Internal Turmoil at Device Maker as Inquiry Grew
By Barry Meier, the New York Times, February 28, 2006
As the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its
heart devices, the company's public message was upbeat and insistent: concerns about the safety of its products were
overblown, it said, and perhaps even irresponsible.
But newly released documents show that, inside Guidant, executives were struggling to contain a mounting crisis. The
records illustrate how a series of miscalculations by Guidant, like its misreading of doctors' tolerance for being kept in
the dark and its initial decision not to recall the devices, put the company on the defensive. As a result, company
executives repeatedly changed course.
In a voice message to sales personnel on June 8, for example, R. Frederick McCoy Jr., the head of Guidant's cardiac
device unit, said he realized after speaking to doctors that Guidant's initial decision not to provide free replacement
devices "was not in the best interest of the company," according to a transcript. The documents are part of a product
liability lawsuit against the company.
Early on, senior executives alerted one another that scrutiny of Guidant might intensify if doctors or others started
looking into a public database that gave details concerning product failures.
The documents also show that sales representatives expressed alarm that some doctors were challenging Guidant's
ethics and had stopped implanting its devices.
Guidant executives, both then and now, have defended their decision not to publicize certain device defects, arguing
that to have done so would have exposed patients to the greater risks posed by replacement surgery. But some company
executives quickly realized that to win back the trust of their customers — doctors — they had to change the way they
disclosed problems, the records show.
Some physicians were particularly upset that Guidant had sold potentially flawed units out of inventory, rather than
pulling them back so that the units would not be implanted.
"I am not critical of Guidant's device problems — these devices are so complex, issues are expected," wrote one
physician, Dr. Brian D. Jaffe of Traverse City, Mich., in a letter last July that was included in the court documents. "I
will not, however, work with a company that put profit and image in front of good patient care and honesty in device
The newly disclosed records, which come from the files of Mr. McCoy, could add to the company's legal problems as it
defends itself against allegations that it put patients at risk by not publicizing defects. At least seven patients have died