Personal Injury Lawyers: Medical Device Maker Agrees to Pay Penalty for Selling Unapproved Devices

Personal injury lawyers at Messa & Associates, P.C. have recently come across news stating that Globus Medical Inc., a spinal implant manufacturer, will pay the U.S. Food and Drug Administration $1 million in penalties for selling its NuBone Osteoinductive Bone Graft product after the FDA rejected the device in 2009. The FDA learned that Globus was distributing the NuBone Osteoinductive, despite being told that the medical device was not substantially equivalent (NSE) to legally-marketed products, during a September 2010 inspection. The company also ignored multiple warnings given by the FDA to stop selling the device, according to a … [Read more...]