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Boston Scientific Responds to DOJ Civil Lawsuit

Fri, 01/28/2011 - 4:32am
Boston Scientific

NATICK, Mass., Jan. 28, 2011 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced that yesterday afternoon, the Civil Division of the U.S. Department of Justice (DOJ) filed a civil False Claims Act complaint against Boston Scientific, Guidant LLC and other entities.  This complaint involves Guidant's conduct leading to the 2005 recalls of PRIZM™ 2 and RENEWAL® implantable cardioverter defibrillators (ICDs).  The Guidant conduct at issue took place from 2002 to 2005, well before Boston Scientific acquired Guidant in 2006.  The Criminal Division of DOJ initiated an investigation into this conduct in 2005, and that investigation resulted in a plea agreement between Guidant LLC and the Criminal Division of the DOJ in November 2009.  Shortly after reaching this plea agreement with the Criminal Division of the DOJ, the Company was notified that the Civil Division of the DOJ was initiating an investigation into whether Guidant should make an additional payment of a civil penalty under the False Claims Act.  This DOJ civil investigation has been disclosed in periodic SEC filings since that time.

The Company is disappointed that the Federal Government, after reaching a criminal resolution with Guidant LLC, has chosen to seek additional money in a civil lawsuit.  However, the Company believes that the ultimate resolution of this matter should not have a significant financial impact.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.  For more information, please visit: www.bostonscientific.com.  

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words.  These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance.  These forward-looking statements include, among other things, statements regarding financial performance, resolution of government proceedings, regulatory compliance and product performance.  If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.  These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release.  As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.  

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors.  All of these factors are difficult or impossible to predict accurately and many of them are beyond our control.  For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter.  We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.  This cautionary statement is applicable to all forward-looking statements contained in this document.

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