MEIER Internal Turmoil at Device Maker as Inquiry Grew

MEIER Internal Turmoil at Device Maker as Inquiry Grew -...

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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 manufacturing." 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
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This note was uploaded on 11/30/2009 for the course ENGINEER 367 taught by Professor Minor during the Spring '09 term at Ohio State.

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MEIER Internal Turmoil at Device Maker as Inquiry Grew -...

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