A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are not unrelated. We most commonly see negligence per se when plaintiffs try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim. State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman. That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that.
It seems pretty straightforward to us, but some courts still resist. That is what happened in Marvin v. Zydus Pharmaceuticals (USA) Inc., No. 15-cv-749, 2016 U.S. Dist. Lexis 112047 (W.D. Wis. Aug. 23, 2016), where the plaintiffs based their negligence per se claim on the defendants' alleged failure 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. Id. at **2-3 (citing 21 C.F.R. §§ 208.1, 208.24(b)).
The defendants allegedly did not provide medication guides to the decedent's pharmacy, but do the decedent's heirs have a private right of action? The defendants justifiably did not think so, and they moved to dismiss on the basis that the plaintiffs' claims were impliedly preempted. Along the way, the district court ordered supplemental briefing on whether Wisconsin law would recognize a claim of negligence per se in the first place.
We are fond of Wisconsin. We once drove from a deposition in Marquette, Michigan, to visit family in Minneapolis. As students of the geography of the Upper Midwest will tell you, that took us across the entire width of Wisconsin. One day we will return to partake of "fresh cheese curd," which we saw advertised at multiple roadside markets along the way. We have more recently learned that it is commonly deep fried and served at carnivals and county fairs across the region.
But for now, we will respectfully state that the district court in Marvin came to the wrong result. The district court held first that federal law did not impliedly preempt the negligence per se claim, and in reaching that result, it cited and quoted extensively from the Seventh Circuit's abominable Bausch opinion. Faithful readers will be familiar with the disdain we have heaped on Bausch for, among other things, its recognition of a "parallel claim" based on even the most general FDA regulations and its blithe rejection of implied preemption without citing or even acknowledging section 337(a). The posts are too numerous to list, but you can get the gist here and here.
The district court followed Bausch—not surprisingly, since Wisconsin is within the Seventh Circuit—but that allegiance regrettably led the court to make the same mistakes. The district court discussed Buckman, but like Bausch it allowed a state-law claim that purported to enforce the FDCA without discussing section 337(a), let alone explain how that section would permit such a claim. Id. at **4-6. Instead, the district court accepted the plaintiffs' argument that they "allege in this case that defendant violated a well-recognized state law duty to warn that is independent of federal requirements." Id. at *11. That is post hoc rationalization at its best, since the claim asserted—the failure to provide medication guides per federal regulations—is anything but "independent of federal requirements." To the contrary, the claim is entirely "dependent" on federal requirements because the plaintiffs are using federal law to define the substance of their claim. Bausch strikes again.
Having cleared the implied preemption hurdle, the district court next held that Wisconsin law would permit a negligence per se claim based on the FDCA. What caught our eye here is that, in deciding this issue, the district court citing and discussed section 337(a) extensively. So the court was aware of the statutory prohibition on private rights of action, yet it both rejected implied preemption and permitted a negligence per se claim. It is difficult to reconcile this result with the statute's mandate.
The district court acknowledged some difficulty with it as well. It discussed cases going both ways, but ended up giving credence to cases allowing the cause of action. An example is Valente v. Sofamor, S.N.C., 48 F. Supp. 2d 862 (E.D. Wis. 1999), where the neighboring district held that "even though the Act does not provide an express statement regarding liability, its clear expression that the Medical Device Amendments were enacted to protect users of medical devices is sufficient under Wisconsin law to show that Congress intended to allow those provisions to provide the basis of negligence per se claims under state common law." Marvin, 2016 U.S. Dist. LEXIS 112047, at *14 (discussing Valente). The problem with this is that the FDCA did "provide an express statement regarding liability," and Congress's intent is both express and clear. There is no private right of action to enforce the FDCA.
The district court also relied on a Wisconsin Court of Appeals case that allowed a negligence per se claim based on an alleged failure to warn regarding oral contraceptives, but that opinion "did not discuss whether there was a legislative [i.e., congressional] intent to impose civil liability or address the enforcement limitation in § 337(a)." Id. at **16-17. In other words, the Court of Appeals opinion did not address a key issue, and neither had the Wisconsin Supreme Court. Id.
In the end, the district court thought it was a "close call" and allowed the negligence per se claim, but we don't think it was close at all. The Marvin order perpetuates the fiction that civil actions to enforce FDCA regulations under the guise of negligence per se are somehow "independent" state law claims. Again, we have a difficult time reconciling that result with the statute, but we understand that others disagree. Perhaps someday we can discuss it over a fresh serving of fried cheese curd.
This article is presented for informational purposes only and is not intended to constitute legal advice.