Orthopedic device maker Globus Medical chalked the $1 million settlement with the FDA up to an "unfortunate miscommunication" rather than to any patient safety problems with its NuBone bone graft products.
The company agreed to pay the penalty, including a fine for CEO David Paul, to settle FDA charges that it marketed the NuBone products without the agency’s approval.
Globus considered NuBone to be exempt from pre-market notification standards and remained in contact with the FDA throughout the product’s life cycle, the company said in a statement sent to MassDevice today.
"Significantly, the amended complaint does not allege any intentional wrongdoing by Globus Medical or Mr. Paul," the company said. "Despite its history of safe use, Globus decided to discontinue NuBone in 2010."
"Globus strives to conduct our business in a manner that is consistent with the highest legal standards in our industry. In this particular situation, there was an unfortunate miscommunication between Globus and FDA such that we believed we were acting in a manner that was acceptable to FDA," Paul said in prepared remarks. "We accept full responsibility and are pleased to have resolved this matter without further legal action, and look forward to a continuation of our long standing relationship with FDA, based on cooperation and mutual respect."
The federal watchdog agency announced the settlement earlier today, which included $550,000 in penalties and a $450,000 charge to Paul.
"Firms can’t simply choose to sell devices that FDA has found are not safe and effective," Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "We took action against Globus Medical to protect patients and we are pleased with the outcome."
Globus filed for 510(k) clearance for its NuBone bone graft device in January 2009, but the FDA denied the bid on the grounds that the product wasn’t substantially equivalent to anything else on the market.
Audubon, Pa.-based Globus continued to sell NuBone products despite receiving a "not substantially equivalent" letter in December 2009, according to an FDA release. The breach was discovered during a September 2010 inspection.
"This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices," Dara Corrigan, associate commissioner for regulatory affairs, said in prepared remarks. "By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices."