Judge Rules Against FDA in Landmark Medical Device Manufacturing Case

26 October 2005

McKenna Long & Aldridge LLP today applauded a ruling by federal judge Bruce S. Jenkins denying the Food & Drug Administration's (FDA) Quality System Regulation (QSR) allegations against Utah Medical Products. The ruling, which acknowledged that the safety of Utah Medical's products was never in question and found that the company did indeed comply with the QSR, has industry-wide implications for all medical device companies regulated by the FDA.

"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 McKenna Long & Aldridge attorney Dan Jarcho. "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." The McKenna, Long & Aldridge trial team was led by Daniel G. Jarcho, Larry R. Pilot, Cass W. Christenson and Daniel L. Russell Jr.

McKenna, Long & Aldridge represented Utah Medical Products Inc. throughout its four year dispute with the FDA. At issue was a disagreement over how the company sought to meet QSR requirements in the areas of adequately validating its manufacturing process, validating its software and uniform complaint handling process. In August 2004 the FDA sought to shut down the operation of Utah Medical's 160-person facility in Midvale, Utah.

"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," Judge Jenkins wrote in his opinion. "Processes and procedures are. 'Validation' is the key word, and has often been noted, 'many roads lead to Rome.'"

Jenkins wrote that the FDA's case, which he characterized as "extended and in some instances 'nitpicking,'" arose "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."

The full opinion is available at
http://www.mckennalong.com/news-pressrelease-1482.html

Reacting to the decision, Utah Medical CEO Kevin Cornwell said, "After a long ordeal, we believe the court has vindicated Utah Medical's robust quality system. I would like to thank our legal counsel, Mr. Dan Jarcho, Mr. Cass Christenson, Mr. Dan Russell and Mr. Larry Pilot of McKenna Long & Aldridge, LLP, Washington, D.C., for their diligent and expert management of the litigation process."

Commenting on the case, attorney Larry Pilot said, "McKenna, Long & Aldridge is delighted that the Court vindicated our client, Utah Medical Products. This has been a hard-fought litigation in which a small company had the will to stand up for itself in the face of enormous pressure and resources brought to bear by the FDA. Utah Medical's willingness to stand on principle is a model for other regulated companies to follow.

"Its courage in defending itself against meritless claims by the FDA should inspire all medical device and pharmaceutical companies to question the performance and the sincerity of the FDA as it evaluates the very meaning of compliance. This precedent setting opinion is a major accomplishment for the entire FDA regulated industry."

Utah Medical Products, Inc., with particular interest in health care for women and their babies, develops, manufactures, assembles and markets a broad range of well-established disposable and reusable specialty medical devices designed for better health outcomes for patients and their care-providers. For more information about Utah Medical Products, Inc., visit UTMD's website at http://www.utahmed.com.

McKenna Long & Aldridge is a full-service law firm of 400 lawyers and public policy advisors with offices in Atlanta, Brussels, Denver, Los Angeles, Philadelphia, San Diego, San Francisco and Washington, DC. The firm provides business solutions in the areas of corporate law, government contracts, intellectual property and technology, complex litigation, public policy and regulatory affairs, international law, real estate, environmental, energy and finance. To learn more about the firm and its services, log on to http://www.mckennalong.com.

Source: PR Newswire

All trademarks and copyrighted information contained herein are the property of their respective owners.