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

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

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.

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.

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.

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.”

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.”

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.”

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.

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.”

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

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?]



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