Lawsuits Outline How Suboxone Causes Tooth Decay, Long-Term Dental Damage

Over the past year, nearly 11,000 Suboxone lawsuits have been filed by former users of the opioid addiction drug, each raising nearly identical allegations that outline how use of the sublingual film caused devastating tooth decay and long-term dental damage, resulting in the need for costly treatments and diminished quality of life. 

Suboxone (buprenorphine and naloxone) was first introduced by Indivior Inc. and approved by the U.S. Food and Drug Administration (FDA) in the early 2000s, as a breakthrough treatment for individuals suffering withdrawal symptoms from an opioid dependency.

However, the drug’s safety profile changed in 2010, when Indivior Inc. updated the delivery method from tablets to sublingual films that dissolve under the tongue or inside the cheek. This modification has been linked to a surge in dental problems reported by users over the last ten years, including:

• Severe dental decay
• Tooth loss
• Tooth extractions
• Cracked/Chipped teeth
• Other serious tooth problems

The FDA publicly recognized the problem in early 2022, requiring the drug maker to update the warning label to include information about the Suboxone tooth decay side effects.  However, lawsuits outline how the drug maker knew or should have known that repeated exposure to the highly acidic Suboxone film may destroy enamel on teeth and result in devastating dental damage.

Former users are now pursuing financial compensation through Suboxone tooth decay lawsuits, claiming that they could have avoided long-term problems with their teeth and the need for extensive dental work if the drug maker had adequately researched the sublingual film and disclosed risks associated with use of the medication.

In this featured post, AboutLawsuits.com will delve deeper into the current status of the growing litigation, as well as the dental side effects of Suboxone, and the allegations raised in tooth decay lawsuits now being pursued to recover damages and other injuries caused by Suboxone.

Suboxone Tooth Decay Lawsuit Multidistrict Litigation

With a growing number of individuals coming forward to seek compensation from the drug maker for its failure to warn about tooth decay injuries from Suboxone, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) in November 2023, requesting that all Suboxone tooth decay claims filed in federal courts be centralized before one judge for coordinated discovery and pretrial proceedings.

With an estimated 16 million people prescribed Suboxone annually, and the potential for the litigation to involve hundreds of thousands of Suboxone users who experienced tooth decay side effects, the manufacturers filed a response in December 2023, agreeing that consolidation would be necessary to effectively manage the claims and potentially negotiate global settlements with plaintiff’s. 

The JPML subsequently issued a Suboxone litigation transfer order on February 2, 2024, instructing that all Suboxone lawsuits over tooth decay problems filed in any federal court to be centralized under U.S. District Judge Philip Calabrese in the Northern District of Ohio for pretrial proceedings. 

While at the time of the order the JPML stated there were 15 lawsuits filed in five districts, the number of Suboxone tooth decay lawsuits has spiked significantly in 2024, with more than 10,000 claims filed over the first six months after the MDL was established.

Indivior Challenges Suboxone Tooth Decay Side Effects

Early in the MDL proceedings, Indivior made an unusual request and asked the court to suspend the traditional discovery process, and first require plaintiffs to establish that Suboxone causes tooth decay side effects.

The drug maker argued that before the parties exchange information on the research and development of the drug, or complete any case-specific discovery in the lawsuits, the litigation should be limited to establishing whether plaintiffs can successfully prove the link between Suboxone and tooth decay.

Plaintiffs immediately opposed the proposal, filing a response outlining evidence about how Suboxone causes tooth decay in May 2024, arguing that there is overwhelming evidence that explains the clear mechanism of action for the injuries, which are the direct result of the acidic nature of Suboxone film.

On June 24, 2024, Judge Calabrese rejected Indivior’s request for “phased” discovery, finding that it would not materially expedite the litigation or simplify the proceedings in the MDL.

Below we will go over the specific evidence outlined in both Suboxone lawsuits filed to date, as well as the evidence outlined in the plaintiff’s successful opposition response.

The Acidity of Suboxone and its Impact on Dental Health

Lawsuits outlined how Suboxone’s two main ingredients are buprenorphine and naloxone, which require an acidic environment to ensure they remain stable and effective while being absorbed into the bloodstream.

To achieve these acidic conditions, Suboxone contains several inactive ingredients or additives that enhance the drug’s acidity. According to the Suboxone Sublingual Film Prescribing Information, Suboxone also contains the following acidic inactive ingredients that can contribute to tooth decay;

• Citric Acid: This is distinctly acidic, and is often used in foods and pharmaceuticals as an acidifying agent, as well as for its tangy flavor.
• Sodium Citrate Dihydrate: This is the sodium salt of citric acid and acts as a buffer. While citric acid is acidic, sodium citrate is more alkaline. When both are present in a formula, they can help control and stabilize the pH, potentially creating a buffer system.
• Acesulfame Potassium: This is an artificial sweetener and isn’t primarily acidic. However, it can have an effect on mouth pH indirectly due to its interactions with oral bacteria.
• Lime Flavour: Natural limes are acidic, primarily because of their citric acid content. Depending on the nature and composition of the flavoring agent, it might contribute some acidity, especially if it contains components derived from the actual fruits.

This is why a user who places a Suboxone sublingual film beneath their tongue might recognize a slightly sour or tangy taste. This taste is a direct indicator of the film’s acidic ingredients to increase the pH levels in the drug’s surroundings.

However, in many personal Suboxone tooth decay stories submitted to AboutLawsuits, readers indicate they were never informed that repeated exposure to the acidity of Suboxone could impact their dental health.

Suboxone Dry Mouth Side Effects on Teeth

Lawyers argue that Suboxone’s acidic ingredients coupled with the drug’s ability to cause dry mouth side effects exacerbates tooth decay risks.

Suboxone has been linked to a condition known as Xerostomia, or dry mouth. The primary cause of dry mouth in relation to Suboxone use is the ingredient buprenorphine, which is known to impact the central nervous system, and among its many effects, reduce the function of the salivary glands.

In a study featured in The Primary Care Companion for CNS Disorders in October 2013, researchers examined a specific population that showed dental health decline following the use of buprenorphine medications. The findings indicated that an astonishing 90% of these buprenorphine users had saliva levels considerably lower than the average, experiencing a drop of roughly 50% compared to the national standard.

Lawsuits allege that the drug makers knew or should have known that this side effect may contribute to the detrimental impact on an individual’s tooth decay from Suboxone, since saliva not only aids in digestion but also helps in neutralizing acids and cleaning the mouth.

A lack of adequate saliva, compounded with the highly acidic ingredients added to Suboxone, can increase the risk of tooth decay, according to lawsuits. As the mouth loses its natural cleaning mechanism and pH balancing capability, plaintiffs indicate this leads to cavities, gum disease, and eventually lost teeth.

Dental Injuries Caused By Suboxone

In most of the Suboxone dental side effects lawsuits filed to date, individuals claim this very acidity used for Suboxone’s function, creates a highly acidic environment in the mouth that can erode tooth enamel, the protective outer layer of our teeth.

When enamel wears down, teeth become more susceptible to decay, leading to cavities and other dental issues. Additionally, a prolonged exposure to acidic substances in the mouth, like when a Suboxone film dissolves sublingually, can exacerbate this effect.

Lawsuits claim that the acidic nature of Suboxone, combined with the active ingredient Buprenorphine’s known ability to reduce protective saliva in the mouth creates promotes permanent tooth decay that can lead to;

• Cavities
• Enamel Erosion
• Dentin Exposure
• Dental Caries
• Gum Disease (Periodontitis)
• Root Decay
• Gum Recession
• Tooth Sensitivity and Pain
• Tooth Abscess
• Tooth Loss
• Bone Loss in the Jaw
• Cracked teeth
• Oral Infections

However, despite the manufacturers intentional design to make these oral Suboxone films highly acidic, and the well established risks of tooth decay from acidic exposure, lawsuits point out that no tooth decay warning for the drug was added to Suboxone for decades. Former users indicate this provides evidence that the manufacturers were more interested in profits than patient safety, causing users to bear the costs of dental treatments after Suboxone use that could have been avoided.

Dental Procedures to Fix Suboxone Tooth Decay

Lawsuits claim that many Suboxone users who have suffered tooth decay have been forced to undergo painful and expensive dental procedures to relieve pain and to prevent their oral health from deteriorating further.

Plaintiffs point out that these corrective dental procedures are not just a one-time fix, but that former users will have to live the rest of their lives worrying about the decayed state of their oral health, while also footing the bill for corrective procedures, which can include;

2024 Suboxone Lawsuit Update

AboutLawsuits first published this featured story in November 2023 as the first claims were being filed. Since then, the size and scope of the litigation has grown exponentially, and additional claims are expected to be filed throughout the rest of 2024 and 2025.

Now that Judge Calabrese’s has rejected the manufacturers attempt to bifurcate the discovery phase, lawyers will begin collecting and exchanging case-specific information about the individual claimants in the litigation, which will lead to the selection of “bellwether” claims that will go through case-specific discovery and be prepared for early trial dates.

It is expected that a series of representative Suboxone tooth decay lawsuits will be selected for early bellwether trials to go before juries, which will help gauge how juries will respond to evidence and testimony that will be repeated throughout the litigation.

As the Suboxone MDL moves forward, lawyers are offering free consultations for Suboxone users who have suffered tooth decay side effects.

Find Out If You Qualify For a Suboxone Dental Decay Lawsuit

Drug manufacturers have a responsibility to adequately research and test drugs to ensure they are safe and free of defective designs, and to warn the public about the potential side effects.

While litigation remains in the early stages, Suboxone lawyers provide free consultations and claim evaluations to help individuals determine if they may be eligible for financial compensation through a Suboxone tooth decay lawsuit.

AboutLawsuits.com has partnered with law firms to provide free claim evaluations, by completing a short on-line questionnaire that will be reviewed by a lawyer to determine if a settlement or lawsuit payout may be available. Claim evaluations are free and all cases are handled by lawyers on a contingency fee basis, which means that there are no fees or expenses unless a recovery is obtained.