Full Press Release Details
City, Utah - The outcome of the U.S. Food & Drug Administration's (FDA or
Agency) lawsuit filed in August 2004 was completely consistent with
representations made since 2003 by Utah Medical Products, Inc. (UTMD or Company)
in its public disclosures. For interested parties, this history can be accessed
SEC's website. The facts simply did not support the FDA's characterization of
UTMD in the lawsuit which irresponsibly sought a court injunction to shut
believes that the right thing for the FDA to do now is to clear UTMD's slate
with the Agency, and ensure that future inspections will be conducted fairly
honestly in compliance with the FDA's IOM. Any Agency official involved in the
recent effort to shut down UTMD should be recused from future involvement
UTMD. In addition, the FDA should immediately release the Certificates to
Foreign Governments that they have withheld from UTMD since early 2003, damaging
UTMD's reputation and business activity overseas. Certificates to Foreign
Governments were approved by Congress to encourage export of U.S. products
relieved that this incredible four year long ordeal is over. It is important
that we recognize and sincerely thank our supporters. First, I would like
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. I would
especially like to thank our employees for their pride in our high quality
products and loyalty to the company during a very distressing experience.
of all, I would like to thank our customers who continued to understand the
value of our products for their patients, and allowed us to stay in business
while we fought against the virtually unlimited power of a government agency
with systemic corruption."
15, 2005, UTMD filed an administrative claim under the Federal Tort Claims
with the U.S. Department of Health and Human Services (HHS) alleging abuse
process, and requesting restitution of litigation costs and lost profits.
has until approximately January 15, 2006 to consider the claim.
Cornwell further states,
formal record established at trial, in addition to extensive discovery in
preparation for trial, provide incontrovertible evidence to support that
damaging experience and gross misuse of public resources was the product
major systemic deficiencies within the FDA. We have been both outraged and
embarrassed that our government chose to retaliate and waste millions of
taxpayer dollars because of UTMD's sincere disagreement with observations and
opinions made by FDA investigators and reviewers - none of whom have had
training, responsibility or experience to manufacture medical devices.
impossible to constructively resolve differences when one side simply shuts
all dialogue. For years, our repeated requests for feedback regarding our
detailed written responses to largely sham FDA-483 observations were ignored.
Our multiple appeals to supervisory personnel for productive open dialogue,
linkage of observations to the QSR, were ignored. Our request for non-binding
mediation prior to filing of the lawsuit was ignored.
mission in this case was not to protect public health, but to show 'who's boss.'
The industry should not tolerate dishonest and abusive regulators, who
ultimately harm the quality and cost of healthcare. Without effective FDA
management, a few incompetent and power-driven bureaucrats may run amok defaming
an innocent company. Then others within the Agency fall into a 'group-think'
disease state: this includes the CDRH, FDA Office of Chief Counsel and other
levels of government. UTMD renews its request for a Congressional investigation
that might lead to important reforms for the benefit of the American
2003, UTMD formally requested that FDA conduct an investigation of inspector
bias. Although UTMD received a letter from the FDA Regional Director in August
2003 that stated, "I am advising you that our investigation of your allegations
is now complete have found no evidence of misconduct, wrongdoing, or bias in
connection with the Denver District's evaluation of the facts ," deposition
of FDA employees under oath during discovery for the now dismissed lawsuit
it clear that no investigation was ever done. Since the current verdict verifies
that the Denver District's evaluation of the "facts" was clearly wrong, UTMD
believes that FDA should now assign an independent and honest official who
actually conduct the previously requested investigation.
Medical Products, Inc., with particular interest in health care for women
their babies, develops, manufactures, assembles and markets a broad range
well-established, proven safe and effective, disposable and reusable specialty