Lawsuit Claims Suboxone Side Effects Caused Permanent Tooth Damage and Need for Substantial Dental Work

Risk of dental erosion from Suboxone was known to the drug maker, yet lawsuit indicates that users and medical community were not adequately warned about the potential side effects.

An Ohio man has filed a product liability lawsuit alleging that side effects of Suboxone left him with permanent tooth damage, which resulted in the need for substantial dental work that could have been avoided if the makers of the opioid addiction drug had adequately disclosed information about the risk of dental erosion on the warning label.

The complaint (PDF) was filed by Ioannis K. Sylvester in the U.S. District Court for the Northern District of Ohio on February 7, pursuing failure to warn claims against the drug makers Indivior Inc., Aquestive Therapeutics Inc, Monosol Rx In., and Reckitt Benckiser LLC, alleging wrongful conduct in the development, design, testing, labeling and packaging of Suboxone film strips, as well as how the drug was marketed.

Suboxone Side Effects and Tooth Damage

Suboxone (buprenorphine and naloxone) was approved by the U.S. Food and Drug Administration (FDA) in 2002, for treatment of recovering opioid addicts; helping them avoid withdrawal symptoms while undergoing therapy to help them break their addiction.

While originally sold as a tablet, the drug makers subsequently introduced Suboxone film, which users place beneath the tongue until it is dissolved. However, thousands of users have reported experiencing devastating tooth decay from Suboxone film side effects, often resulting in broken on extracted teeth, and complaints are being pursued against the drug makers for failing to disclose the risks to users and the medical community.

It was not until early 2022 that Suboxone tooth decay warnings were added to the medication, after the FDA identified more than 300 cases of dental damage reported to the agency.

As a result of the failure to provide earlier warnings, Sylvester and a growing number of other individuals nationwide are now pursuing Suboxone lawsuits against the manufacturers, each raising similar allegations that they may have avoided permanent tooth damage if they had been provided information about the risks and instructed to take certain steps to avoid erosion of enamel and tooth loss.

According to the lawsuit, Sylvester was prescribed Suboxone by his doctor for the treatment of opioid addiction. However, as a result of Suboxone side effects, the lawsuit indicates he suffered permanent damage to his teeth as a direct result.

The lawsuit accuses the manufacturers of concealing or failing to completely disclose their knowledge of the risk of Suboxone tooth damage through the use of appropriate dental warnings. The lawsuit also indicates the manufacturers failed to test Suboxone film strips adequately and failed to instruct healthcare professionals how to safely monitor and identify signs of potentially serious dental complications from Suboxone film.

“During the relevant time periods, Mr. Sylvester and his physicians were given no warning and had no knowledge of the serious risk of dental erosion and decay Suboxone posed,” the lawsuit states. “Specifically, and as discussed more fully below, there was no warning or indication that Suboxone causes permanent damage to the teeth.”

The lawsuit indicates Sylvester has needed substantial dental work to repair Suboxone side effects damage to his teeth.

February 2024 Suboxone Lawsuit Update

Earlier this month, the U.S. Judicial Panel on Multidistrict Litigation issued a transfer order calling for the creation of a Suboxone lawsuit multidistrict litigation (MDL), centralizing complaints filed in federal courts nationwide under U.S. District Judge Philip Calabrese in the Northern District of Ohio for coordinated pretrial proceedings.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

Following coordinated discovery and any bellwether trials in the Suboxone MDL, if the parties are unable to agree to tooth decay settlements or another resolution for the dental injury claims, each individual claim would later be remanded back to the U.S. District Court where it was originally filed for trial.