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Case TitleGOVERNMENT ACCOUNTABILITY PROJECT v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
DistrictDistrict of Columbia
CityWashington, DC
Case Number1:2007cv01702
Date Filed2007-09-25
Date Closed2010-03-09
JudgeJudge Colleen Kollar-Kotelly
PlaintiffGOVERNMENT ACCOUNTABILITY PROJECT
Case DescriptionThe Government Accountability Project submitted a FOIA request to the FDA for records concerning clinical studies submitted regarding the drug Ciprofloxacin. The agency acknowledged receipt of the request, but after hearing nothing further from the agency, GAP filed an administrative appeal. The agency acknowledged receipt of the appeal, but after hearing nothing more from the agency, GAP filed suit.
Complaint issues: Failure to respond within statutory time limit, Litigation - Attorney's fees

DefendantU.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Component U.S. Food & Drug Administration (FDA)
DefendantUNITED STATES FOOD & DRUG ADMINISTRATION
Documents
Docket
Complaint
Complaint attachment 1
Opinion/Order [13]
FOIA Project Annotation: The FDA has experienced consistent backlog problems for years, due in large part because of the complexity of many of the requests it receives as well as a chronic understaffing problem. Added to this are increased public and political demands on the agency to expand its regulatory role without any accompanying increase in funding or resources. To its credit, the FDA FOIA staff has made a significant dent in its backlog, but the problems that have hounded the agency for years still make it difficult to respond to complex requests in anywhere near the statutory time frame. As a result, the agency has had a string of bad luck as far as convincing district court judges to grant it an Open America stay. Two courts in New York and one in New Jersey have rejected the agency's arguments within the past year. Now Judge Colleen Kollar-Kotelly has joined those other courts in turning down the agency's pleas yet again. The case before Kollar-Kotelly was brought by the public interest group Government Accountability Project for records on the drug Cipro, which was used as a preventive measure during the anthrax scare. While Kollar-Kotelly declined to issue a stay, she did not require the agency to actually begin processing GAP's request. Instead, she noted that "although the Court concludes that Defendants have not established exceptional circumstances sufficient to warrant the eighteen-month stay they seek, the Court recognizes that Defendants are faced with a substantial backlog of pending FOIA requests and that Plaintiff's request is currently pending in the processing queue. Therefore. . . the Court shall require Defendants to file a status report with the Court on or before September 5, 2008, advising the Court as to the volume of the requested records, where Plaintiff's FOIA request currently stands in the processing queue, i.e., the date by which Defendants expect to begin processing Plaintiff's FOIA request, and how long they expect it will take to process Plaintiff's request, so that the Court can set an appropriate processing schedule." GAP submitted its request June 27 and its receipt was acknowledged by the agency June 28 and assigned to the Complex Track. After hearing nothing more, GAP filed an administrative appeal August 3, but after hearing nothing more substantive, GAP filed suit September 25. The agency filed a motion for a stay on February 19, 2008. Kollar-Kotelly first noted that "exceptional circumstances" may exist "when an agency faces an unexpected volume of requests for information and has insufficient resources to deal with those requests in the time frames set forth in the FOIA." She also pointed out that "exceptional circumstances" do not exist where "a delay. . . results from a predictable agency workload of requests under this section, unless the agency demonstrates reasonable progress in reducing its backlog of pending requests." In this case, the agency explained that the Division of Information Disclosure Policy in the Center for Drug Evaluation and Research received a high of 5,310 requests in 2003 and that its annual numbers had steadily decreased to 2,888 requests in 2007. Further, DIDP received an average of 240 requests per month in 2007, down from an average of 285 per month in 2006. GAP argued that this downward trend did not support a showing that there was a deluge of requests. Kollar-Kotelly replied by indicating that "GAP is certainly correct that the downward trend in the number of DIDP FOIA requests, at first blush, suggests that the agency is not facing an unexpected volume of requests for information." The agency pointed out that the vast majority of these requests dealt with confidential business information, personal privacy, and deliberative process information. But while Kollar-Kotelly expressed sympathy, she noted that "Defendants' arguments, however, do not suggest that the FOIA requests DIDP is processing have become increasingly or unexpectedly more complex of late." Kollar-Kotelly then gave the agency credit for its candor in bringing its recent string of defeats to her attention. But she observed that "significantly, in each case, the support for the FDA's arguments appears to have come in the form of a declaration supplied by [DIDP] that set forth the same figures for DIDP's workload that [were] proffered in this case. While those cases not are binding on this Court, they are highly persuasive in light of their overwhelming similarity to the instant case." She said she agreed with the other courts' conclusion that "DIDP's declining workload of FOIA cases does not, in and of itself, establish the type of exceptional circumstances necessary to warrant a stay." DIDP argued that there were other unanticipated demands on its resources that made it considerably more difficult to respond to requests within FOIA's time frame. These included requests from Congress, demands for production of records because of litigation, DIDP's attempts to make more information proactively available, and further demands on DIDP as part of the Food and Drug Administration Amendments Act of 2007. Responding to each concern, Kollar-Kotelly explained that the agency had faced increased congressional requests since 2004 and that "by this point, Congressional requests appear to be more of a predictable agency workload than a deluge of unanticipated responsibility." She noted the agency indicated that many of its litigation document demands had been pending for some time and were handled by five full-time employees. "Significantly, because Defendants do not provide the Court with any sense of whether DIDP faced or handled similar litigation requests in previous years, the Court cannot determine whether the 2007 litigation requests were unusual." As to its proactive disclosures, Kollar-Kotelly observed that "this argument suggests that DIDP's workload has not declined as its flow of incoming requests has declined, it does not suggest that DIDP has actually seen an increase in workload sufficient to establish exceptional circumstances." As to its increased obligations under the FDAAA, the agency admitted it was planning to hire more staff. Kollar-Kotelly pointed out that "it appears that DIDP's staffing level has increased dramatically over the past five years, and that its overall workload of incoming FOIA requests combined with other responsibilities has not." Saying that she "commends Defendants for the steps they have taken," Kollar-Kotelly indicated that "the Court cannot determine whether the decrease in DIDP's backlog is attributable to the measures Defendants have undertaken or to the decrease in incoming FOIA requests, and therefore cannot conclude that Defendants have made 'reasonable progress' in reducing their backlog of FOIA requests." She noted that the DIDP's progress in reducing its backlog was an indication it was exercising due diligence. But she pointed out that the unit's response to GAP left something to be desired. She explained that in the eight months between GAP's request and its motion for summary judgment the agency had done very little except acknowledge receipt of the organization's request and appeal. She was also bothered that the agency didn't file its motion for a stay until February. She indicated that "while Defendants are correct that neither the FOIA nor the relevant case law imposes a filing deadline for agencies seeking Open America stays, Defendants' conduct in responding to GAP's FOIA request, as opposed to FOIA requests in general, cannot be described as a model of due diligence."
Issues: Delay - Stay of proceedings
Opinion/Order [26]
User-contributed Documents
 
Docket Events (Hide)
Date FiledDoc #Docket Text

2007-09-251COMPLAINT against U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION ( Filing fee $ 350, receipt number 4616007105) filed by GOVERNMENT ACCOUNTABILITY PROJECT. (Attachments: # 1 Civil Cover Sheet)(td, ) (Entered: 09/26/2007)
2007-09-25SUMMONS (3) Issued as to U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (td, ) (Entered: 09/26/2007)
2007-09-262ORDER Establishing Procedures for Electronic Filing for Cases Assigned to Judge Colleen Kollar-Kotelly, signed on September 26, 2007. (SM) (Entered: 09/26/2007)
2007-10-243NOTICE of Appearance by Beverly Maria Russell on behalf of U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION (Russell, Beverly) (Entered: 10/24/2007)
2007-10-314ANSWER to Complaint by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. Related document: 1 Complaint filed by GOVERNMENT ACCOUNTABILITY PROJECT.(Russell, Beverly) (Entered: 10/31/2007)
2008-01-295MOTION for Judgment on the Pleadings by GOVERNMENT ACCOUNTABILITY PROJECT (Attachments: # 1 Text of Proposed Order)(Condit, Richard) (Entered: 01/29/2008)
2008-02-056Unopposed MOTION for Extension of Time to Respond to Plaintiff's Motion for Judgment on the Pleadings by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Russell, Beverly) (Entered: 02/05/2008)
2008-02-06MINUTE ORDER (paperless) granting 6 Defendants' Unopposed, First Motion for an Extension of Time to Respond to Plaintiff's Motion for Judgment on the Pleadings. Accordingly, Defendants shall have until and including February 19, 2008, to file their response to Plaintiff's motion. Signed by Judge Colleen Kollar-Kotelly on February 6, 2008. (SM) (Entered: 02/06/2008)
2008-02-06Set/Reset Deadlines: Response due by 2/19/2008. (dot, ) (Entered: 02/07/2008)
2008-02-197MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION (Attachments: # 1 Declaration of Nancy B. Sager (February 15, 2008), # 2 Declaration of Frederick J. Sadler, February 4, 2008, # 3 Text of Proposed Order)(Russell, Beverly) (Entered: 02/19/2008)
2008-02-198Memorandum in opposition to re 5 MOTION for Judgment on the Pleadings filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 02/19/2008)
2008-02-279REPLY to opposition to motion re 7 MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings filed by GOVERNMENT ACCOUNTABILITY PROJECT. (Condit, Richard) (Entered: 02/27/2008)
2008-03-0310Memorandum in opposition to re 7 MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings filed by GOVERNMENT ACCOUNTABILITY PROJECT. (Condit, Richard) (Entered: 03/03/2008)
2008-03-1011REPLY to opposition to motion re 7 MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings MOTION to Stay (Open America) and Opposition to Plaintiff's Motion for Judgment on the Pleadings filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 03/10/2008)
2008-08-0412ORDER. For the reasons set forth in the accompanying Memorandum Opinion, (1) Defendants' 7 Motion For an Open America Stay is DENIED; (2) Plaintiff's 5 Motion for Judgment on the Pleadings is GRANTED-IN-PART, insofar as it seeks a judgment that Defendants are required to process Plaintiff's FOIA request and release the documents on a rolling basis; and (3) on or before September 5, 2008, Defendants shall file a status report with the Court advising the Court as to the volume of the requested records, where Plaintiff's FOIA request currently stands in the processing queue, i.e., the date by which Defendants expect to begin processing Plaintiff's FOIA request, and how long Defendants expect it will take to process Plaintiff's request. Upon receipt of that status report, the Court shall set an appropriate processing schedule. Signed by Judge Colleen Kollar-Kotelly on August 4, 2008. (lcckk2) (Entered: 08/04/2008)
2008-08-0413MEMORANDUM OPINION. Signed by Judge Colleen Kollar-Kotelly on August 4, 2008. (lcckk2) (Entered: 08/04/2008)
2008-08-04Set/Reset Deadlines: Status Report due by 9/5/2008. (dot, ) (Entered: 08/05/2008)
2008-09-0414STATUS REPORT by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 09/04/2008)
2008-09-22MINUTE ORDER (paperless). The Court has reviewed Defendants' 14 Status Report and hereby ORDERS that, as the Court denied Defendants' Motion for an Open America Stay in this matter, Defendants are required to begin processing Plaintiff's FOIA request immediately. Defendants shall produce documents to Plaintiff on a rolling basis, beginning no later than November 5, 2008 and shall complete all productions no later than December 5, 2008. No later than December 12, 2008, the parties shall file a Joint Status Report with the Court indicating how they propose to proceed in litigating this matter. Signed by Judge Colleen Kollar-Kotelly on September 22, 2008. (lcckk2) (Entered: 09/22/2008)
2008-09-23Set/Reset Deadlines: all productions due by 12/5/2008. Joint Status Report due by 12/12/2008 (tth) (Entered: 09/23/2008)
2008-12-1215STATUS REPORT (Joint) by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Exhibit 1. Letter from Howard R. Philips to Richard E. Condit, Oct. 22, 2008, # 2 Exhibit 2. Letter from Howard R. Philips to Richard E. Condit, Dec. 2, 2008)(Russell, Beverly) (Entered: 12/12/2008)
2008-12-12MINUTE ORDER: Pursuant to the Joint Status Report filed on December 12, 2008, the parties shall file by January 12, 2009, either a stipulation of dismissal or a joint status report, to include proposed deadlines for briefing and a discussion of issues to be briefed. Signed by Judge Colleen Kollar-Kotelly on December 12, 2008. (SM) (Entered: 12/12/2008)
2009-01-0916Joint MOTION for Extension of Time to File Joint Status Report by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION (Attachments: # 1 Text of Proposed Order)(Russell, Beverly) (Entered: 01/09/2009)
2009-01-13MINUTE ORDER granting 16 The Parties' Motion for Extension of Time to File Their Joint Status Report. Accordingly, Plaintiff shall have up to and including February 11, 2009, to complete its review of the documents produced by defendants in response to plaintiff's Freedom of Information Act request for purposes of clarifying issues, if any, to be litigated in this matter; it is FURTHER ORDERED that the parties shall have up to and including February 18, 2009, to file their Joint Status Report proposing next steps for facilitating resolution of this suit. Signed by Judge Colleen Kollar-Kotelly on January 13, 2009. (SM) (Entered: 01/13/2009)
2009-02-1817STATUS REPORT (Joint) by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 02/18/2009)
2009-02-1918ORDER. The parties shall abide by the schedule herein. Signed by Judge Colleen Kollar-Kotelly on February 19, 2009. (lcckk2) (Entered: 02/19/2009)
2009-02-19Set/Reset Deadlines: Cross Motions due by 5/15/2009. Response to Cross Motions due by 6/9/2009. Reply to Cross Motions due by 7/2/2009. Defendants' Vaughn Document due by 4/15/2009. Summary Judgment motions due by 4/15/2009. Response to Motion for Summary Judgment due by 5/15/2009. Reply to Motion for Summary Judgment due by 6/9/2009. (dot, ) (Entered: 02/20/2009)
2009-04-1519MOTION for Summary Judgment by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION (Attachments: # 1 Second Declaration of Nancy B. Sager, April 15, 2009, # 2 Exhibit 1. Letter from Howard R. Philips to Richard E. Condit, Esq., Oct. 22, 2008, # 3 Exhibit 2. Letter from Howard R. Philips to Richard E. Condit, Dec. 2, 2008, # 4 Vaughn Index, Table A - Paper Records, # 5 Vaughn Index, Table B - Electronic Records, # 6 Statement of Facts, # 7 Text of Proposed Order)(Russell, Beverly) (Entered: 04/15/2009)
2009-05-1520Cross MOTION for Summary Judgment & Opposition to Defendant's Motion for Summary Judgement by GOVERNMENT ACCOUNTABILITY PROJECT (Attachments: # 1 Affidavit, # 2 Text of Proposed Order)(Condit, Richard) (Entered: 05/15/2009)
2009-05-1521Memorandum in opposition to re 19 MOTION for Summary Judgment filed by GOVERNMENT ACCOUNTABILITY PROJECT. (See Document No. 20 to view document). (nmw, ) (Entered: 05/18/2009)
2009-06-0922Memorandum in opposition to re 20 Cross MOTION for Summary Judgment & Opposition to Defendant's Motion for Summary Judgement and Defendants' Reply Memorandum in Further Support of Their Motion for Summary Judgment filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 06/09/2009)
2009-06-0923REPLY to opposition to motion re 19 MOTION for Summary Judgment filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Russell, Beverly) (Entered: 06/09/2009)
2009-07-0224REPLY to opposition to motion re 20 Cross MOTION for Summary Judgment & Opposition to Defendant's Motion for Summary Judgement filed by GOVERNMENT ACCOUNTABILITY PROJECT. (Condit, Richard) (Entered: 07/02/2009)
2010-03-0925ORDER. Based on the reasons set forth in an accompanying memorandum opinion, Defendants' 19 motion for summary judgment is GRANTED-IN-PART and DENIED-IN-PART. Specifically, Defendants' motion is GRANTED as conceded insofar as Defendants assert that information was properly withheld pursuant to Exemption 6, but is DENIED insofar as Defendants assert that information was properly withheld pursuant to Exemption 4. In addition, Plaintiff's 20 cross-motion for summary judgment is GRANTED with respect to the propriety of Defendants' withholdings pursuant to Exemption 4. Accordingly, Defendants shall disclose to Plaintiff all information previously redacted as confidential consumer information under Exemption 4. This is a final, appealable Order. Signed by Judge Colleen Kollar-Kotelly on March 9, 2010. (lcckk2 ) (Entered: 03/09/2010)
2010-03-0926MEMORANDUM OPINION. Signed by Judge Colleen Kollar-Kotelly on March 9, 2010. (lcckk2 ) (Entered: 03/09/2010)
2010-03-2527MOTION for Extension of Time to File Motion for Attorneys' Fees and Costs by GOVERNMENT ACCOUNTABILITY PROJECT (Attachments: # 1 Text of Proposed Order)(Condit, Richard) (Entered: 03/25/2010)
2010-03-29MINUTE ORDER granting 27 Consent Motion for Extension of Time Within Which toFile Motion for Attorneys' Fees and Costs. Accordingly, Plaintiff shall have until and including April 9, 2010, to file its Motion for Attorneys' Fees and Costs. Signed by Judge Colleen Kollar-Kotelly on March 29, 2010. (SM) (Entered: 03/29/2010)
2010-04-0928MOTION for Attorney Fees and Costs by GOVERNMENT ACCOUNTABILITY PROJECT (Attachments: # 1 Declaration, # 2 Text of Proposed Order)(Condit, Richard) (Entered: 04/09/2010)
2010-04-2329Memorandum in opposition to re 28 MOTION for Attorney Fees and Costs as Moot filed by U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD & DRUG ADMINISTRATION. (Attachments: # 1 Text of Proposed Order)(Russell, Beverly) (Entered: 04/23/2010)
2010-04-27MINUTE ORDER (paperless). On April 9, 2010, Plaintiff filed a 28 Motion for Attorney's Fees and Costs, in which Plaintiff argued that it was entitled to an award of attorney's fees and costs in the amount of $25,041.50. On April 23, 2010, Defendant filed a 29 Response to Plaintiff's Motion. As indicated therein, Defendant represents that it will pay the total amount of requested attorney's fees and costs and therefore urges that Plaintiff's motion is moot and should be dismissed on that basis. Accordingly, the Court hereby directs Plaintiff to file, by no later than May 5, 2010, a notice advising the Court whether it agrees that its motion for fees and costs may now be dismissed as moot in light of Defendant's representation that it intends to pay the full amount requested. If Plaintiff disagrees, it must provide the Court with factual and legal support for its assertion to the contrary. Signed by Judge Colleen Kollar-Kotelly on April 27, 2010. (lcckk2 ) (Entered: 04/27/2010)
2010-05-0630ORDER. Plaintiff's 28 Motion for Attorney's Fees and Costs is DENIED AS MOOT. Signed by Judge Colleen Kollar-Kotelly on May 6, 2010. (lcckk2 ) (Entered: 05/06/2010)
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