We’ve argued since PLIVA v. Mensing, 131 S. Ct. 2567 (2011), was first decided that its impossibility preemption rationale extended to innovator/branded drugs and was not limited to generics. We’ve won some in the district courts, but lost all too many as judges chanted “Levine, Levine, Levine” and refused to consider logic.
That seems to be changing. On Friday the First Circuit – not a court with a pro-defense reputation – recognized precisely this in Marcus v. Forest Pharmaceuticals, Inc., No. 14-1290, slip op. (1st Cir. Feb. 20, 2015). Marcus was something of an oddball case, a class action under California consumer protection statutes alleging that an innovator drug label “misleads” consumers by omitting adverse efficacy information. Slip op. at 1, 8. The remedy being sought was to force the defendant to seek a “redo” of its previous FDA approval, on the basis of the supposedly “correct” efficacy information. Id. at 10 (“plaintiffs request that the court ‘[p]ermanently enjoin [defendant] from continuing to sell or market [the drug] with its current drug label and direct [defendant] to seek FDA approval of a new [drug] label”). It may have been precisely the First Circuit’s pro-plaintiff reputation (see our posts on Bartlett and Neurontin) that attracted these unusual claims.
For our Mensing preemption purposes, the essential fact the First Circuit recognized was that none of the information plaintiffs were relying on was in any way “new” or related to safety, as required by the CBE-based rationale of Wyeth v. Levine, 555 U.S. 555 (2009). Marcus, slip op. at 6 (“the change must ‘reflect newly acquired information’) (quoting 21 C.F.R. §314(b)). The CBE requirement, so as not to be an end-run around the FDA, is limited to information that the FDA hasn’t already considered. That made good sense to the Marcus court:
CBE changes rest on the existence of newly acquired information. A state law duty to initiate such a change is therefore not by its nature a second guess of an FDA judgment. To the extent that the underlying policy issue is one of who decides whether and how a drug can be marketed, the line so drawn lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing the states to reach contrary conclusions when new information not considered by the FDA develops.
Slip op. at 16-17 (citations quotation marks, and footnote omitted).
There are also five, and only five proper regulatory bases for the submission of a CBE supplement. Marcus quotes them, but we’ll just paraphrase: (1) to add/strengthen a safety-related warning; (2) to add/strengthen an addiction/overdose warning; (3) to add/strengthen dosage information; (4) to delete a false/misleading indication; and (5) whatever the FDA requests be submitted as a CBE. Slip op. at 7. These purposes also preclude second-guessing of FDA approval decisions:
The CBE regulation, too, covers virtually all situations in which new information indicates new or greater risks, or misleading claims of efficacy. By hinging preemption on the availability of that procedure . . ., [Levine] effectively reserves the launch of new drugs to the expertise of the FDA, but then preserves a wide scope for the states in requiring manufacturers to respond to information not considered by the FDA.
Id. at 17 (footnote omitted).
The complaint did not allege that the drug was unsafe, only inefficacious, and therefore that the defendant violated California consumer protection statutes by claiming that it was effective for an FDA-approved indication. Id. at 10. By seeking to stop the marketing of a currently FDA approved drug, the plaintiffs’ claims went well beyond ordinary product liability. Fortunately, the First Circuit says that Mensing impossibility preemption precludes those claims.
The claims, targeting the defendant’s labeling, would require “change[s to the drug’s] label in order to avoid liability under state law.” Marcus, slip op. at 14. Mensing therefore came into play:
Importantly for our purposes, the [Mensing] Court explained that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.” Id. at 2579 (citing [Levine], 555 U.S. at 573). The Court thus limited [Levine] to situations in which the drug manufacturer can, of its own volition, strengthen its label in compliance with its state tort duty.
Id. at 15-16 (Mensing quotation marks and cite omitted). It was thus “a necessary step in defeating [the] preemption defense” for a plaintiff “to establish that the complaint alleges a labeling deficiency that [the defendant] could have corrected using the CBE regulation.” Id. at 17. This is no less true when the drug is an innovator, as opposed to a generic drug.
Everything in the complaint – as plaintiffs conceded at oral argument – had already been before the FDA when it originally considered, and approved, the drug’s labeling for the indication at issue. Id. at 18 (finding “only two fleeting references to academic articles published after the FDA’s approval. . . . Plaintiffs make no claim that these two academic articles are based on new data.”). Plaintiffs claimed that information submitted to the FDA was “manipulated” (sounding to us like an fraud on the FDA claim), but in any event there was “no claim . . . that this information was unknown to the FDA prior to label approval”). Id. at 20.
For these reasons, the plaintiffs’ claims against the innovator drug manufacturer were preempted under Mensing:
We can find no precedent − and plaintiffs point to none − that would have allowed [defendant] to use the CBE procedure to alter the FDA label in the manner that plaintiffs allege is necessary so as to render it not “misleading.” Indeed, plaintiffs seem to concede this in their prayer for relief, as they ask the Court to “direct [defendant] to seek FDA approval of a new [drug] label.”
Plaintiffs are thus stymied: [defendant] could not independently change its label to read as plaintiffs say it should have read in order to comply with California law. That construction of California law upon which plaintiffs rely . . . is therefore preempted by federal law.
Marcus, slip op. at 21 (Mensing citation omitted).
Marcus may be somewhat unusual in its allegations – but not that much different than the Pennsylvania FDA-should-never-have-approved “negligent design” claim recognized in Lance (discussed here). The proposition that is critical for us in Marcus is fundamental. There is only one preemption doctrine for prescription drugs, and it applies to both innovator and generic drugs. There are a lot of ways that Mensing preemption can restrict claims against innovator drugs, everything from distributor or co-promoter claims, to design claims, to claims based on “major” warning modifications that the FDA does not allow to be made by CBE. The key is for courts to recognize this continuum. That is precisely what Marcus does, emphatically, and in a circuit not known for pro-defense rulings.