Informed consent—a legal evaluation

In the 1960 case of the patient who had bilateral mastectomy for cancer of the breast and severe burns following subsequent radiation therapy, the Kansas Supreme Court decided the radiologist was “obligated to make a reasonable disclosure to the patient of the nature and probable consequences of the suggested or recommended … treatment, and … of the dangers within his knowledge which were incident to, or possible in, the treatment he proposed to administer.” The court noted that if the patient knew of the risk no disclosure would be necessary, and that a doctor might not have to discuss risks if to do so might “so alarm the patient that it would in fact constitute bad medical practice.” A good summary of informed consent appears in the 1975 paperback ACLU handbook “The Rights of Hospital Patients.” Informed consent becomes a legal issue when a patient has had an adverse outcome and the question arises as to whether the doctor adequately considered the possibility of the adverse outcome and adequately communicated that possibility to the patient. The physician has an ethical and legal duty to inform his patient adequately, but what constitutes adequate information and how much of that information should be on a printed “informed consent” form signed by the patient has been the subject of dozens of papers published within the past few years in the literature of ethicists, philosophers, social scientists, physicians, and attorneys. Informed consent should mean that the right thing is being done, as the patient would want it to be done if he were as knowledgeable as the physician should be by keeping apprised of the scientific literature. In the June 1978 Mayo Clinic Proceedings, Moore discusses the advantages and pitfalls of common consent forms and makes suggestions on how they may be used and whether they should be used at all. Among other things, he notes that forms are not a substitute for open discussion. The physician should conduct the key discussion, and the patient's immediate family should be encouraged to be present. Considerable attention should be paid to comprehension by the patient, and the physician should make a timely note in his records about the discussion. It has been reported that even when possible undesirable outcomes are discussed at length and tape-recorded, the patient may subsequently forget the conversation that took place for various reasons, including the wish to suppress undesirable possibilities (Ann. Thorac. Surg. 22:209, 1977). The legal concept of informed consent is that the patient has been informed and has consented; ethically and philosophically, there may often be no such thing, since if the patient has suppressed the information he is psychologically not “informed,” and his consent is that of a less knowledgeable person given to one he perceives as more knowledgeable. Thus, his consent is by reliance on the physician's integrity and good judgment, rather than consent based on adequate presentation of all the information. In diagnosis and therapy, the physician who deals with breast cancer patients as he himself would wish to be dealt with if he had breast cancer, who adheres to the current standard of care, who never loses patience or gives up hope, who never tells a patient his condition is hopeless, and who always involves the patient in his own therapy not only need not fear a legitimate malpractice suit but also protects his patients from worthless and possibly harmful remedies for which the unscrupulous make miraculous claims. Actual injury is the key element in malpractice cases; in half the states, there are now statutory attempts to blunt the strength of informed-consent claims and protect physicians who comply with the statutes (N. Engl. J. Med. 300:929, 1979).