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Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

lawed devices without communicating candidly with the FDA and doctors."

The public is reminded that the charges contained in a criminal information are not evidence of guilt. A defendant is presumed innocent unless and until proven guilty.

The case was investigated by the FDA's Office of Criminal Investigations and is being prosecuted by AUSA Robert M. Lewis of the U.S. Attorney's Office for the District of Minnesota and Trial Attorneys Ross S. Goldstein and Matthew S. Ebert of the Department of Justice's Office of Consumer Litigation. Additional assistance is being provided by Steven Tave of FDA's Office of Chief Counsel.

SOURCE U.S. Department of Justice

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SOURCE U.S. Department of Justice
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