Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

PUBLIC CITIZEN HEALTH RESEARCH GROUP v. FDA

May 11, 1982

PUBLIC CITIZEN HEALTH RESEARCH GROUP, Plaintiff,
v.
FOOD AND DRUG ADMINISTRATION, et al., Defendants



The opinion of the court was delivered by: RICHEY

MEMORANDUM OPINION

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, 192 U.S. App. D.C. 369, 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.

 Before examining the individual documents, the Court will review the applicable law. The primary purpose of FOIA, which provides generally for disclosure of agency records and information, is to open the administrative processes to the scrutiny of the press and the general public. Renegotiation Board v. Bannercraft Clothing Co., 415 U.S. 1, 94 S. Ct. 1028, 39 L. Ed. 2d 123 (1974). There are, however, certain exemptions to the general rule of disclosure. For instance,

 
(b) This section (5 U.S.C. § 552) does not apply to matters that are-
 
(4) trade secrets and commercial or financial information obtained from a person and privileged or confidential; ...

 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:

 
A trade secret may consist of any formula, pattern, device or compilation of information which is used in one's business and which gives him an opportunity to obtain an advantage over competitors or suppliers who do not know or use it.

 IV Restatement of Torts § 757, comment b (1938). Furthermore, the legislative history of the Medical Device Amendments of 1976, while noting that an exact definition of trade secret is impossible, makes specific reference to this particular definition. The House Report noted that

 
The Committee recognizes the need for protection of any trade secret material submitted to the Food and Drug Administration under the provisions of the proposed legislation by manufacturers of medical devices if their competitors are not to gain unfairly from the time and financial commitment expended in developing a device. * * * (It) is widely recognized that an exact definition of a trade secret is impossible, since such subjective considerations ... govern whether information constitutes a trade secret. According to the Restatement of Torts, if there is a key to determining whether information has trade secret status, it is that it has characteristics that give its possessor an opportunity to obtain an advantage over competitors who do not know it.

 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, 162 U.S. App. D.C. 223, 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.

 
commercial ... matter is "confidential' for purposes of the exemption if disclosure of the information is likely to have either of the following effects: (1) to impair the Government's ability to obtain necessary information in the future; n.17 or (2) cause substantial harm to the competitive position of the person from whom the information was obtained.

 n.17 We express no opinion as to whether other governmental interests are embodied in this exemption. Cf. 1963 Hearings at 200 where the problems of compliance and program effectiveness are mentioned as governmental interests possibly served by this exemption.

 Id. at 770; National Ass'n of Gov't Employees v. Campbell, 192 U.S. App. D.C. 369, 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, 213 U.S. App. D.C. 200, 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, 178 U.S. App. D.C. 376, 547 F.2d 673, 681 (D.C.Cir.1976) ("National Parks II "). Further, "it is not necessary to show actual competitive harm. Actual competition and the likelihood of substantial injury is all that need be shown." Gulf & Western Industries, Inc. v. United States, 199 U.S. App. D.C. 1, 615 F.2d 527, 530 (D.C.Cir.1979). Resolution of this issue in favor of the defendants requires them to prove that "(1) they actually face competition, and (2) substantial competitive injury would likely result from disclosure." National Parks II, supra at 679.

 In the instant case, a competitive market exists. All of the IOL manufacturers are vying to be the first to gain general marketing approval from FDA. While it could conceivably be true that the grant of general marketing approval to one of the manufacturers might speed up the eventual grant of the same approval to other manufacturers, there are significant differences between each sponsor's IOL, and the devices are in no way standardized or uniform. For example, Lynell Medical Technology, Inc. makes their IOLs out of glass rather than plastic as is the general custom. The various manufacturing processes also differ. Intermedics Intraocular, Inc. uses a lathe process; Precision-Cosmet Co., Inc. uses an unusual lathing process combined with compression molding. The problems that each firm encounters are also different. For instance, Medical Workshop U.S.A., Inc., because of difficulty ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.