Berman Tabacco recently defeated a set of motions to dismiss a federal False Claims Act action against former pharmaceutical executives and sales managers stemming from their alleged off-label promotion of the orphan drug Juxtapid, a $300,000 drug used to treat an exceedingly rare cholesterol disorder. The company itself has already settled with the government and the whistleblowers and pleaded guilty to criminal charges for misbranding.
Following settlement with the company, the whistleblowers (or, Relators, as they are technically known) continued with their litigation against the senior executives and sales managers allegedly involved in directing the wide-ranging off-label marketing scheme. As alleged, Juxtapid was approved by the FDA to treat an extremely limited population, but the defendants orchestrated a scheme to aggressively promote Juxtapid beyond that population through an aggressive misinformation campaign directed at doctors and other improper sales and marketing tactics. As a result, Relators allege that the federal government was defrauded into paying millions of dollars through Medicare, Medicaid, and other federal prescription drug programs for drug coverage for patients who did not have the underlying disorder.
“We are very pleased with this ruling and look forward to continuing the fight,” commented Berman Tabacco associate Stephen Ryan, who argued the motion.
The case, U.S. ex rel. Clarke, et al. v. Aegerion Pharmaceuticals, Inc., et al., No. 13-cv-11785-IT (D. Mass), is being prosecuted from Berman Tabacco’s Boston office by Patrick Egan and Stephen Ryan.