Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged Feb. 25, 2010 with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators, according to a U.S. Department of Justice (DOJ) press release.

DOJ filed the criminal information in connection with an agreement with Guidant to resolve the charges. A formal guilty plea agreement is expected to be filed with the court at a later date. Boston Scientific previously announced in a November 2009 press release that the company would pay $296 million on behalf of Guidant in connection with these charges, according to the release.

According to the information filed Feb. 25 in federal district court in St. Paul, Minn., Guidant concealed information from the U.S. Food and Drug Administration (FDA) regarding catastrophic failures in some of its lifesaving devices. The charges were filed following a four-year investigation into Guidant’s handling of short-circuiting failures of three models of implantable cardioverter defibrillators (ICDs): the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005.

Failure to report adverse events regarding medical devices or pharmaceutical products, as required by law, may be the basis of a False Claims Act case.

For the full release, go to:

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