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September 3, 2002


The opinion of the court was delivered by: Urbina, District Judge.




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.

This matter is before the court on the plaintiffs and the defendant's motions for summary judgment. Four of the six defendant-intervenors — Circe Biomedical, Inc. ("Circe"); Nextran, Inc. ("Nextran"); Diacrin, Inc. ("Diacrin"); and Diacrin/Genzyme LLC ("Diacrin/Genzyme") — oppose the plaintiffs motion and support the defendant's motion for summary judgment. Novartis Pharmaceuticals Corporation ("Novartis") filed a response asking for a clarification of the plaintiffs request.*fn1

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, 1999)).

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 Case

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 documents." Id.

B. FDA's Search for Documents Relating to CRT's Request Was ...

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