FDAnews Device Daily Bulletin

COURT DOCUMENTS SHOW GUIDANT WAITED TO WARN PHYSICIANS, PATIENTS OF DEVICE HAZARDS

June 8, 2006
A A

Guidant in January 2005 chose not to alert physicians about electrical flaws in two heart defibrillators when the company knew of the defects, allowing heart patients to continue being implanted with the 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 that was never sent warning of potential device failures.

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.

Boston Scientific, which completed its purchase of Guidant in April, is not commenting on the details of the case.

For more information, see the full story in the upcoming June 12 issue of Devices & Diagnostics Letter.