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CLEARY, GOTTLIEB, STEEN & HAMILTON v. HHS

November 26, 1993

CLEARY, GOTTLIEB, STEEN & HAMILTON, Plaintiff,
v.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.



The opinion of the court was delivered by: RICHEY

 Before the Court are cross-motions for summary judgment. *fn1" In light of the papers filed by the parties, the underlying law, and the record herein, the Court shall grant in part and deny in part the parties' cross-motions for summary judgment.

 BACKGROUND

 The plaintiff represents SDK, a manufacturer of the amino acid L-tryptophan, and its subsidiary, SDA, in a massive product liability litigation pending throughout the United States in both federal and state courts. SDK manufactured L-tryptophan from 1982 through November 1989, and SDA distributed it as a dietary supplement to wholesalers and retailers nationwide. In November 1989, the FDA, CDC, and other health authorities reported a possible link between the ingestion of L-tryptophan and a rare syndrome that has only recently been identified as eosinophilia-myalgia syndrome ("EMS"). *fn2" Consequently, SDK immediately ceased production of L-tryptophan and voluntarily recalled products in which it was the sole or major component. Subsequent to its identification in 1989, researchers from the CDC, FDA, NIH, the Mayo Clinic, and SDK started an intensive analysis of products containing L-tryptophan to determine whether these products contain a contaminant causing EMS.

 Since the identification of EMS in 1989, individual plaintiffs have filed over 1000 product liability actions in the United States against SDK, SDA, and other firms involved in the chain of L-tryptophan distribution. Pending in both state and federal courts throughout the country, these actions allege a causal link between L-tryptophan and EMS and seek hundreds of millions of dollars in compensatory and punitive damages. Approximately 700 cases against SDK and SDA have been consolidated in a multi-district litigation in Federal District Court in South Carolina entitled In re: L-Tryptophan Litigation, MDL-865 (D.S.C.) ("MDL"). Many plaintiffs contend that SDK and SDA violated the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., by illegally importing L-tryptophan into the United States. Further, certain claimants allege that SDK failed to cooperate with government investigators, including those investigators who visited SDK's plant in Oita, Japan, in May, 1990.

 Because of these allegations, SDK and SDA have sought information from the FDA regarding that agency's regulatory history of L-tryptophan, as well as information indicating the degree of cooperation between the firms and the federal investigators. Similarly, plaintiff has requested CDC records relating to and including underlying data for the national surveillance system instituted by the CDC. The plaintiff has made several FOIA requests at various times to the CDC, FDA, and NIH, seeking the release of various forms of information, including computer searches, statistical analyses, printouts, and software. In response, the CDC has released well over 25,000 pages of documents. Declaration of Laura W. Leathers, P 33 ("Leathers Dec."). The plaintiff has also requested permission to depose certain agency employees. Deeming the information from the requested records and testimony to be essential to the litigation defense of SDK and SDA, the plaintiff asserts that the FDA and CDC have improperly withheld information and illegitimately restricted its experts from being deposed.

 The parties filed cross-motions for summary judgment on March 1, 1993. Due to the sheer volume of factual and legal issues involved in this case, as well as resolution of certain issues during the course of litigation, the Court has twice directed the parties to clarify the outstanding claims. See, Joint Status Report Regarding Current Status of Case and the FOIA Claims That Remain to Be Resolved of July 8, 1993 ("Joint Report"); Joint Memorandum Setting Forth Each Party's Position Regarding Issues and Claims That Remain to Be Resolved and Supporting Arguments, filed September 29, 1993 ("Joint Memorandum"). Nevertheless, the parties still disagree over the records that remain in dispute, as well as the legal issues before the Court.

 DISCUSSION

 A party may obtain summary judgment by showing "that there is no genuine issue as to any material fact and that [it] is entitled to judgment as a matter of law." Federal Rules of Civil Procedure 56(c). Because there are many sets of records in dispute that implicate a variety of legal concerns, the Court shall set out each legal issue and address the disputed records in turn.

 I. FOIA

 To meet the burden of summary judgment in a FOIA context, "the defending agency must prove that each document that falls within the class requested either has been produced, is unidentifiable, or is wholly exempt from [FOIA's] inspection requirements." Goland v. Central Intelligence Agency, 197 U.S. App. D.C. 25, 607 F.2d 339, 352 (D.C. Cir. 1978), cert. denied, 445 U.S. 927, 63 L. Ed. 2d 759, 100 S. Ct. 1312 (1980) (quoting National Cable Television Ass'n v. Federal Communications Comm'n, 156 U.S. App. D.C. 91, 479 F.2d 183, 186 (D.C.Cir. 1973)).

 
A. The defendants have adequately responded to all FOIA requests for documents pertaining to the published Kamb Study and the Miller Study, but must turn over the electronic version of the Swygert database to the plaintiff.

 The plaintiff contends that the defendants have failed to respond lawfully to its FOIA requests. At the heart of this claim, the plaintiff seeks access to the underlying documentation for certain critical studies performed by the government, information concerning the analysis and investigation of a possible causative link between L-tryptophan and EMS. Despite a series of requests and administrative responses, the plaintiff asserts that defendants have improperly applied exemptions and have failed to produce records which they are mandated to disclose under FOIA.

 The parties are in agreement regarding the administrative proceedings subsequent to the plaintiff's FOIA requests of January 31, 1991, April 19, 1991, and January 22, 1992. Joint Statement of Material Facts, PP 44-59 ("Joint Statement").

 In filing its January 31, 1991, FOIA request with the CDC, the plaintiff sought access to agency records relating to the CDC's investigation of EMS and its association with L-tryptophan. Joint Statement P 44. On February 19, 1991, CDC released redacted correspondence on L-tryptophan in response, stating that it had deleted certain information in this correspondence under FOIA Exemption 6. Id. P 45. On April 23, 1991, the CDC further released a set of microfilmed documents produced between August 1990 and January 1991, informing the plaintiff that CDC withheld documents under FOIA Exemptions 4, 5, and 6, 5 U.S.C. § 552(b)(4), (5) and (6). Joint Statement P 46.

 On January 22, 1992, the plaintiff filed an additional FOIA request with the CDC, requesting records, questionnaires, computer tapes or disks, and other materials relating to a CDC study entitled Eosinophilia Myalgia Syndrome: Results of National Surveillance, JAMA, 1990-264: 1698-1703 ("Swygert Study"). Joint Statement P 54. CDC responded by releasing on microfilm certain records generated from May through August, 1991, by informing the plaintiff that it was withholding certain documents under FOIA Exemptions 4, 5, and 6, and by notifying the plaintiff that the Public Health Service ("PHS") would be in contact regarding the availability of the Swygert Study. P 55. Soon after, the PHS wrote a letter to the plaintiff informing it that FDA had no information regarding this study, that CDC has no additional records, and that "we believe that an adequate search of appropriate files was conducted." Complaint, Exhibit F.

 Questioning the adequacy of the search, the plaintiff appealed the PHS response to the Swygert Study. More specifically, the plaintiff challenged the lack of agency records concerning cases dropped from the Swygert study, and requested that CDC officials query the coauthors of the study remaining with the CDC, the records custodian, and others, for information regarding the location of responsive records. Joint Statement P 58; Complaint, Exh. G. The plaintiff also referred to a different case in which Dr. Leslie Swygert, formerly of the CDC, gave sworn testimony that the CDC kept "back-up" documentation for the Swygert Study. *fn3" On June 25, 1992, Assistant Secretary Mason wrote to the plaintiff, denying its appeal by explaining that the CDC search was adequate.

 With regard to the adequacy of defendants' responses to plaintiff's FOIA requests, three sets of materials are in issue. First, the plaintiff asserts that defendants have failed to disclose seven sets of documents and records relating to the Kamb Study, arguing that the plaintiff has identified missing documents and records, the plaintiff has not specifically searched for these materials, and that plaintiff's affidavits establish their non-production. The plaintiff also contends that defendants are unlawfully withholding 13 sets of documents and records relating to the unpublished Miller Study, in that the Philen Study relied upon such documents and records to reach its conclusions. Joint Memorandum, pp. 1-7. Furthermore, the plaintiff argues that the Swygert database exists, is segregable, and should be disclosed.

 1. The Kamb Study

 In regard to the documents relating to the Kamb Study, plaintiffs are misguided in seeking an order for the defendants to disclose the underlying documentation. The issue is not whether the plaintiff has received all relevant materials within contemplation, but whether an agency has reasonably searched its record system. "The adequacy of an agency's search is measured by a 'standard of reasonableness,' and is 'dependent upon the circumstances of the case.'" Truitt v. Department of State, 283 U.S. App. D.C. 86, 897 F.2d 540, 542 (D.C. Cir. 1990), quoting Weisberg v. Department of Justice, 227 U.S. App. D.C. 253, 705 F.2d 1344, 1351 (D.C. Cir. 1983). Defendants claim that their searches for records were adequate under FOIA, and the Court finds in this case that there is no issue of material fact relating to this contention. By conducting three separate searches for records relating to the Kamb Study, the CDC has satisfied the required standard of reasonableness and adequacy.

 After undergoing its original search, CDC released a microfilm of Kamb documents to plaintiff. Leathers Dec. P 14. Next, as a result of its agreement to perform a further search for "missing" Kamb documents, CDC again searched in response to each of nine categories of documents requested by plaintiff; for each category, the CDC either provided the relevant documents, stated that no such document existed, or stated that no such document could be located. See Letter of June 21, 1993, from Mary Mitchell Armstrong, Joint Report, Exhibit 2. Moreover, after plaintiff's counsel again requested documents related to the Kamb Study, Agency counsel once again contacted Dr. Kamb, but failed to obtain any additional information. See Letter of July 2, 1993, from Mary Mitchell Armstrong, Joint Report, Exhibit 6.

 The Court finds that CDC's efforts entitle it to summary judgment regarding the adequacy of its search for the Kamb records. "In order to obtain summary judgment the agency must show that it has made a good faith effort to conduct a search for the requested records, using methods which can be reasonably expected to produce the information requested." Oglesby v. Department of the Army, 287 U.S. App. D.C. 126, 920 F.2d 57, 68 (D.C. Cir. 1990). Oglesby ruled that genuine issues of material fact existed concerning the adequacy of a search where the Department of State only searched the record system most likely to produce responsive documents, and failed to explain in its affidavit why no other record system was likely to produce responsive documents. Id. In contrast, as the letters indicate, the CDC's multiple inquiries for the requested documents -- such as computer printouts and telephone questionnaires -- involved frequent contact with Dr. Mary Kamb herself as well as searches in her files. The plaintiff presents no affidavit or argument that the CDC acted in bad faith or executed a search that was not "reasonably calculated to uncover all relevant documents." *fn4" Id.

 2. The Miller Study

 With regard to the Miller Study, at issue is whether the CDC disclosed all records in response to plaintiff's January 31, 1991, FOIA request and its subsequent July 28, 1992 FOIA request (which is not at issue in this litigation). *fn5" Because the defendants adequately responded to these requests as they pertain to the Miller Study, the Court shall grant their motion for summary judgment on this issue.

 The plaintiff argues that the only document it received was the draft study, and none others. Paola M.G. De Kock, the Cleary, Gottlieb attorney in charge of maintaining the FOIA records received from the CDC, swears that no other records on this subject were included in the released materials. Affidavit of Paola M.G. De Kock. According to the plaintiff, the "Philen Study makes explicit that it relied upon documents and records relating to the Miller study in order to reach its conclusions." Joint Memorandum at 8. Further, Cleary Gottlieb charges that defendants have not identified which records it released, nor at what time.

 Significantly, there is no evidence that the plaintiff appealed the completeness of the records released. Although defendants cannot cite the date nor content of released documents, counsel for both parties admitted at the motions hearing of October 8, 1993, that they did not know of any duty to maintain such a record of disclosure. While Ms. De Kock has sworn that she did not receive the requested documents, that does not alter the reality that there is no genuine issue of material fact to indicate that defendants did not respond adequately to the FOIA request. The legal tests used in challenging a response to a FOIA request are means-based rather than result oriented, and defendants touched all the necessary bases -- they made a reasonable search for records connected with the Miller Study, and made a good-faith production of them. Regardless of whether the plaintiff in fact received the requested records, this Court emphasizes that federal district court is not the appropriate forum for an initial complaint of incompleteness.

 3. The Swygert Database

 The plaintiff points to four factual bases for its argument that Dr. Swygert's database exists, is identifiable and segregable, and should be disclosed: (1) that researchers used her data after Dr. Swygert completed her work; (2) that defendants recently generated a "second" Swygert database; (3) that defendants have specifically acknowledged a copy of the surveillance database that is presently in use; and (4) that CDC maintains a surveillance database which includes Dr. Swygert's dataset. *fn6" Joint Memorandum at 5-6. Furthermore, the plaintiff asserts that defendants cannot evade FOIA merely by adding more data to the database.

 Defendants counter that their response was reasonable, and that there is no basis to create a triable issue of fact regarding the thoroughness of their search. Defendants contend that their search for records pertaining to the Swygert Study were reasonably calculated to locate responsive records, and that the Swygert database has been sufficiently disclosed.

 The plaintiff has carried its burden for summary judgment on this issue, but is only entitled to a copy of the Swygert database in electronic format. The plaintiff correctly argues that defendants must release the "second" Swygert database as it exists today. According to the defendants, the CDC has already turned over to the plaintiff the one existing database used by Dr. Swygert; all other programs have already been erased. See Leathers Dec. P 32. There is no factual question on this point. *fn7" However, there is a second "existing" Swygert database, albeit a modified version of the database already released by the defendants to the plaintiff. See Posey Dec. P 2. While the plaintiff is not entitled to receive updated materials in this context without filing additional requests, see Mandel Grunfeld & Herrick v. Customs Serv., 709 F.2d 41, 43 (11th Cir. 1983) ("Nothing in the FOIA can be construed as requiring an agency to set up a mailing list to automatically disseminate agency records or information."), the electronic database existed at the time of the original FOIA request and is responsive to it.

 Not only have the defendants taken all the necessary steps in their search, but have also complied with their duty to segregate and release requested non-exempt materials. See 5 U.S.C. § 552(b) ("Any reasonably segregable portion of a record shall be provided to any person requesting such record after deletion of the portions which are exempt under this subsection."). Plaintiff's argument that the CDC has unlawfully failed to ...


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