Noah Bradach v. Pharmavite, LLC

CourtCourt of Appeals for the Ninth Circuit
DecidedMay 17, 2018
Docket16-56598
StatusUnpublished

This text of Noah Bradach v. Pharmavite, LLC (Noah Bradach v. Pharmavite, LLC) is published on Counsel Stack Legal Research, covering Court of Appeals for the Ninth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Noah Bradach v. Pharmavite, LLC, (9th Cir. 2018).

Opinion

NOT FOR PUBLICATION FILED UNITED STATES COURT OF APPEALS MAY 17 2018 MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS FOR THE NINTH CIRCUIT

NOAH BRADACH, On Behalf of Himself No. 16-56598 and All Others Similarly Situated, 17-55064

Plaintiff-Appellant, D.C. No. 2:14-cv-03218-GHK-AGR v.

PHARMAVITE, LLC, MEMORANDUM*

Defendant-Appellee.

Appeal from the United States District Court for the Central District of California George H. King, District Judge, Presiding

Argued and Submitted April 10, 2018 Pasadena, California

Before: BEA and MURGUIA, Circuit Judges, and KEELEY,** District Judge.

Noah Bradach appeals from the district court’s dismissal of his class action

complaint against Defendant-Appellee Pharmavite LLC. Bradach alleges he and

other consumers purchased Pharmavite’s Nature Made Vitamin E dietary

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3. ** The Honorable Irene M. Keeley, United States District Judge for the Northern District of West Virginia, sitting by designation. supplements in reliance of the statement “Helps Maintain a Healthy Heart,”

(“Heart Health statement”) which appears on the product’s label. Bradach filed a

class action lawsuit against Pharmavite contending the statement is false and

misleading and asserting Pharmavite’s use of the statement violates California’s

Unfair Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200, et seq., and

Consumers Legal Remedies Act (“CLRA”), Cal. Civ. Code § 1750 et seq.

Dietary supplement labeling is primarily governed by federal law. See

Gallagher v. Bayer AG, No. 14-cv-04601-WHO, 2015 WL 1056480, at *3–7 (N.D.

Cal. Mar. 10, 2015). Under federal law, dietary supplement manufacturers’

statements on product labels fall into one of two categories. The first is

“structure/function” claims, which allow manufacturers to display truthful,

non-misleading statements about the benefits the dietary supplement provides. See

Gallagher, 2015 WL 1056480 at *6; see also 21 C.F.R. § 101.93(f).

Structure/function claims do not require pre-approval from the Food and Drug

Administration (“FDA”) so long as the “manufacturer has substantiation that the

statements are truthful and not misleading, provides a disclaimer that the statement

has not been approved by the FDA, and notifies the FDA of its use of the statement

no later than 30 days after its first use.” Gallagher, 2015 WL 1056480 at *4 n.2

(citing 21 U.S.C. § 343(r)(6)). The second type of permissible statements are

disease claims, which are defined as statements that a product can diagnose,

2 mitigate, treat, cure, or prevent a specific disease or class of diseases. See

Gallagher, 2015 WL 1056480 at *4; see also 21 C.F.R. § 101.93(g). Disease

claims require FDA pre-approval. See Gallagher, 2015 WL 1056480 at *4 n.3

(citing 21 U.S.C. § 343(r)(3)).

Federal law can preempt state laws that impose different requirements from

those dictated by federal statutes and regulations. The Food, Drug, and Cosmetic

Act (“FDCA”), as amended by the Nutrition Labeling and Education Act

(“NLEA”), contains an express preemption provision. Gallagher, 2015 WL

1056480, at *4 (citing 21 U.S.C. § 343-1(a)(5)). Section 343-1(a)(5) makes clear

that states are prohibited from legislating food labeling laws that are not identical

to federal requirements under 21 U.S.C. § 343(r), including § 343(r)(6). 21 U.S.C.

§ 343-1(a)(5). As Gallagher explained, “preemption only occurs where application

of state laws would impose more or inconsistent burdens on manufacturers than the

burdens imposed by the FDCA.” Gallagher, 2015 WL 1056480, at *4.

The parties do not dispute that, on its face, the Heart Health statement is a

structure/function claim. Federal law does not preempt state requirements that

statements on dietary supplement labels that are structure/function claims and

speak about maintaining heart health be accurate and not misleading. See

Gallagher, 2015 WL 1056480 at *6–7 (citing to 65 Fed. Reg. 1000). However,

federal law does preempt state regulation of statements on dietary supplement

3 labels that are disease claims and speak about preventing heart disease when those

regulations impose requirements that differ from the requirements of the FDCA.

See Gallagher, 2015 WL 1056480 at *6–7.

Here, the district court determined that Bradach lacked standing to assert his

claims under the CLRA and UCL because the district court concluded that

Bradach’s deposition testimony and an interrogatory response indicated that

Bradach believed the Heart Health statement was a disease claim and that

Bradach’s state-law claims were therefore preempted by the FDCA. In turn, the

district court determined that Bradach could not serve as the class representative,

declined to certify a class, and dismissed the case. After the case was dismissed,

the district court awarded Pharmavite $84,862 in costs for a consumer survey

Pharmavite commissioned. Bradach appeals both the dismissal of his lawsuit and

the district court’s subsequent grant of Pharmavite’s motion to recover costs.

We have jurisdiction under 28 U.S.C. § 1291. For the reasons discussed

below, we reverse the district court on both issues and remand for further

proceedings.

1. We review questions of preemption and standing de novo. See

Gingery v. City of Glendale, 831 F.3d 1222, 1226 (9th Cir. 2016) (citation

omitted); see also Galvez v. Kuhn, 933 F.2d 773, 776 (9th Cir. 1991).

The record does not support the proposition that Bradach’s individual claims

4 are solely premised on preempted disease claims. Bradach’s testimony reflects that

he had a mixed understanding of what Pharmavite’s Vitamin E supplement would

do. Bradach understood the Vitamin E product to both maintain his heart health

and prevent heart disease. Courts have recognized that a plaintiff may have claims

based on mixed motives and have allowed claims arising in part from non-

preempted motives to move forward. See Sorosky v. Burroughs Corp., 826 F.2d

794, 799–800 (9th Cir. 1987); Ikekwere v. Southwall Techs., Inc., No. C-04-00027-

JF(PVT), 2005 WL 1683623, at *2–3 (N.D. Cal. 2005). Accordingly, Bradach’s

claims were not preempted.

Additionally, Bradach has standing to sue Pharmavite because he suffered an

injury by buying the supplement when, he contends, he would otherwise not have

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