Device Co. Pleads Guilty To Hiding Toxicity Data From FDA

Law360, New York (January 31, 2014, 6:07 PM EST) -- A medical device manufacturer pled guilty Thursday in California federal court to a felony charge of concealing scientific data from the U.S. Food and Drug Administration, and four staffers admitted roles in withholding information about potentially toxic side effects, according to prosecutors.

San Diego-based Valor Medical Inc., which faces sentencing on Feb. 19, accepted responsibility for failing to tell the FDA about in vitro tests that raised red flags about its liquid polymer product Neucrylate, which is intended to treat aneurysms.

The tests were needed to...
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