FDA product liability 416
September 21st, 2011 
admin Product liability is anther area of San-Diego-Personal-Injury-attorney.com
McGuan v Endovascular Technologies, Inc. 182 Cal.App.4th 974 (2010) (6) Products liability claim against FDA-approved medical device. [1].San-Diego-Auto-Accident-lawyer.com Claims the device was unsafe or the warnings were inadequate are preempted by federal law. FDA determines the design and labeling (i.e., warnings) and California products law would impose requirements different form or in addition to federal law. [2] A fraudulent concealment claim would also require the jury to find the FDA-approved warnings were inadequate, again imposing an additional or different standard than FDA’s. [3] Fraud on the FDA claim (that D withheld injury and defect reports from FDA) also preempted as it would interfere with FDA’s fraud policing function. Buckman, 531 US 341. [4] State law remedies for violating federal requirements would be permissible, but not where FDA specifically found no violations, To allow state action then would conflict with FDA’s fraud-policing function. San Diego personal injury attorney