Future of Suboxone Lawsuits Taken Under Advisement After Motion To Dismiss Arguments

The U.S. District Judge presiding over all Suboxone tooth decay lawsuits filed in the federal court system heard oral arguments on Monday, over a motion to dismiss brought by the manufacturers of the opioid addiction drug, which argued that the state law-based failure to warn claims should be preempted by federal law.

Suboxone film (buprenorphine and naloxone) was on the market for more than a decade before Indivior added tooth decay warnings to the drug label in June 2022, following widespread reports of users experiencing dental damage, cavities, oral infections and lost teeth.

The drug maker now faces more than 11,000 product liability lawsuits brought by former users who claim that Indivior knew or should have known that the sublingual film version of Suboxone may degrade tooth enamel long before 2022, yet continued to market the drug for individuals suffering from opioid addiction, without disclosing the risk or providing instructions on steps that could be taken to prevent tooth loss.

Given common questions of fact and law, all current and future Suboxone lawsuits brought throughout the federal court system have been centralized for coordinated discovery and pretrial proceedings before U.S. District Judge Philip Calabrese in the Northern District of Ohio, as part of a multidistrict litigation, or MDL.

In July 2024, Indivior filed a motion to dismiss Suboxone lawsuits due to federal preemption, arguing that it was prevented by federal laws from updating Suboxone warning labels, which should bar users from pursuing state failure to warn claims.

Plaintiffs have opposed the motion, arguing that the drug manufacturer bears responsibility for the content of its label at all times, maintaining that Indivior could have taken steps to alert users and the medical community to the tooth decay risks. Further, plaintiffs maintain that there were safer alternative designs for the delivery of the active ingredient in Suboxone film, which would have allowed users to avoid loss of tooth enamel.

On December 16, the parties presented oral arguments on the motion to dismiss the Suboxone lawsuits to Judge Calabrese. According to minutes (PDF) from the hearing, the Court has taken the matter “under advisement,” and did not issue an immediate ruling on the motion.

To continue moving the litigation forward, Judge Calabrese did schedule additional case management conferences for the Suboxone lawsuits in 2025, indicating that additional meetings with lawyers involved in the claims will be held on April 17, May 15 and June 17, 2025.

Unless Judge Calabrese issues an unexpected ruling granting the drug makers’ motion to dismiss the failure to warn claims, it is expected that the Court will move forward with identifying a small group of Suboxone tooth decay lawsuits that are a representative sample of the litigation as a whole, to serve as bellwether test cases for early jury trials.

While the outcome of any early bellwether trial dates in the MDL will not have any binding impact on remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone tooth decay settlements the drug maker may offer to avoid the need for each individual lawsuit to go before a jury in the future.