Former Spectranetics executives indicted
This article was originally published in The Gray Sheet
Executive Summary
Three former executives and one contractor with Spectranetics face possible jail time and fines based on a twelve-count indictment on allegations that the company illegally imported unapproved devices into the U.S., the Colorado U.S. Attorney's Office and FDA's Office of Criminal Investigations announced Aug. 30. George John Schulte, former CEO of the excimer laser system maker, Obinna Adhigije, former VP of business development, Trung Pham, former business development manager, and Hernan Ricaurte, the contractor, are charged with conspiring to import devices based on false declarations, to introduce devices in the U.S. market without FDA approval or clearance, and to promote the devices for unauthorized uses, among other detailed counts. Spectranetics itself settled with the Department of Justice for $5 million on similar charges last December (1"The Gray Sheet" Jan. 4, 2010)