Whistleblower suit alleges off-label promotion of stents

A budding whistleblower suit made public Monday exposed allegations that Boston Scientific, Abbott Laboratories and Cordis fraudulently marketed and promoted biliary stents for vascular use—an action not approved by the FDA.

The False Claims Act suit, filed in 2006 by Kevin Colquitt, former regional sales director for Guidant (now Boston Scientific), seeks monetary damages and civil penalties against the stent manufacturers.

The plaintiff claims: “Defendants have engaged in an off-label promotional and marketing scheme that caused and induced physicians to seek coverage and reimbursements for investigational medical devices in the form of biliary stents permanently implanted into patients for the unapproved use of treating peripheral vascular disease.”

According to the documents, biliary stents are not approved by the FDA for use in peripheral vasculature" and that the FDA had "concluded these stents are “not safe and effective for vascular use.” The FDA required the defendants to warn physicians about the safety and efficacy risks to patients regarding these stents.

While the defendants proclaimed these stents would be used only in the palliation of malignant strictures of the biliary tree, Colquitt alledged that “defendants intended to market the devices for use in peripheral vasculature.”

Colquitt claimed that the defendants instructed representatives to “target physicians specializing in peripheral vascular disease to induce the use of the Class II biliary stents” for the treatment of vascular disease.

In addition, Colquitt said that the defendants compensated sales representatives with bonuses if the specific and mandatory quotas for marketing the off-label use of stents were met. Additionally, Colquitt said that the companies vigorously promoted and marketed the off-label use of biliary stents in vascular disease throughout promotional materials.

In the documents, Colquitt contends that more than 700 biliary stent product codes were promoted and marketed off-label for treatment of peripheral vascular disease. “Indeed, virtually all of the approximate 150,000 stents implanted in patients each year to treat vascular disease are adulterated and misbranded biliary stents whose investigational use is not authorized by Federal standards.”