State v. Bristol-Myers Squibb Company

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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
---o0o---
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.
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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
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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
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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
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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
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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
whether the poor responder information was material 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
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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
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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
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