The opinion of the court was delivered by: Urbina, District Judge.
GRANTING IN PART AND DENYING IN PART THE PLAINTIFF'S AND
DEFENDANT'S MOTIONS FOR SUMMARY JUDGMENT
Xenotransplantation involves the implantation of live animal
tissues, cells and organs into human beings for the treatment of
human diseases. The plaintiff, Campaign for Responsible
Transplantation ("CRT"), a non-profit organization dedicated to
educating the public about the health risks associated with
xenotransplantation, brings this action pursuant to the Freedom
of Information Act ("FOIA"), 5 U.S.C. § 552 et seq., to compel
the defendant, United States Food and Drug Administration
("FDA"), to disclose various records concerning
xenotransplantation. Concerned that their investigational new
drugs ("INDs") may fall within the scope of CRT's FOIA request,
six biotechnology companies intervened.
For the reasons that follow, the court grants in part and
denies in part both parties' motions for summary judgment. The
court also orders FDA to resubmit new sample Vaughn
indices*fn2 consistent with this memorandum opinion.
Xenotransplantation involves the introduction of animal cells,
tissues and organs into the human body to replace parts of the
body damaged by disease. Pl.'s Mot. for Summ.J. at 3. CRT's
concerns about xenotransplantation stem from the risk of
cross-species viral infections*fn3 within animal tissue.
Id. at 6. Numerous cross-species viruses, including human
immunodeficiency virus, Creutzfeldt-Jacob (mad cow) disease,
Ebola, Hanta virus, rabies, and influenza, already exist outside
of xenotransplantation. Id. Ex. E at 3. Since pigs are the
animal most commonly used in xenotransplantation, CRT is
particularly concerned with cross-species viruses that are
dormant in pigs but could be dangerous for humans. Id. at 6.
Known as porcine endogenous retroviruses ("PERV"), these
cross-species viruses exist within the DNA of pig cells. Id.
FDA currently regulates xenotransplantation products as INDs
and "biological products" under section 351 of the Public Health
Service Act, 42 U.S.C. § 262, the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 321 et seq., and various other FDA
regulations, e.g. 21 C.F.R. § 312 et seq.; 21 C.F.R. § 601
et seq. FDA is also responsible for reviewing applications by
pharmaceutical and biotechnology companies that conduct human
clinical trials involving xenotransplantation. Compl. ¶ 6.
According to the plaintiff, FDA routinely grants approval for
these trials "without any further federal oversight regarding
health and ethical considerations — despite the Department of
Health and Human Services' acknowledgment that `concerns have
arisen in the last few years about the potential infection,
disease and public health risks associated with
xenotransplantation.'" Id. (citing 64 Fed. Reg. 73562 (Dec. 30,
On March 9, 2000, CRT submitted a written FOIA request to FDA
for all records concerning clinical trials that involved
xenotransplantation. Id. ¶ 7. By letter dated March 14, 2000,
FDA acknowledged receipt of CRT's request and indicated that it
would respond to the request "as soon as possible." Id. ¶ 9.
When CRT did not receive a response by August 2, 2000, CRT
appealed the constructive denial of its FOIA request to FDA.
Id. ¶ 10. After FDA failed to respond to the appeal, CRT filed
suit in this court on November 27, 2000 to compel immediate
disclosure of the
requested records. Id. On March 1, 2001, the court granted
motions by Genezyme Corporation ("Genezyme"), Circe, Diacrin,
Diacrin/Genezyme, Nextran and Norvartis to intervene in this
case. Order dated Mar. 1, 2001.
In its original FOIA request, CRT sought "all FDA records
concerning applications for approval to conduct clinical trials
in humans that involve xenotransplantation, and all information
concerning currently ongoing and concluded clinical trials
involving xenotransplantation." Id. ¶ 7. The original FOIA
request included information previously submitted to FDA by
third parties, including the defendant-intervenors. Id. In
this action, CRT narrowed its original request to include only
those documents generated by FDA. Pl.'s Mot. for Summ.J. at 21.
CRT then moved for a Vaughn index of documents that FDA still
withheld. Id. at 22. The court denied CRT's motion and granted
FDA's motion to produce a representative sample Vaughn index
of one IND.*fn4 Campaign, 180 F. Supp.2d at 34. In response,
FDA produced two Vaughn indices, one pertaining to clinical
trials ("Clinical Trials Vaughn Index") and one pertaining to
IND "G" ("IND "G" Vaughn Index"), the IND that CRT picked.
Pl.'s Mot. for Summ.J. at 22. The plaintiff and the defendant
now both move for summary judgment. Four defendant-intervenors
oppose the plaintiffs motion and one has filed a request for
clarification. Since January 15, 2002, when the plaintiff filed
for summary judgment, FDA has filed Third, Fourth, and Fifth
declarations to supplement the original two Vaughn indices.
A. Legal Standard for Summary Judgment in a FOIA-Review
Summary judgment is appropriate when "the pleadings,
depositions, answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving party
is entitled to a judgment as a matter of law." FED.R.CIV.P.
56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct.
2548, 91 L.Ed.2d 265 (1986); Diamond v. Atwood, 43 F.3d 1538,
1540 (D.C.Cir. 1995). To determine which facts are "material," a
court must look to the substantive law on which each claim
rests. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106
S.Ct. 2505, 91 L.Ed.2d 202 (1986). A "genuine issue" is one
whose resolution could establish an element of a claim or
defense and, therefore, affect the outcome of the action.
Celotex, 477 U.S. at 322, 106 S.Ct. 2548; Anderson, 477 U.S.
at 248, 106 S.Ct. 2505. In ruling on a motion for summary
judgment, the court must draw all justifiable inferences in the
nonmoving party's favor and accept the nonmoving party's
evidence as true. Anderson, 477 U.S. at 255, 106 S.Ct. 2505.
FOIA affords the public access to virtually any federal
government record that FOIA itself does not specifically exempt
from disclosure. 5 U.S.C. § 552; Vaughn, 484 F.2d at 823. FOIA
confers jurisdiction on the federal district courts to order the
release of improperly withheld or
redacted information. 5 U.S.C § 552(a)(4)(B). In a judicial
review of an agency's response to a FOIA request, the defendant
agency has the burden of justifying nondisclosure, and the court
reviews de novo the agency's action. 5 U.S.C. § 552(a)(4)(B);
Al-Fayed v. CIA, 254 F.3d 300, 305 (D.C.Cir. 2001). The court
may grant summary judgment to an agency on the basis of its
affidavits if they (a) "describe the documents and the
justifications for nondisclosure with reasonably specific
detail," (b) "demonstrate that the information withheld
logically falls within the claimed exemption," and (c) "are not
controverted by either contrary evidence in the record nor by
evidence of agency bad faith." Military Audit Project v.
Casey, 656 F.2d 724, 738 (D.C.Cir. 1981). While an agency's
affidavits are presumed to be in good faith, a plaintiff can
rebut this presumption with evidence of bad faith. Ground
Saucer Watch, Inc. v. CIA, 692 F.2d 770, 771 (D.C.Cir. 1981).
But such evidence cannot be comprised of "purely speculative
claims about the existence and discoverability of other
B. FDA's Search for Documents Relating to CRT's Request Was