The relator alleged the defendant engaged in actions that violated the Anti-Kickback Statute and the False Claims Act. The relator claimed that the defendant provided improper benefits to healthcare providers to induce them to submit false claims for government reimbursement related to glucose monitoring devices. The court determined that the relator’s evidence met the but-for causation standard.

United States ex rel. Witkin v. Medtronic, Inc., D. Mass., No. 1:11-cv-10790-IT 

  • Background – The relator claimed that the defendant provided significant support to healthcare providers in administering the defendant’s continuous glucose monitoring device, the iPro. Allegations included the defendant’s provision of office staff and resources that enabled physicians to improperly bill for services not actually rendered. The relator presented various forms of evidence, including claims data linking the defendant’s actions to the alleged false claims.
  • Causation Standard – The court examined the causation standard under the AKS, focusing on whether the phrase “resulting from” required but-for causation. The defendant argued that the claims lacked a proper causal connection under the new standard set forth by the First Circuit in Regeneron Pharmaceuticals, Inc. The court ultimately agreed with the relator’s assertion that the defendant’s actions could indeed meet the but-for causation requirement, allowing the FCA claims to proceed.
  • Alleged Violations of the AKS – The court found that the relator provided adequate evidence suggesting that the defendant’s personnel were excessively engaged in running clinics that crossed the line into improper remuneration. The court found a reasonable basis for a jury to conclude that this conduct led to unlawfully induced claims for government payment, thereby supporting the relator’s FCA claims.
  • False Certification Theory – The defendant’s request for reconsideration regarding the false certification theory was denied. The court clarified that while but-for causation is necessary for certain claims, the false certification theory, which does not require proof of causation, remained viable. The defendant had not adequately moved for summary judgment on this theory, thereby preserving the relator’s ability to argue that compliance with the AKS was misrepresented.