Cleary, Gottlieb, Steen & Hamilton v. DHHS, Civ. A. No. 92-2192 (CRR).

• Decision Date: 26 November 1993
• Docket Number: Civ. A. No. 92-2192 (CRR).
• Citation: 844 F. Supp. 770
• Parties: CLEARY, GOTTLIEB, STEEN & HAMILTON, Plaintiff, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants.
• Court: U.S. District Court — District of Columbia

844 F. Supp. 770

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

Civ. A. No. 92-2192 (CRR).

United States District Court, District of Columbia.

November 26, 1993.

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Charles F. Lettow, Michael R. Lazerwitz, and Michael A. Mazzuchi, Richard W. Hulbert, Evan A. Davis, Stephanie Cotsirilos, and Paolo de Kock of Cleary, Gottlieb, Steen & Hamilton, Washington, DC, for plaintiff.

Susan A. Nellor, Asst. U.S. Atty. together with Jay B. Stephens, U.S. Atty., and John D. Bates, Asst. U.S. Atty. (Mary Mitchell Armstrong, Office of the General Counsel, Dept. of Health and Human Services, of counsel), for defendants.

MEMORANDUM OPINION

CHARLES R. RICHEY, District Judge.

On September 25, 1992, plaintiff Cleary, Gottlieb, Steen & Hamilton filed suit against defendants Department of Health and Human Services ("HHS"), Centers for Disease Control ("CDC"), National Institutes of Health ("NIH"), Food and Drug Administration ("FDA"), James O. Mason, M.D., Assistant Secretary for Health, and David A. Kessler, M.D., Commissioner of Food and Drugs. Seeking declaratory and injunctive relief under the Freedom of Information Act, 5 U.S.C. § 552 ("FOIA"), the Administrative Procedure Act, 5 U.S.C. § 701(a) ("APA"), and the Fifth Amendment of the Constitution, the plaintiff alleges that the defendants have (1) inadequately responded to the plaintiff's FOIA requests, and (2) improperly denied the plaintiff's requests that certain agency employees be permitted to give testimony in underlying lawsuits against plaintiff's clients Showa Denko K.K. ("SDK") and Show Denko America, Inc. ("SDA").

Before the Court are cross-motions for summary judgment.¹ 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").² 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 Federal 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, ¶ 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, 607 F.2d 339, 352 (D.C.Cir.1978), cert. denied, 445 U.S. 927, 100 S.Ct. 1312, 63 L.Ed.2d 759 (1980) (quoting National Cable Television Ass'n v. Federal Communications Comm'n, 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, ¶¶ 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 ¶ 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. ¶ 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 ¶ 46.

The plaintiff appealed the CDC's decision, but limited its appeal to challenging the withholding of "predecisional internal communications" under Exemption 5. Id. ¶ 47. Assistant Secretary Mason denied plaintiff's appeal in part, noting that information was being processed for release of certain studies, including Source of L-Tryptophan Associated with Eosinophilia-Myalgia Syndrome, conducted and reported by Lynn Miller, et al. ("Miller Study"), and Eosinophilia-Myalgia Syndrome Among a Cohort of L-Tryptophan-Exposed Patients in a South Carolina Psychiatric Practice, conducted and reported by Mary L. Kamb, et al. ("Kamb Study"). However, Dr. Mason stated that only a presentation of a different study, Tryptophan Contaminants Associated with Eosinophilia-Myalgia Syndrome, conducted and reported by Rossanne M. Philen, et al. ("Philen Study"), would be released, and that plaintiff's access to all other documents pertaining to the Philen Study would be denied under FOIA Exemption 5. Joint Statement ¶ 48.

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 ¶ 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...