FDA Wanted to Teach Utah Medical a Lesson, But the Joke Was on FDA

A June 2001 FDA inspection of Utah Medical Products began a four-year nightmare for the company that ultimately resulted in FDA being taught a hard lesson. Whether or not the agency actually learned from the experience, however, remains up for debate.

After the inspection, the FDA investigator presented a FDA Form 483 listing observations perceived as objectionable conditions by the investigator. However, according to MD+DI archives, these conditions were not actually violations, and the safety of Utah Medical's products were never in question. Still, despite Utah Medical's prompt and comprehensive written response to the observations, FDA issued a warning letter. Eventually, the agency took Utah Medical to court in a plea for a permanent injunction against the medical device manufacturer.

The agency had asserted that the firm had not validated its manufacturing processes, extrusion process, or software in conformance with quality system regulation (QSR) requirements. Furthermore, FDA said Utah Medical had not maintained a uniform complaint-handling system in conformance with QSR.

In October 2005, after a seven-day trial, Bruce S. Jenkins, a United States Senior District Judge, denied FDA's petition and dismissed the case. The Department of Justice (DOJ) decided against filing an appeal.

Related:Ignoring an Inconvenient Truth

In his ruling, Jenkins threw out FDA's "increasingly prescriptive approach to its quality system inspection technique," James G. Dickinson, a former MD+DI regulatory columnist, later wrote.

Jenkins held that Utah Medical had been in compliance all along and lectured FDA that “many roads lead to Rome.” The federal judge stopped short, however, of addressing the company's complaints about FDA abuse of process and investigator bias because Utah Medical was pursuing a claim for damages and legal costs with FDA's parent, the Department of Health and Human Services.

"Even without a judgment on those issues, it was a devastating defeat for FDA," Dickinson wrote. "And the agency could have avoided it if, even once in four years, it had really listened to Utah Medical's complaints."

Dickinson spoke with Ed McDonnell, a former FDA director-turned-consultant, who reviewed all FDA documents and inspected Utah Medical for the defense before trial. McDonnell's conclusion: FDA wanted to teach Utah Medical a lesson. In retrospect, it would seem the joke was on FDA.

"Who at FDA wanted Utah Medical out of business? McDonnell says he doesn't know. What he does know is that Denver District Compliance Officer Regina Barrell initiated all three of the office's injunction recommendations," Dickinson wrote.

Related:The Utah Medical Case Does Make a Difference

The district sent a recommendation to the Center for Devices and Radiological Health (CDRH) each year until the case was finally launched in 2004. Barrell's district director, Belinda Collins, claimed not to have read any of the recommendations before they went to headquarters.

"It would seem that she assumed a blind trust in the work done by those under her — a trust that all above her would also adopt as the case approached the federal court," Dickinson wrote.

McDonnell told Dickinson he was mystified by the errors he found in Utah Medical's inspection reports. He was even more perplexed by FDA management's failure to investigate the firm's complaints of abuse of process and investigator bias after those inspections.

“FDA officials at all levels were not prepared to understand what Utah Medical was doing because they were told what to believe,” McDonnell said. “And what they were told to believe was not accurate and not factual. It took a judge to settle this.”