Lori Carr suspected something odd was afoot when she took a seat in the office of Utah Medical Products CEO Kevin Cornwell late in the workday of Feb. 3, 2004.
Carr arrived at the Midvale, Utah-based medical device company earlier that morning as part of a three-investigator team from the Food and Drug Administration (FDA) that was there to conduct a follow-up inspection. By that time, the manufacturer and the US agency had been locked in a years-long back-and-forth over alleged quality systems issues.
On that day nearly 22 years ago, “we were unpacking our various things for the inspection, and it was just the three of us investigators in the FDA workroom at Utah Medical,” Carr, now a Principal Consultant for QualityHub, recalled in a recent interview with QHub Insights. “I was about to write the date in my diary, and it was 02/03/04 – and I said, ‘Oh, it’s 2-3-4, isn’t that strange?’”
Later, when she was in Cornwell’s office for the closing meeting for that inspection day, the CEO opened a notebook. Cornwell “sat down and he wrote the date, and he said, ‘Oh, it’s 2-3-4, isn’t that strange?’ He said it using the exact same words, using the exact same inflection that I had used, exactly the way I said it,” she claims.
“Utah Medical was paved with broken glass and I was walking barefoot. Being a part of that inspection was one of the most horrible experiences of my life.” – Lori Carr
Fast forward to the final day of the inspection. On that morning, Carr noticed that an electrical outlet box in the room where she and the other two investigators had been working (and had already used for several days) was now partially hanging out of the wall.
“The outlet’s faceplate had been unscrewed and removed and the outlet box was just hanging there, like the place was under construction. The outlet hadn’t been like that on the other days of our inspection,” Carr said. “So, between that, the echoing of my 2-3-4 comment, and other things that were repeated to the three of us [investigators] – that were said amongst only the three of us – we were pretty certain that a recording device had been placed in that electrical outlet and that the device had been removed on that last day of our inspection.”
While she doesn’t have hard proof that the FDA inspection team’s private workroom conversations were recorded, Carr nevertheless says she has “objective evidence,” including other confidential chats she had with colleagues that were parroted back to her by company officials, and later, their attorneys.
“I’m not a betting person, but if I went to Las Vegas, I’d bet $1M that we were bugged,” she said. “Stranger things have happened during inspections, so it’s not odd to consider that it was an absolute possibility – or even probability.”
FDA policy says its representatives can only be recorded if the agency is aware and records as well. [Editor’s Note: QualityHub contacted Utah Medical Products for comment but did not receive a response by press time.]
Surprisingly, an allegedly bugged FDA workroom wouldn’t be the most unusual thing about the curious case of FDA v. Utah Medical. After all, by the time Carr arrived at the company for that 2004 re-inspection, two FDA inspections (led by other investigators) had already occurred in 2001 and 2003; an agency warning letter had been issued to the firm in 2001; and the FDA began weighing whether to seek a consent decree against the manufacturer by late 2003/early 2004. Communications between Utah Medical and the agency had broken down, sometimes devolving into shouting matches.
“There was some wacky stuff going on,” Carr remembers. “Utah Medical was paved with broken glass and I was walking barefoot. Being a part of that inspection was one of the most horrible experiences of my life.”
And then, only a scant few months after Carr’s visit to Utah Medical, came the next eye-popping chapter in the saga: A lawsuit filed by the FDA against the firm and the company’s subsequent indignance that – *spoiler alert* – led to Utah Medical’s victory over the agency in a landmark decision handed down by Judge Bruce Jenkins of the US District Court for the District of Utah in October 2005.
The situation between Utah Medical and the FDA had evolved into, put simply, a contest between David and Goliath, and David’s aim was steady.
United States of America v. Utah Medical Products
On behalf of the FDA, the US sued Utah Medical in August 2004 claiming the company was in violation of the Quality System Regulation (QSR; 21 CFR, Part 820). The agency asked the court for a permanent injunction to force the firm to stop making products until alleged violations were fixed “in a manner that has been found acceptable to FDA.”
These are the 10 QSR subsections allegedly violated by the company and cited by the FDA in its suit:
- 21 CFR, Part 820.70(a), Production and Process Controls (General);
- 21 CFR, Part 820.70(i), Production and Process Controls, (Automated Processes);
- 21 CFR, Part 820.75(a), Process Validation (General);
- 21 CFR, Part 820.75(b), Process Validation (Establishment of Validation Procedures);
- 21 CFR, Part 820.80(c), Acceptance Activities (In-Process Acceptance Activities);
- 21 CFR, Part 820.80(e), Acceptance Activities (Acceptance Records);
- 21 CFR, Part 820.90(a), Nonconforming Product (Control of Nonconforming Product);
- 21 CFR, Part 820.100(a)(1), Corrective and Preventive Action (Procedures; Identification of Nonconforming Product Causes);
- 21 CFR, Part 820.198(a), Complaint Files (Establish and Maintain Procedures); and
- 21 CFR, Part 820.250(b), Statistical Techniques (Use of Sampling Plans).
Despite the laundry list of allegedly violated subsections, the safety and efficacy of Utah Medical’s products were never in question. Rather, the FDA’s overarching issue was that it claimed the company wasn’t properly validating its extrusion or injection molding processes, which were key to the manufacture of plastic parts for its products and components.
The agency also claimed that Utah Medical didn’t adequately validate software used in production and failed in its complaint handling activities. (Later on, the FDA dropped its demand that the firm stop making product and focused solely on the alleged QSR violations.)
Utah Medical refused to settle, asserting that it was in full compliance with FDA requirements. The case ran from Sept. 26 to Oct. 4, 2005, with many FDA and industry subject matter experts taking the stand, including QualityHub‘s Carr.
“Kevin Cornwell could have said, ‘OK FDA, you know what? I’m going to comply, and I’m going to make the corrections,’” Carr said. “The biggest issues FDA had was that the company allegedly didn’t validate its processes for extrusion and injection-molded parts. If Cornwell would’ve spent some money to get an expert in process validation to help correct those problems, then he would’ve avoided this court case. If he had instead spent money to comply with the FDA, everything would have been smoothed over.”
Interestingly, Utah Medical Products won a lawsuit in 2002 after a jury found that the Softrans intrauterine pressure catheter made by Graphic Controls Corp. infringed on Utah Medical’s patent for a disposable intercompartmental pressure transducer. Graphic Controls was ordered to pay $20M in damages.
“Here’s the major rub: Utah Medical won $20M and Kevin Cornwell decided to spend every red cent of that to fight the FDA,” Carr said.
“If he would’ve spent just a sliver of that $20M and told a process validation expert, ‘Please help me to comply,’ the company would’ve saved millions and the FDA would’ve been satisfied knowing their issues were addressed,” she added. “But Cornwell didn’t. He decided to put on the boxing gloves and start fighting the agency. So that $20M went up in smoke through attorney fees, consultant fees, subject matter expert fees, et cetera, just so he could fight rather than fix.”
“Many roads lead to Rome. 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 that it is wrong.” – Judge Bruce Jenkins
But Dan Jarcho, a litigation partner in the Washington, DC, office of the law firm Alston & Bird, said Utah Medical fought the government’s case because the company had no other choice given that it had complied with the QSR all along.
Further, “there were people involved from the FDA who simply didn’t understand the technology used by Utah Medical, particularly the manufacture of plastics through the extrusion process, and we got into a situation in which investigators were giving their personal opinions about the way things should be changed, as though their personal opinions were legally binding when they were not,” he said. “I believe that was a significant dynamic in the case.”
Jarcho was a partner at the law firm McKenna Long & Aldridge in 2004 when he was retained to be lead counsel in the Utah Medical court case.
“The agency was taking a position that wasn’t consistent with the regulatory requirements and they weren’t being reasonable, so I was pleased to be involved in the litigation. I only came into the case at the point when litigation was unavoidable, so my role was to come in and win the case, which we did. Looking back, I wouldn’t do anything differently,” Jarcho said in an interview.
He noted that “not every case is a case to litigate. Litigation is a last resort. You try to resolve things in a more amicable way. But there are circumstances in which the FDA’s position isn’t justifiable and the demands it’s making are too unreasonable, and that’s when it’s time to let a judge decide.”
A ‘Nitpicking,’ ‘Unusual Case’
And decide, Judge Bruce Jenkins did. His Oct. 21, 2005, ruling in favor of Utah Medical Products was particularly stinging, describing the FDA’s suit as an “unusual case” pushed by an overzealous agency.
“It seems to me that a recurring problem in this extended and in some instances ‘nitpicking’ case is a failure of the regulator and the regulated to communicate,” Jenkins wrote at the time. “It appears to me they have often talked past each other and, while using the same words, have meant entirely different things.”
In the end, the judge pointed out, the safety of products made by Utah Medical were not at issue in the case; rather, its processes and procedures were.
“‘Validation’ is the key word, and has often been noted, many roads lead to Rome,” Jenkins added. “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 that it is wrong or in violation of the regulations.”
The judge went on: “Without a doubt, the United States captured Utah Medical’s attention in the past, and whatever modest deviations from regulations may have occurred in times past no longer exist at present. It makes no sense for the court to order Utah Medical to do something they are already doing.”
Attorney Jarcho told QHub Insights that “the most notable message that came out of the case was that FDA’s view of the quality system requirements was not necessarily binding, and just one view of what the requirements were, and that the regulations build in a lot of flexibility for manufacturers to approach the regs in their own in their own way, in a way that applies appropriately to their own products.”
In “unusual situations,” he says, it’s important for manufacturers to “push back” and stand their ground through litigation.
“But you must do it the right way, and you must understand which is the right case to do it and which is not the right case to do it,” Jarcho said. “It’s important to understand that at the end of the day, it’s really a judge’s decision about whether an injunction will be entered, shutting down a company’s operations. Litigation can truly be an option – but only under the right circumstances.”
Aftermath: FDA
QualityHub‘s Carr said it came as a shock to the FDA that Utah Medical prevailed in the case.
“Leading up to the court case, we were like, ‘We got this.’ And we have all these experts saying, ‘The company’s not compliant.’ So, after the ruling, I think most of our heads at the FDA were just spinning, wondering what the heck just happened. And industry was thinking, ‘Wow, this company literally went up against the agency and prevailed.’”
Carr believes the outcome could’ve been different, but that it was the “perfect storm” of people and circumstances that allowed Utah Medical to prevail.
“If I walked into Utah Medical to do a compliance follow up on a warning letter today, I would expect to see corrections, because most companies are in the business of making corrections and doing better,” she said. “I believe it was a chain of events, that it was all the right people – or wrong people, if you will – at the same place, at the same time. And maybe it wouldn’t have gotten to the point of an injunction case going to court if there were different players” at the agency and Utah Medical.
Because “I was an investigator on the case, I’m obviously going to be in the camp of, ‘We did the best inspection that we could,’” Carr said. “Still, the FDA probably should have won.”
She also believes the outcome would’ve been different had the case been heard outside of Utah. “If that case had been heard in Washington, DC, with federal judges who understood the FDA, it may have been a different outcome,” Carr surmised. “That’s another reason why I say that, in so many ways, this entire saga was a perfect storm.”
After the case ended, Alston & Bird’s Jarcho says it sparked some positive changes at the FDA, including increased oversight by lawyers in the agency’s Office of Chief Counsel (OCC). Among other activities, OCC litigators and counselors “advise agency enforcement officials on pending compliance issues and review certain warning letters sent to firms and individuals believed to have violated the FDCA [Federal Food, Drug, and Cosmetic Act] or related laws,” the FDA explains on its website.
The additional OCC attorney control post-Utah Medical “was a beneficial outcome, because you had lawyers – not just quality professionals, but lawyers – weighing in on what the requirements of the regulations are, and attorneys who had perspective on how a court might look at certain issues,” Jarcho said.
“Enough time has passed since the 2005 suit that most people in the agency aren’t typically worried about the possibility of litigation if they are in a situation where the FDA is seeking a consent decree, which is what US v. Utah Medical was,” he said. Nowadays, agency officials “assume that at the end of the day a consent decree is going to be signed. And most of the time they’re right about that. But certainly, in the aftermath of the case there was more oversight by lawyers internally at the agency, which was beneficial.”
“I have some concern about the pendulum swinging back to the days when people conducted FDA inspections without the proper background.” – Dan Jarcho
Another development since 2005 is that FDA inspection teams now include specialized investigators with expertise in various commodities and the specific manufacturing processes linked to them.
“It used to be that the same investigators who inspected food plants also inspected drug plants and medical device plants, and when they encountered a sophisticated technology like the tech used by Utah Medical, there were mistakes made because inspection teams didn’t have the right people with the right expertise,” Jarcho said.
“That has changed dramatically since 2005, in a favorable way. However, earlier this year, the layoffs and resignations of many FDA staffers led to a substantial depletion of expertise in many areas,” he added. “I have some concern about the pendulum swinging back to the days when people conducted FDA inspections without the proper background.”
Mark Brown, a partner in the Washington, DC, office of law firm King & Spalding, said Utah Medical’s litigation victory had a “chilling effect” on FDA’s enforcement actions in federal court.
“It’s a chilling effect because the FDA needs to be absolutely certain that if the agency decides to push the Department of Justice to file an affirmative action on its behalf, they’re not going to end up potentially losing because that can have a long-term impact on enforcement policy and priorities,” Brown told QHub Insights. “That’s why 99% of the time there are negotiated agreements in the form of consent decrees with industry. And in only very few cases has FDA decided to ‘walk away’ without either an agreement or the filing of a complaint in federal court. And those few cases are not public and never known to the rest of the world.”
Aftermath: Utah Medical Products
Meanwhile, attorney Jarcho surmises that “Utah Medical is in a better position today because it pushed back. And after the trial was over, it was several years before the company was inspected again.”
To put a fine point on it, the FDA did not inspect Utah Medical again until 2010 – a full six years after the previous inspection by the agency team that included QualityHub consultant Carr. No significant issues were found by the FDA during its 2010 inspection.
“In his ruling, Judge Jenkins said, ‘As far as I’m concerned, the company is in compliance and the FDA is nitpicking. This Big Bad Wolf – the FDA – needs to go and try to blow somebody else’s house down and leave Utah medical alone,’” Carr said. “So, after the ruling came down in 2005, the FDA basically said, ‘Utah Medical went up against the agency and the company won. We’re not going to inspect them because they’re going to keep saying that the FDA is picking on them. The agency gave the firm an unwritten reprieve on inspection for several years.”
But Carr isn’t so sure that, despite winning the case, Utah Medical triumphed in the long run.
“After the company won, it became the poster child of what not to do. Don’t spend $20M to fight the FDA. If the FDA says your process validation isn’t up to par, then fix it. Listen to what the FDA has to say and make a correction,” she said.
“I don’t know whether somebody at Utah Medical could have said, ‘Hey, Kevin Cornwell, do not fight the FDA. We’re going to pay to remediate, we’re going to pay to correct, and we’re going to do the right thing,’” Carr added. “After all, if it was my company, I’d want to comply – it’s what I’d do.”
Attorney Brown agrees that fighting the FDA in court can lead to permanent reputational harm and most manufacturers want no part of that risk.
“I don’t believe the FDA acts in a way where it punishes companies, but there’s a perception by industry that if you go down that road, there will be consequences that will be long lasting and impact the company’s ability to achieve its goals. This is a particularly sensitive topic with publicly traded companies,” he said.
“On the public company side of it, boards of directors and company management have fiduciary responsibilities to shareholders,” Brown said. “And if you get in trouble with the FDA, it can breed shareholder litigation, it can breed other reputational harm where competitors are beating a company up over warning letters or enforcement actions and trying to steal business as a result of those difficulties that companies have.”
He added that “there are so many incentives to resolve issues and satisfy FDA concerns in a voluntary manner rather than fight. That’s an important consideration for all companies but it’s heightened for public companies because of all the collateral consequences that can be a byproduct of being viewed as a company that fights regulators.”
Lessons for RA/QA and Industry
As US v. Utah Medical Products fades further into history, QualityHub‘s Carr says it makes for a great case study for students of regulatory affairs and quality assurance, particularly if they’re interested in MedTech. Many young professionals already working in the field should also be made aware, she says.
“People in their 20s and their 30s – I’m pretty sure they don’t know about Utah Medical. I think they should, as a case study, say, ‘Look, this company decided to go up against the FDA, and be aware of it,’” Carr said.
“But to be honest, I’ve worked with a lot of people in their 20s and 30s through my consulting work, and they ‘get it’ – if they get an FDA-483 [inspectional observation form], or, heaven forbid, a warning letter from the agency, they are all in with making the correction,” she added. “They’re not saying, ‘I’m putting the boxing gloves on and I’m going to duke it out with the FDA.’
“I have never, in 18 years of consulting, run into a person or a company that is willing to take on the FDA.”
“Manufacturers are much more focused nowadays on making sure they have the appropriate remediation strategy in the wake of bad inspections and warning letters.” – Mark Brown
Moving forward, Alston & Bird’s Jarcho advises regulatory and quality teams to remain vigilant.
“When a situation arises in which the FDA is demanding something and claiming that it’s legally required, make sure you have qualified lawyers get in the mix because that’s a different question than, what is the gold standard in the industry, or what is the best practice,” he said. “Where that really comes full circle is that FDA in the Utah Medical case was making demands for things that the agency thought would improve the quality system, but those things weren’t legally required, and that’s what the judge held.”
And, with the FDA’s new Quality Management System Regulation (QMSR) coming into force in February 2026 (replacing the QSR), Jarcho says it’s possible that a GMP-related case like US v. Utah Medical could happen again.
“When you’re specifically talking about a new set of device regulations, there could be this same problem of an insistence on requirements as being legal requirements when they actually aren’t in the regulation,” he said.
But King & Spalding’s Brown isn’t necessarily sure that GMP litigation tied to the QMSR is a forgone conclusion.
That’s because “manufacturers are much more focused nowadays on making sure they have the appropriate remediation strategy in the wake of bad inspections and warning letters so they can minimize the risk of becoming an enforcement action,” Brown said.
But he warns: “Stay tuned.”