United States: "A" Is For Preemption

Last Updated: March 5 2018
Article by Steven Boranian

The Seventh Circuit taught us recently that the letter "A" is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary ("typical") into the extraordinary ("atypical"), the melodic ("tonal") into the dissonant ("atonal"), and the virtuous ("moral") into the indifferent ("amoral"). Adding a single A to a Scrabble board can result in a seriously high-value word, provided you can manage to place it on a triple word score appended to a word that already has high value letters, like H or Y, or if you are really lucky, X.

For today, A stands for "Abbreviated"—as in Abbreviated New Drug Application, or ANDA. It's important because the Seventh Circuit held in Guilbeau v. Pfizer, Inc., No. 17-2056, 2018 WL 476343 (7th Cir. Jan. 19, 2018), that implied preemption of a failure-to-warn claim under Pliva v. Mensing depends not on a drug's colloquial description as "generic" or "brand name," but rather on the nature of the drug's approval process. If a drug is approved through an ANDA, federal regulation of drug labeling preempts state-law failure to warn claims—even if the drug is technically the "Reference Listed Drug."

This ruling makes perfect sense, and here is how it works. In Guilbeau, the plaintiffs alleged that manufacturers of a testosterone replacement therapy product called Depo-T failed adequately to warn regarding cardiovascular events. Id. at *1. Depo-T, however, had a slightly unusual regulatory history. When a manufacturer applies for drug approval under an ANDA, it has to demonstrate that the drug has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id. at *2. The predecessor drug is called the Reference Listed Drug. Id.

The Reference Listed Drug is usually the innovator product, approved through the NDA process and often referred to as a "brand-name" drug. The ANDA drug is often called "generic." If, however, an original innovator drug has been discontinued, the FDA can designate the remaining market-leading drug to take its place as the Reference Listed Drug. Id. Something like that (but not exactly) happened to Depo-T. Because of unique circumstances surrounding the timing of the drug's approval, the FDA classified Depo-T as an ANDA-approved drug, but the product also was designated the Reference Listed Drug for its kind of testosterone injection. Id. at *4.

So which is it? "Generic" or "brand name"? It turns out those terms are neither useful nor dispositive when applying implied preemption. Or, as the Seventh Circuit observed, "These colloquial terms are not quite precise enough for our purposes in this case." Id. The relevant distinction is NDA-approved versus ANDA-approved. That distinction determines whether a drug manufacturer can unilaterally update its labeling through the changes being effected (or "CBE") process and thus potentially lose the protection of implied preemption recognized in Pliva v. Mensing. The Seventh Circuit explained it this way:

[D]espite potentially confusing references to brand-name and generic drugs—recall that the relevant FDA terms are NDA-approved and ANDA-approved—Mensing itself unambiguously refers to the lines drawn in the drug approval process as determining access to the CBE regulation. Mensing concludes that while NDA holders may use the CBE regulation to add warnings, ANDA holders (like [the manufacturer] here) may not. . . .

Despite their occasional use of these terms, the Supreme Court, Congress, and the FDA all agree that the meaningful difference is found in approval process classifications, not shorthand terms like brand-name and generic.

Id. at *6. The key point for the Seventh Circuit was that the CBE regulation is unavailable for products approved through the ANDA process. And that goes for every ANDA product, even if it is the Reference Listed Drug—like Depo-T. Because ANDA product manufacturers cannot change their labels unilaterally, it is impossible to change a label in response to state tort law without violating the federal duty of "sameness" that applies to all ANDA products. That is Pliva v. Mensing implied preemption. Id. at **4-5.

The Guilbeau plaintiffs tried to avoid preemption by arguing that, because Depo-T was itself the Reference Listed Drug, the manufacturer's duty was to have labeling the same as its own labeling. According to the plaintiffs, that means the manufacturer could change the label all it wanted to and it would still be the "same" as itself. Id. at *5. We appreciate the metaphysical nature of this argument: How can something ever be different from itself? But the answer is pretty easy. The duty of "sameness" means that ANDA holders must match the labeling for the Reference Listed Drug as approved by the FDA, "not whatever the RLD's manufacturer currently thinks would be best." Id. at *7. In other words, "The statutes, the regulations, and the Mensing opinion do not draw the distinction plaintiffs advocate: a difference in abilities and responsibilities between RLD ANDA holders and other ANDA holders." Id.

In the end, ANDA drugs that are also Reference Listed Drugs are subject to a "duty of sameness indistinguishable from that of all other ANDA drugs." Id. at *8. They all must show that their labeling is the same as the approved labeling. Id. Thus, because Depo-T's manufacturer "may not unilaterally change the FDA-approved language on Depo-T's label," a lawsuit under state law that seeks damages for the manufacturer's failure to do so is preempted by federal law. Id.

One more important note: The Seventh Circuit held that the plaintiffs were not entitled to conduct further discovery. The district court decided this case on a motion to dismiss, and because "preemption is a legal question for determination by courts . . . , discovery of facts may not be as vital to this inquiry as it could be to others." Id. at *10. With recent opinions from the Third Circuit and Ninth Circuit treating preemption as a factual issue on which discovery might be appropriate (discussed here and here), the Seventh Circuit's holding on discovery is most welcome. Preemption can and should be decided on the pleadings in many instances, including the circumstances presented here. The district court in Guilbeau correctly did exactly that, and the Seventh Circuit gave the order an A grade.

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

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