Boston Scientific Corp. will pay $195 million to settle a class-action suit against its Guidant division, ending a legal battle in which patients claimed Guidant Corp. knowingly hid defects in its implantable heart devices.
The Food and Drug Administration is considering not using the word "recall" to warn patients and doctors about defective pacemakers and defibrillators at the request of a physicians' group struggling to deal with a loss of public confidence in the safety of implantable heart devices.
Within the past 18 months alone, Food and Drug Administration recall notices have targeted more than 300,000 implantable heart devices, a majority from Guidant Corp., acquired earlier this year by Boston Scientific.
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.



