Campaign for Responsible Transplantation v. Food & Drug Administration

511 F.3d 187, 379 U.S. App. D.C. 158, 2007 U.S. App. LEXIS 29857, 2007 WL 4553056
CourtCourt of Appeals for the D.C. Circuit
DecidedDecember 28, 2007
Docket06-5333
StatusPublished
Cited by45 cases

This text of 511 F.3d 187 (Campaign for Responsible Transplantation v. Food & Drug Administration) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Campaign for Responsible Transplantation v. Food & Drug Administration, 511 F.3d 187, 379 U.S. App. D.C. 158, 2007 U.S. App. LEXIS 29857, 2007 WL 4553056 (D.C. Cir. 2007).

Opinion

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 xenotran-splantation. CRT subsequently narrowed its FOIA request to include only records pertaining to xenotransplantation clinical trials in 35 investigational new drug (“IND”) applications involving xenotran-splantation. 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.

*189 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 in-dices were inadequate. Campaign for Responsible Transplantation v. FDA, 219 F.Supp.2d 106 (D.D.C.2002) (memorandum opinion) (“CRT IP’).

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 (“CRTIII”).

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.” Buck-hannon 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 xenotran-splantation.” 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 *190 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 Xenotran-splantation 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)(l)-(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.

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511 F.3d 187, 379 U.S. App. D.C. 158, 2007 U.S. App. LEXIS 29857, 2007 WL 4553056, Counsel Stack Legal Research, https://law.counselstack.com/opinion/campaign-for-responsible-transplantation-v-food-drug-administration-cadc-2007.