United States v. Regeneron Pharmaceuticals, Inc.

Court: U.S. Court of Appeals for the First Circuit

Docket: 23-2086

Opinion Date: February 18, 2025

Judge: William Kayatta

Areas of Law: Criminal Law, Government & Administrative Law, Health Law, White Collar Crime

The case involves the United States government alleging that Regeneron Pharmaceuticals violated the Anti-Kickback Statute (AKS) by covering copayments for patients prescribed Eylea, a drug used to treat wet age-related macular degeneration. The government contends that this action induced doctors to prescribe Eylea, leading to Medicare claims that were "false or fraudulent" under the False Claims Act (FCA) because they "resulted from" the AKS violation.

The United States District Court for the District of Massachusetts reviewed the case and agreed with Regeneron's interpretation that the phrase "resulting from" in the 2010 amendment to the AKS requires a but-for causation standard. This means that the government must prove that the AKS violation was the actual cause of the Medicare claims. The district court noted the conflict in case law and sought interlocutory review, which was granted.

The United States Court of Appeals for the First Circuit affirmed the district court's ruling. The court held that the phrase "resulting from" in the 2010 amendment to the AKS imposes a but-for causation requirement. The court reasoned that the ordinary meaning of "resulting from" requires actual causality, typically in the form of but-for causation, unless there are textual or contextual indications to the contrary. The court found no such indications in the 2010 amendment or its legislative history. Therefore, to establish falsity under the FCA based on an AKS violation, the government must prove that the kickback was a but-for cause of the submitted claim.