FDA seeks injunction against Utah medical device maker
Tuesday, August 10th 2004, 12:45 pm
By: News On 6
WASHINGTON (AP) _ 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 certain questions can be resolved.
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.
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.
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.
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 a phone call seeking comment.
However, on the company's Web site, Kevin Cornwell, the publicly traded company's chief executive officer, this spring lashed out against the FDA. ``I am concerned that the FDA intends to further tarnish UTMD's good reputation through a motivation that has nothing to do with the safety or effectiveness of our devices,'' Cornwell said.
FDA's enforcement actions began after a routine inspection at the plant.