The First Circuit will decide the causation standard required in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS), deepening a circuit split on the issue and potentially teeing up Supreme Court intervention.
U.S. District Judge Nathaniel Gorton asked the First Circuit to review his recent ruling that the government need not prove a “but for” causal connection between an AKS violation and an allegedly false claim. In certifying this decision for interlocutory appeal, Judge Gorton acknowledged that there is “substantial ground for difference of opinion” on the standard, likely referencing the growing divide between circuit courts on this outcome-determinative issue.
Judge Gorton’s ruling pauses United States v. Teva Pharmaceuticals USA Inc. — a sprawling FCA case wherein the government accuses Teva Pharmaceuticals of using illegal kickbacks to boost its drug sales, thereby causing Medicare to pay $1.49 billion in tainted claims. Specifically, the government alleges that Teva paid two charitable foundations illegal co-pay subsidies in connection with the sale of Copaxone, a multiple sclerosis drug. Teva estimates its potential exposure in this case may exceed $10 billion — “an enterprise-threatening amount.”
Judge Gorton denied Teva’s argument that the government must demonstrate “but for” causation, instead relying on ambiguous language from the First Circuit requiring only a “sufficient causal connection” between an AKS violation and an alleged...
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