Suboxone Lawsuits Over Failure to Warn About Tooth Decay Risks Cleared To Move Forward

The U.S. District Judge presiding over all federal Suboxone tooth decay lawsuits has denied a motion filed by the drug manufacturer to dismiss certain failure to warn claims, rejecting arguments presented early in the litigation that the claims should be preempted by federal regulations that limited their ability to independently update the label warnings.

More than 11,000 former users of the opioid addiction treatment are currently pursuing failure to warn lawsuits alleging that they were left with devastating tooth decay from Suboxone film, which was introduced in 2010 and has been found to degrade tooth enamel, resulting in lost or broken teeth, as well as the need for substantial dental treatments.

It was not until June 17, 2022 that the U.S. Food and Drug Administration required a warning label update about the Suboxone tooth decay side effects, after identifying hundreds of complaints involving problems experienced by users. However, plaintiffs maintain that they may have avoided permanent damage and costly dental treatments if earlier warnings and instructions had been provided by the drug maker.

Since February 2024, all Suboxone lawsuits over the tooth decay risks have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge Philip Calabrese, for coordinated discovery and pretrial proceedings in the Northern District of Ohio.

Early in the litigation, the drug makers filed a motion to dismiss the Suboxone failure to warn and design defect claims, maintaining that they should be immune from liability since federal law preempts the state-law based claims.

In an opinion and order (PDF) issued on December 31, Judge Calabrese did agree to dismiss plaintiffs’ design-defect claims that relate to the period after the FDA’s approval of Suboxone film in 2010, but allowed pre-approval design defect claims to move forward, as well as the critical claims for failure to warn.

The drug makers had argued that they could not have changed the label, or the formulation, of Suboxone without permission from the U.S. Food and Drug Administration, and a lack of such an order means that the company cannot be held liable for violating state design defect and failure to warn laws, as federal law should take precedence.

“FDA regulations charge a drug’s sponsor with creating an adequate label and ensuring that the product’s warnings remain adequate while the drug remains on the market. Further, they acknowledge that a drug’s safety information may change over time, requiring changes to the label,” the judge wrote in his ruling. “Absent ‘clear evidence that the FDA would not have approved a change to [the drug] label,’ the Supreme Court has declined to conclude that it is impossible to comply with both federal and State requirements for warnings.”

The ruling was focused on a single lawsuit brought by plaintiff Ryan Bennett, but because Judge Calabrese is overseeing the entire litigation, it suggests he will not accept Indivior’s preemption argument for any federal Suboxone lawsuit.

2025 Suboxone Lawsuit Status Update

Judge Calabrese has scheduled a series of status conferences over the first half of 2025, to review progress in the Suboxone litigation with lawyers involved in the claims, including the exchange of certain information and documents.

In mid-2025, it is expected that the parties will identify a small group of Suboxone failure to warn lawsuits that are representative 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.