Case Detail

FOIA Project Annotation: Judge Colleen Kollar-Kotelly has ruled that the FDA failed to show exceptional circumstances that would entitle it to a stay of proceedings in responding to several requests concerning Zicam. Attorneys Nancy Buc and Madhusha Dissanayake made five Zicam-related requests. After the agency failed to respond on time, they filed suit. However, two of the requests had been completed by the time the case was considered, so only three remained at issue. The agency estimated that two of the requests could be completed by July 2011 and the other by September 2011. Kollar-Kotelly had denied the FDA a stay two and a half ago in Gov't Accountability Project v. Dept of Health and Human Services, 568 F. Supp. 2d 55 (D.D.C. 2008), and she indicated that her analysis would focus on whether circumstances at the agency had changed since that time in such a way that the agency would now be entitled to a stay. Although the agency's annual report statistics showed that the number of requests had declined each year, the FDA argued that this drop was due to a decrease in simple requests because more information was posted on its website, with the result that a higher percentage of remaining requests were both more complex and time-consuming. Kollar-Kotelly was not impressed. She noted that "the FDA's arguments fall short of evidencing that incoming requests have, on average, become significantly and unexpectedly more complex as of late. . .[T]here is simply insufficient evidence in the record to draw any concrete and meaningful conclusions as to the composition of the Division of Information Disclosure Policy's workload today in comparison to years past, at least in terms of complexity. In any event, even crediting the FDA's contention that the ratio of complex requests to simple requests has increased over time, that does not necessarily mean that the DIDP now faces, on the whole, a more complex workload where the volume of incoming requests has simultaneously declined over time." The agency also contended that extraordinary circumstances existed because of further burdens created by Congressional and governmental requests, lawsuits, and new statutory disclosure obligations. But Kollar-Kotelly observed that "the FDA again fails to provide a sufficiently particularized showing as to the burdens involved in responding to such requests. . .In fact, the FDA concedes that these types of requests have been '[a] huge part of DIDP's workload since 2004,' which suggests, if anything, that they are more a part of the DIDP's predictable workload than the function of an unanticipated deluge of requests." Kollar-Kotelly expressed skepticism about the agency's conclusions concerning increased burdens from new legislation, specifically the Food and Drug Administration Amendments Act of 2007. The FDA argued that "the disclosure requirements imposed upon it by the FDAAA have proved to be more resource-intensive than originally expected, and '[a]lthough DIDP planned to have put in place procedures to meet its obligations within the first part of 2008, these efforts occupied significant staff time throughout 2008 and 2009.'" Kollar-Kotelly indicated that "while the FDA avers that these disclosure requirements have occupied significant staff time in prior years, it is unclear from the record how much staff time has been allocated. Nor is it clear whether contemporaneous increases in the DIDP's staff levels may have offset or ameliorated these 'new' burdens. . .[W]hile the Court does not doubt that 'newly' imposed statutory obligations may be a valid consideration in determining whether a stay is appropriate, the FDA has failed to provide this Court with sufficient record support to conclude that the enactment of the FDAAA has resulted in an unmanageable deluge of unanticipated requests." The agency also argued that it had made reasonable progress in reducing its backlog through increased emphasis on proactive disclosure. But Kollar-Kotelly pointed out that "the FDA offers little beyond its own speculation that there is a causal connection between its efforts and the downward trend in incoming requests." She added that "the FDA makes no meaningful attempt to establish an affirmative link between broader changes in its processes and procedures and the reduction in the DIDP's backlogâ€"let alone provide the Court with a quantifiable means to evaluate and assess the claimed link." Kollar-Kotelly found that the agency had failed to show that its resources were inadequate. She noted that "in the two years that have intervened since the Court last addressed the workload and resources of the DIDP, the DIDP has added approximately 5 new staff members, an increase of over 16%. Moreover, at the time it filed its moving papers in this action, the FDA intended to augment its staff with an additional 4 full-time employees. The FDA cautions, not without some force, that an increase in staff levels may not necessarily carry with it an instant reduction in workload. However, at best, this counsels in favor of exercising some restraint in drawing an adverse conclusion based upon the increase in the FDA's resources over time. It does not suffice to discharge the FDA's burden of establishing that its 'existing resources are inadequate.'"
Issues: Delay - Exceptional circumstance

Date Filed	Doc #	Docket Text
2010-02-24	1	COMPLAINT against FOOD AND DRUG ADMINISTRATION ( Filing fee $ 350, receipt number 4616027833) filed by NANCY L. BUC, MADHUSHA DISSANAYAKE, BUC & BEARDSLEY, LLP. (Attachments: # 1 Civil Cover Sheet)(td, ) (Entered: 02/25/2010)
2010-02-24	2	NOTICE OF RELATED CASE by NANCY L. BUC, BUC & BEARDSLEY, LLP, MADHUSHA DISSANAYAKE. Case related to Case No. 09-2406 CKK. (td, ) (Entered: 02/25/2010)
2010-02-24		SUMMONS (3) Issued as to FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (td, ) (Entered: 02/25/2010)
2010-02-26	3	ORDER Establishing Procedures for Electronic Filing for Cases Assigned to Judge Colleen Kollar-Kotelly, signed on February 26, 2010. (SM) (Entered: 02/26/2010)
2010-03-05		MINUTE ORDER (paperless). Upon consideration of the parties' Joint Status Report filed in Civ. Act. No. 9cv2406 and the positions set forth therein, the Court orders as follows: (1) Defendant shall file an answer to the complaint in Civ. Act. No. 10cv293 no later than March 15, 2010; and (2) Defendant shall file its motion for an Open America stay no later than March 22, 2010; Plaintiffs shall file their opposition to Defendant's motion for an Open America stay no later than April 5, 2010; and Defendant shall file its reply, if any, in support of its motion for an Open America stay no later than April 12, 2010. The parties shall not file any dispositive motions until Defendant's motion for an Open America stay is resolved. At that time, the Court shall set a schedule for further proceedings, as may be appropriate. Signed by Judge Colleen Kollar-Kotelly on March 5, 2010. (lcckk2) (Entered: 03/05/2010)
2010-03-05		Set/Reset Deadlines: Answer due by 3/15/2010. Defendant's Motion due by 3/22/2010. Response due by 4/5/2010. Reply due by 4/12/2010. (dot, ) (Entered: 03/08/2010)
2010-03-10	4	SUMMONS Returned Executed by NANCY L. BUC, MADHUSHA DISSANAYAKE, BUC & BEARDSLEY, LLP. FOOD AND DRUG ADMINISTRATION served on 3/2/2010, answer due 4/1/2010. (Shepard, Carmen) (Entered: 03/10/2010)
2010-03-15	5	NOTICE of Appearance by Addy Schmitt on behalf of FOOD AND DRUG ADMINISTRATION (Schmitt, Addy) (Entered: 03/15/2010)
2010-03-15	6	ANSWER to 1 Complaint by FOOD AND DRUG ADMINISTRATION.(Schmitt, Addy) (Entered: 03/15/2010)
2010-03-22	7	MOTION to Stay by FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Declaration of Frederick J. Sadler, # 2 Exhibit A to Sadler Declaration, # 3 Exhibit B to Sadler Declaration, # 4 Exhibit C to Sadler Declaration, # 5 Exhibit D to Sadler Declaration, # 6 Exhibit E to Sadler Declaration, # 7 Exhibit F to Sadler Declaration, # 8 Exhibit G to Sadler Declaration, # 9 Exhibit H to Sadler Declaration, # 10 Exhibit I to Sadler Declaration, # 11 Exhibit J to Sadler Declaration, # 12 Exhibit K to Sadler Declaration, # 13 Exhibit L to Sadler Declaration, # 14 Exhibit M to Sadler Declaration, # 15 Declaration of Nancy B. Sager, # 16 Exhibit A to Sager Declaration, # 17 Exhibit B to Sager Declaration)(Schmitt, Addy) (Entered: 03/22/2010)
2010-04-05	8	Memorandum in opposition to re 7 MOTION to Stay filed by NANCY L. BUC, BUC & BEARDSLEY, LLP, MADHUSHA DISSANAYAKE. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F)(Shepard, Carmen) (Entered: 04/05/2010)
2010-04-12	9	REPLY to opposition to motion re 7 MOTION to Stay filed by FOOD AND DRUG ADMINISTRATION. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C)(Schmitt, Addy) (Entered: 04/12/2010)
2011-01-05		MINUTE ORDER (paperless). On or before January 19, 2011, Defendant shall file a Status Report with the Court, not to exceed three (3) pages, briefly advising the Court of its progress in responding to Plaintiffs' outstanding FOIA requests. The Status Report shall, at a minimum, (a) indicate where Plaintiffs' outstanding requests currently stand in the processing queue (i.e., the number of requests ahead of Plaintiffs' outstanding requests) and (b) provide an updated estimate as to when Defendant expects Plaintiffs' outstanding FOIA requests will move to the head of the queue and be fully processed. Signed by Judge Colleen Kollar-Kotelly on January 5, 2011. (lcckk3) (Entered: 01/05/2011)
2011-01-19	10	STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Schmitt, Addy) (Entered: 01/19/2011)
2011-02-01	11	ORDER. For the reasons stated in the accompanying Memorandum Opinion, the FDA's 7 Motion for a Stay is DENIED. The FDA shall (a) begin processing each of Plaintiffs' outstanding FOIA requests immediately, (b) promptly produce any responsive documents to Plaintiffs on a rolling basis, and (c) complete its production on or before March 4, 2011. The FDA shall file a Status Report with the Court within two (2) business days of the completion of its production (a) indicating that it has completed its production, and (b) briefly describing the scope of the production. The parties shall file a Joint Status Report with the Court on or before April 1, 2011 (a) indicating what remaining issues, if any, Plaintiffs intend to pursue in this action and (b) proposing a schedule for proceeding in this action. Signed by Judge Colleen Kollar-Kotelly on February 1, 2011. (lcckk3) (Entered: 02/01/2011)
2011-02-01	12	MEMORANDUM OPINION. Signed by Judge Colleen Kollar-Kotelly on February 1, 2011. (lcckk3) (Entered: 02/01/2011)
2011-02-24	13	MOTION for Extension of Time to Complete Production to March 4, 2011 by FOOD AND DRUG ADMINISTRATION (Schmitt, Addy) (Entered: 02/24/2011)
2011-02-24	14	MEMORANDUM OPINION (AMENDED). Signed by Judge Colleen Kollar-Kotelly on February 24, 2011. (lcckk3) (Entered: 02/24/2011)
2011-02-24		MINUTE ORDER (paperless). The Court has issued an amended 14 Memorandum Opinion correcting two typographical errors in its previous 12 Memorandum Opinion, dated February 1, 2011; specifically, to ensure that the deadlines in the Memorandum Opinion conform to the correct deadlines identified in the accompanying 11 Order. The two versions are otherwise identical. Defendant's 13 Motion for an Extension of Time is DENIED as moot. Signed by Judge Colleen Kollar-Kotelly on February 24, 2011.(lcckk3) (Entered: 02/24/2011)
2011-03-08	15	STATUS REPORT by FOOD AND DRUG ADMINISTRATION. (Schmitt, Addy) (Entered: 03/08/2011)
2011-03-10	16	STIPULATION of Dismissal by NANCY L. BUC, BUC & BEARDSLEY, LLP, MADHUSHA DISSANAYAKE. (Shepard, Carmen) (Entered: 03/10/2011)
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