To The Full Ex-Stent of the Law
More than two years ago, Kevin Colquitt filed a lawsuit in Dallas federal court in which he alleges "the makers of stents approved to treat digestive tract cancers had illegally marketed them for years to treat blocked blood vessels in other parts of the body," as The New York Times recaps this morning. The initial complaint, which you'll find after the jump, was only unsealed on Monday, and it's a mammoth, fascinating document in which Colquitt, who now works at Baron & Budd, recounts his years spent selling medical devices on behalf of Guidant, among the defendants named in the suit for which Colquitt's seeking whistle-blower protection.
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.
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.
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