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Generic Preemption - Still Kicking

By James M. Beck and Mark Herrmann

There's life in generic preemption yet. The court in Gaeta v. Perringo Pharmaceuticals, slip op. (N.D. Cal. Nov. 24, 2009), has denied reconsideration of the preemption summary judgment entered last year pre-Levine. The court holds that Levine's impossibility analysis did not consider the FDCA's requirement that generic labeling be the "same" as name-brand labeling, and that because of this "sameness" issue it was impossible for a generic manufacturer to utilize the changes being effected (CBE) procedure that had defeated preemption in Levine. Slip op. at 6-7. Thus, Levine was not dispositive, and the plaintiff was not entitled to reversal on reconsideration:

The Court finds that Levine did not address a dispositive issue in this case, namely, whether a generic drug manufacturer may use the CBE process to make warning-label changes without prior FDA approval, and thus Levine does not govern whether the Court may grant summary judgment on Plaintiff?s state tort claims based on the defense of impossibility pre-emption.

Slip op. at 7. It appears that the plaintiff did not raise in Gaeta the non-CBE arguments that we've seen in Mensing and Bartlett. If that happened, there's no hint of it in the opinion.

Tip of the cyberhat to Kelly Savage Day at Sedgwick Detert for sending the win along. Good luck on appeal.

Full post as published by Drug and Device Law on November 30, 2009 (boomark / email).