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Appleton v. Food and Drug Administration

August 21, 2006


The opinion of the court was delivered by: Ricardo M. Urbina United States District Judge

Document No. 64




The pro se plaintiff Burton Appleton, a former Food and Drug Administration ("FDA") chemist, brings this action to compel the FDA and the Department of Health and Human Services ("HHS") to provide numerous documents concerning the drug levothyroxine sodium ("LEVO") pursuant to the Freedom of Information Act ("FOIA"). This case is before the court on the defendants' motion for summary judgment. Because defendant FDA's search for responsive documents was adequate, and because the defendants have properly invoked Exemptions 4, 5, 6, and 7(c) of FOIA, the court grants the defendants' motion for summary judgment.


A. Factual Background

In September 2001, the plaintiff submitted a FOIA request to the FDA, seeking "any and all records concerning communications 1) between the [FDA] and the United States Pharmacopeia ["USP"] . . . and 2) within the FDA on the subject of the drug levothryoxine sodium." Compl., Ex. 1. Specifically, he asked for communications regarding orally administered and injectable dosage forms of the drug, including letters, faxes, e-mails, memoranda, and directives, dating from August 14, 1997 to the present. Id.

In response to the plaintiff's request,*fn1 on November 1, 2001, the FDA sent a letter to the plaintiff indicating that information on a certain relevant new drug application (Unithroid) was available on the FDA's website, that information on another relevant new drug application (Levoxyl) required redaction before release, and that a search was underway for the FDA/USP communications. Defs.' Mot. for Summ. J. ("Defs.' Mot.") at 3. On December 7, 2001, the FDA sent the plaintiff redacted information on the Levoxyl application. Id. Also, on January 2, 2002, the FDA forwarded material on FOIA law and regulations to the plaintiff.*fn2 Compl., Ex. 2.

On January 25, 2002, the plaintiff wrote to the FDA to raise concerns regarding the agency's responses, and to amend his original request. Defs.' Mot. at 3. Specifically, the plaintiff highlighted what he believed to be various insufficiencies in the FDA responses, such as inaccurate paraphrasing of his request, missing documents and unnecessary redactions. Id., Ex. A. ("Sagar Decl.") ¶ 14. He also amended his request to enlarge the time frame from August 14, 1997 to "the first time that the FDA began to look into the regulation of the drug." Id. At the same time, he clarified the parameters of his request; stating, for example, that his request was intended to focus primarily on chemistry information, with biopharmaceutical information requested only insofar as it invoked analytical chemistry methodology not elsewhere disclosed. Id.

After receiving no response from the FDA, on March 26, 2002, the plaintiff faxed a letter to the HHS to appeal the FDA's denial of his FOIA request. Id., Ex. 15. On May 8, 2002, after receiving no substantive response to his March letter, the plaintiff again wrote to the HHS to stress what he believed were the FDA's "repeated failures" to abide by FOIA and to ask for information in order to avoid "go[ing] to federal district court prematurely." Sagar Decl., Ex. D.

B. Procedural History

On May 29, 2002, the plaintiff filed a complaint with this court. On July 1, 2002, the defendants filed a partial answer accompanied by a motion requesting an Open America*fn3 stay of proceedings through March 15, 2004. On February 27, 2003, this court granted the defendants' motion in part, held the production of documents in abeyance, and ordered the parties to meet and clarify the scope of the plaintiff's FOIA requests. Appleton v. FDA, 254 F. Supp, 2d 6, 11-12 (D.D.C. 2003).

On March 24, 2002, the court granted leave to intervene to Jerome Stevens Pharmaceuticals, Inc. ("Jerome Stevens"), Jones Pharma, Inc. ("Jones"), and Abbott Laboratories ("Abbott"). Additionally, on June 1, 2004, the court granted leave to intervene to Alara Pharmaceutical Corporation ("Alara"). On November 30, 2004, the FDA filed a motion for summary judgment.*fn4 It is to this motion that the court now turns.


A. Legal Standard for Summary Judgment in a FOIA Case

Summary judgment is appropriate when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." FED. R. CIV. P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986); Diamond v. Atwood, 43 F.3d 1538, 1540 (D.C. Cir. 1995). In deciding whether there is a genuine issue of material fact, the court is to view the record in the light most favorable to the party opposing the motion, giving the non-movant the benefit of all favorable inferences that can reasonably be drawn from the record and the benefit of any doubt as to the existence of any genuine issue of material fact. Adickes v. S.H. Kress & Co., 398 U.S. 144, 157-59 (1970). To determine which facts are "material," a court must look to the substantive law on which each claim rests. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A "genuine issue" is one whose resolution could establish an element of a claim or defense and, therefore, affect the outcome of the action. Celotex, 477 U.S. at 322; Anderson, 477 U.S. at 248.

FOIA affords the public access to virtually any federal government record that FOIA itself does not specifically exempt from disclosure. 5 U.S.C. § 552; Vaughn v. Rosen, 484 F.2d 820, 823 (D.C. Cir. 1973). FOIA confers jurisdiction on the federal district courts to order the release of improperly withheld or redacted information. 5 U.S.C. § 552(a)(4)(B). In a judicial review of an agency's response to a FOIA request, the defendant agency has the burden of justifying nondisclosure, and the court must ascertain whether the agency has sustained its burden of demonstrating that the documents requested are exempt from disclosure under FOIA. 5 U.S.C. § 552(a)(4)(B); Al-Fayed v. CIA, 254 F.3d 300, 305 (D.C. Cir. 2001); Summers v. Dep't of Justice, 140 F.3d 1077, 1080 (D.C. Cir. 1998). An agency may meet this burden by providing the requester with a Vaughn index, adequately describing each withheld document and explaining the exemption's relevance. Summers, 140 F.3d at 1080; Vaughn, 484 F.2d 820 (fashioning what is now commonly referred to as a "Vaughn index").

The court may grant summary judgment to an agency on the basis of its affidavits if they:

[(a)] describe the documents and the justifications for nondisclosure with reasonably specific detail, [(b)] demonstrate that the information withheld logically falls within the claimed exemption, and [(c)] are not controverted by either contrary evidence in the record nor by evidence of agency bad faith.

Military Audit Project v. Casey, 656 F.2d 724, 738 (D.C. Cir. 1981). While an agency's affidavits are presumed to be in good faith, a plaintiff can rebut ...

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