What Is the Suboxone Lawsuit?
The Suboxone tooth decay lawsuit is a federal multidistrict litigation, MDL No. 3092, consolidating personal injury claims that Suboxone sublingual film causes dental damage, centralized in the U.S. District Court for the Northern District of Ohio before Judge J. Philip Calabrese since February 2024.
Plaintiffs allege that Suboxone film, an acidic dissolvable film combining buprenorphine and naloxone used to treat opioid use disorder, eroded their tooth enamel and caused tooth decay, tooth loss, cracked teeth, and related dental damage that its manufacturers did not adequately warn about until the FDA required a label change in 2022. The litigation is not a class action; each plaintiff brings an individual product liability claim that has been transferred into the MDL for coordinated pretrial proceedings, though the cases are commonly referred to together as the Suboxone lawsuit or Suboxone class action.
Indivior Inc., which holds the new drug application for Suboxone film, Indivior Solutions Inc., and Aquestive Therapeutics, Inc., the film's manufacturer, are the named defendants in the great majority of these cases. All three dispute the allegations.
“Plaintiff Ryan Bennett alleges that he sustained personal injuries from his use of Suboxone film to treat opioid use disorder and brings claims against Defendants Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc. under State law.”
Source: U.S. District Court for the Northern District of Ohio, In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, Bennett v. Indivior Inc., Case No. 1:24-sf-65011, Opinion and Order, Document #173 (December 31, 2024)
Why Are People Filing Suboxone Lawsuits?
People are filing Suboxone lawsuits because they allege the drug's manufacturers knew Suboxone film's acidic formulation could damage teeth years before warning patients or doctors.
Suboxone film is designed to be acidic, which helps the drug absorb through the tissue under the tongue, but the same acidity can weaken tooth enamel with repeated exposure. According to court filings in the MDL, the original Suboxone film label carried no warning about dental risk, and published case reports from 2012 and 2013 already linked chronic Suboxone film use to dental damage from the product's acidity. Plaintiffs allege the manufacturers were aware of adverse dental event reports for years but did not update the label or medication guide until regulators intervened.
The FDA issued a formal drug safety communication on January 12, 2022, stating it had identified 305 cases of dental problems, 131 of them classified as serious, associated with buprenorphine medicines that dissolve in the mouth. The agency required manufacturers to add a dental-risk warning to the prescribing information and medication guide, which took effect in June 2022. Plaintiffs argue this decade-long gap between the first published warning signs and the FDA-mandated label change is the core of their failure-to-warn and design-defect claims.
A federal judge's December 2024 ruling on Indivior's motion to dismiss found the amended complaint in one bellwether case plausibly alleges the defendants failed to advise regulators and the medical community that serious dental injuries might be a side effect of Suboxone film, allowing related claims to move forward.
What Injuries Are Included in the Suboxone Lawsuit?
The injuries included in the Suboxone lawsuit fall into four distinct categories of alleged dental harm, each defined in plain language below along with what plaintiffs specifically allege happened to their teeth and gums. Indivior, Aquestive Therapeutics, and Indivior Solutions dispute that Suboxone film is responsible for these injuries in any individual case.
Tooth Decay and Enamel Erosion
Enamel erosion is the gradual wearing away of the hard outer layer of a tooth, typically from repeated exposure to an acidic substance, which can progress into tooth decay if left untreated.
Plaintiffs allege that holding acidic Suboxone film under the tongue or against the cheek for several minutes at a time, often multiple times a day for months or years, wore down enamel and led to widespread tooth decay. Court filings describe published case reports from 2012 and 2013 that linked chronic Suboxone film use to dental erosion attributed to the product's acidity, years before the FDA's 2022 warning.
Tooth Loss and Extractions
Tooth loss, in this context, means a tooth that could not be saved and had to be removed or fell out on its own because of underlying decay or structural damage.
Plaintiffs report losing multiple teeth, in some cases requiring full extractions, root canals, crowns, or dental implants to restore basic function. Several plaintiffs describe having no prior history of dental problems before starting Suboxone film, with damage sometimes appearing within weeks of starting the medication and worsening over months of continued use.
Cracked or Fractured Teeth
A fractured tooth is a tooth with a crack or break in its structure, which can range from a minor chip to a break severe enough to expose the tooth's inner nerve.
Weakened, decayed teeth are more prone to cracking or breaking under normal biting pressure, and plaintiffs allege this pattern of fractures is a direct downstream consequence of the enamel damage Suboxone film's acidity caused. Treating these fractures often requires the same restorative procedures, root canals, crowns, and extractions, that other Suboxone dental injury claims describe.
Gum Disease and Oral Infections
Gum disease is an infection of the tissue surrounding and supporting the teeth, which can range from mild inflammation to advanced disease that damages the soft tissue and bone.
Plaintiffs also report gum inflammation, abscesses, and other oral infections that developed alongside their tooth decay, in some cases requiring surgical treatment. Dental records connecting the timing of these infections to a plaintiff's Suboxone film use are central evidence in these cases, since gum disease can also have unrelated causes.
Who Qualifies for the Suboxone Lawsuit?
You may qualify if:
- You used Suboxone sublingual film, generally for an extended period, to treat opioid use disorder
- You developed new dental problems after starting Suboxone film, such as tooth decay, tooth loss, cracked teeth, or gum disease, including if you had no significant dental history beforehand
- You can produce medical and dental records connecting the timing of your Suboxone use to your dental damage
You may not qualify if:
- You only used a different buprenorphine formulation not centered in this litigation, such as the Sublocade injection, or you used generic buprenorphine film exclusively
- You have no dental treatment records from the period during or after your Suboxone use
- Your state's statute of limitations for a product liability claim has already run, which several firms handling these cases describe as ranging from about two to five years depending on the state and when the injury was discovered
MDL 3092 is not a certified class action and has no confirmed settlement, so eligibility described here reflects what plaintiffs' firms are generally screening for, not a guaranteed qualification. Only an attorney reviewing your specific medical, dental, and prescription records, and your state's own statute of limitations, can confirm whether you currently qualify.
What Is the Current Status of the Suboxone MDL?
The current status of the Suboxone lawsuit is active pretrial litigation in MDL No. 3092, with the case now moving through structured bellwether discovery rather than early motion practice.
In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092
The Judicial Panel on Multidistrict Litigation centralized Suboxone dental injury lawsuits into MDL No. 3092 in the U.S. District Court for the Northern District of Ohio in February 2024, before Judge J. Philip Calabrese. The Judicial Panel on Multidistrict Litigation reported 1,854 pending actions and 1,907 total actions in MDL 3092 as of its January 5, 2026 report, up from 754 pending cases one year earlier. On December 31, 2024, Judge Calabrese granted in part and denied in part the defendants' motion to dismiss a bellwether complaint, allowing plaintiffs to proceed on pre-approval design defect claims against Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc., and on a failure-to-warn claim against Indivior Inc. The court has since approved a bellwether trial schedule that narrows a 100-case pool down to four trial cases, with the first bellwether trial projected for March 2028. No class has been certified and no settlement has been reached.
| Proceeding Type | Federal multidistrict litigation (individual claims, not a class action) |
| Court | U.S. District Court, Northern District of Ohio, Eastern Division |
| MDL Number | MDL No. 3092 |
| Judge | Hon. J. Philip Calabrese |
| Consolidated | February 2024 |
| Pending Cases | 1,827 (1,908 total actions) as of August 3, 2026, per the JPML |
| Key Ruling | Motion to dismiss granted in part, denied in part, December 31, 2024 |
| Stage | Bellwether discovery, first trial projected for March 2028 |
What Is the Suboxone Lawsuit Payout?
The Suboxone lawsuit payout has not been set, because no settlement has been reached in the tooth decay MDL, and any specific figure circulating online is an estimate, not a confirmed amount. Mass-tort attorneys following the litigation have estimated a potential individual settlement payout, if the litigation resolves successfully, in a range of roughly $30,000 to $150,000 depending on the severity of a claimant's documented dental damage.
These figures are attorney estimates based on comparable dental injury litigation, not a confirmed settlement amount, since MDL 3092 has not reached a settlement and its first bellwether trial is not expected until March 2028. Only a qualified attorney reviewing your specific records can estimate what your individual claim might be worth.
If bellwether cases go to trial rather than settle, attorneys following the litigation estimate jury verdicts could run considerably higher, into the hundreds of thousands or low millions of dollars per case, particularly if a jury awards punitive damages, though this too is speculative this early in the litigation.
A payout from the Suboxone tooth decay MDL is separate from the roughly $1.4 billion Indivior and its former parent company, Reckitt Benckiser, paid in 2019 to resolve unrelated federal and state investigations into Suboxone's marketing practices, and a separate roughly $102 million multistate settlement over Suboxone marketing to prescribers, neither of which compensated individual dental injury claims.
Suboxone Lawsuit Updates
Here is the current status of the Suboxone tooth decay lawsuit, updated with new filings, court orders, and case-count changes as they're confirmed.
Suboxone Lawsuit Timeline of Events
JPML Reports 1,827 Pending Actions in MDL 3092
The Judicial Panel on Multidistrict Litigation's August 3, 2026 report counted 1,827 pending actions and 1,908 total actions in the Suboxone MDL, a slight decline from the 1,854 pending actions reported in January 2026. Source: jpml.uscourts.gov, Pending_MDL_Dockets_By_Actions_Pending-August-3-2026.pdf.
Judge Authorizes Provider Depositions in Suboxone MDL
Judge Calabrese entered a case management order allowing depositions of dentists, doctors, and other healthcare providers who treated plaintiffs selected for the MDL's Core Discovery Pool, a step toward building the evidentiary record for bellwether trials.
Plaintiffs' Leadership Reappointed as Bellwether Work Continues
The court reappointed the Suboxone MDL's plaintiffs' leadership structure as the litigation moved deeper into records collection and bellwether case selection, with the first trial still projected for March 2028.
Court Sets a Bellwether Trial Schedule Running Into 2028
Judge Calabrese approved an amended bellwether protocol narrowing a 100-case pool to a 50-case Core Discovery Pool, then to a 15-case Trial Pool by January 2027, with four final bellwether cases selected by June 2027 and the first trial projected for March 2028.
Court Randomly Selects 100 Plaintiffs for Core Discovery
Judge Calabrese ordered the random selection of 100 Suboxone MDL plaintiffs, drawn from cases where records collection was substantially complete, to move into deeper case-specific discovery ahead of bellwether selection.
MDL 3092 Reaches 1,854 Pending Cases
The Judicial Panel on Multidistrict Litigation's January 2026 report counted 1,854 pending actions and 1,907 total actions in the Suboxone MDL, more than double the 754 pending cases reported one year earlier.
Court Presses Indivior and Aquestive Over Records Delays
Judge Calabrese warned he would compel third-party healthcare providers to produce medical and dental records for specific plaintiffs after delays, and a separate order required Indivior and Aquestive to produce internal records on nearly 90 dental adverse-event reports.
Court Reappoints Suboxone MDL Plaintiffs' Leadership
The judge overseeing the Suboxone MDL reappointed roughly 30 attorneys to continue leading the litigation, coordinating discovery and bellwether case selection on behalf of the consolidated plaintiffs.
Court Approves First Phase of Suboxone Bellwether Process
The court approved the first phase of bellwether case selection, directing the collection of medical and dental records from plaintiffs whose cases could be tried first in the MDL.
Court Partially Denies Indivior's Motion to Dismiss
The court partially denied Indivior's motion to dismiss claims against it, allowing Suboxone lawsuits alleging design defects and failure to warn about dental injuries to proceed in the MDL.
Judge Calabrese Rules on Bellwether Motion to Dismiss
Judge J. Philip Calabrese granted in part and denied in part the defendants' motion to dismiss in Bennett v. Indivior, allowing pre-approval design defect claims to proceed against Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc., and a failure-to-warn claim to proceed against Indivior Inc.
JPML Consolidates Suboxone Dental Cases Into MDL 3092
The Judicial Panel on Multidistrict Litigation consolidated Suboxone dental injury lawsuits into a new MDL, No. 3092, in the U.S. District Court for the Northern District of Ohio.
First Suboxone Tooth Decay Lawsuit Filed
A man who alleged permanent oral damage from taking Suboxone film to treat opioid use disorder filed what is described as the first Suboxone tooth decay lawsuit.
FDA-Mandated Dental Warning Added to Suboxone Label
The label for Suboxone sublingual film was updated to add the FDA's dental-risk warning after the agency required manufacturers of buprenorphine medicines that dissolve in the mouth to disclose the risk.
FDA Warns of Dental Problems With Buprenorphine Medicines
The FDA issued a drug safety communication stating it had identified 305 cases of dental problems, 131 of them serious, in patients using buprenorphine medicines dissolved in the mouth, including Suboxone film, and required a new label warning.
How to File a Suboxone Lawsuit
To file a Suboxone lawsuit, follow the 4 steps listed below.
- Gather your dental and medical records: Collect dental x-rays, treatment records, billing statements, and Suboxone prescription and pharmacy records that document both your use of the medication and the timing of your dental damage.
- Confirm your state's filing deadline: Product liability claims are subject to a statute of limitations that varies by state, generally described as running two to five years from when you discovered or reasonably should have discovered the connection between Suboxone and your dental injury.
- Consult a mass-tort or product liability attorney: An attorney evaluating a potential Suboxone claim can confirm whether your specific facts and timeline fit MDL 3092's current criteria, since the MDL is not a class action and each case is evaluated individually.
- File your claim in the MDL: If your attorney determines you have a viable claim, your case is typically filed directly in, or transferred into, MDL No. 3092 in the U.S. District Court for the Northern District of Ohio for coordinated pretrial handling.
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What Evidence Do I Need for a Suboxone Lawsuit?
Building a Suboxone dental injury claim generally requires documentation connecting your medication use to the timing and progression of your dental damage. Commonly requested records include dental x-rays and imaging, dental treatment and billing records, proof of Suboxone prescriptions and pharmacy fill history, before-and-after photos of your teeth, and any written or recorded communication with a healthcare provider about your dental symptoms. A personal statement describing when your dental problems began relative to starting Suboxone, and any prior dental history showing you had no significant issues beforehand, can also help establish the timeline plaintiffs' attorneys say the MDL's bellwether process is now focused on.
What Did Indivior and Aquestive Therapeutics Allegedly Know About Suboxone and Tooth Decay?
Indivior and Aquestive Therapeutics allegedly knew about Suboxone film's tooth decay risk years before warning patients, according to court filings in the MDL. The amended complaint in the MDL's first bellwether case alleges Suboxone film's original label contained no warning about the risk of damage to teeth, even though the defendants knew by 2011 that the film dissolved more slowly in the mouth than described in its own patent, and published case reports from 2012 and 2013 already linked the drug's acidity to dental erosion. Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc. dispute that they are legally responsible for any individual plaintiff's dental injuries.
A federal court order issued in October 2025 required Indivior and Aquestive Therapeutics to produce internal records, including FDA filings, marketing materials, and adverse-event reports covering nearly 90 dental injury reports, material plaintiffs say will help show what the companies knew and when. In its December 2024 ruling, the court found the amended complaint plausibly alleges the defendants failed to advise regulators and the medical community that serious dental injuries might be a side effect of Suboxone film, allowing failure-to-warn and design-defect claims to proceed against specific defendants.
| Defendant | Alleged Role | Status in the Litigation |
|---|---|---|
| Indivior Inc. | Holds the FDA new drug application for Suboxone film and distributes the product | Design defect and failure-to-warn claims allowed to proceed |
| Indivior Solutions Inc. | Subsidiary alleged to have promoted and marketed Suboxone film | Design defect claim allowed to proceed; failure-to-warn claim dismissed as to this defendant |
| Aquestive Therapeutics, Inc. | Exclusive manufacturer of Suboxone sublingual film | Design defect claim allowed to proceed; failure-to-warn claim dismissed as to this defendant |
How Does the Suboxone Tooth Decay Lawsuit Compare to Other Suboxone Cases?
Indivior and its former parent company have faced other, legally separate cases over the years that are sometimes confused with the current tooth decay MDL. None of the cases below involve the dental injury allegations at issue in MDL 3092, even though they share the same defendant.
| Case | What It's About | Relation to This Lawsuit |
|---|---|---|
| 2019 DOJ and Reckitt Benckiser Resolution (roughly $1.4 billion) | Federal criminal and civil claims that Indivior and former parent Reckitt Benckiser used deceptive marketing to protect Suboxone film's market share from generic competition | Separate marketing and antitrust matter, not a personal injury case, resolved years before the tooth decay MDL existed |
| 2019 Multistate Attorneys General Settlement (roughly $102 million) | State claims that Indivior made improper payments related to how Suboxone was marketed to certain prescribers | Separate marketing-conduct settlement with state governments, not a payout to individual dental injury claimants |
| MDL No. 3092 (this lawsuit) | Individual product liability claims that Suboxone film's acidic formulation caused tooth decay and other dental damage | The current, active litigation described on this page |
Frequently Asked Questions
What is the Suboxone tooth decay lawsuit about?
The Suboxone tooth decay lawsuit is a federal multidistrict litigation, MDL No. 3092, alleging that Suboxone sublingual film's acidic formulation caused tooth decay, tooth loss, and other dental damage that its manufacturers did not adequately warn about until the FDA required a label change in 2022.
Is the Suboxone lawsuit a class action?
No, the Suboxone lawsuit is a multidistrict litigation rather than a certified class action, meaning each plaintiff's case is filed and evaluated individually even though the cases are consolidated before one judge for shared pretrial proceedings.
Who is the defendant in the Suboxone lawsuit?
Indivior Inc., which holds the FDA drug application for Suboxone film, is the primary defendant, along with Indivior Solutions Inc. and Aquestive Therapeutics, Inc., the film's manufacturer, though a federal judge has narrowed which claims proceed against each of the three.
Has there been a Suboxone lawsuit settlement?
No, there has been no settlement in the Suboxone tooth decay MDL as of this writing, and the litigation's first bellwether trial is not expected until March 2028, so any specific payout amount described online is an estimate, not a confirmed figure.
Who qualifies for the Suboxone tooth decay lawsuit?
You may qualify for the Suboxone tooth decay lawsuit if you used Suboxone sublingual film for an extended period and developed new dental problems such as tooth decay, tooth loss, or cracked teeth, provided you can document your Suboxone use and dental treatment and you are within your state's statute of limitations.
Is the Suboxone tooth decay lawsuit the same as Indivior's other legal settlements?
No, the Suboxone tooth decay lawsuit is a separate, distinct matter from the roughly $1.4 billion 2019 federal resolution and the roughly $102 million multistate settlement Indivior and its former parent paid over Suboxone's marketing practices, neither of which involved dental injury claims or paid individual patients for tooth damage.