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CAMPAIGN FOR RESPONSIBLE TRANSPLAN. v. U.S. F.D.A.

July 23, 2001

CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION, PLAINTIFF,
V.
UNITED STATES FOOD AND DRUG ADMINISTRATION ET AL., DEFENDANTS.



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

MEMORANDUM OPINION

Denying the Plaintiffs Motion for a Vaughn Index; Granting the Defendants' Motion for a Sample Vaughn Index

I. INTRODUCTION

Xenotransplantation involves the implantation of animal tissues, cells and organs into human beings for the treatment of human diseases. Campaign for Responsible Transplantation ("CRT"), a nonprofit 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, to compel the United States Food and Drug Administration ("FDA") to disclose certain records concerning xenotransplantation. This matter comes before the court on the plaintiffs motion for a Vaughn index of all FDA-generated records responsive to the plaintiffs FOIA request. The FDA has filed a cross-motion in which it argues that it should be required only to produce a sample Vaughn index of FDA-generated documents contained in one representative "investigational new drug" application ("IND"). Five of the intervenor-defendants — Circe Biomedical, Inc.; Nextran, Inc.; Diacrin, Inc. and Diacrin/Genzyme LLC.; Genzyme Corp.; and Novartis Pharmaceuticals Corp. — have filed statements of non-opposition to the plaintiffs motion for a Vaughn index. For the reasons that follow, the court denies CRT's request for a Vaughn index of all withheld FDA-generated records and grants the FDA's motion to permit a sample Vaughn index of the records generated by the FDA for one representative IND.

II. BACKGROUND

The FDA regulates xenotransplantation products as "investigational new drugs" ("IND") 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 FDA regulations, see 21 C.F.R. Parts 312, 601. The FDA is also responsible for reviewing applications by drug and biotechnology companies to conduct clinical trials involving xenotransplantation. See Compl. ¶ 6. According to the plaintiff, the 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)). For example, the plaintiff alleges that "[m]edical procedures involving xenotransplantation — including, for example, the injection of fetal pig cells into human brains — threaten patients, their close contacts and the general public with `zoonoses' — animal diseases that are transmitted to patients, and potentially, to the human population at large. These diseases include . . . HIV/AIDS, Creutzfeldt-Jakob Disease (`mad cow' disease), rabies, and hepatitis B and C." Pl.'s Mot. at 2 (citation omitted).

On March 9, 2000, CRT submitted a written FOIA request to the FDA for all records concerning clinical trials that involved xenotransplantation. See Compl. ¶ 7. By letter dated March 14, 2000, the FDA acknowledged receipt of CRT's request and indicated that it would respond to the request "as soon as possible." See id. ¶ 9. When CRT did not receive a response by August 2, 2000, it appealed the constructive denial of its FOIA request to the FDA. See id. ¶ 10. After the 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. See id.

In its original FOIA request of March 9, 2000, CRT sought "all records concerning applications for approval to conduct clinic trials in humans that involve xenotransplantation, and all information concerning currently on-going [sic] and concluded clinical trials involving xenotransplantation." See Pl.'s Mot. at 4 (citation omitted). The requested records included information submitted to the FDA by third parties, including the intervenor-defendants. CRT has since narrowed its request to include only documents generated by or within the FDA. See Pl.'s Mot. at 6-7.*fn1 Because CRT does not know what these documents are, however, and in an effort to further narrow the scope of the litigation, CRT has moved for a Vaughn index of all such FDA-generated documents. See id. at 7. CRT states that "[o]nce defendant produces such an index, plaintiff may have a basis for deciding which, if any, such records it wishes to pursue." Id. The FDA has filed a cross-motion for a sample Vaughn index, in which it contends that to complete the plaintiffs requested Vaughn index, it would have to review about 240,000 pages of documents, a project that would take an estimated two years. See Def.'s Mot. at 2.

III. LEGAL FRAMEWORK: THE FREEDOM OF INFORMATION ACT

A. Standard of Review

The Freedom of Information Act (FOIA) affords the public access to virtually any federal-government record that is not specifically exempted from disclosure by the Act itself. See 5 U.S.C. § 552; Vaughn v. Rosen, 484 F.2d 820, 823 (D.C.Cir. 1973). FOIA confers jurisdiction on the federal district courts to order the release of improperly withheld or redacted information. See 5 U.S.C § 552(a)(4)(B). District courts review agency decisions to withhold information de novo, and the agency bears the burden of proving that the withheld information is exempt from disclosure. See id.; see also United States Dep't of Justice v. Reporters Committee for Freedom of the Press, 489 U.S. 749, 755, 109 S.Ct. 1468, 103 L.Ed.2d 774 (1989). In Vaughn, the D.C. Circuit set out procedures to assist both courts and plaintiffs in reviewing the validity of an agency's decision to withhold documents without conducting a painstaking inspection of hundreds or, as in this case, thousands of pages of documents. See 484 F.2d at 826-28.

B. The Purpose and Design of the Vaughn Index

A Vaughn index is an affidavit that specifically describes the withheld or redacted documents and justifies, in detail, why each withheld record that would be responsive to the request is exempt from disclosure under FOIA. See King v. United States Dep't of Justice, 830 F.2d 210, 223-24 (D.C.Cir. 1987). The purpose of a Vaughn index is twofold. First, in a FOIA case, the requester is usually unable to argue for the release of redacted or withheld documents with "desirable legal precision" because "the party seeking disclosure cannot know the precise contents of the documents sought." See Vaughn, 484 F.2d at 823. The requester must rely on the agency's representations for an understanding of the material withheld. See Wiener v. FBI, 943 F.2d 972, 977 (9th Cir. 1991). "This lack of knowledge by the party seeking disclosure seriously distorts the traditional adversary nature of our legal system." Vaughn, 484 F.2d at 824. The Vaughn index, therefore, should provide the requester with "a meaningful opportunity" to argue for the release of withheld documents, thereby correcting the imbalance in the adversary process. See King, 830 F.2d at 218.

Second, unless the court inspects every disputed document in camera, the court also must rely on the agency for knowledge of the withheld material. Since the court's review of the agency's decision to withhold information is de novo, the Vaughn index helps "ensure meaningful review of an agency's claim to withhold information subject to a FOIA request." See King, 830 F.2d at 223. A proper Vaughn index should enable the court to make "a reasoned, independent assessment of the claim of exemption." See Vaughn v. United States, 936 F.2d 862, 866-67 (6th Cir. 1991). In sum, a Vaughn index ...


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