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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 hardly-
speculative 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
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
1
Because we hold that the Alliance has standing premised on
the specific grounds of organizational and representational standing,
12
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
we do not reach the Alliance’s broader claim that, notwithstanding its
members’ inability to obtain life-saving medication, they suffer injury-
in-fact merely by facing a barrier to access.
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.