Tag Archives: preemption

Obama And The Preemptive Defense For Medical Products

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Many of bloggers and journalist I read are convinced that Obama’s administration is out to completely strike down preemption as an effective defense by medical manufacturers.  While the Wyeth v. Levine preemption case was a big win for the U.S. trial lawyers and a big set back for the Bush Administration’s attempt to override a State’s rights concerning product liability law, I am not so sure that Obama will not support preemption as a defense for medical manufacturers in the future.

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.

Why The Preemptive Defense Cannot Apply To All FDA Approved Products

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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.