Few issues within the regulation are as topic to abuse because the False Claims Act, 31 USC part 3729 et seq. (the FCA). It was initially enacted to cease large frauds perpetrated by giant contractors throughout the Civil Battle. Now it’s a litigation cottage business.
In United States ex rel. Bennett v. Bayer Corp., 2024 U.S. Dist. LEXIS 63654 (D.N.J. April 4, 2024), the relator alleged that two defendant pharmaceutical firms violated the FCA by deceptive the federal authorities to get approval to promote fluoroquinolone antibiotics (FQs), leading to medical doctors prescribing the FQs and looking for fraudulently-induced reimbursements from federal and state healthcare payors. To our defense-hack eyes, this motion smacks of a declare of fraud on the FDA, which we expect is just not a difficulty for courts however, moderately, the FDA. We usually see courts use preemption to swat away fraud on the FDA claims. However the defendants right here prevailed on their motions to dismiss for a non-preemption cause, and that’s simply wonderful with us.
The relator in Bennett was a little bit of a gadfly (that’s as well mannered a time period as we will muster) who had beforehand filed a number of Citizen’s Petitions with the FDA relating to FQs with (and right here we’re once more endeavoring to be well mannered) blended outcomes — largely denials. The FDA did require some enhanced or clarifying warnings on FQs, however, from what we will inform, the relator doesn’t appear to have been the first cause for that. We espy a little bit of opportunism right here, although we confess our priors on this space, and such priors are suffused with cynicism.
Third Circuit regulation managed in Bennett, and the Third Circuit permits fraudulent inducement legal responsibility beneath the FCA solely within the context of contracts that had been induced by fraud. The alleged inducement right here occurred within the context of a non-contractual interplay with the FDA. The Bennett court docket noticed no good cause to increase legal responsibility past what the Third Circuit has to this point blessed.
In any occasion, the relator’s allegations had been flimsy. The relator alleged “half-truths” manipulated medical trials, and “disaggregation of antagonistic results.” However none of that advised that the defendants did not adjust to the New Drug Utility course of, or that they omitted any info particularly requested by the FDA. All of that provides as much as a failure to plead falsity, and given what the F in FCA stands for, that could be a deadly flaw.
Is “deadly” an overstatement? No. As a result of a further modification can be futile, the court docket dismissed the FCA grievance with prejudice.