Court: FDA Approval Preempts State False Advertising Laws

In a precedential opinion, a U.S. Court of Appeals for the 3rd Circuit judge has upheld a lower court’s ruling that drug advertising based on FDA-approved drug labeling is exempt from state false advertising laws.

Circuit Court Judge D. Brooks Smith ruled recently to uphold the dismissal of a class action suit in which a group of consumers sued AstraZeneca for engaging in deceptive conduct in its advertising of Nexium (esomeprazole magnesium).

The plaintiffs alleged AstraZeneca’s marketing for Nexium was deceptive because it claimed the drug was superior to Prilosec (omeprazole magnesium), the company’s older proton-pump inhibitor for treating acid reflux and heartburn, according to Smith’s opinion. The group had filed suit in 2005 in the U.S. District Court for the District of Delaware.

The plaintiffs alleged that the company aggressively marketed Nexium, which was approved in 2001, because Prilosec was about to go off patent. According to the complaint, AstraZeneca violated the Delaware Consumer Fraud Act and consumer protections in all 50 states. The Delaware court dismissed the complaint with prejudice, Smith wrote.

In the appeal, the circuit court considered, for one, whether state consumer fraud laws “dictate the parameters of false and misleading advertising in the prescription drug context,” Smith wrote.

The full opinion is available at www.ca3.uscourts.gov/opinarch/055340p.pdf.