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Judge Delays Ruling on Boston Scientific Guilty Plea | 24-7-news.com cialis online

Judge Delays Ruling on Boston Scientific Guilty Plea

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It will be at least a few more weeks before Boston Scientific is able to finalize a settlement with the federal government to resolve criminal charges involving its Guidant defibrillators.

According to the Minneapolis Star Tribune, the government investigation that resulted in the proposed settlement centered on three Guidant devices that had the potential to short-circuit — the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155) models of implantable defibrillators. Three safety alerts were issued about these defibrillators in June 2005.

The FDA later determined these were Class I recalls, which are the most serious type of device recall because there is a reasonable change the devices could cause serious health problems or death. Malfunctions in the defibrillators were linked to multiple deaths.

Federal prosecutors alleged that Guidant executives knew about the problems and changed the design of its implantable defibrillators years earlier, falsely telling the FDA its design changes did not affect safety or effectiveness.

Boston Scientific agreed in November to plead guilty to the charges and pay $296 million to resolve the matter with the U.S. Department of Justice. But yesterday, lawyers for people implanted with the potentially defective implantable defibrillators made convinced a federal judge yesterday to delay approval of a deal that would have resolved federal criminal charges against the company. The lawyers are demanding a piece of the settlement for their clients.

Boston Scientific acquired Guidant in 2006 for $28.4 billion.

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