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Campaign for Responsible Transplantation v. U.S. Food and Drug Administration

January 22, 2009


The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document No. 143



This case comes before the court on the plaintiff's motion for attorneys' fees and costs. The plaintiff, Campaign for Responsible Transplantation ("CRT"), is a non-profit organization dedicated to creating awareness regarding the dangers of a cellular treatment therapy called xenotransplantation.*fn1 The plaintiff brings this action pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 et seq., requesting that the court order the defendant, the United States Food and Drug Administration ("FDA"), to compensate the plaintiff for fees and costs incurred as a result of the FDA's delay in disclosing nonexempt documents covered by the plaintiff's FOIA request. After balancing the four factors endorsed by this Circuit to guide the court's decision -- public interest, commercial benefit, nature of the plaintiff's interest and reasonableness of the FDA's decision to withhold documents -- the court concludes that all four factors tip in favor of the plaintiff. Consequently, the plaintiff is entitled to attorneys' fees.


The FDA regulates xenotransplantation products as "investigational new drugs" ("INDs"). Id. at 2. The plaintiff, concerned about potential public health risks of xenotransplantation products, submitted a written FOIA request for records related to thirty-five xenotransplantation INDs on March 9, 2000. Mem. Op. (Sept. 3, 2002) at 3. The FDA acknowledged receipt of the request and indicated it would respond to the request "as soon as possible." Id. When it did not receive a response to its FOIA request by August 2, 2000, the plaintiff filed an appeal with the FDA. Id. After the FDA failed to respond to the plaintiff's appeal, the plaintiff filed suit in this court on November 27, 2000 to compel immediate disclosure of the requested records. Id. After commencing suit, the plaintiff narrowed its original FOIA request to include only documents generated by the FDA and documents concerning clinical trials related to nineteen of the thirty-five INDs. Mem. Op. (Sept. 24, 2004) at 3.

The plaintiff, in an effort to further narrow the scope of the litigation, moved for Vaughn indices*fn2 describing documents related to all nineteen INDs. Mem. Op. (July 23, 2001) at 3-4. The FDA countered that such a request would take an estimated two years to complete because it involved review of approximately 240,000 pages of documents. Id. at 6. In its cross-motion, the FDA asked the court to allow it instead to produce a sample Vaughn index with respect to one of the nineteen INDs. Id. at 6-7. The FDA supported its motion by noting that the "same types of FDA-generated documents are found in every xenotransplantation IND file . . . [and that the FDA] would assert the same exemptions for documents in the indexed IND as it would for the same types of documents in the other INDs." Id. at 8. The court's 2001 opinion denied the plaintiff's motion for Vaughn indices for all nineteen INDs, and instead granted the FDA's motion to produce a sample Vaughn index for one IND ("IND G"). Id. at 7. The FDA produced a sample Vaughn index for IND G on September 4, 2001. Mem. Op. (Sept. 5, 2006) at 3. On December 4, 2001, the court ordered that the FDA release responsive, nonexempt documents before December 17, 2001. Order (Dec. 4, 2001) at 5.

After the FDA produced the sample Vaughn index and released some documents related to the sample IND, both parties moved for summary judgment over the IND G documents that the FDA continued to withhold. Mem. Op. (Sept. 24, 2004) at 3. The plaintiff moved for the immediate release of all IND G documents that the FDA claimed were exempt. Pl.'s Mot. for Summ. J. (Jan. 15, 2002). The FDA, conversely, moved the court for a ruling that the withheld documents were exempt from disclosure. Mem. Op. (Sept. 5, 2006) at 3. On September 3, 2002, the court granted in part and denied in part both summary judgment motions, concluding that the FDA had conducted an adequate search, but that its sample Vaughn index was inadequate to justify the withholdings. Mem. Op. (Sept. 3, 2002) at 16. Rather than rule on the propriety of the FDA's decision to withhold documents by relying on an inadequate Vaughn index, the court postponed judgment on the merits of the parties' claims and ordered the FDA to produce a revised sample Vaughn index. Id.

While preparing its revised Vaughn index for IND G, the FDA released additional documents. Mem. Op. (Sept. 5, 2006) at 4. After the FDA produced its revised sample Vaughn index, the parties filed renewed cross-motions for summary judgment. Mem. Op. (Sept. 24, 2004) at 3. On September 24, 2004, the court denied the plaintiff's motion for immediate release of withheld documents and instead granted the FDA's motion, holding that the FDA lawfully withheld contested documents pursuant to FOIA exemptions. Id. at 23. Because the Vaughn index and the court's ruling related only to the sample IND G, the court also ordered the FDA to release all nonexempt documents related to the other eighteen INDs. Id. at 22. Months later, after the FDA had not released the documents with respect to the other eighteen INDs, the plaintiff moved to enforce the court's order. The court denied the plaintiff's request, stating that "[t]he parties' submissions demonstrate that they have not adequately communicated with each other . . . [and] the court is confident that the parties do not wish to further burden the court with the task of unraveling unnecessary disputes." Order (June 3, 2005).

The plaintiff filed its first motion for attorneys' fees on February 3, 2006. Pl.'s 1st Mot. for Attorneys' Fees. After briefing was complete, the court concluded that the plaintiff had not substantially prevailed and that it was, therefore, not eligible for attorneys' fees. Mem. Op. (Sept. 5, 2006). The Circuit, however, reversed, concluding that the plaintiff substantially prevailed because the court's September 24, 2004 order required the FDA to release documents, and that it was irrelevant that the FDA had already agreed to release the documents. CRT v. FDA, 511 F.3d 187, 196-97 (D.C. Cir. 2007). Having determined that the plaintiff is eligible for attorneys' fees, the Circuit remanded the case to allow this court to determine in the first instance whether the plaintiff is entitled to these fees. The plaintiff filed its second motion for attorneys' fees on May 22, 2008. Pl.'s 2d Mot. for Attorneys' Fees ("Pl.'s Mot."). The FDA then filed an opposition, Def.'s Opp'n, to which the plaintiff replied, Pl.'s Reply. The court now turns to the pending motion.


A. Legal Standard for Attorneys' Fees and Costs Under FOIA

Pursuant to 5 U.S.C. ยง 552(a)(4)(E)(a), the court may assess "reasonable attorneys' fees and other litigation costs reasonably incurred in any case . . . in which the complainant has substantially prevailed." To award attorneys' fees under FOIA, a court must undertake a two-step inquiry. First, the court must determine whether the claimant is eligible for attorneys' fees. Pyramid Lake Paiute Tribe v. U.S. Dep't of Justice, 750 F.2d 117, 119 (D.C. Cir. 1984). To be eligible for fees, the claimant must "substantially prevail" in the underlying FOIA litigation. Id. Moreover, "[a]n agency cannot foreclose an award of attorneys' fees and costs by complying with a FOIA request during the pendency of litigation." Md. Dep't of Human Res. v. Sullivan, 738 F. Supp. 555, 563 (D.D.C. 1990) (citing Cuneo v. Rumsfeld, 553 F.2d 1360, 1365 (D.C. Cir. 1977)). Second, the court must determine that the plaintiff is "entitled" to an award of attorneys' fees and costs. Id. In deciding whether a claimant is entitled to an award of attorneys' fees and costs, the court analyzes four factors: "(1) the benefit to the public, if any, derived from the case; (2) the commercial benefit to the complainant; (3) the nature of the complainant's interest in the records sought; and (4) whether the government's withholding of the records had a reasonable basis in law." Cuneo, 553 F.2d at 1364. The second and third factors ...

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