Robert Daniel Taylor v. Leanne Polhill
964 F.3d 975
| 11th Cir. | 2020Background:
- Federal Medical Device Amendments (MDA) and FDA regulations include an express preemption clause (21 U.S.C. § 360k) and FDA guidance treating state licensing rules as generally not "requirements applicable to a device."
- Florida statutes at issue: Pre-Sale Testing Statute (Fla. Stat. § 484.0501), Licensing Statute (§ 484.053), and Mail Order Ban (§ 484.054).
- Plaintiff Robert Taylor: long‑time hearing‑aid seller and former licensed specialist who declined to renew his license in 2016 believing pre‑sale testing mandates were preempted; continued selling, was cited and paid a civil fine.
- Taylor sued state board members and the Florida Health Secretary (official capacities) seeking declaratory and prospective injunctive relief, claiming federal preemption of the three statutes and due process violations as to the Pre‑Sale Testing Statute.
- District court dismissed: held Taylor lacked standing to challenge the Pre‑Sale Testing Statute and dismissed preemption claims against the Licensing Statute and Mail Order Ban for failure to state a claim.
- Eleventh Circuit: affirmed dismissal for failure to state claims as to the Licensing Statute and Mail Order Ban; reversed the lack‑of‑standing dismissal for the Pre‑Sale Testing Statute and remanded for further proceedings.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing to challenge Pre‑Sale Testing Statute | Taylor would resume licensure and dispensing but for the statute; faces enforcement and fines — imminent injury | Statute applies only to licensed sellers; Taylor is unlicensed and does not intend to remain licensed, so no threat of enforcement | Taylor has standing: alleged imminent injury, causation, and redressability; dismissal reversed and remanded |
| Preemption of Licensing Statute (§ 484.053) | Licensing elements embed pre‑sale testing requirements, so the licensing scheme is preempted by the MDA | Licensing statutes regulate practitioner competency and are not "requirements applicable to a device" under § 360k(a); Florida's licensing text does not incorporate pre‑sale testing | Licensing Statute not preempted; Rule 12(b)(6) dismissal affirmed |
| Preemption of Mail Order Ban (§ 484.054) | Ban effectively prohibits mail sales that avoid pre‑sale testing (or by unlicensed sellers), thus conflicts with federal scheme | Ban is categorical and does not impose device safety/effectiveness requirements or explicitly incorporate pre‑sale testing | Mail Order Ban not preempted as written; plaintiff's conclusory theory rejected; dismissal affirmed |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (standing doctrine and injury‑in‑fact requirement)
- Babbitt v. United Farm Workers Nat'l Union, 442 U.S. 289 (realistic danger of enforcement for facial/statutory challenges)
- Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (causation and redressability in standing analysis)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility standard for Rule 12(b)(6))
- Ashcroft v. Iqbal, 556 U.S. 662 (rejecting conclusory legal allegations at motion to dismiss)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (scope of MDA § 360k preemption framework)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (FDA exemption authority under § 360k(b) and preemption principles)
- Missouri Bd. of Exam'rs for Hearing Instrument Specialists v. Hearing Help Express, Inc., 447 F.3d 1033 (8th Cir. case upholding preemption of a mail‑order ban that mandated pre‑sale testing)
- MeTX, LLC v. Wal‑Mart Stores Texas, LLC, 62 F. Supp. 3d 569 (E.D. Tex. decision addressing Texas licensing scheme that explicitly tied licensure to fitting and testing)