Guidant Corporation had projected in an internal report that some patients might die due to short circuits in a heart device, but did not publicize the flaw to retain // acceptability, company records show.
A company report shows Guidant had determined in mid-2002 that the consequences of the defibrillator’s electrical failure, though rare, could be 'life threatening.' Despite that assessment, the company kept selling potentially flawed devices and did not notify doctors about the defect until last spring, when the problem was about to be made public.
One of the Guidant records shows that the company projected in May, before disclosure of the defibrillator's problems, that about 0.15 percent of the units - or 15 units out of every 10,000 - were likely to short-circuit. In such episodes, Guidant estimated that 12 percent of the patients whose units failed, or about 1 in 10, would experience either a Severity Level 5 (death) or Severity Level 4 (life-threatening) event.
The Guidant documents were filed in a Texas state court by plaintiffs' lawyers in connection with a personal injury lawsuit involving the defibrillator known as Prizm 2 DR. The records appear to be the first internal Guidant documents to have emerged in court filings since the company began facing a wave of lawsuits this year.
Guidant officials have maintained that the company did nothing wrong.
The emergence of the Guidant records could intensify the company's legal problems as well as a broader debate about when manufacturers of heart devices should alert physicians about product risks.
In addition, New York State and the city of Bethlehem, Pa., have filed lawsuits against Guidant seeking reimbursement for device-related health care costs.
Another Guidant document filed in connection with the Texas lawsuit shows that the company determined in February that it would not reopen its own investigation into the device's problem until the nPage: 1 2 3 Related medicine news :1
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