EXCLUSIVE-SmileDirectClub’s top dentist risks losing license in California crackdownReuters | California | Updated: 20-02-2020 01:29 IST | Created: 20-02-2020 00:00 IST
The top dentist and public face of SmileDirectClub is at risk of losing his California license following a two-year state dental board investigation, records reviewed by Reuters show.
The California disciplinary process underway against dentist Jeffrey A. Sulitzer, SmileDirectClub's chief clinical officer, is the latest threat facing the high-flying tele-dentistry firm, which promises to straighten Americans' teeth without a visit to an orthodontist's office for costly treatment. SmileDirectClub sells clear plastic dental aligners prescribed by doctors who review digital images of customers' teeth online and oversee treatment from afar. According to the company's website, "Dr. Sulitzer leads all SmileDirectClub's licensed dentists and orthodontists," a network it says includes 250 medical professionals.
In a formal 24-page complaint filed by the office of California's Attorney General and prepared by the state dental board's executive officer, Sulitzer is accused of violating state law, defrauding state dental regulators and acting with gross negligence toward patients while helping SmileDirectClub grow its business. See the California disciplinary accusation: https://graphics.reuters.com/USA-SMILE-DENTIST/0100B5EB3L7/AccusationDocument.pdf
The document cites nine different causes for discipline. For instance, it alleges Sulitzer committed fraud when applying to operate dental offices in California and assuming liability for services offered patients. In fact, the complaint says, the locations were controlled by SmileDirectClub, which isn't licensed to practice dentistry in the state and requires customers to sign liability waivers before getting treatment. It accuses Sulitzer of "aiding and abetting" the company in the unlicensed practice of dentistry and seeks the revocation or suspension of his 16-year-old California dental license.
Asked by Reuters about the California disciplinary process against its lead dentist, the company declined to make Sulitzer or other company representatives available for an interview on Tuesday. J. Erik Connolly, the company's external litigation counsel in Chicago, wrote in an email that "the accusations against Sulitzer are factually inaccurate, and will be proven false in the course of the process."
Connolly accused California Dental Board members of using the disciplinary process as a retaliatory measure, after SmileDirectClub and Sulitzer sued them last year for allegedly engaging in an illegal investigation and anti-competitive campaign against the company. SmileDirectClub does not engage in the practice of dentistry as the California accusation asserts, Connolly wrote, calling the complaint against Sulitzer "a farce."
In a separate press release Tuesday, the company noted that Florida's dental board had closed its own investigation into SmileDirectClub's business last month, and said it was the 18th U.S. state to "reject unevidenced complaints" about the company. The company says its tele-dentistry platform connects customers with independent doctors who can approve and oversee aligner treatment. "It is the state-licensed dentists who are responsible for all aspects of clinical care," the release said.
California's Department of Consumer Affairs told Reuters the complaint against Sulitzer – filed in Sacramento on November 12 – is expected to lead to a formal disciplinary hearing by the state's Office of Administrative Hearings, which has yet to schedule it. Attorney General Xavier Becerra's office, which represents the department and the dental board, declined to comment. Nashville-based SmileDirectClub says its $1,895 direct-to-consumer aligners cost 60% less than traditional braces. The company's $5 billion market capitalization is one sign Wall Street sees it as an industry-disruptive force.
Yet regulators and dental trade groups have questioned the safety of a SmileDirectClub process that doesn't require doctors who prescribe its aligners to conduct oral examinations on patients before treatment. U.S. customers begin with an interview and digital dental scan at one of the company's nearly 380 Smile Shops nationwide, or by sending the company a dental impression kit. Later, a SmileDirectClub-affiliated dentist or orthodontist can review a patient's information and dental images online and approve aligner treatment when appropriate. The company's website quotes Sulitzer as saying its customers receive "the same level of care" as patients who visit traditional orthodontists.
A Reuters review found nearly 60 complaints about SmileDirectClub's aligners to the U.S. Food and Drug Administration from clinicians or customers, some alleging negative outcomes including loose or lost teeth, jaw pain, bite misalignments, and the need for costly follow-up treatment. Connolly, SmileDirectClub's lawyer, said the complaints account for a "small fraction" of the 750,000 patients who've been treated with its aligners. That treatment, he said, "is as safe or safer than the treatment received by traditional brick-and-mortar dentistry," he wrote.
SmileDirectClub has attributed much of the criticism to a U.S. dental lobby intent on derailing its success. Its website features thousands of positive customer reviews, and the company says less than 1% of its customers "have had any clinical concerns during treatment." CALIFORNIA CRACKDOWN
In October, responding to concerns about tele-dentistry, California passed a bill requiring practitioners to review a patient's dental X-rays before prescribing orthodontic treatment with aligners. News of the measure sent SmileDirectClub's share price down sharply, though it later rebounded. The company is also facing a shareholder lawsuit in Delaware alleging it made false statements and failed to inform investors of regulatory investigations. The specter of sanctions against dentists and orthodontists affiliated with SmileDirectClub, and Sulitzer in particular, may represent a new area of risk for the company. California is home to more than 10% of its U.S. Smile Shops.
Sulitzer has served as SmileDirectClub's most prominent promoter, featuring in marketing materials. Before joining SmileDirectClub, its website says, he worked as a dental executive at Aetna Inc and ran his own practice. The California complaint says he violated several legal and professional standards while helping SmileDirectClub expand on the West Coast since 2017.
In an October filing in federal court in California, where Sulitzer and SmileDirectClub have sued state dental board members, the company said it was targeted with illegal raids at Smile Shops and a "campaign of harassment, intimidation, and anti-competitive conduct." The dental board's December motion to dismiss the lawsuit called it a "preemptive strike against the disciplinary proceedings." The dental board's complaint alleges that Sulitzer fraudulently acquired board permits to open several California Smile Shops and began operations at some shops before permits were granted. It alleges he falsely promised to assume liability and responsibility for serving patients but instead allowed SmileDirectClub to obtain liability waivers from them.
The dental board also accuses Sulitzer of deceptive advertising and allowing unqualified staff to conduct patient health interviews and dental scans without proper supervision. A disciplinary hearing can result in revocation or suspension of a dental license, probation, other reprimands, or no sanctions at all. A pre-hearing settlement is also possible.
The dental board investigation was triggered by customer complaints, said California Consumer Affairs Department spokesman Matt Woodcheke. "The board doesn't have the authority to just pull a license," he told Reuters. "In cases that are particularly egregious we refer it to the Attorney General." Several months can elapse between a formal accusation and a disciplinary hearing, Woodchecke said, and there are currently no restrictions on Sulitzer's state license.
Public records show Sulitzer is also licensed to practice in other states. The California complaint lists his address of record in Oregon. 'DISRUPTIVE' DENTISTRY
Dental aligners move teeth against bone and, as FDA-regulated Class II medical devices, are only available with a doctor's prescription. The American Dental Association and the American Association of Orthodontists say that aligners sold without an in-person oral examination by a prescribing doctor can cause some patients serious injury. Founded in 2014, SmileDirectClub has targeted millennials and others it says are underserved by traditional dentistry.
The Better Business Bureau website includes 1,865 complaints about SmileDirectClub. Some of them, and others submitted to state dental boards and the FDA, allege mouth damage. Some of the complaints say patients aren't able to communicate with their Smile Direct-affiliated dentists and orthodontists when problems arise. The company's shares plunged 16% on Friday after an NBC News report documented poor dental outcomes for some customers. The company issued a statement refuting the NBC report. It says it works with independent doctors who are "available to connect directly with customers at any time before, during and after treatment." It promises to refund dissatisfied customers, but asks some to sign confidentiality statements and delete negative online reviews.
Shaun Veira said he paid upfront for aligners at a Pittsburgh Smile Shop last year. "Before a dentist had even reviewed my digital scan, the Smile Shop told me I was a perfect candidate and wanted a deposit right away," he said. SmileDirect attorney Connolly said the company couldn't discuss Veira's treatment plan or complaint without his consent. Veira said he began the aligner treatment but never communicated with the doctor who approved it. He later complained to the Better Business Bureau that the ill-fitting aligners had caused severe gum bruising and ripped out a molar during his second week of treatment. He sent Reuters photos of mouth damage and the dislodged tooth stuck in a clear aligner.
SmileDirectClub eventually refunded Veira for the aligners, but he said it has refused to pay for dental work needed to fix his mouth damage. Over more than a dozen phone calls Veira made to SmileDirectClub's customer service, Veira says, the company reminded him that his signed contract included a liability waiver.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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