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Government Accountability Project v. U.S. Dep't of Health and Human Services

March 9, 2010


The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge


The above-captioned case arises out of a request filed by Plaintiff, the Government Accountability Project, pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 et seq., seeking the disclosure and release of agency records consisting of clinical study data regarding the drug ciprofloxacin ("cipro"). Plaintiff has named as Defendants in this action the United States Department of Health and Human Services ("HHS") and the United States Food and Drug Administration ("FDA") (collectively "Defendants"). Currently pending before the Court are the parties' cross-motions for summary judgment. The Court has conducted a searching review of the parties' motions and responsive briefing, the exhibits attached to those filings, the relevant case law as well as statutory and regulatory provisions, and the entire record herein. The lone dispute remaining in this case is the propriety of Defendants' redactions from the responsive documents. Specifically, Defendants redacted certain information from the documents at issue pursuant to two separate FOIA Exemptions - Exemption 4 (confidential commercial information) and Exemption 6 (personal privacy information). Upon review of Defendants' opening motion and Vaughn index, Plaintiff now concedes that the information withheld pursuant to Exemption 6 is properly exempt under FOIA.*fn1 Accordingly, Defendants' [19] motion for summary is GRANTED-IN-PART as conceded insofar as Defendants assert that they properly withheld information under Exemption 6. Plaintiff continues to challenge the validity of Defendants' redactions pursuant to Exemption 4, however, arguing that Defendants have not met their burden of demonstrating that the material in dispute may be properly withheld as confidential commercial information. The Court agrees and therefore DENIES-IN-PART the Defendants' [19] motion for summary judgment and GRANTS the Plaintiff's [20] cross-motion for summary judgment with respect to the propriety of Defendants' withholdings pursuant to Exemption 4. Defendants are therefore directed to disclose to Plaintiff all information previously redacted as confidential consumer information under Exemption 4, for the reasons set forth.


The facts of this case are straightforward. Plaintiff submitted a FOIA request to the FDA on June 27, 2007, seeking documents concerning certain clinical study data regarding the drug ciprofloxacin. Defs.' Stmt. ¶ 1.*fn2 Specifically, Plaintiff requested the following two categories of documents relating to cipro:

(ii) in electronic form,...: [a]ll goniometry (joint angle motion measurement) data, including but not limited to, all passive range of motion of joints, by protocol, measured in degrees, recorded from all subjects and sorted by site or investigator number, subject or numeric identification number, the joints measured, the dates of measurement and information on the age of the subject at enrollment or first measurement in months or years, or birth month and year, pertaining to domestic and foreign clinical trial studies 1001169 and 100201; and

(ii) in paper form: all FDA Division of Scientific Investigations ("DSI") reports and records, domestic and outside of US, concerning all DSI inspections pertaining to clinical trial studies 1001169 and 100201.

Defs.' MSJ, Att. 1 (Second Declaration of Nancy B. Sager) (hereinafter, "Sager Decl.") ¶ 6;*fn3 see also Compl., Docket No. [1], ¶ 6.

Having received no response from Defendants to its FOIA request, Plaintiff filed the instant lawsuit on September 25, 2007, see generally Compl., and subsequently moved for judgment on the pleadings based upon Defendants' failure to produce any records responsive to the pending FOIA request, see Pl.'s Mot. for J. on the Pleadings, Docket No. [5]. In response, Defendants filed a Motion for an Open America Stay. See Defs.' Mot. to Stay, Docket No. [7].

On August 4, 2008, this Court issued a memorandum opinion and order denying Defendants' request for an Open America stay and granting-in-part Plaintiff's motion for judgment on the pleadings insofar as Plaintiff sought a judgment that Defendants were required to process its FOIA request and release the documents on a rolling basis. See Gov't Accountability Project v. HHS, 568 F. Supp. 2d 55, 56 (D.D.C. 2008). Defendants were directed to report back to the Court with an estimate as to the volume of the requested records, the time by which Defendants expected to begin processing the FOIA request, and how long they expected it to take to fully process the request. Id. at 57.

Based upon Defendants' response, the Court set a schedule for Defendants' production of the responsive documents and provided Plaintiff additional time to review the documents to determine if any issues remained for litigation. See 9/22/08 Min. Order. In addition, the Court required the parties to submit a joint status report advising as to whether any disputes remained necessitating further litigation. Id. The parties completed the production and review process as required, thereafter advising the Court that they had been unable to resolve all disputes relating to Plaintiff's FOIA request. See 2/19/09 Order, Docket No. [18]; see also Defs.' Stmt. ¶¶ 2-3 (indicating that Defendants provided Plaintiff with the responsive documents in two separate installments on October 22, 2008 and again on December 2, 2008). The parties therefore proceeded to file the pending cross-motions for summary judgment. Briefing on the motions is now complete, and the matter is ripe for the Court's adjudication.


In reviewing a motion for summary judgment under FOIA, the Court must conduct a de novo review of the record. See 5 U.S.C. § 552(a)(4)(B). In the FOIA context, "de novo review requires the Court to 'ascertain whether the agency has sustained its burden of demonstrating that the documents requested... are exempt from disclosure under [] FOIA.'" Assassination Archives & Research Ctr. v. Cent. Intelligence Agency, 334 F.3d 55, 57 (D.C. Cir. 2003) (quoting Summers v. Dep't of Justice, 140 F.3d 1077, 1080 (D.C. Cir. 1998)). Summary judgment is proper when "the pleadings, the discovery [if any] and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c).

Under FOIA, all underlying facts and inferences are analyzed in the light most favorable to the FOIA requester; as such, only after an agency seeking summary judgment proves that it has fully discharged its FOIA obligations is summary judgment appropriate. Moore v. Aspin, 916 F. Supp 32, 35 (D.D.C. 1996) (citing Weisberg v. Dep't of Justice, 705 F.2d 1344, 1350 (D.C. Cir. 1983)). In opposing a motion for summary judgment, a party must offer more than conclusory statements. See Broaddrick v. Exec. Off. of President, 139 F. Supp. 2d 55, 65 (D.D.C. 2001) (citing Laningham v. U.S. Navy, 813 F.2d 1236, 1241 (D.C. Cir. 1987)).

Congress enacted FOIA for the purpose of introducing transparency to government activities. See Stern v. Fed. Bureau of Investigation, 737 F.2d 84, 88 (D.C. Cir. 1984). Congress remained sensitive, however, to the need to achieve balance between this objective and the vulnerability of "legitimate governmental and private interests [that] could be harmed by release of certain types of information." Critical Mass Energy Project v. Nuclear Regulatory Comm'n, 975 F.2d 871, 872 (D.C. Cir. 1992) (en banc); see also Summers, 140 F.3d at 1079. Accordingly, FOIA provides nine exemptions pursuant to which an agency may withhold requested information. See 5 U.S.C. ยงยง 552(a)(4)(B), (b)(1)-(9). The agency must demonstratethe validity of any exemption that it asserts. See id.; Beck v. Dep't of Justice, 997 F.2d 1489, 1491 (D.C. Cir. 1993) ("[c]onsistent with the purpose of the Act, the burden is on the agencyto justify withholding requested documents"). In addition, summary judgment may be granted on the basis of the agency's accompanying affidavits or declarations if they describe "the justifications for nondisclosure with reasonably specific detail, demonstrate that the information withheld logically falls within the claimed exemption, and are not controverted by either contrary evidence in the record ...

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