Suboxone Film Tooth Decay Litigation: What Attorneys Need From Dental and Medical Experts

Opioid use disorder treatment has produced an unusual mass tort: one where the alleged injury is dental. As of the August 3, 2026 JPML statistics report, 1,827 actions are pending in MDL No. 3092 in the Northern District of Ohio, out of 1,908 total historical actions. Plaintiffs allege that Suboxone sublingual film, dissolved under the tongue daily for years, caused severe tooth decay, erosion, fracture and tooth loss, and that the manufacturers failed to warn prescribers and patients until the FDA required a label change in 2022. With a bellwether schedule now running through a March 2028 first trial setting, both sides need experts who can speak credibly about dentistry, oral pathology, addiction medicine and oral pharmacokinetics.

The Litigation Landscape

The Judicial Panel on Multidistrict Litigation centralized these cases in February 2024, creating In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, Master Docket No. 1:24-md-03092, before U.S. District Judge J. Philip Calabrese, with Magistrate Judge Jennifer Dowdell Armstrong handling pretrial matters. The August 3, 2026 JPML report lists 1,827 actions pending and 1,908 total actions historically.¹

That figure understates the number of claimants. Judge Calabrese authorized a block filing mechanism under which a single Schedule A complaint may carry many individual plaintiffs, so the JPML action count and the plaintiff count are not the same number. Counsel evaluating exposure should work from the census data, not from the docket count.

The defendants are Indivior Inc. and Indivior Solutions Inc., which market Suboxone film, and Aquestive Therapeutics Inc., formerly MonoSol Rx, which developed and manufactures the film technology. Plaintiffs allege that the film’s acidic formulation, combined with prolonged daily contact with the teeth and gums during dissolution, promotes enamel demineralization and rampant caries, and that the companies knew or should have known of that risk long before the label was changed. The defendants deny the allegations, contend that patients treated for opioid use disorder carry substantial independent risk factors for dental disease, and argue that federal law preempts significant portions of the claims. Nothing in this litigation has established liability.

The first substantive ruling came on December 31, 2024, when Judge Calabrese granted in part and denied in part the defense motion to dismiss the exemplar complaint in Bennett v. Indivior Inc. The Court trimmed certain preempted theories while allowing core claims to proceed, and the defendants did not seek dismissal of failure to warn claims covering the period between FDA approval of the film in 2010 and the June 17, 2022 label change.² That date now functions as a dividing line in the litigation: conduct before it is where the failure to warn case lives.

The current schedule comes from Second Amended Case Management Order No. 15, the bellwether protocol, entered March 27, 2026. It works a 500 plaintiff Records Collection Pool down through a Core Discovery Pool, then to 15 Trial Pool cases, then to four final bellwether cases selected by June 11, 2027, with expert reports, Rule 702 briefing and a first trial setting in March 2028.³

Two points attorneys should be clear on. No case in MDL 3092 has been tried. No global settlement has been announced. Indivior’s prior $600 million resolution with the Department of Justice concerned marketing conduct and is unrelated to these dental injury claims.

The Injuries at Issue

Suboxone film is placed under the tongue or against the inside of the cheek, where it dissolves over several minutes. Patients in medication assisted treatment often take it once or twice daily for years. The alleged injuries follow from that repeated, prolonged intraoral exposure.

Rampant and Cervical Caries

The pattern plaintiffs describe is aggressive, widespread decay, frequently at the cervical margins near the gumline and on surfaces that ordinarily resist caries. Cases have been reported in patients with no meaningful prior dental history. Decay of this speed and distribution is clinically distinctive and is precisely what a dental expert will be asked to characterize.

Erosion, Fracture and Tooth Loss

Enamel erosion progressing to dentin exposure, tooth fracture, failure and loss of existing restorations, and complete tooth loss are all alleged. FDA’s review noted treatment including extractions, root canals, dental surgery and restorative work ranging from fillings and crowns to implants and dentures.⁴

Infection and Periodontal Disease

Dental abscess, oral infection, and periodontal breakdown appear across the claim set, along with xerostomia, or reduced salivary flow, which itself accelerates caries.

Functional and Psychological Consequences

Full mouth extraction in a patient in their thirties is not a cosmetic problem. Plaintiffs allege chronic pain, impaired chewing and nutrition, speech changes, disfigurement, occupational harm, and psychological injury, in a population already carrying the stigma of opioid use disorder. Some allege they discontinued treatment because of the dental damage, with the relapse risk that carries.

The Science Behind the Claims

On January 12, 2022, the FDA issued a Drug Safety Communication warning that dental problems including tooth decay, cavities, oral infections and tooth loss had been reported with buprenorphine medicines dissolved in the mouth, and required a new warning in the prescribing information and Medication Guide for all transmucosal buprenorphine products. The agency’s review identified 305 cases of dental adverse events reported through the FDA Adverse Event Reporting System, with a substantial share classified as serious and a meaningful fraction in patients with no prior dental problems. Median time to diagnosis was roughly two years into treatment. FDA stated that the benefits of buprenorphine for opioid use disorder continue to outweigh the risks.⁴ The Suboxone film label now carries a dedicated Dental Adverse Events warning at section 5.13, including the instruction to rinse with water after the film dissolves and to wait at least one hour before brushing.⁵

The principal epidemiologic study is Etminan and colleagues in JAMA, a pharmacoepidemiologic analysis of the IQVIA claims database comparing patients newly prescribed sublingual buprenorphine and naloxone against patients on oral naltrexone and on transdermal buprenorphine, and reporting a higher rate of dental disease in the sublingual group.⁶ That study is contested and will be contested at Rule 702. Its comparator design raises confounding by indication, and the defense will press the point that people treated for opioid use disorder have elevated baseline caries risk from methamphetamine and opioid use, smoking, diet, xerostomia from other medications, and interrupted access to dental care.

A pharmacovigilance analysis in Expert Opinion on Drug Safety examined dental adverse drug reactions in the World Health Organization’s VigiBase and found disproportionate reporting for sublingual and buccal buprenorphine compared with other buprenorphine formulations, reporting odds ratio 15.10, 95 percent confidence interval 7.50 to 30.39, and compared with methadone, reporting odds ratio 6.02, 95 percent confidence interval 3.21 to 11.30.⁷ Disproportionality signals are hypothesis generating, not proof of causation, and litigation publicity can itself inflate reporting. Expect that argument.

Mechanism is where the case is likely to be won or lost. Plaintiffs point to the film’s acidity and to sustained local exposure. A 2024 study in the Journal of Addiction Medicine found that salivary glands act as an accumulation site for buprenorphine and norbuprenorphine, with gland concentrations exceeding blood concentrations after sublingual dosing, sustaining high oral fluid exposure, and that buprenorphine promoted biofilm formation by Streptococcus mutans, the principal cariogenic organism.⁸ A 2025 narrative review in the Journal of the California Dental Association collects the clinical literature and sets out the dentist’s role in managing these patients.⁹ The mechanism remains formally characterized as unknown, which cuts both ways: it leaves plaintiffs to build general causation from biologic plausibility plus epidemiology, and it leaves the defense to argue that no one has demonstrated how the drug does what plaintiffs say it did.

Why Expert Witnesses Are Critical

This is a dental injury mass tort, which makes it different from most pharmaceutical litigation. The treating record is a dental chart, not a hospital chart. Radiographs, periodontal charting, restorative history and the sequence of extractions carry the case. Firms staffing these files with general medical experts alone will struggle.

General and Restorative Dentistry

A dentist is needed to read the record as a record: baseline oral health before the first Suboxone prescription, the caries pattern and its distribution, the rate of progression across serial radiographs, the adequacy of the patient’s own hygiene and dental attendance, and whether the decay pattern is consistent with an extrinsic chemical insult or with ordinary neglect. This expert also reconstructs what the patient’s dentition would likely have looked like absent the exposure.

Periodontics and Oral Medicine

Periodontal expertise addresses gingival and attachment loss, cervical lesions at the film placement site, the role of xerostomia, and infection. Where plaintiffs allege a localized effect from where the film was held, a periodontist is the right witness to say whether the tissue findings match that account.

Oral and Maxillofacial Surgery and Prosthodontics

Extraction sequences, alveolar bone loss, grafting requirements, implant candidacy and full arch reconstruction all fall here. These experts drive damages: the difference between a defensible number and an inflated one is usually a surgeon and a prosthodontist agreeing on a staged treatment plan with real costs and real timelines, including the fact that implants and prostheses need replacement over a lifetime.

Addiction Medicine

Every one of these plaintiffs was in treatment for opioid use disorder. An addiction medicine physician addresses the standard of care in medication assisted treatment, what prescribers knew and were told about dental risk before June 2022, what alternatives such as depot buprenorphine existed and when, and the confounders the defense will raise. This expert also handles the learned intermediary question: whether a different warning would have changed the prescribing decision.

Pharmacology, Pharmacokinetics and Toxicology

The mechanism case needs a witness who can explain formulation pH, dissolution time, salivary distribution, local versus systemic exposure, and cariogenic biofilm biology, and who can survive a Rule 702 challenge on animal and in vitro evidence.

Regulatory and Labeling

A regulatory expert addresses FAERS signal detection, when a reasonable manufacturer should have acted on accumulating case reports, and the mechanics of the Changes Being Effected pathway that plaintiffs say permitted an earlier warning.

Life Care Planning and Economics

Lifetime dental care for a patient who has lost their dentition in early adulthood is a long, expensive plan. A life care planner working with the surgical and prosthodontic experts converts the treatment plan into a defensible cost projection.

Key Dates

Dates are taken from Second Amended Case Management Order No. 15 and the Court’s prior orders, and are subject to amendment.³

How Med Legal Pro Helps

The expert reports due in the summer of 2027 will be built from records collected in 2026. Firms that wait for the bellwether selection to identify their dental experts will be working backward from a deadline. The better sequence is to have a dentist review the chart while the case is still in workup, so you know early whether the caries pattern, the timeline and the baseline dental history support the claim, or whether the file has a confounder problem you would rather find now than at deposition.

Med Legal Pro matches attorneys with vetted medical and dental experts, and prepares those experts to withstand Rule 702 scrutiny and cross examination. For the Suboxone film litigation that means restorative dentistry, periodontics, oral and maxillofacial surgery, prosthodontics, addiction medicine, oral pharmacology, and life care planning. We handle the record review, the expert identification, and the report preparation so your team can litigate.

The Expert for Experts.

Sources

1. Judicial Panel on Multidistrict Litigation, Pending MDL Dockets by Actions Pending, August 3, 2026. jpml.uscourts.gov
2. In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, No. 1:24-md-3092, Opinion and Order on Motion to Dismiss, ECF No. 173, N.D. Ohio, December 31, 2024. ohnd.uscourts.gov
3. In re Suboxone, Second Amended Case Management Order No. 15, Bellwether Protocol, ECF No. 668, N.D. Ohio, filed March 27, 2026.
4. U.S. Food and Drug Administration, Drug Safety Communication, “FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain,” January 12, 2022.
5. Suboxone (buprenorphine and naloxone) sublingual film, Prescribing Information, section 5.13, Dental Adverse Events. DailyMed
6. Etminan M, Rezaeianzadeh R, Kezouh A, Aminzadeh K. Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease. JAMA. 2022;328(22):2269. doi:10.1001/jama.2022.17485
7. Sublingual and buccal buprenorphine and dental problems: a pharmacovigilance study. Expert Opinion on Drug Safety. 2023. doi:10.1080/14740338.2023.2247962
8. Buprenorphine Salivary Gland Accumulation Sustaining High Oral Fluid Exposure and Increasing the Risk of Streptococcus mutans Biofilm Formation. Journal of Addiction Medicine. 2024. doi:10.1097/adm.0000000000001401
9. Treatment of Opioid Use Disorder with Buprenorphine and the Dentist’s Role in Managing Its Effects on Dental Health, A Narrative Review. Journal of the California Dental Association. 2025. doi:10.1080/19424396.2025.2510238

Tracy L. Liberatore Esq, PA-Emeritus