Campaign for Responsible Transplantation v. Fda

• Citation: 511 F.3d 187
• Decision Date: 28 December 2007
• Docket Number: No. 06-5333.,06-5333.
• Parties: CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION, Appellant v. FOOD & DRUG ADMINISTRATION, Appellee.
• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)

511 F.3d 187

CAMPAIGN FOR RESPONSIBLE TRANSPLANTATION, Appellant v. FOOD & DRUG ADMINISTRATION, Appellee.

No. 06-5333.

United States Court of Appeals, District of Columbia Circuit.

Argued October 12, 2007.

Decided December 28, 2007.

Appeal from the United States District Court for the District of Columbia (No. 00cv02849).

Howard M. Crystal argued the cause for appellant. With him on the briefs was Katherine A. Meyer.

Alan Burch, Assistant U.S. Attorney, argued the cause for appellee. With him on the brief were Jeffrey A. Taylor, U.S. Attorney, and R. Craig Lawrence, Assistant U.S. Attorney.

Before: GRIFFITH, Circuit Judge, and EDWARDS and WILLIAMS, Senior Circuit Judges.

Opinion for the Court filed by Senior Circuit Judge EDWARDS.

EDWARDS, Senior Circuit Judge:

Appellant, Campaign for Responsible Transplantation ("CRT"), is a not-for-profit organization dedicated to educating the public about the health risks associated with xenotransplantation, a relatively new procedure whereby animal organs or tissues are transplanted to the human body. Since the late 1990s, the Food and Drug Administration ("FDA") has permitted clinical trials of xenotransplantation products. In order to learn more about these trials, CRT submitted a request to FDA under the Freedom of Information Act ("FOIA"), seeking records regarding applications to conduct clinical trials that involve xenotransplantation and past and present clinical trials involving xenotransplantation. CRT subsequently narrowed its FOIA request to include only records pertaining to xenotransplantation clinical trials in 35 investigational new drug ("IND") applications involving xenotransplantation. After CRT's FOIA request was constructively denied through agency nonresponse, CRT initiated suit in the District Court to compel the release of responsive documents.

During the course of litigation, CRT filed a motion to require FDA to produce an index of all documents under Vaughn v. Rosen, 484 F.2d 820 (D.C.Cir.1973), and FDA filed a cross-motion to submit a sample Vaughn index of a representative IND. The trial court granted FDA's request and denied CRT's motion. Campaign for Responsible Transplantation v. FDA, 180 F.Supp.2d 29 (D.D.C.2001) (memorandum opinion) ("CRT I"). After FDA submitted two sample Vaughn indices, both parties moved for summary judgment on whether the sample Vaughn indices were sufficient to satisfy FDA's burden of proof that the withheld documents were exempt from disclosure. The trial court ruled against FDA, holding that the sample Vaughn indices were inadequate. Campaign for Responsible Transplantation v. FDA, 219 F.Supp.2d 106 (D.D.C.2002) (memorandum opinion) ("CRT II").

After FDA produced the revised Vaughn indices, the parties again moved for summary judgment. This time, the trial court found that the indices were adequate and that the exemptions claimed by FDA were valid. In its memorandum opinion, the District Court also ordered FDA to release documents in all other requested INDs that were similar in kind to the documents that had been released for the sample INDs. Campaign for Responsible Transplantation v. FDA, Civ. Action No. 00-2849, mem. op. at 22 (D.D.C. Sept. 24, 2004), reprinted in Joint Appendix ("JA") 109 ("CRT III").

CRT moved for attorney's fees, pursuant to 5 U.S.C. § 552(a)(4)(E) under which a court may assess "reasonable attorney fees" when a "complainant has substantially prevailed." The District Court denied the request for fees on the ground that CRT had not substantially prevailed in its litigation. Campaign for Responsible Transplantation v. FDA, 448 F.Supp.2d 146 (D.D.C.2006) (memorandum opinion) ("CRT IV").

On this record, we reverse in part the judgment of the District Court and hold that CRT was a prevailing party by virtue of the September 24, 2004 memorandum opinion and order. A complainant substantially prevails in litigation only if the court grants some "judicial relief." Buckhannon Bd. & Care Home, Inc. v. W. Va. Dep't of Health & Human Res., 532 U.S. 598, 606, 121 S.Ct. 1835, 149 L.Ed.2d 855 (2001) (emphasis and quotation marks omitted). The trial court's final order in this case — requiring FDA to release documents — was sufficient judicial relief to make CRT a prevailing party. CRT is therefore eligible for attorney's fees. Before fees are awarded, however, a party must not only be eligible for attorney's fees — the party must also be entitled to those fees. See Edmonds v. F.B.I., 417 F.3d 1319, 1327 (D.C.Cir.2005). Because the trial court found CRT to be ineligible, it did not reach the question of whether CRT was entitled to attorney's fees. We therefore remand to the District Court for a determination of whether CRT is entitled to attorney's fees.

I. BACKGROUND

On March 9, 2000, CRT submitted a written FOIA request to FDA for "all records concerning applications for approval to conduct clinical trials that involve xenotransplantation, and all information concerning currently on-going and concluded clinical trials involving xenotransplantation." Letter from Katherine A. Meyer, Attorney representing CRT, to Betty Dorsey, Director, FOIA Office, FDA (Mar. 9, 2000), JA 43. Xenotransplantation is defined as "any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs." UNITED STATES PUBLIC HEALTH SERVICE, OMB CONTROL No. 0910-0456, GUIDELINE ON INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION 4 (2001); see 66 Fed.Reg. 8,120 (Jan. 29, 2001). It is not disputed that FDA has authority under several statutes to regulate xenotransplantation products as drugs or medical devices. See, e.g., 21 U.S.C. §§ 321(g)(1), 355(a), (b); 42 U.S.C. § 262(a); 21 C.F.R. pts. 312, 601. At the time of the FOIA request, FDA had approved over 30 IND applications, authorizing pharmaceutical and biotechnology companies to conduct xenotransplantation clinical trials in humans.

FOIA is a disclosure statute "enacted to facilitate public access to Government documents." Dep't of State v. Ray, 502 U.S. 164, 173, 112 S.Ct. 541, 116 L.Ed.2d 526 (1991). A federal agency that receives a FOIA request must make a determination within 20 working days whether to release the requested documents. 5 U.S.C. § 552(a)(6)(A)(i). Although an agency may seek a brief extension of this deadline, id. § 552(a)(6)(B), it may only continue to withhold responsive records if they fall within one or more of the nine exemptions to the statute's disclosure mandate. Id. § 552(b)(1)-(9).

In a letter dated March 14, 2000, FDA acknowledged CRT's FOIA request and stated that it would respond to the request "as soon as possible." CRT I, 180 F.Supp.2d at 31. When CRT did not receive a response by August 2, 2000, it appealed to the agency. Id. After FDA failed to respond to the appeal, CRT filed suit in the District Court on November 27, 2000. Id. Under 5 U.S.C. § 552(a)(4)(B), when responsive documents have been unjustifiably withheld, a district court has the power to "enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld." The agency bears the burden of proving that withheld information is exempt from disclosure. Dep't of Justice v. Reporters Comm. for Freedom of the Press, 489 U.S. 749, 755, 109 S.Ct. 1468, 103 L.Ed.2d 774 (1989).

Over the course of the litigation, CRT refined its FOIA request. Initially, CRT sought information submitted to FDA by third parties, but CRT eventually narrowed its request to include only FDA-created documents. CRT I, 180 F.Supp.2d at 31. In an effort to identify all responsive documents held by FDA, and further narrow the scope of the litigation, CRT moved for a Vaughn index of all FDA-generated documents, stating, "once defendant produces such an index, plaintiff may have a basis for deciding which, if any, such records it wishes to pursue." Id. (quoting plaintiff's motion) (brackets omitted). A Vaughn index is created by an agency to assist courts and FOIA requesters when the agency claims that responsive documents are exempt from disclosure. The index is supposed to "describe with reasonable specificity the material withheld" and justify why each responsive document is exempt from disclosure under FOIA. King v. Dep't of Justice, 830 F.2d 210, 221 (D.C.Cir.1987). When creating a Vaughn index, "[a] withholding agency must describe each document or portion thereof withheld, and for each withholding it must discuss the consequences of disclosing the sought-after information." Id. at 223-24 (emphasis omitted).

FDA balked at CRT's request for a comprehensive Vaughn index. The agency argued that it would take two years to compile the index sought by CRT and require review of nearly a quarter of a million pages of documents. CRT I, 180 F.Supp.2d at 33 (citing defendant's motion). In response to CRT's motion, FDA filed a cross-motion for a sample Vaughn index whereby a representative IND would be selected, and FDA would compile a Vaughn index of the responsive documents for that IND.

The trial court ruled in favor of FDA, allowing the agency to produce a representative sample Vaughn index. The trial court "accord[ed] FDA deference in its description of the documents in each IND as essentially uniform." Id. at 34 (quotation marks omitted). FDA indicated that it planned to assert the same exemptions for the documents in the sample IND and the same types of documents in the other INDs. In other words, in FDA's view, the sample Vaughn index would provide CRT and the trial court with all necessary information for all of the INDs. Id. In order to "further ensure the representativeness of the sample, . . . the court [allowed] CRT to choose the IND to be indexed." Id. CRT chose IND G to be the subject of the sample Vaughn i...