Utah Medical strikes back
This article was originally published in The Gray Sheet
Executive Summary
HHS has six months from Utah Medical's July 12 bid for reconsideration to honor or deny the firm's request for remedies - including over $7 mil. in damages - at which point the company may pursue legal action, according to CEO Kevin Cornwell. Utah Medical has alleged misconduct on the part of FDA employees during the inspections, review and subsequent enforcement actions that culminated in FDA seeking a permanent sales injunction against the company in Utah federal court. Though Utah Medical emerged victorious in October 2005, it claims the ordeal has done "irreparable harm" to the company's reputation (1"The Gray Sheet" Feb. 20, 2006, p. 13)...