William M Copeland, JD
Informed consent and the OR nurse
While malpractice suits have become a fact of life for physicians, until now nurses have remained relatively sheltered. However, their vulnerability is increasing. Because medical litigation is becoming more common, nurses are bound to be pulled into the courts more and more frequently, either as litigants or as expert witnesses. As the responsibilities and liabilities of nurses are more precisely defined in law, and as increased insurance coverage makes them better able to compensate plaintiffs, the likelihood that they will be named in cases involving negligence is increased.l Even in cases where
William M Copeland, JD, is president, St Francis-St George Hospital, Inc, Cincinnati. He is a graduate of Chase College of Law, Northern Kentucky University, Covington. This article is not intended to be legal advice
and should not be used to resolve legal problems. For legal advice,one's personal attorney should be contacted.
they are not likely t o be held liable themselves, nurses and the institutions that employ them are increasingly more likely to be named in suits against surgeons. It is important, therefore, that every nurse acquire at least a general factual awareness of the current status of the law governing nursing responsibilities and duties, keeping in mind that the law in this area is still being hammered out in legislatures and the courts. Of recent concern is informed consent. The doctrine of informed consent is fundamental to the fiduciary or trusting relationship between physician and patient. It is also a natural outgrowth of our legal tradition, which is based on individual self-determination. In simple terms, informed consent means that a physician may not treat a patient until he has explained the risks and material facts of the treatment and its alternatives, including nontreatment, and has obtained the patient's competent, voluntary, and understanding consent to proceed.2In its application, of course, the doctrine is much more complicated. It has fallen to the courts to define through verdicts and decisions specifically what informed consent means in practice. The issue has been of great concern to surgeons because many of the controversies surrounding the doctrine have involved risks and complications of surgery. As members of the surgical
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AORN Journal, April 1979, Vol29, No 5
team, OR nurses are naturally drawn into the debate. Although the physician carries the legal and professional burden of informed consent, it is the nurse’s professional responsibility to make sure the physician has explained the surgery to the patient, the consent form has been signed, and the information on the form is correct. If a nurse participates in a procedure the patient does not understand and has not consented to, she shares responsibility with the surgeon even though she may not be legally liabie.3 This article outlines the concerns of the medical profession about informed consent, the elements of disclosure necessary t o achieve it, and the circumstances in which consent is necessary. The medical profession seems primarily concerned with situations in which disclosing risks of treatment poses such a threat to the patient that it becomes medically contraindicated or infeasible. It is recognized that patients occasionally become so ill or emotionally distraught from the disclosure that they cannot make a rational decision, their treatment is complicatedor hindered, or perhaps even psychological damage is done.4 The position of the Ohio State Medical Association has been that, whereas the physician “should not withhold material medical information regarding a proposed procedure,” he must at the same time “do what is best for the patient.” If this means that, in the physician’s judgment, full disclosure of possible consequences of a procedure would be psychologically damaging to the patient, such information should be ~ i t h h e l d Few . ~ would disagree with this position. However, it is one thing to talk abstractly about what should be and quite another t o deal with the realities of the patient in the office. This causes much of the anxiety of physicians.
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In an attempt to resolve some of the uncertainty involved in Ohio legislation, a committee was formed among the Ohio State Medical Association, the Ohio Osteopathic Association, and the Ohio Hospital Association. The committee was unable to reach agreement beyond the general propositions that the common law in Ohio requires informed consent and that prudence dictates appropriate documentation thereof.6 There was a law in Ohio requiring use of a prescribed form, which when properly completed provided a presumption of informed consent. Hospitals in the state, on advice of their counsels, were requiring use of the form. The medical profession rebelled and influenced passage of a bill that removed this form from the statute and went one step further: It removed the liability of the hospital for a physician’s failure to obtain an informed consent. Although the Ohio legislature has removed the liability of the hospital for the physician’s misconduct in this area, no other state has done so. Moreover, t h e Joint Commission on Accreditation of Hospitals (JCAH) still has as one of its key standards that the patient’s medical record “shall contain evidence of the patient’s informed consent.”’ Therefore, it is very important that hospitals ensure that informed consent is documented in the medical record prior to a procedure being performed. To give an informed consent has been called the patient’s most important right. This right has been recognized by the JCAH, the American Hospital Association, the courts, and various state legislatures. Thus, it is imperative that hospital personnel as well as physicians have a good understanding of what is required. Although the doctrine of informed consent is a recent development in the law of medical malpractice, it isjust one
AORN Journal, April 1979, V o l 2 9 , No 5
ost suits are based on negligence rather than battery.
M
aspect of the much broader power of individuals t o control their own bodies and lives. In a 1914 case, Benjamin N Cordozo, who was then a New York judge and later a Supreme Courtjustice, described this right in broad terms: Every human being of adult years and sound mind has a right to determine what shall 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 in damages.8 The doctrine of informed consent imposes a duty upon a physician completely separate from his duty t o act with skill and care in diagnosing and treating patients. Reduced to its simplest terms, it requires a physician or a surgeon to disclose t o his patient the risk of proposed medical or surgical treatment. When he does not do so and goes ahead with the treatment knowing the patient is unaware of the risk, he may be liable for a resulting injury. In law, this is called medical batteryintentionally touching a patient’s body without his consent. Recently, the doctrine of informed consent has taken a new turn. In three cases, Cunterbury u Spence, 464 F 2d 772, DC Cir, 1972; Wilkinson u Vesey, 295 A 2d 676, RI 1972; and Cobbs u Grunt, 104 Cal Rptr 505, Sup Ct 1972, the courts held that the failure to disclose material medical risks not only can result in a battery but also can be
934
considered negligence. This means that the failure to get a patient’s informed consent before treatment can be part of a malpractice suit. It need not be brought as a separate suit charging battery. Actually, most cases of failure of informed consent do fall within the negligence category. Let us look at these three cases. In Canterbury u Spence, a 19-year-old patient sued a surgeon and a hospital for negligence, alleging in part that the surgeon negligently performed a laminectomy and negligently failed to disclose to her that serious disability was a significant risk of the operation. The lower court ruled in favor of t?ie defendants, but the appellate court reversed that decision and sent it back to the trial court, holding that the 1%risk of paralysis from the operation presented a question whether the physician’s disclosure of the risk was sufficient. In Wilkinson u Vesey, a woman patient sued a group of radiologists, alleging negligence in initiating deep radiation burns. The plaintiff claimed that, had she known the risks, she would not have undergone the treatment. Again, a lower-court ruling in favor of the defendants was reversed by a higher court because of doubt about the adequacy of consent. In Cobbs u Grunt, the court dealt with a case concerning surgical treatment for a duodenal ulcer. Although the patient
AORN Journal, April 1979, V o l 2 9 , No 5
had been informed of the risks of anesthesia and had been told the surgery would be performed, he had never been advised of the risks inherent in the surgery itself. During the operation, the artery at the hilus of the spleen was severed, but the injury was not discovered until several days later when the patient went into shock from internal bleeding. The spleen was then removed in emergency surgery. A month later, he was readmitted with a gastric ulcer and eventually underwent a gastrectomy. A short time later he returned with internal bleeding due to the premature absorption of a suture. All three of these problems are potential hazards of this kind of surgery. At the trial, the patient alleged the surgeon was negligent in the surgical procedure itself as well as in the failure to achieve informed consent. A jury ruled in favor of the patient, and the defendant surgeon appealed. The Supreme Court of California said the case involved two issues: (1) “whether there was sufficient evidence of negligence” in the surgery itself and (2) whether the trial court’s instructions t o the jury “adequately set forth the nature of a medical doctor’s duty” t o obtain informed consent. However, the verdict was not directed to any specific allegation, so the court could not ascertain upon which of the two issues the jury relied. The case was returned to the lower court for retrial. As these cases illustrate, most suits about failure of informed consent are based on negligence rather than battery. The California court in the Cobbs case discussed why this is so. The court said that it is a plain case of battery when a physician obtains consent of a patient to perform one type of treatment and subsequently performs an entirely different type, such as getting consent to repair a postoperative hernia and then during the operation
936
removing one of the ovaries without consent. However, if a physician fails to advise a patient of a low-risk complication that could result from a procedure, and the complication subsequently develops, the trend is for the courts to hold the physician liable because of negligence. In this situation, the courts say, informed consent was not obtained because the physician neglected to inform the patiedt of all the risks inherent in the procedure. When does the informed consent doctrine apply? If we accept the California court’s rationale, we conclude that most informed consent cases will be based on negligence, as were all three cases above. Therefore, since we are not talking about intentional battery, the question is, How can the courts determine whether or not the informed consent doctrine applies in any particular case? In Cobbs u Grunt, the court based an analysis of the doctrine on the proposition that the physician’s duty is to give the patient adequate information t o weigh the alternatives and decide whether to have the proposed treatment, t o have no treatment, or to have some alternative treatment. The court laid down four postulates: 1. “Patients are generally persons unlearned in the medical sciences and therefore, except in rare instances, will know less than their doctors about the treatment ofdisease and injury.” 2. Any adult of sound mind “has the right in the exercise of control over his own body to determine whether’or not to submit to lawful medical treatment.” 3. The patient’s consent t o treatment, to be effective, must be an informed consent. 4. Since the patient in his relative ignorance in matters medical is dependent on the physician for information that will help him make
AORN Journal, April 1979,Vol29, No 5
ow much information must a physician give a patient?
H
a correct decision, the physician’s responsibility goes beyond that of “arm’s length transactions.” The physician is therefore required to divulge “all information relevant t o a meaningful decisional process.” In many instances, the best decision for the patient seems evident to the physician. However, it “remains the prerogative of the patient and not the physician t o determine for himself the direction in which he believes his best interests lie,” hence the kind of treatment he should have. “To enable the patient t o chart his course knowledgeably, reasonable familiarity with therapeutic alternatives and their hazards becomes essential.” Therefore, it is “an integral part of a physician’s overall obligation to the patient [to make] reasonable disclosure of the available choices with respect to the proposed therapy and of the dangers inherently and potentially involved in each.” In a 1977 case,Surd u Hardy, 379 A 2d 1014, Md Ct of App, Nov 9, 1977, the Maryland Court of Appeals, the highest court in the state, wrote a long analysis of the entire question of informed consent, which not only pulled together the various elements of the problem and the arguments associated with them but also cited dozens of precedents. The Maryland court defined informed consent as following “logically from the universally recognized rule that a physician, treating a mentally compe-
938
tent adult under non-emergency circumstances, cannot properly undertake to perform surgery or administer other therapy without the prior consent of his patient.” The court cited Cardozo’s statement on the rights of patients to control their own bodies and said this concept is “the fountainhead of the doctrine of informed consent.” It pointed out that the other courts, including the California court in the Cobbs decision, have “bottomed the physician’s duty to disclose on the fiducial [trusting] quality of the physician-patient relationship.” This decision reaffirmed Cobbs, saying the physician must “explain the procedure to the patient and . . . warn him of any material risks or dangers inherent in or collateral to the therapy, so as to enable the patient to make an intelligent and informed choice about whether or not t o undergo such treatment.” The questions, then, are: What is material? and How much information must a physician give a patient t o achieve informed consent? The elements of disclosure. When one attempts to define the elements of informed consent and to advise concerning exactly what must be disclosed, there is a great tendency to discuss in abstract the duties of a physician. However, pragmatically, these elements are reduced to four items that provide sufficient information to enable the patient
AORN Journal, April 1979, V o l 2 9 , No 5
to make an intelligent decision. These are: 1. type of procedure or procedures to be performed 2. risks and hazards inherent in the procedures 3. outcome hoped for 4. available alternatives, if any. Seldom, if ever, is there any problem with items 1 and 3. The problems arise with disclosure of the inherent risks and delineation of alternatives. Let us focus on this disclosure of risk. The Illinois Court of Appeals in a 1976 decision, Miceikis u Field, 347 NE 2d 320,I11App 1976,gives some insight into this problem. The court held, “It would be too onerous a burden to place upon a physician the duty of disclosing every conceivable risk which could possibly develop in order to obtain informed consent.” The court defined the physician’s duty as “informing of those factors. . .which the patient would view as significant enough to influence his decision of whether or not to consent to therapy.” In the Canterbury case, the court spoke about disclosure of risk, saying the patient depends on and therefore must trust the physician to reveal what he must know to make an informed decision. “We now find as a part of the physician’s overall obligation to the patient. . . a duty of reasonable disclosure of the choices with respect to the proposed therapy and the dangers inherently and potentially involved.” In the Cobbs case, the court also discussed the criteria by which disclosure may be measured. There is no simple definition of disclosure, the court said, but (‘twoqualifications to a requirement of full disclosure need little explication.” First, the patient’s interest in information is limited: “A mini-course in medical science is not required.” Second, the physician need not warn the patient of remote possibilities of death
or serious bodily harm if the risks are well known to be remote even though inherent in the procedure. He must, however, inform the patient if conditions are present which might cause exceptional risks-adverse reactions t o antibiotics, for example. However, when a complicated procedure is involved, “a medical doctor has a duty to disclose to his patient the potential of death or serious harm, and to explain in lay terms complications that might possibly occur . . . . The scope of the physician’s communications to the patient then must be measured by the patient’s need, and that need is whatever information is material to the decision. Thus, the test for determining whether a potential peril must be divulged is its materiality to the patient’s decision.” Schroeder u Lawrence, 359 NE 2d 1301,Mass Sup Jud Ct, 1977,deals directly with the question of what information is material t o this decision. The case was decided against a woman patient who alleged her vocal cords were injured in an operation to remove an adenoma on her thyroid gland. One part of the complaint charged the physician-defendant failed to inform the plaintiff of the risks of surgery or alternative treatments. The plaintiff alleged she submitted to the surgery relying on the physician’s recommendation. The physician did not offer substantial evidence that he had explained the risks of the operation to the patient. He could only say it was his “common practice,” and he might well have done so. He also stated that although the operation carried some risk of injury to the vocal cords, it was not a high risk and had not occurred in approximately 150 similar operations he had performed. The court refused to discuss the full scope of the doctrine of informed consent but relied heavily on the Canterbury case to conclude that “on any view of a
dAORN Journal, April 1979, Vol29, No 5
939
doctrine of informed consent, a plaintiff, to succeed must show that the undisclosed risk was material and that it materialized.” Although the patient offered as a precedent for her suit a 1973 Ohio case, Congrove u Holmes, 37 Ohio Misc 95, 308 NE 2d 765 (CP 19731, involving a similar operation with similar results, the court rejected it as irrelevant because in that case the plaintiff had no doubt prepared a stronger case by making a more exhaustive investigation of the facts and circumstances surrounding the consent. In fact, the defendant surgeon had offered no defense, stating flatly he had not informed the patient of the risks. The surgeon said, Y feel that were I to point out all the complications-or even half the complications-that I would take the responsibility for in trying to help people, that many people would refuse to have anything done and, therefore, would be much worse off.” The reasonable-person test. To determine what risks would have a bearing on the patient’s decision, the reasonable-person or objective test is generally used. The courts have said it would be unfair t o physicians to allow patients to declare, after a complication of surgery has occurred, that they would not have consented had they known the risk. Instead the test of consent should be, “What would a prudent person in the patient’s position have decided if they had been adequately informed of all the significant perils?” The court in the Sard case stated the criterion in terms of the physician: A material risk is one which a physician knows or ought to know would be significant t o a reasonable person in the patient’s position in deciding whether or not t o submit to a particular medical treatment or procedure. In other words, considering all the circumstances, would a reasonable person
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accept the risks? Keep firmly in mind, however, that it is the patient’s prerogative, not the physician’s-no matter what his or her training and experience, no matter what his or her judgment about the best interest of the patient. It is the patient’s prerogative to decide whether to have the treatment. When disclosure may be excused. There are two general circumstances in which the physician will be excused for treating the patient without the patient’s informed c o n ~ e n tThe . ~ first, of course, is the emergency when the patient is either unconscious or incompetent. In these cases, failure to treat would result in death or serious harm to the patient. This is a common sense exception to the general rule. When there is a genuine emergency, and it is impractical to confer with the patient, the law dispenses with the need for it. Second is when it is medically contraindicated that risks be disclosed to the patient. Occasionally,when the risk is disclosed, a patient becomes so ill or emotionally distraught that either he or she cannot make a rational decision, or the disclosure may result in serious psychological damage. In these circumstances, courts usually have held that the practitioner may keep the information from the patient. The court’s decision usually rests on whether the physician used sound medicaljudgment in deciding that disclosure of the risks would threaten the patient’s well-being. On the other hand, in Sard the court stated, “The physician is free to introduce evidence of his compliance with the prevailing medical standard of care to explain his failure t o disclose. But such proof is not conclusive; it is still for the jury t o decide whether adherence to the professional standard should deprive a patient of his right to selfdetermination.’’ The courts further state that this privilege of the physician t o withhold information must be care-
AORN Journal, April 1979, Vol29, No 5
fully circumscribed. In the Cobbs case, the court listed three situations in which disclosure need not be made: 1. when the patient requests that he or she not be so informed 2. if the procedure “is simple and the danger remote and commonly a p preciated to be remote” 3. when the facts would demonstrate to a reasonable person that the disclosure would “so seriously upset the patient that [he or she] would not be able to dispassionately weigh the risks of refusing to undergo the recommended treatment.” In addition, the physician cannot make the decision because he or she may think the proposed procedure would be rejected if the patient knew the risks. In the Surd case, the court does not mention the first situation but does mention the second and third and says disclosure is not required “where the physician does not know of a risk and should not have been aware of it in the exercise of ordinary care . . . .” Conclusion. These recent court decisions lead to the conclusion that t o be valid, an informed consent must include these four elements: 1. The procedure or procedures must be explained to the patient’s satisfaction, and the physician must ensure the patient understands what is to be done. 2. The material risks and hazards inherent in the procedure must be explained to the patient. 3. The desired outcome must be made known to the patient, and he or she must understand this is a desired outcome and no guarantee. 4. The patient must be made aware of available alternative treatments. If these four requirements are met, and there is some documented proof that they have been followed, then the requirements of a valid informed con-
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sent will be met, and the patient will have adequate information on which to make an intelligent decision about having the procedure. Nurses are not as likely as physicians to be directly involved in informed consent lawsuits since it is generally recognized that the physician is legally responsible for obtaining consent. Nevertheless, because they work so closely with physicians and are responsible to patients and the hospitals where they work, nurses may become involved in such cases as witnesses. This is particularly true for OR nurses. As in all other areas, they have a professional obligation to report lapses in patient care t o the proper authorities. The consent forms they are responsible for checking become part of the patient’s medical record and may become legal documents ifthere is a lawsuit. 0 Notes 1. William C Menges, Jr, “The negligent nurse: R, for the medical malpractice victim,” Tulsa Law Journal12 (1976) 128. Written for lawyers by a lawyer, this article is a lawyer’s view of the nurse in litigation as well as a summary of current law concerning nurses and malpractice. 2. George J Annas, The Rights of Hospital Patients (New York: Avon Books, 1975) 57. 3. Elinor S Schrader, “Informed consent: The nurse’s responsibility,”AORN Journal 18 (October 1973) 667-668. 4. E Hayt, L Hayt, Law of Hospital (Chicago: Physician’s Record Co, 1972) 490. 5. J Pohlman, “Informed consent: The doctor’s dilemma and HB 682 2,” Columbus, Ohio, 1976. (Typewritten) 2. 6. Update on lnformed Consent, Bulletin 1897-A (Columbus: Ohio Hospital Association, 1976). 7. Accreditation Manual for Hospitals (Chicago: Joint Commission on Accreditation of Hospitals, 1976) 95. 8. Schloendotif v Society of New York Hospital, 211 NY 125, 105 NE 92, 93, 1914. 9. J Horty, ”Informed consent: A problem in semantics,” Action Kit for Hospital Law (January 1972) 1. See also Sard v Hardy, 379 A 2d 1014, Md Ct of App, Nov 9, 1977, 1022.
AORN Journal, April 1979, V o l 2 9 , No 5
Informed consent and the OR nurse
While malpractice suits have become a fact of life for physicians, until now nurses have remained relatively sheltered. However, their vulnerability is increasing. Because medical litigation is becoming more common, nurses are bound to be pulled into the courts more and more frequently, either as litigants or as expert witnesses. As the responsibilities and liabilities of nurses are more precisely defined in law, and as increased insurance coverage makes them better able to compensate plaintiffs, the likelihood that they will be named in cases involving negligence is increased.l Even in cases where
William M Copeland, JD, is president, St Francis-St George Hospital, Inc, Cincinnati. He is a graduate of Chase College of Law, Northern Kentucky University, Covington. This article is not intended to be legal advice
and should not be used to resolve legal problems. For legal advice,one's personal attorney should be contacted.
they are not likely t o be held liable themselves, nurses and the institutions that employ them are increasingly more likely to be named in suits against surgeons. It is important, therefore, that every nurse acquire at least a general factual awareness of the current status of the law governing nursing responsibilities and duties, keeping in mind that the law in this area is still being hammered out in legislatures and the courts. Of recent concern is informed consent. The doctrine of informed consent is fundamental to the fiduciary or trusting relationship between physician and patient. It is also a natural outgrowth of our legal tradition, which is based on individual self-determination. In simple terms, informed consent means that a physician may not treat a patient until he has explained the risks and material facts of the treatment and its alternatives, including nontreatment, and has obtained the patient's competent, voluntary, and understanding consent to proceed.2In its application, of course, the doctrine is much more complicated. It has fallen to the courts to define through verdicts and decisions specifically what informed consent means in practice. The issue has been of great concern to surgeons because many of the controversies surrounding the doctrine have involved risks and complications of surgery. As members of the surgical
d) 928
AORN Journal, April 1979, Vol29, No 5
team, OR nurses are naturally drawn into the debate. Although the physician carries the legal and professional burden of informed consent, it is the nurse’s professional responsibility to make sure the physician has explained the surgery to the patient, the consent form has been signed, and the information on the form is correct. If a nurse participates in a procedure the patient does not understand and has not consented to, she shares responsibility with the surgeon even though she may not be legally liabie.3 This article outlines the concerns of the medical profession about informed consent, the elements of disclosure necessary t o achieve it, and the circumstances in which consent is necessary. The medical profession seems primarily concerned with situations in which disclosing risks of treatment poses such a threat to the patient that it becomes medically contraindicated or infeasible. It is recognized that patients occasionally become so ill or emotionally distraught from the disclosure that they cannot make a rational decision, their treatment is complicatedor hindered, or perhaps even psychological damage is done.4 The position of the Ohio State Medical Association has been that, whereas the physician “should not withhold material medical information regarding a proposed procedure,” he must at the same time “do what is best for the patient.” If this means that, in the physician’s judgment, full disclosure of possible consequences of a procedure would be psychologically damaging to the patient, such information should be ~ i t h h e l d Few . ~ would disagree with this position. However, it is one thing to talk abstractly about what should be and quite another t o deal with the realities of the patient in the office. This causes much of the anxiety of physicians.
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In an attempt to resolve some of the uncertainty involved in Ohio legislation, a committee was formed among the Ohio State Medical Association, the Ohio Osteopathic Association, and the Ohio Hospital Association. The committee was unable to reach agreement beyond the general propositions that the common law in Ohio requires informed consent and that prudence dictates appropriate documentation thereof.6 There was a law in Ohio requiring use of a prescribed form, which when properly completed provided a presumption of informed consent. Hospitals in the state, on advice of their counsels, were requiring use of the form. The medical profession rebelled and influenced passage of a bill that removed this form from the statute and went one step further: It removed the liability of the hospital for a physician’s failure to obtain an informed consent. Although the Ohio legislature has removed the liability of the hospital for the physician’s misconduct in this area, no other state has done so. Moreover, t h e Joint Commission on Accreditation of Hospitals (JCAH) still has as one of its key standards that the patient’s medical record “shall contain evidence of the patient’s informed consent.”’ Therefore, it is very important that hospitals ensure that informed consent is documented in the medical record prior to a procedure being performed. To give an informed consent has been called the patient’s most important right. This right has been recognized by the JCAH, the American Hospital Association, the courts, and various state legislatures. Thus, it is imperative that hospital personnel as well as physicians have a good understanding of what is required. Although the doctrine of informed consent is a recent development in the law of medical malpractice, it isjust one
AORN Journal, April 1979, V o l 2 9 , No 5
ost suits are based on negligence rather than battery.
M
aspect of the much broader power of individuals t o control their own bodies and lives. In a 1914 case, Benjamin N Cordozo, who was then a New York judge and later a Supreme Courtjustice, described this right in broad terms: Every human being of adult years and sound mind has a right to determine what shall 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 in damages.8 The doctrine of informed consent imposes a duty upon a physician completely separate from his duty t o act with skill and care in diagnosing and treating patients. Reduced to its simplest terms, it requires a physician or a surgeon to disclose t o his patient the risk of proposed medical or surgical treatment. When he does not do so and goes ahead with the treatment knowing the patient is unaware of the risk, he may be liable for a resulting injury. In law, this is called medical batteryintentionally touching a patient’s body without his consent. Recently, the doctrine of informed consent has taken a new turn. In three cases, Cunterbury u Spence, 464 F 2d 772, DC Cir, 1972; Wilkinson u Vesey, 295 A 2d 676, RI 1972; and Cobbs u Grunt, 104 Cal Rptr 505, Sup Ct 1972, the courts held that the failure to disclose material medical risks not only can result in a battery but also can be
934
considered negligence. This means that the failure to get a patient’s informed consent before treatment can be part of a malpractice suit. It need not be brought as a separate suit charging battery. Actually, most cases of failure of informed consent do fall within the negligence category. Let us look at these three cases. In Canterbury u Spence, a 19-year-old patient sued a surgeon and a hospital for negligence, alleging in part that the surgeon negligently performed a laminectomy and negligently failed to disclose to her that serious disability was a significant risk of the operation. The lower court ruled in favor of t?ie defendants, but the appellate court reversed that decision and sent it back to the trial court, holding that the 1%risk of paralysis from the operation presented a question whether the physician’s disclosure of the risk was sufficient. In Wilkinson u Vesey, a woman patient sued a group of radiologists, alleging negligence in initiating deep radiation burns. The plaintiff claimed that, had she known the risks, she would not have undergone the treatment. Again, a lower-court ruling in favor of the defendants was reversed by a higher court because of doubt about the adequacy of consent. In Cobbs u Grunt, the court dealt with a case concerning surgical treatment for a duodenal ulcer. Although the patient
AORN Journal, April 1979, V o l 2 9 , No 5
had been informed of the risks of anesthesia and had been told the surgery would be performed, he had never been advised of the risks inherent in the surgery itself. During the operation, the artery at the hilus of the spleen was severed, but the injury was not discovered until several days later when the patient went into shock from internal bleeding. The spleen was then removed in emergency surgery. A month later, he was readmitted with a gastric ulcer and eventually underwent a gastrectomy. A short time later he returned with internal bleeding due to the premature absorption of a suture. All three of these problems are potential hazards of this kind of surgery. At the trial, the patient alleged the surgeon was negligent in the surgical procedure itself as well as in the failure to achieve informed consent. A jury ruled in favor of the patient, and the defendant surgeon appealed. The Supreme Court of California said the case involved two issues: (1) “whether there was sufficient evidence of negligence” in the surgery itself and (2) whether the trial court’s instructions t o the jury “adequately set forth the nature of a medical doctor’s duty” t o obtain informed consent. However, the verdict was not directed to any specific allegation, so the court could not ascertain upon which of the two issues the jury relied. The case was returned to the lower court for retrial. As these cases illustrate, most suits about failure of informed consent are based on negligence rather than battery. The California court in the Cobbs case discussed why this is so. The court said that it is a plain case of battery when a physician obtains consent of a patient to perform one type of treatment and subsequently performs an entirely different type, such as getting consent to repair a postoperative hernia and then during the operation
936
removing one of the ovaries without consent. However, if a physician fails to advise a patient of a low-risk complication that could result from a procedure, and the complication subsequently develops, the trend is for the courts to hold the physician liable because of negligence. In this situation, the courts say, informed consent was not obtained because the physician neglected to inform the patiedt of all the risks inherent in the procedure. When does the informed consent doctrine apply? If we accept the California court’s rationale, we conclude that most informed consent cases will be based on negligence, as were all three cases above. Therefore, since we are not talking about intentional battery, the question is, How can the courts determine whether or not the informed consent doctrine applies in any particular case? In Cobbs u Grunt, the court based an analysis of the doctrine on the proposition that the physician’s duty is to give the patient adequate information t o weigh the alternatives and decide whether to have the proposed treatment, t o have no treatment, or to have some alternative treatment. The court laid down four postulates: 1. “Patients are generally persons unlearned in the medical sciences and therefore, except in rare instances, will know less than their doctors about the treatment ofdisease and injury.” 2. Any adult of sound mind “has the right in the exercise of control over his own body to determine whether’or not to submit to lawful medical treatment.” 3. The patient’s consent t o treatment, to be effective, must be an informed consent. 4. Since the patient in his relative ignorance in matters medical is dependent on the physician for information that will help him make
AORN Journal, April 1979,Vol29, No 5
ow much information must a physician give a patient?
H
a correct decision, the physician’s responsibility goes beyond that of “arm’s length transactions.” The physician is therefore required to divulge “all information relevant t o a meaningful decisional process.” In many instances, the best decision for the patient seems evident to the physician. However, it “remains the prerogative of the patient and not the physician t o determine for himself the direction in which he believes his best interests lie,” hence the kind of treatment he should have. “To enable the patient t o chart his course knowledgeably, reasonable familiarity with therapeutic alternatives and their hazards becomes essential.” Therefore, it is “an integral part of a physician’s overall obligation to the patient [to make] reasonable disclosure of the available choices with respect to the proposed therapy and of the dangers inherently and potentially involved in each.” In a 1977 case,Surd u Hardy, 379 A 2d 1014, Md Ct of App, Nov 9, 1977, the Maryland Court of Appeals, the highest court in the state, wrote a long analysis of the entire question of informed consent, which not only pulled together the various elements of the problem and the arguments associated with them but also cited dozens of precedents. The Maryland court defined informed consent as following “logically from the universally recognized rule that a physician, treating a mentally compe-
938
tent adult under non-emergency circumstances, cannot properly undertake to perform surgery or administer other therapy without the prior consent of his patient.” The court cited Cardozo’s statement on the rights of patients to control their own bodies and said this concept is “the fountainhead of the doctrine of informed consent.” It pointed out that the other courts, including the California court in the Cobbs decision, have “bottomed the physician’s duty to disclose on the fiducial [trusting] quality of the physician-patient relationship.” This decision reaffirmed Cobbs, saying the physician must “explain the procedure to the patient and . . . warn him of any material risks or dangers inherent in or collateral to the therapy, so as to enable the patient to make an intelligent and informed choice about whether or not t o undergo such treatment.” The questions, then, are: What is material? and How much information must a physician give a patient t o achieve informed consent? The elements of disclosure. When one attempts to define the elements of informed consent and to advise concerning exactly what must be disclosed, there is a great tendency to discuss in abstract the duties of a physician. However, pragmatically, these elements are reduced to four items that provide sufficient information to enable the patient
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to make an intelligent decision. These are: 1. type of procedure or procedures to be performed 2. risks and hazards inherent in the procedures 3. outcome hoped for 4. available alternatives, if any. Seldom, if ever, is there any problem with items 1 and 3. The problems arise with disclosure of the inherent risks and delineation of alternatives. Let us focus on this disclosure of risk. The Illinois Court of Appeals in a 1976 decision, Miceikis u Field, 347 NE 2d 320,I11App 1976,gives some insight into this problem. The court held, “It would be too onerous a burden to place upon a physician the duty of disclosing every conceivable risk which could possibly develop in order to obtain informed consent.” The court defined the physician’s duty as “informing of those factors. . .which the patient would view as significant enough to influence his decision of whether or not to consent to therapy.” In the Canterbury case, the court spoke about disclosure of risk, saying the patient depends on and therefore must trust the physician to reveal what he must know to make an informed decision. “We now find as a part of the physician’s overall obligation to the patient. . . a duty of reasonable disclosure of the choices with respect to the proposed therapy and the dangers inherently and potentially involved.” In the Cobbs case, the court also discussed the criteria by which disclosure may be measured. There is no simple definition of disclosure, the court said, but (‘twoqualifications to a requirement of full disclosure need little explication.” First, the patient’s interest in information is limited: “A mini-course in medical science is not required.” Second, the physician need not warn the patient of remote possibilities of death
or serious bodily harm if the risks are well known to be remote even though inherent in the procedure. He must, however, inform the patient if conditions are present which might cause exceptional risks-adverse reactions t o antibiotics, for example. However, when a complicated procedure is involved, “a medical doctor has a duty to disclose to his patient the potential of death or serious harm, and to explain in lay terms complications that might possibly occur . . . . The scope of the physician’s communications to the patient then must be measured by the patient’s need, and that need is whatever information is material to the decision. Thus, the test for determining whether a potential peril must be divulged is its materiality to the patient’s decision.” Schroeder u Lawrence, 359 NE 2d 1301,Mass Sup Jud Ct, 1977,deals directly with the question of what information is material t o this decision. The case was decided against a woman patient who alleged her vocal cords were injured in an operation to remove an adenoma on her thyroid gland. One part of the complaint charged the physician-defendant failed to inform the plaintiff of the risks of surgery or alternative treatments. The plaintiff alleged she submitted to the surgery relying on the physician’s recommendation. The physician did not offer substantial evidence that he had explained the risks of the operation to the patient. He could only say it was his “common practice,” and he might well have done so. He also stated that although the operation carried some risk of injury to the vocal cords, it was not a high risk and had not occurred in approximately 150 similar operations he had performed. The court refused to discuss the full scope of the doctrine of informed consent but relied heavily on the Canterbury case to conclude that “on any view of a
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doctrine of informed consent, a plaintiff, to succeed must show that the undisclosed risk was material and that it materialized.” Although the patient offered as a precedent for her suit a 1973 Ohio case, Congrove u Holmes, 37 Ohio Misc 95, 308 NE 2d 765 (CP 19731, involving a similar operation with similar results, the court rejected it as irrelevant because in that case the plaintiff had no doubt prepared a stronger case by making a more exhaustive investigation of the facts and circumstances surrounding the consent. In fact, the defendant surgeon had offered no defense, stating flatly he had not informed the patient of the risks. The surgeon said, Y feel that were I to point out all the complications-or even half the complications-that I would take the responsibility for in trying to help people, that many people would refuse to have anything done and, therefore, would be much worse off.” The reasonable-person test. To determine what risks would have a bearing on the patient’s decision, the reasonable-person or objective test is generally used. The courts have said it would be unfair t o physicians to allow patients to declare, after a complication of surgery has occurred, that they would not have consented had they known the risk. Instead the test of consent should be, “What would a prudent person in the patient’s position have decided if they had been adequately informed of all the significant perils?” The court in the Sard case stated the criterion in terms of the physician: A material risk is one which a physician knows or ought to know would be significant t o a reasonable person in the patient’s position in deciding whether or not t o submit to a particular medical treatment or procedure. In other words, considering all the circumstances, would a reasonable person
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accept the risks? Keep firmly in mind, however, that it is the patient’s prerogative, not the physician’s-no matter what his or her training and experience, no matter what his or her judgment about the best interest of the patient. It is the patient’s prerogative to decide whether to have the treatment. When disclosure may be excused. There are two general circumstances in which the physician will be excused for treating the patient without the patient’s informed c o n ~ e n tThe . ~ first, of course, is the emergency when the patient is either unconscious or incompetent. In these cases, failure to treat would result in death or serious harm to the patient. This is a common sense exception to the general rule. When there is a genuine emergency, and it is impractical to confer with the patient, the law dispenses with the need for it. Second is when it is medically contraindicated that risks be disclosed to the patient. Occasionally,when the risk is disclosed, a patient becomes so ill or emotionally distraught that either he or she cannot make a rational decision, or the disclosure may result in serious psychological damage. In these circumstances, courts usually have held that the practitioner may keep the information from the patient. The court’s decision usually rests on whether the physician used sound medicaljudgment in deciding that disclosure of the risks would threaten the patient’s well-being. On the other hand, in Sard the court stated, “The physician is free to introduce evidence of his compliance with the prevailing medical standard of care to explain his failure t o disclose. But such proof is not conclusive; it is still for the jury t o decide whether adherence to the professional standard should deprive a patient of his right to selfdetermination.’’ The courts further state that this privilege of the physician t o withhold information must be care-
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fully circumscribed. In the Cobbs case, the court listed three situations in which disclosure need not be made: 1. when the patient requests that he or she not be so informed 2. if the procedure “is simple and the danger remote and commonly a p preciated to be remote” 3. when the facts would demonstrate to a reasonable person that the disclosure would “so seriously upset the patient that [he or she] would not be able to dispassionately weigh the risks of refusing to undergo the recommended treatment.” In addition, the physician cannot make the decision because he or she may think the proposed procedure would be rejected if the patient knew the risks. In the Surd case, the court does not mention the first situation but does mention the second and third and says disclosure is not required “where the physician does not know of a risk and should not have been aware of it in the exercise of ordinary care . . . .” Conclusion. These recent court decisions lead to the conclusion that t o be valid, an informed consent must include these four elements: 1. The procedure or procedures must be explained to the patient’s satisfaction, and the physician must ensure the patient understands what is to be done. 2. The material risks and hazards inherent in the procedure must be explained to the patient. 3. The desired outcome must be made known to the patient, and he or she must understand this is a desired outcome and no guarantee. 4. The patient must be made aware of available alternative treatments. If these four requirements are met, and there is some documented proof that they have been followed, then the requirements of a valid informed con-
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sent will be met, and the patient will have adequate information on which to make an intelligent decision about having the procedure. Nurses are not as likely as physicians to be directly involved in informed consent lawsuits since it is generally recognized that the physician is legally responsible for obtaining consent. Nevertheless, because they work so closely with physicians and are responsible to patients and the hospitals where they work, nurses may become involved in such cases as witnesses. This is particularly true for OR nurses. As in all other areas, they have a professional obligation to report lapses in patient care t o the proper authorities. The consent forms they are responsible for checking become part of the patient’s medical record and may become legal documents ifthere is a lawsuit. 0 Notes 1. William C Menges, Jr, “The negligent nurse: R, for the medical malpractice victim,” Tulsa Law Journal12 (1976) 128. Written for lawyers by a lawyer, this article is a lawyer’s view of the nurse in litigation as well as a summary of current law concerning nurses and malpractice. 2. George J Annas, The Rights of Hospital Patients (New York: Avon Books, 1975) 57. 3. Elinor S Schrader, “Informed consent: The nurse’s responsibility,”AORN Journal 18 (October 1973) 667-668. 4. E Hayt, L Hayt, Law of Hospital (Chicago: Physician’s Record Co, 1972) 490. 5. J Pohlman, “Informed consent: The doctor’s dilemma and HB 682 2,” Columbus, Ohio, 1976. (Typewritten) 2. 6. Update on lnformed Consent, Bulletin 1897-A (Columbus: Ohio Hospital Association, 1976). 7. Accreditation Manual for Hospitals (Chicago: Joint Commission on Accreditation of Hospitals, 1976) 95. 8. Schloendotif v Society of New York Hospital, 211 NY 125, 105 NE 92, 93, 1914. 9. J Horty, ”Informed consent: A problem in semantics,” Action Kit for Hospital Law (January 1972) 1. See also Sard v Hardy, 379 A 2d 1014, Md Ct of App, Nov 9, 1977, 1022.
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