Acclarent Didn't Tell FDA About Adverse Events, Jury Told
Law360, Boston (June 28, 2016, 7:58 PM EDT) -- Medical device maker Acclarent Inc. never told regulators that half the patients in a 2007 study for a sinus clearing device developed infections, even though that information should have been turned over, a federal jury in Boston was told Tuesday.
Dr. Anjum Khan, who helps study medical devices for U.S. Food and Drug Administration clearance, testified that a preliminary study on Acclarent’s Stratus sinus-spacer shortly after it was approved included only information about one patient getting a nosebleed. But as she prepared for testimony in a trial of two former Acclarent executives, she said, she learned that seven of 14 patients...
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