Opinion ID: 2832576
Heading Depth: 5
Heading Rank: 6

Heading: The recognized benefits of the recognized

Text: 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.