-----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, FaTIFtShcNYnTZc4s7C5O+h4W/lJkkFVJ9cPOTn0hoxr00GfXNwkhSIi2VXW535x 1oW92wJSO7OW0ZGMAVlMjg== 0001096906-05-000627.txt : 20051024 0001096906-05-000627.hdr.sgml : 20051024 20051024153014 ACCESSION NUMBER: 0001096906-05-000627 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051021 ITEM INFORMATION: Other Events FILED AS OF DATE: 20051024 DATE AS OF CHANGE: 20051024 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: 051151985 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k102105.htm UTAH MEDICAL PRODUCTS FORM 8-K OCTOBER 21, 2005 Utah Medical Products Form 8-K October 21, 2005



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): October 21, 2005


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 incorporation or organization)
(I.R.S. Employer 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 October 24, 2005, Utah Medical Products, Inc. issued a press release announcing that the U.S. Federal District Court dismissed the FDA’s lawsuit against UTMD. 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:              10/24/05               
By:
   /s/ Kevin L. Cornwell       
   
Kevin L. Cornwell
   
CEO





EXHIBIT INDEX



Index
Number
Description
   
99.1
Press release issued October 24, 2005: Utah Medical Products’ Compliance with QSR Confirmed.
 
 
 

EX-99.1 2 utahmed8k102105ex99-1.htm EXHIBIT 99.1 Exhibit 99.1



EXHIBIT 99.1

Salt Lake 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 is operating in compliance with 21 CFR '820, the U.S. Food & Drug Administration (FDA) Quality System Regulation (QSR).

The Court disagreed with all allegations by the FDA, and dismissed the lawsuit filed in August 2004 that sought to shut down UTMD, without any evidence of unsafe, ineffective, or defective products or products causing any patient harm, until UTMD complied with the FDA’s interpretation of the QSR, an interpretation that was never provided to UTMD until after the lawsuit was filed.

According to Judge Bruce S. Jenkins, in the “Memorandum Opinion & Order” dated October 21, 2005,
“This is an unusual case. The safety of the products manufactured by Utah Medical has 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 in complying with the applicable quality system regulations (21 CFR § 820), and asserting that a failure to comply by definition produced an adulterated product 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.

During the extended process carried on by the parties and by the Court in passing on motions 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 product defined as adulterated.

The 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 the FDA misreads its own regulations.”
 
*****

“The 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 its 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 handling.”

*****

“It makes no sense for the court to order Utah Medical to do something they are already doing.”(emphasis added)
 
*****

The full 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.)

UTMD will follow-up this announcement with additional comments.

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 disposable and reusable specialty medical devices designed for better health outcomes for patients and their care-providers. For more information about Utah Medical Products, Inc., visit UTMD’s website at www.utahmed.com.
 
 

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