People across the nation are filing Suboxone tooth decay lawsuits alleging drug maker Indivior and other defendants knew Suboxone causes tooth decay and other dental injuries but failed to warn consumers and the medical community of the risks.
A combination of buprenorphine and naloxone, Suboxone helps people addicted to opioids avoid withdrawal symptoms. But studies have shown that Suboxone can cause significant tooth decay, potentially leading to tooth loss, fractures, and other dental pain.
Suboxone lawyers are bringing tooth decay lawsuits on behalf of individuals alleging Indivior and other defendants knew about significant dental problems associated with Suboxone use for many years but took no steps to alert patients or prescribers of the known dangers.
Per Suboxone lawsuits, patients only know about the link between Suboxone and tooth decay because the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication in 2022 “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.” Prior to the FDA Suboxone warning, the drug manufacturers took no action to warn patients of the known risks, the lawsuits say.
If you used Suboxone for at least six months prior to 2022 and developed problems with your teeth—including tooth decay, broken teeth, extractions, root canals, or other injuries—you may qualify for a Suboxone lawsuit. Please fill out our contact form below. If you have any questions and would like to speak with our legal team, please give us a call at (310) 207-3233.
Suboxone Lawsuit Eligibility Checklist
You may qualify to join the Suboxone tooth decay lawsuit if you:
- Are not time-barred from filing due to expired statute of limitations
- Have used Suboxone film strips or tablets for at least six months prior to 2022
- Experienced unexpected dental issues such as tooth decay, cavities, tooth loss, or dental procedures after starting Suboxone
- Have received dental treatment that can be linked to Suboxone use
- Noticed symptoms starting during use or shortly after discontinuing the medication
- Can provide proof of prescription or usage history
If you meet these criteria, we encourage you to contact our legal team for a free case evaluation.
Suboxone Lawsuit Compensation
If you qualify, you may be entitled to compensation for:
- Medical and dental expenses (restorative procedures, extractions, implants)
- Lost wages and reduced earning capacity due to dental injuries
- Pain, suffering, and emotional distress linked to tooth damage and appearance changes
- Punitive damages if corporate misconduct is proven
What Is Suboxone?
Suboxone is a drug approved by the FDA to help treat Opioid Use Disorder (OUD). It is made up of two medications, buprenorphine and naloxone. Buprenorphine works by blocking the opioid receptors in the brain, which can reduce withdrawal symptoms and cravings for opioids when used under medical supervision.
Naloxone (Narcan) is included in Suboxone to help reverse the dangerous symptoms of an opioid overdose and make it harder for the medication to be abused.
Suboxone is also available in generic forms.
Suboxone Film Strips and Tablets
Suboxone comes in the form of sublingual films or tablets, which are administered as part of a comprehensive treatment program that includes counseling and therapy. The method of taking Suboxone is through oral administration. Suboxone is available in three forms:
- Sublingual Suboxone Tablets (most commonly round, orange, uncoated): These tablets are placed underneath the tongue.
- Sublingual Suboxone Film Strips (most commonly paper thin, orange rectangle or square): These film strips are also placed underneath the tongue.
- Buccal Suboxone Film Strips (most commonly paper thin, orange rectangle or square): These film strips are placed between the gums and teeth.
Suboxone Active and Inactive Ingredients
Suboxone, Belbuca, and Subutex all contain the active ingredient buprenorphine, an opioid partial agonist. The key difference lies in naloxone, which is present in Suboxone but absent in Belbuca and Subutex.
- Belbuca is prescribed for chronic pain and comes as a buccal (cheek) dissolvable film available in several dosages from 75 mcg to 900 mcg. Unlike Suboxone, it does not include naloxone and is not approved to treat opioid use disorder (OUD).
- Subutex contains only buprenorphine and was discontinued as a branded drug in the U.S. in 2011 but is still available as a generic. Subutex is less commonly used compared to Suboxone.
- Suboxone combines buprenorphine and naloxone, the latter serving to reduce abuse potential, and is approved for treating OUD with formulations typically as sublingual films or tablets.
This breakdown highlights the active and inactive ingredient differences and their implications for treatment and regulation.
Suboxone Side Effects and Dental Risks
While Suboxone is effective in treating addiction, research has shown it can cause serious dental problems:
- Tooth decay, cavities, and dental erosion
- Tooth loss and fractures
- Gum disease and infections
- Pain and the need for costly dental procedures such as root canals, crowns, extractions, or implants
The medication’s acidic formulation (pH ~3.4) combined with prolonged sublingual contact is believed to alter oral pH and microbial balance, increasing cavity risk. This issue has been documented in multiple medical studies dating back to 2012, including research published in the Journal of the American Medical Association.
Can I Sue Suboxone for Ruining My Teeth?
Yes, you can pursue compensation in a Suboxone lawsuit if you meet certain requirements (more on this below). Even if you had problems with your teeth before using Suboxone, Belbuca or Subutex, lawsuits allege the medication increased your risk of tooth decay and other dental issues.
How Does Suboxone Affect Your Teeth?
Suboxone is acidic to maximize buprenorphine absorption while minimizing absorption of the naloxone. This acidic formulation leads to dental erosion and decay.
Suboxone teeth problems include:
- Tooth decay
- Tooth loss
- Extraction
- Oral infections
- Cracked teeth
- Cavities
- Root canal
- Dental caries (loss of enamel)
- Crown or crown replacement
- Gingivitis and other gum disease
One thing to remember is that these dental issues are not limited to Suboxone; the FDA also warned about Subutex and Belbuca teeth issues.
Does Suboxone Cause Tooth Decay?
Yes, according to the medical literature. In December of 2022, a research letter published in the Journal of the American Medical Association reported dental adverse events associated with buprenorphine medications like Suboxone. The study, which examined thousands of patients from 2006–2020, found “an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone…”
While this study is the most robust to date in terms of patient cohort and duration, it is not the only research confirming a link between Suboxone and problems with teeth. In 2012, Harvard Medical School professors affiliated with Brigham and Women’s Hospital in Boston published a case report on a patient with sudden dental problems while using Suboxone tablets. The authors concluded that the “patient’s experience of a sudden decline in her oral health without any changes in her dental hygiene practices or sugary food/beverage consumption raises the possibility that chronic use of sublingual buprenorphine/naloxone may have played a role.”
A year later, the lead author from the 2012 study worked with Harvard colleagues to publish a case series of eleven patients at Brigham and Women’s Hospital. The study patients experienced dental caries, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The authors noted that cavities and tooth erosion “occur when teeth are exposed to an environment that has low pH.”
pH is a scale running between 0 and 14 measuring the acidity or basicity of an aqueous solution. It inversely indicates the activity of hydrogen ions in the solution. A pH of 7 indicates neutral. A pH of less than 7 indicates acidity and a pH of greater than 7 indicates a base.
A Suboxone tablet measures acidic at 3.4 pH. Patients are specifically instructed to keep the Suboxone tablet and the accumulating saliva in their oral cavity to maximize absorption. Based on the average ingestion of Suboxone tablets three times daily for an average span of nine minutes to dissolve, the authors of the 2013 and 2012 studies concluded that “prolonged contact between tooth surfaces with buprenorphine/naloxone, therefore, may be a contributing factor in the alteration of the tooth microbial profile and/or the pH to promote dental caries, similar to what has been previously reported in patients who use methamphetamine.”
What the FDA Says About Suboxone and Dental Health
In 2022, the FDA issued a Drug Safety Communication warning of dental problems reported in patients using buprenorphine-containing medications such as Suboxone. These problems include tooth decay, cavitations, oral infections, and tooth loss. Significantly, dental damage was observed even in patients without prior dental history.
Suboxone Lawsuit Update
August 2025: Not many cases have been added to the federal MDL. Still nearly 900 cases pending.
July 2025: There are nearly 900 cases pending in the federal Multidistrict Litigation (MDL) centered in the Northern District of Ohio, overseen by Judge J. Philip Calabrese.
The litigation is actively progressing, with ongoing discovery and preparation for bellwether trials designed to address and resolve key legal and factual issues within the cases.
Recent court rulings have allowed both design defect claims and failure-to-warn claims to move forward. While the defendants continue to raise federal preemption defenses—arguing that compliance with FDA regulations shields them from some state law claims—courts are pushing ahead, emphasizing the adequacy of safety warnings and manufacturer responsibilities.
To date, no settlement agreements have been reached or approved specifically in this tooth decay litigation. However, separate from dental claims, defendants like Indivior have settled various antitrust and marketing-related lawsuits, including a notable $385 million settlement in 2023.
February 3, 2025: The Suboxone tooth decay litigation continues to grow, with 896 cases now pending in the federal MDL before Judge J. Philip Calabrese in the Northern District of Ohio. Recent case management conferences have focused on establishing protocols for bellwether trials and resolving discovery disputes.
January 23, 2025: A key development in the Suboxone litigation involves failure-to-warn allegations. Suboxone attorneys argue that even if patients would have continued taking the medication, proper safety warnings would have given them the chance to take preventive measures against dental damage, such as increased dental visits and other steps to avoid damage to their teeth.
January 5, 2025: In a significant ruling, the MDL judge partially denied defendants' motion to dismiss, allowing both pre-approval design defect claims and failure-to-warn claims to proceed. The court recognized plaintiffs can argue manufacturers should have pursued safer alternatives before FDA approval.
December 5, 2024: The Suboxone MDL continues to grow. Currently, there are 716 pending cases, and attorneys litigating Suboxone claims believe the litigation will grow.
If you want to know whether you qualify for a Suboxone case, contact us today for a free consultation. Our legal team will evaluate your case and let you know whether or not you have grounds to pursue a tooth decay lawsuit.
November 7, 2024: Last month, we did not see significant growth in Suboxone claims. There are now 678 pending cases in the Suboxone MDL.
October 7, 2024: Suboxone tooth decay lawsuits allege Suboxone, a medication used to treat opioid addiction and opioid use disorder (OUD), causes severe dental problems. Plaintiffs claim that the drug's manufacturers failed to warn about potential side effects, including significant dental issues.
As of this month, there are 674 active lawsuits related to Suboxone and tooth decay. Claimants in the litigation report rapid tooth decay and tooth loss, often requiring expensive treatments such as root canals, dentures, or implants.
August 6, 2024: No significant changes to the Suboxone lawsuit count in the MDL. In fact, the case count dropped to 673.
August 1, 2024: The defendants in Suboxone lawsuits filed a motion to dismiss all claims based on the federal preemption doctrine.
The federal preemption doctrine holds that federal law overrides state law when there is a conflict between the two. In product liability lawsuits against drug makers, defendants often invoke federal preemption to argue that their compliance with FDA regulations protects them from state law claims. Specifically, they contend that because the FDA has approved their drugs, state-level lawsuits alleging inadequate labeling or safety issues should be dismissed. However, the landmark case of Wyeth v. Levine (2009) clarified that federal drug approval does not necessarily shield drug companies from all state law claims.
July 16, 2024: Last month there was a surge in Suboxone lawsuits filed in the federal MDL. With 319 cases added, there are now 677 total cases in the Suboxone MDL-3092.
June 11, 2024: Over 350 suboxone lawsuits are consolidated in the federal MDL. While the litigation continues to grow with more cases filed monthly, there have not yet been any publicly disclosed suboxone settlement agreements for tooth decay. No trial dates have been scheduled.
April 3, 2024: The JPML recently released case totals for the federal Suboxone MDL, where dozens of people currently have tooth decay lawsuits pending. There are now 44 Suboxone lawsuits alleging problems with teeth pending in the Northern District of Ohio. As of this writing, there have not been any court-approved Suboxone settlement agreements publicly announced in the litigation, though that could change in the coming months as discovery and pre-trial proceedings continue.
February 4, 2024: As expected, the Judicial Panel on Multidistrict Litigation (JPML) has consolidated Suboxone lawsuits into an MDL. More than a dozen lawsuits filed in several federal courts throughout the country have been consolidated in the U.S. District Court in the Northern District of Ohio before the Hon. Judge J. Philip Calabrese.
The Suboxone lawsuits involve allegations of fraudulent marketing, sales practices, and product liability of Suboxone film, which is important because cases had previously been filed alleging harm after using Suboxone tablets. Each Suboxone lawsuit currently in the MDL alleges teeth issues after Suboxone film, not Suboxone tablets.
January 26, 2024: The Judicial Panel on Multidistrict Litigation (JPML) met today to discuss whether Suboxone lawsuits should be consolidated into a multidistrict litigation (MDL). While this would not be a Suboxone class action lawsuit, an MDL does share some similarities with class litigation.
Both involve:
- Numerous individual claims consolidated to promote efficiency and collective resolution.
- One or more individuals to represent an entire group's legal interests.
- Shared discovery (evidence is collected and shared among all the plaintiffs, reducing redundancy and increasing efficiency).
However, MDLs and class actions are different in the following ways:
- In a class action, many people with similar claims are represented by one or more individuals (class representatives). In an MDL, individual claims are maintained, but pretrial procedures are coordinated among similar cases.
- In a class action, potential plaintiffs are automatically included as part of the class unless they opt-out. In an MDL, plaintiffs initiate their own lawsuits and opt-in to be part of the coordinated proceedings.
- Most importantly, in a class action, there is one judgment for all class members. In an MDL, each plaintiff maintains control over their individual case, with outcomes determined separately.
Class action attorneys at Wisner Baum believe the JPML will issue a ruling in February to consolidate cases into a Suboxone MDL.
January 12, 2024: A new lawsuit was filed today in Pennsylvania alleging Suboxone film caused teeth damage, which resulted in extensive dental procedures. The plaintiff is seeking damages against the defendants for failing to warn about the potential for dental erosion and tooth decay associated with Suboxone film.
December 15, 2023: The defendants in the Suboxone tooth decay lawsuits recently filed a response to the request for multidistrict litigation (MDL) consolidation. Suboxone defendants agreed with the motion to create a new Suboxone MDL and requested that consolidated cases be assigned to Judge Philip Calabrese in the Northern District of Ohio. Attorneys believe a Suboxone MDL will be established in early 2024.
November 28, 2023: Suboxone lawyers representing the plaintiffs in tooth decay lawsuits have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal lawsuits related to Suboxone into a single multidistrict litigation (MDL). The formation of an MDL, which shares similarities with a class action lawsuit, would consolidate cases in front of one judge and provide a more efficient way to handle the litigation.
November 5, 2023: More than a dozen new Suboxone lawsuits were filed in federal courts against Indivior over the last two weeks. Eight of the complaints were filed in the Northern District of Ohio, which currently has the most pending Suboxone lawsuits in the country.
October 25, 2023: The maker of Suboxone (Indivior) agreed to pay a settlement worth $385 million to resolve antitrust claims. This settlement has no effect on Suboxone lawsuits alleging tooth decay. Instead, Indivior agreed to settle claims that accused the company of illegally suppressing generic competition.
October 16, 2023: An Ohio man filed a Suboxone tooth decay lawsuit in federal court. The plaintiff alleges he became addicted to opioids after receiving a script from his doctor and was eventually prescribed Suboxone to treat his addiction. After a year and four months of taking Suboxone, the plaintiff alleges he suffered severe tooth decay and required several tooth extractions. According to the Suboxone lawsuit, neither the plaintiff nor his doctor knew that Suboxone causes tooth decay.
April 14, 2023: The Federal Trade Commission (FTC) paid some consumers who did not join the Suboxone class action lawsuit before the original deadline.
How to Join Suboxone Lawsuit
The only way to know for certain if you qualify for a Suboxone lawsuit is to fill out a case evaluation form. A Suboxone lawyer will review your case and determine if you are eligible.
Potential plaintiffs in Suboxone lawsuits are individuals who used Suboxone for at least six months prior to 2022 and later experienced severe tooth decay or loss, necessitating corrective dental procedures such as fillings, extractions, or implants.
Please keep in mind that the criteria to qualify for a Suboxone lawsuit may change over time due to court rulings, scientific findings, and other variables.
Who Are the Suboxone Lawsuits Against?
Indivior, Inc. and Aquestive Therapeutics Inc. are the pharmaceutical companies named as defendants in the Suboxone lawsuits. Indivior, specifically, is the primary manufacturer of the drug, but both companies play a significant role in the production and marketing of Suboxone.
Indivior was originally a division of Reckitt Benckiser, a larger pharmaceutical company based in the United Kingdom. When the market for opioid dependence drugs expanded, Reckitt spun off Indivior as a separate publicly traded company. Indivior's close relationship with Reckitt, which continues to own a significant percentage of shares, adds weight to their involvement in lawsuits against Suboxone.
Have People Received Suboxone Settlement Checks?
No, there has not been a Suboxone settlement. With the formation of the Suboxone MDL, we anticipate litigation to continue well into 2025. In mass torts, settlement negotiations could begin at any time, but typically, they do not progress until bellwether trials are due to begin, and we are several months away from trial dates.
It should be noted that Indivior has paid Suboxone settlements stemming from its activities in marketing and selling Suboxone.
In October of 2023, Indivior paid a $385 million settlement resolving lawsuits brought by drug wholesalers alleging the company illegally suppressed generic competition for Suboxone.
In August of 2023, Indivior paid a similar settlement of $30 million to resolve a class action lawsuit brought by health care plans.
The Department of Justice indicted Indivior in June of 2023 for participating in an illegal scheme that funneled patients to specific doctors prescribing Suboxone. To resolve the matter, the company agreed to pay a settlement of $102 million to 41 states and Washington D.C.
In 2021, the Federal Trade Commission announced a $60 million settlement with Indivior over deceptive marketing allegations. Nearly 52,000 people received a payout as part of the settlement.
See If You Qualify for a Lawsuit Against Suboxone
If you or someone you love has suffered tooth decay, tooth loss, or other dental problems after using Suboxone, you may be entitled to significant compensation. The experienced product liability attorneys at Wisner Baum offer free case evaluations and can answer any questions you may have.
Call us today at (310) 207-3233 or fill out our secure case evaluation form to find out if you qualify for the Suboxone tooth decay lawsuit.
Frequently Asked Questions (FAQs)
What is Suboxone used for?
Suboxone is a medication approved by the FDA to treat opioid use disorder (OUD). It contains buprenorphine, which helps reduce opioid withdrawal symptoms and cravings, and naloxone, which helps prevent misuse and overdose. Suboxone is part of a comprehensive addiction treatment program that often includes counseling and therapy.
What dental problems does Suboxone cause?
Users of Suboxone have reported serious dental issues such as tooth decay, cavities, tooth fractures, gum disease, infections, root canals, tooth extractions, crowns, and persistent oral pain. These side effects have led to expensive and painful dental procedures.
Why does Suboxone ruin your teeth?
Suboxone’s acidic formulation (about pH 3.4) combined with prolonged contact in the mouth disrupts normal oral pH and the balance of bacteria. This creates an environment conducive to enamel erosion and tooth decay. Prolonged sublingual usage increases the exposure time, aggravating dental damage.
What were the issues with Suboxone's labeling and warnings?
Lawsuits claim that the drug manufacturers, including Indivior, failed to adequately warn patients and healthcare providers about the risk of dental injuries associated with Suboxone use. Despite evidence and FDA warnings issued in 2022, proper disclosure to users was delayed.
What role does Suboxone sublingual film play in the lawsuits?
Most lawsuits focus on the film strip form of Suboxone, which dissolves slowly under the tongue or between gums and teeth. This slow dissolution prolongs exposure of teeth to the acidic medication, increasing the risk of decay and erosion.
Can I file a lawsuit if I’m still taking Suboxone?
Yes, you may be able to file a lawsuit even if you currently use Suboxone. Claims may qualify as long as dental injuries have developed during or after use and a causal link to the medication can be established.
Can I still file a lawsuit if I no longer use Suboxone?
Yes. Many claimants who have discontinued Suboxone but suffered dental damage related to prior use are eligible to pursue claims.
Has there been a Suboxone recall?
No recall related specifically to dental risks has been issued. The lawsuits focus on allegations that the manufacturers failed to warn patients about known dental dangers.
How much is the Suboxone lawsuit going to payout per person?
Exact settlement amounts depend on individual circumstances, with higher amounts possible for severe injuries requiring extensive dental work.
Is Suboxone safe for long-term use?
Suboxone is an effective treatment for opioid use disorder. However, long-term use without proper dental monitoring and preventive care may increase the risk of significant tooth decay and related problems.
Is there a methadone tooth decay lawsuit?
We are not aware of large-scale lawsuits involving methadone and tooth decay. That said, studies have shown that methadone can cause dental decay. That’s because methadone can cause xerostomia (dry mouth), which can make teeth produce more plaque, potentially leading to tooth decay. Methadone is also acidic, which can lead to dental erosion.
If you or a loved one suffered dental damage from Suboxone use, contact Wisner Baum today for a free confidential consultation. We’ll evaluate your case and explain your options with compassion and experience.
