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SALT LAKE CITY (AP) -- A federal judge has rejected a bid from the U.S. Food and Drug Administration to permanently shutter a Utah medical company.
Utah Medical Products Inc., of Midvale had it's 160-employee plant shut down 15 months ago after federal inspectors said they found regulatory violations, including problems with computer software, data analysis and product safety.
The company makes parts for a variety of medical devices used in labor and delivery, neonatal intensive care, gynecology and blood pressure monitoring.
The FDA said Utah Medical had similar violations during inspections in 2001, 2002 and 2003. In 2001 the FDA had also recommended Utah Medical hire an outside consultant to ensure quality control.
Utah Medical didn't hire a consultant, but insisted the problems had been fixed and tried to solve their dispute with the FDA through mediation.
Instead the FDA filed a lawsuit, which U.S. Senior District Judge Bruce Jenkins rejected Friday, chiding the agency for what he called "nitpicking."
"As this case progressed, the court wondered how it had evolved into litigation with hundreds of exhibits, endless depositions and high cost 'experts,"' Jenkins wrote. "Product safety is not an issue in this case."
Jenkins said the company and the federal regulator's problems were the result of a failure to communicate.
Utah Medical CEO Kevin Cornwell said he became emotional reading Jenkins' 15-page opinion.
"After a long ordeal, we believe the court has vindicated Utah Medical's robust quality system," Cornwell said.. "Now we hope to move on and repair our relationship with the government while we continue to serve our customers' needs."
Utah Medical's stock tumbled when the FDA filed its lawsuit, taking a toll on the company's bottom line. But news of Jenkins' ruling buoyed the company Friday and the stock price rose 83 cents.
The FDA could appeal the judgment.
Utah Medical has also filed an abuse of process administrative claim with FDA.
(Copyright 2005 by The Associated Press. All Rights Reserved.)
