First Circuit Affirms Strict Limits of FCA Reach

In U.S. ex rel. Alex Booker and Edmund Hebron v. Pfizer, Inc., the U.S. Court of Appeals for the First Circuit affirmed two district court judgments rejecting allegations of the defendant’s sales and marketing activities related to its drug Geodon, noting that, after 6 years of litigation, the whistleblowers failed to provide sufficient evidence to show that defendant’s alleged conduct resulted in the actual submission of fraudulent claims.

The relators, two former Pfizer employees, alleged that Pfizer promoted Geodon for use in children and adolescents and other off-label uses.  Their cause of action in this regard rested solely on the proffering of aggregated Medicaid reimbursement data for Geodon for pediatric patients.  In analyzing what constitutes a “false” claim, the court stated it is well established that “evidence of an actual false claim” is the essential condition of a FCA violation.  Even if a relator can show a defendant engaged in fraudulent activity, FCA liability only attaches where the conduct actually results in the filing of a false claim for payment.  Applying this standard, the First Circuit held that, at the summary judgment stage, the qui tam relators must do more than merely satisfy Federal Rule of Civil Procedure 9(b)’s heightened pleading standards; rather, relators must “produce competent evidence” of an actual false claim made to the government, since summary judgment is “the put up or shut up moment in litigation.”  This “greater showing” of proof would involve, for example, providing evidence of the medical provider who submitted the false claim, the time period during which the false claim(s) were submitted, location, the amount of the claim and the specific government program to which the alleged false claim was made.  The court deemed relators’ aggregated Medicaid reimbursement data “woefully inadequate,” and affirmed the district court’s dismissal.

The court also affirmed the district court’s dismissal of relators’ reverse FCA claim, premised on an alleged breach of the defendant’s Corporate Integrity Agreement obligations to notify the government of “probable violations” of law deemed to be reasonably credible, within 30 days.  One of the relators allegedly sent an email to the defendant’s compliance department complaining of the alleged off-label promotion.  Relators alleged that the defendant’s failure to disclose this email as a reportable event resulted in the company avoiding the CIA’s stipulated $2,500 per-day penalty for failures to report reportable event.  The First Circuit held that relators failed to assert that the company determined the email to be credible, and therefore failed to show a reportable event occurred.

A copy of the court’s opinion can be found here.