Suboxone Dental Lawsuit
(Tooth Decay & Loss)
Major pharmaceutical litigation against Indivior alleging Suboxone sublingual film causes severe dental damage—including tooth decay, cavities, erosion, and tooth loss—due to prolonged oral exposure and acidic formulation. The FDA issued a safety warning in January 2022 after identifying 305 dental adverse event cases.
Key Takeaways
- 1,832 cases pending as of May 2026 with 337% growth since 2024
- FDA safety warning issued January 2022 after 305 dental adverse events reported
- Injuries include tooth decay, cavities, erosion, and complete tooth loss
- Affects opioid use disorder patients taking medication-assisted treatment
- Defendant Indivior paid $600M in prior DOJ settlement (unrelated marketing issues)
Key Facts (May 2026)
| Pending Actions | 1,832 cases in federal MDL (May 2026) |
| Growth Rate | 336% growth since Jan 2024 |
| Defendant | Indivior Inc. (formerly Reckitt Benckiser Pharmaceuticals) |
| Presiding Judge | Hon. J. Philip Calabrese (N.D. Ohio) |
| FDA Warning Issued | January 12, 2022 |
| Film Approved | September 13, 2010 |
| FDA Adverse Events | 305 cases identified (131 serious) |
| Median Time to Injury | ~2 years (range: 2 weeks to 182 months) |
| Can You Still File? | Yes, lawsuits are actively being filed |
Case Growth (2024-2025)
The Suboxone MDL has seen explosive growth following the FDA's January 2022 warning. Case count has increased 336% as patients report severe dental damage.
Source: JPML MDL Statistics Reports, January 2024-May 2026
FDA Drug Safety Communication (January 2022)
The FDA issued a warning that dental problems—including tooth decay, cavities, tooth erosion, and tooth loss—have been reported with buprenorphine medicines dissolved in the mouth. The agency identified 305 cases of dental adverse events, with 131 classified as serious.
Source: FDA Drug Safety Communication, January 12, 2022
1 What Is This Lawsuit About?
Suboxone is a sublingual film containing buprenorphine and naloxone, used to treat opioid use disorder (OUD). The medication is placed under the tongue or inside the cheek where it dissolves over several minutes, exposing teeth and gums to the medication daily—often for years.
Plaintiffs allege that this prolonged oral exposure, combined with the acidic formulation (containing citric acid and sodium citrate), causes severe dental damage. The FDA identified multiple mechanisms: dry mouth (xerostomia), prolonged medication contact with teeth, acidic pH damaging enamel, and changes to the oral microbiome.
The lawsuits claim Indivior knew or should have known about the dental risks but failed to adequately warn patients and prescribers until the FDA required label changes in 2022—over a decade after the film was approved.
2 About Suboxone Film
Suboxone sublingual film is the primary product at issue in this litigation:
Active Ingredients
- Buprenorphine — Partial opioid agonist that reduces cravings and withdrawal
- Naloxone — Opioid antagonist added to deter injection misuse
Available Dosages
- 2mg/0.5mg (buprenorphine/naloxone)
- 4mg/1mg (buprenorphine/naloxone)
- 8mg/2mg (buprenorphine/naloxone)
- 12mg/3mg (buprenorphine/naloxone)
Administration
The film is placed under the tongue (sublingual) or inside the cheek (buccal) and held in place until completely dissolved. Patients typically take the medication once daily, and treatment often continues indefinitely—exposing teeth to the acidic formulation for extended periods.
3 Alleged Dental Injuries
According to the FDA Drug Safety Communication, reported dental problems include:
Tooth Damage
- Tooth decay (dental caries)
- Rampant caries (severe, widespread decay)
- Tooth erosion
- Tooth fracture
Tooth Loss & Infections
- Complete tooth loss
- Dental abscesses/infections
- Cavities affecting multiple teeth
- Fillings falling out
Required Treatments
- Tooth extractions (71 cases per FDA)
- Root canals
- Crowns and dental implants
- Full or partial dentures
FDA Findings
- 26 cases with no prior dental problems
- 113 cases with 2+ teeth affected
- Average patient age: 42 years
- Median time to diagnosis: ~2 years
4 Warning & Labeling History
FDA approves Subutex and Suboxone tablets for OUD treatment. No dental warnings included.
FDA approves Suboxone sublingual film (NDA 022410). No specific dental warnings despite sublingual delivery method.
FDA approves 4mg/1mg and 12mg/3mg film strengths. Still no dental warnings.
FDA issues Drug Safety Communication warning about dental problems. Requires label changes for all transmucosal buprenorphine products.
New Section 5.13 added: "Dental Adverse Events." Medication Guide updated with oral care instructions. Label now recommends dental checkups and rinsing after use.
5 Do You Qualify for Compensation?
You may be eligible to file a claim if you meet these criteria:
Eligibility Requirements
- Used Suboxone sublingual film — Brand name or generic buprenorphine/naloxone film dissolved in mouth
- Experienced dental damage — Tooth decay, cavities, tooth loss, extractions, root canals, dental infections, or need for dentures
- Can document the medication and injury — Prescription records and dental treatment records
- Within statute of limitations — Generally 2-3 years from injury discovery, varies by state
6 Frequently Asked Questions
What is Suboxone used for?
Why does Suboxone cause dental problems?
Should I stop taking Suboxone?
Who is the defendant?
What about the $600M DOJ settlement?
Have there been any settlements?
Can I still file a lawsuit?
Sources & References
9 official sources cited• JPML MDL Statistics Report — Pending MDL Dockets (March 2026)
• FDA Drug Safety Communication — "FDA warns about dental problems with buprenorphine medicines dissolved in the mouth" (January 12, 2022)
• DailyMed — FDA-approved Suboxone sublingual film label (NDA 022410, revised May 2025)
• SAMHSA — "Medications for Substance Use Disorders" (August 2025)
• SAMHSA — "Buprenorphine" (December 2025)
• NIDA — "Opioids" (November 2024)
• Segelnick SL, Weinberg MA. "Orally dissolving buprenorphine for opioid use disorder linked to caries." J Am Dent Assoc. 2024;155(7):561-564. (PMID: 38691081)
• Zheng Z, et al. "Buprenorphine Salivary Gland Accumulation..." J Addict Med. 2025;19(5):520-528. (PMID: 39621545)
• U.S. District Court, Northern District of Ohio — MDL-3092 case docket
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