Case 4:16-cv-00350-ALM Document 148 Filed 10/26/16 Page 1 of 17 PageID #: 3046
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`United States District Court
`EASTERN DISTRICT OF TEXAS
`SHERMAN DIVISION
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`CASE NO. 4:16-CV-350
`Judge Mazzant
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`ORTHOACCEL TECHNOLOGIES, INC.
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`v.
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`PROPEL ORTHODONTICS, LLC
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`§
`§
`§
`§
`§
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`MEMORANDUM OPINION AND ORDER
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`Pending before the Court is OrthoAccel’s Motion for Preliminary Injunction and
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`Permanent Injunction (Dkt. #57). Based on the pleadings, the numerous briefs and submissions,
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`the arguments and evidence presented at a hearing on the motion, and the applicable law, the
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`Court enters the findings of fact and conclusions of law set forth below. Based on these findings
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`and conclusions, the Court GRANTS OrthoAccel’s Motion for Preliminary Injunction.
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`BACKGROUND
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`Plaintiff, OrthoAccel Technologies, Inc. (“OrthoAccel”), is a medical device company
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`that manufactures dental appliances. In 2008, OrthoAccel developed a prototype hands-free
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`dental device that uses gentle vibrations to accelerate tooth movement when used with
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`orthodontic treatment. This prototype would eventually become the AcceleDent device, which
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`has two main functional components: (1) a “Mouthpiece” and (2) an “Activator.” The Activator
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`is a small extraoral component that generates a vibrational force of 0.25N at 30 Hz. The
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`Activator connects directly to the Mouthpiece, which the patient lightly bites down on for 20
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`minutes daily to accelerate tooth movement during orthodontic treatment.
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`On November 5, 2011, the Food and Drug Administration (“FDA”) granted 510(k)
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`clearance for AcceleDent as “an orthodontic accessory intended for use during orthodontic
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`treatment. It is used in conjunction with orthodontic appliances such as braces and helps
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`facilitate minor anterior tooth movement.” A 510(k) is a premarketing submission made to the
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`FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed
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`device (a “predicate device”) that is not subject to premarket approval. 510(k) clearance is
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`required for Class II devices, but Class I devices are 510(k) exempt. Class I devices are deemed
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`to be low risk and are therefore subject to the least regulatory controls. For example, dental floss
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`is classified as a Class I device. Class II devices are higher risk devices than Class I and require
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`greater regulatory controls to provide reasonable assurance of the device’s safety and
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`effectiveness. Dental implants and braces are examples of Class II devices.
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`In 2012, OrthoAccel launched its Class II AcceleDent device in the United States to be
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`used in conjunction with orthodontic treatment. In 2013, OrthoAccel launched the AcceleDent
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`Aura (“Aura”), the second generation of AcceleDent, which initially was cleared to be used with
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`braces only. On July 8, 2016, the Aura was cleared for use with clear aligners. Orthodontic
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`patients wear a series of these removable aligners, marketed under names such as Invisalign and
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`ClearCorrect, to gradually straighten their teeth.
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`Defendant Propel Orthodontics, LLC (“Propel”) is also a medical device company that
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`manufactures dental appliances. In January 2016, Propel began marketing a vibratory Class I
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`device designed to help seat clear aligners. In March 2016, Propel released the VPro5, which
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`operates at 120 Hz and requires five minutes of daily use to properly seat (i.e., fit better on the
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`teeth) clear aligners. The VPro5 costs significantly less than the OrthoAccel Aura.
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`Propel primarily markets the VPro5 through its sales force in a consultative setting.
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`Propel sales representatives promote the VPro5 by telling orthodontists that the device offers
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`several clinical benefits (“5 Clinical Benefits”). These 5 Clinical Benefits include: (1) more
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`efficient aligner seating, (2) relieves orthodontic pain, (3) accelerates tooth movement, (4) fast
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`tracks retention, and (5) stimulates bone growth and remodeling. Propel’s sales force markets the
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`VPro5 as a quicker, cheaper alternative to the AcceleDent device.
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`On July 19, 2016, OrthoAccel filed its Motion for Preliminary Injunction and Permanent
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`Injunction (Dkt. #57), seeking injunctive relief from Propel’s alleged false advertising under the
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`Lanham Act. On August 30, 2016, Propel filed its response (Dkt. #73). On September 9, 2016,
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`OrthoAccel filed its reply (Dkts. #95, #96). On September 19, 2016, Propel filed its sur-reply
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`(Dkt. #109). The Court held oral argument at the request of the parties on September 20, 2016.
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`The hearing continued on October 3, 2016, and concluded on October 4, 2016.1
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`LEGAL STANDARD
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`To obtain a preliminary injunction, it is well established that a movant must show: (1) a
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`substantial likelihood that the movant will ultimately prevail on the merits; (2) a substantial
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`threat that the movant will suffer irreparable injury if the injunction is not granted; (3) that the
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`threatened injury to the movant outweighs whatever damage the proposed injunction may cause
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`the opposing party; and (4) that granting the injunction will not disserve the public interest.
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`Paulsson Geophysical Servs., Inc. v. Sigmar, 529 F.3d 303, 309 (5th Cir. 2008); Speaks v. Kruse,
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`445 F.3d 396, 399–400 (5th Cir. 2006); Miss. Power & Light Co. v. United Gas Pipe Line Co.,
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`760 F.2d 618, 621 (5th Cir. 1985) (citing Canal Authority of State of Fla. v. Callaway, 489 F.2d
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`567, 572 (5th Cir. 1974)).
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`The decision to grant or deny a preliminary injunction is left to the sound discretion of
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`the district court. Miss. Power & Light, 760 F.2d at 621. A preliminary injunction is an
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`extraordinary remedy which should only be granted if the movant has clearly carried his burden
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`1 On October 14, 2016, OrthoAccel filed a Post-Hearing Brief (Dkt. #126).On October 17, 2016,
`Propel filed a Motion to Strike the brief (Dkt. #130). On October 21, 2016, OrthoAccel filed its
`Response in Opposition (Dkt. #141). The Court did not consider the Post-Hearing Brief and will
`issue a separate order striking the brief.
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`of persuasion on all four factors. Id.; Mazurek v. Armstrong, 520 U.S. 968, 972 (1997) (A
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`preliminary injunction is a “drastic remedy” that “should not be granted unless the movant, by a
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`clear showing, carries the burden of persuasion.”) (citation omitted) (emphasis in original); PCI
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`Trans., Inc. v. Fort Worth & W. RR Co., 418 F.3d 535, 546 (5th Cir. 2005) (“[t]he plaintiff has
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`the burden of introducing sufficient evidence to justify the grant of a preliminary injunction.”).
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`As a result, “[t]he decision to grant a preliminary injunction is to be treated as the exception
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`rather than the rule.” Miss. Power & Light, 760 F.2d at 621; House the Homeless, Inc. v.
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`Widnall, 94 F.3d 176, 180 (5th Cir. 1996).
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`ANALYSIS
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`In a typical preliminary injunction application, the movant must clearly meet its burden of
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`persuasion on all four requirements for the Court to grant injunctive relief. See Nichols v. Alcatel
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`USA, Inc., 532 F.3d 364, 372 (5th Cir. 2008). OrthoAccel, the movant, argues that the burden
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`should shift to Propel under the Novartis exception. See Novartis v. Johnson & Johnson-Merck
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`Consumer Pharm. Co., 290 F.3d 578 (3d Cir. 2002). In Novartis, a pharmaceutical company
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`marketed an antacid as “night time strength” without arguing or presenting any evidence that the
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`drug was specifically formulated for night time heartburn or that its product actually remedied
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`heartburn at night more effectively than heartburn during the day. Id. at 590. The Fifth Circuit
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`noted that it had previously specifically declined to answer “whether completely unsubstantiated
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`advertising claims violate the Lanham Act absent proof that consumers are actually misled by
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`this lack of substantiation.” Id. at 589 (emphasis in original). But the Fifth Circuit decided to
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`answer what it had previously left open and held, “although the plaintiff normally has the burden
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`to demonstrate that the defendant’s advertising claim is false, a court may find that a completely
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`unsubstantiated advertising claim by the defendant is per se false without additional evidence
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`from the plaintiff to that effect.” Id. at 590.
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`OrthoAccel argues that the Court should apply the Novartis exception, but the Fifth
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`Circuit has not adopted the Novartis exception. And the Novartis exception would not apply
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`regardless because Propel’s claims are not completely unsubstantiated. See id. at 589–90. The
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`Court finds the Novartis exception inapplicable because Propel has offered some evidence
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`substantiating its advertising claims. Thus the burden of proof remains with OrthoAccel to show
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`that the advertising is false and misleading.
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`Substantial Likelihood of Success on the Merits
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`In order for the Court to grant injunctive relief, OrthoAccel must show a substantial
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`likelihood that it will ultimately prevail on the merits. See Sigmar, 529 F.3d at 309. OrthoAccel
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`alleges that Propel engaged in deceptive advertising in violation of the Lanham Act and Texas
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`common law. In the Fifth Circuit, the elements of a false advertising claim under the Lanham
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`Act are: (1) the defendant made a false statement of fact about its product in a commercial
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`advertisement; (2) the statement actually deceived or had a tendency to deceive a substantial
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`segment of its audience; (3) the deception was material or likely to influence the purchasing
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`decision; (4) the defendant caused the false statement to enter interstate commerce; and (5) the
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`plaintiff has been or is likely to be injured as a result. Logan v. Burgers Ozark Country Cured
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`Hams, Inc., 263 F.3d 447, 462 (5th Cir. 2001); 15 U.S.C. § 1125. The Court will discuss each
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`5
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`element in turn.
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`Falsity
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`In order to show a substantial likelihood of success on the merits, OrthoAccel must
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`identify a false statement of fact actionable under the Lanham Act. Because per se falsity is not
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`triggered under the Novartis exception, OrthoAccel carries the burden of proving falsity.
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`The Fifth Circuit distinguishes literally false statements from misleading statements. See
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`Pizza Hut, Inc. v. Papa John’s Intern., Inc., 227 F.3d 489 (5th Cir. 2000). In the Fifth Circuit,
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`materiality is presumed for literally false statements. Id. There are several claims made by Propel
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`that are literally false. OrthoAccel first identifies “Vibration Objections and Answers,” an
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`internal Propel document created for a presentation given to its sales force. (PX 2). Propel’s
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`CEO, Bryce Way, testified that the presentation was designed to stimulate and educate the sales
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`force so the representatives could sell the VPro5. The first question asks, “What clinical research
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`do you have that your vibration works?” The proposed answer reads, “We have many research
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`studies that show the benefits of high frequency vibration. Let me detail some of them with you.”
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`A similar claim appears in the March 2016 launch presentation, which states that there are
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`“significant clinical findings that support the VPro5’s ability to increase bone formation and
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`accelerate tooth movement.” (PX 3). But no such studies existed. The claim that Propel had
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`“many studies” to support its claims is literally false because at the time the sales force engaged
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`the marketplace, there were no clinical findings or studies supporting the notion that the VPro5
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`could provide its 5 Clinical Benefits. Another literally false statement appears in the same
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`document, which states the VPro5’s 120 Hz is the “optimal frequency” for achieving the 5
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`Clinical Benefits. (PX 2). This claim is completely unsubstantiated and literally false. See Kinetic
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`Concepts, Inc. v. Bluesky Med. Group, Inc., SA-03-CA-0832-RF, 2005 WL 3068223, at *4
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`(W.D. Tex. Nov. 1, 2005) (“Unsubstantiated comparison claims made in an advertisement have
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`been found per se false.”) None of the studies relied upon by Propel tested the 120 Hz frequency
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`or otherwise concluded that the frequency was optimal for accelerated tooth movement.
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`The final literally false statement identified by OrthoAccel appeared in a Propel
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`advertisement that claimed a “prototype of the VPro5 device” was used in the Dr. M. Alikhani
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`studies. (PX 6). Propel later corrected this advertisement and claims fewer than twenty dentists
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`saw the false statement, but the statement was literally false when disseminated. (DX 17).
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`In addition to proving falsity from these literally false statements, OrthoAccel meets its
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`burden in proving falsity by showing the literature does not support the claims. OrthoAccel
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`asserts that in order to actually scientifically disprove Propel’s claims, it would need to conduct
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`two to three years of blind studies using the VPro5. But when a “defendant’s promotion
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`implicitly or explicitly refers to tests or data, a plaintiff can satisfy its burden of proving that the
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`promotion is literally false by demonstrating that the tests are not sufficiently reliable to permit a
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`person to conclude with reasonable certainty that they established the claim made.” Pamlab, LLC
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`v. Macoven Pharm., LLC, 881 F. Supp. 2d 470, 467 (S.D.N.Y. 2012); see Eastman Chem. Co. v.
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`Plastipure, Inc., 775 F.3d 230 (5th Cir. 2014) (finding falsity where plaintiff established that
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`competitors’ tests were not scientifically reliable). Thus, OrthoAccel can meet its burden as to
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`falsity by showing that Propel’s studies, tests, and data do not support the advertising claims.
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`The first study relied upon by Propel is Dr. Alikhani’s high frequency study. (PX19). Dr.
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`Alikhani studied high frequency vibration as a therapeutic tool to preserve bone following tooth
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`extractions. The study did not involve the VPro5 or any prototype thereof. The study also did not
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`use clear aligners or involve orthodontic tooth movement in any capacity. Propel relies on a
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`second Dr. Alikhani study—Osteogenic Effect of High-frequency Acceleration on Alveolar
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`Bone. (PX 20). Similarly, this study does not involve a VPro5, orthodontic tooth movement, or
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`clear aligners. At oral argument, OrthoAccel’s expert, Dr. Dubravko Pavlin, testified that Dr.
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`Alikhani’s studies do not support the notion that the VPro5 accelerates tooth movement or
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`provides any of the 5 Clinical Benefits. More importantly, Dr. Alikahni himself stated he was
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`“[s]ad this data are being misused” when he learned Propel was attempting to use his studies as
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`support for their advertising claims. (PX 53).
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`Propel also relies upon Dr. Stefan Judex’s article, which studied bone formation induced
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`by applying high-frequency vibration to muscles in rat appendages. (PX 22). Dr. Judex did not
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`study orthodontic tooth movement or utilize the VPro5, clear aligners, or a 120 Hz frequency. At
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`oral argument, Dr. Pavlin conceded that this study was well conducted, but claimed there was no
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`useful comparison to the VPro5. Dr. Judex’s study does not provide a basis for supporting any of
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`the advertised 5 Clinical Benefits.
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`Propel relies on another study, by Dr. Chidchanok Leethanakul, that measured the effect
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`of a vibrating toothbrush placed on a single braces bracket for pain relief. (PX 21). Dr. Pavlin
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`noted at oral argument that this is the only study relied upon by Propel that actually studies
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`orthodontic tooth movement. Dr. Pavlin stated that since Dr. Leethanakul did not disclose the
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`force applied by the toothbrush, a useful comparison to the VPro5 could not be made. Further,
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`the study did not test clear aligners or utilize a device even similar to the VPro5. The study does
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`not support the notion that the VPro5 is capable of providing the alleged 5 Clinical Benefits.
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`The final study relied on by Propel is the Dr. Payam Attai study, which compared aligner
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`seating with a vibratory device versus aligner seating with a “chewie.” (DX 27). A chewie is a
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`small, cylindrical foam stick that patients bite down on to help seat aligners. Dr. Attai’s “study”
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`asked nine dental patients whether they were satisfied with the VPro5’s ease of use in a post-
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`treatment questionnaire. Based on this questionnaire, Dr. Attai concluded that the vibratory
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`device offered better aligner seating than a traditional chewie. This “study” did not address the 5
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`Clinical Benefits or otherwise support any of Propel’s advertising claims.
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`The studies introduced by Propel do not support the VPro5’s advertising claims. Propel
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`attempts to offer various non-study publications as evidence of the VPro5’s efficacy.
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`OrthoAccel, Dr. Pavlin, and the Court agree that these articles do not support the notion that the
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`VPro5 can offer the 5 Clinical Benefits identified, but the Court will address these articles in
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`turn.
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`Propel offers Dr. Amit Lala’s article as evidence of the VPro5’s efficacy. (PX 24). Dr.
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`Lala’s article is not a study—it does not test high frequency vibration, its effects on orthodontic
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`tooth movement, or offer any scientific support for the alleged benefits of the VPro5. Dr. Lala
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`concludes, “It can be hypothesized that a vibration device operating in the high frequency range
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`would likely be most effective in creating [orthodontic tooth movement] . . . .” This article only
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`hypothesizes about the potential benefits orthodontic vibration therapy may provide, and does
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`not address Propel’s 5 Clinical Benefits. Further, Dr. Pavlin testified that the articles cited by Dr.
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`Lala do not support his extrapolation. The Court finds that Dr. Lala’s article does not support
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`Propel’s advertising claims.
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`Propel also offers Dr. Thomas Shipley’s article as evidence of the VPro5’s efficacy. (PX
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`23). Dr. Shipley’s article summarizes a single patient’s experience with the VPro5 device. Dr.
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`Shipley claims that he is able to offer his patients more treatment predictability, less refinements,
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`less discomfort, better patient compliance with a five-minute usage time, and greater patient
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`satisfaction. While Dr. Shipley’s article concludes that the VPro5 might offer some benefits
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`based on a single-patient survey, it does not support the notion that the VPro5 can provide any of
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`the 5 Clinical Benefits.
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`Propel claims that Dr. Gary Brigham’s article supports the VPro5’s marketing claims.
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`(PX 25). Similar to Dr. Lala’s article, Dr. Brigham’s article is neither a study nor a test. Dr.
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`Brigham states, “some preliminary research suggests that high-frequency vibratory devices may
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`accelerate teeth movement.” But Dr. Brigham did not test the VPro5 or conclude that it moved
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`teeth faster, fast tracked retention, reduced pain, or stimulated bone growth and remodeling. Dr.
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`Brigham himself stated, “Independent, randomized, controlled trials have not yet established the
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`efficacy of these appliances.” Further, Dr. Pavlin testified that the articles cited by Dr. Brigham
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`do not support his extrapolation.
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`OrthoAccel has met its burden in proving that the tests and data are not sufficiently
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`reliable to establish that the VPro5 can offer its advertised 5 Clinical Benefits. See Pamlab, LLC,
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`881 F. Supp. 2d at 467. The Court agrees with the line of cases that prevent a defendant from
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`using irrelevant, unreliable studies to support its promotional claims. See Eastman Chem. Co.,
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`775 F.3d at 230; SEB USA, Inc. v. Euro-Pro Operating, LLC, 774 F.3d 192, 202 (3d Cir. 2014)
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`(holding that a defendant’s use of irrelevant studies to support promotional claims was
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`insufficient). Thus OrthoAccel has met its burden in proving literal falsity. See Pamlab, LLC,
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`881 F. Supp. 2d at 467; Eastman Chem. Co., 775 F.3d at 230.
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`Deception
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`Plaintiffs seeking injunctive relief must prove that defendant’s representations “have a
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`tendency to deceive customers.” Pizza Hut, 227 F.3d at 489; see Mission Pharmacal Co. v. Vitus
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`Pharm., LLC, 23 F. Supp. 3d 748, 759 (W.D. Tex. 2014) (“[P]laintiff must show that the
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`statements have a tendency to deceive consumers by producing evidence that at least some
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`consumers were confused.” (citing Pizza Hut, Inc., 227 F.3d at 497–98 (internal citations
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`omitted)). To prove a tendency to deceive, a plaintiff “need not present consumer surveys or
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`testimony demonstrating actual deception.” Pizza Hut, Inc., 227 F.3d at 498; but see Apple Inc. v.
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`Amazon.com Inc., 915 F. Supp. 2d 1084, 1090 (N.D. Cal. 2013) (“If an advertisement is not false
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`on its face, plaintiff asserting false advertising claim under Lanham Act must produce evidence,
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`usually in the form of market research or consumer surveys, showing exactly what message was
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`conveyed that was sufficient to constitute false advertising.”). The Fifth Circuit assumes that
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`literally false statements actually mislead consumers. S&H Industries, Inc. v. Selander, 932 F.
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`Supp. 2d 754 (N.D. Tex. 2013) (“If the statements at issue are shown to be literally false, a court
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`must assume that the statements actually misled consumers, without requiring any evidence of
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`their impact on consumers.” (citing Logan, 263 F.3d at 462; Pizza Hut, 227 F.3d at 497)).
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`Because OrthoAccel has met its burden in proving literal falsity, the Court assumes the
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`statements actually misled customers.
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`OrthoAccel has nonetheless proven actual deception by showing Propel’s claims are
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`misleading and have deceived the doctors and staff to whom Propel markets the VPro5.
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`OrthoAccel provides captures of various dentists’ websites that copy the alleged 5 Clinical
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`Benefits of the VPro5 as proof that some consumers were confused. (PX 33). These websites
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`show that Propel’s advertising had a tendency to deceive consumers. As a more direct indicator
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`of deception, OrthoAccel provides Dr. Mark K. Batesole’s declaration. Dr. Batesole received a
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`marketing email from a Propel sales representative announcing the launch of the VPro5. (PX 12).
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`The email summarized some advantages of the VPro5 and compared its cost to the AcceleDent
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`product. Id. Dr. Batesole stated he “understood that Propel was introducing a competing device
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`[to] AcceleDent” and “would expect the VPro5 to have scientific support, similar to
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`AcceleDent.” (PX 54). This declaration proves actual deception, which is more than what is
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`required for injunctive relief. See Pizza Hut, 227 F.3d at 497.
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`Materiality
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`The parties agree that the deception is material because the advertisements will likely
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`influence the consumer’s purchasing decision. And OrthoAccel does not need to introduce
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`evidence of materiality. See Pizza Hut, 227 F.3d at 497 (“With respect to materiality, when the
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`statements of fact at issue are shown to be literally false, the plaintiff need not introduce
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`evidence on the issue of the impact the statements had on consumers.”). The Court finds that
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`Propel’s false advertising is material.
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`Interstate Commerce
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`In order to show a substantial likelihood of success on the merits, OrthoAccel must prove
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`that the advertising entered interstate commerce. See Logan, 263 F.3d at 462. Propel admits that
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`it promotes and sells the VPro5 to doctors around the United States through its sales force (Dkt.
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`#11). The Court finds that OrthoAccel has met its burden on proving this element. See Seven-Up
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`Co. v. Coca-Cola Co., 86 F.3d 1379, 1384 (5th Cir. 1996) (finding that promotion to those
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`specifically intended to buy the defendants’ product was sufficient dissemination). The Court
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`finds that Propel’s advertising involved interstate commerce.
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`Injury
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` In order to prove substantial likelihood of success on the merits, OrthoAccel must prove
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`it has suffered an injury. Michael Lowe, OrthoAccel’s CEO, testified that OrthoAccel is losing
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`market share to Propel as evidenced by a sharp decline in sales following the launch of the
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`VPro5. (Dkt. #95-1). OrthoAccel has met this burden, which is discussed in depth in the
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`following section.
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`Irreparable Injury
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`OrthoAccel must establish that it will face irreparable harm if the Court does not grant
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`injunctive relief. It is well established that loss of market share due to false advertising
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`constitutes irreparable harm. See Novartis, 290 F.3d at 596 (“In a competitive industry where
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`consumers are brand loyal . . . loss of market share is a potential harm which cannot be redressed
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`by a legal or an equitable remedy following a trial.” (internal citations omitted)). In 38 out of 39
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`months before the VPro5 launch, OrthoAccel’s monthly net U.S. revenues increased on a year-
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`over-year basis. Michael Lowe testified that OrthoAccel’s annual operating plan and actual
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`revenues varied by 7% in 2014 and 2% in 2015. In 2016, from April to July, the variance
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`measured 57% following the launch of the VPro5.
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`Propel only provided a 43-day period of sales data in July and August of 2016 to
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`OrthoAccel for comparison. Over these 43 days, Propel’s sales totaled $1.4 million and
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`OrthoAccel’s sales declined by over $300,000, to $1.1 million. This data supports that
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`OrthoAccel is losing market share to Propel. Propel cites the Mylan case to support its argument
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`that the Court should deny injunctive relief, asserting OrthoAccel is merely attempting to prevent
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`legitimate competition from entering the marketplace. See Mylan Inc. v. SmithKline Beecham
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`Corp., No. CIV.A. 10-04809 JAP, 2010 WL 4181139, at *4 (D.N.J. Oct. 20, 2010) (holding that
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`Plaintiff’s claims of lost market share are merely complaints “about a harm that is a result of
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`legitimate competition in the market.”). But Propel is not legitimate competition. Propel
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`disseminated false and misleading advertisements throughout its participation in the marketplace.
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`The Court finds that OrthoAccel has met its burden in proving irreparable harm.2
`
`
`2 Further, courts in this circuit have held that under the Lanham Act, irreparable injury is
`presumed based on alleged comparative misrepresentations by a competitor. See Greater
`Houston Trans. Co. v. Uber Tech., Inc., No. 4:14–cv–0941, 2015 WL 1034254, at *21 (S.D. Tex.
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`Case 4:16-cv-00350-ALM Document 148 Filed 10/26/16 Page 14 of 17 PageID #: 3059
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`Weighing Equities
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`
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`The Court understands that this decision will have a considerable impact on the
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`livelihood of both companies. But the irreparable harm that OrthoAccel will suffer if the Court
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`does not enjoin Propel from disseminating false advertising greatly outweighs Propel’s likely
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`loss in sales. Propel claims an injunction would restrain truthful speech. But the speech is not
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`truthful and the harm to Propel is self-imposed. See Novartis, 129 F. Supp. 2d at 369 (finding
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`that any financial loss suffered by defendant as a result of its false marketing is “self-imposed”);
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`W.L Gore & Assocs., Inc. v. Totes, Inc., 788 F. Supp. 800, 812 (finding that where false and
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`misleading advertising claims are made, any “prejudice” which accrues to the defendant as a
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`result is self-inflicted). The Court will not completely enjoin Propel from marketing its product.
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`Propel can still claim that the VPro5 aids in aligner seating. It will only enjoin Propel from
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`disseminating claims of the VPro5’s 5 Clinical Benefits, which are false and misleading.
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`Public Interest
`
`
`
`OrthoAccel claims that an injunction would serve the public interest by preventing Propel
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`from marketing a medical device to doctors for use on patients without any clinical or scientific
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`support for its claims. Propel argues that providing an alternative medical device serves the
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`public interest. See Cardiovascular Sys., Inc. v. Medtronic, Inc., No. C95-03577-DLJ, 2008 WL
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`4647384, at *1 (N.D. Cal. Oct. 20, 2008) (basing part of its denial of an injunction extension on
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`the “public policy in terms of making the most medical devices available to the public”). But the
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`public will not be deprived because Propel can still market the VPro5 to dentists as an aligner
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`seater. And public policy favors preventing the dissemination of false and misleading
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`advertising. See Novartis, 209 F.3d at 597; Quantum Fitness Corp. v. Quantum Lifestyle Ctrs.,
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`Mar. 10, 2015). The Court agrees with the Uber court and finds that OrthoAccel will suffer
`irreparable injury if the Court does not grant injunctive relief.
`
`
`
`
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`Case 4:16-cv-00350-ALM Document 148 Filed 10/26/16 Page 15 of 17 PageID #: 3060
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`LLC, 83 F. Supp. 2d 810, 832 (S.D. Tex. 1999) (finding “the public interest is always served by
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`requiring compliance with Congressional statutes such as the Lanham Act.”). The Court finds
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`that the public is best served if Propel is enjoined from disseminating false information.
`
`Unclean Hands
`
`
`
`Propel claims that the doctrine of unclean hands bars OrthoAccel from seeking equitable
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`relief. Propel forms this defense based on statements made by OrthoAccel that allegedly
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`misrepresent Propel’s FDA status. 21 C.F.R. § 807.97 (“Any representation that creates an
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`impression of official approval of a device because of complying with the premarket notification
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`regulations is misleading and constitutes misbranding.”). But these arguments are preempted by
`
`the Food, Drug, and Cosmetic Act. See Healthpoint, Ltd. v. Stratus Pharm., Inc., 273 F. Supp. 2d
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`769, 815–16 (W.D. Tex. 2001) (declining to exercise jurisdiction over FDA claims because “the
`
`proper approach is for the Court to defer to the FDA for the resolution of issues within its
`
`primary jurisdiction and to exercise jurisdiction over Lanham Act and other claims which do not
`
`require application or construction of FDA law, regulations, or policy.”). Even if the argument
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`were not preempted, Propel does not show by clear and convincing evidence that OrthoAccel’s
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`conduct “shock[s] the moral sensibilities of the judge, or . . . was offensive to the dictates of
`
`natural justice.” iFLY Holdings LLC v. Indoor Skydiving Germany Gmbh, No. 2:14-CV-1080-
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`JRG-RSP, 2016 WL 3675136, at *1 (E.D. Tex. Mar. 25, 2016).
`
`CONCLUSION
`
`The Court set out its conclusions of law throughout its above discussion of the case, but it
`
`repeats them here for the sake of clarity:
`
`• There is a substantial likelihood of success on the merits of OrthoAccel’s false
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` advertising claim under the Lanham Act
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`
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`Case 4:16-cv-00350-ALM Document 148 Filed 10/26/16 Page 16 of 17 PageID #: 3061
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`• There is a substantial threat of irreparable injury to OrthoAccel without adequate legal
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` remedy if the injunction does not issue.
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`• OrthoAccel’s threatened injury if the court were to deny the injunction outweighs the
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` harm to Propel should the injunction issue.
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`• The injunction will not disserve the public interest.
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`It is therefore ORDERED that OrthoAccel’s Application for a Preliminary Injunction is
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`hereby GRANTED.
`
`
`
`It is further ORDERED that Propel and all persons acting on its behalf, in concert with it
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`or under its control, is enjoined from engaging in the following activities:
`
`
`
`Representing, orally or in writing, expressly or by implication, in any advertising,
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`promotion, offering for sale, sale of goods and services, or in any commercial matter, that the:
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`• VPro5 accelerates tooth movement;
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`• VPro5 stimulates bone growth and tooth remodeling;
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`• VPro5 fast tracks, or otherwise