Sandra Seegert v. Rexall Sundown, Inc.

• Court: Court of Appeals for the Ninth Circuit
• Decided: February 1, 2022
• Docket: 20-55486
• Status: Unpublished

Opinion

NOT FOR PUBLICATION FILED UNITED STATES COURT OF APPEALS FEB 1 2022 MOLLY C. DWYER, CLERK U.S. COURT OF APPEALS FOR THE NINTH CIRCUIT

SANDRA SEEGERT, individually and on No. 20-55486 behalf of all others similarly situated, D.C. No. Plaintiff-Appellant, 3:17-cv-01243-BEN-JLB

v. MEMORANDUM* REXALL SUNDOWN, INC.,

Defendant-Appellee.

Appeal from the United States District Court for the Southern District of California Roger T. Benitez, District Judge, Presiding

Argued and Submitted September 3, 2021 Pasadena, California

Before: BENNETT and R. NELSON, Circuit Judges, and EZRA,** District Judge.

Sandra Seegert appeals the district court’s order granting summary judgment

for Rexall Sundown, Inc. (“Rexall”). We have jurisdiction under 28 U.S.C. § 1291,

* This disposition is not appropriate for publication and is not precedent except as provided by Ninth Circuit Rule 36-3. ** The Honorable David A. Ezra, United States District Judge for the District of Hawaii, sitting by designation. and we affirm in part, reverse in part, and remand.1

Seegert purchased Osteo Bi-Flex Triple Strength (“Osteo Bi-Flex”), a dietary

supplement manufactured by Rexall that contains a glucosamine compound and a

proprietary ingredient called Joint Shield 5-LOXIN Advanced (“5-Loxin”). Rexall

claims on the product label that Osteo Bi-Flex “Shows Improved Joint Comfort

within 7 Days!” and “supports joint comfort.” Rexall also claims that Osteo Bi-Flex

“helps strengthen joints while helping maintain joint cartilage,” and helps to

strengthen joints, support flexibility, and support mobility. Seegert alleges,

however, that Osteo Bi-Flex and its ingredients do not provide any of these benefits.

Thus, Seegert filed this class action suit against Rexall, claiming violations of

California’s Unfair Competition Law (“UCL”) and Consumers Legal Remedies Act

(“CLRA”). See Cal. Bus. & Prof. Code § 17200; Cal. Civ. Code § 1770(a).

Both parties submitted expert testimony. Seegert submitted the declarations

of Dr. Farshid Guilak and Dr. Timothy McAlindon. Dr. Guilak conducted an in vitro

study on pig cartilage and concluded that Osteo Bi-Flex and 5-Loxin “have no effect

on cartilage function, in the presence or absence of inflammation.” Dr. McAlindon

reviewed many studies and meta-analyses of the ingredients in Osteo Bi-Flex and

concluded that the product doesn’t “support[] mobility, support[] flexibility,

1 We grant Seegert’s and Rexall’s motions to take judicial notice. We deny as moot Rexall’s motion to strike portions of Seegert’s excerpts of record because the relevant portions of the excerpts of record are already sealed.

2 strengthen[] joints, or maintain[] joint cartilage . . . for people with or without

arthritis.” Both of Seegert’s experts also critiqued the studies that Rexall relied on

to support its statements, as well as the testimony of Rexall’s expert witnesses. Both

parties moved to exclude opposing expert testimony.

The district court granted summary judgment for Rexall. The court held that

Rexall’s statements on Osteo Bi-Flex used the correct terms to constitute permissible

structure/function claims under the Food, Drug, and Cosmetic Act (“FDCA”), 21

U.S.C. § 343. Thus, the district court held that Seegert’s state law claims were

preempted by the FDCA’s express preemption provision. The district court also

rejected Seegert’s argument that Rexall’s statements, even though they looked like

acceptable structure/function claims, made implicit disease claims and thus violated

the FDCA. Instead, the court found that “the representations do not suggest

treatment or prevention of a disease,” and so “the representations are proper

structure/function claims according to the federal requirements.”

We review the district court’s grant of summary judgment de novo. Ass’n des

Éleveurs de Canards et d’Oies du Québec v. Becerra, 870 F.3d 1140, 1145 (9th Cir.

2017). We must decide, viewing the evidence in the light most favorable to the

nonmoving party, whether there are any genuine issues of material fact and whether

the district court correctly applied the law. Id. We also review questions of

preemption and statutory interpretation de novo. Id.

3 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). Section 343(r) allows a manufacturer to make

structure/function claims about dietary supplements if: (1) the manufacturer “has

substantiation that such statement is truthful and not misleading,” (2) the statement

contains a prominent disclosure that the statement has not been pre-approved by the

FDA and “is not intended to diagnose, treat, cure or prevent any disease,” and (3)

the statement is not a disease claim. Id. § 343(r)(6)(B), (C). Section 343-1(a)(5)

expressly preempts any state requirement respecting a structure/function claim that

“is not identical to the requirement of § 343(r).”

We begin with Seegert’s argument that Rexall’s representations are implied

disease claims and not structure/function claims. “A statement claims to diagnose,

mitigate, treat, cure, or prevent disease if it claims, explicitly or implicitly, that the

product . . . [h]as an effect on the characteristic signs or symptoms of a specific

disease or class of diseases, using scientific or lay terminology . . . .” 21 C.F.R.

§ 101.93(g)(2)(ii) (emphasis added). In Kroessler v. CVS Health Corp., 977 F.3d

803 (9th Cir. 2020), we considered representations that a glucosamine-based

supplement “supports flexibility & range of motion” and “supports cartilage health

& joint comfort,” id. at 806, and concluded that they were structure/function claims,

not implied disease claims, see id. at 816. We see no material difference between

4 the structure/function claims in Kroessler and Rexall’s representations. Rexall does

not represent that Osteo Bi-Flex “reduces joint pain” or affects any other

characteristic symptom of osteoarthritis. 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, 1016 (Jan. 6, 2000). Nor do any other

representations on Osteo Bi-Flex’s label suggest that the product treats disease

symptoms. And although we may consider extra-label evidence in determining

whether a representation is an implied disease claim, Kroessler, 977 F.3d at 816, the

extrinsic evidence Seegert submitted is not relevant to our inquiry. Thus, we affirm

the district court’s finding that Rexall’s representations are structure/function claims,

not implied disease claims. To the extent that Seegert argues Rexall’s

representations are false or misleading because they present implied disease claims,

her state law claims are preempted.

But the district court erred when it construed § 343-1(a)(5) as preempting

plaintiff’s state law claims whenever the manufacturer’s statement is a

structure/function claim. “The FDCA does not preempt California false advertising

causes of action simply because the challenged label contains a proper

structure/function claim; instead, preemption applies only if the plaintiff’s legal

claims and factual allegations would hold a defendant to a different ‘substantiation’

standard than the FDCA.” Kroessler, 977 F.3d at 813. Thus, the district court must

5 decide whether there is a triable issue on substantiation, which requires looking at

Seegert’s evidence. See Dachauer v. NBTY, Inc., 913 F.3d 844, 849 (9th Cir. 2019)

(“Because the FDCA and California law have the same labeling requirement with

respect to failing to disclose an increased risk of death, § 343-1(a)(5) does not

preempt this particular aspect of Plaintiff’s case. Thus, we address whether Plaintiff

created a genuine issue of material fact as to whether the immune-health claim is

misleading.”). If a reasonable jury could conclude that Rexall failed to substantiate

its claims, then Seegert’s state law claims are not preempted. See id.

On appeal, Rexall argues that we should still affirm the district court’s

preemption decision because Seegert’s evidence is mismatched against the

structure/function claims. See id. Rexall contends that Seegert’s evidence (1)

concerns disease outcomes when Rexall’s structure/function claims do not purport

to treat disease, and (2) relies on studies involving different formulations of the

ingredients in Osteo Bi-Flex. But “[o]nly admissible evidence may be considered

in deciding a motion for summary judgment,” Miller v. Glenn Miller Prods., Inc.,

454 F.3d 975, 988 (9th Cir. 2006), and we do not yet know whether Seegert’s

evidence is admissible because the district court has not ruled on the parties’ Daubert

motions. Because Daubert affords a measure of discretion to the district court, see

Murray v. S. Route Mar. SA, 870 F.3d 915, 923 (9th Cir. 2017), it would be

inappropriate for us to decide the admissibility of Seegert’s evidence in the first

6 instance on appeal. Thus, we reverse the district court’s finding of preemption and

remand so that it can decide the admissibility of Seegert’s evidence and, if the

evidence is admissible, determine whether there is a triable issue on substantiation.

AFFIRMED in part, REVERSED in part, and REMANDED.