Guidant Consultant Advised Company to Release Defect Data

Joe Saunders

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A Guidant Corporationconsultant told the medical device company that it had an ethical obligation to inform doctors of defects in its defibrillator device. Dr. Richard N. Fogoros, also told company executives that their decision to withhold such data, while statistically defensible, was questionable. In one of two lengthy memos to Guidant executives, Fogoros wrote that the company violated a "sacred obligation" it had to doctors by interposing its medical judgment for theirs. He also noted that Guidant had a clear conflict of interest that would naturally lead it to disclose product failures only when "absolutely necessary."