Federal Prosecutors Subpoena Guidant Records

January 2006

Did Guidant executives know more about defective heart defibrillators than they let on? Documents suggesting that Guidant executives debated about telling doctors that some heart defibrillators had the potential of short-circuiting have been subpoenaed by federal prosecutors as the investigation into Guidant continues.

The Justice Department is focusing on Guidant’s handling of safety issues related to the Prizm 2 DR, Contak Renewal and the Contak Renewal 2 defibrillators. To date, the short-circuiting of these defibrillators has led to seven deaths. The requested documents suggest that in October 2004, more than two years after discovering the Prizm 2 DR failures, Guidant recognized that a number of Contak Renewals were also short circuiting. The company waited until June 2005 to disclose the information, after the Food and Drug Administration (FDA) began asking questions.

Guidant, who maintains that the number of failures was too small to report, could face criminal as well as civil charges if these findings are proven true.

For more information, visit the Guidant Pacemaker Legal Center.

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