On February 18, 2025, in a highly anticipated opinion, the United States Court of Appeals for the First Circuit joined a majority of the circuits in adopting the “but-for” causation standard as the threshold for proving a False Claims Act (FCA) claim based on an Anti-Kickback Statute (AKS) violation. United States v. Regeneron Pharmaceuticals, Inc., No. 23-2086 (1st Cir. Feb. 18, 2025), raises the bar for the government and private relators in AKS-based FCA cases and has important litigation and strategic implications for FCA litigants in the First Circuit and beyond.
In Depth
In Regeneron, the First Circuit tilted the circuit split even more on whether FCA liability requires a kickback to be the but-for cause of a claim based on the 2010 amendment to the AKS. While the Sixth, Eighth, and now First Circuits all hold that the 2010 amendment’s “resulting from” language requires a but-for showing, the Third Circuit, relying primarily on legislative history, requires only a “causal link” between the alleged kickback and subsequent claim. Regeneron simultaneously resolved an intra-circuit split among the district courts in Massachusetts: United States v. Teva Pharmaceuticals USA, Inc., No. CV 20-11548-NMG, 2023 WL 4565105 (D. Mass. July 14, 2023), and United States v. Regeneron Pharmaceuticals, Inc., No. CV 20-11217-FDS, 2023 WL 6296393 (D. Mass. Sept. 27, 2023), both issued in 2023, reached opposite conclusions as to the meaning of “resulting from” in an FCA case premised on...
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