MDL Judge Calls for New Census of Suboxone Tooth Decay Lawsuits

From October 1 forward, all new Suboxone tooth decay lawsuits will need to complete a census form within 60 days of filing.

The U.S. District Judge presiding over all Suboxone tooth decay lawsuits has updated the procedures for providing certain census information about each claim filed in the federal multidistrict litigation (MDL), including new requirements that for all cases brought after October 1, plaintiffs must submit a completed census form within sixty days after the lawsuit is filed.

Suboxone (buprenorphine and naloxone) is a widely used prescription medication, which is designed to help individuals avoid opioid withdrawal symptoms while undergoing drug addiction therapy. Although the drug was first instruduced in tablet form in 2002, the litigation centers on a filmstrip version of the medication that the drug maker Indivior later introduced, where users place the medication under the tongue to dissolve, which has been found to cause dental erosion, tooth decay and tooth loss.

In 2022, the U.S. Food and Drug Administration (FDA) required new Suboxone tooth decay warnings for the film strips’ warning label, following hundreds of complaints involving dental damage. Since then, more than 11,000 product liability lawsuits have been filed against Indivior and its parent company, Reckitt Benkiser, each making similar claims that the manufacturers failed to adequately warn consumers and the medical community of the risks of Suboxone dental enamel erosion, leading to dental damage.

Given common questions of fact and law, all Suboxone tooth decay lawsuits filed throughout the federal court system have been consolidated in the Northern District for Ohio under U.S. District Judge Philip Calabrese, who is overseeing coordinated discovery and pretrial proceedings.

Previously, the Suboxone MDL has seen massive influxes of claims as various state statute of limitations dates approached, based off of the 2022 FDA label warning update. To facilitate pretrial proceedings in these large batches of claims, Judge Calabrese has allowed the filing of multiple claims on a single complaint and extended discovery deadlines for each individual case.

Last week, Judge Calabrese issued a new case management order (PDF) establishing new census procedures, which are designed to help the court and lawyers involved in the litigation better understand the size and scope of the litigation.

The original census protocols applied to all cases filed up to October 7, 2024. For all plaintiffs who filed Suboxone tooth decay lawsuits between October 8, 2024 and September 30, 2025, the court is now requiring that completed census forms be submitted by June 1, 2026.

To prevent the creation of another backlog, Judge Calabrese also ordered that for all future Suboxone lawsuits brought after October 1, 2025, plaintiffs must have a completed census form submitted within 60 days after the day the complaint is filed.

Suboxone Tooth Decay Bellwether Lawsuits

Early in the litigation, Judge Calabrese indicated that the parties should focus on preparing a small group of cases for “bellwether” test trials, which will help the lawyers and court see how juries are likely to respond to evidence and testimony that will be repeated throughout the litigation.

The Court previously designated 500 cases for a “Records Collection Pool,” which the parties will narrow down to 100 representative cases that will be eligible for the next phase of discovery.

Following the exchange of case-specific discovery, the parties will then be asked to select a group of claims that will be eligible for the first bellwether trials.

While the outcome of these Suboxone trials will not be binding on other plaintiffs, they will be closely watched to see how jurors may respond to a typical claim. The results of those trials could help the parties in negotiations reach a Suboxone tooth decay settlement agreement, which would prevent the need for thousands of time-consuming and expensive individual federal trials.

If no Suboxone settlement is reached, Judge Calabrese could begin remanding thousands of individual claims to their originating court for individual trial dates.