Alexander Forouzesh v. CVS Pharmacy, Inc., et al, No. 2:2018cv04090 - Document 33 (C.D. Cal. 2019)

Court Description: ORDER GRANTING DEFENDANTS MOTION TO DISMISS 22 by Judge Otis D. Wright, II: the Court GRANTS CVSs Motion to Dismiss. Forouzesh may AMEND his FAC within 21 days of the date of this Order, only as to the FDA-compliant SPF testing of the product he purchased. Should Forouzesh not file an amended complaint within 21 days, this dismissal will convert to one with prejudice. (lc)

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Alexander Forouzesh v. CVS Pharmacy, Inc., et al Doc. 33 O 1 2 3 4 5 6 7 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA 8 9 10 11 12 Case 2:18-CV-04090-ODW (AFMx) ALEXANDER FOROUZESH, on behalf of himself and all others similarly situated, Plaintiff, 13 v. 14 15 16 ORDER GRANTING DEFENDANT’S MOTION TO DISMISS [22] CVS PHARMACY, INC., a foreign business corporation; and DOES 1–25 inclusive Defendants. 17 18 I. 19 INTRODUCTION 20 Plaintiff Alexander Forouzesh brings this putative class action against 21 Defendant CVS Pharmacy, Inc., claiming CVS’s labeling of its SPF 100+ sunscreens 22 is false and misleading. CVS now moves to dismiss Forouzesh’s First Amended 23 Complaint (“FAC”). (Mot. to Dismiss (“Mot.”), ECF No. 22.) For the reasons below, 24 the Court GRANTS CVS’s Motion with leave to amend.1 25 26 27 28 1 After carefully considering the papers filed in support of and in opposition to the Motion, the Court deemed the matter appropriate for decision without oral argument. Fed. R. Civ. P. 78; C.D. Cal. L.R. 7-15. Dockets.Justia.com II. 1 FACTUAL BACKGROUND2 2 In or around November 2016, Forouzesh purchased a bottle of “CVS Sport 3 SPF 100+ Sunscreen Spray” in reliance on its SPF 100+ label. (FAC ¶¶ 9, 17, ECF 4 No. 20.) Forouzesh purchased the product “on the assumption that [it] contained the 5 advertised SPF level of protection.” (Id. ¶ 24.) However, Forouzesh had a CVS Sport 6 SPF 100+ product (“the Product”) tested using FDA-compliant testing protocols, and 7 the testing report (“Report”) revealed an SPF of only 29. (Id. ¶¶ 3, 22; Decl. of Justin 8 Farahi (“Farahi Decl.”), Ex. 1 (Report), ECF No. 20-2.) As a result, Forouzesh 9 alleges, the SPF 100+ label on all CVS Sport SPF 100+ products and CVS’s implied 10 message of superior UVB protection are false and misleading. (FAC ¶¶ 7, 16.) 11 Forouzesh would not have purchased the products had he known the truth about the 12 lower SPF value. (Id. ¶ 24.) 13 Forouzesh filed his initial Complaint on behalf of a putative nationwide class. 14 (Compl., ECF No. 1.) CVS moved to dismiss and Forouzesh amended his complaint. 15 (See FAC.) Accordingly, the Court denied CVS’s first motion to dismiss as moot. 16 (Order Denying Mot. to Dismiss, ECF No. 28.) Based on the allegations above, 17 Forouzesh asserts four causes of action through his FAC, including (1) violation of 18 California Business and Professions Code (“B&P”) section 17200 et seq. (Unfair 19 Competition Law (“UCL”)), (2) violation of B&P section 17500 et seq. (False 20 Advertising Law (“FAL”), (3) violation of California Civil Code section 1750 et seq. 21 (Consumers Legal Remedy Act (“CLRA”)), and (4) breach of express warranty. 22 (FAC 1.) Forouzesh asserts that “all of [his] causes of action are . . . predicated on the 23 fact that [CVS’s] sunscreen is inaccurately labeled as SPF 100+ since product testing 24 following FDA protocol revealed an SPF level of 29.” (Opp’n to Mot. (“Opp’n”) 5–6, 25 ECF No. 29.) Through his FAC, Forouzesh seeks damages and an order that CVS 26 relabel all its CVS Sport SPF 100+ sunscreen products as SPF 29 per his independent 27 28 2 The facts derive from Forouzesh’s FAC and are taken as true for the purposes of this Motion. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). 2 1 testing and conduct a corrective advertising campaign to inform consumers of its 2 deceptive labeling. (FAC ¶ 8; id. at 20–21.) 3 CVS moves to dismiss Forouzesh’s FAC, arguing that Forouzesh’s claims are 4 preempted, should be dismissed under the primary jurisdiction doctrine, and are 5 otherwise improper. (Mot. 3–4.)3 III. 6 LEGAL STANDARD 7 A court may dismiss a complaint under Rule 12(b)(6) for lack of a cognizable 8 legal theory or insufficient facts pleaded to support an otherwise cognizable legal 9 theory. Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 1988). A 10 claim has facial plausibility, and thus survives a motion to dismiss, when the pleaded 11 factual content allows “the court to draw the reasonable inference that the defendant is 12 liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. To survive a motion to 13 dismiss under Fed. R. Civ. P. 12(b)(6), a plaintiff must plead facts sufficient to “state 14 a claim to relief that is plausible on its face.” Id. (quoting Bell Atl. Corp. v. Twombly, 15 550 U.S. 544, 570 (2007)). The factual “allegations must be enough to raise a right to 16 relief above the speculative level.” Twombly, 550 U.S. at 555. 17 The determination of whether a complaint satisfies the plausibility standard is a 18 “context-specific task that requires the reviewing court to draw on its judicial 19 experience and common sense.” Iqbal, 556 U.S. at 679. A court must construe all 20 “factual allegations set forth in the complaint . . . as true and . . . in the light most 21 favorable” to the plaintiff. Lee v. City of Los Angeles, 250 F.3d 668, 688 (9th Cir. 22 2001) (internal quotation marks omitted). 23 conclusory allegations, “allegations that contradict exhibits attached to the complaint 24 or matters properly subject to judicial notice,” “unwarranted deductions of fact, or However, a court need not accept 25 26 27 28 3 Although Forouzesh filed his opposition late, CVS does not challenge his opposition as untimely, possibly because CVS noticed the motion for an improper motion day. (See Mot.; Reply, ECF No. 30; Notification, ECF No. 23.) Despite the untimeliness, the Court still considers Forouzesh’s opposition in full. The Court again advises the parties that future failure to comply with this Court’s rules and deadlines may result in rejection of filings or sanctions. 3 1 unreasonable inferences.” Daniels-Hall v. Nat’l Educ. Ass’n, 629 F.3d 992, 998 (9th 2 Cir. 2010). 3 A court is generally limited to the pleadings in ruling on a Rule 12(b)(6) 4 motion, but may consider documents attached to the complaint or properly subject to 5 judicial notice without converting a motion to dismiss into one for summary 6 judgment. See Lee, 250 F.3d at 688–89. Where a claim includes allegations of fraud, 7 Rule 9(b) requires a party to “state with particularity the circumstances constituting 8 fraud.” Fed. R. Civ. P. 9. IV. 9 REQUEST FOR JUDICIAL NOTICE 10 CVS requests that the Court take judicial notice of several excerpts from the 11 Federal Register (Request for Judicial Notice (“RJN”), Exs. 1–6, ECF No. 22-1) as 12 well as the complaint in Gisvold v. Merck & Co., Inc., 62 F. Supp. 3d 1198 (S.D. Cal. 13 2014) (No. 14-cv-1371 DMS (JLB)) (RJN, Ex. 7). Forouzesh did not oppose CVS’s 14 RJN. 15 The contents of the Federal Register are judicially noticeable as a matter of law. 16 See 44 U.S.C. § 1507; Bayview Hunters Point Cmty. Advocates v. Metro. Transp. 17 Comm’n, 366 F.3d 692, 702 n.5 (9th Cir. 2004) (granting request for judicial notice of 18 a proposed rulemaking published in the Federal Register). Accordingly, the Court 19 takes judicial notice of Exhibits 1–6, excerpts of the Federal Register. 20 As to the Gisvold complaint, courts regularly take judicial notice of proceedings 21 in other courts and facts that “can be accurately and readily determined from sources 22 whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201(b)(2); see also 23 Montantes v. Inventure Foods, No. 14-cv-1128-MWF (RZx), 2014 WL 3305578, at 24 *2 (C.D. Cal. July 2, 2014) (stating that courts “take judicial notice of ‘proceedings in 25 other courts . . . if those proceedings have a direct relation to matters at issue’”) 26 (quoting United States v. Borneo, Inc., 971 F.2d 244, 248 (9th Cir. 1992)). 27 Accordingly, the Court takes judicial notice of Exhibit 7, the Gisvold complaint, but 28 not the truth of the facts contained therein. Lee, 250 F.3d at 690 (stating that judicial 4 1 notice of public records is limited to the existence of the documents, not the truth of 2 their contents). V. 3 DISCUSSION 4 CVS expends a great portion of its Motion arguing that Forouzesh’s claims are 5 expressly and impliedly preempted by the Food, Drug, and Cosmetic Act, 21 U.S.C. 6 § 301 et seq. (“FDCA”). (See Mot. 4–11.) 7 A. Preemption 8 Pursuant to the Supremacy Clause, U.S. Const. art. VI, cl. 2, federal law 9 preempts state law when “(1) Congress enacts a statute that explicitly preempts state 10 law; (2) state law actually conflicts with federal law; or (3) federal law occupies a 11 legislative field to such an extent that it is reasonable to conclude that Congress left no 12 room for state regulation in that field.” Chae v. SLM Corp., 593 F.3d 936, 941 (9th 13 Cir. 2010). Regardless of the type of preemption the “purpose of Congress is the 14 ultimate touchstone of pre-emption analysis.” Cipollone v. Liggett Grp., Inc., 505 U.S. 15 504, 516 (1992) (internal quotation marks omitted). 16 The FDCA includes an unambiguous express preemption clause with respect to 17 sunscreen labeling. It provides “no State or political subdivision of a State may 18 establish or continue in effect any requirement . . . that is different from or in addition 19 to, or that is otherwise not identical with, a requirement under this chapter.” 21 20 U.S.C. § 379r(a)(2). 21 “requirements” subject to preemption. Reigel v. Medtronic, Inc., 552 U.S. 312, 325 22 (2008); Carter v. Novartis Consumer Health, Inc., 582 F. Supp. 2d 1271, 1282 (C.D. 23 Cal. 2008). “The touchstone of preemption under § 379r is the effect that a finding of 24 liability on a particular claim would have on the Defendants, and not the particular 25 common law or state law theory upon which that claim was brought.” Carter, 582 F. 26 Supp. 2d at 1283. State common law causes of action are considered state 27 The FDCA regulates over-the-counter (“OTC”) drugs including non- 28 prescription sunscreens like the one at issue here. See 21 C.F.R. § 201.327. “The 5 1 current regulations establish labeling requirements, provide for effectiveness testing 2 upon which the labeling relies, and identify false and misleading claims that render a 3 product misbranded.” Gisvold, 62 F. Supp. 3d at 1202 (citing 76 Fed. Reg. 35620–21 4 (Jun. 17, 2011) (Labeling and Effectiveness Testing: Sunscreen Drug Products for 5 Over-the-Counter Human Use) (“Final Rule”)); see also 21 C.F.R. § 201.327. 6 B. Plaintiff’s Claims 7 CVS first argues that Forouzesh’s claims are preempted because they are based 8 on the assertion that the product’s SPF label misrepresents that it provides 9 “proportionally greater UVB protection than comparable, lower SPF valued 10 products.” (See Mot. 4 (quoting FAC ¶ 85).) CVS argues this claim is preempted 11 because CVS cannot label its Product in any other way and still comply with FDA 12 regulations. 13 specifically predicated on the accuracy of the SPF value. (See Opp’n 5–6.) Thus, the 14 claims concern whether CVS accurately labeled its CVS Sport SPF 100+ labels in 15 compliance with FDA regulations. (Id. at 6.) However, Forouzesh expressly disavows claims not 16 CVS also argues that Forouzesh’s claims are expressly preempted because they 17 would effectively impose labeling requirements different from or in addition to those 18 required by FDA regulations and that allegations regarding Forouzesh’s independent 19 FDA-compliant testing are simply not plausible. (Mot. 7–11.) Forouzesh responds 20 that he “does not claim to impose a different state requirement regarding labeling of 21 SPF 100+ nor does he seek directly or indirectly to impose liability for conduct 22 sanctioned by the FDA.” (Opp’n 7.) He contends the essential issue is whether 23 CVS’s Product is mislabeled according to FDA-compliant testing. (Id.) 24 1. 25 The federal regulations promulgated by the Final Rule mandate that OTC 26 sunscreens be labeled according to the lengthy, detailed scientific and technical testing 27 procedures laid-out in the regulation. See 21 C.F.R. § 201.327(a)(1)(i), (ii) (requiring 28 OTC sunscreen to be labeled: “SPF [insert numerical SPF value resulting from testing Methodology 6 1 under paragraph (i) of this section].”) Paragraph (i) in turn sets out the extensive 2 testing requirements, including detailed requirements for the solar simulator; number 3 of test subjects and valid test results; determination of subjects’ skin types; method for 4 testing, including application, waiting times, and size of test areas; the method and 5 formula for calculating the SPF from the results; and when and why to reject test data. 6 See id. § 201.327(i)(1)–(6). “[W]here, as here, an FDA regulation provides that the 7 question of compliance must be determined using the method specified therein, a state 8 law claim that seeks to establish a violation of the regulation by a different 9 methodology is preempted.” Mee v. I.A. Nutrition, Inc., No. C-14-5006-MMC, 2015 10 WL 2251303, at *4 (N.D. Cal. May 13, 2015) (citing Salazar v. Honest Tea, Inc., 74 11 F. Supp. 3d 1304, 1313 (E.D. Cal. 2014)). 12 Thus, a claim seeking to enforce SPF labeling according to FDA-compliant 13 testing would be “identical to” FDA requirements and not preempted, while a claim 14 seeking to enforce SPF labeling according to non-FDA-compliant testing would be 15 “different from” that mandate and preempted. 16 2. 17 The Court finds Forouzesh’s allegations of independent FDA-compliant testing 18 conclusory and fail to support a plausible conclusion that his testing was done in 19 compliance with FDA regulations. Forouzesh alleges only that his “independent 20 testing following FDA protocol revealed that the product provides an SPF 29 21 protection.” (FAC ¶¶ 3; see also id. ¶¶ 16, 25, 42, 46.) He fails to allege the product 22 tested is one he purchased. He fails to identify the specific product tested. And he 23 fails to provide any factual support as to how his testing complied with FDA 24 regulations. As just one example, Forouzesh alleges the product he purchased is a 25 “Sunscreen Spray.” (FAC ¶ 9.) Yet he does not explain how the spray was applied 26 according to FDA requirements, where protocol requires application with a “finger cot 27 . . . to spread the product as evenly as possible.” 21 C.F.R. § 201.327(4)(iii). Allegations of FDA-Compliant Testing 28 7 1 Without more, Forouzesh fails to plausibly allege that his independent testing is 2 FDA-compliant. See Mee, 2015 WL 2251303, at *4; Anglin v. Edgewell Pers. Care 3 Co., No. 4:18-CV-00639-NCC, 2018 WL 6434424, at *7 (E.D. Mo. Dec. 7, 2018) 4 (“The substance of the allegations is particularly important in determining the 5 sufficiency of those allegations in situations where, as here, the governing FDA 6 regulation imposes a specific, lengthy, and very detailed methodology for testing the 7 products, including the specific number of subjects to be tested, timelines for testing, 8 etc.”); Curran v. Bayer Healthcare LLC, No. 17 C 7930, 2018 WL 2431981, at *3 9 (N.D. Ill. May 30, 2018) (“[P]laintiff needs to include some facts about his testing 10 procedure in order to make it plausible that defendant’s label was not in compliance 11 with the requirements of 21 C.F.R. § 201.327. . . . He needs to include at least some 12 facts about his testing.”). 13 3. 14 Some courts have found minimal allegations sufficient at the pleading stage 15 when supported by a report of product testing. See Muir v. NBTY, Inc., No. 15-C- 16 9835, 2016 WL 5234596, at *6 (N.D. Ill. Sept. 22, 2016) (finding “chapter-and-verse 17 compliance with FDA testing” was not a pleading requirement). Here, Forouzesh 18 attached a copy of his product-testing Report to his Complaint. However, rather than 19 support the plausibility of his conclusory allegations, the Report contradicts them. See 20 Daniels–Hall, 629 F.3d at 998 (discussing that a court need not accept conclusory 21 allegations or allegations contradicted by exhibits attached to the complaint); see also 22 Mee, 2015 WL 2251303, at *4 (concluding that plaintiffs who attached lab reports 23 showing non-FDA-compliant testing “pleaded facts demonstrating preemption”). The Report 24 First, it is unclear what product was tested and whether it was the product 25 Forouzesh purchased. The Report shows that the product tested was “SPF 100+ 26 Broad Spectrum Sunscreen,” Lot #: 6381316B, while the product Forouzesh 27 purchased was “CVS Sport SPF 100+ Sunscreen Spray.” (Report 1; FAC ¶ 9); see 28 also 76 Fed. Reg. 35620-01, at 35624–25, 35627 (differentiating “Broad Spectrum” 8 1 sunscreens); 21 C.F.R. § 201.372(j) (requiring additional testing for “Broad 2 Spectrum” sunscreens). Additionally, Forouzesh’s counsel declares that “One lot of 3 CVS Sport SPF 100+ material was tested.” (Farahi Decl. ¶ 4.) Yet he fails to clarify 4 whether the “material” was the Sunscreen Spray Forouzesh purchased or some other 5 CVS Sport SPF 100+ “material.” This is particularly significant because Forouzesh’s 6 vague allegations broadly encompass the entire CVS Sport SPF 100+ product line 7 without identifying any factual similarities across those products beyond the SPF 8 value. 9 products labeled with SPF of 100+.”).) Forouzesh does not allege that the product 10 (See FAC ¶ 15 (“the CVS Sport SPF 100+ product, a line of sunscreen tested is the product he purchased or otherwise connect the two. 11 Also, even assuming the product purchased was the product tested, the testing 12 appears not to comply with FDA regulations. FDA regulations require that testing 13 return ten valid results, with a maximum of three rejected subjects. See 21 C.F.R. 14 § 210.372(i)(3). Forouzesh acknowledges this requirement. (See Farahi Decl. ¶ 5 15 (“To determine actual SPF level of a product, a full 10-person panel must be tested 16 with valid results.”).) Yet, the Report shows only eight valid test results, with five 17 subjects being rejected or returning invalid results. (See Report 4, 5 (“Subjects 06 and 18 11 were disqualified”; “Data for subject 10 were rejected”; “Subjects 03 and 12 did 19 not yield evaluable SPF data.”) Forouzesh’s counsel states only that the testing was 20 completed as to ten subjects, but not that testing returned ten valid results. (See Farahi 21 Decl. ¶ 5.) Absent explanation as to how the test results comply with the regulations 22 in the face of these obvious deficiencies, the Report only undermines Forouzesh’s 23 allegations of FDA-compliant testing. 24 Courts disagree regarding whether specific compliance with FDA testing is a 25 pleading requirement at the motion to dismiss stage. Compare Salazar, 74 F. Supp. 26 3d at 1313 (failure to allege compliance with FDA testing protocols required dismissal 27 as preempted); Mee, 2015 WL 2251303, at *3–4 (same); with Smith v. Allmax 28 Nutrition, No. 1:15-cv-00744-SAB, 2015 WL 9434768, at *7 (E.D. Cal. Dec. 24, 9 1 2015) (allegations of precise testing methodology were not required at the pleading 2 stage); Clay v. Cytosport, Inc., No. 15-cv-165 L (DHB), 2015 WL 5007884, at *4 3 (S.D. Cal. Aug. 19, 2015) (same). Here, the Court finds that requiring at least some 4 facts to support a plausible inference of FDA-compliant testing is proper. 5 substance of the allegations is particularly important here because the question of 6 compliance must be determined using a precise and specific methodology; 7 Forouzesh’s claims implicate the particularity pleading standard of Rule 9; and rather 8 than providing support, the Report contradicts Forouzesh’s conclusory allegations. The 9 Even courts that do not require factual support for FDA-compliant testing agree 10 that a claim seeking to use a methodology other than that required by the FDA would 11 be preempted. See Smith, 2015 WL 9434768, at *7 (finding allegations of precise 12 testing methodology not required at the pleading stage where “Plaintiff has not pled a 13 different methodology . . . than those set forth by the FDA”). Here, the Court cannot 14 conclude that Forouzesh’s testing was conducted in compliance with FDA regulations. 15 As the FAC seeks to require CVS to apply this methodology, which is different from 16 or not identical with SPF testing required by FDA regulation, the Court finds 17 Forouzesh’s claims, as pleaded, are preempted. Accordingly, the Court GRANTS CVS’s motion to dismiss Forouzesh’s FAC.4 18 19 C. Leave to Amend 20 Generally, leave to amend shall be freely given when justice so requires. 21 Eminence Capital, LLC v. Aspeon, Inc., 316 F.3d 1048, 1051 (9th Cir. 2003). ‘‘This 22 policy is ‘to be applied with extreme liberality.’’’ Id. (quoting Owens v. Kaiser 23 Found. Health Plan, Inc., 244 F.3d 708, 712 (9th Cir. 2001)). “Dismissal . . . without 24 leave to amend is not appropriate unless it is clear . . . the complaint could not be 25 saved by amendment.” Eminence, 316 F.3d at 1052. To the extent Forouzesh can 26 amend his Complaint in good faith to allege that independent testing of the product he 27 28 4 In light of the Court’s ruling as to preemption, the Court need not address CVS’s additional arguments in support of dismissal. 10 1 purchased complied with the FDA regulations for SPF testing, Forouzesh may amend 2 his FAC within 21 days of this Order. VI. 3 CONCLUSION 4 For the reasons discussed above, the Court GRANTS CVS’s Motion to 5 Dismiss. (ECF No. 22.) Forouzesh may AMEND his FAC within 21 days of the 6 date of this Order, only as to the FDA-compliant SPF testing of the product he 7 purchased. Should Forouzesh not file an amended complaint within 21 days, this 8 dismissal will convert to one with prejudice. 9 10 IT IS SO ORDERED. 11 12 February 15, 2019 13 14 15 16 ____________________________________ OTIS D. WRIGHT, II UNITED STATES DISTRICT JUDGE 17 18 19 20 21 22 23 24 25 26 27 28 11

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