To The Full Ex-Stent of the Law
As The Times points out, Colquitt says he was trained to market the devices, known as biliary stents, to doctors "for off-label uses not approved by the Food and Drug Administration." And research shows that's isn't good:
A 2008 study in a medical journal, the American Journal of Therapeutics, estimated that one million biliary stents were used off-label from 2003 to 2006 to open clogged blood vessels in other parts of the body. That report also found that deaths and injuries had occurred as a result of device malfunctions when the stents were used off-label.Colquitt Whistle-Blower Lawsuit
Biliary stents have a lower regulatory threshold because they were approved for use in cancer patients who are not expected to live long. By contrast, vascular stents must demonstrate an ability to last years or decades.