Key Takeaways
- Thousands of lawsuits have been filed against Suboxone manufacturers, alleging that the sublingual film form of the drug causes severe dental issues such as tooth decay and tooth loss.
- Plaintiffs claim that manufacturers, especially Indivior, failed to provide adequate warnings about these dental risks until a label update in June 2022.
- The lawsuits are ongoing, with eligibility and potential compensation depending on prescription history and documented dental injuries.
Introduction
Suboxone is a prescription medication used to treat opioid use disorder. It contains buprenorphine and naloxone and is commonly administered as a sublingual film that dissolves under the tongue. While Suboxone has played a crucial role in helping individuals recover from opioid addiction, recent legal action has brought attention to serious dental side effects allegedly linked to its use. Over 11,000 lawsuits have been filed, claiming that Suboxone’s manufacturers failed to warn users about the risk of severe tooth decay and other dental injuries.
This guide provides a comprehensive overview of the Suboxone lawsuit, including the nature of the claims, eligibility criteria, legal developments, and broader implications for drug manufacturers and patients.
Background: What Is Suboxone?
Suboxone is a combination medication containing buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist). It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid dependence. The drug is often prescribed as a film that dissolves under the tongue, which allows for rapid absorption.
The sublingual film formulation became popular due to its ease of use and reduced risk of misuse compared to tablet forms. However, concerns have emerged regarding its impact on oral health, particularly when used over extended periods.
For more information about Suboxone’s approved uses, see the FDA’s official page.
Allegations in the Suboxone Lawsuit
Dental Injuries Linked to Suboxone
The core allegation in the Suboxone lawsuits is that the sublingual film form of the drug can cause severe dental problems. Plaintiffs report a range of injuries, including:
- Tooth decay
- Cavities
- Oral infections
- Tooth loss
These injuries are said to result from the acidic nature of the film and its prolonged contact with teeth and gums. Many plaintiffs allege that they were not warned about these risks and only learned of the connection after experiencing significant dental damage.
Failure to Warn
A central claim is that Indivior and other manufacturers failed to provide adequate warnings about the risk of dental injuries. The lawsuits argue that patients and healthcare providers were not informed of these dangers until the FDA required a label update in June 2022. Before this update, the risk of tooth decay and related problems was not prominently disclosed.
The FDA’s safety communication on this issue can be found here.
Consolidation and Scope
Given the large number of similar claims, the lawsuits have been consolidated in federal court as a multidistrict litigation (MDL). This process streamlines pretrial proceedings for cases with common factual questions. Plaintiffs’ attorneys are actively gathering dental records and prescription histories to support individual claims.
Eligibility and Joining the Lawsuit
Who Qualifies?
Eligibility for the Suboxone dental lawsuit generally requires:
- Use of Suboxone sublingual film in the United States between March 1, 2013, and February 28, 2019
- Prescription of Suboxone prior to the June 2022 label update
- Documentation of severe dental injuries (such as tooth decay, cavities, or tooth loss) that occurred after starting Suboxone
Individuals interested in joining the lawsuit are typically asked to provide dental records and proof of Suboxone prescriptions. For more details on eligibility and the sign-up process, see the TruLaw eligibility guide and TorHoerman Law’s FAQ.
How to Join
Potential claimants should consult with an attorney experienced in pharmaceutical litigation. Attorneys will review medical and dental records to determine if a viable claim exists. The process may involve:
- Initial consultation and case evaluation
- Collection of relevant records
- Filing of a claim within the MDL or relevant state court
Legal Developments and Settlements
Status of the Lawsuits
As of mid-2024, the Suboxone dental lawsuits are ongoing. The cases are in the pretrial phase, with plaintiffs and defendants exchanging evidence and expert testimony. No global settlement has been reached for the dental claims, and the outcome remains uncertain.
It is important to note that all allegations are based on current information and have not been proven in court. The legal process may reveal additional facts or result in changes to the claims.
Other Legal Actions Against Indivior
Indivior, the primary manufacturer of Suboxone, has faced additional legal challenges unrelated to the dental lawsuits. In October 2023, Indivior agreed to pay $385 million to resolve antitrust claims. This settlement addressed allegations of anti-competitive practices but does not impact the ongoing dental litigation.
The Massachusetts Attorney General also secured a $6.65 million settlement from Indivior for alleged false and aggressive marketing of Suboxone, which led to improper Medicaid expenditures. These actions highlight broader concerns about pharmaceutical marketing and consumer protection.
For official press releases and settlement details, see the U.S. Department of Justice and Massachusetts Attorney General’s Office.
Estimated Settlement Values
While no settlements have been finalized for the dental lawsuits, some mass tort attorneys estimate that successful claims could result in payouts ranging from $30,000 to $50,000 per claimant. These figures are based on prior pharmaceutical settlements and the severity of alleged injuries. Actual compensation will depend on the strength of individual cases and the outcome of negotiations or trials.
Broader Implications
Drug Manufacturer Responsibilities
The Suboxone lawsuits underscore the importance of transparency and adequate warnings for prescription medications. Drug manufacturers have a legal duty to inform patients and healthcare providers of known risks associated with their products. Failure to do so can result in liability for injuries caused by undisclosed side effects.
Impact on Patients
For patients, these lawsuits highlight the need to stay informed about potential side effects and to report any adverse events to healthcare providers and regulatory agencies. The FDA’s MedWatch program allows consumers to report drug-related problems.
Ongoing Litigation
The outcome of the Suboxone lawsuits may influence future pharmaceutical litigation and regulatory practices. As the cases proceed, courts will consider the adequacy of warnings, causation of injuries, and the extent of damages. Updates on the litigation can be found through official court records and reputable legal news sources.
Resources and Official Information
- FDA Safety Communication on Suboxone Dental Risks
- Indivior Antitrust Settlement - U.S. DOJ
- Massachusetts AG Settlement Announcement
- FDA Suboxone Label
- FDA MedWatch Reporting
Conclusion
The Suboxone lawsuits represent a significant legal challenge for drug manufacturers and a critical issue for patients who have experienced dental injuries. The litigation centers on allegations that the sublingual film form of Suboxone can cause severe tooth decay and that manufacturers failed to provide adequate warnings until recently. The cases are ongoing, and outcomes will depend on the evidence presented and the legal process.
For attorneys and legal professionals seeking in-depth research and updates, visit Counsel Stack.
Disclaimer:
This guide provides a general overview of the Suboxone lawsuits based on publicly available information and current allegations. The litigation is ongoing, and facts may change as cases proceed. This is not legal advice. For advice specific to your situation, consult a qualified attorney.
