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.
The documents, unsealed over Guidant’s objection in a product liability lawsuit in Texas, also show Guidant officials 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 lawsuits.
The company ended up recalling 88,000 defibrillators starting in June 2005. Guidant also has recalled or issued safety warnings for more than 200,000 pacemakers. At least seven deaths have been linked to the devices.
