One of the state laws that can have a major impact on the outcome of a product liability lawsuit is the Statute of Repose.  The Statute of Repose prevents product liability lawsuits against the manufactures, importers, designers and distributors of products based on the age of the product.  However, only 19 of the 50 states have Statute of Repose laws to protect businesses from product liability lawsuits.  Most of the states that have Statute of Repose laws limit product liability lawsuits somewhere between 5 to 12 years after the sale of a product.  Two states, Arizona and Rhode Island, have found Statutes of Repose laws for products unconstitutional.

One of the industries that is very familiar with Statute of Repose laws and the impact they can have on a product liability lawsuit is the Tree Stand industry.  For example, if a kid where to die or become a quadriplegic in a state with a 10 year Statute of Repose law and the age of the tree stand was 11 years from the date of sale, the manufacture, designer and sellers of the tree stand could be protected from a product liability lawsuit because of the 10 year deadline was exceeded.  However, in another state that did not have a Statute of Repose law, the manufacture, designer and sellers of the tree stand could find themselves named as defendants in a product liability lawsuit and, at the very least, incur discovery and settlement costs and, at the worst, large monetary judgments by a sympathetic jury.

Past history shows that while in the Senate, Obama, went against party lines and U.S. trial lawyers and voted for tort reform.  So it is not a slam-dunk that he will look to completely do away preemption as a viable defense.

The bigger issue with preemptive defense for medical products is the FDA seems to ignore the risk/utility analysis  so commonly used in product liability lawsuits to determine if another product on the market at the same time as the alleged defective product would perform the same functions without the alleged defect.   It appears that the FDA routinely approves medical products that have similar uses as existing medical products on the market, but have more side effects without providing superior results.

This leads many to believe that the FDA is not a truly independent agency and that they may be coming under the influence of the big medical and drug companies.  As long as this continues to happen there appears to be no choice but to allow product liability lawsuits to determine if the injury in question could have been avoided.

If preemption is going to be used as an effective product liability defense, the FDA is going to have to tighten its approval guidelines so they have more credibility within the courts.

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.