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This is the second time in the last couple of weeks that we’ve written on a case brought under the False Claims Act (FCA).  That is no accident. We are about to start a FCA trial, and have been studying all things FCA.  Guess what we learned?  Most FCA claims are even more bogus than product liability claims.  The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.  (And it’s probably barred by the “take care” clause of the U.S. Constitution, Article 2.  But we digress.)

In Lewis v. Abbvie f/k/a Allergen, 2024 U.S. Dist. LEXIS 192555 (N.D. Indiana Oct. 22, 2024), a former sales representative brought a FCA claim against his former employer, a pharmaceutical company. He alleged that after he “raised concerns with his supervisors regarding off-label prescription of a certain drug, he faced unlawful retaliation.”  The drug was approved for treatment of bipolar I depression, but was not approved for treatment of major depressive disorder or substance abuse.  The relator alleged that the defendant was “improperly positioning” the drug as a treatment for major depressive disorder and substance abuse by “pressuring and retaliating against sales representatives, illegal marketing tactics, illegal speaker campaigns, and inducements of medical professionals.” 

The government declined to intervene in this matter. 

The defendant filed a motion to dismiss. 

Then the relator amended his complaint to allege only a single count of retaliation under the FCA.  That slimmed down complaint removed any pretense that the relator was seeking compensation on behalf of the government. His case “was only brought on his own behalf.”

The defendant subsequently filed another motion to dismiss the amended complaint. The defendant’s argument was that the relator had failed “to demonstrate that he engaged in protected activity” or that the defendant “was aware that he was protesting fraud, and that he had failed to plead a plausible claim for retaliation.” 

The court granted the motion. 

The court held that the claim failed under the FCA because off-label promotion in and of itself, while it may run afoul of certain FDA rules in certain situations, does not support an FCA claim.  Rather there must be a causal nexus between the off-label speech and improper reimbursement requests made to the government.  The relator complained about supposed off-label promotional efforts, but never alleged that this conduct resulted in any claims submitted to any governmental program.  There was nothing in the complaint suggesting that a reasonable employee in the plaintiff’s (litigious) shoes “would believe that his employer was committing fraud against the government.”

The plaintiff was thus not engaged in any FCA protected activity by complaining about having to engage in off-label speech.  “Merely objecting to promotions or marketing that might lead someday to someone’s violation of the FCA through the submission of a false claim is insufficient.”

The plaintiff sought to save his case by attaching an exhibit and proposing yet another amended complaint.  Exhibits outside the pleadings are not ordinarily considered by courts when it comes to motions to dismiss, but here it didn’t matter.  The exhibit went to the relator’s objections to off-label marketing, but did not say anything as to whether a fraud against the government was actually consummated. In any event, the plaintiff had already amended once, and still could not manage to state a claim. At this point, the court had enough of the relator’s act. The relator had already been “rather replete” in alleging his griping to his employer about off label marketing, but “indefensibly anemic in alleging any fraud against the government.”  By now it was clear that “another attempt to amend would prove futile and wasteful.”  The Lewis court was not going to hand out another chance to amend.  Dismissal was with prejudice