study is trade secret information, (3-4) information regarding adverse reactions received as part of IDE study is trade secret and confidential commercial information.
Analysis : (1), (3): The number of complaints and the number of lenses removed from patients' eyes, identified in conjunction with five months' worth of production of a specific IOLAB lens model would give competitors some idea of the relative success of this particular model. This, in turn, would indicate the advisability vel non of imitating certain features of it. Therefore, items (1) and (3) of document IV-F-57 are confidential commercial information exempt from disclosure under FOIA Exemption 4.
(2), (4): The list of complaints and the investigator's tally of adverse reactions are confidential commercial information. Their disclosure would benefit competitors at IOLAB's expense because by analyzing the problems encountered by IOLAB, the other manufacturers would be able to foresee probable difficulties and, in anticipation thereof, redirect their research and investigations. Therefore, the list and the tally are confidential commercial information and are exempt under FOIA Exemption 4.
(g) I-GG-1 : May 2, 1978 letter to Executive Secretary of the Opthalmic Panel from BMD Device Evaluation regarding IOLAB lens problems.
Portion withheld : Discussion of results of IOLAB IDE study.
Basis advanced for withholding : information regarding IDE study is trade secret and confidential commercial information.
Analysis : the discussion by an FDA official of the results of a sponsor's IDE study are clearly trade secret and confidential commercial information for the reasons discussed in the analyses under IDE-0 through IDE-24, and IV-F-57(2) and (4).
(h) II-B-2 : October 25, 1978 memorandum of telephone conference between BMD and IOLAB attorney J. A. Jacobs regarding an adverse reaction.
Portion withheld : Nature of reported adverse reaction.
Basis advanced for withholding : Results of IDE study are trade secret.
Analysis : While the nature of a particular reported adverse reaction need not always be considered a trade secret or confidential commercial information, it must be considered as such when it is presented in the context of a discussion between a BMD official and the manufacturer or its attorney. Therefore, the portion of document II-B-1 withheld is exempt from disclosure under FOIA Exemption 4.
(i) II-B-2 : November 8, 1978 memorandum of meeting between BMD and IOLAB regarding adverse reaction report.
Portions withheld : (1) nature of adverse reaction, (2) information regarding IOLAB product line.
Corresponding bases advanced for withholding : (1) the results of an IDE study are trade secret information, (2) information regarding product line is confidential commercial information.
Analysis : (1) for the reason stated in the analysis under II-B-1, the nature of this adverse reaction is exempt under FOIA Exemption 4. (2) Information regarding a firm's product line is trade secret and confidential commercial information. Of all the information sought in this lawsuit, this item is perhaps one of the most obviously exempt under FOIA Exemption 4.
(j) IV-D-6 : July 12, 1978 memorandum to Leonard Hessen from Max Talbott, Executive Secretary of Opthalmic Panel, regarding Coburn recall of reprocessed lenses.
Portions withheld : (1) number of reprocessed lenses implanted, (2) percentages of adverse reactions from reprocessed and unreprocessed lenses.
Basis advanced for withholding : Information regarding a firm's IDE study is trade secret and confidential commercial information.
Analysis : (1) the number of reprocessed lenses implanted by a company is sales information, and as such is confidential commercial information. Substantial competitive injury is likely to befall a manufacturer who is forced to disclose the sales volume of a particular item in his product line. "Disclosure would provide competitors with valuable insights ... while the (competitors) could continue in the customary manner of "playing their cards close to their chest.' " National Parks II, supra, at 684. (2) The percentages of adverse reactions from reprocessed and unreprocessed lenses are trade secret information because they provide valuable insights into the feasibility and profitability vel non of reprocessing IOLs. Therefore, both withheld portions of document IV-D-6 are exempt from disclosure under FOIA Exemption 4.
(k) IV-D-8 : October 6, 1978 memorandum to Associate Commissioner for Regulation Affairs from BMD Director for Compliance regarding FDA requested recall of Coburn resterilized lenses.
Portions withheld : number of resterilized lenses implanted.
Basis advanced for withholding : would disclose information regarding Coburn IDE study which is trade secret information.
Analysis : for the reasons analogous to those stated in the analysis under IV-D-6(1), the number of resterilized lenses implanted is exempt under FOIA Exemption 4.
(1) III-1 through III-16 : FDA letters from October, 1978, to August, 1979, giving the IOL manufacturers approval to export the devices.
Portions withheld : whole documents.
Basis advanced for withholding : the letters contain the identity of the sponsor, the country of export, and, in some cases, the number of lenses, all of which is confidential commercial information.
Analysis : the information at issue here constitutes sales and marketing data, which is commercial information. Substantial competitive injury is likely, especially when one considers the international-particularly European and Japanese-composition of the IOL industry. Therefore, documents III-1 through III-16 are exempt from disclosure under FOIA Exemption 4.
In summary then, the Court has held that the following documents are exempt from disclosure under FOIA Exemption 4: V-3(3); VI-1; IDE-24; IDE-0 through IDE-23; IV-F-57; I-GG-1; II-B-1; II-B-2; IV-D-6; IV-D-8; III-1 through III-16. Conversely, the Court has held that the following group of documents are not exempt from disclosure under FOIA Exemption 4: V-3(1) and (2); VI-2.
In this regard, the Court would like to point out that while it has ruled that certain items are trade secret or confidential commercial information at this point in the industry's development, they could conceivably lose that protected status over time. For example, when the time arrives for the FDA advisory committee to publish "a detailed summary of information respecting the safety and effectiveness" of IOLs pursuant to 21 U.S.C. § 360j(h), the disclosure of certain commercial information may no longer be likely to result in substantial competitive injury, and what is now a trade secret may be common knowledge. Until such fundamental changes in the industry occur, however, the Court's ruling stands.
The Court also wishes to note that FDA has more than once guaranteed that information submitted on experimental medical devices would be kept confidential. See, e.g., 21 C.F.R. §§ 314.14, 813.38.
Finally, section 520(c) of the Medical Device Amendments Act of 1976, 21 U.S.C. § 360j(c) provides that information reported to FDA for purposes of obtaining approval for medical devices and which is exempt from disclosure by reason of FOIA Exemption 4 "shall be considered confidential and shall not be disclosed." This is a mandatory withholding statute and thus FDA has no discretion on the issue of whether or not to withhold trade secret or confidential commercial information.
In addition to FOIA Exemption 4, there exists a separate and independent basis for nondisclosure of the information at issue in this action-FOIA Exemption 3.
(b) This section (5 U.S.C. § 552) does not apply to matters that are-
(3) specifically exempted from disclosure by statute ... provided that such statute (A) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or (B) establishes particular criteria for withholding or refers to particular types of matters to be withheld.
5 U.S.C. § 552(b)(3).
The exempting statute applicable here is § 520(h) of the Medical Device Amendments of 1976, 21 U.S.C. § 360j(h). This Court has already ruled, regarding Count II of the complaint in this case, that § 520(h) is not applicable during this clinical test period to require FDA dissemination of summary safety information. Order of February 20, 1981. The Court reaffirms that holding today. There is still no dispute today regarding the fact that the federal defendants have not issued any of the orders described in § 520(h) (1). As the Court held in its Order of February 20, 1981, such an administrative order is necessary to trigger the requirement that summaries of safety and effectiveness information be released. These summaries "shall be made available pursuant to this paragraph only after the issuance of the (administrative) order." 21 U.S.C. § 360j(h)(2). The reason Congress provided that release of these summaries should not occur until issuance of the appropriate administrative order was to guarantee confidentiality to the submitters of information on experimental medical devices. Congress made it very clear in the legislative history of this provision that these summaries were to be made available to the public only after an administrative order described in § 360j(h)(1) was issued, but not before that time. See April 23, 1976 Letter of FDA Chief Counsel R. A. Merrill, inserted in 122 Cong. Rec. S 7287 (daily edition, May 13, 1976), Senator Taft, and 122 Cong. Rec. H 4384 (daily edition, May 13, 1976), Rep. Rogers. See also H.R.Rep.No.94-853, supra, at 48-51 (1976).
In the instant case, the Court is faced with the additional wrinkle that the information sought is not an administratively prepared summary as described in 21 U.S.C. § 360j(h)(1), but rather the original documents on which the summaries would presumably be based once they are prepared. However, it would defy logic to say that the original documents are not exempted from disclosure when summaries prepared from them would be. The same concerns of protecting confidentiality of the information apply even more strongly to the raw data in the original documents submitted by the manufacturers.
Thus, in addition to holding that some of the documents are exempt under FOIA Exemption 4, the Court must also hold that all of the documents are exempt from disclosure under FOIA Exemption 3 by reason of 21 U.S.C. § 360j(h)(2), at least until an administrative order described in 21 U.S.C. § 360j(h)(1) is issued.
In conclusion, then, the Court holds today that all of the documents sought are exempt under FOIA Exemption 3, and, in addition, as previously stated, that all of the documents except VI-2 and V-3(1) and (2) are also exempt under FOIA Exemption 4. Therefore, the defendants are, as a matter of law, entitled to summary judgment in this case, and the complaint must be dismissed.
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