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 Defendant Propel Orthodontics, LLC's
Emergency Motion to Modify the Court's Preliminary
Injunction Order (Dkt. #318). The Court, having considered
the relevant proceedings, 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 (“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 26, 2016, the Court entered a
preliminary injunction order enjoining Propel from
advertising the 5 Clinical Benefits (“Preliminary
Injunction Order”) (Dkt. #148). On November 25, 2016,
Propel filed a notice of appeal of the preliminary injunction
(Dkt. #171). On January 30, 2017, Propel filed its opening
brief to the Fifth Circuit Court of Appeals. On March 26,
2017, Propel filed this Emergency Motion to Modify the
Court's Preliminary Injunction Order (Dkt. #318). On
April 10, 2017, OrthoAccel filed its response (Dkt. #329). On
April 18, 2017, Propel filed a reply (Dkt. #337).
general rule, a notice of appeal ousts the district court of
jurisdiction over the judgment or order appealed. Coastal
Corp. v. Texas E. Corp., 869 F.2d 817, 819 (5th Cir.
1989) (citing U.S. v. Hitchmon, 587 F.2d 1357 (5th
Cir. 1979)). However, Federal Rule of Civil Procedure 62(c)
allows the district court some limited injunctive powers
during the pendency of an appeal. Rule 62(c) provides in
Injunction Pending Appeal. When an appeal is
taken from an interlocutory or final judgment granting,
dissolving, or denying an injunction, the court in its
discretion may suspend, modify, restore, or grant an
injunction during the pendency of the appeal upon such terms
as to bond or otherwise as it considers proper for the
security of the rights of the adverse party.
Fifth Circuit has held that “the authority granted by
Rule 62(c) does not extend to the dissolution of an
injunction . . . the district court's power to alter an
injunction pending appeal is limited to ‘maintaining
the status quo.'” Sierra Club, Lone Star
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