Fraud Hunting Season Remains Open for Off-Label Marketing Schemes

For weeks, the United States Department of Justice has signaled that it will continue to vigorously pursue illegal off-label marketing schemes deployed by dishonest pharmaceutical manufacturers. Recently, Zane Memeger, the United States Attorney for the Eastern District of Pennsylvania, made this point explicitly clear, when he stressed that False Claims Act off-label cases are “a major priority of the department, [Attorney General] Eric Holder and the Obama Administration.”

This clarification was apparently needed to rebuff arguments circulating in the pharmaceutical industry that off-label cases were no longer viable in the wake of a December 2012 appeals court decision overturning the conviction of a pharmaceutical sales representative. In that case, the Court of Appeals for the Second Circuit overturned the conviction of Alfred Caronia, who allegedly violated the Food Drug & Cosmetic Act (FDCA) by promoting drugs off-label. The appeals panel vote was 2-1, and the majority wrote in a carefully worded opinion that the trial jury convicted Caronia solely for exercising his Constitutionally-protected right to free speech.

Business groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA), celebrated the decision, hoping it would derail False Claims Act off-label cases, which have recovered billions of dollars in recent years. However, as the dust settled, defense lawyers scrambled to rein in the excitement, recognizing that that court decision had little real-world impact on civil off-label cases, which are premised largely on FDCA misbranding violations, as opposed to mere speech misconduct.

U.S. Attorney Memeger echoed this distinction, when he stressed, “There is no right of a company or an individual to make false and misleading statements about the use of a drug. I don’t see a difference in prosecuting our cases as vigorously as we have. You want to make sure you have proof and not just a simple statement.”

More information for whistleblowers is located at the Nolan Auerbach website.