US District Court Rejects FDA Suit to Block Device Manufacturer

On Oct. 21, in a decision pharmaceutical compliance professionals are already calling highly significant for their industry, the US District Court for the District of Utah found in favor of device-maker Utah Medical Products (Midvale, UT, www.utahmed.com), dismissing US Food and Drug Administration motions to shut the company down in a dispute over what constitutes compliance with Quality System Regulation (QSR, 21 CFR 820).

In August 2004, FDA’s Center for Devices and Radiologic Health asked the court to enjoin the $26-million maker of extruded and injection-molded plastic specialty medical devices from manufacturing more products until it corrected alleged defects in its quality-control procedures.

According to the decision handed down by District Court Judge Bruce S. Jenkins, FDA never claimed that Utah Medical’s products were unsafe. Rather, a series of Form 483 observations dating back to 2001 faulted the company for documentation and procedures.

The Agency contended that failure to comply with the regulations “in a manner that has been found acceptable to FDA” rendered Utah Medical’s products by definition “adulterated.” Utah Medical, on the other hand, argued that it did have validated processes and procedures in place to ensure product quality, meeting the regulatory requirements in fact, so that the company was compliant whether or not FDA liked the way it was done.

Judge Jenkins found for Utah Medical on three key points: that the company adequately validates its manufacturing process, that the company adequately validates its software, and that the company does have uniform complaint handling process – all in compliance with the Quality System Regulation.

In dismissing FDA’s motions to force compliance, Judge Jenkins wrote:

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. It appears to me thy have often talked past each other and, while using the same words, have meant entirely different things. This seems to be a common characteristic of both, arising in part because of the general nature of the regulations themselves, which have 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 without taking a fresh look themselves at ongoing changes made by Utah Medical in response to questions raised....

As this case progressed, the court wondered how it had evolved into a litigation with hundreds of exhibits, endless depositions, and high-cost “experts.”

The common mission of the manufacturer and the regulating agency is a safe product and the adoption of manufacturing processes which ensure safety.

Product safety is not an issue in this case. Processes and procedures are. “Validation” is the key word, and [as] has often been noted, “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, or in violation of the regulations….

It makes no sense for the court to order Utah Medical to do something they are already doing.

For the full decision, see http://www.utd.uscourts.gov/reports/media/img1021.pdf, pages 135-149.

An FDA spokesperson commented, "FDA has always taken the position that there is no one way to satisfy GMP and our FRs say this explicitly. The disagreement here was over the roads that [Utah Medical] had selected. FDA thinks they don't satisfy GMP; the court disagreed. We see no effect of this decision beyond the facts of this case.".