Suboxone Litigation Speeds Up, and the FDA’s involvement

Invidior, the suboxone manufacturer, is charged with:

• Failure to Warn: Defendants were aware of the dental risks associated with Suboxone film but did not adequately inform healthcare providers or patients.
• Acidic Formulation Leading to Dental Damage: The Suboxone film design is inherently acidic, causing dental erosion and decay when dissolved in the mouth.
• Insufficient Testing and Warnings: Suboxone film testing was inadequate, and the warnings regarding potential dental problems were insufficient.

The FDA and Suboxone

The FDA in January 2022 issued a warning about adverse dental effects including rapid decay, dental abscesses, and tooth fractures associated with Suboxone (buprenorphine/naloxone) films and tablets that dissolve in the mouth. The agency updated labeling and recommended that patients rinse their mouths with water after the medication dissolves. A 2023 study found “significantly disproportionate reporting of dental disorders” in FDA adverse event reports for patients treated with buprenorphine.

By May 2024, the agency updated safety labels of all buprenorphine products to ensure consistency across all generics and branded therapies, including Suboxone, Zubsolv, and others. As of June 2025, it had documented 305 cases of dental problems (131 classified as serious) with buprenorphine medicines dissolved in the mouth, with some cases occurring as soon as two weeks after treatment began. But it stopped short of slapping on a black box warning – the strongest safety alert signifying the most serious risks.

One expert contends that the FDA weighed severe dental complications against what they see as the life-saving benefits of buprenorphine for opioid use disorder. Buprenorphine significantly reduces opioid overdose risk and helps people maintain recovery, so serious dental problems don’t outweigh those mortality benefits. As well, the agency may consider that a black box warning could deter patients and providers from a potentially crucial tool in addiction treatment. But dental damage can occur within two weeks of using suboxone – which is concerning. It suggests people weren’t adequately warned about prevention strategies from the start and begs the question: if stronger warnings were in place earlier, might some dental damage, and possibly psychological damage, could have prevented while still preserving access to treatment?

Speeding Up Suboxone Litigation

Judge Philip Calabrese has approved a “block filing mechanism”, a process of allowing up to 100 plaintiffs with tooth decay claims to file together in a single complaint, which should also reduce costs. And speeding up the legal process of one filing fee per complaint is also expected to create a significant boost in the suboxone tooth decay litigation, regardless how many claimants are added to each complaint. Another key factor that’s growing litigation (890 cases are pending in MDL 3092, up from 716 cases in early 2025) is Case Consolidation and Preparation, where the parties are advancing a focused review of 500 cases, which will be narrowed to 100 for deeper discovery. From this group, 15 cases will be selected for bellwether trial consideration, resulting in four to be chosen for trial. Stay tuned…