State v. Bristol-Myers Squibb Company.

526 P.3d 395, 152 Haw. 418

• Court: Hawaii Supreme Court
• Decided: March 15, 2023
• Docket: SCAP-21-0000363
• Status: Published

Opinion

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Electronically Filed Supreme Court SCAP-XX-XXXXXXX 15-MAR-2023 08:05 AM Dkt. 67 OP

IN THE SUPREME COURT OF THE STATE OF HAWAIʻI

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STATE OF HAWAIʻI, EX REL. HOLLY T. SHIKADA, ATTORNEY GENERAL, Plaintiff-Appellee,

vs.

BRISTOL-MYERS SQUIBB COMPANY; SANOFI-AVENTIS U.S. LLC; SANOFI US SERVICES INC., formerly known as SANOFI-AVENTIS U.S. INC.; and SANOFI-SYNTHELABO LLC, Defendants-Appellants,

and

SANOFI S.A., Defendant-Appellee.

SCAP-XX-XXXXXXX

CERTIORARI TO THE INTERMEDIATE COURT OF APPEALS (CAAP-XX-XXXXXXX; CASE NO. 1CC141000708)

MARCH 15, 2023

RECKTENWALD, C.J., NAKAYAMA, McKENNA, AND EDDINS, JJ.; AND WILSON, J., DISSENTING 1

OPINION OF THE COURT BY EDDINS, J.

1 At the time of this opinion’s publication, Justice Wilson’s dissent is forthcoming. *** FOR PUBLICATION IN WEST’S HAWAI‘I REPORTS AND PACIFIC REPORTER ***

I. INTRODUCTION

This case is about whether two pharmaceutical companies —

Defendants-Appellants Bristol-Myers Squibb and Sanofi — violated

Hawai‘i’s Unfair or Deceptive Acts or Practices law (UDAP) by

misleading the public about the safety and efficacy of their

antiplatelet drug, Plavix.

The State, in a 2014 complaint, alleged that Plavix was

less effective in patients who had certain liver-enzyme

mutations (poor responders). It said that people with these

mutations had worse outcomes on Plavix than others, and that

Defendants knew this fact years before 2009, when the FDA

updated Plavix’s label with information about the poor responder

issue.

The State alleged Defendants violated Hawaiʻi law in two

ways. First, it asserted that the companies – despite knowing

about the issues with Plavix – failed to update the drug’s

warnings to inform the public. Second, the State claimed the

defendant companies intentionally kept the poor responder issue

under wraps and suppressed research into it in order to protect

their bottom line.

The Circuit Court of the First Circuit agreed with the

State on both points. After a bench trial that spanned more

than a month, the court held that Bristol-Myers Squibb and

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Sanofi had violated UDAP by engaging in deceptive and unfair

acts and practices.

The court said the defendant companies misled Hawai‘i

consumers by failing to warn them that Plavix was less effective

for poor responders. It found that this omission injured

consumers by denying them the drug’s full promised antiplatelet

effect, hindering their ability to give informed consent, and

preventing them from taking an alternative drug or undergoing

genetic testing to determine whether they were poor responders.

The court also faulted Defendants for both refusing to

adequately research variability of response and suppressing

research that might confirm a link between ethnicity or genotype

and Plavix responsiveness.

For these acts, the court imposed an $834 million penalty.

We vacate this penalty.

The court improperly granted the State’s motion for partial

summary judgment on a central trial issue: Did the label matter

to consumers?

The summary judgment ruling on materiality circumscribed

the companies’ ability to present a full defense, marred the

court’s deceptive acts holding, and affected the penalty award.

Bristol-Myers Squibb and Sanofi are entitled to a new trial on

the deceptive acts or practices claim.

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But there will be no second trial on the unfair acts or

practices claim. The court’s holding that the companies

committed unfair acts under UDAP has sufficient, independent

evidentiary support.

We also conclude that Defendants’ procedural arguments

fail. The court correctly determined that the State’s claims

were not barred by UDAP’s safe harbor provision or its statute

of limitations. Nor were they preempted by federal law.

We (1) reverse and remand the court’s deceptive acts UDAP

holding, (2) vacate the court’s grant of partial summary

judgment and the penalty award, (3) affirm the court’s unfair

acts UDAP holding, and (4) remand for a penalty award after the

deceptive-acts claim is resolved.

II. BACKGROUND

A. Factual Background

Defendants-Appellants Bristol-Myers Squibb and Sanofi 2 are

multinational pharmaceutical companies that developed Plavix, an

antiplatelet or “blood thinner” drug.

Platelets, tiny pieces of cells in the bloodstream, can

form clots which create serious health problems like heart

attacks. Doctors often prescribe Plavix along with aspirin

(called dual anti-platelet therapy or DAPT) to patients with

2 The defendant companies are Bristol-Myers Squibb Company (BMS) and Sanofi-Aventis U.S. LLC, Sanofi US Services Inc., formerly known as Sanofi- Aventis U.S. Inc., and Sanofi-Synthelabo LLC (Sanofi).

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heart problems or patients who have recently had a procedure

that might put them at risk for platelet clotting, such as

angioplasty 3 or cardiac stenting.

Cardiac stents work by propping and holding open arteries

to improve blood flow. Stents can disturb the plaque naturally

lining our arteries. Platelets in the blood can then accumulate

around the disruption, forming a clot. Patients may take blood

thinners like Plavix to inhibit this clot formation.

Plavix’s chemical name is “clopidogrel.” Clopidogrel is a

“prodrug,” meaning it is only effective once it is changed by

the body. Plavix achieves its antiplatelet effect when it is

metabolized by the liver.

There are a family of enzymes in the liver, called the

“Cytochromes P450” (CYP) that are commonly involved in

metabolizing prodrugs.

Several CYP450 liver enzymes are involved in metabolizing

Plavix. The liver enzyme CYP2C19 is one of them.

Different factors affect how well someone can metabolize

Plavix. “Variability of Response” is “a blanket term that

basically reflects that no one person responds the same to any

pharmaceutical agent.” There will be variability of response to

3 Angioplasty is a medical procedure for opening clogged or narrow arteries. It involves inserting a small catheter with a balloon tip into a blood vessel, and it can also be used to place stents in arteries. Coronary angioplasty and stents. https://www.mayoclinic.org/tests- procedures/coronary-angioplasty/about/pac-20384761 [https://perma.cc/B6SX- NM68].

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all drugs. And it can be caused by intrinsic factors like

height, weight, sex, and genetics, or by extrinsic factors like

smoking, diet, exercise, and other drugs a patient is taking.

If a prodrug is metabolized by CYP2C19, then genetic

variation in the CYP2C19 liver enzyme can cause “poor

responsiveness” to that drug.

Pharmacogeneticists use the star allele system to describe

genetic variation in liver enzymes.

The *1 genetic version of CYP2C19 (CYP2C19*1) confers fully

functional CYP2C19 enzymes. The other versions of CYP2C19

(CYP2C19*2, *3, *4, *5, *6, *7, or *8) confer a reduced ability

to metabolize Plavix. The CYP2C19*2 and CYP2C19*3 genetic types

are the most commonly linked to poor Plavix responsiveness.

Each person has two CYP2C19 alleles.

People with two CYP2C19*1 alleles will have a CYP2C19 liver

enzyme that is very good at metabolizing Plavix; those with one

CYP2C19*1 and one CYP2C19*2 or *3 allele will be “intermediate

metabolizers” and someone with two CYP2C19*2 or CYP2C19*3

alleles (or one *2 and one *3) will be a “poor responder.”

Scientific understandings of CYP2C19’s role in metabolizing

Plavix have evolved over time.

When Plavix launched in the late 1990s, it was known that

the CYP450 enzymes — of which CYP2C19 is one — were involved in

metabolizing Plavix. But the extent of the enzyme’s role in

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metabolizing Plavix and – by extension — the possibility that

poor responders might get less benefit from the drug — were not

generally known at that time.

Terms like “poor responder” or “Plavix resistant” are used

(sometimes interchangeably) to refer to two distinct things: (1)

the genetic makeup of a person’s CYP2C19 enzymes; and (2) the

ability of a person’s liver enzymes (either collectively or

isolated CYP2C19 enzymes alone) to metabolize Plavix in a test

tube (called platelet-function).

There is consensus that a genetic “poor responder” is

someone with two *2 or *3 alleles. But there is less consensus

about what level of response to Plavix (either in a test tube or

in the real world) makes someone a “poor responder” from a

platelet-function perspective. 4

CYP2C19 is not the only enzyme involved in Plavix’s

metabolization. And factors other than CYP2C19 genotype impact

the likelihood of adverse clinical outcomes, including blood

vessel size, family history, and lifestyle factors like diet or

smoking.

4 The trial court collectively called those patients that had less than 20% response to the drug or those with zero response to the drug “poor responders.” The court’s classification of “poor responders” matched the companies’ rubric, which used a cut off of 20% for their meta-analysis. But a pharmacogenetics team leader for BMS pointed out that the 20% response line was “a somewhat arbitrary distinction,” because it was “not based on clinical outcomes” of the patients. She added, “what’s the difference between 20 percent from the mean or 25 percent from the mean? It’s an author’s choice.”

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B. Procedural Background

This lawsuit began in March 2014 when the State filed a

complaint alleging Bristol-Myers Squibb and Sanofi violated

Hawaiʻi’s Unfair or Deceptive Acts or Practices law.

Under UDAP, “unfair or deceptive acts or practices in the

conduct of any trade or commerce are unlawful.” HRS § 480-2(a)

(2008). The State’s complaint alleged that between 1998 and

2010 Defendants had violated this law by: (1) failing to

disclose that Plavix has diminished or no effect in poor

metabolizers; and (2) allowing their research decisions to be

driven by profit-seeking. The State claimed the Defendants’

behavior was both deceptive and unfair.

1. Motion for Summary Judgment

The State moved for partial summary judgment on its

deceptive acts or practices UDAP allegation.

The State’s motion focused on one part of its deceptive

acts claim. A deceptive act is defined as: “(1) a

representation, omission, or practice that (2) is likely to

mislead consumers acting reasonably under the circumstances

where (3) the representation, omission, or practice is

material.” Courbat v. Dahana Ranch, Inc., 111 Hawaiʻi 254, 262,

141 P.3d 427, 435 (2006) (cleaned up). The State argued that

the third part – materiality – should not be up for debate.

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The State argued that there was no need for a trial to

determine the materiality of information about Plavix’s lower

efficacy for poor responders. There was “no doubt that the

information contained in Plavix’s federally mandated black box

warning is material as a matter of law.” Thus, the State asked

the court to decide materiality before trial, at summary

judgment – it would “eliminate any unnecessary time at trial.”

The court resolved the materiality element in the State’s

favor. It decided that there was no genuine dispute of material

fact that Defendants’ omission involved “information that is

important to consumers and, hence, likely to affect their choice

of, or conduct regarding, a product.” Courbat, 111 Hawaiʻi at

262, 141 P.3d at 435 (cleaned up).

The court also gave what the companies dubbed an

“alternative holding.” Since it would fact-find and apply those

facts to the law at a bench trial, the court - calling itself

the “Ultimate Trier of Fact” - felt it “need not resolve

inferences in favor of the non-moving party.” It found the

defendant companies’ evidence “weak and unpersuasive.”

Materiality, an elemental fact to a deceptive acts UDAP

violation, would go untested at trial.

The court’s summary judgment ruling precluded Bristol-Myers

Squibb and Sanofi from presenting trial evidence about the

materiality of the warning. This included evidence showing that

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Hawaiʻi doctors and patients hadn’t changed how they prescribed

or consumed Plavix after information about the poor responder

issue was added in 2010 to the black box warning. The court

forbade the defendant companies from introducing evidence about

what any person “did or did not do in response to, or as a

result of, [t]he addition to the Black Box Warning to the Plavix

label in 2010.”

The rest of the State’s case proceeded to trial in October

and November, 2020.

2. Trial 5

The bench trial was a battle royale of testifying

pharmacology experts, regulatory experts, and medical doctors.

The parties presented evidence on everything from the minutiae

of FDA regulations to whether St. John’s Wort could enhance

Plavix’s efficacy.

Much of the trial’s myriad and diverse evidence, however,

speaks to three central issues.

First, did the defendant companies mislead anyone through

omitting the poor responder information from the Plavix label

between 1998 and May 2009? Or were the companies just doing the

best they could with incomplete and conflicting scientific

information about the causes of variability of response to

Plavix?

5 The Honorable Dean E. Ochiai presided.

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Second, did Defendants suppress research into variability

of response for financial reasons? Did greed prevent them from

confirming CYP2C19’s role in metabolizing Plavix sooner?

And third, did the omission of the poor responder

information from Plavix’s label hurt Hawaiʻi consumers? Did this

omission hinder consumers’ ability to give informed consent?

Were patients duped into taking a drug that might harm them - or

at least not help them - because of Defendants’ omissions?

a. Deception through omission?

Regarding the first question of whether Defendants deceived

consumers though omission, the parties introduced three major

categories of evidence at trial: (1) scientific understanding

before Plavix launched in 1998, (2) evidence concerning the

scientific community’s changing perspectives between 1998 and

2010 on which liver enzymes were principally responsible for

metabolizing clopidogrel, and (3) evidence concerning shifts in

scientific thinking about the link between CYP2C19 genotypes and

clinical outcomes after 2010.

i. Pre-approval

Almost four years before the FDA approved Plavix, Dr. Sonia

de Morais identified the genetic mutation that causes poor

responsiveness in CYP2C19. She looked at the metabolization of

S-mephenytoin - a drug that was known to almost exclusively be

metabolized by CYP2C19 – not clopidogrel.

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Dr. de Morais’ 1994 article also introduced the idea of

genetic testing for poor response in CYP2C19. 6 For her work, she

developed a “simple PCR-based genetic test for [identifying] the

defective CYP2C19 allele.” She later clarified that by

“simple,” she meant when “compared to the expensive and

laborious technique of complete gene sequencing.” Her test “was

only focused on the simple small fragment of DNA that had the

mutation”; it was not intended for direct patient use.

In addition to identifying (for the first time) CYP2C19*2

and CYP2C19*3, Dr. de Morais’ 1994 study found that “[t]here are

large interracial differences in the frequency of the poor

metabolizer phenotype with [Asian] populations having a five

fold greater frequency compared to Caucasians.”

Then in 1996, BMS and Sanofi sponsored CAPRIE (Clopidogrel

versus Aspirin in Patients at Risk of Ischemic Events): a

19,000-person clinical trial designed to compare the relative

efficacy of clopidogrel and aspirin in “reducing the risk of a

composite outcome cluster of ischaemic stroke, myocardial

infarction, or vascular death.” CAPRIE showed that, compared to

aspirin, Plavix conferred a “statistically significant

6 At trial, the State argued that Dr. de Morais’ mid-90s genetic test could have been used to research any correlation between CYP2C19 gene mutations and poor response to Plavix early in the drug’s development. But it was also clear that easy access to genetic testing for patients who could be poor responders has only become available since the boxed warning was added.

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reduction” in the risk of death for patients who had recently

had a heart attack or stroke or who had peripheral artery

disease.

CAPRIE also found a statistically significant relationship

between race and treatment outcomes when Whites and non-Whites

were compared. The CAPRIE investigators noted, however, that

these results should be interpreted cautiously since only 5% of

the study population was non-White. Also, non-Whites were not

well represented in the peripheral artery disease study group

(the subgroup for which Plavix was most effective).

In 1997, BMS and Sanofi investigated which liver enzymes

were involved in Plavix metabolization. That study showed that

the liver enzymes “CYP2B6, CYP2C19 and CYP3A4 are involved in

clopidogrel metabolism in human liver microsomes.” It also

“suggest[ed] possible involvement of CYP1A2, CYP2C9 and CYP2E1

in clopidogrel metabolism.”

On March 5, 1997 – before Plavix’s approval — the companies

wrote to the FDA proposing a label that stated in relevant part:

“In vitro, the isoenzymes responsible for metabolism of

clopidogrel and the carboxylic acid derivative are CYP2B6,

CYP2C19 and CYP3A4; evidence also suggests possible involvement

of CYP1A2, CYP2C9 and CYP2E1 in clopidogrel metabolism.”

(Emphasis added.)

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The FDA prevented Defendants from including that language

on the label.

The FDA approved Plavix in November 1997. In its approval

letter, the FDA warned Defendants that Plavix’s final printed

label “must be identical to the enclosed draft labeling” because

“[m]arketing the product with [a label] that is not identical to

this draft labeling may render the product misbranded and an

unapproved new drug.”

ii. Post-approval

After Plavix was approved, Defendants conducted a “meta-

analysis” of their internal clinical trial data from Phase I and

Phase II clinical studies in March of 1998. The meta-analysis

was a retrospective review of prior studies that examined

previously available data.

The meta-analysis showed there was a variability of

response to Plavix. From the 469 samples examined, 67.8% of

patients were considered good responders: the drug was at least

20% effective at inhibiting clot formation. Only 3.4% of

patients had no response. The extent of that variability

depended on the test used to measure inhibition: one test showed

that 32.2% of patients had less than 20% platelet inhibition

while other tests showed 8.5% of patients. 7

7 At trial, the companies’ witness explained that the 32.2% value encompassed the patients who had tested at least once for less than 20%

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Defendants did not submit the 1998 meta-analysis to the FDA

until 2005, seven years after Plavix’s launch. 8 When they

eventually submitted the meta-analysis to the FDA, it was

presented as an appendix to another document.

Just before Plavix reached the market in December, Sanofi

released a study in November 1998 which concluded that 57% of

clopidogrel metabolization was attributable to the liver enzyme

CYP3A4, while 13% was attributable to CYP2C19. 9

The companies theorized that Plavix might principally be

metabolized by CYP3A4. CYP3A4 is “the most abundant” enzyme in

the liver, and it has the ability to metabolize a variety of

structures. It does not have a loss-of-function allele. CYP3A4

variations are caused by non-genetic factors like diet and

interactions with other drugs.

Plavix sales began in December 1998.

(1) 1998-2008

From 1998 to 2008, the defendant companies sponsored

various studies on Plavix. Researchers not affiliated with the

companies also published on clopidogrel.

inhibition of platelet aggregation. Of that 32.2%, though, 23% of patients still had an overall inhibition of platelet aggregation over 20%.

8 Defendants submitted the meta-analysis to Swiss medical authorities shortly after its completion in March 1998; the Swiss required the meta- analysis before they would approve Plavix.

9 The remaining 30% was attributable to CYP1A2 (18%) and CYP2B6 (12%).

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BMS and Sanofi sponsored a large clinical trial, CURE,

beginning in 1998 and ending in 2000. CURE found that Plavix

plus aspirin reduced the risk of cardiovascular death, heart

attack, or stroke by 20% more than aspirin plus a placebo did.

Of the 12,562 patients enrolled in the CURE trial, 82.1%

(10,308) of them were Caucasian and 2% (254) of them were Asian.

A 2003 study published by researchers outside the companies

examined CYP liver enzymes and clopidogrel metabolization. The

results showed that CYP3A4 and CYP3A5 did the best job

metabolizing clopidogrel.

In June 2003, a BMS research group published an article on

clopidogrel. The group was led by Dr. Paul Gurbel - an expert

on platelet variability of response, then a BMS scientist, and

now a qui tam relator suing the companies elsewhere as he

testified for the State at trial. The article described

clopidogrel non-responsiveness in 31% of the patient population

after procedures such as stenting or angioplasty. The study did

not show a correlation between non-responsiveness to Plavix and

adverse clinical outcomes. 10 But it did show that Plavix didn’t

work so well for nearly one in three patients that had stents

placed or underwent angioplasty.

10 Dr. Gurbel’s paper implied a connection between clots blocking stents (stent thrombosis) and clopidogrel resistance. But because the rate of stent thrombosis was much lower than the rate of Plavix resistance, the study noted that the two were possibly unrelated.

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The defendant companies sponsored the COMMIT study after

CURE. COMMIT was a clinical trial in China with more than

45,000 patients; all enrolled patients were Chinese. The

results published in 2005 showed that when patients who’d had a

heart attack were given Plavix and aspirin, their risk of having

an adverse cardiac event dropped by 9%. 11

Next, the defendant companies sponsored the CHARISMA trial.

It was a large scale (15,000-patient) clinical trial comparing

Plavix’s effects to those of a placebo. It found that for high-

risk patients, “clopidogrel plus aspirin was not significantly

more effective than aspirin alone in reducing the rate of

myocardial infarction, stroke, or death from cardiovascular

causes.”

But, data from the CHARISMA study (published in 2006)

showed that Asian patients had the lowest occurrence of death,

heart attack, or stroke while taking Plavix.

The shift in focus to CYP2C19 and clopidogrel came in 2006.

An independent pharmacogenetics researcher, Dr. Jean-Sebastien

Hulot, published a proof-of-concept study which suggested that

11 After the COMMIT study, the FDA approved a new indication for Plavix: it allowed the drug’s prescription to patients who’d had serious heart attacks even if they were not going to have stents put in.

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CYP2C19 genetic polymorphism was linked to reduced clopidogrel

responsiveness. 12

Then in October 2008, a study came out examining drug

interactions between Plavix and Omeprazole. Omeprazole is a

proton pump inhibitor – a type of drug known to impede CYP2C19’s

function. The study showed that patients prescribed both Plavix

and Omeprazole were more likely to have diagnostic codes for

things like heart attack and stroke than those who weren’t

prescribed Omeprazole. Defendants submitted this study to the

FDA “outside of the normal annual cycle of reporting.”

Defendants met with the FDA. An undated document titled

“Response to FDA Discussion Held 05 December 2008” prepared by

Sanofi summarized the meeting:

The discussion centered on whether differences in the formation of the active metabolite could be a primary source of platelet response variability. It was recognized that the relationship between the variability in platelet response and clinical outcome, as well as the intrinsic and extrinsic factors which modulate the formation of the active metabolite, are not well understood. A specific focus of the discussion was the extrinsic [proton pump inhibitor drugs] and intrinsic (genetic polymorphisms) factors which impact the formation of the active metabolite through CYP2C19.

At the December 5, 2008 meeting the FDA asked Defendants to

prepare a written action plan “in response to the issues

raised.” Defendants did. They proposed looking at “drug-drug

12 Dr. Hulot wrote that “The CYP2C19*2 loss-of-function allele is associated with a marked decrease in platelet responsiveness to clopidogrel in young, healthy male volunteers and may therefore be an important genetic contributor to clopidogrel resistance in the clinical setting.”

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interaction with proton pump inhibitors” and “genetic

polymorphisms and of CYP2C19 and its impact.”

(2) 2008-2009

Then on December 22, 2008, Dr. Jessica Mega published the

results of a genetic study she had conducted using data

collected as part of the TRITON trial. It involved “a head-to-

head-comparison” of Plavix and Effient (prasugrel), another

antiplatelet that was then under development by Defendants’

competitor, Eli Lilly. Dr. Mega’s study (the Mega study) showed

that clopidogrel-treated patients who carried a loss-of-function

allele “had a three-fold greater risk of clotting their stent,

and a 50 percent greater risk of having a heart attack, a stroke

or death.”

The Mega study’s results catalyzed discussions between the

FDA and Defendants about revising Plavix’s label to include

information about CYP2C19. The FDA pushed the companies to act.

It welcomed a counterproposal from the companies, with the

understanding it would disregard unsatisfactory suggestions.

In discussing these revisions, a BMS employee wrote

in a March 30, 2009 email to his colleagues: 13

13 The court overruled the defendant companies’ hearsay objection. The email was not offered for the truth of the matter asserted, the court ruled. Rather, it was evidence of the companies’ knowledge and how the Defendants reacted (or not) to the experts’ comments. We agree. The evidence was admissible for non-hearsay purposes.

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Problem is that I don’t really see a counterproposal but instead it looks like we are into stalling some more. I have to tell you that I have had in depth 1:1’s with about 6 senior [key opinion leaders] since I have been at [the American College of Cardiology] and the mood is very negative towards us (people like Dr. Topol, Gurbel, Eikelboom, Fox are all saying that they have been telling us this for years and we chose to ignore them and bury our head in the sand and so they feel no sympathy toward our current situation!)

In May 2009, the FDA amended the “Precautions” section of

Plavix’s label to read:

Based on literature data, patients with genetically reduced CYP2C19 function have lower systemic exposure to the active metabolite of clopidogrel and diminished antiplatelet responses, and generally exhibit higher cardiovascular event rates following myocardial infarction than do patients with normal CYP2C19 function (see CLINICAL PHARMACOLOGY: Pharmacogenetics).[ 14]

(First emphasis added.)

The May 2009 label also stated that “patients with an

impaired metabolizer status (intermediate and poor combined) had

a higher rate of cardiovascular events (death, myocardial

infarction, and stroke) or stent thrombosis compared to

extensive metabolizers.”

Regarding genetic testing, the 2009 label explained that

“[p]harmacogenetic testing can identify genotypes associated

with variability in CYP2C19 activity.”

(3) 2009-2010

Following the May 2009 label update, Defendants and the FDA

discussed whether the information should be put in a black box

14 The May 2009 version of the “Pharmogenetics” section stated: “diminished antiplatelet responses to clopidogrel have been described . . . in 21 reported studies,” and that “[t]he relative difference in antiplatelet response between genotype groups . . . is typically greater than 30%.”

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warning — the most prominent type of warning on a drug label.

The defendant companies told the FDA that Plavix’s

“labeling adequately describes the safety and efficacy of

clopidogrel and that a boxed warning [was] not necessary at this

time.”

Ultimately, the FDA decided to put the CYP2C19 information

in a black box warning in 2010. Like the May 2009 label, the

black box included language stating that poor metabolizers

taking Plavix are more likely to have adverse cardiac events on

the drug than non-poor responders. 15

iii. After the 2010 Black Box Label

In the first half of the 2010s, several research articles

called into question the link between CYP2C19 genotype and

clinical outcomes identified by the December 2008 Mega study. 16,17

15 The 2010 Black Box label:

16 In 2010, Paré et al. published a study that used genomic data collected in connection with two of Defendants’ big trials. At trial, the companies’

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Others appeared to validate the Mega study’s findings.

One question the research raised was whether CYP2C19 loss-

of-function alleles were related to one particular adverse

outcome: blood clots blocking stents (stent thrombosis).

In a 2015 meta-meta-analysis, Osnabrugge et al. looked at

11 meta-analyses. They found a statistically significant

relationship between CYP2C19 loss-of-function alleles and stent

thrombosis.

But the Osnabrugge study also concluded that the 11

studies’ results and conclusions were “discordant.” It said the

primary culprits of this disagreement were between study

heterogeneity and publication bias. And it concluded

“[c]onfidence in the presence of an association is limited, and

personalized antiplatelet management based on genotyping is not

witness, Dr. Roome, explained that Paré et al.’s article showed that “if you have genomic polymorphisms with loss of function on the CYP2C19, you do not have a worse outcome when you are treated by clopidogrel. You have an outcome that is comparable to those patients with no genomic polymorphisms on CYP2C19.”

Dr. Gurbel, the State’s witness, faulted Paré et al.’s study for excluding people with stents.

17 In 2011, Holmes et al. published a meta-analysis that synthesized the results of 32 original research studies looking at whether CYP2C19 genotype could predict a person’s response to clopidogrel. Holmes et al.’s meta- analysis found that there was “no evidence for a significant association between CYP2C19 genotype and any important cardiovascular outcome.”

Dr. Gurbel criticized Holmes et al.’s work for relying on studies like CURE and CHARISMA, which had heterogeneous study populations. By casting such a wide net, he said, the meta-analysis “dilute[d] the signal of the importance of *2 [carriage].” Dr. Gurbel testified that if you just looked at people who’d had stents put in their hearts, then “the totality of the evidence [was] overwhelming” that there was a link between CYP2C19 genotype and clinical outcomes.

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supported by the currently available evidence.”

Osnabrugge’s analysis suggested a possible correlation

between CYP2C19 and stent thrombosis that was worth further

exploration. Dr. Todd Seto, the medical director of the Center

for Outcomes Research and Evaluation at Queen’s Medical Center,

testified that the “difficulties” in the 11 meta-analyses

prevented Osnabrugge et al. drawing definite conclusions from

the results.

Dr. Gurbel thought differently about Osnabrugge et al.’s

findings. Concerning the link between CYP2C19 genotype and risk

of stent thrombosis, he declared the “totality of the

evidence . . . for stent thrombosis,” was “irrefutable.”

“There’s no argument against it. I mean, you have 11 meta-

analyses reporting the same thing.”

In September 2016, the FDA removed the statement that

CYP2C19 poor metabolizers have worse clinical outcomes on Plavix

from the boxed warning. 18

18 The 2016 Black Box label:

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b. Suppressed research?

The second question the trial focused on was whether

defendant companies suppressed research into Plavix’s poor-

responder issue to protect their profit margins. The State used

internal documents and emails from the companies to support its

allegation.

i. Internal Company Documents

First, the State pointed to the defendant companies’

internal committee documents. They argued these established

that the companies avoided research that could make Plavix look

bad.

BMS and Sanofi have a jointly-staffed Plavix “Life Cycle

Management” committee (LCM). The LCM is tasked with “discussing

all the new data as well as major trials that were ongoing and

sponsored by the companies” and “considering and approving or

rejecting local studies from affiliates around the world.”

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The minutes from LCM meetings in January 2001, June 2001,

and June 2002 reveal that Defendants declined to fund local

studies into variability of response to aspirin.

The minutes from 2001 reflect that the companies were

concerned the studies into variability of response to aspirin

might “lead to a similar trial on clopidogrel resistance.” The

June 2002 meeting minutes reflected that Defendants were

continuing to refuse funding research into this area because it

could lead to a “restrictive positioning of clopidogrel and

could open the door to ‘clopidogrel nonresponders.’”

Another document summarizing the LCM’s activities in 2002

indicated that the committee rejected studies about aspirin

nonresponsiveness because “it could lead to the same questions

about clopidogrel and because the commercial sensitivity and

science of studies in this field is being assessed at a

corporate level first.”

The June 2003 LCM meeting minutes noted the increase in

publications concerning “[v]ariability of response with

clopidogrel.” They identified “[t]hreats for clopidogrel,”

related to variability, including “[p]otential threats for

future sales.”

Then the LCM outlined an “action plan” in 2003 concerning

“clopidogrel response variability.” The first item on the

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action plan was a meta-analysis which would be done exclusively

with already-collected data.

At trial, Dr. Dominique Roome, a Sanofi scientist who

worked on Plavix-related issues from 1999 to 2011, conceded that

their action plan did not include plans to conduct a large-scale

clinical trial on the relationship between CYP2C19 genotype and

clinical outcomes; but she explained this omission by saying

that the issue of CYP2C19 poor metabolizers “wasn’t even a

question that was being discussed or debated in the scientific

literature at that point.”

ii. Internal Emails

The State also presented internal emails from the early and

mid-2000s to demonstrate the companies’ reluctance to engage in

aspirin or clopidogrel-resistance studies.

In May 2000, a BMS researcher wrote his colleagues to

propose a small, clinical trial “comparing the response of

blacks vs. whites on ADP-induced platelet aggregation.” A

colleague recommended holding off on the study to see what

questions the FDA would ask, noting that the “low number of

black people” was not an issue for the FDA in the earlier CAPRIE

study. He added that “[t]he problem is that, given the

variability of the test, we always run the risk to show a

difference in a pharmacology study . . . and then we really are

in trouble.” A counterpart at Sanofi agreed the proposed study

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“could bear a significant risk” and suggested waiting to see if

the FDA would bring it up.

In response to another proposed study on aspirin resistance

in August 2002, a BMS scientist recounted that “Sanofi hs [sic]

generally been ‘down’ on suggestions to study ASA [aspirin]

resistance, because they are afraid that ‘clopidogrel

resistance’ is right behind.” He later wrote in a separate

email:

In my opinion, [Sanofi]’s/our reluctance to go down the path toward documentation of clopidogrel resistance is understandable, but it will catch up with us and perhaps be an unpleasant and costly surprise when others document it without asking our permission to do so.

In June 2003, BMS employees forwarded and discussed Dr.

Gurbel’s recently-published article on Plavix non-

responsiveness. See supra Section II.B.2.a.ii.(1).

Three emails about Dr. Gurbel’s article were presented at

trial.

In the first, a BMS researcher wrote that he “view[ed] the

paper with mixed feelings.” He thought some of the data

presented were “very positive and encouraging” but also noted

that he had “received zero response internally” when he had

asked for information on Plavix non-responders.

In the second email, the Vice President of U.S. Marketing

for Plavix at the time shared the article and wrote that “BMS

U.S. has had difficulty mobilizing the LCM to address the

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importance of understanding Plavix resistance through our data

and proactive research.”

In the third email, the BMS Vice President for the “Sanofi

Alliance” at the time wrote: “Sanofi had an in-house meeting on

aspirin resistance in January and presented their data at the

January LCM meeting. However, Sanofi remains adverse [sic] to

doing any further work on either aspirin or clopidogrel

resistance because of the potential negative marketing

implications.”

In 2005, the defendant companies determined at a meeting

that “[a]dditional studies” were needed on the variability of

platelet response issue and suggested using “small trials to

help [Defendants] ‘shape the debate.’”

In 2006, the defendant companies discussed variability

of platelet response during an advisory board meeting.

They concluded that while some researchers believed that

variability corresponded with “clinical events,” others

disputed this relationship.

c. Consumer harm?

The last question was whether defendant companies’ acts or

practices harmed consumers. The evidence concerned contemporary

understandings of (1) whether CYP2C19 genotype is linked to

adverse clinical outcomes and (2) whether non-White

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(particularly Asian) patients on Plavix are more likely to

receive little or no benefit from the drug.

i. Clinical Outcomes

The State sought to support its theory that poor responders

taking Plavix were at a higher risk of adverse clinical outcomes

like heart attacks, strokes, or death. But this link is

unclear.

In 2019, the State’s witness, Dr. Gurbel, wrote that the

link between poor responders and “major adverse cardiovascular

events” on Plavix “remains controversial.” 19 At trial, he

emphasized that while the link between major adverse

cardiovascular events is not clear, he was “100 percent certain”

that a link between adverse events and poor response exists.

Dr. Laura Plunkett, the State’s regulatory and pharmacology

expert, agreed with Dr. Gurbel. She testified that “people that

can’t metabolize the drug, poor metabolizers, are at an

increased risk of experiencing heart attacks and strokes.” Dr.

Plunkett elaborated on why poor responders are at an increased

risk:

19 In an April 2010 editorial, Dr. Gurbel also wrote that:

no single study has demonstrated a conclusive link between the presence of a loss-of function genetic polymorphism, suboptimal clopidogrel active metabolite generation (pharmacokinetic measurement), decreased clopidogrel responsiveness (pharmacodynamic measurement), and adverse clinical outcomes.

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if [poor responders] don’t activate [Plavix], they can’t get the benefit. And don’t forget this is a drug that’s being given to reduce the risk of life-threatening events -- heart attacks and strokes. So if you don’t activate it and you’re giving the drug to prevent that -- those events, then you’re going to be at increased risk, because obviously without the drug there, you can’t get the benefit.

Dr. Gurbel and Dr. Plunkett didn’t think that poor

responders were more likely to have adverse outcomes on Plavix

because the drug was actively harming them. They thought,

rather, that for those who didn’t activate the drug at all, it

was effectively a “placebo.”

In response, the defendant companies focused on the

difference between patients unable to metabolize the drug at all

versus those who had a reduced but non-zero response to Plavix.

Dr. Seto testified that even a patient with two CYP2C19

loss-of-function alleles would still get some benefit from

Plavix: “there are papers that have shown benefit in patients,

including those who are poor metabolizers.”

Dr. de Morais, the scientist who in 1994 identified the

genetic mutation that causes poor responsiveness in CYP2C19,

testified. She explained that CYP2C19 poor responders may still

metabolize Plavix because “CYP2C19 is not the only enzyme.

There are other enzymes that form the active metabolite.” These

other enzymes, she said “will pick up the tab [and metabolize]”

Plavix if the CYP2C19 enzyme can’t.

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Adding to this, Dr. de Morais expounded on a “very unique”

active metabolite that’s produced when liver CYPs oxidize

Plavix. Even for poor responders, patients can receive clinical

benefits from Plavix, because the active metabolite forms a

long-lasting, stable bond with blood platelets. This bond makes

the platelets slippery so they cannot easily form a clot and

stays slippery for a “couple of days or [a] week or so” before

it’s excreted from the body.

ii. Ethnicity and poor responsiveness

The State also attempted to show that Asian patients faced

a greater risk of adverse effects on Plavix.

There was no dispute that Asians are more likely to carry

the *2 or *3 CYP2C19 alleles than Whites. Dr. Gurbel elaborated

that Asians have a 15% chance of carrying two loss-of-function

alleles and a 50% chance of carrying one.

But the parties disagreed about whether Asian patients were

likely to have worse outcomes on Plavix than White patients.

The defendant companies maintained that the drug worked

for Asian patients. Dr. Seto testified that a 2005 study

conducted at Queen’s Medical Center found that ethnicity did not

appear to affect the success rate or complication rate of

procedures like stenting or angioplasty. Dr. Seto said the

study confirmed that patients who were getting clopidogrel,

“including Asians and our Pacific Islander patients,” did fine.

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For the State, Dr. Gurbel testified that Plavix was

demonstrably less-effective for Asian patients. He compared the

results of the CURE clinical trial (which had mostly White

patients) with the COMMIT clinical trial (which had exclusively

Chinese patients). He pointed out that Plavix had only a 9%

risk reduction effect for the Chinese participants in the COMMIT

trial, less than half of the 20% risk reduction shown in CURE.

Thus, he reasoned, the COMMIT trial showed that Plavix was less

effective for Chinese patients.

In response, Dr. Seto disagreed that the CURE and COMMIT

studies – which used different methodologies – showed a reduced

effectiveness in one group versus another. He testified that it

was not possible to isolate if race or ethnicity was connected

to any supposed difference in the results. He further noted

that the 2016 American College of Cardiology/American Heart

Association (ACC/AHA) guidelines recommend Plavix as an

antiplatelet without any regard to patients’ race or genetics.

And that the guidelines recommend against routine genetic

testing even for patients of Asian or Pacific Island descent.

3. FOF-COLs

In its Findings of Fact and Conclusions of Law, the court

found that the companies had committed both deceptive and unfair

acts. First, it stated that the companies had misled consumers

by not informing patients about the poor responder issue from

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the beginning. Second, the court determined that the companies

engaged in a pattern and practice of suppressing inquiry into

variability of response for financial reasons. Third, the court

decided that the defendant companies’ actions harmed Hawaiʻi

consumers.

a. Deceptive Acts by Omission

First, the court focused on Plavix’s labeling, stating that

the “facts presented show that Defendants had sufficient

knowledge, technology, and ability to update the Plavix label

from launch and continuing for many years.”

The court listed various facts that Defendants knew at the

time of Plavix’s launch. It highlighted these findings: (1)

Defendants’ internal reports revealing that the Cytochrome P450

enzymes, including CYP2C19, were involved in Plavix’s

metabolization; (2) Defendants’ 1998 meta-analysis finding that

32.2% of patients had a reduced response to Plavix when one test

was used; 20 (3) the CAPRIE clinical trial’s showing of a

statistically significant difference in Plavix’s effectiveness

for White patients as compared to non-White patients; (4) Dr. de

Morais’ work showing that “CYP2C19 polymorphisms were found to

be a 100% predictor of poor metabolizers (for S-

20 In a footnote, the trial court “consider[ed] it significant that Defendants did not disclose their 1998 Meta-Analysis to the FDA until after [the] Gurbel study was published.” See supra Section II.B.2.a.ii(1).

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mephenytoin[ 21])”; (5) East Asians were “five-fold” more likely

to have a variant of CYP2C19 that made them Plavix poor

responders; and (6) a genetic test for CYP2C19 variations had

existed for laboratory use since 1994.

The court found that after Dr. Hulot’s 2006 study

supporting the hypothesis that CYP2C19 polymorphisms contribute

to Plavix variability of response “Defendants took no action to

update Plavix’s label to inform prescribing physicians and

patients about Plavix resistance” even though “it was already

established that these CYP2C19 polymorphisms were more prevalent

among certain Asian populations.”

The court concluded the companies failed to use the

information they had about Plavix’s variability of response to

“try to warn the public or the FDA” about the poor responder

issue or pursue information about Plavix’s bioactivation.

b. Suppressed and Avoided Research

Second, the court faulted Defendants for avoiding any

serious examination into CYPC219’s role in driving variability

of response to Plavix. It rejected Defendants’ claim that they

had supported clinical trials looking into variability of

response. 22

21 Unlike Plavix, S-mephenytoin is a drug almost exclusively metabolized by CYP2C19.

22 In rejecting this argument, the court relied on Dr. Gurbel’s testimony that Defendants “didn’t . . . I would say broadly, you know, [do] any

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The court found the companies “evidenced a clear intent not

to conduct or sponsor any research that might confirm the

existence of and/or reason for ‘Plavix resistance’ or

‘Variability of Response’ to a patient’s race or other

identifiable genetic factors.”

It further noted that the companies had a duty to

investigate why some patients had a diminished response to

Plavix. The court cited Dr. Plunkett’s testimony that

pharmaceutical companies must continue to investigate potential

issues with the drugs they sell: “under Section 21 CFR [§] 314,

there are specific requirements for companies to perform this

type of surveillance of their drugs and the literature . . . in

order to understand whether or not there are risks out there” 23

and that this affirmative behavior is “part of good

pharmacovigilance practice.”

The court also rejected Defendants’ claim that they “did

not investigate the impact of CYP2C19 polymorphisms on Plavix

meaningful research, no.” The court also cited Dr. Plunkett’s testimony that “I haven’t seen a large clinical trial that has been done by the company or anyone else of the power to be able to answer definitively those questions, and specifically for the individuals that carry two loss-of-function alleles, we haven’t completely defined that. No study has been done.”

23 More specifically, 21 CFR §§ 314.80 (Postmarketing reporting of adverse drug experiences) and 314.81 (Other postmarketing reports) impose a broad duty of surveillance. 21 CFR §§ 314.80(b) requires, for example, “prompt[] review [of] all adverse drug experience information obtained or otherwise received by the applicant from any source, foreign or domestic, including information derived from commercial marketing experience, postmarketing clinical investigations, postmarketing epidemiological/surveillance studies, reports in the scientific literature, and unpublished scientific papers.”

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Variability of Response because they believed at the time of

launch and for many years afterward” that CYP3A4 was the

“primary means by which a patient’s body produced Plavix’s

active metabolite.” The court said it found “much more

persuasive the words and actions reflected in Defendants’

corporate records, and testimony consistent with them, which

evidence a clear intent by Defendants to avoid any studies that

might unearth negative information about Plavix.”

The court said Defendants’ records showed that their

aversion to certain variability of response research was “tied

to concerns about the potential impact of adverse clinical trial

results on sales of the drug.”

The court made a series of factual findings concerning

Defendants’ internal records. For example, it referenced emails

from 2000 where Defendants shot down a proposed study comparing

clopidogrel response in Black versus White patients as risky.

It then quoted a 2001 document showing that the LCM had rejected

a proposed study on aspirin resistance because “it could lead to

a similar trial on [Plavix] resistance.” The court also cited

two 2002 LCM documents reflecting the committee’s decision to

reject aspirin studies “because they ‘could lead to the same

questions about [Plavix],’ they ‘could open the door to

“[Plavix] non-responders,”’ and because there was ‘no commercial

interest’ in such studies.”

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The court also emphasized how the companies’ behavior

undermined their claim that they believed CYP3A4 primarily

metabolized Plavix. It pointed to a November 2005 meeting

summary (after the COMMIT study was published) where Defendants

observed that they could support “small trials” on the

variability of platelet response issue that could help them

“shape the debate.”

c. Consumer Harm

Lastly, the court found that the companies’ behavior harmed

The court relied on the label’s materiality to reach its

conclusion. It noted that boxed warnings are usually reserved

“for serious warnings, particularly those that may lead to death

or serious injury.” In response to Defendants’ argument at

trial that “the 2016 boxed warning deleted any reference to a

causal relationship between CYP2C19 poor metabolizer status and

clinical outcomes,” the court said that “since the boxed warning

remains on the Plavix label, Defendants’ argument is

unpersuasive.”

The court found that poor responders to the drug “receive

only partial benefit or risk reduction, which may be

insufficient to prevent an adverse event.” It cited to studies

from the later 2000s showing “CYP2C19-based poor responsiveness

to Plavix led to an increased risk of cardiac events . . . when

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compared to patients who were normal or intermediate

responders.” It also found that “the evidence presented at

trial established that Defendants knew . . . at the time of

[Plavix’s] launch . . . that Plavix patients who are poor

metabolizers are likely at higher risk of a recurrent heart

attack or stroke than those who are not poor metabolizers.”

The court’s finding about the increased risk for

cardiovascular events faced by CYP2C19 poor metabolizers

underpinned its conclusions that Defendants’ omission was likely

to mislead consumers. This finding also partly supported the

court’s unfair acts or practices ruling, in particular, that the

defendant companies’ “conduct was substantially injurious to

consumers.” That finding, in turn, informed the court’s

analysis of the “injury to the public” prong of its penalty

calculation.

The court did not explicitly find that Asian patients were

exposed to a high risk of adverse cardiac outcomes while taking

Plavix. But it referenced the notion that Plavix doesn’t work

as well for non-Whites in its analysis of the injuries inflicted

on consumers. For example, the court highlighted Dr. Gurbel’s

testimony comparing the COMMIT and CURE clinical trials. It

detected “a statistically significant disparity in the number of

adverse events suffered by non-[W]hite racial groups.”

The court then linked Defendants’ awareness (from the

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CAPRIE clinical trial) that Plavix was less effective for non-

Whites to their “intent not to conduct or sponsor any research

that might confirm the existence of and/or reason for ‘Plavix

resistance’ or ‘Variability of Response’ to a patient’s race or

other identifiable genetic factors.”

From this, the court concluded that the companies “took no

action to update Plavix’s label to inform prescribing physicians

and patients about Plavix resistance” in spite of the

“established” fact that “CYP2C19 polymorphisms [leading to poor

response] were more prevalent among certain Asian populations.”

4. Appeal

Defendants appealed the circuit court’s judgment to the

Intermediate Court of Appeals. We granted the State’s petition

for transfer to this court.

On appeal, Defendants challenge nearly all the circuit

court’s findings of fact and conclusions of law.

Defendants contend the evidence showed they didn’t know

about the CYP2C19 metabolization issue until the Mega study came

out in December 2008. So, they argue, there is nothing

“deceptive” or “unfair” about their failure to update the Plavix

label with poor responder information before then.

Defendants stress that they investigated Plavix’s safety

and efficacy throughout the 2000s, and they claim that they

decided against funding certain studies into variability of

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response because of those studies’ size and design limitations,

not because they were trying to protect their profits.

Defendants also emphasize the lack of evidence showing the

omission of the poor responder information from Plavix’s label

injured anyone. Even poor responders, Defendants assert, can

benefit from Plavix.

In addition to challenging the substance of the court’s

holding, Defendants also raise procedural defenses.

First, they argue that the State’s claims about Plavix’s

FDA-approved label are barred by UDAP’s “safe harbor” provision,

which exempts from UDAP “[c]onduct in compliance with the orders

or rules of, or a statute administered by, a federal, state, or

local governmental agency.” HRS § 481A-5(a)(1) (2008).

Defendants say that because the FDA approved Plavix’s label they

are “in compliance” with the FDA’s regulations and exempt from

liability under UDAP.

Second, the companies claim that the State’s suit is time-

barred by UDAP’s four-year statute of limitation.

Third, they claim the State’s UDAP claims are preempted by

the Federal Food, Drug, and Cosmetic Act (FDCA) because it would

be “impossible” for the companies to comply with both the

federal law on drug labeling and the duties imposed by Hawaiʻi

law.

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III. DISCUSSION

A. No Procedural Bars to the State’s Claims

First, we address the defendant companies’ procedural

arguments. Neither the UDAP’s safe harbor provision nor its

statute of limitations bar the State’s claims. The claims are

also not preempted by federal law.

1. No Safe harbor

The UDAP’s safe harbor provision does not block the State’s

action.

UDAP’s “safe harbor” exempts “[c]onduct in compliance with

the orders or rules of, or a statute administered by, a federal,

state, or local governmental agency.” HRS § 481A-5(a)(1).

Courts interpreting safe harbor provisions often do so

narrowly, holding they bar only conduct which is not

specifically allowed or required by another authority. See

Showpiece Homes Corp. v. Assurance Co. of Am., 38 P.3d 47, 56

(Colo. 2001) (explaining that “[c]onduct amounting to deceptive

or unfair trade practices . . . would not appear to be ‘in

compliance’ with other laws” where it was not specifically

authorized by those laws).

The FDA did not issue the companies a special dispensation

absolving them of any state-law duties they may have (above and

beyond their obligations under federal law) to update the Plavix

label as the relevant science evolves. The FDA’s approval of

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Plavix’s label does not confer the agency’s imprimatur on the

companies’ decision not to add information about variability of

response to its warnings before 2009. And Defendants have not

pointed to any federal statutes specifically authorizing the

omissions and conduct the State alleges violates the UDAP.

This is not an old-fashioned false advertising consumer

protection case. The State’s allegations and the circuit

court’s FOFs and COLs are concerned with Defendants’ conduct,

not only the contents of the Plavix label. The State’s UDAP

allegations also expressly involve Defendants’ approach to

publicizing and investigating the variability of response issue.

Defendants offer no explanation of why UDAP’s safe harbor should

bar the claims that, for instance, Defendants violated the law

by failing to disclose the results of their 1998 meta-analysis

to the public or by avoiding research on variability of response

to protect their profits.

Because there is no federal or state law, order, or rule

expressly authorizing the omissions the State claims violated

the UDAP, and because of the conduct-centric nature of the

State’s allegations, we hold that the UDAP’s safe harbor

provision does not bar the State’s claims.

2. No Statute of Limitations

The State’s action is not time-barred.

Under HRS § 657-1.5 (1993), the State is not subject to any

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limitations periods unless it is “specifically designated in

such a statute as subject to the limitation period contained

therein.”

Defendants maintain that HRS § 480-24(b) (2008)

“specifically designated” the State as subject to HRS § 480-

24(a)’s four-year limitations period. But it does not.

A statute does not “specifically designate” the State as

subject to its statute of limitations unless it clearly and

unambiguously provides that its limitations period applies to

the State. HRS § 480-24(b) identifies three situations in which

the State is exempted from subsection (a)’s statute of

limitations. 24 But while those exemptions may imply that the

24 HRS § 480-24(b) (2008) provides:

(b) The following shall toll the time for commencement of actions by the State under this chapter if at any time:

(1) Any cause of action arising under this chapter accrues against any person, the person is out of the State, the action may be commenced within the terms respectively limited, after the return of the person into the State, and if, after the cause of action has accrued, the person departs from and resides out of the State, the time of the person’s absence shall not be deemed or taken as any part of the time limited for the commencement of the action.

(2) Any cause of action arising under this chapter accrues against any person, the person has petitioned for relief under the bankruptcy code, the time during which the bankruptcy case is pending shall not be deemed or taken as any part of the time limited for the commencement of the action.

(3) Any cause of action arising under this chapter accrues against any person, there is a criminal action pending which arises out of the same occurrence, the time during which the criminal action is pending shall not be deemed or taken as any part of the time limited

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State is subject to HRS § 480-24(a)’s limitations period, they

do not unambiguously and expressly state that HRS § 480-24(a)’s

limitations period applies to the State.

Under HRS § 657-1.5, then, the State is not subject to the

limitations period contained in HRS § 480-24(a). 25

3. No Preemption

Federal law does not preempt the State’s claims.

The companies assert this case is one of implied conflict

preemption, that is, Hawaiʻi law conflicts with or contradicts

federal law. See Rodrigues v. United Pub. Workers, AFSCME Local

646, AFL-CIO, 135 Hawaiʻi 316, 323, 349 P.3d 1171, 1178 (2015)

(defining “implied conflict preemption” as “when state law is in

actual conflict with federal law.”) (citation omitted). If “it

is impossible for a private party to comply with both state and

federal requirements,” then implied conflict preemption occurs.

for the commencement of the action. As used in this paragraph, a criminal action is pending until its final adjudication in the trial court.

25 The legislative history to the 2016 amendment repealing HRS § 480-24(b) supports this conclusion. The House bill that eventually became that amendment observed:

In the context of claims brought by the State and its agencies pursuant to chapter 480 of the Hawaiʻi Revised Statutes, the Hawaiʻi legislature has never specifically designated the State or its agencies as being subject to any limitation period. Consequently, no limitation period can apply to actions brought by the State under chapter 480, Hawaiʻi Revised Statutes.

House Bill No. 2329, A Bill for an Act Relating to Consumer Protection. https://www.capitol.hawaii.gov/session2016/bills/HB2329_.pdf [https://perma.cc/C3FT-AHDF].

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Hawaii Mgmt. All. Ass’n v. Ins. Comm’r, 106 Hawaiʻi 21, 30, 100

P.3d 952, 961 (2004) (cleaned up)).

The companies argue there was no way they could have

updated Plavix’s label to provide the warning the State says

UDAP requires and at the same time comply with federal law.

The Defendants overstate the differences between state and

federal law. The fact that state law imposes a greater duty to

warn on drug makers than the FDA, does not give rise to implied

conflict preemption. 26 On the other hand, if a drug maker cannot

comply with both the labeling duties imposed by the FDA and its

duties under state law, “federal law controls and . . . state-

law tort claims must be dismissed.” Guilbeau v. Pfizer Inc.,

880 F.3d 304, 310 (7th Cir. 2018).

Generally, drug manufacturers only update their products’

labels once the FDA has approved a supplemental application.

But under the agency’s CBE regulation:

if a manufacturer is changing a label to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” it may make the labeling

26 See Motus v. Pfizer Inc., 127 F. Supp. 2d 1085, 1092 (C.D. Cal. 2000) (“[M]ost courts have found that FDA regulations as to design and warning standards are minimum standards which do not preempt state law . . . failure to warn claims.”); Wells v. Ortho Pharm. Corp., 788 F.2d 741, 746 (11th Cir. 1986) (“An FDA determination that a warning is not necessary may be sufficient for federal regulatory purposes but still not be sufficient for state tort law purposes.”); Hill v. Searle Lab’ys, a Div. of Searle Parms., Inc., 884 F.2d 1064, 1068 (8th Cir. 1989) (“FDA approval is not a shield to liability. . . . FDA regulations are generally minimal standards of conduct unless Congress intended to preempt common law, which Congress has not done in this area.”).

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change upon filing its supplemental application with the FDA; it need not wait for FDA approval.

Wyeth v. Levine, 555 U.S. 555, 568 (2009) (quoting 21 CFR

§§ 314.70(c)(6)(iii)(A), (C)).

In Wyeth, the Supreme Court said that the maker of a

prescription drug could establish that it was impossible for it

to comply with both state law and the FDCA with “clear evidence

that the FDA would not have approved a change to [the brand name

drug’s] label” required by state law. Id. at 571. “Clear

evidence” that the FDA would not have approved a change requires

a showing that the drug maker “fully informed the FDA of the

justifications for the warning required by state law and that

the FDA, in turn, informed the drug manufacturer that the FDA

would not approve changing the drug’s label to include that

warning.” 27 Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct.

1668, 1678 (2019).

Here, Defendants have not provided “clear evidence” that

the FDA would have rejected an earlier label-update proposal.

In fact, as the State points out, the record shows that the FDA

eventually put information about the poor responder issue in a

27 The drug maker need not show that the FDA formally rejected the proposed label change, just that it would have rejected it had it been sought. See In re Zofran (Ondansetron) Prod. Liab. Litig., 541 F. Supp. 3d 164, 203 (D. Mass. 2021) (“Multiple courts have found [conflict] preemption where the manufacturer had not requested the precise warning sought by the plaintiffs when the FDA had nonetheless made it clear that it would not accept that label change.”); Seufert v. Merck Sharp & Dohme Corp., 187 F. Supp. 3d 1163, 1170 (S.D. Cal. 2016) (“[M]anufacturer submission of a proposed labeling change is relevant, but not dispositive, in determining whether a defendant can establish conflict preemption.”).

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black box warning on Plavix’s label. It’s conceivable that the

FDA would have rejected any pre-Mega study attempts to update

Plavix’s label on the grounds that the CYP2C19 poor responder

information wasn’t necessarily clinically relevant. But there’s

no “clear evidence” that would have happened.

Defendants’ contention that they could not have used the

CBE regulation to update Plavix’s label before December 2008

because CBE-updates are only allowed when drug makers have “new

information” about a drug is unconvincing. Wyeth considered -

and rejected - the drug maker’s similar argument that it could

not have used the CBE regulation to update its label with a

warning required by state law because it did not have “newly

acquired information” about its product. 28 The FDA’s definition

of “‘newly acquired information’ is not limited to new data, but

also encompasses ‘new analyses of previously submitted data.’”

Wyeth, 555 U.S. at 569 (citation omitted).

The FDA’s expansive definition of “newly acquired

information” 29 drowns Defendants’ preemption claim. If, as the

28 The Court explained that this broad definition of newly acquired information “accounts for the fact that risk information accumulates over time and that the same data may take on a different meaning in light of subsequent developments.” Wyeth, 555 U.S. at 569.

29 The definition of “newly acquired information” provided in 21 CFR § 314.3(b) is:

Newly acquired information is data, analyses, or other information not previously submitted to the Agency, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new

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State alleges, Defendants knew enough about the poor responder

issue to trigger a duty under state law to update the Plavix

label, then they would also have enough “newly acquired

information” to effectuate that update through the CBE

regulations.

Defendants have not established it would have been

impossible under federal law for them to add information about

the poor responder issue to the Plavix label.

B. Summary judgment on materiality

We now turn to the circuit court’s summary judgment ruling

on materiality.

The defendant companies argue that the court erred by

granting partial summary judgment to the State on materiality.

They also argue the court made an “alternative” ruling that

ignored the summary judgment framework. We agree.

We review a trial court’s grant of summary judgment de

novo. Umberger v. Dep’t of Land & Nat. Res., 140 Hawaiʻi 500,

512, 403 P.3d 277, 289 (2017). Because materiality is

“ordinarily for the trier of fact,” summary judgment on this

element is “often inappropriate.” Courbat, 111 Hawaiʻi at 263,

141 P.3d at 436 (cleaned up).

analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

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Here, the summary judgment grant was inappropriate for two

reasons. First, the circuit court disregarded evidence that

raised genuine factual disputes about the materiality of the

information in the 2010 Black Box Warning. Second, calling

itself the “Ultimate Trier of Fact,” the court made an

alternative ruling and weighed evidence before trial, finding

materiality, and straying from the summary judgment framework.

We vacate both the court’s “traditional” and “alternative”

summary judgment rulings.

1. Disregarded Evidence

Under UDAP, a representation or omission is considered

material if it “involves information that is important to

consumers and, hence, likely to affect their choice of, or

conduct regarding, a product” — in this case, Plavix. Courbat,

111 Hawaiʻi at 262, 141 P.3d at 435 (cleaned up). The test is

objective, not subjective. Id. It considers the viewpoint of

the “reasonable consumer, not the particular consumer.” See

Yokoyama v. Midland Nat’l Life Ins. Co., 594 F.3d 1087, 1092

(9th Cir. 2010).

Urging summary judgment, the State argued that the

information placed in the 2010 boxed warning was material to

consumers. The State stressed that a black box warning is the

most serious warning the FDA can require. Both BMS and the FDA

considered the information on this label “the most important

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information.” It also presented eight survey findings from the

defendant companies’ 40-doctor telephone survey on how the boxed

warning impacted the doctors’ prescribing behavior.

The defendant companies did not deny that black box

warnings are important in the abstract. Rather, they argued

that in this case, no speculation was necessary about whether

the label information relating to poor-responders was “likely”

to affect doctors’ prescribing decisions. There was already a

decade of evidence about what Hawaiʻi doctors actually did in

response to the label change: not much.

Their expert testimony, the companies said, “uniformly

demonstrates that the boxed warning did not affect [doctors’]

prescriptions of Plavix.” The companies stressed that the

Hawaiʻi doctors said that their clinical practices were not

impacted by the disclosure of information about CYP2C19 poor

metabolizers.

Dr. Todd Seto, for example, stated that even though 70

percent of his patients are of Asian or Pacific Island descent,

the black box warning hasn’t affected his practice. He

maintained that “nearly all” the angioplasty patients at Queen’s

Medical Center in Honolulu take Plavix. Dr. Seto also said that

he was “not aware” of any physician at Queen’s who “conducts

routine genetic testing before prescribing Plavix” to determine

if someone is a poor responder.

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The companies also pointed to evidence from the State’s

public health journal: it recommended that Hawaiʻi doctors not

change their prescribing practice based on the boxed warning and

that genetic testing not be done. Adding to that, State public

health agencies reimburse for Plavix without regard to race or

genotype and without requiring genetic testing. Further, the

companies said, Hawaiʻi Medicaid reimbursements of Plavix

increased after the boxed warning, including for patients of

most Asian ethnicities.

Taken in the light most favorable to them, the companies

argued, the black box warning did not change the medical

community’s prescribing practices or genetic testing practices.

They maintained that consumers continued to take Plavix despite

the warning, raising a strong inference that the warning was not

material to consumers.

The circuit court disagreed. It rejected the companies’

materiality evidence, finding that when information relates to

safety and health, there’s a presumption that it’s material.

Since materiality is determined by an objective, patient-

oriented test, evidence about the behavior of doctors could

never create a genuine issue of material fact. The court ruled

that the defendant companies failed to overcome the materiality

presumption.

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The court erred. First, it overstated the presumption of

materiality. Second, in refusing to consider any evidence about

doctors’ prescribing behavior, the court misinterpreted the

objective, patient-centered materiality test.

The presumption of materiality that the court relied on

comes from the deceptive advertising context. See Novartis

Corp. v. F.T.C., 223 F.3d 783 (D.C. Cir. 2000); In re Thompson

Med. Co., Inc., 104 F.T.C. 648 (1984); In re Simeon Mgmt. Corp.,

87 F.T.C. 1184 (1976). 30

A presumption of materiality does not end things. It’s not

“an inflexible rule that eliminates [the] need to look at

materiality on a case-by-case basis.” Thompson Med., 104 F.T.C.

at 648 n.45. Overcoming the presumption of materiality is “not

a high hurdle.” In re Novartis Corp., 127 F.T.C. 580, 686

(1999). Defendants may always counter the presumption with

extrinsic evidence, including “expert testimony, consumer

research, and evidence of how the networks and other expert

bodies interpreted the advertisements.” Thompson Med., 104

F.T.C. at 24.

The State’s materiality argument is ultimately one from

intuition – the intuition that something the FDA considers very

30 The State only cited Novartis Corp. v. F.T.C. for its presumption of materiality argument. And the court cited only one case that concerned an omission, rather than affirmative deception. It involved a company that advertised its product as medical but did not tell consumers the product was not FDA-approved. In re Simeon Mgmt., 87 F.T.C. 1184. This case did not mention a presumption of materiality.

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important for consumers to see must be material to those

But materiality is about what consumers do, not what the

FDA thinks. See In re ConAgra Foods, Inc., 90 F. Supp. 3d 919,

1020 (C.D. Cal. 2015) (in misleading marketing case the

“relevant question” was not whether the FDA requires that GMO

food be labeled non-natural, but rather, how a “reasonable

consumer” would have understood the term “100% Natural” and

whether it would have been “material to [their] purchasing

decision”). If the companies are able to present evidence that

the information did not, in fact, change consumer behavior, they

are entitled to do so.

Nor are the companies’ statements that they considered the

label information “important” a slam-dunk for the State.

Because the standard is whether the information is material to a

reasonable consumer, not the defendants. See Courbat, 111

Hawaiʻi at 262, 141 P.3d at 435; see also In re McCormick & Co.,

Inc., Pepper Products Mktg. & Sales Practices Litig., 422 F.

Supp. 3d 194, 250 (D.D.C. 2019) (observing that “evidence of a

defendant’s opinion as to materiality is not an adequate

substitute for extrinsic evidence.”).

In short, the circle of what the FDA and the companies

consider “important” may not wholly overlap with the circle of

what consumers consider “material” to their decisions.

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The same can be said for what doctors consider important.

But while the prescribing decisions of doctors are not

synonymous with consumer behavior, they are certainly not

irrelevant to it.

The reality is that patients do not operate in a vacuum

when making decisions about prescription drugs. Objectively

reasonable patients may rely on their doctors to help them make

sense of drug labels. See In re Reglan Litig., 142 A.3d 725,

738 n.8 (N.J. 2016) (“While the drug labels are initially

disseminated to doctors and pharmacists, they, in turn, inform

their patients, passing the warnings on to consumers.”).

So, while patients and doctors cannot be conflated, the

testimony of prescribing doctors also cannot be completely

written off. The fact that cardiologists in Hawaiʻi continued to

prescribe Plavix to patients of all ethnicities even after the

introduction of the black box warning bore on whether a

“reasonable” patient would choose to purchase the drug. The

circuit court erred by shutting out this category of evidence

entirely.

The substantial evidence and testimony the defendant

companies mustered that Hawaiʻi doctors did not change their

Plavix prescribing practices after the placement of the label

and did not recommend genetic testing to patients was enough to

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create a genuine dispute of material fact on materiality. To

hold otherwise was error.

2. Alternative Ruling

The circuit court gave a back-up explanation for granting

the State’s partial summary judgment motion. This alternative

ruling involved the court weighing the evidence as if it were

trying the case. The court felt “confident” it “would reach the

same conclusion” if the materiality issue were presented at

trial. So it ruled on materiality at the summary judgment

stage, disregarding the summary judgment framework: “When ruling

on summary judgment prior to a bench trial — as here — the court

need not resolve inferences in favor of the non-moving party.”

That is not how summary judgment works. A court must

consider the evidence “in the light most favorable to the non-

moving party” at summary judgment. Ralston v. Yim, 129 Hawaiʻi

46, 56, 292 P.3d 1276, 1286 (2013) (cleaned up). The moving

party bears the burden of persuasion. Yoneda v. Tom, 110 Hawaiʻi

367, 384, 133 P.3d 796, 813 (2006). To prevail, the moving

party must demonstrate that there’s no genuine dispute about the

material facts and the “undisputed facts” show the court should

grant summary judgment as a matter of law. Id. (citing Lee v.

Puamana Cmty. Ass’n, 109 Hawaiʻi 561, 567, 128 P.3d 874, 880

(2006)).

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Whether a motion for summary judgment is brought in a jury

trial or a bench trial makes no difference. A judge deciding a

summary judgment motion may not fact-find, even if the matter is

set for a for a bench trial. See Anderson v. Liberty Lobby,

Inc., 477 U.S. 242, 249 (1986) (“[A]t the summary judgment stage

the judge’s function is not himself to weigh the evidence and

determine the truth of the matter but to determine whether there

is a genuine issue for trial.”)

Summary judgment is no substitute for trial. The record is

thinner. There’s no cross-examination. The court has seen only

a small snapshot of the case. An improvident grant of summary

judgment denies a party the chance to fully mount an offense or

defense.

That is why the summary judgment process has a safeguard –

the inference in favor of the non-moving party. Ralston, 129

Hawaiʻi at 56, 292 P.3d at 1286; see also Nolan v. Heald College,

551 F.3d 1148, 1154 (9th Cir. 2009) (trial court that weighed

evidence at the summary judgment stage “ignor[ed] the

protections that summary judgment usually affords the non-moving

party”). Without this safeguard, summary judgment would end-run

the trial right.

The circuit court deviated from the normal summary judgment

framework. The court found a material fact – materiality -

before trial, supporting its “alternative ruling” with a

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citation to TransWorld Airlines, Inc. v. Am. Coupon Exch., Inc.,

913 F.2d 676 (9th Cir. 1990), recommended by the State. Quoting

the Ninth Circuit, the court said: “where the ultimate fact in

dispute is destined for decision by the court rather than by a

jury, there is no reason why the court and the parties should go

through the motions of a trial if the court will eventually end

up deciding on the same record.” TransWorld, 913 F.2d at 684.

TransWorld did not prod trial judges to weigh facts at the

summary judgment stage. Rather, in TransWorld the court scolded

the judge below for skipping to summary judgment on a “wholly

inadequate” factual record. Id. at 683 (“[W]e conclude that the

record is wholly inadequate, and the district court’s own

opinion is the most persuasive testimony to that inadequacy.”).

TransWorld acknowledged that when a question was pure law,

where trial would not alter the factual record, there is no need

to “go through the motions of trial.” Id. at 684. But, the

court stressed, “courts must not rush to dispose summarily of

cases — especially novel, complex, or otherwise difficult cases

of public importance — unless it is clear that more complete

factual development could not possibly alter the outcome and

that the credibility of the witnesses’ statements or testimony

is not at issue.” Id. at 684–85.

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For a case like this one – novel, complex, and of great

public importance – a developed factual record is essential to a

fair trial.

Here, the court found the defendant companies’ evidence

“weak and unpersuasive.” It said that “even” if the Defendants

presented other evidence, “this Court is convinced that if the

issue of materiality were litigated at trial the Court would

ultimately conclude that the information in the Black Box

Warning is material.”

Trial courts have no business factfinding at the summary

judgment stage. We vacate the court’s alternative ruling.

C. UDAP – Deceptive Acts or Practices

The court’s grant of summary judgment on materiality

reverberated throughout the trial. Because the materiality

ruling formed the basis of the court’s holding that the

defendant companies committed deceptive acts or practices, we

vacate this part of the holding.

Materiality is an essential element of a UDAP deceptive

acts violation. See Courbat, 111 Hawaiʻi at 262, 141 P.3d at 435

(To prove a deceptive act or practice under UDAP, a plaintiff

must show “(1) a representation, omission, or practice that (2)

is likely to mislead consumers acting reasonably under the

circumstances where (3) the representation, omission, or

practice is material.”) When the court issued its findings of

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fact and conclusions of law, it remarked that it had “already

determined that the information in the 2016 boxed warning was

material.” But we have vacated that determination. Materiality

is now an unproven element. The deceptive acts holding based on

it cannot stand.

For deceptive acts liability, the court must also find that

the omission in question was likely to mislead consumers. In

its decision, the court found that “the omission of this

material information was likely to mislead consumers.”

(Emphasis added.) This phrasing suggests that the court found

the omission likely to mislead consumers in part or in whole

because it was an omission of material information. This throws

the other main element of deceptive acts liability into doubt as

well.

Lack of an essential element (or two) is enough to vacate a

result. But the materiality ruling marred the trial outcomes in

other, more far-reaching ways. In its summary judgment order,

the court ruled that evidence of “what’s happening in Hawaiʻi,”

such as “prescription practices and genetics testing practices”

after the 2010 Black Box Warning could not be introduced at

trial. The court drew a thick line in the sand: it would not

hear medical expert testimony on anything that happened after

2010, when the FDA first placed its boxed warning on Plavix.

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Based on its materiality ruling, the court granted a motion

in limine by the State to substantially limit the testimony of

Defendants’ main expert witnesses, three Hawaiʻi cardiologists.

These doctors were not allowed to testify about “their own

practices regarding use of Plavix” after 2010. Nor could they

provide any opinions based on “medical or scientific literature”

that drew upon post-2010 data.

Defendants had wanted to argue that the Plavix story didn’t

end in 2010. Hawaiʻi doctors continued to treat patients of all

ethnic backgrounds with Plavix, guidelines continued to

recommend Plavix treatment, and in 2016, the FDA walked back

part of its 2010 warning, removing language that warned of worse

clinical outcomes for CYP2C19 poor-responders. But Defendants

could not make this argument; their expert witnesses were not

allowed to discuss any of it.

At the heart of the State’s case is the notion that, for a

large chunk of Hawaiʻi’s population, Plavix is a bad drug, little

better than a placebo. Bristol-Myers Squibb and Sanofi

vehemently disagree. But unlike the State, they did not have

the chance to make their case fully at trial. We therefore

vacate the circuit court’s deceptive acts holding.

D. UDAP – Unfair Acts or Practices

Unfair act UDAP claims are distinct from deceptive act UDAP

claims. To violate HRS § 480-2, a plaintiff may show that an

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act or practice is deceptive or unfair. See Bronster v. U.S.

Steel Corp., 82 Hawaiʻi 32, 50-51, 919 P.2d 294, 312-13 (1996)

(jury instructions wrongly conflated deceptive acts and unfair

acts under UDAP). A practice is unfair if it (1) offended

public policy, (2) was immoral, unethical, oppressive, or

unscrupulous, or (3) substantially injured Hawaiʻi consumers.

See Hungate v. Law Office of David B. Rosen, 139 Hawaiʻi 394,

411, 391 P.3d 1, 18 (2017).

The circuit court found that the defendant companies

violated the UDAP in each unfair acts or practices way.

We conclude that the court’s materiality ruling affected

its unfair acts finding on “substantial injury.” The State,

however, proved separate and independent grounds to find the

defendant companies’ conduct offended public policy and was

immoral under UDAP. These findings support the court’s unfair

acts holding.

1. No Substantial Injury

The Defendants argue that the court’s unfair acts holding

must meet the same fate as its deceptive acts holding. Because

both were impermissibly tainted by the materiality ruling,

neither can stand.

The companies acknowledge, as they must, that materiality

is not an element of unfair act claims. But they maintain that

the court’s premature materiality ruling prevented them from

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mounting a complete defense on their unfair acts or practice

claim. And they point to language in the court’s holding that

assumed the materiality of the black box warning.

We agree – up to a point.

The circuit court found the companies’ conduct unfair by

every possible measure: it was against public policy; it was

immoral, unethical, and unscrupulous; and it was substantially

injurious to consumers.

The court’s misplaced materiality ruling played a part in

some of these findings. Most significantly, it impacted the

court’s finding that the companies’ conduct substantially

injured consumers.

Substantial injury, more so than the other unfair prongs,

focuses on consequences for consumers. Defendants’ most basic

argument against materiality – that in practice, the information

in the black box did not matter and patients were not harmed by

its absence – goes to substantial injury just as much as it goes

to materiality. And the evidence that Defendants wished to but

could not introduce about what actually happened after 2010 is

probative to the question of consumer injury.

The court first found that consumers were injured because

they were denied “the opportunity to consider whether to undergo

genetic testing” to determine their response to Plavix. At

summary judgment, Defendants mustered evidence that Hawaiʻi

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hospitals and doctors do not currently perform genetic testing

before prescribing Plavix. If patients aren’t given genetic

testing before taking Plavix now, Defendants argued, how were

they harmed by not having genetic testing then? This evidence

and this argument were not tested at trial. The court prevented

the companies from introducing any evidence of medical practices

after 2010, including genetic testing practices.

Second, the court found that “patients with CYP2C19 loss-

of-function alleles” were injured because they were deprived of

“the opportunity to make informed decisions” about taking Plavix

versus an alternative treatment. For a lack of information to

harm consumers, that information must be material to them. It

may well have been. But because the court prematurely decided

the materiality issue, findings of harm to consumers that hinge

on that materiality also cannot stand.

The court similarly found that patients were harmed because

they could not “give informed consent to their treatment.” This

more broadly-phrased restatement of the court’s second finding

fails for the same reason.

Lastly, the court found that the defendant companies harmed

“an indeterminate number” of patients who were deprived of the

“intended risk reduction [they] were relying on Plavix to

provide.” This holding also rests on a chain of assumptions

that the materiality ruling prevented the Defendants from

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contesting. Namely, Defendants were foreclosed from arguing

that if doctors do not currently test patients for CYP2C19

alleles before prescribing and still prescribe Plavix regularly

across ethnic groups, it is reasonable to infer that the medical

community thinks Plavix provides adequate risk reduction.

Doctor testimony on their current practice is plainly relevant

to the question of whether a drug substantially injures patients

by providing lower risk reduction, but the court’s materiality

ruling effectively barred that testimony.

Materiality mattered for each of the court’s substantial

injury findings. So we throw out that portion of the court’s

unfair act holding.

2. Hawaiʻi Unfair Acts or Practices Law

Substantial injury is out. Under the Federal Trade

Commission Act – the original inspiration for UDAP - this would

be the end of the matter: no substantial injury, no unfair acts

claim.

But under Hawaiʻi law, the State didn’t need to run the

table on unfair conduct. Our UDAP caselaw does not require a

plaintiff to prove all three prongs of unfair acts. Rather,

“[a] practice may be unfair because of the degree to which it

meets one of the criteria or because to a lesser extent it meets

all three.” Hungate, 139 Hawaiʻi at 411, 391 P.3d at 18 (quoting

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Kapunakea Partners v. Equilon Enters., LLC, 679 F. Supp. 2d

1203, 1210 (D. Haw. 2009)).

This conflicts with the federal approach. Congress amended

the FTC Act in 1994. Now, plaintiffs suing under the FTC Act

must prove substantial injury (and more) for an unfair acts

claim. 31 See LabMD, Inc. v. Fed. Trade Comm’n, 894 F.3d 1221,

1226 n.10 (11th Cir. 2018) (explaining that “for an act or

practice to be unfair, the act or practice [1] causes or is

likely to cause substantial injury to consumers [2] which is not

reasonably avoidable by consumers themselves and [3] not

outweighed by countervailing benefits to consumers or to

competition.”) (quoting 15 U.S.C. § 45(n)) (cleaned up)).

When interpreting the UDAP, we give “due consideration to

the rules, regulations, and decisions of the Federal Trade

Commission and the federal courts interpreting section 5(a)(1)

of the Federal Trade Commission Act (15 U.S.C. [§] 45(a)(1)), as

from time to time amended.” HRS § 480-2(b). But no one – not

31 15 U.S.C. § 45(n) (2006) reads:

The Commission shall have no authority under this section or section 57a of this title to declare unlawful an act or practice on the grounds that such act or practice is unfair unless the act or practice causes or is likely to cause substantial injury to consumers which is not reasonably avoidable by consumers themselves and not outweighed by countervailing benefits to consumers or to competition. In determining whether an act or practice is unfair, the Commission may consider established public policies as evidence to be considered with all other evidence. Such public policy considerations may not serve as a primary basis for such determination.

(Emphases added.)

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the State, nor the defendant companies – raised the 1994 FTC Act

amendment. (Nor apparently did the parties in our earlier UDAP

cases.) Everyone operated under the assumption that the federal

changes did not matter, and the State could win without proving

substantial injury. This assumption must remain.

We turn to a separate issue that the circuit court

spotlighted: an incongruity in this court’s treatment of UDAP

unfair acts or practices suits.

The circuit court pointed out that despite Hungate’s “meets

one of the criteria” directive, that case also said “[a]

practice is unfair when it [1] offends established public policy

and [2] when the practice is immoral, unethical, oppressive,

unscrupulous or [3] substantially injurious to consumers.” 139

Hawaiʻi at 411, 391 P.3d at 18 (citation omitted) (emphases

added). This implied that UDAP plaintiffs must demonstrate

public policy plus one of the other elements, while at the same

time allowing any one element, alone, to suffice.

We clarify Hawaiʻi’s unfair acts or practices UDAP test in

one respect: meeting any one of the three criteria supports an

unfair acts or practices UDAP claim.

Our approach to unfair acts or practices traces to F.T.C.

v. Sperry & Hutchinson Co., 405 U.S. 233 (1972). In Sperry, the

Supreme Court ruled that the FTC Act gave the FTC broad powers

to determine practices as unfair or deceptive, despite their

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effect on competition. Sperry adopted factors the FTC had

developed in the cigarette advertising context to determine

whether a practice was unfair:

(1) [W]hether the practice, without necessarily having been previously considered unlawful, offends public policy as it has been established by statutes, the common law, or otherwise—whether, in other words, it is within at least the penumbra of some common-law, statutory, or other established concept of unfairness; (2) whether it is immoral, unethical, oppressive, or unscrupulous; (3) whether it causes substantial injury to consumers . . .

405 U.S. at 244 n.5. Sperry left open what combination of these

factors would be sufficient to show unfair acts liability.

In Spiegel, Inc. v. F.T.C., 540 F.2d 287 (7th Cir. 1976),

the Seventh Circuit took a “public policy plus” approach to the

Sperry factors. It inserted the disjunctive “or” between

Sperry’s second and third criteria, holding that “A practice is

unfair when it offends established public policy and when the

practice is immoral, unethical, oppressive, unscrupulous or

substantially injurious to consumers.” Id. at 293 (emphases

added).

Then, in Rosa v. Johnston, 3 Haw. App. 420, 427, 651 P.2d

1228, 1234 (1982), the Intermediate Court of Appeals adopted

Spiegel’s rearrangement of Sperry. Later, in the context of

holding that deceptive and unfair are distinct under UDAP, we

mentioned Rosa in passing and said that the ICA “properly”

defined unfair acts. Bronster, 82 Hawaiʻi at 51, 919 P.2d at

313.

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But Spiegel’s interpretation of Sperry was not the only

one. The FTC read Sperry to mean that “[a]ll three criteria do

not need to be satisfied to support a finding of unfairness. A

practice may be unfair because of the degree to which it meets

one of the criteria or because to a lesser extent it meets all

three.” Promulgation of Trade Regulation Rule and Statement of

Basis and Purpose, Disclosure Requirements and Prohibitions

Concerning Franchising and Business Opportunity Ventures, 43

Fed. Reg. 59614, 59635 (1978).

The FTC’s reading worked for the United States District

Court for the District of Hawaiʻi. Kapunakea, 679 F. Supp. 2d at

1210. Weighing in on HRS § 480-2, the district court referred

to Rosa, Bronster, and Spiegel. Id. Then it returned to

Sperry, noting that the Sperry test came straight from the FTC

and that the FTC in 1978 interpreted the three factors to be

disjunctive. The district court followed the FTC’s approach.

When we took up the unfair acts issue once more in Hungate,

we approved Kapunakea’s reasoning: any one of the three criteria

could constitute an unfair practice under HRS § 480-2. 139

Hawaiʻi at 411, 391 P.3d at 18. But Hungate inharmoniously

retained the “and-or” language from Spiegel. Hungate didn’t

clarify whether the appropriate test was fully disjunctive.

We interpret Hawaiʻi’s consumer protection law in a way that

maximizes consumer protection. The UDAP “was constructed in

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broad language in order to constitute a flexible tool to stop

and prevent fraudulent, unfair or deceptive business practices

for the protection of both consumers and honest

business[people].” Zanakis-Pico v. Cutter Dodge, Inc., 98

Hawaiʻi 309, 317, 47 P.3d 1222, 1230 (2002) (citation omitted).

The Spiegel approach does not reflect this breadth. We

conclude that a disjunctive reading of the Sperry factors best

aligns with UDAP’s primary purpose - to protect consumers.

Other states have reached the same conclusion. See

Cheshire Mortg. Serv., Inc. v. Montes, 612 A.2d 1130, 1143–44

(Conn. 1992) (holding that under Sperry, “[a] practice may be

unfair because of the degree to which it meets one of the

criteria or because to a lesser extent it meets all three.”);

see also Robinson v. Toyota Motor Credit Corp., 775 N.E.2d 951,

961 (Ill. 2002) (“[A]ll three of the criteria in Sperry do not

need to be satisfied to support a finding of unfairness.”).

3. Separate, Independent Grounds for UDAP Liability

Having clarified UDAP unfair acts law, all that remains is

to apply it to the present case.

The circuit court determined that the defendant companies’

conduct violated each of the three elements for an unfair acts

or practices claim. Their conduct: (1) offended public policy;

(2) was immoral, unethical, oppressive or unscrupulous; and (3)

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substantially injured Hawaiʻi consumers. See Hungate, 139

Hawaiʻi at 411, 391 P.3d at 18.

The court’s materiality ruling knocked out its

substantially injurious findings. See supra.

That error, however, is not enough for the companies to

avoid liability. The court determined that two separate types

of unfair acts or practices occurred. The first type focused on

the black box label. These findings rely on – and thus were

tainted by - the materiality finding. But the second type of

conduct – suppressing research and inquiry into the drug for

financial reasons – had no connection to the court’s materiality

ruling. The court’s findings about the companies suppressing

inquiry into Plavix poor response have nothing to do with the

black box label. They have nothing to do with doctors’

prescribing habits after 2010. Rather, these findings have

everything to do with defendant companies “burying their heads

in the sand” over potential issues with a drug on the market.

The court’s findings spoke to the other two elements of

UDAP unfair acts claims. The court found sufficient facts to

support the State’s allegation that defendant companies’ conduct

offended public policy 32 and was unethical.

32 Defendant companies argue that materiality impacted the court’s public policy findings, pointing out that the court said: “Defendants’ failure to update the Plavix drug warning after learning of the safety risks posed to poor metabolizers offends this well-established public policy.” We agree with Defendants: this finding is only relevant if the black box label matters

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First, we turn to the court’s public policy findings.

Public policy covers a broad range, from state and federal law,

to common law, to Hawaiʻi policy. See Hungate, 139 Hawaiʻi at

411, 391 P.3d at 18 (“[a] practice may be unfair if it offends

public policy as it has been established by statutes, the common

law, or otherwise.”) (Cleaned up.)

Pharmaceutical companies have a common law duty to warn

consumers “when the risks of a particular drug become apparent.”

Albrecht, 139 S. Ct. at 1677.

The court-as-factfinder concluded that the companies aimed

to avoid their common law duty by: “suppressing research and

continuously and repeatedly failing to further investigate the

risks of reduced platelet inhibition in poor metabolizers.” In

its findings, the court determined that the companies knew -

from the moment Plavix launched - about the diminished effects

of Plavix in non-White populations. It maintained that the

companies did not volunteer this information to the FDA. The

court further found the companies avoided funding studies which

could draw more attention to the variability of response, for

instance, by rejecting a study on aspirin resistance because “it

could lead to a similar trial on [Plavix] resistance.”

to consumers. The court’s materiality ruling foreclosed that evidentiary inquiry.

But the court’s reference to the label formed only one part of the court’s public policy decision. The other public policy findings had no connection to the black box label or related evidence.

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The companies’ actions, the court found, set back the

research into CYP2C19 by consciously, repeatedly, and actively

avoiding the poor responder problem. All this, according to the

court, was to avoid “negative marketing implications” for

Plavix.

Preventing risks from becoming apparent for financial gain

offends Hawaiʻi public policy. Hawaiʻi law cannot incentivize

drug companies to ignore safety risks in the hope that

everything will turn out all right in the end. Even if the drug

proves to be safe, avoiding investigation into known safety

issues in order to keep profits up offends public policy. See,

e.g., 21 CFR §§ 314.80, 314.81 (requiring a continuing duty of

surveillance and post-marketing reporting to the FDA of adverse

drug experiences).

The court’s findings also animate its determination that

the companies behaved in an “immoral, unethical, oppressive,

unscrupulous” manner. 33 The court determined that the companies

prioritized profits over patients: defendant companies “buried

their heads in the sand” about the problems with Plavix to

protect the corporate bottom line. The court found the

33 There is another difference between Hawaiʻi’s consumer protection law and federal law. The FTC scrapped Sperry’s second criteria long ago. In its 1980 Unfairness Policy Statement, the FTC called the “immoral, unethical, oppressive, unscrupulous” features of an unfair act or practice “largely duplicative.” “Conduct that is truly unethical or unscrupulous,” the FTC continued, “will almost always injure consumers or violate public policy as well.” FTC Policy Statement on Unfairness. https://www.ftc.gov/legal- library/browse/ftc-policy-statement-unfairness [https://perma.cc/3VA6-JMFK].

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companies “continued to deny” the issues surrounding poor

response to the drug despite evidence to the contrary, giving

the impression that no one had any reason to be alarmed. See

Hawaii Cmty. Fed. Credit Union v. Keka, 94 Hawaiʻi 213, 229, 11

P.3d 1, 17 (2000) (describing conduct as unethical and

unscrupulous when defendant attempted to convince a family to

execute loan documents through false assurances about a lower

interest rate).

4. No Clear Error in FOFs

The defendant companies argue the court clearly erred in

most of the elemental unfair acts and practice factual findings.

We disagree.

The trial court fulfilled its duty as fact-finder. See In

re ASK, 152 Hawaiʻi 123, 127, 522 P.3d 270, 274 (2022) (“Our view

reflects a central feature of any trial: the fact-finder – judge

or jury - finds facts, weighs and values those facts, and finds

other facts, the facts of consequence.”). The court weighed the

trial evidence; it drew inferences; it made credibility

determinations; it valued some testimony and evidence over other

testimony and evidence.

Clearly erroneous facts are either (1) not supported by

substantial evidence in the record, Panoke v. Reef Dev. of

Hawaii, Inc., 136 Hawaiʻi 448, 460, 363 P.3d 296, 308 (2015) or

(2) ones where “despite evidence to support the finding, the

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appellate court is left with the definite and firm conviction

that a mistake has been committed.” Chun v. Bd. of Trs. of the

Emps.’ Ret. Sys. of the State of Hawaiʻi, 106 Hawaiʻi 416, 430,

106 P.3d 339, 353 (2005) (cleaned up). The circuit court’s

findings do not leave us with either conviction.

The court made sufficient findings of fact that defendant

companies’ conduct offended public policy and was immoral under

UDAP. The substantial injury findings drop because they were

affected by the materiality ruling. But the court’s findings as

to the other two elements are uncoupled from that error. These

findings support the court’s unfair acts decision. Thus, the

court’s ruling that Defendants committed unfair acts or

practices under UDAP stands.

E. Penalties

Lastly, we turn to the penalties. The defendant companies

maintain that the court’s materiality ruling impaired its

damages calculation. We agree.

We vacate the damage award and remand the penalty issue for

determination after the deceptive acts question has been

settled.

The court based the penalty for violating UDAP on both

deceptive and unfair acts. But now, only the State’s unfair

acts UDAP violation remains. Any penalty for the deceptive acts

claim cannot continue to stand pending a new trial.

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We find that the court’s heavy reliance on its materiality

ruling to reach its penalties determination makes it necessary

to remand the entire question of damages. The court reasoned

that the $834 million penalty was justified because Defendants

had substantially injured the public. Those injuries, the court

explained, flowed from the fact that Defendants had denied

patients material information. The “injury to the public”

paragraph in the court’s penalty award discussion uses the word

“material” no fewer than three times. The court relied on its

materiality findings – and thus the deceptive acts UDAP claim –

to calculate its penalty award.

The per-prescription based penalty also shows the circuit

court’s reliance on the materiality ruling. This type of

penalty only makes sense if the missing black box warning was

material to consumers. To illustrate this point, the court used

the example of hanging an unlawful billboard versus sending

thousands of unlawful mailers. For the billboard, an

appropriate penalty would count every day the billboard hangs;

for the mailers, an appropriate penalty would count every mailer

sent. The circuit court thought this case was more like the

mailer situation. But this only fits if the omitted information

was material to consumers, making it an injury each time they

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received the prescription without that information. That is

what the new trial will consider. 34

The claim that Defendants engaged in unfair practices

better fits the billboard example. Here, the State’s claim

focuses on the idea that Defendants suppressed research or

failed to sufficiently investigate leads. In these

circumstances, an appropriate penalty would correlate more with

the length of time the Defendants “buried their heads in the

sand.”

That the court landed on a per-prescription penalty reveals

how crucial materiality was to the damage calculations.

Because the penalty award relied on the court’s faulty

materiality ruling, it must be vacated. Only the claim that

Defendants committed unfair acts or practices in violation of

UDAP remains. At the new trial, it may be that Defendants will

be found to have committed deceptive acts as well, or found to

have only committed unfair practices. The nature of the UDAP

violation will determine the proper penalty for that violation.

Since the final penalty will be partially contingent on the

result, the penalty determination should take place after the

new trial, by the judge who conducts that trial.

34 We are unpersuaded by the defendant companies’ arguments regarding “coercive” and “biased” treatment by the trial court. This case, however, is remanded to a new trial judge.

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IV. CONCLUSION

We vacate the circuit court’s grant of partial summary

judgment on materiality, the court’s deceptive acts holding, and

its penalty award. The court’s unfair acts holding stands. We

remand only as to the deceptive acts and penalty issues.

Neal Kumar Katyal /s/ Mark E. Recktenwald (Paul Alston, Claire Wong Black, /s/ Paula A. Nakayama Anand Agneshwar, Daniel S. Pariser, Katherine B. Wellington /s/ Sabrina S. McKenna on the briefs) /s/ Todd W. Eddins for appellants

Thomas C. Goldstein (L. Richard Fried, Jr., Patrick F. McTernan, Kimberly T. Guidry, Nicholas M. Mclean, Daniel Alberstone, Peter Klausner, Evan Zucker, Elizabeth Smiley, Catherine H. Dorsey on the briefs) for appellees