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.
If the regulation is implemented, will the liability shift to the generic manufacturer? Does a fact that a generic drugmaker will be to make changes the generic drugmaker to make those changes?
ReplyDeleteSome words in the original comment got truncated, so I am re-posting it:
ReplyDeleteIf the regulation is implemented, will the liability shift to the generic manufacturer? Does a fact that a generic drugmaker will be allowed to make changes require the generic drugmaker to make those changes?
The generic drugmakers will not be required to make changes by the rule, but if they don't make changes, plaintiffs could try to recover from them arguing they should have - assuming they can support a prima facie case. The new rule would prevent generic manufacturers from escaping liability by simply saying they could not have done anything about the text of the warnings.
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