Court Opinion

ID: 1037922
Source: CourtListenerOpinion
Date Created: 2013-08-20 00:00:49.538669+00
Date Added: 2024-06-11T09:57:37.763075
License: Public Domain

Case: 12-14309       Date Filed: 08/19/2013       Page: 1 of 10

                                                                      [DO NOT PUBLISH]

                  IN THE UNITED STATES COURT OF APPEALS

                            FOR THE ELEVENTH CIRCUIT
                              ________________________

                                    No. 12-14309
                              ________________________

                          D.C. Docket No. 1:08-cv-03773-CAP

STIEFEL LABORATORIES, INC.,

                                                                        Plaintiff - Appellant,

                                            versus

BROOKSTONE PHARMACEUTICALS, L.L.C.,

                                                                      Defendant - Appellee.

                              ________________________

                      Appeal from the United States District Court
                         for the Northern District of Georgia
                            ________________________

                                     (August 19, 2013)

Before MARTIN and FAY, Circuit Judges, and EDENFIELD, * District Judge.

PER CURIAM:

*
 Honorable B. Avant Edenfield, United States District Judge for the Southern District of
Georgia, sitting by designation.
                  Case: 12-14309     Date Filed: 08/19/2013        Page: 2 of 10

       Stiefel Pharmaceutical (Stiefel) sued Brookstone Pharmaceutical

(Brookstone), claiming that Brookstone falsely advertised its acne gel, BPO Gel, as

a generic equivalent to Stiefel’s acne gel, Brevoxyl, in violation of section 43(a) of

the Lanham Act, 15 U.S.C. § 1125(a)(1)(B). The district court granted summary

judgment in favor of Brookstone, determining that Stiefel did not present enough

evidence for a reasonable jury to find that Brookstone violated the Lanham Act. 1

Stiefel appealed. After careful consideration, and having had the benefit of oral

argument, we affirm.

             I.      BACKGROUND AND PROCEDURAL HISTORY

       Stiefel and Brookstone are pharmaceutical companies who produce

competing prescription topical acne gels. Even though BPO Gel and Brevoxyl are

prescription drugs, they are “generally recognized as safe and effective” (GRAS/E)

which means a non-name brand drug, such as BPO Gel, does not need approval

from the Food and Drug Administration (FDA) before calling itself a “generic” for

a name-brand drug, such as Brevoxyl. In fact, even if a pharmaceutical company

asked the FDA for approval to call its GRAS/E drug a generic, the FDA would not

give permission because it does not approve or accept comparative testing for this

category of drugs. Because the FDA does not regulate the labeling of generics for
1
  Stiefel also alleged violations of Georgia state law. Because the same factual and legal analysis
is used for these claims as the Lanham Act claims, the district court also found summary
judgment appropriate on the state-law claims. Stiefel does not argue this on appeal, except to
mention that if summary judgment is reversed for the federal-law claims, it should also be
reversed for the state-law claims.
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GRAS/E drugs, these drugs, including BPO Gel and Brevoxyl, are not found in the

so-called “Orange Book,” which is the FDA publication listing FDA-approved

generics.

      Brookstone competed with Stiefel by advertising its BPO Gel as a generic

for Stiefel’s Brevoxyl. Stiefel says that BPO Gel is not a generic for Brevoxyl, so

Brookstone falsely advertised BPO Gel as a generic in violation of the Lanham

Act. Specifically, Stiefel claims that three categories of Brookstone’s

advertisements violated the Lanham Act. First, Brookstone submitted “Labeling

Statements” to a pharmaceutical database listing the product name as “Benzoyl

Peroxide 4% Gel” and “Benzoyl Peroxide 8% Gel” instead of “BPO 4% Gel” and

“BPO 8% Gel.” Second, in “Marketing Statements,” Brookstone announced

through several communications that its BPO Gel was a generic for Brevoxyl.

Third, on a Texas Medicaid Form, Brookstone indicated that BPO Gel was graded

an “A” in the “Orange Book.”

       In granting summary judgment in favor of Brookstone, the district court

found that Stiefel failed to produce enough evidence for a reasonable jury to

conclude that Brookstone’s Marketing Statements were false or misleading, as

required to establish a violation of the Lanham Act. For the Labeling Statements

and the Texas Medicaid form, the district court found that Steifel produced

competent proof of falsity. However, the court concluded that Stiefel did not

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present enough evidence of the material impact of these false statements to survive

summary judgment.

                                II.   DISCUSSION

      We review a district court’s grant of summary judgment de novo, applying

the same legal standard as the district court. Whatley v. CNA Ins. Cos., 189 F.3d

1310, 1313 (11th Cir. 1999). Summary judgment should be granted only when

“there is no genuine issue as to any material fact and the movant is entitled to

judgment as a matter of law.” Fed. R. Civ. P. 56(a). In making this decision, we

view all evidence and draw all reasonable inferences in favor of the party opposing

summary judgment. Whatley, 189 F.3d at 1313.

      To establish a false advertising claim under section 43(A) of the Lanham

Act, Stiefel must establish that 1) Brookstone’s ads were false or misleading; 2)

Brookstone’s ads deceived, or had the capacity to deceive, consumers; 3) the

deception had a material effect on purchasing choices; 4) BPO Gel affects

interstate commerce; and 5) Stiefel has been, or is likely to be, injured because of

the false advertising. See Johnson & Johnson Vision Care, Inc. v. 1-800 Contacts,

Inc., 299 F.3d 1242, 1247 (11th Cir. 2002).

      Stiefel challenges three of the district court’s conclusions. First, Stiefel

contends that it presented evidence that Brookstone’s statements were both false

and misleading, and thus, the district court got it wrong by considering only

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Stiefel’s evidence that Brookstone’s statements were false, and not whether

Brookstone’s statements were misleading. Second, Stiefel challenges the district

court’s conclusion that Stiefel did not present competent evidence that

Brookstone’s statements were literally false. Finally, for the statements on the

Texas Medicaid form and the Labeling Statements, Stiefel argues that the district

court erred in concluding there was insufficient evidence for a reasonable jury to

decide that the false statements had a material impact. We consider each argument

in turn.

                                        A.

       First, Stiefel argues the district court erred in only considering whether

Brookstone’s statements were literally false. Under the first element of the test for

a violation of the Lanham Act, a plaintiff must show either that the statements were

literally false or misleading. Hickson Corp. v. N. Crossarm Co., Inc., 357 F.3d

1256, 1261 (11th Cir. 2004). The evidence that a plaintiff must present to satisfy

the first element depends on whether the plaintiff is claiming the statements were

literally false or misleading. See Johnson & Johnson, 299 F.3d at 1247. A

plaintiff alleging misleading statements must present evidence of consumer

deception, while a plaintiff alleging literally false statements need not present

evidence of deception. Id. Here, Stiefel was not explicit about whether it was

claiming Brookstone’s statements were false or misleading. Because Stiefel did

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not point to evidence supporting any direct claims that Brookstone’s statements

were misleading, the district court decided that Stiefel was alleging Brookstone’s

statements were literally false. The district court then proceeded with the summary

judgment analysis only on the theory of literal falsity.

      Stiefel argues the district court erred in limiting its claims to literal falsity

because its evidence included an expert report, which Stiefel says it offered for the

purpose of proving the statements were misleading. However, Stiefel did not

clearly identify this report as supporting, as the theory of the case, that

Brookstone’s statements were misleading. Instead, it appears that Stiefel argued

that Brookstone’s statements were false, and this report was cited to advance

arguments in support of the falsity theory. While Stiefel points us to a few uses of

the word “misleading” in its brief in opposition to summary judgment, none clearly

support the conclusion that Stiefel was advancing a theory that Brookstone’s

statements were misleading within the meaning of the Lanham Act. While we

draw all reasonable inferences in favor of Stiefel, we will not marshal evidence in

support of arguments which were not supported in this way for the District Judge.

Cf. Peppers v. Coates, 887 F.2d 1493, 1498 (11th Cir. 1989) (“[W]hen a motion

for summary judgment is made and supported according to Rule 56, the

nonmoving party’s response must set forth specific facts showing a genuine issue

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for trial.”). For these reasons, we consider only whether Brookstone’s statements

were literally false.

                                        B.

       Stiefel next challenges the district court’s conclusion that it did not produce

competent evidence to show the literal falsity of Brookstone’s marketing

statements that BPO Gel is a generic for Brevoxyl. For two reasons, we conclude

that Stiefel did not produce sufficient proof for a reasonable jury to conclude that

Brookstone’s statements were literally false.

       First, Stiefel did not establish the meaning of the term “generic” in the

relevant context. In considering false advertising claims under the Lanham Act,

we “must analyze the message conveyed in full context,” Johnson & Johnson, 299

F.3d at 1248 (quotation marks omitted), because it is only possible to determine the

falsity of an advertisement when it is considered contextually. See, e.g., Osmose,

Inc. v. Viance, LLC, 612 F.3d 1298, 1311 (11th Cir. 2010) (“This Court has

[repeatedly] recognized the importance of context when analyzing false advertising

claims.”).

       Thus, we must examine the context in which we consider the meaning of the

term “generic.” Since BPO Gel and Brevoxyl are prescription drugs, Stiefel urges

us to look to the FDA definition of “generic” to derive the meaning of term.

Brookstone counters that the FDA definition of “generic” is not relevant here,

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because BPO Gel and Brevoxyl are GRAS/E drugs not subject to FDA approval.

Brookstone allows that the term “generic” has a different meaning in the context of

non-regulated drugs.

      Our review of the record leads us to conclude that Stiefel did not present

competent evidence to show that, in the context of drugs not regulated by the FDA,

pharmacists understand the term “generic” to have the same meaning as it does in

the regulated context. On appeal, Steifel points to several pieces of evidence in

arguing that the FDA definition of “generic” should apply in the context of

GRAS/E drugs not subject to FDA-approval. None are availing. In fact, Stiefel’s

evidence reflects uncertainty about the meaning of the term “generic” in the

context of GRAS/E drugs. For example, three emails from Brookstone executives

address the potential dual meaning of the term “generic” in the regulated and non-

regulated context. Because Stiefel did not produce contextually appropriate

evidence in support of its definition of the term “generic,” a reasonable jury could

not decide that Brookstone’s statements were literally false.

      Second, even if we assume that Stiefel did present evidence on the meaning

of the term “generic,” it did not present equivalency tests to show that

Brookstone’s BPO Gel was not a generic. While Stiefel argues that BPO Gel and

Brevoxyl have different ingredients, Stiefel stresses the only way to establish

whether a drug is “generic” as understood by the FDA is through bioequivalence

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testing. However, in its own statement of facts, Stiefel concedes that “BPO Gel

has never been tested for bioequivalence, pharmaceutical equivalence or

therapeutic equivalence to Brevoxyl Gel.” We agree with the district court’s

assessment that Stiefel’s arguments and evidence are contradictory: On the one

hand, Stiefel argues that Brookstone falsely stated that BPO Gel is a generic and

that equivalency testing is required to determine whether or not BPO Gel is a

generic. On the other hand, Stiefel presents no equivalency testing to show that

BPO Gel is not a generic. Because there is no evidence from which a reasonable

jury could conclude that Brookstone’s marketing statements claiming generic

equivalency were literally false, there is “an absence of evidence to support

[Stiefel’s] case,” and summary judgment is appropriate. See Celotex Corp. v.

Catrett, 477 U.S. 317, 325, 106 S. Ct. 2548, 2554 (1986).

                                       C.

      Finally, Stiefel argues the district court erroneously found that the false

statements in the Texas Medicaid form and the Labeling Statements did not have a

material impact on the consumer’s purchasing decision. Stiefel says it offered

evidence of materiality by showing that pharmacies “linked” BPO Gel and

Brevoxyl, which caused pharmacists to substitute the less expensive BPO Gel for

the more expensive Brevoxyl. Stiefel’s argument based on this evidence fails

because it shows only that Brookstone captured some of Stiefel’s market share; it

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does not show that Brookstone’s false statements influenced pharmacists’

purchasing choices. See Johnson & Johnson, 299 F.3d at 1250 (“The materiality

requirement is based on the premise that not all deceptions affect consumer

decisions.”); Osmose, 612 F.3d at 1319 (“In order to establish materiality, the

plaintiff must demonstrate that the defendant’s deception is likely to influence the

purchasing decision.” (quotation marks omitted)). Because Stiefel did not show

that Brookstone’s false statements on the Texas Medicaid form and the Labeling

Statements influenced consumer choices, the district court properly granted

summary judgment. See Osmose, 612 F.3d at 1319 (“Even if an advertisement is

literally false, the plaintiff must still establish materiality.”).

                                 III.   CONCLUSION

       For these reasons, summary judgment is appropriate in favor of Brookstone.

The decision of the district court is AFFIRMED.

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