Suboxone Dental Erosion Makes Film Strips “Unreasonably Dangerous,” Lawsuit Alleges

The makers of Suboxone face a product liability lawsuit brought by a New York man, who indicates that the dissolving film strips used for opioid addiction treatment were “unreasonably dangerous” and lacked sufficient warnings about the risk of severe dental erosion, which left him with permanent tooth decay.

The complaint (PDF) was filed by Michael Nappi in the U.S. District Court for the Northern District of Ohio on April 2, pursuing damages from Indivior Inc., Aquestive Therapeutics, and Reckitt Benckiser LLC, as defendants, indicating that the companies intentionally took advantage of the opioid epidemic to rake in profits with a dangerous and unsafe product.

Suboxone Dental Erosion Risks

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 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 dental erosion warnings were added to the medication, after the FDA identified more than 300 cases of tooth decay reported to the agency.

As a result of the failure to provide earlier warnings, 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 dental erosion risks, and instructed to take certain steps to avoid erosion of enamel and tooth loss.

Nappi indicates he was prescribed Suboxone film by a doctor for the treatment of an addiction, which he acquired while taking opioids for pain management. However, neither Nappi nor his doctor were warned that using Suboxone could cause dental erosion and tooth decay, according to the lawsuit.

As a result, Nappi indicates he has been left with permanent tooth damage, requiring substantial dental work, which he says could have been prevented if proper label warnings were present.

“Defendants knew or should have known through testing, scientific knowledge, advances in the field, published research, and/or its own post-marketing studies, that Suboxone film created a risk of serious dental issues,” Nappi’s lawsuit states. “Despite the fact that Defendants knew or should have known that Suboxone film caused unreasonable and dangerous side effects, it continued to promote and market Suboxone film without stating that there existed safer and more or equally effective alternative drug products and/or providing adequate clinically relevant information and data.”

Nappi presents claims of strict product liability, negligent failure to warn, defective design, negligent design defect, and seeks both compensatory and punitive damages.

April 2024 Suboxone Dental Erosion Lawsuits Update

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) recently centralized Suboxone lawsuits before U.S. District Judge Philip Calabrese in the Northern District of Ohio, as part of an MDL or multidistrict litigation.

As part of the coordinated management of the litigation, Judge Calabrese will preside over discovery into common issues that apply to all claims, and is expected to establish a bellwether process, where small groups of representative Suboxone dental erosion lawsuits will go through case-specific discovery and be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation.

It is expected that potentially thousands of additional Suboxone lawsuits like Nappi’s will be filed in the coming months, as many states have a two-year statute of limitations on filing complaints after a plaintiff knows or should have known that the drug caused their injuries. With the manufacturer adding Suboxone tooth decay warnings in June 2022, many plaintiffs will have only until early this summer to file.

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