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 FDA Compliance (Dkt.
#264). The Court, having considered the relevant pleadings,
finds Propel Orthodontics, LLC's 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. Thus, a Class I device is not
“cleared”; rather, a Class I device is
“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. Class II devices are either
“exempt” or “cleared.” Dental
implants and braces are examples of Class II devices. Class
III devices are high-risk medical devices-such as a
pacemaker-that require a more rigorous premarket review than
the 510(k) pathway. Class III devices are
“approved” by the FDA.
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.
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 nationwide 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 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 FDA
Compliance (Dkt. #264). On January 27, 2017, OrthoAccel filed
a response (Dkt. #276). On February 6, 2017, Propel filed a
reply (Dkt. #283). On February 14, 2017, OrthoAccel filed a
sur-reply (Dkt. #291).
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 partial summary judgment in favor of
Propel against OrthoAccel's claims that Propel falsely
advertised the VPro5 as FDA registered, cleared, or approved
between January 2016 and May 19, 2016. Propel claims that it
complied with all FDA regulations by listing the VPro5 as a
510(k) exempt Class I medical device. Further, Propel claims
there is no evidence that Propel promoted the VPro5 as
FDA-registered, FDA-cleared, or FDA-approved. OrthoAccel
contends it never alleged Propel violated FDA regulations;