Georgia Federal District Court Grants Defendant’s Motion For Summary Judgment in Lanham Act Suit Involving Two Unapproved Drugs

November 29, 2009

By J.P. Ellison –      

Earlier this month a federal district court in Georgia granted summary judgment in a Lanham Act suit that raised a number of FDA issues.  The plaintiff in the suit manufactured two prescription acne products under the trade name Benziq.  Defendant manufactured two products under the name Benprox that competed with plaintiff’s products. 

The plaintiff alleged that defendant violated the Lanham Act, a federal cause of action that provides a remedy to plaintiffs harmed by false or misleading commercial advertising or promotion by a competitor.  In this case, the plaintiff alleged that the defendant’s false and misleading statements took two forms:  (1) submissions to third party pricing services; and (2) product labeling. The court granted the defendant’s motion for summary judgment on both grounds.

Before considering those claims, the court addressed a threshold issue that often arises in Lanham Act suits that implicate FDA issues, namely whether a Lanham Act suit is precluded because the substance of the allegations are the province of the FDA.  In this case, after examining a number of the prior cases, the court concluded that it could address the claims raised.

On the plaintiff’s first theory, that the defendant’s submissions to third party pricing services were false and misleading, the court ruled that the plaintiff’s had not presented any evidence of falsity.  On the plaintiff’s second theory, that the product labeling was false and misleading, the court ruled that plaintiff’s arguments either required interpretation of an issue on which FDA had not provided guidance, or in the alternative that plaintiff’s had failed to present evidence to support that theory.

In sum, the Court’s opinion is fairly fact specific, but nevertheless provides an overview of the issues that arise in Lanham Act cases that implicate FDA issues.

Categories: Drug Development