Opinion ID: 2832576
Heading Depth: 2
Heading Rank: 1

Heading: An Overview of Informed Consent in Hawaiʻi

Text: The common law doctrine of informed consent was first recognized as a subset of medical negligence actions. In Nishi, this court explained that the common law doctrine of informed consent imposed upon a physician “a duty to disclose to his 19  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  patient 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.” 52 Haw. at 191, 473 P.2d at 119 (citation omitted), overruled by Carr, 79 Hawaiʻi 475, 904 P.2d 489. In determining the question of a physician’s liability for nondisclosure, the Nishi court noted that “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.” 52 Haw. at 195, 473 P.2d at 121. The Nishi court then held that the “plaintiffs did not adduce any expert medical testimony to establish a medical standard from which the jury could find that defendants deviated from their duty . . . .” 52 Haw. at 196, 473 P.2d at 121. Rather, the “defendants, by their testimonies, established the medical standard applicable to this case. The medical standard so established was that [of] a competent and responsible medical practitioner . . . .” 52 Haw. at 196-97, 473 P.2d at 121. 20  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  In 1976, the informed consent doctrine was codified in HRS § 671-3.12 HRS § 671-3 (1976 Repl.) “directed the board of medical examiners (board) to specifically itemize the probable risks and effects of each specific treatment or surgical procedure.” Mroczkowski, 6 Haw. App. at 567, 732 P.2d at 1258. The resulting itemizations were to be prima facie evidence of the information a physician was required to disclose to a patient in order to obtain informed consent. Id. (explaining 12 HRS § 671-3 (1976 Repl.) stated:
incident that occurred after January 1, 1977, based on the rendering of professional service without informed consent, evidence may be introduced that the health care provider complied with standards established by the board of medical examiners governing the information required to be given by or at the direction of the health care provider to a patient, or the patient’s guardian in the case of a patient who is not competent to give informed consent. (b) The board of medical examiners shall, insofar as practicable, establish reasonable standards of medical practice, applicable to specific treatment and surgical procedures, for the substantive content of the information required to be given and the manner in which it is given and in which consent is received in order to constitute informed consent from a patient or a patient’s guardian. The standards shall include provisions which are designed to reasonably inform and to be understandable by a patient or a patient’s guardian of the probable risks and effects of the proposed treatment or surgical procedure, and of the probable risks of not receiving the proposed treatment or surgical procedure. The standards established by the board shall be prima facie evidence of the standards of care required but may be rebutted by either party. (c) Nothing in this section shall require informed consent from a patient or a patient’s guardian when emergency treatment or emergency surgical procedure is rendered by a health care provider and the obtaining of consent is not reasonably feasible under the circumstances without adversely affecting the condition of the patient’s health. 21  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  that the board’s standards were “admissible as evidence of the required specific standards of care only if the board’s specific standards [we]re designed to reasonably inform the patient of, inter alia, the recognized serious possible risks and complications of each specific treatment or surgical procedure”). The board, however, did not fulfill the statutory mandate because there were too many medical and surgical procedures to provide such an itemization. 6 Haw. App. at 567, 732 P.2d at 1259. In Leyson, 5 Haw. App. 504, 705 P.2d 37, overruled by Bernard II, 79 Hawaiʻi 362, 903 P.2d 667, the ICA first recognized the emerging confusion in the informed consent doctrine. First, the ICA opined that that there appeared to be a conflict in Nishi regarding the scope of a physician’s duty. The ICA explained that “Nishi initially describe[d] the [informed consent] doctrine as a precise and definite duty[,]” 5 Haw. App. at 513, 705 P.2d at 44, on the part of the physician 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[,]” 5 Haw. App. at 512, 705 P.2d at 44 (quoting Nishi, 52 Haw. at 191, 473 P.2d at 119), “but then it alternatively describe[d] the doctrine as a duty to comply with relevant medical standards[]” by requiring 22  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  plaintiffs to prove the applicable medical standard of disclosure. 5 Haw. App. at 513, 705 P.2d at 44. Second, the ICA noted that the duty to inform had been codified in HRS § 671-3; however, it was “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.” 5 Haw. App. at 516, 705 P.2d at 46. The ICA also noted that under the common law, a “physician [was] not required to disclose risks that are unexpected or immaterial, by whatever standard, nor . . . risks that are commonly understood, obvious, or already known to the patient.” 5 Haw. App. at 513-14, 705 P.2d at 45 (footnote omitted) (quoting W. Page Keeton, Dan B. Dobbs, Robert E. Keeton, and David G. Owen, Prosser and Keeton on The Law of Torts, § 32 at 192 (5th ed. 1984)). The ICA then set out five material elements for the tort of a physician’s negligent failure to disclose risks of harm prior to treatment, which this court adopted in Bernard II, 79 Hawaiʻi 362, 903 P.2d 670. The five elements are as follows:
patient] the risk of one or more of the collateral injuries that [the patient] suffered; (2) [the physician] breached [his or her] duty; (3) [the patient] suffered injury; and (4) [the physician’s] breach of duty was a cause of [the patient’s] injury in that: (a) [the physician’s] treatment was a substantial factor in bringing about [the patient’s] injury and (b) [the patient], acting rationally and reasonably, would not have undergone the treatment had he [or she] been informed of the risk of the harm that in fact occurred; and (5) no other cause is a superseding cause. 23  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  Bernard II, 79 Hawaiʻi at 365, 903 P.2d at 670 (alterations in original) (quoting Leyson, 5 Haw. App. at 516–17, 705 P.2d at 47); see also Barcai, 98 Hawaiʻi at 483-84, 50 P.3d at 959-60 (reaffirming the five elements required to establish a claim of negligent failure to obtain informed consent under Hawaiʻi law). HRS § 671-3 was amended in 1983,13 and provided that the applicable general standard of information a physician was required to disclose, among other things, was “all recognized 13 HRS § 671-3 (Supp. 1983) provided: (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.
medical examiners include provisions which are designed to reasonably inform a patient, or a patient’s guardian, of:

treatment or surgical procedure;

treatment; and
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 required of the health care providers. 24  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  serious possible risks of harm and complications that the physician knew of or should have known[.]” Mroczkowski, 6 Haw. App. at 567, 732 P.2d at 1258; see also Keomaka v. Zakaib, 8 Haw. App. 518, 525, 811 P.2d 478, 483, cert. denied, 72 Haw. 618, 841 P.2d 1075 (1991) (holding that a physician owes a duty to disclose items set forth in HRS § 671-3(b), “including the ‘recognized serious possible risks’ and the ‘recognized possible alternative forms of treatment[]’”). 2. The Patient-Oriented Standard of Disclosure and Expert Testimony Requirements Nishi and HRS § 671-3 left unresolved the question of the standard applicable to the tort of a physician’s negligent failure to obtain informed consent, as well as the role of expert testimony in establishing a prima facie case of negligent failure to obtain informed consent. In Carr, 79 Hawaiʻi 475, 904 P.2d 489, this court addressed these issues. This court first expressly adopted the “patient- oriented standard” to govern whether a physician owes a duty to disclose a particular piece of information to a patient prior to treatment, overruling Nishi to the extent that it required a plaintiff to prove the applicable standard of disclosure of material risks prior to treatment by expert medical testimony. 79 Hawaiʻi at 485, 904 P.2d at 499. Recognizing that (1) Nishi was decided without the benefit of the seminal decision on the 25  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  patient-oriented standard of disclosure, Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064 (1972); (2) the informed consent doctrine had been codified; and (3) the growing nationwide trend favored the patient-oriented standard, this court held that the dispositive inquiry regarding a physician’s duty of disclosure in an informed consent case was no longer “what the physician believes his or her patient needs to hear in order for the patient to make an informed and intelligent decision[.]” 79 Hawaiʻi at 486, 904 P.2d at 500. Rather, “the focus should be on what a reasonable person objectively needs to hear from his or her physician to allow the patient to make an informed and intelligent decision regarding proposed medical treatment.” Id. This court therefore held, “a plaintiff is not required to prove the standard of disclosure required for informed consent with medical expert evidence[.]” 79 Hawaiʻi at 487, 904 P.2d at 501. In a footnote, this court differentiated between the standard of care and the standard of disclosure of material risks prior to treatment with respect to the necessity of expert testimony as follows: It is clear that the standard of care for a claim based on allegedly negligent medical treatment must be established by reference to prevailing standards of conduct in the applicable medical community and must be so proved by expert medical testimony because . . . “a jury generally lacks the requisite special knowledge, technical training, and background to be able to determine the applicable standard without the assistance of an expert.” The 26  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  standard of disclosure of material risks prior to treatment, however, as we have discussed above, is capable of determination under the patient-oriented standard without reference to prevailing medical standards or medical judgment, although such evidence may, subject to a Hawaiʻi Rule of Evidence 403 balancing, be relevant and admissible. 79 Hawaiʻi at 485 n.6, 904 P.2d at 499 n.6 (internal citation omitted) (quoting Craft, 78 Hawaiʻi at 298, 893 P.2d at 149). Next, citing to the ICA’s decision in Bernard I, however, this court cautioned “that our adoption of the patientoriented standard does not relieve plaintiffs of their burden to provide expert medical testimony[,]” 79 Hawaiʻi at 486, 904 P.2d at 500 (citing Bernard I, 79 Hawaiʻi at 383, 903 P.2d at 688), “to establish the ‘materiality’ and/or the magnitude of the risk of harm that in fact occurs.” 79 Hawaiʻi at 486 n.7, 904 P.2d at 500 n.7. This court held that “a plaintiff maintains the burden of adducing expert medical testimony 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.’” 79 Hawaiʻi at 486, 904 P.2d at 500 (quoting Bernard I, 79 Hawaiʻi at 383, 903 P.2d at 688). See also Barcai, 98 Hawaiʻi at 484, 50 P.3d at 960; Ray, 125 Hawaiʻi at 268, 259 P.3d at 584. In further support of the conclusion in Carr that expert testimony is required in informed consent cases, this 27  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  court cited the United States Court of Appeals for the District of Columbia’s decision in Canterbury, 464 F.2d 772. This seminal decision explained why expert testimony is critical in informed consent cases: Experts are ordinarily indispensable to identify and elucidate for the factfinder the risks of therapy and the consequences of leaving existing maladies untreated. They are normally needed on issues as to the cause of any injury or disability suffered by the patient . . . . Save for relative[ly] infrequent instances where questions of this type are resolvable wholly within the realm of ordinary human knowledge and experience, the need for the expert is clear. 464 F.2d at 791-92, quoted in Carr, 79 Hawaiʻi at 486, 904 P.2d at 500. In Barcai, this court reaffirmed our holdings concerning the “materiality” of the risk in informed consent cases. This court explained that “expert testimony will ordinarily be required” to establish the first aspect of “materiality” -- “the ‘materiality’ of the risks, i.e., ‘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.’”14 98 Hawai‘i at 484, 50 P.3d at 960 (emphasis added) 14 We note that expert testimony is not required in all situations. As stated infra, expert testimony is not required to determine what a reasonable patient needs to hear in order to make an informed decision regarding proposed medical treatment. In addition, expert testimony is ordinarily, but not universally required to rebut a defendant physician’s justification of nondisclosure on the basis of the therapeutic privilege exception. Barcai, 98 Hawaiʻi at 486, 50 P.3d at 962 (“[W]here [a] defendant physician justifies nondisclosure on the basis of the therapeutic privilege (continued . . . ) 28  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  (quoting Carr, 79 Hawaiʻi at 486, 904 P.2d at 500 (citing Bernard I, 79 Hawaiʻi at 383, 903 P.2d at 688)). This court then explained that, “[b]ecause lay jurors do not normally possess such information, it must be made available to them by an expert[,]” so that the jury can make a factual determination regarding the second aspect of “materiality” -- the materiality of the medical information to a patient’s decision, i.e., “whether a reasonable person would have wanted to consider the purportedly withheld information before consenting to the treatment.” Id. (citing 79 Hawai‘i at 486, 904 P.2d at 500). ( . . . continued) exception, expert testimony may be required to refute the contention.”). The therapeutic privilege exception “recognizes that, under some circumstances, disclosure of certain risks would not be in the patient’s best medical interests.” Carr, 79 Hawaiʻi at 480, 904 P.2d at 494. With regard to the necessity of expert testimony to rebut the therapeutic privilege exception, this court has stated: If the jury could evaluate the defendant physician’s testimony without specialized expert knowledge, no such expert testimony is needed and the jury should be instructed on the informed consent issue. . . . It is only when the particular facts associated with the physician’s rationale for withholding disclosure involve “medical facts” that expert testimony will be required to rebut the claim and allow the jury to consider an informed consent claim. 98 Hawaiʻi at 486 n.10, 50 P.3d at 962 n.10. Barcai further stated that “all of the Hawai‘i cases cited since Nishi-- and [] Canterbury, as well-- . . . repeatedly discuss the exception in the context of explicating ‘limits’ to the patient oriented standard, thereby suggesting that Hawai‘i appellate courts have intended this exception to remain applicable.” 98 Hawai‘i at 485 n.9, 961 n.9 (citations omitted). We discuss the exception as illustrative of the necessity of expert testimony in informed consent cases. We do not address the continued viability of the therapeutic privilege exception under the current iteration of HRS § 671- 3(b), as that issue is not before us. 29  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  The second aspect of materiality does not require expert testimony, although, as recognized by footnote 6 from Carr quoted above, expert testimony can also be helpful. Following Barcai, HRS § 671-3 was amended in 2003 (effective January 1, 2004) to integrate advances to legal and medical standards regarding the materiality of the risk of harm. See 2003 Haw. Sess. Laws Act 114, § 2 at 221-222; see also S. Stand. Comm. Rep. No. 1228, in 2003 Senate Journal, at 1547. HRS § 671-3 (Supp. 2003)15 mandated disclosure of specific 15 HRS § 671-3 (Supp. 2003) provided, in relevant part: (a) The board of medical examiners may establish standards for health care providers to follow in giving information to a patient, or to a patient’s guardian or legal surrogate if the patient lacks the capacity to give an informed consent, to ensure that the patient’s consent to treatment is an informed consent. The standards shall be consistent with subsection (b) and may include: (1) The substantive content of the information to be given; (2) The manner in which the information is to be given by the health care provider; and (3) The manner in which consent is to be given by the patient or the patient’s guardian or legal surrogate. (b) The following information shall be supplied to the patient or the patient’s guardian or legal surrogate prior to obtaining consent to a proposed medical or surgical treatment or a diagnostic or therapeutic procedure: (1) The condition to be treated; (2) A description of the proposed treatment or procedure; (3) The intended and anticipated results of the proposed treatment or procedure; (continued . . . ) 30  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  information, in particular, “recognized material risks of serious complications or mortality[,]” as opposed to general standards of medical practice established by the board, and maintained the patient-oriented standard from Carr. See S. Stand. Comm. Rep. No. 1228, in 2003 Senate Journal, at 1547; see also H.B. 651, H.D. 2, 22d Leg., Reg. Sess. (2003) (prior version of bill that became the 2003 act amending HRS § 671-3(b) contemplated switching to a physician-oriented standard). In Ray, this court “interpreted HRS § 671-3(b) as supplying the standard for a physician’s duty to disclose information to the patient.” 125 Hawaiʻi at 266, 259 P.3d at 582. Under HRS § 671-3(b) (Supp. 2008), a physician’s duty to inform encompasses four separate duties: (1) the general duty to supply information about a proposed medical treatment or procedure embodied by HRS § 671-3(b)(1)-(3); (2) the duty to ( . . . continued) (4) The recognized alternative treatments or procedures, including the option of not providing these treatments or procedures; and (5) The recognized material risks of serious complications or mortality associated with: (A) The proposed treatment or procedure (B) The recognized alternative treatments or procedures; and (C) Not undergoing any treatment or procedure; and
alternative treatments or procedures. 31  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  inform the patient of recognized alternative treatments or procedures, including the option of not providing these treatments or procedures, as provided in HRS § 671-3(b)(4); (3) the duty to warn of material risks as provided in HRS § 671- 3(b)(5); and (4) the duty to inform patients of the recognized benefits of any recognized alternative treatments or procedures as provided in HRS § 671-3(b)(6). Under HRS § 671-3(b)(5)(A), Plaintiffs’ main claim, a physician is required to inform patients of “recognized material risks of serious complications or mortality associated with . . . [t]he proposed treatment or procedure[.]” Thus, at trial, a plaintiff alleging a violation of this subsection bears the burden of presenting expert medical evidence to establish prima facie that the risk of harm to which the plaintiff was subjected is a “recognized material risk[] of serious complications or mortality associated with . . . [t]he proposed treatment or procedure[.]” Cf. Ray, 125 Hawaiʻi at 268, 259 P.3d at 584 (holding that a “plaintiff will need to show that the medical community recognizes the different dosage as an alternative treatment” in an HRS § 671-3(b)(4) claim). “[E]xpert ‘testimony is not conclusive and like any testimony, the jury may accept or reject it.’” 125 Hawaiʻi at 262, 259 P.3d at 578 (quoting Bachran v. Morishige, 52 Haw. 61, 67, 469 P.2d 808, 812 (1970)). 32  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  Once a plaintiff adduces expert testimony establishing prima facie that the risk of harm that occurred is a “recognized material risk[] of serious complication or mortality[,]” whether the physician was required to supply that information to the patient prior to obtaining consent is a question for the factfinder that does not require expert testimony, although, as noted in the quotation from Carr, supra (citing Craft), expert testimony can also be relevant and admissible. See 79 Hawaiʻi at 485 n.6, 904 P.2d at 499 n.6 (citation omitted). In other words, the jury, applying the patient-oriented standard, decides “what a reasonable person objectively needs to hear from his or her physician to allow the patient to make an informed and intelligent decision regarding proposed medical treatment.” Ray, 125 Hawaiʻi at 267, 259 P.3d at 583 (quoting Carr, 79 Hawaiʻi at 486, 904 P.2d at 500) (quotation marks omitted). B. The Circuit Court Erred in Granting JMOL Because Reglan’s Package Insert Combined With Expert Testimony Sufficiently Established the Materiality of the Risk of Reglan Plaintiffs argue that the ICA erred in concluding that they failed to establish the materiality of the risk by expert testimony, and in affirming the circuit court’s grant of JMOL in Defendants’ favor on that basis. Plaintiffs assert that the manufacturer’s warning, in combination with expert testimony as to the significance of that information, sufficiently established the materiality of the risk of harm to which Minor 33  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  was subjected when Defendant administered Reglan to Minor. We agree. “Claims for negligent failure to obtain informed consent typically arise when a plaintiff patient alleges that the defendant physician failed to warn the patient of a particular risk associated with the procedure and the particular risk ultimately occurred.” Barcai, 98 Hawaiʻi at 483, 50 P.3d at 959. To establish a claim of negligent failure to obtain informed consent under Hawaiʻi law, the plaintiff must demonstrate that: (1) the physician owed a duty to disclose the risk of one or more of the collateral injuries that the patient suffered; (2) the physician breached that duty; (3) the patient suffered injury; (4) the physician’s breach of duty was a cause of the patient’s injury in that (a) the physician’s treatment was a substantial factor in bringing about the patient’s injury and (b) a reasonable person in the plaintiff patient’s position would not have consented to the treatment that led to the injuries had the plaintiff patient been properly informed; and (5) no other cause is a superseding cause of the patient’s injury. 98 Hawaiʻi at 483-84, 50 P.3d at 959-60 (citation omitted).16 The first prong of this common law formulation of the tort is 16 Although not raised by the parties nor on appeal, we note that in granting JMOL in Defendant’s favor on the informed consent claim, the circuit court stated, “the parents . . . were never asked whether if they had been informed of certain things they would have given permission[.]” Plaintiffs’ subjective view is, however, unnecessary. We have held, the question of part (b) causation in an action based on the doctrine of informed consent is to be judged by an objective standard, that is, whether a reasonable person in the plaintiff-patient’s position would have consented to the treatment that led to his or her injuries had the plaintiff-patient been properly informed of the risk of the injury that befell him or her. Bernard II, 79 Hawaiʻi at 371, 903 P.2d at 676. Thus, in this case, a determination of proximate causation depends upon whether there was sufficient evidence for a jury to find that, had Plaintiffs been advised of (continued . . . ) 34  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  subject to appropriate modification based on the specific provisions of HRS § 671-3(b) alleged to have been violated; in other words, the first prong is now “the physician violated a duty of disclosure under HRS § 671-3(b).” In proving the elements of an informed consent claim alleging an HRS § 671- 3(b)(5)(A) violation, a plaintiff must present expert testimony to establish prima facie that the risk of harm to which the plaintiff was subjected is an undisclosed “recognized material risk[] of serious complications or mortality associated with . . . [t]he proposed treatment or procedure[.]” Although not explicitly required by HRS § 671-3(b)(5), expert testimony is typically necessary to establish the medical information statutorily required to be disclosed. In this case, the ICA misconstrued Craft, 78 Hawaiʻi 287, 893 P.2d 138, when it concluded that the manufacturer’s insert “does not constitute ‘expert testimony’ and does not permit a legitimate inference regarding the materiality of the risk.” Ngo, mem. op. at 19 (citing 78 Hawaiʻi at 306, 893 P.2d at 157). In Craft, we affirmed the trial court’s reading of a jury instruction “that a plaintiff who brings ‘an action based on informed consent must establish the applicable standard of ( . . . continued) the risks of Reglan, they would not have consented to its use to treat Minor. Plaintiffs need not testify as to what they subjectively would have done if properly informed of the risks. 35  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  care through expert medical testimony and manufacturer’s package inserts do not, by themselves, set the standard of care which is applicable to a physician on the issue of informed consent.’” 78 Hawaiʻi at 306, 893 P.2d at 157 (brackets omitted). Thus, Craft recognized the view that “a drug manufacturer’s package insert merely constitutes evidence to be considered along with the expert’s testimony[,]” but does not supplant expert testimony. 78 Hawaiʻi at 299, 893 P.2d at 150 (discussing the conflicting views of package inserts). Therefore, under Craft, although information contained in a manufacturer’s insert cannot, on its own, satisfy a plaintiff’s burden of production in an informed consent case, it can constitute evidence that the jury or fact finder may consider along with the requisite expert testimony. In the instant case, while the manufacturer’s insert did not establish the materiality of the risk of increased diarrhea by itself, Plaintiffs adduced expert testimony regarding the significance of the information in the manufacturer’s insert. Plaintiffs’ expert testimony, in conjunction with the manufacturer’s insert, established prima facie that Defendant failed to supply Plaintiffs with “recognized material risks of serious complications or mortality associated with” Reglan, as required by HRS § 671-3(b)(5)(A). Applying the standard applicable to a motion for JMOL, it cannot 36  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  be said that there was no evidence to support a jury verdict in Plaintiffs’ favor on their informed consent claim. Ray, 125 Hawaiʻi at 261, 259 P.3d at 577 (brackets omitted) (quoting Miyamoto, 104 Hawaiʻi at 7, 84 P.3d at 515). Therefore, Plaintiffs’ informed consent claim should have been presented to the jury. The ICA erred in concluding that “expert testimony was not adduced to establish the ‘probabilities of therapeutic success’ or ‘the frequency of the occurrence of particular risks’ and therefore Plaintiffs failed to carry their evidentiary burden.” Ngo, mem. op. at 16 (citing Carr, 79 Hawaiʻi at 486, 904 P.2d at 500). The “probabilities of therapeutic success” is not part of an informed consent claim based on an alleged HRS § 671-3(b)(5)(A) violation, but is information required to be provided under HRS § 671-3(b)(3), the “intended and anticipated results of the proposed treatment or procedure[.]” With respect to the risks that must be disclosed under HRS § 671-3(b)(5)(A), at trial, Plaintiffs’ expert medical evidence established that increased diarrhea is a risk associated with Reglan. Defendant expressly admitted that he knew diarrhea was a side effect of Reglan. With respect to adverse gastrointestinal reactions, the manufacturer’s insert listed: “nausea and bowel disturbances, primarily diarrhea[.]” Plaintiffs’ expert, Dr. Towle, testified that “one of the ways 37  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  Reglan works is that it gets the pylorus, or the sphincter between the stomach and small intestines, to relax and open up and allow the contents of the stomach to pass through to the small intestine.” Dr. Towle further stated that in Minor’s case, although Reglan did not directly affect the lower intestine and cause diarrhea in and of itself, “if you’re emptying the stomach and you’re dumping things into the small intestine, it kind of gets the intestines going and diarrhea is one of the more common side effects with Reglan.” Moreover, Dr. Towle pointed out that the contraindications section in the manufacturer’s insert states that Reglan should not be used whenever stimulation of gastrointestinal motility might be dangerous. He further testified that Reglan “should not have been given no matter what in the circumstances of this case.” Finally, Dr. Towle testified that Reglan is more likely to increase diarrhea than Zofran or other anti-emetics. Therefore, Plaintiffs’ expert medical evidence established increased diarrhea as a common side effect of Reglan. Plaintiffs’ other expert witness, Dr. Gallup testified that, in his opinion, Reglan moderately increased the amount of fluid excreted out of Minor’s system through diarrhea, thereby significantly increasing her dehydration. He further testified that this increase in dehydration was a substantial factor in leading to her hypovolemic shock. 38  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  Although diarrhea is not a serious complication that generally results in death, in the instant case, the evidence established that Minor was moderately dehydrated and losing fluid through both vomiting and diarrhea. Plaintiffs’ expert testimony and the manufacturer’s insert established increased diarrhea as a risk associated with Reglan, and that Reglan should not be used when stimulation of gastrointestinal motility might be dangerous. Therefore, Plaintiffs presented expert evidence that Minor might not be able to tolerate increased diarrhea. In short, Plaintiffs did adduce expert testimony establishing the “probabilities of therapeutic success” and “the frequency of the occurrence of particular risks” under the former common law formulation of the duties. More importantly, however, Plaintiffs adduced expert testimony regarding a violation of Defendant’s current statutory duty under HRS § 671- 3(b)(5)(A). Accordingly, the ICA erred in concluding that Plaintiffs’ “expert testimony presented at trial [did] not sufficiently establish the ‘materiality of the risk of harm’ imposed by [Defendant’s] administration of ten milligrams of Reglan to [Minor].” Ngo, mem. op. at 15. 39  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  C. The ICA Erred in Concluding that Plaintiffs Waived Their Claim that Defendant Failed to Provide Other Statutorily Mandated Information Plaintiffs also contend that the ICA erred in ruling that they waived their argument that Defendant failed to provide all statutorily required disclosures, including information about “alternative treatments or medications, the risks of Reglan and alternative treatments, or the alternative of no treatment, or the benefits of Reglan and its alternatives, including the alternative of no treatment.” Plaintiffs assert that they in fact raised the nondisclosure issue. Plaintiffs specifically alleged in their complaint that Defendant treated Minor “without obtaining the informed consent of Plaintiff,” and “failed to adequately inform Plaintiffs of the nature of the treatment and risks thereof[.]” Although Plaintiffs’ complaint omitted the specific statutory provisions, Plaintiffs’ allegation that Defendant treated Minor “without obtaining the informed consent of Plaintiff[]” clearly implicated a physician’s duty of disclosure, which includes the duties enumerated in HRS § 671-3(b). We recently ruled on the scope of a physician’s duty under HRS § 671-3(b)(4) in Ray, 125 Hawaiʻi 253, 259 P.3d 569. The plaintiffs in Ray adduced evidence in support of their contention that recognized alternative dosing regimens of the same treatment had a lower risk of the harm the patient 40  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  ultimately suffered. 125 Hawaiʻi at 267, 259 P.3d at 583. The defendants moved for JMOL on the issue of informed consent because it was undisputed that defendants informed the patient of the risk of injury that occurred. 125 Hawaiʻi at 265, 259 P.3d at 581. This court held that the circuit court properly denied the defendant’s motion because “an alternative dosage can constitute a ‘recognized alternative treatment’ within the meaning of HRS § 671-3(b)(4).” 125 Hawaiʻi at 267, 259 P.3d at 583. This court further held, “[i]f a reasonable patient would need to hear the information to make an informed decision, the physician is required to disclose that information.” Id. In the instant case, Plaintiffs similarly adduced evidence of recognized alternative treatments to Reglan. Plaintiffs’ counsel elicited testimony from Defendant indicating that, at the time he administered Reglan to Minor, he knew of the existence of alternative anti-emetic medications, including Zofran, which did not have Reglan’s side effects, and Phenergan, which was specifically approved by the FDA to treat nausea in pediatric patients. Dr. Towle testified that safer alternatives to Reglan existed, including Zofran, which had been approved for use in pediatric patients, had a lower risk of causing diarrhea, and could be the most “popular” anti-emetic. In addition, Dr. Gallup testified that while Reglan relaxes the “sphincter so that any fluid in the stomach can easily get transported down 41  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  through the small intestine into the large intestine,” does not do this and in fact, “works almost exactly in the opposite direction.” Thus, at trial, Plaintiffs raised the issue of Defendant’s failure to inform them of recognized alternative treatments pursuant to HRS § 671-3(b)(4). Moreover, although expert evidence of the “probabilities of therapeutic success” was not required as part of Plaintiffs’ HRS § 671-3(b)(5)(A) claim, as discussed in Part IV.B, supra, a physician’s failure to provide such information implicates a claim based on a violation of HRS § 671-3(b)(3), which requires disclosure of the “intended and anticipated results of the proposed treatment or procedure[.]” In this case, Defendant admitted that he did not inform Plaintiffs that the manufacturer’s insert stated that “[s]afety and effectiveness in pediatric patients have not been established (see overdosage).” See (Reglan insert). The manufacturer’s insert also stated that “[t]he safety profile of [Reglan] in adults cannot be extrapolated to pediatric patients.” Dr. Towle testified that the manufacturer’s statement meant that the safety and effectiveness of Reglan in pediatric patients was undetermined. In addition, Dr. Towle testified that “Reglan is not recommended for use in children except for very specific circumstances” not present in this 42  FOR PUBLICATION IN WEST’S HAWAII REPORTS AND PACIFIC REPORTER  case. Despite these warnings, Defendant prescribed Reglan based on Minor’s weight of 150 lbs. Accordingly, the ICA erred in concluding that Plaintiffs waived these additional informed consent claims.