Denial of Subpoena to Sanofi Pasteur Regarding Fluzone


Halverson v. HHS, (Fed. Cl. Spec. Mstr. Oct. 29, 2015) (Roth, SM)

Petitioner had informally requested information from Sanofi Pasteur, manufacturer of Fluzone vaccine. Sanofi Pasteur objected, and Petitioner moved for issuance of a subpoena.  Petitioner also submitted a FOIA request to the FDA related to Fluzone.  Specifically, Petitioner sought human and animal data, dose-response curves, and adverse events.

Petitioner argued that his expert required the information “in order to conduct a comprehensive assessment of the issues in this matter,” and that the documentation was necessary to present “the strongest causation evidence in this matter.”

At the same time, Petitioner submitted that his expert had already concluded to a reasonable degree of professional certainty that the evidence demonstrated a causative link between the administration of the vaccine and adverse cardiac events and death.  A second expert also supported the case.

The Court noted that discovery is not a matter of right in the Vaccine Program, and the standard to obtain discovery is whether the information sought is reasonable and necessary.  This equates to a finding that the special master could not make a fair and well-informed ruling on those factual issues without the requested material.  Further, the special master must consider the burden on the party who would be required to testify or produce documents.

However, the Court observed, vaccine manufacturers are not exempt from discovery in the Vaccine Program, and may be required to produce documentation in appropriate circumstances, except not trade secrets or commercial or financial information.

Because Petitioner already had two supportive experts, the information sought did not appear “necessary.”  Further, the FOIA request could obtain the desired information.  Thus, the motion was denied, with the proviso that it could be renewed upon a showing that the information sought was required.

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