Third Circuit on FDA Preemption – Dismissal of Nexium Class Action Affirmed

On Friday, the United States Court of Appeals for the Third Circuit affirmed the dismissal with prejudice of a putative class action against Zeneca alleging that the company’s advertising of the drug Nexium was deceptive:  Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc.  The Third Circuit ruled that the Food Drug & Cosmetic Act and the FDA’s accompanying regulations on drug labeling preempted state law consumer fraud claims: 

By specifically excluding advertisements covered by 21 U.S.C. Sec. 352(n)and the regulations promulgated thereunder from the scope of 15 U.S.C. sec. 52, Congress signaled its intent to give the FDA exclusive authority to regulate prescription drug advertising.  The FDA has established specific regulations regarding such advertising.  To allow generalized consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress’s and the FDA’s objectives in protecting the nation’s prescription drug users.  Accordingly, the state consumer fraud laws are preempted by the extensive federal legislative and regulatory framework.

– SBS