Suboxone Tooth Decay Lawsuit | 2025 Latest Updates

If you or a loved one experienced tooth decay, dental caries, tooth loss, or other severe dental problems following Suboxone use, you may be entitled to pursue compensation.

At Schmidt & Clark, we are dedicated to helping individuals who have suffered due to the manufacturer’s failure to warn about these serious side effects.

Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark today for a free, no-obligation consultation.

Suboxone Tooth Decay Lawsuit Overview

Suboxone is a prescription medication containing buprenorphine and naloxone used to treat opioid use disorder (OUD).

As stated by a Harvard Health Publishing study from 2021, these drugs work by tricking the brain into thinking that it is receiving a full dose of an opioid, while naloxone blocks the activation of opioid receptors, thereby reversing the euphoric effects of buprenorphine [1].

Lawsuits against the manufacturers allege that the drug’s acidic nature causes severe tooth decay and permanent dental damage when used as directed.

Plaintiffs claim the manufacturers, including Indivior, Aquestive Therapeutics, MonoSol Rx, and Reckitt Benckiser, knew about these risks but failed to properly warn patients and healthcare providers.

In January 2022, the FDA finally issued a warning about these dental risks after receiving 305 reports of dental problems, with 131 classified as serious [2].

Latest Suboxone Lawsuit Updates

• February 2025 – There are currently 896 active cases pending in MDL No. 3092 (In Re: Suboxone Film Marketing, Sales Practices, and Products Liability Litigation) in the Northern District of Ohio. The next case management conference is scheduled for January 14, 2025, focusing on census protocols, procedural strategies, and bellwether trial preparation.
• December 2024 – Judge Calabrese ruled that key claims against the defendants could proceed, allowing the litigation to move forward, although certain design defect claims were dismissed. This ruling represents a significant milestone for plaintiffs seeking compensation for Suboxone-related dental injuries.
• September 2023 – The Northern District of Ohio heard its first lawsuit claiming that Suboxone causes severe tooth decay and permanent dental damage. Plaintiff David Sorensen alleged that the drug’s high acidity resulted in serious dental issues requiring extensive treatment.

The lawsuit argued that the manufacturer was aware of these risks long before the FDA issued warnings, citing over 20 reports submitted to the FDA by the end of 2010 documenting dental problems linked to Suboxone.

Defendants knew or should have known that Suboxone when used as prescribed and intended, causes harmful damage to the teeth due to the acidity of buprenorphine, – the complaint states.

FDA Reports and Statistics

On January 12, 2022, the U.S. Food and Drug Administration (FDA) issued an official warning highlighting severe dental issues associated with buprenorphine-containing medications dissolved in the mouth, such as Suboxone tablets and films [3].

The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth.  The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.- The U.S. Food and Drug Administration (FDA).

The FDA’s investigation revealed:

• 305 cases of dental problems reported with buprenorphine products
• 131 cases (43%) were classified as serious
• Reports included tooth decay, cavities, oral infections, and tooth loss
• Many patients had no previous history of dental issues
• The median time to onset of dental problems after starting buprenorphine treatment was approximately 2 years

Following these findings, the FDA required manufacturers to update prescribing information and patient Medication Guides to include warnings about the risks of dental problems [4].

A comprehensive study published in the Journal of the American Medical Association (JAMA) in December 2022 analyzed data from 2006 to 2020 involving 21,404 users of sublingual buprenorphine/naloxone, 5,385 users of transdermal buprenorphine, and 6,616 users of oral naltrexone [5].

This study found an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone . Sublingual buprenorphine/naloxone is acidic in nature. Patients are instructed to hold the tablet under the tongue for 5 to 10 minutes to maximize absorption. Thus, prolonged acidic exposure of the drug in the mouth might lead to tooth damage. – Mahyar Etminan, PharmD, 
Faculty of Medicine, University of British Columbia.

Suboxone Injuries & Side Effects

Suboxone use has been associated with a range of dental and systemic side effects, varying in severity and duration [6].

• Severe Dental Side Effects: Tooth decay (progressive deterioration of tooth structure), cavities (permanent damage leading to holes in teeth), dental caries (loss of enamel, dentine, and other tooth substances), tooth loss (severe decay or infection leading to extraction), and root canal (necessary when decay reaches the tooth pulp)
• Moderate Dental Side Effects: Crown replacement (required for extensive damage), cracked teeth (resulting from prolonged exposure to acidic substances), oral infections (bacterial infections affecting gums and tissues), burning mouth syndrome (persistent burning sensation), and redness in the mouth (inflammation and irritation)
• Non-Dental Side Effects: Headaches, opioid withdrawal symptoms (body aches, abdominal cramps, rapid heart rate), anxiety, insomnia, excessive sweating, depression, constipation, nausea, weakness/fatigue, and back pain
• Mechanism of Damage: The acidic nature of sublingual Suboxone erodes tooth enamel when held under the tongue for 5-10 minutes as directed. This is compounded by reduced saliva production (xerostomia), which normally protects teeth by neutralizing acids. The breakdown of enamel creates an ideal environment for bacterial growth, leading to cavities, plaque buildup, and infections

An October 2013 case report published in The Primary Care Companion, described a patient who experienced a sudden decline in oral health while using Suboxone tablets [7].

Do You Qualify for a Suboxone Lawsuit?

You may qualify for a Suboxone tooth decay lawsuit if:

• You were prescribed and used Suboxone (buprenorphine/naloxone) sublingual tablets or film for treatment of opioid use disorder
• You experienced severe dental problems after starting Suboxone treatment, such as tooth decay, cavities, dental caries, tooth loss, or other serious dental issues
• Your dental issues required professional treatment, including fillings, crowns, root canals, extractions, or other dental procedures
• You did not have a history of significant dental problems prior to Suboxone use, or your dental health significantly worsened after starting Suboxone
• You were not adequately warned about the potential for severe dental damage by the prescribing doctor or through the medication’s labeling (particularly before January 2022)

Evidence Required for a Suboxone Lawsuit

To build a strong case, you must provide medical evidence proving the connection between Suboxone use and your dental injuries:

• Dental Records: Documentation of tooth decay, cavities, infections, cracked teeth, and extractions; records of past and future dental treatments (e.g., root canals, implants, or dentures)
• Medical Records: Documentation confirming your Suboxone prescription history, including dosage and treatment duration; reports from dentists, oral surgeons, and medical professionals stating that Suboxone contributed to your dental health issues
• Treatment Bills & Financial Records: Receipts and invoices for dental procedures already performed; estimated costs for future dental treatments required to restore oral health
• Personal Testimony & Photos: Before-and-after photos showing visible dental damage caused by Suboxone use; written statements describing pain, discomfort, and the impact on daily life

Damages You Can Recover

Individuals filing lawsuits over Suboxone-related dental issues may be entitled to compensation for both financial and personal losses:

• Economic Damages:
  • Dental Procedures: Fillings ($100-$500 per tooth), crowns ($500-$2,000 per tooth), root canals ($300-$1,000+ per tooth), dental implants ($3,000-$6,000 per implant)
  • Ongoing Dental Care: Regular check-ups, cleanings, and preventive treatments
  • Related Medical Treatments: Expenses for complications such as infections
  • Future Dental Costs: Anticipated treatments for permanent damage
• Non-Economic Damages:
  • Pain and Suffering: Physical discomfort and dental pain
  • Emotional Distress: Anxiety, depression, or embarrassment linked to dental problems
  • Loss of Enjoyment of Life: Impact on eating, speaking, or socializing

While no official settlements have been reached, compensation estimates based on similar pharmaceutical lawsuits suggest individual payouts could range from $25,000 to over $150,000 per plaintiff, depending on the severity of dental damage.

Suboxone Recall Information

There has not been a complete market-wide recall of Suboxone specifically related to dental issues. However, significant regulatory actions have been taken:

• January 12, 2022: The FDA required manufacturers to add warnings about dental problems to all buprenorphine-containing medicines that are dissolved in the mouth. This included updating prescribing information and patient Medication Guides.
• Updated Recommendations: The FDA issued new guidance for patients using Suboxone, including:
  • Rinsing the mouth thoroughly with water after each dose
  • Waiting at least 1 hour before brushing teeth after taking the medication
  • Having regular dental checkups while using the medication
  • Informing dentists about Suboxone use
  • Seeking prompt dental care at the first sign of a problem
• Healthcare Provider Directive: The FDA instructed healthcare providers to refer patients to dental care and develop tooth decay prevention strategies before starting buprenorphine treatment.

Buprenorphine used for addiction treatment is given sublingually, and the properties of this treatment may have a direct and adverse effect on dentition. The prolonged contact between tooth surfaces with buprenorphine/naloxone, therefore, may be a contributing factor in the alteration of tooth surface microbial profile and/or the pH to promote dental caries, similar to what has been previously reported in patients who use methamphetamine. – The Primary Care Companion Study

Instead of issuing a recall, the FDA has focused on strengthening warnings and improving patient education about proper use to reduce the risk of dental damage while maintaining access to this important treatment for opioid use disorder.

Statute of Limitations for Suboxone Lawsuits

The timeframe for filing a Suboxone tooth decay lawsuit varies by state and is generally determined by when the injury occurred or when you discovered (or reasonably should have discovered) that Suboxone caused your dental problems. This is known as the “discovery rule.”

Typical statutes of limitations across states range from 1-6 years:

• 1-2 Years: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin, Wyoming
• 3 Years: Arkansas, District of Columbia, New York, Vermont, Washington
• 4-6 Years: Florida (4 years)

Important considerations that may affect your filing deadline:

• Discovery Rule: In many states, the clock starts when you discovered or reasonably should have discovered the connection between Suboxone and your dental damage – potentially extending your filing window
• FDA Warning Impact: The January 2022 FDA warning about Suboxone’s dental risks may affect when you “should have known” about the connection
• Continuing Treatment: Some states recognize a “continuing treatment” doctrine that may extend the filing deadline if you remained under the care of the same provider

Because of these complexities and variations, it’s critical to consult with an attorney as soon as possible to determine the specific deadline that applies to your case.

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FAQs

1. How Does Suboxone Cause Tooth Decay?

Suboxone causes tooth decay through several mechanisms. Its acidic formulation erodes tooth enamel when held under the tongue for 5-10 minutes as directed. The drug also reduces saliva production, eliminating a natural protective barrier against acids and bacteria. This combination creates an ideal environment for dental caries, allowing bacteria to penetrate weakened enamel and cause progressive tooth damage.

2. Who Manufactures Suboxone?

Suboxone is primarily manufactured by Indivior (formerly part of Reckitt Benckiser). Other companies named in lawsuits include Aquestive Therapeutics and MonoSol Rx, which were involved in developing the film technology. Reckitt Benckiser LLC is also named as a defendant in many cases. The drug was approved by the FDA in October 2002 for treating opioid use disorder.

3. When Did Manufacturers Know About Suboxone Dental Risks?

Lawsuits allege that manufacturers knew about Suboxone’s dental risks years before warning patients. Court documents claim that by the end of 2010, at least 20 reports of dental problems linked to Suboxone had been submitted to the FDA. Despite this knowledge, manufacturers did not add dental warnings to the product labeling until January 2022, when required by the FDA.

4. Is Suboxone Still Prescribed Despite Dental Risks?

Yes, Suboxone is still prescribed because its benefits in treating opioid use disorder often outweigh the dental risks for many patients. Following the FDA warning, prescribers now implement additional precautions, including dental referrals before starting treatment, enhanced oral hygiene protocols, and proper instructions on minimizing dental exposure to the medication.

5. How Is MDL No. 3092 Different From a Class Action Lawsuit?

MDL No. 3092 is a multidistrict litigation, not a class action. In an MDL, individual lawsuits are consolidated for pretrial proceedings to improve efficiency, but each case remains separate with its own outcome. Unlike class actions where compensation is divided among all plaintiffs, MDL settlements are based on individual injuries and damages, potentially resulting in different compensation amounts for each plaintiff.

6. Can I File a Lawsuit If I Still Need to Take Suboxone?

Yes, you can file a lawsuit while continuing Suboxone treatment. The lawsuits primarily focus on the manufacturer’s failure to warn about dental risks, not the medication’s effectiveness for treating opioid use disorder. Your attorney can help you pursue compensation for dental injuries while ensuring your ongoing treatment needs are respected and maintained.

7. What Makes a Strong Suboxone Dental Damage Case?

Strong cases typically involve documented dental damage that developed or significantly worsened after starting Suboxone, clear evidence linking the timeline of Suboxone use to dental deterioration, minimal pre-existing dental issues, compliance with prescribed usage instructions, and substantial dental treatment needs resulting from the damage. Expert testimony connecting the damage specifically to Suboxone’s acidic properties also strengthens cases.

See all related dangerous drug lawsuits our attorneys covered so far.

Get a Free Suboxone Tooth Decay Lawsuit Evaluation From Our Lawyers

If you or a loved one has suffered dental damage after using Suboxone, time is limited to pursue legal action. State statutes of limitations restrict the window for filing pharmaceutical injury claims, typically to just 1-4 years from when you discovered the connection between Suboxone and your dental problems.

Waiting too long could permanently bar you from receiving the compensation you deserve for:

• Costly dental procedures including fillings, crowns, root canals, and implants
• Ongoing dental care and follow-up treatments
• Physical pain and emotional suffering
• Lost wages from time off work for dental appointments

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – we only get paid if you win
• Extensive experience handling pharmaceutical injury cases
• A dedicated team that will fight tirelessly for your rights

Don’t let pharmaceutical companies escape responsibility for failing to warn about serious side effects. Contact us today to learn about your legal options and take the first step toward securing the compensation you deserve.

References

1. https://www.health.harvard.edu/blog/5-myths-about-using-suboxone-to-treat-opiate-addiction-2018032014496

2. https://www.reuters.com/legal/indivior-pay-385-mln-end-suboxone-monopoly-lawsuits-2023-10-23/

3. https://www.fda.gov/media/155352/download?attachment

4.https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022410s046s047lbl.pdf#page=35

5. https://jamanetwork.com/journals/jama/fullarticle/2799415

6. https://www.medicalnewstoday.com/articles/325827

7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907320/