A Medical Device Daily
DJO (San Diego) and Orthofix International (Boston) have both reported that a federal whistleblower complaint also known as False Claims Act, or qui tam, that was filed on March 23, 2005, against the companies and other primary manufacturers of bone growth stimulators in the U.S. has been unsealed by the U.S. District Court for the District of Massachusetts.
The civil complaint against these manufacturers appears to focus on alleged reimbursement-related false claims associated with the sale vs. the rental of devices.
The unsealing of the civil action is routine procedure, according to DJO and Orthofix, and allows the individual plaintiff involved to pursue civil claims in federal court.
The companies also reported that within the last few days they have received related subpoenas from the U.S. Department of Justice requesting documentation for a period from 1995 to 2009. Both companies said they are evaluating the complaint and preparing to respond.
DJO's product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular systems, electrical stimulators used for pain management and physical therapy products.
Orthofix produces a broad line of minimally invasive surgical and non-surgical products for the spine, orthopedic and sports medicine market sectors.
Last year, a grand jury in Little Rock, Arkansas, charged a licensed practical nurse with violations of the kickback statute, mail fraud and falsifying documents as part of an alleged scheme to order and purchase allograft bone from Osteotech (Eatontown, New Jersey), according to a May 8, 2008, statement from the U.S. Attorney, Eastern District of Arkansas.