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Guidant Pacemaker | Defibrillator Recall News Article |
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| June 8, 2006 |
Associated Press, "Guidant
Weighed Warning Doctors" |
Newly
unsealed court documents show that Guidant Corp. drafted a letter warning doctors
of a dangerous electrical malfunction in some of its devices designed to restore
a normal heartbeat, but the letter was never sent.
Instead, the company
issued a more routine and less-targeted "product update" after learning
of a short-circuiting problem that had occurred in some units of two defibrillator
models -- a flaw that could prevent a device from delivering a potentially lifesaving
shock to the heart.
The documents, unsealed
over Guidant's objection in a product liability lawsuit in Texas, also indicate
that Guidant executives who devised the company's communications strategy worried
about creating "undue alarm" about the electrical problem, fearing
it could lead to surgeries to remove the potentially faulty devices -- procedures
that might carry more risk than leaving the devices in.
The timeliness and
content of Guidant's safety notifications and its decisions to continue selling
potentially faulty products are the focus of government investigations and more
than 100 class-action and individual suits.
A memorandum of a
June 2005 meeting about a product recall shows that Guidant executives told regulators
that they believed there was a low risk of further problems from the flaw, despite
two patient deaths at that point.
The company ultimately
recalled 88,000 defibrillators starting that month, including the two models
at issue in the warning that was never sent. Guidant also has recalled or issued
safety warnings for more than 200,000 pacemakers. At least seven deaths have
been linked to the devices. |
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| Founded in 1972, Lieff Cabraser
Heimann & Bernstein, LLP is an over fifty attorney
law firm with offices in San Francisco, New York and
Nashville. For the last six years, the National
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representing scores of Guidant patients with
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To learn more about our firm, click
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| Our firm consists
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Our lawyers
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There is no
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We are pleased
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We have expert
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