CareToLive v. FDA

CourtCourt of Appeals for the Sixth Circuit
DecidedJanuary 6, 2011
Docket09-4084
StatusPublished

This text of CareToLive v. FDA (CareToLive v. FDA) is published on Counsel Stack Legal Research, covering Court of Appeals for the Sixth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
CareToLive v. FDA, (6th Cir. 2011).

Opinion

RECOMMENDED FOR FULL-TEXT PUBLICATION Pursuant to Sixth Circuit Rule 206 File Name: 11a0005p.06

UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT _________________

X Plaintiff-Appellant, - CARETOLIVE, A Not for Profit Corporation, - - - No. 09-4084 v. , > - Defendant-Appellee. - THE FOOD AND DRUG ADMINISTRATION, - N Appeal from the United States District Court for the Southern District of Ohio at Columbus. No. 08-00005—Gregory L. Frost, District Judge. Argued: December 8, 2010 Decided and Filed: January 6, 2011 Before: MARTIN, NORRIS, and COOK, Circuit Judges.

_________________

COUNSEL 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. _________________

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

1 No. 09-4084 CareToLive v. The Food and Drug Administration Page 2

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. No. 09-4084 CareToLive v. The Food and Drug Administration Page 3

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

1 This delay appears to have occurred because CareToLive sent the request to the FDA’s Cincinnati District Office and not directly to its Division of Freedom of Information as required by 21 C.F.R. § 20.40(a) (2010). 2 The division between the “Simple” and “Complex” tracks appears to be based primarily on whether another party has previously requested the information and not on the type of request made. If another party has previously made the same request, the request is “Simple” because the FDA can simply resend the documents it has already found, reviewed, and redacted. No. 09-4084 CareToLive v. The Food and Drug Administration Page 4

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,

Related

Department of the Air Force v. Rose
425 U.S. 352 (Supreme Court, 1976)
Anderson v. Liberty Lobby, Inc.
477 U.S. 242 (Supreme Court, 1986)
Trentadue v. Federal Bureau of Investigation
572 F.3d 794 (Tenth Circuit, 2009)
Campbell v. United States Department of Justice
164 F.3d 20 (D.C. Circuit, 1998)
Schrecker v. United States Department of Justice
349 F.3d 657 (D.C. Circuit, 2003)
Wilbur v. Central Intelligence Agency
355 F.3d 675 (D.C. Circuit, 2004)
David Carney v. United States Department of Justice
19 F.3d 807 (Second Circuit, 1994)
Graham A. Peters v. The Lincoln Electric Company
285 F.3d 456 (Sixth Circuit, 2002)
Popovich v. Sony Music Entertainment, Inc.
508 F.3d 348 (Sixth Circuit, 2007)

Cite This Page — Counsel Stack

Bluebook (online)
CareToLive v. FDA, Counsel Stack Legal Research, https://law.counselstack.com/opinion/caretolive-v-fda-ca6-2011.