907 F.2d 936 (10th Cir. 1990), 86-2246, Anderson v. Department of Health and Human Services

Docket Nº:86-2246, 86-2495.
Citation:907 F.2d 936
Party Name:Celia ANDERSON, Plaintiff-Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES; Margaret Heckler, Secretary, Department of Health and Human Services; Food and Drug Administration; and Dr. Frank Young, M.D., Commissioner, Food and Drug Administration, Defendants-Appellees, and Dow Corning Corporation, Defendant/Intervenor-Appellee.
Case Date:June 22, 1990
Court:United States Courts of Appeals, Court of Appeals for the Tenth Circuit

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907 F.2d 936 (10th Cir. 1990)

Celia ANDERSON, Plaintiff-Appellant,



Secretary, Department of Health and Human Services; Food

and Drug Administration; and Dr. Frank Young, M.D.,

Commissioner, Food and Drug Administration, Defendants-Appellees,


Dow Corning Corporation, Defendant/Intervenor-Appellee.

Nos. 86-2246, 86-2495.

United States Court of Appeals, Tenth Circuit

June 22, 1990

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Daniel F. Bertch of Robert J. Debry & Associates (Robert J. Debry of Robert J. Debry & Associates, with him on the brief), Salt Lake City, Utah, for plaintiff-appellant.

Burt A. Braverman of Cole, Raywid & Braverman, Washington, D.C. (Susan Paradise Baxter and Kenneth A. Grant of Cole, Raywid & Braverman, Washington, D.C., Ray R. Christensen of Christensen, Jensen & Powell, Salt Lake City, Utah, and Harvey Steinberg of Dow Corning Corp., Midland, Mich., with him on the brief), for defendant/intervenor-appellee.

Before HOLLOWAY, Chief Judge, and BARRETT and EBEL, Circuit Judges.

EBEL, Circuit Judge.

This appeal concerns plaintiff-appellant Celia Anderson's attempt under the Freedom of Information Act ("FOIA"), 5 U.S.C. Sec. 552, to compel defendant-appellee Food and Drug Administration ("FDA") to disclose certain documents submitted to the FDA by defendant-intervenor Dow Corning Corporation. The district court granted summary judgment to defendants, holding that the requested documents contain confidential information that is exempt from the disclosure requirements of the FOIA. We affirm in part, reverse in part, and remand.

The following issues are raised on appeal: (1) whether Exemption 4 of the FOIA, 5 U.S.C. Sec. 552(b)(4), allowed the FDA to refuse to disclose all of the documents at issue; (2) whether 18 U.S.C. Sec. 1905, 21 U.S.C. Sec. 360j(c), or 21 U.S.C. Sec. 331(j) justify nondisclosure of the documents pursuant to Exemption 3 of the FOIA, 5 U.S.C. Sec. 552(b)(3); and (3) whether the district court should have vacated its judgment pursuant to Federal Rule of Civil Procedure 60(b)(3).


Appellant sued Dow in state court for injuries allegedly caused by an injection of liquid silicone manufactured by Dow. 1 In connection with her state suit, appellant submitted a FOIA request to the FDA in order to obtain over 16,000 pages of documents that Dow had submitted to the FDA concerning Dow's liquid silicone, which is still in the testing phase and for which Dow has been seeking FDA approval for over 20 years. The FDA rejected appellant's request.

The documents at issue consist of over 16,000 pages contained in a Notice of Claimed Investigational Exemption for a New Drug ("IND"), a New Drug Application ("NDA"), and an Application for an Investigational Device Exemption ("IDE"), all submitted by Dow to the FDA. An IND is filed as a precondition to clinical testing of a drug. 21 U.S.C. Sec. 355(i), 21 C.F.R. Sec. 312.50. Once the IND is approved by the FDA, the sponsor of the new drug can ship the drug for use in clinical tests, the results of which are reported to the FDA. 21 C.F.R. Sec. 312.10. When adequate evidence of complete clinical testing has been submitted to the FDA, the sponsor may file an NDA, the approval of which is required before a drug can be marketed in interstate commerce. 21 U.S.C. Sec. 355(a), (b), and (j). The NDA must contain extensive data regarding the composition, manufacture, and effects of the drug, including full reports of clinical and nonclinical investigations, adverse reaction reports, and published articles on the effectiveness of the drug. 21 C.F.R. Sec. 314.50.

After Dow filed its IND for injectable silicone, amendments to the Food, Drug, and Cosmetic Act were passed, giving the FDA regulatory authority over medical devices. As a result of those amendments, injectable silicone was reclassified from a drug to a medical device, and Dow was required to convert its IND to an Application for an Investigational Device Exemption ("IDE"), the medical device equivalent of an IND. See 21 U.S.C. Sec. 360j(g); 21

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C.F.R. Sec. 812.20. Dow's IDE essentially contains the research that has been carried out by Dow under its IND and NDA. 2

Appellant brought suit in the district court seeking disclosure of the documents in the IND, NDA and IDE pursuant to the FOIA. Dow intervened and has defended the action on behalf of the FDA. Dow prepared an eighty-five page "Vaughn index" 3 listing roughly 16,000 documents at issue by in-house number. Across from the entries was a brief description of the document(s) and a coded explanation referring to one of seven specific categories of information "for which confidentiality is claimed:"

  1. Manufacturing and processing information, including formulations, chemistry and quality assurance procedures.

  2. Protocols, including forms for reporting results of research and informational materials supplied to clinical investigators.

  3. Preclinical test data.

  4. Clinical test data including adverse reaction reports and interim data.

  5. Patient information.

  6. Contractor and consultant identities.

  7. Marketing, sales and customer information.

    Vaughn Index at iv. In addition to those brief explanations, Dow filed as an exhibit the affidavit of Robert T. Rylee, II, a Vice President and General Manager of Dow. In that affidavit, Mr. Rylee provided more thorough explanations of the seven justifications listed in the Vaughn index. However, Mr. Rylee's affidavit did not elaborate on the description or asserted justification for nondisclosure of the individual documents.

    For approximately half of the documents listed in the Vaughn index, no coded explanation entry appeared. Instead, Dow had written "n/a" in the explanation column. In the introduction to the Vaughn index, Dow explained its reasons for not disclosing those documents for which no explanation had been offered:

    This index identifies portions of the documents at issue that are subject to withholding because they contain privileged or confidential commercial information or trade secrets within the meaning of Exemption 4 of the Freedom of Information Act, 5 U.S.C. Sec. 552, and the Trade Secrets Act, 18 U.S.C. Sec. 1905. However, Dow Corning also asserts that all of the documents at issue, including documents or portions of documents that have not been identified in this index as falling within Exemption 4 or the Trade Secrets Act, are required to be withheld pursuant to Defendant FDA's statutory authority and implementing regulations.

    Vaughn Index at iv-v. 4

    The district court granted Dow's motion for summary judgment, determining that there were no material facts in dispute and holding that the documents at issue are exempt from disclosure pursuant to Exemptions 3 and 4 of the FOIA, 5 U.S.C. Sec. 552(b)(3) & (4), and are prohibited from disclosure under 18 U.S.C. Sec. 1905, 21 U.S.C. Sec. 331(j), and 21 U.S.C. Sec. 360j(c). See R.Doc. 71 (August 12, 1986 Order).

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    Appellant subsequently obtained all of the documents at issue through discovery in her state court suit. The documents, however, are subject to a protective order entered in that suit that prohibits their use outside the litigation. Appellant still seeks the documents free from any restrictions, claiming that she wants to make the public aware of the dangers of silicone injections. See Appellant's Br. at 5.

    After appellant filed the first of these two appeals (No. 86-2246), she discovered additional evidence which, in her view, indicated that Dow's documents did not contain trade secrets. Armed with the new evidence, appellant filed a motion to vacate the district court's judgment pursuant to Federal Rule of Civil Procedure 60(b)(3). The district court denied appellant's motion. She then filed the second of these appeals (No. 87-2495), challenging the district court's denial of her Rule 60(b)(3) motion.


    Congress enacted the FOIA in 1966, and it became effective in 1967. It generally provides that the public has a right of access, enforceable in court, to federal agency records, subject to nine specific exemptions. See 5 U.S.C. Sec. 552. The basic purpose of the Act "is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed." NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242, 98 S.Ct. 2311, 2327, 57 L.Ed.2d 159 (1978). To achieve that goal, the FOIA is designed to " 'pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.' " Wren v. Harris, 675 F.2d 1144, 1145 (10th Cir.1982) (quoting Department of the Air Force v. Rose, 425 U.S. 352, 361, 96 S.Ct. 1592, 1599, 48 L.Ed.2d 11 (1976)). The FOIA is to be broadly construed in favor of disclosure, Alirez v. NLRB, 676 F.2d 423, 425 (10th Cir.1982), and its exemptions are to be narrowly construed. Irons & Sears v. Dann, 606 F.2d 1215, 1219 (D.C.Cir.1979), cert. denied, 444 U.S. 1075, 100 S.Ct. 1021, 62 L.Ed.2d 757 (1980). The federal agency resisting disclosure bears the burden of justifying nondisclosure. Alirez, 676 F.2d at 425.

    The FOIA contains nine exemptions from disclosure, set forth at Section 552(b). Those exemptions are exclusive under the Act. See 5 U.S.C. Sec. 552(c); E.P.A. v. Mink, 410 U.S. 73, 79, 93 S.Ct. 827, 832, 35 L.Ed.2d 119 (1973). The following two exemptions are relevant to this appeal:

    This section [requiring disclosure of government documents] does not apply to matters that are--


    (3) specifically exempted from disclosure by statute ... provided that such statute (A) requires that matters be withheld from the...

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