Sandra Seegert v. Rexall Sundown, Inc. ( 2022 )


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  •                            NOT FOR PUBLICATION                           FILED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.
    7
    

Document Info

Docket Number: 20-55486

Filed Date: 2/1/2022

Precedential Status: Non-Precedential

Modified Date: 2/1/2022