Impossibility preemption bars state claims where compliance with both federal and state requirements is impossible. In pharmaceutical litigation it applies where a manufacturer could not unilaterally change federally approved labeling.
Generic manufacturers receive broader protection than brand manufacturers.
Alternative Names:
Impossibility Defense, Dual Compliance Impossibility
Why it Matters?
The generic and brand distinction is decisive, since Mensing held generic manufacturers cannot unilaterally alter labeling and therefore cannot satisfy a state duty to strengthen warnings. Brand manufacturers can use the changes being effected process, which limits the defense to showing the agency would have rejected the change. Establishing what the manufacturer could have done unilaterally is the analysis.
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Frequently asked questions
Why do generic manufacturers receive broader protection?
What limits the brand manufacturer defense?
