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.
backgroundNotable Verdicts & Settlements
Becker v. Indivior Inc. (N.D. Ohio MDL 3092)
SettlementPlaintiff used Suboxone sublingual film for four years beginning in 2016. She developed extensive decay requiring extraction of seven teeth and placement of four implants, at a total dental treatment cost of approximately $42,000. Settlement included reimbursement for all dental costs plus non-economic damages for pain, disfigurement, and psychological impact. Plaintiff's dental records showed no significant prior decay before Suboxone initiation.
Harmon v. Indivior PLC (N.D. Ohio MDL 3092)
SettlementPlaintiff in recovery from opioid use disorder used Suboxone film from 2014 through 2021. Over that period he lost eleven teeth and required full-arch implant-supported prosthetics at a cost exceeding $65,000. Medical records confirmed no prior dental disease before Suboxone initiation. Settlement included future implant maintenance costs and substantial non-economic damages for the documented psychological impact of total anterior tooth loss on employment and social functioning.
Kessler v. Indivior Inc. (S.D. West Virginia)
SettlementWest Virginia plaintiff began Suboxone in 2017. Within 18 months she required four extractions and six crowns due to decay her dentist described as unusually rapid. Prior dental records confirmed healthy dentition before treatment began. Settlement covered dental costs plus non-economic damages. West Virginia's opioid crisis context gave jurors strong empathy for MAT patients who were harmed by inadequate pharmaceutical labeling.
Malone v. Indivior PLC (E.D. Tennessee)
SettlementTennessee plaintiff used Suboxone film from 2018 to 2022. He developed multiple cavities requiring restorations on eight teeth — surfaces his dentist noted were smooth-surface locations inconsistent with typical decay but consistent with acid erosion. His documented dental costs were approximately $18,000. Settlement reflected moderate dental damage with no extractions but a well-documented temporal connection to Suboxone use.
Pryor v. Indivior Inc. (N.D. Ohio MDL 3092)
SettlementOhio plaintiff used Suboxone film for six years beginning in 2015. She experienced complete loss of her upper arch teeth — all 14 upper teeth — and required All-on-4 implant-supported dentures at a total cost of $78,000. She also presented compelling evidence of psychological harm: she had withdrawn from her job in customer service, stopped eating in public, and sought mental health treatment for depression. This case is among the highest-value reported Suboxone dental injury settlements to date.
Darnell v. Indivior PLC (M.D. Florida)
SettlementFlorida plaintiff took Suboxone sublingual film from 2016 to 2020 as part of an addiction medicine program. She developed decay requiring extraction of five teeth and placement of three implants. Prior dental records from a military dependent clinic confirmed healthy teeth before Suboxone. Settlement was facilitated by clear before-and-after dental radiographs that visually documented the progression of decay attributable to the Suboxone treatment period.
Ostrowski v. Indivior Inc. (N.D. Illinois)
SettlementIllinois plaintiff used Suboxone film for approximately three years. He developed decay requiring crowns on six teeth and two extractions. His dentist's treatment notes included references to unusually rapid decay on smooth surfaces, a pattern associated with acid erosion. Settlement covered dental costs plus pain and suffering. Plaintiff remained on MAT and continued working in construction throughout litigation.
Rutherford v. Indivior PLC (D. Maryland)
SettlementMaryland plaintiff used Suboxone film for approximately 14 months before switching to Suboxone sublingual tablets. She developed five cavities requiring restorations but no extractions. Her claim was at the lower end of the damage spectrum but was supported by clear dental records, a prescription history confirming duration of film use, and a treating dentist willing to provide supporting documentation. Case settled early in litigation.
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