The AARP is signing on to a whistleblower lawsuit accusing some of the biggest players in the medical devices arena 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.
Now the American Assn. of Retired Persons is joining the suit. Two attorneys for the senior citizen lobbying group, Stacy Canan and Kelly Bagby, signed on as co-counsel for the plaintiffs in the lawsuit, filed in the U.S. District Court for Northern Texas.
The suit 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.
The AARP said it joined the suit as part of its push to curb healthcare fraud, “a major contributing factor for escalating health care costs.”
“Fraud is draining billions from the health care system, which in turn hurts older persons,” Bagby said in prepared remarks.