The most notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988, when Wyeth submitted revised labeling incorporating the proposed changes.

Wyeth argued that this Vermont law was federally preempted because it was in "actual conflict [with] a specific FDA order" regarding drug labeling.

In other words, the Vermont law was not preempted (or overruled) by FDA regulations; thus, the plaintiff could argue her case before a state court jury.

[3] The Supreme Court found in that case that the appellant had demonstrated sufficient evidence to prove that the FDA had considered and rejected, and thus preempted, an addition to a warning label for Fosamax.

Justice Breyer noted that, while the issue was not present here, the FDA may create regulations that pre-empt state law tort claims.