United States District Court, E.D. Texas, Sherman Division
ORTHOACCEL TECHNOLOGIES, INC.
PROPEL ORTHODONTICS, LLC
MEMORANDUM OPINION AND ORDER
L. MAZZANT UNITED STATES DISTRICT JUDGE
before the Court is Propel Orthodontics, LLC's Motion for
Partial Summary Judgment Regarding the Benefits of the VPro5
(Dkt. #268). The Court, having considered the relevant
pleadings, finds Propel Orthodontics, LLC's motion is
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 (“ADNow”). The ADNow
agreements require doctors to offer the AcceleDent device to
all patients in their practice and keep a certain number of
units in stock. As of January 12, 2017, OrthoAccel had 127
providers signed up for the ADNow program.
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 originally
promoted 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 originally marketed 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 January 13, 2017, Propel filed this Motion for Partial
Summary Judgment Regarding the Benefits of the VPro5 (Dkt.
#268). On January 27, 2017, OrthoAccel filed a response (Dkt.
#277). On February 6, 2017, Propel filed a reply (Dkt. #280).
On February 14, 2017, OrthoAccel filed a sur-reply (Dkt.
purpose of summary judgment is to isolate and dispose of
factually unsupported claims or defenses. Celotex Corp.
v. Catrett, 477 U.S. 317, 323-24 (1986). Summary
judgment is proper under Rule 56(a) of the Federal Rules of
Civil Procedure “if the movant shows that there is no
genuine dispute as to any material fact and the movant is
entitled to judgment as a matter of law.” Fed.R.Civ.P.
56(a). A dispute about a material fact is genuine when
“the evidence is such that a reasonable jury could
return a verdict for the nonmoving party.” Anderson
v. Liberty Lobby Inc., 477 U.S. 242, 248 (1986).
Substantive law identifies which facts are material.
Id. The trial court “must resolve all
reasonable doubts in favor of the party opposing the motion
for summary judgment.” Casey Enters., Inc. v. Am.
Hardware Mut. Ins. Co., 655 F.2d 598, 602 (5th Cir.
party seeking summary judgment bears the initial burden of
informing the court of its motion and identifying
“depositions, documents, electronically stored
information, affidavits or declarations, stipulations
(including those made for purposes of the motion only),
admissions, interrogatory answers, or other materials”
that demonstrate the absence of a genuine issue of material
fact. Fed.R.Civ.P. 56(c)(1)(A); Celotex, 477 U.S. at
323. If the movant bears the burden of proof on a claim or
defense for which it is moving for summary judgment, it must
come forward with evidence that establishes “beyond
peradventure all of the essential elements of the
claim or defense.” Fontenot v. Upjohn Co., 780
F.2d 1190, 1194 (5th Cir. 1986). Where the nonmovant bears
the burden of proof, the movant may discharge the burden by
showing that there is an absence of evidence to support the
nonmovant's case. Celotex, 477 U.S. at 325;
Byers v. Dall. Morning News, Inc., 209 F.3d 419, 424
(5th Cir. 2000). Once the movant has carried its burden, the
nonmovant must “respond to the motion for summary
judgment by setting forth particular facts indicating there
is a genuine issue for trial.” Byers, 209 F.3d
at 424 (citing Anderson, 477 U.S. at 248-49). A
nonmovant must present affirmative evidence to defeat a
properly supported motion for summary judgment.
Anderson, 477 U.S. at 257. Mere denials of material
facts, unsworn allegations, or arguments and assertions in
briefs or legal memoranda will not suffice to carry this
burden. Rather, the Court requires ‘“significant
probative evidence'” from the nonmovant to dismiss
a request for summary judgment. In re Mun. Bond Reporting
Antitrust Litig., 672 F.2d 436, 440 (5th Cir. 1982)
(quoting Ferguson v. Nat'l Broad. Co., 584 F.2d
111, 114 (5th Cir. 1978)). The Court must consider all of the
evidence but “refrain from making any credibility
determinations or weighing the evidence.” Turner v.
Baylor Richardson Med. Ctr., 476 F.3d 337, 343 (5th Cir.
asks the Court to grant summary judgment on OrthoAccel's
claim that Propel violated the Lanham Act in advertising the
VPro5's 5 Benefits. Specifically, Propel claims
OrthoAccel has not evidenced literal falsity under Section
43(a) of the Lanham Act and Texas common law unfair
competition. Propel contends that OrthoAccel has not carried
its burden in demonstrating that the 5 Benefits are literally
false because OrthoAccel has produced no study or test to
prove that the VPro5 cannot offer the advertised benefits.
But when a “defendant's promotion implicitly or
explicitly refers to tests or data, a plaintiff can satisfy
its burden of proving that the promotion is literally false
by demonstrating that the tests are not sufficiently reliable
to permit a person to conclude with reasonable certainty that
they established the claim made.” Pamlab, LLC v.
Macoven Pharm., LLC, 881 F.Supp.2d 470, 467 (S.D.N.Y.
2012); see Eastman Chem. Co. v. Plastipure, Inc.,
775 F.3d 230 (5th Cir. 2014) (finding falsity where plaintiff
established that competitors' tests were not
scientifically reliable); Mylan Labs., Inc. v.
Matkari, 7 F.3d 1130, 1138 (4th Cir. 1993) (finding
plaintiff properly pleaded false advertising on generic drug
where plaintiff alleged “that bioequivalence studies
either had not been performed or had been performed on a drug