Guidant warning letter written, but not sent

By Amy Teeple

Published on June 12, 2006

The newly released documents indicate that Guidant officials were aware of the potentially deadly defect of at least two models of their defibrillators and had drafted a warning letter to doctors that should have been sent in January 2005.

Officials decided against sending the warning letters in order to reduce "undue alarm" over the products. Instead, a "product update" was issued that told doctors to watch for electrical problems in the defibrillators. The update did not note that there were documented issues with specific defibrillators (Renewal models).

Additional unsealed documents showed that even after two deaths, Guidant did not acknowledge any trend and believed "that there is not a reasonable probability of serious adverse health consequences or death."

In June 2005, Guidant recalled about 88,000 defibrillators, including the two models mentioned in the warning letter that was never sent.

Guidant, now owned by Boston Scientific Corp., is the defendant in over 100 class-action and individual lawsuits as well as several government investigations. The focus of these cases is Guidant's actions regarding the defective products. The main issues are the timeline of the company's warnings and the content of those warnings.

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