United States District Court, E.D. Texas, Sherman Division
ORTHOACCEL TECHNOLOGIES, INC.
PROPEL ORTHODONTICS, LLC No. 4
MEMORANDUM OPINION AND ORDER
L. MAZZANT, UNITED STATES DISTRICT JUDGE
before the Court is Plaintiff OrthoAccel Technologies,
Inc.'s Partial Motion to Dismiss Defendant's
Counterclaims, or in the Alternative for a More Definite
Statement (Dkt. #159). The Court, having considered the
relevant pleadings, finds the motion is denied.
OrthoAccel Technologies, Inc. (“OrthoAccel”), is
a medical device company that manufactures dental appliances.
In 2008, OrthoAccel developed a prototype hands-free dental
device that uses gentle vibrations to accelerate tooth
movement when used with orthodontic treatment. This prototype
would eventually become the AcceleDent device, which has two
main functional components: (1) a “Mouthpiece”
and (2) an “Activator.” The Activator is a small
extraoral component that generates a vibrational force of
0.25N at 30 Hz. The Activator connects directly to the
Mouthpiece, which the patient lightly bites down on for 20
minutes daily to accelerate tooth movement during orthodontic
November 5, 2011, the Food and Drug Administration
(“FDA”) granted 510(k) clearance for AcceleDent
as “an orthodontic accessory intended for use during
orthodontic treatment. It is used in conjunction with
orthodontic appliances such as braces and helps facilitate
minor anterior tooth movement.” A 510(k) is a
premarketing submission made to the FDA to demonstrate that
the device to be marketed is as safe and effective as a
legally marketed device (a “predicate device”)
that is not subject to premarket approval. 510(k) clearance
is required for Class II devices, but Class I devices are
510(k) exempt. Class I devices are deemed to be low risk and
are therefore subject to the least regulatory controls. For
example, dental floss is classified as a Class I device.
Class II devices are higher risk devices than Class I and
require greater regulatory controls to provide reasonable
assurance of the device's safety and effectiveness.
Dental implants and braces are examples of Class II devices.
2012, OrthoAccel launched its Class II AcceleDent device in
the United States to be used in conjunction with orthodontic
treatment. In 2013, OrthoAccel launched the AcceleDent Aura
(“Aura”), the second generation of AcceleDent,
which initially was cleared to be used with braces only.
OrthoAccel offers its customers special pricing through its
AcceleDent NOW Program, which Propel alleges contains
anticompetitive vertical pricing constraints and other
Propel Orthodontics, LLC (“Propel”) is also a
medical device company that manufactures dental appliances.
In January 2016, Propel began marketing a vibratory Class I
device designed to help seat clear aligners. Orthodontic
patients wear a series of these removable aligners, marketed
under names such as Invisalign and ClearCorrect, to gradually
straighten their teeth. In March 2016, Propel released the
VPro5, which operates at 120 Hz and requires five minutes of
daily use to properly seat (i.e., fit better on the teeth)
clear aligners. The VPro5 costs significantly less than the
OrthoAccel Aura. On July 8, 2016, OrthoAccel's
product-the Aura- was cleared for use with clear aligners.
primarily markets the VPro5 through its sales force in a
consultative setting. Propel sales representatives promote
the VPro5 by telling orthodontists that the device offers
several clinical benefits (“5 Clinical
Benefits”). These 5 Clinical Benefits include: (1) more
efficient aligner seating, (2) relieves orthodontic pain, (3)
accelerates tooth movement, (4) fast tracks retention, and
(5) stimulates bone growth and remodeling. Propel's sales
force markets the VPro5 as a quicker, cheaper alternative to
the AcceleDent device.
2016, OrthoAccel sued Propel, claiming Propel falsely
advertised the VPro5's 5 Clinical Benefits in violation
of the Lanham Act. On October 3, 2016, Propel filed its
counterclaims against OrthoAccel (Dkt. #118). On October 26,
2016, the Court entered a preliminary injunction enjoining
Propel from advertising the 5 Clinical Benefits (Dkt. #148).
On November 7, 2016, OrthoAccel filed its Partial Motion to
Dismiss Defendant's Counterclaims or in the Alternative
for a More Definite Statement (Dkt. #159). On November 25,
2016, Propel filed its response (Dkt. #172). On December 5,
2016, OrthoAccel filed a reply (Dkt. #212). On December 12,
2016, Propel filed a sur-reply (Dkt. #245). On December 16,
2016, OrthoAccel filed a notice of new supplemental authority
(Dkt. #250). On December 23, 2016, Propel filed a response to
the supplemental authority (Dkt. #255).
Federal Rules of Civil Procedure require that each claim in a
complaint include a “short and plain statement . . .
showing that the pleader is entitled to relief.”
Fed.R.Civ.P. 8(a)(2). Each claim must include enough factual
allegations “to raise a right to relief above the
speculative level.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007).
12(b)(6) motion allows a party to move for dismissal of an
action when the complaint fails to state a claim upon which
relief can be granted. Fed.R.Civ.P. 12(b)(6). When
considering a motion to dismiss under Rule 12(b)(6), the
Court must accept as true all well-pleaded facts in
plaintiff's complaint and view those facts in the light
most favorable to the plaintiff. Bowlby v. City of
Aberdeen, 681 F.3d 215, 219 (5th Cir. 2012). The Court
may consider “the complaint, any documents attached to
the complaint, and any documents attached to the motion to
dismiss that are central to the claim and referenced by the
complaint.” Lone Star Fund V (U.S.), L.P. v.
Barclays Bank PLC, 594 F.3d 383, 387 (5th Cir. 2010).
The Court must then determine whether the complaint states a
claim for relief that is plausible on its face.
‘“A claim has facial plausibility when the
plaintiff pleads factual content that allows the [C]ourt to
draw the reasonable inference that the defendant is liable
for the misconduct alleged.'” Gonzalez v.
Kay, 577 F.3d 600, 603 (5th Cir. 2009) (quoting
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
“But where the well-pleaded facts do not permit the
[C]ourt to infer more than the mere possibility of
misconduct, the complaint has alleged-but it has not
‘show[n]'-‘that the pleader is entitled to
relief.'” Iqbal, 556 U.S. at 679 (quoting
Iqbal, the Supreme Court established a two-step
approach for assessing the sufficiency of a complaint in the
context of a Rule 12(b)(6) motion. First, the Court should
identify and disregard conclusory allegations, for they are
“not entitled to the assumption of truth.”
Iqbal, 556 U.S. at 664. Second, the Court
“consider[s] the factual allegations in [the complaint]
to determine if they plausibly suggest an entitlement to
relief.” Id. “This standard
‘simply calls for enough facts to raise a reasonable
expectation that discovery will reveal evidence of the
necessary claims or elements.'” Morgan v.
Hubert, 335 F. App'x 466, 470 (5th Cir. 2009)
(citation omitted). This evaluation will “be a
context-specific task that requires the reviewing [C]ourt to
draw on its judicial experience and common sense.”
Iqbal, 556 U.S. at 679.
“[t]o survive 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