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,
THE QUEEN'S MEDICAL CENTER, a Hawai'i Domestic Nonprofit Corporation; THINH T. NGUYEN, M.D.; THE EMERGENCY GROUP, INC., a Hawai'i Domestic Professional Corporation, Respondents/Defendants-Appellees
As Corrected September 1, 2015.
[Copyrighted Material Omitted]
CERTIORARI TO THE INTERMEDIATE COURT OF APPEALS. ICA NO. 30172; CIV. NO. 07-1-0268.
John S. Edmunds, Ronald J. Verga, and Joy S. Omonaka, for petitioner Leo Young, in his capacity as Personal Representative of the Estate of Jennifer Giao Nguyen, Deceased, and Michael J.Y. Wong, 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.
RECKTENWALD, C.J., NAKAYAMA, McKENNA, AND POLLACK, JJ., AND CIRCUIT JUDGE AYABE, ASSIGNED BY REASON OF VACANCY.
[136 Hawai'i 57] McKENNA, J.
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 body. Ngo v. Queen's Med. Ctr., No.
30172 (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" ), 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. 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. The Intermediate 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.
Hawai'i 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 Hawai'i 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 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 Hawai'i 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 Hawai'i 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
[136 Hawai'i 58] to Craft v. Peebles, 78 Hawai'i 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 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.
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. Defendant treated Minor at the QMC ER, where he performed a variety of tests, 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. 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 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?
[136 Hawai'i 59] Q. After the IV was in process, did you ever tell the parents of any risks associated with Reglan?
. . .
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?
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 (" 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 the time (" manufacturer's insert" ) was entered into evidence over objection.
The manufacturer's insert states, in relevant part, as follows:
[Reglan] should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, ...