Informed consent: from the ambivalence of Arato to the thunder of Thor.

AuthorArabian, Armand
PositionCalifornia

The law of informed consent touches on some of the most fundamental rights and interests of modern society. Ideas of self-preservation, self-determination, and self-fulfillment are jeopardized when consent to a medical procedure is either uninformed, involuntary, or absent. It is thus essential that applicable law be firmly contoured across the country, especially in light of the impending changes in our national health care system. The goals of the doctrine of informed consent, the preservation of patient autonomy and improved decisionmaking, will be furthered by careful designation and delimited standards.

We must note that, valuable as legal standards are, the voice of law does not end the dialogue; it marks its beginning. The legal aspect of informed consent is limited by the very nature of the questions involved in its appropriate application such as are few other areas of the law. For guidance, it is essential that we observe the medical profession and fathom the intricacies of the physician-patient relationship because the law of informed consent, whether established by legislation or case law, dramatically impacts that relationship and the delivery of medical care in the United States. It is this fact that must remain foremost in the minds of all who discuss the proper definition and role of the law and is a primary reason why we must proceed with caution.

This discussion will focus on three areas of informed consent law that have experienced recent growth and are essential to the proper functioning of the doctrine:(1) the methods for determining competency, the proper level of physician disclosure, and the importance of ascertaining the patient's intent. Two recent California Supreme Court decisions, Thor v. Superior Court(2) and Arato v. Avedon,(3) will provide the basis for this analysis and will be relied upon extensively for foundation and perspective.

Historical Background

For hundreds of years, the law has required physicians to obtain the consent of their patients before undertaking a procedure.(4) This early obligation, however, bears only minimal similarity to what we call "informed consent" today.(5) For example, to avoid prosecution for battery, physicians needed only to advise patients of proposed treatment and obtain their consent.(6) This requirement still exists, and it constituted the physician's sole obligation in some jurisdictions until quite recently.(7) Today, more comprehensive information relating risks, benefits, and available alternatives, including no treatment, is required.(8) In response, two competing approaches have emerged, each based on analytically different reasonableness standards. One requires a physician to disclose whatever information a reasonable patient would find material;(9) the other requires disclosure of whatever information a reasonable medical practitioner would provide.(10) The national trend, and the law in California, is to define informed consent from the patient's point of view,(11) and that is the approach presented here. Physician-Patient Disclosure and the Judiciary

As informed consent law has developed, one thing that has become vividly clear is the imprudence and generally harmful result of excessive judicial meddling with the delicate physician-patient relationship.(12) Some states have closely circumscribed the information a physician must provide through various statutory compilations,(13) each necessarily requiring a degree of interpretation and application by the judiciary. However, specific rules of action are not appropriate beyond a certain point. The issue of whether a specific or a more abstract formulation of a physician's duty should be utilized was faced in Arato v. Avedon.(14)

In Arato, physicians told a patient with pancreatic cancer that the disease was nearly always fatal but did not give information concerning his life expectancy or mortality statistics. In a series of more than seventy visits to his oncologists, neither the patient nor his wife ever asked for information concerning life expectancy. A course of treatment involving chemotherapy and radiation proved unable to stop the spread of the disease. Not long after his death, Mr. Arato's wife and children brought suit against the physicians, alleging they failed to adequately disclose the shortcomings of the proposed treatment and thus had failed to obtain the patient's informed consent.(15) Specifically, they argued that the morbidity rate of pancreatic cancer was material to Mr. Arato's decision whether to undergo postoperative treatment and that, had he known only five to ten percent of those afflicted live for as long as five years, he would have chosen to live out his last days at peace with his wife and children and arranging his business affairs.(16)

The jury received a modified version of California's standardized jury instruction,(17) the so-called reality of consent instruction drawn from Cobbs v. Grant,(18) and various other special and general instructions, none specifically requiring disclosure of mortality rates.(19) The California Supreme Court found that the instruction embodied the proper rule.(20) In opting for a somewhat abstract formulation of the rule, the court declined to endorse a mandatory disclosure of life expectancy probabilities(21) and refused to further intrude on the subtleties of the physician-patient relationship by requiring disclosure of information that might or might not be indicated in a given treatment context:

The contexts and clinical settings in which physician and patient interact and exchange information to therapeutic decisions are so multifarious, the informational needs and degree of dependency of individual patients so various, and the professional relationship itself such an intimate and irreducibly judgment-laden one, that we believe it is unwise to require as a matter of law that a particular species of information be disclosed. We agree with the insight in Salgo, that in administering the doctrine of informed consent, 'each patient presents a separate problem, that the patient's mental and emotional condition is important and in certain cases may be crucial, and that in discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent.'(22)

In my view, this statement defines the proper role of the judiciary in the law of informed consent. Once competency is determined and the legal and metaphysical perspectives established, the actual level of disclosure is something the law cannot clearly dictate. This task we must relegate to the venerable American jury, which presumably is also composed of typical patients. Any practical guidance must come from the medical profession(23) and from further exploration of the foundational policies the doctrine of informed consent is intended to advance.

The Principle of Autonomy

Of those interests guiding the doctrine of informed consent, the principle of personal autonomy must be considered preeminent.(24) This is exemplified by Thor v. Superior Court.(25) In Thor, Howard Andrews, a prisoner under a life sentence, became a quadriplegic from a fall. Subsequently, he refused to eat or receive necessary medication, placing him at serious risk of further injury and death. Staff psychiatrists found him depressed but mentally competent to understand and appreciate his circumstances. His attending physician initiated proceedings, seeking an order allowing the use of a gastrojejunostomy tube or percutaneous gastrostomy tube to feed and medicate Andrews against his will.

In refusing the order, the California Supreme Court emphasized the importance of personal autonomy. "The developing interdisciplinary consensus ... uniformly recognizes the patient's right of control over bodily integrity as the subsuming essential in determining the relative balance of interests."(26)

Anglo American law starts with the premise of thorough-going self determination. It follows that each man is considered to be master of his own body, and he may, if he be of sound mind, expressly prohibit the performance of lifesaving surgery ... the law does not permit [a doctor] to substitute his own judgment for that of the patient by any form of artifice or deception.(27)

Effectuating the patient's freedom of choice remains the primary goal.(28) Drawing from California case law and a wide panoply of state and federal decisions, the court concluded that a competent adult has the right to decline medical treatment after proper disclosure of the relevant information,(29) even when death will inevitably result.(30)

The court went on to balance this fundamental interest against four countervailing state interests: preserving life, preventing suicide, maintaining the integrity of the medical profession, and protecting innocent third parties.(31) It concluded that none of these state interests outweighed a competent, informed adult's interest in exercising self-determination and control of bodily integrity.(32) Although jurisdictions are not in agreement as to the origins of the right,(33) there is a general consensus that the right exists.(34) Early decisions extended the right only to cases where the patient was comatose and there was no reasonable possibility of returning to a cognitive, sapient state,(35) but courts have generally abandoned this distinction.(36) The decision to exercise informed consent in life and death situations nevertheless remains difficult.(37)

Patients as Decisionmakers

Informed consent issues arise in two distinct scenarios. The first and most obvious occurs when the patient is the decisionmaker. Information must be disclosed to the patient, who will interpret it and apply it, seeking the advice of others only if so inclined. Unquestionably, these comprise the bulk of the cases, and questions revolve around the ebb and flow of the physician-patient relationship and the proper level of disclosure a...

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