Product Liability “FDA Defense” Prospects Hampered By Vioxx Shrapnel
This article was originally published in The Tan Sheet
Executive Summary
An "FDA defense" from product liability punitive damages will be a tough sell on Capitol Hill in the next session, in light of burgeoning concerns about FDA's handling of Vioxx and agency oversight of approvals and postmarketing
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A one-sentence provision tucked into draft House legislation renewing FDA's drug user fee program seeks to weaken manufacturers' ability to use FDA approval as a defense in state product liability lawsuits
Federal Pre-emption Defense Under Fire In Draft House Bills
A one-sentence provision tucked into draft House legislation renewing FDA's drug user fee program seeks to weaken manufacturers' ability to use FDA approval as a defense in state product liability lawsuits