Suboxone tooth decay lawsuit

The docket record

Full docket title: IN RE: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation. Programmatic record page: MDL 3092.

Where it stands

As of the Judicial Panel on Multidistrict Litigation's September 1, 2026 pending-cases report, 1,827 actions are pending in MDL No. 3092 before Judge J. Philip Calabrese, unchanged from the prior report. The court has been managing the docket in phases: a December 31, 2024 ruling let design-defect and failure-to-warn claims against Indivior proceed past a motion to dismiss on preemption grounds; 2025 orders (CMO 13-19) set up medical and dental records collection and a bellwether selection protocol; and a February-July 2026 process narrowed an initial pool of 500 cases to a 100-case Core Discovery Pool now in fact-witness and provider depositions. No settlement has been announced. Plaintiff-side sources report the case count is far larger once abbreviated 'Schedule A' mass-filed claims are counted, but the JPML's own pending-actions figure, which is the only count settlementrecord.com treats as authoritative, is 1,827.

Sources: FDA warns about dental problems with buprenorphine medici… · In Re: Suboxone (Buprenorphine/Naloxone) Film Marketing, … · Pending Multidistrict Litigation report, September 1, 2026 · MDL 3092: In re Suboxone (Buprenorphine/Naloxone) Film Pr…; full list at the end of this page.

What the lawsuits are about

Suboxone is a brand-name combination of buprenorphine and naloxone used to treat opioid use disorder. It was originally sold as a tablet and later as a sublingual film that dissolves under the tongue or against the cheek. Plaintiffs allege the film was formulated to be acidic and that prolonged contact with that acidic film in the mouth caused tooth decay, cavities, enamel erosion, tooth fractures and tooth loss, and that the manufacturers knew of this risk and failed to warn patients and prescribers.

on February 2, 2024, the Judicial Panel on Multidistrict Litigation centralized the litigation, then consisting of fifteen actions in five federal districts plus eleven related actions, into MDL No. 3092 in the U.S. District Court for the Northern District of Ohio, assigned to Judge J. Philip Calabrese. The Panel found the cases shared common factual questions about whether Suboxone film's design and formulation caused dental injury and whether the manufacturers adequately tested for and warned of that risk.

the case has moved through pretrial organization rather than trial. A December 31, 2024 opinion resolved the first motion to dismiss, allowing a bellwether plaintiff's design-defect claims against all three Indivior entities and a failure-to-warn claim against Indivior Inc. to proceed, while finding some claims preempted by federal drug-labeling law. Through 2025 and into 2026 the court entered case management orders governing records collection, a joinder/mass-filing protocol, and a bellwether discovery pool; by mid-2026 that process had narrowed to a 100-case Core Discovery Pool undergoing depositions, with dispositive motions due in 2027 and the first bellwether trial set for March 2028.

Injuries named in the filings

• Tooth decay and cavities
• Tooth erosion
• Tooth fractures
• Tooth loss
• Oral infections
• Gum injury
• Tongue injury

Principal defendants: Indivior Inc.; Indivior Solutions, Inc.; Aquestive Therapeutics, Inc.; Reckitt Benckiser LLC; Reckitt Benckiser Healthcare (UK) Ltd..

Sources: FDA warns about dental problems with buprenorphine medici… · In Re: Suboxone (Buprenorphine/Naloxone) Film Marketing, … · Pending Multidistrict Litigation report, September 1, 2026 · MDL 3092: In re Suboxone (Buprenorphine/Naloxone) Film Pr…; full list at the end of this page.

Who the filings say qualifies

Court-ordered case management orders require plaintiffs in the discovery pool to submit plaintiff fact sheets and supporting medical, pharmacy and dental records documenting Suboxone film use and the dental injury alleged; the underlying injury definitions come from the master complaint and the FDA's own description of the reported adverse events.

• Used Suboxone sublingual film (the dissolving film, not the tablet or the Sublocade injection) as prescribed for opioid use disorder or pain treatment
• Developed a dental injury after starting Suboxone film use, such as tooth decay, cavities, tooth loss, tooth fracture, or oral infection, as alleged in the master complaint
• Can document Suboxone film use and the dental injury with prescription, pharmacy, medical, or dental records, which the court's case management orders require claimants in the discovery pool to produce
• Files or joins a case within the applicable state statute of limitations, subject to case management orders on mass-filed 'Schedule A' claims and any related tolling terms entered by the court

Source: N.D. Ohio, MDL 3092: In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation - case management orders.

These are the criteria in the public record, not a promise about any individual case. A law firm evaluates each case on its own facts, and limitations periods vary by state.

Key dates

1. January 12, 2022FDA warns that buprenorphine medicines dissolved in the mouth, including Suboxone film, are linked to dental problems including tooth decay, cavities, oral infections and tooth loss, based on a review of 305 adverse-event reports (131 serious); FDA requires new warnings in prescribing information and the Medication Guide. source
2. February 2, 2024The Judicial Panel on Multidistrict Litigation issues a transfer order centralizing Suboxone film dental-injury lawsuits into MDL No. 3092 in the Northern District of Ohio, before Judge J. Philip Calabrese, consolidating fifteen actions from five districts plus related actions. source
3. May 16, 2024Court enters CMO 4, establishing a 'Schedule A' master-docket complaint procedure that lets plaintiffs' counsel add claimants to a single complaint rather than filing individual suits, as summarized by plaintiff-side sources. source
4. December 31, 2024Court grants in part and denies in part defendants' motion to dismiss the first bellwether case, allowing pre-approval design-defect claims against Indivior Inc., Indivior Solutions and Aquestive Therapeutics and a failure-to-warn claim against Indivior Inc. to proceed; some claims held preempted by federal law. source
5. February 13, 2025Court enters CMO 13, requiring collection of medical and dental records to substantiate claims, as summarized by plaintiff-side sources. source
6. March 14, 2025Court enters CMO 14 (joinder-of-complaints protocol) and CMO 15 (bellwether protocol for the records-collection pool), as summarized by plaintiff-side sources. source
7. February 10, 2026Court identifies cases randomly selected as candidates for the bellwether Core Discovery Pool, as summarized by plaintiff-side sources. source
8. September 1, 2026JPML pending multidistrict litigation report lists 1,827 actions pending in MDL 3092, Northern District of Ohio, Judge J. Philip Calabrese, flat from the prior report. source

Questions people ask

Sources: FDA warns about dental problems with buprenorphine medici… · In Re: Suboxone (Buprenorphine/Naloxone) Film Marketing, … · Pending Multidistrict Litigation report, September 1, 2026 · MDL 3092: In re Suboxone (Buprenorphine/Naloxone) Film Pr…; full list at the end of this page.

Track this docket

We re-read the JPML report on the first business day of each month. Get an email when this record changes: case count, status, or a settlement development.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation, “Pending MDL Dockets by Actions Pending,” monthly reports March 1, 2024 to September 1, 2026. Transferee court: Northern District of Ohio, J. Philip Calabrese.
2. FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder, U.S. Food and Drug Administration. Accessed September 3, 2026.
3. In Re: Suboxone (Buprenorphine/Naloxone) Film Marketing, Sales Practices, and Products Liability Litigation - Transfer Order, MDL No. 3092, U.S. Judicial Panel on Multidistrict Litigation. Accessed September 3, 2026.
4. Pending Multidistrict Litigation report, September 1, 2026, U.S. Judicial Panel on Multidistrict Litigation. Accessed September 3, 2026.
5. MDL 3092: In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation - court MDL page and case management orders, U.S. District Court, Northern District of Ohio. Accessed September 3, 2026.
6. In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation - Opinion and Order on Motion to Dismiss, Bennett v. Indivior Inc. et al. (Doc. #173), U.S. District Court, Northern District of Ohio. Accessed September 3, 2026.
7. Suboxone Tooth Decay Lawsuit: September 2026 Updates, Drugwatch (plaintiff-side). Accessed September 3, 2026.
8. Suboxone MDL 3092 Court Filings & Case Management Orders (CMOs), Nigh Goldenberg Raso & Vaughn PLLC (plaintiff-side law firm). Accessed September 3, 2026.
9. Suboxone Tooth Decay Lawsuit Settlement June 2026 Update, Lawsuit Information Center (plaintiff-side). Accessed September 3, 2026.

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