Fed 4th Cir. Applies Rigid Pleading Standard in Off-Label Marketing False Claims Act Case

Posted on Health Care Law News by author

The Federal Fourth Circuit Court of Appeals dismissed an off-label marketing False Claims Act case based upon the lack of identification in the complaint of specific false claims presented to the government. In U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc., No.11–2077 (4th Cir. January 11, 2013), the court brushed aside the other substantial detailed allegations of the scheme alleged in the complaint and dismissed holding that the relator failed to adequately allege that claims had actually been presented to the government as a result of the off-label marketing conducted by the drug manufacturer. Applying the heightened pleading standards called for by Rule 9(b), and the plausibility requirements imposed by the Supreme Court’s decision in Iqbal, the court found that the relator’s allegations established that false claims “could” have been presented to the government, but that since they need not necessarily have been submitted, the relator was required to come forward with specific examples of where false claims had been presented. Since the relator had not identified specific claims in the amended complaint, the court affirmed the dismissal of the case. The court did not allow the relator to further amend the complaint, finding that the relator had already had the opportunity to amend previously.