Seventh Circuit Affirms Dismissal of FDA-related Lanham Act Case and Quotes William Blake to Boot

November 1, 2009

JP Ellison

In March of 2008, we reported on a Wisconsin federal district court opinion that dismissed a plaintiff’s Lanham Act claim against three manufacturers of generic prescription drug products.  On October 29, 2008, the Seventh Circuit issued a decision in an appeal of that same case.  As we noted in our earlier post, Hyman, Phelps & McNamara, P.C. represented one of the defendants in the case. 

Between March of 2008 and October 2009, the district court had modified its dismissal from with prejudice to without prejudice and the plaintiff and two of the defendants had appealed and cross-appealed, respectively.

The central issue before the Seventh Circuit was whether a Lanham Act claim could proceed when the claim was based upon FDA-required labeling. On appeal, the panel (in an opinion written by Judge Posner) agreed with the district court’s reasoning that such a claim could not proceed unless and until FDA had made a finding with respect to that labeling, which it had not yet done.  In concluding that FDA had not yet made a finding, the Seventh Circuit reached the same conclusion as the district court, namely that letters from an FDA employee to the defendants did not constitute final agency action.

The Seventh Circuit also affirmed the district court’s denial of the plaintiff’s motion for partial summary judgment based upon a claim of “literal falsity.”  In doing so, Judge Posner observed:  “William Blake declared that ‘to Generalize is to be an Idiot.  To Particularize is the Alone Distinction of Merit.’  That is a bit extreme, but uncritical generalization is the path to error.”  We’re not sure the quote is central to the court’s holding, but it seemed a shame to omit a William Blake quote from a report on an appellate court opinion.

Categories: Drug Development