FDA Reaches Settlement with Medical Device Firm

The U.S. Food and Drug Administration (FDA) has reached a $1 million civil money penalty settlement with Globus Medical Inc. for the distribution of unapproved medical devices.

The settlement requires Audubon, Pa.-based Globus Medical to pay a $550,000 penalty and CEO David C. Paul to pay a $450,000 penalty, for a total of $1 million.

The fines were levied against the company after the FDA learning that Globus Medical had marketed its NuBone Osteoinductive Bone Graft product without proper premarket approval or clearance as required by law.

“The device-clearance process assures the quality and safety of devices before they reach the market. Firms can’t simply choose to sell devices that FDA has not found to be safe and effective,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We took action against Globus Medical to protect patients and we are pleased with the outcome.”

Globus Medical had sought clearance of its NuBone product in January 2009, but the FDA declined to clear the product after determining it was not substantially equivalent (NSE) to legally-marketed products. The FDA advised Globus Medical that it could not distribute the product, but the firm continued to do so despite the agency’s ruling.

The FDA filed a complaint for civil money penalties against Globus Medical and the company’s CEO for distributing the NuBone product without proper FDA approval or clearance. The agency informed Globus Medical and Paul of the complaint in November 2011, and later participated in settlement discussions leading to the $1 million penalty agreement.

“This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices,” said Dara A. Corrigan, associate commissioner for regulatory affairs. “By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”