Gary you are right that the FDA can approve and for a change of labeling of pharma products. There is a hell of a process to go through in part because the labeling has to be approved by the FDA in the first place as well as any changes. So I don't think that from a legal stand point anyone would be able to win a case on labeling... it happens but the percentages are next to nothing and usually because the company has lied about the side effects... so also typically shady business practices. Now it is something else completely to say that the FDA could force labeling changes to make the warning more visible and easier to understand. That could take place and is within the FDA's authority, but the labels on them today were approved by the FDA also.