469 F.3d 129 (D.C. Cir. 2006), 04-5350, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach

Docket Nº:04-5350.
Citation:469 F.3d 129
Party Name:ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS and Washington Legal Foundation, Appellants v. Andrew C. Von ESCHENBACH, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration, and Michael O. Leavitt, in his official capacity as Secretary, United States Department of Health and Human Services, Appellees.
Case Date:November 21, 2006
Court:United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit

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469 F.3d 129 (D.C. Cir. 2006)



Andrew C. Von ESCHENBACH, M.D., in his official capacity as Acting Commissioner, Food and Drug Administration, and Michael O. Leavitt, in his official capacity as Secretary, United States Department of Health and Human Services, Appellees.

No. 04-5350.

United States Court of Appeals, District of Columbia Circuit.

November 21, 2006

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[Copyrighted Material Omitted]

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Appeal from the United States District Court for the District of Columbia No. 03cv01601.

Peter G. Keisler, Assistant Attorney General, U.S. Department of Justice, Kenneth L. Wainstein, U.S. Attorney at the time the petition was filed, Gregory G. Katsas, Deputy Assistant Attorney General, Jeffrey Bucholtz, Principal Deputy Assistant Attorney General, Michael J. Ryan and Rhonda C. Fields, Assistant U.S. Attorneys, Mark B. Stern, Scott R. McIntosh, and I. Glenn Cohen, Attorneys, U.S. Department of Justice, Daniel Meron, General Counsel, Food & Drug Administration, Eric M. Blumberg, Deputy Chief Counsel for Litigation, and Karen E. Schifter, Associate Chief Counsel, were on the petition for rehearing and rehearing en banc and supplemental brief on standing for appellees.

J. Scott Ballenger, David A. Price, Daniel J. Popeo, and Richard A. Samp were on the response to the petition for rehearing and rehearing en banc and supplemental brief on standing for appellants.

Before: GINSBURG, Chief Judge, and ROGERS and GRIFFITH, Circuit Judges.

Opinion concurring in part and dissenting in part filed by Circuit Judge GRIFFITH.

On Petition for Rehearing


ROGERS, Circuit Judge.

On May 2, 2006, the court held that the district court erred in dismissing a complaint filed by the Abigail Alliance for Better Access to Developmental Drugs ("the Alliance"). We concluded that the district court's dismissal for failure to state a claim pursuant to Fed.R.Civ.P. 12(b)(6) was premature because the Alliance had stated a liberty interest protected by the Due Process Clause. We remanded the case to the district court to address whether the challenged policy of the Food and Drug Administration ("FDA") was narrowly tailored to address a compelling governmental interest. Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, 445 F.3d 470, 484-86 (D.C. Cir. 2006).

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The FDA filed a petition for rehearing and rehearing en banc, challenging the merits of our original disposition and, for the first time, raising the issue of Article III standing. We requested supplemental briefing to develop the jurisdictional basis for the Alliance's claims. We now deny the petition for rehearing.


Article III standing is a fundamental prerequisite to any exercise of our jurisdiction. See Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). A showing of standing requires, at the "irreducible constitutional minimum," id., that the litigant has suffered a concrete and particularized injury that is actual or imminent, traceable to the challenged act, and redressable by the court. See Allen v. Wright, 468 U.S. 737, 750-51, 104 S.Ct. 3315, 82 L.Ed.2d 556 (1984); Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 37-38, 96 S.Ct. 1917, 48 L.Ed.2d 450 (1976). An organization can have standing on its own behalf, see Havens Realty Corp. v. Coleman, 455 U.S. 363, 378-79, 102 S.Ct. 1114, 71 L.Ed.2d 214 (1982); Warth v. Seldin, 422 U.S. 490, 511, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975), or on behalf of its members, see United Food & Commercial Workers Union Local 751 v. Brown Group, Inc., 517 U.S. 544, 553, 116 S.Ct. 1529, 134 L.Ed.2d 758 (1996); Hunt v. Wash. State Apple Adver. Comm'n, 432 U.S. 333, 343, 97 S.Ct. 2434, 53 L.Ed.2d 383 (1977). At each stage of trial, the party invoking the court's jurisdiction must establish the predicates for standing "with the manner and degree of evidence required at" that stage of trial. Defenders of Wildlife, 504 U.S. at 561, 112 S.Ct. 2130. At the motion to dismiss stage, "general factual allegations of injury resulting from the defendant's conduct may suffice, for on a motion to dismiss we 'presum[e] that general allegations embrace those specific facts that are necessary to support the claim.' " Id. (quoting Lujan v. Nat'l Wildlife Fed'n, 497 U.S. 871, 889, 110 S.Ct. 3177, 111 L.Ed.2d 695 (1990)).

The Alliance maintains that it has made an adequate showing of standing, both as an organization and as a representative of its members. To remedy any possible shortcomings in its original complaint, the Alliance has filed an unopposed motion for leave to amend its complaint in order to add additional allegations as to standing. See 28 U.S.C. § 1653; Fed.R.Civ.P. 15(a). We grant the Alliance's motion. Upon consideration of the amended complaint, we hold that the Alliance has made allegations both as to organizational standing and as to representational standing that are sufficient to survive a motion to dismiss.


The Alliance contends that the actions of the FDA have caused the Alliance as an organization to suffer cognizable injuries that will continue without this court's intervention. "There is no question that an association may have standing in its own right to seek judicial relief from injury to itself and to vindicate whatever rights and immunities the association itself may enjoy." Warth, 422 U.S. at 511, 95 S.Ct. 2197.

The Alliance's amended complaint alleges:

Defendants' conduct has frustrated Abigail Alliance's efforts to assist its members and the public in accessing potentially life-saving drugs and its other activities, including counseling, referral, advocacy, and educational services. The challenged regulations have caused a drain on Abigail Alliance's resources and time because the organization has had to divert significant time

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and resources from these activities toward helping its members and the public address the unduly burdensome requirements that the FDA imposes on experimental treatments.

Am. Compl. ¶ 6.

The Supreme Court addressed a similar claim to organizational standing in Havens Realty. In that case, the Court found allegations of standing sufficient to withstand a motion to dismiss where an organization that provided counseling and referral services for home-seekers claimed that the defendants' actions led it "'to devote significant resources to identify and counteract the defendant's [sic] racially discriminatory steering practices.'" 455 U.S. at 379, 102 S.Ct. 1114 (quoting plaintiff's complaint); see also Metro. Wash. Airports Auth. v. Citizens for the Abatement of Aircraft Noise, Inc., 501 U.S. 252, 264-65, 111 S.Ct. 2298, 115 L.Ed.2d 236 (1991)

This court has applied Havens Realty to justify organizational standing in a wide range of circumstances. See, e.g., Fair Employment Council of Greater Wash., Inc. v. BMC Mktg. Corp., 28 F.3d 1268, 1276 (D.C. Cir. 1994); Haitian Refugee Ctr. v. Gracey, 809 F.2d 794, 799 (D.C. Cir. 1987); Action Alliance of Senior Citizens v. Heckler, 789 F.2d 931, 936-39 (D.C. Cir. 1986). The court has distinguished organizations that allege that their activities have been impeded from those that merely allege that their mission has been compromised. See Nat'l Treasury Employees Union v. United States, 101 F.3d 1423, 1429-30 (D.C. Cir. 1996). The Alliance has met this threshold by alleging that it actively engages in "counseling, referral, advocacy, and educational services." Am. Compl. ¶ 6; see also Competitive Enter. Inst. v. NHTSA, 901 F.2d 107, 122 (D.C. Cir. 1990); Action Alliance, 789 F.2d at 938 & n.7. Moreover, the Alliance alleges that this injury is directly attributable to FDA policies. Am. Compl. ¶ 6; Decl. of Frank Burroughs ¶¶ 4-5; see Rainbow/PUSH Coalition v. FCC, 396 F.3d 1235, 1240-42 (D.C. Cir. 2005).

The FDA presents no arguments—and we find none—that counsel against finding that the Alliance's allegations of organizational standing are sufficient. Although the FDA suggests that holding the Alliance has standing would allow "public interest organizations to bring legal challenges at will to any and all regulations (and statutes) that they dislike," Appellees' Supp. Br. Regarding Article III Standing at 3, our holding does not relax the standing requirements. For standing to be based upon injury to the organization's activities there must still be a direct conflict between the defendant's conduct and the organization's mission. See Nat'l Treasury Employees Union, 101 F.3d at 1430. Furthermore, an organization is not injured by expending resources to challenge the regulation itself; we do not recognize such self-inflicted harm. See, e.g., Fair Employment, 28 F.3d at 1276-77.


The Alliance also alleges standing on behalf of its members. The standard for representational standing is well-established:

[A]n association has standing to bring suit on behalf of its members when: (a) its members would otherwise have standing to sue in their own right; (b) the interests it seeks to protect are germane to the organization's purpose; and (c) neither the claim asserted nor the relief requested requires the participation of individual members in the lawsuit.

United Food & Commercial Workers, 517 U.S. at 553, 116 S.Ct. 1529 (quoting Hunt, 432 U.S. at 343, 97 S.Ct. 2434).

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The only question here is whether a member of the Alliance would have standing to sue in his or her own right.

In the amended complaint, the Alliance alleges that its members include "terminally ill individuals whose best chance of survival is to obtain access to certain drugs with a record of clinical success in pre-approval testing, but which have not yet been approved by the FDA for marketing." Am. Compl. ¶ 7. The Alliance further alleges that these members had been unable to gain access to clinical...

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