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
July 7, 2006 (Press Release) --
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 Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators. The revelation could also have implications for Boston Scientific, which completed its acquisition of Guidant in April, the newspaper said.
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. And a spokesman for Boston Scientific said the company would not comment on the Guidant documents, but added that his company recognized the need for more transparent communication with patients and doctors.
Since last fall, the federal inquiry has delved into Guidant's handling of safety issues affecting several defibrillators that have since been recalled. Two legal experts have said that the type of federal health care statutes under which the company is being investigated could result in civil or criminal charges, the Times reported.
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
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 Food and Drug Administration have been conducting an inquiry into Guidant's handling of safety issues affecting several now-recalled defibrillators. The revelation could also have implications for Boston Scientific, which completed its acquisition of Guidant in April, the newspaper said.
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. And a spokesman for Boston Scientific said the company would not comment on the Guidant documents, but added that his company recognized the need for more transparent communication with patients and doctors.
Since last fall, the federal inquiry has delved into Guidant's handling of safety issues affecting several defibrillators that have since been recalled. Two legal experts have said that the type of federal health care statutes under which the company is being investigated could result in civil or criminal charges, the Times reported.
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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