On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False Claims Act (FCA) liability, the government (or relators) must prove that the alleged kickbacks were the “but for” cause of the alleged false claim (United States v. Regeneron Pharmaceuticals, Inc., No. 23-2086 (1st Cir. Feb 18, 2025)). The case is significant because:

• By requiring the government to prove that alleged kickbacks were the direct or “but for” cause of a doctor’s prescribing decision, the court rejected the government’s argument that exposure to an improper inducement and a later claim was enough to satisfy the causation requirement.
• The First Circuit followed recent decisions by the Sixth and Eighth Circuits and rejected the Third Circuit’s more lenient approach, thus signaling a growing consensus that plaintiffs must prove “but for” causation to establish FCA liability under the AKS statute.
• Plaintiffs may still be able to prove an FCA case without establishing “but for” causation if they can show that the defendant expressly or implicitly certified that it had complied with the AKS when it submitted its claims.
• The case highlights the need for life sciences companies to implement strong controls around their interactions with health care providers to ensure prescribing decisions are based solely on the provider’s independent medical...

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