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.
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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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