A federal judge has thrown out a lawsuit filed by the U.S. Food and Drug Administration against a Midvale-based medical manufacturer, calling the lawsuit a "nitpicking" case — the result of a communication failure between the two parties.
In August 2004, the FDA filed for a permanent injunction against Utah Medical Products Inc., 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.
Those parts can be found in a variety of the company's products, which include medical devices used in labor and delivery, neonatal intensive care, gynecology and blood pressure monitoring.
In his decision, U.S. District Judge Bruce S. Jenkins found that Utah Medical adequately validated its manufacturing process, including the company's injection-molding systems.
Jenkins also found that Utah Medical had properly installed its machinery, validated its software and handled customer complaints properly.
"The question here is whether the processes and procedures used by Utah Medical to currently produce product comply with the applicable regulations," Jenkins said in his order. "The answer is yes, they do."
While the FDA could appeal the judgment, calls to the agency seeking comment were not immediately returned.
Kevin Cornwell, Utah Medical's chief executive officer, said he was pleased by the judge's decision.
"I have to say I'm not pleased with the ordeal that the FDA put us through and the waste of resources on both sides," Cornwell said. "We bent over backwards in a very respectful and diligent way to communicate, but they shunned all of our attempts to constructively resolve our disagreement."
Cornwell said the case has never been about unsafe or recalled defective products. Instead, he said, the issue centers on a 2001 disagreement in which the FDA demanded that the company hire an outside consultant to validate its quality-control systems.
"They don't really have the right to do that," Cornwell said. "In a nutshell, no one had ever refused their demand to hire a consultant. And so I suppose we insulted them, and their response was, 'OK, if you're not going to do what we tell you to do, we're going to shut you down.' "
The judge said the two sides "often talked past each other."
The general nature of the FDA regulations, he continued, had "the virtue of generality and the vice of imprecision.
"This endemic problem is perhaps augmented by decision-makers who themselves rely too much on inspectors' reports," Jenkins said, "without taking a fresh look themselves at ongoing changes made by Utah Medical in response to questions raised."
Jenkins chided the FDA for what he saw as a case evolving into a "litigation of hundreds of exhibits, endless depositions and high-cost 'experts.' "
Cornwell said his company has spent more than $3 million in legal fees fighting the FDA's allegations.
"My guess is the government has spent at least that much themselves," Cornwell said, "and there have been literally hundreds of FDA people involved in this over a four-year period of time."
Utah Medical Products has filed an abuse of process administrative claim with the FDA. The FDA is expected to respond to that by January. Depending on that decision, the company could file a lawsuit of its own, Cornwell said, suing the FDA for abuse of process.
"The real damage to the company is that we had historically been an innovative company, bringing out products that have unique features," Cornwell said. "Our new product development has essentially been shut down for three years because of this. As far as our senior management goes, we've easily spent a third of our time over the last four years on this."
Utah Medical Products stock, which fell 32.8 percent to $17.99 per share the day the FDA's suit was filed in August 2004, has since rebounded. The company's stock rose 41 cents, or 1.6 percent, to close at $25.86 per share Friday on Nasdaq. In the past year, the price has ranged from $17.50 to $26.05.
E-mail: danderton@desnews.com