Caretolive v. the Food

• Decision Date: 06 January 2011
• Docket Number: No. 09–4084.,09–4084.
• Citation: 631 F.3d 336
• Parties: CARETOLIVE, A Not for Profit Corporation, Plaintiff–Appellant,v.The FOOD AND DRUG ADMINISTRATION, Defendant–Appellee.
• Court: U.S. Court of Appeals — Sixth Circuit

631 F.3d 336

78 Fed.R.Serv.3d 459

CARETOLIVE, A Not for Profit Corporation, Plaintiff–Appellant,

v.The FOOD AND DRUG ADMINISTRATION, Defendant–Appellee.

No. 09–4084.

United States Court of Appeals, Sixth Circuit.

Argued: Dec. 8, 2010.Decided and Filed: Jan. 6, 2011.

ARGUED: Kerry M. Donahue, Bellinger & Donahue, Dublin, Ohio, for Appellant. John J. Stark, Assistant United States Attorney, Columbus, Ohio, for Appellee. ON BRIEF: Kerry M. Donahue, Bellinger & Donahue, Dublin, Ohio, for Appellant. John J. Stark, Assistant United States Attorney, Columbus, Ohio, for Appellee.Before: MARTIN, NORRIS, and COOK, Circuit Judges.

OPINION

BOYCE F. MARTIN, JR., Circuit Judge.

CareToLive filed a request with the Food and Drug Administration, which we will refer to generally as the FDA, under the Freedom of Information Act seeking copies of letters sent between its medical experts regarding Provenge, an immunotherapy treatment for late stage prostate cancer. The FDA was slow to respond to this request, and CareToLive filed a lawsuit demanding the immediate production of responsive documents. The district court stayed proceedings while the FDA responded to the request and delivered responsive documents. The FDA then moved for summary judgment based on having fulfilled CareToLive's request, which the district court granted. CareToLive now appeals the grant of summary judgment in favor of the FDA and asserts that the district court erred by denying it discovery. However, CareToLive has not identified any material question of fact as to the adequacy of the FDA's search. Additionally, the district court did not abuse its discretion by denying CareToLive leave to conduct discovery. Therefore, we AFFIRM the decision of the district court.

I.

CareToLive is an association of cancer patients, patient families, doctors, investors, and advocates focused on helping men suffering from late stage prostate cancer. This lawsuit arose as a result of the FDA's decision denying a Biologics License Application for Provenge. Immunotherapy treatments, like Provenge, train the body's immune system to recognize cancer cells and attack them. Although the FDA advisory panel had initially recommended approving Provenge, the agency did not follow that recommendation. After the FDA's initial denial, CareToLive suspected foul play and filed a request under the Freedom of Information Act with the FDA on August 15, 2007. The request sought:

A copy of all letters written to the FDA (or prepared by the FDA) and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming in between March 29th 2007 and April 30th of 2007, regarding the [Biologics License Application] submitted for Provenge also known as Sipuleucel–T including the envelope or other means of communication whereby the FDA received such letters and a copy of any record of those letters then being disclosed to any media or other persons or specifically a publication called “The Cancer Letter,” including the means of communication to the Cancer Letter of the Scher, Hussain and Fleming letters from the FDA or its employees to outside persons, publications or companies.

Although he was not named in the request, CareToLive suggests that Dr. Richard Pazdur was the FDA's “cancer czar” and at the center of the alleged improprieties. The doctors specifically identified in CareToLive's request appear to be Dr. Pazdur's advisors.

The FDA's Division of Freedom of Information received the request on September 11, and advised CareToLive by letter the same day that the request had been received.¹ CareToLive's request was the 8,316th request under the Freedom of Information Act that the FDA had received that year. The FDA's Division of Freedom of Information initially forwarded the request to the Center for Biologics Evaluation and Research because the request sought records relating to an unapproved biological product regulated by that Center. The request was also sent to the Office of the Commissioner, Office of the Executive Secretariat because it sought records relating to agency correspondence.

On November 6, the Center for Biologics responded with records. The Office of the Commissioner, Office of the Executive Secretariat responded on January 24, 2008 that it had not found any responsive records.

While these searches were pending, the Division of Freedom of Information also sent CareToLive's request to the Division of Information Disclosure Policy in the FDA's Center for Drug Evaluation and Research because the Center for Biologics indicated that additional records might be found there. The Division of Information Disclosure received the request on October 15, 2007 and assigned it to its “Complex Track.” Requests that can be answered quickly with readily available documents and do not require any searching or redaction are considered simple, and placed on a faster track known as the “Simple Track.” In contrast, if searching or redaction will be required, the request is placed on the “Complex Track.” ² The Division of Information Disclosure believed that CareToLive's request sought documents not readily available and would require searching and possibly redacting. On December 4, the Division of Information Disclosure left a telephone message with CareToLive's counsel stating that it follows a first-in/first-out, two track policy to respond to Freedom of Information Act requests and it would process CareToLive's request accordingly. The Division of Information Disclosure left the same message again on December 31.

Not content to wait, CareToLive filed a lawsuit in the Southern District of Ohio on January 2, 2008 seeking immediate production of all documents responsive to its request. On May 22, the district court granted the FDA's motion to stay proceedings and ordered the Center for Drug Evaluation to provide responsive documents no later than May 18, 2009. On May 18, the Division of Information Disclosure delivered one additional responsive document. The FDA also filed a motion for summary judgment the same day, based on its compliance with CareToLive's request for documents.

CareToLive subsequently filed a motion for discovery, which was also titled as a partial memorandum in opposition to the FDA's summary judgment motion. After briefing concluded, the district court granted the FDA's motion for summary judgment and denied CareToLive's motion for discovery.

II.

We review de novo a district court's grant of summary judgment in a Freedom of Information Act proceeding. Rugiero v. U.S. Dep't of Justice, 257 F.3d 534, 543 (6th Cir.2001). Summary judgment is appropriate if there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Id. “The moving party has the initial burden of proving that no genuine issue of material fact exists,” and we must draw all reasonable inferences in the light most favorable to the nonmoving party. Vaughn v. Lawrenceburg Power Sys., 269 F.3d 703, 710 (6th Cir.2001). A mere scintilla of evidence is insufficient to create a material question of fact and defeat a motion for summary judgment; “there must be evidence on which the jury could reasonably find for the [non-movant].” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).

A. The Act's Requirements to Search for Responsive Documents.

The Freedom of Information Act generally requires federal agencies to promptly make records available after receiving a request that reasonably describes the records and is made in accordance with the agency's published rules governing such requests. 5 U.S.C. § 552(a)(3)(A) (2006); Rugiero, 257 F.3d at 543. The agency may only withhold or limit the availability of records that fall within one of the Act's specific exceptions. 5 U.S.C. § 552(d); Rugiero, 257 F.3d at 543. These exceptions are to be narrowly construed, Rugiero, 257 F.3d at 543 (citing Dep't of Interior v. Klamath Water Users Protective Ass'n, 532 U.S. 1, 7–8, 121 S.Ct. 1060, 149 L.Ed.2d 87 (2001)), and do not apply in this case. The Act reflects “a general philosophy of full agency disclosure unless information is exempted under clearly delineated statutory language.” Dep't of the Air Force v. Rose, 425 U.S. 352, 360–61, 96 S.Ct. 1592, 48 L.Ed.2d 11 (1976).

An agency responding to a request under the Act must make a good faith effort to conduct a search for the requested records using methods reasonably expected to produce the requested information. Rugiero, 257 F.3d at 547 (citing Campbell v. U.S. Dep't of Justice, 164 F.3d 20, 27 (D.C.Cir.1998)). “At all times the burden is on the agency to establish the adequacy of the search.” Id. “ ‘The factual question ... is whether the search was reasonably calculated to discover the requested documents, not whether it actually uncovered every document extant.’ ” Grand Cent. P'ship v. Cuomo, 166 F.3d 473, 489 (2d Cir.1999) (quoting SafeCard Servs., Inc. v. SEC, 926 F.2d 1197, 1201 (D.C.Cir.1991)).

To meet this burden, “the agency may rely on affidavits or declarations providing reasonable detail of the scope of the search. In the absence of countervailing evidence or apparent inconsistency of proof, [such affidavits] will suffice to demonstrate compliance with the obligations imposed by the [Act].” Id. (internal quotations and citations omitted); see also Weisberg v. U.S. Dep't of Justice, 627 F.2d 365, 371 (D.C.Cir.1980) (agency affidavits that “do not denote which files were searched, or by whom, do not reflect any systematic approach to document location, and do not provide information specific enough to enable [the requester] to challenge the procedures utilized” are insufficient to support summary judgment). This inquiry focuses not on whether additional documents exist that might satisfy the request, but on the reasonableness of the agency's search. Id. District courts typically dispose of Freedom of Information Act cases on summary judgment based on affidavits from the agency...