I am "Joe-the-average-citizen", and I live in Michigan, a State who, in 1995, granted the Drug Industry complete immunity from liability if their FDA approved drug harms or kills. Most of our citizens have no idea the Michgan's Drug Immunity Law even exists. And it's coming to a country near to your heart.
America, beware of FDA preemption, or preemption in any disguise. Dress it up as "tort reform", make it over as "anti-frivolous-law-suit", sell it as "economically beneficial"...granting any industry total immunity is wrong and it is dangerous.

Great article Steve. I have posted an article on pre-emption also.

I do agree that it is reasonable to argue that the FDA has more expertise to determine what is in the best interest of the American public than twelve random jurors. However, when I see the FDA approving things such as the Ortho Evra birth control patch I believe it will be impossible for the preemptive defense to be used on all FDA approved products.

When a jury is asked to determine whether a product has a Design Defect they use commonly what is known as risk/utility analysis. One of the criteria of risk/utility analysis is the availability of a substitute product or products at the time of manufacture, sale or distribution, which would meet the same needs of perform the same functions as the product without containing the alleged defect.

As long as the FDA continues to approve products such as Ortho Evra, when safer alternatives exist, it will be, in my opinion, impossible for courts to rule in favor of preemption.