False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
The District of Massachusetts has joined the growing chorus of courts that have applied a heightened causation standard in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS). U.S. District Judge F....more
Two Massachusetts federal district courts recently addressed—and disagreed about—an important False Claims Act (FCA) issue that has also divided the federal circuit courts: when an alleged FCA violation is based on an...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more