Glaxo Documents in Avandia Lawsuit Must Be Produced

A federal judge overseeing the <"">Avandia multidistrict litigation has ordered GlaxoSmithKline to produce dozens of documents in a lawsuit over Avandia’s heart side effects. In doing so, the judge rejected Glaxo’s claim that the documents were subject to attorney-client or work product privilege.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline, the maker of Avandia and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia.

In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. Since the May 2007 study highlighting Avandia’s heart risks was released, thousands of people injured by the drug have filed lawsuits against Glaxo.

Many of those lawsuits have been consolidated in a multidistrict litigation before the Honorable Cynthia M. Rufe of the United States District Court for the Eastern District of Pennsylvania. In an order dated December 9, 2009, Judge Rufe ordered Glaxo to produce dozens of documents that it withheld on claims of privilege.

In her opinion, Judge Rufe noted that “attorney-client privilege does not shield documents merely because they were transferred or routed through an attorney,” and that “documents prepared by a corporation as part of efforts to ensure compliance with federal regulatory agencies or maintain a positive public image for its products, and not because of possible litigation, are not protected by [the] work-product doctrine.”

Jude Rufe rejected Glaxo’s interpretation of the “primary purpose” requirement of the attorney- client privilege. Pennsylvania law provides that in order to come within that privilege, the primary purpose of a document must be to secure or give legal advice. The documents Glaxo wanted withheld included ones sent to a group of persons, only one (or more) of whom was an attorney. The drug maker argued that in determining whether the “primary purpose” requirement applied, the inquiry should be only to the purpose of sending the document to the attorney(s), rather than the primary purpose of the document as a whole.

Judge Rufe found that Glaxo’s interpretation has “no support” in cases applying Pennsylvania law, including the lead case that that the company relied on in making its argument.

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