September 3, 2019

Direct services or unauthorized practice?

Administrative Law
Unauthorized Practice

Internet-based or mail-order medical products are testing out their jurisdiction in Canada. Most recently, Nashville-based SmileDirectClub recently filed a lawsuit against the Manitoba Dental Association (MDA), on August 14, 2019.

According to various news reports, SmileDirectClub, LLC, and its Canadian company (SDC Canada Incorporated), sued the MDA (including its eleven-person board) for making “false and misleading” statements about SmileDirect, through two email alerts which reminded members that they must provide patients with in-person exams, and that taking impressions of teeth for retainers is a regulated activity that must be done with a dentist on site. Under s. 2(1) of the Dental Association Act, a person practices dentistry including where he “(e) makes, produces, reproduces, fits, constructs, furnishes, supplies, alters or repairs any prosthetic denture, bridge, appliance or thing to replace, improve or supplement any human tooth or to prevent, alleviate, correct, or improve any condition of the oral cavity or to be used in, upon or in connection with any human tooth, jaw or associated structure or tissue or in the treatment of any condition thereof or gives any advice or assistance in connection therewith….”

SmileDirect disputes that in-person exams by members of the MDA are required prior to treatment, and asserts that their digital imaging is a non-regulated activity. SmileDirect makes impressions of customers’ teeth, through either digital photographs taken at their “SmileShops”, or by sending customers an at-home impression kit. SmileDirect then produces and ships “invisible” aligners (i.e., transparent plastic braces) directly to customers.

According to a Winnipeg Free Press article (here), SmileDirect has sued “a number of dentists, orthodontists and state dental associations in the U.S.” Similarly, the American Association of Orthodontists is reported as having filed complaints against SmileDirect with thirty-six state dental boards and attorneys general in the United States. (The AAO has also issued a press release here about, among other concerns, “some entities claiming that certain direct-to-consumer activities do not constitute the practice of dentistry.”)

On May 8, 2019, a U.S. federal court dismissed a number of claims by SmileDirect against the Georgia Board of Dentistry (see the order here), where a rule (Georgia Rule 150-09-.02(3)(aa)) requires “digital scans for fabrication [of] orthodontic appliances” to be performed by an expanded duty dental assistant acting under the direct supervision of a licensed dentist.” The court specifically rejected a claim by SmileDirect for a declaratory judgment that digital scanning of a patient’s teeth does not constitute the practice of dentistry. The court found that acts of taking digital scans for the purpose of a dentist or orthodontist approve of a treatment plan for correcting a malposition of the patient’s teeth “falls squarely within the definition of the practice of dentistry….”

The outcome of the SmileDirect dispute may be informed by a possible Supreme Court of Canada appeal by Ontario’s College of Optometrists, concerning online eyeglass retailer Essilor Group Canada – we blogged about the Ontario Court of Appeal decision here and one can track the progress of the SCC proceeding here.

Lisa C. Fong and Michael Ng