People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts the FDA said.
The FDA's claim of "federal preemption" was included as a preamble to guidelines designed to make drug labeling information more accessible and readable for doctors and consumers. Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position.
The new labeling rules now make drugmakers highlight the most important advisory information in the "package insert" or each drug. The FDA was told by drug company execs and later convinced that they deserved more broadly stated FDA support because the new labeling would make them more vulnerable to lawsuits. Obviously, attorneys and also state lawmakes said it's a bad idea.
There have already been court decisions regarding the FDA and preemption. On Minnesota, James Rosenbaum overturned FDA-supported pre-emption arguments in a 2005.
In McKay v. Pfizer, the Court addressed Pfizer's alleged failure to warn about the suicide risk on the label of its antidepressant, Zoloft.
The Court rejected the re-emption defense in cases involving wrongful deaths due to manufacturers' failure to warn about lethal drug side-effects, such as suicide linked to their drugs.
The Court actually called the pre-emption argument made by the FDA "perverse."
The Judge wrote that State consumer-protection law compliments sytem.