Medical Device Daily Associate

Utah Medical Products (UTMD; Salt Lake City) said it has asked the federal government to review its allegations that the FDA was abusive in the way it inspected a company plant.

The company, which focuses on gynecological and neonatal products, said it has filed an administrative claim with the Department of Health and Human Services (HHS), the parent of the FDA, alleging “abuse of process in relation to the negligence and wrongful acts of FDA employees.”

It filed the same administrative claim with HHS in July 2005, which HHS denied this past February (Medical Device Daily, Feb. 16, 2006). The company is now requesting that HHS reconsider the claim.

The matter goes back to August 2004, when the FDA issued a press release alleging that the Utah plant was not in compliance with quality system regulations.

The FDA later sued the company alleging the plant failed to comply with good manufacturing practices. The FDA ultimately lost that suit (MDD, Oct. 25, 2005), which was originally designed to permanently enjoin UTMD from making and distributing medical devices, and the company has hoped to regain its good name and reputation which it said were damaged by the unnecessary regulatory actions.

The negative publicity has continued to hurt sales of company products, the company said, even though it was found to be in compliance with U.S. quality regulations.

Among other things, UTMD's administrative claim requests that the FDA remove the Aug. 10, 2004, press release that remains posted on the agency's web site.

It also asks that the FDA inspectors and reviewers involved in the company's plant inspections between 2001 and 2003 be barred from any future involvement with Utah Medical.

The company also has requested a public declaratory statement from the Secretary of HHS that the FDA must comply with its own regulations, and that “unethical conduct that violates the Standards of Ethical Conduct for Employees of the Executive Branch will not be tolerated.”

As part of informing public shareholders of the HHS denial in February, UTMD indicated that it had an Aug. 9 deadline to file suit against the FDA in U.S. District Court, or file a request for reconsideration. In order to disseminate an answer to shareholder follow-up questions fairly, the company revealed that it filed a request for reconsideration with HHS on July 12.

While the company is taking the road toward reconsideration at this point, Kevin Cornwell, CEO of UTMD, told Medical Device Daily that the litigation avenue “remains open” if the company's grievances are not addressed, although he said he would prefer not to go down that path. “Everybody loses if you go back to court, so why not do everything you can possibly do [first] without going back to court?”

While saying he would prefer not to pursue the litigation path, Cornwell stressed that the company has proof that certain officials affiliated with the FDA committed fraud. “We've got a solid case,” he said

Cornwell said the statutory rules state that HHS should provide the company with a written response to its reconsideration response within six months

In a public statement, Cornwell took umbrage with recent comments made by David Elder, director of the FDA office of enforcement, in the August 2006 issue of the Guide to Medical Device Regulation.

“FDA enforcement cannot be properly judged by counting the number of actions taken by the agency,” Elder said. “FDA has increasingly used an enforcement strategy based on efficient risk management principles that focuses on combating the greatest public health risks and maximizing our deterrent effect against potential violators.”

“To my knowledge, the lawsuit brought by FDA in 2004 seeking an injunction to shut down UTMD's operations because of alleged violations of the Quality System Regulation [QSR] has been the only such action litigated through trial on behalf of the FDA in the 10 years since promulgation of the QSR,” said Cornwell. “After three years of intensive and extensive inspections of UTMD and 'review' by so-called agency experts, the federal court decided unequivocally against the FDA.

“I question the basis for Mr. Elder's statements, because his representation about FDA using efficient risk management principles does not comport with UTMD's experience with the FDA.”

Cornwell added that in contrast to Elder's statement, his company found “the FDA's action was neither prompt nor based on any risk to the public. The fact that no risk assessment was ever done by the FDA was a travesty. There were no FDA allegations that UTMD's devices were defective, or not safe or not effective. The agency never investigated whether UTMD's finished devices met specifications, and never challenged the soundness of the risk assessments that we had performed.”

Finally, he expressed frustration at what he sees as a double standard being promulgated by the FDA. “I do not understand how the leadership of the FDA can reconcile the fact that it is a significant violation of the Quality System Regulation when companies do not follow their written procedures, but when employees of the FDA, which is charged with the enforcement of the QSR, do not follow important agency procedures, it is simply ignored.”