Utah Medical Seeks HHS ReconsiderationUtah Medical Seeks HHS Reconsideration

August 1, 2006

6 Min Read
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Last October, Utah Medical Products Inc. (UTMD; Midvale, UT) successfully defended itself against FDA charges that the company had failed to comply with the good manufacturing practices requirements of the agency's quality system regulation (QSR). In spite of the company's unprecedented court victory, however, UTMD has continued to suffer indignities at the hands of FDA. In July, the company decided to seek correction of its ongoing grievances through a formal request to the U.S. Department of Health and Human Services (HHS; Washington, DC), which oversees the agency.

UTMD originally sought relief from HHS even before the conclusion of last year's trial. In a claim filed under the terms of the Federal Tort Claims Act (FTCA), UTMD alleged “abuse of process in relation to the negligence and wrongful acts of FDA employees while acting within the scope of their employment during the inspections, review, and subsequent enforcement actions taken and/or attempted, including public statements, during the period of 2001 through 2005.”

HHS responded to the months-old claim last February, denying the company's allegation of abuse of process and refusing the company's request for restitution of litigation costs and lost profits. In a brief letter, HHS informed UTMD that its claim “is not cognizable under the FTCA . . . and is hereby denied.”

Following the HHS rejection, UTMD had until August 9 to sue FDA or seek reconsideration from HHS. On July 12, the company chose the latter course of action and informed its shareholders of the decision.

A major factor in the company's decision was the continued presence of documents on the FDA Web site alleging that UTMD was not in compliance with the QSR. Such documents include the agency's August 10, 2004, press release, “ FDA Seeks Injunction against Utah Medical Device Manufacturer,” which was a precursor to the FDA lawsuit. Executives at UTMD expressed concern that the presence of such documents continues to damage the company's reputation, despite the fact that Federal District Judge Bruce Jenkins had dismissed all QSR noncompliance charges against UTMD.

In seeking reconsideration from HHS, UTMD is formally requesting that the following actions be taken.

• Removal of the August 10, 2004, press release that remains posted on FDA's Web site.

• Acknowledgement of the irreparable harm that has been done to Utah Medical's reputation for manufacturing high-quality products.

• Posting of a public press release from FDA acknowledging that Utah Medical's quality system is and has been in compliance with the QSR (per the court's judgment).

• Issuance of a public statement from the secretary of HHS that FDA must comply with its own regulations and that unethical conduct will not be tolerated.

• Barring the FDA inspectors and reviewers who were involved in the 2001–2003 Utah Medical inspections from any future involvement with the company.

• Purging all FDA's administrative files related to inspection reports, CDRH memos, interoffice e-mails, and other fraudulent memoranda from 2001 through 2004.

• Conducting, documenting, and publicly disclosing the results of a formal investigation of FDA actions in this case by an independent authority.

• Retraining, reprimanding, reassigning, and/or dishonorably discharging FDA personnel who violated government rules and regulations.

• Providing recovery of pecuniary damages incurred by Utah Medical as a result of FDA conduct.

At press time, documents pertaining to UTMD's alleged QSR violations remain posted on the Web site of FDA's Office of Regulatory Affairs . Some of the documents appear to have been redacted, and each page of every report is stamped “Purge.”

On August 16, UTMD chairman and CEO Kevin Cornwell wrote to FDA associate commissioner for regulatory affairs Margaret Glavin, requesting that her office immediately withdraw the documents from its Web site.

In his letter, Cornwell asked Glavin, “In light of the scores of communications with the company including the formal adjudication of all of the issues regarding the content of the posted documents, why has your office done this?” Noting that “the issues have been resolved,” Cornwell also questioned why the agency's posting had omitted “the most important document, namely the opinion of the trial judge Bruce S. Jenkins' finding that the company was in QSR compliance?”

Cornwell says he is frequently asked why he continues to pursue the matter with HHS and FDA. “ It's simply the right thing to do, and I'm counting on our government's healthcare regulatory agencies to do it,” he says. “There was never any question about the quality or safety of our products. While the court cleared our name unequivocally—and we're thankful for that—HHS needs to ensure that FDA sets the record straight for the benefit of our employees, our customers, our shareholders, and ultimately the patients that use and benefit from our products. Based on our experiences with FDA and HHS, maybe I shouldn't be optimistic about pursuing this further. But I am.

“FDA needs to use the principles of quality assurance to learn from the Utah Medical experience, and respond responsibly to our request for remedies,” Cornwell adds. “I do not understand how the leadership of FDA can reconcile the fact that it is a significant violation of the QSR when companies do not follow their written procedures, but when employees of FDA, which is charged with the enforcement of the QSR, do not follow important agency procedures, it is simply ignored.”

UTMD, with more than 200 employees, manufactures a number of products for the gynecology, perinatology, neonatology, electrosurgery, and critical-care sectors. In 2005, the company posted revenues of $27.7 million, an increase of 4.6% over 2004 revenues of $26.5 million.

Details of UTMD's request for reconsideration from HHS are available at www.utahmed.com/pdf/Request%20for%20Reconsideration.pdf.

© 2006 Canon Communications LLC

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