ROBERT DANIEL TAYLOR, Plaintiff-Appellant, versus LEANNE POLHILL, solely in her official capacity as a Member of the Florida Board of Hearing Aid Specialists, et al., Defendants-Appellees.
No. 18-14934
United States Court of Appeals, Eleventh Circuit
July 1, 2020
EBEL, Circuit Judge
[PUBLISH]; D.C. Docket No. 6:18-cv-00613-GAP-DCI; Appeal from the United States District Court for the Middle District of Florida
Before MARCUS, ANDERSON, and EBEL,* Circuit Judges.
Plaintiff-Appellant Robert Daniel Taylor sued Defendants-Appellees, the members of the Florida Board of Hearing Aid Specialists and the Secretary of the Florida Department of Health, each in their official capacities, alleging that three Florida statutes administered by the Defendants are preempted by federal law and/or violate Taylor‘s due process rights. The district court dismissed the case in its entirety, dismissing one of Taylor‘s claims for lack of standing and the others for failure to state a claim upon which relief could be granted. Taylor challenges the district court‘s dismissal of his claims. Having jurisdiction under
I. BACKGROUND
In 1976, Congress amended the Federal Food, Drug, and Cosmetics Act through passage of the Medical Device Amendments (“MDA“) which, together with regulations promulgated by the Food & Drug Administration (“FDA“), created a federal regulatory scheme for different kinds of medical devices, including hearing aids. The MDA contains an express preemption provision,
Florida, like most states, has enacted its own statutory scheme regulating professions and occupations, which includes statutes applicable to those who fit and dispense hearing aids.
Taylor has been selling hearing aids in Florida for over thirty years and, until 2016, Taylor was a licensed hearing aid specialist. In 2016, based on his belief that the pre-sale testing requirements established by Florida‘s statutory scheme were preempted by the MDA, he did not renew his license. Taylor did not cease his business, but rather continued selling hearing aids utilizing the testing procedures he believes are necessary. Taylor was cited by Defendants for selling hearing aids without a license, and he was assessed a civil fine, which he paid.
Taylor then filed this suit against the members of the Florida Board of Hearing Aid Specialists and the Secretary of the Florida Board of Health, in their official capacities, alleging that the three aforementioned Florida statutes are unconstitutional because all three are preempted by federal law and because the Pre-Sale Testing Statute infringes on his due process rights. Taylor sought prospective declaratory and injunctive relief. The Defendants filed a motion to dismiss Taylor‘s complaint, which the district court granted.
The district court dismissed Taylor‘s challenges to the Pre-Sale Testing Statute for lack of standing, and it dismissed Taylor‘s challenges to the Licensing Statute and the Mail Order Ban for failure to state a claim under
Because this appeal arises from a motion to dismiss, our review is de novo, “accepting the allegations in the complaint as true and construing them in the light most favorable to the plaintiff.” Timson v. Sampson, 518 F.3d 870, 872 (11th Cir. 2008).
II. DISCUSSION
The district court concluded that Taylor (1) did not have standing to challenge the Pre-Sale Testing Statute; (2) failed to state a claim as to the Licensing Statute; and (3) failed to state a claim as to the Mail Order Ban. We address these conclusions in turn.
A. Standing to Challenge the Pre-Sale Testing Statute
The district court determined that, because the Pre-Sale Testing Statute imposes requirements on licensed hearing aid sellers, and because Taylor is not and does not intend to become a licensed hearing aid seller, the Pre-Sale Testing Statute neither applies to nor poses a threat of future injury to Taylor. Thus, the district court concluded that Taylor does not have
Standing consists of three elements: (1) injury in fact, (2) causation, and (3) redressability. Lujan, 504 U.S. at 560-61. To show an injury in fact, the plaintiff must show “an invasion of a legally protected interest which is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical.” Id. at 560 (citations omitted). “A plaintiff who challenges a statute must demonstrate a realistic danger of sustaining a direct injury as a result of the statute‘s operation or enforcement.” Babbitt v. United Farm Workers Nat‘l Union, 442 U.S. 289, 298 (1979). “When a plaintiff has stated that he intends to engage in a specific course of conduct ‘arguably affected with a constitutional interest,’ however, he does not have to expose himself to enforcement to be able to challenge the law. ‘If the injury is certainly impending, that is enough.‘” Am. Civil Liberties Union v. Fla. Bar, 999 F.2d 1486, 1492 (11th Cir. 1993) (quoting Babbitt, 442 U.S. at 298) (internal citation omitted).
Taking the factual allegations in the complaint as true, as we must, Taylor has sufficiently alleged an injury in fact. Taylor challenges the Pre-Sale Testing Statute‘s constitutionality, arguing both that the statute violates his right to due process and that it is preempted by federal law. In his complaint, Taylor alleges that, prior to giving up his license, he was a state-licensed hearing aid specialist for thirty years and had operated his own hearing aid retail store for over twenty-six years. Taylor also alleges that “[b]ut for Florida‘s prohibition for dispensing hearing aids without using its required fitting procedures and equipment, [he] would immediately begin dispensing hearing aids.” (Complaint ¶ 86.) In other words, the only thing keeping Taylor from dispensing hearing aids is the threat of enforcement of the allegedly unconstitutional Pre-Sale Testing Statute. And, as Florida‘s statutory scheme for dispensing hearing aids has been enforced against Taylor in the past, the chance that it will be enforced against him in the future is not speculative. Taylor is thus put in the position of either refraining from conduct he alleges to be unconstitutionally prohibited or engaging in such conduct and exposing himself to enforcement. The Constitution does not require that Taylor expose himself to enforcement
Because the district court erroneously determined that Taylor did not show an injury in fact, it did not address whether Taylor satisfied the remaining standing requirements. However, as the question of Taylor‘s standing is reviewed de novo, Bochese, 405 F.3d at 975, we address the remaining standing requirements here to conclude that Taylor has standing to challenge the Pre-Sale Testing Statute.
After properly alleging an injury in fact, the plaintiff must show causation and redressability to establish standing. Lujan, 504 U.S. at 560-61. To satisfy these elements, Taylor must allege that his injury in fact is “fairly traceable to the challenged conduct of the defendant” and is “likely to be redressed by a favorable judicial decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). Here, Taylor‘s alleged injury in fact is the impending imposition of a fine by Defendants in the course of their enforcement of the Pre-Sale Testing Statute. Because Taylor could not be fined were the Pre-Sale Testing Statute invalidated, Taylor has satisfied the causation requirement. And, because if Taylor were to succeed on any of his challenges to the Pre-Sale Testing Statute, the statute would not be enforced against him, and Taylor‘s injury would be redressed by this litigation.
Thus, we conclude that Taylor has standing to challenge the Pre-Sale Testing Statute, and we therefore REVERSE the district court‘s dismissal of Taylor‘s claims for lack of standing as to the Pre-Sale Testing Statute and REMAND for further proceedings on that claim.4
B. Failure to State a Claim Pertaining to the Licensing Statute and the Mail Order Ban
The district court dismissed Taylor‘s preemption challenges to the Licensing Statute and the Mail Order Ban for failure to state a claim under
1. Preemption and the MDA
“It is a familiar and well-established principle that the Supremacy Clause invalidates state laws that interfere with, or are contrary to, federal law.” Hillsborough Cty. v. Automated Med. Labs., Inc., 471 U.S. 707, 712 (1985) (internal citation, quotation omitted). “[W]hen acting within constitutional limits, Congress is empowered to pre-empt state law by so stating in express terms.” Id. at 713. In
While
within the purview of
2. The Licensing Statute
When promulgating regulations to administer the MDA, the FDA stated “that strong State and local licensing laws are needed to establish and maintain minimum competency requirements for those persons who test for hearing loss and select and fit hearing aids.” Professional and Patent Labeling and Conditions for Sale, 42 Fed. Reg. 9,286, 9,287 (Feb. 15, 1977); see also Medical Devices; Applications for Exemption From Federal Preemption of State and Local Hearing Aid Requirements, 45 Fed. Reg. 67,325 (Oct. 10, 1980) (“Problems regarding the competency of hearing aid dealers to measure hearing loss will be adequately addressed by strong State and local licensing provisions.“). In that vein, the promulgated regulations explain that state licensing requirements are an example of “State or local requirements that affect devices that are not preempted by section [
Taylor‘s challenge to the Licensing Statute is really premised on a more indirect attack, asserting that the Pre-Sale Testing Statute is preempted and those pre-sale testing requirements are embedded into the qualifying elements to obtain a license under the Licensing Statute, thus resulting in the Licensing Statute being preempted as well. Taylor concedes that “[a] licensing scheme that does not enforce the Pre-Sale Testing Mandate would be unobjectionable,” but he argues that “at the very least, elements of the Licensure Requirement are pre-empted.” (Appellant‘s Br. at 14, 22.)7 We disagree.
The Pre-Sale Testing Statute‘s requirements are not “embedded” into the elements of the Licensing Statute. The Licensing Statute is short and straightforward, first providing a list of prohibited acts:
(1) A person may not:
(a) Practice dispensing hearing aids unless the person is a licensed hearing aid specialist;
(b) Use the name or title “hearing aid specialist” when the person has not been licensed under this part;
(c) Present as her or his own the license of another;
(d) Give false, incomplete, or forged evidence to the board or a member thereof for the purposes of obtaining a license;
(e) Use or attempt to use a hearing aid specialist license that is delinquent or has been suspended, revoked, or placed on inactive status;
(f) Knowingly employ unlicensed persons in the practice of dispensing hearing aids; or
(g) Knowingly conceal information relative to violations of this part.
None of the prohibited acts in the Licensing Statute mention or reference either the Pre-Sale Testing Statute or its requirements.
Taylor‘s reliance on MeTX, LLC v. Wal-Mart Stores Texas, LLC, 62 F. Supp. 3d 569 (E.D. Tex. 2014), is unavailing. That case concerned a similar preemption challenge to Texas‘s hearing aid licensing scheme. Id. at 574. However, the Texas law clearly ties licensing to the “fitting and dispensing of hearing instruments.” Id. at 584 (citing
Florida, by contrast, draws a distinction between those who must be licensed hearing aid dispensers and those who must perform pre-sale testing. For example, a licensee undertaking acts pertaining to the warranty of a previously sold hearing aid is, by statutory definition, “dispensing hearing aids“; however, because he has already sold the hearing aid and is addressing the device‘s post-purchase warranty, he is not “fitting and selling” hearing aids and the Pre-Sale Testing Statute‘s mandate would not be applicable.
Because any infirmity in the Pre-Sale Testing Statute is not inextricably linked to the Licensing Statute, and because state licensing schemes are not preempted by
3. The Mail Order Ban
Florida‘s Mail Order Ban provides that: “It is unlawful for any person to sell or distribute hearing aids through the mail to the ultimate consumer.”
Taylor‘s second theory is that the Mail Order Ban has the purpose and effect of prohibiting sales conducted without complying with the Pre-Sale Testing Statute‘s requirements. This theory also fails.
We do not accept Taylor‘s conclusory allegation that the purpose and effect of the Mail Order Ban is to prohibit sales that do not comply with the Pre-Sale Testing Statute. See Iqbal, 556 U.S. at 678 (“[W]e are not bound to accept as true a legal conclusion couched as a
That case upheld a preemption challenge to Missouri‘s mail order ban, which “provides that ‘[n]o person shall (1) sell through the mails, hearing instruments without prior fitting and testing by a hearing instrument specialist.‘” Id. at 1036-37 (quoting
Since we do not accept Taylor‘s conclusory legal assertion as to the Mail Order Ban‘s purpose and effect, we look to the plain language of the Mail Order Ban itself to determine whether it is preempted by
Thus, because the Mail Order Ban does not embed the Pre-Sale Testing Statute within it, and because the Mail Order Ban does not relate to the safety or effectiveness of the device, Taylor has failed to state a claim that the Mail Order Ban is preempted by federal law.
III. CONCLUSION
For the foregoing reasons, we AFFIRM the district court‘s dismissals for failure to state a preemption claim as to Florida‘s Licensing Statute and Mail Order Ban. We REVERSE the district court‘s dismissal for lack of standing as to Taylor‘s due process and preemption challenges to Florida‘s Pre-Sale Testing Statute and REMAND to the district court for further proceedings consistent with this opinion.
Notes
Specifically,
Section [
360k(a) ] does not preempt State or local permits, licensing, registration, certification, or other requirements relating to the approval or sanction of the practice of medicine, dentistry, optometry, pharmacy, nursing, podiatry, or any other of the healing arts or allied medical sciences or related professions or occupations that administer, dispense, or sell devices.
Thus, by issuing these regulations, the FDA is not creating blanket exemptions from preemption for licensing schemes; rather, the FDA is explaining that such laws (specifically including licensing laws for the practice of dispensing hearing aids) did not fall within