Subscribe to Updates in Legal, Economic & Regulatory Affairs

RSS By Email

RSS By RSS

Add to Google Reader or Homepage

Subscribe in Bloglines


The Expertise Imperative and Compliance Technology
Access to a diverse array of specialized expert inputs drives superior decisions in every organizational context: within corporations, by investors and consultancies, and within nonprofits. When decision makers are confident of their decision inputs, they can respond more quickly and creatively to challenges and opportunities.Learn more about GLG's Compliance Framework


This page may include content provided by Council Members, your access to which is subject to the Terms of Use.
Find Out More

June 23, 2008

Preemption: Congress may be stepping in!

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Martin Alpert
Claim Director, CAMBRIDGE INTEGRATED SERVICES GROUP INC
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:
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.


Report a Concern

More GLG News in
Legal, Economic & Regulatory Affairs

Most Popular:
Source Article | Expert Analyses
 

GLG News: What Experts Think Is Important





Analytics


Generated at 2008-09-04T21:45:16.757