HHS Denies Utah Medical’s Claim Against FDA Workers

MIDVALE — Utah Medical Products Inc. said Wednesday that the U.S. Department of Health and Human Services has denied a company claim that alleged abuse of process by the U.S. Food & Drug Administration in connection with the acts of FDA workers during inspections, review and enforcement actions taken or attempted from 2001 through 2005.

A federal judge last year threw out an FDA suit against the company, calling the lawsuit a “nitpicking” case resulting from a communication failure between the two parties.

In August 2004, the FDA filed for a permanent injunction against Utah Medical, seeking to shut down operations because of what the agency said were problems with plastic parts manufactured by the company through an injection molding machine. The district judge ruled that the company adequately validated its manufacturing process, including the company’s injection-molding systems; properly installed its machinery; validated its software; and handled customer complaints properly.

“The company believes that it has proof of fraudulent reports by inspectors, reviewers and other FDA employees which led to an ordeal in which the company prevailed but was significantly damaged,” Utah Medical said Wednesday.

The company said it is considering its options, which include filing a suit against the FDA in federal district court or filing a request for reconsideration before Aug. 10.

Utah Medical develops, manufactures, assembles and markets specialty medical devices.