Kaufman v. CVS Caremark Corp. , 836 F.3d 88 ( 2016 )

United States Court of Appeals
For the First Circuit
No. 16-1199
RONDA KAUFMAN,
on behalf of herself and all others similarly situated,
Plaintiff, Appellant,
v.
CVS CAREMARK CORPORATION; CVS PHARMACY, INC.,
Defendants, Appellees.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF RHODE ISLAND
[Hon. Mary M. Lisi, U.S. District Judge]
Before
Torruella, Kayatta, and Barron,
Circuit Judges.
Brian D. Penny, with whom Goldman Scarlato & Penny, P.C., was
on brief, for appellant.
Robert M. Andalman, with whom A&G Law LLC was on brief, for
appellees.
September 6, 2016
KAYATTA, Circuit Judge. CVS Pharmacy, Inc. ("CVS")
sells a Vitamin E dietary supplement with a label that touts the
product as supporting "heart health." Having purchased CVS's
Vitamin E product, Ronda Kaufman alleges that CVS's label deceives
consumers because no scientifically valid studies show that the
label's "heart health" statements are both truthful and not
misleading. Finding that federal law does not preempt Kaufman's
effort to maintain this action under New York's consumer protection
law, we reverse the district court's order dismissing Kaufman's
complaint.
I. Background
Because the district court dismissed this lawsuit on a
motion to dismiss for failure to state a claim, Fed. R. Civ.
P. 12(b)(6), our review is de novo and we assume that the facts
alleged in the complaint, plus reasonable inferences drawn from
those facts, are true. In re Celexa & Lexapro Mktg. & Sales
Practices Litig., 779 F.3d 34, 39 (1st Cir. 2015).
Ronda Kaufman purchased CVS-brand Vitamin E 400
International Units ("IU") Softgels (100 count) at a CVS located
in Plainview, New York. The bottle containing the Vitamin E
product bore the following label:
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Kaufman alleges that in deciding to purchase the product, she
relied on the label.
Kaufman now claims that there are no scientifically
valid studies supporting CVS's "heart health" statements. Rather,
she alleges that various studies1 evaluating Vitamin E "demonstrate
that vitamin E and vitamin E supplementation offer no
1
Stephen P. Fortmann et al., Vitamin and Mineral Supplements
in the Primary Prevention of Cardiovascular Disease and Cancer:
An Updated Systematic Evidence Review for the U.S. Preventive
Services Task Force, 159 Annals of Internal Med. 824 (2013); I-Min
Lee et al., Vitamin E in the Primary Prevention of Cardiovascular
Disease and Cancer--The Women's Health Study: A Randomized
Controlled Trial, 294 J. Am. Med. Ass'n 56 (2005); Eva Lonn et
al., Effects of Long-Term Vitamin E Supplementation on
Cardiovascular Events and Cancer: A Randomized Controlled Trial,
293 J. Am. Med. Ass'n 1338 (2005); Edgar R. Miller III et al.,
Meta-Analysis: High-Dosage Vitamin E Supplementation May Increase
All-Cause Mortality, 142 Annals of Internal Med. 37 (2005); Howard
D. Sesso et al., Vitamins E and C in the Prevention of
Cardiovascular Disease in Men--The Physicians' Health Study II
Randomized Controlled Trial, 300 J. Am. Med. Ass'n 2123 (2008);
Paul G. Shekelle et al., Effect of Supplemental Vitamin E for the
Prevention and Treatment of Cardiovascular Disease, 19 J. Gen.
Internal Med. 380 (2004); Salim Yusuf et al., Vitamin E
Supplementation and Cardiovascular Events in High-Risk Patients,
342 New Eng. J. Med. 154 (2000).
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cardiovascular benefit" and "do[] not reduce the risk of suffering
a cardiovascular event, such as a heart attack, nor [do they]
reduce the risk of dying from cardiovascular disease." She adds
that one study reflects "that those taking vitamin E had higher
rates of heart failure and were more likely to be hospitalized for
heart failure," while another study found "an increase in mortality
that progressively increased as daily dosage exceeds 150 iu." The
complaint further states that "[a]ll variations of [CVS's] pill-
type vitamin E products exceed the 150 iu level shown to increase
mortality in this study." As a result, she alleges, CVS's
representation that its product supports heart health is
misleading.
Kaufman marshalled these allegations in service of a
putative class action complaint that advances two counts at issue
on appeal: violation of the New York Consumer Protection Act,
N.Y. Gen. Bus. Law § 349 ("NYCPA section 349"), which makes
unlawful "[d]eceptive acts or practices in the conduct of any
business, trade or commerce or in the furnishing of any service"
in New York, id. § 349(a), and a piggy-back common law claim of
unjust enrichment. The district court found that federal law
preempts both of these statements because CVS's label on its
Vitamin E product complied with labeling requirements for dietary
supplements under the Federal Food Drug and Cosmetic Act ("FDCA"),
21 U.S.C. §§ 301 et seq.; see also id. § 343-1(a)(5). Kaufman v.
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CVS Caremark Corp., No. 14-216-ML, 2016 WL 347324, at *8 (D.R.I.
Jan. 28, 2016).
II. Discussion
The parties initially debate whether the district court
erred in requiring Kaufman to state with particularity the
circumstances constituting the alleged deception at issue in this
case under Federal Rule of Civil Procedure 9(b). We agree with
CVS that Kaufman waived any objection to that requirement, having
failed twice to argue in the district court that Rule 9(b) did not
apply. See United States v. Argentine, 814 F.2d 783, 791 (1st
Cir. 1987). At the same time, we also find that the applicability
of Rule 9(b) has no bearing on any possible disposition of this
appeal. The circumstances to be stated with particularity under
Rule 9(b) generally consist of "the who, what, where, and when of
the allegedly [misleading] representation." Alt. Sys. Concepts,
Inc. v. Synopsys, Inc., 374 F.3d 23, 29 (1st Cir. 2004) (quoting
Powers v. Bos. Cooper Corp., 926 F.2d 109, 111 (1st Cir. 1991)).
CVS makes no argument that the complaint fails to provide this
particularity. And, indeed, it does contain sufficient
particularity: CVS is the "who"; the heart health statements are
the "what"; the label is the "where"; and the occasion on which
Kaufman purchased the product is the "when." Therefore, as CVS
acknowledges, "[t]he District Court's decision did not turn on
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whether the applicable pleading standard was pursuant to Fed. R.
Civ. P. 8(a) or 9(b)." Neither does our decision.
Rather, the pivotal question on this appeal is whether
Kaufman's complaint plausibly describes conduct by CVS that fell
outside the preemptive safe harbor provided by federal law.
A. FDCA Preemption
The FDCA circumscribes Kaufman's ability to bring this
claim against CVS. Section 343-1(a)(5) of the FDCA provides that
no state may "establish . . . any requirement respecting any claim
of the type described in section 343(r)(1) of [the FDCA], made in
the label or labeling of food that is not identical to the
requirement of section 343(r)." 21 U.S.C. § 343-1(a)(5). Section
343(r)(1), in turn, governs statements, among others, that concern
a nutrient's relationship "to a disease or a health-related
condition."2 Id. § 343(r)(1)(B). The parties agree (and we
therefore assume) that section 343(r)(6), which provides the
requirements for statements made on labels of dietary supplements,
relates back to section 343(r)(1)(B), and section 343(r)(6)
2
The regulations promulgated by the FDA define a "[d]isease
or health-related condition" as "damage to an organ, part,
structure, or system of the body such that it does not function
properly (e.g., cardiovascular disease), or a state of health
leading to such dysfunctioning (e.g., hypertension)." 21 C.F.R.
§ 101.14(a)(5). A health claim, in turn, is defined as "any claim
made on the label or in labeling of a food, including a dietary
supplement, that expressly or by implication . . . characterizes
the relationship of any substance to a disease or health-related
condition." Id. § 101.14(a)(1).
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statements are therefore governed by section 343-1(a)(5)
preemption. Effectively adding belt to suspenders, the New York
law under which Kaufman seeks to proceed independently welcomes
the preemptive force of the federal statute, providing that
compliance with applicable federal rules and regulations provides
a "complete defense" to a claim under NYCPA section 349(a). N.Y.
Gen. Bus. Law § 349(d). On all of this, the parties agree.
The net effect of the foregoing is that CVS must prevail
if its label satisfies the requirements of FDCA section 343(r),
but neither federal nor state law poses any bar to recovery under
NYCPA section 349 to the extent that recovery is predicated on a
failure by CVS to comply with the requirements of FDCA
section 343(r). Accordingly, we turn our attention to determining
whether the complaint plausibly alleges conduct by CVS that
violates the requirements of FDCA section 343(r).
B. Compliance with FDCA Labeling Requirements
Section 343(r)(6) of the FDCA provides that
a statement for a dietary supplement may be
made if--
(A) the statement . . . describes the role of
a nutrient or dietary ingredient intended to
affect the structure or function in
humans . . . ,
(B) the manufacturer of the dietary supplement
has substantiation that such statement is
truthful and not misleading, and
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(C) the statement contains, prominently
displayed and in boldface type, the following:
"This statement has not been evaluated by the
Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or
prevent any disease.".
A statement under this subparagraph may not
claim to diagnose, mitigate, treat, cure, or
prevent a specific disease or class of
diseases. If the manufacturer of a dietary
supplement proposes to make a statement
described in the first sentence of this
subparagraph in the labeling of the dietary
supplement, the manufacturer shall notify the
Secretary no later than 30 days after the first
marketing of the dietary supplement with such
statement that such a statement is being made.
21 U.S.C. § 343(r)(6).
CVS's label for its 400 IU Vitamin E supplement makes
four statements that are subject to the requirements of section
343(r)(6): that Vitamin E "supports antioxidant health"; that
Vitamin E helps "maintain healthy blood vessels"; that Vitamin E
"supports heart health"; and that Vitamin E "supports the immune
system." The parties agree--and we therefore presume without
deciding--that these statements are all what the Food and Drug
Administration ("FDA") calls "structure/function claims" under
FDCA section 343(r)(6)(A). See Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the
Structure or Function of the Body, 65 Fed. Reg. 1000, 1002 (Jan. 6,
2000) (codified at 21 C.F.R. pt. 101). So-called
structure/function claims are statements that "describe[] the role
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of a nutrient or dietary ingredient intended to affect the
structure or function in humans." 21 U.S.C. § 343(r)(6)(A). The
manufacturer of a dietary supplement may make such statements if
the manufacturer both "has substantiation that such statement is
truthful and not misleading," id. § 343(r)(6)(B), and includes on
the label a prominent disclaimer stating that the FDA has not
evaluated the label's statement and that the "product is not
intended to diagnose, treat, cure, or prevent any disease," id.
§ 343(r)(6)(C). The parties agree, and we therefore again assume
without deciding, that the label in this case contains just such
a disclaimer. We therefore limit our inquiry to determining
whether the complaint plausibly alleges that CVS lacks
"substantiation" that the "support" and/or "maintain"
structure/function statements are "truthful and not misleading."
In urging an affirmative answer to this question,
Kaufman offers no developed argument that CVS lacks substantiation
that Vitamin E functions as an antioxidant. Kaufman also does not
develop any argument that challenges the sufficiency of CVS's
substantiation of the statements that Vitamin E supports the immune
system or that it helps maintain healthy blood vessels. Instead,
training her critique on the label's several statements that
Vitamin E "supports heart health," Kaufman asserts that there
exists no substantiation that such a description of the nutrient's
function is truthful and not misleading.
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The FDCA does not define the term "substantiation."
FDA guidance, however, advances a common sense interpretation of
"substantiation," also adopted by the Federal Trade Commission, as
meaning "competent and reliable scientific evidence." Food & Drug
Admin., Guidance for Industry: Substantiation for Dietary
Supplement Claims Made Under Section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act Part I.B. (Dec. 2008),
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregu
latoryinformation/dietarysupplements/ucm073200.htm (last accessed
Aug. 22, 2016) (hereinafter "Guidance for Industry"). Kaufman's
express allegation that there are no "scientifically valid
studies" substantiating CVS's heart health statements fairly
implies that CVS has no competent and reliable evidence to support
its heart health statements.3 This allegation would normally
3 Paragraph 1 of the complaint reads:
CVS markets, sells, and distributes six
versions of vitamin E supplements. On all
vitamin E packages, Defendants represent the
product is intended for "heart health."
However, numerous double-blind, placebo-
controlled studies demonstrate that vitamin E
and vitamin E supplementation offer no
cardiovascular benefit. Vitamin E does not
reduce the risk of suffering a cardiovascular
event, such as a heart attack, nor does it
reduce the risk of dying from cardiovascular
disease. There are no comparable,
scientifically valid studies supporting
Defendants' representation.
We read "representation" in the last sentence as referring to what
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suffice to save from preemption Kaufman's attempt to impose
liability on CVS for misleading customers because the imposition
of such a liability would not establish any requirement that
differs from the requirement of section 343(r)(6)(B)--that CVS
must have substantiation for its heart health statements. See 21
U.S.C. § 343-1(a)(5); Dachauer v. NBTY, Inc., No. 16-cv-00216-VC,
2016 WL 3176612, at *1 (N.D. Cal. June 3, 2016).4
CVS, however, contends that Kaufman effectively shot
herself in the foot by describing in the complaint seven studies
of Vitamin E that, CVS argues, provide the required substantiation.
See Trujillo v. Walgreen Co., No. 13 CV 1852, 2013 WL 4047717, at
*3 (N.D. Ill. Aug. 9, 2013) (plaintiff "effectively pled herself
out of Court" by not disputing that Vitamin E is an antioxidant
and that antioxidants have been shown to contribute to
cardiovascular health). In CVS's words, the studies show Vitamin
E's "salutary functions in the body" are "scientific fact."
We agree with CVS that the district court's, and now
our, consideration of the studies cited in the complaint is
CVS is said to "represent" in the first sentence (the heart health
statement that the parties agree is a function/structure claim).
4 A 2012 report by the Inspector General revealed that many
dietary supplements failed to meet federal requirements for making
structure/function claims. Daniel R. Levinson, Inspector General,
Dietary Supplements: Structure/Function Claims Fail to Meet
Federal Requirements (Oct. 2012),
https://oig.hhs.gov/oei/reports/oei-01-11-00210.pdf.
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appropriate even under Rule 12(b)(6) where the complaint itself
directly references and purports to summarize the studies. See
Giragosian v. Bettencourt, 614 F.3d 25, 27–28 (1st Cir. 2010).
That consideration though, provides no license to engage at this
stage of litigation in rejecting plausible readings of those
studies. See Abdallah v. Bain Capital LLC, 752 F.3d 114, 119 (1st
Cir. 2014) ("no fact finding" in assessing complaint under
Rule 12(b)(6)). Rather, we look at the studies for a limited
purpose: do the studies on their face render implausible Kaufman's
claim that there exist no scientifically valid studies
establishing that CVS's heart health statements are truthful and
not misleading? For at least two independent reasons, they do
not.
First, read in chronological order and with attention to
what they presume and what they find, the studies do not support
a judicial declaration under Rule 12(b)(6), unaided by expert
testimony, that they substantiate the heart health statements. As
CVS itself concedes, none of the studies were designed to test the
statement that Vitamin E functions to support heart health.
Rather, most of the studies presumed that to be so, and instead
tested the hypothesis that Vitamin E prevents certain diseases.
See, e.g., I-Min Lee et al., Vitamin E in the Primary Prevention
of Cardiovascular Disease and Cancer--The Women's Health Study: A
Randomized Controlled Trial, 294 J. Am. Med. Ass'n 56, 56 (2005)
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("Vitamin E has antioxidant properties . . . leading to the
hypothesis that it can prevent [cardiovascular disease]."
(emphasis supplied)); Eva Lonn et al., Effects of Long-Term Vitamin
E Supplementation on Cardiovascular Events and Cancer: A
Randomized Controlled Trial, 293 J. Am. Med. Ass'n 1338, 1338
(2005) ("Epidemiological data indicate an inverse association
between cardiovascular risk and vitamin E intake from dietary
sources and/or supplements." (emphasis supplied)); Edgar R. Miller
III et al., Meta-Analysis: High-Dosage Vitamin E Supplementation
May Increase All-Cause Mortality, 142 Annals of Internal Med. 37,
37 (2005) ("On the basis of the premise that vitamin E reduces
oxidative stress, many clinical trials have tested vitamin E
supplementation as a therapy to prevent various chronic diseases."
(emphasis supplied)); Howard D. Sesso et al., Vitamins E and C in
the Prevention of Cardiovascular Disease in Men--The Physicians'
Health Study II Randomized Controlled Trial, 300 J. Am. Med. Ass'n
2123, 2123 (2008) ("Basic research studies suggest that
vitamin E . . . and other antioxidants reduce cardiovascular
disease by trapping organic free radicals, by deactivating excited
oxygen molecules, or both, to prevent tissue damage." (emphasis
supplied)); Paul G. Shekelle et al., Effect of Supplemental Vitamin
E for the Prevention and Treatment of Cardiovascular Disease, 19
J. Gen. Internal Med. 380, 380 (2004) (referencing literature
"suggest[ing] a beneficial effect of antioxidant-rich foods, as
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well as specific antioxidants," such as Vitamin E (emphasis
supplied)); Salim Yusuf et al., Vitamin E Supplementation and
Cardiovascular Events in High-Risk Patients, 342 New Eng. J. Med.
154, 154 (2000) ("Observational and experimental studies suggest
that the amount of vitamin E ingested in food and in supplements
is associated with a lower risk of coronary heart disease and
atherosclerosis" (emphasis supplied)).
Second, the studies Kaufman cites, including the results
of a randomized controlled trial,5 are also plausibly construed,
in the aggregate, as indicating that Vitamin E, in dosages such as
that packaged by CVS, can even damage the heart. One study, for
example, found that in some populations, increasing Vitamin E
intake by supplementation may increase the risk for heart failure.
See Lonn et al., supra page 12, at 1346. And another found that
"high-dosage" Vitamin E supplements of 400 IU or more--the very
dosage that Kaufman purchased--may increase all-cause mortality.
Miller III et al., supra page 13, at 37, 40. This indication,
which the studies at least render plausible, would seem to mean
that Vitamin E can play a role in harming heart health.
5
See Lonn et al., supra note 1. The FDA has indicated that
such trials are the "gold standard," whereas animal studies and in
vitro studies such as those relied on by CVS and the district court
cannot, by themselves, provide adequate substantiation. See
Guidance for Industry, supra page 10.
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The statute grants CVS a preemptive license to describe
in its label "the role of a nutrient or dietary ingredient." 21
U.S.C. § 343(r)(6)(A) (emphasis supplied). In so doing, Congress
did not similarly license a description of "a role" of the nutrient
that may mislead the consumer by omitting mention of a directly
related, conflicting role. If Vitamin E's actual role is both to
support and to harm heart health, depending on the dosage actually
supplied, then a label on a product presented in the harmful dosage
yet revealing only the former aspects of the vitamin's role
relative to health is incomplete in a way that could be material
to the consumer's exercise of choice in deciding whether to buy
the product.
This conclusion finds textual support in section 321(n)
of the FDCA, which provides that when evaluating whether an article
(i.e., a product) is misbranded because the labeling6 is
misleading, we "shall" take into account, among other things,
not only representations made or suggested by
[the] statement . . . but also the extent to
which the labeling . . . fails to reveal facts
material in the light of such representations
or material with respect to consequences which
may result from the use of the article to which
the labeling . . . relates under the
conditions of use prescribed in the
labeling . . . or under such conditions of use
as are customary or usual.
6 "Labeling," includes the product's "label," 21 U.S.C.
§ 321(m), which includes "written, printed, or graphic matter upon
the immediate container of any article," id. § 321(k).
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Id. § 321(n).
This statutory command that we consider the omission of
material facts fits hand-in-glove with the mandate of
section 343(r)(6)(B) that the seller's substantiation show that a
health statement is both "truthful and not misleading." Id.
§ 343(r)(6)(B). More broadly, it aligns well with the FDA's stated
mission to "promote," id. § 393(b)(1), and "protect the public
health by ensuring that . . . [dietary supplements] are
safe . . . and properly labeled," id. § 393(b)(2)(A). If a
particular dietary supplement functions to harm health in the
supplied or recommended dosage, a label claiming that the product
supports health is plausibly viewed as misleading within the
meaning of section 343(r)(6)(B). To rule otherwise would be to
treat the FDCA as granting license to entice consumers to
unwittingly incur risk and harm.
In so reasoning, we do not accept Kaufman's argument
that evidence showing a supplement does not reduce heart disease
necessarily implies that the nutrient itself has no function in
maintaining heart health. On the contrary, Congress has expressly
specified that sellers of dietary supplements can "describe[] the
role of a nutrient . . . intended to affect the structure or
function in humans," id. § 343(r)(6)(A), even while simultaneously
disavowing any claim that the product is intended "to . . . prevent
any disease," id. § 343(r)(6)(C). And the FDA has in turn
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promulgated a regulation blessing terms like "promote,"
"maintain," and "support," so long as the seller has substantiation
for the description. See Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the
Structure or Function of the Body, 65 Fed. Reg. at 1014. Thus,
any nutrient or ingredient that, for example, the heart needs might
be described as supporting heart health, even if taking the
supplement form of the nutrient actually does nothing to improve
the health of one's heart, as long as the claimed beneficial
function is substantiated and the description of the nutrient's
role is not misleadingly incomplete. And while Kaufman plausibly
suggests that the drawing of such a distinction between the
ingredient's function and its lack of any impact on morbidity
likely tricks many consumers who unwittingly think that such a
product will reduce the likelihood of poor heart health, this is
a form of finesse that the statute and the regulations allow. See,
id. (suggesting increased consumer "choice" as a reason for
allowing such marketing). On the other hand, a section 343(r)(6)
disclaimer, while legally sufficient to immunize a
structure/function claim that is truthful and not misleading, does
not immunize a structure/function claim for which the manufacture
lacks the required substantiation or that misleadingly fails to
disclose the harmful aspects of the nutrient's structure/function.
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As we have already noted, we read the studies referenced
in the complaint only to see if, on their face, they render
implausible Kaufman's allegation that substantiation for CVS's
heart health statements does not exist. CVS might have other
studies that paint a different and more credible overall picture.
Expert testimony might also shed a different light than that cast
by the complaint or by a bare reading of the studies unaided by
additional context. The point, simply, is that the cited studies
do not on their face render implausible the allegation that CVS
lacks substantiation that the "heart health" and "supports heart
health" statements are truthful and not misleading descriptions of
the function of Vitamin E supplements in humans. For purposes of
Rule 12(b)(6), it therefore follows both that Kaufman has
adequately pled that CVS's labeling of its Vitamin E supplement is
not in keeping with the requirements of FDCA section 343(r), and
that federal law does not, therefore, preempt application of New
York state law for the purpose of holding CVS accountable for
misleading consumers by failing to satisfy those requirements.
With CVS advancing no argument that unsubstantiated and deceptive
health claims made in marketing a consumer product are not
actionable under New York law, we therefore reverse the dismissal
of Kaufman's claim under NYCPA section 349.
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C. Unjust Enrichment
Kaufman's claim of unjust enrichment under New York law
rests necessarily on her allegation that CVS's label was
"deceptive." CVS correctly observes that if the label does not
violate the FDCA's requirements, the unjust enrichment claim also
necessarily fails. See Cleary v. Philip Morris, Inc., 656 F.3d
511, 517 (7th Cir. 2011) ("[I]f an unjust enrichment claim rests
on the same improper conduct alleged in another claim, then the
unjust enrichment claim will be tied to this related claim--and,
of course, unjust enrichment will stand or fall with the related
claim."). The district court agreed, and dismissed the unjust
enrichment claim. Kaufman, 2016 WL 347324, at *8.
Given our finding that the complaint adequately alleges
that the label's statements were misleading in a manner that
violated the requirements of section 343(r), it follows that the
unjust enrichment count is also not preempted to the extent that
its reference to deceptive conduct is solely to the conduct that
would render the label misleading under section 343(r). CVS offers
no other grounds for dismissing the unjust enrichment count. We
therefore reverse the dismissal of that count for all the reasons
set forth concerning the NYCPA section 349 count.
III. Conclusion
The district court's dismissal of Kaufman's complaint is
reversed.
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