Suboxone Oral Film Lawsuit Claims Opioid Treatment Causes Tooth Decay

Reports of dental damage began while Suboxone was still sold as a tablet, but complaints became more common after introduction of dissolvable film strips.

A former Suboxone oral film user has filed a lawsuit alleging Indivior knew the opioid treatment could cause severe dental damage and tooth decay, yet withheld warnings to protect profits from patients seeking help for a potentially deadly addiction.

The complaint (PDF) was brought by Kenneth Cress in the U.S. District Court for the Northern District of Ohio on May 13. It names Indivior Inc, its subsidiary Indivior Solutions Inc., and Aquestive Therapeutics Inc., formerly known as MonoSol Rx LLC, as defendants.

Cress alleges that he suffered permanent tooth decay and extensive dental damage after using Suboxone oral film strips to treat opioid addiction.

Suboxone Film Strip Risks

Suboxone (buprenorphine and naloxone) was originally approved in 2002 in tablet form by the U.S. Food and Drug Administration (FDA) for the treatment of opioid addiction. Designed to reduce cravings and lessen withdrawal symptoms, the manufacturer redesigned Suboxone as an oral film strip when the patent was about to run out, which some critics say was more to maintain exclusivity than provide recovering addicts with a better product.

Following hundreds of complaints linking the film strips to severe tooth decay and other dental damage, the FDA issued a Suboxone tooth decay warning in June 2022. The agency indicated the drug’s erosion of dental enamel had caused some users to suffer tooth loss, disfigurement and the need for extensive dental work.

Indivior now faces thousands of Suboxone oral film lawsuits, each alleging the manufacturer failed to warn patients or their doctors about the potential tooth decay risks until the FDA forced it to do so.

Suboxone Tooth Decay Allegations

According to the lawsuit, Cress was prescribed Suboxone oral film strips as a treatment for opioid use disorder, but was never informed about the potential dental decay risks. As a result of his use, Cress now suffers permanent tooth damage, leading to the need for “substantial dental work” to repair the damage, the lawsuit states.

Cress alleges Indivior knew for years that buprenorphine exposure could erode dental enamel, even before the company reformulated Suboxone into dissolvable film strips. He argues those dental problems were already appearing among tablet users, and that the film version increased the risk by keeping the medication in prolonged contact with patients’ teeth and gums.

The lawsuit notes that the manufacturer knew the tablets and film strips were acidic but ignored numerous adverse event reports from patients and doctors who tried to warn the manufacturer that they were seeing instances of severe dental damage linked to the drug’s use.

“Before the FDA released its Safety Communication on January 12, 2022, Defendants were aware of at least 136 reports of adverse dental events in patients taking Suboxone tablets or film, but took no steps to alert patients or prescribers of the danger to oral health that Suboxone posed until after the FDA required them to do so.”

– Kenneth Cress v. Indivior Inc. et al.

The FDA data noted that the agency received hundreds of such complaints from not just the manufacturer, but patients and doctors as well, with 40% of those reports involving serious instances of tooth decay and tooth loss. More than a third of the complaints involved two or more teeth, with many appearing in patients with no history of dental problems.

Cress presents claims of failure to warn, negligent failure to provide adequate warnings and instructions, defective design and negligent design defect. He seeks both compensatory and punitive damages.

Suboxone Oral Film Lawsuits

The complaint is expected to be consolidated with thousands of similar claims pending in the Northern District of Ohio before U.S. District Judge Philip Calabrese. The cases are centralized as part of the federal Suboxone oral film lawsuit MDL for coordinated discovery and pretrial proceedings.

The judge is currently leading the parties through the process of preparing a group of representative cases to serve as early “bellwether” trials, designed to give the plaintiffs and defendants a chance to see how juries respond to evidence and testimony they expect to be repeated throughout the litigation.

Originally starting with a Records Collection Pool of 500 claims last May, 100 cases have been chosen from that group for further case-specific discovery. Judge Calabrese has called for parties and the court to select 20 random cases from the list for core discovery by June 10. The parties will then select 15 claims to serve as bellwether trials by July 13, 2026, and then will choose four final bellwether trial selections by June 2027.

The first trial is not expected until at least March 2028, and while the outcome of that and the following bellwether trials will not be binding on the other cases, they will be closely watched, as the outcomes will likely play a role in any Suboxone settlement negotiations. 

If the bellwether trials and pretrial proceedings conclude with no settlement or other resolution to the litigation, Judge Calabrese would likely begin remanding cases back to their original district courts for individual trial dates.

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