1 2 3 6 7 JOSEPH DIGIACINTO, Case No. 22-cv-04690-DMR
8 Plaintiff, ORDER ON DEFENDANT'S MOTION 9 v. FOR JUDGMENT ON THE PLEADINGS Re: Dkt. No. 55 11 Defendant.
12 Plaintiff Joseph DiGiacinto filed this putative class action against Defendant RB Health 13 (US) LLC (“RB Health”) alleging false, misleading, and deceptive marketing practices with 14 respect to the labeling of its “Children’s Delsym Cough Relief” product. RB Health moves 15 pursuant to Federal Rule of Civil Procedure 12(c) for judgment on the pleadings. [Docket No. 16 55.] This matter is suitable for resolution without a hearing. Civ. L.R. 7-1(b). For the following 17 reasons, the motion is denied. 19 The court incorporates by reference its summary of the allegations in DiGiacinto’s 20 amended complaint from the April 11, 2023 Order denying RB Health’s motion to dismiss and 21 assumes familiarity with those allegations here. See DiGiacinto v. RB Health (US) LLC, No. 22- 22 CV-04690-DMR, 2023 WL 2918745, at *1-2 (N.D. Cal. Apr. 11, 2023). RB Health now moves 23 for judgment on the pleadings based on its second affirmative defense: that DiGiacinto’s claims 24 are expressly preempted by federal law. Mot. 7-14. It also argues that DiGiacinto asserts 25 “deceptive by implication” claims that are not viable under California law. Id. at 14-16. 26 A. Legal Standard 27 A Rule 12(c) motion for judgment on the pleadings “is properly granted when, accepting 1 moving party is entitled to judgment as a matter of law.” Chavez v. United States, 683 F.3d 1102, 2 1108 (9th Cir. 2012). “Rule 12(c) is functionally identical to Rule 12(b)(6) and . . . the same 3 standard of review applies to motions brought under either rule.” U.S. ex. rel. Cafasso v. Gen. 4 Dynamics C4 Sys., Inc., 637 F.3d 1047, 1054 n.4 (9th Cir. 2011). Accordingly, the “court must 5 assess whether the complaint ‘contains sufficient factual matter, accepted as true, to state a claim 6 to relief that is plausible on its face.’” Chavez, 683 F.3d at 1108 (quoting Ashcroft v. Iqbal, 556 7 U.S. 662, 678 (2009)). “When considering a motion for judgment on the pleadings, th[e] court 8 may consider facts that ‘are contained in materials of which the court may take judicial notice.’” 9 Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 971, 981 n.18 (9th Cir. 1999) (quoting Barron 10 v. Reich, 13 F.3d 1370, 1377 (9th Cir. 1994)). 11 1. Preemption 12 With respect to preemption, RB Health argues that DiGiacinto’s state law claims 13 challenging the labels of the Children’s Delsym Cough Relief product (the “children’s product”) 14 are expressly preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 15 301-399i. It contends that the Food and Drug Administration (FDA) approved the labels on the 16 children’s product and the Delsym Cough Relief product (the “adults’ product”) pursuant to a 17 New Drug Application (“NDA”) and Supplemental New Drug Applications (“sNDA”), and that 18 the “FDA-approved labels have been changed” only “in minor ways since 2014.” Mot. 4-5. RB 19 Health argues that DiGiacinto’s claims are preempted “because the FDA specifically approved the 20 labels of both Products, and in so doing found the Products are not ‘false or misleading in any 21 particular.’” Id. at 1 (quoting 21 U.S.C. § 352(a)(1)). 22 RB Health filed a request for judicial notice (“RJN”) with its opening brief in which it asks 23 the court to take judicial notice of 11 documents pertaining to its preemption argument, two of 24 which are FDA guidance materials. The remaining documents are records from the FDA related 25 to the NDA and sNDAs for the products at issue in this case. [Docket No. 55-1 (RJN) Exs. 1-11.] 26 RB Health states that all of the documents “are publicly available on the FDA’s website or 27 through a Freedom of Information Act [FOIA] request,” although it does not describe any FOIA 1 the court may take “judicial notice of records and reports of administrative bodies” and cites 2 district court cases in which courts have taken judicial notice of FDA materials. RJN 2. 3 Federal Rule of Evidence 201 governs judicial notice. Under Rule 201, a court may take 4 judicial notice of “an adjudicative fact if it is ‘not subject to reasonable dispute.’” Khoja v. 5 Orexigen Therapeutics, Inc., 899 F.3d 988, 999 (9th Cir. 2018) (quoting Fed. R. Evid. 201(b)). A 6 fact is “not subject to reasonable dispute” if it is “generally known,” or “can be accurately and 7 readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 8 201(b). However, “accuracy is only part of the inquiry under Rule 201(b).” Khoja, 899 F.3d at 9 999. “Just because [a] document itself is susceptible to judicial notice does not mean that every 10 assertion of fact within that document is judicially noticeable for its truth.” Id. If a court takes 11 judicial notice of a document, it must identify the specific fact or facts it is noticing from the 12 document. Id. Further, “[i]t is improper to judicially notice a [document] when the substance of 13 the [document] is subject to varying interpretations, and there is a reasonable dispute as to what 14 the [document] establishes.” Id. at 1000 (internal quotation marks and citation omitted)). 15 RB Health’s RJN includes a basic description of each exhibit in chart form and brief 16 argument regarding the relevance of the materials. However, it does not address the relevance of 17 each individual exhibit. More importantly, it does not identify precisely what fact or facts in each 18 exhibit it asks the court to judicially notice, or whether it asks the court to simply take notice of 19 the existence of the Exhibits. See generally RJN. 20 DiGiacinto opposes the RJN as to Exhibits 7-11, which are letters from the FDA to third 21 parties1 and what RB Health describes as “approved labeling” for the NDA and sNDAs in 22 question. DiGiacinto argues that judicial notice of these materials is inappropriate because 23 “Defendant attempts to use them for their purported truth and to suggest that the documents 24 demonstrate that the FDA pre-approved the challenged children-specific labeling.” [Docket No. 25
26 1 Some of the exhibits attached to RB Health’s RJN consist of communications between the FDA and third parties, including Pennwalt Corporation, Celltech Pharmaceuticals, Inc., and Reckitt 27 Benckiser Inc. RB Health explains that “NDA 18-658 has been owned by many corporations 1 58-4 (Opp’n to RJN) 2.] He also disputes RB Health’s interpretations of and the completeness of 2 these materials. Id. at 2-4. For example, RB Health offers Exhibit 10, an undated letter from the 3 FDA to Reckitt Benckiser LLC, to argue that the FDA approved changes to the labeling of the 4 children’s product following submission of an sNDA in 2013 and amendments thereto in 2014. 5 See Mot. 4. However, as DiGiacinto correctly notes, Exhibit 10 does not include the labeling that 6 was approved.
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1 2 3 6 7 JOSEPH DIGIACINTO, Case No. 22-cv-04690-DMR
8 Plaintiff, ORDER ON DEFENDANT'S MOTION 9 v. FOR JUDGMENT ON THE PLEADINGS Re: Dkt. No. 55 11 Defendant.
12 Plaintiff Joseph DiGiacinto filed this putative class action against Defendant RB Health 13 (US) LLC (“RB Health”) alleging false, misleading, and deceptive marketing practices with 14 respect to the labeling of its “Children’s Delsym Cough Relief” product. RB Health moves 15 pursuant to Federal Rule of Civil Procedure 12(c) for judgment on the pleadings. [Docket No. 16 55.] This matter is suitable for resolution without a hearing. Civ. L.R. 7-1(b). For the following 17 reasons, the motion is denied. 19 The court incorporates by reference its summary of the allegations in DiGiacinto’s 20 amended complaint from the April 11, 2023 Order denying RB Health’s motion to dismiss and 21 assumes familiarity with those allegations here. See DiGiacinto v. RB Health (US) LLC, No. 22- 22 CV-04690-DMR, 2023 WL 2918745, at *1-2 (N.D. Cal. Apr. 11, 2023). RB Health now moves 23 for judgment on the pleadings based on its second affirmative defense: that DiGiacinto’s claims 24 are expressly preempted by federal law. Mot. 7-14. It also argues that DiGiacinto asserts 25 “deceptive by implication” claims that are not viable under California law. Id. at 14-16. 26 A. Legal Standard 27 A Rule 12(c) motion for judgment on the pleadings “is properly granted when, accepting 1 moving party is entitled to judgment as a matter of law.” Chavez v. United States, 683 F.3d 1102, 2 1108 (9th Cir. 2012). “Rule 12(c) is functionally identical to Rule 12(b)(6) and . . . the same 3 standard of review applies to motions brought under either rule.” U.S. ex. rel. Cafasso v. Gen. 4 Dynamics C4 Sys., Inc., 637 F.3d 1047, 1054 n.4 (9th Cir. 2011). Accordingly, the “court must 5 assess whether the complaint ‘contains sufficient factual matter, accepted as true, to state a claim 6 to relief that is plausible on its face.’” Chavez, 683 F.3d at 1108 (quoting Ashcroft v. Iqbal, 556 7 U.S. 662, 678 (2009)). “When considering a motion for judgment on the pleadings, th[e] court 8 may consider facts that ‘are contained in materials of which the court may take judicial notice.’” 9 Heliotrope Gen., Inc. v. Ford Motor Co., 189 F.3d 971, 981 n.18 (9th Cir. 1999) (quoting Barron 10 v. Reich, 13 F.3d 1370, 1377 (9th Cir. 1994)). 11 1. Preemption 12 With respect to preemption, RB Health argues that DiGiacinto’s state law claims 13 challenging the labels of the Children’s Delsym Cough Relief product (the “children’s product”) 14 are expressly preempted by the federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 15 301-399i. It contends that the Food and Drug Administration (FDA) approved the labels on the 16 children’s product and the Delsym Cough Relief product (the “adults’ product”) pursuant to a 17 New Drug Application (“NDA”) and Supplemental New Drug Applications (“sNDA”), and that 18 the “FDA-approved labels have been changed” only “in minor ways since 2014.” Mot. 4-5. RB 19 Health argues that DiGiacinto’s claims are preempted “because the FDA specifically approved the 20 labels of both Products, and in so doing found the Products are not ‘false or misleading in any 21 particular.’” Id. at 1 (quoting 21 U.S.C. § 352(a)(1)). 22 RB Health filed a request for judicial notice (“RJN”) with its opening brief in which it asks 23 the court to take judicial notice of 11 documents pertaining to its preemption argument, two of 24 which are FDA guidance materials. The remaining documents are records from the FDA related 25 to the NDA and sNDAs for the products at issue in this case. [Docket No. 55-1 (RJN) Exs. 1-11.] 26 RB Health states that all of the documents “are publicly available on the FDA’s website or 27 through a Freedom of Information Act [FOIA] request,” although it does not describe any FOIA 1 the court may take “judicial notice of records and reports of administrative bodies” and cites 2 district court cases in which courts have taken judicial notice of FDA materials. RJN 2. 3 Federal Rule of Evidence 201 governs judicial notice. Under Rule 201, a court may take 4 judicial notice of “an adjudicative fact if it is ‘not subject to reasonable dispute.’” Khoja v. 5 Orexigen Therapeutics, Inc., 899 F.3d 988, 999 (9th Cir. 2018) (quoting Fed. R. Evid. 201(b)). A 6 fact is “not subject to reasonable dispute” if it is “generally known,” or “can be accurately and 7 readily determined from sources whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 8 201(b). However, “accuracy is only part of the inquiry under Rule 201(b).” Khoja, 899 F.3d at 9 999. “Just because [a] document itself is susceptible to judicial notice does not mean that every 10 assertion of fact within that document is judicially noticeable for its truth.” Id. If a court takes 11 judicial notice of a document, it must identify the specific fact or facts it is noticing from the 12 document. Id. Further, “[i]t is improper to judicially notice a [document] when the substance of 13 the [document] is subject to varying interpretations, and there is a reasonable dispute as to what 14 the [document] establishes.” Id. at 1000 (internal quotation marks and citation omitted)). 15 RB Health’s RJN includes a basic description of each exhibit in chart form and brief 16 argument regarding the relevance of the materials. However, it does not address the relevance of 17 each individual exhibit. More importantly, it does not identify precisely what fact or facts in each 18 exhibit it asks the court to judicially notice, or whether it asks the court to simply take notice of 19 the existence of the Exhibits. See generally RJN. 20 DiGiacinto opposes the RJN as to Exhibits 7-11, which are letters from the FDA to third 21 parties1 and what RB Health describes as “approved labeling” for the NDA and sNDAs in 22 question. DiGiacinto argues that judicial notice of these materials is inappropriate because 23 “Defendant attempts to use them for their purported truth and to suggest that the documents 24 demonstrate that the FDA pre-approved the challenged children-specific labeling.” [Docket No. 25
26 1 Some of the exhibits attached to RB Health’s RJN consist of communications between the FDA and third parties, including Pennwalt Corporation, Celltech Pharmaceuticals, Inc., and Reckitt 27 Benckiser Inc. RB Health explains that “NDA 18-658 has been owned by many corporations 1 58-4 (Opp’n to RJN) 2.] He also disputes RB Health’s interpretations of and the completeness of 2 these materials. Id. at 2-4. For example, RB Health offers Exhibit 10, an undated letter from the 3 FDA to Reckitt Benckiser LLC, to argue that the FDA approved changes to the labeling of the 4 children’s product following submission of an sNDA in 2013 and amendments thereto in 2014. 5 See Mot. 4. However, as DiGiacinto correctly notes, Exhibit 10 does not include the labeling that 6 was approved. DiGiacinto also contends that RB Health did not produce the 2014 sNDA, “so it is 7 unclear what exact changes were requested or approved.” Opp’n to RJN 4. Exhibit 10 also refers 8 to an “approval letter dated June 19, 2014 which contained the following error: The labeling 9 images in the attached labeling were incorrect,” so the exhibit itself is confusing. RJN Ex. 10. 10 RB Health’s failure to provide a clear explanation of which facts in Exhibits 7-11 it 11 contends are judicially noticeable precludes the court’s ability to evaluate DiGiacinto’s objections 12 and ultimately to determine whether the unspecified facts are subject to judicial notice. 13 RB Health also submitted a supplemental RJN with its reply in which it asks the court to 14 take judicial notice of four additional exhibits, Exhibits 12-15. [Docket No. 62-4.] While it 15 explains the relevance of each exhibit, RB Health again failed to identify which facts in the 16 materials it contends are judicially noticeable. Moreover, “[n]ew evidence submitted as part of a 17 reply is improper because it does not allow the [opposing party] an adequate opportunity to 18 respond.” Townsend v. Monster Beverage Corp., 303 F. Supp. 3d 1010, 1027 (C.D. Cal. 2018) 19 (quotation marks and citation omitted). 20 RB Health later submitted a third RJN more than five weeks after it filed its reply, to 21 which DiGiacinto objected. [Docket Nos. 68 (2d Supp. RJN), 71.] It asks the court to take 22 judicial notice of a December 2013 letter that appears to respond to DiGiacinto’s argument that 23 Exhibit 10 is incomplete and/or lacking complete context. According to RB Health, it identified 24 the document after it filed its motion for judgment on the pleadings. 2d Supp. RJN 1 n.1. This 25 submission violated Local Rule 7-3(d), which states that “[o]nce a reply is filed, no additional 26 memoranda, papers or letters may be filed without prior Court approval, except” objections to 27 1 reply evidence and statements of recent decision.2 2 RB Health’s preemption argument relies entirely on materials outside the complaint that it 3 contends are judicially noticeable. However, as set forth above, its original RJN was deficient as 4 it did not identify the specific facts it contends are judicially noticeable in the documents. It is not 5 the court’s responsibility to comb through its submissions to try to determine what facts in its 6 documents are at issue. RB Health also improperly filed an RJN with its reply, as well as another 7 RJN weeks after the briefing was complete, seeking to introduce a document that appears to be 8 key in assessing its preemption argument without leave of court and without showing good cause. 9 Given the identified problems with RB Health’s RJNs, as well as the parties’ disputes about the 10 meaning and relevance of the materials, the court declines to take judicial notice of any of the 11 documents submitted by the parties. See Khoja, 899 F.3d at 999, 1000. Moreover, given the 12 nature of the disputes identified by the parties in their briefing and RJN submissions, the court 13 concludes that the preemption issue is more appropriate for a motion for summary judgment, on a 14 full record that walks through the relevant evidence regarding the history of the products’ 15 packaging and any FDA approvals thereof. That portion of the motion for judgment on the 16 pleadings is accordingly denied without prejudice to RB Health raising this issue at summary 17 judgment. 18 2. Whether DiGiacinto Makes “Deceptive by Implication” Claims 19 RB Health also moves for judgment on the pleadings on the ground that California law 20 does not allow “deceptive by implication” claims like those at issue here. Mot. 14. It argues that 21 DiGiacinto’s claims “seek to impose liability based on an entirely true representation by virtue of 22 what it ‘implies’ about other products not referenced on the label and that may or may not be sold 23 in proximity or even in the same store.” Mot. 14. According to RB Health, such claims are not 24 actionable under Shaeffer v. Califia Farms, LLC, 44 Cal. App. 5th 1125, 1139 (2020). Id. 25
26 2 For his part, DiGiacinto submitted a request for judicial notice in which he asks the court to take judicial notice of nine documents that he claims are relevant to his opposition. [Docket No. 60-2 27 (P’s RJN).] DiGiacinto does not explain the relevance of these materials and, like RB Health, 1 In Shaeffer, the plaintiff challenged as misleading the label on “Cuties Juice,” a tangerine 2 juice product. The label stated “100% Tangerine Juice,” “No Sugar Added,” and “Never From 3 Concentrate.” Id. at 1132. Even though it was true that Cuties Juice had “No Sugar Added,” the 4 plaintiff alleged that the statement was nevertheless fraudulent because it was “likely to deceive 5 reasonable consumers in its implications.” Such implications include that competing brands do 6 contain added sugar, “such that Cuties Juice ‘contain[s] less sugar than competing brands that did 7 not have sugar-content claims on their front labels,” and that “Cuties Juice is therefore ‘different 8 and healthier than . . . competing tangerine juice.’” Id. at 1132-33 (citations omitted). Because 9 competing brands did not contain added sugar, the plaintiff alleged that the Cuties Juice label 10 constituted a fraudulent business practice, untrue or misleading advertisement, and unfair method 11 of competition. Id. at 1133. 12 The court discussed the spectrum of labeling statements that are “likely to deceive” a 13 “reasonable consumer” and thus are actionable under state law. Id. at 1137-39. At one end of the 14 spectrum are untrue affirmative statements about a product on its label that are by definition 15 “fraudulent” and “false.” Id. at 1138. “[A]t the far end of the spectrum are statements a business 16 affirmatively and truthfully makes about its product and which do not on their face mention or 17 otherwise reference its competing products at all.” Id. at 1139. The court found that “whether a 18 truthful statement about one’s own product is actionable turns on whether a reasonable consumer 19 is (1) likely to infer from such a statement that the very same statement is untrue as to comparable, 20 competing products, (2) likely to infer that the product at issue is consequently superior to its 21 competition, and (3) likely to be deceived if the statement is true as to the comparable, competing 22 products?” Id. (emphasis in original). The court held that such statements, including the 23 statement “No Sugar Added” on the Cuties Juice label, are not actionable as a matter of law in part 24 because “a reasonable consumer is unlikely to make the series of inferential leaps outlined above.” 25 Id. The court explained that it was “hesitant to adopt a theory upon which almost any 26 advertisement [truthfully] extolling a product’s attributes would be fodder for litigation.” Id. 27 (cleaned up). 1 Shaeffer.” Mot. 15. It argues that DiGiacinto’s claims are based on the allegations that a 2 reasonable consumer viewing the word “children” on the children’s product label would believe it 3 implies that the children’s product “is a superior product for children as compared to” the adults’ 4 product, and that the adults’ product is not for children. Id. However, it argues, the label of the 5 children’s product contains no references to the adults’ product, and the packaging of both 6 products shows that the ingredients and concentrations are the same. Accordingly, RB Health 7 argues, DiGiacinto’s claims fail as a matter of law. Id. 8 RB Health misapprehends DiGiacinto’s allegations about the labels at issue. DiGiacinto 9 alleges that the children-specific representations on the children’s product, including the word 10 “Children’s,” the cartoon image of a child, and statement “Ages 4+,” caused him and reasonable 11 consumers to believe that the children’s product is “specially formulated for children,” even 12 though it is not. See FAC ¶ 26. “This inference is a much smaller ‘leap’ than the one in Shaeffer 13 and has nothing to do with practices by competitors.” See Adams v. Starbucks Corp., No. SACV 14 20-00225 JVS (KESX), 2020 WL 4196248, at *4 (C.D. Cal. July 9, 2020) (holding that inference 15 made by consumer “who sees a menu board with different calories and prices for larger sizes of 16 the same product” was “simple—that buying the same coffee drink in a larger size from the same 17 company would mean she would get more coffee and more caffeine.”); Scilex Pharms. Inc. v. 18 Sanofi-Aventis U.S. LLC, No. 21-CV-01280-JST, 2021 WL 11593043, at *12 (N.D. Cal. Aug. 16, 19 2021) (holding that allegations that defendants’ advertising and marketing is likely to deceive a 20 reasonable consumer to believe that “Defendants’ patches offer ‘the maximum amount of 21 lidocaine available in patch form’ and ‘adhere to the skin and provide pain relief for periods of 8 22 or 12 hours . . . do not require any ‘inferential leaps’”). Ultimately, the Ninth Circuit has 23 cautioned that the reasonable consumer standard “raises questions of fact” and that it is only in 24 “rare situations” that such questions should be resolved on the pleadings. See Reid v. Johnson & 25 Johnson, 780 F.3d 952, 958 (9th Cir. 2015) (quotation marks and citation omitted). The court 26 concludes that the FAC adequately alleges how RB Health’s labeling has “the capacity, likelihood 27 or tendency to deceive or confuse the public.” Schaeffer, 44 Cal. App. 5th at 1135. This portion I. CONCLUSION For the foregoing reasons, the court denies the motion for judgment on the pleadings 2 without prejudice to RB Health raising the issue of preemption in its motion for summary 3 judgment.? The motion for judgment on the pleadings is denied as to RB Health’s argument that 4 DiGiacinto brings “deceptive by implication” claims that are not actionable. 5 Additionally, DiGiacinto filed an administrative motion to file the exhibits to his RJN 6 under seal and seeks to redact portions of his opposition referring to those materials on the ground 7 that RB Health designated the exhibits as confidential pursuant to the parties’ stipulated protective 8 order. [Docket No. 58.] RB Health filed a corresponding motion to strike or seal portions of the 9 exhibits attached to DiGiacinto’s RJN. [Docket No. 63.] The parties’ administrative motions to 10 seal are denied as moot, as the court did not rely on the sealed materials in deciding this motion. 11 Finally, the parties filed a joint discovery letter on October 20, 2023 regarding their dispute 12 about whether discovery should be stayed pending the court’s ruling on the motion for judgment 13 on the pleadings. [Docket No. 75.] Given the court’s ruling on the motion, the joint discovery 14 S letter is denied. KES DISTRIGS 15 Ay oO 2 ON 16 ky DIO IT IS SO ORDERED. RE tips s0 ORDE Dated: October 30, 2023 5 < Z 18 □ j fl Rw ti C\ | “Bair Yo 50 PN Vili ate Judge □□□ oN OY 21 Ly oS DISTRICS 22 23 24 25 26 || 3 RB Health’s RJNs consisted of separate multiple-page briefs, as did DiGiacinto’s own RJN, the 27 || parties’ objections to the RJNs, and RB Health’s reply in support of its original RIN. These submissions resulted in the parties’ briefs going beyond applicable page limits. In future motions, 28 the parties should include any argument supporting or opposing requests for judicial notice within the main briefs.