Suboxone Lawsuit Updates
Judge Issues Order to Streamline Medical Record Collection
A new order in the MDL establishes procedures for obtaining medical and dental records efficiently. It applies to all plaintiffs and entities holding relevant records, including hospitals, pharmacies, doctors, and dentists. Medical providers must accept signed authorizations—electronic or ink—without requiring additional forms or identification. Records must be released within 30 days, and failure to comply will be treated as a violation of Rule 45 of the Federal Rules of Civil Procedure, potentially leading to court penalties. Plaintiffs’ attorneys will monitor compliance, ensuring delays do not hinder the litigation. This order aims to eliminate obstacles and expedite access to critical medical evidence.
Status Conference Held for The Suboxone MDL
The court held a status conference to address key procedural matters in the Suboxone litigation. The judge outlined a process for the withdrawal of counsel for plaintiffs listed on Schedule A and directed attorneys to collaborate on discovery issues, including compliance with records requests and the scope of electronically stored information (ESI) production. Defendants were ordered to produce the new drug application (NDA) for Sublocade. An informal working session on ESI search terms is set for March 10, 2025. The next status conference is scheduled for March 11, 2025, with related deadlines set for March 5 and March 7, 2025.
FDA Delays Decision on Sublocade Label Changes
Indivior announced that the FDA has delayed its decision on proposed label changes for Sublocade, its lead opioid addiction treatment. The company sought approval to expand injection sites beyond the abdomen and allow a second dose as early as one week after the first injection, aiming to improve flexibility and adherence. The delay comes amid growing competition from Brixadi and a 21% decline in Indivior’s stock over six months. While this setback is notable, Indivior’s greater challenge remains the mounting Suboxone litigation, with investors increasingly aware of the company’s significant financial exposure.
Indivior Faces High-Stakes Over Suboxone Injuries
Indivior may believe plaintiffs’ histories of opioid addiction weaken their cases, but this would be a costly miscalculation. Juries do not judge individuals solely by their past—they focus on the devastating dental injuries caused by Suboxone and Indivior’s failure to warn despite knowing the risks. Plaintiffs’ stories of disfiguring tooth loss, career setbacks, and emotional distress will resonate in court. Indivior’s past legal troubles also undermine its credibility. If the company underestimates the strength of these cases, it risks massive jury verdicts. Plaintiffs’ attorneys are prepared to go to trial if settlement offers do not adequately reflect the harm suffered.
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 Pre-Qualify for the Suboxone Lawsuit
To pre-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 Manufacture 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 pre-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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