Court Opinion

ID: 2832576
Source: CourtListenerOpinion
Date Created: 2015-09-01 01:06:26.756233+00
Date Added: 2024-06-11T15:05:20.726503
License: Public Domain

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                                                     Electronically Filed
                                                     Supreme Court
                                                     SCWC-30172
                                                     31-AUG-2015
                                                     08:02 AM
           IN THE SUPREME COURT OF THE STATE OF HAWAIʻI

                                ---oOo---

 CUC THI NGO, ANGELO NGUYEN, ANTHONY NGUYEN, AN VAN NGUYEN, and
 LEO YOUNG, ESQ., in his capacity as Personal Representative of
         the Estate of Jennifer Giao Nguyen, Deceased,
               Petitioners/Plaintiffs-Appellants,

                                    vs.

    THE QUEEN’S MEDICAL CENTER, a Hawaiʻi Domestic Nonprofit
 Corporation; THINH T. NGUYEN, M.D.; THE EMERGENCY GROUP, INC.,
          a Hawaiʻi Domestic Professional Corporation,
               Respondents/Defendants-Appellees.

                                SCWC-30172

         CERTIORARI TO THE INTERMEDIATE COURT OF APPEALS
               (ICA NO. 30172; CIV. NO. 07-1-0268)

                            August 31, 2015

  RECKTENWALD, C.J., NAKAYAMA, McKENNA, AND POLLACK, JJ., AND
      CIRCUIT JUDGE AYABE, ASSIGNED BY REASON OF VACANCY

                OPINION OF THE COURT BY McKENNA, J.

                           I.    Introduction
          This case arises from the death of a nine-year-old

minor child (“Minor”) from cardiac arrest caused by hypovolemic

shock, a condition that results when “severe blood and fluid

loss make the heart unable to pump enough blood” through the
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body.    Ngo v. Queen’s Med. Ctr., No. 30172, at 5 (App. Dec. 30,

2013) (mem.).     Petitioners/Plaintiffs-Appellants are Minor’s

parents (“Parents”), brothers, and the personal representative

of Minor’s Estate (collectively “Plaintiffs”).           Plaintiffs

claim, inter alia, that Respondents/Defendants-Appellees the

Queen’s Medical Center (“QMC”),1 Dr. Thinh T. Nguyen (hereinafter

“Defendant”), and The Emergency Group, Inc. (collectively,

“Defendants”) failed to provide information required under the

informed consent doctrine before treating Minor for nausea and

vomiting with the anti-emetic medication Reglan.2            Plaintiffs

assert that Reglan led to Minor’s hypovolemic shock because it

increased the motility of Minor’s stomach and small intestines,

or, in other words, increased Minor’s diarrhea.           It is

undisputed that Defendant did not give Plaintiffs any

information about Reglan or its risks and side effects, and did

not provide any information regarding alternative treatments.

            The Circuit Court of the First Circuit (“circuit

court”) granted judgment as a matter of law (“JMOL”) in favor of

Defendants on the informed consent claim.3          The Intermediate

     1
            QMC is not a party in the appellate proceedings as the sole issue
on appeal is Defendant’s alleged failure to obtain Plaintiffs’ informed
consent; thus, issues concerning QMC will not be discussed except where
relevant.
     2
            Anti-emetic medications help to prevent nausea and vomiting.
     3
            The Honorable Glenn J. Kim presided.

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Court of Appeals (“ICA”) affirmed the circuit court’s decision

on appeal, concluding that Plaintiffs failed to meet their

evidentiary burden regarding the “materiality of the risk of

harm” that resulted from Defendant’s treatment of Minor with

Reglan.

          At issue in this appeal is the extent of a plaintiff’s

burden of presenting expert medical evidence regarding the

“materiality of the risk of harm” that occurred in order to

support a prima facie case for a physician’s negligent failure

to obtain informed consent.4

          Hawaiʻi law on the doctrine of informed consent has

evolved significantly in the past three decades.           The doctrine

originated in the common law, and was largely codified in 1976

in Hawaiʻi Revised Statutes (“HRS”) § 671-3, which has since been

amended several times.     Some common law precepts, however, still

govern.   For example, we have held that “expert testimony will

ordinarily be required to establish the ‘materiality’ of the

     4
          Plaintiffs present the following questions on certiorari:

          1. Whether it was error to exclude or discount evidence of
             information contained in a drug’s package insert or
             [Physicians’ Desk Reference] entry, in combination with
             expert testimony as to the significance of that
             information, on a claim of informed consent.

          2. Whether a physician’s admitted failure to disclose the
             information required by [Hawaiʻi Revised Statutes (“HRS”)
             §§] 671-3(b)(1) through (6), when coupled with evidence
             of the materiality of such failure, precludes a finding
             of informed consent.

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risks, i.e., ‘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[]’” (“expert testimony

requirements”).    Ray v. Kapiolani Med. Specialists, 125 Hawaiʻi

253, 262, 259 P.3d 569, 578 (2011) (citations omitted).            “The

standard of disclosure of material risks prior to treatment,

however, . . . is capable of determination under the patient-

oriented standard without reference to prevailing medical

standards or medical judgment . . . .”         Carr v. Strode, 79

Hawaiʻi 475, 485 n.6, 904 P.2d 489, 499 n.6 (1995).

          In this case, Plaintiffs’ experts testified on the

risks of Reglan generally, and also explained the significance

of the information in the manufacturer’s insert.           Moreover,

pursuant to Craft v. Peebles, 78 Hawaiʻi 287, 893 P.2d 138

(1995), although a manufacturer’s insert cannot, on its own,

satisfy a plaintiff’s burden of producing expert testimony to

establish the materiality of a risk, it can constitute evidence

that a fact finder may consider along with expert testimony on

the issue.   We hold, therefore, that Plaintiffs presented

sufficient expert medical evidence to advance their informed

consent claim to the jury.

          In addition, Plaintiffs’ complaint clearly alleged

that Defendant treated Minor “without obtaining the informed

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consent of Plaintiff[.]”        The informed consent doctrine includes

a physician’s duty to disclose “recognized alternative

treatments or procedures” and “intended and anticipated results

of the proposed treatment or procedure[.]”           Relevant evidence of

alternative treatments and the use of Reglan in children was

adduced.      Therefore, the ICA erred in concluding that Plaintiffs

waived the issue of Defendant’s failure to inform them of all

statutorily mandated information.

              Accordingly, we vacate in part (1) the ICA’s February

11, 2014 Judgment on Appeal as to Plaintiffs’ informed consent

claims; and (2) the circuit court’s July 28, 2009 Final Judgment

as well as its order granting Defendants’ motion for JMOL as to

Plaintiffs’ informed consent claims, and remand the case to the

circuit court for further proceedings consistent with this

opinion.

                              II.    Background
A.    Facts

              On Friday, February 13, 2004, Minor’s Parents and two

brothers took nine-year-old Minor to the QMC emergency room

(“ER”) to be treated for diarrhea and vomiting, which she had

been experiencing since the previous night.5           Defendant treated

Minor at the QMC ER, where he performed a variety of tests,
      5
            Parents are not fluent in English, but their children are fluent.
Minor’s brother Anthony Nguyen served as an interpreter for Defendant and
Parents while Minor was in the hospital.

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which revealed an elevated heart rate, mild to moderate

dehydration, and a possible infection.

           Defendant diagnosed Minor with viral gastroenteritis,

an infection of the stomach.        He ordered intravenous (“IV”)

fluid of normal saline and ten milligrams of Reglan through an

IV line.   Upon discharge, Minor was given a prescription for ten

milligrams of Reglan tablets to take as needed for nausea, and

instructed to follow up with her primary physician in three to

four days.

           Minor continued to suffer from diarrhea and vomiting

after returning home.      Minor’s mother testified that she gave

Minor Reglan tablets every six hours as directed.6            One of

Minor’s brothers called QMC three times -– on Friday night,

Saturday morning, and Saturday night –- concerning Minor’s

continued symptoms.      Each time, QMC staff told him to let the

medicine work, and to follow up with Minor’s primary physician

on Monday.    The family testified that Minor’s symptoms remained

the same throughout the weekend.

           At 3:00 a.m. on Sunday morning, Minor told her Parents

that she was having trouble breathing.          At 7:00 a.m., Minor

became unconscious and an ambulance was called to take her to

     6
            Plaintiffs’ expert testimony focused mainly on the IV
administration of Reglan because whether any Reglan tablets actually entered
Minor’s system was disputed.

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the hospital, where she died of cardiac arrest caused by

hypovolemic shock.

B.    Circuit Court Proceedings

            On February 12, 2007, Plaintiffs filed a complaint in

circuit court against Defendants, alleging medical negligence

and negligent failure to obtain informed consent.

      1.    The Trial
            a.    Testimony of Defendant

            At trial, Plaintiffs called Defendant as an adverse

witness.    The following exchange took place regarding

Defendant’s failure to provide pretreatment disclosures:

                  Q. When you prescribed and caused the intravenous
            dosage of Reglan to be given, before doing so, did you ever
            tell the parents of any risks involved with Reglan?

                  A.   No.

                  Q. After the IV was in process, did you ever tell
            the parents of any risks associated with Reglan?

                  A.   No[.]

                  . . .

                  Q. When you wrote out the prescription, . . . before
            the parents left the hospital, did you at any time give
            them any warnings of any kind about the drug Reglan?

                  A.   No.

            Defendant testified that he did not inform Parents of

the manufacturer’s position on the safety and effectiveness of

Reglan in pediatric patients.         He contended that the

manufacturer’s warning meant that the safety and effectiveness

of Reglan in pediatric patients had not been established to

standards set by the United States Food and Drug Administration

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(“FDA”); however, he testified that “[his] training and

experience has made this drug a safe medication.”           Defendant

also testified that he prescribed Reglan to pediatric patients

as “an off-label use[,]” and that he prescribed the dosage based

on Minor’s weight, which was approximately 150 lbs.

          Defendant testified that he knew diarrhea was a side

effect of Reglan.    He further testified that he did not attempt

to treat Minor’s diarrhea other than by ordering IV fluids to

hydrate her.

          In addition, Defendant testified that at the time he

administered Reglan to Minor, he knew that an alternative drug

without Reglan’s side effects was “out there but [he] didn’t use

it” because “it wasn’t available to [him] to use.”           Plaintiffs’

counsel clarified that the alternative drug was Zofran.

Plaintiffs’ counsel also introduced into evidence a list of

drugs approved by the FDA in 1991, which included Zofran.

Defendant further testified that he knew of the existence of an

alternative anti-emetic medication approved by the FDA to treat

pediatric patients for nausea, Phenergan; however, he contended

that it was a “worse drug[.]”

          b.    Reglan Manufacturer’s Package Insert

          During Defendant’s testimony, a printout of the FDA

version of the Reglan manufacturer’s package insert in effect at

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the time (“manufacturer’s insert”) was entered into evidence

over objection.7

           The manufacturer’s insert states, in relevant part, as
follows:

           CONTRAINDICATIONS
           [Reglan] should not be used whenever stimulation of
           gastrointestinal motility might be dangerous, e.g., in the
           presence of gastrointestinal hemorrhage, mechanical
           obstruction or perforation.

           . . . .

           Pediatric Use
           Safety and effectiveness in pediatric patients have not
           been established (see OVERDOSAGE).

           . . . .

           The safety profile of [Reglan] in adults cannot be
           extrapolated to pediatric patients.

           . . . .

           ADVERSE REACTIONS
           In general, the incidence of adverse reactions correlates
           with the dose and duration of [Reglan] administration. The
           following reactions have been reported, although in most
           instances, data do not permit an estimate of frequency:

           . . . .

           Gastrointestinal
           Nausea and bowel disturbances, primarily diarrhea.

           c.    Testimony of Dr. Gary Leroy Towle (“Dr. Towle”)
           Plaintiffs called Dr. Towle to testify as an expert on

the standard of care and the material risks of Reglan.               Dr.

Towle testified that “Reglan is not recommended for use in

children except for very specific circumstances” not present in

     7
            Defendant testified that although he had not read the version of
the manufacturer’s insert admitted at trial, he had known of the information
it contained at the time he administered Reglan to Minor. In addition,
another expert, Dr. Gary Leroy Towle, explained that the version admitted at
trial was substantially similar to the Physicians’ Desk Reference or
manufacturer’s package insert for Reglan.

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this case.   Interpreting the manufacturer’s insert, Dr. Towle

testified that the manufacturer could not say Reglan was safe to

treat pediatric patients, but was not saying it was unsafe

either.   Rather, Reglan’s safety in pediatric patients was

undetermined.

          Dr. Towle testified that “one of the ways 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.”

He stated that “[t]he problem with Reglan is it increases the

motility of the stomach and small intestine.          In other words, it

gets it going, it gets things flowing through it.”           Dr. Towle

also testified that the contraindications section in the Reglan

insert states that Reglan should not be used whenever

stimulation of gastrointestinal motility might be dangerous.

Dr. Towle stated that in Minor’s case, although Reglan did not

directly 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.”

          Dr. Towle testified that he would have started with

other anti-emetics, such as Phenergan and Zofran, which the FDA

has specifically approved to treat pediatric patients, and which

were safer for use in children with nausea and vomiting.            He

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testified that one of the more common side effects of Reglan was

increased diarrhea, and while Zofran or other “anti-emetics

theoretically can increase diarrhea[,] Reglan is more likely to”

have this effect.     Dr. Towle also testified that Zofran was an

“excellent anti-emetic.     It’s used in chemotherapy patients, in

cancer patients, and also for people with gastroenteritis.             It

works very well.    It has a relatively low side effect profile.

It’s very popular and it could be the most popular one now

replacing even Tigan and Phenergan.”

          Dr. Towle stated, however, that he could not testify

to a reasonable degree of medical probability that Reglan

increased Minor’s nausea and diarrhea, nor that it had any side

effects that were of consequence to Minor.         Dr. Towle also

stated that he could not say whether Defendant should have

warned Parents about any risks because “[i]t’s like asking

what’s the dose of some medicine you’re not supposed to give.               I

can’t answer that.”

          d.    Testimony of Dr. James Gallup (“Dr. Gallup”)
          Plaintiffs also called Dr. Gallup to testify as an

expert on the cause of Minor’s death.        With respect to any

effect Reglan may have had on Minor’s system, Dr. Gallup opined

that “it did what Reglan is noted well to do and that is

stimulate the contraction of smooth muscle, particularly in the

intestine and the stomach to a lesser extent.”          Dr. Gallup

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testified that Reglan relaxes the “sphincter so that any fluid

in the stomach can easily get transported down through the small

intestine into the large intestine.”        He further testified that

Zofran does not do this and “works almost exactly in the

opposite direction.”

            Dr. Gallup opined that Reglan moderately increased

Minor’s diarrhea, which significantly increased her dehydration.

He further opined that the increase in dehydration was a

substantial factor leading to Minor’s hypovolemic shock because

the dehydration “quite significantly hastened the loss of

workable fluid . . . into the intestinal tract and loss from the

body ultimately.”    As to Minor’s cause of death, he opined that

Minor “died from cardiac arrest as a result of hypovolemic

shock[.]”    He further opined that Reglan was a substantial

factor in causing Minor’s death.

            On redirect, Dr. Gallup clarified that Reglan “may

have increased the volume [of diarrhea, but] may not have

increased the frequency.”

            e.   Motion for Judgment as a Matter of Law

            At the close of Plaintiffs’ case in chief, Defendants

moved for JMOL on the issue of informed consent, arguing that

Plaintiffs’ experts failed to opine on the materiality of the

risks of Reglan to meet Plaintiffs’ burden of adducing expert

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medical testimony.      Plaintiffs cross-moved for JMOL,8 contending

that the testimony of Drs. Towle and Gallup in combination with

the manufacturer’s insert constituted “competent expert

evidence” of the risks.

            The circuit court agreed with Defendants, and stated:

            [T]he issue essentially is there’s not a legally cognizable
            informed consent claim in this case. . . .

                  In the Court’s view, not only is there no expert
            testimony, as is required[,] . . . the parents . . . were
            never asked whether if they had been informed of certain
            things they would have given permission, etc., etc., [sic]
            which are all elements of informed consent.[9]

                  . . . [W]hat we’ve got here is a case of medical
            negligence, period. Informed consent may sound like –- may
            sound viable sort of in some sort of common sensible view,
            well, he should have told the parents about Reglan and what
            it could cause, etc. But . . . in the Court’s view there

      8
            Hawaii Rules of Civil Procedure (HRCP) Rule 50(a) (2000)
provides:

                 (1) If during a trial by jury a party has been fully
            heard on an issue and there is no legally sufficient
            evidentiary basis for a reasonable jury to find for that
            party on that issue, the court may determine the issue
            against that party and may grant a motion for judgment as a
            matter of law against that party with respect to a claim or
            defense that cannot under the controlling law be maintained
            or defeated without a favorable finding on that issue.

                 (2) Motions for judgment as a matter of law may be
            made at any time before submission of the case to the jury.
            Such a motion shall specify the judgment sought and the law
            and the facts on which the moving party is entitled to the
            judgment.

HRCP Rule 50(a) (emphasis added). Although Plaintiffs cross-moved for JMOL,
the circuit court would not have been able to grant the motion at that time
because Defendants had not presented any evidence, and thus, had not “been
fully heard” on the informed consent claims.
      9
            We note that the circuit court erred in concluding that
Plaintiffs failed to establish an element of informed consent by not
specifically testifying that they would have withheld consent if properly
informed of the risks. We address this error in note 16 in Part IV.B, infra.

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            simply is no legally cognizable claim for informed consent
            on the facts of this case.

                  And you add that to –- and in a sense that’s why
            there was no expert testimony on materiality because it’s
            simply not an informed consent case.

The circuit court granted JMOL in Defendants’ favor on the issue

of informed consent, concluding that, even viewing the evidence

and inferences therefrom in the light most favorable to

Plaintiffs, a reasonable jury could not find in their favor.                On

July 28, 2009, the circuit court subsequently entered its Final

Judgment.

     2.     Plaintiffs’ Renewed Motion

            On August 10, 2009, Plaintiffs filed a “Renewed Motion

to Amend the Complaint to Conform to the Evidence and Renewed

Motion for Judgment as a Matter of Law, or, in the Alternative,

Motion for New Trial” (“Renewed Motion”).          Plaintiffs argued,

inter alia, that JMOL on the informed consent claim should have

been entered in their favor because Defendant failed to provide

statutorily mandated information pursuant to HRS § 671-3(b)

(Supp. 2008)10 about (1) recognized alternative treatments and/or

     10
            HRS § 671-3 (Supp. 2008) provides, in relevant part:

                 (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 . . . )

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medications, and (2) recognized material risks of serious

complications or mortality associated with the proposed

treatment or procedure.

            The circuit court denied Plaintiffs’ Renewed Motion at

an October 14, 2009 hearing, and entered its order the following

day.

            On November 13, 2009, Plaintiffs appealed the July 28,

2009 Final Judgment and October 15, 2009 order denying their

Renewed Motion to the ICA.

C.     Appeal to the ICA

            On appeal, the ICA affirmed the circuit court’s grant

of JMOL in Defendant’s favor, 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.      In particular, the ICA

( . . . continued)
            (4) The recognized alternative treatments or procedures,
                including the option of not providing these treatments
                or procedures;

            (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

            (6) The recognized benefits of the recognized alternative
                treatments or procedures.

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concluded 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).

          With respect to Plaintiffs’ evidence at trial, the ICA

concluded that Dr. Towle’s testimony that he could not opine on

whether the risks should have been explained to “[P]arents

because Reglan ‘should not have been given [to Minor] no matter

what in these circumstances[]’” “did not sufficiently elaborate

on the probabilities that Reglan treatment would be

successful[.]”    Id.   The ICA further concluded that Dr. Towle’s

testimony “that Reglan posed a greater risk of gastric motility,

i.e., diarrhea, than other anti-emetics” did not establish the

frequency of occurrence nor significance of that risk.            Ngo,

mem. op. at 17.

          Addressing Plaintiffs’ argument that Defendant’s

testimony in conjunction with the manufacturer’s warning

established the materiality of the risk, the ICA concluded that

“the manufacturer’s warning, in and of itself, does not

establish the materiality of risk of harm with respect to

Reglan, because it does not constitute ‘expert testimony’ and

does not permit a legitimate inference regarding the materiality

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of the risk.”11    Ngo, mem. op. at 19 (citing Craft, 78 Hawaiʻi at

306, 893 P.2d at 157).

           Finally, the ICA held that Plaintiffs waived their

claim that Defendant “failed to provide statutorily mandated

information to [Minor’s] parents other than the risks of Reglan

. . . [b]ecause Plaintiffs failed to raise this argument to the

circuit court[.]”     Ngo, mem. op. at 22.

                          III. Standard of Review

           “A trial court’s ruling on a motion for judgment as a

matter of law is reviewed de novo.”         Ray, 125 Hawaiʻi at 261, 259

P.3d at 577 (emphasis omitted) (citations omitted).            Hawaiʻi

appellate courts apply the same standard as the trial court.

Miyamoto v. Lum, 104 Hawaiʻi 1, 7, 84 P.3d 509, 515 (2004)

(citation omitted).      Trial courts apply the following standard:

           A motion for judgment as a matter of law may be granted
           only when after disregarding conflicting evidence, giving
           to the non-moving party’s evidence all the value to which
           it is legally entitled, and indulging every legitimate
           inference which may be drawn from the evidence in the non-
           moving party’s favor, it can be said that there is no
           evidence to support a jury verdict in his or her favor.

Ray, 125 Hawaiʻi at 261, 259 P.3d at 577 (brackets omitted)

(quoting Miyamoto, 104 Hawaiʻi at 7, 84 P.3d at 515).

     11
            The ICA explained that its holding “that no legitimate inference
about the materiality of risks . . . can be drawn from the Reglan
manufacturer’s warning is consistent with case law in other jurisdictions,
which hold that testimony that a treatment may or may not be safe does not
establish risks pertinent to an informed consent issue.” Ngo, mem. op. at 20
(citations omitted).

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                            IV.    Discussion

          Hawaii’s informed consent doctrine is generally based

on the policy judgment that “every human being of adult years

and sound mind has a right to determine what shall be done with

his or her own body[.]”     Leyson v. Steuermann, 5 Haw. App. 504,

513, 705 P.2d 37, 44 (1985) (brackets and citation omitted),

overruled on other grounds by Bernard v. Char, 79 Hawaiʻi 362,

903 P.2d 667 (1995) (hereinafter “Bernard II”).          “Physicians

have an obligation to obtain the informed consent of their

patients before administering diagnostic and treatment

procedures.”   Barcai v. Betwee, 98 Hawaiʻi 470, 483, 50 P.3d 946,

959 (2002) (citing Carr, 79 Hawaiʻi at 479, 904 P.2d at 493).               It

is “well-settled that a physician owes a duty to a patient to

disclose sufficient information about a proposed course of

treatment or surgical procedure so that the patient can make an

informed and intelligent decision about whether to submit to the

treatment or surgical procedure[.]”        Bernard v. Char, 79 Hawaiʻi

371, 380, 903 P.2d 676, 685 (App. 1995), aff’d, 79 Hawaiʻi 362,

903 P.2d 667 (hereinafter “Bernard I”).

          Before the informed consent doctrine was codified in

HRS § 671-3, Hawaiʻi courts recognized the common law doctrine of

informed consent.    See Nishi v. Hartwell, 52 Haw. 188, 191, 473

P.2d 116, 119 (1970), overruled by Carr, 79 Hawaiʻi 475, 904 P.2d

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489.    The expert testimony requirements originated in the common

law.    See, e.g., Mroczkowski v. Straub Clinic & Hosp., Inc., 6

Haw. App. 563, 567, 732 P.2d 1255, 1258 (1987) (trial court

granted directed verdict based on patient’s failure to introduce

expert testimony as to specific risks of harm defendant was

required to disclose); Bernard I, 79 Hawaiʻi at 383, 903 P.2d at

688 (adopting expert testimony requirements in dental

malpractice case founded on the common law doctrine of informed

consent).     When the doctrine was codified, Hawaiʻi courts

continued to utilize elements of the common law doctrine to

analyze and interpret the statutory requirements.             See Leyson, 5

Haw. App. at 516, 705 P.2d at 46, overruled on other grounds by

Bernard II, 79 Hawaiʻi 362, 903 P.2d 667 (noting that it was not

clear from the language or history of HRS chapter 671 whether

the legislative intent was to supplant Nishi’s general standards

of required disclosures).        As the interplay between the common

law and the statute has not always been clear, we review the

development of the doctrine of informed consent.

A.     An Overview of Informed Consent in Hawaiʻi
       1.   The Common Law Doctrine of Informed Consent

            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

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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.

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          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:

                (a) In any action for medical tort based on an
          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.

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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

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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:

            (1) [the physician] owed a duty to disclose to [the
            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.

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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.

               (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 required of the health care providers.

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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

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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

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           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 patient-

oriented 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

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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 . . . )

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(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.

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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 . . . )

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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

                     (6) The recognized benefits of the recognized
                         alternative treatments or procedures.

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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)).

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            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

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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 . . . )

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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.

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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

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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

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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.

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            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.

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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

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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

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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

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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.

                              V.    Conclusion

           Based on the evidence adduced at trial, the circuit

court erred in granting JMOL in favor of Defendants on

Plaintiffs’ informed consent claims.         Because the court did so

at the end of Plaintiffs’ case, however, the defense may not

have been fully heard on the informed consent claims.             Although

we answer Plaintiffs’ first question on certiorari in the

affirmative and rule that Plaintiffs presented sufficient

evidence to have the jury consider their informed consent

claims, we decline to answer the second question.17            Accordingly,

we vacate in part (1) the ICA’s February 11, 2014 Judgment on

Appeal as to Plaintiffs’ informed consent claims; and (2) the

circuit court’s July 28, 2009 Final Judgment as well as its

order granting Defendants’ motion for JMOL as to Plaintiffs’

      17
            See supra notes 4 (questions on certiorari) and 8 (regarding HRCP
Rule 50, which governs JMOLs).

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informed consent claims and its award of costs, and remand the

case to the circuit court for further proceedings consistent

with this opinion.

John S. Edmunds,                          /s/ Mark E. Recktenwald
Ronald J. Verga, and
Joy S. Omonaka,                           /s/ Paula A. Nakayama
for petitioner Leo Young,
in his capacity as                        /s/ Sabrina S. McKenna
Personal Representative of the
Estate of Jennifer Giao Nguyen,           /s/ Richard W. Pollack
Deceased, and
Michael J.Y. Wong,                        /s/ Bert I. Ayabe
for petitioners
Cuc Thi Ngo, Angelo Nguyen,
Anthony Nguyen, and
An Van Nguyen

John Reyes-Burke
for respondent
Thinh T. Nguyen, M.D., and
the Emergency Group, Inc.

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