[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT

________________________

No. 20-10497

________________________

D.C. Docket No. 8:17-cv-02353-JSM-AAS

BELCHER PHARMACEUTICALS, LLC, 

 Plaintiff-Appellant,

 versus

HOSPIRA, INC.,

 Defendant-Appellee.

________________________

Appeal from the United States District Court

for the Middle District of Florida

________________________

(June 24, 2021)

Before MARTIN, GRANT, and BRASHER, Circuit Judges.

GRANT, Circuit Judge: 

This case falls at the intersection of two federal statutes. The Food, Drug, 

and Cosmetic Act—as the name implies—gives the Food and Drug Administration 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 1 of 11
2

regulatory and enforcement authority over food, drugs, and cosmetics. That 

authority extends to product labels. The Lanham Act offers complementary 

authority to the private sector—it provides competitors with a cause of action to 

block unfair competition stemming from misleading labeling or advertising. Taken 

together, these statutes mean that both government authorities and private parties 

can police the marketplace to prevent misleading advertising. 

Belcher Pharmaceuticals decided to sue one of its competitors, Hospira, 

under the Lanham Act. Belcher alleged that the labels for two of Hospira’s drug 

products falsely implied that the products and their uses were FDA-approved, and 

that Hospira’s misrepresentations allowed it to cut into the sales of Belcher’s drug. 

But that claim did not survive summary judgment; the district court found that 

resolving it would invade the FDA’s enforcement authority under the FDCA. And 

even if the claim were allowed, the district court held, Belcher had failed to show 

that Hospira made misleading statements. Belcher now challenges the district 

court’s decision, arguing that its claim was both allowed and supported.

We agree with Belcher in at least one respect. The Lanham Act can 

peacefully coexist with the FDCA for many drug-related claims, including this 

one. Still, we affirm the district court’s decision. Though Belcher’s Lanham Act 

claim was not precluded by the FDCA, it also was not supported by evidence of 

any misleading statements on Hospira’s labels. Because Belcher never showed 

that Hospira made representations that misled consumers about the FDA’s 

approval of its drug products, Hospira is entitled to summary judgment.

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 2 of 11
3

I.

Injectable epinephrine has been sold in the United States for more than a 

century. It is used to respond to a variety of conditions, including emergency 

treatment of allergic reactions.

1

 But until 2012, no pharmaceutical company 

received official FDA approval to market the drug. Manufacturers instead treated 

their epinephrine products as “grandfathered” drugs, meaning that they were 

exempt from the FDA’s new drug approval procedures. Grandfathered drugs are 

those that were on the market prior to the passage of the Food, Drug, and Cosmetic 

Act in 1938 and that contain in their labeling “the same representations concerning 

the conditions of use as [they] did prior to passage.” See U.S. Food & Drug 

Admin., Marketed Unapproved Drugs Compliance Policy Guide: Guidance for 

FDA Staff and Industry 11 (2011) (FDA Compliance Guide); 21 U.S.C. 

§ 321(p)(1).

2

 

In 2012, the FDA approved its first epinephrine product, a 1mg/mL ampule 

manufactured by JHP Pharmaceuticals.3

 A few years later, Belcher 

1 Another injectable epinephrine product, one not at issue in this case, has become a household 

name under the EpiPen moniker. 

2 There is no application process to designate a drug as “grandfathered,” so manufacturers treat

their products as grandfathered based on the statutory definition unless and until the FDA 

challenges that assumption. See FDA Compliance Guide at 11–12. If the FDA brings an 

enforcement action claiming that a pharmaceutical company is marketing a new drug without 

FDA approval, the manufacturer may argue that the drug is grandfathered as a defense. United 

States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875, 878 (5th Cir. 1972). The parties 

disagree about whether Hospira’s products qualified for grandfathered status. But what matters 

is that Hospira never claimed that its products were FDA-approved, and that FDA approval is not 

required for a drug to be on the market. Because the designation is not at issue in this case, we 

proceed assuming that Hospira’s epinephrine products are grandfathered. 

3 An ampule is a “sealed vial made of glass or plastic that contains a sterile medicinal solution.” 

The American Heritage Dictionary of the English Language 62 (5th ed. 2011).

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 3 of 11
4

Pharmaceuticals followed with its own FDA-approved 1mg/mL epinephrine 

ampule. These newly approved epinephrine ampules, though, did not push other 

“grandfathered” epinephrine products out of the market. Hospira, whose 

predecessor Abbott Laboratories began supplying injectable epinephrine before the 

FDCA was enacted, marketed two of those epinephrine products: a 1mg/mL 

ampule and a .1mg/mL prefilled syringe. 

Both Belcher’s and Hospira’s epinephrine products, like other drugs, 

contained package inserts with indications for use—that is, a list of uses for the 

drug. Because Belcher had submitted a “new drug application” to the FDA, its 

indications for use were limited to those the FDA approved: (1) to “increase mean 

arterial blood pressure in adult patients with hypotension associated with septic 

shock”; (2) for “induction and maintenance of mydriasis during intraocular 

surgery”; and (3) for “emergency treatment of allergic reactions (Type 1),

including anaphylaxis.” Hospira’s epinephrine ampule and syringe, on the other 

hand, were grandfathered, so their indications were not limited to those FDAendorsed uses. Hospira accordingly 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. 

The two companies’ epinephrine products overlapped on the market for two 

years. Hospira discontinued its ampule after that, but continued to produce and 

market an epinephrine syringe. As the law of supply and demand might predict, 

Belcher started to see an uptick in profits for its own ampule after Hospira’s partial 

exit. And once Belcher realized that it had been losing sales to Hospira’s 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 4 of 11
5

unapproved products for the last several years, the company sued in federal district 

court for unfair competition under the Lanham Act.4

 

The Lanham Act, known primarily for its federal trademark provisions, also 

allows industry competitors, like Belcher, to sue for unfair competition based on

misleading advertising, which includes misleading labeling. POM Wonderful LLC 

v. Coca-Cola Co., 573 U.S. 102, 107 (2014). To prevail on its false advertising 

claim, Belcher needed to prove that Hospira made “false or misleading” statements

and that “the statements deceived, or had the capacity to deceive, consumers.” HiTech Pharms., Inc. v. HBS Int’l Corp., 910 F.3d 1186, 1196 (11th Cir. 2018) 

(quotation omitted). Belcher pointed to Hospira’s package inserts—which 

contained the unapproved indications for use—for the allegedly misleading 

statements.5

 It did not contend that the indications themselves presented false 

information; instead, it argued that these inserts gave the false impression that 

Hospira’s epinephrine products (along with their indications) were approved by the 

FDA. Belcher thought that this gave Hospira a competitive advantage, as its 

products seemed “safer and/or more effective” than Belcher’s.

After discovery, Hospira moved for summary judgment, arguing both that 

Belcher’s claim “improperly asks the Court to make determinations about the 

safety, efficacy, and legality of Hospira’s products,” and that Belcher “failed to 

4 Belcher also pleaded additional counts, including tortious interference and common law unfair 

competition, but those were dismissed or disposed of at the summary judgment stage and not 

appealed. 

5 At summary judgment, Belcher asserted additional Lanham Act claims based on other 

statements by Hospira. The court granted summary judgment for Hospira on the remaining 

claims and Belcher appealed only the court’s decision on the package insert statements. 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 5 of 11
6

produce any evidence” supporting its allegations of false advertising under the 

Lanham Act. The district court agreed. While Belcher claimed that Hospira’s 

package inserts “misled consumers into believing Hospira’s epinephrine products 

were FDA-approved,” the court held that Belcher needed to “show more than the

mere fact that a drug has been placed on the market with standard packaging and 

inserts.” Otherwise, the court said, it would “usurp the FDA’s authority to enforce 

the Food, Drug, and Cosmetic Act.”

The court added that Belcher’s case also suffered from other “fatal flaws.” 

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 fact that Hospira’s package inserts included 

unapproved indications for use was simply “not enough to support a Lanham Act 

claim.” The court entered summary judgment in favor of Hospira, which Belcher 

now appeals. 

II.

We review the grant of summary judgment de novo, viewing the evidence in 

the light most favorable to the nonmoving party. Tracy v. Fla. Atl. Univ. Bd. of 

Trs., 980 F.3d 799, 811 (11th Cir. 2020). We may affirm the district court “on any 

basis the record supports,” regardless of whether that basis was “addressed, 

adopted or rejected by the district court.” Fla. Wildlife Fed’n Inc. v. U.S. Army 

Corps of Eng’rs, 859 F.3d 1306, 1316 (11th Cir. 2017) (quotation omitted).

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 6 of 11
7

III.

A.

The Lanham Act and the FDCA, along with their prohibitions on 

misbranding, have operated side by side for 75 years. See Lanham Act, Pub. L. 

No. 79-489, 60 Stat. 427 (1946); Food, Drug, and Cosmetic Act, Pub. L. No. 75-

717, 52 Stat. 1040 (1938). Though questions have occasionally arisen in the lower 

courts about whether the FDCA’s misbranding provisions preclude Lanham Act 

false advertising claims for FDCA-regulated products, the Supreme Court only 

recently laid that issue to rest—at least for food and beverage labels.

In POM Wonderful LLC v. Coca-Cola Co., the Supreme Court considered 

whether a private competitor could bring a Lanham Act claim challenging an 

FDA-regulated beverage label. 573 U.S. at 111. The answer was a unanimous 

yes—a conclusion that followed naturally from the text and structure of the two 

statutes. Id. at 113–16. Starting with the text, the Court observed that “neither the 

Lanham Act nor the FDCA, in express terms, forbids or limits Lanham Act claims 

challenging labels that are regulated by the FDCA.” Id. at 113. And the FDCA’s

preemption provision reinforced the Court’s reading: it forbids a “State or political 

subdivision of a State” from imposing additional requirements for food and 

beverage labeling, but says nothing about other federal laws. Id. at 114–15

(quoting 21 U.S.C. § 343-1). Given that context, the absence of an express federal 

preclusion provision spoke volumes.

The Court was also clear that the structures of the two acts “reinforce the 

conclusion drawn from the text.” Id. at 115. In fact, the Lanham Act and the 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 7 of 11
8

FDCA “complement each other in major respects.” Id. Though both statutes 

address food and beverage labeling, the Lanham Act “protects commercial 

interests against unfair competition,” while the FDCA “protects public health and 

safety.” Id. Because competitors can sue for false advertising under the Lanham 

Act, they are able to protect their commercial interests against false advertising 

even if the FDA declines to use its limited resources to pursue enforcement 

measures. So those Lanham Act suits actually help the FDA police the market. 

See id. at 115–16 (“Allowing Lanham Act suits takes advantage of synergies 

among multiple methods of regulation.”).

For food and beverage labels, then, the answer is clear—Lanham Act suits 

can go forward. But Hospira insists that the FDA’s heightened regulation of 

pharmaceutical products means we cannot extend POM Wonderful’s rule to the 

drug label context. We cannot agree—nothing in the text of the Lanham Act or the 

FDCA suggests a different rule for drug products. Id. at 113–16. Nor does the 

FDA’s regulatory role for drug products convince us that a different rule is 

necessary. Even in the food and beverage context, the Supreme Court recognized 

the significance of the FDA’s regulatory role: “Enforcement of the FDCA and the 

detailed prescriptions of its implementing regulations is largely committed to the 

FDA.” Id. at 115. But it also saw a role for private action: 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. Id. Nothing about 

those two points is different in the drug industry. 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 8 of 11
9

That said, some differences do exist. For example, the Supreme Court 

contrasted the FDA’s lack of preapproval procedures for food and beverages with 

its more rigorous approval measures for new pharmaceutical products. See id. at 

116. And it is well understood that drug approval is a demanding and complicated 

process. So there may be reasons to 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.6

 Indeed, 

our own Court has approvingly cited cases recognizing that Lanham Act claims 

may be barred if their resolution requires 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.” Hi-Tech Pharms., 910 F.3d at 1199

(quotations omitted) (citing PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 928 (9th Cir. 

2010); Hi-Tech Pharms., Inc. v. Hodges Consulting, Inc., 230 F. Supp. 3d 1323, 

1330 (N.D. Ga. 2016)). 

But this case is not about those potential exceptions. For starters, Belcher’s 

challenge is to drug-package inserts that—like food and beverage labels—have not

received preapproval from the FDA and that Hospira believes do not require 

preapproval. Belcher is thus not asking us to contradict any regulatory conclusion 

reached by the FDA. Nor does Belcher’s claim ask us to make any original 

6 Hospira notes that some courts have considered whether the primary jurisdiction doctrine, 

rather than the preclusion doctrine, may bar these types of claims. See, e.g., Alpharma, Inc. v. 

Pennfield Oil Co., 411 F.3d 934, 937–39 (8th Cir. 2005). But that doctrine is not applicable in 

this case, where no one is asking the Court to decide an issue for which the FDA has special 

expertise. So we decline to consider whether that doctrine would more broadly apply to other

Lanham Act drug labeling claims.

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 9 of 11
10

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. 

Instead, this case falls within the core of POM Wonderful’s rule that the FDCA 

does not categorically preclude Lanham Act claims. The only question at issue 

here is whether Hospira’s package inserts falsely imply that its epinephrine 

products or the package insert claims that go along with them are FDA-approved. 

Nothing in the FDCA prohibits a competitor from bringing that kind of claim. 

B.

Though the FDCA does not preclude Belcher’s Lanham Act claim, it takes 

more to survive summary judgment. A Lanham Act plaintiff has a fundamental 

burden to prove that the defendant made false or misleading statements in its 

advertisements and to show that those statements “deceived, or had the capacity to 

deceive, consumers.” Hi-Tech Pharms., 910 F.3d at 1196; see 15 U.S.C. § 1125. 

And though the false advertisements do not need to be “literally false,” they must

at least “implicitly convey a false impression,” be “misleading in context,” or be 

“likely to deceive consumers.” Hi-Tech Pharms., 910 F.3d at 1196 (quotation 

omitted). 

The fatal flaw for Belcher’s case is that it does not offer any such evidence. 

The company claims that Hospira’s package inserts are misleading because they 

falsely imply FDA approval of the drugs and their indications—but it never shows

how or where. 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 

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 10 of 11
11

enough. To raise a genuine issue of material fact, Belcher needed to offer at least 

some evidence not only that customers erroneously believed that Hospira’s 

products were FDA-approved, but that a specific representation or statement by 

Hospira created that misconception. We agree with the district court that Belcher 

failed to offer that evidence here.

* * *

The Lanham Act and the FDCA continue to operate as complementary—not 

preclusive—statutes. Companies can protect their commercial interests by suing 

competitors for false advertising, even for products regulated by the FDA. But to 

do so, they need to point us to some false or misleading statement. Because 

Belcher did not, we affirm the district court’s grant of summary judgment to 

Hospira.

AFFIRMED.

USCA11 Case: 20-10497 Date Filed: 06/24/2021 Page: 11 of 11