Why The Preemptive Defense Cannot Apply To All FDA Approved Products

Over the past few years I have gone back and forth over whether preemption is good for the American public.

Many of the pharmaceutical and medical device company reps that contact me for product liability insurance quotes are quick to point out that there products should be better than average risk because of the preemptive defense, which allows federal law to preempt state laws and since their products are FDA approved they are protected by federal statute. The general rule with Preemption is that once the federal government enacts a statute on an issue, no state can enact contradictory laws

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.

The Johnson & Johnson Ortho Evra birth control patch is a great example what is wrong with the preemption argument.

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.

Studies on the Ortho Evra birth control patch show this product has double the risk of the pill that is currently on the market. So far, 20 deaths have been linked to Ortho Evra and listed symptoms are deep vein thrombosis, blood clots in legs and lungs, pulmonary embolisms and stroke.

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.