Oral Arguments Over Motion To Dismiss Suboxone Tooth Decay Lawsuits Set for December 16

Indivior claims federal law prevented it from updating the Suboxone tooth decay warnings before June 2022, indicating that thousands of lawsuits should be dismissed.

The U.S. District Judge presiding over all federal Suboxone tooth decay lawsuits will hear arguments later this month on a motion to dismiss filed by Individor, in which the drug maker argues that more than 11,000 failure to warn claims brought by former users of the opioid addiction treatment are preempted by federal law.

Each lawsuit raises similar allegations, indicating that Indivior knew or should have known that the sublingual film version of Suboxone may degrade tooth enamel, yet it 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.

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

Former users are now pursuing lawsuits, alleging that they could have avoided damage to their teeth if Individior had provided earlier warnings about the potential risk of Suboxone tooth decay side effects.

Given common questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a Suboxone tooth decay lawsuit MDL earlier this year, centralizing the failure to warn claims before U.S. District Judge Philip Calabrese in the Northern District of Ohio, for coordinated discovery and pretrial proceedings.

Suboxone Motion to Dismiss Hearings

In July, Indivior filed a motion to dismiss the Suboxone lawsuits, arguing that it could not have added the warning any sooner due to federal laws, which dictated what the manufacturer could put in the label warnings. Therefore, the drug maker has asked Judge Calabrese to rule that the state-law based failure to warn lawsuits are preempted by federal law, absolving Indivior from liability for the dental injuries users have experienced.

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.

Following a status conference held on November 21, Judge Calabrese issued an order (PDF) announcing that he will hear oral arguments over the motion to dismiss on December 16. The order calls for the parties to submit a joint report by December 12, detailing any additional issues the court should take up during those arguments.

If the litigation is allowed to continue past the motion to dismiss, it is expected that Judge Calabrese will move forward with identifying a small group of Suboxone tooth decay cases 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 Suboxone tooth decay lawsuit payout may impact the amount of money the drug maker will be required to pay to avoid the need for each individual lawsuit to go before a jury in the future.