While waiting for next month’s Bartlett oral argument and then the Supreme Court’s decision, and as plaintiffs continue to prod and poke to find ways around Mensing, the Fifth Circuit gave us a nice (though unpublished) Valentine’s Day present in Morris v. Pliva USA, Inc., No. 12-30319, 2013 U.S. App. LEXIS 3167 (5th Cir. Feb. 14, 2013). In a terrific opinion, the Fifth Circuit rejected the Bartlett “just don’t sell it” reasoning, as well as plaintiffs’ attempts to fashion failure to warn claims from generic manufacturers’ alleged failures to communicate approved warnings via Dear Doctor Letters or failure to update labels to match that of the branded manufacturer. We’d like to think that this decision gives us momentum heading toward the Supreme Court’s handling of Bartlett.
Let’s start, however, with the Fifth Circuit’s treatment of plaintiffs’ attempts to find “failure to warn” claims still standing in the wake of Mensing. Plaintiffs argued that, while Mensing held that claims that generic manufacturers should have sent Dear Doctor Letters with warnings different from those in the branded manufacturer’s label are preempted, plaintiffs can still bring claims that the generic manufacturers should have communicated the approved warnings via Dear Doctor Letters. First of all, this doesn’t reconcile well with plaintiffs’ claims, made elsewhere, that the branded label itself was inadequate. But set that aside.
The Fifth Circuit emphasized that federal law demands that “generic drug labels be the same at all times as the corresponding brand-name labels” – something often referred to as the “duty of sameness.” Id. at *6 (quoting Mensing). This reasoning similarly preempts a state law claim that would require a generic manufacturer to send on its own a Dear Doctor Letter about an approved warning. Requiring a generic manufacturer to take such a unilateral step would improperly imply a difference between the generic and branded drug, something not allowed under Mensing:
To avoid liability [if such a state-law was allowed], the manufacturer must take affirmative steps to alert consumers, doctors, or pharmacists of changes in the drug label. Because the duty of sameness prohibits the generic manufacturers from taking such action unilaterally, they are dependent on brand-names taking the lead. Id. at 2576 (“[I]f generic drug manufacturers, but not the brand-name manufacturer, sent [additional warnings such as a ‘Dear Doctor’ letters], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly ‘misleading.’“). Under federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not whether the proposed warning to be disseminated contains substantially similar information as the label. Because no brand-name manufacturer sent a warning based on the 2004 label change, the generic manufacturers were not at liberty to do so. As Mensing concluded, preemption is thus triggered since it would be impossible for PLIVA to comply with both the state law duty to warn and the federal law duty of sameness.
Id. at *6-7.
Plaintiffs next tried a “failure to update” claim – that is, that the generic manufacturer failed to meet its duty under federal law to update its label to match that of the branded manufacturer. The problem with this claim, however, is that this duty is entirely federal in nature. It is created by the FDCA and FDA regulations and has nothing to do with state law. Section 337(a) of the FDCA, along with the reasoning of Buckman, leaves only to the United States, not private plaintiffs, the enforcement of the FDCA. In other words, “failure to update” claims are preempted:
[A] claim that PLIVA breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted. 21 U.S.C. § 337(a); see Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4, 121 S. Ct. 1012, 1018 n.4 (2001).
This is the first circuit court to address a “failure to update” claim. We’re off to a good start.
Next, plaintiffs claimed that the designation of defendants’ drug as the Reference Listed Drug, a designation that the FDA unilaterally gives to one generic drug once the branded drug is no longer marketed, means that the RLD should be treated like the branded drug. Therefore, the argument goes, the generic manufacturer of that RLD in fact had the authority to unilaterally change its label. There is one problem with this argument. It’s complete make-believe. There is nothing in the FDCA or FDA regulations that says that the manufacturer of an RLD has the unilateral power to change its label:
[W]e agree with the district court’s analysis, in rejecting this claim, that it “assumes, without authority, that the FDA considered [defendant] to be a brand name manufacturer with the requisite duty to unilaterally change its product’s labeling simply because the FDA designated [defendant’s] metoclopramide as the RLD.”
Id. *8-9. This claim was preempted.
The court next turned to plaintiffs’ non-failure-to-warn claims. First, plaintiffs claimed that defendants had a duty to test or inspect the product. This claim has essentially the same problems as plaintiffs’ other claims. At best, it’s based on a federal duty that private plaintiffs are not authorized to enforce. At worst, it’s based on the notion that testing or inspecting would have forced the FDA to act and change the warning, something explicitly rejected as a basis for liability by the Mensing Court:
First, the Federal Food, Drug, and Cosmetic Act (“FDCA”) provides no private right of action for these violations. “[A]ll such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States.” 21 U.S.C. § 337. Nor can a violation be used as evidence of a breach of duty. While any testing and reports could have been used to alert the FDA of the need to strengthen labels and warnings, the Supreme Court specifically addressed this argument in Mensing. A federal duty to ask for such help might have existed but state tort law “did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label.” Mensing, 131 S. Ct. at 2578. Finally, any “useful” reporting–at least from the standpoint of those injured–would ostensibly consist of some sort of warning. This argument, then, is yet another attempt to circumvent disfavored failure-to-warn claims.
Id. at *9-10.
Finally, plaintiffs made the Bartlett argument – that is, that “the drug is unreasonably dangerous as designed and so, in fact, no warnings would have been sufficient: metoclopramide should not have been sold at all.” In what we hope is foreshadowing of a bigger rejection, the Fifth Circuit explicitly rejected the reasoning of Bartlett:
While this type of claim has been recognized by the First Circuit [footnoting to Bartlett], it has been rejected by this one. See Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 186-87 (5th Cir. 2012) (per curiam). Demahy is more convincing. A breach of warranty claim that goes directly to the sufficiency of the generic manufacturers’ labeling is clearly unacceptable. Metoclopramide has legitimate therapeutic purposes, as evidenced by the FDA’s approval of Reglan in the first place. Any state law-based holding that the generic manufacturers should have acted differently with respect to warnings or should have ceased manufacturing these products because of insufficient warnings not only violates the duty of sameness but conflicts with FDA’s exclusive authority to approve drugs and drug labels. This claim is preempted.
Id. at *10-11.
Congratulations to Richard Dean and his colleagues at Tucker Ellis for a terrific win.