Suboxone Lawsuits Over Tooth Decay Problems Consolidated in Multidistrict Litigation in Ohio

With a rapidly growing number of Suboxone lawsuits being filed in U.S. District Courts nationwide, each involving similar allegations that that users of the opioid addiction treatment suffered devastating tooth decay, a panel of federal judges has decided to centralize the claims as part of a multidistrict litigation (MDL) in Ohio.

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, 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. Plaintiffs each raise similar allegations indicating that they may have avoided permanent tooth decay problems 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 joined together to file a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) in November 2023, calling for the centralization of all lawsuits over Suboxone in the U.S. District Court for the Northern District of Ohio.

Facing a potential flood of complaints brought throughout the federal court system, the manufacturers filed a response agreeing a Suboxone MDL was needed in December, and consenting to the transfer of cases to the Northern District of Ohio for coordinated pretrial management and potential settlement negotiations.

Suboxone Lawsuits Centralized in Northern Ohio

Following oral arguments held on January 25, the JPML issued a transfer order (PDF) on February 2, determining that Suboxone lawsuits over tooth decay problems filed in any federal court centralized under U.S. District Judge Philip Calabrese in the Northern District of Ohio for pretrial proceedings, where similar MDL proceedings were previously administered for lawsuits stemming from the opioid abuse epidemic.

At the time the request for consolidation was filed, there were already 15 lawsuits filed in five districts. However, since then, the JPML has been notified of 11 additional related actions filed in nine districts, and lawyers are expected to file thousands of claims before the two year anniversary of the warning label update later this year.

“After considering the argument of counsel, we find that these actions involve common questions of fact, and that centralization in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation,” the JPML ruled. “These actions share complex factual questions arising from the alleged propensity of Suboxone film, which is used for the treatment of opiate addiction, to cause dental erosion and decay.”

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.