UTMD Announces Filing a Request for Reconsideration with HHS
|Contact: Kevin L. Cornwell||
August 7, 2006
Salt Lake City,
Utah - On July 15, 2005, Utah Medical Products, Inc. (Nasdaq: UTMD)
filed an administrative claim with the Department of Health and Human
Services (HHS), the parent of the U.S. Food & Drug Administration (FDA),
under the Federal Tort Claims Act (FTCA), alleging 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.
This letter constitutes the notice of final determination on this claim, as required by 28 U.S.C. '1346(b). Your client’s [UTMD’s] claim is not cognizable under the FTCA. Accordingly, the claim of Utah Medical Products, Inc, is hereby denied.
On February 15, 2006, as part of informing public shareholders of the HHS
denial, UTMD indicated that it had an August 9, 2006 deadline to file suit
against the FDA in the federal district court, or file a request for
reconsideration. In order to disseminate an answer to shareholder follow-up
questions fairly, the Company is announcing that it filed a request for
reconsideration with HHS on July 12, 2006. The request for reconsideration
is now available to the public on UTMD’s website www.utahmed.com, or by
contacting Kevin Cornwell.
REQUEST FOR REMEDIES
Utah Medical believes that the Company, its employees, shareholders, suppliers and customers, along with all other taxpaying and non-taxpaying U.S. citizens, are entitled to expect that the federal government will act in good faith to carry out its responsibilities, and not waste dear taxpayer resources for an improper purpose. Utah Medical respectfully seeks the following administrative remedies:
1) removal of the August 10, 2004 FDA press release which remains posted on
the FDA’s website;
In recent criticism, Rep. Henry A. Waxman, D-Calif., stated that “the FDA can’t do its job when its enforcement arm is tied behind its back.” In response, David Elder, Director of the FDA Office of Enforcement, was quoted in the August 2006 issue of the “Guide to Medical Device Regulation,” as follows:
“FDA enforcement cannot be properly judged by counting the number of actions taken by the agency,” he [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. As a result of FDA’s focus on those firms and those violations that present the highest risk to consumers and public health, the agency has taken prompt, targeted and aggressive action against firms that are in violation of law.” (emphasis added)
According to UTMD CEO Kevin Cornwell,
“I agree with Mr. Elder that the number of administrative Warning Letters
issued by FDA has no correlation with the quality of medical devices being
manufactured by industry. I also agree that FDA should be allocating its
limited enforcement resources based on risk to the public health. But that’s
where my agreement with Mr. Elder ends.
The FDA’s published mission statement states, in part,
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
Mr. Cornwell further states,
“The FDA has the power to destroy public institutions and people’s careers
and lives. That power should be used carefully and judiciously. If there’s
not a risk to public health, FDA should not be capriciously using its power
to punish people. It’s a direct contradiction to their mission.
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 www.utahmed.com.