Papers Show Guidant Considered Warning Doctors of Hazards

Last year, as executives of the Guidant Corporation of Indianapolis, IN defended their decision not to tell doctors about significant heart device defects, they cited concerns that doing so could have exposed patients to risks from unnecessary device replacement. But newly released company records show that the medical device manufacturer drafted a detailed document last year that disclosed such hazards to physicians. In that proposed “Dear Doctor” letter, dated January 2005, 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, according to the New York Times. That letter, however, was never sent and more heart patients apparently kept getting those devices: advanced defibrillators known as the Contak Renewal and Contak Renewal 2. 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. Paul Donovan, a spokesman for Boston Scientific, which is based in Natick, Mass., said the company would not comment on specific Guidant documents. But in a statement, Donovan said: “We understand and acknowledge the need for more timely and transparent communication. We are committed to doing a better job of communication with patients and physicians.”