DOJ Investigates Off-Label Use of Medtronic's Infuse Device

"The Department of Justice (DOJ) is investigating the off-label use of a Medtronic Inc. implant for promoting bone growth, bringing government scrutiny of such unapproved uses to the heart of the $189 billion medical-device industry." The company denies marketing Infuse for off-label uses, and claims it has fully complied with federal laws. It calls Infuse a 'revolutionary' product that saves patients the trauma of bone grafts taken from the hip to use in spinal fusions."

Some patients claim they have been harmed in off-label uses of Infuse, which is approved by the FDA only for a small section of the spine in the lower, lumbar region. The FDA has received at least 280 reports of side effects involving Infuse, about three-quarters of which involve off-label use. "In July, the agency issued a safety alert about complications from the off-label use of Infuse in the neck, or cervical, area of the spine." Read more.