Suboxone Dry Mouth Lawsuit Claims Dental Problems Could Have Been Avoided With Sublocade Shot

Federal regulators approved the once-monthly Sublocade shot in 2017, which does not carry Suboxone’s tooth enamel-eroding side effects.

A group of five plaintiffs have filed a joint lawsuit against the makers of Suboxone film strips, saying the opioid treatment caused severe and lasting dental problems that could have been avoided with adequate label warnings or by promotion of an already-approved monthly injection.

The complaint (PDF) was brought by Mandie Boatman, Corey Goode, Katie Kjonaas, Troy Wallace and Scott Knutson, who is representing himself and the estate of Cam E. Knutson, in the U.S. District Court for the Northern District of Ohio on June 12. It names Indivior Inc., Indivior Solutions Inc. and Aquestive Therapeutics Inc., formerly known as MonoSol RX LLC, as the defendants.

All of the plaintiffs claim they were prescribed Suboxone film strips, which resulted in them suffering dry mouth, enamel erosion and other dental problems. They accuse the defendants of failing to tell them or their prescribing physicians the true risks of Suboxone dental damage.

Suboxone Dental Problems

Suboxone (buprenorphine and naloxone) was first approved in tablet form in 2002 for the treatment of opioid addiction. Designed to help reduce cravings and withdrawal symptoms, the tablets, while having minimal contact with teeth, were linked to tooth enamel erosion soon after hitting the market. Then, as the original patent protection was running out, the manufacturers introduced the oral film strip version, which critics say was more about maintaining exclusivity than providing a better way to deliver Suboxone to recovering addicts.

Following hundreds of reports of dental decay and tooth damage, the U.S. Food and Drug Administration (FDA) issued a Suboxone tooth decay warning in June 2022, alerting consumers and doctors that the film strips presented serious risks of tooth enamel erosion. According to the agency, use of Suboxone film strips can lead to tooth loss, disfigurement and the need for dental surgery.

Since then, thousands of Suboxone dental damage lawsuits have been filed nationwide, each alleging the manufacturers knew, or should have known, about the potential risks, yet failed to provide adequate tooth decay warnings.

Suboxone Tooth Decay Allegations

According to the lawsuit, switching from tablets to film strips lengthened the amount of time dental enamel was exposed to Suboxone, increasing the risks of damage. While a tablet is swallowed in seconds, Suboxone film strips can take up to 30 minutes to fully dissolve and may leave residue in the mouth for as long as two hours. Users take up to three film strips at a time.

While Suboxone tablets did not originally carry a tooth decay warning in the U.S., plaintiffs behind this latest lawsuit say it was obvious the manufacturers knew it was a problem, as Indivior warned consumers in other countries, but not the U.S.

“Unlike the American labels, the combined Product Monograph for the tablets and the film in Canada reports that 7.8% of the patients in the pivotal tablet trials experienced ‘tooth disorder’ and warns of dry mouth, gingivitis, gum hemorrhage, and tooth caries.”

– Mandy Boatman et al. v. Indivior Inc. et al.

The plaintiffs say the manufacturers kept the warnings off U.S. products until forced to update them by the FDA. The reason for this delayed response was allegedly to protect and increase profits by cashing in on the opioid addiction crisis. Since 1999, more than 760,000 people have died from a drug overdose, of which nearly three-quarters involved opioid use.

The lawsuit indicates the manufacturers took advantage of addicts seeking to recover, noting that the Suboxone tablets were just as effective as the film strips, which were only created to protect Indivior’s profits and not Suboxone users. According to the complaint, the “victims of the opioid epidemic needed safe and reliable support to manage their disease. And again, the American pharmaceutical industry let them down.”

The lawsuit claims that Indivior had a much safer alternative in a monthly injection called Sublocade, which has been approved by the FDA since 2017. The injections would mean that patients avoid exposure to the enamel-eroding side effects of buprenorphine. However, Suboxone film strips proved more profitable.

Plaintiffs present claims of failure to warn, negligent failure to warn, pre-approval defective design, pre-approval negligent design defect and survival action. They seek both compensatory and punitive damages.

Suboxone Dental Problem Lawsuits

These latest claims will be consolidated with thousands of other Suboxone dental problem lawsuits filed throughout the nation and centralized in the Northern District of Ohio before U.S. District Judge Philip Calabrese for coordinated discovery and pretrial proceedings.

The judge has the parties currently working on preparing a group of representative claims for early test trials. Known as “bellwether trials,” some of these claims will go before juries to see how they respond to evidence and testimony that is likely to be repeated throughout the litigation.

Judge Calabrese has ordered the parties to select 15 lawsuits to serve as the bellwether pool by July 13, of which four will be selected to serve as bellwether trials by June 11, 2027. The first trial is not expected to go before a jury until March 2028.

Despite the results of these trials not being binding on other Suboxone dental erosion lawsuits, they will still be closely observed by the parties, as the outcomes could have a significant effect on Suboxone lawsuit settlement negotiations. If there is no settlement by the time the bellwether trials and pretrial proceedings are completed, Judge Calabrese will likely begin remanding cases back to their original district courts to be prepared for individual trial dates.

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