Pliva v Mensing

The Pliva v Mensing ruling in the US Supreme Court on June 23, 2011 will have positive ramifications for both generic drug manufacturers as well as their product liability insurers.

The headline take away from the ruling is that Federal law is supreme. Generic drug manufacturers can no longer be sued by consumers under state law in the US for ‘failure to warn' so long as they have labeled their product to be in compliance with the FDA1 approved labeling for the original innovative drug.

To contrast this with a ‘brand name' manufacturer's exposure one must look back at the Wyeth v Levine ruling in 2009. In that decision the Supreme Court set a higher barrier for relying on pre-emption - i.e., the branded manufacturer must show clear evidence that the FDA would have rejected a proposed labelling change in order for the court to find the state law preempted.

This gives the strange position that an alleged injured party could successfully bring a ‘failure to warn' case against an innovative drug manufacturer but had that person taken the generic version of the drug then they could not.

Download the full bulletin (Adobe PDF Format - 192Kb)