A whistleblower lawsuit has been filed against Medtronic Inc., claiming that the device maker illegally marketed biliary, or bile-duct, stents. A whistleblower lawsuit has been filed against Medtronic Inc., claiming that the device maker illegally marketed biliary, or bile-duct, stents.
According to The Wall Street Journal, plaintiffs in the lawsuit are Enda Dodd, an engineer formerly in Medtronic’s vascular business in Santa Rosa, Calif., and Tricia Nowak, a former sales representative in the same division.
According to The Wall Street Journal, they both claim to have been fired because they protested illegal marketing by Medtronic. Their lawsuit was filed in U.S. District Court in Boston and unsealed Friday.
The lawsuit accuses Medtronic of “unlawfully and unabashedly” marketing biliary stents for off-label uses. The lawsuit also alleges that the use of bile-duct stents in arteries has resulted in the need for additional surgery, perforated vessels, stroke, heart attack and death.
Biliary stents are approved by the Food and Drug Administration (FDA) to keep open bile ducts that have narrowed. According to a report published in The New York Times in January 2008, more than one million patients suffering from clogged arteries and veins in their torsos and legs received biliary stents that had not been approved or tested for this use.
Even though they are not approved for this use, physicians can use FDA approved medical devices or drugs in any way they see fit – something known as off-label use.
Such off-label uses are estimated to account for as much as 90 percent of the market
In the case of the biliary stents, such off-label uses are estimated to account for as much as 90 percent of the market, the Times said. What’s more, between 2003 and 2006, nearly 88 percent of the 561 problems reported to the FDA involving biliary stents occurred in off-label uses. According to The Wall Street Journal, selling biliary stents for use in peripheral arteries has become a $900 million annual business.
According to The Wall Street Journal, the lawsuit appears to parallel a federal investigation by the Department of Justice in Boston into marketing of the biliary stents.