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TEICH v. FDA

November 26, 1990

DOUGLAS L. TEICH, M.D., Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants, and DOW CORNING CORPORATION, Intervenor-Defendant and Cross-Claim Defendant


Stanley Sporkin, United States District Judge.


The opinion of the court was delivered by: SPORKIN

STANLEY SPORKIN, UNITED STATES DISTRICT JUDGE

 On October 17, 1990, this case came before the Court on cross-motions for summary judgment of plaintiff Douglas L. Teich's FOIA request for certain information concerning silicone gel breast implants submitted to defendant, the Food and Drug Administration ("FDA"), by Dow Corning Corporation ("Dow Corning"), the intervenor-defendant in this action.

 Plaintiff has made a FOIA request for a series of animal studies as well as for a summary of consumer complaints about Dow Corning's breast implants. The FDA contends that the animal studies are privileged from disclosure under exemption 4 to the FOIA, 5 U.S.C. § 552 (b) (4), as "confidential commercial information." Although the FDA takes no position on the release of the complaint summary, Dow Corning resists its production because it contends that the complaint summary is privileged from disclosure under the FDA's presubmission review procedure, 21 C.F.R. § 20. 44. Because this Court concludes that the FDA's presubmission review regulation violates the FOIA and is therefore invalid, and because this Court further finds that neither the animal studies nor the complaint summary are exempt from disclosure, summary judgment will be entered for the plaintiff.

 Background :

 Dow Corning has manufactured and sold silicone gel breast implants since the 1960's. Although there are other competitors in this market, Dow Corning is the major supplier of these devices. Over 2,000,000 women currently have silicone gel breast implants, and this number is rapidly increasing. In 1988 alone, 130,000 of these prostheses were implanted. The FDA estimates that only 15% of these implants were undertaken for reconstructive purposes following a mastectomy, while the other 85% were done solely for cosmetic reasons.

 In early 1987, Dow Corning became aware of certain adverse results from an ongoing study involving rats implanted with a formulation of Dow Corning silicone gel. The study revealed an increased incidence of fibrosarcomas at the implant site. Although these results did not necessarily indicate that the implants posed a danger to humans, Dow Corning decided to assemble an expert panel to study the risks. The panel concluded there was no indication of risk to human health. However, Dow Corning decided that it should share this information with the FDA. Consequently, on August 5, 1987, Dow Corning volunteered this study to the FDA.

 As a result of this information, the FDA decided to convene a meeting of its General and Plastic Surgery Devices Advisory Panel on November 22, 1988. The FDA intended to use the information presented during the panel meetings to inform the agency in connection with its rulemaking procedure concerning silicone gel breast implant safety testing.

 On November 23, 1988, the FDA panel wrote to Dow Corning requesting silicone gel breast implant research data. *fn1" Dow Corning undertook and funded a number of animal studies in the 1960's and early 1970's. The test results were submitted by Dow Corning to the FDA in support of Dow Corning's new drug application for injectable silicone products. *fn2" In 1988, the panel was unable to locate these studies due to agency reorganizations that had occurred during the intervening years. The panel therefore requested that Dow resubmit the information to the FDA within 30 days. On January 9 and 25, 1989, Dow Corning submitted over 5,000 pages of research data, including a resubmission of the earlier studies as well as a number of later studies.

 In addition to the animal studies, Dow Corning was requested to and did furnish the FDA with a summary of the complaints it had received from consumers of its silicone gel breast implants. This compilation contained the complaints received by Dow Corning concerning its breast implants during the years 1984 through 1988. The complaint summary was compiled by the company in response to a specific request by the FDA as part of the 1988 panel investigation.

 All the information was submitted to the FDA pursuant to the agency's presubmission review regulation, 21 C.F.R. § 20.44. This regulation provides for information submitted to the agency to be held "confidentially and separately," and specifically states that the information "is not received as part of FDA's files" pending determination whether part or all of the information would be exempt from mandatory disclosure pursuant to an FOIA request. 21 C.F.R. § 20.44 (b), (c). In the event that the FDA concludes that some or all of the information could not be protected under an exemption to the FOIA, the regulation accords the person seeking presubmission review discretion to withdraw the information. If withdrawn, no copies or summaries of the information are to be retained by the FDA. Id. § 20.44 (d).

 In this case, the FDA concluded that while the animal studies could be protected from disclosure under the FOIA, Dow Corning's complaint summary would be subject to mandatory disclosure. Thus, under the presubmission review regulation, Dow Corning could and did request to withdraw the complaint summary. With the filing of this lawsuit, however, the FDA decided it would not return the document to Dow Corning in order to preserve the status quo. Contrary to the provisions of the presubmission review regulation, the complaint summary found its way into the FDA's unrestricted files and was used by the staff in preparation for a proposed inspection of Dow Corning's manufacturing facilities.

 Plaintiff's January 27, 1989, FOIA request to the FDA involved two categories of documents: (1) the animal studies and associated correspondence; and (2) the complaint summary. *fn3" By letter dated March 17, 1989, the FDA rejected plaintiff's first request, stating that the animal study records were privileged under exemption 4 of the FOIA. The FDA also denied plaintiff access to the complaint summary on the grounds that it was not an agency record under its presubmission review regulation. *fn4"

 Later, the FDA informed the Court that the complaint summary had been used by the agency and that it had therefore become an "agency record" which could no longer be protected by its presubmission review regulation or by any exemption to the FOIA. Under these circumstances, the FDA stated that it would no longer deny access to the complaint summary and would leave the ultimate decision up to the Court. Because Dow Corning disagreed with the FDA's decision, the company has intervened to prevent the agency from turning the complaint summary over to plaintiff.

 Presubmission Review

 The Court cannot uphold the validity of the FDA's presubmission review regulation, 21 C.F.R. § 20.44, as applied to Dow Corning's submission of the complaint summary. If the FDA were permitted to assure confidentiality to those it regulates as spelled out in the presubmission review regulation, the FOIA would be completely frustrated. As counsel for the FDA conceded in oral argument, the presubmission review procedure was adopted specifically to avoid public disclosure of information as required by the FOIA.

 This is clearly an attempt by the agency to nullify a congressionally enacted law. While certainly the agency can deny access to records that the FOIA itself protects, its presubmission review cannot be used to forge a Northwest passage around the FOIA:

 
It will be for the District Court ultimately to determine any dispute as to whether [an] exemption was properly invoked. It will obviously not be enough for the agency to assert simply that it received the file under a pledge of confidentiality to the one who supplied it. Undertakings of this nature can not, in and of themselves, override the Act.

 Ackerly v. Ley, 137 U.S. App. D.C. 133, 420 F.2d 1336, 1339-40 n. 3 (D. C Cir. 1969).

 This Court rejects the FDA's attempt to override the FOIA by promising its regulatees that under its presubmission review policy, the agency will return those documents it determines are not entitled to protection under the FOIA without those documents becoming "agency records" subject to FOIA disclosure. The argument that Dow Corning's complaint summary was at no time an agency record is untenable. Even if the regulation could validly protect the complaint summary, the FDA now concedes that it failed to follow the precise terms of its own regulations since it made substantive use of the document. This alone made the complaint summary an agency record.

 Had the FDA not used the complaint summary, however, the Court's conclusion would have been the same, because once filed with the FDA, the document became an agency record. The determination whether a document is an "agency record" is not one left to the agency's determination. A record is an agency record if the agency "either create[s] or obtain[s]" the document United States Dept. of Justice v. Tax Analysts, 492 U.S. 136, 106 L. Ed. 2d 112, 109 S. Ct. 2841, at 2847 (1989). Furthermore, "the agency must be in control of the requested materials at the time the FOIA request is made." Id., at 2848. The Supreme Court has defined documents over which the agency has control as "materials [which] have come into the agency's possession in the legitimate conduct of its official duties." Id.

 The FDA came to possess the complaint summary in the "legitimate conduct of its official duties." Even if the FDA does not recognize its authority to compel submission of documents from Dow Corning, the voluntary submission process is certainly part of its legitimate duties. These legitimate duties include anything done "'under Federal law or in connection with the transaction of public business.'" Tax Analysts, 109 S. Ct. at 2848 (quoting the Records Disposal Act, 44 U.S.C. § 3301). The FDA's panel, in requesting submission of documents from Dow Corning, was transacting the public ...


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