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Health Care & Hospital Law

Jun. 14, 2003

Guilty Plea In Malfunction Of Devices for Aneurysms

SAN FRANCISCO - A Menlo Park medical device company pleaded guilty Thursday to 10 criminal counts of failing to report malfunctions in its product to treat aortic aneurysms and agreed to pay $92.4 million, the largest settlement in Food and Drug Administration history for failing to alert regulators to problems.

By Pamela A. MacLean
Daily Journal Staff Writer
        SAN FRANCISCO - A Menlo Park medical device company pleaded guilty Thursday to 10 criminal counts of failing to report malfunctions in its product to treat aortic aneurysms and agreed to pay $92.4 million, the largest settlement in Food and Drug Administration history for failing to alert regulators t...

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