DALLAS (October 28, 2010) – AARP Foundation Litigation (“AFL”) attorneys are  joining forces as co-counsel with national law firm Baron & Budd, P.C. and Stein, Mitchell & Muse in a medical device whistleblower lawsuit involving the aggressive marketing of off-label use of vascular stents.  AARP seeks to curb health care fraud, a major contributing factor for rising health care costs.  The AFL attorneys work for AARP Foundation, AARP’s charitable subsidiary.

The suit was first filed by Kevin N. Colquitt, a whistleblower and former sales representative for Guidant, now a part of Abbott Laboratories.  While working as a sales representative and attending law school, Colquitt became concerned about Guidant’s marketing of stents for unauthorized use. He filed suit in September 2006.  Subsequently, Colquitt became an attorney at Baron & Budd.  He is represented in this suit by Laura Baughman of Baron & Budd in Dallas; Andrew M. Beato and David U. Fierst of Stein, Mitchell & Muse in Washington, D.C.; and Kelly Bagby and Stacy Canan of AFL.

The suit alleges that defendant stent makers, including Guidant, Cordis, Johnson & Johnson and Boston Scientific, violated Federal laws by making false claims to the Food and Drug Administration (FDA) to market Biliary stents and then promoted the misbranded stents exclusively off-label as vascular stents without FDA approval. Patients who had the unapproved devices implanted have needlessly suffered injuries including aneurysms, air embolisms, strokes, internal bleeding, arterial dissections and even death.

“The pain of the improperly used devices is not just limited to the injured patients and their families – it is a pain shared by every taxpayer who has trusted our system to weed out fraud and stop spending that is not only unnecessary but also harmful,” said Laura Baughman of Baron & Budd, PC.

Fewer than 20,000 people in the U.S. need biliary stents each year, whereas 250,000 or more receive vascular stents. Colquitt estimates that the defendants have sold over a million of their biliary stents for vascular use in the United States. Federal law allows device manufacturers to market biliary stents without conducting clinical trials if the devices are substantially similar to devices already on the market and are marketed solely for the treatment of biliary tree cancers. To help prevent patients from being exposed to high-risk devices in experimental or investigational procedures, federal law prohibits device makers from marketing biliary stents to treat vascular disease. The lawsuit alleges that defendants have violated federal law by lying to the FDA about the intended use of their stents and by promoting their biliary stents almost exclusively to treat vascular disease. 

“Health care fraud is draining billions from the health care system, which in turn hurts older persons and endangers the future of Medicare,” said Kelly Bagby, AFL Senior Attorney. 

The suit highlights the need for patients to become their own advocates and ask their health care providers about the risks of medical devices before having surgery.

About Baron & Budd
Dallas-based Baron & Budd, P.C., with offices in Baton Rouge, Austin, Los Angeles and Miami, is a nationally recognized law firm with a 30-year history of "Protecting What’s Right" for people and communities harmed by corporate negligence. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals, government and business entities in areas as diverse as asbestos-related illnesses such as Mesothelioma, water contamination, Qui Tam, California Proposition 65 violations, pharmaceutical injuries, Chinese drywall, insurance claims and securities fraud. Most recently, the firm has begun to represent individuals and businesses affected by the Gulf Oil Spill. Active in the community, Baron & Budd pledged $3 million over five years to the International Pleural Mesothelioma Program at Brigham Women’s Hospital and has supported the Asbestos Disease Awareness Organization, Lung Cancer Alliance and other asbestos awareness and advocacy organizations. //baronandbudd.com/.

About AARP
AARP is a nonprofit, nonpartisan social welfare organization with a membership that helps people 50+ have independence, choice and control in ways that are beneficial and affordable to them and society as a whole. AARP does not endorse candidates for public office or make contributions to either political campaigns or candidates. We produce AARP The Magazine, the definitive voice for 50+ Americans and the world’s largest-circulation magazine with over 35.1 million readers; AARP Bulletin, the go-to news source for AARP’s millions of members and Americans 50+; AARP VIVA, the only bilingual U.S. publication dedicated exclusively to the 50+ Hispanic community; and our website, AARP.org. AARP Foundation is an affiliated charity that provides security, protection, and empowerment to older persons in need with support from thousands of volunteers, donors, and sponsors. We have staffed offices in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands.

About Stein, Mitchell, & Muse
. . . .

 

Contact;  Greg Schmalz, Kalligeros Communications, gschmalz@kalligeros.com,  (732) 785-9317