the majority rule is more practical than the minority r u l e . . , result in too much time wasted by the doctor, and law suit consciousness would color his daily actions." Closer scrutiny of the time and logistics elements of full disclosure indicates that time is not as important as the logistics. For example, as radiologists our consent problems are focused mainly on procedures involving the injections of radiographic contrast material. Radiologists in the U.S. would not consider performing an angiogram on a patient without first having seen the patient 14
the night before, detailing the indication for as well as methods and risks of the procedure to the patient. That is standard practice because we know the~omplication rate for angiography, although low, is significantly higher t h a n for any of the other radiographic procedures we most commonly perform. We do not make proper allowance for the careful explanation of risks for m a n y of the other procedures, such as venography, arthrography, urography, cholangiography and herniography, which are done daily on a routine basis. It is understandable and obvious, with the schedule in a busy hospital or office radiologic practice, t h a t the logistics have not been adequately planned and resources have not b~en allocated to provide for this service. The complication from contrast media most feared is the idiosyncratic reaction leading to death. This is a topic difficult to approach with a patient who has not been seen before by the radiologist and is already on the radiographic table, waiting for the injection in anticipation of a "kidney x-ray."t In such cases one can be reasonably certain t h a t the referring physician did not discuss this with the patient in detail and specifically. In order to avoid alarming the patient and upsetting the departmental schedule, the radiologist will usually not broach the subject, even though the fear of a fatal response lurks in the back of his mind. The radiologist m a y elect to continue through the examination in hopes t h a t the 1 in 40,000-100,000 chance of death will not arrive on his doorstep t h a t day. Although those odds are good for the doctor and the patient, virtually every radiologist will have undergone sometime in his career the experience of a very serious or fatal reaction to contrast material. When this occurs, if the patient was uninformed of t h a t contingency, the radiologist is always at a disadvantage trying to explain why he failed to inform about this very significant risk. A simple, frank explanation of the risks of a procedure in a brochure for the patient to read and a consent form will tend to allay patients' fears and will often provide a good legal defense in case of a suit. We realize this is counter to the recommendation by the American College of Radiology (ACR) concerning informing patients of fatal reactions to contrast material for ordinary procedures, but in the legal atmosphere in which we find ourselves practicing, it would be legally unwise not to inform the patient. We would submit t h a t our efforts should be how to go about informing patients in the most compassionate and efficient manner, not how to create ingenious excuses to absolve us of our duty to inform properly. An interesting response to the informed consent problem has tSimilar logistics problems are created by patients who, 30 secondsbeforethe scheduledexamination,demandfull disclosuresof all the possible harmful effects ofradiographicexposure. 15
been formulated by the state legislature in Texas. This has resulted in the creation of the Texas Medical Disclosure Panel, as reported in the ACR News, June, 1979. The panel consists of 6 physicians and 3 attorneys who have drawn up an ~'A" list for which physicians must disclose all specific risks, and a ~'B" list of procedures that do not require disclosure. The theory is that for any procedure on the '~B" list the physician does not have a legal responsibility to inform the patient of associated risks. There has been favorable response to this proposal both from the medical and the legal professions, but initially this seems a rather incomplete and simplistic, although unique, plan. This measure may give physicians a false sense of security concerning informed consent. It is our opinion that we do not need panels or another layer of bureaucracy to inform patients of the risks they will undergo in the physician's hands. Physicians need to create a mechanism for basic communication with patients and the best way to attain that is a simple, open and calm disclosure of the risks, by the physician, which is appropriately documented. It is recognized that this is a difficult problem, but it may be alleviated by organization of time and personnel. The most obvious question created by this type of discussion is what to tell our patients in order to disclose the risks adequately and how to tell them. How can we meet our moral and legal obligations of disclosure without undue expenditure of time? We cannot give specific legal advice, but we can provide opinions and proposals on this topic. First, as mentioned previously, even the minority rule courts will not impose the burden of disclosing every possible but improbable risk to a patient. The courts have repeatedly stated, following Cobbs, that physicians do not have to conduct ~'minicourses in science," nor do most patients expect or want that. Furthermore, if the patient states that he/she does not want to hear any more about the risks and complications, then the doctor has no duty to press forward with them. In the recent Maryland case of Sard vs. Hardy, the Court of Appeals (Maryland's Supreme Court), sensing physicians' confusion as to how much to tell their patients, gave an outline that is basically no more than ordinary common sense. The court said a physician's duty to disclose includes telling the patient the nature of his ailment, the nature of proposed treatment or diagnostic procedure, the probability of success and the alternative choices as well as the risks of unfortunate consequences. This hardly comes across as excessive judicial interference in the practice of medicine, but, in fact, succinctly states what every physician should know and practice as his duty of disclosure. Alfidi, Meany and Lalli have given us an even simpler but legally sound formula for disclosure, especially for diagnostic radiologists: 16
~ . . . information on common complications and mortality must be given to the patient to provide the basis for truly informed consent." If their advice is followed and the disclosure is properly documented, then the radiologist m a y rest assured that he has satisfied his professional and legal duty to inform. This assertion' is supported by Rubsamen's collection of jury verdicts in California cases during the first 4 years after the Cobbs decision. The California juries, who have not distinguished themselves heretofore for their pro-doctor stance, showed a pattern of demanding thorough disclosure on elective procedures where there is a reasonable alternative treatment (or diagnostic procedure) proposed. In instances where treatment (or diagnostic procedure) was essential the juries tolerated lesser disclosure. Again, similar to the Maryland Court of Appeals in S a r d vs. H a r d y , the juries showed a rather commonsensical attitude. After establishing what to tell the patient, the next step is how to accomplish the disclosure gracefully and with a minimum of time and discomfort to both physicians and their patients. We propose that at the time of scheduling an examination of any type involving injection of contrast material, the patient be provided with a disclosure brochure that outlines the reason for and methods of the procedure. It should also state clearly that there is a small risk of death. If the statistics of that risk, which in this particular instance are approximately 1 in 40,000100,000, are also disclosed in the brochure, then that risk is put into proper perspective and will not serve to unduly alarm the patient. In addition to the explanation of the procedure, the brochure should also include a statement that if anything in the brochure is unclear to the patient, the radiologist will discuss it with him. Finally, patients should sign a simple and witnessed form stating that they have read and understood the brochure and knowingly assume the risks involved. For inpatients, an identical procedure could be used except that the information and consent form would probably be distributed by the nursing staff and signed in the patient hospital area. Radiologists should be warned that generalized consent or authorization forms that are commonly used in patient care (often referred to in legal jargon as ~'boiler plate"), which give wide authorization, have very little legal validity. In some instances, they appear to attempt to contract away liability and absolve the health care personnel. The form used should contain the specific information in appropriate detail for the examination proposed. Again, appropriate detail does not impose the burden of conducting '~minicourses in medicine" or outlining extremely remote or speculative risks. Regarding inpatients (especially minors or patients mentally incompe17
tent or anyone bearing a legal infirmity that precludes giving consent), physicians should not assume that, just because a patient is in the hospital and his/her doctor has ordered a diagnostic procedure, automatically there exists the patient's implied consent. Under many state laws, there is no implied consent or presumption of consent. Rather than depend on a priori consideration of implied consent, the radiologist should ascertain that actual consent has been given before the procedure. If these guidelines are followed, we believe that radiologists will have satisfied their moral and legal obligations and thereby have a good defense against an informed consent charge. Of equal importance, the patient's mind will be put at ease and the doctorpatient relationship will be enhanced and not diminished by the disclosure. Implied in this statement is the caveat that this conduct will not insure against the institution of a lawsuit. However, it will diminish the chances because of positive patient attitudes and will provide an excellent defense should a lawsuit be initiated. In this age of consumerism, public initiatives and media exposure regarding the virtues and shortcomings of the medical profession, we must strive for better communication and relationship with our patients. Even though some m a y regard the informing of patients secondary to their proper care and as no more than an elaborate form of courtesy, in order to have a legally viable defense, we must inform and document that we have done so. In summary, the physician's duty to inform has been described and discussed. The minority and majority rule have also been defined and analyzed along with the major causes of physician failure and resistance to disclose risks. In a proper physician-patient relationship, informed consent controversy should be rare. A calm, clear, direct and properly documented disclosure of risks of a procedure is the best defense in any jurisdiction.
ACKNOWLEDGMENTS We wish to thank our professors and colleagues at the Vanderbilt School of Law and the School of Law at the American University for their inspiration and knowledge and for allowing us to use their facilities. Ms. Betty Burnside was especially helpful in preparing the drafts and manuscript. We also wish to acknowledge the excellent manuscript preparation by Ms. Pam Kerns, who, as usual, worked both cheerfully and indefatigably. Finally, our medical and legal collaborators have offered us many insights that have added immeasurably to this communication.
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BIBLIOGRAPHY Alfidi, R.: Informed consent and special procedures, Cleve. Clin. Q. 40:21, 1973. Alfidi, R.: Controversy, alternatives and decisions in complying with the legal doctrine of informed consent, Radiology 114:231, 1975. Alfidi, R., Meany, T., and Lalli, A.: Complications and Legal Implications of Radiological Special Procedures (St. Louis: C. V. Mosby Co., 1973). Allen, R. W.: Informed consent: a medical decision, Radiology 119:233, 1976. Canterbury vs. Spence, 464 F 2d, 772 (D.C. Circ. 1972). Cobbs vs. Grant, 8 CAL 3d 229, 502 P 2d, 1 (1972). Collins, V.: Consent to radiologic examinations, Radiology 91:90, 1968. Gillmore, G.: The Death of Contract (Columbus, Ohio: Ohio State University Press, 1974). Lankten, J., Batchelder, B., and Ominsky, A.: Emotional responses to detailed risk disclosure for anesthesia: perspective, randomized study, Anesthesiology 46:294, 1977. Meisel, A.: The expansion of liability for medical accidents: from negligence to strict liability by way of informed consent, Nebraska Law Review 56:124, 1977. Mohr vs. Williams, 95 Minn. 261, 104 N.W., 12 (1905). Natanson vs. Kline, 187 KAN 186, 354 P 2d, 670 (1960). Pegram vs. Cisco, 406 F 2d, 778 (1976). Riedinger vs. Collburn, 361 F Supp., 1073 (1973). Rubsamen, D.: Professional Liability Newsletter 7:12, 1976. Salgo vs. Leland Stanford Jr. University Board of Trustees, 317 P 2d, 181 (1968). Sard vs. Hardy, 281 Md. 432 (1977). Schloendorffvs. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). Woods vs. Brumlop, 1 N.M. 221,377 P 2d, 520 (1962).
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A N o t e f r o m the E d i t o r and P u b l i s h e r We wish to assure you that you will receive the issues you are entitled to through your subscription to CURRENT PROBLEMS IN DIAGNOSTIC RADIOLOGY. Several problems have caused delays in publishing issues on schedule, but we hope to solve those problems soon. Your patience is appreciated.
0363-0188/79/06001-19505.00 9 1979 Year Book Medical Publishers, Inc.
TABLE OF CONTENTS THE PURPOSE OF THIS DISCUSSION . . . . . . . . . . . .
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practices radiology in a 13-man group with Fairfax Radiology Consultants, Inc., in Fairfax, Virginia. He received his M.D. from Howard University Medical School, completed his residency at Georgetown University, and took a two-year fellowship in pediatric radiology at Johns Hopkins. Dr. Johnson graduated from the American University School of Law in 1978 and is a member of the Maryland Bar. He has lectured on medical-legal topics at Vanderbilt, Johns Hopkins and Georgetown Universities.
is Professor and Chairman of Radiological Sciences, and Professor of Medical Administration, Vanderbilt University. His publications include over 200 manuscripts, 34 book chapters and 7 medical texts on a variety of topics including cerebrospinal fluid physiology, biomedical engineering, biological burden of medical studies and legal medicine. Dr. James was educated at the University of North Carolina, Duke, Harvard, Johns Hopkins and Vanderbilt.
T HE PURPOSE OF THIS DISCUSSION is to outline the legal responsibilities and pitfalls radiologists encounter in t hei r dut y to inform th eir patients of the risks involved in diagnostic and therapeutic procedures. There is certainly no shortage of comm en t on this topic in the medical literature. The Index Medicus has been providing those interested with more t h a n 300 references on this topic since 1972; most of t h e m have been published in the past 5 years. These articles are preponderantly fulminations against the unfairness of t he minority rule and implications representing judicial overreactions and intrusion into the practice of medicine. In this monograph we will discuss the minority 3
rule and its m a n y implications, some of which reach beyond the geographic confines of the jurisdictions where the rule is followed. More important, we will discuss the possibility t h a t the physician can lose an informed consent case in a jurisdiction where the minority rule is not followed or in the instance where neither the minority nor the majority rule have been firmly established by the courts. Physicians must be aware of the legal atmosphere in which their practice resides, for to do otherwise is inviting legal risks t h a t are not compatible with the care with which they conduct their practices. The topic of informed consent both in abstract theory and in the reality- of the practice of medicine continues to fascinate physicians, but at the same time, it also invariably invokes feelings of frustration, inadequacy, hopelessness and, at times, h o s t i l i t y . The more one analyzes the informed consent issue, the more one will be impressed t h a t much more is involved in it t h a n the outlining of risks, benefits and alternate choices to a patient concerning a proposed course of t r e a t m e n t or diagnostic procedure. The informed consent problem is a microcosm of the forces and changes which are shaping society and very definitely the medical profession. The development of the minority rule, as we shall subsequently demonstrate, has had a reasonably logical judicial progression and is a strange hybrid of the unintentional tort of negligence and the intentional tort of battery. At the same time, however, the minority rule shows the undeniable influence of welfarism, as well as t h a t of "no fault" and the "deepest pocket" theories of recoveries for injuries. There is also an emphasis on consumerism mixed with those other influences. Although medical malpractice cases based solely on an informed consent issue are relatively uncommon, it is our opinion t h a t there is a potential viable informed consent issue in most malpractice disputes. We can, therefore, expect to see more cases brought containing a charge of failure to adequately disclose as one of the plaintiff's assertions. Probably the most important and least understood factor of informed consent is t h a t it focuses the sharp differences in the frames of reference in which the physician, patient, lawyer and courts find themselves when presented with an identical set of facts. The words '~informed consent" imply a meeting of the minds between physician and patient, which is another way of saying adequate communication. Every case t h a t comes into the courtroom with an informed consent issue represents in some m a n n e r a failure of communication. Every failure of communication has its origin in the parties involved being unable and/or unwilling to appreciate and understand the frame of reference of the other. This inability to understand the basic philosophical approach of another person is based on cultural, intellectual, educational, 4
class and economic differences, and these considerations are beneath the surface of every malpractice litigation. The best defense in a n y jurisdiction against the charge of inadequate informing is, simply, to inform the patient in a calm, clear and direct manner of the benefits and risks of the anticipated procedure and then properly to document this exchange. This is as near as one can approach a complete and perfect defense in this imperfect world. This communication will define the majority and minority rule and will list the jurisdictions where the minority rule is in effect and how one may come to accommodation with implications of this interpretation. In outlining the development of the minority rule and exploring the sources of physicians' attitudes and resistance, we hope to provide the readers with not only an understanding of the problem but also a reasonable approach in reducing their liability. The majority rule is also called the ~community standard rule." As this appellation would imply, the physician must inform his patient of the risks and benefits of a particular treatment or procedure to the same extent as a physician would who is practicing in similar circumstances in the community. In jurisdictions that follow the majority rule, the plaintiff must show by expert testimony that the physician failed in that duty. Similarly, the physician defendants may offer in testimony their expert witness to establish the propriety of the physician's conduct. This standard is well known to all physicians and needs no expansive comment except to say that the "community" of physicians is for practical consideration at present nationwide. The expansion of the community of physicians is logical, in that ease of travel and communication of medical knowledge has obviated most of these community norms of practice. To illustrate this point, expert witnesses from England have been allowed to testify as to medical standards of care in Maryland. Therefore, the community standard is not so impervious a shield as physicians would believe. Additionally, there are a number of expert witnesses available on a nationwide basis to testify on medical subjects at any time. Therefore, it follows both logically and in actual fact that there is little comfort or protection in practicing in a majority rule state because the plaintiff can readily produce an expert to testify to the inadequacy of the physician's risk disclosure. The majority rule simply means that the plaintiffs must bear the expense and difficulty of finding an expert witness to support their allegations and the defendant physician may elect to do the same. In general, irrespective of the testimony of the expert witness from either side, while these witnesses are testifying the jury is observing the victim of an undisclosed risk and will seek to find compensation for that unfortunate person. Therefore, the best defense is not an expert witness of community standard, but 5
well-documented evidence of disclosure and assumption of risk by the injured party. The minority rule was first established in 1962 in a New Mexico case, Woods vs. Brumlop. The rule can be summarized by stating t h a t the physician's duty to inform is measured by what the patient needs to know in order to make a decision as to assumption of the risk. This has been termed a '~consumerist" concept. The effect of the minority rule is t h a t the patient does not need to provide expert testimony as to the standard of adequate disclosure, because the patient's need to know is the measure of the adequacy of the physician's disclosure. (One cannot help but wonder whether the minority rule places the burden on the physician of"reading patients' minds" as to their needs.) Similarly, the physician defendant in such jurisdictions is barred from bringing in expert testimony in his defense. This latter circumstance has caused much of the consternation and confusion over the minority rule in the medical community. Many physicians faced with the minority rule feel t h a t the courts have set the standard of medical performance for which the legal profession has no training or experience to do so, while, conversely, they have denied physicians the defense of standard of practice of their medical peers. Nearly all of the large volume of articles in the medical literature and the response to them in the letters columns of those various medical journals have in one form or another expressed this underlying concern. This conceptual incongruity again illustrates the basic differences in frames of reference between physicians, patients and courts. In Cobbs vs. Grant, the California Supreme Court very perceptively addressed this issue. The court simply stated the risk was the patient's, not the doctor's; the physicians' duty did not include m a k i n g the patients' decisions in their behalf. The physician's duty was discharged by diagnosing and proposing the treatment. After doing so, the physician was no longer obligated to an active role until the patient decided on accepting or refusing the t r e a t m e n t or procedure recommended: A medical doctor, being the expert, appreciates the risks inherent in the procedure he is prescribing, the risks of not to undergo the treatment, and the probability of successful outcome of treatment. But once this information has been disclosed, that aspect of the doctor's expert function has been performed. The weighing of these ~risks against the undisclosed subjective fears and hopes of the patient is not an expert skill. Such evaluation and decision is a nonmedical judgement reserved to the patient alone. A patient should be denied the opportunity to weigh the risks only where it is evident he cannot evaluate the data, as for example, where there is an emergency or the patient is a child or incompetent. 6
Most physicians would regard the court's reasoning as somewhat theoretical and simplistic, for they know by experience t h a t patients' decisions are almost never made in such a detached fashion. But the court was correct in its observation t h a t the risk was not the doctor's but the patient's to assume. Physicians in their compulsion and zeal to heal often lose sight of the basic fact t h a t the untoward results or complications of the t r e a t m e n t or diagnostic procedure fall on the patient, not the doctor. These informed consent cases and the controversy they cause m a y often be reduced to these very basic and unavoidable premises: is there risk, and if so, who will suffer as a result of its occurrence? When viewed from this frame of reference, the answer should be clear as to disclosure of risk. For patients there is the physical and emotional suffering in addition to the economic loss if the risk is realized, so they should make the decisions as to assuming the risks. The obvious exception, of course, which is recognized by all courts, is t h a t of extreme emergencies or where the patient is legally incompetent. Therefore, regardless of the rule followed by the legal jurisdiction in which one practices, is it not basically fair and moral t h a t the patient should be the one to make the decision? The corollary of t h a t is t h a t the doctor should provide adequate information about the risks involved so the patient can make an intelligent and ~informed" decision. The minority rule had a fascinating development, which should be traced in order to give the reader a better understanding of its implications and the overall problems encountered in informing patients. The late Supreme Court Justice Cardoza had a remarkable affinity for coining phrases and summarizing legal concepts in a m a n n e r t h a t facilitates our understanding and recall. While a justice of the New York Court of Appeals, he made the famous statement defining battery in regards to medical practice: "Every human being of adult years and sound mind has a right to determine what should be done with his own body; and a surgeon who performs an operation without his patient's consent commits an assault, for which he is liable for damages." Cardoza, J. Schloendorff vs. Society of N e w York Hospital 211 N.Y. 125,103 N.E. 92 (1914) Battery is an intentional tort. That is, it is an intentional, unconsented touching (which m a y be either harmful or beneficial) of one person by another. All physicians are familiar with this concept, but the lesson to be learned is not from Cardoza's quote, but in the facts of the case t h a t provided the basis for the quotation. The appellate review is sketchy, but it seems t h a t the patient, 7
Mrs. Schloendorff, had a pelvic mass. The doctor, evidently an employee of the New York Hospital, examined her and told her he thought it was a leiomyoma (fibroid), but he wanted to examine her under anesthesia to be more complete in his study and certain of his diagnosis (this occurred in 1914; now one might request a pelvic sonogram). Mrs. Schloendorff agreed, but stipulated that, ~'nom a t t e r what you find you are not to operate on me." He performed the examination under anesthesia, confirming what he thought was a large fibroid and proceeded to do a hysterectomy! The record does not preserve his testimony, but we are willing to speculate t h a t his reasoning, which was and is typical of m a n y physicians', went as follows: "Mrs. Schloendorff has this big fibroid which needs to come out. She is unconscious now and it will be easy to do the procedure. Despite what she told me, ! am sure she will be glad t h a t it is done when she wakes up and will agree t h a t I knew what was best for her under these circumstances." Mrs. Schloendorff was not pleased and sued and won a judgement against the doctor on a battery charge. Note there was no allegation by her of fraud, deceit or improper diagnosis or treatment. She sued because her body was touched in a m a n n e r against her consent. Schloendorff is a classic example of a physician assuming to know what is best for a patient, which he m a y well have, and also assuming the patient would agree with his presumption. The essence here is not whether the physician knows best; rather, it is t h a t the patient has the choice. It is the patient's body or domain t h a t is to be ~violated." The patient bears the physical and emotional risk and thus should make this decision. Another medical case, Mohr vs. Williams from Minnesota (1905), has been used in legal texts for years to illustrate t h a t an unconsented touching, even when it is intended to benefit, not to h a r m the one touched, is still an act of battery. Mrs. Mohr gave Dr. Williams permission to do a stapedectomy on her right ear. When he examined her under anesthesia, he found her left ear to be the more severely damaged and after consulting with her family physician, who was in the room, Dr. Williams operated on the left ear. Mrs. Mohr lost hearing in the ear subsequent to surgery, a risk of which she had been warned and consented to assume on the right ear. She sued on a battery theory and won a substantial judgement. Again, as in the Schloendorff case, the p l a i n t i f did not allege incompetence or malpractice, fraud or deceit. Thus, this represents another situation where a doctor was sued for battery where he had no intent to do a n y t h i n g but benefit his patient. Once more, although the record does not tell us about the conversation between Dr. Williams and the primary care physician in the operating room after the left ear was found to be the more seriously involved, we might attempt to speculate t h a t both 8
physicians were in complete agreement as to the advisability of operating on the patient's left ear without the further delay of requesting specific consent again. Mrs. Mohr did not agree, brought suit on the charge of battery and won a judgement. The principle underlying these cases, which Mrs. Schloendortfs and Mrs. Mohr's physicians (and all of us too often) failed to grasp, to their dismay, is the basic concept t h a t was to be learned from the California Supreme Court in Cobbs 60 years later, namely, t h a t the risk was the patient's and not the doctor's to assume. Legal entanglements in any jurisdiction can be avoided if t h a t simple principle is used as the foundation of activity. The battery theory has worked well for recovery in cases such as Schloendorff and Mohr, where there was no consent to treatment. But cases appeared more frequently in which there was consent based on inadequate disclosure of risk. In such cases the courts followed the battery theory by reasoning t h a t a consent based on inadequate disclosure was no consent at all and, therefore, the touching was a battery. This theory was unwieldy and the courts did not like to apply it because it carried the stigma of socially unacceptable behavior. The courts freely admitted t h a t the physicians in virtually all such cases had acted in good faith and in what they thought were the patient's best interests. These conflicts were given some resolution by the Kansas case of Natanson vs. Kline in 1960, in which the Kansas Supreme Court stated t h a t failure to inform adequately was just another facet of medical negligence and should be treated by the courts as such. Furthermore, the standard should be established by expert testimony as in any other allegation of medical malpractice. This decision shifted failure to inform adequately from the tort of battery and into t h a t of negligence. (Interestingly, both torts in the medical malpractice situation arise out of an implied service contract. Physicians are almost always sued on a tort, but not on contract theories. There has been a growing overlap of tort and contract actions and considerations in the past 100 years.) It was not until 1968, however, t h a t the minority rule, as currently interpreted, was formulated by the New Mexico Supreme Court in Woods vs. Brumlop. The definition of the minority rule by t h a t court was clear and succinct: A physician has a duty to make a full and frank disclosure to the patient of all pertinent facts relative to the illness, treatment, surgery or therapy prescribed or recommended therefore. If a physician fails to so advise the patient, and afterwards the patient would have refused the treatment, surgery or therapy performed, the physician has committed an act of malpractice and is liable for all harmful consequences which follow proximate cause of the failure to disclose. Because of the relationship that exists between a phy-
sician and patient, expert medical testimony is not necessary to show what a reasonable medical practitioner would disclose under the same or similar circumstances in a community. Dr. Collins, a d i s t i n g u i s h e d r a d i o l o g i s t / a t t o r n e y , perceived the significance of t h e m i n o r i t y r u l e and r e p o r t e d it in Radiology long before m a n y legal scholars b e c a m e a w a r e of it. Dr. Collins' observations b e a r r e p e a t i n g : With this it becomes evident that a new type of action for malpractice is evolving. In addition to the battery that concerned Judge Cardozo and to negligence, there is a third type, failure to inform. This differs from ordinary negligence in that no question of skill, competence, or deviation from standard of medical care is involved. It differs from both in the matter of causation. In the case of battery or negligence, the act must be shown to have caused injury. It cannot be said that failure to inform caused the injury complained of. This form of malpractice is based upon the right of the patient to know the risks involved in treatment which is carried out or even recommended, and upon the duty of the physician to offer this information. The reason for consent here is not to excuse a battery but to acknowledge warning. N o t e t h a t plaintiffs m u s t show not only a lack of disclosure of risk and proof t h a t t h e i r i n j u r y was caused by the m a t e r i a l i z a t i o n of t h a t risk, b u t also t h a t t h e y would h a v e refused the procedure h a d t h e y b e e n a d e q u a t e l y informed. This existence of probable refusal is a h u r d l e t h a t all plaintiffs m u s t cross before t h e y can recover a j u d g e m e n t in a n informed consent suit. In d e t e r m i n i n g w h e t h e r the p a t i e n t would h a v e refused t h e a s s u m p t i o n of the risk, most courts use the objective test, or the " r e a s o n a b l e m a n " rule, i.e., would a r e a s o n a b l e m a n h a v e refused the procedure a f t e r b e i n g given such disclosure u n d e r similar circumstances? T h e m i n o r i t y r u l e did not gain w i d e s p r e a d application until 1972, w h e n t h e U.S. District C o u r t of Appeals in W a s h i n g t o n , D.C., in Canterbury vs. Spence and the California S u p r e m e C o u r t decision in Cobbs vs. Grant established t h e m i n o r i t y r u l e in those jurisdictions. T h e r e are now 14 jurisdictions w h e r e t h e m i n o r i t y r u l e is in effect (table). The rule was established in N e w York by Zelesnik vs. Jewish Chronic Disease Hospital, in 1975. It was, however, s t r u c k down and the m a j o r i t y r u l e was reestablished by the l e g i s l a t u r e t h a t y e a r as p a r t of a legislative response to t h e t h r e a t of a physicians' s t r i k e p r e c i p i t a t e d by t h e t h e n c u r r e n t m a l p r a c t i c e i n s u r a n c e crisis. T h e legislative r e v e r s a l of the rule in N e w York was in response to a v e r y u n i q u e j u x t a position of c i r c u m s t a n c e s at the time. However, if one p r e s e n t l y is practicing in a s t a t e w h e r e t h e m i n o r i t y rule is followed, it is probably unrealistic to a n t i c i p a t e t h a t a s i m i l a r legislative re10
JURISDICTIONS FOLLOWING THE MINORITY RULE AS OF AUGUST, 1978 California Colorado Louisiana
Cobbs vs. Grant 8 Cal. 3d 229, 502 P 2d, 1 (1972) Hamilton vs. H a r d y 549 P 2d, 1099 (1976) Percle vs. St. Paul Fire and Marine Insurance Company
Maryland New Mexico New York*
S a r d vs. Hardy 281 Md. 432 (1977) Woods vs. Brumlop 1 N.M. 221,377 P 2d, 520 (1962) Zelesnik vs. J e w i s h Chronic Disease Hospital
349 So. 2d 1289 (1977)
Ohio Oregon
Pennsylvania Rhode Island Vermont
Washington Wisconsin District of Columbia
47 Ap 2d 99, 366 N.Y.S. 2d, 163 (1975) 37 Ohio Misc. 95 308 N.E. 2d, 765 (1973) GetcheU vs. Mansfield 260 Or. 174, 489 P 2d, 953 (1971) Holland vs. Sisters o f St. Joseph Peace 522 P 2d, 208 (1974) confirmed and followed Getchell. Cooper vs. Roberts 220 Pa. Sup. 260, 286 A 2d, 647 (1971) Wilkinson vs. Vesey 295 A 2d, 676 (1972) S m a l l vs. Gifford Memorial Hospital 349 A 2d, 703 (1975) Holt vs. Nelson 523 P 2d, 211 (1974) Miller vs. Kennedy 522 P 2d, 852 (1974) Shier vs. Freedman 206 N.W. 2d, 166 (1973) Canterbury vs. Spence 464 F 2d, 772 (D.C. Circ. 1972) Congrove vs. Holmes
*The minority rule was abolished and the majority rule reestablished by the New York State Legislature in July, 1975, in response to a threatened doctors' strike over the malpractice insurance crises of that time.
sponse would be forthcoming in the present atmosphere of consumerism. The supreme courts of 10 jurisdictions have decided to continue to use the majority rule.t Three state supreme courts have had the issue presented but have not decided because it was not sufficiently framed by the case reviewed. The courts deferred commitment on establishing or refusing to establish the minority rule until an appropriate case with that issue was brought before them.$ However, the courts seem to be posturing themselves to look favorably on establishing the minority rule if presented with an appropriate case. In hearing nonconstitutional, nonfederal question cases, the federal courts are bound by the precedent of the state in which the court sits. If there is no precedent to follow as to which rule of informed consent has been established in that jurisdiction, which is the case in about one half of the states, then the federal court is free to go outside the jurisdiction for precedent. In this tArizona, Maine, Montana, Carolina, Oklahoma, Kansas, Illinois, Texas, U t a h and Virginia. SAlaska, Iowa and Massachusetts. 11
mobile society, and with many of our largest metropolitan areas actually continuing across state borders, there are m a n y malpractice cases that will be heard in federal courts because of federal jurisdiction being conferred by the diversity of citizenship of the parties. As an example, in Riedinger vs. Collburn (1973) the 6th Circuit Federal Court in Idaho followed Cobbs and applied the minority rule, but in the 8th Circuit Court in Arkansas in Pegram vs. Cisco, the majority rule was followed. As mentioned, approximately one half of the state supreme courts have not firmly decided which rule is to be followed in their jurisdiction. Consequently, in those jurisdictions, physicians bear the risk of being the party, in the precedent case in which the minority rule was first established in their jurisdiction. In analyzing the jurisdictions where this issue has been adjudicated, the chances of the rule being established are slightly better than 5 0 - 50. Thus, the best defense in any jurisdiction is a calm, clear, complete and well-documented disclosure of risk, rather than the existence or nonexistence of the majority rule. The majority and minority rules have been discussed in sufficient detail to be familiar to the reader. Also, the concept that the risk is not the doctor's but the patient's to bear should have been established. Assuming that most physicians agree at least to the concept of properly informing their patients, why is the resistance to completely informing in general and to the minority rule in particular? It is our position that, as in any complex issue involving rather sophisticated concepts, there is more than one answer. Among the most common reasons expressed by physicians for failing to inform their patients adequately of all of the risks are: (1) fear of patient refusal for a clinically necessary procedure; (2) fear of precipitating an untoward psychological or even physical reaction or diminished response to the therapy proposed; (3) frame of reference problems (i.e., "they would not understand it anyway"); (4) physician time and the logistics of providing the information; and (5) a sense of futility on the part of the physician CI will be sued anyway if there is a serious complication and it will just be my word against the patient's. The jury will render a sympathy verdict so my precautions will not protect me sufficiently to justify the effort."). The fear of refusal or of precipitating untoward reactions is more apparent than real when analyzed. Alfidi found that informing patients of the complications of radiographic special procedures did not lead to an increase of unwise refusals. Lankton et al. discovered that fully explaining an anesthetic risk to patients preoperatively did not increase the patient anxiety or refusals and even seemed to have a calming effect on some patients. They also found, however, that on interviewing the same patients after the operation, about one-half would not want to be fully informed 12
before going through subsequent surgical procedures. Lalli, however, found mild and moderate contrast reactions were increased by fully disclosing the possibility of risks to patients. One caveat might be offered here regarding studies in which the observation is an increase in minor reactions. Elaborate and overly thorough warnings of psychosomatic reactions offer no more than psychic sensitization and become self-fulfilling prophecies. It has been the experience of the first author that full disclosure made in a calm, simple and direct manner does not increase refusals or untoward reactions and, in fact, establishes a better rapport between physician and patient. To physicians, refusal by a patient means a constraint on doing what they believe is best for the patient under the circumstances. Therefore, with every good intention and in what they deem is the patient's best interest, they will often not inform for fear of refusal. This is a pitfall in which physicians continually fall with sometimes disastrous legal results, as illustrated by the Schloendorffand Mohr cases. As physicians, our frame of reference enables us to understand and sympathize with those feelings, but in laymen's minds and in their frame of reference, this attitude is interpreted as arrogance, paternalism or even the fear of losing the opportunity of income. The minority decisions in Cobbs and Canterbury discuss this problem at length and afford the physician, as do all the minority jurisdictions, the "therapeutic privilege" of withholding information if in the opinion of the physician that information would have deleterious psychological effects on the patient. This operates on the theory that the information should preclude a rational decision being made by the patient. The "therapeutic privilege," however, is not a loophole and will be very strictly defined by the courts. In general, one should not fear an unwise refusal or adverse psychological reaction from a patient who has been approached and informed in a calm, open and direct manner. In this age of consumerism it is unrealistic to believe that the courts or the public will look favorably on a physician's failure to inform because he feared unwise refusal. There is belief by physicians regarding the disclosure of risks or discussion of medical topics that "the patient would not understand it anyway." There is some truth to that assertion as we know from daily experience, and it is also, to a certain extent, documented in literature. In a long-term genetic counseling study involving 155 couples, Leonard et al. found 50% of the subjects had a good understanding of what was explained, 35% "gained something" and 25% learned very little. Epstein and Lasagne found that 8% of their patients, who were clearly told orally and in print that fatal reactions could result from the proposed procedure, did not comprehend or remember that fact. Epstein and Lasagne also discovered that the longer the form and time used in 13
explanation, the less the patient's comprehension and the less likely a forthcoming consent. All of these facts lead us to believe that the patient's frame of reference will have small likelihood of being the same as the physician's, so that we must not only communicate the information material to the patient's decision making, but also document our disclosure. The problem of futility is closely related to that of frame of reference. As stated above, patients will often fail to comprehend or remember what is explained. This probably is due more to the basic h u m a n characteristic of selective listening and denial rather than lack of education, of intelligence, or disinterest. An interesting observation of this point was made by Robinson and Marov who tested 20 patients for recall of significant points of their informed consent interviews, 4 - 1 5 months after they had had open heart surgery. These patients had received multiple, meticulous explanations of their diagnosis, proposed treatment, potential risks and benefits as well as alternative therapy. All 20 patients failed to recall accurately what had been documented at the interview. This comes as little surprise to most physicians, but it will not provide a viable defense in the courtroom to a charge of failure to inform adequately. These studies, and the intuitive knowledge we have regarding informed consent from the daily practice of medicine, indicate that courtroom examinations of adequacy of disclosure do not have a very large reality factor. Nevertheless, physicians still must in some w a y meet the duty to inform the patient and, if the disclosure is properly documented, then the patient's failure of memory in a courtroom can be successfully rebutted. In radiology we might use the patient's chart for consultation notes. These have a more personal impact and greater credibility than standard consent forms. Finally, on the topic of physician resistance, probably the most important causes of resistance to full disclosure are the logistical problems and time involved in disclosure. A number of courts have concurred with the medical community in this regard by refusing to establish the minority rule, as typified by the North Carolina Supreme Court in Butler vs. Berkley: " . . . the majority rule is more practical than the minority r u l e . . , result in too much time wasted by the doctor, and law suit consciousness would color his daily actions." Closer scrutiny of the time and logistics elements of full disclosure indicates that time is not as important as the logistics. For example, as radiologists our consent problems are focused mainly on procedures involving the injections of radiographic contrast material. Radiologists in the U.S. would not consider performing an angiogram on a patient without first having seen the patient 14
the night before, detailing the indication for as well as methods and risks of the procedure to the patient. That is standard practice because we know the~omplication rate for angiography, although low, is significantly higher t h a n for any of the other radiographic procedures we most commonly perform. We do not make proper allowance for the careful explanation of risks for m a n y of the other procedures, such as venography, arthrography, urography, cholangiography and herniography, which are done daily on a routine basis. It is understandable and obvious, with the schedule in a busy hospital or office radiologic practice, t h a t the logistics have not been adequately planned and resources have not b~en allocated to provide for this service. The complication from contrast media most feared is the idiosyncratic reaction leading to death. This is a topic difficult to approach with a patient who has not been seen before by the radiologist and is already on the radiographic table, waiting for the injection in anticipation of a "kidney x-ray."t In such cases one can be reasonably certain t h a t the referring physician did not discuss this with the patient in detail and specifically. In order to avoid alarming the patient and upsetting the departmental schedule, the radiologist will usually not broach the subject, even though the fear of a fatal response lurks in the back of his mind. The radiologist m a y elect to continue through the examination in hopes t h a t the 1 in 40,000-100,000 chance of death will not arrive on his doorstep t h a t day. Although those odds are good for the doctor and the patient, virtually every radiologist will have undergone sometime in his career the experience of a very serious or fatal reaction to contrast material. When this occurs, if the patient was uninformed of t h a t contingency, the radiologist is always at a disadvantage trying to explain why he failed to inform about this very significant risk. A simple, frank explanation of the risks of a procedure in a brochure for the patient to read and a consent form will tend to allay patients' fears and will often provide a good legal defense in case of a suit. We realize this is counter to the recommendation by the American College of Radiology (ACR) concerning informing patients of fatal reactions to contrast material for ordinary procedures, but in the legal atmosphere in which we find ourselves practicing, it would be legally unwise not to inform the patient. We would submit t h a t our efforts should be how to go about informing patients in the most compassionate and efficient manner, not how to create ingenious excuses to absolve us of our duty to inform properly. An interesting response to the informed consent problem has tSimilar logistics problems are created by patients who, 30 secondsbeforethe scheduledexamination,demandfull disclosuresof all the possible harmful effects ofradiographicexposure. 15
been formulated by the state legislature in Texas. This has resulted in the creation of the Texas Medical Disclosure Panel, as reported in the ACR News, June, 1979. The panel consists of 6 physicians and 3 attorneys who have drawn up an ~'A" list for which physicians must disclose all specific risks, and a ~'B" list of procedures that do not require disclosure. The theory is that for any procedure on the '~B" list the physician does not have a legal responsibility to inform the patient of associated risks. There has been favorable response to this proposal both from the medical and the legal professions, but initially this seems a rather incomplete and simplistic, although unique, plan. This measure may give physicians a false sense of security concerning informed consent. It is our opinion that we do not need panels or another layer of bureaucracy to inform patients of the risks they will undergo in the physician's hands. Physicians need to create a mechanism for basic communication with patients and the best way to attain that is a simple, open and calm disclosure of the risks, by the physician, which is appropriately documented. It is recognized that this is a difficult problem, but it may be alleviated by organization of time and personnel. The most obvious question created by this type of discussion is what to tell our patients in order to disclose the risks adequately and how to tell them. How can we meet our moral and legal obligations of disclosure without undue expenditure of time? We cannot give specific legal advice, but we can provide opinions and proposals on this topic. First, as mentioned previously, even the minority rule courts will not impose the burden of disclosing every possible but improbable risk to a patient. The courts have repeatedly stated, following Cobbs, that physicians do not have to conduct ~'minicourses in science," nor do most patients expect or want that. Furthermore, if the patient states that he/she does not want to hear any more about the risks and complications, then the doctor has no duty to press forward with them. In the recent Maryland case of Sard vs. Hardy, the Court of Appeals (Maryland's Supreme Court), sensing physicians' confusion as to how much to tell their patients, gave an outline that is basically no more than ordinary common sense. The court said a physician's duty to disclose includes telling the patient the nature of his ailment, the nature of proposed treatment or diagnostic procedure, the probability of success and the alternative choices as well as the risks of unfortunate consequences. This hardly comes across as excessive judicial interference in the practice of medicine, but, in fact, succinctly states what every physician should know and practice as his duty of disclosure. Alfidi, Meany and Lalli have given us an even simpler but legally sound formula for disclosure, especially for diagnostic radiologists: 16
~ . . . information on common complications and mortality must be given to the patient to provide the basis for truly informed consent." If their advice is followed and the disclosure is properly documented, then the radiologist m a y rest assured that he has satisfied his professional and legal duty to inform. This assertion' is supported by Rubsamen's collection of jury verdicts in California cases during the first 4 years after the Cobbs decision. The California juries, who have not distinguished themselves heretofore for their pro-doctor stance, showed a pattern of demanding thorough disclosure on elective procedures where there is a reasonable alternative treatment (or diagnostic procedure) proposed. In instances where treatment (or diagnostic procedure) was essential the juries tolerated lesser disclosure. Again, similar to the Maryland Court of Appeals in S a r d vs. H a r d y , the juries showed a rather commonsensical attitude. After establishing what to tell the patient, the next step is how to accomplish the disclosure gracefully and with a minimum of time and discomfort to both physicians and their patients. We propose that at the time of scheduling an examination of any type involving injection of contrast material, the patient be provided with a disclosure brochure that outlines the reason for and methods of the procedure. It should also state clearly that there is a small risk of death. If the statistics of that risk, which in this particular instance are approximately 1 in 40,000100,000, are also disclosed in the brochure, then that risk is put into proper perspective and will not serve to unduly alarm the patient. In addition to the explanation of the procedure, the brochure should also include a statement that if anything in the brochure is unclear to the patient, the radiologist will discuss it with him. Finally, patients should sign a simple and witnessed form stating that they have read and understood the brochure and knowingly assume the risks involved. For inpatients, an identical procedure could be used except that the information and consent form would probably be distributed by the nursing staff and signed in the patient hospital area. Radiologists should be warned that generalized consent or authorization forms that are commonly used in patient care (often referred to in legal jargon as ~'boiler plate"), which give wide authorization, have very little legal validity. In some instances, they appear to attempt to contract away liability and absolve the health care personnel. The form used should contain the specific information in appropriate detail for the examination proposed. Again, appropriate detail does not impose the burden of conducting '~minicourses in medicine" or outlining extremely remote or speculative risks. Regarding inpatients (especially minors or patients mentally incompe17
tent or anyone bearing a legal infirmity that precludes giving consent), physicians should not assume that, just because a patient is in the hospital and his/her doctor has ordered a diagnostic procedure, automatically there exists the patient's implied consent. Under many state laws, there is no implied consent or presumption of consent. Rather than depend on a priori consideration of implied consent, the radiologist should ascertain that actual consent has been given before the procedure. If these guidelines are followed, we believe that radiologists will have satisfied their moral and legal obligations and thereby have a good defense against an informed consent charge. Of equal importance, the patient's mind will be put at ease and the doctorpatient relationship will be enhanced and not diminished by the disclosure. Implied in this statement is the caveat that this conduct will not insure against the institution of a lawsuit. However, it will diminish the chances because of positive patient attitudes and will provide an excellent defense should a lawsuit be initiated. In this age of consumerism, public initiatives and media exposure regarding the virtues and shortcomings of the medical profession, we must strive for better communication and relationship with our patients. Even though some m a y regard the informing of patients secondary to their proper care and as no more than an elaborate form of courtesy, in order to have a legally viable defense, we must inform and document that we have done so. In summary, the physician's duty to inform has been described and discussed. The minority and majority rule have also been defined and analyzed along with the major causes of physician failure and resistance to disclose risks. In a proper physician-patient relationship, informed consent controversy should be rare. A calm, clear, direct and properly documented disclosure of risks of a procedure is the best defense in any jurisdiction.
ACKNOWLEDGMENTS We wish to thank our professors and colleagues at the Vanderbilt School of Law and the School of Law at the American University for their inspiration and knowledge and for allowing us to use their facilities. Ms. Betty Burnside was especially helpful in preparing the drafts and manuscript. We also wish to acknowledge the excellent manuscript preparation by Ms. Pam Kerns, who, as usual, worked both cheerfully and indefatigably. Finally, our medical and legal collaborators have offered us many insights that have added immeasurably to this communication.
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BIBLIOGRAPHY Alfidi, R.: Informed consent and special procedures, Cleve. Clin. Q. 40:21, 1973. Alfidi, R.: Controversy, alternatives and decisions in complying with the legal doctrine of informed consent, Radiology 114:231, 1975. Alfidi, R., Meany, T., and Lalli, A.: Complications and Legal Implications of Radiological Special Procedures (St. Louis: C. V. Mosby Co., 1973). Allen, R. W.: Informed consent: a medical decision, Radiology 119:233, 1976. Canterbury vs. Spence, 464 F 2d, 772 (D.C. Circ. 1972). Cobbs vs. Grant, 8 CAL 3d 229, 502 P 2d, 1 (1972). Collins, V.: Consent to radiologic examinations, Radiology 91:90, 1968. Gillmore, G.: The Death of Contract (Columbus, Ohio: Ohio State University Press, 1974). Lankten, J., Batchelder, B., and Ominsky, A.: Emotional responses to detailed risk disclosure for anesthesia: perspective, randomized study, Anesthesiology 46:294, 1977. Meisel, A.: The expansion of liability for medical accidents: from negligence to strict liability by way of informed consent, Nebraska Law Review 56:124, 1977. Mohr vs. Williams, 95 Minn. 261, 104 N.W., 12 (1905). Natanson vs. Kline, 187 KAN 186, 354 P 2d, 670 (1960). Pegram vs. Cisco, 406 F 2d, 778 (1976). Riedinger vs. Collburn, 361 F Supp., 1073 (1973). Rubsamen, D.: Professional Liability Newsletter 7:12, 1976. Salgo vs. Leland Stanford Jr. University Board of Trustees, 317 P 2d, 181 (1968). Sard vs. Hardy, 281 Md. 432 (1977). Schloendorffvs. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914). Woods vs. Brumlop, 1 N.M. 221,377 P 2d, 520 (1962).
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