128 F.4th 324
1st Cir.2025Background
- The United States alleged Regeneron Pharmaceuticals violated the federal Anti-Kickback Statute (AKS) by inducing Medicare prescriptions of its drug Eylea through copayment assistance via a charitable foundation.
- Under a 2010 amendment to the AKS, a claim “resulting from” an AKS violation is automatically (“per se”) false under the False Claims Act (FCA).
- The primary legal question was the meaning of “resulting from” in this amendment: does it require finding that the violation was the “but-for” cause of the claim, or a looser standard?
- Regeneron argued for a but-for causation standard; the government sought a more relaxed causation, claiming just “exposure” to the kickback suffices.
- The district court sided with Regeneron; the government appealed. The First Circuit granted interlocutory review and affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper causation standard for “resulting from” in AKS 2010 amendment | Only requires showing patient/claim “exposed” to kickback, not but-for causation; looser causal link suffices | “Resulting from” should follow default but-for causation rule; only claims caused by AKS violations should trigger FCA | “Resulting from” carries ordinary but-for causation; government must prove the kickback actually caused the claim |
| Alignment with AKS’s criminal standard | Criminal AKS doesn’t require causation; civil liability should mirror this | FCA is designed for restitution; causation serves a different remedial purpose | Distinction between purposes (criminal/fraud restitution) justifies different causation standards |
| Whether 2010 amendment changed false-certification pathway under FCA | It carried over existing false-certification standards (which require no causation) | 2010 amendment is a new pathway, independent of false-certification | Amendment did not alter false-certification law; each path to liability is distinct |
| Practical difficulty in proving causation | Requiring but-for causation unduly burdens enforcement | Standard evidentiary difficulty; government can still meet its burden | Difficulty of proof is not a justification to abandon default causation standard |
Key Cases Cited
- Guilfoile v. Shields, 913 F.3d 178 (1st Cir. 2019) (discussed scope of causation under the AKS and FCA)
- United States ex rel. Hutcheson v. Blackstone Med., Inc., 647 F.3d 377 (1st Cir. 2011) (addressed false-certification theory under the FCA)
- United States ex rel. Martin v. Hathaway, 63 F.4th 1043 (6th Cir. 2023) (interpreted “resulting from” as requiring but-for causation)
- United States ex rel. Cairns v. D.S. Med. LLC, 42 F.4th 828 (8th Cir. 2022) (but-for causation required for AKS/FCA claims)
- Universal Health Servs., Inc. v. United States, 579 U.S. 176 (2016) (key FCA materiality precedent)
- Burrage v. United States, 571 U.S. 204 (2014) (interpreted similar causation language as but-for standard)
- Paroline v. United States, 572 U.S. 434 (2014) (discussed when to deviate from but-for causation based on statutory context)