Have You (or a Loved One) Suffered From Tooth Decay, Tooth Loss or Other Dental Complications After Taking Suboxone?
Suboxone Tooth Injury Lawsuits & Settlements
Reviewed by Jacobs Kolton, Chtd. Attorneys at Law; Updated May 2026
The Suboxone tooth decay lawsuits involve claims that manufacturers of Suboxone sublingual film failed to adequately warn patients and doctors that film dissolved in the mouth may cause serious dental injuries, including tooth decay, cavities, tooth fractures, infections, tooth loss, and the need for dental repair or implants.
Our team of drug injury lawyers and class action attorneys is investigating potential Suboxone tooth decay injury lawsuit cases and settlement claims of individuals who suffered from tooth decay, tooth loss and/or other dental problems after taking Suboxone sublingual film/strips.
If you (or a loved one) suffered from tooth decay, tooth fractures, cavities, tooth loss or other dental complications after taking Suboxone, you may be entitled to recover compensation from a Suboxone lawsuit case or settlement claim.
Suboxone (pronounced “Sub‐OX‐own”) is a combination prescription drug used to treat opioid addiction that contains buprenorphine (a partial opioid agonist used to treat opioid use disorder and pain) and naloxone (an opioid antagonist used to reverse or reduce the effects of opioids). Suboxone has been available as either a sublingual tablet or as a small, thin piece of sublingual film placed under the tongue until it is dissolved.
Unfortunately, according to a January 2022 FDA buprenorphine drug safety warning, dental problems have been reported with certain medicines that contain buprenorphine that are dissolved in the mouth, including, among others, tooth decay, cavities, oral infections, and loss of teeth, even in patients with no history of dental issues.
Injured individuals are now coming forward and filing Suboxone lawsuits seeking compensation and justice for the harm and suffering they may have endured after using Suboxone sublingual film/strips.
Suboxone Lawsuit: Overview
- What Is The Suboxone Lawsuit About?
- What Is Suboxone Sublingual Film/Strips?
- Are Attorneys Investigating Suboxone Tooth Injury Cases?
- Who May Qualify For a Suboxone Lawsuit or Settlement?
- What Are Some Key Facts to Know About Suboxone Lawsuits?
- What Dental Injuries May Be Associated With Suboxone Use?
- Have Studies Linked Sublingual Buprenorphine To Dental Injury?
- Are There Dental Treatments for Tooth Decay?
- What Companies Have Been Sued in the Suboxone Litigation?
- What is The Status of The Suboxone Lawsuits?
- Can I Recover Compensation From a Suboxone Lawsuit?
- Is There A Time Limit To File a Suboxone Lawsuit?
- Request A Free Case Review From A Suboxone Injury Lawyer
Suboxone Tooth Decay Lawsuit & Settlement Cases
Suboxone lawsuit and settlement cases potentially being investigated include claims involving patients who, after using Suboxone, suffered tooth decay or other dental complications including the following:
- Tooth decay
- Tooth loss
- Tooth extraction
- Damaged teeth
- Broken teeth
- Tooth fractures
- Tooth cracking
- Tooth erosion
- Jawbone loss
- Dental implants required
- Dental cavities
- Holes in teeth
- Gum disease
- Periodontitis
- Oral infection
- Gum recession
- Root decay
- Erosion of enamel
- Dentin exposure (inner tooth layer)
- Tooth abscess
- Other dental injury lawsuit cases
If you or someone you love suffered tooth damage and/or related dental complications after using Suboxone, you may be eligible to recover compensation from a Suboxone lawsuit or settlement case.
Who May Qualify for a Suboxone Lawsuit
Individuals may qualify for a Suboxone tooth decay injury lawsuit case or settlement claim if they (or a loved one):
- Used Suboxone Sublingual Film/Strips: Used Suboxone dissolvable sublingual (i.e., applied under the tongue) film/strips (preferably for at least six months).
- Suffered Dental Injury or Complications: Suffered dental complications or injury after using Suboxone sublingual film or strips, including, tooth decay, tooth loss, tooth fractures, cavities, tongue injuries, gum injuries or other serious dental complications.
Other criteria may apply in order to be eligible. Not all individuals or cases qualify for a Suboxone lawsuit. Individuals may not qualify if: (1) medical factors or unclear timing make it difficult to link the injuries to Suboxone; (2) they only had street use (use without prescription); (3) had no dental care (i.e., never went to a dentist or oral hygienist for routine dental care) prior to Suboxone usage; (4) the claim is outside the statute of limitations or statute of repose period (if an individual waits too long they may be legally barred from suing); and/or (5) medical/dental records do not support the claims. Individuals may not qualify for other reasons.
Suboxone Lawsuit: Summary of Key Information
| Key Information | What It Means |
|---|---|
| Suboxone | Suboxone is a prescription medication used to treat opioid use disorder. |
| Active Ingredients in Suboxone | Suboxone contains two active ingredients: buprenorphine (a partial opioid agonist that activates opioid receptors but only to a limited degree compared to full opioids, which helps reduce cravings and withdrawal symptoms without producing the same intensity of euphoria) and naloxone (an opioid antagonist that attaches to opioid receptors and reverses and blocks the effects of other opioids). |
| Sublingual Film/Strips | Suboxone sublingual film (or strips) is a thin dissolvable medication placed under the tongue or inside the cheek. Lawsuits generally focus on this film/strip form because it dissolves in the mouth, allegedly exposing teeth and gums to acidic ingredients that may contribute to tooth decay, enamel erosion, cavities, tooth fractures, infections, and tooth loss. |
| Suboxone Tooth Decay Lawsuit | A legal action brought by plaintiffs (injured individuals) against one or more defendant (the sued party) alleging that they suffered injury (tooth decay, tooth loss, cavities, tooth fractures, dental infections, or other serious dental injuries) after using Suboxone sublingual film and seeking to recover compensation in the form of money damages. |
| Who May Be Eligible | Individuals may qualify if they used prescription Suboxone sublingual film/strips and later suffered serious dental injuries such as tooth decay, tooth loss, tooth fractures, cavities, oral infections, or dental repair requiring extractions, root canals, crowns, implants, dentures, or other treatment. |
| Possible Injuries | Potential injuries include tooth decay, cavities, tooth loss, tooth extraction, cracked or broken teeth, tooth fractures, enamel erosion, root decay, dental abscesses, oral infections, gum disease, gum recession, jawbone loss, and the need for dental implants, dentures, crowns, bridges, root canals, or dental surgery. |
| Potential Defendants | Defendants named in Suboxone lawsuits have included developers, manufacturers, sellers and/or distributors of Suboxone, including Indivior, Reckitt Benckiser-related entities, MonoSol Rx, MonoSol, and Aquestive Therapeutics. |
| Alleged Wrongdoing | Plaintiffs may allege that Suboxone film was acidic and that manufacturers knew or should have known that film dissolved in the mouth could cause serious dental injuries but failed to provide adequate warnings to patients and healthcare providers. |
| Possible Legal Claims | Legal claims may include negligence, strict liability, failure to warn, design defect, consumer protection violations, fraudulent concealment, misrepresentation and other possible claims. |
| Helpful Evidence | Helpful evidence may include Suboxone prescription records, pharmacy records, dental records before and after Suboxone use, dental treatment plans, x-rays, oral surgery records, proof of tooth extractions, implant or denture records, dental bills, photographs, insurance records, and documentation showing when dental symptoms began. |
| Possible Compensation | Depending on the facts of the case and jurisdiction, injured individuals may seek compensation for dental bills and future dental treatment (including for oral surgery, implants, dentures, crowns, root canals, etc.), lost wages, reduced earning capacity, pain and suffering, emotional distress, loss of enjoyment of life, disfigurement, and other possible damages. |
| Status of Litigation | Federal Suboxone tooth decay lawsuits are centralized in MDL No. 3092, In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, in the Northern District of Ohio before Judge J. Philip Calabrese. Attorneys are still investigating new Suboxone injury cases. |
| Settlements & Verdicts | No global Suboxone settlement has been announced. Settlements, verdicts, or case results in one case do not guarantee a similar result in any future case. Each case depends on its own facts, evidence, injuries, product use, dental history, medical and dental records, defendant, court rulings, and applicable law. |
Suboxone Injury Lawsuit Complaints
Numerous Suboxone lawsuits have been filed seeking money damages in connection with plaintiffs’ use of Suboxone film to treat opioid use disorder. According to the Suboxone injury lawsuits, Plaintiffs suffered damage to their teeth (including permanent tooth damage, sometimes requiring substantial dental repair work) as a result of using Suboxone.
The Suboxone lawsuits allege, among other things, that Suboxone film is acidic, which can lead to dental erosion and decay when the film is dissolved in the mouth. The Suboxone lawsuit complaints allege that defendants knew or should have known that Suboxone film can cause damage to teeth due to its acidity but failed to warn plaintiffs of the risks.
The Suboxone tooth decay lawsuits allege legal claims for strict products liability (failure to warn), products liability (negligent failure to provide adequate warning and instructions), strict products liability (defective design) and products liability (negligent design defect), among others.
Suboxone lawsuits filed in federal court have been consolidated or transferred into a multi-district litigation or MDL in the Northern District of Ohio for coordinated or consolidated pretrial proceedings, in In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL Case No. 3092 (Judge Philip Calabrese).
Companies Sued Over Suboxone Tooth Injuries
Defendants in the Suboxone lawsuits have included developers, manufacturers, sellers and/or distributors of Suboxone including:
- Reckitt Benckiser LLC
- Reckitt Benckiser Healthcare (UK) Ltd.
- Indivior, Inc.
- Indivior PLC
- Indivior Solutions
- MonoSol Rx, Inc.
- MonoSol, LLC and
- Aquestive Therapeutics Inc.
Suboxone Lawsuit & Settlement Updates
Recent updates about Suboxone lawsuits and settlements include:
- May 2026: Suboxone tooth decay lawsuits filed in federal court remain centralized in MDL No. 3092 in the Northern District of Ohio. The litigation is moving through records collection, plaintiff/defendant fact sheets, and bellwether case-selection procedures. No global Suboxone tooth decay settlement has been announced.
- April 2026: Judge Calabrese entered a new case management order establishing the bellwether selection process and schedule in the Suboxone tooth decay MDL. The order set procedures for selecting cases from the records collection pool into the core discovery pool and future trial-selection process, giving the litigation a clearer path toward resolution.
- December 2025: On December 10, 2025 the parties filed a joint agenda for their December 17, 2025 case management conference, including issues relating to third-party discovery, plaintiff-centered discovery, defendant-centered discovery and proposed dates for future case management conference and discovery hearings. As of December 10, 2025 more than 5,900 plaintiffs had filed claims in the Suboxone film tooth decay litigation.
- November 2025: As of November 3, 2025, there were 1,871 Suboxone injury lawsuit complaints pending in the Suboxone MDL litigation. Since the Court has permitted up to 100 plaintiffs to be added to each complaint filed, the number of plaintiffs with Suboxone cases is estimated to be even more.
- June 2025: On June 20, 2025 the Court issued a case management order governing the depositions of witnesses noticed for deposition in the Suboxone MDL.
- May 2025: On May 19, 2025 the Court issued an amended case management order governing the bellwether trial protocol and identification of plaintiffs for the record collection pool.
- March 2025: On March 14, 2025 the Court issued a case management order governing the selection of a pool of plaintiffs (the Record Collection Pool) from whom medical records will be collected in advance of case-specific discovery in order to facilitate the selection of bellwether (test) trial cases.
- November 2024: On November 22, 2024, the Court issued a case management order allowing Suboxone cases to be directly filed in the MDL litigation.
- September 2024: On September 10, 2024 the Court, by agreement of the parties, dismissed Plaintiffs’ claims against certain defendants, including Indivior PLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd.
- February 2024: On February 5, 2024, the United States Judicial Panel on Multidistrict Litigation issued a transfer order centralizing all Suboxone lawsuit cases pending in federal court to the Northern District of Ohio, finding that they involve common questions of fact arising from the alleged propensity of Suboxone film (which is used for the treatment of opioid addiction or opioid use disorder) to cause dental erosion and tooth decay due to its acidity. The coordinated or consolidated Suboxone cases were assigned to Judge Philip Calabrese for pretrial proceedings.
Suboxone Dental Injury Claims
According to the new Suboxone warning label, patient cases of dental cavities, tooth fracture, tooth loss, dental abscesses/infection, tooth erosion, fillings falling out and other dental injury claims were reported after use of certain buprenorphine-containing products.
5.13 Dental Adverse Events
Cases of dental caries, some severe (i.e., tooth fracture, tooth loss), have been reported following the use of transmucosal buprenorphine‐containing products. Reported events include cavities, tooth decay, dental abscesses/infection, rampant caries, tooth erosion, fillings falling out, and, in some cases, total tooth loss. Treatment for these events included tooth extraction, root canal, dental surgery, as well as other restorative procedures (i.e., fillings, crowns, implants, dentures). Multiple cases were reported in individuals without any prior history of dental problems.Refer patients to dental care services and encourage them to have regular dental checkups while taking SUBOXONE. Educate patients to seek dental care and strategies to maintain or improve oral health while being treated with transmucosal buprenorphine‐containing products. Strategies include, but are not limited to, gently rinsing the teeth and gums with water and then swallowing after SUBOXONE has been completely dissolved in the oral mucosa. Advise patients to wait for at least one hour after taking Suboxone before brushing teeth [see Dosing and Administration (2.5), Information for Patients (17), Medication Guide].
Studies Linking Sublingual Buprenorphine / Naloxone To Dental Injuries
Several studies have found a potential link between sublingual buprenorphine or naloxone medications and the risk of developing tooth decay or other dental injuries, including:
| Medical Study or Warning | Summary |
|---|---|
| Suzuki J, Park EM. “Buprenorphine/naloxone and dental caries: a case report.” The American Journal on Addictions. 2012;21(5):494–495. doi:10.1111/j.1521-0391.2012.00254.x. | This case report described a patient who experienced worsening dental health while using buprenorphine or naloxone. The FDA later cited this case report in its buprenorphine dental warning. |
| Suzuki J, Mittal L, Woo SB. “Sublingual buprenorphine and dental problems: a case series.” The Primary Care Companion for CNS Disorders. 2013;15(5):PCC.13l01533. doi:10.4088/PCC.13l01533. | This case series described patients on buprenorphine maintenance treatment who reported worsening dental health after starting treatment. The FDA cited this case series in its 2022 warning. |
| U.S. Food and Drug Administration. “FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain.” Drug Safety Communication. January 12, 2022. | FDA warned that dental problems had been reported with buprenorphine medicines dissolved in the mouth, including tooth decay, cavities, oral infections, and tooth loss, even in some patients with no prior dental history. The FDA required a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth. |
| Etminan M, Rezaeianzadeh R, Kezouh A, Aminzadeh K. “Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease.” JAMA. 2022;328(22):2269–2271. doi:10.1001/jama.2022.17485. | This observational cohort study and claims-database analysis found higher rates of dental adverse events among sublingual buprenorphine / naloxone users compared with transdermal buprenorphine and oral naltrexone users. The adjusted hazard ratio was 1.42 vs. transdermal buprenorphine (the sublingual buprenorphine / naloxone group had a 42% higher rate of dental adverse events over time) and 1.67 vs. oral naltrexone (the sublingual buprenorphine / naloxone group had a 67% higher rate of dental adverse events over time). The study explained that “Sublingual buprenorphine/ naloxone is acidic” and that “prolonged acidic exposure of the drug in the mouth might lead to tooth damage.” |
| Woods RH. “Dental Disorders Reported to the FDA Adverse Event Reporting System in Association with Buprenorphine: An Analysis by Ingredient Composition and Route of Administration.” Current Drug Safety. 2024;19(2). | This FAERS adverse-event analysis found disproportionate reporting of dental disorders among patients treated with buprenorphine-containing medications, including products administered by sublingual, buccal, and oral routes. |
| Segelnick SL. “Orally dissolving buprenorphine for opioid use disorder linked to caries.” Journal of the American Dental Association. 2024. | This dental journal article discussed caries risk (likelihood of developing dental cavities or decay) with orally dissolving buprenorphine and dental-prevention steps, including rinsing after the medication dissolves and delaying brushing. |
| DeVore SL. “Treatment of Opioid Use Disorder with Buprenorphine and the Dentist’s Role in Managing Its Effects on Dental Health.” Substance Abuse. 2025. | This narrative review discussed buprenorphine treatment for opioid use disorder and dentists’ role in managing dental-health effects. The review cites earlier research, including the 2012 case report, 2013 case series, 2022 JAMA study, and FDA warning. |
Tooth Decay Dental Treatments
Dental treatments for tooth decay and/or other dental injury or complications can include the following, among others:
- Dental implants
- Dentures
- Veneers
- Dental fillings
- Root canal
- Crowns
- Bridges
- Tooth extraction
- Bone grafting
- Dental surgery
- Gum surgery
- Other restorative procedures
- Other dental treatments
Compensation For Tooth Injury From Suboxone
Plaintiffs who bring Suboxone tooth injury lawsuits may be able to recover compensation for the injuries suffered to their teeth, including money damages for losses incurred as a result, such as:
- Compensatory damages for pain and suffering
- Loss of wages or earnings due to missed work
- Loss of future earning capacity
- Medical care expenses incurred or to be incurred
- Other out of pocket expenses
- Loss of quality or enjoyment of life
- Mental anguish/emotional distress
- Loss of consortium
- Other possible monetary damages
Time Is Limited To File A Suboxone Lawsuit
Deadlines known as statutes of limitation and statutes of repose may limit the time that individuals have to file a Suboxone lawsuit to try to recover compensation for injuries they claim to have suffered (e.g., loss of teeth, decayed teeth and other dental injury) after taking Suboxone.
This means that if a Suboxone lawsuit claim is not filed before the applicable deadline or limitations period, the claimant may be barred from ever pursuing litigation or taking legal action regarding their Suboxone injury claim. That is why it is important to connect with a Suboxone injury lawyer or attorney as soon as possible.
If you or a loved one suffered from tooth decay, tooth loss or other dental injury after taking Suboxone, you may be entitled to recover compensation from a Suboxone lawsuit case or settlement claim. Contact a drug injury lawyer to request a free case review.
*If you or a loved one are experiencing health issues, side effects or complications after taking a prescription drug or medication, we urge you to promptly consult with your doctor or physician for an evaluation.
**The listing of a company (e.g., Reckitt Benckiser, Reckitt Benckiser Healthcare, Indivior, Indivior Solutions, MonoSol Rx, MonoSol, and Aquestive Therapeutics Inc., etc.) or product (e.g., Suboxone) is not meant to state or imply that the company acted illegally or improperly or that the product is unsafe or defective; rather only that an investigation may be, is or was being conducted to determine whether legal rights have been violated.
***The use of any trademarks, tradenames or service marks is solely for product identification and/or informational purposes.
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