Blog

The Takeaway

To protect patients and practice good risk management—especially for patients who have used buprenorphine (Suboxone) to treat opioid use disorder—dentists should:

• take a comprehensive medical history for every patient
• ensure each patient’s chart includes a current, complete, and patient-verified medication list
• update that medication list regularly
• make sure patients are aware of the concerns and potential adverse effects from using Suboxone
• stay up to date on best dental practices by regularly attending continuing education conferences and reading professional journals

The Suboxone Class Action Lawsuit

Even when providing routine dental care, dental practitioners may encounter potential claims related to issues in class action lawsuits. Such is the case with Suboxone, a drug used to treat opioid addiction.

In January 2022, the Food and Drug Administration (FDA) issued a public warning that the use of oral buprenorphine (Suboxone) could be linked with developing dental problems. Suboxone is now the subject of a class action lawsuit pending in the Northern District of Ohio. The class against the drug manufacturer Indivior and others has reached over 670 active cases and alleges that as a result of using Suboxone, class members have experienced serious dental issues including tooth decay, oral infections, and cavities. The claim also alleges that Indivior was aware of the dental health risks and failed to warn consumers and medical providers of that risk.

Defendants have moved to dismiss the case, arguing that: (1) these claims are preempted by federal law, and (2) the FDA’s approval of Suboxone’s label precludes any state law claims with respect to inadequate warning. An oral argument date has been set for October 4, 2024. Ryan Bennett v. Indivior Inc., et al. 1:24-sf-65011.

While this case is not a dental malpractice case (it was filed against the manufacturer and distributor of Suboxone), it is a stark reminder that good risk management means dental practitioners need to be aware of public warnings and pending claims.

Standards of Care

Plaintiffs in malpractice cases often assert the theory of “public safety.” They frequently claim a practitioner deviated from current standards of care because the practitioner failed to follow up-to-date practices. In our experience, one way that manifests itself is for plaintiffs to allege that a dental professional knew or should have known a patient’s medical history, current medications, and the impact those factors have on oral health and dental care. When defending against a malpractice claim, it’s difficult to dispute that a practitioner must stay updated on practices, literature, and protocols of their profession through continuing education, training, and literature review, as well as being involved with dental associations, study clubs, and other colleagues on issues that affect the dental community.  

How Dental Practitioners Can Protect Themselves

The issues in the Suboxone case clearly highlight the potential link of this widely used medication for opioid addiction to potential serious oral health problems. This in turn highlights the need for practitioners to take steps to assure they stay aware of such issues and how their profession may address them in treating patients.

To protect their patients and practice good risk management, dentists should take a comprehensive medical history of all patients; ensure they have a complete, current, and patient-verified medication list; and that both of these are well documented and regularly updated in patients’ charts. These steps will be crucial in defending against malpractice claims that may stem from any adverse oral health effects for any patient who was on Suboxone. If a patient is or has been on Suboxone, the prudent practitioner should also make sure the patient is aware of the FDA’s concerns and stay attentive to any signs of adverse effects.

With regular verified updates to a patient’s chart, both dental and medical practitioners can safeguard against what could well be an uptick in claims alleging that a dental practitioner knew or should have known of outside implications affecting dental care and treatment related to Suboxone.