Tuesday, March 10, 2009

U.S. Supreme Court Orders Another Look at Drug Ad Case

This posting was written by William Zale, Editor of CCH Advertising Law Guide.

In a suit asserting that advertising of the prescription drug Nexium violated the consumer protection statutes of the 50 states, the U.S. Supreme Court has vacated a lower court’s decision that the state law claims were federally preempted.

In August 2007, the U.S. Court of Appeals in Philadelphia held that the state law claims were preempted by the federal Food, Drug, and Cosmetic Act and regulations of the Food and Drug Administration (Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., CCH Advertising Law Guide ¶62,622; CCH State Unfair Trade Practices Law ¶31,463).

According to a class action complaint, drug manufacturer Zeneca misleadingly advertised Nexium as superior to Prilosec (another Zeneca drug) for treating gastroesophageal reflux disease. The patent for Prilosec was due to expire in 2001.

The appellate court took the position that allowing generalized state 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.

The Supreme Court remanded the case to the appellate court for further consideration in light of the Court’s March 4, 2009 decision in Wyeth v. Levine, No. 06-1249. In Wyeth, the Court upheld a jury verdict of liability against a pharmaceutical manufacturer (Wyeth) in a case based on Vermont common law claims of negligence and strict liability for failure to warn of the dangers of injecting an anti-nausea drug directly into a patient’s vein.

Federal Preemption

In rejecting Wyeth’s contention of federal preemption, the Court observed that if Congress thought state law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision for prescription drugs at some point during the Food, Drug, and Cosmetic Act’s 70-year history. But despite the 1976 enactment of an express pre-emption provision for medical devices, Congress has not enacted such a provision for prescription drugs. Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, was viewed by the Court as powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

What effect, if any, the Wyeth decision will have upon the preemption issue in the Nexium case must now be determined by the U.S. Court of Appeals in Philadelphia.

Further details on the Court’s March 9 summary decision vacating and remanding Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., No. 07-822, will be reported in CCH Advertising Law Guide and CCH State Unfair Trade Practices Law. The March 9 order list appears here.

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