Medtronic Decision: Strengthening AKS Enforcement in the First Circuit

November 24, 2025

The District of Massachusetts’ recent ruling in United States ex rel. Witkin v. Medtronic, Inc., No. 1:11-cv-10790-IT (D. Mass. Nov. 14, 2025), is a pivotal development for whistleblowers and government enforcement under the Anti-Kickback Statute (AKS) and False Claims Act (FCA). Coming on the heels of the First Circuit’s influential decision in United States v. Regeneron Pharmaceuticals, Inc., 128 F.4th 324 (1st Cir. 2025), the Medtronic case demonstrates how courts are applying the clarified causation standard—and why relators still have strong tools to hold violators accountable.

The AKS-FCA Connection and Regeneron’s Impact

The AKS prohibits offering or receiving remuneration to induce referrals for items or services reimbursable under federal healthcare programs. Congress strengthened enforcement in 2010 by amending the AKS to state that any claim “resulting from” a violation constitutes a false claim under the FCA (42 U.S.C. § 1320a-7b(g)). This amendment created a per se pathway to FCA liability for kickback-tainted claims.

For years, courts debated what “resulting from” meant. Did it require strict causation or permit a more attenuated connection? In Regeneron, the First Circuit resolved the issue: the phrase requires but-for causation—the kickback must be a substantial factor in causing the claim. While this raised concerns about enforcement, the court also reaffirmed a second, independent theory of FCA liability: false certification, which requires no proof of causation.

Two Pathways to Prove AKS Violations

The First Circuit recognizes two distinct routes for FCA liability based on AKS violations:

1. Per Se Liability Under the 2010 Amendment
   • Requires but-for causation between the kickback and the claim.
   • Relators must show the claim would not have been submitted but for the kickback.
   • Circumstantial evidence and reasonable inferences—such as temporal proximity and patterns of conduct are acceptable.
     (Regeneron, 128 F.4th at 327–330.)
2. False Certification Theory
   • Requires proof that the defendant falsely certified AKS compliance as a material condition of payment.
   • No causation requirement, making it easier to establish liability when direct linkage is complex.
     (Regeneron, 128 F.4th at 332–334.)

This dual framework is critical for enforcement. It ensures that even if causation is difficult to prove, relators can still succeed under false certification.

Medtronic: Applying the But-For Standard

In Medtronic, the relator alleged that the company provided extensive free services, including staffing physician offices, running iPro clinics, and managing patient scheduling, in order to induce physicians to prescribe Medtronic insulin pumps. The court found that these activities constituted remuneration under the AKS and were designed to “add value” to physician practices, which crossed the line from product support to inducement.

The relator linked these inducements to actual claims submitted to CMS. Evidence included:

• Claims data showing temporal and operational overlap between Medtronic’s presence at a clinic and that clinic’s billing practices.
• Internal documents tying demonstration clinics to sales growth and strategies to convert “stagnant” accounts into “100% Medtronic.”
• Direct evidence of intent, such as instructions for field personnel to schedule patients, provide equipment, and interpret data so that physicians to choose Medtronic pumps.

The court concluded that this evidence was sufficient to survive summary judgment even under the but-for causation standard articulated in Regeneron. Importantly, causation does not require exclusivity, only that the kickback was more likely than not a cause of the false claim. The court noted that the detailed matching between Medtronic’s presence in clinics and the resulting CMS claims, together with internal documents showing deliberate efforts to drive prescriptions, provided the kind of concrete evidence that satisfies the but-for standard. (Medtronic, Mem. & Order at 8–9.)

Why This Decision Helps Relators and the Government in AKS Enforcement

The District Court’s ruling in Medtronic is a roadmap for relators:

• It confirms that but-for causation is achievable with robust evidence of inducement and claim linkage.
• It underscores that circumstantial evidence matters—patterns of conduct, timing, and internal communications can satisfy causation.
• It reaffirms that false certification remains a viable theory, requiring no causation and offering an alternate path to liability.
• It broadens litigation strategy, as relators should assert both theories to maximize chances of success.

For whistleblowers and compliance professionals, the message is clear: AKS violations remain actionable even under heightened causation standards. Kickbacks distort medical judgment and inflate costs to federal programs, and courts continue to recognize that such conduct undermines the integrity of our healthcare system.

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