Court rules that FDA labeling trumps state false-advertising laws

WASHINGTON A potentially precedent-setting case against AstraZeneca has been dismissed by a the U.S. Court of Appeals for the Third Circuit, in connection to a class action lawsuit in a lower court that ruled that drug advertising based on Food and Drug Administration-approved drug labeling is exempt from state false-advertising laws.

The drug named in the lawsuit was Nexium, a medication used for treating acid reflux and heartburn. The plaintiffs claimed that the marketing used for Nexium made it look superior to another AstraZeneca proton-pump inhibitor medication, Prilosec.

In his dissenting opinion, Judge Robert Cowen pointed out that the plaintiffs were not questioning Nexium’s labeling, but rather AstraZeneca’s methods of advertising, and that "there is no risk that a successful state law claim, alleging that Nexium advertisements contain false and misleading drug comparisons, would conflict with the FDA’s approval of the statements in the Nexium labeling."