-----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, LQDjVkLW1HYDDMSOBgPxCDn9qapwpCthAUK/bi7fMUMFHJ/SHRcTqnpt1ASOYhYM SVcVc49i5oYDMEwuwmStkQ== 0001096906-04-000328.txt : 20040811 0001096906-04-000328.hdr.sgml : 20040811 20040811113808 ACCESSION NUMBER: 0001096906-04-000328 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040810 ITEM INFORMATION: Other events FILED AS OF DATE: 20040811 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: 04966187 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k081104.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): August 10, 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 5. OTHER EVENTS - -------------------------------------------------------------------------------- On August 10, 2004, Utah Medical Products, Inc. issued a press release, further commenting on the FDA Complaint and FDA Employee Comments. 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: 8/11/2004 By: /s/ Kevin L. Cornwell --------------------- -------------------------- Kevin L. Cornwell CEO - -------------------------------------------------------------------------------- EXHIBIT INDEX Index Number Description - ------ ----------- 99.1 Press release issued August 10, 2004: UTMD Further Comments on FDA Complaint and FDA Employee Comments. EX-99.1 2 utahmed8k081104ex99-1.txt EXHIBIT 99.1 Salt Lake City, Utah - Utah Medical Products, Inc. (NASDAQ:UTMD) is responding to a Press Release issued today and comments made by Food and Drug Administration (FDA) employees which UTMD believes are deliberately misleading to the reader. The complaint which the FDA filed and publicized has not been served on UTMD. However, UTMD understands that the content of this complaint is standard and that the FDA has the burden to prove its allegations. An answer to the complaint will be filed, but UTMD believes in the judicial process and welcomes the opportunity to seek the discovery it has been denied for over three years. Neither the complaint nor any direct FDA communications to UTMD has identified or suggested any issue relating to the safety or effectiveness of UTMD devices. This fact coupled with ISO 13485 Certification are continuing verification of the superiority of UTMD quality systems. Users of UTMD devices can take comfort in the quality and performance of its devices. UTMD Chairman and CEO Kevin Cornwell, after reviewing statements made by FDA employees, had this to say: "It is unfortunate that FDA would publicize comments that border on hearsay and attribute them to Acting Commissioner Lester M. Crawford and Larry Spears. I spoke personally on two very recent occasions with Les Crawford and he never expressed any concern about the performance of any of our devices. The statements attributed to him are not supported by fact and I confirm that users can continue to expect that our devices are safe and effective. The employees that provided the information underlying the statements do not and, to our knowledge, never have had the responsibility to manufacture any medical device. While disappointed in the comments attributed to Crawford, I am very troubled by the hearsay comments attributed to Larry Spears. The FDA makes allegations of violations/deviations in the hundreds of Warning Letters it issues annually. Yet, it is rarely challenged to prove these allegations. There is not and never has been an imminent public health risk relating to UTMD's products, and this statement attributed to Mr. Spears is correct: "There's not a serious enough problem to say ..." that. As a matter of fact, the FDA has a variety of remedies to address device risks without any resort to the courts. None of these has ever been applied to any UTMD device, because none has been justified. Finally, an attorney from FDA indicated as long ago as last October that this case does not involve any allegations of defective products. This case instead involves QSR allegations that the agency has been unable to substantiate." UTMD maintains support for the quality, performance, safety and effectiveness of devices in distribution as these are manufactured daily by dedicated employees complying with procedures that have been verified by independent experts. The prospect of litigation is rarely welcome, but UTMD is confident that when the FDA's allegations are scrutinized by the Court, aided by the power of discovery, that UTMD will prevail. -----END PRIVACY-ENHANCED MESSAGE-----