Pom Wonderful applies to pharmaceuticals, but "implied FDA approval" claim still fails

Belcher Pharms., LLC v. Hospira, Inc., 1 F.4th 1374 (11^th Cir. 2021)

Belcher alleged that the labels for two of Hospira’s drugs falsely implied that the products and their uses were FDA-approved. The district court rejected that claim on the grounds that resolving it would invade the FDA’s enforcement authority under the FDCA. And anyway, it held, Belcher had failed to show that Hospira made misleading statements.

Belcher appealed, and the court of appeals found that its claim wasn’t precluded, but it also wasn’t sufficiently supported by a showing of misleadingness, so summary judgment was appropriately granted.

Injectable ephinephrine is (for purposes of this litigation) grandfathered into the US market, though there are also actual FDA-approved ampules; they just didn’t push the grandfathered products out of the market.

Because Belcher submitted an NDA to the FDA, its indications for use were limited to those the FDA approved: for hypotension associated with septic shock; during intraocular surgery; and emergency treatment of allergic reactions. Hospira, being grandfathered (again, for purposes of this litigation), “listed additional historical uses, claiming, among other things, that its products could be used to treat cardiac arrest and to prolong the effects of anesthetics.”

Belcher argued that Hospira’s inserts gave the false impression that Hospira’s epinephrine products (along with their indications) were approved by the FDA. The district court held that, to avoid FDCA preclusion, Belcher needed to “show more than the mere fact that a drug has been placed on the market with standard packaging and inserts.” Also, though Belcher offered evidence that “some consumers believed Hospira’s epinephrine products were FDA-approved,” it was “unable to tie those beliefs to actionable acts by Hospira.”

Does the greater regulation of pharmaceuticals mean that Pom Wonderful applies differently to them than to food and beverage labels? “[N]othing in the text of the Lanham Act or the FDCA suggests a different rule for drug products.” Nor is the extensiveness of FDA’s regulatory role matter—FDA’s role in food/beverage labels is already detailed. But Pom Wonderful stated that the FDA “does not have the same perspective or expertise in assessing market dynamics that day-today competitors possess,” and the Lanham Act harnesses that expertise by motivating competitors to challenge certain misleading labels. “Nothing about those two points is different in the drug industry.”

There are some reasons a court might “disallow label challenges involving certain drug claims that call on courts to contradict a conclusion of the FDA or to make an original determination on an issue committed to the FDA’s discretion.” In particular “an original determination that is committed to the FDA,” such as “whether a drug is ‘new,’ and whether it can be lawfully marketed under the FDCA, may be for the FDA alone. But this case wasn’t like that.

For one thing, these labels hadn’t been preapproved by the FDA. Nor was Belcher asking for an original determination “that only the FDA could make—such as whether the indications for use are safe or effective, or whether Hospira’s drug is approved or grandfathered.”

So, contrary to some previous cases, the court found that whether the package inserts falsely implied FDA approval was cognizable under the Lanham Act.

But the claim still failed: “Hospira’s inserts never claimed FDA approval, nor does Belcher point us to any language that hints at it. As best we can tell, Belcher relies solely on the existence of the drug and its inserts on the market. That is simply not enough.” There was no consumer evidence. [Query what kind of survey would have been appropriate. What if you showed relevant consumers the inserts with a clear disclosure of lack of approval as a control—would that be ok?]