Attorneys involved in pharmaceutical product liability litigation have been living with a United States Supreme Court decision in Pliva v. Mensing. In this case, the United States Supreme Court ruled that lawsuits against generic drug manufacturers are preempted by federal drug regulations which require a generic drug label to match the brand warning label word for word regardless of mounting evidence that a generic drug carries a risk far greater than what is disclosed in the label. The case has essentially eliminated all claims form users of generic drugs from bring claims against generic manufacturers.
For consumers, often times, the first time they hear of preemption is when their attorney informs them they have no case because the product they used was a generic drug and not a branded drug. So what is preemption? Most pharmaceutical product liability are based on a failure to warn. This means the drug label failed to warn the user of the true risk or risks associated with the drug. Because Congress wanted to promote the generic drug industry they created a different path for approval of generic drugs and branded drugs. A company seeking approval of a generic drug must only show that the drug is a bioequivalent of the branded drug. On the other hand, the branded drug must show the drug is safe and effective as labeled. The branded drug creates the label and the generic manufacturer of the drug adopts the branded drugs label. The generic manufacturer has no control over the label.