Bloomberg, L.P. v. United States Food and Drug

• Decision Date: 15 August 2007
• Docket Number: No. 06 Civ 6552(VM).,06 Civ 6552(VM).
• Parties: BLOOMBERG L.P., Plaintiff v. UNITED STATES FOOD and DRUG ADMINISTRATION and United States Department of Health and Human Services, Defendants.
• Court: U.S. District Court — Southern District of New York

500 F.Supp.2d 371

BLOOMBERG L.P., Plaintiff v. UNITED STATES FOOD and DRUG ADMINISTRATION and United States Department of Health and Human Services, Defendants.

No. 06 Civ 6552(VM).

United States District Court, S.D. New York.

August 15, 2007.

Thomas H. Golden, Willkie Farr & Gallagher LLP, New York City, for Plaintiff.

Lara K. Eshkenazi, U.S. Attorney's Office, New York City, for Defendants.

DECISION AND ORDER

MARRERO, District Judge.

Defendants, the United States Food and Drug Administration ("FDA") and United States Department of Health and Human Services ("HHS") (collectively, "Defendants" or "the Government"), moved for a twenty-month stay of the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, et seq., proceeding initiated by Bloomberg, L.P. ("Bloomberg"), on November 3, 2006. On June 29, 2007, the Court issued an order denying Defendants' motion to stay. This decision and order sets forth the findings, reasoning, and conclusions referenced in the Court's previous ruling.

I. BACKGROUND¹

A. THE PARTIES

Bloomberg provides real-time business, financial, and legal news to its subscribers worldwide by way of its global news service, international radio and television programming, and 24-hour news television stations. Bloomberg also publishes two monthly magazines and more than fifty books each year, in addition to distributing information by way of its website, which receives 3.5 million visits each month.

Defendant HHS is the principal government agency responsible for protecting the health of all Americans, as well as providing them with human services. Defendant FDA is an agency within HHS that evaluates, among other things, the safety and effectiveness of prescription and over-the-counter drugs. The Center for Drug Evaluation and Research ("CDER") is the division of the FDA that responds to FOIA requests regarding drugs; CDER's Division of Information Disclosure Policy ("DIDP"), in turn, processes those requests.

B. FACTUAL ALLEGATIONS

In March or April of 2005, the FDA sent letters ("Initial FDA Inquiries") to several manufacturers of certain anti-epileptic drugs, including Topamax, Lyrica, and Neurontin, requesting information on the potential for those drugs to contribute to suicidal thoughts or actions. The FDA released copies of the Initial FDA Inquiries to the public and various media outlets reported on the content of those inquiries.

By letter dated February 2, 2006, Bloomberg submitted a FOIA request (the "FOIA Request") to the FDA seeking:

1. Any correspondence from Russell Katz of FDA to Pfizer dated on or about March 16, 2005 requesting data regarding suicidal thoughts or actions triggered by Neurontin;

2. Any correspondence dated from January 1, 2004 to present, from the FDA to manufacturers of other medications including Topamax, Lyrica, and other anti-epileptic drugs regarding suicidal thoughts or actions triggered by those chemicals; and

3. Letters and other material submitted to FDA by manufacturers of Neurontin, Topamax,. Lyrica, and other anti-epileptic drugs in response to letters from Russell Katz and other requests by FDA for data on the development of suicidal thoughts and actions by patients taking Neurontin, Topamax, Lyrica, and other anti-epileptic drugs during clinical trials or during the post-marketing period.

The FDA received the FOIA Request on February 28, 2006. Pursuant to FOIA, the FDA was required to respond to this request by March 28, 2006. Bloomberg also requested expedited treatment for its FOIA Request, which the FDA was obligated to respond to by March 10, 2006. The FDA responded to Bloomberg on April 19, 2006, denying the request for expedited processing and leaving the substance of the request unaddressed.

By e-mail dated May 9, 2006, Bloomberg requested guidance on when the FDA would provide a substantive response to its FOIA Request. An employee of the FDA's FOIA staff indicated to Bloomberg via telephone that it would take the FDA approximately one year to respond to the substance of the FOIA Request. On May 19, 2006, Bloomberg sent a letter to FIRS, appealing both the FDA denial of expedited processing and the FDA decision to delay its substantive response to the FOIA request; HHS did not respond. On June 28, 2006, Bloomberg sent another letter, asking for a response to its FOIA Request and further indicated that it would file a suit to compel public disclosure if no response was received. The FDA did not respond. Bloomberg has exhausted its administrative remedies.

II. DISCUSSION

A. STANDARD OF REVIEW

When an agency does not respond to a FOIA request in accordance with the time period specified by statute, the requester may seek judicial review "to enjoin the agency from withholding agency records and to order the production of any agency records and to order the production of any agency records improperly withheld." 5 U.S.C. 552(a)(4)(B). The Court reviews agency decisions, including those regarding expedited processing of FOIA requests, de novo. See id.; see also Al-Fayed v. C.I.A., 254 F.3d 300, 304-06 (D.C.Cir.2001). FOIA requires expedited processing of requests if the relevant party demonstrates a compelling need for the materials. 5 U.S.C. 552(a)(6)(E)(i). A "compelling need" encompasses "request[s] made by a person primarily engaged in disseminating information" that relate to an issue to which there is an "urgency to inform the public concerning actual or alleged Federal Government activity." 5 U.S.C. 552(a)(6)(E)(v)(I-II).

However, if an agency can demonstrate that both exceptional circumstances exist and that it is exercising due diligence in responding to any type of FOIA processing request, "the court may retain jurisdiction and allow the agency additional time to complete its review of the records." 5 U.S.C. 552(a)(6)(C)(i). Pursuant to that provision, courts have granted agencies a stay of litigation if (1) the agency is deluged with an volume of requests for information on a level unanticipated by Congress; (2) existing agency resources are inadequate to deal with the volume of requests within the time limits established 552(a)(6)(C); and (3) and the agency can show that it is exercising due diligence in processing the requests. See Open America v. Watergate Special Prosecution Force, 547 F.2d 605, 616 (D.C.Cir.1976).

B. THE GOVERNMENT'S REQUEST FOR A STAY OF THE PROCEEDINGS

1. Exceptional Circumstances

According to the statutory language of FOIA, two factors drive the determination regarding the existence of "exceptional circumstances": unexpected volume and insufficient resources. See Ross v. Reno, No. 95-CV-1088, 1996 WL 612457, at *5 (E.D.N.Y. Aug. 13, 1996). The statute also makes clear that "the term `exceptional circumstances' does not include a delay that results from a predictable agency workload" of requests. 5 U.S.C. 552(a)(6)(C)(ii).

In the instant case, the Government's own description of the agency's response times and workload places its current number of FOIA requests squarely within anticipated levels. The FDA indicates that it processes a "constant stream of new FOIA requests," offers a steady monthly estimate of those requests, and, in fact, puts forth figures that indicate a downward trend. (See Gov.'s Mem. in Supp. Mot. Stay, dated Nov. 3, 2006 ("Gov.'s Mem.") at 7, 19.) DIDP, the division of CDER that handles the FOIA requests received by the FDA regarding drugs, notes a decrease in requests from 5,310 in 2003 to 4,050 in 2005; only 2,400 requests had been made as of the first eight months of 2006. (See id. at 19.) Such evidence is reflective, not of an unpredicted spike in requests, but rather of a manageable workload flow encountered in the due course of FOIA processing. Thus, allowing a mere showing of a normal backlog of requests to constitute "exceptional circumstances" would render the concept and its underlying Congressional intent meaningless. See, e.g., Reno, 1996 WL 612457, at *5 ("Since it appears that the [agency] always has a huge backlog, the exception, would, in effect, become the norm.")(emphasis in original); see also Fiduccia v. Dep't of Justice, 185 F.3d 1035, 1041 (9th Cir.1999) (noting that "ordinary and expected" agency circumstances necessarily conflict with the YOU requirement of "exceptional" circumstances).

The Court is mindful of DIDP's management of other responsibilities, including responses to subpoenas, postings to FDA's website, and document requests from Congress and other levels of government. However, the primary activity cited by DIDP as a source of some considerable increase — responding to Congressional document requests — is, according to the Government's submissions, situational and often timelimited.² While the examples provided are helpful to the Court in enabling it to gain an understanding of the effects of such Congressional inquiries, DIDP does not detail an existing request that has overwhelmed its resources and staff. In the absence of such information, coupled with what appears to be a manageable inflow of FOIA requests, the Court is not persuaded that "exceptional circumstances" are sufficiently evident here.

2. Due Diligence

If an agency's delay is the result of an expected workload of requests, the agency must demonstrate "reasonable progress in reducing its backlog of pending requests." 5 U.S.C. § 552(a)(6)(C)(ii). The statutory contours of what defines "reasonable progress" have not been explicitly elaborated upon in this Circuit, but courts generally have considered a range of factors, including requests for additional funding, modernizing practices and equipment, and initiatives tied directly to backlog reduction. See Elec. Frontier Found. v. Dep't of Justice, No. 06-1708, 2007 WL 1334973, at *6 (D.D.C. May 7, 2007)(providing specific detail of backlog reduction efforts, including reductions in processing time); Center for Pub. Integrity v. Dep't of State, No. 05-2313, 2006 WL 1073066, at *3 (D.D.C. April 24, 2006)(describing...