Ngo v. The Queen's Medical Center. , 136 Haw. 54 ( 2015 )

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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.
2
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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.
3
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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.
5
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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.
6
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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 at500 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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