Several <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical device makers are being investigated by the U.S. Justice Department over the marketing of surgical-ablation devices. According to The Wall Street Journal, these devices are widely used to perform atrial fibrillation, but have not been cleared by the Food & Drug Administration (FDA) for this procedure.
Boston Scientific Corp., Medtronic Inc. and St. Jude Medical Inc. have all confirmed that they are the subject of such probes, the Journal said. Elaine George, a former medical-device saleswoman, has whistleblower lawsuits pending against the three firms alleging they marketed surgical-ablation devices for the unapproved use of fixing these faulty heartbeats. Though the government hasn’t joined her suits, her lawyer asserts the Justice Department began investigating these issues because of her litigation.
In a separate lawsuit initiated by George which the government did join, another firm, AtriCure, agreed to pay $3.8 million to resolve allegations it marketed its surgical-ablation devices for the unapproved purpose of treating these irregular heartbeats. George will receive $688,000 of the settlement.
According to The Wall Street Journal, surgical-ablation devices, which have sales of about $100 million a year, are used almost exclusively to treat atrial fibrillation. They are approved for “ablation,” or the destruction of tissue, which typically involves sealing a wound to stop bleeding. They aren’t specifically approved to treat atrial fibrillation, a far more complex procedure. Expensive clinical testing would be required before the FDA would give such approval, the Journal said.
While doctors may use drugs or devices for off-label treatments, device makers may not legally promote those uses. But according to The Wall Street Journal, an examination of some documents from leading device makers indicate that “some companies seem to have encouraged hospitals and doctors to consider the possibility of using their devices specifically for A-fib.”
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. According to The Journal, 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.