United States of America, et al. v. Gilead Sciences, Inc.

Analysis Group was retained on behalf of biopharmaceutical company Gilead Sciences, the defendant in a qui tam action brought by plaintiff-relator Toby Travis on behalf of the US government. Travis, a former Gilead sales representative for direct-acting antivirals designed to treat the hepatitis C virus, alleged that Gilead violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by establishing a “sham” speaker program to induce high-volume prescribers through meals, vacations, and cash payments.  The plaintiff further alleged that Gilead funneled money to support patients taking its medications through a third-party entity called the Patient Access Network (PAN) Foundation.

An Analysis Group team led by Managing Principal Brad Rice, Vice Presidents Nori Mehta and Nicholas Van Niel, and Managers Molly Frean and Clayton Mersmann supported academic affiliate Anupam B. Jena, who filed three expert reports and testified at deposition. Dr. Jena rebutted the plaintiff’s experts on causation and damages opinions related to speaker programs and copay assistance through the PAN Foundation.

Referring at multiple points to Dr. Jena’s submissions, a judge in the US District Court for the Eastern District of Pennsylvania granted summary judgment to Gilead, writing in her opinion that the plaintiff “has not adduced sufficient evidence to demonstrate that the speaker programs were a sham” and  “points to no evidence that anyone at Gilead knew that its donations to the PAN Foundation violated the AKS—or, alternatively, was deliberately ignorant of, or acted with reckless disregard to, AKS violations.”