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Lofton: Levine Does Not Undercut Buckman

By James M. Beck and Mark Herrmann

We previously posted about the decision in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662 (N.D. Tex. 2010), here, so this post will be brief.  Plaintiffs sought reconsideration, and recently the court denied the motion.  As usual with reconsideration motions, there wasn't a whole lot to reconsider, but the plaintiffs made an argument that Levine somehow limited the Supreme Court's prior, unanimous opinion in Buckman.  We liked the Lofton court's rejection of that argument and thought our readers would, too:

In Wyeth, the Court specifically rejected the argument that the FDA's labeling requirements were ?both a floor and a ceiling,? and held that a plaintiff could bring state law claims even where a drug bore a warning label approved by the FDA.  This holding, however, does not implicate the FDA's right to determine whether parties have committed fraud upon it, and the court maintains that Plaintiffs' claims, which are based upon an argument already rejected by the FDA, are preempted.  The only claims that are barred by the court's holding are claims that assert fraud on the FDA that have already been considered and rejected by the agency.  The court finds that, in those narrow circumstances, the Texas statutory exception to the rebuttable presumption should not apply because it risks creating a conflict between the court's possible findings and the FDA's conclusion.  This holding does not otherwise affect the conclusion of the Court in Wyeth that plaintiffs may bring state claims even where the FDA approved the label.

Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 2010 WL 2484505, at *3 (N.D. Tex. June 17, 2010).

Full post as published by Drug and Device Law on July 05, 2010 (boomark / email).