United States District Court, N.D. Georgia, Gainesville Division
RICHARD W. STORY UNITED STATES DISTRICT JUDGE
case comes before the Court on Defendants Winder
Laboratories, LLC and Steven Pressman's Motion to Dismiss
, Plaintiff's Motion to Submit Supplemental Authority
in Support of Its Opposition to Defendants' Motion to
Dismiss , and Plaintiff's Motion to Submit March 2,
2017 Authority in Support of Its Opposition to
Defendants' Motion to Dismiss . After a review of the
record, the Court enters the following Order.
Concordia Pharmaceuticals Inc., S.À.R.L. is a
pharmaceutical company that produces the DONNATAL
pharmaceutical products, which are used to treat irritable
bowel syndrome and acute enterocolitis. (First Am. Compl.,
Dkt.  ¶10). On December 30, 1980, Plaintiff's
predecessor-in-interest, A.H. Robins Company, obtained
conditional approval Abbreviated New Drug Applications for
both DONNATAL Tablets and DONNATAL Elixer. (Id.
¶15.) This became necessary after Congress amended the
Federal Food, Drug, and Cosmetic Act (“FDCA”) in
1962 to require the Food and Drug Administration
(“FDA”) to conduct retrospective evaluations of
drugs previously approved. (Id. ¶13.) On June
20, 1978, the FDA required any drugs involved in the Drug
Efficacy Study Implementation review program, including
DONNATAL, to obtain an approved New Drug Application or an
approved Abbreviated New Drug Application. (Id.
¶14.) Plaintiff claims that under this process, it is
the only company legally permitted to market PBA products.
and its predecessors-in-interest, have consistently used the
DONNATAL mark as the brand name for its line of irritable
bowel syndrome products since at least April 1, 1936.
(Id. ¶23.) The DONNATAL mark was registered by
the United States Trademark and Patent Office as U.S. Reg.
No. 338, 733 in connection with medicinal preparation used in
the treatment of gastro-intestinal disturbances in
International Class 5 on September 15, 1936. (Id.
¶29.) This registration is valid and subsisting, and all
rights under it were assigned to Plaintiff on or around May
15, 2014. (Id. ¶¶30-31.)
Winder Laboratories, LLC is a manufacturer of generic drug
products. (Id. ¶33.) Defendant Steven Pressman
is the owner of Defendant Winder. (Id. ¶34.) In
2013, Defendants began plans to manufacture a generic version
of DONNATAL to be marketed by a third party, Method
Pharmaceuticals, LLC (“Method”), under the name
Me-PB-Hyos. (Id. ¶37.) After Me-PB-Hyos was
listed on several drug databases, Plaintiff sued Method and
Defendants in the Western District of Virginia. (Id.
¶38.) Defendants were dismissed from that litigation for
lack of jurisdiction on July 1, 2015. (Id.
¶40.) Defendants subsequently took steps to begin
production and marketing of a generic version of DONNATAL on
their own. (Id. ¶¶42-46.)
January 2016, Defendants listed B-Donna pharmaceutical
products with the FDA and subscription pharmaceutical drug
databases, including Medi-Span and First DataBank
(collectively “Drug Databases”). (Id.
¶47.) B-Donna was removed from the FDA website but
remains listed with the Drug Databases. (Id.
¶53.) In February 2016, Defendants listed the Phenohytro
pharmaceutical product with the FDA and Drug Databases.
(Id. ¶55.) The Drug Databases are
subscription-based and used by health care professionals,
insurers, payers, and pharmaceutical manufacturers to
determine whether generic substitutes are available for brand
named products. (Id. ¶¶62-63.)
Pharmaceutical products that are pharmaceutically equivalent,
that is, those that contain the same active ingredients, in
the same amounts, and in the same dosage forms, are
“linked” in the drug Databases. (Id.
¶¶64-65.) The B-Donna and Phenohytro products were
submitted with labels and package inserts indicating that
they contained the same active ingredients, in the same
amounts, and in the same dosage forms as the DONNATAL
products. (Id. ¶66.) The products were
therefore linked on the Drug Databases. The labels and
package inserts also indicated that the B-Donna and
Phenohytro products had been reviewed and classified by the
FDA. (Id. ¶67.) As a result, the relevant
market players believe that Defendants' products are
FDA-approved generic equivalents that are substitutable for
DONNATAL, the brand name product. (Id. ¶78.)
March 24, 2016, Plaintiff filed its First Amended Complaint
 bringing various claims under the Lanham Act and state
law. Defendants filed their Motion to Dismiss  on April
22, 2016, claiming that Plaintiff's claims are precluded
or preempted by the FDCA or, in the alternative, that
Plaintiff has failed to adduce sufficient facts to state a
claim. On January 30, 2017, Plaintiff filed its Motion to
Submit Supplemental Authority of Its Opposition to
Defendants' Motion to Dismiss , and on March 6, 2017,
Plaintiff filed its Motion to Submit March 2, 2017 Authority
in Support of Its Opposition to Defendants' Motion to
Dismiss . The Court now considers the parties'
Rule of Civil Procedure 8(a)(2) requires that a pleading
contain a “short and plain statement of the claim
showing that the pleader is entitled to relief.” While
this pleading standard does not require “detailed
factual allegations, ” “labels and
conclusions” or “a formulaic recitation of the
elements of a cause of action will not do.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
(2007)). In order to withstand a motion to dismiss, “a
complaint must contain sufficient factual matter, accepted as
true, to ‘state a claim to relief that is plausible on
its face.'” Id. (quoting Twombly,
550 U.S. at 570). A complaint is plausible on its face when
the plaintiff pleads factual content necessary for the court
to draw the reasonable inference that the defendant is liable
for the conduct alleged. Id.
motion to dismiss stage, “all-well pleaded facts are
accepted as true, and the reasonable inferences therefrom are
construed in the light most favorable to the
plaintiff.” Bryant v. Avado Brands, Inc., 187
F.3d 1271, 1273 n.1 (11th Cir. 1999). However, the same does
not apply to legal conclusions set forth in the complaint.
Sinaltrainal v. Coca-Cola Co., 578 F.3d 1252, 1260
(11th Cir. 2009) (citing Iqbal, 556 U.S. at 678).
“Threadbare recitals of the elements of a cause of
action, supported by mere conclusory statements, do not
suffice.” Iqbal, 556 U.S. at 678. Furthermore,
the court does not “accept as true a legal conclusion
couched as a factual allegation.” Twombly, 550
U.S. at 555. Using the framework articulated above, the Court
considers Defendants' Motion to Dismiss Plaintiff's
brings multiple claims under both federal and state law, all
of which Defendants argue should be dismissed with prejudice.
As an initial matter, the Court GRANTS Plaintiff's Motion
to Submit Supplemental Authority in Support of Its Opposition
to Defendants' Motion to Dismiss . However, the Court
DENIES Plaintiff's Motion to Submit March 2, 2017
Authority in Support of Its Opposition to Defendants'
Motion to Dismiss . In the motion, Plaintiff urges the
Court to consider an opinion issued in Concordia
Pharmaceuticals, Inc. v. Method Pharmaceuticals, LLC, et
al., Case No. 3:14CV00016 (W.D. Va. March 2, 2017).
However the Court finds that there are significant
differences in the facts of that case and those in the
present case. Those differences are sufficient to cause the
Court to find the opinion unpersuasive. The Court now
addresses each of Plaintiff's claims in turn.
False Advertising in Violation of Lanham Act §
43(a)(1)(B) (Count I)
43(a) of the Lanham Act creates a civil remedy for entities
injured by their competitor's false or misleading
advertising. Phx. of Broward, Inc. v. McDonald's
Corp., 441 F.Supp.2d 1241, 1246 (N.D.Ga. 2006) (internal
quotations omitted). The statute creates liability for the
use in commerce of any “false or misleading description
of fact, or false or misleading representation of fact which
in commercial advertising or promotion, misrepresents the
nature, characteristics, qualities, or geographic origin of
his or her or another person's goods, services, or
commercial activities.” 15 U.S.C. § 1125(a)(1)(B).
To succeed on this claim, Plaintiff must show: “(1)
[Defendants'] advertisements are false or misleading; (2)
the advertisements deceived, or had the capacity to deceive,
consumers; (3) the deception had a material effect on
purchasing decisions; (4) the misrepresented advertisements
affect interstate commerce; and (5) [Plaintiff] has been or
is likely to be injured as a result of the false
advertising.” Phx. of Broward, Inc., 441
F.Supp.2d at 1246 (citing Johnson & Johnson Vision
Care, Inc. v. 1-800 Contacts, Inc., 299 F.3d 1242, 1247
(11th Cir. 2002)).
alleges multiple false or misleading statements in
Defendants' advertising materials. First, Plaintiff
alleges that “Defendants made literally false
statements on the labels and package inserts for its B-Donna
and Phenohytro products, including that those drugs have been
reviewed and classified by the FDA, and that Phenohytro has
been indicated (without qualification) for certain
uses.” (Pl.'s Opp'n to Defs.' Mot. to
Dismiss (“Pl.'s Opp'n”), Dkt. , at
13.) Defendants argue that a Lanham Act claim here is
inappropriate as precluded by the FDCA. The Court agrees.
Supreme Court has held that the “Lanham Act and the
FDCA complement each other in major respects, for each has
its own scope and purpose.” POM Wonderful LLC v.
Coca-Cola Co., 134 S.Ct. 2228, 2238 (2014).
“Although both statutes touch on food and beverage
labeling, the Lanham Act protects commercial interests
against unfair competition, while the FDCA protects public
health and safety.” Id. The same holds true
with drug labeling. Neither the Lanham Act nor the FDCA
contain provisions expressly precluding the other from
applying where the two overlap. Id. at 2237. Courts
are, however, wary of permitting a claim under the Lanham Act
where determining falsity of a representation requires
interpretation and application of regulatory provisions of
the FDCA. Graceway Pharm., LLC v. River's Edge
Pharm., LLC, No. 2:08-CV-0067-RWS, 2009 WL 3753586, at
*6 (citing Mutual Pharm. Co. v. Ivax Pharm., Inc.,
459 F.Supp.2d 925, 934 (C.D. Cal. 2006)). “[O]nce the
FDA has taken a position on a particular matter, courts have
consistently allowed the Lanham Act claim to proceed even if
in determining the falsity of the alleged representation the
court must make reference to the FDA action.”
Mutual Pharm. Co., 459 F.Supp.2d at 934-35.
Regulation by the FDCA alone, however, is not enough to
preclude a claim under the Lanham Act. Graceway Pharm.,
LLC, 2009 WL 3753586, at *6.
theory of liability here depends on Defendants'
statements, that B-Donna and Phenohytro were reviewed and
classified by the FDA and that Phenohytro was indicated for
certain uses, being false. Their falsity, in turn, depends on
the meaning of the word “drug” in an FDA
regulation. Once a “Drug Efficacy Study Implementation
notice on a prescription drug” has been published in
the Federal Register, the FDA requires “all package
labeling . . ., promotional labeling, and
advertisements” to include “an appropriate
qualification of all claims evaluated as other than
‘effective' by a panel of the National Academy of
Sciences-National Research Council, Drug Efficacy Study Group
. . . .” 21 C.F.R. § 201.200(c). Plaintiff's
drug, DONNATAL, includes such language in its packaging and
inserts because of a 1975 Drug Efficacy Study Implementation
(“DESI”) notice published by the FDA classifying
Barbidonna tablets and elixir as “possibly
effective.” 40 Fed. Reg. 52, 644, 52, 646. Plaintiff
argues that unlike DONNATAL, neither of Defendants drugs has
received the same classification from the FDA. Including the
relevant language is therefore false. This argument is
predicated on defining the term “drug” in the
1975 DESI to mean “product.” Defendants argue,
however, that “drug” is defined by the FDA to
mean a specific combination of active ingredients in
particular strengths and dosage amounts. Since B-Donna and
Phenohytro contain the exact same active ...