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Murphy's Preemption Law

By James M. Beck and Mark Herrmann

We've just been tipped off (thanks to Kamie Brown of Snell & Wilmer) to a new Buckman preemption win in Utah.  It's Murphy v. Mylan, Inc., No. 080500804, slip op. (Utah Dist. Iron Co. May 10, 2010).  Iron County?  Where's that?  Well, if you've ever been to Zion National Park, chances are you've driven through it, since Cedar City's in it and I-15 goes through it.

Anyway, this pleasant place has produced a most pleasant opinion.  Utah has a statute, Utah Code Ann. §78B-8-203, that bars punitive damages against makers of FDA approved drugs.  That statute has an exception "if it is shown by clear and convincing evidence that the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the" FDA.  §78B-8-203(2).  In other words, there's a "fraud on the FDA" exception.

The court in Murphy thus had to choose between the pro-preemption approach to these types of statutory exceptions, exemplified by Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and the anti-preemption position of Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).  Well, the court in Murphy spent 18 pages comparing and contrasting the two approaches, and we're happy to say comes down squarely in the pro-preemption camp.  The conclusion:

Moreover, while Desiano presents an attractive argument for why a drug manufacturer already has plenty of incentive to give the FDA whatever it has, that argument is no better supported by hard evidence than is Garcia's argument that "a state court proceeding" like the one contemplated by the statutory exception at issue here "would raise the same inter-branch-meddling concerns that animated Buckman."  385 F.3d at 966.  As the cases presented by the Mylan Defendants demonstrate, that is a sentiment frequently expressed by the lower courts that have considered the question.  Additionally, Garcia's reference to "inter-branchmeddling concerns" highlights an issue that was prominent in Buckman but hardly touched on in Desiano - namely, the implications of an entirely federal relationship being put under the microscope of a state court.  In the end, then, while Desiano meets with some success in portraying itself as in harmony with the letter of the law laid down in Buckman, this court finds Garcia more consistent with both the letter and the spirit of that case.

Murphy, slip op. at 18-19.

Full post as published by Drug and Device Law on May 20, 2010 (boomark / email).