Suboxone Lawsuit Updates
Court Considers Sanctions Against Noncompliant Providers in MDL Records Dispute
Judge Calabrese held a show-cause hearing regarding four providers who failed to produce medical records despite court orders and extensive efforts by plaintiffs’ counsel since March 2025. No representatives for the providers appeared. The judge is now considering imposing sanctions, including payment of fees and expenses incurred by plaintiffs to compel compliance. This issue is critical to advancing the MDL, as missing prescription histories prevent plaintiffs from proving their cases. The court’s willingness to enforce sanctions underscores the urgency of breaking procedural logjams to maintain momentum toward bellwether trials and settlements.
54 Plaintiffs File Joint Suboxone Lawsuit Alleging Acidic Film Caused Permanent Dental Damage
A group of 54 plaintiffs from across the United States has filed a joint complaint in the Suboxone MDL, alleging severe, irreversible dental injuries caused by the prescribed use of Suboxone film. The lawsuit claims manufacturers knowingly designed the dissolvable film with an acidic formulation that erodes tooth enamel, leading to decay, erosion, tooth loss, and extensive dental procedures, while failing to adequately warn patients or physicians of these risks. Each plaintiff asserts they suffered permanent dental harm after using the film as prescribed for opioid use disorder or pain management. The complaint alleges defendants ignored internal data and scientific literature linking the product’s acidity to oral damage and violated their duty to promptly update warnings via the FDA’s Changes Being Effected (CBE) process. Only a limited warning was added in June 2022 following an FDA mandate.
Court Escalates Enforcement Against Pharmacies Delaying Suboxone Dental Injury Records
Persistent delays in obtaining medical and pharmacy records remain a major obstacle in Suboxone tooth decay litigation. Despite court orders, many pharmacies have failed to produce prescription histories proving plaintiffs used brand-name Suboxone film before dental injuries occurred. On August 25, custodians from nearly twenty noncompliant pharmacies must appear before Judge Calabrese to show cause for defying production deadlines. This follows documented failures to respond to requests. Without these critical records, plaintiffs cannot advance claims, stalling the selection of 15 bellwether cases from 500 and impeding settlement prospects. Resolving this bottleneck is essential for trial progress and global resolution.
Suboxone Tooth Decay Litigation Holds at 889 Cases; Legal Pathways Remain Open
As of August 1, 2025, the Suboxone multidistrict litigation (MDL 3092) involves 889 active cases alleging the opioid treatment drug caused severe dental injuries (e.g., enamel erosion, tooth loss). While new filings have stabilized, individuals harmed by Suboxone may still explore compensation options despite some expired deadlines. Attorneys are pursuing alternative legal strategies for eligible victims, and select firms—including ours—continue evaluating cases to advise on potential claims. The litigation targets manufacturers Indivior and Reckitt Benckiser for failing to warn about the acidic film’s corrosive effects on teeth.
About Suboxone Lawsuits
The Suboxone tooth decay lawsuit involves cases against the pharmaceutical company behind the opioid addiction treatment, Suboxone. Claimants allege that the medication causes severe dental issues, including tooth decay, cavities, and even tooth loss.
Suboxone, which contains two main ingredients, buprenorphine, and naloxone, has been widely prescribed to help individuals overcome opioid dependence and decrease the severity of withdrawal symptoms. However, many users have reported unexpected and severe oral health problems after long-term use of the drug.
Indivior, the maker of Suboxone, originally manufactured this drug as a tablet. However, they developed Suboxone film in 2010 to compete with the generic version of the drug. Up until 2021, a multitude of cases related to declining oral health were reportedly associated with using Suboxone film, indicating defendants’ awareness of the dental health issues.
The plaintiffs in these lawsuits argue that the drug manufacturers failed to adequately warn patients and healthcare providers about the potential risks of tooth decay and other dental issues associated with Suboxone use. The lawsuits claim that patients could have taken preventive measures or explored alternative treatment options if Indivior had adequately communicated the risks.
In response, the drug manufacturers have maintained that they provided all necessary warnings and instructions regarding the drug’s use, including advising patients to rinse their mouths after taking Suboxone to mitigate dental risks. Indivior had a legal obligation to inform customers of the risks associated with the sublingual film version of this drug.
However, because the company didn’t explicitly warn users about the risk of tooth decay, Indivior breached its duty of care and could be liable for the damages that users incurred. As the lawsuits continue to develop, patients affected by these dental issues are seeking compensation for medical bills, dental treatments, and pain and suffering.
In January of 2022, the FDA required Indivior to include a warning of tooth decay caused by this drug. However, this was too little, too late, as the drug had been on the market for almost 20 years without a tooth decay warning for consumers.
This case raises important questions about the responsibility of pharmaceutical companies to fully disclose side effects, especially when the drug in question is used as a long-term treatment for addiction recovery.
How is Suboxone Linked to Dental Health Issues?
Victims who used Suboxone sublingual film to treat opioid dependence are facing significant dental deterioration, tooth and gum injuries, and, in some cases, tooth loss.
A 2012 study by Harvard Medical School highlighted a case where a patient on long-term Suboxone treatment suffered rapid dental deterioration. Researchers suggested that the medication's sublingual delivery and low pH (3.4) may contribute to these dental health problems in patients.
Plaintiffs in the Suboxone lawsuit argue that manufacturers had enough evidence to be aware of the risks but failed to provide adequate warnings, favoring profits over patient safety.
How to Potentially Qualify for the Suboxone Lawsuit
To potentially qualify for the Suboxone tooth decay lawsuit, you must prove the following:
- You used Suboxone sublingual films as prescribed to treat opioid addiction or for pain management before 2022.
- Used prescription Suboxone for at least six months before suffering injuries.
- You experienced severe dental issues beyond the average rate of tooth decay.
- Because of your dental injuries, you sustained monetary damages.
If you meet the above requirements, you may be entitled to compensation. We encourage you to seek legal advice to determine your eligibility. Various factors impact eligibility, and all cases are unique.
To demonstrate that Suboxone directly caused dental problems, plaintiffs must present personalized evidence, such as the victim’s dental records and expert dental assessments. Suboxone-related dental issues include:
- Severe tooth decay
- Tooth loss and extraction
- Dental erosion
- Cracked teeth and increase in cavities
- Injuries to the gum and teeth
- Gingivitis
You must meet the burden of proof, which means there needs to be a clear connection between Indivior’s actions, your dental issues, and your financial losses because of your medical bills. Your compensation eligibility will depend on the medical evidence documented by your provider, as well as your own statements and documentation.
Which Companies are involved in the Suboxone Lawsuit?
The Suboxone lawsuits primarily target Indivior, Inc., a pharmaceutical company specializing in treatments for substance use disorders and serious mental illnesses.
Indivior was originally a division of the British company Reckitt Benckiser, but in 2014, Reckitt spun off Indivior as a separate, publicly traded company. Both Indivior and Reckitt, along with their U.S. operating entities, are named as defendants, although primary liability rests with Indivior.
Another key defendant is Aquestive Therapeutics, a New Jersey-based pharmaceutical company that co-developed Suboxone with Indivior.
How Much Has The Manufacturer Agreeded To Pay?
In October 2023, Indivior agreed to a $385 million settlement to end cases in a multidistrict litigation.
Please note that there is a broad range of what each individual may receive on a per-case basis. We cannot provide you with an accurate estimate of compensation; however, the potential compensation you could receive will depend on the details of your specific case.
We encourage you to start the process of finding out if you may qualify for a Suboxone class action lawsuit. We can help you stay informed and provide you with the latest updates regarding the lawsuit. Subscribe to OnlyClassActions for further details.
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