Belcher Pharmaceuticals, LLC v. Hospira, Inc.
1f4th1374
| 11th Cir. | 2021Background
- Belcher Pharmaceuticals marketed an FDA‑approved 1 mg/mL epinephrine ampule; Hospira marketed grandfathered epinephrine products (a 1 mg/mL ampule and a 0.1 mg/mL prefilled syringe) that listed broader, historical indications.
- Belcher alleged Hospira’s package inserts (listing unapproved indications) gave the false impression that Hospira’s products and their uses were FDA‑approved, diverting sales from Belcher.
- At summary judgment the district court held the suit would intrude on FDA enforcement authority and found Belcher failed to show specific misleading statements by Hospira; it granted summary judgment for Hospira.
- On appeal the Eleventh Circuit held that the FDCA does not categorically preclude Lanham Act false‑advertising claims about drug labels, but such claims are barred if they require courts to make FDA‑exclusive determinations.
- The court affirmed summary judgment because Belcher produced no evidence identifying a specific Hospira representation that caused consumer confusion about FDA approval.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the FDCA precludes Lanham Act challenges to drug labeling | Lanham Act claim is permitted; FDCA does not bar private suits | FDCA and FDA enforcement preclude private Lanham challenges here | Not precluded; Lanham and FDCA are complementary (POM Wonderful applies) |
| Whether resolving the claim would usurp FDA authority / require FDA expertise | Court can assess whether labels imply FDA approval without deciding drug safety/effectiveness | Deciding would intrude on FDA's exclusive regulatory domain | No usurpation here; claim did not require original FDA determinations |
| Whether Hospira made a false or misleading statement implying FDA approval | Hospira’s package inserts and market placement implied FDA approval | Inserts contain no statement of approval; mere presence on market is not a misrepresentation | Plaintiff failed to identify any specific misleading representation by Hospira |
| Whether summary judgment was proper given the evidence of consumer belief | Some consumers believed Hospira’s products were FDA‑approved; this supports Lanham claim | No evidence ties those beliefs to any Hospira representation | Affirmed: insufficient evidence linking Hospira’s statements to consumer deception |
Key Cases Cited
- POM Wonderful LLC v. Coca‑Cola Co., 573 U.S. 102 (U.S. 2014) (Lanham Act suits challenging FDA‑regulated labels are not categorically precluded by the FDCA)
- Hi‑Tech Pharms., Inc. v. HBS Int’l Corp., 910 F.3d 1186 (11th Cir. 2018) (elements and deception standard for Lanham Act false‑advertising claims)
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) (Lanham claims may be barred if resolution requires determinations committed to FDA)
- Tracy v. Fla. Atl. Univ. Bd. of Trs., 980 F.3d 799 (11th Cir. 2020) (de novo review of summary judgment)
- Fla. Wildlife Fed’n Inc. v. U.S. Army Corps of Eng’rs, 859 F.3d 1306 (11th Cir. 2017) (appellate court may affirm on any record‑supported basis)
- United States v. An Article of Drug (Bentex Ulcerine), 469 F.2d 875 (5th Cir. 1972) (grandfathered‑drug defense when FDA challenges new‑drug status)