Papers Show Guidant Considered Warning Doctors of Hazards
More corporate misdeeds....read more at nytimes.com regarding documents that Guidant's lawyer had tried to keep from the public, but which plaintiffs' lawyers were able to wrench free through a court order:
////
Newly released company records show that Guidant -- a major heart implant manufacturer -- drafted a detailed document last year that disclosed hazards of an electrical flaw in its heart devices 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.
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.
Both Contak Renewal models and another Guidant defibrillator, the Prizm 2 DR, had insulation flaws that could cause them to short-circuit and catastrophically fail. While the Prizm 2 DR was failing at a relatively low rate, Guidant engineers projected in one analysis that 1 out of every 100 Contak Renewals could short-circuit, a failure rate considered high by experts. Guidant also suspected by late 2004 that the Renewal models would become increasingly prone to failure as the devices aged, documents indicate.
At least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of the electrical defect, five involving Contak Renewals. But many experts believe that the number is probably higher because an implanted heart device is rarely examined after a patient's death to determine if it was working properly.
A defibrillator is a life-saving device intended to sense and electrically disrupt potentially fatal heart rhythms. The Contak Renewal combines a pacemaker and a defibrillator, a type of unit that is often referred to as a cardiac resynchronization therapy device, or CRT-D. Such units cost about $35,000 each.
By mid-2004, Guidant had received reports of several electrical failures in the two Contak Renewal models. The Contak Renewal models are mechanically similar though the Renewal 2 has different software. The Renewal 2 was sold only outside the United States, though it was used in this country in clinical trials.
////
Newly released company records show that Guidant -- a major heart implant manufacturer -- drafted a detailed document last year that disclosed hazards of an electrical flaw in its heart devices 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.
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.
Both Contak Renewal models and another Guidant defibrillator, the Prizm 2 DR, had insulation flaws that could cause them to short-circuit and catastrophically fail. While the Prizm 2 DR was failing at a relatively low rate, Guidant engineers projected in one analysis that 1 out of every 100 Contak Renewals could short-circuit, a failure rate considered high by experts. Guidant also suspected by late 2004 that the Renewal models would become increasingly prone to failure as the devices aged, documents indicate.
At least seven patients are known to have died in episodes in which Guidant defibrillators failed to work because of the electrical defect, five involving Contak Renewals. But many experts believe that the number is probably higher because an implanted heart device is rarely examined after a patient's death to determine if it was working properly.
A defibrillator is a life-saving device intended to sense and electrically disrupt potentially fatal heart rhythms. The Contak Renewal combines a pacemaker and a defibrillator, a type of unit that is often referred to as a cardiac resynchronization therapy device, or CRT-D. Such units cost about $35,000 each.
By mid-2004, Guidant had received reports of several electrical failures in the two Contak Renewal models. The Contak Renewal models are mechanically similar though the Renewal 2 has different software. The Renewal 2 was sold only outside the United States, though it was used in this country in clinical trials.
posted by Carolin Shining at 9:47 PM
0 Comments:
Post a Comment
<< Home