The Suboxone dental injury multidistrict litigation continues to advance through the federal court system, with significant developments over the past several months. This update summarizes the status of MDL No. 3092 in the U.S. District Court for the Northern District of Ohio under Judge J. Philip Calabrese.
Court Ruling Allows Key Claims to Proceed
In a pivotal decision issued on December 31, 2024, Judge Calabrese largely denied Indivior Inc.’s motion to dismiss, allowing the core elements of the litigation to move forward. The ruling addressed two primary areas of claims: failure to warn and design defects.
The court found that design defect claims relating to decisions made before FDA approval in 2010 can proceed against all defendants, including Indivior Inc., Indivior Solutions, and Aquestive Therapeutics. These claims center on allegations that the companies should have designed a safer alternative, such as an injectable form of the medication, before seeking FDA approval for the sublingual film formulation.
However, the court dismissed design defect claims related to changes that could have been made after FDA approval, recognizing that federal law prevents manufacturers from altering an approved drug’s formulation without agency permission.
The failure-to-warn claims were preserved but with specific limitations. These claims can proceed against Indivior Inc. as the holder of the FDA approval, but only for the period between 2010 and June 2022, when the company added dental risk warnings to the product labeling.
Current Case Volume and Filing Procedures
As of June 2025, the MDL includes 892 active federal cases. To manage the large volume of cases, Judge Calabrese issued Case Management Order No. 14, which allows attorneys to file complaints containing up to 100 plaintiffs in a single document. This procedural change has streamlined the filing process, reduced associated costs, and maintained the court’s ability to manage its growing caseload.
The case volume has expanded significantly since the beginning of 2025, growing from 754 pending cases in January to nearly 900 by February.
Discovery Process and Compliance Measures
The litigation has entered an intensive discovery phase, with the court implementing several measures to ensure the timely production of essential evidence and documentation.
In March 2025, the court resolved a significant dispute regarding search terms for electronically stored information. This ruling cleared the path for plaintiffs’ attorneys to review Indivior’s internal documents, emails, and reports that may reveal the company’s knowledge of Suboxone’s dental risks and the timeline of that knowledge.
To expedite the collection of medical evidence, the court issued an order in February 2025, requiring healthcare providers and pharmacies to produce requested patient records within 30 days of receiving a request. The order accepts electronic signatures and standard forms to streamline the process.
Plaintiffs’ attorneys are also planning to conduct corporate depositions of Indivior. These depositions will examine the company’s knowledge of dental injury complaints, the circumstances surrounding the 2022 FDA-mandated label change, and the corporate structure related to the development and distribution of Suboxone.
Bellwether Trial Preparations
The court has made substantial progress toward establishing bellwether trials, which will serve as test cases to evaluate the strength of legal theories and potentially influence future settlement discussions.
The bellwether selection process involves multiple phases designed to create a representative sample of cases. At first, a pool of 500 plaintiffs was identified for focused discovery. These individuals must provide medical authorizations and dental records by August 1, 2025.
From this initial group, 100 cases will be randomly selected for in-depth discovery proceedings. This core discovery pool will then be narrowed to 50 cases through random selection and strategic choices by both plaintiffs’ and defendants’ counsel. Ultimately, four cases will move forward as bellwether trials.
Background on Dental Risk Claims
The litigation centers on allegations that Suboxone’s acidic formulation causes severe dental problems, including tooth decay, fractures, oral infections, and tooth loss. The sublingual film, designed to dissolve under the tongue for maximum absorption, exposes teeth to highly acidic conditions that can erode enamel.
The plaintiffs’ arguments received significant support when the FDA issued a warning in January 2022 regarding dental problems associated with buprenorphine medications administered sublingually. Following this FDA communication, Indivior updated Suboxone’s warning label in June 2022 to include information about potential dental problems.
Timeline and Settlement Prospects
The court’s structured approach to bellwether trial preparation suggests that initial trials will begin in 2026. These bellwether trials will provide essential insights into jury reactions to the evidence and the viability of various legal theories.
While no settlements have been reached as of June 2025, industry observers expect that meaningful settlement discussions may intensify following the choice of bellwether trial cases and potentially after initial trial outcomes. Current projections suggest that any comprehensive settlement resolution is more likely to occur in 2026.
The discovery process will continue to focus on Indivior’s pre-2022 knowledge of dental risks and the development decisions made before the 2010 FDA approval. These areas of inquiry will be critical to establishing the foundation for both the failure-to-warn and design defect claims that survived the motion to dismiss.
Moving Forward
The Suboxone dental injury litigation has reached an important juncture, with the court’s December 2024 ruling setting the legal framework for moving forward. The structured discovery process and bellwether trial preparation show the court’s commitment to efficiently managing this complex litigation while ensuring a thorough examination of the key issues.
As the case progresses through discovery and toward trial, the focus will remain on documenting the extent of Indivior’s knowledge regarding dental risks and evaluating whether the company met its obligations to warn users and design a reasonably safe product. The outcomes of the upcoming bellwether trials will likely provide significant guidance for resolving the cases in the MDL.