-----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, G6iITxv6wp4j+YNY2IzjXm21paaXsgvP8uXFbvUZmNsIelWiuvr/b+NrMRy11XFp WeWYR1e4mqWs7kKDqRCoug== 0001096906-06-000087.txt : 20060215 0001096906-06-000087.hdr.sgml : 20060215 20060215111233 ACCESSION NUMBER: 0001096906-06-000087 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060214 ITEM INFORMATION: Other Events FILED AS OF DATE: 20060215 DATE AS OF CHANGE: 20060215 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: 06620317 BUSINESS ADDRESS: STREET 1: 7043 S 300 WEST CITY: MIDVALE STATE: UT ZIP: 84047 BUSINESS PHONE: 8015661200 8-K 1 utahmed8k021406.htm UTAH MEDICAL PRODUCTS, INC. FORM 8-K FEBRUARY 14, 2006 Utah Medical Products, Inc. Form 8-K February 14, 2006



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): February 14, 2006


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 February 15, 2006, Utah Medical Products, Inc. issued a press release announcing that on February 14, 2006 it received a letter from the Department of Health and Human Services denying its claim under the Federal Tort Claims Act alleging abuse of process in relation to the negligence and wrongful acts of U.S. Food & Drug Administration employees. 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:           2/15/06            
By:
  /s/ Kevin L. Cornwell
   
Kevin L. Cornwell
   
CEO



 


EXHIBIT INDEX



Index
Number
Description
   
99.1
Press release issued February 15, 2006: Utah Medical Products’ Claim Denied by HHS
 
 
 
 
 
 
 
 
 
 
 
 

EX-99.1 2 utahmed8k021406ex99-1.htm EXHIBIT 99.1 Exhibit 99.1



EXHIBIT 99.1

Salt Lake City, Utah - On July 15, 2005, Utah Medical Products, Inc. (UTMD) filed an administrative claim with the Department of Health and Human Services (HHS), the parent of the U.S. Food & Drug Administration (FDA), under the Federal Tort Claims Act (FTCA), alleging abuse of process in relation to the negligence and wrongful acts of FDA employees while acting within the scope of their employment during the inspections, review and subsequent enforcement actions taken and/or attempted, including public statements, during the period of 2001 through 2005.

On February 14, 2006, UTMD received a letter from HHS dated February 10, 2006,
“This letter constitutes the notice of final determination on this claim, as required by 28 U.S.C. '1346(b). Your client’s [UTMD’s] claim is not cognizable under the FTCA. Accordingly, the claim of Utah Medical Products, Inc, is hereby denied.”

The claim that UTMD filed is now available to the public on UTMD’s website www.utahmed.com, or by contacting Kevin Cornwell.

It remains UTMD’s conviction that the claim is valid. The very misleading August 10, 2004 press release which appeared on the official FDA website is a good example. The Company believes that it has proof of fraudulent reports by inspectors, reviewers and other FDA employees which led to an ordeal in which the Company prevailed, but was significantly damaged.

According to Judge Bruce S. Jenkins, in the “Memorandum Opinion & Order” dated October 21, 2005,

“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.”
 
*****
 
According to CEO Kevin Cornwell,
“We were hoping that independent and objective representatives of the executive branch of government would have been assigned to investigate this claim, and be willing to discuss a constructive settlement with UTMD. Such a settlement would include restoring our reputation for manufacturing high quality products, rectifying a permanent public record that is incorrectly disparaging of UTMD, actually conducting the UTMD requested investigation in which FDA claimed it found no evidence of inspector bias but has been proven never to have happened, and repaying UTMD’s totally unnecessary costs of litigation that resulted because no one in FDA wanted to open a dialogue regarding UTMD’s responses to predetermined inspectional observations. It continues to be disappointing that officials in our government prefer to hide than to admit any wrongdoing. It’s not hard, with an effective quality system, to do the right thing necessary to take corrective actions, and appropriate preventive actions for the future.

There is much more of a story here of systemic corruption than has been publicly disclosed to date. Fraud, which according to a dictionary is “deliberate deception for unfair gain,” is not included in the discretionary function privilege of the government.”

UTMD now is free to file suit against the FDA in the federal district court, or file a request for reconsideration, before August 10, 2006. The Company will carefully consider all of its options.

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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