Suboxone Film Lawsuit Highlights How Dental Decay Problems Continue To Be Reported Even After Label Change

Reports suggest that Suboxone dental decay problems are still causing users to experience tooth fractures, infections, bone loss and jaw issues.

Even after Indivior updated the Suboxone film warning label in June 2022, indicating for the first time that the opioid addiction treatment may cause tooth decay and dental damage, a recently filed lawsuit claims that the U.S. Food and Drug Administration (FDA) continues to receive reports involving severe issues experienced by users.

The FDA required the drug maker to add information to the label about Suboxone dental decay problems more than two years ago, warning that some users were experiencing broken or lost teeth, as the sublingual film breaks down dental enamel. However, more than 11,000 Suboxone film lawsuits are now being pursued throughout the federal court system, alleging that these warnings were inadequate and came years too late.

In a complaint (PDF) filed in the U.S. District Court for the Northern District of Ohio on December 2, plaintiff Kim Wooden points out that the FDA has received at least 30 new adverse event reports involving Suboxone film dental decay since the 2022 label change, claiming that the label warnings are still not strong enough and do not fully disclose the magnitude of the tooth decay risks.

Suboxone (buprenorphine and naloxone) was approved by the FDA in 2002, for treatment of recovering opioid addicts, helping them avoid withdrawal symptoms while undergoing therapy to help them break their addiction. While originally sold as a tablet, the drug makers subsequently introduced Suboxone film in 2010, which users place beneath the tongue until it is dissolved.

However, lawsuits allege that the film version was only developed to delay competition from generic versions of the original drug, and that safer alternative designs were available that could have helped users avoid dental damage from Suboxone film.

In her complaint, Wooden indicates that she was prescribed Suboxone film to treat opioid use disorder, but neither her nor her doctors were adequately warned about the risk of dental decay, which has left her with permanent tooth damage and the need for extensive dental work.

The lawsuit seeks damages from Indivior and Aquestive Therapeutics, Inc., claiming that the developers and manufacturers of Suboxone film had years to address the risks associated with the medication, or add better label warnings that could have allowed Wooden and other plaintiffs to avoid dental decay.

Continuing Reports of Suboxone Dental Problems

Wooden’s lawsuit notes that the manufacturers conducted clinical trials as early as 2012, which showed that there was a risk of Suboxone dental damage with the film version of the drug. However, they waited to provide some warning to patients and doctors until forced by the FDA in 2022.

Even then, the updated label failed to adequately convey information to users and the medical community about the risk of dental problems while on Suboxone, according to the complaint.

“Before the FDA released its Safety Communication on January 12, 2022, Defendants were aware of at least 136 reports of adverse dental events in patients taking Suboxone tablets or film, but took no steps to alert patients or prescribers of the danger to oral health that Suboxone posed until after the FDA required them to do so,” the lawsuit states. “Even after the FDA forced Defendants to include reference to potential dental injuries in the label, additional information about the risk of dental injuries continued to pile up.”

The lawsuit outlines more than 30 new reports of tooth decay, bone disorders, jaw disorders, tooth infections, tooth fractures, tooth loss and other Suboxone dental problems reported over the last two years, some of which included:

• A February 11, 2023 report of a patient “suffering dysgeusia, gingival recession, and exposed bone in jaw while taking Suboxone and other prescription medications”
• A May 30, 2023 report of a patient suffering toothache, tooth fracture and mastication disorder
• Another report, filed in January of this year, detailing a patient not only suffering tooth loss, but also suffering tongue hemorrhaging, brittle teeth, tooth socket hemorrhage and other injuries

Adverse events submitted to the FDA typically only account for between 1% and 10% of actual problems being experienced by users.

Wooden presents claims of strict liability and negligent failure to warn and defective design. She seeks both compensatory and punitive damages.

December 2024 Suboxone Film Lawsuit Update

The complaint filed by Wooden will be consolidated with thousands of other Suboxone film lawsuits currently pending in the federal court system.

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

As part of the management of the rapidly growing litigation, it is expected that Judge Calabrese will call for a small group of Suboxone film lawsuits to be prepared for a series of early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

While the outcome of any early bellwether trial dates in the MDL will not have any binding impact on remaining claims, the average Suboxone film lawsuit payout may influence the amount of money the drug maker will be required to pay to avoid the need for each individual case to go before a jury in the future.