Biliary Stents Off-Label Use May be Putting Patients at RiskJan 22, 2008 | Parker Waichman LLP
Biliary Stents, used off-label to prop open clogged arteries in the legs and torso, could be injuring thousands of patients each year. Biliary Stents, approved by the Food & Drug Administration (FDA) to help drain digestive fluids from the bile ducts of cancer patients, are used far more often to clear clogged arteries. Unfortunately, because Biliary Stents were never approved for this use, there is little data on the safety or effectiveness of Biliary Stents used in this way.
According to an article in The New York Times, from 2003 through 2006, more than one million patients suffering from clogged arteries and veins in their torsos and legs received Biliary Stents that had not been approved or tested for this use. But under law, physicians can use FDA approved medical devices or drugs in any way they see fit – something known as off-label use. In the case of the Biliary Stents, such off-label uses are estimated to account for as much as 90 percent of the market. Unfortunately, such alternative uses might be putting patients at risk.
Between 2003 and 2006, nearly 88 percent of the 561 problems reported to the FDA involving Biliary Stents occurred in off-label uses. But those numbers could be much higher, because it is generally accepted that device malfunctions and injuries occur far more often than they are reported. And it is not uncommon for injuries that are caused by off-label use of a device to go undisclosed, as such injuries are the most likely to lead to lawsuits.
Many doctors believe that Biliary Stents provide many patients with the best option for treating clogged arteries in the legs and torso. Unfortunately, there is no data to back up this claim. According to The New York Times, Biliary Stents were approved by the FDA under a portion of the device regulation that requires minimal testing and supervision. According to an article to be published Monday in the “American Journal of Therapeutics”, doctors, professional medical societies, Biliary Stent makers and the FDA all bear responsibility for the growing problems surrounding off-label use of Biliary Stents.
For its part, the FDA met last March with the makers of Biliary Stents to remind them they could not engage in any activity that could be construed as marketing the devices for anything other than their labeled use. And it urged the companies to accelerate investments in trials that could generate the data needed for their approval for use in the circulatory system. Still, the FDA is sending mixed messages, and continues to approve Biliary Stents with little scrutiny.
Some makers of Biliary Stents have also begun studies to determine the safety and effectiveness of off-label uses. According to The New York Times,the device maker EV3 has trials started in both Europe and the United States for use of its EverFlex Biliary Stent in a major leg artery. But it has not yet finished enrolling the 250 patients it seeks for the trial in the United States. Among other things, the trial will track fracture rates — a major vulnerability for stents in the leg — for five years.