Suboxone Teeth

MDL 3092 (In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation) now exceeds 11,000 federal cases before Judge J. Philip Calabrese in the Northern District of Ohio, with the court narrowing 500 records-collection cases to four bellwether trials by June 11, 2027, and the first trial set for March 2028. Plaintiffs allege Indivior and Aquestive Therapeutics knew by 2011-2012 that the film's acidic sublingual formulation caused severe dental injuries but failed to warn until the FDA mandated label changes in January 2022. The litigation survived a partially denied motion to dismiss in January 2025 and employs a block-filing mechanism permitting up to 100 plaintiffs per complaint.

MDL 3092 is in active bellwether discovery before Judge J. Philip Calabrese in the N.D. Ohio. Second Amended Case Management Order No. 15 (entered March 27, 2026) governs a 500-case Records Collection Pool narrowing to 50 Core Discovery cases, then 15 Trial Pool cases, with four final bellwether selections due June 11, 2027. Core Discovery depositions run July 13, 2026 through January 15, 2027. The first bellwether trial is projected for March 2028. Judge Calabrese's December 31, 2024 order in Bennett v. Indivior Inc. preserved failure-to-warn claims for the 2010–June 2022 period and design-defect claims against Indivior Inc., Indivior Solutions, and Aquestive Therapeutics.

FDA Drug Safety Communication (January 12, 2022) mandated dental warning after reviewing 305 FAERS cases through December 2018, with 43% serious and 8.5% in patients with no prior dental problems. JAMA 2022 study (Etminan et al.) found adjusted hazard ratio 1.67 (95% CI 1.41-1.98) for dental adverse events with sublingual buprenorphine/naloxone vs. oral naltrexone. MDL 3092 exceeds 11,000 federal cases with 20,000+ additional plaintiffs via block filing as of mid-2026.

• Ohio

  MDL 3092 (In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation), Master Docket No. 1:24-md-03092, centralized before Judge J. Philip Calabrese in the U.S. District Court for the Northern District of Ohio. 1,827 pending federal actions as of September 1, 2026 JPML report; 11,000+ federal lawsuits with 20,000+ additional plaintiffs via block filing mechanism permitting up to 100 plaintiffs per complaint. First bellwether trial projected March 2028.

• West Virginia

  High opioid use disorder treatment penetration. Two-year SOL states face 2026 filing deadlines for patients with 2020-2022 exposure who discovered injury following FDA's January 12, 2022 Drug Safety Communication.

• Kentucky

  Extended-duration Suboxone film use common during 2010-2022 unwarned period. Two-year SOL states face 2026 filing deadlines for claims with discovery date of January 2022.

• Pennsylvania

  Major medication-assisted treatment prescriber concentration. FDA FAERS dental adverse events disproportionately reported in U.S. vs. Europe per 2023 VigiBase pharmacovigilance study (ROR=15.10, 95% CI 7.50-30.39 for sublingual/buccal vs. other formulations).

• Massachusetts

  High buprenorphine/naloxone prescribing rates. JAMA 2022 study (Etminan et al.) identified 21,404 new sublingual buprenorphine/naloxone users in commercial claims data with 21.6 dental adverse events per 1,000 person-years; adjusted HR 1.67 (95% CI 1.41-1.98) vs. oral naltrexone.

• Tennessee

  Rural MAT expansion drove extended Suboxone film use 2012-2022. Two-year SOL runs from January 12, 2022 FDA Drug Safety Communication for many claimants; 2026 deadlines imminent.

• North Carolina

  Significant opioid treatment program enrollment. Block filing mechanism in MDL 3092 facilitates volume intake from high-exposure states.

• Michigan

  Industrial corridor with documented opioid use disorder treatment scale-up. FDA FAERS data through December 2018 identified 305 dental adverse event cases nationwide, with median two-year time-to-diagnosis from treatment initiation.

• Florida

  Large MAT patient population. Four-year SOL preserves 2022 discovery-date claims through 2026; intake teams must verify exposure dates and dental injury documentation.

• California

  2025 California Dental Association narrative review (DeVore et al.) confirmed FDA warning basis and cited 43% serious classification of FAERS dental adverse events. Two-year SOL from discovery; 2022 FDA warning date controls for most claimants.

MDL 3092 (In re: Suboxone Film Products Liability Litigation), N.D. Ohio, Judge Dan Aaron Polster. Indivior's June 2022 warning label update and FDA January 2022 Drug Safety Communication are defendant's preferred accrual dates. Plaintiffs argue individualized discovery dates based on when each patient learned of Suboxone-dental injury causation.