by Al Anthony Mercado, Esq., managing attorney of the downstate region of the law firm Mercado May-Skinner (MMS) and an employee of MLMIC Insurance Company
On March 23, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of certain dental devices being used by dentists that were not cleared or approved by the FDA. The FDA further stated that the safety and effectiveness had not been established for the use of these devices.
The use of non-FDA approved devices and products pose increased risks for dentists. Similarly, the use of FDA approved devices and products in ways beyond their approval can pose risks for dentists too.
This blog will explore the increased liability risks associated with the use of non-FDA approved devices as well as the risks related to the off-label use of FDA approved devices and products.
The FDA’s Role in Safety and Effectiveness
The FDA does not regulate the practice of dentistry. All dentists must comply with relevant state and federal laws as well as practice within the accepted standards of dentistry.
The FDA does have regulatory authority over evaluating the safety and effectiveness of devices used in dentistry. In addition, the FDA evaluates and regulates the marketing, labeling and promotion of devices.
The Dangers of Using of Non-FDA Approved Devices and Products
Recently, the dangers of using non-FDA approved devices have been in the media. More specifically, there have been numerous lawsuits, national media coverage and an FDA issued safety communication about certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions.
The devices of concern include:
Anterior Growth Guidance Appliance (AGGA) and Fixed Anterior Growth Guidance Appliance (FAGGA);
Anterior Remodeling Appliance (ARA) and Fixed Anterior Remodeling Appliance (FARA);
Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA); and
Any other similar device types.
These devices were non-FDA approved and being used to treat conditions for which their safety and effectiveness had not been established through evaluation. The FDA safety communication cautioned the dental community and public about problems and concerns related to these non-FDA approved devices including chronic pain, tooth dislocation, flared teeth, uneven bite, difficulty eating, damaged gums, exposed roots and bone erosion.
In one highly publicized lawsuit involving the AGGA, it was learned that the device was never submitted for FDA approval. The patient-plaintiff in that lawsuit was an accomplished concert clarinetist who alleges that the non-FDA approved device pushed her teeth forward through the bone that anchors their roots in place dislodging her front teeth. She is alleging $150,000 in dental repairs and an unspecified amount in pain and suffering and lost earnings.
Professional liability claims involving the use of non-FDA approved devices are very difficult, if not impossible to defend. As a preliminary matter, it is extremely difficult, if not impossible, to prove that the use of a non-FDA approved device is within the standard of care. In addition, the import, use and sale of non-FDA approved devices or materials can violate FDA regulations. Finally, the use of a non-FDA approved device may also violate state regulations for professional misconduct.
The Increased Risks of the Off-Label Use of FDA Approved Devices and Products
The term “off-label use” refers to any use of approved drugs, licensed biologics and approved or cleared medical devices in any manner that is inconsistent with the FDA’s approved labeling of the medical product. “Clinician-directed application” or “provider-directed application” are also terms that are indicative of off-label use.
“Labeling” means any documentation that may accompany a device such as use information, package inserts and professional product instructions. “Off-label” use means the use of a device for an unapproved indication, patient population or use outside of the product labeling.
Good practice and the best interests of the patient require that a dentist use legally available devices and products according to their best knowledge and judgment. If a dentist uses a device or product for an indication not in the approved labeling, they have the responsibility to be well informed about it, to base its use on firm scientific rationale and on sound scientific evidence, and to maintain records of the device or product’s use and effects. Such use of a marketed device or product in this manner when the intent is the “practice of medicine exception” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB).
Essentially, a dentist must also use their professional judgment to determine the best treatment plan for a patient and be aware of uses, limitations, safety concerns and scientific basis for the use of a treatment including devices. The dentist should have a thorough discussion with the patient about the off-label nature of the treatment, including the material risks, benefits and alternatives. A consent must be obtained before beginning treatment. The rationale for off-label treatment, as well as the informed consent discussion, should be documented in the dental record.
Despite a dentist complying with all the above, an off-label use of a device or products carries increased risk. In a professional liability lawsuit, the dentist’s judgment will be subject to greater scrutiny for choosing an off-label use. A patient-plaintiff can allege that they were unaware of the off-label use and would not have consented to the treatment if they had known. Finally, at trial an expert can attack the off-label use while the plaintiff attorney tries to convince the jury it was not only negligent, but experimental.
Depending on the facts, a dentist can also face professional misconduct proceedings if the off-label use is not supported by a scientific rationale, is harmful to the patient and/or is not properly documented in the dental record.
The Financial Risks of Using Non-FDA Approved Devices or the Off-Label Use of Approved Devices
In addition to the increased risks described above, there is the potential financial risk that claims related to the use of non-FDA approved devices and off-label use will not be covered by professional liability insurance. Most professional liability insurance contain terms and conditions that do not provide insurance coverage related to the use of non-FDA approved devices and/or off-label uses.
- The FDA does have regulatory authority over evaluating the safety and effectiveness of devices used in dentistry.
- The use of non-FDA approved devices can result in increased liability risks, professional misconduct charges and allegations that are not covered by professional liability insurance.
- The use of FDA approved devices and products in an off-label manner can result in increased liability despite a scientific basis, special consent discussion and increased documentation. Off-label use may not be covered by professional liability insurance.
MLMIC policyholders can reach our 24/7 emergency support services for questions regarding the use of non-FDA devices by calling (844) MMS-LAW1. You can also submit a specific question by emailing email@example.com.
Dental professionals can stay up to date on the latest risk management guidance and alerts by monitoring the MLMIC Dental blog, The Scope: Dental Edition and Dental Impressions and following us on Twitter and LinkedIn.