It isn't often that a small manufacturer can go up against a powerful federal regulatory agency and prevail, but that's exactly what Utah Medical Products Inc. (Midvale, UT) did in October. The company vigorously defended itself against FDA's charges that the company had failed to comply with the good manufacturing practices requirements of the agency's quality system regulation (QSR). In the end, Utah Medical won a stunning victory when the U.S. District Court in Salt Lake City dismissed the case with a ruling that chided the actions of FDA.

Judge Bruce S. Jenkins described FDA's oversight actions as “extended” and “at times, nitpicking.” In affirming Utah Medical's full compliance with the QSR, Jenkins said he was impressed with the company's documented procedures and added, “ It makes no sense for the court to order Utah Medical to do something they are already doing.”

Utah Medical's Cornwell: Relief in triumph.

Commenting on the court ruling, Utah Medical Products CEO Kevin Cornwell said, “We are relieved that this incredible four-year-long ordeal is over. FDA's mission in this case was not to protect public health, but to show who's boss. The industry should not tolerate dishonest and abusive regulators, who ultimately harm the quality and cost of healthcare. Without effective FDA management, a few incompetent and power-driven bureaucrats may run amok defaming an innocent company.”

In rendering his decision, Judge Jenkins said, “The common mission of the manufacturer and the regulating agency is a safe product and the adoption of manufacturing processes that ensure safety. Product safety is not an issue in this case.” Utah Medical has long maintained this stance, and during discovery FDA also acknowledged that product safety was not the issue at hand in the case.

The case, said Jenkins, was about processes and procedures. “Validation is the key word, and has often been noted, ‘Many roads lead to Rome,'” Jenkins wrote.

Pilot: Defending against ‘meritless' claims.