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In a victory for the plaintiffs’ lawyers in the fen-phen diet drug litigation, a Pennsylvania federal judge has ordered the Food and Drug Administration to turn over certain documents related to a May 1999 article in the Journal of the American Medical Association after finding they were not protected by the “deliberative process” privilege. In the JAMA article, six FDA officials wrote that, at the time the FDA approved the drugs, neither the FDA, the manufacturers nor the medical community had reason to believe that they were potentially associated with heart-valve disease. One of the main defendants in the litigation, American Home Products Corp., began to use the article in its defense to show that it acted reasonably in distributing its product based upon information available at the time. Hoping to refute AHP’s defense, the Plaintiffs’ Management Committee attempted to depose each of the JAMA article’s authors, but the FDA refused its requests as to five of them. In its letter requesting the depositions, the PMC noted that certain information about the health effects of the diet drugs was available to AHP before March 1997, including medical literature indicating cardiotoxic effects of fenfluramine, a dexfenfluramine toxicology study showing fibrosis in the hearts of rats and 105 reports of heart valvulopathy received by drug manufacturers. The PMC alleged that AHP withheld this information from the FDA. The FDA responded with a letter stating that at the time the JAMA article was published, to the best of its knowledge, the FDA was not in possession of any of the health-effects information identified by the PMC. The one author who was deposed by the PMC, Dr. Jeffrey E. Shuren, said he was unaware of the information when the article was written. AHP’s lawyer, William Vodra of Washington, D.C.’s Arnold & Porter, then wrote a letter to the FDA that said the company had provided the information to the FDA before the article was published. After reviewing its records, the FDA wrote the PMC to confirm that it possessed much of the information at the time of the article’s publication and listing the documents that it possessed. The PMC responded by demanding answers to five questions: � Why were the JAMA article’s authors unaware of this information? � What investigation did the FDA make before stating in the July 21, 1999, letter that it was unaware of the information? � Did AHP fail to appropriately bring the information to the FDA’s attention? � In light of the information, did the authors reevaluate the representations made in the JAMA article? � And, if so, what did they conclude? The PMC also requested further discovery, including production of documents related to its letter, the FDA’s two letters and the Vodra letter. The FDA provided some documents to the PMC but withheld 132 others for which it provided only a “privilege log” that described the documents and why they had been withheld. The PMC then turned to Senior U.S. District Judge Louis C. Bechtle, of the Eastern District of Pennsylvania, and asked that he enforce its subpoenas and its requests made pursuant to the Freedom of Information Act. The FDA argued that its decision not to produce the 132 documents on the basis of privilege — both attorney-client privilege and deliberative-process privilege — must be reviewed under the “arbitrary and capricious” standard of the Administrative Procedures Act. But the PMC insisted that because the discovery requests were made through subpoenas and FOIA, the FDA’s privilege claims should only be reviewed under Exemption 5 of FOIA or Federal Rule of Civil Procedure 45. Bechtle found that there is a “split of authority” on the question of whether a non-party federal agency’s decision not to comply with federal subpoenas is reviewed pursuant to the APA’s arbitrary and capricious standard or de novo under the court’s discretionary right to limit burdensome discovery under the Federal Rules of Civil Procedure. But Bechtle found that none of the cases addressed requests for production under FOIA. Siding with the PMC, Bechtle said he would conduct a de novo review of the FDA’s denial of the FOIA request. “The court is not reviewing the quality of the FDA’s decision making with regard to matters within its expertise, but rather the application of a general federal statute that is unrelated to the FDA’s mandate of ensuring the safety of food, drugs and medical devices,” he wrote. FDA lawyers argued that the PMC cannot invoke FOIA without following its procedures and filing suit, but Bechtle said “the court believes that the subpoena is sufficient to bring the issue before the court for decision. To require a formal suit under FOIA would create needless delay and expense only to bring the same issue before the court at a later time.” When deciding whether to apply a FOIA exemption, Bechtle said, “the agency’s opinion carries no more weight than the opinions of others before the court.” Bechtle found that FOIA exempts from disclosure any “inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency.” The exemption, Bechtle said, “extends to documents that are traditionally privileged from discovery, including the ‘deliberative process’ privilege and the attorney-client privilege.” But Bechtle also found that FOIA exemptions “are read narrowly” and that disputes over claimed exemptions should be “resolved by rough analogy to the rules of discovery.” To prevail, Bechtle said, the FDA would have to do more than assert “conclusory assumptions of privilege” but must instead provide “a relatively detailed justification, specifically identifying the reasons why a particular exemption is relevant and correlating those claims with the particular part of a withheld document to which they apply.” Applying that test, Bechtle concluded that the privilege log submitted by the FDA in lieu of producing the 132 documents at issue “is insufficient to prove the applicability of [the] exemption.” The privilege log, he said, “identifies only the author, the person to whom it was addressed, the date, the type of document (e.g., e-mail) and a brief description of the memorandum such as ‘FDA’s possession of documents.”‘ After looking at the withheld documents himself, Bechtle concluded that there was “insufficient proof of the applicability of the deliberative process privilege to any of the documents,” but that the attorney-client privilege applies to all of the documents for which it was invoked. Bechtle found that the deliberative process privilege encompasses “confidential deliberations of law or policy-making, reflecting opinions, recommendations or advice.” The purpose of the privilege, he said, is to “prevent injury to the quality of agency decisions.” But the privilege does not protect “factual information that is severable from an otherwise protectable document,” he found, and does not extend to “communications made subsequent to an agency decision.” Two key factors in applying the privilege, he said, are whether the document was created before adoption of the agency policy and therefore “predecisional” and whether it is truly deliberative. The PMC insisted that publication of the JAMA article is the “agency action” at issue and that therefore the privilege is inapplicable because the documents reflect “post-decisional” communications. But the FDA argued that its responses to letters from the PMC and Vodra are the agency action at issue. Bechtle concluded that the deliberative process privilege was inapplicable. “There is little in the nature of these documents that can be considered deliberation over agency policy. Rather, the documents withheld on the basis of the deliberative process privilege contain communications concerning whether the FDA possessed certain documents, what those documents were and who they were being sent to within the agency,” he wrote. “First, these documents reflect largely factual information. Second, contrary to the FDA’s assertion, its responses to the PMC’s FOIA requests are not discretionary agency actions or policies for purposes of the deliberative process privilege. Third, the FDA has not demonstrated why formulating a response to the letter from AHP’s counsel should be considered an agency policy for purposes of the deliberative process privilege.” Bechtle found that the internal deliberations prior to the FDA’s responses are “not the sort of internal communications that the deliberative process privilege was intended to protect.” By contrast, Bechtle sided with the FDA in each instance that it claimed an attorney-client privilege. “All of the documents withheld from disclosure by the FDA on the basis of attorney-client privilege contain communications between an FDA official and an FDA attorney,” he wrote. While the underlying facts discussed in the communications might not be privileged, Bechtle found that the communications themselves are privileged. “Formulating a response to requests for documents is clearly a legal service rendered by FDA attorneys,” he wrote.

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