Suboxone Tooth Decay Lawsuit

What Is the Suboxone Tooth Decay Lawsuit About?

The Suboxone tooth decay lawsuit is a growing mass tort litigation alleging that Indivior Inc. (formerly Reckitt Benckiser Pharmaceuticals) failed to adequately warn patients and healthcare providers that Suboxone sublingual film and other buprenorphine products dissolved in the mouth can cause severe dental problems, including tooth decay, tooth loss, oral infections, and gum disease. The cases are consolidated in MDL 3092 in the Northern District of Ohio under Judge J. Philip Calabrese.

Suboxone is a prescription medication containing buprenorphine and naloxone, approved by the FDA in 2002 for the treatment of opioid use disorder (OUD). It is delivered as a sublingual film or tablet that dissolves under the tongue. Millions of Americans have used Suboxone as part of medication-assisted treatment (MAT) for opioid addiction — a critical public health tool during the ongoing opioid epidemic.

In January 2022, the FDA issued a required warning update for all buprenorphine medicines dissolved in the mouth, alerting patients and healthcare providers to the risk of dental problems. The FDA reported identifying 305 cases of dental adverse events — including tooth decay, cavities, oral infections, tooth loss, and tooth fracture — many of which occurred in patients with no prior history of dental problems. Plaintiffs allege that Indivior knew or should have known about these risks years before the FDA warning and failed to act.

For other pharmaceutical lawsuits involving allegations of inadequate warnings, see our pages on the Ozempic stomach paralysis lawsuit and the Tylenol autism/ADHD lawsuit.

Sublingual Buprenorphine Products Involved

The lawsuit encompasses several sublingual buprenorphine products used for opioid addiction treatment. All share the same fundamental delivery mechanism — dissolving in the mouth — which is alleged to cause the dental damage:

Suboxone sublingual film is by far the most widely prescribed of these products, accounting for the majority of claims in MDL 3092. The film formulation requires the medication to dissolve slowly against the oral mucosa, exposing the teeth and gums to the acidic formulation for extended periods — typically several minutes per dose, multiple times per day.

How Suboxone Causes Dental Damage

The dental damage caused by Suboxone results from two primary mechanisms. Understanding how sublingual delivery affects oral health is central to the lawsuit's allegations:

Severity of Dental Damage

Many Suboxone users have reported rapid and devastating dental deterioration. According to the FDA's 2022 safety communication, reported dental problems included cavities, tooth loss, tooth fracture, and oral infections. In many cases, patients had no prior history of dental problems before starting Suboxone, making the connection between the medication and the dental damage particularly compelling.

Who Qualifies for the Suboxone Lawsuit?

You may qualify to file a claim in the Suboxone tooth decay lawsuit if you used sublingual buprenorphine products and developed dental problems. Each case is evaluated individually by an attorney:

Lawsuit Timeline

The Suboxone tooth decay litigation has built momentum since the FDA's January 2022 warning. Here are the key milestones in this case:

Settlement Amounts and Projections

As of early 2026, no global settlement has been reached in the Suboxone tooth decay litigation. The cases remain in the discovery phase. However, based on the severity of dental damage, the strength of the FDA warning evidence, and comparable pharmaceutical litigation, legal analysts have projected the following settlement ranges:

Settlement amounts in individual cases will depend heavily on the extent of documented dental damage, dental records before and after Suboxone use, duration of medication use, and out-of-pocket costs for dental treatment. For general information, see our guide on mass tort settlement amounts.

How to File a Suboxone Dental Claim

If you experienced severe dental damage from Suboxone or another sublingual buprenorphine product, here is the process for pursuing a legal claim:

For more detailed information about the legal process, read our guide on how to join a mass tort lawsuit. Learn about what to expect regarding timelines in our guide on how long mass tort lawsuits take.

Named Defendants

The Suboxone tooth decay lawsuits primarily name the following defendant:

• Indivior Inc. — Formerly Reckitt Benckiser Pharmaceuticals, Indivior is the company responsible for manufacturing and marketing Suboxone sublingual film and tablets. Indivior was created as a spin-off of Reckitt Benckiser's pharmaceutical division in 2014. The company is headquartered in Richmond, Virginia, and Suboxone remains its flagship product. Plaintiffs allege that Indivior had knowledge of the dental risks associated with sublingual buprenorphine delivery for years before the FDA required label changes in 2022 and failed to adequately warn patients and healthcare providers.

Some lawsuits also name Reckitt Benckiser Group as a defendant for its role in developing and marketing Suboxone prior to the Indivior spin-off. Additionally, manufacturers of generic sublingual buprenorphine products may be included in some claims.

Scientific and Medical Evidence

The scientific and medical evidence supporting the Suboxone tooth decay claims draws from several key sources:

• FDA Safety Communication (January 2022): The FDA identified 305 cases of dental adverse events reported to the FAERS database and required a new warning on all buprenorphine medicines dissolved in the mouth. This is a powerful piece of evidence because the FDA determined the risk was significant enough to mandate a label change.
• Mechanism of injury: The acidic pH of Suboxone film (measured around pH 3.4) combined with the prolonged oral exposure time creates conditions known to erode tooth enamel. This is supported by established dental science regarding acid erosion of teeth.
• Xerostomia (dry mouth) effect: Buprenorphine is known to reduce salivary flow, which is a well-documented risk factor for dental caries. Saliva plays a critical role in neutralizing oral acid, washing away food particles, and remineralizing tooth enamel.
• Post-marketing surveillance data: Indivior's own pharmacovigilance data may contain signals of dental adverse events that were not acted upon. Discovery in MDL 3092 is expected to reveal what the company knew and when.
• Dental literature: Published case reports and studies have documented severe dental deterioration in patients taking sublingual buprenorphine, including patients with no prior dental history, lending additional scientific support to plaintiffs' claims.
• Absence of prior warnings: For approximately 20 years (2002-2022), Suboxone labeling did not include any warnings about dental problems, despite the growing body of adverse event reports.

The discovery phase of MDL 3092 will be critical in uncovering internal Indivior documents about what the company knew about dental risks, when they knew it, and why they did not update their labeling earlier. For a broader understanding of how evidence is used in these cases, see our guide on how mass tort lawsuits work.