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Guidant Failed to Warn?

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At a glance:

Guidant considered warning doctors about a malfunction in its implantable defibrillator devices - but decided not to, according to documents. Instead of a warning letter that had been drafted, Guidant sent a routine "product update". 
 
Ultimately, Guidant ended up recalling the devices in question, and some pacemakers as well, after at least seven patient deaths. 
 
The failure to warn, and continued marketing of the defective devices up until the recall, are now the subject of lawsuits and a government investigation.

Guidant never sent doctors letter about defibrillator risks

St. Louis Post-Dispatch - 6/8/2006 5:03 PM

BOSTON — Newly unsealed court documents show 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
 
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