The Pre-emptive Defense for Medical Products

What will Obama do?

Many journalists are convinced that President Obama’s administration is out to completely strike down pre-emption as an effective medical liability defense by medical manufacturers.

In 2009, the Supreme Court ruled in Wyeth v. Levine that state juries may award damages for harm from unsafe drugs. They ruled so even though the manufacturers had satisfied FDA regulations. The Wyeth v. Levine pre-emption case was a big win for U.S. trial lawyers. It was a big setback for the Bush administration’s attempt to override states’ rights concerning Product Liability law.

However, I am not so sure that Obama won’t support pre-emption as a defense for medical manufacturers in the future.

While in the Senate, Obama went against party lines and U.S. trial lawyers by voting for tort reform.  Therefore, an attempt to  completely do away with pre-emption as a viable defense isn’t a slam dunk.

What’s the FDA’s angle?

There’s a bigger issue with a pre-emptive defense for medical products. The FDA seems to ignore the risk/utility analysis so commonly used in product liability lawsuits. It’s used to determine if another product on the market would perform the same functions without the alleged defect. The FDA routinely approves medical products with similar uses as existing medical products on the market that have more side effects without providing superior results.

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

If pre-emption is going to be used as an effective product liability defense, the FDA must tighten its approval guidelines so they have more credibility with the courts.