Boston Scientific (Natick, Massachusetts) said it received a subpoena last week from the Department of Health and Human Services seeking information about the performance of some of its implanted defibrillators.
The subpoena, received on May 5, requested information related to the 2008 launch of two brands of implanted cardioverter defibrillators made by Boston Scientific, the company said in a regulatory filing on last Thursday. The subpoena seeks information about the launch of its Cognis and Teligen lines of devices, which treat arrhythmias. Its Cognis device is a defibrillator for the treatment of ventricular tachycardia, ventricular fibrillation and heart failure. Its Teligen defibrillator, said to be among the smallest and thinnest high-energy defibrillators in the world, are designed to detect and terminate ventricular tachycardia and ventricular fibrillation and provide atrial and ventricular pacing.
The subpoena was issued by the Office of the Inspector General of the HHS, which is responsible for identifying fraud and waste in government health programs such as Medicare and Medicaid.
In other legal news: Cardiovascular Systems (St. Paul, Minnesota) reported that it received a letter from the U.S. Attorney's Office for the Western District of North Carolina stating that it is investigating the company to determine whether it has violated the False Claims Act, resulting in the submission of false claims to federal and state healthcare programs, including Medicare and Medicaid. The letter enclosed a Civil Investigative Demand for written interrogatories and document requests. Cardiovascular said in a statement, "The company maintains rigorous policies and procedures to promote compliance with the False Claims Act and other regulatory requirements, and is working with the U.S. Attorney's Office to promptly respond to the CID. However, the company cannot predict when the investigation will be resolved, the outcome of this investigation or its potential impact on the company."