Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 1 of 41
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`PAIGE M. TOMASELLI (State Bar No. 237737)
`The Law Office of Paige Tomaselli
`P.O. Box 71022
`Richmond, CA 94807
`T: (619) 339-3180
`paige@tomasellilaw.com
`
`CRISTINA R. STELLA (State Bar No. 305475)
`LARISSA LIEBMANN (pro hac vice)
`Animal Legal Defense Fund
`525 E. Cotati Avenue
`Cotati, CA 94931
`T: (707) 795-2533
`cstella@aldf.org
`lliebmann@aldf.org
`
`Counsel for Plaintiffs
`
`
`THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`
`ANIMAL LEGAL DEFENSE FUND,
`et al.,
` Plaintiffs,
` v.
`
`ALEX AZAR, et al.,
`
` Defendants,
`
`and
`
`ELANCO ANIMAL HEALTH,
`
` Intervenor-Defendant.
`
`
`
`
`
`Case No. 3:20-cv-03703-RS
`PLAINTIFFS’ OPPOSITION TO
`DEFENDANTS’ AND INTERVENOR’S
`MOTIONS TO DISMISS
`Hearing Date: January 14, 2021
`Hearing Time: 1:30 p.m.
`Department: Courtroom 3
`
`Honorable Richard Seeborg
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`CASE NO. 3:20-cv-03703-RS
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`PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ AND INTERVENOR’S MOTIONS TO DISMISS
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 2 of 41
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`TABLE OF CONTENTS
`
`INTRODUCTION........................................................................................................................... 1
`
`BACKGROUND............................................................................................................................. 2
`
`STANDARD OF REVIEW..............................................................................................................5
`
`ARGUMENT……………………………………………………………………………………...6
`
`I. Plaintiffs Have Standing.............................................................................................................6
`
`A. Plaintiffs Have Adequately Alleged Associational Standing..........................................7
`
`B. Plaintiffs Have Adequately Alleged Injury-in-Fact........................................................8
`
`1. Experior’s Presence in the Food Supply is Imminent.........................................8
`
`2. FDA’s Approval of Experior Causes Plaintiffs to Suffer
`Legally-Cognizable Harms.............................................................................. 10
`
`3. Plaintiffs’ Harms Constitute Injury-in-Fact Under the FDCA..........................13
`
`4. Plaintiffs’ Harms Constitute Injury-in-Fact Under NEPA................................15
`
`C. Plaintiffs’ Injuries Are Fairly Traceable to FDA’s Action and Redressable by
`this Court……………......……………………………………………………………18
`
`II. Plaintiffs Exhausted Administrative Remedies........................................................................22
`
`A. FDA Regulations Permit Exhaustion Through a Stay Petition……………………….22
`
`B. The Stay Petition Alerted the Expert Agency to Plaintiffs’ Concerns and
`Provided the Agency the First Opportunity to Correct its Mistakes..............................25
`
`C. A Stay of this Action Requiring Plaintiffs to File a Duplicative Petition
`Would Waste Judicial and Administrative Resources and Cause Unnecessary
`and Unwarranted Delays..............................................................................................28
`
`III. Plaintiffs’ First Claim for Relief States a Claim........................................................................29
`
`CONCLUSION..............................................................................................................................32
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`CASE NO. 3:20-cv-03703-RS
`PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ AND INTERVENOR’S MOTIONS TO DISMISS
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 3 of 41
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`
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`
`
`TABLE OF AUTHORITIES
`
`
`Federal Cases
`Abbott Labs. v. Gardner,
`387 U.S. 136 (1967) ................................................................................................................... 28
`
`
`Abigail All. for Better Access to Developmental Drugs v. Eschenbach,
`469 F.3d 129 (D.C. Cir. 2006) ..................................................................................................... 7
`
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ............................................................................................................... 5, 30
`
`
`Ass’n of Am. Physicians & Surgeons, Inc. v. FDA,
`539 F. Supp. 2d. 4 (D.D.C. 2008) .............................................................................................. 25
`
`
`Barker v. Riverside Cty. Office of Educ.,
`584 F.3d 821 (9th Cir. 2009) ........................................................................................................ 6
`
`
`Baur v. Veneman,
`352 F.3d 625 (2d Cir. 2003) ....................................................................................... 7, 13, 14, 20
`
`
`Bell Atlantic Corp. v. Twombly,
`550 U.S. 544 (2007) ............................................................................................................... 5, 30
`
`
`Bennett v. Spear,
`520 U.S. 154 (1997) ............................................................................................................... 6, 19
`
`
`Bontkowski v. Smith,
`305 F.3d 757 (7th Cir. 2002) ...................................................................................................... 31
`
`
`Bowen v. Massachusetts,
`487 U.S. 879 (1988) ................................................................................................................... 28
`
`
`Buckingham v. Dep’t of Agric.,
`603 F.3d 1073 (9th Cir. 2010) .................................................................................................... 28
`
`
`Cantrell v. City of Long Beach,
`241 F.3d 674 (9th Cir. 2001) ...................................................................................................... 17
`
`
`Cent. Delta Water Agency v. United States,
`306 F.3d 938 (9th Cir. 2002) ...................................................................................................... 16
`
`
`Citizens for Better Forestry v. U.S. Dep’t of Agric.,
`341 F.3d 961 (9th Cir. 2003) ................................................................................................ 17, 18
`
`
`City of Davis v. Coleman,
`521 F.2d 661 (9th Cir. 1975) ...................................................................................................... 29
`
`
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 4 of 41
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`
`
`
`City of Los Angeles v. Lyons,
`461 U.S. 95 (1983) ..................................................................................................................... 16
`
`
`Clapper v. Amnesty Int’l USA,
`568 U.S. 398 (2013) ................................................................................................................... 15
`
`
`Ctr. for Envtl. Health v. Perdue,
`2018 WL 9662437 (N.D. Cal. Aug. 21, 2018) ........................................................................... 15
`
`
`Ctr. for Food Safety v. Hamburg,
`142 F. Supp. 3d 898 (N.D. Cal. 2015) ....................................................................................... 24
`
`
`Ctr. for Food Safety v. Hamburg,
`696 F. App’x 302 (9th Cir. 2016)......................................................................................... 24, 25
`
`
`Ctr. for Food Safety v. Price,
`2018 WL 4356730 (S.D.N.Y. Sept. 12, 2018) ..................................................................... 19, 20
`
`
`Darby v. Cisneros,
`509 U.S. 137 (1993) ................................................................................................................... 28
`
`
`Delano Farms Co. v. Cal. Table Grape Comm’n,
`623 F. Supp. 2d 1144 (E.D. Cal. 2009) ...................................................................................... 32
`
`
`Dep’t of Transp. v. Pub. Citizen,
`541 U.S. 752 (2004) ............................................................................................................. 28, 29
`
`
`Dichter-Mad Family Partners, LLP v. U.S.,
`709 F.3d 749 (9th Cir. 2013) ........................................................................................................ 5
`
`
`Ecological Rights Found. v. Pac. Lumber Co.,
`230 F.3d 1141 (9th Cir. 2000) .................................................................................................... 16
`
`
`Ecology Ctr. of La., Inc. v. Coleman,
`515 F.2d 860 (5th Cir. 1975) ...................................................................................................... 29
`
`
`Envtl. Def. Fund v. Envtl. Prot. Agency,
`922 F.3d 446 (D.C. Cir. 2019) ................................................................................................... 19
`
`
`Fla. Audubon Soc’y v. Bentsen,
`94 F.3d 658 (D.C. Cir. 1996) ..................................................................................................... 16
`
`
`Foust v. Page,
`2014 WL 3340916 (D. Az. July 8, 2014) ................................................................................... 31
`
`
`Friends of the Clearwater v. Dombeck,
`222 F.3d 552 (9th Cir. 2000) ...................................................................................................... 29
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 5 of 41
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`
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`Friends of the Earth, Inc., v. Laidlaw Envtl. Servs. (TOC), Inc.,
`528 U.S. 167 (2000) ..................................................................................................................... 6
`
`
`Gettman v. Drug Enf’t Admin.,
`290 F.3d 430 (D.C. Cir. 2002) ..................................................................................................... 8
`
`
`Great Basin Mine Watch v. Hankins,
`456 F.3d 955 (9th Cir. 2006) ...................................................................................................... 26
`
`
`Greene v. Bowen,
`639 F. Supp. 554 (C.D. Cal. 1986) ............................................................................................. 31
`
`
`Herrington v. Johnson & Johnson Consumer Co., Inc.,
`2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) ............................................................................. 15
`
`
`Hunt v. Wash. State Apple Growers Ass’n,
`432 U.S. 333 (1977) ................................................................................................................. 6, 7
`
`
`Idaho Sporting Cong., Inc. v. Rittenhouse,
`305 F.3d 957 (9th Cir. 2002) ...................................................................................................... 26
`
`
`Int’l Harvester Credit Corp. v. East Coast Truck,
`547 F.2d 888 (5th Cir. 1977) ...................................................................................................... 32
`
`
`Jenkins v. McKeithen,
`395 U.S. 411 (1969) ................................................................................................................... 30
`
`
`Jordan v. United States,
`2015 WL 5919945 (S.D. Cal. Oct. 8, 2015) ............................................................................... 32
`
`
`Lacey v. Maricopa Cty.,
`693 F.3d 896 (9th Cir. 2012) ........................................................................................................ 6
`
`
`Laird v. Integrated Res., Inc.,
`897 F.2d 826 (5th Cir. 1990) ...................................................................................................... 31
`
`
`Lands Council v. McNair,
`629 F.3d 1070 (9th Cir. 2010) .............................................................................................. 26, 27
`
`
`Lands Council v. Vaught,
`198 F. Supp. 2d 1211 (E.D. Wash. 2002) .................................................................................. 29
`
`
`League v. Mumma,
`956 F.2d 1508 (9th Cir. 1992) .................................................................................................... 16
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`
`Leonard v. Clark,
`12 F.3d 885 (9th Cir. 1993) .......................................................................................................... 8
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 6 of 41
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`Lujan v. Defs. of Wildlife,
`504 U.S. 555 (1992) ............................................................................................................ passim
`
`
`Lujan v. Nat’l Wildlife Fed’n,
`497 U.S. 871 (1990) ..................................................................................................................... 5
`
`
`Massachusetts v. EPA,
`549 U.S. 497 (2007) ................................................................................................................... 21
`
`
`Maya v. Centex Corp.,
`658 F.3d 1060 (9th Cir. 2011) .................................................................................................. 5, 7
`
`
`Mendia v. Garcia,
`768 F.3d 1009 (9th Cir. 2014) .................................................................................................... 18
`
`
`Mendoza v. Perez,
`754 F.3d 1002 (D.C. Cir. 2014) ................................................................................................. 18
`
`
`Mexichem Specialty Resins, Inc. v. Envtl. Prot. Agency,
`787 F.3d 544 (D.C. Cir. 2015) ................................................................................................... 32
`
`
`Monaco v. Liberty Life Assurance Co.,
`2007 WL 420139 (N.D. Cal. Feb. 6, 2007) ................................................................................ 31
`
`
`Motor Vehicle Mfrs. Assoc. v. State Farm Mutual Auto. Ins. Co.,
`463 U.S. 29 (1983) ..................................................................................................................... 31
`
`
`Native Ecosystems v. Dombeck,
`304 F.3d 886 (9th Cir. 2002) .......................................................................................... 25, 26, 27
`
`
`Nat’l Park Conservation Ass’n v. BLM,
`606 F. 3d 1058 (9th Cir. 2010) ....................................................................................... 25, 26, 27
`
`
`Nat’l Pork Producers Council v. EPA,
`635 F.3d 738 (5th Cir. 2011) ...................................................................................................... 19
`
`
`Nat. Res. Def. Council v. EPA,
`464 F.3d 1 (D.C. Cir. 2006) ....................................................................................................... 16
`
`
`Nat. Res. Def. Council v. FDA,
`710 F.3d 71, 80 (2d Cir. 2013) ............................................................................................ passim
`
`
`Nat. Res. Def. Council v. U.S. Consumer Product Safety Comm’n,
`2017 WL 3738464 (S.D.N.Y. Aug. 18, 2017) ........................................................................... 20
`
`
`Nw. Tissue Ctr. v. Shalala,
`1 F.3d 522 (7th Cir. 1993) .......................................................................................................... 29
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 7 of 41
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`Ocean Advocates v. U.S. Army Corps of Eng’rs,
`402 F.3d 846 (9th Cir. 2005) ...................................................................................................... 16
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`Or. Advocacy Ctr. v. Mink,
`322 F.3d 1101 (9th Cir. 2003) ...................................................................................................... 8
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`Or. Nat. Desert Ass’n v. McDaniel,
`751 F.Supp. 2d 1151 (D. Or. 2011) ............................................................................................ 27
`
`
`Pennsylvania v. West Virginia,
`262 U.S. 553 (1923) ................................................................................................................... 16
`
`
`Safe Air for Everyone v. Meyer,
`373 F.3d 1035 (9th Cir. 2004) ...................................................................................................... 6
`
`
`Salmon River Concerned Citizens v. Robertson,
`32 F.3d 1346 (9th Cir.1994) ....................................................................................................... 17
`
`
`San Luis & Delta–Mendota Water Auth. v. U.S. Dep’t of Interior,
`905 F. Supp. 2d 1158 (E.D. Cal. 2012) ...................................................................................... 16
`
`
`Shaughnessy v. Pedreiro,
`349 U.S. 48 (1955) ..................................................................................................................... 28
`
`
`Sierra Club v. Marsh,
`872 F.2d 497 (1st Cir. 1989) ...................................................................................................... 16
`
`
`Sierra Club v. Trump,
`977 F.3d 853 (9th Cir. 2020) ................................................................................................ 19, 21
`
`
`Skilstaf, Inc. v. CVS Caremark Corp.,
`669 F.3d 1005 (9th Cir. 2012) ...................................................................................................... 5
`
`
`Stauber v. Shalala,
`895 F. Supp. 1178 (W.D. Wis. 1995) ................................................................................... 14, 28
`
`
`Summers v. Earth Island Inst.,
`555 U.S. 488 (2009) ................................................................................................................... 16
`
`
`Tamosaitis v. URS Inc.,
`781 F.3d 468 (9th Cir. 2015) ...................................................................................................... 26
`
`
`U.S. Citrus Sci. Council v. U.S. Dep’t of Agric.,
`2017 WL 4844376 (E.D. Cal. Oct. 25, 2017) ............................................................................ 16
`
`
`Warth v. Seldin,
`422 U.S. 490 (1975) ..................................................................................................................... 6
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`Case 3:20-cv-03703-RS Document 39 Filed 11/30/20 Page 8 of 41
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`Winter v. Nat. Res. Def. Council,
`555 U.S. 7 (2008) ....................................................................................................................... 18
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`
`Wolfe v. Strankman,
`392 F.3d 358 (9th Cir. 2004) ........................................................................................................ 6
`
` Z
`
` Channel, Ltd. v. Home Box Office, Inc.,
`931 F.2d 1338 (9th Cir. 1991) .................................................................................................... 32
`
`
`‘Illio’ulaokalani Coal. v. Rumsfeld,
`464 F.3d 1083 (9th Cir. 2006) .................................................................................................... 28
`
`Federal Statutes
`5 U.S.C. § 702 ................................................................................................................................. 3
`5 U.S.C. § 705 ........................................................................................................................... 4, 32
`5 U.S.C. § 706 ............................................................................................................................. 3, 4
`21 U.S.C. § 360b ....................................................................................................................... 2, 21
`21 U.S.C. § 393 ............................................................................................................................... 2
`42 U.S.C. § 4332 ............................................................................................................................. 3
`
`Federal Rules
`Fed. R. Civ. P. 8(a)(2) ..................................................................................................................... 5
`Fed. R. Civ. P. 54(c) ..................................................................................................................... 32
`
`Federal Regulations
`21 C.F.R. § 10.20 ............................................................................................................................ 2
`21 C.F.R. § 10.25 ...................................................................................................................... 2, 28
`21 C.F.R. § 10.35 ................................................................................................................ 3, 23, 30
`21 C.F.R. § 10.40 ...................................................................................................................... 2, 29
`21 C.F.R. § 10.45 ...................................................................................................... 2, 3, 22, 23, 30
`21 C.F.R. § 20.61 ............................................................................................................................ 2
`21 C.F.R. pt. 25 ............................................................................................................................. 29
`21 C.F.R. § 25.1 ........................................................................................................................ 2, 28
`21 C.F.R. § 25.10 .......................................................................................................................... 29
`21 C.F.R. § 514.1 ............................................................................................................................ 2
`40 C.F.R. § 1500.1 .......................................................................................................................... 3
`40 C.F.R. § 1502.14 ........................................................................................................................ 3
`40 C.F.R. § 1508.7 .......................................................................................................................... 3
`40 C.F.R. § 1508.8 .................................................................................................................... 3, 21
`40 C.F.R. § 1508.14 ........................................................................................................................ 3
`76 Fed. Reg. 65,431 (Oct. 21, 2011) ............................................................................................. 19
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`INTRODUCTION
`Plaintiffs Animal Legal Defense Fund (ALDF), Food & Water Watch (FWW), and Food
`
`Animal Concerns Trust (FACT) (collectively Plaintiffs) challenge a nationwide approval by the
`Food and Drug Administration (FDA or the Agency) that allows for the widespread agricultural
`use of Experior, a novel and controversial animal drug, in cattle feedlots across the country. The
`FDA approved Experior without adequately considering the animal health, public health, and
`environmental impacts of Experior’s use. Within weeks of Experior’s approval, Plaintiff ALDF
`petitioned the FDA to stay the approval unless and until the Agency conducted a more thorough
`analysis of these harms, one that complies with the FDA’s statutory mandates under the Federal
`Food, Drug, and Cosmetic Act (FDCA) and the National Environmental Policy Act (NEPA). The
`FDA issued a final decision denying ALDF’s petition, and in doing so, it acknowledged each of
`Plaintiffs’ concerns and had the opportunity to address them.
`
`Experior’s imminent, widespread distribution harms Plaintiffs’ members and threatens
`the natural environments and rural landscapes where they recreate and live. Plaintiffs’ members
`are beef consumers who are harmed because they cannot avoid exposure to Experior in the food
`supply while consuming conventionally-raised beef and, because there is no way for them to
`know whether Experior is being used in the meat they purchase, they are forced to change their
`purchasing habits or forgo beef consumption altogether. Other members are rural residents who
`live and recreate in close proximity to beef feedlots where Experior is approved for use, and beef
`producers and business owners whose businesses stand to suffer from Experior’s approval. All of
`these members rely heavily on the FDA to ensure animal drugs are safe, effective, and
`environmentally sound. Plaintiffs’ injuries are legally cognizable under the FDCA and NEPA,
`directly traceable to the FDA’s actions, and redressable by this Court.
`Both the FDA’s and Elanco’s Motions to Dismiss overstate the standard of review at this
`early stage of litigation, mischaracterize the harms to Plaintiffs’ members, and misconstrue
`Plaintiffs’ allegations, claims, and requests for relief. Plaintiffs have amply established subject
`matter jurisdiction, have exhausted their administrative remedies, and have adequately pled their
`claims. The Court should deny the Motions.
`
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`CASE NO. 3:20-cv-03703-RS
`PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ AND INTERVENOR’S MOTIONS TO DISMISS
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`BACKGROUND
`Statutory Background. This action involves three statutes: the FDCA, NEPA, and the
`Administrative Procedure Act (APA). In enacting the FDCA in 1938, Congress provided the
`FDA with the authority and obligation to protect public health and safety by overseeing certain
`food products, drugs, and cosmetics. 21 U.S.C. § 393. The FDCA governs the use of all animal
`drugs. Id. § 360b. In order to legally sell an animal drug, the drug manufacturer must petition the
`FDA for approval in the form of a New Animal Drug Application, requesting the FDA to issue a
`regulation authorizing and prescribing lawful conditions for the drug’s use. Id. § 360b(b)(1); 21
`C.F.R. § 10.25(a)(1). The FDA’s approval of an animal drug is a final agency action, published
`in the Federal Register, and effective immediately as a regulation under the FDCA. 21 U.S.C.
`§ 360b(i).
` In approving an animal drug, the FDA analyzes the drug’s effects on human and animal
`health. Id. § 360b(d); 21 C.F.R. § 514.1. The FDA is also required to comply with NEPA and
`assess the effects of a drug on the environment prior to approving it. 21 C.F.R.
`§§ 514.1(b)(14), 25.1 (“All agencies of the Federal Government shall comply with the
`procedures in section 102(2) of NEPA except where compliance would be inconsistent with
`other statutory requirements.”). The FDA is not required to engage in notice-and-comment
`rulemaking to issue new animal drug regulations, id. § 10.40(e)(3), and is exempt from public
`disclosure of drug-related information, see id. §§ 10.20(j), 20.61. Thus, the FDA typically does
`not make its approval and corresponding NEPA determination public until the Agency has taken
`final action.
`The FDA regulations provide several ways that interested persons can challenge the
`FDA’s administrative actions, including its approval of new animal drugs. The FDA regulations
`require that an interested person submit “a petition under § 10.25(a) . . . before any legal action is
`filed in a court complaining of the action or failure to act.” Id. § 10.45(b). Section 10.25(a)
`creates a non-exhaustive list of potential petitions that an interested person may use to challenge
`an administrative action. One type of petition is a petition for a stay of action. Id. §§ 10.25(a)(1),
`10.35(b). An interested person can, within 30 days of the approval, request that the FDA stay a
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`particular approval pending further review. Id. § 10.35(b). The FDA Commissioner must grant a
`stay in any proceeding if all of the following apply: (1) the petitioner will otherwise suffer
`irreparable injury; (2) the petitioner’s case is not frivolous and is being pursued in good faith;
`(3) the petitioner has demonstrated sound public policy grounds supporting a stay; and (4) the
`delay resulting from the stay is not outweighed by public health or other public interests. Id.
`§ 10.35(e)(1). The FDA’s decision to grant or deny a petition to stay is a separate final agency
`action subject to immediate judicial review. Id. § 10.45(d).
`NEPA is “our basic national charter for protection of the environment.” 40 C.F.R.
`§ 1500.1(a). The twin pillars of NEPA are the requirements that agencies (1) carefully evaluate
`the environmental impacts of major federal actions before undertaking the action, and (2) fully
`advise the public of the potential impacts of those actions. Id. § 1500.1.
`In a NEPA analysis, the federal agency—here, the FDA—must identify the direct,
`indirect, and cumulative impacts of the proposed action and consider alternative actions and their
`impacts before making an irreversible and irretrievable commitment of resources. 42 U.S.C.
`§ 4332(2)(C); 40 C.F.R. §§ 1508.7, 1508.8, 1502.14. “Impacts” include ecological, aesthetic,
`historic, cultural, economic, social, or health—a wide range of potential effects on the quality of
`the human environment. 40 C.F.R. § 1508.8. NEPA also requires agencies to evaluate economic
`or social and natural or physical environmental effects that are interrelated. Id. § 1508.14.
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`NEPA procedures must insure that environmental information is available to public
`officials and citizens before decisions are made and before actions are taken. The
`information must be of high quality. Accurate scientific analysis, expert agency
`comments, and public scrutiny are essential to implementing NEPA.
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`Id. § 1500.1(b) (emphasis added).
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`The APA grants a right of judicial review to “[a] person suffering legal wrong because of
`agency action, or adversely affected or aggrieved by agency action . . . .” 5 U.S.C. § 702. Under
`the APA, a court must “hold unlawful and set aside agency action . . . found to be . . . arbitrary,
`capricious, an abuse of discretion, or otherwise not in accordance with law . . . .” Id. § 706(2)(A).
`A court must also “hold unlawful and set aside” any agency action taken that is “in excess of
`statutory jurisdiction, authority, or limitations, or short of statutory right.” Id. § 706(2)(C).
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`CASE NO. 3:20-cv-03703-RS
`PLAINTIFFS’ OPPOSITION TO DEFENDANTS’ AND INTERVENOR’S MOTIONS TO DISMISS
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`Finally, a court shall also “hold unlawful and set aside” any agency action that was promulgated
`“without observance of procedure required by law.” Id. § 706(2)(D).
`The section of the APA governing preliminary relief allows “the reviewing court” to
`“issue all necessary and appropriate process to postpone the effective date of an agency action or
`to preserve status or rights pending conclusion of the review proceedings” to “the extent
`necessary to prevent irreparable injury.” Id. § 705. It therefore authorizes courts to stay agency
`action pending judicial review.
`Factual Background. On November 6, 2018, the FDA approved Experior, a beta
`3-adrenergic agonist/antagonist (“β3-AA”) animal drug. First Amended Complaint (FAC) ¶ 1.
`Beta-adrenergic agonist/antagonist (“β-AA”) drugs like Experior are linked to significantly
`higher mortality rates in c