Medtronic Faces Charges For Promotion Of Off-label Usage Of Biliary Stents

The lawsuit claimed that the company advocated biliary stents in the treatment of obstructions in peripheral blood vessels. The companies that make them are barred from promoting or encouraging such practices as they are designed for use in cancer patients who are not expected to survive for long.

The suit also accused Medtronic of retaliating against and ultimately firing two former employees after they objected to the alleged off-label promotion.

According to the complaint, almost 90% of Medtronics’ biliary stent sales are made for off-label use and accuses the company of Medicare fraud and filing fraudulent clearance applications with the FDA.

The complaint said: “As Enda Dodd examined the design process employed and the product evaluations on file, a hybrid development strategy appeared. The design process implemented was governed by the ‘FDA Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents’ while the sole and only commercial intent, as articulated by Trung Pham, (Senior Product Manager) and others, was the treatment of stenosed (blocked) renal (kidney) arteries.

Medtronic said it “is aware of the complaint and intends to vigorously dispute its allegations, including filing a motion to dismiss at the outset of the case. We don’t comment on any specific allegations,” reported the Wall Street Journal.