Fust v. Gilead Sciences, Inc.

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