Alvarez v. NBTY, Inc.
- Proceeding
- district
- Area
- civil
- Panel
- Cynthia Ann Bashant (author)
Analysis
Defendants moved for judgment on the pleadings, arguing that the plaintiff's claims that their biotin supplements are unnecessary are preempted by the Federal Food, Drug, and Cosmetic Act. The court denied the motion, holding that the defendants failed to establish that their product labels were not false or misleading, a factual issue previously found to be in dispute during summary judgment proceedings.
| What the court decided | The model |
|---|---|
Defendants' Motion for Judgment on the Pleadings is denied.“For the foregoing reasons, the Court DENIES Defendants’ Motion for Judgment on the Pleadings.” | agree with court The court correctly applied the Rule 12(c) standard, which is identical to the Rule 12(b)(6) standard, requiring the moving party to establish that no material issue of fact remains and that they are entitled to judgment as a matter of law. The court relied on its prior ruling on summary judgment (ECF No. 96) which found a genuine dispute of material fact regarding whether a reasonable consumer would find the products misleading. Because the defendants did not provide new evidence or legal arguments sufficient to overcome this prior finding, and because the court correctly noted that a different outcome in a non-binding district court case (Greenberg) does not constitute an intervening change in controlling law warranting reconsideration, the denial of the motion is legally sound. |
The order itself: sound — The order is sound. The court correctly identified the legal standard for judgment on the pleadings and the burden of proof for the moving party. It properly distinguished the non-binding district court decision in Greenberg from its own prior ruling on summary judgment, correctly noting that a different district court's view does not constitute an intervening change in controlling law that would warrant reconsideration of a prior factual finding. The court's reliance on its prior finding of a genuine dispute of material fact regarding consumer deception is consistent with the Rule 12(c) standard, which requires the absence of material factual disputes.
Opinion
8 9 UNITED STATES DISTRICT COURT 10 SOUTHERN DISTRICT OF CALIFORNIA 11 ROSA ALVAREZ, on behalf of Case No. 17-cv-00567-BAS-BGS 12 herself and all others similarly situated, ORDER DENYING 13 DEFENDANTS’ MOTION FOR Plaintiff, JUDGMENT ON THE 14 PLEADINGS v. 15 [ECF No. 116] NBTY, INC., et al., 16 Defendants. 17 18 19 Plaintiff Rosa Alvarez brings a complaint against Defendants NBTY, Inc. and 20 Nature’s Bounty, Inc. Plaintiff alleges Defendants have violated California’s unfair 21 competition law (“UCL”); and Consumers Legal Remedies Act (“CLRA”). 22 Defendants previously moved for summary judgment, and Plaintiff moved for 23 class certification—the Court denied both motions. (ECF Nos. 96, 97.) Defendants 24 now move for judgment on the pleadings. (“Mot.,” ECF No. 116.) Plaintiff filed an 25 opposition to the motion, (“Opp’n,” ECF No. 119), and Defendants filed a reply, 26 (“Reply,” ECF No. 121).1 27 1 The Court finds this motion suitable for determination on the papers 2 submitted and without oral argument. See Civ. L.R. 7.1(d)(1). For the reasons 3 stated below, this Court DENIES Defendants’ Motion. 4 I. BACKGROUND 5 Defendants manufacture, market, sell, and distribute biotin supplements under 6 the Nature’s Bounty brand. (Second Amended Complaint, “SAC,” ECF No. 38, 7 ¶ 1.) The products at issue here are: Biotin 5000 mcg, SUPER POTENCY Biotin 8 5000 mcg, QUICK DISSOLVE Biotin 5000 mcg, Biotin 10,000 mcg rapid release 9 softgels, and Biotin 10,000 mcg HEALTH & BEAUTY rapid release liquid softgels 10 (hereinafter, “the Products”). (Id.) The Products’ labels state the Products 11 “Support[] Healthy Hair, Skin, and Nails” and provide “Energy Support.” (Id. ¶ 20.) 12 In approximately 2014, Plaintiff Rosa Alvarez’s hair began falling out. 13 (“Alvarez Depo.,” Exhibit B of ECF No. 51-2, at 54:5–12.) Around this time, 14 Plaintiff went to her regular nail salon for a manicure. The nail technician told her 15 there was a supplement on the market that helps with hair and nails. (Id. at 66:3–15.) 16 The nail technician took out his bottle of biotin, showed it to Plaintiff and others, and 17 recommended taking the supplement in softgel form. (Id. at 68:4–15.) Plaintiff 18 subsequently went to the store and purchased Defendants’ 10,000 mcg HEALTH & 19 20 subject to reasonable dispute because they are either generally known or can be readily determined 21 by reference to sources whose accuracy cannot reasonably be questioned. “When considering a motion for judgment on the pleadings, [a] court may consider facts that ‘are contained in materials 22 of which the court may take judicial notice.’” Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 971, 981 (9th Cir. 1999). “Judicial notice is appropriate for records and ‘reports of administrative 23 bodies.’” United States v. 14.02 Acres of Land More or Less in Fresno Cty., 547 F.3d 943, 955 (9th Cir. 2008). 24 All three documents are published on governmental agency websites. Defendants contest 25 the proprietary of the Court taking judicial notice of Exhibit C, which is a study conducted by the Office of Inspector General of the Department of Health and Human Services. Defendants argue 26 the study “dealt with different supplements and different issues from this case, and made contested factual findings in doing so.” (ECF No. 121, at 14.) The Court finds judicial notice of the study is 27 not proper—just because a study was undertaken by a government agency does not mean that the 1 BEAUTY rapid release liquid softgels biotin product. (Id.; SAC ¶ 15). She took 2 biotin for a few years. 3 Plaintiff states she purchased the product “in reliance on Defendants’ health 4 benefit representations.” (SAC ¶ 15.) She claims these representations are false, 5 misleading, and reasonably likely to deceive the public. In sum, Plaintiff claims 6 Defendants’ representations are false because the supplements do not support healthy 7 hair, skin, and nails. (Id. ¶ 9.) “The human body only requires a finite amount of 8 biotin on a daily basis for it to perform its enzymatic functions as there are a finite 9 number of enzymes that use biotin. Once there is sufficient biotin in the body, 10 saturation occurs and the body just does not use this surplus biotin.” (Id. ¶ 3.) The 11 average person ingests more than enough biotin from his or her normal daily diet. 12 (Id.) “Thus, biotin is not a ‘more is better’ substance, nor is more biotin needed from 13 supplementation to complete these daily enzymatic functions.” (Id. ¶ 5.) “[O]nce 14 one consumes a sufficient amount of biotin, which is easily met by the general 15 population in their everyday diets, the remainder becomes functionally superfluous 16 and does not convey any additional health benefits.” (Id.) 17 Plaintiff’s expert Dr. Wolf agrees that “the nutrient biotin plays a cellular and 18 biochemical role in the support of healthy hair, skin, nails and energy.” (Wolf Depo, 19 ECF No. 69-2, at 53:9–17.) But Dr. Wolf opines that Defendants’ Products (i.e. 20 “mega-doses” of biotin) “do not provide any benefits to the general population and, 21 thus, they do not help support healthy hair, skin and nails, or energy or energy 22 production” and are “superfluous and unnecessary.” (“Wolf Report,” Exhibit D of 23 ECF No. 51-2, at ¶ 11.) Due to “the metabolic characteristics of biotin, its availability 24 from most food sources, and the finite needs of the human body for biotin,” one has 25 no need for any biotin supplements, and Defendants’ Products are “worthless.” (Id. 26 ¶ 12.) 27 II. LEGAL STANDARD 1 may move for judgment on the pleadings.” Fed. R. Civ. P. 12(c). A court ruling on 2 Rule 12(c) motion for judgment on the pleadings applies the same standard used in a 3 Rule 12(b)(6) motion to dismiss for failure to state a claim. Fleming v. Pickard, 581 4 F.3d 922, 925 (9th Cir. 1996). The court must accept all factual allegations in the 5 complaint as true and construe them in the light most favorable to the non-moving 6 party. Id. “Judgment on the pleadings is proper when the moving party clearly 7 establishes on the face of the pleadings that no material issue of fact remains to be 8 resolved and that it is entitled to judgment as a matter of law.” Hal Roach Studios, 9 Inc. v. Feiner & Co., Inc., 896 F.2d 1542, 1550 (9th Cir. 1989). It is the moving 10 party’s burden to demonstrate that both of these requirements are met. Doleman v. 11 Meiji Mut. Life Ins. Co., 727 F.2d 1480, 1482 (9th Cir. 1984). 12 III. ANALYSIS 13 Defendants argue that Plaintiff’s claim that biotin supplements are 14 unnecessary is preempted. The Food, Drug and Cosmetic Act (“FDCA”) expressly 15 preempts any state law that imposes “any requirement respecting any claim of the 16 type described in section 343(r)(1) of this title made in the label or labeling of food 17 that is not identical to the requirement of section 343(r) of this title.” 21 U.S.C. § 18 343-1(a)(5); Dachauer v. NBTY Inc., 913 F.3d 844, 847 (9th Cir. 2019). For dietary 19 supplements, the FDCA distinguishes between “disease claims” and 20 “structure/function claims” that manufacturers make about their products. A 21 structure/function claim “‘describes the role of a nutrient or dietary ingredient 22 intended to affect the structure or function in humans’ or ‘characterizes the 23 documented mechanism by which a nutrient or dietary ingredient acts to maintain 24 such structure or function.’” Dachauer, 913 F.3d at 846 (quoting 21 U.S.C. § 25 343(r)(6)). Structure/function claims must meet three requirements: “(1) the 26 manufacturer has substantiation that the statement is truthful and not misleading; (2) 27 the statement contains a prominent disclaimer that the Food and Drug Administration 1 diagnose, treat, cure, or prevent any disease’; and (3) the statement itself does not 2 ‘claim to diagnose, mitigate, treat, cure, or prevent’ disease.” Id. at 847.2 3 In arguing preemption, Defendants rely heavily on Greenberg v. Target Corp., 4 402 F. Supp. 3d 936 (N.D. Cal. 2019).3 The plaintiffs in Greenberg brought claims 5 against Target regarding its biotin supplements. The label on Target’s supplements 6 states: “Helps support healthy hair and skin” with asterisks at the end directing 7 readers to a disclaimer: “This statement has not been evaluated by the Food and Drug 8 Administration. This product is not intended to diagnose, treat, cure, or prevent any 9 disease.” 402 F. Supp. 3d at 837. Plaintiff Greenberg alleged that the 10 “structure/function claims regarding the Biotin Supplements are false and misleading 11 based on evidence that any form of supplemental biotin is superfluous for the general 12 public, i.e., has no effect on human structure or function.” Id. at 840. The court 13 noted that it was undisputed that the nutrient Biotin “does indeed affect human 14 structure or function” but the plaintiff’s argument was that although the nutrient 15 affects structure/function, “the supplement at issue will impact the health of only a 16 small proportion of the population.” Id. at 840–41. The court concluded, 17 “Greenberg identifies no federal regulation requiring a dietary supplement to 18 substantiate its structure/function claims with evidence that the supplement, as 19 opposed to the nutrient, will have the practical effect of impacting the health of a 20 sizeable proportion of the general public.” Id. at 841. Therefore, his claims are 21 preempted. Id. 22 Although Defendants here have not previously argued preemption (the main 23 issue in Greenberg), they did argue that their products’ labels are not false or 24 25 2 “Although the FDCA requires manufacturers to have substantiation for their structure/function 26 claims, California law does not allow private plaintiffs to demand substantiation for advertising claims. Instead, a private plaintiff bears the burden of producing evidence to prove that the 27 challenged statement is false or misleading.” Dachauer, 913 F.3d at 847 (citations omitted). 1 ||misleading. (See generally ECF No. 51.) To successfully demonstrate preemption, 2 ||Defendants must establish, inter alia, that the products are not false or misleading. 3 || See Hadley v. Kellogg Sales Co., 273 F. Supp. 3d 1052, 1072 (N.D. Cal. 2017) 4 || (holding the defendant has the burden of showing the plaintiff's nutrient content or 5 □□ health claims are subject to preemption). The Court has already ruled on this issue, 6 || finding: 7 A jury could conclude that a reasonable consumer would find g Defendants’ Products misleading. Drawing all inferences from the underlying facts in the light most favorable to the Plaintiff, the Court 9 finds there is a disputed issue as to whether reasonable consumer could 10 believe that the high doses of biotin in Defendants’ Products support the consumer’s hair, skin, and nails, when, as Plaintiff presents, the 11 biotin in one’s diet sufficiently supports hair, skin, and nails, and one 12 does not need biotin from Defendants’ Products for such support. 13 || (ECF No. 96, at 13.) Defendants are essentially asking the Court to reconsider this 14 |/finding. And while it is true that the court in Greenberg found differently, this is not 15 ||a basis for reconsideration. See Sch. Dist. No. 1J, Multnomah Cty. v. ACands, Inc., 16 |/5 F.3d 1255, 1263 (9th Cir. 1993) (holding reconsideration may be appropriate if 17 ||there is “an intervening change in controlling law’). The Court finds no reason to 18 change its prior ruling. Accepting all factual allegations in the Complaint as true and 19 |\construing them in the light most favorable to Plaintiff, the Court finds that 20 ||Defendants are not entitled to judgment as a matter of law. 21 CONCLUSION 22 For the foregoing reasons, the Court DENIES Defendants’ Motion for 23 ||Judgment on the Pleadings. Pursuant to the recent order by Judge Skomal, (ECF No. 24 |/110), the parties are to contact Judge Skomal’s chambers within 3 court days of the 25 || date of this Order to schedule a mandatory settlement conference. 26 IT IS SO ORDERED. /) □□ Z f (YilWg \<AohhaAd 27 ||DATED: January 3, 2020 asl Veh Hel 28 United States District Judge