Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 1 of 23
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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.
`
`
`
`
`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,
`
` THE UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`SAN FRANCISCO DIVISION
`
` No. 3:20-CV-03703-RS
`
`
`
`FEDERAL DEFENDANTS’ REPLY BRIEF IN
`SUPPORT OF THEIR MOTION TO DISMISS
`THE 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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`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 2 of 23
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`TABLE OF CONTENTS
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`STATEMENT OF ISSUES TO BE DECIDED ....................................................................................... 1
`BACKGROUND ....................................................................................................................................... 1
`ARGUMENT ............................................................................................................................................. 1
`I. Plaintiffs Remain Unable To Demonstrate Injury In Fact And Therefore Lack Standing ............ 2
`A. Plaintiffs’ Members Do Not Face Actual Or Imminent Harm .......................................... 2
`B. Plaintiffs Also Fail To Establish That Exposure To An Enhanced Risk Alone Is
`Sufficient To Qualify As Injury In Fact ............................................................................. 5
`C. Plaintiffs’ Members Lack A Concrete Interest Necessary For Procedural Injury ............. 9
`II. Plaintiffs Also Fail To Demonstrate Standing Because Their Members’ Harms, If
` Any, Are Fairly Traceable To Causes Other Than FDA’s Approval Of Experior ...................... 11
`III. Plaintiffs Likewise Fail To Show That A Favorable Decision Would Redress Any
` Harms Sustained By Their Members ........................................................................................... 14
`CONCLUSION ........................................................................................................................................ 15
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 3 of 23
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`TABLE OF AUTHORITIES
`CASES
`
`
`Ashley Creek Phosphate Co. v. Norton,
`420 F.3d 934 (9th Cir. 2005) .............................................................................................................. 9
`Ashley Creek Props., L.L.C. v. Timchak,
`649 F. Supp. 2d 1171 (D. Idaho 2009),
`aff’d sub nom. Ashley Creek Props., L.L.C. v. Larson,
`403 F. App’x 273 (9th Cir. 2010) ....................................................................................................... 9
`Baur v. Veneman,
`352 F.3d 625 (2d Cir. 2003) ................................................................................................... 5, 6, 7, 8
`Cantrell v. City of Long Beach,
`241 F.3d 674 (9th Cir. 2001) ........................................................................................................ 9, 11
`Cent. Delta Water Agency v. United States,
`306 F.3d 938 (9th Cir. 2002) .............................................................................................................. 5
`Citizens for Better Forestry v. USDA,
`341 F.3d 961 (9th Cir. 2003) ............................................................................................................ 10
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013) .............................................................................................................. 3, passim
`Cottonwood Env’t Law Ctr. v. U.S. Forest Serv.,
`789 F.3d 1075 (9th Cir. 2015) .......................................................................................................... 11
`Ctr. for Biological Diversity v. EPA,
`861 F.3d 174 (D.C. Cir. 2017) .................................................................................................... 11, 12
`Ctr. for Env’t Health v. Perdue,
`No. 18-cv-01763-RS, 2018 WL 9662437 (N.D. Cal. Aug. 21, 2018) .......................................... 7, 13
`Ctr. for Food Safety v. Price,
`No. 17-CV-3833 (VSB), 2018 WL 4356730 (S.D.N.Y. Sept. 12, 2018) ................................... 13, 14
`Env’t Def. Fund v. EPA,
`922 F.3d 446 (D.C. Cir. 2019) .......................................................................................................... 11
`Fla. Audubon Soc’y v. Bentsen,
`94 F.3d 658 (D.C. Cir. 1996) .............................................................................................................. 5
`Herrington v. Johnson & Johnson Consumer Cos.
`No. C 09-1597 CW, 2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) .................................................... 8
`Hunt v. Wash. State Apple Advert. Comm’n,
`432 U.S. 333 (1977) ........................................................................................................................... 2
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`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 4 of 23
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`In re Apple iPhone Antitrust Litig.,
`No. 11-CV-06714-YGR, 2013 WL 4425720 (N.D. Cal. Aug. 15, 2013) .......................................... 1
`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992) ..................................................................................................................... 9, 14
`Massachusetts v. EPA,
`549 U.S. 497 (2007) ......................................................................................................................... 14
`McGee v. S-L Snacks Nat’l,
`--- F.3d ---, 2020 WL 7087008 (9th Cir. Dec. 4, 2020) ...................................................................... 8
`Mendia v. Garcia,
`768 F.3d 1009 (9th Cir. 2014) .......................................................................................................... 12
`Mendoza v. Perez,
`754 F.3d 1002 (D.C. Cir. 2014) .................................................................................................. 13, 15
`Nat. Res. Def. Council v. U.S. Consumer Prod. Safety Comm’n,
`No. 16-cv-9401 (PKC), 2017 WL 3738464 (S.D.N.Y. Aug. 18, 2017) ........................................... 13
`Nat. Res. Def. Council, Inc. v. U.S. FDA,
`710 F.3d 71 (2d Cir. 2013), as amended (Mar. 21, 2013) ........................................................ 6, 7, 13
`Nuclear Info. & Res. Serv. v. Nuclear Regul. Comm’n,
`457 F.3d 941 (9th Cir. 2006) ........................................................................................................ 9, 10
`San Diego Cnty. Gun Rights Comm. v. Reno,
`98 F.3d 1121 (9th Cir. 1996) ............................................................................................................ 12
`San Luis & Delta-Mendota Water Auth. v. Haugrud,
`848 F.3d 1216 (9th Cir. 2017) ............................................................................................................ 9
`Schmier v. U.S. Court of Appeals for the Ninth Circuit,
`279 F.3d 817 (9th Cir. 2002) .............................................................................................................. 2
`Sierra Club v. Trump,
`977 F.3d 853 (9th Cir. 2020) ...................................................................................................... 12, 14
`Spokeo, Inc. v. Robins,
`136 S. Ct. 1540 (2016) ........................................................................................................................ 7
`Stauber v. Shalala,
`895 F. Supp. 1178 (W.D. Wis. 1995) ................................................................................................. 7
`Sugar Cane Growers Coop. of Fla. v. Veneman,
`289 F.3d 89 (D.C. Cir. 2002) ............................................................................................................ 11
`Summers v. Earth Island Inst.,
`555 U.S. 488 (2009) ............................................................................................................ 7, 9, 10, 15
`
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`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Susan B. Anthony List v. Driehaus,
`573 U.S. 149 (2014) ....................................................................................................................... 5, 7
`Tozzi v. U.S. Dep’t of Health & Human Servs.,
`271 F.3d 301 (D.C. Cir. 2001) .......................................................................................................... 12
`Valley Forge Christian Coll. v. Ams. United for Separation of Church & State,
`454 U.S. 464 (1982) ........................................................................................................................... 3
`Warth v. Seldin,
`422 U.S. 490 (1975) ........................................................................................................................... 1
`Wilderness Soc’y, Inc. v. Rey,
`622 F.3d 1251 (9th Cir. 2010) .......................................................................................................... 10
`Zeneca, Inc. v. Shalala,
`213 F.3d 161 (4th Cir. 2000) .............................................................................................................. 4
`
`Other
`
`Fed. R. Civ. P. 12(b)(1) ............................................................................................................................ 1
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`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 6 of 23
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`FEDERAL DEFENDANTS’ REPLY BRIEF IN SUPPORT OF THEIR
`MOTION TO DISMISS THE FIRST AMENDED COMPLAINT
`STATEMENT OF ISSUES TO BE DECIDED
`Whether Plaintiffs Animal Legal Defense Fund (“ALDF”), Food & Water Watch (“FWW”), and
`
`Food Animal Concerns Trust (“FACT”) (collectively, “Plaintiffs”) failed to establish associational
`standing through their members, thereby requiring dismissal of the First Amended Complaint
`(hereinafter, “Amended Complaint”) for lack of Article III standing under Fed. R. Civ. P. 12(b)(1).1
`BACKGROUND
`Defendants Alex Azar, Stephen Hahn, and the United States Food and Drug Administration
`(“FDA,” and collectively, “Federal Defendants”) respectfully incorporate by reference the factual
`circumstances and procedural posture described in their Memorandum of Points and Authorities in
`support of their Motion to Dismiss the First Amended Complaint, filed on October 29, 2020. ECF No.
`36. That same day, Intervenor-Defendant Elanco, US, Inc. (“Elanco”) also sought dismissal of the
`Amended Complaint. ECF No. 35. On November 30, 2020, Plaintiffs filed a brief opposing both
`motions. ECF No. 39.
`
`ARGUMENT
`Plaintiffs raise various concerns with feedlots and animal drugs, but such concerns alone do not
`furnish Article III standing for this challenge to FDA’s approval of Experior. Federal Defendants
`described at length why Plaintiffs have not established injury in fact, causation, or redressability.
`However, despite submitting a ream of declarations for the Court’s consideration,2 Plaintiffs still have
`
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`1 Although Federal Defendants’ Motion to Dismiss also raised the issue of whether Plaintiffs have
`established organizational standing, Plaintiffs’ Opposition expressly disclaims any pursuit of
`organizational standing. Pls.’ Opp’n at 6 n.1, ECF No. 39.
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`2 While Plaintiffs rely on Warth v. Seldin to argue that they may submit this “supplemental evidence”
`even in response to a facial jurisdictional challenge, Pls.’ Opp’n at 6, the case itself makes clear that this
`Court has the discretion to decide whether to permit such supplementation, either through declarations or
`an amended pleading. 422 U.S. 490, 501–02 (1975). In light of the nature of Federal Defendants’
`challenge, the Court should “consider[] those declarations only with respect to whether leave to amend
`should be granted,” In re Apple iPhone Antitrust Litig., No. 11-CV-06714-YGR, 2013 WL 4425720, at
`*7 & n.6 (N.D. Cal. Aug. 15, 2013), which would be futile in this case for the reasons discussed herein.
`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`not shown (1) that any of their members has been exposed to Experior; (2) whether or when any of their
`members (or the geographic areas where they live or recreate) will be exposed; (3) that, even if exposure
`were to occur, any actual harm would befall either their members or the surrounding environment;
`(4) that, even in the unlikely event that harm did occur, such harm would result from FDA’s approval,
`rather than other causes, including the actions of third parties or the members themselves; or (5) that, in
`light of these deficiencies, any favorable decision by this Court could furnish redress. The Court should
`therefore dismiss this case.
`I.
`Plaintiffs Remain Unable To Demonstrate Injury In Fact And Therefore Lack Standing.
`Plaintiffs’ Members Do Not Face Actual Or Imminent Harm.
`A.
`By acknowledging that Experior is not yet on the market, Plaintiffs effectively concede that their
`members3 have not sustained any actual harm from Experior at present. See Pls.’ Opp’n at 8–9. Rather,
`Plaintiffs raise the prospect of imminent harm, based on Elanco’s references to a product launch that may
`occur sometime over the next year. See id. at 9. But Plaintiffs have not identified any authority for the
`notion that the potential launch of a drug at an indefinite point in the future threatens imminent harm.
`And even if a launch on that time frame could theoretically threaten imminent harm to someone, still
`Plaintiffs must show that harm to their members is imminent, in order to establish associational standing.
`See Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333, 342–43 (1977). They have not done so.
`Instead, Plaintiffs try to skirt the legal requirement of a member-specific showing of imminent
`harm by relying on a factual assertion. Plaintiffs acknowledge that they do not know—and argue they
`“will never be able” to confirm—“which specific feedlots will use Experior.” Pls.’ Opp’n at 8–9. Yet
`even if that assertion is true (a point Federal Defendants do not concede),4 it does not absolve Plaintiffs
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`3 Plaintiffs submit declarations attesting that Plaintiff FACT has members and supporters whose injuries
`FACT can rely on to establish standing. Pls.’ Opp’n at 8 n.3; see generally Roach Decl., ECF No. 39-3.
`Because the FACT member allegations largely track the allegations of other Plaintiffs’ members, at this
`stage of the litigation Federal Defendants do not challenge the sufficiency of the evidence that FACT has
`members but reserve the right to assess, and challenge as appropriate, Plaintiffs’ support for these
`allegations at later stages of the case if it survives this motion. See Schmier v. U.S. Court of Appeals for
`the Ninth Circuit, 279 F.3d 817, 823 (9th Cir. 2002) (discussing standards of proof for standing at
`different stages of litigation).
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`4 Plaintiffs do not claim that they would be scientifically unable to ascertain the presence of Experior
`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 8 of 23
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`of the Article III requirement to establish an imminent threat of harm to their members. And although
`Plaintiffs claim that holding them to their burden would “permanently insulate [FDA and Elanco] from
`judicial review,” id., the Supreme Court has flatly rejected that argument for dispensing with standing
`requirements, reasoning in part that an “assumption that if [Plaintiffs] have no standing to sue, no one
`would have standing, is not a reason to find standing,” Clapper v. Amnesty Int’l USA, 568 U.S. 398, 420
`(2013) (quoting Valley Forge Christian Coll. v. Ams. United for Separation of Church & State, Inc., 454
`U.S. 464, 489 (1982) (internal quotation marks omitted)). Indeed, Plaintiffs’ “view would convert
`standing into a requirement that must be observed only when satisfied.” Valley Forge, 454 U.S. at 489.
`Plaintiffs’ specific allegations of harm to their members reflect speculation, not an imminent
`threat.5 The consumer members are concerned about “potentially unsafe animal drug residues—and
`Experior, specifically—in beef,” Pls.’ Opp’n at 10 (emphasis added), but Plaintiffs fail to allege that
`Experior is currently on the market, how Experior would reach their members if it became available for
`sale, or how Experior has or will imminently harm human health through beef consumption. See Fed.
`Defs.’ Mem. at 14–15. Indeed, according to one of Plaintiffs’ own members, Experior “for the most part
`passes through the animal and ends up in the waste.” Lobdell Decl. ¶ 10, ECF No. 39-7 (emphasis added).
`As for what may remain in the animal, Plaintiffs ignore FDA’s regulations limiting Experior
`residues in food-producing animals. See Fed. Defs.’ Mem. at 15 & n.5 (citing regulations setting an
`equivalent threshold for arsenic in drinking water). That omission enables Plaintiffs to avoid explaining
`why the Experior limits are unsafe, for either humans or cattle. Nor do they explain why those regulations
`will not be enforced. Because FDA has already “carr[ied] out its duties” to protect consumers, Plaintiffs
`have no reason to shoulder “the FDA’s burden” by making their own assessments of drug safety. See
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`once it is marketed, through measures such as analysis of food or groundwater.
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`5 Plaintiffs’ Opposition reframes the alleged harms to Plaintiffs’ members that serve as the basis for
`associational standing in a way that differs from the Amended Complaint. Whereas the Amended
`Complaint mainly discusses effects of feedlots and beta-agonists as a class, (see Am. Compl. ¶¶ 63–120,)
`the Opposition focuses on harms from eating beef that may contain Experior residue; harms to
`recreational and environmental interests (including drinking water); and harms to the business of a beef
`producer. See Pls.’ Opp’n at 10–12. In this Reply, Federal Defendants focus on the injuries Plaintiffs
`discuss in their Opposition. For the other injuries alleged in Plaintiffs’ Amended Complaint but not
`discussed in their Opposition, Federal Defendants rely on the arguments in their opening brief.
`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Pls.’ Opp’n at 10; cf., e.g., Zeneca, Inc. v. Shalala, 213 F.3d 161, 170 (4th Cir. 2000) (recognizing “the
`FDA’s judgments as to what is required to ascertain the safety and efficacy of drugs fall squarely within
`the ambit of the FDA’s expertise and merit deference from” the court (internal quotation marks omitted)).
`Plaintiffs likewise speculate about water contamination and other environmental harms faced by
`members who live or recreate in some geographic areas. Pls.’ Opp’n at 11–12. But Plaintiffs have not
`offered any non-speculative reason for believing feedlots in those areas are likely to use Experior, or that
`any such use would contaminate the environment. Fed. Defs.’ Mem at 9, 11. Instead, Plaintiffs rely on
`alleged harms that pre-date Experior, chiefly, the contamination of waterways with “animal drug-laden
`feedlot pollution.” Pls.’ Opp’n at 11. Yet any such pollution with unspecified drugs does not show that
`Experior poses an imminent threat of harm, either “on its own [or] in combination.”6 See id. at 12.
`Because of members’ speculative concerns with drug safety and environmental harm, they
`allegedly incur a further set of “harms” by avoiding eating food that may contain Experior residues7 and
`refraining from certain recreational activities. Id. at 10–11. But as Federal Defendants explained, courts
`must reject Plaintiffs’ attempts to “manufacture standing merely by inflicting harm on themselves based
`on their fears of hypothetical future harm that is not certainly impending.” Clapper, 568 U.S. at 416. In
`Clapper, the Supreme Court held that expenses incurred in an effort to avoid surveillance did not generate
`standing because plaintiffs’ fears were based on a “highly attenuated chain of possibilities.” Id. at 410.
`So too here, there is no “certainly impending” harm. See Fed. Defs.’ Mem. at 9, 11–17.
`Lastly, Plaintiffs urge standing based on an alleged economic injury to a beef-producing member,
`who raises drug-free meat and is concerned about the collateral effects of Experior’s approval on
`consumer trust in his product. Pls.’ Opp’n at 12; Bearce Decl. ¶ 10, ECF No. 39-9. But Plaintiffs did not
`respond to Federal Defendants’ critique that this harm, too, is “wholly speculative: there are no allegations
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`6 Plaintiffs also fail to explain how FDA’s alleged inability to guarantee that “Experior is effective for its
`intended purpose” establishes an injury in fact. See Pls.’ Opp’n at 12.
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`7 To the extent consumer members are also concerned about the “cumulative amount of drug residues
`they already consume through cow, pig, and turkey products,” Pls.’ Opp’n at 11, those harms fall outside
`the scope of this litigation, which concerns the grounds for FDA’s approval of Experior alone. See Fed.
`Defs.’ Mem. at 19–20 & n.9.
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`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`that approval of other beta-agonists has had such an effect on the member’s business, nor is there any
`suggestion of whether or when such feared changes [in public perceptions of beef safety and labeling]
`would affect his business.”8 Fed. Defs.’ Mem. at 17 n.8. Plaintiffs could just as easily project an increase
`in the member’s business because “a customer base [ ] very concerned with wanting the meat they
`purchase to be safe to consume,” may find his “drug-free, humanely raised beef,” Bearce Decl. ¶ 10, more
`attractive if such customers share Plaintiffs’ concerns about Experior. These unsubstantiated fears,
`accordingly, do not constitute injury in fact. See Clapper, 568 U.S. at 420 (denying standing where
`plaintiffs “present no concrete evidence to substantiate their fears, but instead rest on mere conjecture”).
`Plaintiffs Also Fail To Establish That Exposure To An Enhanced Risk Alone Is
`B.
`Sufficient To Qualify As Injury In Fact.
`In the context of their arguments about food safety, Plaintiffs incorrectly claim that they can
`establish injury in fact merely by alleging “exposure to an enhanced risk” in a consumer product. Pls.’
`Opp’n at 13 (quoting Baur v. Veneman, 352 F.3d 625, 628 (2d Cir. 2003)). But mere exposure to any
`increase in risk is insufficient to create standing; instead, the risk must be “substantial” so as to create a
`“credible threat” of harm. Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158–59 (2014) (internal
`quotation marks omitted); see also Baur, 352 F.3d at 637 (“Given the potentially expansive and nebulous
`nature of enhanced risk claims, . . . plaintiffs . . . must allege a ‘credible threat of harm’ to establish
`injury-in-fact based on exposure to enhanced risk.” (emphasis added) (citing Cent. Delta Water Agency
`v. United States, 306 F.3d 938, 950 (9th Cir. 2002)); cf. Fla. Audubon Soc’y v. Bentsen, 94 F.3d 658, 669
`(D.C. Cir. 1996) (en banc) (requiring “substantial probability that . . . agency action . . . created a
`demonstrable risk, or caused a demonstrable increase in an existing risk, of injury” to establish causation
`in procedural injury case (citation omitted)).
`The cases relied on by Plaintiffs recognize two ways in which a toxic exposure plaintiff can
`adequately allege a credible threat of harm: “(1) ‘uncontested exposure to a potentially harmful
`
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`8 As discussed in Federal Defendants’ opening brief, beta-agonists are a class of animal drugs that activate
`certain receptors known as beta-1, beta-2, and beta-3. Fed. Defs.’ Mem. at 20 n.10. Experior is the first
`new animal drug that FDA’s Center for Veterinary Medicine has approved that specifically activates the
`beta-3 receptor. Id.
`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`Case 3:20-cv-03703-RS Document 41 Filed 12/14/20 Page 11 of 23
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`substance,’ . . . and (2) ‘potential exposure to an undisputedly dangerous contaminant.’” Nat. Res. Def.
`Council, Inc. v. U.S. FDA (NRDC), 710 F.3d 71, 83 (2d Cir. 2013), as amended (Mar. 21, 2013) (quoting
`Baur, 352 F.3d at 634 n.8). Where a plaintiff established that its member had actually been exposed to
`triclosan, and further established that triclosan presented “a credible threat notwithstanding the
`uncertainty as to triclosan’s harmfulness to humans,” the plaintiff had adequately shown injury in fact.9
`Id. at 81–84. And where a plaintiff alleged that he might be exposed to a consumer product—beef from
`downed cattle infected with mad cow disease—that would cause a “deadly disease with no known cure
`or treatment,” Baur, 352 F.3d at 637, he had adequately alleged standing.
`In contrast, potential exposure to a potentially harmful substance is insufficient to create standing.
`See NRDC, 710 F.3d at 85–86. Although in NRDC, the court determined that the plaintiff had standing
`to challenge the FDA’s treatment of triclosan, it lacked standing as to a different substance, triclocarban,
`to which its members had not been “directly exposed.” Id. at 85. Even though the plaintiff presented
`evidence that triclocarban “may harm human health” as an “endocrine disruptor[],” id. at 78 (internal
`quotation marks omitted), the plaintiff’s inability to establish its members’ exposure to triclocarban
`deprived it of an injury in fact. The Second Circuit specifically rejected the claim that triclocarban “may
`lead to the development of antibiotic-resistant bacteria” as creating only a “contingent and far-off” injury
`insufficient to establish standing. Id. at 85–86.
`Similarly here, Plaintiffs fail to allege anything more than potential exposure to a potentially
`harmful substance. Plaintiffs do not claim they have been or will be actually exposed to Experior, as they
`concede that Experior is not even on the market and that they do not know where, if anywhere, Experior
`will be used. See supra at 2. Nor have Plaintiffs presented any allegations that Experior is indisputably
`dangerous to humans. See, e.g., Roach Decl. ¶ 24 (claiming only that Experior is a “potentially unsafe
`drug,” without any explanation for how it might harm human health). At best, Plaintiffs claim that
`Experior may contribute “to the rise in antibiotic resistant pathogens,” Lobdell Decl. ¶ 15, thereby
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`9 Plaintiffs cannot draw support from NRDC’s treatment of Clapper. See Pls.’ Opp’n at 15. It was on
`the basis of actual exposure to triclosan that NRDC distinguished Clapper, which involved “uncertainty
`about possible government conduct.” NRDC, 710 F.3d at 82–83 (emphasis added). NRDC’s distinction
`offers no support here, where Plaintiffs fail to allege that their members have actually been exposed to
`Experior. This case is therefore governed by Clapper, not NRDC.
`Federal Defendants’ Reply Brief in Support of Their Motion to Dismiss – Case No. 3:20-CV-03703-RS
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`repeating the rejected theory of standing to sue for exposure to triclocarban in NRDC, 710 F.3d at 85–86.
`The other two cases Plaintiffs cite to support their theory are similar to the basis for standing in
`NRDC, in that there was clear evidence that the feared harm could not be avoided. In Stauber v. Shalala,
`the plaintiffs were allegedly “unable to consume dairy products known to be free of milk” from cows
`treated with rbST, which the court characterized as a “potentially dangerous” substance based on
`plaintiffs’ allegation of a procedural deficiency, so the court determined they had sustained injury in fact
`based on “their exposure.”10 895 F. Supp. 1178, 1187–88 (W.D. Wisc. 1995). Similarly, in Center for
`Environmental Health v. Perdue, this Court found that the plaintiffs had standing to challenge the U.S.
`Department of Agriculture’s revocation of a proposed regulation containing new standards for organic
`livestock because the plaintiffs were “force[d] [ ] to spend money investigating” information that would
`have been readily available had USDA’s rule been implemented. No. 18-cv-01763-RS, 2018 WL
`9662437, at *1, *4–*5 (N.D. Cal. Aug. 21, 2018). Thus, once again, the plaintiffs were actually exposed
`to the situation or substance they feared.
`Plaintiffs overlook two significant flaws in their claim based on Stauber that their “members are
`entitled to [rely on FDA to accomplish] a food supply free of potentially unsafe foods.” Pls.’ Opp’n at
`14 (drawing analogy to Stauber, 895 F. Supp. at 1187–88). First, to the extent that the portion of Stauber
`on which Plaintiffs rely was once good law, it is no longer so following the Supreme Court’s decisions
`in Summers v. Earth Island Institute, 555 U.S. 488 (2009), Clapper, and Spokeo, Inc. v. Robins, 136 S.
`Ct. 1540 (2016). See Stauber, 895 F. Supp. at 1187–88 (suggesting that speculative injuries are
`cognizable contrary to Clapper and that bare procedural violations of a statute give rise to Article III
`standing contrary to Summers and Spokeo). As the Supreme Court recently confirmed, “Article III
`standing requires a concrete [and particularized] injury even in the context of a statutory violation,”
`Spokeo, 136 S. Ct. at 1549, thereby requiring at least a “substantial risk” of harm, Driehaus, 573 U.S. at
`158 (internal quotation marks om