According to recently unsealed federal lawsuits filed in Texas, several medical-device makers paid kickbacks to have their products used. The claims were made by former employees of the companies, who allege that heart surgeons were paid to use certain devices to treat atrial fibrillation,which a heart-rhythm defect in which blood pools inside the heart. It can lead to stroke. In surgical ablation, surgeons use devices that emit radiofrequencies to correct the heartbeat. At least four companies are named in the lawsuits, including Medtronic Inc., Boston Scientific Corp., St. Jude Medical Inc., and AtriCure Inc. Though the lawsuits were filed in 2007, a federal judge in Texas only recently unsealed them. The allegations in the lawsuits are related to a US Justice Dept. inquiry in Texas. The lawsuits allege that the medical-device companies engaged in a "fraudulent marketing and inducement campaign" in which Medicare was excessively billed due to kickbacks to doctors and hospitals. The plaintiff in the case against Boston Scentific is a former saleswoman who claims that after she complained about illegal practices, she was fired. This woman is also a plaintiff in cases against Medtronic and AtriCure, alleging that surgical ablation equipment was improperly marketed for use in treating atrial fibrillation, despite the lack of FDA approval for that use. Federal law prohibits companies from marketing their products or medical devices for unapproved uses, even though doctors can use some products for off-label use.
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