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Sunday, August 17, 2025

FALSE CLAIMS ACT—D. Mass. - VitalLaw.com

The fact that the Government did not explicitly state a “false certification” theory in its Complaint was of little impact where factual allegations put the Provider on notice of the claim asserted and the grounds upon which it rested.

A federal District Court in Massachusetts has granted the Government’s “Motion for Leave to File a Second Motion for Partial Summary Judgment and to Reopen Discovery on a Limited Basis” in a False Claims Act (FCA) lawsuit brought against Regeneron Pharmaceuticals, Inc. (Regeneron or Provider). Although the original Complaint was based on a “2010 Amendment” theory of AKS liability, a subsequent federal court opinion regarding the applicable standard for asserting a “false certification” theory of liability prompted the Government to request leave to file a subsequent motion as well as for leave to reopen discovery. Given the court’s broad discretion as to granting or denying such motions, the court granted the motion after finding that the “false certification” theory was just a different pathway to the same AKS-based FCA claim (United States of America v. Regeneron Pharmaceuticals, Inc., No. 1:20-cv-11217-FDS (D. Mass. Aug. 4, 2025)).

Donations to CDF. The United States (Government) brought suit against Regeneron, manufacturer of the drug Eylea, alleging that Regeneron improperly funneled millions of dollars to the Chronic Disease Fund (CDF)—a purportedly independent charitable foundation—to subsidize patient copays for Eylea. According to...



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