Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 1 of 35
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`JEFFREY BOSSERT CLARK
`Acting Assistant Attorney General
`DANIEL J. FEITH
`Deputy Assistant Attorney General
`GUSTAV W. EYLER
`Director
`HILARY K. PERKINS
`Assistant Director
`JONATHAN E. AMGOTT (DCBN 1031947)
`Trial Attorney
`Consumer Protection Branch
`U.S. Department of Justice
`P.O. Box 386
`Washington, DC 20044-0386
`Telephone: 202-532-5025
`Facsimile: 202-514-8742
`E-mail: Jonathan.E.Amgott@usdoj.gov
`Attorneys for Federal Defendants
`ALEX AZAR, STEPHEN HAHN, and
`U.S. FOOD AND DRUG ADMIN.
`
`
` THE UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`SAN FRANCISCO DIVISION
`
`
`
`ANIMAL LEGAL DEFENSE FUND,
`FOOD & WATER WATCH, and FOOD
`ANIMAL CONCERNS TRUST,
`Plaintiffs,
`v.
`ALEX AZAR, Secretary of the United States
`Department of Health and Human Services;
`STEPHEN HAHN, Commissioner of the
`United States Food and Drug Administration;
`and UNITED STATES FOOD AND DRUG
`ADMINISTRATION,
`Defendants,
`
` No. 3:20-CV-03703-RS
`
`
`
`FEDERAL DEFENDANTS’ NOTICE OF
`MOTION AND MOTION TO DISMISS FIRST
`AMENDED COMPLAINT
`
`Hearing Date: Thursday, January 14, 2021
`Hearing Time: 1:30 p.m.
`Courtroom: 3
`
`Hon. Richard Seeborg
`
`
`and
`ELANCO ANIMAL HEALTH,
` Intervenor-Defendant.
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 2 of 35
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`TABLE OF CONTENTS
`
`B.
`
`
`NOTICE OF MOTION AND MOTION TO DISMISS ........................................................................... 1
`RELIEF SOUGHT .................................................................................................................................... 1
`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF FEDERAL
`DEFENDANTS’ MOTION TO DISMISS THE FIRST AMENDED COMPLAINT ................. 1
`INTRODUCTION .................................................................................................................................... 1
`STATEMENT OF ISSUES TO BE DECIDED ....................................................................................... 3
`BACKGROUND ...................................................................................................................................... 3
`LEGAL STANDARD ............................................................................................................................... 4
`ARGUMENT ........................................................................................................................................... 4
`I.
`Neither Plaintiffs Nor Their Members Have Suffered An Injury In Fact. .................................... 5
`Plaintiffs Do Not Have Organizational Standing Because The Organizations
`A.
`Have Not Established Their Own Injury In Fact. ............................................................. 5
`Plaintiffs Do Not Have Associational Standing Because Their Members Have
`Not Suffered Injury In Fact. .............................................................................................. 7
`Air And Water Contamination .............................................................................. 9
`
`Industrial Farming Operations ............................................................................ 11
`
`Outdoor Recreation And Wildlife Observation .................................................. 13
`
`Food Safety ......................................................................................................... 14
`
`Plaintiffs Fail To Adequately Allege That Any Purported Harms Were Caused By
`FDA’s Approval Of Experior. .................................................................................................... 17
`Many Of The Alleged Harms Are Attributable To Existing Third-Party Feedlot
`A.
`Practices. ......................................................................................................................... 18
`B. Many of the Alleged Harms Are Not Attributable to Experior Specifically. ................. 19
`C. The Alleged Harms Would Be Caused, If At All, By Third Parties, Not Experior. ....... 20
`D.
`Self-Inflicted Harms Are Not Fairly Traceable To FDA’s Approval. ............................ 22
`The Amended Complaint Fails To Allege That A Favorable Decision Would Redress
`Plaintiffs’ Asserted Harms. ......................................................................................................... 22
`CONCLUSION ....................................................................................................................................... 25
`
`
`II.
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`
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`III.
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`Federal Defendants’ Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 3 of 35
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`TABLE OF AUTHORITIES
`CASES
`
`Allen v. Wright,
`468 U.S. 737 (1984) ............................................................................................................................ 24
`
`Ashley Creek Phosphate Co. v. Norton,
`420 F.3d 934 (9th Cir. 2005) ........................................................................................................... 8, 10
`
`Ass’n of Am. Physicians & Surgeons, Inc. v. FDA,
`539 F. Supp. 2d 4 (D.D.C. 2008),
` aff’d, 358 F. App’x 179 (D.C. Cir. 2009) (per curiam) ...................................................................... 13
`
`Backus v. Gen. Mills, Inc.,
`122 F. Supp. 3d 909 (N.D. Cal. 2015) ................................................................................................ 15
`
`Boysen v. Walgreen Co.,
`No. C 11-06262 SI, 2012 WL 2953069 (N.D. Cal. July 19, 2012)..................................................... 15
`
`Carroll v. Nakatani,
`342 F.3d 934 (9th Cir. 2003) ................................................................................................................. 7
`
`Citizens for Quality Educ. San Diego v. Barrera,
`333 F. Supp. 3d 1003 (S.D. Cal. 2018) ................................................................................................. 6
`
`City of Los Angeles v. Lyons,
`461 U.S. 95 (1983) .............................................................................................................................. 12
`
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013) ................................................................................................................. 2, passim
`
`Ctr. for Biological Diversity v. U.S. Dep’t of Interior,
`563 F.3d 466 (D.C. Cir. 2009) ............................................................................................................ 21
`
`DaimlerChrysler Corp. v. Cuno,
`547 U.S. 332 (2006) .............................................................................................................................. 4
`
`Friends of Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,
`528 U.S. 167 (2000) .............................................................................................................................. 4
`
`Frye v. L’Oreal USA, Inc.,
`583 F. Supp. 2d 954 (N.D. Ill. 2008) .................................................................................................. 15
`
`Gordon v. United States,
`739 F. App’x 408 (9th Cir. 2018) ..................................................................................................... 4, 7
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`Federal Defendants’ Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Greenlining Inst. v. Fed. Commc’ns Comm’n,
`802 F. App’x 232 (9th Cir. 2020) ......................................................................................................... 6
`
`Havens Realty Corp. v. Coleman,
`455 U.S. 363 (1982) .............................................................................................................................. 5
`
`Haynie v. Harris, No. C,
`10-01255 SI, 2014 WL 899189 (N.D. Cal. Mar. 4, 2014),
` aff’d, 658 F. App’x 834 (9th Cir. 2016). ............................................................................................... 6
`
`Herrington v. Johnson & Johnson Consumer Cos., No. C,
`09-1597 CW, 2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) ......................................................... 14, 15
`
`HomeAway Inc. v. City & Cty. of San Francisco,
`No. 14-CV-04859-JCS, 2015 WL 367121 (N.D. Cal. Jan. 27, 2015) ................................................ 25
`
`Hunt v. Wash. State Apple Advert. Comm’n,
`432 U.S. 333 (1977) .................................................................................................................... 2, 7, 11
`
`In re Fruit Juice Prods. Mktg. & Sales Practices Litig.,
`831 F. Supp. 2d 507 (D. Mass. 2011) ................................................................................................. 15
`
`Juliana v. United States,
`947 F.3d 1159 (9th Cir. 2020) ....................................................................................................... 23, 24
`
`Klamath Water Users Ass’n v. Fed. Energy Regulatory Comm’n,
`534 F.3d 735 (D.C. Cir. 2008) .............................................................................................................. 6
`
`Koronthaly v. L’Oreal USA, Inc.,
`374 F. App’x 257 (3d Cir. 2010),
` aff’g, No. 07–CV–5588, 2008 WL 2938045 (D.N.J. July 29, 2008) .................................................. 15
`
`La Asociacion de Trabajadores de Lake Forest v. City of Lake Forest,
`624 F.3d 1083 (9th Cir. 2010) ............................................................................................................... 5
`
`Levine v. Vilsack,
`587 F.3d 986 (9th Cir. 2009) ......................................................................................................... 23, 24
`
`Lexmark Int’l Inc. v. Static Control Components, Inc.,
`572 U.S. 118 (2014) ............................................................................................................................ 24
`
`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992) ................................................................................................................. 5, passim
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`M.S. v. Brown,
`902 F.3d 1076 (9th Cir. 2018) ............................................................................................................. 23
`
`McCarthy v. United States,
`850 F.2d 558 (9th Cir. 1988) ................................................................................................................. 4
`
`Native Vill. of Kivalina v. ExxonMobil Corp.,
`696 F.3d 849 (9th Cir. 2012) ............................................................................................................... 18
`
`Nuclear Info. & Res. Serv. v. Nuclear Regulatory Comm’n,
`457 F.3d 941 (9th Cir. 2006) .................................................................................................... 8, passim
`
`Or. Prescription Drug Monitoring Program v. U.S. Drug Enf’t Admin.,
`860 F.3d 1228 (9th Cir. 2017) ............................................................................................................. 22
`
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`Physicians for Integrity in Med. Rsch., Inc. v. Cm'r,
` No. CV1108334GAFFMOX, 2012 WL 12882760 (C.D. Cal. May 23, 2012),
` aff'd sub nom., Physicians for Integrity in Med. Rsch., Inc. v. Hamburg,
` 556 F. App’x 621 (9th Cir. 2014) ......................................................................................................... 6
`
`Radich v. Guerrero,
`729 F. App’x 623 (9th Cir. 2018) ....................................................................................................... 22
`
`Rodriguez v. City of San Jose,
`930 F.3d 1123 (9th Cir. 2019),
` cert. denied, No. 19-1057 (Oct. 13, 2020) ............................................................................................ 5
`
`Safe Air for Everyone v. Meyer,
`373 F.3d 1035 (9th Cir. 2004) ............................................................................................................... 4
`
`Scott v. Pasadena Unified Sch. Dist.,
`306 F.3d 646 (9th Cir. 2002) ............................................................................................................... 12
`
`Simon v. E. Ky. Welfare Rights Org.,
`426 U.S. 26 (1976) ........................................................................................................................ 20, 23
`
`Smith v. Pac. Props. & Dev. Corp.,
`358 F.3d 1097 (9th Cir. 2004) ........................................................................................................... 2, 5
`
`Spokeo, Inc. v. Robins,
`136 S. Ct. 1540 (2016) ...................................................................................................................... 4, 7
`
`Summers v. Earth Island Inst.,
`555 U.S. 488 (2009) .............................................................................................................................. 7
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`Susan B. Anthony List v. Driehaus,
`573 U.S. 149 (2014) .................................................................................................................... 2, 7, 13
`
`Tulacz v. Tri-Cty. Metro. Transp. Dist. of Oregon,
`No. CIV. 91-1010-JO, 1992 WL 205942 (D. Or. July 14, 1992) ....................................................... 13
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`Tyler v. Cuomo,
`236 F.3d 1124 (9th Cir. 2000) ............................................................................................................... 2
`
`United States v. Richardson,
`418 U.S. 166 (1974) ............................................................................................................................ 12
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`Vill. of Arlington Heights v. Metro. Hous. Dev. Corp.,
`429 U.S. 252 (1977) .............................................................................................................................. 5
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`Warth v. Seldin,
`422 U.S. 490 (1975) ............................................................................................................ 4, 11, 12, 23
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`Wash. Envtl. Council v. Bellon,
`732 F.3d 1131 (9th Cir. 2013) ................................................................................................. 18, 20, 21
`
`Whitmore v. Arkansas,
`495 U.S. 149 (1990) ........................................................................................................................ 7, 12
`
`Wilderness Soc., Inc. v. Rey,
`622 F.3d 1251 (9th Cir. 2010) ....................................................................................................... 11, 24
`
`Wolfe v. Strankman,
`392 F.3d 358 (9th Cir. 2004) ................................................................................................................. 4
`
`STATUTES
`
`5 U.S.C. § 551 ............................................................................................................................................ 1
`21 U.S.C. § 301 .......................................................................................................................................... 1
`21 U.S.C. § 603(a) ................................................................................................................................... 17
`42 U.S.C. § 4321 ........................................................................................................................................ 1
`
`Fed. R. Civ. P. 12(b)(1).......................................................................................................................... 3, 4
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`RULES
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 7 of 35
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`REGULATIONS
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`9 C.F.R. § 309.2 ...................................................................................................................................... 17
`21 C.F.R. § 10.30 ....................................................................................................................................... 6
`21 C.F.R. § 10.35 ................................................................................................................................... 3, 6
`21 C.F.R. § 165.110(b)(4)(iii)(A) ............................................................................................................ 15
`21 C.F.R. § 556.370 ................................................................................................................................. 15
`40 C.F.R. § 141.62(b)(16) ........................................................................................................................ 15
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 8 of 35
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`NOTICE OF MOTION AND MOTION TO DISMISS
`TO ALL PARTIES AND THEIR ATTORNEYS OF RECORD:
`PLEASE TAKE NOTICE that on Thursday, January 14, 2021, at 1:30 p.m., or as soon thereafter
`as they may be heard in San Francisco Courthouse, Courtroom 3 (17th Floor), Defendants Alex Azar,
`Stephen Hahn, and the United States Food and Drug Administration (“FDA,” and collectively, “Federal
`Defendants”), by and through counsel, will and hereby do move to dismiss this action, filed on June 4,
`2020, by Plaintiffs Animal Legal Defense Fund (“ALDF”), Food & Water Watch (“FWW”), and Food
`Animal Concerns Trust (“FACT”) (collectively, “Plaintiffs”), for lack of Article III standing, pursuant to
`Rule 12(b)(1) of the Federal Rules of Civil Procedure. Defendants’ Motion is based on this Notice, the
`Points and Authorities incorporated herein, any matters for which the Court may take judicial notice, and
`any written and oral argument and authorities that are presented at or before the hearing on this Motion.
`RELIEF SOUGHT
`Defendants seek an order dismissing the First Amended Complaint (hereinafter, “Amended
`
`Complaint”) under Rule 12(b)(1) because Plaintiffs have not established organizational standing, nor do
`they show associational standing through their members, who lack an injury in fact that is fairly traceable
`to Defendants’ action nor is it likely redressable by a ruling in their favor.
`MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF FEDERAL
`DEFENDANTS’ MOTION TO DISMISS THE FIRST AMENDED COMPLAINT
`
`INTRODUCTION
`Plaintiff organizations ALDF, FWW, and FACT ask this Court to vacate FDA’s approval of the
`new animal drug Experior, which is approved to reduce ammonia gas emissions from cattle. Experior
`belongs to a subtype of a broader category of drugs called “beta-agonists” that facilitate increased
`industrial meat production. Plaintiffs allege that beta-agonists inflict harmful collateral effects on cows,
`humans, and the environment. Invoking these concerns, Plaintiffs claim that FDA’s approval of Experior
`violated the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq., the National
`Environmental Policy Act (“NEPA”), 42 U.S.C. § 4321 et seq., and the Administrative Procedure Act
`(“APA”), 5 U.S.C. § 551, et seq. But Plaintiffs lack Article III standing to bring this suit, and their claims
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`should therefore be dismissed.
`The first deficiency fatal to Plaintiffs’ action is the dearth of a constitutional injury in fact, either
`to Plaintiffs or to their members. Because Plaintiffs have not alleged that they diverted their resources to
`address their asserted harms, they have not established organizational standing. See, e.g., Smith v. Pac.
`Props. & Dev. Corp., 358 F.3d 1097, 1101, 1105 (9th Cir. 2004). Nor have Plaintiffs established
`associational standing through their members, because those members have not suffered harms that are
`both concrete and particularized, and actual or imminent. See, e.g., Hunt v. Wash. State Apple Advert.
`Comm’n, 432 U.S. 333, 342–43 (1977). All of Plaintiffs’ alleged harms fall short of the “certainly
`impending” or “substantial risk” threshold. Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014)
`(quoting Clapper v. Amnesty Int’l USA, 568 U.S. 398, 409, 414 n.5 (2013)).
`Even if the Amended Complaint made out a legally cognizable injury (it does not), Plaintiffs are
`unable to establish causation because they have not shown that any of the purported harms are fairly
`traceable to FDA’s approval of Experior. See Tyler v. Cuomo, 236 F.3d 1124, 1131–32 (9th Cir. 2000).
`Instead, the alleged harms to Plaintiffs’ members are caused by the practices of industrial farms, by other
`drugs used on food-producing cattle, or by the decisions of independent third parties, including feedlot
`operators, or of Plaintiffs’ members themselves. (See, e.g., Am. Compl. ¶¶ 22, 63–75, 91–120.)
`Yet even if the Court were to reach the third element, Plaintiffs still do not satisfy the
`constitutional minimum to bring this case. They have not shown—beyond mere speculation—that any
`harm fairly traceable to FDA’s approval of Experior is likely redressable by this Court. See Tyler, 236
`F.3d at 1131–32. Plaintiffs do not allege that withdrawal of Experior’s approval will lead to fewer
`industrial farms or reduce the use of similar drugs. Indeed, they do not allege that it would have any
`impact on the decisions of third parties concerning the feedlot industry and other beta-agonists. Nor
`could that withdrawal remedy precautions that Plaintiffs’ members themselves may have already taken.
`Plaintiffs have therefore not shown that the relief they seek will remedy their alleged injuries.
`For these reasons, and as further explained below, the Court should grant Federal Defendants’
`Motion and dismiss Plaintiffs’ claims.
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`STATEMENT OF ISSUES TO BE DECIDED
`Whether Plaintiffs failed to establish organizational standing or associational standing through
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`their members, thereby requiring dismissal of the Amended Complaint for lack of Article III standing
`under Fed. R. Civ. P. 12(b)(1).
`
`BACKGROUND
`On November 6, 2018, FDA approved the new animal drug Experior (lubabegron Type A
`medicated article), manufactured by Elanco, US, Inc. (“Elanco”) (First Amended Complaint (“Am.
`Compl.”), ECF No. 30, ¶¶ 1–2.) Experior has been shown to lower ammonia gas emissions in cattle fed
`in confinement for slaughter for the last 14-91 days on feed. (See id. ¶ 1.) Experior is classified as an
`adrenergic agonist/antagonist, which is a subtype of a broader category of drugs known as beta-adrenergic
`agonist/antagonists. (See id. ¶¶ 3, 63.) Experior marks the first new animal drug that FDA’s Center for
`Veterinary Medicine has approved that activates from the beta-3 receptor (“beta-3”) subtype and the first
`new animal drug approved to reduce gas emissions from an animal or its waste. (See id. ¶ 123.)
`On December 6, 2018, Plaintiff ALDF sought a stay of Experior’s approval by submitting a
`Petition for Stay of Action under 21 C.F.R. § 10.35 (“Petition”). (See Am. Compl. ¶¶ 10, 125.) The
`Petition alleged that FDA failed to sufficiently analyze Experior’s environmental impact, did not consider
`alternatives to Experior’s approval, and failed to prepare an Environmental Impact Statement (“EIS”)
`addressing the effects Experior may have on animals, humans, and the environment. (Id. ¶ 9.) The
`Petition requested that FDA stay Experior’s approval until the agency addressed ALDF’s concerns. (See
`id. ¶¶ 9, 10, 125–26.)
`FDA responded to ALDF’s Petition on May 20, 2019 (“Response”) by denying ALDF’s request
`to stay the approval. (See Am. Compl. ¶¶ 11, 128–30.) FDA’s Response addressed each point raised in
`the Petition and concluded that none of ALDF’s arguments established any basis recognized by statute
`or regulation for a stay. (See id.)
`On June 4, 2020, Plaintiffs filed suit, asking this Court to, inter alia, “[v]acate FDA’s decision to
`approve Experior.” (Compl., ECF No. 1, at 34, ¶ 3.) Plaintiffs’ Amended Complaint filed on September
`29, 2020, asserts claims under the FDCA, NEPA, and the APA. (See Am. Compl. at 35–38.) In addition
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`to requesting vacatur of the approval, Plaintiffs pursue declaratory and injunctive relief that includes
`“enjoining the use of Experior” until, in their view, FDA’s approval process “complies” with those three
`statutes. (Id. at 38, Request for Relief ¶ 4.) Elanco has been permitted to join this case as an Intervenor-
`Defendant. (ECF No. 25.) Federal Defendants now move to dismiss this action in its entirety because
`Plaintiffs lack Article III standing.
`
`
`
`LEGAL STANDARD
`Federal Defendants challenge the sufficiency of the jurisdictional allegations in the Amended
`Complaint under Federal Rule of Civil Procedure 12(b)(1). See Safe Air for Everyone v. Meyer, 373 F.3d
`1035, 1039 (9th Cir. 2004). Although a court may “assume [a plaintiff’s] allegations to be true and draw
`all reasonable inferences in [its] favor,” Wolfe v. Strankman, 392 F.3d 358, 362 (9th Cir. 2004), “plaintiff,
`as the party invoking federal jurisdiction, bears the burden of establishing the[] elements” of standing,
`Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). “Where, as here, a case is at the pleading stage,
`the plaintiff must ‘clearly . . . allege facts demonstrating’ each element” of standing to secure this Court’s
`jurisdiction. Id. (quoting Warth v. Seldin, 422 U.S. 490, 518 (1975)). “[W]hen considering a motion to
`dismiss pursuant to Rule 12(b)(1) the district court is not restricted to the face of the pleadings, but may
`review any evidence, such as affidavits and testimony, to resolve factual disputes concerning the
`existence of jurisdiction.” Gordon v. United States, 739 F. App’x 408, 411 (9th Cir. 2018) (quoting
`McCarthy v. United States, 850 F.2d 558, 560 (9th Cir. 1988) (alteration in original)).
`ARGUMENT
`This matter fails to satisfy minimum constitutional requirements for a federal case. Rooted in
`Article III’s limitation of judicial power to cases and controversies, the standing “doctrine limits the
`category of litigants empowered to maintain a lawsuit in federal court to seek redress for a legal wrong.”
`Spokeo, 136 S. Ct. at 1547. A plaintiff must show that it has: “(1) suffered an injury in fact, (2) that is
`fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a
`favorable judicial decision.” Id. That showing must be made for “each claim” asserted, DaimlerChrysler
`Corp. v. Cuno, 547 U.S. 332, 352 (2006), and “separately for each form of relief sought,” Friends of
`Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 185 (2000).
`Federal Defendants’ Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 12 of 35
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`Organizational plaintiffs may establish standing in one of two ways: (1) directly, by demonstrating
`that the organizations themselves satisfy each element of the standing inquiry; or (2) by association,
`through one or more of their members who can meet the standing elements. See Havens Realty Corp. v.
`Coleman, 455 U.S. 363, 378–79 (1982); see also Vill. of Arlington Heights v. Metro. Hous. Dev. Corp.,
`429 U.S. 252, 260–64 (1977).
`Where, as here, plaintiffs are not themselves “the object” of a challenged government action,
`standing is “substantially more difficult to establish.” Lujan v. Defs. of Wildlife, 504 U.S. 555, 562
`(1992). In these instances, independent third parties attenuate the causal chain and undermine the court’s
`ability to furnish redress. Id.
`This is a paradigmatic case of failure to establish standing. The organizations not only fail to
`demonstrate cognizable injury, but also fail to show that the government action caused their alleged harms
`or that such harms would be redressed by this Court. Because Plaintiffs have not discharged their burden,
`the Court should dismiss this case for lack of jurisdiction.
`I.
`Neither Plaintiffs Nor Their Members Have Suffered An Injury In Fact.
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`A.
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`Plaintiffs Do Not Have Organizational Standing Because The Organizations Have
`Not Established Their Own Injury In Fact.
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`An organization may assert injury in fact on its own behalf if it alleges: “(1) frustration of its
`organizational mission; and (2) diversion of its resources” to combat the defendant’s actions. Pac. Props.,
`358 F.3d at 1101, 1105. This standard requires a showing “that the defendant’s actions run counter to
`the organization’s purpose, that the organization seeks broad relief against the defendant’s actions, and
`that granting relief would allow the organization to redirect resources currently spent combating the
`specific challenged conduct to other activities that would advance its mission.” Rodriguez v. City of San
`Jose, 930 F.3d 1123, 1134 (9th Cir. 2019), cert. denied, No. 19-1057 (Oct. 13, 2020). An organization
`cannot “manufacture the [diversion of resources] injury by incurring litigation costs or simply choosing
`to spend money fixing a problem that otherwise would not affect the organization at all.” Id. (quoting La
`Asociacion de Trabajadores de Lake Forest v. City of Lake Forest, 624 F.3d 1083, 1088 (9th Cir. 2010)).
`Even assuming that the Amended Complaint sufficiently pleads that FDA’s approval of Experior
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`Federal Defendants’ Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 36 Filed 10/29/20 Page 13 of 35
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`frustrates Plaintiffs’ missions, Plaintiffs have not established organizational standing because their
`Amended Complaint lacks any allegations regarding resource diversion. Plaintiffs make no effort to
`articulate how, if at all, they have expended financial or other resources in response to Experior’s
`approval. Nor do they argue that they have redirected such resources from other initiatives.
`Plaintiffs’ failure to allege diversion of resources is fatal to any claim of organizational standing.
`See Greenlining Inst. v. Fed. Commc’ns Comm’n, 802 F. App’x 232, 233–34 (9th Cir. 2020) (no standing
`for organizations that failed to prove either prior and ongoing diversion of resources, or an “estimate of
`the resources that will be diverted as a result of the [challenged government] order”); Citizens for Quality
`Educ. San Diego v. Barrera, 333 F. Supp. 3d 1003, 1021 (S.D. Cal. 2018) (no standing where “neither
`organization allege[d] a diversion of resources” (emphasis omitted)); Haynie v. Harris, No. C 10-01255
`SI, 2014 WL 899189, at *7 (N.D. Cal. Mar. 4, 2014) (Illston, J.) (no standing where sole allegation of
`diversion of resources was one organization’s “allegations that it paid for the defense of several
`members,” and organizations did “not allege that they have incurred any expenses aside