Ciba-Geigy Corp. v. Mathews, 75 Civ. 5049 (CHT).

• Decision Date: 08 March 1977
• Docket Number: No. 75 Civ. 5049 (CHT).,75 Civ. 5049 (CHT).
• Citation: 428 F. Supp. 523
• Parties: CIBA-GEIGY CORPORATION, Plaintiff, v. David MATHEWS, in his capacity as Secretary of the Department of Health, Education, and Welfare, et al., Defendants.
• Court: U.S. District Court — Southern District of New York

428 F. Supp. 523

CIBA-GEIGY CORPORATION, Plaintiff, v. David MATHEWS, in his capacity as Secretary of the Department of Health, Education, and Welfare, et al., Defendants.

No. 75 Civ. 5049 (CHT).

United States District Court, S. D. New York.

March 8, 1977.

Davis, Polk & Wardwell, New York City, for plaintiff; Daniel F. Kolb, New York City, of counsel.

Daniel R. Murdock, Acting U.S. Atty., S.D.N.Y., New York City, for Federal Government defendants; Naomi Reice Buchwald, Asst. U.S. Atty., New York City, Stuart M. Pape, Dept. of Health, Education and Welfare, Washington, D.C., of counsel.

Francis B. Burch, Atty. Gen. of Maryland, Baltimore, Md., for defendants University of Maryland and Dr. Christian R. Klimt; David H. Feldman, Mary Elizabeth Kurz, Asst. Attys. Gen., Baltimore, Md., of counsel.

MEMORANDUM

TENNEY, District Judge.

This dispute involves plaintiff's request for the production of a substantial amount of data and materials pursuant to the Freedom of Information Act, 5 U.S.C. § 522 ("FOIA" or "the Act"). Plaintiff is the CIBA-GEIGY Corporation, a manufacturer of pharmaceuticals including phenformin, an oral hypoglycemic drug used to lower the blood glucose levels in patients with maturity-onset diabetes mellitus. Defendants named in this action are the Secretary of Health, Education and Welfare ("HEW"); the National Institutes of Health ("NIH"), which is a division of the Public Health Service of HEW; and the Commissioner of the Food and Drug Administration ("FDA"), an administrative agency within HEW. (These three defendants are collectively referred to hereinafter as the "federal defendants"). Also named are Dr. Christian Klimt ("Klimt"), as coordinator of the University Group Diabetes Program ("UGDP"), and the University of Maryland (the "research defendants"). Plaintiff has moved for an order compelling production of "agency records" for purposes of inspection and copying. Federal defendants have moved under Rule 12(b) of the Federal Rules of Civil Procedure ("Rules") to dismiss the complaint or, in the alternative, for summary judgment in their favor pursuant to Rule 56. Research defendants have also moved to dismiss the complaint and to quash the service of process. For the reasons stated below, the plaintiff's motion is denied, and the federal defendants' motions are granted to the extent set forth herein. The research defendants' motions are denied as moot.

An explanation of the underlying factual circumstances is necessary. In mid-1959 scientists at various university medical research clinics throughout the United States conceived a study which had as one of its objectives the evaluation of the efficacy of various hypoglycemic treatments in the prevention of vascular complications in patients with mild diabetes. To finance their research, these private parties applied for federal grants from the National Institute of Arthritis, Metabolism and Digestive Diseases ("NIAMDD"), one of the institutes of NIH. Grants were awarded to six university clinics in addition to the coordinating center at the University of Maryland, where Dr. Klimt was the principal investigator. Each submitted a separate grant application. Subsequently, six additional universities became involved in the study, and each also received an individual grant. The clinics involved in the UGDP study began their research in 1961. Test results from each medical clinic were sent to the UGDP coordinating center where all the data was collected and recorded. (Complaint ¶ 10).

The study focused on the relationship between the control of blood sugar in patients suffering from maturity-onset diabetes and the development of complications from that disease. Defendants contend that the UGDP's goal was a general expansion of knowledge and not the testing of a hypothesis that one form of treatment caused greater cardiovascular complications than another, and that the UGDP did not have a particular regulatory impact in mind. (Whedon Affidavit ¶ 4). It appears that the raw data assembled from the study consists of millions of documents involving over 1,000 patients examined since the study commenced in 1961. (Id. ¶ 9).

The terms of the grant applications provided that the "raw data generated by the UGDP study at the 12 clinics are the property of the individual investigators and the coordinating center" (Dickson Affidavit ¶ 3), that the investigators would retain the right to publish the results provided that any such publication acknowledge the support of the grants, and that the responsibility lay with the individual grantees for "management of the day-to-day operations of grant-supported activities." (Whedon Affidavit ¶ 9). Although NIH has access to the raw data generated by funded projects under 45 C.F.R. § 74.23, it customarily relies solely upon the interim and final reports which must be submitted to it under 45 C.F.R. §§ 74.80, 74.82 (Whedon Affidavit ¶ 9 and Exhibits 2 and 3 thereto).

The FDA was not initially involved in the UGDP study. However, when the UGDP reported results indicating a significantly higher mortality apparently due to cardiovascular causes for patients being treated with oral hypoglycemic drugs, and in 1967 voluntarily submitted these findings in report form to the FDA, the FDA decided to become involved. In 1970, the FDA convened an ad hoc expert committee to consider the UGDP findings and their possible regulatory significance. It reviewed the results of the UGDP study and in addition obtained the opinions of other experts in the fields of diabetes treatment and pharmacology as well as the assessment of the Biometrics Society, an organization of biostatisticians independently retained by the FDA to review the UGDP study.¹ On these bases, the FDA concluded that a warning in the labeling of oral hypoglycemic drugs was necessary to inform physicians of the ostensibly increased risk of cardiovascular complications arising from treatment with such drugs as compared to treatment with diet alone or diet plus insulin. (Crout Affidavit ¶¶ 6-9).²

In July 1975 the FDA proposed revised labeling requirements and at the same time solicited comments from interested persons. An announcement was printed in the Federal Register that an informal public hearing would be held to receive additional data and information on the proposed labeling requirement.³ (40 Fed.Reg. 28587 (July 7, 1975); Crout Affidavit ¶ 12 and Exhibit 3 thereto).

Plaintiff challenges the manner in which the UGDP raw data was handled at the UGDP coordinating center and consequently questions the accuracy of the results reported. Accordingly plaintiff instituted this action pursuant to the FOIA to obtain access to the data underlying the UGDP reports, claiming that such data constitutes agency records within the purview of the Administrative Procedure Act. 5 U.S.C. §§ 551(1) et seq. Plaintiff contends that the UGDP is de facto a federal agency and that its records are therefore agency records. Plaintiff further contends that even if the UGDP is not a federal agency in itself, it nevertheless served as an extension of a federal agency. Plaintiff also justifies its action against the University of Maryland on the theory that the university, acting as the UGDP coordinating center, maintains custody of the above mentioned Government records. All defendants dispute that the UGDP is a federal agency and that its underlying records are Government or agency records.

The FOIA grants a district court jurisdiction to "enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant." 5 U.S.C. § 552(a)(4)(B). The Act is directed at Government agencies and enables the court to compel an agency to release its records. Soucie v. David, 145 U.S.App.D.C. 144, 448 F.2d 1067 (1971) ("Soucie"). If the UGDP is such an agency, then it is obligated to release any non-exempt records requested by plaintiff. If the UGDP is not a federal agency, plaintiff contends that disclosure of its records may still be compelled if those records can be characterized as Government agency records. Cf. Nichols v. United States, 325 F.Supp. 130, 137 (D.Kan. 1971), aff'd, 460 F.2d 671 (10th Cir. 1972), cert. denied, 409 U.S. 966, 93 S.Ct. 268, 34 L.Ed.2d 232 (1972) ("Nichols"). If the Court neither finds that the UGDP is a Government agency nor accepts plaintiff's construction of the UGDP records as Government agency records, then it is without power to grant plaintiff's request under the FOIA for relief in this action.

The UGDP is Not an "Agency"

Courts analyzing the "agency" status of various organizational entities under the FOIA have not applied a precise standard but have adopted a functional analysis, examining numerous factors including whether the organization has the authority in law to perform the decisionmaking functions of a federal agency and whether its organizational structure and daily operations are subject to substantial federal control.

In Soucie, supra, the United States Court of Appeals for the District of Columbia Circuit examined a congressionally created executive office which, in addition to advising the President, performed the legislatively delegated investigatory function of "evaluating federal programs." 448 F.2d at 1075. Utilizing the standard that an administrative unit must have "substantial independent authority in the exercise of specific functions," id. at 1073, the court found the unit to be an agency within the meaning of the FOIA. Unlike the entity in Soucie, the UGDP has no independent authority to perform specific Governmental functions.

In Washington Research Project, Inc. v. HEW, 164 U.S.App.D.C. 169, 504 F.2d 238 (1974), cert. denied, 421 U.S. 963, 95 S.Ct. 1951, 44 L.Ed.2d 450 (1975) ("Washington Research"), the court considered the nature of outside private consultants appointed by the National Institute for Mental Health ("NIMH"), a subdivision of HEW, to...