500 Suboxone Tooth Decay Cases Randomly Selected for Bellwether Record Collection Pool

Lawyers will begin case-specific discovery in the Suboxone cases, with a smaller number being selected in the future as potential bellwether trial candidates.

The U.S. District Judge presiding over all federal Suboxone tooth decay lawsuits has announced the random selection of 500 cases that will make up a “record collection pool,” which will go through case-specific discovery and further work up as part of a process designed to identify claims most suitable for a series of early test trials in the future.

The Suboxone cases were selected from more than 11,000 product liability lawsuits brought in the federal court system, each raising similar allegations that users of the opioid addiction treatment were not adequately warned about the risk that the sublingual film version of the drug can cause severe tooth decay problems.

Suboxone (buprenorphine and naloxone) was first introduced in 2002, and originally sold in tablet form to help users avoid withdrawal symptoms while undergoing therapy to help them break their addiction. However, the product’s manufacturer, Indivior, subsequently introduced a filmstrip version, which users place beneath their tongue until it dissolves.

Within a few years of the design change, Indivior and federal health officials began receiving dental damage reports from patients, resulting in Suboxone tooth decay side effects being added to the drug’s warning label in June 2022. However, plaintiffs allege they could have avoided permanent dental problems if earlier warnings and instructions had been provided.

Last year, all federal Suboxone tooth decay cases were centralized as part of a multidistrict litigation (MDL) in the Northern District of Ohio, where U.S. District Judge Philip Calabrese was appointed to oversee coordinated discovery and pretrial proceedings in claims brought by former users throughout the country.

Once the Suboxone MDL was established, a potential deadline for individuals living in states with a two-year statute of limitations led to an influx of new claims that needed to be filed in June 2024. To avoid overwhelming the court, Judge Calabrese allowed the filing of one bundled Suboxone lawsuit, known as the Schedule A cases, which included about 9,600 individuals who were still gathering documentation to support their claims.

As lawyers continue to work to investigate these claims, Judge Calabrese has called on the parties to identify a small group of representative tooth loss claims, which will serve as bellwether test cases for early jury trials and promote potential Suboxone settlement talks to resolve the litigation as a whole.

Suboxone Record Collection Pool

Last month, a case management order (PDF) was issued by Judge Calabrese, indicating that the court would randomly choose 500 Suboxone tooth decay lawsuits to serve as a Records Collection Pool, meaning those cases will undergo case-specific discovery. The list (PDF) was released on April 18, including 100 cases selected as individually filed lawsuits, as well as 400 cases filed in the bundled Schedule A complaint.

“The Record Collection Phase will be deemed substantially complete when (1) Defendants have completed records collection for 85% (425) of the Plaintiffs in the Records Collection Pool, or fewer upon agreement of the parties and (2) the parties have substantially completed their ESI (electronically stored information) productions,” Judge Calabrese wrote. “The parties will jointly advise the Court when that threshold is met.”

Throughout the remainder of 2025, parties will continue to work with the Court to identify a small group of Suboxone tooth loss lawsuits, which raise allegations representative of others in the litigation, to prepare for a series of early bellwether trials in the future.

While the outcome of these early Suboxone trial dates in the MDL will not have any binding impact on remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone settlements the drug maker may offer to avoid the need for each individual lawsuit to go before a jury in the future.