United States: The Cheese Runneth Over . . . Into Illinois

Last September we expressed our curiosity over Wisconsin cheese curd and our distaste for an order from the Western District of Wisconsin rejecting implied preemption in an amiodarone case. As we explained then, the district court allowed a claim alleging that the defendants failed to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Marvin v. Zydus Pharmaceuticals (USA) Inc., 203 F. Supp. 3d 985, 986 (W.D. Wis. 2016) (citing 21 C.F.R. §§ 208.1, 208.24(b)).

A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the district court in Wisconsin concluded that this very federal-sounding claim was actually based on an "independent" state duty to warn. Go figure.

That cheesy conclusion spilled over last week into an amiodarone case in Illinois, which again alleged that the defendants failed to provide medication guides. And again the district court concluded that federal law did not impliedly preempt the plaintiffs' state law tort claims based on a failure to warn. The case is Hernandez v. Wyeth-Ayerst Laboratories, Inc., No. 15 C 11176, 2017 U.S. Dist. LEXIS 58743 (N.D. Ill. Apr. 18, 2017), and if anything, these plaintiffs were even more forward about co-opting federal regulations that the plaintiffs were in Marvin.

The Hernandez plaintiffs alleged two violations of the FDCA: First, that the defendants violated the FDCA by promoting amiodarone off label as a first-line anti-arrhythmic medication; and second, that the defendants failed to provide medications guides. Id. at *3. The generic drug manufacturer defendants justifiable argued that these claims were preempted under PLIVA v. Mensing and Buckman v. Plaintiffs' Legal Committee, but the district court rejected both arguments.

The district court's discussion of Mensing is a bit confused. Applying the often-misunderstood "parallel claim" exception to express preemption, the court held that because the plaintiffs were alleging a violation of federal regulations, their claim was "parallel" to federal law and thus was not preempted. Id. at **8-10. The problem with this is that Mensing did not apply express preemption. It was an implied preemption case, and the district court had no business applying "parallel claim" analysis to implied preemption, where a "parallel claim" exception does not exist. The district court even concluded that the plaintiffs' claim was "not expressly preempted." Id. at *9. That is fine as far as it goes. But we would be surprised if the generic defendants argued express preemption. And even if they did, disposing of express preemption does not dispose of implied preemption. They are different things.

What cases did the district court cite? One was the Seventh Circuit's opinion in Bausch v. Stryker Corp., for which we have expressed our vigorous disagreement multiple times (including here and here), and another was a district court case called Garross v. Medtronic. Both addressed express preemption as applied to pre-market approved medical devices. Apples versus oranges. Or if staying with our cheese theme, cheddar versus Limburger.

The district court's treatment of Buckman fares no better. According to the court, the "plaintiff alleges that [the generic manufacturer defendant] violated its duty to warn under Illinois law because it violated the FDCA's requirement to provide distributors with medication guides." Hernandez, at *9 (emphasis in original). Did you catch that? The plaintiff was suing because the defendant alleged violated the FDCA. The court even put "because" in italics. This is a recipe for implied preemption under Buckman, and it runs directly into section 337(a) of the FDCA, which gives the government exclusive power to enforce the Act. We have often observed that plaintiffs seeking to avoid preemption have to weave their way through a "narrow gap" by alleging that are suing for a violation of the FDCA, but not because the defendant violated the FDCA.

These plaintiffs were not even close. The district court acknowledged they were suing because the defendants violated the FDCA, but it somehow found that Buckman did not apply. Recall that Buckman held that claims were preempted where "federal enactments [were] a critical element" in the plaintiffs' case. Buckman, 531 U.S. 341, 352 (2001). That seems to describe the Hernandez plaintiffs' case to a tee. The district court also did not discuss, or even acknowledge, section 337(a), which prohibits private causes of action to enforce the FDCA. The district court again cited Bausch, and it observed that the generic defendant did not cite an express preemption provision. It did not otherwise explain how these plaintiffs could so overtly purport to enforce the FDCA through a state law failure-to-warn lawsuit.

The defendants also argued statute of limitations and that the plaintiffs did not sufficiently plead their claims, but the former argument failed, and latter resulted only in leave to amend. For our part, summer is approaching, and we still have not tried Wisconsin cheese curd. Maybe we will soon have the good fortune of attending a Midwestern county fair, where we are told cheese curd runs in abundance. Or maybe we'll just go to Chicago and have a hot dog.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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