Courtroom Success: Jack Fernandez

Zuckerman Spaeder LLP Partners Win False Claims Act Case for Solvay Pharmaceuticals

On December 4, 2009, the U.S. Court of Appeals for the Eleventh Circuit in Atlanta issued a 24-page opinion in James Hopper v. Solvay Pharmaceuticals, Inc., No. 08-15810. The court affirmed the district court’s dismissal of a False Claims Act (FCA), (31 U.S.C. 3729 et. seq.) lawsuit that two former sales representatives (relators) of Solvay Pharmaceuticals, Inc. filed in 2004, in the U.S. District Court for the Middle District of Florida. The Court of Appeals ruled that the relators’ complaint, which had alleged a scheme to market a pharmaceutical off-label, had failed to plead fraud with the specificity required by Rule 9(b) of the Federal Rules of Civil Procedure.

This was an issue of first impression in the Eleventh Circuit, which before this ruling had not considered a False Claims Act case grounded in the off-label promotion of a pharmaceutical. Moreover, the Eleventh Circuit’s ruling is the first decision by a U.S. Court of Appeals that an action under the FCA grounded in off-label marketing of pharmaceuticals should be dismissed when, as here, the relators failed to present any evidence of an actual false claim. In this case, company sales representatives claimed first hand knowledge of an off-label sales program, but the Eleventh Circuit decided that these allegations, even if taken as true, were not enough absent evidence of reimbursement practices that actually involved false claims. In this case, the relators had no such knowledge, and this, the Eleventh Circuit ruled, was fatal to their FCA action.

IADC member Jack Fernandez of Zuckerman Spaeder LLP argued the case in the district court and the Eleventh Circuit. Assisting Mr. Fernandez in the defense of this case were Marcos E. Hasbun, also of Zuckerman Spaeder, and John Fleder and Douglas Farquhar of Hyman, Phelps & McNamara P.C.