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.

Guidant is now owned by Natick, Mass.-based Boston Scientific Corp. Shares of Boston Scientific fell 31 cents, or 1.5%, to $20.22 on Wednesday.