More Deaths Linked to Guidant’s Heart Device

From the New York Times:

The added reports may reflect the fact that doctors and family members, in light of the attention given to the Guidant devices, are increasingly having the units checked for problems after a heart patient’s death. They also suggest that the devices’ possible contributions to earlier deaths may have gone unnoticed because implanted heart units are not routinely examined post-mortem.
The new data may pose further legal problems for Guidant because the electrical failures, while involving different models, are all related to the company’s use of an insulating material in a way that apparently made it prone to deterioration. The Justice Department, as part of an investigation into Guidant’s handling of safety issues, is looking into its use of that material, called polyimide.
In a statement, Guidant, which is based in Indianapolis, said that it “regularly communicates information about product performance to various stakeholders including physicians and regulatory bodies.” The company also pointed out that it had recently begun publicly releasing more detailed data about product malfunctions.
In 2002, Guidant discovered that one of its heart devices was prone to short-circuiting. Company officials declined to respond yesterday to written questions about the steps Guidant took, if any, at that time to determine if other company heart devices had the same flaw.
Both the F.D.A. and Guidant have told patients with the affected units that they should consult with their doctors to decide whether the risks posed by the device outweighed those posed by replacement surgery. One heart device specialist, Dr. William H. Maisel, who is based in Boston, said yesterday that the new death reports should not necessarily affect those decisions, because most doctors look at a device’s overall failure rate, rather than the percentage of those failures that involve deaths.

Here’s a timeline detailing Guidant’s annus horrilibus.

Posted by on December 14th, 2005 at 5:17 am


The information in this blog post represents my own opinions and does not contain a recommendation for any particular security or investment. I or my affiliates may hold positions or other interests in securities mentioned in the Blog, please see my Disclaimer page for my full disclaimer.