A few of the biggest players in the medical devices arena are accused in a whistleblowers lawsuit of promoting the off-label use of biliary stents to treat cardiovascular disease in hundreds of thousands of patients.
Former Guidant Corp. regional sales director Kevin Colquitt filed a "qui tam" lawsuit accusing Boston Scientific Corp. (NYSE:BSX), Johnson & Johnson (NYSE:JNJ) and its Cordis Corp. subsidiary and Abbott (NYSE:ABT) of encouraging physicians to use the biliary stents to treat blocked blood vessels. The stents are designed to treat bile duct cancers and are not approved or cleared for other uses by the Food & Drug Administration. The whistleblower lawsuit allows Colquitt to file suit on behalf of the government and to collect a third of any monetary judgment resulting from the case.
The lawsuit, filed in the U.S. District Court for Northern Texas and unsealed Jan. 18, alleges that Abbott (which acquired Guidant’s stents business in 2006 as part of Guidant’s acquisition by Boston Scientific) and the other companies promoted the use of the biliary stents to treat obstructions in peripheral blood vessels. The biliary stents faced a lower regulatory hurdle because they’re designed for use in cancer patients who are not expected to survive for long. Although physicians are allowed to use devices for off-label treatments, the companies that make them are barred from promoting or encouraging such practices.
Colquitt, who joined Guidant in 2004, filed the lawsuit on behalf of the U.S. government and eight states (California, Florida, Illinois, Louisiana, Massachusetts, Tennessee, Texas and Virginia). The suit accuses the companies of Medicare fraud and filing fraudulent clearance applications with the FDA. The firms allegedly counseled sales reps to target doctors specializing in peripheral vascular disease, sponsored studies of the off-label use of the stents, actively marketed the devices to peripheral vascular specialists (largely ignoring the gastroenterologists and hepatologists who would use the devices for their approved applications), gave sales reps mandatory quotas and bonuses for off-label sales and instructed healthcare providers to falsely code reimbursement claims using codes for vascular stents, according to court documents.
"Indeed, virtually all of the approximate [sic] 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 based on Defendants’ failure to establish that the devices are safe and effective under Federal law," according to the lawsuit. "The impact on beneficiaries’ health and safety cannot be overstated as reflected in adverse events reported by healthcare providers. … The adverse events reported include death, fractures of the devices after implantation, migration and dislodgement of the devices after implantation, arterial dissection and occlusion, arterial and stent embolizations, aneurysms, acute renal insufficiency, amputations, air embolisms, fistulization, strokes, late restenosis, allergic reactions, infections, clots, internal bleeding, and persistent vessel spasms."