Notice: Medtronic, Inc. Cardiovascular Division, Santa Rosa, CA; Notice 
of Revised Determination on Remand

Federal Register: April 24, 2008 (Volume 73, Number 80)             
                  Page 22173-22175

Agency:  DEPARTMENT OF LABOR
         Employment and Training Administration


    On February 27, 2008, the United States Court of International 
Trade (USCIT) granted the Department of Labor's motion for voluntary 
remand for further investigation in Former Employees of Medtronic, Inc. 
v. United States, Court No. 07-362.
    The worker-filed petition for Trade Adjustment Assistance (TAA) and 
Alternative Trade Adjustment Assistance (ATAA), dated June 14, 2007, 
alleged that the subject workers produced ``medical stents'' and that 
the subject firm shifted production to a foreign country. Petitioners 
did not identify the foreign country to which production shifted.
    On July 19, 2007, the Department of Labor (Department) issued a 
negative determination regarding eligibility to apply for TAA/ATAA for 
workers and former workers of Medtronic, Inc.,

[[Page 22174]]

Cardiovascular Division, Santa Rosa, California (the subject firm). The 
initial investigation revealed that the subject workers produced 
cardiovascular stents and that, during the relevant period, the subject 
firm did not import cardiovascular stents and did not shift production 
to a foreign firm. A survey of the subject firm's major declining 
domestic customers was not conducted because the subject firm sold its 
stents to an affiliated, foreign facility. The Department's Notice of 
negative determination was published in the Federal Register on August 
2, 2007 (72 FR 42436).
    In the request for reconsideration, dated August 7, 2007, the 
petitioning workers alleged that production ``was indeed shifted to a 
foreign country, Ireland, based on the information we received from'' 
the subject firm. The Department issued a Notice of Affirmative 
Determination Regarding Application for Reconsideration on August 16, 
2007. The Notice was published in the Federal Register on August 27, 
2007 (72 FR 49026).
    On September 11, 2007, the Department issued a negative 
determination on reconsideration stating that Section (a)(2)(B) of the 
Trade Act of 1974, as amended, was not met. The negative determination 
was based on the Department's findings that, while the subject firm did 
shift cardiovascular stent production to Ireland, as alleged, Ireland 
does not have a free trade agreement with the United States and is not 
named as a beneficiary country under the Andean Trade Preference Act, 
the African Growth and Opportunity Act or the Caribbean Basin Economic 
Recovery Act, and that, following the shift of production, the subject 
firm did not import or plan to import articles like or directly 
competitive with those produced at the subject firm. The Department's 
Notice of negative determination on reconsideration was published in 
the Federal Register on September 21, 2007 (72 FR 54074).
    In their complaint to the USCIT, dated October 3, 2007, the 
Plaintiffs made the same allegation they made in the request for 
reconsideration--that production shifted to Ireland--and two new 
allegations--that production shifted to Mexico and that the subject 
firm shifted production to a foreign country and will import stents 
like or directly competitive with those produced at the subject firm 
(``Medtronic's is awaiting FDA approval of their Drug Eluding Stents 
(DES) * * * the DES will be made available to the medical markets in 
the United States'').
    In order to be certified under Section (a)(2)(B) of the Trade Act 
of 1974, as amended, the Department must determine that the following 
was satisfied:

    A. A significant number or proportion of the workers in such 
workers' firm, or an appropriate subdivision of the firm, have 
become totally or partially separated, or are threatened to become 
totally or partially separated; and
    B. There has been a shift in production by such workers' firm or 
subdivision to a foreign country of articles like or directly 
competitive with articles which are produced by such firm or 
subdivision; and
    C. One of the following must be satisfied:
    1. The country to which the workers' firm has shifted production 
of the articles is a party to a free trade agreement with the United 
States; or
    2. The country to which the workers' firm has shifted production 
of the articles is a beneficiary country under the Andean Trade 
Preference Act, African Growth and Opportunity Act, or the Caribbean 
Basin Economic Recovery Act; or
    3. There has been or is likely to be an increase in imports of 
articles that are like or directly competitive with articles which 
are or were produced by such firm or subdivision.

    During the remand investigation, the Department confirmed that 
cardiovascular stent production shifted from the Medtronic facility in 
Santa Rosa, California, to Galway, Ireland, and did not shift to 
Mexico. Accordingly, the Department determines that Section 
(a)(2)(B)(A) and Section (a)(2)(B)(B) have been met, and that Section 
(a)(2)(B)(C)(1) and Section (a)(2)(B)(C)(2) have not been met. 
Consequently, in order to be certified as eligible to apply for TAA, 
the Department must determine that the petitioning worker group 
satisfies Section (a)(2)(B)(C)(3).
    The Department obtained new information during the remand 
investigation that, after the Department issued its negative 
determination on reconsideration, the U.S. Food and Drug Administration 
(FDA) approved Medtronic's application for approval of a drug-eluding 
cardiovascular stent to be used in the United States.
    On February 1, 2008, Medtronic issued a news release stating that 
the FDA-approved DES, Endeavor, ``provides a consistent and sustained 
reduction in the need for repeat procedures compared to a bare-metal 
stent'' and that ``The U.S. market launch of the Endeavor stent begins 
immediately.'' The news release further states that, prior to FDA 
approval of the DES, Medtronic has been ``strengthening our field and 
manufacturing capabilities in anticipation of considerable demand for 
the Endeavor stent in the United States'' and that Medtronic plans to 
``ship 100,000 units to U.S. hospitals in the next 30 days to assure 
full availability of this next-generation technology.''
    During the remand investigation, the Department conducted an 
industry research of cardiovascular stents. The Department's research 
revealed that bare-metal stents function similarly to drug-eluding 
stents in that both devices are tiny mesh tubes used to keep open 
arteries to increase or restore blood flow to the heart muscle. The two 
devices differ in that the DES delivers medication that reduces the 
probability that blockages will reform in the artery, while the bare-
metal stent is a static, structural device. Accordingly, the Department 
determines that drug-eluding cardiovascular stents are like and 
directly competitive with bare-metal cardiovascular stents.
    As the result of the remand investigation, the Department 
determined that there was a shift in production by the subject firm to 
a foreign country of articles like or directly competitive with the 
cardiovascular stents produced by the subject firm and that, following 
the shift of production to a foreign country, there is an increase in 
imports (actual or likely) by Medtronic, Inc. of articles that are like 
or directly competitive with the article produced at the subject firm.
    In accordance with Section 246 of the Trade Act of 1974 (26 U.S.C. 
2813), as amended, the Department herein presents the results of its 
investigation regarding certification of eligibility to apply for ATAA. 
The Department has determined in this case that the group eligibility 
requirements of Section 246 have been met.
    A significant number of workers at the firm are age 50 or over and 
possess skills that are not easily transferable. Competitive conditions 
within the industry are adverse.

Conclusion

    After careful review of the facts generated through the remand 
investigation, I determine that there was a total or partial separation 
of a significant number or proportion of workers at the subject firm, 
and that there was a shift in production to a foreign country followed 
by likely increased imports of articles like or directly competitive 
with cardiovascular stents produced at the subject firm.
    In accordance with the provisions of the Act, I make the following 
certification:

    All workers of Medtronic, Inc., Cardiovascular Division, Santa 
Rosa, California, who became totally or partially

[[Page 22175]]

separated from employment on or after June 14, 2006, through two 
years from the issuance of this revised determination, are eligible 
to apply for Trade Adjustment Assistance under Section 223 of the 
Trade Act of 1974, and are eligible to apply for alternative trade 
adjustment assistance under Section 246 of the Trade Act of 1974.

    Signed at Washington, DC, this 25th day of March 2008.
Elliott S. Kushner,
Certifying Officer, Division of Trade Adjustment Assistance.
[FR Doc. E8-8978 Filed 4-23-08; 8:45 am]

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