Full Press Release Details
City, Utah - On July 15, 2005, Utah Medical Products, Inc. (UTMD) filed an
administrative claim with the Department of Health and Human Services (HHS),
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
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
February 14, 2006, UTMD received a letter from HHS dated February 10,
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."
that UTMD filed is now available to the public on UTMD's website www.utahmed.com,
contacting Kevin Cornwell.
remains UTMD's conviction that the claim is valid. The very misleading August
10, 2004 press release which appeared on the official FDA website is a good
example. The Company believes that it has proof of fraudulent reports by
inspectors, reviewers and other FDA employees which led to an ordeal in which
the Company prevailed, but was significantly damaged.
to Judge Bruce S. Jenkins, in the "Memorandum Opinion & Order" dated October
court has been impressed as well by Utah Medical's design of product, its
record-keeping of each step along the way, the acceptance in the market of
products, the Company's uniform processing of complaints, and the manner in
which change is made in practice and procedure as a result of complaint
no sense for the court to order Utah Medical to do something they are already
to CEO Kevin Cornwell,
hoping that independent and objective representatives of the executive branch
government would have been assigned to investigate this claim, and be willing
discuss a constructive settlement with UTMD. Such a settlement would include
restoring our reputation for manufacturing high quality products, rectifying
permanent public record that is incorrectly disparaging of UTMD, actually
conducting the UTMD requested investigation in which FDA claimed it found
evidence of inspector bias but has been proven never to have happened, and
repaying UTMD's totally unnecessary costs of litigation that resulted because no
one in FDA wanted to open a dialogue regarding UTMD's responses to predetermined
inspectional observations. It continues to be disappointing that officials
our government prefer to hide than to admit any wrongdoing. It's not hard, with
an effective quality system, to do the right thing necessary to take corrective
actions, and appropriate preventive actions for the future.
much more of a story here of systemic corruption than has been publicly
disclosed to date. Fraud, which according to a dictionary is "deliberate
deception for unfair gain," is not included in the discretionary function
privilege of the government."
is free to file suit against the FDA in the federal district court, or file
request for reconsideration, before August 10, 2006. The Company will carefully
consider all of its options.
Medical Products, Inc., with particular interest in health care for women
their babies, develops, manufactures, assembles and markets a broad range
well-established disposable and reusable specialty medical devices designed
better health outcomes for patients and their care-providers. For more
information about Utah Medical Products, Inc., visit UTMD's website at