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In re Fosamax Products Liability Litigation

August 4, 2009

IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION


The opinion of the court was delivered by: James C. Francis IV United States Magistrate Judge

MDL NO. 1789

MEMORANDUM AND ORDER

This Document Relates To All Actions:

This is a multidistrict litigation that was consolidated in this district for purposes of discovery. The plaintiffs, through the Plaintiffs' Steering Committee, allege that the prescription drug Fosamax, manufactured by Merck & Co., caused adverse effects, in particular, osteonecrosis of the jaw. During discovery, the plaintiffs subpoenaed Dr. Bruce M. Psaty, who participated in a drug safety report issued by the National Academy of Sciences (the "Academy"). Dr. Psaty now moves to quash the subpoena pursuant to Rule 45(c)(3) of the Federal Rules of Civil Procedure.

Background

A. Factual History

The Academy is a private, non-profit corporation charted by Congress in 1863. See 36 U.S.C. §§ 150301-150304. It is dedicated to furthering science for the general welfare. (Declaration of Dr. E. William Colglazier dated December 19, 2008 ("Colglazier Decl."), attached as Exh 3 to Dr. Bruce M. Psaty's Motion to Quash Third Party Subpoena ("Motion to Quash"), ¶ 6). Often commissioned by U.S. government agencies, the Academy establishes committees to conduct research and assess issues of scientific concern, including public health. (Colglazier Decl., ¶¶ 6, 9). The Committee on the Assessment of the U.S. Drug Safety System (the "Drug Safety Committee") was one of the committees established by the Academy's Institute of Medicine. (Declaration of Dr. Kathleen Stratton dated December 19, 2008 ("Stratton Decl."), attached as Exh. 2 to Motion to Quash, ¶¶ 3, 5). The Drug Safety Committee was created at the request of the U.S. Food and Drug Administration (the "FDA") to conduct an independent assessment of drug safety in the United States. (Stratton Decl., ¶ 5).

In 2004, the Academy asked Dr. Psaty to serve on the Drug Safety Committee. (Motion to Quash at 2). He accepted, knowing that, like all Committee members, he would not be compensated for his work. (Stratton Decl., ¶ 4). Dr. Psaty served on the Drug Safety Committee for 15 months between 2004 and 2006. (Motion to Quash at 2).

During his tenure, Dr. Psaty participated in a detailed examination of the current drug safety system in the United States. (Stratton Decl., ¶ 7). In September 2006, the Committee released its findings in a detailed report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public" (the "Drug Safety Report"). (Drug Safety Report, attached as Exh. 4 to Motion to Quash). This 317-page report contains recommendations for improving national drug safety, many of which involve proposals to change the structure and activities of the FDA's Center for Drug Evaluation and Research. (Stratton Decl., ¶ 7). The report did not focus on any single drug or category of pharmaceuticals. (Drug Safety Report at 25-26). In particular, it did not study Fosamax.

B. Procedural History

The Plaintiffs' Steering Committee served Dr. Psaty with a deposition subpoena on December 1, 2008. (Subpoena of Bruce Psaty, M.D., Ph.D., attached as Exh. 1 to Motion to Quash). On December 22, 2008, Dr. Psaty filed this motion to quash in the United States District Court for the Western District of Washington. Thereafter, a United States Judicial Panel on Multidistrict Litigation denied Dr. Psaty's request to vacate a previous decision to include this case among the actions consolidated for discovery in this district. (Transfer Order dated June 9, 2009 at 1). The motion to quash is therefore before this Court for determination.

Discussion

A. Rule 45(c)(3)

Under Rule 45(c)(3), a subpoena may be quashed if it requires "disclosing a trade secret or other confidential research, development, or commercial information." Fed. R. Civ. P. 45(c)(3)(B)(i). The plaintiffs argue that they "[do] not seek to discovery [sic] confidential information about the deliberations of the committee." (Plaintiff Steering Committee's Response to Dr. Psaty's Motion to Quash Third Party Subpoena ("Plaintiffs' Memo.") at 2). Instead, they contend ...


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