FDA Says St. Jude Illegally Promoted Surgical Ablation DevicesMay 11, 2010 | Parker Waichman LLP
St. Jude Medical Inc. has been accused of illegally marketing its Epicor “surgical ablation” devices for off-label uses. According to The Wall Street Journal, the U.S. Food & Drug Administration (FDA) alleges that St. Jude promoted the Epicor system to treat atrial fibrillation, a use that has not been approved by the agency.
While doctors are permitted to use medical devices in any way they see fit, manufacturers are legally barred from marketing or promoting such uses.
Surgical ablation devices like the Epicor system are approved for “ablation,” or the burning of tissue, to seal a wound to stop bleeding. However, according to an earlier Wall Street Journal report, such devices are used almost exclusively to treat atrial fibrillation. This involves a far more complex procedure, and the devices would have to undergo expensive clinical testing before the FDA would approve them for this purpose.
In a Warning Letter dated April 23, the FDA cited marketing statements such as one on the St. Jude’s website last year that the Epicor system is “designed to safely, effectively and reproducibly create a classic box lesion in a single step.” According to the Journal, the statement referred to a pattern of burns imprinted on the heart during atrial fibrillation surgery. The letter said statements like that violated the Federal Food, Drug and Cosmetic Act.
St. Jude is not the first medical device maker to get into trouble over marketing of surgical ablation devices. In March, we reported that St. Jude, along with Medtronic Inc. and Boston Scientific Inc., confirmed that the Department of Justice was investigating their marketing of the devices. Another firm, AtriCure, agreed to pay $3.8 million to resolve allegations it marketed its surgical ablation devices for the unapproved purpose of treating atrial fibrillation.
It is estimated the about 80 percent of atrial fibrillation patients are effectively treated with drugs. Unfortunately, there are few studies available that compare the safety of ablation to other types of atrial fibrillation treatments. Since 2008, there have been at least five U.S. patient deaths reported to an FDA data base in procedures using AtriCure devices and one involving a Medtronic device.