In June 2011, the U.S. Supreme Court held in Pliva v. Mensing that injured patients' state-law failure-to-warn claims against generic-drug manufacturers are preempted by federal law because the Food and Drug Administration requires those manufacturers to use labeling that is the same as the brand-name labeling.
Surprisingly, it is now being reported that the FDA is considering a
regulatory change that would allow generic manufacturers to change their labeling in
appropriate circumstances. If such a
regulatory change is adopted, it could eliminate pre-emption of
failure-to-warn claims against generic-drug manufacturers. For more details go to Thomson-Reuters, AboutLawsuits and Pharmalot.
Interestingly, in this case the regulatory change might actually be a reaction to the reality of practice. According to a recent study, manufacturers of generic drugs have been changing the warnings they use for their products already even though there are not supposed to. (Their study concluded that that nearly 78 percent of generic medicines have
safety warnings that differ from labeling on equivalent brand-name
drugs.) (Here is an abstract). For more on the study and some links go here.