Saturday, June 25, 2011

Supreme Court decides case on preemption of claims vs generic drug manufacturers

Big news out of the Supreme Court this week: The Court issued a decision in the highly awaited consolidated cases PLIVA v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501) on the right to sue in state court when a generic drug maker fails to change its label to warn consumers of new harmful side-effects.  For some background information on this case, go to my previous posts on it here, here and here. For a copy of the opinion and all other relevant documents, lower court opinions and briefs go here.

In another 5 to 4 decision, the Court decided that federal law preempts state lawsuits because their effect could be to force the defendants to offer labeling that is different from what appears on the label of the brand-name drug. Writing in dissent, Justice Sonia Sotomayor concludes that “The court today invokes the doctrine of impossibility preemption to hold that federal law immunizes generic drug manufacturers from all state-law failure-to-warn claims because they cannot unilaterally change their labels. I cannot agree. We have traditionally held defendants claiming impossibility to a demanding standard: Until today, the mere possibility of impossibility had not been enough to establish preemption." 

Here are some links of coverage of the full story from around the internet (thanks to the SCOTUS blog):

Wall Street Journal law blog
FDA law blog
ABA Journal
Los Angeles Times
Atlantic Wire
CBS News
Courthouse News Service
David Savage (Los Angeles Times)
Jess Bravin (Wall Street Journal)
USA Today
The Drug and Device law blog has even more links here.

Prof. Steven Schwinn offers more detailed analysis in a short article called "Court charts new course in preemption analysis" here.

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