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`Civil Action No. __________________
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`JURY TRIAL DEMANDED
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`SMILEDIRECTCLUB, LLC,
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`
`Plaintiff
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`v.
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`GEORGIA BOARD OF DENTISTRY;
`TANJA D. BATTLE, in her official
`capacity as Executive Director of the
`Georgia Board of Dentistry; and
`THOMAS P. GODFREY, GREGORY
`G. GOGGANS, RICHARD BENNETT,
`REBECCA B. BYNUM, TRACY GAY,
`STEVE HOLCOMB, LOGAN
`NALLEY, JR., ANTWAN L.
`TREADWAY, H. BERT YEARGAN,
`and WENDY JOHNSON, individually
`and in their official capacities as
`Members of the Georgia Board of
`Dentistry,
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`Defendants.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 1 of 37
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF GEORGIA
`ATLANTA DIVISION
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`
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`COMPLAINT FOR DAMAGES, DECLARATORY, AND INJUNCTIVE
`RELIEF
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`Plaintiff SmileDirectClub, LLC (“Plaintiff” or “SDC”) alleges the following
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`against Defendants the Georgia Board of Dentistry (the “Board”), Thomas P.
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`Godfrey, Gregory G. Goggans, Richard Bennett, Rebecca B. Bynum, Tracy Gay,
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`Steve Holcomb, Logan Nalley, Jr., Antwan L. Treadway, H. Bert Yeargan, and
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 2 of 37
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`Wendy Johnson (each of the foregoing individuals is sued in his or her individual
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`capacity and in his or her official capacity as Members of the Board), and Tanja D.
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`Battle in her official capacity as Executive Director of the Board:
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`INTRODUCTION
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`1.
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`This is an action to enjoin the enforcement of an unauthorized and
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`improper rule adopted by the Georgia Board of Dentistry. Specifically, the Board
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`recently approved a rule that purportedly “expanded” the list of duties a dental
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`assistant may perform if directly supervised by a licensed dentist under Georgia
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`Rule of Dentistry 150-9-.02(3). A true and correct copy of Rule 150-9-.02,
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`including the list of ten “expanded” duties, is attached hereto and incorporated
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`herein by reference as Exhibit A. Subparagraph (aa) of the new Rule provides that
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`a dental assistant may perform “[d]igital scans for fabrication (sic) orthodontic
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`appliances and models” only “under the direct supervision of a licensed dentist.”
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`Digital scanning, however, is not the practice of dentistry or dental hygiene and,
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`thus, the Board lacks the authority to regulate this conduct.
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`2.
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`By including “digital scans” within the framework of Rule 150-9-
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`.02(3), Subparagraph (aa) bars technicians from performing digital scans of a
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`patient’s teeth and gums unless under the direct supervision of a licensed dentist.
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`Notably, the supervision contemplated by the new Rule simply requires that a
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 3 of 37
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`licensed dentist be in the building while the digital scanning is performed. It does
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`not require that the licensed dentists perform the digital scan themselves, observe
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`the digital scans, or even be in the same room as the patient when the digital scan
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`is performed. Thus, effectively, Subparagraph (aa) is aimed uniquely at shops that
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`offer digital scan services apart from dental services. As a result, Subparagraph
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`(aa) unlawfully restricts Georgia residents’ access to affordable aligner treatment,
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`fails to protect the public in any manner, stifles competition, harms consumers, and
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`makes it virtually impossible for Plaintiff to lawfully conduct business in the State
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`of Georgia without making costly and prohibitive changes to its present business
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`model.
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`THE PARTIES
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`3.
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`Plaintiff SDC is a dental service organization that provides non-
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`clinical administrative support services to contractually affiliated dental practices
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`in Georgia that wish to offer doctor-directed at-home clear aligner treatment for
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`cases of mild to moderate malocclusion (i.e. improper positioning of the teeth
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`when the jaws are closed). SDC is licensed to practice business in the State of
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`Georgia.
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`4.
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`The Board consists of eleven members appointed by the Governor to
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`regulate and enforce the standards of the practice of dentistry. By statute, nine
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 4 of 37
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`members of the Board must be dentists, one member of the Board must be a dental
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`hygienist who is not a dentist, and one member of the Board must be an individual
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`who is neither a dentist nor a dental hygienist. O.C.G.A. § 43-11-2. Upon
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`information and belief, one of the nine seats allocated to dentists is presently
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`vacant, meaning that the Board presently consists of ten members, eight of whom
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`are dentists. The Board’s authority is limited to regulating the practice of dentistry
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`and dental hygiene and those who practice dentistry or dental hygiene in the State
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`of Georgia. The Board has no authority over activities that do not constitute
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`dentistry or dental hygiene or individuals and organizations, such as SDC, that
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`provide non-clinical administrative support services to dental providers.
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`5.
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`Defendant Tanja D. Battle is the Executive Director of the Georgia
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`Board of Dentistry.
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`6.
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`Defendant Thomas P. Godfrey, D.M.D., is the President and one of the
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`eight current dentist members of the Board. Upon information and belief, Dr.
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`Godfrey is a licensed, practicing dentist with an office in Atlanta, Georgia.
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`7.
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`Defendant Gregory G. Goggans, D.M.D., is the Vice President and
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`one of the eight current dentist members of the Board. Upon information and
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`belief, Dr. Goggans is a licensed, practicing orthodontist with offices in various
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`locations throughout Georgia. According to the website for his practice, Dr.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 5 of 37
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`Goggans offers patients clear aligner treatment products and services that compete
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`with the products and services offered by SDC and its affiliated dental practices.
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`8.
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`Defendant Richard Bennett, D.M.D., is one of the eight current dentist
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`members of the Board. Upon information and belief, Dr. Bennett is a licensed,
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`practicing dentist with an office in Gainesville, Georgia.
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`9.
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`Defendant Rebecca B. Bynum, R.D.H., is a current member of the
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`Board. Upon information and belief, Ms. Bynum is a registered dental hygienist.
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`10. Defendant Tracy Gay, D.M.D., is one of the eight current dentist
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`members of the Board. Upon information and belief, Dr. Gay is a licensed,
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`practicing dentist with an office in Dublin, Georgia. According to the website for
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`his practice, Dr. Gay offers patients clear aligner treatment products and services
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`that compete with the products and services offered by SDC and its affiliated
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`dental practices.
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`11. Defendant Steve Holcomb, D.M.D., is one of the eight current dentist
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`members of the Board. Upon information and belief, Dr. Holcomb is a licensed,
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`practicing dentist with an office in Byron, Georgia.
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`12. Defendant Logan “Buzzy” Nalley, Jr., D.M.D., is one of the eight
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`current dentist members of the Board. Upon information and belief, Dr. Nalley is a
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`licensed, practicing prosthodontist with an office in Augusta, Georgia.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 6 of 37
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`13. Defendant Antwan L. Treadway, D.M.D., is one of the eight current
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`dentist members of the Board. Upon information and belief, Dr. Treadway is a
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`licensed, practicing oral surgeon with an office in Atlanta, Georgia.
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`14. Defendant H. Bert Yeargan, D.M.D., is one of the eight current dentist
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`members of the Board. Upon information and belief, Dr. Yeargan is a licensed,
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`practicing dentist with an office in Brunswick, Georgia.
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`15. Defendant Wendy Johnson is a current member of the Board.
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`JURISDICTION AND VENUE
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`16. This Court has subject matter jurisdiction over the claims asserted in
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`this Action pursuant to 28 U.S.C. §§ 1331, 1337, 1343, 1367 and 42 U.S.C. § 1983.
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`17. The Board was created by the Georgia Legislature to regulate and
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`enforce the standards of the practice of dentistry in the State of Georgia. See
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`O.C.G.A. §§ 43-11-1 et seq. The Board operates in the State of Georgia and the
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`events giving rise to the claims asserted in this Action occurred in the State of
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`Georgia. Upon information and belief, Defendants Battle, Godfrey, Goggans,
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`Bennett, Bynum, Gay, Holcomb, Nalley, Treadway, and Yeargan are all citizens of
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`the State of Georgia. See O.C.G.A. § 43-11-2 (requiring members of the Georgia
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`Board of Dentistry to be citizens of the State of Georgia). Accordingly,
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`Defendants are subject to personal jurisdiction in Georgia.
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`18. Venue is proper in this District pursuant to 28 U.S.C. § 1391 and 15
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`U.S.C. § 22 because the Board is deemed to reside in any judicial district in which
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`it is subject to personal jurisdiction with respect to this Action, which includes this
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`District. Venue is also proper in this District because a substantial part of the
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`events or omissions giving rise to the claims asserted in this Action occurred in this
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`District.
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`19. The Defendants’ actions substantially and adversely affect interstate
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`commerce in the “Relevant Market” as described herein. Defendants provide
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`services in interstate commerce and certain of the Defendants perform aligner
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`treatment using products that are sold across state lines and from outside the State
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`of Georgia into the State of Georgia. In addition, by restraining competition for
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`aligner treatment in Georgia, the flow of interstate commerce is interrupted
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`because the purchase of supplies needed for such treatment, and any related
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`services, from outside of Georgia is reduced. Thus, Defendants’ actions have the
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`effect of reducing the amount of interstate commerce to the detriment of
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`consumers.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 8 of 37
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`FACTUAL BACKGROUND
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`A.
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`SDC Provides Non-Clinical Administrative Support Services to
`Licensed Dental Providers.
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`20. SDC is a dental service organization that provides non-clinical
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`administrative support services to contractually affiliated dental practices that wish
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`to offer doctor-directed at-home clear aligner treatment for cases of mild to
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`moderate malocclusion using the teledentistry platform and portal provided by
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`SDC. A clear aligner is a removable appliance made from a strong plastic material
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`that is fabricated to fit an individual’s mouth to move the individual’s teeth in
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`increments until the desired positioning is achieved. Teledentistry enables the
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`provision of dental treatment and care via remote technology, rather than on-site
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`personal contact with patients.
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`21. Through SDC’s teledentistry platform, dentists and orthodontists
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`licensed in the state of Georgia who affiliate with SDC are able to offer at-home
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`aligner treatment at a substantially lower price than traditional aligner treatment
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`offered in an established dental office and are therefore able to treat many patients
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`who otherwise would not have access to an orthodontist. The SDC platform is
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`built around its proprietary SmileCheck system, a web-based portal that connects
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`patients and doctors, facilitating timely and convenient interaction.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 9 of 37
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`22. SDC’s affiliated practices are revolutionizing orthodontic treatment by
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`dramatically lowering the price of aligner treatment for mild to moderate cases of
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`malocclusion and providing greater access to aligner treatment for the residents of
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`the State of Georgia.
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`23. SDC’s mission of providing affordable aligner treatment to the
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`underserved is important in the State of Georgia, where approximately 63.5% of
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`Georgia counties do not have a licensed orthodontist.
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`24. Among the suite of non-clinical administrative support services
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`offered by SDC is the provision of a SmileShop to SDC-affiliated licensed dentists
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`and orthodontists.
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`25. SmileShops are locations where customers may receive digital
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`photographs of their teeth and gums through the use of an iTero scanner to
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`determine if they are a candidate for SDC’s clear aligner product. The iTero
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`scanner is cleared as safe and effective by the FDA. And unlike devices that are
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`used for medical or dental procedures, such as x-ray machines, the iTero scanner
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`does not need to be registered with or inspected by the state prior to use. The
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`digital photographs created by the iTero scanner are necessary for SDC’s licensed
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`dentists and orthodontists to provide aligner treatment and thereby compete in the
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`“Relevant Market” as defined below.
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`26. The digital scan at the SDC SmileShops in Georgia is performed by a
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`trained technician or assistant using an iTero scanner, which is essentially a wand
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`with a camera, to take thousands of photographs of a customer’s teeth and gums.
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`The photographs are sent to the SDC lab, where trained technicians receive the
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`patient’s scans on behalf of the treating dentist or orthodontist, and, if the scans are
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`deemed acceptable, coordinate the creation of a 3D digital model from those scans
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`to create a model treatment plan. This treatment plan, along with the photographs,
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`customer health history, and other required information, is provided to a Georgia
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`licensed dentist or orthodontist for review and evaluation.
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`27. The digital scan consists of thousands of photographs, which generate
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`a 3D model of the patient’s maxillary and mandibular dentition, along with the
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`attached gingiva and supporting oral mucosa, from different perspectives such as
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`maxillary, open, mandibular open, and in centric occlusion. The iTero scanner
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`takes approximately 6,000 photographs per second.
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`28. The technician also takes standard digital photographs of the
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`customer’s teeth and gums which are also provided to the Georgia licensed dentist
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`or orthodontist for review and evaluation to identify periodontal disease, cavities,
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`or any other presentation that would require further clearance or prevent the
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`customer from being a candidate for SDC clear aligners.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 11 of 37
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`29. The Georgia licensed dentist or orthodontist evaluates the customer’s
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`digital scans, photographs, and medical and dental history questionnaire to
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`determine if aligner therapy is appropriate for the patient. The Georgia licensed
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`dentist or orthodontist also determines whether any additional information, x-rays,
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`or further photographs are required or appropriate. If so, the dentist indicates what
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`additional information is required before a treatment decision can be made.
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`30. Throughout the process, the licensed dentist or orthodontist maintains
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`sole responsibility for all aspects of patient care and all clinical decisions,
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`including evaluating, diagnosing, and, if appropriate in the licensed dentist’s or
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`orthodontist’s independent professional judgment, treating the patient’s condition
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`with SDC clear aligners.
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`31. Each SDC-affiliated dentist or orthodontist who treats a Georgia
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`citizen is licensed and qualified to practice dentistry in the State of Georgia.
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`32. SDC’s entry into the market and offering of top-notch, low-cost clear
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`aligners has been embraced by many in the public and dental community. Through
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`the use of SmileShops and its web-based teledentistry platform, SDC has been able
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`to drastically reduce the cost of expensive (and often overpriced) aligner treatment
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`and increase access to aligner treatment for many unreached segments of the
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 12 of 37
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`population, all while ensuring that patients receive treatment from and are closely
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`monitored by Georgia licensed dentists and orthodontists.
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`33. Since SDC opened its first SmileShop in Georgia in July 2017, SDC
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`has performed thousands of scans for customers in Georgia without a single
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`incident or complaint of physical injury, infection, or other adverse patient
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`outcome associated with the performance of the scan. In addition, SDC has
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`performed hundreds of thousands of scans on a national basis without a single such
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`incident or complaint.
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`B.
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`The Board Improperly Votes To Regulate Digital Scans.
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`34. Against this backdrop of lower-cost treatments, increased access to
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`patient care, and direct oversight by Georgia licensed dentists and orthodontists,
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`the Board approved amendments to Georgia Board of Dentistry Rule 150-9-.02 on
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`or about January 24, 2018, which are scheduled to become effective on May 22,
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`2018.
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`35. A true and correct copy of the amendments to Georgia Board of
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`Dentistry Rule 150-9-.02 is attached hereto as Exhibit A.
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`36. The amendments added ten additional duties to the list of “expanded”
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`duties a dental assistant may perform under Rule 150-9-.02(3).
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 13 of 37
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`37. One of the additional duties added to the list appears as Subparagraph
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`(aa) of Rule 150-9-.02(3) and states as follows: “(aa) Digital scans for fabrication
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`(sic) orthodontic appliances and models” (hereinafter “Subparagraph (aa)”).
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`38. As written, Subparagraph (aa) will require digital scans in Georgia to
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`be made in a dentist’s office under the direct supervision of a licensed dentist,
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`rather than in a SmileShop with a trained technician who provides the same digital
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`scans to a Georgia licensed dentist or orthodontist through SDC’s web-based
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`platform.
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`39. Moreover, when Subparagraph (aa) becomes effective, SDC will
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`potentially be subject to the threat of: (1) Board action seeking to enjoin SDC from
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`conducting business in Georgia, see O.C.G.A. § 43-11-2(e); and (2) enforcement
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`action by the State seeking criminal penalties, see O.C.G.A. §§ 43-11-50, 43-11-
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`76.
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`40. Prior to the adoption of Subparagraph (aa), SDC customers could, and
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`did, visit a conveniently located SmileShop and request a digital scan from a
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`qualified technician without requiring the presence or direct supervision of a
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`licensed dentist or orthodontist. At no time prior to the adoption of Subparagraph
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`(aa) did the Georgia Board of Dentistry advise SDC that its SmileShops were in
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 14 of 37
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`violation of any law, regulation, or rule regarding the practice of dentistry or dental
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`hygiene.
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`41.
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`Indeed, such direct supervision is wholly unnecessary because (1) the
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`process is simple, only involving use of a wand with a disposable sleeve and
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`camera, (2) there is no trauma or health or safety risk to a customer, (3) the scan
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`does not emit radiation, (4) the software in all digital scanners on the market
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`prevents the technician from uploading an incomplete scan that has not captured
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`all necessary intraoral structures, and (5) all photographs are later reviewed by a
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`Georgia licensed dentist or orthodontist to ensure the quality of the photographs, a
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`customer’s candidacy for treatment, and a proper treatment plan.
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`42. The adoption of Subparagraph (aa) fails to acknowledge such realities.
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`To the contrary, it places patients last by severely impairing SDC’s ability to
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`deliver affordable products and services to affiliated licensed dentists and
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`orthodontists, who in turn pass these savings along to their patients.
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`43.
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`Indeed, the adoption of Subparagraph (aa) makes it virtually
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`impossible for SDC and its affiliated licensed dentists and orthodontists to lawfully
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`conduct business in Georgia without making costly and prohibitive changes to
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`SDC’s current business model.
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 15 of 37
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`44. Thus, as set forth in greater detail below, Subparagraph (aa) should be
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`removed from the amendments because it (1) reduces Georgia citizens’ access to
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`care, (2) increases the cost of digital scans and overall orthodontic care, (3) does
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`not protect the public, (4) disproportionately regulates a safe procedure, (5) creates
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`an unnecessary barrier to employment for Georgia citizens, (6) is beyond the
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`Board’s rulemaking authority, (7) distinguishes between technicians employed by
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`SDC and extended duty dental assistants who perform scans “directly supervised”
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`(within the meaning of Rule 150-9-.01(2)) by licensed dentists and orthodontists,
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`without a rational basis for such a distinction, and (8) deprives SDC of its
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`constitutionally protected liberty and property interests.
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`45. On April 30, 2018, Georgia Governor Nathan Deal signed a
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`“Certification of Active Supervision,” pursuant to the Georgia Professional
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`Regulation Reform Act, O.C.G.A. § 43-1C-1 et seq. The context and
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`circumstances, however, demonstrate that the State of Georgia did not actively or
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`adequately supervise the Board with regard to its action in passing Subparagraph
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`(aa). Instead, the Board impeded the State of Georgia’s ability to actively and
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`adequately supervise the substance of the Board’s actions by failing to fully advise
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`the Governor of the reasons for its action and the objections to its actions in
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`passing Subparagraph (aa). For example, the Board’s official minutes fail to
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 16 of 37
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`provide a full and complete summary of objections to the Board’s action expressed
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`during official Board meetings, thereby depriving the State of Georgia of the
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`information needed to actively and adequately supervise the Board’s conduct. The
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`Board also failed to explain to the State of Georgia the impact Subparagraph (aa)
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`will have on consumers in the “Relevant Market” and failed to reveal the conflicts
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`of interest of the Defendants who will benefit monetarily, now or in the future, by
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`restraining trade in the “Relevant Market.”
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`C.
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`The Relevant Market.
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`46. The “Relevant Market” in which to evaluate the anticompetitive effect
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`of the conduct of Defendants is the market for aligner treatment for mild to
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`moderate malocclusion in Georgia.
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`47. The relevant products in this market are aligner treatments for mild
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`and moderate malocclusion. The relevant products include clear aligners and
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`traditional braces that use brackets and wires, as well as potentially non-fixed
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`dental braces such as retainers, headgear, and palate expanders. Treatment options,
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`of course, vary based on the particular needs of a patient, but these products are
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`viable substitutes for consumers to consider in the treatment of mild-to-moderate
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`malocclusion. The relevant market properly excludes aligner treatment of severe
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`malocclusion because clear aligners are generally not an option for such treatment,
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 17 of 37
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`and as such, consumers who need treatment for severe malocclusion do not regard
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`clear aligners as a viable substitute. Treatment of severe malocclusion is
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`substantially more expensive than treatment of mild-to-moderate malocclusion and
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`may involve surgical services as well.
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`48. The relevant geographic market is properly limited to Georgia. The
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`Board purports to exercise authority over the provision of digital scan services for
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`aligner treatment in Georgia. Furthermore, consumers in Georgia almost always
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`seek aligner treatment from local providers in the State. Consumers who desire
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`such services in Georgia do not travel out of state in any appreciable numbers to
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`obtain aligner treatment. If the price of aligner treatment for mild-to-moderate
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`malocclusion in Georgia increases as a result of actions of the Board, consumers in
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`Georgia will not seek aligner treatment from providers in other states. Rather, such
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`consumers will be forced to pay the higher prices for aligner treatment and travel
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`long distances within Georgia to seek such services only from licensed dentists in
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`Georgia.
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`D.
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`The Board Exceeded Its Rulemaking Authority.
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`49. The Board is limited in its rulemaking authority—it may only regulate
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`the practice of dentistry and those professionals who engage in the practice of
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`dentistry. The Board has no authority to regulate industries or activities that do not
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 18 of 37
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`constitute the practice of dentistry or dental hygiene, such as dental support
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`organizations, or those individuals who are not engaged in the practice of dentistry
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`or dental hygiene. See O.C.G.A. § 43-11-9.
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`50.
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`“Dentistry” is defined in the Georgia statutes as the “evaluation,
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`diagnosis, prevention, or treatment, or any combination thereof, whether using
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`surgical or nonsurgical procedures, of diseases, disorders, or conditions, or any
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`combination thereof, of the oral cavity, maxillofacial area, or the adjacent and
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`associated structures, or any combination thereof, and their impact on the human
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`body provided by a dentist, within the scope of his or her education, training, and
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`experience, in accordance with the ethics of the profession and applicable
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`law . . . .” O.C.G.A. § 43-11-1(6).
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`51. The taking of a digital scan, in and of itself, does not constitute an
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`“evaluation, diagnosis, prevention, or treatment” and, therefore, falls outside of the
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`practice of dentistry. Similarly, the taking of a digital scan is not listed as one of
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`the acts that constitute the practice of dental hygiene as that term is used in the
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`Georgia Dental Practice Act. See O.C.G.A. § 43-11-74. Moreover, trained
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`technicians do not provide diagnosis or dental advice; instead, they are simply
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`taking a digital scan and uploading this information to a state licensed dentist or
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`orthodontist for review, diagnosis, and preparation of a treatment plan.
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`18
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 19 of 37
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`Accordingly, the Board has no authority to regulate scans or those technicians who
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`would otherwise be permitted to conduct digital scans, such as SDC technicians.
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`52. Thus, the Board has impermissibly exceeded the scope of its
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`rulemaking authority in approving Subparagraph (aa) and seeking to regulate
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`activities that do not constitute the practice of dentistry and individuals who are not
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`engaged in providing dental evaluation, diagnosis, prevention, or treatment. The
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`decision of the Board was made without cause or explanation and is merely
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`designed to protect the business interests of traditional orthodontic practices.
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`E.
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`Subparagraph (aa) Will Reduce Georgia Citizens’ Access to Care.
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`53. Subparagraph (aa) will diminish Georgia citizens’ access to care by
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`reducing the number of locations where digital scans may be taken for fabrication
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`of orthodontic appliances and models.
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`54. At present, only 58 of 159 Georgia counties have a licensed
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`orthodontist.
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`55. Despite the massive volume of underserved patients in Georgia, the
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`Board seeks to impose a new rule that would needlessly complicate an otherwise
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`safe procedure that an unlicensed person can perform in a variety of locations.
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`56. Under such a scheme, SDC would no longer be able to provide one of
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`the key elements of the services it currently offers to Georgia licensed dentists and
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`19
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 20 of 37
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`orthodontists, which allows them to provide affordable treatment to potential
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`patients. The dentist members of the Board, however, would be able to use their
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`dental assistants to continue to provide such scans to patients. Moreover, no law or
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`regulation would prohibit the dentist members of the Board who are not currently
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`providing digital scans to potential patients from providing such scans in their
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`offices in the future.
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`57. Despite current plans to open additional SmileShops across the State
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`of Georgia, many in areas where people cannot easily access orthodontic care and
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`treatment, SDC would be forced to limit, if not entirely eliminate, its plans for
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`increasing access to affordable orthodontic care across the State of Georgia if
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`Subparagraph (aa) were to take effect.
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`58. As a result, rather than protect patients, the Board’s decision will
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`unnecessarily drive up costs and decrease access to care in the Relevant Market
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`based on the mistaken belief that a 3D scan must be performed by, or directly
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`supervised by, a dentist. Indeed, the Board’s decision does not require that a
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`licensed dentist visually monitor or observe the taking of a digital scan; it requires
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`only that a licensed dentist be in the same building at the time the scan is
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`performed.
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`20
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 21 of 37
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`59. Taking a digital scan of a customer’s teeth and gums is neither
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`dangerous nor risky. It is nothing more than the taking of photographs. Nor does it
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`require the knowledge, training, and education of a licensed dentist or orthodontist
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`or an extended duty dental assistant to properly execute.
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`60. Properly trained technicians such as those employed by SDC are
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`capable of safely and accurately taking a digital scan of a customer’s teeth and
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`gums without the need for a dentist to be present. Indeed, the scan is not even a
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`dental procedure, but rather a non-invasive use of digital technology to create an
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`accurate three-dimensional model of a prospective patient’s teeth, bite, gums, and
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`palate.
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`61. There is no known evidence that digital scans taken under the “direct
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`supervision” of a licensed dentist or orthodontist are somehow safer or more
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`accurate than scans taken without such “supervision.”
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`F.
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`Subparagraph (aa) Will Increase The Cost Of Digital Scans And
`Overall Orthodontic Care.
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`62. The adoption of Subparagraph (aa) will unnecessarily increase the
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`cost of digital scans and overall aligner treatment for Georgia consumers by
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`requiring highly paid personnel to perform an otherwise safe and simple procedure.
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`Many Georgia consumers also will incur increased costs by needing to travel to
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`and pay for an office visit to a dentist or orthodontist, particularly when the office
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`21
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 22 of 37
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`visit is not covered by insurance. This increase in cost will be borne by consumers,
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`who will pay more for such services than they otherwise would need to pay.
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`63. Plaintiff SDC also will suffer significant economic injury and damage
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`as a result of the implementation of Subparagraph (aa). SDC will suffer lost
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`business that it would have obtained by offering lower priced and superior services
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`to those offered by dentists and orthodontists.
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`64.
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`Indeed, the only parties who benefit from such a rule change are the
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`licensed dentists and orthodontists who offer, or will offer, such services in their
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`offices, because they will be able to demand additional compensation for requiring
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`a photo session to take place in their office. Such requirements drive up costs and
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`entirely eliminate the ability of some citizens to receive convenient, affordable
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`care; indeed, care that has been proven to positively impact many other aspects of a
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`person’s overall health.
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`G.
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`Subparagraph (aa) Does Not Protect The Public.
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`65. Even if the Board had the authority to impose regulations on the
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`taking of digital scans, which it does not, Subparagraph (aa) would not provide any
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`additional protection to the public.
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`66. The taking of a digital scan is extremely safe, and the process consists
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`of using a wand with a camera at varying angles to approximate the teeth and
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`22
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`Case 1:18-cv-02328-SDG Document 1 Filed 05/21/18 Page 23 of 37
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`tissue so as to get a more accurate and predictable model of the teeth and gums
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`than physical impressions.
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`67. The technology of taking digital scans is extremely user-friendly,
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`providing real time feedback to the user regarding the accuracy of the scan and
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`informing the user of where additional scans are needed to complete the full scan.
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`68. This advanced process does not use any radiation and allows a
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`technician to photograph a patient’s teeth and gums without the patient
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`experiencing any trauma, pain, or morbidity.
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`69. The digital scanners are also easy to clean between patients and thus
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`present no meaningful risk of cross-contamination as long as the technicians
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`remove and discard the disposable cover
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