Formation of the MDL
In February 2024, the Judicial Panel on Multidistrict Litigation combined federal lawsuits alleging that Suboxone film caused tooth decay into a single coordinated proceeding. The case is formally known as In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, and is assigned to Judge J. Philip Calabrese in the Northern District of Ohio. The defendants named in the litigation include Indivior and Aquestive Therapeutics.[2]
A multidistrict litigation, or MDL, is a procedural tool used by federal courts when many similar cases are filed in different districts across the country. The cases are transferred to a single judge who oversees pretrial proceedings, including discovery and motion practice. This coordination is meant to avoid duplicative work and inconsistent rulings. Individual cases remain separate and can later be remanded to their original courts if they do not settle or get resolved during the MDL process.
The lawsuits in this MDL allege that the use of Suboxone film caused serious dental damage. No court has yet ruled on the merits of these allegations.[2]
Discovery Orders
In October 2025, Judge Calabrese issued an order requiring the defendants to produce extensive internal records. The order specifically directed Indivior and Aquestive to turn over adverse event reports that had been searched using dental-related terms.[3]
Adverse event reports are records that pharmaceutical companies maintain about health problems reported by patients or healthcare providers in connection with their products. Discovery is the phase of litigation in which each side must share relevant documents and information with the other. Orders like this one are common in product liability MDLs, where plaintiffs seek to learn what the manufacturers knew about potential risks and when they knew it.
Growth of the MDL and Bellwether Preparation
By May 2026, the MDL had grown to include 1,832 lawsuits. At that point, Judge Calabrese had approved a bellwether pool and set deadlines related to it.[4]
A bellwether pool is a group of cases selected to go through intensive preparation for early trial. These cases are meant to be representative of the larger group of claims. Bellwether trials serve several purposes: they test the strengths and weaknesses of each side's arguments, they give both parties a sense of how juries may respond to the evidence, and they often provide a foundation for settlement negotiations. The results of bellwether trials are not binding on other plaintiffs, but they can influence the trajectory of the litigation.
Label Warning
Indivior added a warning about tooth decay to the Suboxone label in 2022. The FDA had first approved the drug approximately 20 years before that warning was added.[1]
The timing of the warning is a background fact relevant to the litigation. Plaintiffs in product liability cases often point to the timing of label changes as part of their argument that a manufacturer should have warned users earlier. However, the addition of a warning does not by itself establish liability, nor does it mean that the product caused the harm alleged. Courts evaluate these questions based on the full evidentiary record.
Where Things Stand Now
The first bellwether trial in the Suboxone MDL is scheduled for March 2028.[5]
As of the record we track, the defendants have not been found liable in any trial. There is no settlement in place, and no claim form has been made available to plaintiffs.[5]
The litigation remains in the pretrial phase. Discovery is ongoing, and the bellwether process is moving forward on the schedule set by the court. The March 2028 trial date represents the next major milestone, but much can happen between now and then, including additional motion practice, further discovery disputes, and the possibility of settlement discussions.
What Is Not Known Yet
The record we track does not show whether any individual cases have been dismissed, whether any motions to dismiss or for summary judgment have been filed or decided, or whether settlement negotiations are underway. We do not have information about the specific allegations in the bellwether cases selected for early trial, the identities of retained experts, or the results of any mediation sessions that may have occurred. The outcome of the March 2028 trial, and whether it will actually proceed on schedule, remains to be seen.
Sources
- Suboxone label (2022-06-01). Secondary report: verusllc.com
- In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092 (N.D. Ohio) (2024-02-02). Primary document: jpml.uscourts.gov
- MDL No. 3092 (N.D. Ohio) (2025-10-08). Secondary report: wisnerbaum.com
- MDL No. 3092 (N.D. Ohio) (2026-05-01). Secondary report: robertkinglawfirm.com
- MDL No. 3092 (N.D. Ohio) (2026-06-24). Secondary report: openclassactions.com
Litigation facts on this page come from the TortIntel litigation record and the documents linked above. Last checked against that record on 2026-10-24. If you see an error, tell us and we will correct it.