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Thursday, April 23, 2026

ROI Tracking as Mens Rea ? Novartis Ruling Reframes AKS Pleading Risk - Crowell & Moring LLP

Is evidence that a company tracked return on investment (ROI) for certain actions and expenses sufficient to prove mens rea and plead a violation of the federal Anti-Kickback Statute (AKS) with the requisite particularity? A recent decision in the U.S. District Court for the Southern District of New York (SDNY) suggests that it is.

On March 30, 2026, a district court judge permitted an embattled qui tam lawsuit against pharmaceutical manufacturer Novartis to proceed to discovery, finding that the relator — Steven Camburn, a former sales employee — had sufficiently stated a False Claims Act (FCA) claim when he alleged that the company had knowingly violated the AKS by maintaining a sham physician speaker program that, he asserted, conveyed kickbacks to doctors for the purposes of improperly boosting prescriptions for a multiple sclerosis drug.

This development in United States ex rel. Camburn v. Novartis Pharms. Corp. comes over a decade and multiple revisions after the relator originally filed suit, concluding a prolonged litigation prologue in which two complaints were dismissed by the district court for failure to satisfy Rule 9(b)’s particularity requirement, a third was superseded by the parties’ own stipulation and ultimately vindicated in part on appeal, and the resulting Third Amended Complaint (TAC) was dismissed in 2022, only to be partially revived by the U.S. Court of Appeals for the Second Circuit and, following remand, allowed to proceed for discovery.

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