Campbell v. Department of Health and Human Services, 81-1839

• Decision Date: 25 June 1982
• Docket Number: No. 81-1839,81-1839
• Parties: , 8 Media L. Rep. 1984 James T. CAMPBELL, Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES and Eli Lilly and Company.
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 256

682 F.2d 256

221 U.S.App.D.C. 1, 8 Media L. Rep. 1984

James T. CAMPBELL, Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES and Eli Lilly and Company.

No. 81-1839.

United States Court of Appeals District of Columbia Circuit.

Argued Feb. 2, 1982.

Decided June 25, 1982.

Appeal from the United States District Court for the District of Columbia (CA 80-02996).

Katherine Anne Meyer, Washington, D. C., with whom Alan B. Morrison, Washington, D. C., was on the brief, for appellant.

Patricia J. Kenney, Asst. U. S. Atty., Washington, D. C., with whom Charles F. C. Ruff, U. S. Atty., Washington, D. C., at the time the brief was filed, Royce C. Lamberth, Kenneth M. Raisler, and Michael J. Ryan, Asst. U. S. Attys., Washington, D. C., were on the brief, for appellee Dept. of Health and Human Services.

Richard Frank Kingham, Washington, D. C., with whom Alvin J. Lorman, Washington, D. C., was on the brief, for appellee Eli Lilly and Co.

Before WALD, MIKVA and GINSBURG, Circuit Judges.

Opinion for the Court filed by Circuit Judge GINSBURG.

GINSBURG, Circuit Judge:

Exemption 7(A) of the Freedom of Information Act (FOIA), 5 U.S.C. § 552(b)(7) (A), permits an agency to withhold from public disclosure "investigatory records compiled for law enforcement purposes, but only to the extent that the production of such records would ... interfere with enforcement proceedings." This case presents the novel question whether the Food and Drug Administration (FDA) may rely upon Exemption 7(A) in justification of a blanket refusal to release to a third party any information submitted by a potential target of an FDA enforcement action. The district court answered that question in the affirmative. 518 F.Supp. 1114 (D.D.C.1981). We conclude that the district court's response was too quick and categorical to comport with the congressional directive. That directive, we hold, requires a more particularized showing by the government and a more precise examination by the district court before a judgment may be made that the production sought would "interfere with enforcement proceedings."

I.

Appellant Campbell held various technical positions with appellee Eli Lilly and Company for a quarter-century. From April 1973 through January 8, 1978, he worked on research teams studying the drugs darvon, aprindine, and monensin. ¹ In late 1977, Campbell informed Lilly's staff counsel that his superiors had failed to report to the FDA adverse reaction data and toxicological information concerning these drugs. ² Following an in-house investigation, Lilly placed Campbell on unpaid leave and ultimately discharged him. Campbell sought damages and reinstatement in the Indiana state courts. His complaint was dismissed on the ground that Indiana law does not recognize a cause of action for retaliatory discharge in the circumstances Campbell's case presented. Campbell v. Eli Lilly and Co., Ind.App., 413 N.E.2d 1054, 1059-62 (1980), transfer denied, Ind., 421 N.E.2d 1099 (1981). Campbell also informed the FDA of his allegations that Lilly had not reported to the agency safety- and health-related problems associated with its products. The agency thereupon commenced an investigation which is still in progress.

On July 21, 1980, while appellate review of his state court action was pending, Campbell sought access to four categories of documents concerning the FDA investigation. His letter request asked the agency for an opportunity to inspect and copy:

1. Any internal pre-investigation memoranda prepared by Lilly officers or employees which were submitted to the FDA;

2. Any written statements provided by present or former officers or employees of Lilly(;)

3. Any depositions or other statements given to the FDA by present or former officers or employees of Lilly(;)

4. Any letters, memoranda or other transmittals from Lilly to the FDA concerning the investigation, together with enclosures thereto.

Joint Appendix (J.A.) 6. This specification was designed to elicit only those documents provided by or available to Lilly or its past and present employees, not internal FDA materials. ³ See Brief of Plaintiff-Appellant at 5.

On August 14, 1980, the FDA notified Campbell that it had no records responsive to category 1 of his request and invoked Exemptions 4 ⁴ and 7(A)-(C) ⁵ as grounds for withholding information in the other categories. J.A. 73-74. Campbell filed an administrative appeal. When the agency failed to resolve the appeal within twenty working days, see 5 U.S.C. § 552(a)(6)(A) (ii), Campbell sought injunctive relief from the district court on November 2, 1980. ⁶

On February 2, 1981, the district court granted Lilly's unopposed motion to intervene as a party-defendant. J.A. 33. Pursuant to its established policy requiring the submitter of confidential commercial information to defend the trade secret status of such materials in FOIA litigation, see 21 C.F.R. § 20.53 (1981), ⁷ the FDA had notified the company of Campbell's resort to judicial remedies. The applicable regulation required Lilly, a potential target of enforcement proceedings, to itemize, index, and justify the withholding of the documents for which Exemption 4 was claimed. Alleging that providing Lilly access to these materials would alert the company to the direction, focus, and scope of the investigation, the government sought to defer the trade secrets issue pending resolution of the Exemption 7 question. J.A. 36.

On February 25, 1981, the agency submitted three public and four in camera affidavits in support of its position that all documents in its possession responsive to Campbell's FOIA request are records properly withheld under Exemption 7. On April 6, the government moved for summary judgment on this basis. On July 21, the district court granted this motion and entered an order dismissing the case. Campbell thereupon appealed, contending that the court had misconstrued Exemption 7 and denied him a meaningful opportunity to participate in the litigation. ⁸

II.

To establish that Exemption 7 permits withholding documents in its possession, an agency must show (1) that the requested documents are "investigatory records compiled for law enforcement purposes," and (2) that release of the material would have one of the six adverse consequences specified in the Act. FBI v. Abramson, --- U.S. ----, ----, 102 S.Ct. 2054, 2059, 72 L.Ed.2d 376 (1982). Campbell concedes that the documents he seeks satisfy the first requirement: the FDA obtained the requested information in connection with its investigation of Campbell's allegations that Lilly had failed to submit reports required by law concerning the safety of darvon, aprindine, and monensin. The controversy before us centers upon whether disclosure of these records would, as stated in Exemption 7(A), "interfere with enforcement proceedings."

Both sides press extreme positions on the showing an agency must make to establish the requisite interference. Campbell asserts that Exemption 7(A) applies "only on a document-by-document basis." Brief of Plaintiff-Appellant at 10. The government maintains, and the district court ruled, that an agency carries its burden simply by demonstrating that "the withheld information was clearly related to (an ongoing investigation)." 518 F.Supp. at 1115. We reject both formulations. Campbell's would impose an unreasonably onerous standard upon the agency; the FDA's would automatically shield from disclosure all records relating to an ongoing investigation. ⁹ Congress, we conclude, based on the words it employed and the relevant legislative history, did not authorize blanket exemption for such records. It required something more. We hold that, to prevail under Exemption 7(A), the government must show, by more than conclusory statement, how the particular kinds of investigatory records requested would interfere with a pending enforcement proceeding.

(A)

Throughout this litigation, in the district court and on appeal, the FDA has responded to a case other than the one Campbell brought. To assure that, on remand, the government will advert specifically to the case at hand, we underscore the nature of Campbell's request.

This is not a situation in which the potential target of an enforcement action seeks access to records not in its possession. Instead, a third party is attempting to procure materials that a target prepared and submitted to the agency. Campbell confined his FOIA request to four categories of documents "obtained by the Food and Drug Administration in connection with the FDA's investigation of Eli Lilly and Company concerning Lilly's suppression of adverse drug reaction data and/or toxicological information regarding the drugs darvon, apridine (sic) and monensin." J.A. 6. He sought access to statements, depositions, letters, memoranda, and other written materials prepared by present or former Lilly officers or employees. See supra p. 258. He limited his request to information Lilly personnel submitted to the agency after the initiation of the FDA investigation. ¹⁰ Campbell sought no documents supplied by sources other than Lilly personnel. He did not request any materials developed by the agency in the course of its investigation. See supra note 3 and accompanying text.

Remarkably, in light of a request so circumscribed, the government's submissions appear to assume that Campbell seeks a full accounting of the investigation in progress. For example, the in camera affidavits describe the course and conduct of the investigation and the various sources from which evidence was gathered. Three of these affidavits contain lists of records, some acquired from sources other than Lilly or its present and former officers or employees, and some prepared by FDA officials. No submission lists clearly and discretely the agency records responsive to Campbell's request.

Similarly, all of the affidavits repeat the government's dominant assertion that disclosure of the documents could aid...