WHO DID WHAT IN 2005 1346

Utah Medical Court Victory Unlikely to Be Bellwether

Utah Medical Products Inc.'s (Midvale, UT) victory over FDA in court could have a tremendous effect on companies that want to challenge FDA findings of GMP violations. But it probably won't.

Federal Judge Bruce S. Jenkins's finding that FDA was not justified in its enforcement actions against Utah Medical because no public health risks were evident could give other firms leverage to challenge questionable FDA actions. Utah Medical's executive team, led by CEO Kevin Cornwell, could become a role model for those who wish to stand up to the agency. However, legal experts say, Utah Medical's situation may end up being anomalous.

“It was such a unique circumstance,” says Bradley Thompson, a partner at Baker & Daniels (Indianapolis). “The facts were very unusual. I don't think it will spill over very much.”

There are several reasons for this. One, there appear to have been serious personality conflicts between Utah Medical executives and certain FDA officials. These may have prompted the move to litigation where other parties would have forged a compromise. Two, engaging FDA in litigation is extremely time-consuming and expensive. Many firms will go to any lengths to avoid it.

“We represent more than 600 medical device companies, and the approach of almost every one of them is to stay within the quality system regulation [QSR] as best they can,” says Jonathan Kahan, a partner at Hogan & Hartson LLP (Washington, DC). “If FDA raises issues, they cooperate. I rarely, if ever, see a situation like Utah Medical's. The issues could have been resolved but weren't because of the personalities involved. Normally, you do what you can to work around it because the legal fees are huge. I believe Utah Medical was correct in this case, but there was a bit of blindness on both sides, which makes it an unusual aberration.”

Might the incident change the agency's approach, even if the threat of litigation is rare? That won't be known for a while, since the agency rarely discusses such things publicly. However, FDA lawyers have been saying that the agency retains the right to take enforcement actions for GMP violations even when there is no public safety issue, because the products that result are adulterated.

Still, Larry Pilot, a partner at McKenna, Long & Aldridge LLP (Washington, DC), who was part of Utah Medical's legal team, says he expects the agency to “be much more careful about the allegations it makes against firms in regard to the implementation of the QSR.” He expects the agency to take steps to ensure that the sloppiness that occurred during the inspection and appeal processes is not repeated.

He adds that what may take a hit is the agency's reputation of being willing to work with firms when a dispute arises. Many times when agency officials speak publicly, they tout CDRH's dispute resolution processes and encourage communication from firms. Will industry decide this is nothing but hollow talk after the Utah Medical incident?

“They always say that if there's a problem, go to the district, and if there's a problem there, go to the regional director, and if there's a problem there, go to the ombudsman,” says Pilot. “[Utah Medical] followed that chain as rapidly as it could under the circumstances. What happened? Nothing. The regional director was blasé about it. The ombudsman did not do [his] job. There was not even an investigation. For the company, [FDA's public position about dispute resolution] was a fairy tale. The center's performance was amateurish and regrettable.”

In the end, the case's significance for industry may not involve the legal right to use alternative methods to the QSR. Rather, it may be any steps FDA takes to restore confidence in its dispute resolution process. —ES

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