June 23, 2008
Preemption: Congress may be stepping in!
Analysis of:
Device Preemption Ruling Threatened by Draft Bill | fdanews.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Implications: State court actions on FDA issues may have a revival!Greater consideration should be given to utilizing the Supreme Court to resolve issues that Congress should have acted upon!
Analysis:
Analysis:
The current draft of the bill to give guidance on Device preemption will likely not resolve al issues, but it is certainly a step in the right direction. What also seemed to be a common sense analysis will also be finally fully defined to not leave much room for any interpretation. Nonetheless, the legal system allowed many resources to be utilized to deal with this creative posturing by trial lawyers when the Supreme Court could have been spending time on other exigent circumstances. We should also learn an interesting lesson from the Supreme Court's ruling, in light of the fact it essentially went against what really was the intent of the FDA regulations. Those regulations were clearly never intended to be utilized as a shield for lawsuits. It is just a shame it took so long for congress to step up to straighten this out. Unfortunately, the current draft of the bill will not resolve all federal preemption issues, but certainly those relating to the FDA. www.fdanews.com/ext/files/FinalBill.pdf Hopefully, it will not take congress more than a couple of months to resolve this. The net effect may be greater litigation costs & higher medical costs. The double edge sword, so be careful what you wish for.
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