Seegert v. Rexall Sundown, Inc.

• Court: District Court, S.D. California
• Decided: April 3, 2020
• Docket: 3:17-cv-01243
• Status: Unknown

Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 SANDRA SEEGERT, individually and on Case No.: 3:17-cv-01243-BEN-JLB behalf of all others similarly situated, 12 ORDER: Plaintiff, 13 v. (1) GRANTING DEFENDANT’S 14 MOTION FOR SUMMARY REXALL SUNDOWN, INC., 15 JUDGMENT Defendant. 16 (2) DENYING AS MOOT 17 PLAINTIFF’S MOTION FOR CLASS CERTIFICATION 18

19 [Doc. Nos. 107, 101]

20 21 Before the Court is Plaintiff Sandra Seegert’s (“Plaintiff”) Motion for Class 22 Certification, and Defendant Rexall Sundown, Inc.’s (“Defendant”) Motion for Summary 23 Judgment. The Court finds them suitable for determination on the papers submitted and 24 without oral argument. See S.D. Cal. CivLR 7.1(d)(1). 25 BACKGROUND 26 This case arises out of Defendant’s alleged false statements about the joint health 27 28 1 benefits of its Osteo Bi-Flex product line. Plaintiff alleges she purchased Osteo Bi-Flex 2 Triple Strength on February 20, 2017, from a Walgreens retail store, for approximately 3 $31.99.2 (Doc. No. 1 ¶¶ 11-12.) Defendant’s packaging and advertisements for Osteo 4 Bi-Flex represent it supports joint health, as well as improving “Range of Motion,” and 5 “helps strengthen joints while helping to maintain joint cartilage essential for comfortable 6 joint movement”.3 According to the Complaint, these representations are false because 7 studies show that Defendant’s Osteo Bi-Flex products, cannot provide the promised 8 benefits.4 Id. ¶ 13. 9 The Complaint alleges that despite clinical studies demonstrating the 10 ineffectiveness of Osteo Bi-Flex, Defendant continues to convey that its Osteo Bi-Flex 11 products are joint health supplements capable of supporting/benefiting joint health.5 12 (Doc. No. 1 ¶ 70.) As a result, “Plaintiff and the class members have been and will 13 continue to be deceived or mislead by Defendant’s false and deceptive representations.” 14 Id. ¶ 73. 15

16 1 Osteo Bi-Flex is a joint health supplement containing 1,500 mg of glucosamine 17 hydrochloride in pill form. (Doc. No. 101 at 2.) 2 Defendant’s glucosamine products it issue are sold under the “Osteo Bi-Flex” 18 brand name (collectively the ‘Osteo Bi-Flex Products’): Osteo Bi-Flex One Per Day; 19 Osteo Bi-Flex Triple Strength; Osteo Bi-Flex Triple Strength MSM; and Osteo Bi-Flex Triple Strength with Vitamin D. (Doc. No. 1 at 3.) 20 3 “To reinforce the overall joint health benefits message, the front label of the Osteo 21 Bi-Flex One Per Day, Osteo Bi-Flex Triple Strength, and Osteo Bi-Flex Triple Strength with Vitamin D products states, ‘JOINT SHIELD’ and that it ‘Shows Improved Joint 22 Comfort within 7 Days!’ Similarly, the front label of the Osteo Bi-Flex Triple Strength 23 MSM product states that it ‘Supports Cartilage Health’ and ‘Helps Strengthen Your Joints.’” (Doc. No. 1 ¶ 24.) 24 4 Defendant, through its advertisements and packaging/labeling, has consistently 25 conveyed to consumers throughout the United States that its products support and promote joint health. Id. ¶ 22. 26 5 For example, Plaintiff alleges that Defendant knew, but failed to disclose, or should 27 have known, that the Osteo Bi-Flex products cannot benefit joint health and that well- conducted, clinical studies have found the Osteo Bi-Flex products’ primary ingredients 28 1 The Complaint asserts three state law causes of action: (1) violation of the 2 California Unfair Competition Law (“UCL”); violation of the California Consumers 3 Legal Remedies Act (“CLRA”); and (3) Violation of the California False Advertising 4 Law (“FAL”).6 Id. ¶¶ 87-123. The prayer for relief asks for restitution and disgorgement 5 of Defendant’s revenues, actual, statutory and punitive damages, and attorney’s fees and 6 costs. (Doc. No. 1 at 27.) Plaintiff now moves to certify a class while Defendant seeks 7 summary judgment of all of Plaintiff’s claims. Because Defendant is entitled to summary 8 judgment, Defendant’s motion is addressed first. 9 DISCUSSION 10 I. Defendant’s Motion for Summary Judgment 11 Defendant seeks summary judgment on all of Plaintiff’s claims based on the 12 following four grounds: (1) Plaintiff’s state law false advertising claims are preempted by 13 the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301, et seq.; (2) 14 Plaintiff has not presented any evidence pertaining to Rexall’s proprietary ingredient 15 Joint Shield™ 5-LOXIN Advanced® which Plaintiff claims to have relied upon in 16 purchasing Osteo Bi-Flex® Triple Strength7; (3) Plaintiff has proffered no evidence of 17 actual falsity regarding any other label claims on Rexall’s product line; (4) Plaintiff’s 18 California Unfair Competition Law (“UCL”) Cal. Bus. & Prof. Code 17200, et seq, claim 19 should be dismissed because it only allows for equitable remedies. (Doc. No. 107 at 102- 20 03.) 21 Summary judgment is appropriate “if the movant shows that there is no genuine 22

23 6 These statutes are designed to protect consumers who are exposed to materially 24 misleading package labeling and advertisements, and under the statutes, materiality is 25 measured using objective criteria. See In re Tobacco II, 46 Cal. 4th 298, 312 n.8, 327 (2009) (discussing the FAL and UCL); In re Vioxx Class Cases, 180 Cal. App. 4th 116, 26 125 (2009) (discussing the CLRA). 27 7 Joint Shield™ 5-LOXIN Advanced® is the key ingredient in each of the Products and the basis for the only label statement that Plaintiff claims to have relied upon in 28 1 dispute as to any material fact and the movant is entitled to judgment as a matter of law.” 2 Fed. R. Civ. P. 56(a). In order to prevail, a party moving for summary judgment must 3 show the absence of a genuine issue of material fact with respect to an essential element 4 of the non-moving party’s claim, or to a defense on which the non-moving party will bear 5 the burden of persuasion at trial. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). 6 Once the movant has made this showing, the burden then shifts to the party opposing 7 summary judgment to identify “specific facts showing there is a genuine issue for trial.” 8 Id. The party opposing summary judgment must then present affirmative evidence from 9 which a jury could return a verdict in that party’s favor. Anderson v. Liberty Lobby, 477 10 U.S. 242, 257 (1986). 11 On summary judgment, the Court draws all reasonable factual inferences in favor 12 of the non-movant. Anderson, 477 U.S. at 255. In deciding a motion for summary 13 judgment, “[c]redibility determinations, the weighing of the evidence, and the drawing of 14 legitimate inferences from the facts are jury functions, not those of a judge.” Id. 15 Whether the NELA Preempts Plaintiff’s State Law Claims 16 Turning to the substance of the summary judgment motion, Defendant first argues 17 that the NELA expressly preempts Plaintiff’s state law claims. 18 Federal preemption can be either express or implied. See Fid. Fed. Sav. & Loan 19 Ass’n v. de law Cuesta, 458 U.S. 141, 152-53 (1982). Express preemption exists when a 20 statute explicitly addresses preemption. See Chicanos Por La Causa, Inc. v. Napolitano, 21 558 F.3d 856, 863 (9th Cir. 2009). The federal Nutrition Labeling and Education Act 22 (“NLEA”) expressly preempts state law. NELA “preempts state law requirements 23 respecting any claim of the type described in section § 343(r)(1) of this title made in the 24 label or labeling of food.” 21 U.S.C. § 343-1(a)(5). The NLEA classifies dietary 25 supplements as food; indeed, § 343-1 (“National uniform nutrition labeling”) and § 343 26 (“Misbranded food”) fall under the NLEA’s “Food” subchapter. “Thus, a 27 structure/function claim also constitutes a claim ‘made in the label or labeling of food.’” 28 Dachauer v. NBTY, Inc., 913 F.3d 844, 847 (9th Cir. 2019) (citing 343-1(a)(5)). The 1 NLEA provides that no state may “directly or indirectly establish … any requirement for 2 the labeling of food that is not identical” to the federal requirements. 21 U.S.C. § 343- 3 1(a)(5). The phrase “not identical to” means “that the State requirement directly or 4 indirectly imposes obligations or contains provisions concerning the composition or label 5 of food [that] … [a]re not imposed by or contained in the applicable [federal regulation] 6 … or [d]iffer from those specifically imposed by or contained in the applicable [federal 7 regulation]. 21 C.F.R. § 100.1(c)(4). Defendant’s labeling statements about which 8 Plaintiff complains are structure/function claims. 9 The NLEA distinguishes between “structure/function claims” and “disease claims” 10 that manufacturers make about their products. A structure/function claim “describes the 11 role of a nutrient or dietary ingredient intended to affect the structure or function in 12 humans” or “characterizes the documented mechanism by which a nutrient or dietary 13 ingredient acts to maintain such structure or function,” but “may not claim to diagnose, 14 mitigate, treat, cure, or prevent a specific disease or class of diseases.” 21 U.S.C. § 15 343(r)(6). A disease claim, conversely, “claims to diagnose, mitigate, treat, cure, or 16 prevent disease,” either explicitly or implicitly (such as by claiming that a product treats a 17 disease’s “characteristic signs or symptoms”). 21 C.F.R. § 101.93(g)(2)(ii). NELA, 18 Structure/function claims must meet three requirements: (1) the manufacturer has 19 substantiation that the statement is truthful and not misleading; (2) the statement contains 20 a prominent disclaimer that the Food and Drug Administration (“FDA”) has not 21 evaluated the statement and that the product “is not intended to diagnose, treat, cure, or 22 prevent any disease”; and (3) the statement itself does not “claim to diagnose, mitigate, 23 treat, cure, or prevent” disease. 21 U.S.C. § 343(r)(6). 24 Although the FDCA requires manufacturers to have substantiation for their 25 structure/function claims, California law does not allow private plaintiffs to demand 26 substantiation for advertising claims. Dachauer, 913 F.3d at 847 (9th Cir. 2019) (citing 27 Nat’l Council Against Health Fraud, Inc. v. King Bio Pharm, Inc., 107 Cal. App. 4th 28 1336, 1344 (2003)). The FDCA does not define the term “substantiation,” but FDA 1 guidance advances a common-sense interpretation of “substantiation,” as meaning 2 “competent and reliable scientific evidence.” See Kaufman v. CVS Caremark Corp., 836 3 F.3d 88, 93 (1st Cir. 2016). The FDA has published guidance in the Federal Register 4 discussing, among other things, acceptable structure/function claims. Regulations on 5 Statements Made for Dietary Supplements Concerning the Effect of the Product on the 6 Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan. 6, 2000). In relevant part, 7 the FDA states that “‘joint pain’ is characteristic of arthritis … [but] [t]he claim ‘helps 8 support cartilage and joint function,’ on the other hand, would be a permissible 9 structure/function claim, because it relates to maintaining normal function rather than 10 treating joint pain.” Id. at 1016-17. 11 In this case, Defendant relies on the guidance issued by the FDA discussing 12 acceptable structure/function claims and analogizes this case to Dachauer. The FDA has 13 published guidance in the Federal Register discussing, among other things, acceptable 14 structure/function claims. (See Supra.) “The guidance recognizes that structure/function 15 claims may use general terms such as ‘strengthen,’ ‘improve,’ and ‘protect,’ as long as 16 the claims ‘do not suggest disease prevention or treatment.’” Dachauer, 913 F.3d at 847 17 (citing 65 Fed. Reg. at 1028.) 18 As applied here, the NLEA’s preemption provision preempts Plaintiff’s CLRA, 19 UCL and FAL claims, and this conclusion is hardly novel. What is novel is Plaintiff’s 20 implied disease claim. Specifically, Plaintiff alleges Defendant’s representations are 21 improper structure/function claims because they imply effects on characteristic signs and 22 symptoms of osteoarthritis, a disease claim.8 Id. at 12. Despite Plaintiff’s assertions, the 23 representations do not purport to “reduce” or “improve” anything nor do they mention 24

25 8 In this case Plaintiff attempts to argue that labeling statements like: “improves 26 mobility,” “joint discomfort,” “joint mobility,” “flexibility,” “‘Osteo Bi-Flex,’ and even 27 ‘we created Osteo Bi-Flex®, the only joint care brand with Joint Shield, to help … and improve mobility,’ is an implied disease claim because it ‘suggests it is intended to treat, 28 1 “joint pain.” Furthermore, the representations do not suggest treatment or prevention of a 2 disease. As a result, each satisfies the requirements under the NLEA for 3 structure/function claims. Therefore, the representations are proper structure/function 4 claims according to the federal requirements. See 65 Fed. Reg. at 1016-17. 5 Plaintiff further avers that even if the representations are found to be permissible 6 structure/function claims, it bears little merit on the analysis, since state law challenges 7 must either impose greater, or inconsistent burdens, to those under the FDCA, before the 8 claims can be preempted.9 (See Doc. No. 141 at 13-14.) Notably, however, the Ninth 9 Circuit took a contrary position in Dachauer, finding that it matters a great deal to the 10 analysis how the representations are ultimately classified. For example, as applied to the 11 facts at hand, “Plaintiff’s argument would vitiate the FDCA’s distinction between disease 12 claims and structure/function claims. This is because the FDA allows manufacturers of 13 supplements to make general claims … and to substantiate them with evidence that a 14 supplement has some structural or functional effect on a given part of the human body.” 15 Dachauer, 913 F.3d at 848 (citing 65 Fed. Reg. at 1012). Unlike Dachauer, where the 16 court concluded the NLEA did not preempt plaintiff’s claim that the defendant’s 17 structure/function claim about immune health was misleading10, Plaintiff makes no such 18 claim here. In fact, the product labels do not even refer to joint pain; instead, each 19 reference supporting joint function. Thus, it is accurate to say that “the statements 20 Plaintiff identifies as misleading are archetypal structure/function claims of the sort the 21 22 23 9 “The FDCA expressly prohibits structure/function statements that are ‘false or misleading in any particular …’ 21 U.S.C. 343(a); see also Dachauer, 913 F.3d at 847- 24 48 (false and misleading prohibition applies to dietary supplements).” Plaintiff asserts 25 that because California consumer protection statutes use the identical standards, Plaintiff’s CLRA causes of action are not preempted by the FDCA, as other courts have 26 held. See Hawkins v. Kroger Co., 906 F.3d 763, 772 (9th Cir. 2018) (no preemption 27 because FDCA does not authorize deceptive labels.) (See Doc. No. 141 at 14.)” 10 The Court found it misleading because the supplements increased the risk of all- 28 1 || FDA has determined to be appropriate.’’'! (Doc. No. 107 at 9.) 2 It also bears noting that District Judge Cathy Ann Bencivengo dismissed similar 3 || CLRA and UCL claims brought by Plaintiff's counsel in a similar glucosamine 4 || supplement case because she found them to be proper structure/function claims. 5 || Kroessler v. CVS Health Corp., No. 19-cv-277, 2019 WL 2164054, *5 (S.D. Cal. May 6 || 16, 2019) (notice of appeal filed). Her reasoning is persuasive and adopted here. In this 7 || case, “[rJather than actually focusing on the language that the consumer sees,” Plaintiff 8 || chose to “rely on internal Rexall documents to theorize that Rexall ‘intended’ to make 9 ||implied disease claims.” (Doc. No. 185 at 4.) This approach falls flat on analysis 10 however because Defendant complied with federal labeling requirements for dietary 11 supplements. 12 Therefore, Plaintiffs state law false advertising claims under the CLRA, UCL, and 13 || FAL are expressly preempted by the NLEA. 14 = Plaintiff's Motion for Class Certification 15 Having granted Defendant’s motion for summary judgment, Plaintiff's motion for 16 certification is hereby DENIED as moot. 17 CONCLUSION 18 For the foregoing reasons, the Court GRANTS Defendant’s Motion for Summary 19 || Judgment, and DENIES as moot Plaintiff's Motion for Class Certification. 20 IT IS SO ORDERED. . 21 22 || Dated: April 3, 2020 3 HON. ROGER T. BENITEZ United State District Judge YJ 25 “Plaintiff challenges the following Product statements: ‘JOINT HEALTH’; ‘JOINT SHIELD’; ‘Shows Improved Joint Comfort within 7 Days!’; ‘Range of Motion’; ‘Strengthen Joints’; “Support Flexibility’; ‘Support Mobility’; ‘[S]upports joint comfort’; 27 || ‘[D]efend your joints’; ‘[H]elps strengthen joints while helping to maintain joint cartilage 28 essential for comfortable joint movement’; and ‘#1 Pharmacist Recommended Brand.’” (Doc. No. 107 at 9, n*6.)