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 number of failures exceeded a specific number at a given point.
In a posting on its Web site yesterday, Guidant said that it knew of two patient deaths associated with short circuits in the Prizm 2 DR and five other patient deaths associated with short circuits in devices called the Contak Renewal and Contak Renewal 2. The flaws are all associated with Guidant's use of an insulating material in a way that caused it to deteriorate.
Dr. William H. Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, said yesterday in a telephone interview that all heart device makers typically perform hazards assessments after discovering a device flaw. But Dr. Maisel said he remained troubled that Guidant d not disclose the data about the short circuits and the statistical analysis the company performed.
Largely as a result of the Guidant episode, device makers, doctors and the F.D.A. are trying to develop uniform guidelines for manufacturers to disclose product flaws to physicians. Doctors can then weigh such risks against those posed by added surgery in deciding whether to replace a device early.
Guidant initially said that it believed that the risk of replacing a Prizm 2 DR might outweigh those posed by the device itself. It was in early 2002 that it learned from reports that the Prizm 2 DR was prone to short-circuiting.
In April and November 2002, company engineers took steps to prevent the short-circuiting. But the company kept selling older models out of inventory even after an improved one was available.
In its June 2002 assessment, Guidant described the flaws 'overall health risk index' as 'very low.'
At about the same time that Guidant discovered the problem with the Prizm 2 DR, the company was awaiting approval from the F.D.A. to market the Contak Renewal.
Company officials have repeatedly declined to describe the steps they took, if any, at that time to determine if the Contak Renewal might also short-circuit.
The Texas lawsuit, which is scheduled to begin in late February, could be the first Guidant case in the current wave of lawsuits to go to trial.
The company in its profit forecast said on Dec. 14 that it had received seven reports of deaths related to heart defibrillator failures since the company recalled 109,000 of the devices in June.
Boston Scientific and Johnson & Johnson are bidding to acquire Guidant.