The Suboxone tooth decay litigation has drawn increasing attention from patients, attorneys, and the pharmaceutical industry alike. Lawsuits alleging that Suboxone’s buprenorphine/naloxone sublingual film causes serious dental injuries are consolidated in federal court, and attorneys say more than 11,000 are filed in courts throughout the country.
At Wisner Baum, we believe in providing clear, accurate, and timely information to potential claimants. In this update, we cover the status of the Suboxone MDL, recent court developments, the prospect of settlements, and what victims of Suboxone-related dental injuries should know about pursuing legal action.
Learn more about Suboxone lawsuits.
Current Status: Suboxone MDL Case Numbers Surge
As of July 1, 2025, there are 890 pending in Multidistrict Litigation (MDL) No. 3092 before the U.S. District Court for the Northern District of Ohio under Judge J. Philip Calabrese. This marks a significant increase from the 716 cases pending at the start of 2025.
Several key factors continue to drive growth in this litigation:
- Block Filing Mechanism: Under Case Management Order No. 14, the Court has allowed “block filings” that enable plaintiffs to file complaints grouping up to 100 individual cases per submission. This approach streamlines filings and has enabled an efficient influx of new cases.
- Case Consolidation and Preparation: The parties are advancing a focused review of 500 cases, which will be narrowed to 100 for deeper discovery. From this group, 15 cases will be selected for bellwether trial consideration, with four ultimately chosen for trial.
Many firms finalized filings ahead of the June 2025 statute of limitations deadline for states with three-year statutes. In total, attorneys estimate around 11,000 Suboxone-related lawsuits against Indivior have been filed nationwide.
Court Developments
Several key developments have shaped the current litigation landscape:
- MDL Consolidation: All federal Suboxone tooth decay lawsuits have been consolidated in the Northern District of Ohio.
- Partial Dismissals: Defendants Indivior PLC (parent company) and Reckitt Benckiser entities were dismissed from certain claims based on jurisdictional challenges.
- Discovery Phase: Discovery is ongoing, with plaintiffs and defendants exchanging evidence and expert reports.
- Case Management Orders: The Court has issued multiple case management orders, including Case Management Order No. 14 allowing block filings and setting schedules for focused discovery and bellwether trial selection.
- Bellwether Trial Preparation: A structured process is underway to review 500 cases, narrow to 100 for deeper discovery, select 15 trial candidates, and ultimately choose four cases for the first bellwether trials. See Amended CMO 15 (Bellwether Protocol).
Timeline of Key Events in the Suboxone Litigation
- February 2024: JPML consolidates Suboxone tooth decay lawsuits into MDL No. 3092 in the Northern District of Ohio.
- Late 2024: Initial case management orders issued; discovery begins.
- January 2025: Case count surpasses 700 pending cases.
- April 2025: Court issues CMO No. 14 allowing block filings; focused review of 500 cases initiated.
- May 2025: Court issues Second Amended CMO No. 16 updating bellwether Records Collection Pool.
- June 2025: Statute of limitations deadline for many states.
- Late 2025: Bellwether trial candidate selection process expected to continue.
Has There Been a Suboxone Settlement?
No Tooth Decay Settlement Yet
As of July 2025, no settlement has been reached in the Suboxone tooth decay litigation. While some online sources may speculate, the litigation remains in the pre-trial phase, with discovery ongoing and bellwether trial preparations underway.
In large pharmaceutical mass torts such as this, settlements typically do not materialize until the litigation reaches a point of leverage — usually when bellwether trials are scheduled and imminent, or after verdicts are reached. These trials act as a testing ground, giving both plaintiffs and defendants insight into how juries may respond to the evidence.
At this stage, Indivior continues to litigate the claims vigorously. It is common in mass tort litigation for defendants to delay settlement discussions while pre-trial proceedings advance. However, as bellwether trials move closer, the pressure to resolve cases may increase.
Suboxone Settlement History
While the current litigation focuses on dental injuries, Indivior’s legal history is marked by prior settlements related to its marketing of Suboxone and efforts to stifle generic competition. These earlier cases have resulted in substantial financial penalties and provide important context for the present litigation.
Key prior settlements include:
- October 2023: Indivior agreed to pay $385 million to resolve monopoly lawsuits alleging unlawful practices to restrict competition.
- July 2023: Indivior reached a $102.5 million settlement with 42 states over inflated costs linked to blocking generic alternatives.
- May 2021: The FTC returned nearly $60 million to consumers allegedly overcharged for Suboxone due to anti-competitive conduct.
- July 2019: The U.S. Justice Department secured a $1.4 billion settlement from Reckitt Benckiser (Indivior’s former parent company) over alleged false marketing and safety misrepresentations.
This pattern of regulatory and legal challenges – while not related to the current tooth decay litigation – underscores Indivior’s ongoing vulnerability to litigation and highlights the importance of holding the company accountable in the current wave of dental injury lawsuits.
Settlement Projections
While no settlement values have been set, legal analysts currently estimate potential Suboxone tooth decay settlement payouts could be substantial. Actual compensation amounts depend on multiple factors, including:
- Severity of dental injuries (such as extensive extractions or implants).
- Past and future dental treatment needs.
- Strength of medical documentation.
- Impact on quality of life.
Who Is the Defendant in Suboxone Lawsuits?
The primary defendant in the Suboxone tooth decay litigation is Indivior Inc., the pharmaceutical company that manufactures and markets Suboxone Film, as well as Suboxone Tablets. Indivior was originally part of Reckitt Benckiser, a UK-based pharmaceutical company, before being spun off as an independent publicly traded company in 2014.
Aquestive Therapeutics is also named as a defendant. Aquestive collaborated with Indivior in developing the sublingual film technology used in Suboxone.
The following entities have been dismissed from certain claims (they are not the primary manufacturing defendants):
- Indivior PLC (parent company based in UK)
- Reckitt Benckiser LLC (former corporate affiliate)
- Reckitt Benckiser Healthcare (UK) Ltd. (UK entity)
The lawsuits allege that Suboxone’s manufacturers engaged in wrongful and negligent conduct related to the drug’s design, labeling, and marketing. Specifically, plaintiffs claim that the defendants knew — or should have known — that Suboxone Film’s acidic formulation could cause severe dental damage when used as directed, yet failed to warn consumers and healthcare providers of this risk.
It wasn’t until January 2022, after an FDA safety communication, that a warning about dental risks was added to Suboxone’s label. Many plaintiffs had already suffered permanent dental harm by that time.
The claims in these lawsuits generally include:
- Failure to warn about the risk of severe dental injuries.
- Design defect, alleging the product is inherently dangerous when used as intended.
- Negligence in the development, testing, and marketing of Suboxone Film.
- Breach of warranty regarding the drug’s safety.
What Suboxone Products Are Part of the Lawsuit?
The lawsuits primarily target Suboxone Sublingual Film, a thin strip placed under the tongue to deliver a combination of buprenorphine and naloxone for the treatment of opioid use disorder (OUD).
Suboxone Film is designed to dissolve over several minutes, during which time its acidic formulation is in prolonged contact with the teeth and oral tissues. This method of delivery, combined with the film’s pH (measured at approximately 3.4), is believed to contribute to rapid tooth enamel erosion and severe dental damage.
Additional products named in some lawsuits include Suboxone Tablets, which were also administered sublingually and exposed oral tissues to similar risks.
Both formulations share the same active ingredients:
- Buprenorphine: A partial opioid agonist used to reduce cravings and withdrawal symptoms.
- Naloxone: An opioid antagonist added to deter misuse.
Patients were often instructed to keep the product in the mouth for 5-10 minutes during each dose — repeated multiple times per day over long treatment periods. Many reported severe dental problems after months or years of such use, even when they had no prior history of dental disease.
Notably, generic equivalents are not the primary focus of the current litigation. The lawsuits largely target brand-name Suboxone products manufactured by Indivior.
When Will the Suboxone Litigation End?
At this stage, no firm trial dates have been scheduled. However, the litigation is progressing steadily through the discovery and bellwether trial preparation phases. The court is actively overseeing the selection of bellwether trial candidates — a key milestone that typically signals forward momentum in mass tort litigation.
Here is the current outlook:
- The discovery process remains ongoing, with extensive document review and depositions in progress.
- A narrowed group of bellwether candidates is expected to be selected later in 2025 or early 2026.
- The first bellwether trials would likely follow after that selection and trial scheduling.
In other MDLs, some cases resolved early while others remained active for several years, depending on trial outcomes and settlement dynamics. Based on the current timeline, legal analysts have made the following projections (though these could change as the litigation continues):
- Meaningful settlement negotiations may begin in late 2025 or 2026.
- A broad resolution of cases could extend into 2026–2027.
- Individual cases may settle at varying times — some sooner, some later — depending on their strength and procedural posture.
In the meantime, filing deadlines remain urgent. Many states’ statutes of limitations are approaching, and potential claimants should not delay in evaluating their legal options.
How Do Global Settlements Work?
While the Suboxone litigation is sometimes confused with a class action, it is in fact a mass tort — an important distinction.
- In a mass tort, individual cases are consolidated in an MDLunder one federal judge (here, Judge J. Philip Calabrese).
- This allows for coordinated discovery, motions, and bellwether trial preparation, increasing efficiency while maintaining the individual nature of each case.
- Each plaintiff retains their own lawsuit — with settlements or verdicts determined based on their unique facts and injuries.
- There is no single class-wide verdict or payout — each case is evaluated individually.
How an MDL Can Lead to a Settlement
One of the key features of an MDL is the bellwether trial process:
- A small number of representative cases proceed to early jury trials.
- These outcomes give both sides insight into how juries are likely to respond to the evidence.
- Strong plaintiff verdicts in bellwethers often increase pressure on the defendant to negotiate a global settlement.
- Conversely, if defense verdicts occur, it may impact settlement dynamics in the opposite direction.
Typical MDL Settlement Structure
If a Master Settlement Agreement were reached in this litigation, it would likely involve a point-based compensation system, where various factors determine each plaintiff’s award:
- Severity of dental injuries (e.g., number of extractions, implants, reconstructive dental work).
- Extent of treatment required.
- Strength of supporting medical records.
- Causal link between Suboxone use and the injuries.
As part of this agreement, higher point values would translate into higher compensation. The total settlement fund would be distributed based on these point allocations.
The Settlement Process for Plaintiffs
If a settlement is reached, plaintiffs would typically:
- Be notified of the terms.
- Have an opportunity to submit a claim package, including proof of Suboxone use, dental records and treatment documentation, and other supporting evidence.
- Undergo a claims review process administered by a neutral third-party administrator.
- Receive compensation based on their individual scoring.
Importantly, plaintiffs are not obligated to accept a settlement:
- They may choose to opt out and continue pursuing their case individually.
- Opting out may extend the timeline but allows the plaintiff to seek a separate verdict.
Who Is Eligible for a Suboxone Lawsuit in 2025?
If you are wondering whether you may qualify to file a Suboxone tooth decay lawsuit, you are not alone. Many individuals are just now learning about the risks linked to Suboxone use — and the legal options available to them.
While every case is unique, you may be eligible if:
- You used brand-name Suboxone Film (sublingual administration).
- You developed documented dental injuries after Suboxone use, such as:
- Severe tooth decay.
- Tooth loss.
- Root canals, crowns, or extractions.
- You have dental records or other medical documentation linking your injuries to Suboxone use.
- Your claim is within the applicable statute of limitations in your state (many deadlines are rapidly approaching).
Given that filing deadlines are close for people in some states, and that the facts of each case matter — including your history of Suboxone use, timing of injuries, and the state in which you live — the best way to understand your options is to speak with an experienced attorney.
Our legal team is actively reviewing Suboxone-related claims and can provide a free, confidential case evaluation to help you move forward.
Retain Suboxone Attorneys with Experience
Suboxone litigation is complex. Hiring a firm with a proven track record in mass torts and pharmaceutical litigation is critical. An experienced attorney can:
- Evaluate the merits of a claim.
- Navigate the MDL process.
- Secure expert testimony.
- Negotiate the best possible settlement.
If you believe you suffered dental injuries after using Suboxone, you may have legal options. Our experienced legal team at Wisner Baum is here to help. Call (310) 207-3233 or contact us online for a FREE consultation.
