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PUBLIC CITIZEN HEALTH RESEARCH GROUP v. FDA

October 17, 1996

Public Citizen Health Research Group, Plaintiff,
v.
Food and Drug Administration, Defendant, and Anesta Corporation, and Abbott Laboratories, Defendant-Intervenors.



The opinion of the court was delivered by: URBINA

 DENYING THE PARTIES' CROSS-MOTIONS FOR SUMMARY JUDGMENT AND GRANTING DEFENDANT-INTERVENORS' MOTION FOR A PROTECTIVE ORDER

 This matter comes before the court upon the parties' cross-motions for summary judgment. In addition, Defendant-Intervenors Anesta Corporation and Abbott Laboratories (Defendant-Intervenors) have filed a motion seeking a protective order which would forbid the disclosure by Public Citizen Health Research Group (HRG) of a table of information released to HRG by the FDA. The table was inadvertently released to HRG pursuant to a Freedom of Information Act (FOIA) request and is one of seven tables at issue in this case.

 The parties' cross-motions for summary judgment shall be denied as there are substantial issues of material fact in dispute. See Fed.R.Civ.P. 56(c). Defendant-Intervenors' motion for a protective order shall be granted. Accordingly, HRG will not disclose or make use of the information contained in Table 1.dose Variables. In addition, the portions of the court record which contain a reference to Table 1.dose Variables will be sealed pending this court's adjudication of the underlying merits of this dispute.

 I. BACKGROUND

 This case has its genus in a FOIA request filed with the FDA by HRG dated January 5, 1994. In its request, HRG sought all documents distributed by the FDA to its advisory committees in preparation for the August 24, 1993 advisory committee discussion on Fentanyl Oralet (Oralet). Oralet is a lollipop containing the narcotic fentanyl that was eventually approved by the FDA in October 1993. Oralet is a premedication for children who are about to undergo anesthesia and/or surgery. After receiving no response to its FOIA request, HRG filed this action on February 1, 1994. In the complaint, HRG asked the court to find that the withholding of the requested information is in violation of FOIA and, further, to order the FDA to release the information to HRG. HRG seeks this information because it is concerned about the safety of Oralet and the possible negative consequences of "off-label" use by medical practitioners.

 HRG first included Table 1 in Plaintiff's Opposition to Defendant's and Defendant-Intervenors' Motion for a Protective Order, dated April 18, 1994. Defendant-Intervenors first mentioned the allegedly illegitimate release of Table 1 in their Motions for Summary Judgment filed on May 25, 1994. HRG inserted Table 1 in another pleading dated August 19, 1994, Plaintiff's Reply to Defendant's and Defendant-Intervenors' Opposition to Plaintiff's Cross-Motion for Summary Judgment. Defendant-Intervenors filed this motion for a protective order some three months after they apparently first learned of Table 1's release.

 II. DISCUSSION

 A. Summary Judgment

 When more than one party moves for summary judgment, each party must carry its own burden of proof. United States Dep't. of Justice v. Reporters Comm. for Freedom of the Press, 489 U.S. 749, 755, 103 L. Ed. 2d 774, 109 S. Ct. 1468 (1989). In order to meet its burden, the moving party must prove that no genuine issue of material fact is in dispute and that it is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); National Cable Television Assoc., Inc. v. Federal Communications Commission, 156 U.S. App. D.C. 91, 479 F.2d 183, 186 (D.C. Cir. 1973).

 In FOIA cases, a court "may grant summary judgment solely on the basis of agency affidavits if they are clear, specific and reasonably detailed, and there is no contradictory evidence on the record [.]" Hayden v. National Sec. Agency/Cent. Sec. Serv., 197 U.S. App. D.C. 224, 608 F.2d 1381, 1387 (D.C. Cir. 1979), cert. denied, 466 U.S. 937 (1980). However, since summary judgment is such a "drastic remedy, courts should grant it with caution so that no person will be deprived of his or her day in court to prove a disputed material factual issue." Greenberg v. FDA, 256 U.S. App. D.C. 135, 803 F.2d 1213, 1216 (D.C. Cir. 1986).

 The central issue in this case is whether the information sought by HRG is exempt from disclosure pursuant to exemption four of FOIA because the public dissemination of this information would cause substantial harm to the competitive positions of Defendant-Intervenors. All of the parties have submitted affidavits supporting their respective positions on this issue. Expectedly, the experts for HRG declare that the dissemination of this information will in no way harm the competitive positions of Defendant-Intervenors. Conversely, the experts offered by Defendant FDA and Defendant-Intervenors posit that making this information public will cause substantial harm to the competitive positions of both Anesta and Abbott.

 In circumstances such as the ones presented in this case, the D.C. Circuit Court of Appeals has cautioned against the resolution of the dispute via summary judgment. In Greenberg v. FDA, 256 U.S. App. D.C. 135, 803 F.2d 1213 (D.C. Cir. 1986), a FOIA "exemption four" case similar to the case presently before the court, a staff attorney with HRG requested from the FDA a list of customers who had purchased CAT scanners from a manufacturer. 803 F.2d at 1214. The FDA refused to release the information; and Mr. Greenberg sued. Id. Technicare, the company which manufactured the CAT scanners that were the subject of Greenberg's FOIA request, filed a motion for summary judgment supported by affidavits outlining how the release of this information would work a substantial harm to the company's competitive position. Id. at 1215. Technicare posited that the information was properly withheld under exemption four of FOIA. Id. In his opposition, Greenberg offered affidavits which contradicted Technicare's claims regarding the purported harm the release of this information would have on the company's competitive position. Id. at 1217-18. The district court ruled that Greenberg had not carried his burden of rebutting Technicare's evidence and it therefore granted defendant FDA's motion for summary judgment. Id. at 1217. The D.C. Circuit Court of Appeals reversed. The court stated that the plaintiff's "showing [was] enough to rebut Technicare's summary judgment motion [.]" Id. at 1218. The court ...


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