Fust et al v. Gilead Sciences, Inc.
Filing
41
MEMORANDUM and ORDER signed by Senior Judge William B. Shubb on 2/21/2024 DENYING 28 Motion to Remand, GRANTING 10 Motion to Dismiss, and DISMISSING plaintiffs' complaint with prejudice. CASE CLOSED (Woodson, A)
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UNITED STATES DISTRICT COURT
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EASTERN DISTRICT OF CALIFORNIA
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----oo0oo----
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DEBORAH FUST, INDIVIDUALLY AND
ON BEHALF OF ALL OTHERS
SIMILARLY SITUATED; AND EDWARD
PIMENTEL, INDIVIDUALLY AND ON
BEHALF OF ALL OTHERS SIMILARLY
SITUATED,
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No. 2:23-cv-2853 WBS DB
MEMORANDUM AND ORDER
Plaintiffs,
v.
GILEAD SCIENCES, INC., A
DELAWARE CORPORATION REGISTERED
TO DO BUSINESS AND HEADQUARTERED
IN CALIFORNIA,
Defendant.
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----oo0oo---Plaintiffs Deborah Fust and Edward Pimentel originally
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filed this putative class action against defendant Gilead
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Sciences, Inc. (“Gilead”) in Shasta County Superior Court,
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seeking monetary and equitable relief pursuant to California’s
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Consumers Legal Remedies Act (Claim 1); False Advertising Law
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(Claim 2); Unfair Competition Law (Claim 3); money had and
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received (Claim 4); negligent misrepresentation (Claim 5); and
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unjust enrichment (Claim 6).
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exaggerated the benefits and downplayed the dangers of its drug
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remdesivir (sold under the brand name Veklury), an antiviral
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medication indicated for COVID-19 treatment.
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Plaintiffs allege that defendant
The court now considers plaintiffs’ motion to remand
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(Docket No. 28) and defendant’s motion to dismiss (Docket No.
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10).
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I.
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Motion to Remand
A.
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CAFA Jurisdiction
Defendant removed this action from Shasta County
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Superior Court pursuant to the Class Action Fairness Act
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(“CAFA”), 28 U.S.C. § 1332(d).
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2.)
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over class actions in which the class members number at least
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100, at least one plaintiff is diverse in citizenship from any
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defendant, and the aggregate amount in controversy exceeds $5
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million, exclusive of interest and costs.
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1332(d)(2).
(See Removal (Docket No. 1) at
CAFA gives federal district courts original jurisdiction
28 U.S.C. §
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Plaintiffs argue that defendant has not sufficiently
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demonstrated that the amount in controversy under CAFA is met.
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In the alternative, plaintiffs urge the court to decline
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jurisdiction on discretionary grounds, notwithstanding the
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court’s diversity jurisdiction under CAFA.
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1.
Amount in Controversy Under CAFA
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“[W]hen the defendant’s assertion of the amount in
27
controversy is challenged by plaintiffs in a motion to remand,
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the Supreme Court has said that both sides submit proof and the
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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)).
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summary-judgment-type evidence relevant to the amount in
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controversy at the time of removal.’”
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Inc., No. 2:20-CV-00052 WBS KJN, 2020 WL 1303796, at *1 (E.D.
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Cal. Mar. 19, 2020) (citing Ibarra, 775 F.3d at 1197).
9
Gonzales v. CarMax Auto Superstores, LLC, 840 F.3d 644, 648-49
Proof “includes affidavits, declarations, or ‘other
Sifuentes v. Roofline,
See also
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(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”).
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Plaintiffs seek a corrective advertising campaign and
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recall of advertising materials; disgorgement of defendant’s
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revenues from Veklury; and actual and punitive damages and
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attorney’s fees.
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Defendant argues that any one of these remedies likely places the
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amount in controversy north of $5 million, and at any rate the
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remedies taken together clearly surpass the $5 million bar.
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(See generally Compl., Prayer for Relief.)
The court agrees.
A corrective campaign alone, for
22
instance, is more likely than not to cost defendant over $5
23
million.
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costs of a corrective campaign that range from $9.8 million to
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$41.8 million.
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
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(9th Cir. 1986) ($13.6 million); San Diego Comic Convention v.
In support, defendant provides several cases estimating
See Stone Brewing Co., LLC v. MillerCoors LLC,
3
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
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3491854, at *7 (S.D. Cal. July 18, 2018) ($15 million).
5
Defendant also points out that in 2009, the California Attorney
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General announced an agreement with Bayer Corporation regarding
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its oral contraceptives, requiring Bayer to run a corrective
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advertising campaign that cost $20 million.
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n.2.)
10
(See Removal at 4 &
Plaintiffs, by contrast, offer no competing facts
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bearing on the likely cost of a corrective campaign, or on any of
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the other injunctive or monetary relief that they seek.
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plaintiffs only assert the following: “[D]efendant’s analysis
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purporting that the $5 million threshold is exceeded, is at best
15
highly speculative.”
16
Instead,
(Mot. to Remand (Docket No. 28) at 13.)
As the court must presently “decide[] where the
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preponderance lies” after weighing both sides’ proof, Ibarra, 775
18
F.3d at 1198, the court concludes that the amount in controversy
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is met, and that it accordingly has jurisdiction over this suit
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pursuant to CAFA.
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2.
CAFA’s Discretionary Exception
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Plaintiffs also urge the court to decline jurisdiction
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under 28 U.S.C. § 1332(d)(3), which provides that a court may,
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“in the interests of justice and looking at the totality of the
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circumstances,” decline jurisdiction if the citizenship of
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between one-third and two-thirds of a putative class, the
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citizenship of the primary defendants, and the state in which the
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action was originally filed are all the same state.
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See id. §
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1332(d)(3).
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Plaintiffs assert, without support, that it “seems
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reasonable enough” to assume that at least one-third of the
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putative class here are California citizens because of
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California’s large population and its “massive healthcare
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infrastructure.”
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“Once CAFA jurisdiction has been established . . . the burden
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falls on the party seeking remand . . . to show that an exception
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to CAFA jurisdiction applies.
(Mot. to Remand at 14.)
This is not enough.
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).
14
Inc., 873 F.3d 1118, 1121 (9th Cir. 2017) (“Congress passed CAFA
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with the overall intent . . . to strongly favor the exercise of
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federal diversity jurisdiction over class actions with interstate
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ramifications.”) (cleaned up).
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See also Brinkley v. Monterey Fin. Servs.,
Accordingly, the court will not decline CAFA
jurisdiction pursuant to Section 1332(d)(3).
B.
Quackenbush, Saldana, Granato
The remainder of plaintiffs’ arguments for remand, such
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as they are, center on three cases that plaintiffs devote entire
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pages of their briefs to excerpt from.
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that plaintiffs seem to put on these cases, the court addresses
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the relevance of each in turn.
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Quackenbush.
Due to the sheer weight
Plaintiffs appear to cite to Quackenbush
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v. Allstate Ins. Co., 517 U.S. 706 (1996), for the proposition
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that remand here would affirm and duly show “deference to the
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paramount interests of another sovereign [and] principles of
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comity and federalism.”
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Id. at 723.
(See Mot. to Remand at 9.)
The court is unpersuaded for two reasons.
First, it is
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unclear how the question of remand here actually implicates
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material federalism concerns.
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“humanitarian remedies . . . are completely unavailable to the
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state plaintiffs in federal court according to the defendant’s
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own arguments in its’ [sic] lengthy motion to dismiss . . . .”
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(Mot. to Remand at 2-3.)
Plaintiffs argue that so-styled
Not only does this confusingly veer
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into the merits of defendant’s pending motion to dismiss; it
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assumes, incorrectly, that defendant’s federal defense premised
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on the Public Readiness and Emergency Preparedness Act (“PREP
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Act”) can be asserted in federal court, but not in state court.
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Contra 42 U.S.C. § 247d-6d(a)(1) (PREP Act provides immunity
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“from suit and liability under Federal and State law.”).
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Second, Quackenbush discusses whether remand was proper
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pursuant to Burford abstention.
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723-31 (citing Burford v. Sun Oil Co., 319 U.S. 315 (1943)).
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Burford abstention concerns when a federal court sitting in
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equity must decline to interfere with the proceedings or orders
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of state administrative agencies.
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Serv., Inc. v. Council of City of New Orleans, 491 U.S. 350, 361
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(1989) (summarizing Burford doctrine).
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inapplicable here, and the court will not remand on this basis.
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Saldana.
See Quackenbush, 517 U.S. at
See, e.g., New Orleans Pub.
It is plainly
Plaintiffs also argue that, because a Ninth
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Circuit panel in Saldana v. Glenhaven Healthcare LLC, 27 F.4th
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679 (9th Cir. 2022) held that the PREP Act was not a “complete
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preemption” statute, remand is therefore proper.
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The court disagrees.
As already discussed, this court
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has jurisdiction over this case pursuant to CAFA.
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plaintiffs’ state law claims are completely preempted by federal
4
law, thereby raising a federal question, is therefore irrelevant
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to the present motion.1
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Granato.
Whether or not
Plaintiffs quote extensively from Granato v.
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Apple Inc., No. 5:22-CV-02316-EJD, 2023 WL 4646038 (N.D. Cal.
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July 19, 2023), to apparently argue that the court lacks
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equitable jurisdiction over plaintiffs’ claims.
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(See, e.g., Mot.
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
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834 (9th Cir. 2020), where a panel held that equitable relief is
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not available in federal court when there is an adequate legal
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remedy.
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why Sonner would vitiate the court’s already-established CAFA
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jurisdiction.
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appear to seek damages as well as equitable relief.
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Prayer for Relief, subsection (i) (requesting “[a]n Order
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requiring Defendant to pay all actual and statutory damages
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permitted under the causes of action alleged herein . . . .”).)
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Second, plaintiffs offer no binding authority requiring remand at
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the pleading stage for lack of power to grant equitable relief.
24
See Hansen v. Group Health Coop., 902 F.3d 1051, 105758 (9th Cir. 2018) (“Once completely preempted, a state-law claim
ceases to exist. [. . .] But that does not mean the plaintiff
has no claim at all. Instead, the state-law claim is simply
‘recharacterized’ as the federal claim that Congress made
exclusive.” (citing Vaden v. Discover Bank, 556 U.S. 49, 61
(2009))) (cleaned up).
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See generally id.
However, it is unclear to the court
(See supra § I.A.)
1
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First, plaintiffs in fact
(See Compl.,
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Neither can the court find any.2
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Accordingly, the court will deny plaintiffs’ motion to
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remand.3
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II.
Motion to Dismiss
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Defendant moves to dismiss all of plaintiffs’ claims on
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three independent grounds: (1) immunity pursuant to the PREP Act;
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(2) insufficient pleading under Federal Rules of Civil Procedure
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8(a) and 9(b); and (3) immunity pursuant to the learned
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intermediary doctrine.
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No. 10).)
A.
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(See generally Mot. to Dismiss (Docket
Facts
The court takes every following allegation from
Cf. Kim v. Walmart, Inc, No. 2:22-CV-08380-SB-PVC, 2023
WL 196919, at *2 (C.D. Cal. Jan. 13, 2023) (“Remand is
inappropriate because diversity jurisdiction exists, and the
Court's authority to hear this case does not depend on its
equitable powers. [. . .] [Plaintiff] has sued not just for
equitable relief -- for which equitable authority is required to
award a remedy -- but also money damages, which is the archetypal
form of legal relief.”); Naseri v. Greenfield World Trade, Inc.,
No. SACV2101084CJCKESX, 2021 WL 3511040, at *1 (C.D. Cal. Aug.
10, 2021) (“But Sonner did not hold that failure to allege an
inadequate legal remedy deprives a court of subject matter
jurisdiction. Rather, Sonner held that failure to allege an
inadequate legal remedy precludes a plaintiff from recovering at
all. [. . .] [Sonner] shows that federal courts may exercise
jurisdiction over equitable claims under the UCL and CLRA.”);
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
and concluding “Sonner does not preclude courts from exercising
jurisdiction over [purely equitable] claims”); Treinish v. iFit
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
remanding this case, because CAFA provides subject matter
jurisdiction here”).
2
Defendant’s request for judicial notice relating to the
motion to remand (Docket No. 31-1) is denied as moot.
3
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plaintiffs’ complaint as true and draws every reasonable
2
inference in favor of plaintiffs.
3
Defendant Gilead Sciences, Inc. is a Delaware
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pharmaceutical company with its principal place of business in
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Foster City, California.
6
Defendant manufactures, advertises, and promotes remdesivir, also
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known under the brand name Veklury, which is an antiviral drug
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used to treat severe COVID-19 symptoms.
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(Compl. (Docket No. 1 Ex. 1) ¶ 7.)
(Id. ¶¶ 5, 18-19.)
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
13
the end of the COVID-19 public health emergency on May 11, 2023.
14
HHS SECRETARY XAVIER BECERRA STATEMENT
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EMERGENCY, Dep’t of Health & Human Servs. (May 11, 2023),
16
https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-
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becerra-statement-on-end-of-the-covid-19-public-health-
18
emergency.html.
19
protections for “covered persons” and “covered countermeasures”
20
with respect to COVID-19 until December 31, 2024.
21
30769 (May 12, 2023).
22
ON
END
The Secretary declared
OF THE
COVID-19 PUBLIC HEALTH
However, the Secretary also extended PREP Act
88 Fed. Reg.
On March 20, 2020, the Food and Drug Administration
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(“FDA”) gave emergency use authorization for Veklury to be used
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for hospitalized patients with severe COVID-19.
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26
27
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(Compl. ¶ 19.)
The court will grant defendant’s request for judicial
notice relating to the motion to dismiss as to Exhibit 1, which
supplies the HHS Secretary’s March 17, 2020 declaration of COVID19 as a public health emergency. (Docket No. 10-1.) The court
will deny defendant’s request as to all other exhibits as moot.
4
9
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.
4
44407 (July 26, 2022).
5
87 Fed. Reg.
A number of scientific studies warn about the dangerous
6
side effects of Veklury, including damage to the kidneys, liver,
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the heart, and the vascular system.
8
studies point out Veklury’s lack of efficacy in reducing
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mortality or the time that COVID-19 patients take to recover.
(Compl. ¶¶ 28-42.)
10
(Id. ¶¶ 25-27.)
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promote Veklury as safe and effective.
12
Other
Despite this, defendant continued to market and
(Id. ¶¶ 43-44.)
Plaintiffs are patients who were prescribed, purchased,
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and ingested Veklury while hospitalized for COVID-19.
14
Named plaintiff Debora Fust sues on behalf of her deceased
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husband, Michael Fust, who died after receiving Veklury.
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6.)
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Veklury.
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individuals who were given Remdesivir (Veklury) while
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hospitalized for Covid-19 and who, as a result of its
20
administration, survived and suffered serious physical injury,
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and (2) [a]ll individuals who were given Remdesivir (Veklury)
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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.”
26
27
28
(Id. ¶ 5.)
(Id. ¶
Named plaintiff Edward Pimentel was injured after receiving
B.
(Id.)
The putative class comprises “(1) [a]ll
(Id. ¶ 9.)
Legal Standard
Federal Rule of Civil Procedure 12(b)(6) allows for
dismissal when the plaintiff’s complaint fails to state a claim
10
1
upon which relief can be granted.
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).
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.
12
See Fed. R. Civ. P. 12(b)(6).
In deciding
Id.
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.’”
15
Motors, Inc., 985 F.3d 1173, 1176 (9th Cir. 2021) (quoting
16
Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009)).
17
Whitaker v. Tesla
“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).
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.”
23
2022) (cleaned up).
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 . . . .”
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)).
However, “a complaint may be
Boquist v. Courtney, 32 F.4th 764, 774 (9th Cir.
An affirmative defense is grounds for
Durnford v. MusclePharm Corp., 907
11
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.
7
U.S.C. § 247d-6b(b).
See generally 42
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.
12
(iii).
13
emergency use or approved for use by the FDA.
14
therefore a covered countermeasure for purposes of the PREP Act.
15
Id. § 247d-6b(i)(7)(B)(i),
At all relevant times, Veklury was either authorized for
Veklury is
“[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).
18
therefore counts as a covered person pursuant to the Act’s
19
provisions.
Defendant, as the manufacturer of Veklury,
(See Compl. ¶ 5.)
20
2.
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] . . . .”
27
28
Claims of Loss and Scope of Immunity
42 U.S.C. § 247b-6d(a)(1).
The court now examines whether plaintiffs’ claims
allege the kinds of loss against defendant that are barred by the
12
1
PREP Act.
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.”
8
9
The Act defines “loss” in sweeping terms: “‘loss’
Id. § 247b-6d(a)(2)(A).
The category of acts covered by immunity is similarly
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.”
17
Id. § 247b-6d(a)(2)(B).
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.”
28
generally id. ¶¶ 43-71.)
(Compl. ¶¶ 43, 49 (emphasis added); see
Plaintiffs also allege that “Plaintiffs
13
1
and others in the Class were aware of representations by Gilead
2
as to the ‘safety and efficacy’ of Remdesivir.
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.)
6
include persons who were injured or died “as a result of
7
[Veklury’s] administration . . . .”
8
Put another way, plaintiffs allege (1) acts by defendant, (2)
9
injuries to plaintiffs, and (3) a causal relationship between the
To the extent
Finally, plaintiffs’ class definition explicitly
(Id. ¶ 9 (emphasis added).)
10
two.
11
allegations regarding act, injury, and causation manifestly
12
implicate the broad protections provided by Section 247b-
13
6d(a)(2).
14
Every major noun and verb comprising plaintiffs’
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.
19
Providence Health & Services, No. CV 23-9082-JFW(JPRX), 2024 WL
20
487769 (C.D. Cal. Feb. 6, 2024).
21
found that PREP Act immunity applies against similar claims
22
regarding COVID-19 drugs.
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.
See generally Baghikian v.
Several other courts have also
See, e.g., Bird v. State, 2023 WY 102,
14
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.
18
v. Marquez, 942 F.2d 617, 628 (9th Cir. 1991).
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
Roth
Because Rule
Here, the court concludes that amendment would be
23
futile.
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
27
28
The applicability of PREP Act immunity against these
Accordingly, the court need not consider whether
plaintiffs’ claims are inadequately pled or the applicability of
the learned intermediary doctrine.
5
15
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.6
9
Dated:
February 21, 2024
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
The court expresses no opinion on the viability of
different claims which might be brought in the appropriate court
under the PREP Act’s willful misconduct exception, 42 U.S.C. §
247d-6d(d)(1), or compensation sought under the PREP Act’s
Covered Countermeasures Process Fund, id. § 247d-6e.
16
6
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