Alert
Close

Join the Drive to End Hunger! Watch the NASCAR race on Sunday at Kansas Speedway.

HIGHLIGHTS

Open
10,000 Games Galore Sweepstakes from AARP
Celebrate Hispanic Heritage Month

AUTO BUYING PROGRAM

AARP Auto Buying Program

Download the ipad App

AARP-iPad-ePub-app

DRIVER SAFETY

Piggy bank on the road - AARP Driver Safety

Take the new AARP Smart Driver Course!

Contests and
Sweeps

Safe Driving in 2014 Sweepstakes

Learn how AARP Driver Safety can help you stay safe—and enter for a chance to win $1,000. See official rules. 

KEEP BRAIN ACTIVE!

AARP Games - Play Now!

AARP BOOKS

Planning for Long-Term Care for Dummies

Get expert advice on planning for your own or a relative’s future care needs.

Webinars

Learn From the Experts

Sign up now for an upcoming webinar or find materials from a past session.

Learning centers

Get smart strategies for managing health conditions.

 

Arthritis

Heart Disease

Diabetes

Most Popular

Viewed

Nothing has been viewed

share your thoughts

What does the health care law mean to you? Your story is important. We read and learn from every story and it helps us in our educational efforts. We may even use your comments (with permission) to brief legislators, inspire readers and more. Please share your story with us. Do

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.

Topic Alerts

You can get weekly email alerts on the topics below. Just click “Follow.”

Manage Alerts

Processing

Please wait...

progress bar, please wait

Tell Us WhatYou Think

Please leave your comment below.

Discounts & Benefits

From companies that meet the high standards of service and quality set by AARP.

Reading eyeglasses eyemed 6 membership benefit health

Members save 25% on orders of $200 or more and get 25% off lens upgrades at glasses.com.

AARP/Walgreens Wellness Bus Stops in Clarksdale, MS

Members can get exclusive points offers from Walgreens and Duane Reade.

Member Benefits

Join or renew today! AARP members receive exclusive member benefits & affect social change.

Rewards for Good

Your Points Balance:

Learn More

Earn points for completing free online activities designed to enrich your life.

Find more ways to earn points

Redeem your points to save on merchandise, travel, and more.

Find more ways to redeem points