Court Opinion

ID: 4090101
Source: CourtListenerOpinion
Date Created: 2016-10-17 21:01:29.232151+00
Date Added: 2024-06-11T07:46:00.107198
License: Public Domain

NOT FOR PUBLICATION

                    UNITED STATES COURT OF APPEALS
                                                                           FILED
                            FOR THE NINTH CIRCUIT
                                                                           OCT 17 2016
                                                                        MOLLY C. DWYER, CLERK
                                                                         U.S. COURT OF APPEALS
PHYSICIANS FOR INTEGRITY IN                      No.   14-56907
MEDICAL RESEARCH, INC.,
                                                 D.C. No.
              Plaintiff-Appellant,               2:14-cv-00755-JAK-FFM

 v.
                                                 MEMORANDUM*
STEPHEN OSTROFF, Commissioner,
Food and Drug Administration,

              Defendant-Appellee.

                    Appeal from the United States District Court
                       for the Central District of California
                    John A. Kronstadt, District Judge, Presiding

                            Submitted October 4, 2016**
                               Pasadena, California

Before: D.W. NELSON and PAEZ, Circuit Judges, and BUCKLO,*** District

Judge.

         *
             This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
         **
             The panel unanimously concludes this case is suitable for decision
without oral argument. See Fed. R. App. P. 34(a)(2).
       Physicians for Integrity in Medical Research, Inc. (PIMR) filed this action

against the Food and Drug Administration (FDA) alleging that the FDA’s refusal

to revoke the approval given to the drug roflumilast was arbitrary and capricious

under 5 U.S.C. § 706(2)(A). The district court dismissed PIMR’s complaint for

lack of standing, and PIMR now appeals. We have jurisdiction under 28 U.S.C.

§ 1291, and we affirm.

1.     Any alleged injury must have a “causal connection . . . [to] the conduct

complained of — the injury has to be fairly traceable to the challenged action of

the defendant, and not the result of the independent action of some third party not

before the court.” Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (1992)

(internal quotation marks, alterations, and ellipses omitted).

       Dr. Nilesh Desai, a member of PIMR who filed a declaration in this action,

is unable to demonstrate that any of his alleged injuries is “fairly traceable” to the

FDA. Because Dr. Desai does not have standing, PIMR also does not have

standing. See Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528

U.S. 167, 181 ( 2000) (“An association has standing to bring suit on behalf of its

members when its members would otherwise have standing to sue in their own

right.”).

                                           2
      All of Dr. Desai’s claims rely on the independent decisions of actors

unrelated to the FDA. With respect to PIMR’s claims that Dr. Desai will lose

patients and suffer a loss of reputation, even assuming that Dr. Desai has suffered

injuries-in-fact, these injuries would arise from the independent decisions made by

his patients. Patients who choose to stop seeing Dr. Desai as a result of Dr. Desai’s

comments regarding roflumilast, or who end up finding him less reputable, are

making an independent choice unrelated to the FDA’s actions. See Clapper v.

Amnesty Int’l USA, 133 S. Ct. 1138, 1150 (2013) (declining to “endorse standing

theories that rest on speculation about the decisions of independent actors”).

      PIMR’s allegation that Dr. Desai suffers injury because he will be

uncompensated for the time he spends explaining to patients his beliefs regarding

roflumilast fails for the same reason. Whether and how Dr. Desai is compensated

depends on insurance carriers’, HMOs’, Medicaid’s, and Medicare’s rules

regarding reimbursement, not on the FDA.

2.    PIMR’s argument that it should be granted standing in this case in order to

allow patients to sue the FDA is not supported by caselaw. See id. at 1154 (“[T]he

assumption that if respondents have no standing to sue, no one would have

standing, is not a reason to find standing.”) (citation and internal quotation marks

omitted).

                                           3
AFFIRMED.

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