Opinion ID: 1387022
Heading Depth: 3
Heading Rank: 1

Heading: Hawai`i's Doctrine of Informed Consent and the Expert Medical Testimony Requirement

Text: In Nishi v. Hartwell, 52 Haw. 188, 191, 473 P.2d 116, 119 (1970), this court acknowledged a common law cause of action for a physician's negligent failure to disclose to [his or her] patient all relevant information concerning a proposed treatment, including the collateral hazards attendant thereto. In Nishi, the plaintiff (Nishi), sought to recover damages for injuries he suffered that allegedly resulted from his undergoing a thoracic aortography, a diagnostic surgical procedure used to detect aneurysms. The procedure was recommended and performed by the defendant-physicians. In Nishi, we initially noted that: (1) the complaint framed the action as one sounding in battery, for the defendants' unlawful touching of Nishi without his consent; (2) battery, however, was inapplicable to the case because Nishi had consented to defendants' touching; and (3) pursuant to Hawai`i Rules of Civil Procedure Rule 15(b), because the right of a plaintiff to relief does not depend on his or her allegations or his or her theory of the case, we treated the action as one sounding in negligence, explicitly recognizing and adopting the tort cause of action based on a physician's breach of his or her duty to disclose to his or her patient all relevant information concerning a proposed treatment, which reflected a growing nationwide trend. Id. at 190-91, 473 P.2d at 118-19. Despite our acknowledgment of the doctrine of informed consent, we nevertheless affirmed the trial court's dismissal of Nishi's complaint for two alternative reasons. First, the defendant-physicians' alleged failure to disclose the collateral risk of the thoracic aortography procedure that injured Nishi was justified by the therapeutic privilege exception to the physician's duty to disclose risk information. This exception recognizes that, under some circumstances, disclosure of certain risks would not be in the patient's best medical interests. Undisputed testimony was presented at trial that Nishi was apprehensive about his heart and circulatory system problems and that disclosure of information may have exacerbated his condition. Id. at 193, 473 P.2d at 120. Second, and most importantly for the present case, under the physician-oriented or professional standard of disclosure, Nishi bore the burden to produce expert medical testimony to establish a medical standard from which the jury could find that defendants deviated from their duty [of disclosure] to [the plaintiff]. Id. at 196, 473 P.2d at 121. We noted: In determining the question of [a] physician's liability for nondisclosure courts generally follow the rule applicable to medical malpractice actions predicated on alleged negligence in treatment which requires the question of negligence to be decided by reference to relevant medical standards and imposes on the plaintiff the burden of proving the applicable standard by expert medical testimony. Id. at 195, 473 P.2d at 121 (emphasis added) (citations omitted). Because Nishi had failed to adduce expert medical testimony regarding what physicians in the community disclosed to their patients regarding the particular medical procedure, we affirmed the trial court's dismissal of Nishi's complaint, and by so holding, adopted the physician-oriented standard of disclosure for actions based on the doctrine of informed consent. Two years later, however, the United States Court of Appeals for the District of Columbia Circuit decided the seminal case of Canterbury v. Spence, 464 F.2d 772, reh'g denied, 464 F.2d 772 (D.C.Cir.), cert. denied, 409 U.S. 1064, 93 S.Ct. 560, 34 L.Ed.2d 518 (1972), and spearheaded what has become known as the patient-oriented standard of disclosure for actions founded on the doctrine of informed consent. Agreeing that the physician's noncompliance with a professional custom to reveal, like any other departure from prevailing medical practice, may give rise to liability to the patient, the Canterbury court nevertheless disagreed with the then-prevailing view that the patient's cause of action is dependent upon the existence and nonperformance of a relevant professional tradition. Id. at 783. The court, in expressing its concerns with the physician-oriented standard, stated: There are, in our view, formidable obstacles to acceptance of the notion that the physician's obligation to disclose is either germinated or limited by medical practice. To begin with, the reality of any discernible custom reflecting a professional concensus on communication of option and risk information to patients is open to serious doubt. We sense the danger that what in fact is no custom at all may be taken as an affirmative custom to maintain silence, and that physician-witnesses to the so-called custom may state merely their personal opinions as to what they or others would do under given conditions. We cannot gloss over the inconsistency between reliance on a general practice respecting divulgence and, on the other hand, realization that the myriad of variables among patients makes each case so different that its omission can rationally be justified only by the effect of its individual circumstances. Nor can we ignore the fact that to bind the disclosure obligation to medical usage is to arrogate the decision on revelation to the physician alone. Respect for the patient's right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves. Id. at 783-84. Thus, dissatisfied with the physician-oriented standard and acknowledging that the patient's right of self-determination regarding submission to a particular medical procedure can be effectively exercised only if the patient possesses enough information to enable an intelligent choice, id. at 786, the Canterbury court concluded that the scope of the physician's communications to the patient ... must be measured by the patient's need, and that need is the information material to decision. Id. (emphasis added). Therefore, the test for determining whether a particular peril must be divulged is its materiality to the patient's decision: all risks potentially affecting the [patient's] decision must be unmasked. Id. at 786-87. The Canterbury court was quick to note, however, that the central inquiry of materiality was to be judged by an objective standard: The scope of the standard is not subjective as to either the physician or the patient; it remains objective with due regard for the patient's informational needs and with suitable leeway for the physician's situation. In broad outline, we agree that a risk is thus material when a reasonable person, in which the physician knows or should know to be the patient's position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy. Id. at 787 (internal footnote and quotation marks omitted). In this context, many considerations factor into the factfinder's determination of materiality: The topics importantly demanding a communication of information are the inherent and potential hazards of the proposed treatment, the alternatives to that treatment, if any, and the results likely [to be expected] if the patient remains untreated. The factors contributing significance to the dangerousness of a medical technique are, of course, the incidence of injury and the degree of the harm threatened. A very small chance of death or serious disablement may well be significant; a potential disability which dramatically outweighs the potential benefit of the therapy or the detriments of the existing malady may summon discussion with the patient. There is no bright line separating the significant from the insignificant; the answer in any case must abide a rule of reason. Some dangersinfection, for example are inherent in any operation; there is no obligation to communicate those of which persons of average sophistication are aware. Even more clearly, the physician bears no responsibility for discussion of hazards the patient has already discovered, or those having no apparent materiality to patients' decision on therapy. The disclosure doctrine, like others marking lines between permissible and impermissible behavior in medical practice, is in essence a requirement of conduct prudent under the circumstances. Whenever nondisclosure of particular risk information is open to debate by reasonable-minded [persons], the issue is for the finder of the facts. Id. at 787-88. Following Canterbury, the Hawai`i legislature in 1976 enacted HRS chapter 671, which deals with medical torts, and codified the tort of a physician's negligent failure to disclose risk information prior to treatment. The statute was subsequently amended in 1983. Today, HRS § 671-3 (1985) deals specifically with informed consent and provides in pertinent part: Informed consent; board of medical examiners standards. (a) The board of medical examiners, insofar as practicable, shall establish standards for health care providers to follow in giving information to a patient, or to a patient's guardian if the patient is not competent to give an informed consent, to insure that the patient's consent to treatment is an informed consent. The standards may include the substantive content of the information to be given, the manner in which the information is to be given by the health care provider and the manner in which consent is to be given by the patient or the patient's guardian. (b) If the standards established by the board of medical examiners include provisions which are designed to reasonably inform a patient, or a patient's guardian, of: (1) The condition being treated; (2) The nature and character of the proposed treatment or surgical procedure; (3) The anticipated results; (4) The recognized possible alternative forms of treatment; and (5) The recognized serious possible risks, complications, and anticipated benefits involved in the treatment or surgical procedure, and in the recognized possible alternative forms of treatment, including non-treatment, then the standards shall be admissible as evidence of the standard of care of the health care providers. (Bold in original.) Recognizing Canterbury 's innovations in the doctrine of informed consent and faced with the question of the effect of HRS chapter 671 on Hawai`i's doctrine of informed consent, the Intermediate Court of Appeals (ICA) in Leyson v. Steuermann, 5 Haw.App. 504, 705 P.2d 37 (1985), closely examined our decision in Nishi and questioned the continued viability of Nishi 's pronouncements regarding a physician's duty to disclose risk information regarding proposed medical treatment. In Leyson, the ICA suggested that Nishi 's descriptions of the doctrine appear to be contradictory, noting that the Nishi opinion initially describes the doctrine as a precise and definite duty but then it alternatively describes the doctrine as a duty to comply with relevant medical standards. Id. at 513, 705 P.2d at 44. Citing Canterbury, the Leyson court noted that the portion of Nishi that imposed on the plaintiff the burden of proving the applicable standard by expert medical testimony fails to recognize that [e]very human being of adult years and sound mind has a right to determine what shall be done with his [or her] own body, and that what the medical profession thinks their patients should be told is not necessarily what their patients would find significant in making their informed choices. Id. at 513, 705 P.2d at 44-45 (brackets in original) (quoting Schloendorff v. Society of New York Hospital, 211 N.Y. 125, 129, 105 N.E. 92, 93 (1914)). However, despite the ICA's discomfort over the state of the law and, although the plaintiffs in Leyson had submitted jury instructions couched in the patient-oriented viewpoint, the Leyson court did not reach the issue whether the physician- or patient-oriented standard governed the physician's duty of disclosure in Hawai`i, because the plaintiffs in Leyson had agreed to the presentation of the defendant's proposed instruction regarding the standard of disclosure. Moreover, the ICA noted that the duty to disclose, as prescribed by HRS § 671-3 and as delineated in our opinion in Nishi, were in conflictwhere Nishi mandates a duty to disclose all collateral hazards, HRS § 671-3 requires a physician to disclose the probable risks and effects of the proposed treatment or surgical procedure. [4] Although the ICA noted that [i]t is not clear from the language or history of chapter 671 whether the legislature's intent was to supplant Nishi 's ambiguously defined duty of disclosure, it nevertheless identified five material elements of the tort of a physician's negligent failure to disclose the risks of harm prior to treatment: (1) the physician owed a duty to disclose to the patient prior to treatment the risk of the harm suffered by the patient; (2) the physician negligently performed or failed to perform his [or her] duty of disclosure; (3) the patient suffered the harm; (4) the physician's negligent performance or nonperformance of duty was the [legal] cause of the patient's harm in that (a) the physician's treatment was a substantial factor in bringing about the patient's harm, and (b) the patient, acting rationally and reasonably, would not have undergone the treatment had he or she been properly informed of the risk of the harm that in fact occurred; and (5) no other cause is a superseding cause. See Leyson, 5 Haw.App. at 516-17, 705 P.2d at 47. Two years later, in Mroczkowski v. Straub Clinic & Hospital, Inc., 6 Haw.App. 563, 732 P.2d 1255 (1987), the ICA revisited the informed consent doctrine and explicitly held that HRS chapter 671 modified the description of the general standards of required disclosures announced in Nishi.  Id. at 567, 732 P.2d at 1258. The ICA explained: Act 219[, § 2, 1976 Haw.Sess.Laws 523-24] (1976) directed the board of medical examiners (board) to specifically itemize the probable risks and effects of each specific treatment or surgical procedure. It made the resulting specific itemizations, if any, prima facie evidence of what the physician was required to disclose to the patient before obtaining the patient's informed consent. Act 223[, § 1, 1983 Haw.Sess.Laws 468-69] (1983) asked the board to establish specific standards for health care providers to follow in disclosing information to a patient before obtaining the patient's informed consent. It made the board's specific standards, if any, admissible as evidence of the required specific standards of care only if the board's specific standards are designed to reasonably inform the patient of, inter alia, the recognized serious possible risks and complications of each specific treatment or surgical procedure. Since under both Acts 219 and 223 the board's specifically itemized components of the statutory general standard are relevant evidence of the applicable general standard, it necessarily follows that the statutory general standard is the applicable general standard. Id. at 567, 732 P.2d at 1258 (emphasis added). Because Mroczkowski was injured in 1980, the ICA applied the 1976 statutory standard. In so doing, the ICA held that, had the Board of Medical Examiners developed the specifically itemized components of the statutory general standard, as contemplated by HRS § 671-3(b) (1976), Mroczkowski would have been required to prove the specific components because, as stated in the statute, the board's itemization would have been prima facie evidence of the specific information required to be given. Due to the overwhelming amount of medical and surgical procedures, however, the board did not comply with HRS § 671-3(b), and the ICA accordingly held that Mroczkowski was therefore required to prove by proper evidence that the harm he is complaining about was a probable risk.... Id. at 568, 732 P.2d at 1259 (emphasis added). The ICA, however, did not further elucidate as to what would constitute proper evidence, and, moreover, explicitly declined, in a footnote, to answer the question whether the seriousness of the risk as delineated in the 1983 amendments to HRS § 671-3 was to be answered from the point of view of the patient, the physician, or otherwise. Id. at 567-68 n. 1, 732 P.2d at 1259, n. 1. Subsequently, in Keomaka v. Zakaib, 8 Haw.App. 518, 811 P.2d 478, cert. denied, 72 Haw. 618, 841 P.2d 1075 (1991), the ICA explicitly held that the statutory standard set out in HRS § 671-3(b) would govern the physician's duty of disclosure and noted that a physician or surgeon has a duty to reasonably inform his [or her] patient regarding those items specified in HRS § 671-3(b) as to the proposed treatment or surgical procedure in order to obtain an informed consent from his [or her] patient. Id. at 524, 811 P.2d at 482-83. The Keomaka court did not, however, address the issue whether the statutory factors were to be viewed from the viewpoint of the physician or the patient. Finally, in Bernard v. Char, 79 Hawai`i 371, 903 P.2d 676 (Haw.App.1995), cert. granted, 78 Hawai`i 474, 896 P.2d 930 (1995), the ICA explicitly addressed the issue whether the physician's duty of disclosure, in the dental context, would be assessed from the viewpoint of the physician or the patient. In Bernard, the ICA reiterated the physician's duty to disclose risk information as phrased in Nishi that a physician owes a duty to disclose all relevant information concerning a proposed treatment, including the collateral hazards attendant thereto, so that the patient's consent to the treatment would be an intelligent one based on complete information. Bernard, 79 Hawai`i at 382, 903 P.2d at 687. Citing growing acceptance in recent years for the patient-oriented standard across the nation, the ICA held that, [b]ecause the focus of this duty is on what information a patient needs in order to make an intelligent decision regarding a course of treatment, we conclude that the patient standard applies. Id., 79 Hawai`i at 382, 903 P.2d at 687. The ICA went on to explain: Under the patient standard, expert testimony is not critical to demonstrate the amount of information a patient needs in order to intelligently decide between two treatment options. The decision as to what procedure to undergo is ultimately the patient's; to impose a standard of disclosure dictated by experts would be to undermine the decision-making power of patients in similar situations. Therefore, in proving the element of duty for informed consent purposes, a patient is not required to produce any expert medical testimony regarding what other reasonable dentists would have disclosed under the same or similar circumstances. Id. (emphasis added.) The Bernard court cautioned, however, that the adoption of the patient standard should not be construed to mean that expert [medical] testimony may be dispensed with entirely in informed consent cases, id., 79 Hawai`i at 383, 903 P.2d at 688, and noted that [e]xpert testimony will still be required to establish the nature of risks inherent in a particular treatment, the probabilities of therapeutic success, the frequency of the occurrence of particular risks, and the nature of available alternatives to treatment. Id. (internal quotation marks, internal brackets, and citation omitted). However, the Bernard court did note that, regarding the therapeutic privilege exception, pursuant to Nishi, the physician-oriented standard applied because a physician's nondisclosure of risk information pursuant to the therapeutic privilege exception would be based on the physician's exercise of his or her professional judgment. Id., 79 Hawai`i at 381-82, 903 P.2d at 686-87. As noted in Nishi, a defendant doctor's testimony may, in appropriate circumstances, satisfy the expert testimony requirement pursuant to the physician-oriented standard.