Suboxone Dental Erosion Lawsuit Alleges Indivior Should Have Known About Tooth Decay Risks

Lawsuit claims Indivior downplayed how long Suboxone film strips stayed in direct contact with patients’ teeth and gums, allegedly concealing the extent of their exposure to enamel-eroding ingredients.

Nine individuals from across the country have filed a Suboxone dental erosion lawsuit, alleging they suffered severe tooth decay and other dental damage after using the opioid treatment’s dissolvable film strips.

The complaint (PDF) was brought by Jason Bates, Bryce Bell, Curtis Carvell, Stephen Dixon, Renell Swain, Robert White, Kevin Wilks, Loni Williams and Terri Ziolkowski in the U.S. District Court for the Northern District of Ohio on June 5. It names Indivior Inc., Indivior Solutions Inc. and Aquestive Therapeutics, which was formerly known as Monosol RX LLC, as defendants.

Plaintiffs argue that Indivior knew about Suboxone dental erosion risks, yet failed to provide adequate warnings to the medical community or doctors. As a result, they join thousands of other Suboxone tooth decay lawsuits filed throughout the U.S. court system, each alleging the manufacturer placed profits before patients at the expense of their dental health.

Suboxone Oral Film Risks

Originally, Suboxone (buprenorphine and naloxone) was approved for use in tablet form in 2002 for the treatment of opioid addiction by helping reduce cravings and withdrawal symptoms. As the original patent protection was running out, Indivior, the manufacturer, introduced the oral film strip version. Critics say the move was more about maintaining exclusivity than providing a better way to deliver Suboxone to recovering addicts.

In June 2022, the U.S. Food and Drug Administration (FDA) issued a Suboxone tooth decay warning, indicating the agency had received hundreds of complaints linking the film strips to severe tooth decay and dental damage. FDA investigators determined that the drug, particularly in film strip form, causes dental enamel erosion, leading to tooth loss, disfigurement and the need for extensive dental surgery.

Suboxone Dental Erosion Allegations

According to the lawsuit, Indivior intentionally designed one of the active ingredients, buprenorphine, to be acidic, which helps maximize the body’s absorption, making it more effective.

Even before Suboxone was introduced as a dissolvable film, the plaintiffs argue Indivior had received reports of dental erosion linked to the tablet form. However, they go on to claim the film strips remain in contact with teeth and gums for longer periods, increasing exposure to both the medication and substances that can damage dental enamel.

The lawsuit alleges Suboxone film strips can take up to 30 minutes to fully dissolve and may leave residue in the mouth for as long as two hours, extending the amount of time patients’ teeth and gums are exposed to acidic ingredients.

All nine plaintiffs state they were prescribed Suboxone to treat opioid addiction, and allege their doctors were never warned that the film strips could cause dental erosion, tooth decay or other permanent dental damage.

According to the complaint, each plaintiff developed lasting tooth injuries, often requiring substantial dental work to repair damage allegedly caused by Suboxone film.

The lawsuit claims that Indivior knew about the increased dental risks and the extended time needed for the strips to dissolve, despite representing in a patent that the film would dissolve in about three minutes. They also note that many patients are prescribed two or three doses per day, which may involve repeated daily exposure to multiple film strips.

“This design was specifically intended to secure Defendants’ monopoly on the brand name drug to the detriment of the generic equivalents that were entering the market. The film was not designed to be better or safer than the tablets, and Defendants could have continued marketing the FDA-approved tablets.”

– Jason Bates et al. v. Indivior Inc. et al.

The plaintiffs present claims of failure to warn, negligent failure to provide adequate warnings and instructions, pre-approval defective design and pre-approval negligent design defect. They seek both compensatory and punitive damages.

Suboxone Tooth Decay Lawsuits

This complaint will be consolidated with thousands of other Suboxone dental erosion lawsuits, which have been consolidated in the Northern District of Ohio before U.S. District Judge Philip Calabrese for coordinated pretrial proceedings.

Judge Calabrese has been directing the parties to prepare a group of representative Suboxone claims for what are known as “bellwether” trials. These early test cases are designed to give the parties the opportunity to see how juries respond to evidence and testimony that will likely be repeated throughout the litigation.

Starting with a 500-lawsuit Records Collection Pool in May 2025, that pool was whittled down to 100 claims. In March, Judge Calabrese ordered the parties to select 20 random cases from the list for core discovery by June 10. The parties will then select 15 lawsuits to serve as a bellwether trial pool by July 13. Four of those cases will be selected to serve as bellwether trials by June 11, 2027.

The first trial is not expected to go before a jury until March 2028.

While the results of these trials will not be binding on other Suboxone dental erosion lawsuits, they will be closely watched, as the outcomes could play a significant role in any Suboxone lawsuit settlement negotiations. If no agreement is reached, Judge Calabrese will likely begin remanding cases back to their original district courts to be prepared for individual trial dates.

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