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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Filed On November 21, 2006

No. 04-5350

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

Appeal from the United States District Court

for the District of Columbia

(No. 03cv01601)

On Petition for Rehearing 
2

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 for the Court filed by Circuit Judge ROGERS.

Opinion concurring in part and dissenting in part filed by

Circuit Judge GRIFFITH.

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
3

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).

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.

I.

Article III standing is a fundamental prerequisite to any

exercise of our jurisdiction. See Lujan v. Defenders of Wildlife,

504 U.S. 555, 560 (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 (1984); Simon

v. E. Ky. Welfare Rights Org., 426 U.S. 26, 37-38 (1976). An

organization can have standing on its own behalf, see Havens

Realty Corp. v. Coleman, 455 U.S. 363, 378-79 (1982); Warth

v. Seldin, 422 U.S. 490, 511 (1975), or on behalf of its members,

see United Food & Commercial Workers Union Local 751 v.

Brown Group, Inc., 517 U.S. 544, 553 (1996); Hunt v. Wash.

State Apple Adver. Comm’n, 432 U.S. 333, 343 (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. 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.
4

Nat’l Wildlife Fed’n, 497 U.S. 871, 889 (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.

A.

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.

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 and resources from these activities

toward helping its members and the public address the

unduly burdensome requirements that the FDA
5

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 (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 (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). 
6

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. 

B.

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 (quoting

Hunt, 432 U.S. at 343). 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
7

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 trial programs and that any request to

the FDA for entry into an expanded access program is futile in

light of its current regulations. Id.; see also Decl. of Steven

Walker ¶¶ 4-16.

The amended complaint and accompanying affidavits

reference seven members of the Alliance. Am. Compl. ¶ 22

(Abigail Burroughs); id. ¶ 23 (David Baxter); id. ¶ 24 (Alita

Randazzo); id. ¶ 25 (Joel Oppenheim); Decl. of Victoria Jean

Doran ¶¶ 2, 6-7 (Patrick Joseph Smid, Jr.); Decl. of Carole

Steele ¶¶ 2, 6-8 (James Michael Steele); Decl. of Shari Kahane

¶¶ 1-2 (herself). Burroughs, Baxter, and Randazzo had already

died when the complaint was filed. As a result, they cannot be

the source of our jurisdiction, see Friends of the Earth, 528 U.S.

at 191.

It is understandably difficult for the Alliance to produce the

affidavits typically used to establish standing. Because of the

nature of their predicaments, many of those Alliance members

who were members on July 28, 2003, when the complaint was

filed, have succumbed to their terminal illnesses. However, the

allegations in the complaint supplemented by the affidavits

supplied by the Alliance establish that “at least one member . . .

has standing to pursue this challenge,” Am. Library Ass’n v.

FCC, 406 F.3d 689, 696 (D.C. Cir. 2005).

Joel Oppenheim was a member of the Alliance when the

initial complaint was filed. He suffered injury-in-fact that was

traceable to the FDA and redressable by judicial action.

Oppenheim was diagnosed with multiple myeloma in 1995. The

disease became active in 1999. Am. Compl. ¶ 25. He was
8

treated with dexamethadrone (“dex”) and thalidomide, the latter

of which was FDA-approved only to treat leprosy but was still

available to Oppenheim under FDA policies as an off-label use.

Id.; see Abigail Alliance, 445 F.3d at 483. As his condition

worsened, his oncologists recommended that he seek access to

Revamid or PS-341 Velcade, two medications that were not yet

FDA-approved but were available in clinical trials. Am. Compl.

¶ 26. Oppenheim “was unable to obtain a place in the Revamid

trials or Velcade trials because [of] his prior treatment with

dex.” Id. As a result, he was kept on thalidomide “for a period

much longer than his physician thought advisable,” Decl. of

Steven Walker ¶ 21, and was forced to undergo “a dangerous

and damaging” autologous bone marrow transplant that “had

been made necessary by his lack of access to Velcade or

Revamid,” Am. Compl. ¶¶ 27-28. As Oppenheim’s cancer

continued to worsen, he continued to seek access to Velcade

trials but continued to be rejected. Id. ¶ 28. In desperation, he

stopped taking any medication in order to make himself eligible

to enter a trial. Id. He finally was admitted to a trial of

Revamid just before the initial complaint was filed. Id.

However, the years of delay had severely diminished

Oppenheim’s chances of responding to the medication because

cancers like Oppenheim’s mutate as the disease progresses and

his excessive exposure to thalidomide likely made him resistant

to the chemically-similar Revamid. Decl. of Steven Walker ¶

21. Oppenheim died before Revamid was approved by the FDA

earlier this year. Id. ¶ 22.

Oppenheim’s injury is clear. When he had no other

medically-feasible options, he was denied access to a medication

that had saved others’ lives. That he was ultimately able to join

a clinical trial—and subjected to the harsh limitations on his

medical care that accompany such trials—well after the

medication’s period of likely effectiveness had come and gone

does not make him less injured. The FDA challenges whether
9

this result was caused by its actions and whether judicial action

can redress injuries like Oppenheim’s. We hold that the

Alliance has made the requisite showings.

For standing to be proper, it must be that the injury “fairly

can be traced to the challenged action of the defendant, and not

injury that results from the independent action of some third

party not before the court.” E. Ky. Welfare Rights Org., 426

U.S. at 41-42. The FDA claims that Alliance members like

Oppenheim have not properly sought individual-use approval

and that their inability to access investigational new drugs that

have survived Phase I clinical trials thus cannot be attributed to

the FDA.

The Alliance responds that its terminally-ill members

cannot be required to apply for individual-use approval from the

agency when the FDA procedures they challenge are

“effectively inoperative,” Decl. of Steven Walker ¶ 5, and make

success virtually impossible. Taking the sworn statements

supplied by the Alliance as true, requests for individual use “are

in all material and regulatory aspects clinical trials that

effectively cannot be requested or initiated by any patient or any

physician.” Id. The net result is that for this approach to

succeed, a sponsor must have a preexisting program approved

by the FDA, an Institutional Review Board must grant its

approval, and the patient must meet the restrictive eligibility

requirements of the sort that failed Oppenheim time and again.

Id. ¶ 6. The FDA controls these programs so that they are

“almost never available until the months prior to FDA

approval.” Id. ¶ 8. Furthermore, the FDA has an acknowledged

“private stance on expanded access” that, unsurprisingly,

pharmaceutical companies awaiting approval are unwilling to

violate. Id. ¶ 15; see also Decl. of Shari Kahane ¶ 15.

The Alliance’s amended complaint and accompanying
10

affidavits make clear that many hurdles impeding Alliance

members from accessing post-Phase I investigational new drugs

have been erected by the FDA. This is sufficient to establish

causation.

The FDA challenges redressability on the grounds that,

even if its regulations were changed, it is merely speculation that

drug manufacturers would sell their investigational medications

to members of the Alliance. Its reliance on National Wrestling

Coaches Ass’n v. Department of Education, 366 F.3d 930 (D.C.

Cir. 2004), is misplaced. In that case, wrestling coaches were

found to lack standing because, in order for their injuries to be

redressed, a wrestling program would have to be reinstated,

possibly at the expense of another men’s athletic program, and

no school had indicated an inclination to do so. See id. at 936-

40. Here, it would be in the drug companies’ pecuniary interests

to expand access to experimental drugs and thereby develop a

market, particularly if the FDA allows them to charge market

prices. This makes the question of redressability a hardlyspeculative exercise in naked capitalism, and our skepticism

from National Wrestling Coaches Ass’n need not transfer. The

FDA also maintains that elimination of the regulation would not

change the FDA’s alleged hostility to access or the drug

companies’ fear of reprisal, but the agency’s perceived hostility

to access will no doubt diminish if it rescinds the regulation that

sets up the barrier to compassionate use programs in the first

place.

That Oppenheim died before the lawsuit was resolved does

not divest the federal courts of jurisdiction. If the Alliance

establishes a “continuing interest” that survives Oppenheim’s

death, Friends of the Earth, 528 U.S. at 191-92; see Sosna v.

Iowa, 419 U.S. 393, 402 (1975), then the court may continue to

hear the case. The affidavit of Alliance member Shari Kahane

makes this showing.
11

1

 Because we hold that the Alliance has standing premised on

the specific grounds of organizational and representational standing,

Kahane suffers from metastasized breast cancer and has

exhausted standard treatments for her condition. Decl. of Shari

Kahane ¶¶ 3, 11-12. Her declaration addresses injury-in-fact,

causation, and redressability. See Am. Library Ass’n, 406 F.3d

at 696. The injury-in-fact is Kahane’s inability to obtain

potentially life-saving treatments. Her injury is traceable to

FDA policies because, notwithstanding the likely failure, she has

sought access to “compassionate use” programs of experimental

drugs and has been told that FDA regulations “are preventing

[drug companies] from providing [her] with access.” Decl. of

Shari Kahane ¶ 15. This injury would be redressable by judicial

action, according to Kahane, because “manufacturers of those

medications have indicated that they would be likely to make

those medications available to cancer patients outside of their

clinical trials if . . . [the] FDA did not make it so difficult to

establish ‘compassionate use programs’ and if manufacturers

were permitted to charge market prices for their medications.”

Id.

Even if the Alliance could not supply a particular

terminally-ill member, at each moment, who has exhausted all

conventional treatments but has not died, this is a classic case of

a situation “capable of repetition, yet evading review.” S. Pac.

Terminal Co. v. ICC, 219 U.S. 498, 515 (1911). By the very

nature of its membership, the Alliance has a reasonable

expectation that its members will continue to suffer the same

short-lived injuries that this doctrine addresses. Cf. Weinstein

v. Bradford, 423 U.S. 147, 149 (1975) (per curiam); Sosna, 419

U.S. at 402.

Having satisfied all of the requirements, the Alliance has

adequately pleaded representational standing.1
12

we do not reach the Alliance’s broader claim that, notwithstanding its

members’ inability to obtain life-saving medication, they suffer injuryin-fact merely by facing a barrier to access.

II.

On the merits, we remain convinced that “the Alliance’s

claim . . . falls squarely within the realm of rights the Supreme

Court has held are ‘implicit in the concept of ordered liberty’”

that enjoy special protection from the Due Process Clause.

Abigail Alliance, 445 F.3d at 483-84 (quoting Palko v.

Connecticut, 302 U.S. 319, 325 (1937)).

The narrowly-defined liberty interest that is articulated in

Abigail Alliance, id. at 472, is consistent with the treatment of

such rights by the Supreme Court, which has said:

In a long line of cases, we have held that, in addition to

the specific freedoms protected by the Bill of Rights,

the “liberty” specially protected by the Due Process

Clause includes the rights to marry, Loving v. Virginia,

388 U.S. 1 (1967); to have children, Skinner v.

Oklahoma ex rel. Williamson, 316 U.S. 535 (1942); to

direct the education and upbringing of one’s children,

Meyer v. Nebraska, 262 U.S. 390 (1923); Pierce v.

Society of Sisters, 268 U.S. 510 (1925); to marital

privacy, Griswold v. Connecticut, 381 U.S. 479 (1965);

to use contraception, ibid.; Eisenstadt v. Baird, 405

U.S. 438 (1972); to bodily integrity, Rochin v.

California, 342 U.S. 165 (1952), and to abortion,

[Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833

(1992)]. We have also assumed, and strongly

suggested, that the Due Process Clause protects the

traditional right to refuse unwanted lifesaving medical

treatment. Cruzan [v. Dir., Mo. Dep’t of Health, 497
13

U.S. 261 (1990)].

Washington v. Glucksberg, 521 U.S. 702, 720 (1997). We see

no reason to retreat from the analysis set forth in Abigail

Alliance. Alliance members who are terminally ill and who lack

government-approved treatment options have a due process

interest in self-determination that protects their pursuit of

promising new medications to save their lives.

On rehearing the FDA attempts to construe the Alliance’s

due process claim as seeking “a right of access to unapproved

experimental drugs.” Appellees’ Petition for Panel Rehearing

and Rehearing En Banc at 6 [hereinafter “Petition”]. In so

doing, the FDA confuses the means of enforcing the right with

the right itself. As the court recognized, the Alliance seeks to

enforce “the right of terminally ill patients to make an informed

decision that may prolong life.” Abigail Alliance, 445 F.3d at

477. As their lives hang in the balance, they ask “that the

decision to assume . . . known or unknown risks be left to the

terminally ill patient and not to the FDA.” Id. at 478. So

described, this right to self-determination is so fundamental that

it is no wonder that no federal law has needed to articulate its

precise boundaries. A unanimous declaration sent to England’s

King George III more than two centuries ago noted that the

“unalienable Rights” of “Life, Liberty and the pursuit of

Happiness” were “self-evident.” THE DECLARATION OF

INDEPENDENCE para. 2 (U.S. 1776). Justice Cardozo found no

difficulty applying this principle in the celebrated case of

Schloendorff v. Society of the New York Hospital, 105 N.E. 92

(N.Y. 1914), overruled on other grounds by Bing v. Thunig, 143

N.E. 2d 3 (N.Y. 1957), where he noted that “[e]very human

being of adult years and sound mind has a right to determine

what shall be done with his own body.” Id. at 93. The Supreme

Court has reinforced the manifest clarity of this cardinal right:

“It cannot be disputed that the Due Process Clause protects an
14

interest in life as well as an interest in refusing life-saving

medical treatment.” Cruzan, 497 U.S. at 281.

Moreover, in taking issue with the history of drug

regulation confirmed by no less than an FDA historian, see

Abigail Alliance, 455 F.3d at 482 n.13, and others, see, e.g.,

EDWARD KREMERS & GEORGE URDANG, HISTORY OF

PHARMACY 271-79 (2d ed. 1951), the FDA ignores the crucial

distinction between regulation for safety and regulation for

efficacy. See Abigail Alliance, 445 F.3d at 483. The FDA’s

acknowledgment that it has been “[d]eveloping policies for

treatment uses of investigational drugs . . . for more than twenty

years,” Petition at 13, only underscores the newness of the

federal government’s endeavors to restrict the ability of the

terminally ill to determine their own best course.

It bears repeating that the recognition of a liberty interest

does not end this case. As the Supreme Court acknowledged in

addressing a due process challenge to state-mandated

inoculation for smallpox, even “the inherent right of every

freeman to care for his own body and health in such way as to

him seems best” is not “absolute,” Jacobson v. Massachusetts,

197 U.S. 11, 26 (1905). In assessing that liberty interest, which

is strikingly similar to the interest this court addressed, the

Supreme Court in Jacobson observed that it “has more than once

recognized it as a fundamental principle that ‘persons and

property are subjected to all kinds of restraints and burdens,’” id.

(quoting R.R. Co. v. Husen, 95 U.S. 465, 471 (1878)), and that

liberty could be compromised when “‘essential to the safety,

health, peace, good order and morals of the community,’” id.

(quoting Crowley v. Christensen, 137 U.S. 86, 89 (1890)).

Neither in our opinion nor now do we prejudge whether the

FDA policy challenged here outweighs the Alliance members’

interests in self-determination; we require further inquiry by the

district court on remand as to the FDA’s countervailing interests.
15

See Abigail Alliance, 455 F.3d at 407. At that time, concerns

expressed by the FDA about the implications for federal drug

regulation, see Petition at 2, 4, 7, 14-15, can be addressed on the

basis of fulsome briefing not previously provided.

Accordingly, we deny the petition for rehearing. Although

the Alliance reminds the court that it has an additional basis for

its claims, see Appellants’ Response to Petition for Rehearing

and Rehearing En Banc at 10-12; Abigail Alliance, 445 F.3d at

476, based on the demands of “personal dignity and autonomy”

when human life depends upon medical decision-making,

Casey, 505 U.S. at 851, it suffices for the court to hold that the

Alliance has Article III standing and to reaffirm the analysis in

Abigail Alliance, 445 F.3d 470, without reaching the Alliance’s

other grounds for its claim. The Alliance’s other grounds are

properly preserved.
GRIFFITH, Circuit Judge, concurring in part, dissenting

in part: Although I agree that Abigail Alliance has made a

sufficient showing of standing at this stage in the proceedings,

for the reasons set forth in my dissent, Abigail Alliance for

Better Access to Developmental Drugs v. von Eschenbach, 445

F.3d 470, 486-500 (D.C. Cir. 2006), I would vote to grant the

petition for rehearing.