Full Press Release Details
City, Utah - Utah Medical Products, Inc. (UTMD) announces that the U.S. Federal
District Court in Salt Lake City, on October 21, 2005, confirmed that UTMD
operating in compliance with 21 CFR '820,
U.S. Food & Drug Administration (FDA) Quality System Regulation (QSR).
disagreed with all allegations by the FDA, and dismissed the lawsuit filed
August 2004 that sought to shut down UTMD, without any evidence of unsafe,
ineffective, or defective products or products causing any patient harm,
UTMD complied with the FDA's interpretation of the QSR, an interpretation that
was never provided to UTMD until after the lawsuit was filed.
to Judge Bruce S. Jenkins, in the "Memorandum Opinion & Order" dated October
an unusual case. The safety of the products manufactured by Utah Medical
never been at issue. Even though product safety is a non-issue, the relief
originally sought by the United States was to stop Utah Medical's products from
entering commerce because of alleged persistent deficiencies of Utah Medical
complying with the applicable quality system regulations (21 CFR 820), and
asserting that a failure to comply by definition produced an adulterated
and subjected the product and the persons responsible for the product to
regulatory action. In short, the United States asked that Utah Medical be
ordered to stop the sale of product until Utah Medical complies with the
regulation 21 CFR 820 and
in a manner that has been found acceptable to FDA.
the extended process carried on by the parties and by the Court in passing
and during the pretrial conference, and during the trial itself, the United
States on the record softened the relief that it sought to simple regulatory
compliance, and abandoned the more draconian relief of stopping sales of
defined as adulterated.
relief early sought by the United States assumed that compliance with the
regulations and in a manner satisfactory to the FDA are the same. But Utah
Medical has asserted full compliance with the regulations and insists that
FDA misreads its own regulations."
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
makes no sense for the court to order Utah Medical to do something they are
already doing."(emphasis
text of the Court's decision can be accessed on the Internet at
http://www.utd.uscourts.gov/reports/media/img1021.pdf. (The report is displayed
on pages 135-149 of the PDF file.)
follow-up this announcement with additional comments.
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