Monday, December 17, 2012
New study challenges the premise upon which preemption of claims for inadequate warnings against generic drug manuracturers is based
As long time readers of this blog know, in PLIVA v. Mensing, the Supreme Court held that state-law damages claims based on inadequate warnings by a generic drug manufacturer were preempted by federal law because federal law prohibited the generic manufacturers are required to use the same labels as the branded labels. This ruling makes it extremely difficult for a plaintiff to support a state-law damages claim based on a generic drug manufacturer's failure to warn. A new study by an Indiana University medical school professor and two co-authors has found that nearly 78 percent of generic medicines have safety warnings that differ from labeling on equivalent brand-name drugs. The study is called "Consistency in the safety labeling of bioequivalent drugs." (Here is an abstract). With a new case on the subject before the Supreme Court, this study is sure to become very important in the debate. Pharmalot has more on the story here. Public Citizen has more here.