Utah Medical victory in FDA legal dispute
US Food & Drug Administration (FDA) in a four-year dispute
against Utah Medical Products.
The landmark ruling has industry-wide implications for all medical device and pharmaceutical companies regulated by the FDA, and may inspire other companies to launch future legal challenges against FDA's regulative authority.
Reacting to the decision, Utah Medical CEO Kevin Cornwell said, "After a long ordeal, we believe the court has vindicated Utah Medical's quality system."
At issue was a disagreement over how the company sought to meet Quality System Regulation (QSR) requirements in the areas of adequately validating its manufacturing process, validating its software and uniform complaint handling process.
The FDA alleged that Utah Medical was non-compliant, and filed a lawsuit in August 2004 to shut down the operation of Utah Medical's facility in Utah, until they complied with the FDA's interpretation of the QSR, an interpretation that was never provided to Utah Medical until after the lawsuit was filed.
The Court, however, disagreed with all allegations by the FDA, and has now dismissed the lawsuit, citing no evidence of Utah Medical's products as being unsafe, ineffective, defective or causing any patient harm.
In summing up, federal judge Bruce Jenkins acknowledged that the QSR of Utah Medical's products was never in question and described the FDA's case as "extended and in some instances 'nitpicking.'"
He criticised the general nature of the FDA's regulations themselves, which he described as having 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," commented Jenkins.
FDA spokeswoman Julie Zawisza said the agency's guidance documents and regulations did allow for broad interpretation of good manufacturing practices (GMPs).
"This is a landmark decision that clearly shows that medical device companies need to comply with the relevant regulations, not the subjective demands of FDA personnel," said Dan Jarcho, attorney for McKenna Long & Aldridge, who represented Utah Medical.
"This ruling is a common sense breath of fresh air that affirms that regulated companies can turn to the courts when the FDA refuses to act fairly," he said.
Utah Medical Products, with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of disposable and reusable specialty medical devices.
The full opinion from federal judge Bruce Jenkins is available at McKenna Long & Aldridge's website.
