Lawsuit Claims Suboxone Strips Caused Dental Erosion and Tooth Decay for New York Man

A product liability lawsuit has been filed against the makers of Suboxone sublingual film, indicating that the strips added to the problems of those recovering from opioid drug addiction, by causing them to suffer severe dental erosion and tooth decay.

The complaint (PDF) was filed by Vincent Delcastillo on February 13 in the U.S. District Court for the Eastern District of New York, pursuing claims against the drug manufacturers Indivior Inc., Aquestive Therapeutics Inc, Monosol Rx In., and Reckitt Benckiser LLC, as defendants, alleging that users and the medical community were not adequately warned about the potential dental risks linked to Suboxone strips.

Suboxone Strip Dental Erosion and Tooth Decay

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 strips, which users place beneath the tongue until it is dissolved. However, thousands of users have reported experiencing devastating tooth decay from Suboxone strip 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, Delcastillo and a growing number of other individuals nationwide are now pursuing Suboxone strip 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.

Delcastillo’s lawsuit indicates he became addicted to opioids after they were prescribed by a physician for pain management. To combat the addiction and treat his opioid use disorder, he was prescribed Suboxone strips.

The lawsuit indicates neither he nor his physician were given any warning of the serious dental erosion and tooth decay risks linked to the dissolvable film strips.

“The formulation of Suboxone film is designed to be acidic to maximize absorption of the buprenorphine while minimizing absorption of the naloxone. This acidic formulation leads to dental erosion and decay,” the lawsuit states. “Defendants knew or should have known that Suboxone film, when used as prescribed and intended, causes harmful damage to the teeth due to the acidity of buprenorphine.”

As a result, Delcastillo suffered severe and permanent tooth damage, requiring substantial dental work, his lawsuit states.

Delcastillo’s complaint indicates the manufacturers underreported adverse events to the FDA, and marketed the Suboxone strips to a vulnerable population.

“For the patient population Defendants have targeted, the risk of being lost to follow-up care is higher than for patients not suffering from opioid use disorder,” Delcastillo’s lawsuit notes. “Patients suffering from opioid use disorder experience barriers related to stigma, insurance, and finances generally.”

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.