PRESS 
    RELEASE 
      
    UTMD Updates Status of FDA Lawsuit 
    
    December
    15, 2004 
    Contact: Kevin L. Cornwell  
    (801) 566-1200  
    Salt Lake City, Utah -
    Utah Medical Products, Inc. (Nasdaq: UTMD) is a defendant in a 
    lawsuit filed four months ago by the Food and Drug Administration (FDA or 
    Agency) in the U.S. District Court in Salt Lake City, alleging violations of 
    the Quality System Regulation (QSR). Compliance with the requirements of the 
    QSR “are intended to ensure that finished devices will be safe and 
    effective…” 
     
    On November 16, 2004, UTMD disclosed the subsequent admissions made by a 
    designated FDA enforcement official, testifying under oath as part of 
    discovery in the lawsuit, that the FDA is not claiming that UTMD’s 
    devices are unsafe, ineffective, defective or causing any harm to patients.
     
     
    Another month has passed in the discovery process since that announcement, 
    and UTMD wishes to update shareholders, clinicians, and other interested 
    constituents with respect to the litigation progress.  
     
    UTMD continues to manufacture and distribute all of its products worldwide 
    without any regulatory restriction, more than four months since the FDA 
    filed its lawsuit. During this time, as part of the discovery process 
    preceding a trial, a number of FDA documents have been obtained, and a few 
    depositions of FDA officials have been taken by UTMD’s lawyers. In the 
    discovery process to date, the FDA has not produced anything that 
    compromises UTMD’s previous opinions that it is in compliance with the QSR. 
    In that context, there is no “bad news” to report to shareholders. 
     
    Unfortunately, the FDA has withheld more than 150 documents pertinent to the 
    case under an assertion of the “deliberative process privilege.” The failure 
    of the FDA to produce these documents has delayed additional depositions of 
    pertinent FDA witnesses. To address this situation, UTMD filed a “Motion to 
    Compel Production of Documents” with the Federal Court on December 10. The 
    Court will need time to consider the Motion and provide a ruling.  
     
    Since the filing of the lawsuit, UTMD has continued to retain highly 
    qualified and respected experts to review its manufacturing operations and 
    quality systems, on-site in Utah. UTMD’s experts continue to strongly 
    support the Company’s position that it is operating in a state of control, 
    in compliance with the QSR. The formal written reports of experts for both 
    sides are due on January 10, 2005.  
     
    After the U.S. Court decides on UTMD’s Motion to Compel, and the expert 
    reports are produced, additional depositions will be required in order to 
    complete discovery. The pretrial hearing is scheduled for May 16. UTMD 
    remains hopeful that the discovery process will remain on track to meet that 
    important date. 
     
    The effectiveness of UTMD’s Quality System continues to be demonstrated, as 
    it was prior to the current dispute which began over three years ago, by the 
    consistently excellent safety and effectiveness performance of UTMD’s 
    products in the marketplace.  
     
    Most users of UTMD devices who rely on the quality and performance of UTMD’s 
    devices have continued to support the Company. UTMD sincerely appreciates 
    that support, and renews its long term proven commitment to the welfare of 
    patients who need the use of UTMD’s market-leading specialty products to 
    help ensure optimal health outcomes.  
     
    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. 
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