Suboxone sublingual film strips — a medication-assisted treatment (MAT) for opioid use disorder — dissolve under the tongue and contain citric acid and other acidic excipients that, with repeated use, erode tooth enamel and cause rapid, severe dental decay. Thousands of patients who faithfully took Suboxone as prescribed to manage opioid dependence later discovered they had lost multiple teeth, required extensive dental reconstruction, or faced thousands of dollars in oral surgery costs — through no fault of their own. Manufacturer Indivior (formerly part of Reckitt Benckiser) knew or should have known about these dental risks for years but failed to include adequate warnings on the product label. The FDA confirmed the danger with a formal safety communication on January 12, 2022, requiring updated product labeling. Patients who suffered dental injuries while using Suboxone sublingual film may have valid product liability claims against Indivior for failure to warn.
Litigation Timeline
Lawsuit Filed Against Indivior
A product liability lawsuit is filed against Indivior PLC and related entities, alleging failure to warn, negligence, strict liability for defective product (failure to warn), and in some cases fraudulent concealment. The complaint details the plaintiff's history of Suboxone use, the development and progression of dental injuries, the costs of dental treatment, and the non-economic damages including pain, disfigurement, and psychological harm. Cases filed in federal court are transferred to MDL 3092 in the Northern District of Ohio for consolidated pretrial proceedings. The MDL judge oversees discovery, case management orders, and bellwether trial selection. Individual cases will either be resolved through a global settlement or tried individually after MDL proceedings conclude.
legalPatient Connects Suboxone to Dental Damage and Seeks Legal Help
After learning of the FDA's January 2022 safety communication — through news coverage, a healthcare provider, or their own research — the patient makes the connection between years of Suboxone use and their substantial dental injuries. The patient gathers their dental records documenting the decay, extractions, and other damage. The patient consults a pharmaceutical litigation attorney who evaluates the timeline of Suboxone use, the extent of dental damage, and the applicable statute of limitations. The attorney files the client's case, typically in the Suboxone MDL (MDL 3092, Northern District of Ohio), or as an individual lawsuit in state court.
legalFDA Issues Safety Communication — January 12, 2022
The U.S. Food and Drug Administration issues a formal drug safety communication warning that buprenorphine medicines dissolved in the mouth — including Suboxone sublingual film — can cause serious dental problems including tooth decay, cavities, dental abscesses, tooth fractures, and tooth loss. The FDA reviewed 305 adverse event reports in the FDA Adverse Event Reporting System (FAERS) and found the dental problems to be severe. The FDA requires manufacturers to add new warnings to prescribing information and patient medication guides. This announcement is the first official government confirmation of the link between Suboxone and dental injuries, and represents the point at which many patients first learn that their medication caused their tooth damage.
regulatoryDental Decay Begins — Patient and Dentist Unaware of Cause
Within months to years of starting Suboxone sublingual film, the patient notices unusual dental symptoms — teeth becoming sensitive, chipping, darkening, or developing cavities faster than expected. The patient's dentist observes rapid, generalized decay inconsistent with the patient's reported hygiene habits. Because neither the patient nor the dentist has been warned about Suboxone's dental risks, the medication is not identified as the cause. The patient may be counseled about dry mouth, hygiene, or dietary habits. Decay progresses, and some teeth may become non-restorable, requiring extraction. The patient does not yet know they have a legal claim against Indivior.
injuryPatient Begins Suboxone Sublingual Film for MAT
A patient is diagnosed with opioid use disorder and begins medication-assisted treatment with Suboxone (buprenorphine/naloxone) sublingual film, prescribed by a licensed addiction medicine provider. The patient dissolves film strips under their tongue or against their cheek multiple times daily as prescribed. No dental warnings are included in the medication guide. The prescribing physician does not counsel the patient about dental hygiene precautions because no such warnings existed in the prescribing information at the time. The patient begins a course of treatment that may last months to years.
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