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The First Circuit’s recent Regeneron opinion endorsed the alternative “false certification” or “implied certification” pathway to prove an Anti-Kickback Statute (AKS)-based False Claims Act (FCA) case. Beginning with the Eighth Circuit’s decision in Cairns, three circuit courts have held that to establish a false claim under the FCA via the 2010 amendment to the AKS, a plaintiff must prove that the allegedly false claims would not have contained the items or services at issue but for the alleged kickback.1 Our recent post explained that courts have applied but-for causation in a manner that makes it quite difficult to satisfy. The near-term viability of FCA kickback claims will therefore be shaped to a large degree by whether plaintiffs can prove their claims using the alternative false certifications theory that does not require them to demonstrate but-for causation.2
Diverging Paths and Interpretations
In the years before Cairns was issued in 2022, courts generally applied a proximate causation standard in FCA kickback cases.3 Cairns applied but-for causation, relying on a textual interpretation of the 2010 amendment to the AKS. The court also included language that plaintiffs and defendants interpret very differently: “[o]ur ruling today is narrow. We do not suggest that every case arising under the False Claims Act requires a showing of but-for causation. Rather, when a plaintiff seeks to establish falsity or fraud through the 2010 amendment, it must prove that a defendant would not have included particular ‘items or services’ but for the illegal kickbacks.”4 In the interpretation of many plaintiffs, the Cairns court’s “through the 2010 amendment” language leaves open two paths to proving an AKS/FCA claim:
- Path 1: Prove that the claims are materially false without relying on the 2010 amendment, as plaintiffs had in pre-2010 cases. Proximate causation applies.
- Path 2: Rely on the 2010 amendment. No need to prove materiality, as the 2010 amendment explicitly states that AKS-tainted claims are false. But-for causation applies.
Defendants interpret Cairns differently, reasoning that after the 2010 amendment, plaintiffs seeking to prove an FCA kickback case must rely on the 2010 amendment. Plaintiffs must live with whatever standard courts apply to those claims, and cannot use the false certifications theory as an escape hatch to avoid the trend towards but-for causation.
Intra-District Split
When Cairns was decided in July 2022, a significant FCA kickback case, Fesenmaier, was on the verge of trial in the District of Minnesota.5 The United States alleged that a cataract lens distributor provided kickbacks to ophthalmologists to induce them to implant cataract lenses sold by the distributor. The court had already ruled on summary judgment the previous year that proximate causation, not but-for causation, applied.6 After Cairns, the plaintiffs and defendants advanced competing interpretations of Cairns as set forth above, with the government arguing that it did not need to prove but-for causation because it would only seek to prove its claims through the false certification theory—the alternative pathway—and not through the 2010 amendment to the AKS. The court held that “if Plaintiffs can establish all the elements of their material falsity theory without reliance on the 2010 Amendment—including that the purported AKS violations were material—Plaintiffs need not prove but-for causation to establish liability under the FCA.”7
The following year, another District of Minnesota court reached the opposite conclusion. In Sunovion, the court held that the idea that Cairns left intact an alternative false certification pathway in AKS-based FCA cases “rests on a flawed interpretation” of the 2010 amendment and Cairns.8 The court’s reasoning was twofold. First, if an alternative “pathway” that did not require proof of but-for causation existed, the 2010 amendment “would have little practical effect.”9 Second, the “narrowness” of Cairns’ holding was not that it was limited solely to the 2010 AKS amendment, but that it was limited only to AKS-based FCA cases.10 The better interpretation, the Sunovion court reasoned, is that “there is no such thing as a False Claims Act case premised on an Anti-Kickback violation that need not go through [the 2010 amendment].”11
Recent Cases Have Adopted the Alternative Pathway
Last year, the Northern District of Georgia agreed that the plaintiffs could pursue AKS-based FCA claims under the alternative “false certification” theory.12 The court applied proximate causation, and rejected the defendant’s request for interlocutory appeal of that conclusion because “[r]egardless of how the Eleventh Circuit interprets [the 2010 AKS amendment], however, the Court has already determined that [Relator’s] alternative theory of causation, implied certification, should proceed to trial.” Id.
Most recently, the First Circuit in Regeneron endorsed the false certification “pathway.” It held that in passing the 2010 amendment, Congress “did not clearly intend to alter false-certification caselaw by imposing a but-for causation requirement.”13 It held that the 2010 amendment merely “offer[s] a pathway to establish falsity in FCA actions based on AKS violations without reliance on [the false certification] theory,” and held that “nothing in the 2010 amendment . . . requires proof of but-for causation in a false-certification FCA case.”14
The Northern District of Illinois will likely be the next court to weigh in on this debate. Allergan has moved to dismiss AKS-based FCA claims against it, citing Sunovion.15 The Relator has countered by citing Cairns, Precision Lens, and Heller.16
Takeaways
Recent trends suggest that courts will interpret the 2010 amendment as requiring plaintiffs to demonstrate but-for causation, and will interpret that as a rigorous standard. Companies evaluating the reach of FCA kickback liability should pay close attention to whether courts endorse this alternative pathway that allows plaintiffs to prove their cases under a less rigorous causation standard.
[1] See United States ex rel. Cairns v. D.S. Medical LLC, 42 F.4th 828, 830 (8th Cir. 2022); United States ex rel. Martin v. Hathaway, 63 F.4th 1043, 1055 (6th Cir.), cert. denied, 144 S. Ct. 224, (2023); United States v. Regeneron Pharms., Inc., No. 23-2086, 2025 WL 520466, at *9-10 (1st Cir. Feb. 18, 2025). Precisely what but-for causation requires is also the subject of ongoing debate.
[2] Courts also refer to the false certification theory as material falsity or implied certification.
[3] Plaintiffs must actually demonstrate causation under both the AKS and FCA, but teasing that out is a complicated analysis that is beyond the scope of this post.
[4] Cairns, 42 F.4th at 836.
[5] United States ex rel. Fesenmaier v. Cameron-Ehlen Grp., Inc., No. 13-CV-3003. Mr. Blumenfield was the lead government attorney on that case.
[6] 2021 WL 101193 (D. Minn. Jan. 12, 2021).
[7] Id.
[8] United States ex rel. Louderback v. Sunovion Pharms., Inc., 703 F. Supp. 3d 961, 979 (D. Minn. 2023).
[9] Id. at 980.
[10] See id. (“Not every False Claims Act case depends on Anti-Kickback violations.”)
[11] Id. at 980.
[12] United States ex rel. Heller v. Guardian Pharmacy of Atlanta, LLC, No. 18-CV-03728, 2024 WL 102211, at *2 (N.D. Ga. Jan. 9, 2024).
[13] Regeneron, 2025 WL 520466, at *7.
[14] Id. at *8. Interestingly, the Sunovion and Regeneron courts both relied on the Sixth Circuit’s Hathaway decision to support opposing conclusions. In rejecting the false certification pathway, the Sunovion court cited Hathaway’s statement that “When it comes to violations of the Anti-Kickback Statute, only submitted claims ‘resulting from’ the violation are covered by the False Claims Act.” Sunovion, 703 F. Supp. at 980 (quoting Hathaway, 63 F.4th at 1052) (emphasis added). In contrast, the First Circuit cited Hathaway for the proposition that “The circuit courts that read the 2010 amendment as imposing a but-for causation requirement also agree that the 2010 amendment did not disturb alternative theories of FCA liability (e.g., false certification).” Regeneron, 2025 WL 520466, at *8.
[15] United States ex rel. Wilkerson v. Allergan Ltd., No. 22-CV-03013, 2024 WL 4754171 (N.D. Ill. Sep. 11, 2024).
[16] Allergan, No. 22-CV-03013, 2024 WL 4754064 (N.D. Ill. Oct. 21, 2024).
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