What is the Pre-emptive Defense?

Why it cannot apply to all FDA-approved products

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

The Pre-emptive Defense

Many pharmaceutical and medical device companies contacting me for Product Liability insurance quotes say the same thing. They think their products should be better than average risks because of the pre-emptive defense.  This means that federal law pre-empts state laws. These companies think they are protected by federal law since their products are FDA approved. The FDA is , of course, a federal regulator.

The general rule with pre-emption is that once the federal government enacts a statute on an issue, states can’t enact contradictory laws

It’s reasonable to assume that the FDA is better qualified to determine what’s in the best interest of the American public than 12 random jurors.

The  Ortho Evra birth control patch is a great example what is wrong with the pre-emption argument. The FDA approves products such as the Ortho Evra birth control patch. But courts can’t allow for the pre-emptive defense to be used on all FDA-approved products.

Products that will fail the pre-emptive defense

Juries use a risk/utility analysis to determine whether a product has a design defect. One criteria is the availability of any substitute products that meet the same needs or perform the same functions as the alleged defective product.

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. Listed symptoms are deep vein thrombosis, blood clots in legs and lungs, pulmonary embolisms and stroke.

In my opinion

It will be impossible for courts to rule in favor of pre-emption as long as the FDA continues to approve products such as Ortho Evra when safer alternatives exist, .