                                                                     [PUBLISH]


               IN THE UNITED STATES COURT OF APPEALS

                        FOR THE ELEVENTH CIRCUIT                  FILED
                         ________________________        U.S. COURT OF APPEALS
                                                           ELEVENTH CIRCUIT
                                                              MARCH 18, 2002
                                No. 01-13482
                                                            THOMAS K. KAHN
                          ________________________               CLERK

                      D. C. Docket No. 00-02920 CV-WBH-1

THIS THAT AND THE OTHER GIFT AND
TOBACCO, INC., d.b.a. This That & The
Other, CHRISTOPHER PREWETT,

                                                       Plaintiffs-Appellants,

                                     versus

COBB COUNTY, GEORGIA, PAUL FOSTER,
in his official capacity as Business License
Division Manager for Cobb County, Georgia, et al.,

                                                       Defendants-Appellees.
                          ________________________

                  Appeal from the United States District Court
                     for the Northern District of Georgia
                       _________________________
                              (March 18, 2002)


Before BIRCH, CARNES and COX, Circuit Judges.

COX, Circuit Judge:
      This case requires us to consider issues of federal statutory and constitutional

law in the context of a state’s effort to prohibit the advertising and distribution of

sexual devices. The district court concluded that the plaintiffs did not demonstrate a

substantial likelihood of success on the merits of their claims, and for that reason

declined to enjoin preliminarily the enforcement of a Georgia statute banning such

advertising and distribution as obscene. Because we conclude that the plaintiffs have

demonstrated a substantial likelihood of success on their claim that the advertising ban

violates the First Amendment, however, we vacate and remand for further proceedings

to determine whether a preliminary injunction should issue with regard to the ban on

advertising.

                                    I. Background

      This That & The Other Gift and Tobacco, Inc. and Christopher Prewett

(collectively referred to as “the plaintiffs”) own and operate a retail establishment in

Cobb County, Georgia. In applying for the permits and licenses necessary to operate

their business, the plaintiffs informed the County that they would be selling devices

designed or marketed primarily for the stimulation of human genital organs. The

County and its Business License Division Manager, Paul Foster, approved the

plaintiffs’ licenses and permits on April 24, 1998, although they later expressed

concern about the nature of the devices sold by the plaintiffs. Nonetheless, the


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plaintiffs’ licenses and permits subsequently were renewed in 1999 and 2000.

       In early 2000, however, the County threatened the plaintiffs with criminal

prosecution and adverse administrative action for violating O.C.G.A. § 16-12-80,

which prohibits the advertising and distribution of obscene material. This statute

defines as obscene “[a]ny device designed or marketed as useful primarily for the

stimulation of human genital organs.” O.C.G.A. § 16-12-80(c). The statute also

provides an affirmative defense where dissemination of obscene material is restricted

to: (1) a faculty member or student “associated with an institution of higher learning”

who is “teaching or pursuing a course of study related to such material”; or (2) “[a]

person whose receipt of such material was authorized in writing by a licensed medical

practitioner or psychiatrist.” O.C.G.A. § 16-12-80(e). Based on the threats made by

the County, the plaintiffs ceased selling sexual devices on June 25, 2000. The record

does not indicate either the specific devices that gave rise to the threats of prosecution

or the devices that the plaintiffs have refrained from selling as a result of those threats.

       The plaintiffs filed this action on November 3, 2000, raising claims under 42

U.S.C. § 1983, 42 U.S.C. § 1985, and Georgia law. The plaintiffs seek money

damages, injunctive relief, and a declaratory judgment that O.C.G.A. § 16-12-80 is

unconstitutional. The plaintiffs subsequently filed a motion for a preliminary

injunction restraining the County from enforcing O.C.G.A. § 16-12-80. Based on the


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plaintiffs’ verified complaint, affidavits, and other documents, but without conducting

an evidentiary hearing, the district court denied the plaintiffs’ request.          This

interlocutory appeal follows.      We have jurisdiction pursuant to 28 U.S.C. §

1292(a)(1).

                                II. Standard of Review

      In reviewing the district court’s denial of a request for a preliminary injunction,

we review findings of fact for clear error and conclusions of law de novo. Horton v.

City of St. Augustine, Fla., 272 F.3d 1318, 1326 (11th Cir. 2001). The actual denial

of the plaintiffs’ request for a preliminary injunction may be reversed only if there was

a clear abuse of discretion. Siegel v. Lepore, 234 F.3d 1163, 1175 (11th Cir. 2000)

(en banc).

                                    III. Discussion

      To be entitled to a preliminary injunction, the plaintiffs must demonstrate that

(1) they have a substantial likelihood of success on the merits, (2) they will suffer

irreparable injury unless the injunction issues, (3) the threatened injury to them

outweighs the damage that the injunction would have on the opposing parties, and (4)

if issued, the injunction would not disserve the public interest. See, e.g., Horton, 272

F.3d at 1326. In this case, the district court concluded that the plaintiffs did not

demonstrate a substantial likelihood of success and thus denied the request for a


                                           4
preliminary injunction without considering the other prerequisites. On appeal, the

plaintiffs present four arguments that they contend show a substantial likelihood of

success on their claims under § 1983 and § 1985: (1) enforcing O.C.G.A. § 16-12-80

violates the Supremacy Clause because the statute is preempted by the Medical Device

Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq.; (2) O.C.G.A. § 16-12-80

bans protected speech in violation of the First Amendment, as applied to the states

through the Fourteenth Amendment; (3) O.C.G.A. § 16-12-80 is unconstitutionally

vague as applied in this case; and (4) the County has applied O.C.G.A. § 16-12-80 in

an arbitrary and unequal manner that violates principles of due process and equal

protection. On this record, the fourth argument is meritless and does not warrant

further discussion. See 11th Cir. R. 36-1. We consider the remaining arguments in

turn.

                                   A. Preemption

        The plaintiffs contend that O.C.G.A. § 16-12-80 is preempted, both expressly

and implicitly, by the MDA. We disagree.

        The Supreme Court has recognized three types of preemption: (1) express

preemption, where a federal statute contains “explicit preemptive language”; (2) field

preemption, where the federal regulatory scheme is “so pervasive as to make

reasonable the inference that Congress left no room for the States to supplement it”;


                                          5
and (3) conflict preemption, where “compliance with both federal and state

regulations is a physical impossibility” or where state law “stands as an obstacle to the

accomplishment and execution of the full purposes and objectives of Congress.”

Wisconsin Public Intervenor v. Mortier, 501 U.S. 597, 604-05, 111 S. Ct. 2476, 2481-

82 (1991). Congressional intent is the “ultimate touchstone” in a preemption case,

Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S. Ct. 2240, 2250 (1996), and this

intent “governs our determination of whether federal law preempts state law.” Boyles

v. Shell Oil Prods. Co., 199 F.3d 1260, 1267 (11th Cir. 2000).

      We readily conclude that the MDA does not expressly preempt O.C.G.A. § 16-

12-80. The plaintiffs base their claim of express preemption on 21 U.S.C. § 360k(a),

which provides in relevant part:

      [N]o State or political subdivision of a State may establish or continue

      in effect with respect to a device intended for human use any

      requirement —

             (1) which is different from, or in addition to, any requirement

      applicable under this chapter to the device, and

             (2) which relates to the safety or effectiveness of the device or to

      any other matter included in a requirement applicable to the device under

      this chapter.


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Although this provision expressly preempts some state law in certain instances, it is

clear from the statute’s language that it preempts state requirements applicable to

medical devices only where those requirements differ from or add to a specific federal

requirement, and only where they relate to the safety or effectiveness of the devices

at issue or some other matter governed by the statute. See Medtronic, 518 U.S. at 500,

116 S. Ct. at 2257. Moreover, the legislative history makes clear that the purpose of

the MDA is “to provide for the safety and effectiveness of medical devices intended

for human use.” Id. at 490, 116 S. Ct. at 2253 (quoting Medical Device Amendments

of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976) (preamble)). Because O.C.G.A. §

16-12-80 does not impose any requirements relating to the safety or effectiveness of

the sexual devices mentioned by the plaintiffs, but rather relates to public morality and

the distribution of obscene material, it is not expressly preempted by § 360k(a).

      For similar reasons, O.C.G.A. § 16-12-80 is not implicitly preempted.1 With

regard to field preemption, we find no clear and manifest indication that Congress

intended the MDA to displace state authority over public morality. See Medtronic,


      1
       The district court found the plaintiffs’ implied preemption argument to be
without merit because the MDA expressly provides the parameters of preemption.
The existence of an express preemption clause, however, neither bars the ordinary
working of conflict preemption principles nor by itself precludes a finding of
implied preemption. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,
354, 121 S. Ct. 1012, 1019 (2001); Irving v. Mazda Motor Corp., 136 F.3d 764,
768 (11th Cir. 1998).
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518 U.S. at 485, 116 S. Ct. at 2250 (stating that fields traditionally occupied by the

states are assumed not to be supplanted unless there is clear and manifest purpose to

the contrary); Williams v. Pryor, 240 F.3d 944, 949 (11th Cir. 2001) (“The crafting

and safeguarding of public morality has long been an established part of the States’

plenary police power . . . .”). Additionally, there is no conflict preemption because

it is not impossible to comply with both the MDA and O.C.G.A. § 16-12-80, nor does

the Georgia statute stand as an obstacle to Congress’s objectives in enacting the MDA.

The MDA does not regulate what medical devices may be considered obscene or

offensive to public morals, nor does it dictate that any particular medical device must

be made available to consumers. Rather, as demonstrated, Congress enacted the MDA

only to ensure the minimal safety of those medical devices that actually reach the

marketplace. See Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1378, 1380 (11th Cir.

2001). Georgia’s obscenity statute does not conflict with that objective, and it is

therefore not preempted by the MDA.

      Because the MDA does not preempt O.C.G.A. § 16-12-80 as it relates to sexual

devices, the district court did not err in concluding that the plaintiffs failed to

demonstrate a substantial likelihood of success based on this argument.

                                B. First Amendment

      The plaintiffs likewise contend that O.C.G.A. § 16-12-80 forbids the advertising


                                          8
of sexual devices and therefore bans commercial speech in violation of the First

Amendment. For commercial speech to fall within the protections of the First

Amendment, it must concern lawful activity and not be misleading. Central Hudson

Gas & Elec. Corp. v. Public Serv. Comm’n, 447 U.S. 557, 566, 100 S. Ct. 2343, 2351

(1980). If this requirement is satisfied, commercial speech may still be restricted, but

only where the asserted governmental interest is substantial, the regulation directly

advances that interest, and the regulation is no more extensive than necessary to serve

that interest. Id.; see also Ibanez v. Fla. Dep’t of Bus. & Prof’l Regulation, 512 U.S.

136, 142, 114 S. Ct. 2084, 2088 (1994). Applying these standards to this case, we

conclude that the advertising ban found in O.C.G.A. § 16-12-80 violates the First

Amendment.

      We first address whether the speech at issue is misleading or relates to unlawful

activity. In analyzing this issue, the district court first concluded that it was unclear

whether the sexual devices being advertised were lawful products. Additionally, the

district court concluded that any advertisements for such devices would inherently

mislead consumers. This was so, according to the district court, because the products

could be purchased only by a limited consumer base and because a complicated legal

explanation would be required to inform the public of that fact.

      As the district court implicitly acknowledged, however, the statute plainly


                                           9
allows sexual devices to be distributed to certain consumers — i.e., those individuals

authorized to receive the devices by a licensed medical practitioner or psychiatrist, as

well as specified students and faculty at institutions of higher learning. See O.C.G.A.

§ 16-12-80(e). Therefore, when distributed to such consumers, the products clearly

are lawful. Moreover, we are not convinced that an advertisement targeting such

consumers necessarily would be misleading simply because certain persons

encountering the advertisement could not lawfully purchase the device, nor are we

convinced that an explanation of those persons entitled to purchase the device needs

to be lengthy and complex. Accordingly, we disagree with the district court’s analysis

of the first prong of Central Hudson.

      We also disagree with the district court’s analysis of the last prong of Central

Hudson. Assuming that Georgia has asserted a substantial interest in safeguarding

public morality, and that the ban on advertising directly advances that interest, we

nonetheless conclude that the ban contained in O.C.G.A. § 16-12-80 is more extensive

than necessary.    Even though sexual devices clearly are lawful under certain

circumstances, the statute contains a per se prohibition on advertising related to such

devices. Distributors of sexual devices are forbidden unqualifiedly from advertising

their products, even when the market they seek to reach consists of those consumers

lawfully entitled to purchase those products. Less onerous restrictions adequately


                                          10
would serve Georgia’s interest, and the per se ban on advertising therefore violates the

First Amendment.

      For these reasons, the district court erred in concluding that the plaintiffs did

not show a substantial likelihood of success on their First Amendment claim, and it

should consider on remand whether the plaintiffs have satisfied the remaining

prerequisites for a preliminary injunction.

                                C. Void for Vagueness

      Finally, the plaintiffs contend that O.C.G.A. § 16-12-80 is unconstitutionally

vague because the medical necessity exception found in § 16-12-80(e)(2) fails to give

adequate notice as to what conduct is prohibited or allowed under that exception.2 On

the record before us, we find no error in the district court’s denial of preliminary relief

as it relates to the plaintiffs’ vagueness allegations.

      Limiting our discussion to the specific arguments presented in this appeal, we

do not think that the plaintiffs have shown that their vagueness challenge has a

substantial likelihood of success. The medical necessity exception provides an

affirmative defense if “dissemination of the [obscene] material was restricted to . . .[a]

person whose receipt of such material was authorized in writing by a licensed medical



      2
       The plaintiffs do not raise on appeal any vagueness challenge to the
educational exception found in O.C.G.A. § 16-12-80(e)(1).
                                            11
practitioner or psychiatrist.” O.C.G.A. § 16-12-80(e)(2). The plaintiffs complain that

they cannot determine who constitutes a “licensed medical practitioner,” nor can they

determine what type of “writing” is required to authorize receipt. The plaintiffs then

assume that a formal prescription is required and assert that, for this reason, it is

unclear whether sexual devices may be dispensed by people other than pharmacists.

Finally, the plaintiffs contend that, even if people other than pharmacists may

distribute sexual devices, it is unclear whether they lawfully can obtain such devices

in the first place.

       We agree that the wording of the medical necessity exception is not precise in

all respects. But the Constitution does not require precision; “all that is required is

that the language ‘conveys sufficiently definite warning as to the proscribed conduct

when measured by common understanding.’” Roth v. United States, 354 U.S. 476,

491, 77 S. Ct. 1304, 1312 (1957) (quoting United States v. Petrillo, 332 U.S. 1, 7-8,

67 S. Ct. 1538, 1542 (1947)). We are not convinced that a reasonable person reading

O.C.G.A. § 16-12-80 with common understanding would not be able to discern the

meanings of the terms “licensed medical practitioner” or “writing.” We note also that

the terms “prescription” and “pharmacy” are not found anywhere in the relevant

provision. Moreover, because the statute makes it an offense for “[a] person” to

distribute obscene material, see O.C.G.A. § 16-12-80(a), it is reasonable to assume


                                          12
that this all-inclusive term applies equally to the affirmative defense, meaning that any

person able to prove the affirmative defense may lawfully distribute sexual devices.

If a person can distribute sexual devices, it also stands to reason that he lawfully may

obtain such devices himself, as the plaintiffs concede elsewhere in their brief. We

find no error in the denial of preliminary relief on the basis of the vagueness

arguments presented by the plaintiffs.

                                    IV. Conclusion

      Because we conclude that the district court erred in its analysis of the plaintiffs’

claim for violations of the First Amendment, we vacate the denial of preliminary

injunction as it relates to that claim and remand for further proceedings consistent with

this opinion. The denial of preliminary injunctive relief is otherwise affirmed.

      AFFIRMED IN PART; VACATED AND REMANDED IN PART.




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