EXHIBIT 99.1
Salt Lake City, Utah - Utah Medical Products, Inc. (Nasdaq:UTMD) continues its
efforts to discover the basis for a lawsuit filed eight months ago by the Food
and Drug Administration (FDA or Agency) in the U.S. District Court in Salt Lake
City, alleging failure to comply with the FDA Quality System Regulation (QSR).
The discovery of documents and deposition testimony of responsible FDA personnel
provides considerable doubt about FDA management of its resources and
procedures, and interpretation of the QSR.
UTMD, consistent with the stated intent of the QSR "to ensure that finished
devices will be safe and effective..." implemented and maintains procedures
since the QSR became effective in 1997. On November 16, 2004, UTMD announced
that a FDA designated enforcement official admitted under oath that the FDA is
not claiming that UTMD's devices are unsafe, ineffective, defective, or causing
any patient harm. UTMD welcomed these admissions and assures users that it
continues to manufacture safe and effective devices without interruption.
CEO Kevin Cornwell states,
"We remain disappointed and surprised by the conduct of personnel
within the FDA who are responsible for this aggressive and unnecessary
lawsuit against UTMD and its employees. Our desire has always been to
manufacture and distribute devices of the highest quality. I believe
our procedures meet those directed by the QSR, conform to ISO 13485
certification, and result in release of high quality devices that
perform as intended. As the discovery process continues, I am confident
that there is credible evidence to support responsible criticism of FDA
performance."
During the last four months, scores of FDA documents that would not otherwise
have seen the light of day have been produced through the fairness required by
the litigation process. Additionally, testimony under oath has been provided by
numerous FDA personnel including FDA device specialists and national experts.
One of the national device experts was Monica Wilkins, a FDA official who
formerly reviewed inspection reports, and made recommendations for regulatory
actions including injunctions. As part of her testimony under oath about her
five weeks' duration inspection of UTMD during 2004 along with two FDA device
specialists, Ms. Wilkins made a number of statements that support UTMD's
position.
The questions (denoted "Q") are being asked by UTMD legal counsel. The answers
(denoted "A") are provided by Ms. Wilkins under oath.
Q. So you found no evidence during the 2004 inspection that there were
procedures required by the regulations that did not exist; is that true?
A. What I recall, I don't remember citing anything specific to that,
so that would be correct.
****
Q. All I can ask you about is what you've reviewed, and based on what you
reviewed during the 2004 inspection, you found no evidence of Utah
Medical failing to follow its own procedures; is that true?
A. That is true.
****
Q. And through looking at all of those records, you didn't come up with a
single example in which you believed a corrective action should have
been open[ed] but wasn't; is that correct?
A. ....no, I did not find any instance where they did not take
corrective action.
****
Q. That's the words I'm using. There was no observation from the 2004
inspection that a corrective action should have been open[ed] but
wasn't; is that true?
A. Yes, correct.
****
Q. For the corrective actions that had been fully pursued and completed,
you did not see any example of a corrective action that was undertaken
but undertaken improperly; is that correct?
A. Correct, for the sample of records I reviewed.
****
Q. We've gone through a number of observations today in which you reached a
different conclusion than the prior investigator.
A. That is correct.
****
Q. Do you ever remember another inspection in which there were so many
observations that you reached a different conclusion than the prior
inspector?
A. That I wouldn't recall without looking at specific information.
****
CEO Kevin Cornwell states,
"The Federal Court will interpret the evidence presented by the
government and UTMD to decide whether or not UTMD is in compliance with
the QSR.
We sincerely regret that the FDA selected this avenue to discuss our
disagreement with observations and opinions made by FDA investigators
and reviewers who never have had the training, responsibility or
experience to manufacture medical devices. Our efforts to exercise our
option to "disagree with any agency decision, action, or operation
without fear of retaliation" as expressed in a required attachment to
the FDA 482 announcement of inspection was rejected and ignored. Our
repeated requests for feedback regarding UTMD's detailed written
responses to FDA-483 observations were ignored. Our multiple appeals
to supervisory personnel were ignored. Our request to mediate prior to
filing of the lawsuit was ignored. This was not the reception we
expected when we sought to exercise our option to disagree in the year
2001.
The facts do not support the FDA's characterization of UTMD in its
lawsuit. UTMD has dedicated, well-trained personnel who understand the
importance of accuracy and following procedures in the course of
manufacturing millions of specially hand-assembled devices. As UTMD
proceeds to discover the truth, the whole truth, and nothing but the
truth, we hope that the new representatives of this Administration
will recognize that this lawsuit was neither justified nor necessary.
Moreover, we truly believe that the right thing for the government to
do is to acknowledge the great performance of UTMD during a long
history of providing safe and effective medical devices for the
benefit of health care providers and their patients."
For the benefit of shareholders, UTMD affirms its belief in previous statements
in press releases about its conscientious compliance with the QSR, as well as
significant deficiencies in the FDA's performance, which have been increasingly
supported by the evidence in discovery to date. For the benefit of customers,
UTMD continues to manufacture and distribute all of its safe and effective
products worldwide without any regulatory restriction.
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, proven safe and effective, disposable and reusable specialty
medical devices.