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`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 1 of 20
`
`
`
`Emily Johnson Henn (CA Bar No. 269482)
`COVINGTON & BURLING LLP
`3000 El Camino Real
`5 Palo Alto Square
`Palo Alto, California 94306-2112
`Telephone: (650) 632-4700
`Fax: (650) 632-4800
`Email: ehenn@cov.com
`
`Bradley K. Ervin (pro hac vice)
`Virginia A. Williamson (pro hac vice)
`COVINGTON & BURLING LLP
`One CityCenter
`850 10th Street NW
`Washington, DC 20001-4956
`Telephone: (202) 662-6000
`Fax: (202) 662-6291
`Emails: bervin@cov.com
`vwilliamson@cov.com
`
`Attorneys for Intervenor-Defendant
`ELANCO ANIMAL HEALTH
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`Civil Case No. 3:20-cv-03703-JCS
`
`
`ELANCO ANIMAL HEALTH’S
`REPLY IN SUPPORT OF
`MOTION TO DISMISS FOR
`LACK OF ARTICLE III
`STANDING AND FAILURE TO
`EXHAUST ADMINISTRATIVE
`REMEDIES
`
`Date: January 14, 2021
`Time: 1:30 p.m.
`Dept: San Francisco, Courtroom 3
`Judge: Hon. Richard Seeborg
`
`
`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,
`
`and
`
`ELANCO ANIMAL HEALTH,
`
`
`
` Intervenor-Defendant.
`
`
`
`
`
`
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 2 of 20
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF AUTHORITIES ......................................................................................................... ii
`
`INTRODUCTION ..........................................................................................................................1
`
`ARGUMENT ..................................................................................................................................2
`
`I.
`
`PLAINTIFFS HAVE NOT ESTABLISHED ARTICLE III STANDING.........................2
`
`A.
`
`B.
`
`Plaintiffs Have Not Established That Their Members Suffer Or Will Imminently
`Suffer Cognizable Injuries In Fact. .........................................................................2
`
`Plaintiffs Have Not Shown That Their Alleged Injuries Are Fairly Traceable To
`FDA’s Approval of Experior. .................................................................................9
`
`PLAINTIFFS HAVE NOT PROPERLY EXHAUSTED THEIR MANDATORY
`ADMINISTRATIVE REMEDIES. ..................................................................................11
`
`PLAINTIFFS’ FIRST CLAIM SHOULD BE DISMISSED FOR FAILURE
`PROPERLY TO REQUEST RELIEF. .............................................................................14
`
`II.
`
`III.
`
`CONCLUSION.............................................................................................................................15
`
`
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`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`i
`
`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 3 of 20
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`1075 Market Street Owners’ Assoc. v. Dep’t of Health & Human Servs.,
`No. 19-cv-07313, 2020 WL 5229163 (N.D. Cal. Feb. 11, 2020) .............................................4
`
`Adarand Constrs., Inc. v. Pena,
`515 U.S. 200 (1995)..................................................................................................................3
`
`Ass’n of Flight Attendants-CWA, AFL-CIO v. Chao,
`493 F.3d 155 (D.C. Cir. 2007) ................................................................................................14
`
`Ass’n of Flight Attendants, CWA, AFL-CIO v. Dep’t of Transp.,
`564 F.3d 462 (D.C. Cir. 2009) ..................................................................................................9
`
`Azizi v. United States,
`No. 15-cv-07456-CAS, 2015 WL 6755193 (C.D. Cal. Nov. 4, 2015) ...................................14
`
`Baur v. Veneman,
`352 F.3d 625 (2d Cir. 2003) .................................................................................................6, 7
`
`Berni v. Barilla S.p.A.,
`964 F.3d 141 (2d Cir. 2020) ...................................................................................................10
`
`Cent. & S.W. Servs., Inc. v. EPA,
`220 F.3d 683 (5th Cir. 2000) ....................................................................................................8
`
`Citizens for Better Forestry v. Dep’t of Agric.,
`341 F.3d 961 (9th Cir. 2003) ....................................................................................................8
`
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013)........................................................................................................ passim
`
`Ctr. for Bio. Diversity v. EPA,
`937 F.3d 533 (5th Cir. 2019) ............................................................................................1, 3, 8
`
`Ctr. for Bio. Diversity v. Dep’t of Interior,
`563 F.3d 466 (D.C. Cir. 2009) ..................................................................................................3
`
`Ctr. for Env’t Health v. Perdue,
`No. 18-cv-01763-RS, 2018 WL 9662437 (N.D. Cal. Aug. 21 2018) .......................................7
`
`Ctr. for Food Safety v. Hamburg,
`696 F. App’x 302 (9th Cir. 2017) .............................................................................................2
`
`Ctr. for Food Safety v. Hamburg,
`142 F. Supp. 3d 898 (N.D. Cal. 2015) ....................................................................................11
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`ii
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`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 4 of 20
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`Ctr. for Food Safety v. Vilsack,
`636 F.3d 1166 (9th Cir. 2011) ..................................................................................7, 8, 11, 12
`
`Food & Water Watch, Inc. v. Vilsack,
`808 F.3d 905 (D.C. Cir. 2015) ................................................................................................10
`
`Holistic Candlers & Consumers Ass’n v. FDA,
`770 F. Supp. 2d 156 (D.D.C. 2011) ........................................................................................12
`
`Kan. Corp. Comm’n v. FERC,
`881 F.3d 924 (D.C. Cir. 2018) ..................................................................................................3
`
`Lojas v. Washington,
`347 F. App’x 288 (9th Cir. 2009) ...........................................................................................15
`
`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992)..............................................................................................................3, 5
`
`Myers v. Bethlehem Shipbuilding Corp.,
`303 U.S. 41 (1938)..................................................................................................................13
`
`Nat’l Council of La Raza v. Gonzales,
`468 F. Supp. 2d 429 (E.D.N.Y. 2007) ......................................................................................6
`
`Naturo v. Slater,
`888 F.3d 418 (9th Cir. 2018) ....................................................................................................5
`
`NRDC v. FDA,
`710 F.3d 71 (2d Cir. 2013) .......................................................................................................6
`
`Or. Prescription Drug Monitoring Program v. Drug Enf’t Admin.,
`860 F.3d 1228 (9th Cir. 2017) ..................................................................................................5
`
`Robinson v. Wells Fargo Bank Nat’l Ass’n,
`No. 17-cv-1898, 2018 WL 4214988 (W.D. Wash. Sept. 5, 2018) .........................................14
`
`Safe Air for Everyone v. Meyer,
`373 F.3d 1035 (9th Cir. 2004) ..................................................................................................2
`
`Sever v. City of Salem,
`390 F. Supp. 3d 299 (D. Mass. 2019) .......................................................................................6
`
`Sierra Club v. EPA,
`292 F.3d 895 (D.C. Cir. 2002) ..............................................................................................2, 9
`
`Spokeo, Inc. v. Robins,
`136 S. Ct. 1540 (2016) ..............................................................................................................6
`
`Stauber v. Shalala,
`895 F. Supp. 1178 (W.D. Wis. 1995) .......................................................................................6
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`iii
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`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 5 of 20
`
`
`
`Summers v. Earth Island Inst.,
`555 U.S. 488 (2009)......................................................................................................1, 4, 5, 7
`
`Susan B. Anthony List v. Driehaus,
`573 U.S. 149 (2014)..................................................................................................................6
`
`W. Watersheds Project v. Kraayenbrink,
`632 F.3d 472 (9th Cir. 2011) ....................................................................................................8
`
`Woodford v. Ngo,
`548 U.S. 81 (2006)............................................................................................................12, 13
`
`Regulations
`
`21 C.F.R. § 10.25 ......................................................................................................................1, 11
`
`21 C.F.R. § 10.30 ....................................................................................................................13, 15
`
`21 C.F.R. § 10.35 ..........................................................................................................................11
`
`21 C.F.R. § 10.45 ..........................................................................................................................11
`
`Rules
`
`Federal Rule of Civil Procedure 54 ..............................................................................................15
`
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`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`iv
`
`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 6 of 20
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`INTRODUCTION
`Plaintiffs’ Amended Complaint should be dismissed because Plaintiffs have not complied
`with basic prerequisites for bringing suit in federal court.
`First, Plaintiffs have not met their burden of establishing Article III standing. The
`declarations filed by Plaintiffs fail to show that their members face present or imminent harms
`caused by the Food and Drug Administration’s (FDA) approval of Experior. Plaintiffs
`acknowledge that Experior is not being used at any feedlot anywhere, yet claim to suffer present
`injuries based on their members’ purported efforts to avoid exposure to the drug. See Opposition
`Brief, Dkt. 39, 8–9 (“Opp’n”). Those arguments fail because “threatened injury must be certainly
`impending to constitute injury in fact,” and Plaintiffs “cannot manufacture standing by choosing
`to make expenditures based on hypothetical future harm that is not certainly impending.” Clapper
`v. Amnesty Int’l USA, 568 U.S. 398, 402, 409 (2013) (quotation marks omitted). Indeed,
`Plaintiffs’ allegations would fail even if Experior were already on the market, because Plaintiffs
`have not shown the required nexus between FDA’s approval of Experior and the injuries they
`assert. See Summers v. Earth Island Inst., 555 U.S. 488, 496 (2009). Plaintiffs attempt to excuse
`the absence of that showing based on the purported difficulty of making it, but courts have
`repeatedly rejected attempts to bypass Article III’s requirements in that way. See, e.g., Ctr. for
`Bio. Diversity v. EPA, 937 F.3d 533, 539 (5th Cir. 2019) (plaintiffs did “not provide nearly enough
`information to infer, with any degree of certainty,” injury-in-fact from pollutant discharge in Gulf
`of Mexico without accounting for the size of the Gulf or the impacts of “wind, weather, and tides”
`necessary to carry pollution to areas inhabited and visited by plaintiffs).
`Second, Plaintiffs have not adequately exhausted their administrative remedies. One
`Plaintiff’s filing of a stay petition—not the citizen petition required by 21 C.F.R. § 10.25(a)—
`does not suffice to exhaust remedies for that Plaintiff, let alone for two other Plaintiffs that did
`not participate at all in the agency proceedings. The requirement to exhaust mandatory
`administrative remedies before seeking judicial review is particularly important where, as here,
`Plaintiffs are requesting a remedy from the Court—vacatur of the decision approving Experior—
`that no Plaintiff ever sought from FDA, including in the administrative stay petition filed by the
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`1
`
`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 7 of 20
`
`
`
`I.
`
`Animal League Defense Fund (ALDF). The Ninth Circuit addressed a closely related
`circumstance in Center for Food Safety v. Hamburg and held that the “proper[]” approach is for
`Plaintiffs “to comply with the FDA’s citizen petition requirement” before proceeding in court.
`696 F. App’x 302, 303–04 (9th Cir. 2017). The Court should apply the same rule here.
`ARGUMENT
`PLAINTIFFS HAVE NOT ESTABLISHED ARTICLE III STANDING.
`Because Plaintiffs have supplied declarations to establish their members’ standing, they
`may not rest on the allegations in their Amended Complaint and instead must establish standing
`as a factual matter. See Safe Air for Everyone v. Meyer, 373 F.3d 1035, 1039 (9th Cir. 2004)
`(where factual basis for plaintiff’s standing is at issue, “the party opposing the motion [to dismiss]
`must furnish affidavits or other evidence necessary to satisfy its burden of establishing subject
`matter jurisdiction” and courts “need not presume the truthfulness of plaintiff’s allegations”).
`Having exceeded the general allegations of their pleading, Plaintiffs must now provide “specific
`facts” establishing their standing. Sierra Club v. EPA, 292 F.3d 895, 899 (D.C. Cir. 2002)
`(quoting Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992)). Plaintiffs have not carried that
`burden.
`
`A.
`
`Plaintiffs Have Not Established That Their Members Suffer Or Will
`Imminently Suffer Cognizable Injuries In Fact.
`Plaintiffs’ declarations are not sufficient to satisfy Article III’s injury-in-fact requirement.
`
`Plaintiffs contend that their members presently suffer injuries based on Experior’s “imminent”
`presence in the environment and the food supply. Opp’n 8–12. In particular, Plaintiffs contend
`that (1) Elanco’s statements to investors about the company’s desired timeline for Experior’s entry
`onto the market establish imminence, (2) Plaintiffs must presently have standing to challenge
`FDA’s approval of Experior because, when Experior is in use, “Plaintiffs will never be able to
`obtain the information necessary to assert with certainty where Experior is being used,” and
`(3) Plaintiffs’ members have standing because they have been “forced to alter their purchasing
`habits” and curtail their recreation activities to avoid the risk of exposure to Experior residues.
`Opp’n 8–12. Each of Plaintiffs’ theories is insufficient.
`
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`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`2
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`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 8 of 20
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`First, with respect to Experior’s launch date, the burden is on Plaintiffs to establish
`
`imminence, not on Elanco to negate it as Plaintiffs suggest. Regardless, the earnings calls cited
`by Plaintiffs establish precisely what Elanco has argued before this Court: that Experior is not
`presently on the market, that there is no fixed date by which Experior will enter the market, and
`that Elanco currently projects that it will begin marketing Experior by the end of next year but
`does not know exactly when that will be. Plaintiffs claim that statements by an Elanco official
`during two recent earnings calls show otherwise. See Opp’n 9. But Elanco’s belief that Experior
`“remain[s] on track toward . . . launch[] by the end of 2021,” id., does not establish that Experior’s
`release to market is imminent. In fact, Elanco has not consistently projected Experior’s year of
`release, let alone established a concrete date on which the drug will be in use. See Statement of
`Jeffrey Simmons, President and Chief Executive Officer, ELAN Q4 2019 Earnings Call (Feb. 19,
`2020),
`at
`https://investor.elanco.com/events-and-presentations/event-
`available
`details/2020/ELAN-Q4-2019-Earnings-Call/default.aspx (“[W]e plan on launching new products
`in 2020, such as Experior.”).
`
`Even if Elanco’s current projections come to pass and Experior enters the market by the
`end of 2021, Plaintiffs can only speculate that, more than a year into the future, their members
`may face risk of exposure to Experior’s residues. Imminence, though, “cannot be stretched
`beyond its purpose, which is to ensure that the alleged injury is not too speculative for Article III
`purposes—that the injury is certainly impending.” Lujan, 504 U.S. at 565 n.2 (quotation marks
`omitted); see also Adarand Constrs., Inc. v. Pena, 515 U.S. 200, 211 (1995) (“impending” means
`the injury must occur “sometime in the relatively near future”); Ctr. for Bio. Diversity, 937 F.3d
`at 537 (purpose of imminence requirement is to “reduce the possibility of deciding a case in which
`no injury would have occurred at all”). For that reason, courts routinely find that plaintiffs lack
`standing where, as here, they offer only speculative assertions that they may face risk of harm at
`some indefinite point in the future. See, e.g., Kan. Corp. Comm’n v. FERC, 881 F.3d 924, 930
`(D.C. Cir. 2018) (“A petitioner that asserts a harm that may occur ‘some day,’ with no
`‘specification of when the some day will be,’ does not establish standing.” (quoting Lujan, 504
`U.S. at 564)); Ctr. for Bio. Diversity v. Dep’t of Interior, 563 F.3d 466, 478 (D.C. Cir. 2009)
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`3
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`

`

`Case 3:20-cv-03703-RS Document 40 Filed 12/14/20 Page 9 of 20
`
`
`
`(“Petitioners can only aver that any significant adverse effects of climate change ‘may’ occur at
`some point in the future. This does not amount to the actual, imminent, or ‘certainly impending’
`injury required to establish standing.”); 1075 Market Street Owners’ Assoc. v. Dep’t of Health &
`Human Servs., No. 19-cv-07313, 2020 WL 5229163, at *16 (N.D. Cal. Feb. 11, 2020) (“doubtful”
`that “a harm projected two years in the future satisfies th[e] [imminence] requirement”).
`
`Second, Plaintiffs have not established the required nexus between their asserted injuries
`and FDA’s approval of Experior. See Elanco Motion to Dismiss, Dkt. 35, 10–12 (“Mot.”).
`Plaintiffs seek to work around this requirement by arguing that it would be difficult to show that
`particular members face particularized risks of harm. See Opp’n 8–9. The Supreme Court
`foreclosed that argument in Clapper, holding that plaintiffs had not established standing to
`challenge government surveillance programs because the plaintiffs had not shown that their
`communications were likely to be targeted for surveillance. See 568 U.S. at 411–13. The Court
`emphasized that it was plaintiffs’ “burden to prove their standing by pointing to specific facts, not
`the Government’s burden to disprove standing by revealing details of its surveillance priorities.”
`Id. at 412 n.4 (citation omitted). The same principle applies here: Whatever difficulty Plaintiffs
`may face in establishing that their members live, recreate, and shop in areas where Experior will
`be used (or where Experior is otherwise likely to be present),1 the obligation to do so is theirs.
`Moreover, Plaintiffs’ theory, if accepted, would dictate that Plaintiffs would automatically
`have standing to challenge every cattle drug approved by FDA regardless of whether and to what
`extent the drugs affect Plaintiffs’ members. But that is not the law. See Summers, 555 U.S. at
`498. Even if no plaintiff can easily meet the burden of demonstrating standing, that is not a
`justification to bypass Article III’s requirements. See Clapper, 568 U.S. at 420 (“[T]he
`
`
`1 In any event, this Court should disregard Plaintiffs’ bare assertion that “there is no way” for
`them to find out “which specific feedlots will use Experior.” Opp’n 8. Plaintiffs detail no efforts
`to find out which feedlots even may plan to use Experior and offer no more than speculation that
`this information will be unavailable when Experior enters the market. Additionally, Plaintiffs’
`members describe specific circumstances in which other cattle drugs have been used in the past,
`see, e.g., Dkt. 39-8, Decl. of Nick Schutt ¶ 9, making it particularly doubtful that similar
`information will be impossible to obtain regarding Experior.
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
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`assumption that if respondents have no standing to sue, no one would have standing, is not a
`reason to find standing.”).
`
`Plaintiffs’ third alternative theory of injury fares no better. Plaintiffs assert that, regardless
`of whether Experior’s arrival on the market is imminent, they are presently injured because FDA’s
`approval of Experior has “eroded” their members’ “confidence in the safety of the beef supply.”
`Opp’n 8. Plaintiffs contend that, because of concerns about risk of exposure to Experior, their
`members are “forced to alter their purchasing habits by spending more time, energy, and money
`sourcing drug-free beef products” or must “forego beef consumption altogether.” Opp’n 11.
`Plaintiffs also say their members “would recreate in and along their local waterways but for their
`desire to avoid direct contact with animal drug-laden feedlot pollution.” Opp’n 11. But, once
`again, Plaintiffs rely on an argument that the Supreme Court rejected in Clapper: “[Plaintiffs]
`cannot manufacture standing merely by inflicting harm on themselves based on their fears of
`hypothetical future harm that is not certainly impending.” 568 U.S. at 416; see also, e.g., Or.
`Prescription Drug Monitoring Program v. Drug Enf’t Admin., 860 F.3d 1228, 1235 (9th Cir.
`2017) (intervenors suffered only self-inflicted injuries under Clapper where they took
`“preventative measures” to avoid disclosure of medical records they feared DEA would seek,
`regardless of whether intervenors’ fears were serious and reasonable, because the harm alleged
`was not certainly impending).2 The critical point is that an individual has standing only if he or
`she is geographically and temporally proximate to (or purchases beef from) a feedlot where
`Experior will be used, and Plaintiffs have not made such a showing here. E.g., Summers, 555
`
`
`2 Plaintiffs’ members also appear to rely on injuries to cows who may ingest Experior. See Opp’n
`10 (noting members’ “concerns . . . for the welfare of the cows to whom [Experior] is
`administered”); see also, e.g., Dkt. 39-5, Decl. of Shannon Monaghan ¶ 5 (expressing “deep[]
`concern[]” about “the negative effects Experior will have on farmed animals”); Dkt. 39-9, Decl.
`of Mark Bearce ¶ 5 (“From what is known about Experior’s effect on cows, I am concerned about
`the negative effects it will have on farm animals’ well-being.”). Plaintiffs cannot rely on alleged
`injuries to animals to establish standing to bring their National Environmental Policy Act and
`Federal Food, Drug, and Cosmetic Act claims. See Naturo v. Slater, 888 F.3d 418, 422 (9th Cir.
`2018) (“[W]e decline to recognize the right of next friends to bring suit on behalf of animals,
`absent express authorization from Congress.”); cf. Lujan, 504 U.S. at 567 n.3 (“It cannot be that
`a person with an interest in an animal automatically has standing to enjoin federal threats to that
`species of animal, anywhere in the world.”).
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
`
`
`5
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`U.S. at 496 (refusing “to assume” that the declarant “will stumble across” a tract affected by
`allegedly unlawful regulation amongst a large geographic area). Avoidance costs incurred by
`individuals whose lives are unlikely to be affected by Experior are not sufficient.
`
`Plaintiffs likewise err in arguing that they need not comply with Clapper’s certainly-
`impending standard. See Opp’n 13–18. Although Plaintiffs invoke the probabilistic-standing
`theory applied in Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003), subsequent cases have
`substantially narrowed the range of future injuries capable of satisfying Article III’s imminence
`requirement. Following Clapper, the Supreme Court has explained that potential future harm
`qualifies only upon a showing that the harm is “certainly impending” or that there is “a substantial
`risk that the harm will occur,” Susan B. Anthony List v. Driehaus, 573 U.S. 149, 158 (2014), and
`that the harm must “entail a degree of risk sufficient to meet [Article III’s] concreteness
`requirement,” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1550 (2016).3 Courts have thus recognized
`that Baur presents an “outdated” and overly permissive standard. See, e.g., Sever v. City of Salem,
`390 F. Supp. 3d 299, 307 n.4 (D. Mass. 2019); Nat’l Council of La Raza v. Gonzales, 468 F. Supp.
`2d 429, 438-40 (E.D.N.Y. 2007) (declining to apply Baur and observing that its rationale “has
`been criticized by other courts”). Plaintiffs’ claims fail because their declarations do not establish
`a “substantial risk that the [asserted] harm[s] will occur.” Driehaus, 573 U.S. at 158 (emphasis
`added).4 Baur also involved a significantly different factual scenario. In Baur, the plaintiffs had
`
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`3 Plaintiffs assert that “[t]here is no requirement that the risk of future injury satisfy any particular
`threshold of significance, nor of certainty.” Opp’n 16 (cleaned up). But Clapper, Driehaus, and
`Spokeo—which postdate nearly all of the cases Plaintiffs cite—establish that Article III does
`impose those requirements.
`4 Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995), and NRDC v. FDA, 710 F.3d 71 (2d
`Cir. 2013), cited by Plaintiffs (Opp’n 14), are inapposite for much the same reason. To the extent
`these cases hold that a plaintiff may establish standing merely by pointing to an “increased risk
`of potential harm,” Stauber, 895 F. Supp. at 1188, or to evidence that harmful effects “may” arise,
`NRDC, 710 F.3d at 82, those cases apply a less rigorous test than required under the Supreme
`Court’s subsequent decisions. Further, both Stauber and NRDC are distinguishable because there
`was no dispute in either case that the plaintiffs were exposed to the allegedly harmful substances
`at issue. See Stauber, 895 F. Supp. at 1187; NRDC, 710 F.3d at 81 (no genuine dispute that
`plaintiff was “exposed to triclosan at her workplace” and “washe[d] her hands with triclosan-
`containing soap more than fifty times in a typical workday”). Here, in contrast, Plaintiffs have
`not established that their members will ever be exposed to Experior.
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
`Case No. 3:20-cv-03703-JCS
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`established a “moderate increase in the risk” of plaintiffs becoming infected with “a deadly
`disease with no known cure or treatment.” 352 F.3d at 637. Here, Plaintiffs’ members have not
`shown a present or imminent future risk of exposure to Experior, and Plaintiffs’ vague allegation
`that exposure to Experior may be “unsafe” (Opp’n 14) pales in comparison to the extreme and
`well-documented harm faced by the plaintiffs in Baur. Thus, even under the non-binding and
`superseded analysis of Baur, Plaintiffs cannot establish injury here.
`
`Plaintiffs’ analogy to this Court’s decision in Center for Environmental Health v. Perdue
`is equally unavailing. See Opp’n 23. In Perdue, the Court held that plaintiffs had standing to
`challenge the U.S. Department of Agriculture’s withdrawal of a rule that would have created
`nationwide standards for raising, transporting, and slaughtering organic livestock. 2018 WL
`9662437, at *1, 5 (N.D. Cal. Aug. 21 2018). The Court found standing because, unlike the
`plaintiffs in Clapper, the plaintiffs incurred expenses due to non-hypothetical future harms—
`specifically, plaintiffs’ need to “spend money investigating which private labels could be used to
`determine whether the certified USDA organic animal products they consume are in fact produced
`without the use of harmful practices.” Id. at 4–5. Those harms necessarily arose every time the
`Perdue plaintiffs purchased covered animal products, because (1) withdrawal of the rule deprived
`the plaintiffs of information indicating whether the animals had been inhumanly raised,
`transported, or slaughtered, and (2) the informational harm did not depend in any way on third-
`party conduct or other external causes. Not so here. Unlike in Perdue, Plaintiffs can only
`speculate that their members may live near feedlots where Experior is used and may shop at
`grocery stores where beef from cattle given Experior is sold. Plaintiffs’ purported injuries are
`hypothetical under Clapper, thus, any expense their members have incurred is voluntary.
`
`For Plaintiffs’ NEPA claims, they further argue that “increased threat of harm is enough
`to confer standing.” Opp’n 15–16. But Plaintiffs ignore that they must show not only a “threat
`of harm,” but also that the harm is “concrete and particularized.” See Ctr. for Food Safety v.
`Vilsack, 636 F.3d 1166, 1171 (9th Cir. 2011) (citing Summers, 555 U.S. at 493). To meet this
`standard, Plaintiffs must establish a “nexus between the individual asserting the claim and the
`location suffering an environmental impact.” Id. (quoting W. Watersheds Project v.
`ELANCO’S REPLY IN SUPPORT OF MOTION TO DISMISS
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`Kraayenbrink, 632 F.3d 472, 485 (9th Cir. 2011)). In other words, Plaintiffs must show that their
`members “will suffer harm by virtue of their geographic proximity to and use of areas that will be
`affected by the [agency’s action].” Citizens for Better Forestry v. Dep’t of Agric., 341 F.3d 961,
`971 (9th Cir. 2003) (emphasis added). Plaintiffs have not done so.
`
`Plaintiffs purport to meet the nexus requirement by asserting that they have no idea where
`Experior may be used. See, e.g., Dkt. 39-4, Decl. of Kathy Kowalski ¶ 7 (alleging that her
`enjoyment of activities near the Mississippi River “is diminished by knowing Experior’s use on
`feedlots has been approved by FDA” and “the uncertainty of knowing exactly where and in what
`quantities it is being used”). Because Plaintiff