Guidant/EVT Lesson Learned: Post Senior Compliance Execs To Acquired Unit
This article was originally published in The Gray Sheet
Executive Summary
Integration of a parent firm's adverse event reporting and compliance structure into a subsidiary should begin immediately upon acquisition, as illustrated by Guidant's experience with Menlo Park, Calif. unit Endovascular Technologies
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Guidant Ancure resolution
Guidant fulfills its obligations related to June 12 plea agreement by meeting "specific requirements around the [abdominal aortic aneurysm] EVT business with reporting and having third parties also look at any events" and by instituting "training mechanisms across the rest of the firm," CEO and President Ron Dollens explains at JPMorgan annual healthcare conference Jan. 12. Of 15 lawsuits relating to improper reporting by the firm's EVT unit of Ancure AAA stent-graft adverse events, 11 have been settled, Dollens adds (1"The Gray Sheet" June 23, 2003, p. 15)...