A Tennessee dentist who has been sued by a number of temporomandibular joint dysfunction and sleep apnea sufferers over an unproven dental gadget he invented has stated below oath that he by no means taught dentists to make use of the gadget for these illnesses—contradicting video footage of him telling dentists learn how to use it.
Steve Galella, the inventor of the Anterior Progress Steerage Equipment, or “AGGA,” has stated in court docket depositions that his gadget had been used on about 10,000 sufferers, and that he skilled many dentists to make use of the AGGA in courses across the U.S. and abroad.
Not less than 23 sufferers, a few of whom described being determined for reduction from sleep apnea or temporomandibular joint dysfunction (TMJ), have sued Galella in recent times claiming that the AGGA broken their mouths and, in some circumstances, triggered tooth loss. Galella denied wrongdoing in these lawsuits and has settled nearly all of them inside the previous few months.
Galella was deposed earlier than he settled the most important of these lawsuits. In accordance with a deposition transcript not too long ago obtained by KFF Well being Information and CBS Information, Galella stated below oath that he had not represented that the AGGA may deal with or treatment TMJ or sleep apnea.
Video footage tells a unique story.
Galella repeatedly references treating TMJ and sleep apnea sufferers with the AGGA, generally at the side of different gadgets, in footage from a coaching session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.
At one level within the footage, Galella will be seen displaying two variations of the AGGA to the dentists, pointing to 1 he says is most popular by “TMJ and sleep sufferers”—after which saying, “And I give it to them.”
“Are you able to treatment TMJ? Sure,” Galella advised dentists as his 2017 coaching started, based on the footage. “Are you able to treatment gentle to reasonable sleep apnea? Sure.”
The AGGA, which Galella not too long ago rebranded because the Osseo-Restoration Equipment, resembles a retainer and makes use of springs to use stress to the entrance enamel and higher palate, based on a patent utility filed in 2021. In 2023, after a joint investigation by KFF Well being Information and CBS Information reported allegations of sufferers harmed by the AGGA, the FDA and the Division of Justice opened investigations into the gadget.
Dentists throughout the nation have promoted the AGGA on their web sites, usually claiming it might probably “develop,” “transform,” or “broaden” an grownup’s jaw with out surgical procedure, generally saying it has the potential to make sufferers extra enticing and to deal with widespread illnesses like TMJ and sleep apnea, which afflict tens of millions of People. Galella has stated in depositions and video footage that the AGGA causes the bones in an grownup’s jaw to “transform” ahead, reshaping their face.
The 2017 video footage accommodates different examples of Galella instructing dentists to deal with TMJ and sleep apnea sufferers with the AGGA, which he generally calls a “progress equipment.” In a single phase, he describes utilizing a progress equipment on “9 out of 10” of his TMJ sufferers. In one other occasion, Galella presents images of what he says is a TMJ affected person, then proceeds to explain how he handled them with an AGGA whereas displaying images of the affected person’s gadget and saying: “It is easy with this equipment.”
The footage additionally reveals Galella calling a progress equipment “the treatment” for sleep apnea, and he later says in reference to sleep apnea that “with a progress equipment, yeah, you’ll be able to repair it.”
When Galella was confronted with this video footage throughout his current deposition, he stated his statements had been taken “out of context,” based on the deposition transcript.
The AGGA plaintiffs alleged of their lawsuits not that Galella handled them immediately however as a substitute that he or his firm consulted with their dentists and ready AGGA “remedy plans” for every affected person.
Galella stated throughout his deposition he had reviewed greater than 12,000 remedy plans however stated he’d by no means seen one which used the AGGA to deal with TMJ or sleep apnea, based on the transcript. Within the AGGA lawsuits, a few dozen remedy plans are filed as displays, and a few of these plans checklist the affected person’s “chief grievance” as TMJ or sleep apnea.
Galella’s attorneys didn’t reply to a number of current requests for remark, and Galella declined to be interviewed when approached in particular person in February. One among Galella’s attorneys, Alan Fumuso, stated in a written assertion in February that the AGGA “is secure and might obtain useful outcomes” when used correctly.
The KFF Well being Information-CBS Information investigation of the AGGA was primarily based on interviews with 11 individuals who stated they had been damage by the gadget and dental specialists who stated they’d witnessed extreme problems in AGGA sufferers. The investigation discovered no report of the AGGA being registered with the FDA and no peer-reviewed proof displaying the gadget “expands” or “remodels” the jaw as Galella and different dentists have claimed.
“The whole idea of this gadget, of this remedy, makes zero sense,” stated Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has revealed analysis on AGGA sufferers. “It does not develop the jaw. It does not widen the jaw. It simply pushes the enamel out of their authentic place.”
Within the wake of the KFF Well being Information-CBS Information investigation, the FDA introduced it was “evaluating security considerations” concerning the AGGA and an identical gadget, the Anterior Transforming Equipment. The company stated the gadgets had been used to deal with TMJ and sleep apnea though they weren’t cleared by the FDA and their security and effectiveness had not been established.
Weeks later, the felony investigation into the AGGA was disclosed in court docket filings by Galella and gadget producer Johns Dental Laboratories, who stated the U.S. legal professional’s workplace in Memphis, Tennessee, was “doubtlessly bringing felony expenses” in opposition to them. In one other court docket submitting, Johns Dental supplied a replica of a grand jury subpoena in search of all kinds of AGGA paperwork, together with “any complaints acquired from any supply in any way concerning the AGGA.”
Since then, Galella has resolved lawsuits from at the very least 19 AGGA plaintiffs by out-of-court settlements with none public admission of fault. Further AGGA lawsuits had been filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they had been harmed whereas being handled for TMJ or sleep apnea.
Alice Runion, a 30-year-old IT guide dwelling outdoors Indianapolis, alleged in a kind of lawsuits that sporting an AGGA as a part of her TMJ remedy resulted in “everlasting impairment and disfigurement” and “triggered extreme injury to the roots of [her] enamel.”
In an interview, Runion added that the AGGA triggered lingering migraines which have left her unable to work on a pc for lengthy stretches, forcing her out of her job. Runion stated that even after corrective jaw surgical procedure that price tens of hundreds of {dollars}, a few of her enamel should be in danger.
“My surgeon and my well being care suppliers have advised me that it’s attainable that I may lose enamel sooner or later nonetheless due to the remedy I acquired,” Runion stated.
The AGGA can also be being studied by orthodontists Neal Kravitz and Jeffrey Miller, who stated they intend to publish a analysis paper subsequent 12 months on how the gadget hurts sufferers. Miller, who has been a paid guide for some AGGA plaintiffs, stated he has examined dental scans from at the very least 30 sufferers who had been “broken” by the AGGA.
“It isn’t troublesome to see the sample,” Miller stated. “The sufferers lose bone that helps the housing of their enamel.”
Miller and Kravitz stated that they purchased an AGGA in Might for his or her analysis and that the Division of Justice despatched an official to {photograph} the unboxing of the gadget for the felony investigation.
Miller and Kravitz added that Johns Dental was prepared to promote them the AGGA provided that they didn’t discuss with the gadget by identify whereas buying it. They supplied KFF Well being Information and CBS Information with a replica of an e mail during which a Johns Dental worker writes: “To order the expansion home equipment from right here on out, you may have to keep away from utilizing the names of these home equipment or Dr. Galella’s identify.”
A Johns Dental facility was inspected by the FDA in July, based on on-line inspection information. These information present the corporate was issued seven citations pertaining to medical gadgets, however don’t particularly point out the AGGA or any particular gadget.
One quotation was for an unspecified gadget whose “design historical past file doesn’t show that the design was developed following the necessities” of federal legislation. Johns Dental declined to remark by its legal professional, Jeffrey Oberlies.
Ten days after that FDA inspection, Johns Dental proprietor Jerry Neuenschwander was deposed in an AGGA lawsuit, court docket information present. He pleaded the Fifth in response to each query, based on a deposition transcript obtained by KFF Well being Information and CBS Information.
Spokespeople for the Justice Division and the FDA declined to touch upon the AGGA. Attorneys for Neuenschwander didn’t reply to requests for remark.
2024 KFF Well being Information. Distributed by Tribune Content material Company, LLC.
