Guidant Corporation, which last year defended its decision not to tell physicians about significant heart-device defects, had drafted a "Dear Doctor" letter to disclose the hazards but decided not to send it, The New York Times reported Wednesday.

The proposed letter and other company records, released this week by a Texas state judge, may have significant legal and financial consequences. Since last fall, the U.S. Department of Justice and the Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators.

A spokeswoman for the United States attorney's office in Minneapolis that's heading the federal inquiry declined to comment on the investigation, according to the paper's report.

At least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of an electrical defect. But many experts believe that the number is probably higher because implanted heart devices are rarely examined after a patient's death to see if they were working properly, the newspaper said.

A defibrillator is an implanted device that senses potentially fatal heart rhythms and corrects them with a timed electrical shock to restore a normal heartbeat.

Source: http://health.msn.com/centers

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