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Medical Devices Marketed for Uses Unapproved by the FDA

Whistle-blower files suit against four makers

For more than a decade, sales representatives for Guidant Corp., a medical device company, told doctors that stents made to treat digestive tract cancers were also safe and effective for treating blocked blood vessels. The Food and Drug Administration didn't agree.

Since 2006, Kevin Colquitt, 39, a former sales manager for the firm, has taken Guidant to task. Colquitt filed a whistle-blower lawsuit that accused four medical device makers of fraudulently marketing the stents. Although the FDA approved using them to open bile ducts closed by cancerous tumors, the firms were marketing them as safe for vascular disease. A 2008 American Journal of Therapeutics study estimated that 1 million biliary stents, as they are known, were used off-label from 2003 to 2006 to open clogged blood vessels elsewhere in the body, sometimes resulting in death or injury.

"Patients have been put at risk, and many millions of federal dollars have been wasted," said Kelly Bagby, senior attorney for AARP Foundation Litigation, which has joined the case as cocounsel. In his lawsuit, Colquitt claimed that he had been trained to market the devices as suitable for vascular diseases, a treatment not authorized by the FDA. Besides Guidant (now part of Abbott Laboratories), the lawsuit cites similar practices at Johnson & Johnson and Boston Scientific. While doctors can use an approved drug or medical device any way they choose, manufacturers can promote them only for their approved use. In 2007, the FDA warned biliary device manufacturers about promoting them for vascular use.

"These companies placed profits ahead of patients and falsified documents to avoid FDA scrutiny," said Colquitt, who worked at Guidant for two years. "The result is that hundreds of thousands of patients received unproven technology, many of whom were injured in the process."

Colquitt intends to have any damages from the lawsuit paid to Medicare and Medicaid. The firms would not discuss the case.

What it means to you: Make sure medical devices prescribed for you are approved for that use. See the list of FDA approvals.


Emily Sachar is a journalist and author based in Brooklyn, N.Y.

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