campaign/responsible v. Fda

CourtDistrict Court, District of Columbia
DecidedJanuary 22, 2009
DocketCivil Action No. 2000-2849
StatusPublished

This text of campaign/responsible v. Fda (campaign/responsible v. Fda) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
campaign/responsible v. Fda, (D.D.C. 2009).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

CAMPAIGN FOR RESPONSIBLE : TRANSPLANTATION, : : Plaintiff, : Civil Action No.: 00-2849 (RMU) : v. : Document No.: 143 : U.S. FOOD AND DRUG : ADMINISTRATION et al., : : Defendants. :

MEMORANDUM OPINION

GRANTING THE PLAINTIFF’S MOTION FOR ATTORNEYS’ FEES AND COSTS

I. INTRODUCTION

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. 1 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.

1 Xenotransplantation involves the implantation of animal tissues, cells and organs into human beings for treatment of human diseases. Mem. Op. (July 23, 2001) at 1. II. FACTUAL & PROCEDURAL BACKGROUND

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 2 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

2 The Vaughn index is an affidavit that describes the withheld or redacted documents and justifies, in detail, why each record is exempt from disclosure under FOIA. King v. U.S. Dep’t of Justice, 830 F.2d 210, 223-24 (D.C. Cir. 1987). The index serves to aid the requester in determining what documents to request, as well as to aid the court in reviewing the validity of the agency’s withholding.

2 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

3 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

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campaign/responsible v. Fda, Counsel Stack Legal Research, https://law.counselstack.com/opinion/campaignresponsible-v-fda-dcd-2009.