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  Legal concerns become less dominating and intrusive, and more likely to be supplanted by ethical considerations, when critical care teams initiate and continue sensitive, consistent, and honest communication with their patients and significant others.

  
  
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  Most informed consent legal cases are framed as negligence actions, in which the alleged unintentional wrong is the physician’s violation of the fiduciary or trust duty to serve the patient’s best interests by informing the patient adequately as part of the testing and treatment authorization process.

  
  
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  In order to be considered legally effective, consent to medical treatment must (in the absence of a valid exception such as an unforeseeable emergency) be voluntary, informed, and made by a cognitively and emotionally capable decision maker.

  
  
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  Consent remains necessary for the treatment of decisionally incapacitated patients, but the consent must be obtained from a surrogate acting on the patient’s behalf.

  
  
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  A properly informed, mentally capable patient has the right to make personal medical decisions, including a decision to refuse even life-prolonging treatment.

  
  
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  A surrogate is expected to make decisions consistent with what the patient would choose if he or she were presently able to make and express choices personally—the substituted judgment standard.

  
  
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  The ability of physicians to consult institutional guidelines concerning patient admission to, retention in, and discharge from ICUs generally leads to better, more consistent decisions that are easier to defend against later claims of impropriety.

  
  
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  The “brain death” standard provides, as either an alternative to or a replacement for the traditional heart-lungs approach, that a person is legally dead when there is irreversible cessation of all brain function.

  
  
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  Creating and maintaining accurate records of patient care is an integral part of the duty that a health care provider owes to a patient.

  
  
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  Particular areas of attention in a critical care–sensitive risk management program should include the organization and administration of ICUs, the roles and responsibilities of the different professionals having contact with patients in those units, medical records, equipment maintenance, equipment modification, equipment records, analysis of equipment malfunctions, incident reporting, and trend analysis of unexpected incidents.

The making, implementation, and documentation of patients’ treatment decisions in the practice of critical care medicine raise a host of potential legal implications. This chapter briefly outlines some of the more salient issues and suggests avenues for their management and further exploration.

This chapter concentrates primarily on the chief legal ramifications of critical care medicine in the United States. It should be recognized, however, that law is increasingly influencing the delivery of critical care medicine elsewhere in the world as well. Historically, Non-American critical care physicians have tended to behave more paternalistically and unilaterally than their American counterparts, but “the apparently increasing frequency of contentious legal cases in other countries” in the critical care context has been noted.¹ Today, “European intensive care physicians [as well as physicians in other parts of the globe] are well aware that the decisions made in end-of-life situations, or in other cases when recovery of essential vital functions is not possible, are governed by different laws in different countries.”²

Because critical care is evolving rapidly throughout the world, the contributions of the respective legal systems, positive and negative, to health care and society are difficult to pin down precisely. It is clear, though, that legal concerns become less dominating and intrusive, and more likely to be supplanted by ethical considerations, when critical care teams initiate and continue sensitive, consistent, and honest communication with their patients and significant others.

The established legal doctrine of informed consent (more properly, informed decision making) is based on the ethical principles of autonomy (personal self-determination) and beneficence (doing good for the patient). Early lawsuits growing out of medical interventions conducted in the absence of any semblance of consent were predicated on a battery theory (the wrong of touching the patient without permission). Most modern legal cases, however, are framed as negligence actions, in which the alleged unintentional wrong is the physician’s violation of the fiduciary or trust duty to serve the patient’s best interests by informing the patient adequately as part of the testing and treatment authorization process.

In order to be considered legally effective, consent to medical treatment must meet three tests (in the absence of a valid exception such as an unforeseeable emergency).

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  Voluntariness

  
  
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  Information

  
  
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  Decisional capacity

First, consent must be voluntary—that is, not coerced or based on the exercise of undue influence, in nature. In a patient and family-centered model of critical care delivery, the patient (or surrogate decision maker) must retain the ultimate power to accept or reject the available medical interventions.

Second, consent must be adequately informed or knowing. About half of the jurisdictions within the United States still enforce a physician-oriented standard of information disclosure, inquiring whether the amount of information shared by the physician with the patient or surrogate was consistent with the usual practice of other prudent physicians in similar circumstances. By comparison, the remaining states have adopted a more patient-oriented standard, requiring physicians to disclose all the information that a reasonable patient would want to know under the circumstances. This latter approach is also termed the materiality standard, because it mandates the disclosure of information that would be material—that is, information that might affect the decision-making calculus—of a reasonable patient.

Under either a physician- or patient-oriented approach, several particular kinds of information need to be disclosed in understandable lay language (rather than using medical jargon). These informational items include

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  Nature of the patient’s medical problem

  
  
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  Prognosis with and without the intervention

  
  
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  Nature of the suggested intervention

  
  
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  Likely benefits from the intervention

  
  
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  Reasonable alternatives

  
  
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  Foreseeable risks or side effects of the suggested intervention and the various alternatives

  
  
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  The probable financial ramifications of the medical decision

Third, informed consent is sufficient only when given by an individual with adequate mental (both cognitive and emotional) capacity and legal authority. This element of consent may be especially problematic in critical care and is discussed in the next section.

A note of caution regarding the legal value of written consent forms must be added here. Contrary to popular belief, a written consent form is not the equivalent of legally effective informed consent. True informed consent is the process of mutual communication, negotiation, and ultimate patient or surrogate choice as described earlier.³ The written form is only tangible documentation or evidence that the communication and negotiation process occurred. This evidence may be very important to the physician in defending against a lawsuit claiming that medical intervention was inflicted in the absence of informed consent, by creating a legal presumption that consent was properly obtained. However, when inadequate communication actually took place, the presumption created by the consent form may be successfully rebutted or overcome by the plaintiff.

While broad blanket consent forms used in many hospitals are sufficient to authorize routine, noninvasive medical interventions, more specifically tailored and informative forms are preferable for interventions that are nonroutine or invasive. Certainly, specifically detailed written consent forms are necessary for interventions that might be characterized as investigational or innovative.

Application of these general principles is somewhat complicated in critical care by the fact that in the intensive care unit (ICU), interventions can be nearly continuous for the most unstable patients. Informed consent is required any time the physician proposes doing anything to a patient (ie, any medical intervention). For quasi-continuous interventions, informed consent must be obtained at the initiation of the intervention, and the patient or surrogate must be afforded the opportunity to withdraw that consent at any later point.

Most interventions in critical care may be categorized as risky or invasive, that is, an intervention involving a higher degree of risk or intrusion for the patient than he or she would ordinarily face in normal, everyday life. However, this categorization is relevant only to the question of the extent of advisable documentation; the requirement of a meaningful informed consent process itself applies regardless of an intervention’s level of risk or invasiveness.

Minor children (defined by the states for medical purposes as those individuals younger than 18 years old) are presumed legally to be incapable of making their own medical decisions. In the absence of an exception based on the minor’s “emancipated” or “mature” status, the natural parent or court-appointed guardian/conservator is legally empowered to act as the medical decision maker. In sharp contrast, adults are presumed legally to be decisionally capable to act on their own behalf. In critical care, some patients remain capable of making and expressing medical choices, or at least participating in the decision-making process to some extent (with or without the assistance of family or friends), based on a rational thought process of digesting and weighing information about the benefits and risks of different alternatives.⁴ Many critical care patients, though, are so ill and debilitated that they lack sufficient present decisional capacity.

Although in theory the same degree of mental capacity is necessary whether the patient is accepting or declining the recommended medical intervention, in practice, a formal inquiry into patient capacity usually occurs only in the case of patient refusal. Ideally, a judgment about patient decisional capacity, which may fluctuate widely over time because of a variety of natural and iatrogenic factors, is being made at least implicitly by the attending physician each time the patient is seen.⁵ Such an inquiry ought to be built automatically into every physician-patient encounter. When decisional capacity is questioned seriously, a more focused examination needs to be conducted. In especially ambiguous cases, documentation in the patient’s medical record by consultants who have evaluated the patient’s decisional capacity is prudent risk management for the physician proposing an intervention, since that physician is the one ultimately responsible for ensuring informed consent; the legal system affords psychiatrists a great deal (arguably an excessive amount) of deference as consultant assessors of patients’ decisional capacity.

For patients who—in fact—lack sufficient ability to engage in a rational decision-making process, the presumption of capacity is rebutted or overcome. This does not mean, however, that the physician may dispense with obtaining informed consent prior to initiating particular interventions. Consent remains necessary for the treatment of incapacitated patients, but the consent must be obtained from a surrogate acting on the patient’s behalf.⁶ Several approaches to surrogate decision making have been developed.⁷

The overwhelming majority of states have enacted “family consent statutes,” which specify relatives and other people (ordinarily in a priority order) who may legally make medical decisions for an incapacitated family member. Advance proxy directives (see the next section), especially the durable power of attorney, may be used by currently capable persons to designate their own surrogates in the event of future incapacity. A formal guardianship or conservatorship (precise terminology varies among jurisdictions) proceeding may be initiated, in which a court finds the patient (the ward) to be decisionally incapacitated (the legal term usually employed is incompetent) and appoints someone else (the guardian or conservator of the person) as the surrogate decision maker.

In most cases, however, the physician relies on a family member as the surrogate decision maker for an incapacitated patient, even when there is not a specific statute, advance directive, or court order expressly empowering the family to act in this role. This informal process of making do using next of kin, even without explicit legal authority, works well in the vast majority of situations in which the family members agree on a course of conduct both among themselves and with the physician, and where they appear to be acting consistently with the patient’s own values and preferences (the substituted judgment standard) or with the patient’s objectively determined best interests.⁸

Some patients retain a sufficient degree of capacity to make and express their own medical decisions even after admission to an ICU. Legal precedent is very clear that, except in cases in which the welfare of a third party such as a minor dependent is jeopardized, a properly informed, mentally capable patient has the right to make personal medical decisions, including a decision to refuse even life-prolonging treatment.

If the patient is decisionally incapacitated, a more difficult scenario may confront the physician.⁹ A surrogate decision maker may be identified (see the previous section) by either a state family consent statute, the patient’s prior execution of a durable power of attorney naming a health care agent, court appointment of a guardian/conservator, or informally relying on available, willing family members. The surrogate is expected to make decisions consistent with what the patient would choose if he or she were presently able to make and express choices personally—the substituted judgment standard, or “donning the mental mantle” of the incapacitated person. If there is no reliable indication of the patient’s preference under the circumstances (a number of states require proof of this fact by clear and convincing evidence),¹⁰ the surrogate must act benevolently in the patient’s best interests, considering—from the patient’s perspective—the proportionality or comparison of likely benefits and burdens associated with available medical alternatives. The surrogate frequently is guided in fulfilling his or her decision-making role by treatment recommendations offered by the attending physician.¹¹

A serious problem arises when another relative or friend of the patient accuses the surrogate of making choices that are contrary to both the patient’s substituted judgment and best interests and that relative or friend demands a contrary course of treatment. Such unfortunate circumstances, such as those surrounding the infamous Florida case of persistent vegetative state patient Terri Schiavo, often end up being resolved in a courtroom.¹²

Surrogate decision making for others is a difficult, stressful endeavor.¹³ Especially as the population ages, an increasing percentage of patients lack available and willing relatives or friends to act as surrogate decision makers for them. In such cases, there are several potential sources of guidance for the physician.