A U.S. District Judge will hear arguments later this month on a motion to dismiss filed by Indivior, the maker of Suboxone, in a series of lawsuits involving tooth decay. The company argues that over 11,000 claims brought by former users of the opioid addiction treatment are preempted by federal law.
The lawsuits share similar allegations: that Indivior was aware, or should have been aware, that its Suboxone film—a sublingual treatment for opioid addiction—could cause tooth enamel to deteriorate. Despite this, the drug maker continued to market the product without disclosing the risk or offering guidance on how users could prevent tooth damage.
Suboxone film, which combines buprenorphine and naloxone, was available for more than a decade before the company updated the warning label in June 2022. This update came after numerous reports from users about dental issues such as cavities, oral infections, and tooth loss.
Plaintiffs in these lawsuits contend that they could have avoided dental damage if Indivior had issued earlier warnings about the potential for tooth decay. In response to the growing number of claims, the U.S. Judicial Panel on Multidistrict Litigation (JPML) created a centralized legal process earlier this year. This consolidated the failure-to-warn lawsuits before U.S. District Judge Philip Calabrese in the Northern District of Ohio, allowing for coordinated discovery and pretrial proceedings.
Upcoming Hearing
On November 21, Judge Calabrese ordered that oral arguments on the motion to dismiss will take place on December 16. He also instructed both parties to submit a joint report by December 12, outlining any additional issues to be discussed during the hearing.
If the court denies the motion to dismiss, the litigation is expected to proceed. Judge Calabrese will likely select a group of representative cases from the larger group of lawsuits to serve as bellwether test cases for early trials. While the outcomes of these trials will not directly affect other claims, they may influence the potential financial settlements that Indivior could be required to offer to avoid a lengthy trial process for each individual lawsuit.
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