-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UWR1PmCyMxjNwV+sdngGPxmadI34Aq+c6a1OPiheawqrITUDdFDHXHuVUUY1zaTI rYyAoKtTcCs6a8XHxXx8Kw== 0001096906-04-000526.txt : 20041215 0001096906-04-000526.hdr.sgml : 20041215 20041215120947 ACCESSION NUMBER: 0001096906-04-000526 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041215 ITEM INFORMATION: Other Events FILED AS OF DATE: 20041215 DATE AS OF CHANGE: 20041215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UTAH MEDICAL PRODUCTS INC CENTRAL INDEX KEY: 0000706698 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 870342734 STATE OF INCORPORATION: UT FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12575 FILM NUMBER: 041203856 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k121504.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (date of earliest event reported): December 15, 2004 Commission File No. 0-11178 ------- UTAH MEDICAL PRODUCTS, INC. --------------------------- (Exact name of Registrant as specified in its charter) UTAH 87-0342734 ------------------------------- ------------------ (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 7043 South 300 West Midvale, Utah 84047 ------------------- Address of principal executive offices Registrant's telephone number: (801) 566-1200 -------------- - -------------------------------------------------------------------------------- ITEM 8.01 OTHER EVENTS - -------------------------------------------------------------------------------- On December 15, 2004, Utah Medical Products, Inc. issued a press release providing an update on the status of FDA litigation. A copy of the press release is attached hereto as Exhibit 99.1 - -------------------------------------------------------------------------------- SIGNATURES - -------------------------------------------------------------------------------- Pursuant to the requirements of the Securities Exchanges Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. UTAH MEDICAL PRODUCTS, INC. --------------------------- REGISTRANT Date: 12/15/04 By: /s/ Kevin L. Cornwell ------------------- ------------------------ Kevin L. Cornwell CEO - -------------------------------------------------------------------------------- EXHIBIT INDEX Index Number Description - ------ ----------- 99.1 Press release issued December 15, 2004: UTMD Updates Status of FDA Lawsuit EX-99.1 2 utahmed8k121504ex99-1.txt EXHIBIT 99.1 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. -----END PRIVACY-ENHANCED MESSAGE-----