Guidant Wrote Warning Letter it Never Sent

Joe Saunders

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In a letter dated January 2005, Guidant Corp. executives were prepared to warn doctors of potential flaws in their heart device product. However, the letter was never sent because these same officials were concerned about the potential consequences and backlash from sending such a letter. Guidant stated that two company models had an electrical flaw. It also told physicians that it had pulled back all units not yet implanted into patients.

Since last fall, the Department of Justice and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several defibrillators now recalled, including those models.

The proposed "Dear Doctor" letter and other company records released this week by a Texas state judge suggest that the legal and financial consequences from that inquiry could be significant for Guidant and Boston Scientific, which completed its acquisition of Guidant in April.