updated 8/10/2004 5:39:22 PM ET 2004-08-10T21:39:22

The Food and Drug Administration is seeking a court order to force Utah Medical Products to stop making and selling medical devices used by obstetricians, gynecologists, urologists and neonatal intensive care wards until it improves certain manufacturing practices.

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U.S. District Court Judge Bruce S. Jenkins has not yet set a hearing date for FDA’s request for a permanent injunction, filed late Monday on its behalf by the Justice Department.

The agency’s Center for Devices and Radiological Health rarely seeks such legal remedies, filing only five such injunction requests in any given year.

“It’s a fairly significant action,” Larry Spears, deputy director of the center’s enforcement arm, said Tuesday. “We don’t take those actions until after we have provided appropriate warning what the problems are.”

The legal action follows two warning letters and four comprehensive inspections over three years at Utah Medical’s Midvale manufacturing facility. The inspections uncovered a pattern of “significant deviations,” officials said.

Inspections reveal problems
During the latest inspections this spring, FDA officials said the company did not adequately control manufacturing processes — which it said could permit a device that doesn’t meet specifications to enter the market. It also said the company failed to create an effective system to follow up complaints and correct problems.

Violations documented during FDA visits in 2001, 2002 and 2003 were found to still persist in 2004, when agency officials spent from Feb. 2 to March 3 inspecting the plant. “Despite defendant’s awareness, notice and ample time to correct the violations, defendants have failed to bring their operations into compliance with the law,” Justice department trial attorneys wrote in the 11-page complaint.

The FDA says these irregularities call into question whether Utah Medical’s products, which include tools that monitor fetal health during delivery, neonatal oxygen hoods and electrosurgical scalpels, are safe and effective.

The agency also has refused to issue the company certificates needed to sell its devices to foreign governments. “They have to be in compliance,” Spears said.

Utah Medical Products challenged that denial in lawsuits filed against the drug regulatory agency on June 5, 2003 and Jan. 30, 2004, according to the permanent injunction complaint.
“FDA will not tolerate manufacturing practices that can potentially put patients at risk,” FDA Acting Commissioner Dr. Lester M. Crawford said in a prepared statement. “Patients have a right to expect that the medical devices used to treat them are safe and effective.”

No injury or death has been associated with the problems cited by FDA.

Spears, in fact, stopped short of calling the company’s devices unsafe. Nor did the agency seek to immediately halt their manufacture. Pending the court hearing, Utah Medical can continue to make and market its medical devices.

“There’s not a serious enough problem to say there is an imminent public-health risk,” Spears said.

Utah Medical spokesman Paul Richins did not immediately return phone calls seeking comment.

However, on the company’s Web site, Kevin Cornwell, the publicly traded company’s chief executive officer, lashed out against the FDA. “We are innocent until the government proves otherwise. There’s never been an FDA allegation that UTMD is not producing safe and effective products.”

FDA’s enforcement actions began after a routine inspection at the plant.

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