Utah Medical Prevails in Court over FDA Charges

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.

Hailing the decision as a precedent-setting ruling, Utah Medical attorney Larry R. Pilot, a partner with McKenna Long & Aldridge LLP (Washington, DC), lauded the company’s “courage in defending itself against meritless claims by FDA.”

FDA spokeswoman Julie Zawisza said, “The agency’s guidance documents and regulations allow for broad interpretation of good manufacturing practices, or GMPs. FDA has always taken the position that there is no one way to satisfy GMPs. The disagreement here was over the roads that Utah Medical had selected. FDA thinks they didn’t satisfy GMP. The court disagreed. We see no effect of this decision beyond the facts of this case.”

Utah Medical Products has formally requested that FDA clear its name, ensure that any future inspections be conducted fairly and honestly, and recuse any agency personnel involved with the recent injunction attempt from future dealings with the company. Additionally, the company wants FDA to “immediately release the certificates to foreign governments that they have withheld from Utah Medical since early 2003, damaging the company’s reputation and business activity overseas.”

In a related action, Utah Medical filed a claim this past July with the U.S. Department of Health and Human Services (HHS; Washington, DC) regarding FDA. The claim alleges abuse of process and requests restitution of litigation costs and lost profits. HHS, which has FDA oversight authority, is expected to consider the merits of the claim before January 15, 2006.

Utah Medical, to further demonstrate its commitment to the efficacy and safety of its products, announced earlier this month that it had completed its annual surveillance audit and was recertified to maintain its registration to ISO 13485, a set of international quality standards for medical device manufacturers. In 2003, the company converted from the ISO 9001-EN 46001 standard to the more rigorous medical device ISO 13485 standard.

© 2005 Canon Communications LLC

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