Case: 18-14934       Date Filed: 07/01/2020      Page: 1 of 19




                                                                                [PUBLISH]

                 IN THE UNITED STATES COURT OF APPEALS

                           FOR THE ELEVENTH CIRCUIT
                             ________________________

                                    No. 18-14934
                              ________________________

                      D.C. Docket No. 6:18-cv-00613-GAP-DCI

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.
                             ________________________

                     Appeal from the United States District Court
                         for the Middle District of Florida
                           ________________________

                                       (July 1, 2020)

Before MARCUS, ANDERSON, and EBEL,∗ Circuit Judges.

EBEL, Circuit Judge:



∗The Honorable David M. Ebel, Senior United States Circuit Judge for the United States Court
of Appeals for the Tenth Circuit, sitting by designation.
              Case: 18-14934     Date Filed: 07/01/2020    Page: 2 of 19




      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 28 U.S.C.

§ 1291, we AFFIRM the district court’s dismissals for failure to state a claim upon

which relief could be granted and REVERSE the district court’s dismissal for lack

of standing and REMAND to the district court for further proceedings consistent

with this opinion.

                                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, 21

U.S.C. § 360k, which preempts state laws which are “different from, or in addition


                                          2
                Case: 18-14934        Date Filed: 07/01/2020        Page: 3 of 19



to” the federal requirements and “which relate[] to the safety or effectiveness of the

device or to any other matter included in a [federal] requirement applicable to the

device.” § 360k(a). This same section also provides for the FDA to create a

process through which states can request exemptions from express preemption.

§ 360k(b); see 21 C.F.R. pt. 808 (providing a procedure for requesting

exemption). 1

        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. Fla. Stat. §§ 484.0401 et seq. Three of those statutes

are at issue in this case. The first, Fla. Stat. § 484.0501 (the “Pre-Sale Testing

Statute”), requires that when fitting and selling hearing aids, pre-sale audiometric

testing be conducted following specific minimum procedures and using specified

equipment. The second, Fla. Stat. § 484.053 (the “Licensing Statute”), prohibits

dispensing hearing aids without a state hearing aid specialist license or through

improper or fraudulent use of a state hearing aid specialist license. The third, Fla.

Stat. § 484.054 (the “Mail Order Ban”), bans all sales of hearing aids through the

mail.

        Taylor has been selling hearing aids in Florida for over thirty years and, until



1
  Neither the constitutionality nor the validity of the FDA’s promulgated regulations is at issue in
this litigation.
                                                 3
              Case: 18-14934     Date Filed: 07/01/2020    Page: 4 of 19



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 Federal Rule of

Civil Procedure 12(b)(6). Taylor appeals the dismissal of all of his claims.

      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, 

, 872 (11th Cir.


                                           4
                Case: 18-14934        Date Filed: 07/01/2020       Page: 5 of 19



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 to challenge the Pre-

Sale Testing Statute. 2 We disagree.3

       Article III, Section 2 of the United States Constitution limits our jurisdiction

to cases and controversies; consequently, plaintiffs wishing to utilize the federal

courts must establish that they have standing for each of their claims. U.S. Const.



2
 The standing analysis applies equally to Taylor’s preemption claim and his due process claim
challenging the Pre-Sale Testing Statute.
3
  The court below did not reach the merits of Taylor’s challenges to the Pre-Sale Testing Statute;
thus, we limit our review to whether Taylor has standing to challenge the Pre-Sale Testing
Statute, and we do not express an opinion as to the merits of either Taylor’s preemption
challenge or his due process challenge to the Pre-Sale Testing Statute.
                                                5
              Case: 18-14934     Date Filed: 07/01/2020    Page: 6 of 19



art. III, § 2; Lujan v. Defs. of Wildlife, 

, 559–60 (1992). Standing is a

jurisdictional issue that we review de novo. Bochese v. Town of Ponce Inlet, 

, 975 (11th Cir. 2005). “[W]hen a question about standing is raised at the

motion to dismiss stage, ‘it may be sufficient to provide general factual allegations

of injury resulting from the defendant’s conduct.’”

Pub. Interest

Research Grp. Citizen Lobby, Inc. v. EPA, 

, 1083 (11th Cir. 2004)).

      Standing consists of three elements: (1) injury in fact, (2) causation, and

(3) redressability. 

–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.”

(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,

, 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, 

, 1492 (11th Cir. 1993) (quoting

) (internal citation omitted).

      Taking the factual allegations in the complaint as true, as we must, Taylor


                                           6
              Case: 18-14934      Date Filed: 07/01/2020    Page: 7 of 19



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 of the statute before he can challenge the statute.

Hence, Taylor has properly alleged an injury in fact.

      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,


                                           7
                Case: 18-14934        Date Filed: 07/01/2020       Page: 8 of 19

, 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. 

–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, 

, 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




4
  Because we determine that Taylor has standing based on his assertion that he would become a
licensed hearing aid seller but for the Pre-Sale Testing Statute, we do not address his additional
standing argument that unlicensed hearing aid sellers are subject to enforcement of the Pre-Sale
Testing Statute.
                                                 8
               Case: 18-14934     Date Filed: 07/01/2020     Page: 9 of 19



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 Federal Rule of

Civil Procedure 12(b)(6). Dismissal under Rule 12(b)(6) is proper when the facts

alleged in the complaint fail “to state a claim to relief that is plausible on its face.”

Bell Atl. Corp. v. Twombly, 

, 570 (2007). On a motion to dismiss,

we accept the plaintiff’s factual allegations as true. Ashcroft v. Iqbal, 

, 678 (2009). “However, conclusory allegations, unwarranted factual

deductions or legal conclusions masquerading as facts will not prevent dismissal.”

Davila v. Delta Air Lines, Inc., 

, 1185 (11th Cir. 2003).

      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., 

, 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.”

In § 360k(a) of the MDA, Congress expressly preempted any state

requirement “with respect to a device intended for human use . . . which is

different from, or in addition to, any requirement applicable . . . to the device, and

. . . relates to the safety or effectiveness of the device or to any other matter in a
                                            9
                 Case: 18-14934        Date Filed: 07/01/2020    Page: 10 of 19



requirement applicable to the device.” 21 U.S.C. § 360k(a). Thus, § 360k(a) acts

to preempt a state requirement when (1) there is both a federal and a state

requirement applicable to the same device, and (2) the state requirement is

“different from, or in addition to,” the federal requirement and relates to the

device’s safety or effectiveness. Riegel v. Medtronic, Inc., 

, 321–22

(2008).

       While § 360k(a) preempts state requirements, § 360k(b) gives the FDA the

authority to grant states, upon their application, exemptions from preemption. See

Medtronic, Inc. v. Lohr, 

, 496 (1996). The FDA promulgated

regulations which “prescribe[] procedures for the submission, review, and approval

of applications for exemption.” 21 C.F.R. § 808.1. The regulations also set forth

examples of types of state requirements “that are not preempted by [§ 360k(a)]

because they are not ‘requirements applicable to a device’ within the meaning of

[§ 360k(a)],” including licensing schemes. 5

a state requirement falls



       5
           Specifically, 21 C.F.R. § 808.1(d)(3) states that

       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
§ 360k(a)’s preemptive scope to begin with.
                                                  10
             Case: 18-14934      Date Filed: 07/01/2020   Page: 11 of 19



within the purview of § 360k(a), and it has not been exempted pursuant to

§ 360k(b), that state requirement is preempted.

      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

[§ 360k(a)] because they are not ‘requirements applicable to a device’ within the




                                          11
               Case: 18-14934        Date Filed: 07/01/2020       Page: 12 of 19



meaning of [§ 360k(a)].” 21 C.F.R. § 808.1(d), (d)(3) (quoting § 360k(a)(2)). 6

Thus, the Licensing Statute is not a “requirement applicable to a device” and is not

expressly preempted by § 360k(a).

       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



6
  Section 808.1(d)(3) provides that there are two types of federal requirements which, should
they conflict with state licensing requirements, would preempt such state licensing
requirements: (1) requirements enacted when the Secretary has restricted the sale of a device
under 21 U.S.C. § 360j(e), and (2) requirements enacted exempting devices from federal
requirements in order to encourage scientific investigation under 21 U.S.C. § 360j(g). However,
the Licensing Statute is a state law which addresses “the competency of hearing aid dealers to
measure hearing loss,” 45 Fed. Reg. at 67,325, and Taylor has not alleged that either excepted
federal requirement is applicable here. Therefore, neither of these provisions are relevant to our
case.
7
  Taylor states that he “challenges the licensing requirements that impose conditions of sale that
are ‘different’ from and ‘in addition to’ federal law and which relate to the ‘safety and
effectiveness’ of hearings aids,” (Appellant’s Br. at 22); he does not, however, tell the court
which elements of the Licensing Statute impose such conditions, nor does the court find any such
elements in the Licensing Statute.
                                               12
              Case: 18-14934     Date Filed: 07/01/2020       Page: 13 of 19



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.

Fla. Stat. § 484.053(1). The Licensing Statute then goes on to provide penalties for

undertaking any aforementioned prohibited acts.

(3). None of

these prohibited acts pertains to any device sold by a properly certified licensee or

to any testing procedures that must be undertaken by a licensee when selling a

particular device.

      None of the prohibited acts in the Licensing Statute mention or reference

either the Pre-Sale Testing Statute or its requirements.

Even

subsection (1)(g) of the Licensing Statute, which references “violations of this

part,” does not prohibit a person from violating another section; rather, it only

prohibits a person from knowingly concealing information about such violations.


                                           13
             Case: 18-14934     Date Filed: 07/01/2020   Page: 14 of 19



In other words, the Licensing Statute does not prohibit a licensed hearing aid

specialist from selling hearing aids without performing pre-sale testing, even

though it does prohibit him from knowingly concealing information about such

sales. As is shown by its focus on the knowing concealment of a violation, the

Licensing Statute properly addresses the truthfulness of the licensee, which is

certainly a factor in a licensee’s competency. But liability for underlying acts of

selling hearing aids is addressed under other sections of Florida’s statutory scheme

rather than under the Licensing Statute, which is the basis for Taylor’s claim.

      As all of the Licensing Statute’s prohibitions are properly aimed at ensuring

a minimal level of competency and truthfulness for licensees, rather than creating

requirements “applicable to the device,” enforcement of the Pre-Sale Testing

Statute’s requirements is not embedded into the Licensing Statute, and the

Licensing Statute cannot be attacked with an argument that the Pre-Sale Testing

Statute is preempted.

      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.

However, the Texas law clearly ties licensing to the “fitting and dispensing of

hearing instruments.”

(citing Tex. Occ. Code § 402.451); see also Tex.

Occ. Code § 402.001(6) (defining “license” as “a license issued by the department


                                         14
              Case: 18-14934     Date Filed: 07/01/2020    Page: 15 of 19



under this chapter to a person authorized to fit and dispense hearing instruments”).

And, the Texas Code defines “fitting and dispensing hearing instruments” as “the

measurement of human hearing by the use of an audiometer or other means to

make selections, adaptations, or sales of hearing instruments.” MeTX, LLC, 62 F.

Supp. 3d at 578 (quoting Tex. Occ. Code § 402.001). Thus, under the Texas law

one could not become licensed without satisfying the pre-sale testing requirements.

      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. Fla. Stat. §§ 484.041(3)(b), 484.0501. Thus,

unlike in Texas, it is possible to be a licensed hearing aid specialist in Florida

without automatically being subject to the Pre-Sale Testing Statute.

      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

§ 360k(a)’s express preemption provision, Taylor has failed to state a claim that the

Licensing Statute is preempted by federal law.

      3. The Mail Order Ban

                                           15
              Case: 18-14934    Date Filed: 07/01/2020    Page: 16 of 19



      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.” Fla. Stat.

§ 484.054. Taylor pursues his challenge to the Mail Order Ban through two

theories. First, he asserts that the Mail Order Ban has the purpose and effect of

prohibiting sales by unlicensed sellers. This theory rests on the assertion that

Florida may not prohibit sales by unlicensed sellers, because any such restriction in

the Licensing Statute would be prohibited by the MDA. Because we rejected this

assertion above in concluding that Florida’s Licensing Statute is not preempted,

Taylor’s first theory fails.

      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 

(“[W]e are not bound to accept as true

a legal conclusion couched as a factual allegation.”). The plain text of the Mail

Order Ban does not expressly require compliance with the Pre-Sale Testing

Statute, as it categorically bans all mail order sales. Thus, although Taylor alleges

that the Mail Order Ban prohibits sales that do not comply with the Pre-Sale

Testing Statute, it would be just as accurate to allege that the Mail Order Ban


                                          16
               Case: 18-14934        Date Filed: 07/01/2020       Page: 17 of 19



prohibits sales that do comply with the Pre-Sale Testing Statute. A comparison of

Missouri’s ban on mail order sales, addressed in Missouri Board of Examiners for

Hearing Instrument Specialists v. Hearing Help Express, Inc., 

, 1035

(8th Cir. 2006), highlights this difference.

       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.’”

(quoting Mo. Rev. Stat. § 346.110 (subsequently amended))

(emphasis added). The court concluded that Missouri’s ban was preempted by

§ 360k(a) solely because the ban contained a mandatory pre-sale testing

requirement.

The same cannot be said for the Mail Order Ban at issue

here, which does not contain such a requirement and works to ban even those mail

order sales undertaken with pre-sale testing. Moreover, the only language common

to both the Missouri and the Florida bans—“[n]o person shall (1) sell through the

mails, hearing instruments”—was never discussed by the court in Missouri Board

of Examiners. Hence, Florida’s ban does not contain the same incorporation of a

pre-sale testing requirement as does Missouri’s ban, and Missouri Board of

Examiners is distinguishable 8


8
 This is not to say that we endorse the court’s approach to pre-sale testing requirements in
Missouri Board of Examiners, which was not informed by this circuit’s long-standing
precedents. We merely hold that it is distinguishable.
                                                17
              Case: 18-14934      Date Filed: 07/01/2020    Page: 18 of 19



      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 § 360k(a): “It is unlawful for

any person to sell or distribute hearing aids through the mail to the ultimate

consumer.” Fla. Stat. § 484.054. Under § 360k(a), the Mail Order Ban would be

preempted if it is “different from, or in addition to,” a federal requirement and if it

relates to the safety or effectiveness of the device. Taylor’s argument that the Mail

Order Ban relates to the safety and effectiveness of the device is based not on the

Mail Order Ban itself, but on the fact that pre-sale testing relates to safety and

effectiveness. He makes no argument, nor could he, that prohibiting sales by mail,

in and of itself, relates to the safety or effectiveness of the device.

      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


                                           18
                Case: 18-14934   Date Filed: 07/01/2020   Page: 19 of 19



Statute and REMAND to the district court for further proceedings consistent with

this opinion.




                                          19