Health-care molder Utah Medical Products Inc. has won its long-running and unusual battle with the Food and Drug Administration, after a federal judge tossed out an FDA lawsuit that sought to shut the company down over violations of government manufacturing rules.
U.S. District Judge Bruce Jenkins in Salt Lake City ruled Oct. 21 that the FDA did not show why the court needed to order the company to stop manufacturing, and at one point he said the case at times amounted to ``nitpicking'' and a failure of the two parties to communicate.
``This was a very unusual case,'' Jenkins wrote. ``The safety of the products manufactured by Utah Medical has never been an issue.''
Midvale, Utah-based UM said the decision vindicates positions it has taken since 2001, when a quarrel began with FDA inspectors over procedures the firm follows in its extrusion and injection molding operations.
The company reacted with a very strident tone, with Chief Executive Officer Kevin Cornwell saying in a statement that the firm ``fought against the virtually unlimited power of a government agency with systemic corruption.''
``We have been both outraged and embarrassed that our government chose to retaliate and waste millions of taxpayer dollars because of [Utah Medical's] sincere disagreement with observations and opinions made by FDA investigators and reviewers - none of whom have had the training, responsibility or experience to manufacture medical devices,'' Cornwell said.
Company spokesman Paul Richins declined to comment on the economic impact of the case but said the firm lost customers after the case was filed. UM molds devices for obstetrics, gynecology, neonatal intensive care and other areas.
FDA officials could not be reached for comment. The agency could appeal the ruling.
At issue was how to interpret federal Quality System Regulations, which govern manufacturing in the highly regulated medical-device sector.
The agency contended in its August 2004 lawsuit that the company did not follow the regulations in its extrusion and injection processes, its software and in how it handles failures. It said that failing to comply with the regulations increases safety risks.
During the trial, the FDA dropped its demand that manufacturing stop and said it was seeking compliance with regulations.
Jenkins wrote that the regulations are vague, and said both the government and the company had valid points. Utah Medical may have lacked proper documentation in the past, he said, but any ``modest deviations'' had been fixed.
``The fact that the road chosen by Utah Medical may be different in degree than that thought to be appropriate by a regulator does not mean it is wrong, or in violation of the regulations,'' Jenkins wrote. ``As the case progressed, the court wondered how it had evolved into a litigation with hundreds of exhibits, endless depositions and high-cost `experts.' ''
The case attracted a lot of attention among medical-device and pharmaceutical companies because it's rare for a manufacturer to fight the FDA so vigorously, said Larry Pilot, Utah Medical's lawyer and a partner with McKenna Long & Aldridge LLP in Washington.
Pilot, a former FDA staffer and longtime lawyer in the medical-device industry, said the case will have ``shock value'' for how the FDA conducts inspections, because most companies do not contest agency rulings, preferring to sign consent orders to resolve complaints.
Utah Medical also called for congressional hearings on its experience.
