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 commissioner for regulatory affairs.
The settlement requires Globus Medical to pay a $550,000 penalty fee and the company’s CEO, David Paul, to pay an additional $450,000 fine.
Personal Injury Lawyers: FDA Approval Process Required NuBone Osteoinductive Devices to Be Substantially Equivalent
The FDA currently uses two procedures to approve medical devices. Clinical trials are necessary to get approval for more critical devices. However, Globus Medical’s NuBone Osteoinductive is considered a medical device that poses a lower level of risk to patients. Therefore, Globus Medical was only required to show that the NuBone Osteoinductive was substantially equivalent to similar medical devices that are already on the market.
Personal Injury Lawyers in Philadelphia and New Jersey
The Philadelphia personal injury lawyers at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of personal injury lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have been injured by a defective medical device, a negligent medical provider, or have endured any other type of personal injury, contact the personal injury lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
For immediate assistance, click the CHAT LIVE button to your right.