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FISHER v. NIH

August 13, 1996

BERNARD FISHER, M.D., Plaintiff,
v.
NATIONAL INSTITUTES OF HEALTH, et al., Defendants.



The opinion of the court was delivered by: URBINA

 GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT AND DENYING PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT

 This matter comes before the court upon the plaintiff's motion for partial summary judgment and the defendants' cross-motion for summary judgment. Upon consideration of the submissions of the parties, and for the reasons articulated on the records and contained herein, the court concludes that the defendants are entitled to summary judgment as a matter of law. The defendants' motion for summary judgment shall be granted.

 I. Background Facts

 Plaintiff Bernard Fisher, M.D. ("Dr. Fisher") is a Professor of Surgery at the University of Pittsburgh and served as the chairperson of the National Surgical Adjuvant Breast and Bowel Project ("NSABP") from 1967 to 1994. The NSABP is a private, independent, consortium of institutions that conducts research on the treatment and prevention of breast and bowel cancer. The NSABP is able to conduct large scale clinical trials of treatment and prevention techniques. Starting in the 1970s, NSABP undertook a series of major studies to compare the effectiveness of different forms of surgery for breast cancer.

 In the summer of 1990, NSABP personnel discovered anomalies in the data submitted by one of the institutions participating in the study, St. Luc Hospital in Montreal, Canada ("St. Luc"). To determine the extent of the anomalies and to ascertain whether these anomalies were due to falsification, the NSABP conducted an audit of St. Luc records. The audit revealed that in several instances patient eligibility had been altered so that patients who did not meet the eligibility criteria could participate in the study. In February 1991, shortly after the audit was completed, Dr. Roger Poisson ("Dr. Poisson"), the physician at St. Luc responsible for the hospital's participation in the NSABP breast cancer trials, informed Dr. Fisher that he had altered the patient records.

 Subsequent to the St. Luc audit, Dr. Poisson was placed under investigation for scientific misconduct. In April 1993, the Office of Research Integrity ("ORI") *fn1" issued its final report in which it concluded that Dr. Poisson had engaged in scientific misconduct. The ORI made no findings against Dr. Fisher or the NSABP in its report.

 In January 1994, members of the staff of Representative John Dingell, then Chairman of the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee, contacted officials from the National Cancer Institute ("NCI") and ORI about Dr. Poisson and the discrepant St. Luc data. The Subcommittee held hearings on the scientific misconduct committed at St. Luc in April and June of 1994. In the spring of 1994, ORI began a scientific misconduct investigation of Dr. Fisher for including the discrepant St. Luc data in published papers.

 MEDLINE, CANCERLIT and PDQ (collectively the "databases") are computer databases containing information about articles that have been published in biomedical scientific journals. *fn2" The databases are research tools that can be used to locate published articles. Each file in the database provides bibliographic information about the article including the title of the article, the title of the publication, the name or names of the author or co-authors and a summary or abstract of the article. Beginning in June 1994, annotations such as "[scientific misconduct - data to be reanalyzed]" *fn3" (the "annotations") were added to the title field in the files of articles which incorporated the St. Luc data. *fn4"

 After discussions with the defendants did not result in the removal of the annotations from the databases, Dr. Fisher filed the instant action on March 6, 1995 against the National Institute of Health, National Library of Medicine, National Cancer Institute, Office of Research Integrity, Department of Health and Human Service and various officials in their official capacities. *fn5" On March 16, 1995, this court entered a stipulated preliminary injunction which contained the agreement previously reached between the parties providing for the removal of the annotations and the addition of a new annotation -- "[prior annotation incorrect]."

 II. Analysis

 Before the court are plaintiff's motion for partial summary judgment and the defendants' cross-motion for summary judgment. Rule 56 (c) provides that summary judgment "shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions of file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56 (c). Rule 56(c) mandates summary judgment if a party fails to establish the existence of an element essential to that party's case and on which that party will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). To meet its burden, the moving party must demonstrate that there is an absence of evidence to support the non-moving party's case. Id. at 325. The party opposing a motion for summary judgment "may not rest upon the mere allegations or denials of his pleading, but...must set forth specific facts showing that there is a genuine issue for trial." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (quoting First National Bank of Arizona v. Cities Service Co., 391 U.S. 253, 288, 20 L. Ed. 2d 569, 88 S. Ct. 1575 (1968)). The court construes all evidence in favor of the non-movant, and all justifiable inferences are to be drawn in his favor. Anderson, 477 U.S. at 249. The court concludes that there are no material facts in dispute and that this dispute is ripe for summary judgment.

 Plaintiff contends that the defendants violated the Privacy Act when it added the annotations to the database files. Plaintiff's position is that the defendants were disclosing inaccurate records about him once the annotations were added to the database files. The defendants' argue that the database files are not covered by the Privacy Act because: (1) they are exempt from coverage because they are library reference materials, and (2) they do not qualify as "records" as the term is defined under the Act. Plaintiff also alleges that the defendants improperly disclosed information from files the ORI maintained about him in connection with his scientific misconduct investigation. The defendants argue that there has been no violation of the Privacy Act because: (1) the ORI files, as they were maintained at the time of the alleged disclosure, were not maintained in a "system of records," and (2) the plaintiff cannot demonstrate the necessary nexus between the disclosures and the ORI files to demonstrate a violation of the Privacy Act.

 The court is unpersuaded by the defendant's argument that the database files are exempt form the Privacy Act because they are "library reference materials." The court determines, however, that the database files are not "records" for purposes of the Privacy Act. Further, the court concludes that at the time of the alleged disclosures, the ORI files were not maintained in a system of records, and thus were not subject to the Privacy Act. Moreover, even if the ORI files were covered by the Privacy Act, the plaintiff has failed to present evidence to demonstrate the necessary connection between the disclosures and the files.

 To establish a violation of the Privacy Act, a plaintiff must establish that the information in question is covered by the Act as a "record" contained within a "system of records." 5 U.S.C. § 522a(b) (1996). Once a plaintiff establishes that the information is covered under the Privacy Act, he must then demonstrate that the agency improperly disclosed the information. A plaintiff who is able to establish these first two requirements is entitled to declaratory and injunctive relief. 5 U.S.C. § 522a(g)(2)(A) (1996). If a plaintiff wishes to additionally recover monetary damages, he must demonstrated that the disclosure had an "adverse effect" on him and that the agency acted in an "intentional or willful" manner. 5 U.S.C. §§ 522a(g)(1)(D), (g)(4) (1996).

 Under the Privacy Act, a record is defined as "any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, his education, financial transactions, medical history, and criminal or employment history and that contains his name... ." 5 U.S.C. § 552a(a)(4). The D.C. Circuit examined the Privacy Act's definition of a "record" in Tobey v. N.L.R.B., 309 U.S. App. D.C. 213, 40 F.3d 469 (1994), and concluded that to qualify as a record the information must (1) contain the individual's name or other identifying particular and (2) be "about" the individual. Tobey, 40 F.3d at 471. The court was clear to establish that "the fact that information contains an individual's name does not mean that the information is 'about' the individual." Id. (rejecting the Third Circuit's interpretation of "record" as too broad). The court also noted that "so long as the information is 'about' an individual, nothing in the Act requires that it additionally be about a 'quality or characteristic' of the individual." Id., at 472 (rejecting the Ninth and Eleventh Circuit's interpretations of "record" as too narrow).

 The D.C. Circuit has also provided district courts with factors to consider when determining if a "system of records" exists. Initially, the Court of Appeals recognized that there is a distinction between a group of records and a system of records. The court held that "in determining whether an agency maintains a system of records keyed to individuals, the court should view the entirety of the situation, including the agency's function, the purpose for which the information was gathered, and the agency's ...


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