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Suboxone Manufacturer Faces Nearly 18,000 Dental Erosion Lawsuits

The makers of the opioid addiction treatment Suboxone face 17,911 lawsuits filed by individuals nationwide who say the film strips have caused severe dental damage, as attorneys continue to parse through a pool of potential test cases that will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony likely to be repeated throughout the litigation.

Each of the lawsuits involve similar claims that users were not adequately warned about the risk of dental decay from Suboxone film strips, which have been widely prescribed to reduce cravings and ease withdrawal symptoms among opioid addicts. The drug was first approved in tablet form in 2002, before later being reformulated as a dissolvable film strip placed under the tongue.

Indivior, the manufacturer of Suboxone, began facing a growing number of dental erosion lawsuits after reports linked the sublingual film strips to severe tooth decay, tooth loss, disfigurement and extensive dental work. By June 2022, the U.S. Food and Drug Administration (FDA) issued a Suboxone tooth decay warning after receiving hundreds of reports involving dental problems and required updated label warnings.

Plaintiffs allege those warnings should have appeared on Suboxone packaging from the start, with lawsuits claiming Indivior knew, or should have known, about the risk of serious dental damage, but withheld the information from users and the medical community.

Suboxone Lawsuits Over Tooth Decay and Tooth Loss
Suboxone Lawsuits Over Tooth Decay and Tooth Loss

Common questions of fact and law run through all of the federal Suboxone dental erosion lawsuits, which led to their centralization as part of a multidistrict litigation (MDL) in the Northern District of Ohio before U.S. District Judge Philip Calabrese, who is overseeing coordinated discovery and pretrial proceedings.

Judge Calabrese previously directed the parties to prepare a group of representative cases for a series of bellwether trials, which are designed to give them an opportunity to observe how juries respond and evaluate the strengths or weaknesses of their claims, potentially promoting settlement negotiations.

On June 26, the Plaintiffsโ€™ Leadership Committee (PLC), a group of attorneys appointed to represent the common interests of individuals pursuing Suboxone tooth damage claims, submitted a census report (PDF) to update Judge Calabrese on the size of the litigation. According to the report, 17,911 federal Suboxone dental erosion lawsuits had been served against Indivior and consolidated in the MDL as of the close of business on June 25.

However, that figure does not necessarily reflect the total number of individual plaintiffs pursuing claims. A number of the lawsuits have been filed as multi-plaintiff complaints, with some naming dozens of individuals, and in some cases up to 100 plaintiffs, in a single filing. While those complaints may appear on the docket as one lawsuit, each named plaintiff is pursuing an individual claim based on their own Suboxone use and dental injuries.

The total also includes a group of claims known as the โ€œSchedule Aโ€ list, which consists of thousands of abbreviated complaints allowed by Judge Calabrese before the two-year anniversary of the FDAโ€™s warning label requirement in June 2024, which may have served as the statute of limitations deadline in many states.

Those abbreviated filings lacked key details, such as injury data, medical records and product use history. However, the Schedule A process allowed claims to be filed before state deadlines while lawyers continued working to secure supporting documentation.

Last month, Judge Calabrese called for those claims to be quickly incorporated into the main body of lawsuits. Originally including more than 9,600 Suboxone claims, the latest census report indicates that only 4,854 remain on the Schedule A list.

Suboxone Dental Erosion Bellwether Lawsuits

Judge Calabrese has been directing the parties to prepare a group of representative Suboxone dental erosion lawsuits to serve as potential bellwether trials.

He originally designated 500 Suboxone tooth decay lawsuits as part of a Records Collection Pool in May 2025. That pool has been slowly whittled down over the last year. For the next stage, the parties have been ordered to select 15 claims by July 13, 2026.

That group will be cut down to four final bellwether selections by June 11, 2027. However, the first Suboxone bellwether trial is not expected to go before a jury until March 2028.

While the outcomes of these early test trials are not binding on other cases, they are usually watched closely, as the results could factor into any Suboxone dental erosion lawsuit settlement agreement. If the bellwether trials end without such a settlement or other resolution to the litigation, Judge Calabrese would likely begin remanding them back to their originating federal districts for individual trial dates.

To stay up to date on this litigation, sign up to receive Suboxone tooth decay lawsuit updates sent directly to your inbox.

Irvin Jackson
Written By: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.



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