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.
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:
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.
Several key developments have shaped the current litigation landscape:
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.
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:
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.
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:
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):
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:
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:
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.
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:
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):
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.
While the Suboxone litigation is sometimes confused with a class action, it is in fact a mass tort — an important distinction.
One of the key features of an MDL is the bellwether trial process:
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:
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.
If a settlement is reached, plaintiffs would typically:
Importantly, plaintiffs are not obligated to accept a settlement:
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:
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.
Suboxone litigation is complex. Hiring a firm with a proven track record in mass torts and pharmaceutical litigation is critical. An experienced attorney can:
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.