Fust v. Gilead Sciences, Inc.

• Court: District Court, E.D. California
• Decided: February 22, 2024
• Docket: 2:23-cv-02853
• Status: Unknown

Opinion

1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 ----oo0oo---- 11 12 DEBORAH FUST, INDIVIDUALLY AND No. 2:23-cv-2853 WBS DB ON BEHALF OF ALL OTHERS 13 SIMILARLY SITUATED; AND EDWARD PIMENTEL, INDIVIDUALLY AND ON 14 BEHALF OF ALL OTHERS SIMILARLY MEMORANDUM AND ORDER SITUATED, 15 Plaintiffs, 16 v. 17 GILEAD SCIENCES, INC., A 18 DELAWARE CORPORATION REGISTERED TO DO BUSINESS AND HEADQUARTERED 19 IN CALIFORNIA, 20 Defendant. 21 22 ----oo0oo---- 23 Plaintiffs Deborah Fust and Edward Pimentel originally 24 filed this putative class action against defendant Gilead 25 Sciences, Inc. (“Gilead”) in Shasta County Superior Court, 26 seeking monetary and equitable relief pursuant to California’s 27 Consumers Legal Remedies Act (Claim 1); False Advertising Law 28 (Claim 2); Unfair Competition Law (Claim 3); money had and 1 received (Claim 4); negligent misrepresentation (Claim 5); and 2 unjust enrichment (Claim 6). Plaintiffs allege that defendant 3 exaggerated the benefits and downplayed the dangers of its drug 4 remdesivir (sold under the brand name Veklury), an antiviral 5 medication indicated for COVID-19 treatment. 6 The court now considers plaintiffs’ motion to remand 7 (Docket No. 28) and defendant’s motion to dismiss (Docket No. 8 10). 9 I. Motion to Remand 10 A. CAFA Jurisdiction 11 Defendant removed this action from Shasta County 12 Superior Court pursuant to the Class Action Fairness Act 13 (“CAFA”), 28 U.S.C. § 1332(d). (See Removal (Docket No. 1) at 14 2.) CAFA gives federal district courts original jurisdiction 15 over class actions in which the class members number at least 16 100, at least one plaintiff is diverse in citizenship from any 17 defendant, and the aggregate amount in controversy exceeds $5 18 million, exclusive of interest and costs. 28 U.S.C. § 19 1332(d)(2). 20 Plaintiffs argue that defendant has not sufficiently 21 demonstrated that the amount in controversy under CAFA is met. 22 In the alternative, plaintiffs urge the court to decline 23 jurisdiction on discretionary grounds, notwithstanding the 24 court’s diversity jurisdiction under CAFA. 25 1. Amount in Controversy Under CAFA 26 “[W]hen the defendant’s assertion of the amount in 27 controversy is challenged by plaintiffs in a motion to remand, 28 the Supreme Court has said that both sides submit proof and the 1 court then decides where the preponderance lies.” Ibarra v. 2 Manheim Invs., Inc., 775 F.3d 1193, 1198 (9th Cir. 2015) (citing 3 Dart Cherokee Basin Operating Co., LLC v. Owens, 574 U.S. 81, 88- 4 89 (2014)). Proof “includes affidavits, declarations, or ‘other 5 summary-judgment-type evidence relevant to the amount in 6 controversy at the time of removal.’” Sifuentes v. Roofline, 7 Inc., No. 2:20-CV-00052 WBS KJN, 2020 WL 1303796, at *1 (E.D. 8 Cal. Mar. 19, 2020) (citing Ibarra, 775 F.3d at 1197). See also 9 Gonzales v. CarMax Auto Superstores, LLC, 840 F.3d 644, 648-49 10 (9th Cir. 2016) (amount in controversy includes “damages 11 (compensatory, punitive, or otherwise) and the cost of complying 12 with an injunction, as well as attorneys’ fees awarded under fee 13 shifting statutes”). 14 Plaintiffs seek a corrective advertising campaign and 15 recall of advertising materials; disgorgement of defendant’s 16 revenues from Veklury; and actual and punitive damages and 17 attorney’s fees. (See generally Compl., Prayer for Relief.) 18 Defendant argues that any one of these remedies likely places the 19 amount in controversy north of $5 million, and at any rate the 20 remedies taken together clearly surpass the $5 million bar. 21 The court agrees. A corrective campaign alone, for 22 instance, is more likely than not to cost defendant over $5 23 million. In support, defendant provides several cases estimating 24 costs of a corrective campaign that range from $9.8 million to 25 $41.8 million. See Stone Brewing Co., LLC v. MillerCoors LLC, 26 3:18-cv-00331-BEN-MDD, 2023 WL 6450199, at *8 (S.D. Cal. Sept. 27 28, 2023) ($41.8 million); U–Haul v. Jartran, Inc., 793 F.2d 1034 28 (9th Cir. 1986) ($13.6 million); San Diego Comic Convention v. 1 Dan Farr Prods., 14-cv-1865 AJB (JMA), 2017 WL 4869152, at *2 2 (S.D. Cal. Oct. 27, 2017) ($9.8 million); Cross-Fit, Inc. v. 3 Nat’l Strength & Conditioning Ass’n, 14-cv-1191-JLS(KSC), 2018 WL 4 3491854, at *7 (S.D. Cal. July 18, 2018) ($15 million). 5 Defendant also points out that in 2009, the California Attorney 6 General announced an agreement with Bayer Corporation regarding 7 its oral contraceptives, requiring Bayer to run a corrective 8 advertising campaign that cost $20 million. (See Removal at 4 & 9 n.2.) 10 Plaintiffs, by contrast, offer no competing facts 11 bearing on the likely cost of a corrective campaign, or on any of 12 the other injunctive or monetary relief that they seek. Instead, 13 plaintiffs only assert the following: “[D]efendant’s analysis 14 purporting that the $5 million threshold is exceeded, is at best 15 highly speculative.” (Mot. to Remand (Docket No. 28) at 13.) 16 As the court must presently “decide[] where the 17 preponderance lies” after weighing both sides’ proof, Ibarra, 775 18 F.3d at 1198, the court concludes that the amount in controversy 19 is met, and that it accordingly has jurisdiction over this suit 20 pursuant to CAFA. 21 2. CAFA’s Discretionary Exception 22 Plaintiffs also urge the court to decline jurisdiction 23 under 28 U.S.C. § 1332(d)(3), which provides that a court may, 24 “in the interests of justice and looking at the totality of the 25 circumstances,” decline jurisdiction if the citizenship of 26 between one-third and two-thirds of a putative class, the 27 citizenship of the primary defendants, and the state in which the 28 action was originally filed are all the same state. See id. § 1 1332(d)(3). 2 Plaintiffs assert, without support, that it “seems 3 reasonable enough” to assume that at least one-third of the 4 putative class here are California citizens because of 5 California’s large population and its “massive healthcare 6 infrastructure.” (Mot. to Remand at 14.) This is not enough. 7 “Once CAFA jurisdiction has been established . . . the burden 8 falls on the party seeking remand . . . to show that an exception 9 to CAFA jurisdiction applies. To meet this burden, the moving 10 party must provide some facts in evidence from which the district 11 court may make findings regarding class members’ citizenship.” 12 Adams v. W. Marine Prod., Inc., 958 F.3d 1216, 1221 (9th Cir. 13 2020) (cleaned up). See also Brinkley v. Monterey Fin. Servs., 14 Inc., 873 F.3d 1118, 1121 (9th Cir. 2017) (“Congress passed CAFA 15 with the overall intent . . . to strongly favor the exercise of 16 federal diversity jurisdiction over class actions with interstate 17 ramifications.”) (cleaned up). 18 Accordingly, the court will not decline CAFA 19 jurisdiction pursuant to Section 1332(d)(3). 20 B. Quackenbush, Saldana, Granato 21 The remainder of plaintiffs’ arguments for remand, such 22 as they are, center on three cases that plaintiffs devote entire 23 pages of their briefs to excerpt from. Due to the sheer weight 24 that plaintiffs seem to put on these cases, the court addresses 25 the relevance of each in turn. 26 Quackenbush. Plaintiffs appear to cite to Quackenbush 27 v. Allstate Ins. Co., 517 U.S. 706 (1996), for the proposition 28 that remand here would affirm and duly show “deference to the 1 paramount interests of another sovereign [and] principles of 2 comity and federalism.” Id. at 723. (See Mot. to Remand at 9.) 3 The court is unpersuaded for two reasons. First, it is 4 unclear how the question of remand here actually implicates 5 material federalism concerns. Plaintiffs argue that so-styled 6 “humanitarian remedies . . . are completely unavailable to the 7 state plaintiffs in federal court according to the defendant’s 8 own arguments in its’ [sic] lengthy motion to dismiss . . . .” 9 (Mot. to Remand at 2-3.) Not only does this confusingly veer 10 into the merits of defendant’s pending motion to dismiss; it 11 assumes, incorrectly, that defendant’s federal defense premised 12 on the Public Readiness and Emergency Preparedness Act (“PREP 13 Act”) can be asserted in federal court, but not in state court. 14 Contra 42 U.S.C. § 247d-6d(a)(1) (PREP Act provides immunity 15 “from suit and liability under Federal and State law.”). 16 Second, Quackenbush discusses whether remand was proper 17 pursuant to Burford abstention. See Quackenbush, 517 U.S. at 18 723-31 (citing Burford v. Sun Oil Co., 319 U.S. 315 (1943)). 19 Burford abstention concerns when a federal court sitting in 20 equity must decline to interfere with the proceedings or orders 21 of state administrative agencies. See, e.g., New Orleans Pub. 22 Serv., Inc. v. Council of City of New Orleans, 491 U.S. 350, 361 23 (1989) (summarizing Burford doctrine). It is plainly 24 inapplicable here, and the court will not remand on this basis. 25 Saldana. Plaintiffs also argue that, because a Ninth 26 Circuit panel in Saldana v. Glenhaven Healthcare LLC, 27 F.4th 27 679 (9th Cir. 2022) held that the PREP Act was not a “complete 28 preemption” statute, remand is therefore proper. 1 The court disagrees. As already discussed, this court 2 has jurisdiction over this case pursuant to CAFA. Whether or not 3 plaintiffs’ state law claims are completely preempted by federal 4 law, thereby raising a federal question, is therefore irrelevant 5 to the present motion.1 6 Granato. Plaintiffs quote extensively from Granato v. 7 Apple Inc., No. 5:22-CV-02316-EJD, 2023 WL 4646038 (N.D. Cal. 8 July 19, 2023), to apparently argue that the court lacks 9 equitable jurisdiction over plaintiffs’ claims. (See, e.g., Mot. 10 to Remand at 11-13.) 11 Much of the decision in Granato discusses the Ninth 12 Circuit’s decision in Sonner v. Premier Nutrition Corp., 971 F.3d 13 834 (9th Cir. 2020), where a panel held that equitable relief is 14 not available in federal court when there is an adequate legal 15 remedy. See generally id. However, it is unclear to the court 16 why Sonner would vitiate the court’s already-established CAFA 17 jurisdiction. (See supra § I.A.) First, plaintiffs in fact 18 appear to seek damages as well as equitable relief. (See Compl., 19 Prayer for Relief, subsection (i) (requesting “[a]n Order 20 requiring Defendant to pay all actual and statutory damages 21 permitted under the causes of action alleged herein . . . .”).) 22 Second, plaintiffs offer no binding authority requiring remand at 23 the pleading stage for lack of power to grant equitable relief.

24 1 See Hansen v. Group Health Coop., 902 F.3d 1051, 1057- 58 (9th Cir. 2018) (“Once completely preempted, a state-law claim 25 ceases to exist. [. . .] But that does not mean the plaintiff 26 has no claim at all. Instead, the state-law claim is simply ‘recharacterized’ as the federal claim that Congress made 27 exclusive.” (citing Vaden v. Discover Bank, 556 U.S. 49, 61 (2009))) (cleaned up). 28 1 Neither can the court find any.2 2 Accordingly, the court will deny plaintiffs’ motion to 3 remand.3 4 II. Motion to Dismiss 5 Defendant moves to dismiss all of plaintiffs’ claims on 6 three independent grounds: (1) immunity pursuant to the PREP Act; 7 (2) insufficient pleading under Federal Rules of Civil Procedure 8 8(a) and 9(b); and (3) immunity pursuant to the learned 9 intermediary doctrine. (See generally Mot. to Dismiss (Docket 10 No. 10).) 11 A. Facts 12 The court takes every following allegation from 13 2 Cf. Kim v. Walmart, Inc, No. 2:22-CV-08380-SB-PVC, 2023 14 WL 196919, at *2 (C.D. Cal. Jan. 13, 2023) (“Remand is inappropriate because diversity jurisdiction exists, and the 15 Court's authority to hear this case does not depend on its equitable powers. [. . .] [Plaintiff] has sued not just for 16 equitable relief -- for which equitable authority is required to 17 award a remedy -- but also money damages, which is the archetypal form of legal relief.”); Naseri v. Greenfield World Trade, Inc., 18 No. SACV2101084CJCKESX, 2021 WL 3511040, at *1 (C.D. Cal. Aug. 10, 2021) (“But Sonner did not hold that failure to allege an 19 inadequate legal remedy deprives a court of subject matter jurisdiction. Rather, Sonner held that failure to allege an 20 inadequate legal remedy precludes a plaintiff from recovering at 21 all. [. . .] [Sonner] shows that federal courts may exercise jurisdiction over equitable claims under the UCL and CLRA.”); 22 Lopez v. Cequel Commun., LLC, No. 2:20-CV-02242 TLN JDP, 2021 WL 4476831, at *2 (E.D. Cal. Sept. 30, 2021) (joining with Naseri 23 and concluding “Sonner does not preclude courts from exercising jurisdiction over [purely equitable] claims”); Treinish v. iFit 24 Inc., No. CV 22-4687-DMG (SKX), 2022 WL 5027083, at *4 (C.D. Cal. Oct. 3, 2022) (“[lack of equitable jurisdiction] does not justify 25 remanding this case, because CAFA provides subject matter 26 jurisdiction here”). 27 3 Defendant’s request for judicial notice relating to the motion to remand (Docket No. 31-1) is denied as moot. 28 1 plaintiffs’ complaint as true and draws every reasonable 2 inference in favor of plaintiffs. 3 Defendant Gilead Sciences, Inc. is a Delaware 4 pharmaceutical company with its principal place of business in 5 Foster City, California. (Compl. (Docket No. 1 Ex. 1) ¶ 7.) 6 Defendant manufactures, advertises, and promotes remdesivir, also 7 known under the brand name Veklury, which is an antiviral drug 8 used to treat severe COVID-19 symptoms. (Id. ¶¶ 5, 18-19.) 9 On March 17, 2020, the Department of Health and Human 10 Services (“HHS”) Secretary designated COVID-19 as a “public 11 health emergency . . . under the PREP Act [42 U.S.C. § 247d-6d].” 12 85 Fed. Reg. 15198-01 (Mar. 17, 2020).4 The Secretary declared 13 the end of the COVID-19 public health emergency on May 11, 2023. 14 HHS SECRETARY XAVIER BECERRA STATEMENT ON END OF THE COVID-19 PUBLIC HEALTH 15 EMERGENCY, Dep’t of Health & Human Servs. (May 11, 2023), 16 https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier- 17 becerra-statement-on-end-of-the-covid-19-public-health- 18 emergency.html. However, the Secretary also extended PREP Act 19 protections for “covered persons” and “covered countermeasures” 20 with respect to COVID-19 until December 31, 2024. 88 Fed. Reg. 21 30769 (May 12, 2023). 22 On March 20, 2020, the Food and Drug Administration 23 (“FDA”) gave emergency use authorization for Veklury to be used 24 for hospitalized patients with severe COVID-19. (Compl. ¶ 19.)

25 4 The court will grant defendant’s request for judicial 26 notice relating to the motion to dismiss as to Exhibit 1, which supplies the HHS Secretary’s March 17, 2020 declaration of COVID- 27 19 as a public health emergency. (Docket No. 10-1.) The court will deny defendant’s request as to all other exhibits as moot. 28 1 On April 25, 2022, the HHS Secretary revoked Veklury’s emergency 2 use authorization because the FDA approved defendant’s 3 supplemental new drug application for Veklury. 87 Fed. Reg. 4 44407 (July 26, 2022). 5 A number of scientific studies warn about the dangerous 6 side effects of Veklury, including damage to the kidneys, liver, 7 the heart, and the vascular system. (Compl. ¶¶ 28-42.) Other 8 studies point out Veklury’s lack of efficacy in reducing 9 mortality or the time that COVID-19 patients take to recover. 10 (Id. ¶¶ 25-27.) Despite this, defendant continued to market and 11 promote Veklury as safe and effective. (Id. ¶¶ 43-44.) 12 Plaintiffs are patients who were prescribed, purchased, 13 and ingested Veklury while hospitalized for COVID-19. (Id. ¶ 5.) 14 Named plaintiff Debora Fust sues on behalf of her deceased 15 husband, Michael Fust, who died after receiving Veklury. (Id. ¶ 16 6.) Named plaintiff Edward Pimentel was injured after receiving 17 Veklury. (Id.) The putative class comprises “(1) [a]ll 18 individuals who were given Remdesivir (Veklury) while 19 hospitalized for Covid-19 and who, as a result of its 20 administration, survived and suffered serious physical injury, 21 and (2) [a]ll individuals who were given Remdesivir (Veklury) 22 while hospitalized for Covid-19 and who, as a result of its 23 administration, died and are survived by their aggrieved family 24 members who now represent them in their capacities as personal 25 representatives.” (Id. ¶ 9.) 26 B. Legal Standard 27 Federal Rule of Civil Procedure 12(b)(6) allows for 28 dismissal when the plaintiff’s complaint fails to state a claim 1 upon which relief can be granted. See Fed. R. Civ. P. 12(b)(6). 2 The inquiry before the court is whether, accepting the 3 allegations in the complaint as true and drawing all reasonable 4 inferences in the plaintiff’s favor, the complaint has alleged 5 “sufficient facts . . . to support a cognizable legal theory,” 6 Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001), and thereby 7 stated “a claim to relief that is plausible on its face,” Bell 8 Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). In deciding 9 such a motion, all material allegations of the complaint are 10 accepted as true, as well as all reasonable inferences to be 11 drawn from them. Id. 12 The court “need not accept as true legal conclusions or 13 ‘[t]hreadbare recitals of the elements of a cause of action, 14 supported by mere conclusory statements.’” Whitaker v. Tesla 15 Motors, Inc., 985 F.3d 1173, 1176 (9th Cir. 2021) (quoting 16 Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009)). 17 “Ordinarily affirmative defenses may not be raised by 18 motion to dismiss . . . .” Scott v. Kuhlmann, 746 F.2d 1377, 19 1378 (9th Cir. 1984) (per curiam). However, “a complaint may be 20 dismissed when the allegations of the complaint give rise to an 21 affirmative defense that clearly appears on the face of the 22 pleading.” Boquist v. Courtney, 32 F.4th 764, 774 (9th Cir. 23 2022) (cleaned up). An affirmative defense is grounds for 24 dismissal at the pleading stage only if “the plaintiff pleads 25 itself out of court -- that is, admits all the ingredients of an 26 impenetrable defense . . . .” Durnford v. MusclePharm Corp., 907 27 F.3d 595, 603 n.8 (9th Cir. 2018) (quoting Xechem, Inc. v. 28 Bristol-Myers Squibb Co., 372 F.3d 899, 901 (7th Cir. 2004)). 1 C. Discussion 2 The bulk of defendant’s motion centers on PREP Act 3 immunity. The PREP Act protects “covered persons” using a 4 “covered countermeasure” during a declared public health 5 emergency from suit and liability under federal and state law 6 based on claims of loss related to that use. See generally 42 7 U.S.C. § 247d-6b(b). 8 1. Covered Persons and Countermeasures 9 The PREP Act defines “covered countermeasure,” in 10 relevant part, as a drug either authorized for emergency use or 11 approved and cleared by the FDA. Id. § 247d-6b(i)(7)(B)(i), 12 (iii). At all relevant times, Veklury was either authorized for 13 emergency use or approved for use by the FDA. Veklury is 14 therefore a covered countermeasure for purposes of the PREP Act. 15 “[M]anufacturer[s] of such countermeasure[s]” are 16 “covered persons” under the Act. 42 U.S.C. § 247b- 17 6d(i)(2)(B)(i). Defendant, as the manufacturer of Veklury, 18 therefore counts as a covered person pursuant to the Act’s 19 provisions. (See Compl. ¶ 5.) 20 2. Claims of Loss and Scope of Immunity 21 Defendant, as a covered person manufacturing a covered 22 countermeasure, is “immune from suit and liability under Federal 23 and State law with respect to all claims for loss caused by, 24 arising out of, relating to, or resulting from the administration 25 to or the use by an individual of a covered countermeasure [i.e., 26 Veklury] . . . .” 42 U.S.C. § 247b-6d(a)(1). 27 The court now examines whether plaintiffs’ claims 28 allege the kinds of loss against defendant that are barred by the 1 PREP Act. The Act defines “loss” in sweeping terms: “‘loss’ 2 means any type of loss, including (i) death; (ii) physical, 3 mental, or emotional injury, illness, disability, or condition; 4 (iii) fear of physical, mental, or emotional injury, illness, 5 disability, or condition, including any need for medical 6 monitoring; and (iv) loss of or damage to property, including 7 business interruption loss.” Id. § 247b-6d(a)(2)(A). 8 The category of acts covered by immunity is similarly 9 expansive: it “applies to any claim for loss that has a causal 10 relationship with the administration to or use by an individual 11 of a covered countermeasure, including a causal relationship with 12 the design, development, clinical testing or investigation, 13 manufacture, labeling, distribution, formulation, packaging, 14 marketing, promotion, sale, purchase, donation, dispensing, 15 prescribing, administration, licensing, or use of such 16 countermeasure.” Id. § 247b-6d(a)(2)(B). 17 Such capacious language makes it difficult to see how 18 PREP Act immunity would not apply against plaintiffs’ claims. 19 Plaintiffs allege that “Despite . . . serious adverse events 20 including numerous fatalities, and so many others documents in 21 ‘real life’, Defendant Gilead continued to market Remdesivir as 22 safe and effective;” and “Defendant Gilead failed to disclose 23 these crucial details regarding the dangers of Remdesivir in its 24 marketing and advertising campaign to patients who agreed to use 25 of Remdesivir without knowledge of this crucial information; thus 26 Gilead falsely advertising [sic] Remdesivir and nullifying their 27 informed consent.” (Compl. ¶¶ 43, 49 (emphasis added); see 28 generally id. ¶¶ 43-71.) Plaintiffs also allege that “Plaintiffs 1 and others in the Class were aware of representations by Gilead 2 as to the ‘safety and efficacy’ of Remdesivir. To the extent 3 they even had a say in the matter, Plaintiffs and the Class 4 agreed, albeit without informed consent, to taking the drug.” 5 (Id. ¶ 72.) Finally, plaintiffs’ class definition explicitly 6 include persons who were injured or died “as a result of 7 [Veklury’s] administration . . . .” (Id. ¶ 9 (emphasis added).) 8 Put another way, plaintiffs allege (1) acts by defendant, (2) 9 injuries to plaintiffs, and (3) a causal relationship between the 10 two. Every major noun and verb comprising plaintiffs’ 11 allegations regarding act, injury, and causation manifestly 12 implicate the broad protections provided by Section 247b- 13 6d(a)(2). 14 A court in the Central District of California very 15 recently reached the same conclusion regarding Veklury. It held, 16 on substantially identical grounds, that the PREP Act immunized 17 defendant Gilead against similar claims predicated on informed 18 consent about the dangers of Veklury. See generally Baghikian v. 19 Providence Health & Services, No. CV 23-9082-JFW(JPRX), 2024 WL 20 487769 (C.D. Cal. Feb. 6, 2024). Several other courts have also 21 found that PREP Act immunity applies against similar claims 22 regarding COVID-19 drugs. See, e.g., Bird v. State, 2023 WY 102, 23 ¶¶ 15-17, 537 P.3d 332, 336 (Wyo. 2023) (PREP Act immunity 24 applies to claims alleging failure to provide information 25 reasonably necessary to make informed decision about COVID-19 26 vaccine); Cowen v. Walgreen Co., 2022 WL 17640208, at *3 (N.D. 27 Okla. Dec. 13, 2022) (same re: administering COVID shot instead 28 of flu shot without patient consent); M.T. as next friend of M.K. 1 v. Walmart Stores, Inc., 528 P.3d 1067, 1084 (Kan. Ct. App. 2023) 2 (“a claim based on the administration of a covered countermeasure 3 without parental consent is causally related to the 4 administration of a covered countermeasure”); Gibson v. Johnson 5 and Johnson, 2023 WL 4851413, at *3 (E.D. Pa. July 28, 2023) 6 (PREP Act immunity applies to marketing-based claim that Johnson 7 & Johnson “provid[ed] intentionally misleading information that 8 it knew or should have known”); see also Kehler v. Hood, 2012 WL 9 1945952, at *1 (E.D. Mo. May 30, 2012) (PREP Act immunity applied 10 to “failure to warn claims” in H1N1 context). 11 The court therefore concludes that the PREP Act 12 immunizes defendant from suit and liability and will dismiss 13 plaintiffs’ claims on this basis.5 14 D. No Leave to Amend 15 Courts commonly consider four factors when deciding 16 whether to grant leave to amend a complaint under Rule 15(a): bad 17 faith, undue delay, prejudice, and futility of amendment. Roth 18 v. Marquez, 942 F.2d 617, 628 (9th Cir. 1991). Because Rule 19 16(b)’s “good cause” inquiry essentially incorporates the first 20 three factors, if a court finds that good cause exists, it should 21 then deny leave to amend only if such amendment would be futile. 22 Here, the court concludes that amendment would be 23 futile. The applicability of PREP Act immunity against these 24 claims by these plaintiffs is plain on the face of plaintiffs’ 25 complaint, and when asked by the court at oral argument how 26 5 Accordingly, the court need not consider whether 27 plaintiffs’ claims are inadequately pled or the applicability of the learned intermediary doctrine. 28 nnn nnn nee en enn nn nnn en ne nn nnn nn nnn eo OI OD

1 | plaintiffs might amend their complaint if granted leave to do so, 2 plaintiffs’ counsel was unable to suggest any amendments which 3 could overcome PREP Act immunity. 4 IT IS THEREFORE ORDERED that plaintiffs’ motion to 5 remand (Docket No. 28) be, and the same hereby is, DENIED. 6 IT IS FURTHER ORDERED that defendant’s motion to 7 dismiss (Docket No. 10) be, and the same hereby is, GRANTED, and 8 plaintiffs’ complaint is hereby DISMISSED with prejudice. 9 | Dated: February 21, 2024 be te ak. Ld, KE 10 WILLIAM B. SHUBB 1 UNITED STATES DISTRICT JUDGE

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 6 The court expresses no opinion on the viability of different claims which might be brought in the appropriate court 27 under the PREP Act’s willful misconduct exception, 42 U.S.C. § 247d-6d(d) (1), or compensation sought under the PREP Act’s 28 | Covered Countermeasures Process Fund, id. § 247d-6e. 16