Public Citizen Health Research v. Food & Drug Admin.
Decision Date | 11 May 1982 |
Docket Number | Civ. A. No. 79-1710. |
Citation | 539 F. Supp. 1320 |
Parties | PUBLIC CITIZEN HEALTH RESEARCH GROUP, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, et al., Defendants. |
Court | U.S. District Court — District of Columbia |
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Patricia J. Kenney, Asst. U. S. Atty., Philip Derfler, Chief Counsel's Office, David C. Vladeck, Public Citizen Health Research Group, Washington, D. C., for plaintiff.
Leighton, Conklin, Lemov, Jacobs & Buckley, Jerald A. Jacobs and Richard F. Mann, Washington, D. C., for defendants.
This matter is before the Court on cross-motions for summary judgment, oppositions to the motions, replies, and various other supplemental filings.
In this action under the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552, plaintiff Public Citizen Health Research Group ("HRG"), a non-profit organization engaged in research and consumer advocacy on health and safety matters, brings suit against the Food & Drug Administration ("FDA"), the Department of Health & Human Services ("HHS"), and various manufacturers of intraocular lenses ("IOLs") who are the sponsors of FDA studies of IOLs.
HHS is an agency of the United States and is charged with administration of the federal Food, Drug & Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301-679. Under its regulations, HHS is responsible for reviewing appeals from denials by the FDA of requests for records under FOIA. Defendant FDA is an agency within HHS and has possession of the records to which plaintiff seeks access.
The corporate defendants, manufacturers of "IOLs", are conducting clinical tests under the authority of the FDA to confirm the safety and effectiveness of IOLs. In order to obtain approval to conduct these clinical tests, the corporate defendants submitted extensive information about IOLs in applications to FDA. They have continued to modify and supplement that information through additional filings and reports.
Plaintiff has requested portions of the clinical test information in a series of six requests under FOIA. FDA has denied portions of these requests, leading to plaintiff's filing of this action. Since the action was filed, plaintiff has narrowed the scope of its requests.
On these cross-motions for summary judgment, the Court has considered all the pleadings, the affidavits and the entire record herein. If either moving party shows that there is no genuine issue as to any material fact and that he is entitled to a judgment as a matter of law, the motion will be granted. Fed.R.Civ.P. 56(c). When the Court reviews the motions, however, "all inferences to be drawn from the underlying facts contained in the movant's materials must be viewed in the light most favorable to the party opposing the motion." United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 994, 8 L.Ed.2d 176 (1962). "Indeed, the record must show the movant's right to summary judgment with such clarity as to leave no room for controversy, and must demonstrate that his opponent would not be entitled to prevail under any discernable circumstances." National Ass'n of Government Employees v. Campbell, 593 F.2d 1023, 1027 (D.C.Cir.1978) (quoting United States v. Diebold, Inc., 369 U.S. at 655, 82 S.Ct. at 994). Applying these principles to the case at bar, the Court first concludes that the instant circumstances do not present any disputed issues of material fact.
The corporate defendants have maintained the clinical test information in confidence, revealing portions of it only to outside consultants or proper governmental employees on a need-to-know basis, that is, to the extent necessary to gain approval from the FDA. This kind of limited disclosure does not destroy the confidentiality of the information. 21 C.F.R. § 20.81(a)(1), (3); 21 C.F.R. § 813.20(b)(6)(i).
IOLs are tiny clear disks that surgeons implant in patients' eyes to correct vision following removal of cataracts. The concept is not new. During World War II, British surgeons discovered that bits of plastic airplane canopy embedded in the eyes of downed airplane pilots had remained inert there. Prompted by these findings, they were moved to devise the first IOLs, and the devices were publicly available more or less continuously from those times until 1978 when FDA decided that investigations were necessary to confirm the safety and effectiveness of IOLs. Since then, IOLs have been available in the United States only on a limited basis. For the time being, the manufacturers are to conduct a wide range of tests and report extensively on the results to FDA. In conjunction with the manufacturers, a limited number of doctors are allowed to implant IOLs into the eyes of patients as part of the tests. The manufacturers are also required to report extensively on their prior experience (pre-1978) with IOLs.
5 U.S.C. § 552(b)(4).
Insofar as it may be necessary to resort to a precise definition of trade secret, the Court will use the Restatement definition, since it is by far the most widely accepted. It reads as follows:
H.R.Rep.No.94-853, at 48-49, 94th Cong.2d Sess. 48 (1976). In its regulations, the FDA has adopted the Restatement definition verbatim. 21 C.F.R. § 20.61(a). According to the law of this Circuit, once a document in question is determined to be a trade secret, the inquiry ends there and the document is exempt from the requirements of FOIA. National Parks & Conservation Ass'n v. Morton, 498 F.2d 765, 766 (D.C.Cir.1974), ("National Parks I").
However, the other important category under FOIA Exemption 4 is "commercial or financial information obtained from a person and privileged or confidential." This category requires a more intricate analysis than the trade secret category. "In order to bring a matter (other than a trade secret) within this exemption, it must be shown that information is (a) commercial or financial, (b) obtained from a person, and (c) privileged or confidential." National Parks I at 766.
The first question, whether the information sought is of a "commercial" nature, is better answered during specific examination of the individual documents. (The defendants do not maintain that the information is "financial" in nature). With regard to the second consideration, there is no dispute as to the fact that this information has been "obtained from a person," namely, each of the corporate manufacturers.
Id. at 770; National Ass'n of Gov't Employees v. Campbell, 593 F.2d 1023, 1026 (D.C. Cir.1978).
Since the IOL manufacturers are required to submit the information in question in order to gain approval to market their devices, we presume that the government's ability to obtain necessary information in the future is not likely to be impaired by release of the documents sought here. Worthington Compressors, Inc. v. Costle, 662 F.2d 45 at 52 (D.C.Cir.1981).
The next question, whether disclosure is likely to cause substantial harm to the competitive position of the submitter, has been the subject of extensive judicial interpretation and is often determinative in Exemption 4 cases in this Circuit. This determination should not be an elaborate, antitrust litigation-style examination. National Parks & Conservation Ass'n v. Kleppe, 547 F.2d 673, 681 (D.C.Cir.1976) ("National Parks...
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...Plaintiff's motion is in all other respects denied. 1 The discovery of IOLs was succinctly summarized in Public Citizen Health Research Group v. FDA, 539 F.Supp. 1320, 1324 (D.D.C.1982): IOLs are tiny clear disks that surgeons implant in patients' eyes to correct vision following removal of......
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Public Citizen Health Research Group v. Food and Drug Admin.
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