Kaufman v. CVS Caremark Corp.

Decision Date06 September 2016
Docket NumberNo. 16-1199,16-1199
Parties Ronda Kaufman, on behalf of herself and all others similarly situated, Plaintiff, Appellant, v. CVS Caremark Corporation; CVS Pharmacy, Inc., Defendants, Appellees.
CourtU.S. Court of Appeals — First Circuit

Brian D. Penny , with whom Goldman Scarlato & Penny, P.C. , Wayne, PA, was on brief, for appellant.

Robert M. Andalman , with whom A&G Law LLC was on brief, for appellees.

Before Torruella, Kayatta, and Barron, Circuit Judges.

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:

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 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. 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 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) 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
(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 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...

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