Healthy Skepticism Library item: 17054

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Meier B
Lawsuit Challenges Marketing of Stents
The New York Times 2010 Jan 11
http://www.nytimes.com/2010/01/11/business/15stent.html

Full text:

A former medical device executive claimed in a potential whistle-blower lawsuit that was unsealed this week that the makers of stents approved to treat digestive tract cancers had illegally marketed them for years to treat blocked blood vessels in other parts of the body.

In the lawsuit, Kevin N. Colquitt, a former regional sales director for Guidant, stated that he had been trained to market the devices, which are known as biliary stents, to doctors for off-label uses not approved by the Food and Drug Administration.

Mr. Colquitt’s lawsuit, which was filed in Federal District Court in Dallas, was unsealed late Monday.

Along with Guidant and Abbott, which acquired Guidant’s stent operations, the other defendants in the lawsuit are Boston Scientific and Cordis, a division of Johnson & Johnson. A spokesman for Abbott disputed the lawsuit’s accusations. Spokesmen for Cordis and Boston Scientific declined to comment on the suit’s specifics.

Mr. Colquitt is seeking whistle-blower status and has asked the Justice Department and eight states to join his action. The Justice Department and two of those states, Florida and Tennessee, said in court filings that they were declining for the moment to do so, but added that they were continuing to investigate.

Biliary stents are used to open blockages in bile ducts and other parts of the digestive system that form as a result of cancerous tumors. But their widespread off-label use to treat blocked blood vessels in legs, the hip and elsewhere has come under increasing scrutiny because the Food and Drug Administration approval process for vascular stents is far more rigorous than the one for biliary devices.

A 2008 study in a medical journal, the American Journal of Therapeutics, estimated that one million biliary stents were used off-label from 2003 to 2006 to open clogged blood vessels in other parts of the body. That report also found that deaths and injuries had occurred as a result of device malfunctions when the stents were used off-label.

Biliary stents have a lower regulatory threshold because they were approved for use in cancer patients who are not expected to live long. By contrast, vascular stents must demonstrate an ability to last years or decades.

In 2008, the United States attorney’s office in Boston sent subpoenas to major manufacturers of biliary stents related to their marketing of the devices. Some critics have asserted that producers knowingly used the easier biliary approval route to clear devices that have been marketed for other uses, a claim the companies deny.

While doctors are free to use an approved drug or medical devices in any way they choose, manufacturers can promote them only for their approved use.

Mr. Colquitt left Guidant in mid-2006, about the time its stent division was acquired by Abbott. He now works at a Dallas law firm, Baron & Budd, that specializes in plaintiffs’ litigation. His lawyer, Andrew M. Beato, declined to make him available for comment.

Among other things, Mr. Colquitt said he had attended meetings shortly after joining Guidant in 2004 at which he was trained to market the company’s biliary stents to treat blockages in peripheral arteries. At the time, Guidant did not have any vascular stents that had been approved by the F.D.A.

He also said in court papers that he had taken part in other sessions in which sales officials practiced placing biliary stents in the arteries of anatomical dummies. He also stated that many of the biliary stents manufactured by Guidant were not of the proper size or shape for use in bile ducts but were of the right specifications for use in blood vessels.

Mr. Colquitt, who filed his lawsuit in 2006, said in court papers that his discussions with sales officials of other companies, as well as his observations of them, made it clear that competing manufacturers were also training employees to market biliary stents off-label.

In 2007, the F.D.A. warned biliary device manufacturers about promoting them for vascular use.