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Sorin Group plans $10 million DOJ settlement

This article was originally published in The Gray Sheet

Executive Summary

Milan-based cardiovascular device company announces March 12 a tentative settlement with the U.S. Department of Justice over a 2006 investigation into its U.S. cardiac rhythm management business unit, Ela Medical Inc. The firm expects a definitive agreement will require a corporate integrity agreement with the DOJ and HHS' Office of Inspector General. Sorin admits no wrongdoing, says no charges were filed, and asserts patient and product safety were not at issue in the investigation. Ela Medical received a subpoena in September 2006 requesting all documents that could show the company "may have provided benefits to persons in a position to recommend purchase of devices" between January 2004 and September 2006
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