Suboxone Manufacturers Agree MDL Needed for Lawsuits Over Dental Injuries, Tooth Loss

Faced with a mounting number of lawsuits over Suboxone dental injuries, manufacturers of the opioid dependency drug indicate they agree with plaintiffs that the federal courts should establish an MDL, or multidistrict litigation, where all claims can be coordinated before one judge for discovery and pretrial proceedings.

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, users have reported experiencing devastating dental injuries from Suboxone film, including tooth decay and loss, and a growing number of former users are now pursuing lawsuits against the drug maker seeking financial compensation for failing to disclose the risks to users and the medical community.

It was not until early 2022 that Suboxone tooth loss warnings were added to the medication, after the FDA identified more than 300 cases of dental problems reported to the agency. Plaintiffs each raise similar allegations indicating that they may have avoided permanent dental damage if they had been warned about the risks and instructed to take certain steps to avoid erosion of enamel and tooth loss.

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, several plaintiffs motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on November 14, calling for the centralization of all lawsuits over Suboxone dental injuries in the U.S. District Court for the Northern District of Ohio.

Manufacturers Support Suboxone Dental Injury Lawsuit MDL

On December 6, responses supporting the establishment of a Suboxone MDL were filed by both Indivior (PDF) and Reckitt-Benckiser (PDF), indicating that the drug makers not only believe that centralization is needed, but also that they agree with plaintiffs that the Northern District of Ohio is the most appropriate venue.

“Defendants agree that there are issues of fact common to the cases identified in the Schedule of Actions accompanying Plaintiffs’ Brief,” Indivior wrote in its response. “Defendants also agree that transfer of these and any subsequently filed ‘tag-along’ cases involving similar factual allegations or claims to the Honorable J. Philip Calabrese, United States District Court for the Northern District of Ohio, for consolidated pretrial proceedings is appropriate.”

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.

As Suboxone tooth decay lawyers continue to review and file claims for individuals who experienced dental erosion after receiving the opioid addiction treatment, it is ultimately expected that hundreds of claims will be brought throughout the federal court system.

It is not expected that the U.S. JPML will consider the motion until an upcoming hearing in late January 2024, at which time a panel of judges will determine whether to transfer the claims to one court and confirm the judge appointed to preside over the proceedings.

Following coordinated discovery and any bellwether trials held in an MDL, if the parties are unable to resolve the dental injury claims through a Suboxone settlement agreement, each individual claim would later be remanded back to the U.S. District Court where it was originally filed for trial.