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For most Americans, the assumption feels simple: if a medical or dental procedure is being offered in a professional office, it has likely been thoroughly tested, properly regulated, and performed by someone with extensive specialized training. The reality is often far more complicated. In many states, general dentists are legally permitted to perform a broad range of procedures, including orthodontics, certain surgical interventions, airway-related treatments, and complex appliance-based therapies, without completing the multiyear specialty residency programs required of orthodontists or oral surgeons. For patients, however, those distinctions are rarely obvious. “The public assumes one thing,” said Scott E. Charnas, founder of Charnas Law Firm, P.C., who has spent years litigating cases involving dental devices and appliance-related injuries. “The regulations technically allow another.” That disconnect, Charnas argues, has quietly created one of the least understood oversight gaps in modern healthcare. A Broad License and a Public That Rarely Understands It The issue is not necessarily that general dentists are prohibited from performing these procedures. In many states, they are legally permitted to do so. What patients often do not realize is that a provider offering orthodontic treatment may not actually be an orthodontist. “When I was a kid and my parents took me to get braces, they took me to an orthodontist, not a dentist,” Charnas said. “So I was surprised to learn that a general dentist could legally perform orthodontic procedures.” According to Charnas, many patients simply assume that if a provider is offering a specialized treatment, advanced specialty credentials must accompany it. In some cases, that assumption can persist for years. “Very recently, I had a conversation with a young woman who suffered serious damage from a dental appliance,” he said. “She referred to the provider as an orthodontist. I told her, ‘No, I have taken his deposition in several cases. He’s actually a general dentist.’ She was shocked. She believed she had been treated by an orthodontist the entire time.” Former patients interviewed for this article described how easily that confidence can be built. One former patient from the greater Edmonton area recalled that the credentials displayed on her provider’s waiting room wall gave her “some reassurance.” The dentist had answered her questions and, she said, presented himself as experienced with the treatment. “I felt I was doing the right thing and wanted to believe him.” The distinction matters because orthodontists and oral surgeons complete additional years of formal residency training beyond dental school, with supervised clinical experience specific to their specialties. “Most people do not know that an orthodontist has to go to school for two to three more years beyond dental school,” Charnas said. Yet in many states, the legal framework governing dentistry still permits general dentists to perform many of the same orthodontic procedures. And despite differences in training, liability standards may not necessarily change. “In the multiple states where I’ve litigated these cases,” Charnas noted, “a dentist performing orthodontics is held to the standard of an orthodontic specialist.” The Rise of Appliance-Based Dentistry Appliance-based treatments have drawn interest from patients seeking cosmetic improvements, relief from jaw problems, and treatment for airway-related concerns. Continuing education programs have helped introduce these treatments to dental practices, where they can also create substantial revenue opportunities. “There are economic pressures on every profession,” Charnas said. “Dentistry is no exception.” According to Charnas, appliance-based treatments can become highly lucrative. “In regard to the AGGA device, I saw patients charged anywhere from $15,000 to as much as $60,000 for treatment,” he said. “Meanwhile, the actual device cost the dentist less than $500.” AGGA, short for Anterior Growth Guidance Appliance, has become the subject of controversy and litigation. The device was marketed as a method of advancing an adult patient’s upper jaw, with claims that it could improve airway function, alleviate temporomandibular joint disorders, and enhance facial structure. “There’s no scientific basis for any of this,” Charnas said. “It’s well established that you cannot advance an adult upper jaw without surgery.” For patients, the sales pitch did not necessarily feel like a sales pitch. A former patient from Colorado said she had already trusted the dentist for other care. Two friends in her community were undergoing AGGA treatment, as were two dental professionals who worked in the office. Those signals, she said, made the treatment feel established rather than experimental. “You just don’t go into your dentist’s office thinking they are going to sell you something that will harm you,” she said. Nearly three years later, she said, her jaws were still not aligned, her bite remained off, and the desired tooth movement had not occurred. It was only then that she sought a round of second opinions. According to Charnas, use of the device was taught through continuing education courses attended by dentists across the country and around the world. Those programs included courses offered through the Las Vegas Institute, or LVI, a dental continuing education organization. Charnas says that years after courses promoting the appliance had already been taught, institute leadership acknowledged concerns about how the device’s function had been represented. “The question becomes,” Charnas said, “why was that work not done before the course was offered—instead of after dentists had already returned home and installed these devices on patients?” Continuing Education Versus Specialty Training The debate surrounding AGGA has also raised broader questions about continuing education programs and the role they play in legitimizing emerging treatments. Continuing education requirements for dental license renewal are established by state licensing authorities. Programs such as the American Dental Association’s Continuing Education Recognition Program, or CERP, and the Academy of General Dentistry’s Program Approval for Continuing Education, or PACE, recognize or approve continuing education providers. For example, the Dental Board of California’s requirements distinguish approval of a provider from approval of each individual course. Charnas questions how deeply some organizations investigate the scientific validity of the treatments being taught. “One has to wonder how often independent research is actually conducted,” he said, “as opposed to simply taking the word of the course proponent and cashing the check.” Charnas recognizes the value of continuing education but believes there is a meaningful distinction between exposure to a concept and years of supervised specialty training. That distinction may be especially important when treatments involve irreversible changes to the jaw or bite. Former patients interviewed for this article described how personal assurances and professional affiliations reinforced their confidence in treatment. A New York patient said her provider’s explanation of how the appliance worked seemed convincing; learning that his own daughter had used AGGA strengthened her trust. An Alberta patient found additional reassurance in an LVI Facebook group, where dentists affiliated with the program answered patients’ questions. These experiences helped patients view the treatment as established and supported by professional expertise, without necessarily understanding the evidence behind it. FDA Assumptions and Regulatory Reality One of the most troubling misconceptions, according to Charnas, is the assumption that all dental devices have undergone meaningful FDA scrutiny before entering widespread clinical use. Many patients assume that if a device is being used in a dental office, it must already be FDA approved. That assumption, he says, can be dangerously incomplete. “The FDA may not even have been made aware of the appliance, despite federal regulations requiring such product to be listed with the FDA,” Charnas said. “You may assume the FDA approved the product. You may assume that the dentist had specialized training. You may assume the courses they took had a scientific basis. But those assumptions may not be correct.” A similar expectation of regulatory protection appeared in the account of a Canadian patient. She said she believed her dentist was a trustworthy health professional operating within a system that would prevent unapproved or unsafe treatments from reaching patients. Looking back, she said she had assumed her country would not allow an unproven, untested device onto the market. In the United States, FDA registration and device listing are distinct from clearance or approval. The FDA expressly states that an entry in its registration and listing database does not mean a device has been approved, cleared, or authorized. FDA registration and listing guidance. Medical devices are assigned to one of three regulatory classes based on their risks and the controls needed to assure safety and effectiveness. Class I includes the lowest-risk devices, while Class III includes the highest-risk devices. The requirements for premarket review depend on the device’s classification, intended use, and any applicable exemptions. FDA device classification guidance. Charnas alleges that some dental appliances used in clinical practice were never properly submitted for FDA review. He points specifically to AGGA, which he says was marketed and taught extensively despite lacking meaningful scientific validation. In a March 30, 2023, safety communication, the FDA identified AGGA and several similar appliances as devices of concern. The agency stated that their safety and effectiveness for treating obstructive sleep apnea or temporomandibular joint disorders, or for remodeling the adult jaw, had not been established, and that the devices had not been cleared or approved for those uses. It also described reports of serious complications, including tooth displacement, bone erosion, and tooth loss. FDA safety communication. “Informed consent only works if patients understand the actual risks and benefits of the proposed treatment,” he said. What Patients Should Ask Charnas believes patients considering orthodontic, surgical, or appliance-based treatments should ask more detailed questions before proceeding. Among them: Are you trained in this specialty, and where? How many cases like mine have you performed? Are there peer-reviewed studies supporting this treatment? Are there clinical trials demonstrating safety and efficacy? Has this product been reviewed or cleared by the FDA for this use? “If a provider becomes annoyed by those questions,” Charnas said, “that itself may tell you something.” He also urges patients not to confuse marketing language with scientific validation. “A seminar approval or continuing education certification does not necessarily mean a product has strong scientific support,” he said. The patients interviewed for this article arrived at similar advice through their own experiences. A New York patient said she now wishes she had sought second, third, or even fourth opinions and looked more closely for peer-reviewed research before agreeing to treatment. “Even if you consider yourself intelligent and someone who does ask questions, don’t take things at face value,” she said. “Dig deeper.” The Transparency Gap For Charnas, the larger issue is not necessarily whether dentists should be allowed to expand beyond traditional procedures. The issue, he argues, is transparency. Patients often believe multiple layers of oversight exist, from specialty credentialing to FDA review to dental board enforcement. Charnas argues that, in practice, those protections may be fragmented, inconsistent, or heavily dependent on self-regulation. “You may assume someone is protecting the consumer, when no such protection may exist,” Charnas said. “By the time a lawyer gets involved, the damage has already occurred.” That, he believes, is the central problem modern dentistry has yet to fully confront: the gap between patients’ perception of competence, training and oversight, and what is too often reality.

Piles of urine-stained clothes on the floor. A bed stripped of sheets and bowed and broken in the middle. A cup of liquid filled with dead ants. That was the condition of Wally Lassiter’s bedroom at a Schenectady group home in 2017. On July 4, as the region was in the midst of a heat wave, the 26-year-old developmentally disabled man was found dead in his bed while wearing multiple layers of shirts. A former employee who provided photographs to the Times Union that showed the condition of Lassiter’s room last year said the man’s untimely death was horrifying but not surprising. What Legal Issues Can Arise in Group Home Neglect Cases? Cases involving group homes and facilities caring for vulnerable individuals may involve: Negligence Wrongful death Failure to supervise Medical neglect Abuse of developmentally disabled adults Violations of state regulations Families deserve answers when a loved one suffers serious injury or death due to inadequate care. About Scott E. Charnas Scott E. Charnas is a New York trial attorney with decades of experience representing victims and families in serious injury and wrongful death cases. Read the full story at Times Union: https://www.timesunion.com/news/article/a-death-at-schenectady-group-raises-questions-13179533.php

For years, patients have assumed that if a medical device reaches the market, it has been properly vetted, tested, and cleared for use. The reality is far more complicated. The recent FDA Class I recall involving certain Stryker temporomandibular joint (“TMJ”) implants used to reconstruct or replace the jaw joint connecting the lower jaw to the skull, underscores a larger concern in medical device safety: even highly specialized implants can reach patients before critical design issues are fully discovered. According to the FDA, the recall involved a discrepancy between the screw-hole position listed in the design specifications and the actual fossa design, creating a risk that screws could penetrate the cranial vault and lead to dural tissue damage, bleeding, cerebrospinal fluid leak, meningitis, or other serious injury. As someone who has spent years representing victims injured by defective medical and dental devices, I can tell you this is not an isolated event. “What’s alarming is not simply that recalls happen,” said Scott E. Charnas, Esq., founder of Charnas Law Firm, P.C. “It’s the frequency with which we continue to see patients suffer life-altering injuries tied to products they were told were safe. In many of these cases, patients are only discovering the true source of their injuries years later.” The numbers surrounding medical device recalls continue to raise serious questions across the healthcare and legal industries. According to FDA data, thousands of medical device recalls have been issued over the past decade, including Class I recalls reserved for situations involving a reasonable probability of serious injury or death. The medical device industry itself exceeds $500 billion globally, with manufacturers often operating under aggressive timelines to bring products to market. For patients, the consequences are not abstract; they are physical, financial, and permanent. Many individuals impacted by defective implants face: • multiple revision surgeries • chronic nerve pain • infection risks • bone loss and structural damage • long-term disability • substantial medical costs and lost income “We continue seeing cases where patients trusted the system, trusted their doctors, and trusted the manufacturers behind these devices,” Charnas added. “When those systems fail, the impact follows people for the rest of their lives.” The broader issue extends beyond a single manufacturer or product category. Litigation involving dental devices, orthopedic implants, surgical mesh, joint replacements, and other implanted products continues to grow nationwide as more patients come forward alleging inadequate warnings, flawed design, and insufficient long-term testing. Regulatory clearance does not always equal long-term safety, and that distinction matters. As scrutiny surrounding medical device oversight intensifies, accountability will continue becoming a central issue for manufacturers, regulators, and healthcare providers alike. Patients deserve transparency before products enter the market — not years after injuries have already occurred.

Harmed by a botched implant, braces, or oral surgery? Charnas Law Firm handles dental malpractice claims nationwide. Free consultation: 212-980-6800. Dental Appliance Malpractice Representation for serious injuries caused by defective dental devices, improper placement, or negligent treatment, often resulting in permanent damage, chronic pain, or loss of function. Dental appliances are intended to improve health; not cause lasting harm. When negligence, improper design, or failure to warn leads to significant injury, these cases require detailed medical analysis and experienced litigation strategy. Support When Medical Treatment Causes Harm Patients trust dental professionals with their health. When that trust is broken, the consequences can be devastating. We provide clear guidance, thorough investigation, and strategic advocacy to help injured patients pursue compensation for medical costs, long-term care, and diminished quality of life. Defective Dental Devices Dental appliances placed on the market without proper testing or safeguards can cause irreversible harm. We pursue manufacturers and distributors whose products fail patients instead of helping them. Improper Appliance Placement When dental devices are poorly fitted or improperly installed, the result can be nerve damage, jaw injury, or chronic pain. These are not “complications”—they are preventable failures. Failure to Warn Patients are entitled to understand the risks associated with dental appliances. When providers or manufacturers withhold known dangers, they can be held fully accountable. Permanent Injury & Chronic Pain Defective or negligent dental treatment can lead to lasting injury, TMJ disorders, facial nerve damage, and lifelong discomfort. We litigate cases involving serious, long-term medical consequences. As Seen on CBS A dental device was sold to fix patients' jaws, but some claim it wrecked their teeth. An investigation by CBS News and Kaiser Health News found a dental device allegedly left a trail of mangled mouths and devastated patients. Anna Werner reports. AGGA Dental Device Lawsuits The FDA has raised safety concerns regarding the Anterior Growth Guidance Appliance (AGGA) and related dental devices used in adults. The agency has stated that the safety and effectiveness of these devices for certain intended uses have not been established and has identified reports of serious complications. See If You Have an AGGA Case

Charnas Law Firm, P.C. is a personal injury lawyer representing victims of serious accidents, negligence, wrongful death, and medical malpractice nationwide for over 30 years. Experience Matters. So Does Integrity. Charnas Law Firm, P.C. brings a rare combination of discipline, precision, and unwavering resolve to every case, delivering the kind of advocacy that forces accountability when it matters most. And when we take on a client, we treat their fight like it’s our own. Get Legal Help Now Compassionate Legal Representation Proven Track Record of Success Client-Centered Approach Every Step A Proven Record of Results: Over 50 Million Recovered for Clients Results matter, especially when the stakes are life-altering. Scott Charnas has secured over $50 million in recoveries for individuals and families facing catastrophic injury, professional negligence, and wrongful death. Every case is pursued with precision, urgency, and the expectation that responsible parties will be held fully accountable. See the Results Our Practice Areas When life changes in an instant, you need an attorney who knows exactly how to fight back. Scott Charnas brings decades of experience to some of the most complex and devastating injury cases, standing up to insurers, corporations, and anyone who tries to avoid accountability. Every case is handled with precision, strategy, and relentless advocacy. Catastrophic Injury & Death Traumatic brain injuries Spinal cord injuries Life-altering injuries Wrongful death Severe or permanent disability claims Learn More Dental Appliance/Surgical Injuries Serious injury caused by: Attempts to grow an adult upper jaw forward with an appliance Improper use of dental appliances Negligently performed dental surgery Learn More Workplace Injuries Construction site accidents Scaffolding/ladders/falls Nail gun accidents Heavy machinery injuries Workplace negligence Learn More Premises Liability Slip, trip & fall injuries Dog bites & animal attacks Unsafe stairs, walkways & floors Negligent security & assaults Pool, elevator & escalator accidents Learn More Hearing Loss/Acoustic Trauma Sudden noise exposure injuries Long-term noise damage Occupational hearing loss Acoustic trauma injuries Permanent hearing impairment Learn More Medical Malpractice Medical malpractice Diagnostic errors Surgical errors Medication mistakes Learn More Construction Site Injuries Falls from scaffolds & elevated work areas Struck-by falling objects or equipment Machinery, crane & heavy equipment injuries Unsafe jobsite conditions & safety violations Learn More Serious Vehicle Accidents Car, SUV & multi-vehicle collision claims Reckless & impaired driving accidents Highway, intersection & high-speed crashes Injury claims caused by negligent drivers Learn More Building & Structural Lawsuits Porch, balcony & deck collapse injuries Building collapse & structural failure claims Unsafe stairs, railings & load-bearing defects Negligent maintenance & property conditions Learn More News & Media 1 2 3 4 Read More Articles Forever Grateful “From the moments of our first consultation through the process of litigation, negotiation and ultimate settlement, I felt fully confident in Scott’s ability to represent me with integrity. This was very important to me, I wanted to be represented by a lawyer I could be sure would not only act in my best interests, but work for me in a way which was congruent to my ethics.　 Scott was that person. He took care to be compassionate as well as professional. I am forever grateful for his being there for me when I needed counsel.” – G. Benkert

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