FDAnews Device Daily Bulletin

COURT DOCUMENTS SHOW GUIDANT WAITED TO WARN OF DEVICE HAZARDS

June 15, 2006
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Guidant in January 2005 chose not to alert physicians about electrical flaws in two heart defibrillators when the company knew of the defects, allowing patients to continue being implanted with the faulty devices, according to recently released documents.

A Texas district judge June 6 unsealed 22 court documents related to a product liability lawsuit against Guidant, including a detailed draft of a "Dear Doctor" letter warning of potential device failures that was never sent.

The lawsuit claims Guidant knew its Ventak Prizm 2 defibrillators might fail and did not warn patients. Guidant has fought to keep thousands of pages in the Texas product liability lawsuit confidential, according to reports.

An independent panel commissioned last summer to review Guidant's handling of its failed heart devices said the company's internal and external communications methods "burdened the company's ability to manage and communicate low-frequency malfunctions." The panel also found that decisions about how to address product problems were motivated by statistical projections by engineers rather than medical assessments by clinicians.

Problems first surfaced in May 2005, but it became apparent that Guidant's Cardiac Rhythm Management (CRM) group had known about the defects since at least April 2002, according to the report.

(http://www.fdanews.com/ddl/33_24/)