Informed Consent and Documentation

THE DOCTRINE OF INFORMED CONSENT

Definition of Informed Consent

Informed consent is obtained when a patient intentionally agrees to treatment in the absence of external controlling influences, based on an understanding of relevant information.³ The core elements of an informed consent have been defined over time in the courts and by ethicists, and are now uniformly reflected in case law and state statutes, as well as promulgations by groups such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the American Medical Association (AMA).⁴ At a minimum, physicians are obligated in most instances to disclose, prior to treatment, information regarding (i) the nature of the procedure, including whether its purpose is therapeutic or diagnostic, (ii) the risks involved, particularly those that are most likely to occur and those that are most severe, (iii) the expected benefits of the procedure, and (iv) reasonable alternatives to the procedure and attendant risks⁵ (Box 38-1). As discussed further in the following, there are a few narrow exceptions to informed consent requirements, most notably in emergent situations in which the patient is incapable of giving consent.

BOX 38-1 Key Elements of Informed Consent

images Nature of the procedure: diagnostic or therapeutic

images Risks of the procedure: especially those that are common or severe

images Expected benefits

images Reasonable alternatives: including the risks of nontreatment

The Legal Doctrine of Informed Consent

Until approximately 1975, the law of informed consent was developed solely in the court system, creating a judicial doctrine of informed consent.⁶ Cases decided prior to the 1950s recognized the patient’s basic right to autonomy and to be free from nonconsensual contact, but did not address entitlement to information about treatment.⁷ At that time, the physician was merely required to obtain authorization from the patient for the proposed treatment, without any concomitant obligation to discuss other treatment considerations. Around the turn of the 20th century, there were several important court decisions that expanded the physician’s duty to obtain consent to include a disclosure of the procedure’s benefits, risks, and alternatives. Those cases help define the requirements the doctrine places upon the physician and continue to form the framework of informed consent law to the present day.

Cases addressing consent issues began appearing in the early 1900s.⁸ Nearly all of the early consent actions arose in connection with surgical treatment, usually alleging that the surgeon altered the surgical plan after the patient was anesthetized.⁹ One prominent defense raised by physicians in those cases is that a patient’s consent for treatment was implied by his or her consultation of the physician’s expertise.¹⁰ The courts weighed the right of an individual to protect bodily integrity from intrusion against the discretion of the surgeon to proceed under the theory of implied consent and found that “the patient must be the final arbiter as to whether he will take his chances with the operation, or take his chances without it.”¹¹ By the late 1920s, the courts had generally established that the physician was allowed to provide treatment to the extent of the patient’s consent, but no further.¹²

In 1957, a California court ruled that physicians have an affirmative duty to go beyond obtaining a recognizable consent and must disclose enough information to enable patients to give an informed consent.¹³ This case, Salgo v. Leland Stanford Jr. University Board of Trustees, is historic in that the decision is the first to coin the term informed consent and marks the expansion of the physician’s obligation regarding consent to include disclosure.¹⁴ Courts in other states followed suit and within a number of years this became a standard requirement in conjunction with obtaining consent.¹⁵ Salgo signified the beginning of a judicial shift in the focus of consent cases from the issue of whether consent was obtained to whether the consent was sufficiently informed, where it substantially remains today. Unfortunately, the language of the opinion provides little assistance in defining a sufficient disclosure, or any other type of analysis that would be helpful to providers charged with informing their patients prior to treatment. In fact, the court introduced a great deal of confusion into this area by suggesting that the physician has discretion to withhold alarming information while disclosing facts necessary for the patient to reach an informed consent.¹³ This decision embodies that period’s conflicting sentiments about patient care, with a growing deference to patient autonomy on the one hand and on the other an historic reliance on the physician’s acting independently in what he or she judged to be the best interests of the patient.¹⁶

Cause of Action: From Battery to Negligence

A cause of action is a theory of liability by which the plaintiff seeks to recover in a civil action. In early consent cases, the plaintiff’s sole source of redress for unauthorized treatment was a civil action utilizing the law of battery.¹⁷ A civil action for battery protects the patient’s dignity interest of bodily integrity and does not require a showing of injury.¹⁸ This theory of liability fits well with instances in which the plaintiff complains that the physician proceeded with treatment without consent or else operated on a part of the body other than the one discussed.¹⁹ Although civil battery allegations continue to surface to the present day, by the mid- to late 1950s, there was a growing sense that battery was less suitable in consent cases that focused on the sufficiency of the disclosure.²⁰ Around this time, many courts began to suggest that the physician’s failure to obtain informed consent is more accurately considered a matter of physician error or neglect in keeping with theories of medical negligence, which is part of tort (or personal injury) law.²¹ Tort law is generated by each individual state and varies to some extent based on the prevailing state law. To prevail in a negligence action, the plaintiff must demonstrate that the defendant had a legally established duty to the plaintiff the defendant breached by failing to adhere to the standard of care expected and that this breach of duty caused injury to the plaintiff.²²

Medical malpractice is essentially negligence within the confines of health care delivery. The standard used to determine whether the alleged breach reaches the bar of negligence in most medical malpractice actions is medical custom; that is, the standard of care expected of the average reasonable practitioner in similar circumstances.²³ The standard of care is established by testimony of an expert in the field. At trial, plaintiff and defendant offer contrary expert testimony as to what constitutes the applicable care standards and whether the defendant deviated from those standards. The trier of fact (usually the jury, but in some instances the judge) then makes a decision based on the more credible expert testimony, along with other factual issues.

Under the doctrine of informed consent, providers have a duty to disclose relevant information in the course of the consent process, and if they fail to do so, they may be found negligent. The doctrine has evolved to require the physician to obtain the patient’s informed consent by disclosing the nature of the proposed treatment, the expected risks, reasonable alternatives to the procedure, and the attendant risks.²⁴ Plaintiffs alleging a breach of this obligation may sue under a negligent disclosure theory of liability. Plaintiffs bringing a negligent disclosure case typically allege that the physician provided an insufficient disclosure and that if there had been an adequate disclosure the patient would not have undergone the treatment at issue and would not have been injured. The difficulty in negligent disclosure cases most often lies in determining the amount of information the physician is required to disclose, particularly in terms of the potential risks of the proposed procedure.

THE PHYSICIAN’S OBLIGATION TO OBTAIN INFORMED CONSENT

Professional- versus Patient-oriented Standard for Disclosure

Depending on the jurisdiction, there are two primary standards used to judge the sufficiency of the disclosure: one based on medical custom and the other focusing on the perspective of the patient. In all early negligent disclosure cases, the scope of the disclosure was a decision that was uniformly left to the discretion of the physician and was judged to be sufficient as long as the disclosure was in keeping with the standard of care of practitioners in the field.²⁵ This is referred to as the professional standard. The professional standard requires that the practitioner disclose to a patient that which a reasonable medical practitioner would disclose to a patient under the same or similar circumstances when obtaining their consent for a procedure.²⁵ “Same or similar circumstances” is usually interpreted narrowly to mean the clinical circumstances of the patient, as opposed to any nonmedical considerations that are unique to the patient.²⁶ Because the scope of an appropriate disclosure is predicated on factual medical circumstances and may be derived from medical education, clinical training, continuing education, and informal discourse among colleagues, practitioners often feel most comfortable with this standard.²⁷

The professional standard mirrors the legal standard for medical malpractice, in which the physician is held to the standard of care of the average physician practicing in that specialty at the time and under similar circumstances. As such, in professional standard jurisdictions, there must be expert testimony on both sides, with the plaintiff and defendant expert physicians offering contrary assertions as to whether the defendant disclosed information and obtained consent in accordance with the prevailing standard of care.

This standard applied in most jurisdictions until 1972, when a District of Columbia Appeals Court handed down an influential decision that introduced a new standard for determining the adequacy of an informed consent disclosure. In Canterbury v. Spence, the court stated that it did not agree that a patient’s cause of action was dependent on the existence of a common practice or medical custom of disclosing the information at issue and struck down the professional standard in that jurisdiction.²⁸ Essentially, the court turned the focus from the perspective of the physician to that of the patient and held that the adequacy of the disclosure should be judged by whether the physician provided information that a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to in deciding whether or not to forego the proposed therapy.²⁸ This is known as the lay, or patient-oriented, standard. This standard was rapidly adopted in numerous jurisdictions.²⁷

Under the patient-oriented standard, the scope of the disclosure is not tied to the recognized custom or practice of physicians. Instead, the physician has an obligation to assess the patient’s situation to some extent and tailor the disclosure accordingly. The standard requires the physician to perform an affirmative inquiry into the circumstances of each patient, in order to obtain at least a minimal understanding of the patient’s situation before determining what information to discuss.²⁹ From there, the physician is obligated to disclose information that would be “material” to the treatment decision of someone in the patient’s situation.²⁷ Information is material if a reasonable person would be likely to attach significance to it. One court has held that materiality is the product of the severity of the injury and the likelihood of its occurrence³⁰ The “reasonable person” aspect of the standard refers to a hypothetical legal construct signifying an average, prudent person. The trier of fact uses it to develop and apply community standards of reasonable conduct.²⁷ Thus, if a jury finds that an average person would find a particular risk to be important to be advised of when making a decision about treatment, that information will be deemed material to the decision.

Although the patient-oriented standard appears to require more than the professional standard in terms of performing inquiries into each individual patient’s situation, in practice the courts have not held physicians to particularly stringent standards.³¹ Often the courts only require that physicians discover and account for the patient’s medical circumstances, such as his or her clinical condition and proposed treatment.³² This is not always the case, however, and physicians should be aware of at least some of the individual patient’s circumstances and goals. For example, in one negligent disclosure action, two Army physicians were found to have breached their duties of disclosure for failing to discuss alternatives to hysterectomy for a patient suffering from pelvic pain.³³ The court found both physicians liable for failing to account for the patient’s desire to remain fertile when making their treatment recommendations and disclosures.³³ The case illustrates that there is a baseline requirement to be aware of the individual patient’s situation and treatment goals, particularly those that may be directly affected by the proposed treatment.

A further implication of the patient-oriented standard is that the plaintiff’s burden of proof is somewhat eased. Because the focus of the inquiry is on the reasonable patient, a layperson, the plaintiff does not need to obtain physician expert support for his or her contention that the physician did not divulge risks that a reasonable person would find material to their decision. However, the physician must still conform to medical custom with respect to being cognizant of the relevant risks. Expert testimony is required to establish the technical issues of treatment, including what the risks of a particular procedure are, the alternative methods of treatment, the risks relating to the alternative methods of treatment, and the likely consequences of the patient remaining untreated.³⁴

All states now have a litigation remedy for failure to obtain informed consent.³⁵ States that developed the remedy through case law have generally adopted the reasonable patient standard.³⁶ Between 1975 and 1977, a number of states that had no clearly defined standard passed legislation adopting the professional standard, due in no small part to physician lobbying groups that opposed the judicial movement toward the more plaintiff-friendly patient-oriented standard.³⁷ There is an almost equal division among jurisdictions as to which standard they adhere to, with some applying a hybrid standard or variations of the two standards.³⁸ It is important to keep in mind that the standard adopted by a jurisdiction is only significant in the context of litigation and ideally should not influence the physician-patient relationship or the process of obtaining informed consent. As a matter of prudent practice, the provider should attempt in all cases to have as extensive a discussion as possible regarding the proposed treatment and its risks, benefits, and alternatives.

Negligent Disclosure Actions

As with the disclosure standard by which the physician is judged, the grounds and criteria a plaintiff must meet in order to establish and prevail in a negligent disclosure action vary from state to state. Some states have enacted statutes setting out the grounds for these actions along with recognized defenses, whereas in other jurisdictions, the courts have developed the legal framework through case law.³⁹ Generally, the elements of a negligent consent case mirror those of a general negligence action. To show negligent disclosure, a plaintiff must establish that (i) the provider had a duty to disclose certain information, (ii) there was a breach by the provider by failing to disclose this information, (iii) if the provider had discussed the undisclosed information the patient would not have consented to treatment, and (iv) the provider’s failure to disclose this information was the proximate cause of the plaintiff’s injury.⁴⁰

The most difficult question is usually whether the physician had a duty to disclose certain treatment information, such as a particular risk of treatment. This element may be broken down into two subparts. First, did a duty to disclose arise? Second, was there a duty to disclose the specific information at issue? With respect to the first question, the existence of the disclosure duty generally arises when a physician contemplates providing treatment to a patient. Circumstances such as the patient’s refusal of treatment, emergency situations, or an emotionally fragile patient complicate the issue.

Exceptions to the Duty to Disclose

If the patient refuses treatment, the disclosure obligation shifts from discussing the risks associated with the proposed treatment to disclosing the risks of nontreatment. The provider should assume that a duty still exists in the face of refusal of treatment. A California case arising from the death of a woman from cervical cancer directly addresses this issue.⁴¹ The patient was under the care of a general practitioner, who advised her that she needed a Pap smear without disclosing the risks of declining the test. She refused to undergo a Pap smear on at least two different occasions, on the basis of the cost. She was eventually referred to a gynecologist, who diagnosed advanced cancer. She died at the age of 30. The California Supreme Court found that the woman’s refusal of the Pap smear was not informed and thus not valid. The case highlights the requirement that the consent process applies to decisions to refuse or withdraw from treatment as well as decisions to undergo treatment.

In medical emergencies in which the patient is unable to provide consent due to loss of consciousness or other incapacity, the law recognizes an exception to the requirement to obtain consent.⁴² This is based on a legal presumption that a person who is physically unable to provide consent would nonetheless want life-saving treatment. Two factors must be present in order to override the consent requirement. First, the patient must be incapacitated and unable to make an informed choice, such as in instances in which the patient is suffering from sudden injury, alcohol or drug intoxication, shock, trauma, or an underlying mental or physical disease or handicap.⁴³ Second, the patient must have a life- or health-threatening disease or injury, as determined by medical judgment, which requires emergent treatment.⁴³ The most important thing to keep in mind is that both of these factors must be simultaneously present, and they must be well documented in the medical record. Moreover, a change in the patient’s condition does not justify disregarding a decision that was articulated while the patient was capable of making an informed choice.⁴⁴

Disclosure of Treatment Information

After the plaintiff demonstrates that the physician had a baseline duty to disclose, he or she must then show that the physician was obligated to disclose the specific information at issue in the case, whether a particular risk or alternative to treatment. This is usually the issue in controversy. As previously discussed, the scope of the disclosure is judged differently in various jurisdictions. Accordingly, the plaintiff must demonstrate that the physician deviated from the standard of care, failed to disclose information that was material to the patient’s decision, or some combination thereof as required in that jurisdiction for a showing of negligence. Although we provide some guidelines and practical rules for obtaining consent in the following, there are no universal criteria for defining a sufficient disclosure, and ultimately an adequate disclosure is whatever a jury determines it to be.

Causation and Harm

In addition to showing that certain risks should have been disclosed, the patient must be able to prove that if he or she had been properly informed, consent to the procedure would not have been given.⁴⁵ Some jurisdictions use the “actual patient” standard, which focuses on the testimony of the patient as to whether he or she would have consented if the information at issue had been disclosed.⁴⁶ This raises the issue of credibility, as the plaintiff has the advantage of hindsight, as well as an interest in winning the suit. Other jurisdictions employ a reasonable person standard, which considers what a reasonable person in the patient’s position would have done if the risk information had been disclosed.⁴⁷ Although the “reasonable person” is a hypothetical legal construct, this is a fact-specific standard that depends on the circumstances presented by each case. Both standards underscore the importance of taking into account the unique situation of each patient when obtaining consent. In keeping with general negligence principles, a plaintiff in informed consent cases must further show that an actual harm occurred as a direct result of the physician’s failure to disclose information. If there was no physical injury stemming from the breach in the duty to disclose risk information, the plaintiff cannot recover.

Disclosure in the Clinical Setting

Ideally, the immense body of case law, statutes, and commentary that has been generated on the issue of informed consent would by now provide specific instruction regarding what treatment information must be disclosed, which risks are material, and which alternatives should be discussed. Much like the practice of medicine, however, there are very few hard and fast rules in informed consent law. It is not possible to set out universally applicable disclosure requirements, given the variations in state-based law, unique clinical presentations, and discrepancies in jury dispositions. Nevertheless, there are general principles that may be drawn from the law and commentary to guide the provider in obtaining a patient’s consent for treatment (Box 38-2).

BOX 38-2 Clinical Caveat

In the absence of universal criteria that define sufficient disclosure, physicians and patients may be best served by discussions of informed consent that:

images Establish an interactive dialogue about the proposed intervention, including its risks, benefits, and alternatives