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Generic Drug Preemption - Reconsideration denied in Morris

By James M. Beck and Mark Herrmann

A tip of the cyberhat to Kennedy Simpson over at Thompson, Morris & Simpson for passing along the good news that reconsideration was just denied in the generic drug preemption case, Morris v. Wyeth. Here's the slip opinion. This isn't your usual two paragraph denial of reconsideration, either. It's a 20-pager.

The rulings: (1) McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr. 3d 810 (Cal. App. 2008), got it wrong in finding generic and name-brand preemption indistinguishable, and in any event was bound by a prior California Supreme Court decision; (2) Demahy v. Wyeth, Inc., 586 F. Supp.2d 642 (E.D. La. 2008), incorrectly read the FDA's regs and administrative history with respect to CBEs and generic drugs; (3) neither Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351 (N.D. Ga. 2008), nor Sharp v. Leichus, 2006 WL 515532 (Fla. Cir. 2006), were preemption decisions; (4) the after-the-fact views of an individual congressman don't qualify as legislative history, thus there was "no reason to view Representative Waxman?s views as indicative of congressional intent"; and (5) the views of a state attorney general could not possibly express federal congressional intent.

Keep those wins coming.

Full post as published by Drug and Device Law on February 20, 2009 (boomark / email).