Some Advice on " Informed Consent "

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As a service to its members, the California Medical Association has prepared advice and guidance for physicians on the applications of “informed consent” in light of the recent CaliforniaSupreme Courr ruling on this subject. These questions and answers cover general topics of importance. More specific advice is being prepared by the C M A ad hoc Committee on Informed Consent for distribution ut u futuredate. Q The California Supreme Court recently handed which affects every physician who is actively prncticing medicine. We are told it has a significant and immediate effect on the physician’s responsibility to obtain I patient’s consent before providing medical treatment. Please explain what this decision is Before discussing the recent decision, it would be useful to understand the origin of the physician’s duty in this respect. Under the law, if injury results from physical contact, the injured person has a civil cause of action known as assault and battery. The law recognizes certain defenses, the most c m - mon being “consent.” If one penon consents to the possibility that he will be harmed by another, the law will not allow the injured party to complain. This rule applies in the area of medical treatment. In emergencies where it is physically impractical or impossible for the patient to express his consent, the law implies that he has consented. But in nonemergency situations, his consent must be given. Q Physicians have heard over and over again about the doctrine of “informed consent.” What do the courts redly mean when they say that “consent” The law recognizes that medicine is a mystery to the average patient, and he might consent to a particular treatment or procedure without really understanding the consequences. When courts say that a patient’s consent must be informed, the courts are saying that the patient‘s consent, to be binding,must be made with his eyes open to the consequences. This increasing focus by the courts on the patient’s rights may be more readily understood by viewing it as another illustration of the growing trend toQ: Why have the courts singled out physicias In lLir tient-physician relationship which auka doctors particularly vulnerable in this area? Yes.In the Cobbs vs. Grant decision. the Suprrnx Court explained and expanded upon the realom for the doctrine. The Court adopted four b . 5 ~pcinciples. They are: 1 . Patients are generally persons unlerrned in thc 2. An adult person of sound mind has h e right IO determine whether or not to submit to livid 3. The patient’s consent to treatment. to be kdly effective. must be an informed consent 4. The patient, being unlearned in medical ULKIIZI. has dependence upon and trust in his php ri in for the information upon which he relies dunng his decision process. This raises an obligrrron lor the physician that transcends the mukccplrct. These basic principles call for a “due care duty“ for physicians to explain to patients thacr r K t s necessary For the patient to make an informed judgment regarding his conscnt to medical treatmcni Q: It is apparent that the patient, and not the physician, ha5 the legal right to determine whether or not he will undergo a proposed medial procednm Does this mean that the patient has h e right l o refuse medical treatment, even that which woald k in his best interest, and the physician m a abide Precisely. For example, the physician may regard a radical mastectomy as the best treatment for the patient’s breast cancer. But he must dixuss possible alternatives such as a simple mastectomy or radiation theraw. It will be U D to the Datient to make the final d&is.on

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Q: It is extremely important that physicians know how extensively they must inform the patient Exactly what are these things which have to be disclosed? The “what” of informed consent basically can be divided into three areas: 1. The physician must describe the proposed treatment in lay terms so that the patient understands the nature of what is prop cd. The explanation does not have to constitute a “minicourse” in 2. The risks of the proposed therapy must be ex3. If there are any alternative choices of treatment, those should be disclosed. Q Because this doctrine potentially applies to virtually every kind of medical treatment which involves “contacting” the patient in some way, it would also apply to any type of elective major surgery. But what about the prescription or administration of potent drvgs or of minor surgical procedures such as the removal of warts and so on? The Court distinguishes between those procedures which it labels “complex” and those which it labels which are complex (certainly electiw surgery and risky diagnostic procedures fall into this category), the physician has a duty to explain the nature of the procedure; any risks, regardless of their likelihood, which could cause serious bodily harm; and the alternative methods of treatment, if any. As to procedures which are “simple” and “common,” the Court states that a physician cannot be expected to explain risks which are commonly understood to be remote. The Court cited a “blood count” as an example. A typical physical examination would probably be another example. Q: There are going to be many typa of medical treatment which do not fall clearly into either complex or simple procedures. For example, whaf about the prescription of certain drugs, sucb ns Chloromycetin? These drugs may involve certain risk which, although extremely remote, may cause serious illness or even death. There is no question but that the decision leaves many questions unanswered. There are going to be gray zones. procedures which defy simple catemon.” The prescription of potent drugs is one such area. The Court appears to say that for drugs whose prescription is relatively common, there is no duty to disclose remote risks. On the other hand, even remote risks must be described if the drug is in the experimental stage, prescribed only rarely, or has been on the market for a relatively short period explaining the nature ot the treatment, risks, and alternative methods of treatment. Please elaborate on when an explanation of ”alternative methods of A: The importance of this statement in the Court’s opinion cannot be overemphasized. For example, take the patient who is told he must have a thyroidectomy for his Graves’ disease, and then winds up with some inherent complication of the procedure. The physician runs a severe risk of professional liability if he has failed to warn the patient, not only of the risks, but also of the alternative treatments, such as radioactive iodine therapy and the use of antithyroid drugs. Furthermore, where surgery is purely elective, the physician must be especially careful to explain alternative treatments and risks. What is there about more u w n t treatment which places less of a burden on the physician? The Court does not expressly distinguish between urgent and elective types of treatment, but, in practical terms, there is an important difference. In addition to proof that an informed consent was not obtained, the Court requires that the patient prove ment, if the essentialinformation had been provided. Under this rule, a patient is not going to make a convincing case if be merely testifies that he would not haw consented bad he known certain facts, in the f a n of strong medical necessity for the treatment given. It is doubtful in such a case that a jury would consider his refusal under those circumQ: Nevertheless, wouldn’t it appear that the safest practice Is to inform all patients routinely? A: Undoubtedly this is true. However, in cases where the treatment is urgent, it would appear that the patient is going to have a heavier burden in convincing a jury that a “reasonable man” would have refused if he had known a particular risk or alterOn the other hand, for example, take the patient who has low back pains and no neurological changes and is subjected to surgery without explanation of risks or a discussion of conservative and long-term

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treatment. This patient has a sure-fire case if he winds up with arachnoiditis. Q Them is a stmng feeling in tbe medid community tbnt physicians should, in cerlnin situations, be able to withhold certain information wlthout incurring legal liability. What abont the gravely ill patient for whom the procedure contemplated by the cian might decide not to explain cedain risks for fear that such infarmation would hamper the patient’s treatment or seriously depress him. Under these circumstnnces, what is a physician’s duty? This is one of the most important but also one of the most difficult areas in which to advise. The decision appears to state that a physician may make a judgment to withhold information about certain risks if he decides that disclosure would be detrimental to the mental or physical well-being of the patient. However, the Court is careful to point out that the standard to be applied in deciding whether the physician was justified in withholding this i n - formation will not be a medical one, but will be a ”reasonable man” standard. This means that the jury will decide, without the aid of expert medical testimony, whether the physician was justified in withholding this infomation. There is no question but that a physician who takes this course increases his malpractice liability risk. Q. What is a physicinn’s duty if the patient really doesn’t want to hear about details of an operation If the patient, on his own initiative, informs the physician that he does not want to be informed, the physician’s duty to inform ceases as of that point. It is imperative, however, that the patient’s decision be made freely and not the result of any intimidation on the part of the physician. Q It’s one thing to understand the problem and the masom why it is necessary that physicians obtain an informed consent. But how can physicians prove in court that the consent was an informed consent? Isn’t it just his word against the patient’s? This decision makes several things very clear. First, if a physician relies solely on the fact that he had a conversation with the patient and preserves no written evidence of that conversation, he is begging to be held liable for malpractice. Secondly, the typical standardized hospital consent form is virtually useless as a protection to the physician. There are several reasons for this. The most important is that the typical consent form contains no actual explanation of the treatment or of the risks, so it conveys none of the essential information to the patient. Therefore, physicians may not rely on (I) conversations which have not been documented or ( 2 ) on standardized hospital consent form. However, there are several measurn physicians may take which will be quite effective in a court of law. For those procedures which a physician repeatedly performs, it may be practical and useful to develop carefully prepared written explanations, in lay language, which spell out the risks and alternative methods of treatment. The patient could be asked to read the form in advance and then be given the opportunity to discuss it with his physician before consent is requested. Other methods of conveying the information should be explored. In certain settings, it may be practical to reduce the explanations to tape and play the recording for the From the physician’s point of view, is there more to it than the imparting of this information? Regardless of whether the physician relies on a convenation, written material or a tape recording, it is essential that the physician personally discuss the matter with the patient and make dctoiled notes of the discussion and the patient’s reactions in the patienf’s medical chart. These notes should be made at the time of the discussion or as soon thereafter as is physically possible to make the cal chart are his best protection in the event of a Can my office staff assist me in fulfilling the obligations of informed consent? The Supreme Court made it crystal clear that the duty to inform and explain rests with the physician and the physician alone. Physicians should no more delegate this duty to a nurse, admission clerk, receptionist or any other nonphysician than they would delegate the performance of major surgery to such persons. Lcgal protection flows from the physician ( 1 ) doing it himself and (2) recording what he does in the patient’s chart or record.

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Lawrenso Sorkoly Laborrlg Alchhrei and Raordr olase CALIFORNIA MEDICAL ASSOCIATION 693 Sutter Street San Francisco, California 94102