Lawsuit Alleges Suboxone Dental Damage Warnings Were Issued Too Late

Illinois man claims manufacturers knew Suboxone was linked to dental damage before it released its film strip form, which increased the risk of enamel erosion.

According to a new lawsuit, James Quinn underwent root canals, extractions, crowns, bridges and dentures after using Suboxone film strips to treat opioid addiction, which he claims lacked adequate warnings about the risk of dental damage.

The complaint (PDF) was brought in the U.S. District Court for the Northern District of Ohio on April 30. It names Indivior Inc., Indivior Solutions Inc. and Aquestive Therapeutics Inc. as defendants.

Quinn is attempting to hold the manufacturers of Suboxone film strips liable for the extensive dental damage he claims to have suffered.

Suboxone Film Strip Risks

Suboxone (buprenorphine and naloxone) was originally approved in tablet form in 2002, as a prescription treatment for individuals recovering from opioid addiction. It is designed to reduce cravings and lessen withdrawal symptoms. However, as the patent was running out, the manufacturers released a sublingual film strip formulation, retaining exclusivity.

Reports then began to surface linking Suboxone film strips to incidents of severe tooth decay and dental damage, leading many users to require extensive dental work due to tooth loss and disfigurement. In June 2022, the U.S. Food and Drug Administration (FDA) added a Suboxone tooth decay warning after receiving hundreds of complaints, which was followed by a wave of personal injury claims.

The manufacturers now face thousands of Suboxone dental damage lawsuits filed by individuals nationwide, who say they failed to warn millions of patients and their doctors about the risks of tooth decay until forced to do so by federal regulators.

Suboxone Dental Damage Allegations

According to Quinn’s lawsuit, he became addicted to opioids as a minor after they were prescribed to him by a doctor following arm surgery in 1997. As an adult, he sought to break the addiction and was prescribed Suboxone film strips to help with the withdrawal symptoms.

Once Quinn began using the film strips, he began experiencing “severe and progressive dental deterioration,” the lawsuit states. This led to tooth loss, tooth fractures, infections and abscesses, and the need for extensive dental treatments.

“During the relevant time periods, Plaintiff and Plaintiff’s treating physicians were given no warning and had no knowledge of the serious risk of dental erosion and decay Suboxone film posed.”

– James Quinn v. Indivior Inc. et al

The lawsuit alleges that manufacturers knew about the risks of dental erosion linked to buprenorphine for years. However, because it was originally in tablet form, dental enamel exposure was not a significant issue, yet even that delivery system was linked to some reports of tooth decay. Quinn goes on to note that the FDA has been receiving adverse event reports regarding the tablets since 2007.

The influx of those reports accelerated once Suboxone film strips hit the market. Prior to the FDA’s 2022 safety communication, the agency had received at least 136 reports of dental damage from patients taking Suboxone tablets or film.

Despite these warning signs, the filing notes that the label warning in the U.S. was not changed until the FDA order. However, in Europe and other parts of the world, the labels already carried specific warnings of potential dental enamel erosion and tooth decay.

The lawsuit indicates the manufacturers purposefully played down or hid Suboxone dental damage risks from U.S. doctors and patients in order to maximize profits in its largest market, at the expense of consumers’ dental health. The filing presents claims of failure to warn, negligent failure to provide adequate warnings and instructions, defective design, and negligent design defect. It is seeking both punitive and compensatory damages.

Suboxone Dental Damage Lawsuits

Quinn’s complaint will be consolidated with other Suboxone dental damage lawsuits centralized as part of a multidistrict litigation (MDL) in the Northern District of Ohio, where they are undergoing coordinated pretrial proceedings under U.S. District Judge Philip Calabrese.

Over the past year, Judge Calabrese has guided the parties through the process of preparing a group of representative cases for bellwether trials, which are designed to help both sides gauge how juries may respond to evidence and arguments likely to be repeated throughout the Suboxone litigation. 

Having started with a Records Collection Pool consisting of 500 claims in May 2025, the pool has since been whittled down to 100 claims. 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.

In June 2027, plaintiffs and defendants will select four final bellwether selections. The first trial is not expected to go before a jury until at least March 2028.

While the outcomes of these bellwether trials are not binding, they will be closely watched because their results would likely play a role in any Suboxone lawsuit settlement agreements. 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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