Suit: Amgen Under-Reported Adverse Events to FDA on All Products
Amgen under-reported adverse events to the FDA on all its products, according to a lawsuit filed in California.
Shawn O'Brien was a senior project manager responsible for at Amgen until April 2007, when the company identified "product complaints" as "a potential issue for Amgen." O'Brien claims he was then assigned to work on post-marketing product complaints. He didn't like what he found, according to the suit:
Download O'Brien v. Amgen hereAmgen was not adequately or consistently identifying phone calls or mail related to Post-Marketing adverse Events or Product Complaints. It appeared Amgen was under reporting Post-Marketing Adverse Event data to the FDA for every product they were marketing.The suit alleges the under-reporting is a false claims violation. O'Brien alleges he alerted his bosses and a few weeks later was fired.
Hat tip to the Courthouse News Service.
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