Moreno v. Vi-Jon, Inc.

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6 UNITED STATES DISTRICT COURT

7 SOUTHERN DISTRICT OF CALIFORNIA

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9 ANTHONY MORENO, individually, and Case No.: 20cv1446 JM(BGS)

on behalf of others similarly situated,

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ORDER ON MOTION TO DISMISS

Plaintiff,

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v.

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VI-JON, INC.,

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Defendant.

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16 Presently before the court is Defendant Vi-Jon, LLC’s1 motion to dismiss filed

17 pursuant to Federal Rules of Civil Procedure 9(b), 12(b)(1), and 12(b)(6). (Doc. No. 15.)

18 The motion has been fully briefed and the court finds it suitable for submission on the

19 papers and without oral argument in accordance with Civil Local Rule 7.1(d)(1). For the

20 reasons set forth below, Defendant’s motion is granted.

21 I. BACKGROUND

22 On July 27, 2020, Plaintiff filed a consumer class action complaint against

23 Defendant, seeking damages and equitable relief for the alleged false and misleading

24 labeling on Defendant’s hand sanitizing products. (Doc. No. 1, at ¶¶ 1-8.) The complaint

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27 1 Defendant notes that the FAC incorrectly identifies it as a Missouri Corporation, (FAC at

¶ 25) when it converted to a Delaware Limited Liability Company as of August 21, 2020.

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1 alleges violations of California’s Unfair Competition Law (“UCL”), CAL. BUS. & PROF.

2 CODE § 17200, et seq; violation of the California’s False Advertising Law (“FAL”), CAL.

3 BUS. & PROF. CODE § 17500, et seq; violation of the California Consumer Legal Remedies

4 Act (“CLRA”), CAL. CIV. CODE § 1770, et seq; breach of warranty; and quasi-contract.

5 On September 14, 2020, Plaintiff filed the First Amended Complaint. (Doc. No. 13,

6 “FAC”.) The FAC asserts FAL, UCL, CLRA, breach of express warranty, breach of

7 implied warranty, and quasi contract claims against Defendant for misrepresenting and

8 misleading consumers regarding the hand sanitizers (the “Products”)2. The FAC alleges

9 that the front-facing, primary display panel of each Product contains the statement “kills

10 99.99% of germs” (the “Representation”) when they in fact do not “kill” 99.99% of the

11 organisms that cause disease. (FAC ¶¶ 3, 5.) Plaintiff contends that the Products are

12 ineffective against certain microbes, viruses, protozoa and bacterial spores. (Id. ¶¶ 6, 37.)

13 To illustrate his point, Plaintiff points to the Products ineffectiveness against numerous

14 organisms that cause disease including norovirus, polio, polyomavirus, hand, foot, and

15 mouth disease (“HFMD”), human papillomavirus (“HPV”), hepatitis A, cryptosporidium,

16 C. difficile, enterococci, and influenza A. (Id. ¶¶ 13, 39-67.) Plaintiff maintains that this

17 list is simply illustrative and is not, however, a comprehensive summary of all

18 microorganisms against which the Products are ineffective. (Id. ¶ 38.) Plaintiff claims

19 that “evaluated alone or collectively, the Products are ineffective against more than .01%

20 of ‘germs’ therefore the uniform Representation that they kill 99.99% of germs is false and

21 misleading.” (Id. at ¶ 68.) In other words, the germs the Products do not kill, “comprise

22 more than .01% of ‘germs’ and more than .01% of ‘harmful germs.’” (Id. at ¶ 33.)

23 Further, Plaintiff alleges that the Products are misbranded under the law, are legally

24 worthless, and are not capable of being legally sold. (Id. ¶¶ 73, 82-84.) Plaintiff purchased

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27 2 The hand sanitizers at issue including the following four brands: (1) CVS Health and/or

CVS Pharmacy; (2) Equate (Walmart); (3) Germ-X; (4) Walgreen Co.

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1 each of the branded Products one or more times in stores in San Diego between November

2 2019 through February 20203. Had the Products not claimed to kill 99.99% of germs,

3 Plaintiff alleges that he would have not purchased them, or alternatively, had he known

4 they did not kill 99.99% of germs and were not legally saleable, he would not have

5 purchased them at the premium price. (Id. ¶¶ 89-96.)

6 Plaintiff seeks to represent a California Class consisting of “all citizens of California

7 who, within four years prior to the filing of the initial Complaint, purchased Defendant’s

8 Products and who did not claim any personal injury from using the Products.” (Id. at ¶ 97.)

9 The FAC’s Prayer for Relief includes, among other things, an order for restitution,

10 disgorgement and an award of compensatory, monetary and punitive damages. (Id. at 30.4)

11 On September 28, 2020, Defendant filed a motion to dismiss. (Doc. No. 15.)

12 Plaintiff filed his opposition to the motion5, (Doc. No.16) and Defendant filed its reply,

13 (Doc. No. 20).

14 II. LEGAL STANDARDS

15 Federal Rule of Civil Procedure 12(b)(1) allows a party to move to dismiss based on

16 the court’s lack of subject matter jurisdiction. Fed. R. Civ. P. 12(b)(1). “[T]hose who seek

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19 3 Plaintiff purchased: (1) the CVS product from a CVS store in San Diego for

approximately$3.99; (2) the Equate product from a Walmart store in San Diego for

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approximately $3.97; (3) the Germ-X product from a Walmart store in San Diego for

21 approximately $2.66; and (4) the Walgreens product from a Walgreens store in San Diego

for $2.99. FAC at ¶ 88; see also Doc. No. 13-1, Declaration of Anthony Moreno, ¶¶ 5, 8-

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10, 12.

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4 Document numbers and page references are to those assigned by CM/ECF for the docket

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entry.

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5 In his opposition, Plaintiff makes passing objections to the declaration of Alisa Benson,

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stating a handful of reasons why the court should disregard it. See Doc. No. 16. n. 1. Ms.

27 Benson’s declaration was filed in support of Defendant’s motion to dismiss. (Doc. No. 15-

2.) Having not considered Ms. Benson’s declaration in ruling on this motion, Plaintiff’s

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1 to invoke the jurisdiction of the federal courts must satisfy the threshold requirement

2 imposed by Article III of the Constitution by alleging an actual case or controversy.” City

3 of L.A. v. Lyons, 461 U.S. 95, 101 (1983). Article III requires that: “(1) at least one named

4 plaintiff suffered an injury in fact; (2) the injury is fairly traceable to the challenged

5 conduct; and (3) the injury is likely to be redressed by a favorable decision.” Lujan v.

6 Defenders of Wildlife, 504 U.S. 555, 560-61 (1992) (quotation marks and citation omitted).

7 Plaintiff has the burden of establishing that the court has subject matter jurisdiction over

8 an action. Ass’n of Med. Colls. v. U.S., 217 F.3d 770, 778-79 (9th Cir. 2000). A party may

9 make either a facial or factual attack on subject matter jurisdiction. See, e.g., Warren v.

10 Fox Family Worldwide, Inc., 328 F.3d 1136, 1139 (9th Cir. 2003). To resolve a facial

11 challenge, as Defendant makes here, the court considers whether “the allegations contained

12 in [the] complaint are insufficient on their face to invoke federal jurisdiction.” Safe Air for

13 Everyone v. Meyer, 373 F.3d 1035, 1039 (9th Cir. 2004). The court must accept the

14 allegations as true and must draw all reasonable inferences in the plaintiff's favor. Whisnant

15 v. United States, 400 F.3d 1177, 1179 (9th Cir. 2005); Wolfe v. Strankman, 392 F.3d 358,

16 362 (9th Cir. 2004).

17 Under Federal Rule of Civil Procedure 12(b)(6), a party may bring a motion to

18 dismiss based on the failure to state a claim upon which relief may be granted. A Rule

19 12(b)(6) motion challenges the sufficiency of a complaint as failing to allege “enough facts

20 to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S.

21 544, 570 (2007). This is because a “pleading that offers ‘labels and conclusions’ or ‘a

22 formulaic recitation of the elements of a cause of action will not do.’” Ashcroft v. Iqbal,

23 556 U.S. 662, 678 (2009) (quoting Twombly, 550 U.S. at 555). Ordinarily, for purposes of

24 ruling on a Rule 12(b)(6) motion, the court “accept[s] factual allegations in the complaint

25 as true and construe[s] the pleadings in the light most favorable to the non-moving party.”

26 Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir. 2008). The

27 court must be able to “draw the reasonable inference that the defendant is liable for the

28 misconduct alleged.” Iqbal, 556 U.S. at 663. “Determining whether a complaint states a

1 plausible claim for relief … [is] a context-specific task that requires the reviewing court to

2 draw on its judicial experience and common sense.” Id. at 679.

3 Under Federal Rule of Civil Procedure 9(b), a plaintiff must plead fraud with

4 particularity. “Averments of fraud must be accompanied by the who, what, when, where,

5 and how of the misconduct charged.” Vess v. Ciba–Geigy Corp. USA, 317 F.3d 1097, 1106

6 (9th Cir. 2003) (internal quotation marks omitted). Even if “fraud is not a necessary

7 element of a [particular] claim,” Rule 9(b) will apply if the plaintiff has “allege[d] a unified

8 course of fraudulent conduct and rel[ied] entirely on that course of conduct as the basis of

9 [the] claim.” Id. at 1103.

10 III. DISCUSSION

11 Defendant moves to dismiss all of Plaintiff’s claims on the grounds that Plaintiff

12 lacks Article III standing. Defendant also seeks dismissal under Rule 12(b)(6) of the

13 Federal Rules of Civil Procedure, arguing that the FAC fails to allege facts sufficient to

14 state any claim upon which relief can be granted. Further, Defendant claims that Plaintiff

15 has failed to satisfy the heightened pleading requirements of Rule 9(b). Defendant also

16 moves to dismiss on the grounds that federal regulations preempt Plaintiff’s claims.

17 Finally, Defendant maintains that Plaintiff’s claim for equitable relief should be dismissed.

18 The Court will address each of Defendant’s arguments in turn.

19 A. Rule 12(b)(1)

20 Defendant moves for dismissal under Rule 12(b)(1), asserting this court lacks subject

21 matter jurisdiction because Plaintiff has not met the Article III standing requirements. It

22 argues that Plaintiff has not pled any injury in fact as a result of his purchases. (Doc. No.

23 15-1 at 15-17.) In support, Defendant points to the allegations in the FAC that hypothesize

24 the “potential risk of disease – an unrealized risk of harm that could have resulted from use

25 of the Products (or which the Products allegedly failed to prevent), but which Moreno does

26 not claim occurred.” (Id. at 15.) Relatedly, Defendant argues that Plaintiff is attempting

27 to recast his not cognizable no-injury products liability claims into consumer fraud claims.

28 (Id. at 16.) Plaintiff counters that he suffered an injury in fact based on the amount he paid

1 for the misbranded products. (Doc. No. 16 at 11-13.) Additionally, Plaintiff maintains that

2 his claims are based on Defendant’s affirmative misrepresentation and are not a no-injury

3 product liability case. (Id. at 13-14.)

4 “There is no subject matter jurisdiction without standing, and the “irreducible

5 constitutional minimum” of standing consists of three elements.” Romero v. Securus

6 Techs., Inc., 216 F. Supp. 1078, 1085 (2016). A plaintiff must have “(1) suffered an injury

7 in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that

8 is likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robbins,

9 136 S. Ct. 1540, 1547 (2016). In a class action, at least one of the named plaintiffs must

10 meet the Article III standing requirements. Bates v. United Parcel Servs., Inc., 511 F. 3d

11 974, 985 (9th Cir. 2007). Defendant’s arguments implicate the first element.

12 “To establish injury in fact, a plaintiff must show that he or she suffered ‘an invasion

13 of a legally protected interest’ that is ‘concrete and particularized’ and ‘actual or imminent,

14 not conjectural or hypothetical.’” Spokeo, 136 S. Ct. at 1547 (quoting Lujan, 504 U.S. at

15 560). To that end, “[a] ‘concrete’ injury must be ‘de facto’; that is, it must actually exist.”

16 Id. “Where, as here, a case is at the pleading stage, the plaintiff must ‘clearly . . . allege

17 facts demonstrating” the existence of an injury in fact.” Id. (quoting Warth v. Seldin,

18 422 U.S. 490, 518 (1975)). Thus, for Plaintiff to have Article III standing, the FAC must

19 allege facts demonstrating that Plaintiff has suffered a concrete injury as a result of the

20 violations of the FAL, UCL, CLRA and breach of express warranty, breach of implied

21 warranty, and quasi contract claims alleged in the FAC.

22 The FAC does not meet this requirement. Pointing to a list of various diseases

23 Plaintiff makes the conclusory allegation that the Products are ineffective against 0.01% of

24 germs and, therefore, the Representation that they kill 99.99% of germs is false and

25 misleading, (see FAC ¶¶ 7, 33, 38, 68). Nowhere in the FAC does Plaintiff plead any harm

26 or material risk of harm that he suffered as a consequence of purchasing the hand sanitizers.

27 He has not alleged a negative experience associated with the Products, despite the

28 allegations in the FAC that the Products are not legally saleable. Further, neither in the

1 FAC nor in his attached declaration, (Doc. No. 13-1), does Plaintiff even allege that he

2 purchased or used the Products to prevent any of the diseases or viruses listed in the FAC.

3 Neither has Plaintiff alleged that he contracted any of the diseases or viruses he alleges that

4 the Products do not purportedly protect against. Moreover, the possibility of contracting

5 one of the listed diseases/viruses because the Products have not killed the germs which

6 cause them, depends on too many outside variables. In other words, Plaintiff does not

7 plead facts to suggest that a palpable risk exists. Setting aside the unassailable reality that

8 the Products do not represent they will kill, for example, polio, HPV, or other serious

9 disease microbes, Plaintiff has done nothing more than “mathematically” calculate that the

10 percentage of serious disease bearing “germs” must, logically, exceed 0.01% of the

11 universe of germs and, therefore, cannot “kill” all of the most serious germs. This argument

12 is insufficient to confer Article III standing. See, e.g., Birdsong v. Apple, 590 F.3d 955,

13 961 (9th Cir.2009) (plaintiff did not adequately allege injury in fact due to false labeling

14 when defendant adequately disclosed potential risks to customers); Boysen v. Walgreen

15 Co., No. C 11- 06262 SI, 2012 WL 2953069, at * 7 (N.D. Cal. July 19, 2012); Herrington

16 v. Johnson & Johnson Consumer Cos., Inc., No. C 09-1597 CW, 2010 WL 3448531, at *

17 3 (N.D. Cal. Sept. 1, 2010); In re McNeil Consumer Healthcare, 877 F. Supp. 2d 254 (E.D.

18 Pa. 2012); Williams v. Purdue Pharma Co., 297 F. Supp. 2d 171 (D.D.C. 2003).6

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21 6 But cf., Degelman v. Advanced Medical Optics, 659 F.3d 835 (9th Cir. 2011) vacated

699 F.3d 1103 (9th Cir 2012). Degelman is, however, easily distinguishable from the

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instant case. There, the Ninth Circuit reversed a district court's dismissal for lack of

23 standing where plaintiffs purchased contact lens solution that was later recalled due to high

incidence of infection, though plaintiffs themselves suffered no such infection. The

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Degelman plaintiffs supported their claims of economic injury with plausible allegations

25 that the product actually performed at a lower level than comparable products and less well

than advertised because it caused a serious eye infection. Here, Plaintiff has provided no

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such plausible allegations, the FDA has not withdrawn the hand sanitizers in question, and

27 Plaintiff makes only passing references to the conclusions of various studies while

overlooking the disclosure on the rear of the label.

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1 In sum, Plaintiff has not pled an injury and has failed to allege an injury that “actually

2 exist[ed]” and that affected him in “a personal and individual way.” Spokeo, 136 S. Ct. at

3 1548. Rather, Plaintiff has only pled a conjectural and hypothetical injury: that the

4 Products kill 99+% of germs when they do not “kill” certain germs, which comprise more

5 than .01% of “germs” and more than .01% of “harmful germs.” See Lujan, 504 U.S. at 560

6 (To establish injury in fact—the relevant element here—the plaintiff must show that he or

7 she suffered “an invasion of a legally protected interest” that is “concrete and

8 particularized” and “actual or imminent, not conjectural or hypothetical”) (internal

9 quotations omitted). Consequently, the motion to dismiss the complaint, made pursuant to

10 Rule 12(b)(1), is GRANTED, with leave to amend.

11 B. Sufficiency of Plaintiff’s Allegations

12 Second, Defendant contends that Plaintiff has failed to plead sufficient facts to

13 support his claims, or with the requisite specificity, required by Federal Rules of Civil

14 Procedure 9(b) and 12(b)(6).

15 1. CLRA, FAL & UCL claims

16 Defendant makes several arguments in favor of dismissal of these claims. (Doc. No.

17 15-1 at 21-25.) The court will focus on Defendant’s assertion that Plaintiff’s claims should

18 be dismissed because the court can conclude as a matter of law that members of the public

19 are not likely to be deceived by the advertisement. (Id. at 21.) Relatedly, Defendant argues

20 Plaintiff’s reading of the front label is implausible and inconsistent with how a reasonable

21 consumer would understand the Products’ function7. (Id. at 23.) Plaintiff counters that it

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7 The court will consider the back labels of the products as depicted in the photographs

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submitted in Plaintiff’s declaration which was attached to the FAC (see Doc. No. 13-1 at

25 7-8) and described in ¶ 29 of the FAC (“Defendant uniformly states on the back-panel

labels of the Products that they are ‘Effective at eliminating more than 99.99% of many

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common harmful germs & bacteria in as little as 15 seconds.”). See, e.g., Knievel v. ESPN,

27 393 F.3d 1068, 1076-77 (9th Cir. 2005) (explaining how the incorporation by reference

doctrine allows a court, at the motion to dismiss stage, to consider “documents whose

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1 is premature at the pleadings stage to determine whether a reasonable consumer would be

2 deceived by the label. (Doc. No. 16 at 16.) Plaintiff also asserts that this case has not

3 presented the court with one of the rare situations where dismissing a product mislabeling

4 case at the pleadings stage would be appropriate. (Id. at 17.) Further, Plaintiff argues that

5 the language on the back panel does not dispel or alleviate the deception. (Id. at 17-21.)

6 (i) Reasonable Consumer

7 Defendant contends that a cursory review of the entire front label reveals that the

8 language about which Plaintiff complains, “Kills more than 99.99% of germs*” is followed

9 by an asterisk, which alerts the consumer to the language on the rear label: “*Effective at

10 eliminating 99.99% of many common harmful germs and bacteria in as little as 15

11 seconds.” (Doc. No. 15-1 at 21.) Defendant maintains that, when read as whole, the

12 Product packaging and labels would not establish that reasonable consumers could be

13 misled. (Id.)

14 In order to protect its citizens from unfair, deceptive or fraudulent business practices

15 California has enacted a number of consumer protection statutes. The CLRA prohibits

16 “unfair or deceptive acts or practices undertaken by any person in a transaction intended to

17 result or which results in the sale or lease of goods or services to any customer.” CAL. CIV.

18 CODE § 1770(a). Similarly, the UCL prohibits any “unlawful, unfair or fraudulent business

19 act or practice,” and the FAL prohibits any “unfair, deceptive, untrue or misleading

20 advertising.” CAL. BUS. & PROF. CODE §§ 17200, 17500. These claims are governed by

21 the “reasonable consumer” test. Williams v. Gerber Prods. Co., 552 F.3d 934, 938 (9th

22 Cir. 2008). The test requires that plaintiff demonstrate “more than the mere possibility that

23 the label ‘might conceivably be misunderstood by some few consumers viewing it in an

24 unreasonable manner.’” Ebner v. Fresh, 838 F.3d 958, 965 (9th Cir. 2016) (quoting Lavie

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27 how the doctrine may be used to incorporate pages and images surrounding the

[defamatory] statement when plaintiff has failed to provide the complete context in which

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1 v. Procter & Gamble Co., 105 Cal. App. 4th 496 (2003)). “Rather, the reasonable consumer

2 standard requires a probability that a significant portion of the general consuming public

3 or of targeted consumers, acting reasonably in the circumstances, could be misled.” Id.

4 (internal quotation marks omitted).

5 Whether a business practice is deceptive will usually be a question of fact not

6 appropriate for determination at the pleadings stage. Williams, 552 F.3d at 938. “However,

7 in certain instances, [and as recognized by Williams at 939] a court can properly make this

8 determination and resolve claims based on its review of the product packaging.” Brown v.

9 Starbucks Corp., Case No.: 18cv2286 JM (WVG), 2019 WL 996399, at * 3 (S.D. Cal. Mar.

10 1, 2019) (quoting Pelayo v. Nestle USA, Inc. 989 F. Supp. 2d 973, 978 (C.D. Cal. 2013)).

11 Qualifying language in the challenged advertising making the meaning of the alleged

12 misrepresentation clear have led district courts within the Ninth Circuit to grant motions to

13 dismiss. See, e.g., Freeman v. Time, Inc., 68 F.3d 285, 289 (9th Cir. 1995) (affirming the

14 district court's dismissal of the California consumer claim when “[n]one of the qualifying

15 language is hidden or unreadably small” and appears “immediately next to the

16 representations it qualifies”); Sponchiado v. Apple Inc., Case No. 18-cv-07533-HSG,

17 2019 WL 6117482, at *4 (N.D. Cal. Nov. 18, 2019) (concluding “a reasonable consumer

18 could not be deceived by the iPhone Products’ screen size representation, given the

19 qualifying language expressly notifying the consumer that the actual screen area is less

20 than indicated.”); Dinan v. SanDisk LLC, Case No. 18-CV-05420-BLF, 2020 WL 364277,

21 at *7-8 (N.D. Cal. Jan 22, 2020) (finding a reasonable consumer could not be deceived

22 regarding the number of gigabytes in the product, given the disclosure sought to clarify the

23 use of the term); Elbaz v. Vitals Int’l Grp., Case No. 8:17-cv-01673-JLS-DFM, 2018 WL

24 5868739 at * 3 (C.D. Cal. Apr. 10, 2018) (“No reasonable consumer would understand the

25 representation 100% Natural Preservative System” to mean that every ingredient in the

26 Shampoo is 100% natural…. A consumer would have to ignore half of the representation

27 in order to conclude that “100% Natural” applies to the Shampoo as a whole.”); Bobo v.

28 Optimum Nutrition, Inc., Case No.: 14CV2408 BEN (KSC), 2015 WL 13102417, at *5

1 (S.D. Cal. Sept. 11, 2015) (dismissing claims when language elsewhere on packaging

2 clarified that “100% WHEY” did not mean “100% protein,” because “a reasonable

3 consumer, like the plaintiff in Freeman, cannot look at only one statement to the exclusion

4 of everything else and claim he has been misled”); Garcia v. Sony Computer Entm’t Am.,

5 LLC, 859 F. Supp. 2d 1056, 1065 (N.D. Cal. 2012) (statement on package about product

6 compatibility was accompanied by an asterisk directing consumers to a separate document,

7 but plaintiff selectively omitted portions of the alleged misrepresentation attributable to

8 defendants, leading the court to conclude that the statements were “only partial statements,

9 and do not rise to the level of affirmative misrepresentations.”).

10 Here, Plaintiff claims that he and reasonable consumers were deceived by

11 Defendant’s Representation that the Products kill 99.99% of germs. (FAC ¶¶ 114, 123,

12 130, 131, 133, 140, 147.) Plaintiff alleges that “‘germs’ is defined by Merriam-Webster as

13 amongst other things, ‘especially: a microorganism causing disease.’” (Id. at ¶ 31.)

14 Further, he alleges that “the Products do not ‘kill’ certain germs, which comprise more than

15 0.01% of “germs” and more than .01% of ‘harmful germs.’” (Id. at ¶ 33.) Yet, Plaintiff

16 entirely ignores the fact that the Products’ primary display panel contains an asterisk right

17 next to the 99.99% germs language. This asterisk directs the consumer to the back panel

18 of the Products where the rear label states “*Effective at eliminating 99.99% of many

19 common harmful germs & bacteria.” The disclaimer simply confirms and clarifies the

20 expectation raised on the front panel, rather than contradicts it. See Dinan, 2020 WL

21 364277 at *8 (“Asterisks are common in both commerce and elsewhere to denote that the

22 ‘reader’ should be aware that there is more than meets the eye.”). Plaintiff cannot simply

23 look to the statement on the front panel, ignore the asterisk, and claim he has been misled.

24 Bobo 2015 WL 13102417 at *5. This is especially true, where as here, there are no other

25 words, pictures or diagrams adorning the packaging that would make the front label

26 statement deceptive. See Ebner, 838 F.3d at 966. (“Apart from the accurate weight label,

27 there are no other words, pictures, or diagrams adorning the packaging …from which any

28 inference could be drawn or on which any reasonable belief could be based about how

1 much of the total lip product can be accessed by using the screw mechanism.”). Put another

2 way, Defendant’s use of the word germ is clarified by the disclosure on the back panel,

3 namely that the hand sanitizer is effective at eliminating 99.99% of many common harmful

4 germs and bacteria. See Ebner, 838 F.3d at 966. (taking into consideration how the

5 reasonable consumer’s understanding of how the mechanics of the product works).

6 Further, the court agrees with Defendant that Plaintiff’s reading of the front label is

7 implausible and inconsistent with how a reasonable consumer would understand the

8 Products’ function. (See Doc. No. 15-1 at 23.) Several pages of the FAC are dedicated to

9 recounting various diseases and illnesses, including polio, HPV, C. difficile, enterococci,

10 hepatitis A, and cryptosporidium, which Plaintiff references to support his conclusion that

11 the Products are ineffective against 0.01% of germs. Including polio in the “common

12 germs” count is puzzling since an active case of polio has not been reported in the United

13 States since 1979. See https://www.cdc.gov/polio/what-is-polio/polio-us.html. Similarly,

14 Plaintiff refers to HPV, and baselessly alleges that the virus is “transmitted primarily

15 through skin-to-skin contact, including by contact with someone who is carrying the virus

16 on their hands or fingers or by touching something that someone else touched who carried

17 HPV on their hands.” (FAC at ¶ 53.) Plaintiff, without providing a citation continues: “A

18 study published by Science Daily states that individuals with current genital infections of

19 HPV also have high levels of HPV DNA on their fingers.” (Id.) Ordinarily, a court must

20 read a complaint in the light most favorable to the Plaintiff, but this does not mean a court

21 needs to believe out and out falsehoods. HPV can only be spread by intimate skin on skin

22 contact, in other words through oral, anal or vaginal sex, to allege otherwise is

23 irresponsible. See https://www.cdc.gov/std/hpv/stdfact-hpv.htm. Further, Plaintiff points

24 to C. difficile, a germ that causes life-threatening diarrhea, that is usually a side-effect of

25 taking antibiotics. See https://www.cdc.gov/HAI/organisms/cdiff/Cdiff_infect.html. This

26 bacterium generally occurs in patients over 65 years of age and older who have been taking

27 antibiotics for a long period of time or who stay in a healthcare or long-term care facility

28 for a long time. See id. Likewise, Plaintiff’s reference to enterococci, (FAC ¶¶ 65-66), is

1 interesting because this bacterium lives in the intestines and genital tract and can travel into

2 a person’s blood, urine or could do so during surgery causing infection.

3 https://www.cdc.gov/hai/organisms/vre/vre.html#Spread. The bacteria can spread through

4 hospitals if healthcare workers do not wash their hands properly. Id. Additionally,

5 hepatitis A is a virus that is normally found in the blood or stool of individuals and is spread

6 when ingested. See https://www.cdc.gov/hepatitis/hav/afaq.htm. The virus can be spread

7 from close, personal contact with an infected person, like oral or anal sex, caring for

8 someone who is ill or using recreational drugs. See id. Occasionally, in the United States

9 foodborne outbreaks of hepatitis A have occurred from people eating contaminated fresh

10 and frozen imported food products. Id. To help contain the spread of the virus, in the

11 1990’s the hepatitis A vaccine became part of regular childhood immunizations, see

12 https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepa.pdf. Cryptosporidium can

13 be found in water, food, soil or on surfaces or dirty hands that have been contaminated with

14 the feces of humans or animals infected with the parasite.

15 https://www.cdc.gov/parasites/crypto/general-info.html. It can be spread in a variety of

16 ways, including swallowing recreational water, eating undercooked food, touching your

17 mouth with contaminated hands or exposure to an infected person via sexual contact. Id.

18 Broadly speaking the allegations regarding these diseases are troubling to the court

19 on four fundamental grounds. First, Plaintiff presupposes that the hand sanitizer Products

20 were meant to be used to “disinfect” after exposure to the harmful germs or to people with

21 these diseases instead of washing with soap and water. But the importance of handwashing

22 is well known, even amongst school children. The widely known concept that washing

23 hands is preferable to using hand sanitizer, is best illustrated by the CDC’s own website

24 wherein it:

25 recommends washing hands with soap and water whenever possible because

handwashing reduces the amounts of all types of germs and chemicals on

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hands. But if soap and water are not available, using a hand sanitizer with at

27 least 60% alcohol can help you avoid getting sick and spreading germs to

others.

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1 https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html. Second,

2 Plaintiff makes passing references to studies which have purportedly found that hand

3 sanitizer may be relatively ineffective against certain diseases and viruses, (see FAC ¶¶ 43-

4 45, 48, 52, 54, 56, 66, 67). Further, Plaintiff hypothesizes that the germs causing these

5 diseases are commonly transferred by hand -to -hand touching. While Plaintiff has

6 “opened the door” for the court to consider the citations it has noted above, Plaintiff has

7 omitted full citations to the studies he cites, has failed to attach copies of them to the FAC,

8 and has failed to provide any other means for the court to establish that the unsubstantiated

9 conclusions are valid or even relevant regarding the Products’ effectiveness. Plaintiff’s

10 passing references and paraphrased conclusions regarding unsubstantiated study

11 conclusions do not constitute facts. Third, Plaintiff’s conclusively assumes these

12 diseases/viruses should be included as part of “99.9% of many common harmful germs &

13 bacteria” referenced on the back of all of the Products, notwithstanding that at least two of

14 the referenced diseases require inoculations and thus can hardly be considered “common

15 harmful germs.” As Defendant noted “common sense and logic dictate that a hand sanitizer

16 product will eliminate the germs and bacteria commonly found on hands. With few

17 exceptions, the organisms Plaintiff identifies in the FAC either do not occur on human

18 hands or are not common.” (Doc. No 15-1 at 23.) Finally, Plaintiff imagines that the

19 Products will be ineffective at killing some of these germs if used properly without

20 providing any facts to support this assertion. Essentially, the allegations surrounding the

21 ineffectiveness of the Products in relation to these diseases are disjointed and conjectural.

22 In sum, the court finds nothing on the front label to be deceptive and that it is simply

23 not plausible that the reasonable consumer could be misled into thinking that the Products

24 would kill 99.99% of all germs, including polio, HPV, C. difficile, enterococci and hepatitis

25 A. Furthermore, the court is not persuaded that the reasonable consumer, given the public

26 general awareness around the importance of handwashing, would think that hand sanitizer

27 is a substitute for washing with soap and water. See Ebner, 838 F.3d at 966. (concluding

28 “that it is not plausible that ‘a significant portion of the general consuming public or of

1 targeted consumers, acting reasonably in the circumstances, could be misled.’”) (citation

2 omitted.) See also Lavie, 105 Cal.App.4th at 508 (“likely to deceive” means “more than a

3 mere possibility that the advertisement might conceivably be misunderstood by some few

4 consumers viewing it in an unreasonable manner”). Thus, Plaintiff has failed to state a

5 claim that the packaging on Defendant’s Products is misleading under the CLRA, FAL,

6 and UCL.

7 In accordance with the foregoing, Defendant’s motion to dismiss the CLRA, FAL

8 and UCL claims, made pursuant to Rule 12(b)(6), is GRANTED, with leave to amend.

9 Having dismissed the CLRA, FAL and UCL claims as a matter of law, the court declines

10 to address Defendant’s alternate argument for dismissal of these claims.8

11 (ii) Remaining State Law Claims.

12 Plaintiff’s failure to plausibly allege that Defendant made any misrepresentation or

13 misleading nondisclosure undermines his remaining claims.

14 “To prevail on a breach of express warranty claim, the plaintiff must prove (the

15 seller’s statements constitute an ‘affirmation of fact or promise’ or a ‘description of the

16 goods’; (2) the statement was ‘part of the basis of the bargain’; and (3) the warranty was

17 breached.” Weinstat v. Dentsply Int’l, Inc., 180 Cal. App 4th 1213, 1227 (2010). See also

18 Viggiano v. Hansen Natural Corp., 944 F. Supp. 2d 877, 893 (C.D. Cal. 2013) (adding

19 fourth requirement that “the breach caused injury to the plaintiff.”). Here, the court has

20 already concluded that Defendant has not stated the hand sanitizers “kills 99% of all germs”

21 as Plaintiff proposes. Rather, the packaging discloses that Defendant is claiming that the

22

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24 8 Defendant also argues that the FAC fails to support an FAL claim because there is no

25 basis to infer that Defendant had knowledge of a false statement allegedly made to Plaintiff.

(Doc. No. 15-1 at 25.) Further, Defendant asserts that the UCL claim must fail because

26

Plaintiff has not identified any conduct by it that offends an established public policy or

27 violates an underlying law. (Id.) Finally, Defendant claims that Plaintiff has failed to plead

the claims with the heightened pleading requirements of Rule 9(b). (Id. at 18-20.)

28

1 Products kill more than 99+% of germs , (see FAC at 7-8), and that they are “effective at

2 eliminating 99.99% of many common harmful germs and bacteria,” (id at ¶ 29). Plaintiff

3 has alleged no well-pleaded facts suggesting that Defendant has stated, or expressly

4 warranted, that its hand sanitizer kills 99.9% of all germs known to mankind. As a result,

5 there is no statement by Defendant of any “fact or promise” that it has breached that forms

6 the basis of any bargain. Furthermore, Plaintiff’s understanding of the bargain is

7 implausible and inconsistent with the understanding of a reasonable consumer. Plaintiff

8 has failed to plausibly allege that Defendant breached any express warranty. See

9 Forouzesh v. Starbucks Corp., Case No. CV-16-3830 PA (AGRx), 2016 WL 4443203, at

10 * 4 (C.D. Cal. Aug. 19, 2016) (“Plaintiff’s strained interpretation of Defendant’s menu

11 descriptions, which is inconsistent with the understanding of a reasonable consumer, does

12 not form the ‘basis of the bargain’ that could support a breach of express warranty claim

13 in these circumstances.”); see also Solak v Hain Celestial Grp., Inc., 3:17-CV-0704

14 (LEK/DEP), 2018 WL 1870474, at * 11 (N.D.N.Y. Apr. 17, 2018) (“the caselaw makes

15 clear that for a statement or representation to provide the basis for an express warranty

16 claim, it still must meet the threshold requirement of ‘being material to a reasonable

17 consumer.’”) (quoting In re ConAgra Foods, Inc., 90 F. Supp. 3d 919, 985) (C.D. Cal.

18 2015)).

19 With respect to the implied warranty of merchantability, the court is not satisfied

20 that Plaintiff has plausibly alleged that the Products he purchased are unfit for the ordinary

21 purpose of hand sanitizers. See CAL. COM. CODE § 2314(2) (the implied warranty may be

22 violated if (1) the product does not “[p]ass without objection in the trade under the contract

23 description,” (2) is not “fit for the ordinary purposes for which such good [is] used,” or

24 (3) does not “[c]onform to the promises or affirmations of fact made on the container or

25

26

27 9 Specifically, the statements on each of four Products claim to either: (1) “kills more than

99.99% of germs;” (2) “kill 99.99% of germs;” (3) “kills more than 99.99% of germs; ” or

28

1 label if any”); Mocek v Alfa Leisure, Inc., 114 Cal. App. 4th 402, 204 (2003) (“a breach of

2 the implied warranty of merchantability means the product did not possess even the most

3 basic degree of fitness for ordinary use.”). This conclusion is further buttressed by the fact

4 that none of the products listed in the complaint appear on the FDA’s website of hand

5 sanitizers consumers should not use. See https://www.fda.gov/drugs/drug-safety-and-

6 availability/fda-updates-hand-sanitizers-consumers-should-not-use.

7 Plaintiff has failed to plead a quasi-contract claim because, as explained above, there

8 was no false representation. Plaintiff’s quasi-contract claim is asserted under the theory of

9 unjust enrichment and seeks restitution and/or disgorgement. But with no false

10 representation appearing on the Products, and no apparent fraud on the part of Defendant,

11 there can be no unjust enrichment. See Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753,

12 762 (9th Cir. 2015) (To bring an action based on a quasi-contract, a plaintiff must allege

13 “that a defendant has been unjustly conferred a benefit through mistake, fraud, coercion,

14 or request.”). See also Myers-Taylor v. Ornau Foods N. Am., Inc., Case No.:

15 3:18- cv- 01538- H-MDD, 2019 WL 424703, * 6 (S.D. Cal. Feb. 4, 2019) (in order to

16 successfully plead a quasi-contract claim based on unjust enrichment, a plaintiff must show

17 some fraud.); First Nationwide Sav. v. Perry, 11 Cal. App. 4th 1657, 1670 (1992) (“A

18 quasi-contract action, in the form of a common count for money had and received, to

19 recover money obtained by fraud (waiver of tort) or mistake, is governed by the fraud

20 statute.”). Likewise, the absence of a fraudulent and misleading representation means that

21 Plaintiff’s claim for restitution is not supported by sufficient facts at this time. Pulaski &

22 Middleman, LLC v. Google, Inc., 802 F.3d 979, 989 (9th Cir. 2015) (“[I]n calculating

23 restitution under the UCL and FAL, the focus is on the difference between what was paid

24 and what a reasonable consumer would have paid at the time of purchase without the

25 fraudulent or omitted information.”); Astiana v. Kashi Co., 291 F.R.D. 493, 506 (S.D. Cal.

26 2013) (the various California consumer protection laws provide the court with “very broad

27 discretion to determine an appropriate remedy as long as it is supported by the evidence

28

1 and is consistent with the purpose of restoring to the plaintiff the amount that the defendant

2 wrongfully acquired.”) (internal citation omitted).

3 In accordance with the foregoing, the court GRANTS Defendant’s motion to

4 dismiss the breach of warranty, breach of implied warranty, and quasi-contract claims, with

5 leave to amend.

6 C. Preemption Issues

7 Finally, Defendant asserts that Plaintiff is seeking to impose duties on Defendant

8 that are different than those imposed by federal law and moves for dismissal on these

9 grounds, arguing Plaintiff’s state law claims are exclusively and impliedly preempted by

10 the Food and Drug Administration. (Doc. No. 15-1 at 25-31.) In opposition, Plaintiff

11 counters that (1) his claims are all based on violations of California’s consumer law and

12 are, therefore, not preempted; (2) there is no express preemption in relation to consumer

13 claims based on drug products; and (3) there is no conflict between any federal law and his

14 state law claims. (Doc. No. 16 at 24-32.)

15 The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq.,

16 confers on the United States Food and Drug Administration (“FDA”) the responsibility for

17 protecting the public health by ensuring drugs and cosmetics are safe, effective and

18 properly labeled. 21 U.S.C. § 393(b)(2)(B)-(D). Before a new drug may enter interstate

19 commerce the FDA must first determine that it is generally recognized as safe and effective

20 (GRAS/E) for the particular use described in its product labeling. See 21 U.S.C.

21 § 321 (p)(1) (a “new drug” is defined as one that “is not generally recognized, among

22 experts … as safe and effective for use under the conditions” noted in the drug’s labeling);

23 id. § 355(a) (prohibiting a “new drug” from entering interstate commerce without FDA

24 approval). And 21 U.S.C. § 352 provides “[a] drug or device shall be deemed to be

25 misbranded…(a) false or misleading label (1) If its labeling is false or misleading in any

26 particular.”

27 The alcohol-based hand sanitizers at issue here are regulated under the FDA’s over-

28 the counter (“OTC”) drug review. In 1972, the FDA established a “monograph” system

1 for regulating OTC drugs. See 21 C.F.R. § 330.10; 37 Fed. Reg. 9464 (May 11, 1972).

2 This allows manufacturers to bypass individualized review. See 21 C.F.R. § 330.10; see

3 also21 U.S.C. § 355. Under this system, the FDA issues a detailed regulation—a

4 “monograph”—for each therapeutic class of OTC drug products. The monograph provides

5 the FDA-approved active ingredients for a given therapeutic class of OTC drugs and sets

6 forth the conditions under which each active ingredient is GRAS/E. See NRDC, Inc. v.

7 FDA, 710 F. Supp. 71, 75 (2d Cir. 2013) ("Like a recipe, each monograph sets out the

8 FDA-approved active ingredients for a given therapeutic class of OTC drugs and provides

9 the conditions under which each active ingredient is GRAS/E.”) Active ingredients

10 deemed not GRAS/E or about which there is insufficient information are excluded from

11 the FDA’s monographs.

12 The monograph for alcohol-based hand sanitizers is yet to be finalized. The

13 Tentative Final Monograph (“TFM”) for Health Care Antiseptic Drug Products dated

14 June 17, 1994 represents the FDA’s current thinking on these products. See 59 Fed. Reg.

15 31402, §333.455. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security

16 Act (the “CARES Act”) deemed currently marketed OTC drugs as GRAS/E if they are

17 classified as Category I. PL 116–136, Subtitle F-Over-the Counter-Drugs, sec. 505-G. The

18 CARES Act did not impact the labeling requirements as outlined in the 1994 TFM.

19 The court is not persuaded by Defendant’s express or implied preemption arguments.

20 Defendant argues that Plaintiff is violating 21 U.S.C. § 337(a) of the FDCA. In part section

21 337(a) provides: “(a) Except as provided in subsection (b) of this section, all such

22 proceedings for the enforcement, or to restrain violations of this chapter, shall be by and in

23 the name of the United States….” 21 U.S.C. 337(a).

24 For a court to conclude that Congress has preempted a state law, its intent to do so,

25 must be “clear and manifest.” Wyeth v. Levine, 555 U.S. 555, 565, (2009). Generally,

26 courts have found that claims based on parallel state laws that mirror the relevant sections

27 of the FDCA are not preempted by the Act. See, e.g., Khasin v. Hershey Co.,

28 No. 5:12- CV- 0862 EJD, 2012 WL 5471153, at * 4 (N.D. Cal. Nov. 9, 2012). As a result,

1 consumer fraud claims alleging material misrepresentations have been found to be

2 permissible under the FDCA. See Wyeth, 555 U.S. at 574, 577-78 (2009) (the FDCA

3 creates a floor but not a ceiling for warning labels regarding prescription drugs and

4 recognizing that “[i]f Congress thought state-law suits posed an obstacle to its objectives,

5 it surely would have enacted an express preemption provision at some point during the

6 FDCA’s 70-year history”); Summit Tech. v. High-Line Medical Instruments Co., 922

7 F. Supp. 299, 307 (C.D. Cal. 1996) (“Summit I”)(“a plaintiff may bring a Lanham Act cause

8 of action for affirmatively mispresenting facts, even if the truth of those facts may be

9 governed by FDA regulations.”).

10 Here Plaintiff is alleging violations of various state consumer protection laws. To

11 the extent that Plaintiff’s claims simply require the court to make factual determinations as

12 to whether the statements are false, such claims do not give rise to preemption. See, e.g.,

13 Astiana, 783 F.3d at 757 (“we have little difficulty concluding that the FDCA does not

14 preempt state laws that allow consumers to sue cosmetics manufacturers that label or

15 package their products in violation of federal standards”); Morgan v. Wallaby Yogurt Co.,

16 Inc., Case No. 13-cv-00296–WHO, 2013 WL 5514563, at *4 (N.D. Cal. Oct.4, 2013)

17 (whether a label is misleading is within the ability of the Court and frequently determined

18 by courts); In re Epogen & Aransep Off-Label Mktg. & Sales Practices Litig., 590 F. Supp.

19 2d. 1282, 1291 (C.D. Cal. 2008) (state consumer fraud claims based on allegation that

20 statements were false are not barred by FDCA); Summit I, Summit Tech., Inc. v. High-Line

21 Medical Instruments, Co, 933 F. Supp. 918, 933 (C.D. Cal. 1996) (“Summit II”) (noting

22 that “false statements are actionable under the Lanham Act, even if their truth may be

23 generally within the purview of the FDA.”). Plaintiff is alleging Defendant's Products are

24 “misbranded under identical federal and California laws,” (FAC at ¶ 17), and is suing

25 because Defendant's conduct allegedly violates California's Sherman Law, the UCL,

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1 CLRA and FAL , all of which “could have imposed the exact same regulations even if the

2 FDCA was never passed.” See Gustavson v. Wrigley Sales Co., 961 F. Supp. 2d 1100,

3 1119 (N.D. Cal. 2013).

4 Aside from section 337(a), the only regulation cited by Defendant is the TFM

5 regulating Health Care Antiseptic Drug Products. However, because the TFM regarding

6 the labeling requirements of hand sanitizers has never been adopted, it only has the legal

7 status of a proposed rule. The opening summary of the TFM clearly states: “the FDA is

8 issuing a notice of proposed rulemaking in the form of an amended tentative final

9 monograph that would establish conditions under which over-the-counter (OTC) topical

10 health-care antiseptic drug products are generally recognized as safe and effective and not

11 misbranded.” 59 Fed. Reg. 31402. Further, the TFM contains the following clarifying

12 language: “The legal status of each tentative final monograph, however, is that of a

13 proposed rule.” Id. at 31403. See also Won Kyung Hwang v Ohso Clean, Inc.,

14 No. C- 12- 06355 JCS, 2013 WL 1632697, at * 17 (N.D. Cal. Apr. 16, 2013) (declining to

15 find plaintiff’s FAL, CLRA, UCL impliedly preempted because the TFM only has the

16 status of a proposed rule.).

17 Accordingly, at this stage of the proceedings, the court cannot say that Plaintiff’s

18 argument is preempted. Therefore, Defendant’s motion to dismiss on these grounds is

19 DENIED.

20 IV. CONCLUSION

21 In accordance with the foregoing, the court GRANTS Defendant’s motion to

22 dismiss, with leave to amend. (Doc. No. 15.) Plaintiff has up to an including March 24,

23 ///

24 ///

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27 10 In fact, the FAC specifically avers that “Plaintiff does not bring this action pursuant to

any FDA regulation, but under the applicable consumer protection laws and common law,

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1 || 2021, to file an amended complaint.

2 IT IS SO ORDERED.

3 || Dated: March 3, 2021

5 orf. Seffreyj1. Miller

‘ nited States District Judge

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