FDAnews Device Daily Bulletin

GUIDANT SUED BY 20 INSURANCE GROUPS OVER DEFECTIVE DEFIBRILLATORS

June 5, 2006
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Patients implanted with defective Guidant defibrillators who are seeking to replace those devices have learned that replacing them can pose an even greater risk.

Those patients require lifetime monitoring by physicians, a service which is having a negative impact on the bottom lines of health insurance companies. As a result, 20 of BlueCross/BlueShield's 38 nationwide plans have filed lawsuits against Guidant for an undisclosed amount.

Guidant issued a recall of the devices in June 2005, but it became clear that its Cardiac Rhythm Management (CRM) division had known about the defects since at least April 2002. While information on the defects was reported to the FDA by CRM at the time they were discovered, that information was not passed on to Guidant management, the public or patients, an independent report found.