State v. Bristol-Myers Squibb Company

Opinion

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Electronically Filed Supreme Court SCAP-XX-XXXXXXX 30-MAR-2023 07:58 AM Dkt. 69 OPD

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-Appellant.

SCAP-XX-XXXXXXX

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

MARCH 30, 2023

RECKTENWALD, C.J., NAKAYAMA, McKENNA, WILSON, AND EDDINS, JJ.

DISSENTING OPINION BY WILSON, J. *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

I. INTRODUCTION

The Majority’s holding strips protection from a global

set of consumers who unwittingly took Plavix without

understanding that it imposed risk of heart attack, stroke and

death. These consumers did not understand Plavix imposed grave

risk because they were deceived, in violation of Hawaiʻi’s Unfair

or Deceptive Acts or Practices law (“UDAP”), by pharmaceutical

companies Bristol-Myers Squibb (“BMS”) and Sanofi (together, the

“Defendants”). BMS and Sanofi deceived consumers for

approximately eleven years by failing to warn that they may

respond poorly to Plavix—the antiplatelet drug consumers were

trusting to save their life. The Defendants earned

approximately $74 billion selling Plavix from the drug’s launch

in December of 1998 through 2012. Yet the record reflects that

BMS and Sanofi knew in March of 1998, prior to Plavix’s launch

in December of 1998, that almost one-third of Plavix patients

(32.2%) received less than 20% of Plavix’s antiplatelet effect,

making them a “poor responder.” BMS and Sanofi omitted this

“poor responder” information from the Plavix label. This

omission constituted a failure to warn, and exposed Plavix poor

responders to what was quantified in 2008 to be “a 50 percent

greater risk of having a heart attack, a stroke or death.” This

deception by omission perpetrated by BMS and Sanofi lasted

approximately eleven years, until the Food and Drug 2 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

Administration (“FDA”) compelled the Defendants to update the

Plavix label with a warning to consumers about the increased

risks of death and serious injury to Plavix poor responders.

Antiplatelet drugs are used to treat medical patients

already at increased risk of heart attack, stroke and death.

This acutely vulnerable set of consumers were victimized by BMS

and Sanofi’s omission of the poor responder issue, and the

systematic suppression of information and research into the

variability of response to Plavix. This egregious conduct

deprived consumers of Plavix’s promised antiplatelet effect, and

prevented them from undergoing genetic testing to determine

whether they were poor responders who should seek alternative

drugs or treatment.

At issue in this case is the viability of the legal

framework protecting consumers whose lives depend on

pharmaceutical companies not deceiving them about the safety and

efficacy of the drugs they sell. The Circuit Court of the First

Circuit (“circuit court”) was correct to grant summary judgment

on materiality as a matter of law. The judgment and penalties

should be affirmed.

II. BACKGROUND

BMS and Sanofi brought Plavix to market in December of

1998 knowing that almost one-third of patients who take Plavix

would be poor responders, and would not receive the drug’s

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promised antiplatelet effect. This “poor responder” problem was

discovered by the Defendants’ internal 1998 meta-analysis study.

The Defendants also knew at Plavix launch that (1) the CYP2C19

enzyme played a principal role in Plavix metabolization; (2) the

CYP2C19 enzyme was a 100% predictor of poor responders for the

drug S-mephenytoin; and (3) genetic tests were available to

determine one’s CYP2C19 status.

The variability in response to Plavix dramatically

increased the risk of heart attack, stroke, and death for poor

responders, and would ultimately become the single most

important data point the FDA compelled BMS and Sanofi to warn

consumers about. But because BMS and Sanofi omitted poor

responder information from its labeling, failed to disclose it

to the FDA, and suppressed research into why Plavix had a

variability of response, the warning about poor responders

didn’t reach Plavix’s label until 2009, approximately eleven

years after the launch of Plavix.

The poor responder issue began its journey to

disclosure when the Defendants submitted the 1998 meta-analysis

study demonstrating the poor responder problem to the FDA in

2005—a full seven years after the poor responder problem was

known to the Defendants. When the Defendants did submit the

1998 meta-analysis to the FDA in 2005, it was submitted as an

appendix to a separate, subsequent study, and not as a stand-

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alone disclosure of the 1998 meta-analysis itself. There is

nothing in the record to support the inference that the FDA

became aware of the poor responder issue as a result of the 2005

submission of the 1998 meta-analysis study.

In 2006, independent researcher Dr. Jean-Sebastien

Hulot published a study supporting the hypothesis that CYP2C19

was linked to reduced clopidogrel responsiveness (Plavix’s

chemical name is “clopidogrel”). In October 2008, a study

concluded that when the drug Omeprazole, a drug known to impede

CYP2C19’s function, was given to patients who were taking

Plavix, the Omeprazole caused a corresponding reduction in

Plavix’s antiplatelet effect, making those patients more likely

to have diagnostic codes for heart attack and stroke than Plavix

patients not taking Omeprazole.

This study caused significant concern at the FDA, and

a December 5, 2008 meeting was called between the FDA, BMS and

Sanofi. The FDA pressed BMS and Sanofi for information

regarding (1) the implications of CYP2C19 impact on Plavix

effectiveness, and (2) how the Plavix label should be updated

accordingly.

Just two weeks later, and before any changes were made

to the Plavix label, Dr. Jessica Mega published her study on

December 22, 2008 (the “Mega study”) which showed that carriers

of a reduced-function CYP2C19 allele (poor responders) “had a

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three-fold greater risk of clotting their stent, and a 50

percent greater risk of having a heart attack, a stroke or

death.”

Several months later, the FDA amended Plavix’s label

to include the poor responder issue and warn consumers about the

increased risk of heart attack, death and stroke (“higher

cardiovascular event rates”) for poor responders (“patients with

genetically reduced CYP2C19 function”): “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[.]”

In May of 2010 the FDA compelled BMS and Sanofi to

place the CYP2C19 poor responder information in a boxed warning.

The FDA boxed warning is the most serious warning a drug label

can reflect, and is particularly reserved for warnings that may

lead to death or serious injury. The Plavix boxed warning

prominently alerts the consumer of “diminished effectiveness”

for “poor metabolizers” (poor responders) who take Plavix

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because they “exhibit higher cardiovascular event rates” (heart

attack, stroke or death)1 than non-poor responders:

For approximately eleven years, BMS and Sanofi omitted

the poor responder problem from the Plavix label, exposing

Plavix patients who were poor responders to a fifty-percent

greater risk of heart attack, stroke and death, along with a

three-fold risk of clotting their stent. Only when the

Defendants’ hand was forced by independent research verifying

Plavix’s CYP2C19 poor responder issue, followed by the FDA’s

regulatory authority compelling the Defendants to revise their

label, did the Plavix poor responder warning finally reach

consumers.

1 Sanofi defines cardiovascular events as death, myocardial infarction, and stroke. The Merriam-Webster Online Dictionary defines myocardial infarction as “heart attack.” Myocardial infarction, Merriam- Webster,https://www.merriam-webster.com/dictionary/myocardial%20infarction (last visited March 1, 2023).

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In March of 2014, the State filed a complaint alleging

that BMS and Sanofi violated UDAP. The State’s complaint

alleged that between 1998 and 2010 BMS and Sanofi had violated

UDAP by: (1) failing to disclose that Plavix has diminished or

no effect in poor responders; and (2) suppressing research and

inquiry into Plavix for financial reasons. The State claimed

the Defendants’ behavior was both deceptive and unfair.

The circuit court ruled for the State on both points.

Following a bench trial that lasted more than a month, the court

held that BMS and Sanofi had violated UDAP by engaging in

deceptive and unfair acts and practices. The circuit court

found that BMS and Sanofi misled Hawai‘i consumers by failing to

warn them that Plavix was less effective for poor responders.

The circuit court determined that this omission injured

consumers by denying them Plavix’s full promised antiplatelet

effect. The circuit court further determined that the omission

prevented consumers from undergoing genetic testing to determine

whether they were poor responders, and seeking alternative

treatments accordingly. In addition, the circuit court

concluded that the Defendants failed to sufficiently research

the variability of response in Plavix, and actively suppressed

research that might confirm a link between ethnicity or genotype

and Plavix responsiveness. The circuit court imposed an $834

million penalty for these violations of UDAP.

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The Majority now vacates the penalty and remands for

retrial on the deceptive acts claim. The Majority holds that

the trial court erred in granting the State’s motion for partial

summary judgment on the deceptive act claim with respect to

whether the poor responder information was material to

consumers. The Majority leaves the unfair acts or practices

claim under UDAP intact.

III. DISCUSSION

A. The circuit court did not err in granting summary judgment. Omitted information about poor responders was material as a matter of law.

After conducting a bench trial, the circuit court

concluded BMS and Sanofi violated UDAP by engaging in both

deceptive and unfair acts and practices. Prior to trial, the

circuit court granted summary judgment with respect to the

materiality component of the State’s deceptive acts claim. The

Majority contends that the circuit court erred in granting

summary judgment on the issue of materiality, and that such

error infected the remainder of the trial, the deceptive acts

holding, and the penalty. The Majority’s position is without

merit.

The centerpiece of the State’s deceptive acts claim is

that BMS and Sanofi misled Hawaiʻi consumers by failing to warn

them that Plavix was less effective for poor responders, and

that poor responders using Plavix faced increased risks of death 9 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

and serious injury. The State alleged that the omission from

Plavix’s label about poor responders from 1998 until 2009

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. UDAP provides that “unfair or deceptive acts or

practices in the conduct of any trade or commerce are unlawful.”

Hawaiʻi Revised Statutes (“HRS”) § 480-2(a) (2008). An unlawful

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 deceptive act’s third prong –

materiality – was already established as a matter of law,

because the omitted information with respect to Plavix poor

responders was ultimately published in Plavix’s federally

mandated black box warning. Specifically, the State argued

there was “no doubt that the information contained in Plavix’s

federally mandated black box warning is material as a matter of

law.” On these grounds, the State asked the court to resolve

materiality at summary judgment in order to “eliminate any

unnecessary time at trial.” Materiality is an essential element 10 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

of a UDAP deceptive acts violation. Id. In order to prevail on

its deceptive acts claim, the State must establish that the poor

responder information was material to consumers, and that BMS

and Sanofi likely misled consumers by omitting it from the

Plavix label.

The test for UDAP materiality is objective, “turning

on whether the act or omission is likely to mislead consumers as

to information important to consumers in making a decision

regarding the product or service.” Courbat, 111 Hawai‘i at 262,

141 P.3d at 435. (cleaned up) (emphases added). 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). Although the objective

materiality test “is ordinarily for the trier of fact,” where

“evidence is so clear that no reasonable person would determine

the issue in any way but one[,]” summary judgment is

appropriate. Courbat, 111 Hawai‘i at 263, 141 P.3d at 436

(cleaned up). In addition, materiality is in fact presumed for

“claims that significantly involve health, safety, or other

areas with which the reasonable consumer would be concerned,

including a claim that concerns the purpose, safety, efficacy, .

. . performance, . . . or a finding by another agency regarding

the product.” Novartis Corp. v. FTC, 223 F.3d 783, 786 (D.C.

Cir. 2000) (cleaned up). In 2010 the FDA mandated the poor 11 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

responder issue to be placed in an FDA boxed warning. An FDA

boxed warning (colloquially known as a “black box warning”) is

the strongest warning that the FDA requires, and is solely

reserved for risks of death or serious injury. Since 2010,

consumers have been warned that their life might be at risk if

they consume Plavix and prove to be a poor responder. Consumers

who took Plavix between 1998 and 2009 were deprived of this

life-protecting information, and likely misled by this omission

in their decision to take Plavix.

1. The FDA boxed warning is material as a matter of law.

It is unequivocal: information contained within an

FDA boxed warning is of the highest legal magnitude,

specifically designated under the Federal Food, Drug, and

Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., to protect

consumers from death and life-altering injury with the force of

law. A boxed warning is the strongest warning that the FDA

requires, and it is reserved for risks of death or serious

injury.

Here, the FDA placed the poor responder issue in a

boxed warning to warn consumers about the potentially fatal

consequences of taking Plavix as a poor responder. Because the

FDA designated the poor responder issue to be the most important

information under law that a consumer must know when considering

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Plavix, it is axiomatic that such information is material.

Information is material to consumers when it is “important to

consumers” and therefore “likely to affect their choice of, or

conduct regarding, a product.” Courbat, 111 Hawai‘i at 262, 141

P.3d at 435 (citations omitted) (emphasis added). The poor

responder information is “important to consumers” as a matter of

law because of the FDA boxed warning designation bestowed upon

it for posing a potentially fatal threat to consumers. Id.

Because BMS and Sanofi omitted the poor responder information

for eleven years from the Plavix label, consumers were misled

with respect to their choice of Plavix, because they did not

have the material information that Plavix may pose a fatal

threat to them. The State is correct that there is “no doubt

that the information contained in Plavix’s federally mandated

black box warning is material as a matter of law.” The FDCA’s

statutory and regulatory framework set forth below outlines the

FDA’s legal authority, and further illustrates why the FDA boxed

warning makes the poor responder issue material as a matter of

law.

The FDCA is a consumer protection statute enacted in

1938 by the United States Congress. The FDCA’s primary purpose

is to “safeguard” and “protect” the consumer from being exposed

to “dangerous products” affecting public health and safety.

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United States v. Sullivan, 332 U.S. 689, 696 (1948). The FDA,

established under the FDCA, is the primary agency that

administers and enforces the FDCA. 21 U.S.C. § 393(a).2 The

central mission of the FDA is to “promote” and “protect the

public health” with respect to product safety, and specifically

to “ensure[] that . . . drugs are safe and effective[.]” 21

U.S.C. § 393(b)(1)-(2).

2 21 U.S.C. § 393 [Food and Drug Administration] states in part:

(a) In general. There is established in the Department of Health and Human Services the Food and Drug Administration (hereinafter in this section referred to as the “Administration”).

(b) Mission. The Administration shall —

(1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

(2) with respect to such products, protect the public health by ensuring that — (A) foods are safe, wholesome, sanitary, and properly labeled; (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use; (D) cosmetics are safe and properly labeled; and (E) public health and safety are protected from electronic product radiation;

(3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

(4) as determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products.

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To carry out its mission, the FDA is statutorily

empowered to enforce the FDCA’s mandates through administrative

actions. Specifically, the FDA has the statutory authority to

prohibit certain products from being sold in interstate commerce

unless those products have been evaluated and approved by the

FDA. See, e.g, 21 U.S.C. § 355(a)-(b) (prohibiting market entry

for any new drug unless FDA-approved). With respect to the

instant case, the FDA has the statutory authority to prohibit

any new drug from entering into interstate commerce unless the

FDA has approved it through its extensive new drug application

process. Id. Put simply, the FDA has the force of law with

respect to pre-market approval of a drug, and determining

whether a drug comes to market. That force of law includes

authority to ensure a drug is accurately and effectively labeled

so that consumers are aware of the drug’s safety and efficacy.

See, e.g., 21 C.F.R. § 201.56(a)(1) (labeling must contain

“essential scientific information needed for the safe and

effective use of the drug[.]”) (emphasis added). As such, the

FDA has a statutory mandate to ensure drugs are safe and

effective and accurately labeled, and no drug enters the streams

of commerce without the FDA’s approval and oversight.

Importantly, the FDA’s statutory mandate does not end

with pre-market approval: the FDA is endowed with substantial

post-market surveillance authority, including overseeing the

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continued safety of an approved drug and the continued adequacy

of its label. See, e.g., 21 C.F.R. § 314.70(c)(6)(iii)(A)

(requiring drug manufacturers to notify the FDA about changing a

label in order to “reflect newly acquired information . . . [t]o

add or strengthen a contraindication, warning, precaution, or

adverse reaction for which the evidence of a causal association

satisfies the standard for inclusion in the labeling under §

201.57(c)[.]”) (emphasis added).

A boxed warning is the strongest warning that the FDA

requires, and is reserved for risks of death or serious injury.

Boxed warnings reveal “[c]ertain contraindications or serious

warnings, particularly those that may lead to death or serious

injury” and “ordinarily must be based on clinical data.” 21

C.F.R. § 201.57(c)(1) (emphasis added). The boxed warning isn’t

just the strongest warning the FDA has in its arsenal to

regulate the safety of drugs; a “black box warning is the

strongest type of warning allowed in drug labeling, and to

ensure their significance is undiluted, use of a black box

warning is permitted only where specifically required by the

FDA.” Amos v. Biogen Idec Inc., 249 F.Supp.3d 690, 694

(W.D.N.Y. 2017) (emphasis added).

On these grounds, information contained in an FDA

boxed warning is designated by law to be the most essential

information a consumer needs to know with respect to the safety

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and efficacy of a drug. As such, information in an FDA boxed

warning is material as a matter of law. Here, the FDA mandated

the poor responder information to be placed in a boxed warning

to alert consumers about Plavix’s diminished effectiveness in

poor responders, and the consequent risks of death and life-

altering injury (in the form of higher cardiovascular event

rates) for poor responders:

The title of the boxed warning, in bold black

capitalized letters, prominently warns the consumer of

“diminished effectiveness[.]” The bullet-points in the boxed

warning clarify that: (1) poor metabolizers (poor responders)

taking Plavix exhibit higher cardiovascular events rates (heart

attack, stroke or death) than non-poor responders; (2) “tests

are available” for a consumer to determine if they are a poor

responder, which will aid in determining an appropriate

therapeutic strategy; and (3) poor metabolizers are directly

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instructed to “consider alternative treatment or treatment

strategies[.]”

The provision of the information in the FDA boxed

warning that Plavix poor responders face higher risk of

cardiovascular events is material for consumers who are

specifically seeking to reduce their risks of cardiovascular

events. This information informs the consumer that Plavix may

not deliver the antiplatelet effect they seek, and that they

should seek testing and/or alternative treatments. The

consumers in this case are categorically vulnerable medical

patients with cardiac issues, already at increased risk of

death, heart attack and stroke, who are seeking to reduce their

risks of cardiovascular events by taking an antiplatelet drug

that is specifically designed to do just that. It is axiomatic

that information relating to the possibility that Plavix would

in fact exacerbate the very risks of heart attack, stroke and

death the patient seeks to treat would be information profoundly

important to the consumer. The Defendants themselves now

acknowledge and explicitly state in the Plavix medication guide

that the poor responder information is the most important

information a consumer needs to know when considering Plavix.

The Plavix medication guide, authored by BMS and

Sanofi and included within the Plavix label, directs patients to

“[r]ead this Medication Guide before you start taking Plavix and

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each time you get a refill.” That medication guide states that

“the most important information [consumers] should know about

Plavix” includes “Plavix may not work as well in people who []

have certain genetic factors that affect how the body breaks

down Plavix” and that a physician “may do genetic tests to make

sure Plavix is right for you.” Thus, BMS and Sanofi themselves

agree with the FDA that information about poor responders is

“the most important information [a consumer] should know about

Plavix” and therefore essential to consumers’ choice about

whether to take Plavix. Pursuant to the FDCA’s statutory and

regulatory framework, the FDA’s boxed warning, and even the

Defendants’ Plavix medication guide, there is no information

about Plavix that is more important for consumers than the poor

responder information. Because the poor responder information

warns consumers that (1) they may face fatal consequences if

they respond poorly to Plavix, and (2) they can get tested to

see if they should seek alternative treatment, there is no

question this information is important to consumers themselves.

As such, the poor responder information is “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). There is no genuine dispute

of material fact: the poor responder information is material as

a matter of law. The Defendants’ conduct to suppress and omit

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the poor responder information prior to its inclusion on the

Plavix label further proves its materiality.

2. BMS and Sanofi demonstrated materiality through their efforts to conceal the poor responder issue.

The record reflects that BMS and Sanofi suppressed

research and inquiry into Plavix for financial reasons. For

reasons set forth below, this conduct further demonstrates the

materiality of the omitted poor responder issue with respect to

the State’s deceptive acts claim.

The Majority concedes that BMS and Sanofi’s

suppression of research and inquiry into Plavix for financial

reasons constituted an unfair act or practice in violation of

UDAP. Specifically, the Majority upholds the circuit court’s

findings of fact that: (1) BMS and Sanofi “suppress[ed]

research and continuously and repeatedly fail[ed] to further

investigate the risks of reduced platelet inhibition in poor

metabolizers[;]” (2) BMS and Sanofi “knew - from the moment

Plavix launched - about the diminished effects of Plavix in non-

White populations;” (3) BMS and Sanofi did not volunteer this

information to the FDA; and (4) that the reason BMS and Sanofi

did so was to avoid “negative marketing implications” for

Plavix. As such, the Majority finds sufficient support in the

record to conclude that BMS and Sanofi (1) knew about poor

responder outcomes; (2) suppressed research into the poor

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responder issue; and (3) failed to disclose this knowledge to

the FDA. It is undisputed that the Defendants engaged in this

conduct for financial reasons, and to avoid negative marketing

implications for Plavix. The Majority relies on these findings

of fact in holding that BMS and Sanofi committed unfair acts or

practices in violation of UDAP with respect to Plavix by

suppressing information and research. BMS and Sanofi have thus

been determined by the Majority to have suppressed information

and research concerning reduced efficacy and increased risks of

death and serious injury for poor responders, all for “financial

reasons.”

BMS and Sanofi’s conduct of suppressing research and

inquiry into the Plavix poor responder issue demonstrates the

materiality of the poor responder issue, because the Defendants

believed their conduct would influence consumer choice of

Plavix. See, e.g., Kraft v. FTC, 970 F.2d 311, 323 (7th Cir.

1992) (finding the defendant’s conduct was evidence of

materiality, where it was determined that the defendant thought

its conduct induced consumers to purchase the product). Here,

the record demonstrates that it was known to the Defendants that

the poor responder information would be relied upon by consumers

in a way that would affect their purchasing decisions. On June

11, 2003 (seven years before the FDA mandated the 2010 Plavix

boxed warning) Juergen Froehlich, a former BMS Vice President

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involved in the BMS/Sanofi Plavix Lifecycle Management Committee

(“LCM”), wrote in an email that “Sanofi had an in-house meeting

on aspirin resistance in January and presented their data at the

January LCM meeting. However, Sanofi remains adverse to doing

any further work on either aspirin or clopidogrel resistance

because of the potential negative marketing implications.” In

addition, LCM meeting minutes from June 2003 further noted an

increase in publications concerning “[v]ariability of response

with clopidogrel[,]”which was determined to be a “[p]otential

threa[t] for future sales.”

These facts demonstrate that the Defendants viewed

suppression of the poor responder information as material to an

informed consumer choice. BMS and Sanofi’s conduct in

suppressing research and inquiry into the poor responder issue

was believed to eliminate “potential threat[s] for future

sales.” By “eliminating potential threats for future sales[,]”

BMS and Sanofi were inducing consumers to continue purchasing

Plavix, unimpeded by a warning that they may not receive the

life-saving antiplatelet effect Plavix promised. Therefore, BMS

and Sanofi’s conduct in suppressing research and inquiry into

the poor responder issue further demonstrates the materiality of

the omitted poor responder issue with respect to the State’s

deceptive acts claim.

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3. BMS and Sanofi failed to present any evidence to overcome the presumption of materiality with respect to the poor responder information.

Because the poor responder information in the Plavix

boxed warning “significantly involves health, safety . . . [and]

efficacy” the information is in fact “presumed material[]” with

respect to the State’s deceptive acts claim. Novartis Corp. v.

FTC, 223 F.3d 783, 786 (D.C. Cir. 2000) (finding that

materiality is presumed for “claims that significantly involve

health, safety, or other areas with which the reasonable

consumer would be concerned, including a claim that concerns the

purpose, safety, efficacy, . . . performance, . . . or a finding

by another agency regarding the product.”). Here, the poor

responder information warns consumers of diminished efficacy,

and increased risk of death and serious injury for patients who

respond poorly to Plavix. The State’s claim is that BMS and

Sanofi omitted the Plavix poor responder information for

approximately eleven years, which exposed almost one-third of

all Plavix users to increased risk of death, stroke and heart

attack. As such, this claim “significantly involves health,

safety…[and] efficacy” of the highest order. Id. This claim

also involves “a finding by [an] agency” —the FDA—that the

product poses a risk of death and serious injury that warrants a

boxed warning, which is the most serious warning label a drug

can be given under law. Id. The poor responder information is

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thus presumed material for the State’s deceptive acts claim

pursuant to Novartis Corp. v. FTC, 223 F.3d 783, 786 (D.C. Cir.

2000). Because BMS and Sanofi failed to present any evidence

that created a genuine dispute of material fact with regard to

consumers, the Defendants failed to overcome the presumption of

materiality in the instant case.

Contrary to the conclusion of the Majority that the

omitted poor responder information may not have been of

consequence to the consumer, the FDA, BMS and Sanofi all agree

that the poor responder issue is information of the highest

order that a consumer needs to know about Plavix when

determining whether Plavix is “right for [them].” BMS and

Sanofi’s omission of this information in their labeling prior to

2009 is thus an omission of “information that is important to

consumers” which is therefore “likely to affect their choice of,

or conduct regarding, a product.” Courbat, 111 Hawai‘i at 262,

141 P.3d at 435 (emphasis added).

The Majority, however, opines that such a conclusion

amounts to mere “intuition” that just because the FDA, BMS and

Sanofi have determined this information to be life-and-death

material to a reasonable consumer, it therefore is material to a

reasonable consumer. The Majority states that “materiality is

about what consumers do, not what the FDA thinks” and cites

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Courbat for the proposition that “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.

To be clear: the record reflects that almost one-third of all

Plavix patients were poor responders, and therefore subject to

“a 50 percent greater risk of having a heart attack, a stroke or

death.” The Defendants’ eleven-year omission of the poor

responder information from its label therefore exposed nearly

one third of all Plavix patients to a secret, life-threatening

risk: they faced a 50 percent greater chance of having a heart

attack, stroke or death because they would not receive the

antiplatelet effect Plavix promised. It is indisputable that

the potentially fatal consequences of the poor responder issue

would be material to a reasonable Plavix consumer, and that its

“omission is likely to mislead consumers as to information

important to consumers in making a decision regarding” Plavix.

Courbat, 111 Hawai‘i at 262, 141 P.3d at 435 (cleaned up)

(emphases added). Yet the Majority argues that this potentially

fatal information is so inconsequential that it could be ignored

by a reasonable consumer, and that the Defendants should have

been able to present evidence to that effect. The Majority’s

position strains credulity.

The Majority cites no evidence in the record with

respect to “what consumers do” with the poor responder 25 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

information. Instead, the Majority points out that BMS and

Sanofi sought to avoid summary judgment on the basis of evidence

comprised of (1) the post-disclosure prescribing decisions of a

few doctors in Hawaiʻi, along with (2) an article from the

State’s public health journal purportedly encouraging doctors to

ignore the Plavix boxed warning, and (3) insurance reimbursement

practices and trends with respect to Plavix. In this respect,

the Majority concludes that BMS and Sanofi should have had the

opportunity to present evidence that some “cardiologists in

Hawaiʻi continued to prescribe Plavix to patients of all

ethnicities even after the introduction of the black box

warning” and that such evidence “bore on whether a ‘reasonable’

patient would choose to purchase the drug.”

Evidence about a doctor choosing to prescribe Plavix

after the introduction of the black box warning does not

implicate the materiality of the poor responder information to

the consumer. The Majority states that “[o]bjectively

reasonable patients may rely on their doctors to help them make

sense of drug labels.” First, this statement proves an

important point: a doctor cannot help a reasonable patient make

sense of a drug label that omits a life-threatening warning such

as the Plavix poor responder issue. It is simply self-evident

that the doctor cannot advise a patient on what they themselves

do not know. Second, the Majority still concedes that “patients 26 *** FOR PUBLICATION IN WEST’S HAWAIʻI REPORTS AND PACIFIC REPORTER ***

and doctors cannot be conflated.” The Majority is correct—

doctors and consumers cannot be conflated. UDAP provides legal

protections to consumers. The UDAP materiality standard for

assessing deceptive acts is whether the information is material

to a reasonable consumer, not the reasonable consumer’s doctor.

See Courbat, 111 Hawaiʻi at 262, 141 P.3d at 435. Even taken in

the light most favorable to BMS and Sanofi, none of the evidence

cited by the Majority overcomes the presumption of materiality

with respect to the poor responder information in the FDA’s

boxed warning. BMS and Sanofi failed to overcome the

presumption of materiality, and evidence concerning doctor

prescription habits is irrelevant to the materiality standard

concerning the reasonable consumer. The test for materiality is

objective, “turning on whether the act or omission is likely to

mislead consumers as to information important to consumers in

making a decision regarding the product or service.” Courbat,

111 Hawai‘i at 262, 141 P.3d at 435 (emphases added). Failing to

inform a reasonable consumer about the potentially fatal

consequences of Plavix’s poor responder issue would objectively

be likely to mislead the consumer about information important to

them in deciding to take Plavix, or seek an alternative

treatment. Because the “evidence” of poor responder materiality

“is so clear that no reasonable person would determine the issue

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in any way but one,” the circuit court did not err in granting

summary judgment. Courbat, 111 Hawai‘i at 263, 141 P.3d at 436.

The Majority holds that there is a genuine issue of

material fact about whether BMS and Sanofi deceived reasonable

consumers already at increased risk of heart attack, stroke or

death by failing to include information in their label about the

fact that consumers who take Plavix may experience greater risk

of heart attack, stroke and death because the drug won’t work as

well—or at all—for them. The Majority finds the suppression of

this information “immoral, unethical, oppressive, unscrupulous”

and yet not sufficient to even “likely” influence a reasonable

consumer’s choice of Plavix. This position is untenable. A

global set of consumers rely on the legal framework comprised of

the FDCA, the FDA, and UDAP to protect them from being exposed

to dangerous products and deceived by the companies that sell

them. The Majority’s holding removes those protections and

fails to hold BMS and Sanofi accountable for their deceptive

acts and practices.

IV. CONCLUSION

The Majority’s decision rejects the legal authority

and life-saving import of the FDA boxed warning. Pharmaceutical

companies cannot omit information from their drug labels

concerning the most serious risks known to them concerning

possible death and life-altering injury for consumers. The

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comprehensive legal framework comprised of the FDCA, the FDA and

UDAP is specifically designed to protect consumer health and

safety in the pharmaceutical arena. This legal framework

exposed calculated suppression of unequivocally life-threatening

information, and compels holding that the Plavix poor responder

issue is material as a matter of law. Summary judgment in this

case was proper. Because summary judgment was proper, I would

affirm the entirety of the circuit court’s Findings of Fact,

Conclusions of Law, Decision and Order. Respectfully, I

dissent.

/s/ Michael D. Wilson