Suboxone Lawsuit Updates
FDA to Revise Buprenorphine Dosage Guidelines Amid AMA Concerns Over Prescriber Confusion
The FDA plans to adjust maximum dosage recommendations for buprenorphine-containing medications (e.g., Suboxone) following American Medical Association (AMA) input. The AMA asserts current labeling ambiguities confuse prescribers about permissible dosing for opioid use disorder treatment. While clarified guidelines may improve treatment accessibility, they could inadvertently increase dental decay risks associated with long-term buprenorphine exposure—a known side effect recently highlighted in product liability litigation. This regulatory refinement aims to balance therapeutic efficacy against patient safety considerations. Healthcare providers should monitor emerging guidance to optimize risk-benefit assessments when treating addiction. The update reflects ongoing efforts to align prescribing protocols with clinical evidence and risk management.
Judge Moves Forward with Walgreens Show-Cause Hearing in Suboxone Case
Obtaining pharmacy records remains a key hurdle in the Suboxone litigation. On June 19, 2025, the court addressed noncompliance with Case Management Order No. 13, which mandates that pharmacies produce records within 30 days of receiving valid medical authorizations. Walgreens, Safeway, and Porch Light Health | Front Range Clinic had been ordered to show cause for alleged delays. However, the judge has since withdrawn the order for Safeway and Porch Light Health after they were found compliant. Walgreens, however, still faces a show-cause hearing scheduled for Friday to address its failure to meet the record production requirements.
Suboxone Bellwether Trial Pool Advances as Plaintiffs Submit Documentation
Judge J. Philip Calabrese has identified plaintiffs for the Suboxone multidistrict litigation’s (MDL 3065) bellwether trial pool. These cases will proceed to early trials to gauge outcomes for broader claims alleging dental erosion, addiction, and other injuries. Currently, 190 plaintiffs have submitted required documentation, and records requests have been issued to 847 medical providers to substantiate injuries. This phase signals efficient progress toward bellwether trials, accelerating resolution pathways for thousands alleging harm from the opioid-dependence drug. While settlements remain possible, the structured discovery process strengthens plaintiffs’ leverage in negotiations.
Court Holds Walgreens Accountable for Delayed Suboxone Records
The Suboxone litigation faces persistent challenges in obtaining pharmacy records, with providers often dragging their feet. Last month, a judge issued show-cause orders to Walgreens, Safeway, and Porch Light Health | Front Range Clinic for failing to comply with Case Management Order No. 13, which mandates pharmacy record production within 30 days of receiving valid authorizations. While the court lifted the order for two providers after confirming compliance, Walgreens must still appear at Friday’s hearing to justify its delays. The ruling underscores judicial impatience with obstructionist tactics that slow progress in this complex litigation.
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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