MDL Track
MDL 3092
N.D. Ohio
Suboxone (buprenorphine/naloxone) film products liability
1,849 pending
Pharmaceutical · claims involving dental injuries allegedly associated with sublingual Suboxone films
Defendant
Indivior Inc.
MDL / Track
MDL 3092
N.D. Ohio
Judge
Judge J. Philip Calabrese
Plaintiffs
roughly 2,105 pending (1,849 per JPML's March 2, 2026 report, plus ~256 new filings tracked since)
Bellwether / Trial
No verdicts yet
Settlement Status
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Case overview
MDL 3092 (In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation) before Judge J. Philip Calabrese in the Northern District of Ohio now exceeds 11,000 federal cases as of mid-2026 alleging Indivior and Aquestive Therapeutics failed to warn that Suboxone sublingual film causes severe dental injury. The first bellwether trial is projected for March 2028 following a partially denied motion to dismiss in January 2025. Plaintiffs focus on the 2010-2022 warning gap: internal documents show adverse dental event reports reached Indivior by 2011-2012, yet the FDA-required label warning did not appear until June 2022.
Causation Theory
The sublingual film's acidic formulation (pH ~3.4) dissolves in the mouth for several minutes per dose, exposing teeth to chronic acid contact. A December 2022 JAMA pharmacoepidemiologic study found sublingual buprenorphine/naloxone users had 1.67-fold higher risk of dental adverse events versus oral naltrexone and 1.42-fold versus transdermal buprenorphine, with dental caries/tooth loss hazard ratios of 1.71 and 1.57 respectively. The FDA's January 2022 safety communication confirmed the association, leading to a June 2022 label update.
Case Management Orders
Litigation status
MDL 3092 is in active bellwether preparation before Judge J. Philip Calabrese in the Northern District of Ohio. The court selected a 100-case Core Discovery Pool in February 2026 and is narrowing to 50 cases for depositions running July 2026 through January 2027. First bellwether trial is scheduled for March 2028.
MDL Track
MDL 3092
N.D. Ohio
Suboxone (buprenorphine/naloxone) film products liability
1,849 pending
MDL 3092 Leadership
Plaintiff Leadership
Co-Lead Counsel
Ashlie Case Sletvold
PEIFFER WOLF CARR KANE CONWAY & WISE, LLP
asletvold@peifferwolf.com(216) 589-9280Executive Committee and Liaison Counsel
Alyson Steele Beridon
HERZFELD, SUETHOLZ, GASTEL, LENISKI, AND WALL, PLLC
alyson@hsglawgroup.com(513) 381-2224Executive Committee
Defense Leadership
Defense Leadership
Geographic exposure
Approximately 21,404 new users of sublingual buprenorphine/naloxone identified in JAMA pharmacoepidemiologic study cohort; incidence of dental adverse events 21.6 per 1,000 person-years. FDA FAERS database contained 305 dental adverse event reports through December 2018, with 625 total reports by 2022. Two-year SOL states entering critical window in 2026 for plaintiffs discovering injury in 2024.
MDL 3092 (In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation) active with 1,832 pending cases as of May 2026. Direct-filing order preserves home-state-law advantages. Bellwether selection in progress.
Defendant Indivior Inc. headquartered in Richmond. Clear state court jurisdiction exists; favorable forum for avoiding diversity removal.
Defendant Aquestive Therapeutics Inc. incorporated here. State court jurisdiction available.
Defendant presence creates jurisdiction. Two-year discovery rule applies; clock starts from January 2022 FDA warning or actual discovery of dental injury link.
Defendant operations present. State court filing possible with MDL transfer option.
Four-year statute of limitations. Discovery rule extends window for patients connecting dental injury to Suboxone film post-January 2022.
Three-year discovery rule. Open intake as of 2024; favorable for late-discovering plaintiffs.
Three-year SOL from discovery. Large patient population using sublingual buprenorphine/naloxone for opioid use disorder treatment.
Two-year discovery rule. Significant Medicaid and commercial insurance coverage for Suboxone film creates exposure concentration.
Two-year discovery rule with potential tolling. Large OUD treatment population; Houston and Dallas metro areas show high prescription volume for sublingual film formulations.
Key defendants
Indivior Inc.
Role: Manufacturer
Primary defendant; motions to dismiss largely denied Dec. 2024. Pushing federal preemption defense. Discovery ongoing with FDA filings and marketing docs ordered produced.
Indivior Solutions, Inc.
Role: Manufacturer
Subsidiary co-defendant; remains in MDL after Indivior PLC dismissed Sept. 2024. No separate defense posture noted.
Aquestive Therapeutics, Inc.
Role: Formulation Developer
Exclusive film formulation partner; court ordered production of internal records and FDA filings Sept. 2025. No dismissal motion granted.
| Defendant | Role | Intelligence Note |
|---|---|---|
| Indivior Inc. | Manufacturer | Primary defendant; motions to dismiss largely denied Dec. 2024. Pushing federal preemption defense. Discovery ongoing with FDA filings and marketing docs ordered produced. |
| Indivior Solutions, Inc. | Manufacturer | Subsidiary co-defendant; remains in MDL after Indivior PLC dismissed Sept. 2024. No separate defense posture noted. |
| Aquestive Therapeutics, Inc. | Formulation Developer | Exclusive film formulation partner; court ordered production of internal records and FDA filings Sept. 2025. No dismissal motion granted. |
Timeline
Suboxone Film Market Launch
Reckitt Benckiser Pharmaceuticals launches Suboxone Film (buprenorphine/naloxone sublingual strip) as alternative to tablet formulation. Film dissolves in mouth over extended period.
Internal Dental Injury Reports Alleged
Plaintiffs allege Indivior's internal pharmacovigilance records document dental injury pattern from film use. FAERS data shows accumulating adverse event reports.
FDA Mandates Dental Warning Label
FDA issues Drug Safety Communication requiring label revision for Suboxone Film and five other oral buprenorphine products to warn of dental caries, enamel erosion, cavities, oral infections, and tooth loss. Agency discloses 305 dental adverse event reports received through December 2018, with 131 classified as serious.
JPML Creates MDL 3092
Judicial Panel on Multidistrict Litigation consolidates federal Suboxone dental injury cases in MDL No. 3092, In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, transferring to Judge J. Philip Calabrese in the Northern District of Ohio. Docket held 1,833 pending actions as of JPML transfer order.
Court Denies Motion to Dismiss
Judge Calabrese issues order largely denying Indivior's motion to dismiss, rejecting federal preemption defense. Failure-to-warn claims for 2010–June 2022 period and design-defect claims tied to pre-approval decisions survive against Indivior Inc., Indivior Solutions, and Aquestive Therapeutics. Case No. 1:24-md-03092.
Block Filing Authorized
Court permits 'block filing' mechanism allowing up to 100 plaintiffs per complaint. MDL expands to over 11,000 represented plaintiffs through batch filings.
Bellwether Protocol Established
Second Amended Case Management Order No. 15 sets bellwether roadmap: 100-case pool narrows to 50-case Core Discovery Pool (June–July 2026), then 15-case Trial Pool (January 2027), with four final bellwether cases selected by June 11, 2027. First bellwether trial projected March 2028. Case No. 1:24-md-03092.
Core Discovery Pool Selection Begins
Court initiates Core Discovery Pool selection: 20 random cases selected June 10, 2026; 15 plaintiff picks and 15 defense picks due June 24; final 50-case list due July 2, 2026. Core discovery depositions scheduled July 13, 2026–January 15, 2027. MDL docket reports 1,832 pending actions as of July 1, 2026.
Statute of limitations
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.
⚠New York
3 years from discovery
Rule: Product liability and personal injury claims; CPLR 214(2)
Discovery: Accrual tied to when plaintiff knew or should have known of Suboxone-dental injury link
June 2025 marks 3-year anniversary of Indivior's warning label update; intake window closing
Florida
4 years from discovery
Rule: Product liability claims under Fla. Stat. § 95.11(3)(a)
Discovery: Accrual begins when plaintiff discovers or should discover injury and its cause
Longer SOL provides buffer; FDA January 2022 warning and June 2022 label update remain key accrual dates
⚠Texas
2 years from discovery
Rule: Product liability claims under Tex. Civ. Prac. & Rem. Code § 16.003
Discovery: Accrual upon discovery of injury and causal connection
June 2024 marked 2-year anniversary of label update; late 2024 filings likely time-barred unless later discovery pleaded
⚠California
2 years from discovery
Rule: Product liability claims under Cal. Code Civ. Proc. § 335.1
Discovery: Accrual upon discovery of injury and its cause
June 2024 deadline passed for claims discovering injury at label update; ongoing use cases may argue later accrual
⚠Ohio
2 years from discovery
Rule: Product liability claims under Ohio Rev. Code § 2305.10
Discovery: Accrual upon discovery of injury and causal connection
MDL venue (N.D. Ohio); 2-year SOL from June 2022 label update has closed for most claims
⚠Massachusetts
3 years from discovery
Rule: Product liability claims under Mass. Gen. Laws ch. 260, § 2A
Discovery: Accrual upon discovery of injury and its cause
June 2025 deadline approaching for claims tied to label update; intake priority for late-discovery cases
North Carolina
6 years from occurrence
Rule: Product liability claims under N.C. Gen. Stat. § 1-50(6)
Discovery: Discovery rule limited; repose period runs from sale
Extended SOL advantageous, but 6-year repose from first sale may bar older Suboxone use; screen for first prescription date
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| ⚠New York | 3 years from discovery | Product liability and personal injury claims; CPLR 214(2) | Accrual tied to when plaintiff knew or should have known of Suboxone-dental injury link | June 2025 marks 3-year anniversary of Indivior's warning label update; intake window closing |
| Florida | 4 years from discovery | Product liability claims under Fla. Stat. § 95.11(3)(a) | Accrual begins when plaintiff discovers or should discover injury and its cause | Longer SOL provides buffer; FDA January 2022 warning and June 2022 label update remain key accrual dates |
| ⚠Texas | 2 years from discovery | Product liability claims under Tex. Civ. Prac. & Rem. Code § 16.003 | Accrual upon discovery of injury and causal connection | June 2024 marked 2-year anniversary of label update; late 2024 filings likely time-barred unless later discovery pleaded |
| ⚠California | 2 years from discovery | Product liability claims under Cal. Code Civ. Proc. § 335.1 | Accrual upon discovery of injury and its cause | June 2024 deadline passed for claims discovering injury at label update; ongoing use cases may argue later accrual |
| ⚠Ohio | 2 years from discovery | Product liability claims under Ohio Rev. Code § 2305.10 | Accrual upon discovery of injury and causal connection | MDL venue (N.D. Ohio); 2-year SOL from June 2022 label update has closed for most claims |
| ⚠Massachusetts | 3 years from discovery | Product liability claims under Mass. Gen. Laws ch. 260, § 2A | Accrual upon discovery of injury and its cause | June 2025 deadline approaching for claims tied to label update; intake priority for late-discovery cases |
| North Carolina | 6 years from occurrence | Product liability claims under N.C. Gen. Stat. § 1-50(6) | Discovery rule limited; repose period runs from sale | Extended SOL advantageous, but 6-year repose from first sale may bar older Suboxone use; screen for first prescription date |
Live intelligence
AI litigation brief
Suboxone Teeth remains active mdl with 59 current signals in the accepted feed.
Overview
MDL 3092 is in active bellwether preparation before Judge J. Philip Calabrese in the Northern District of Ohio. The court selected a 100-case Core Discovery Pool in February 2026 and is narrowing to 50 cases for depositions running July 2026 through January 2027. First bellwether trial is scheduled for March 2028.
Key developments
Trajectory
Court filings and press coverage are both active in MDL 3092, pointing to sustained litigation pressure rather than a one-off headline cycle. 6 live sources are contributing current context.
Editorial intelligence
MDL 3092 should stay on the lead docket watch because it is the primary consolidation vehicle for Suboxone Teeth.
Generated Aug 12, 2026, 2:00 AM UTC
59 events detected
Google News (10)
Suboxone Class Action Lawsuit: How Much Will I Get - LawFold.com
New Suboxone Lawsuit Update 2026: Key Facts - LawFold.com
All Opioids – Not Just Suboxone – Raise Risk of Dental Disease - Pain News Network
Many Rx Opioids – Not Just Suboxone – Raise Risk of Dental Disease - Pain News Network
Suboxone Dental Lawsuit 2026: Who Qualifies & Settlements - LawFold.com
Suboxone Tooth Decay Lawsuit Payout Guide 2026 - lawfold.com
Suboxone Tooth Decay Lawsuit Update 2026 Guide - LawFold.com
Suboxone Lawsuit Teeth: 2026 Updates and Payouts - LawFold.com
Suboxone Lawsuit Update 2026: Settlements & Who Qualifies - LawFold.com
Can I Still Apply for Suboxone Lawsuit in 2026? - LawFold.com
Journal of research in pharmacy practice • Agarwalla R • PMID 42553867 • Journal Article.
CNS drugs • Shaparin N • PMID 42481912 • Journal Article.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology • Fanelli G • PMID 42468074 • Journal Article.
Frontiers in pain research (Lausanne, Switzerland) • Stanicic F • PMID 42454247 • Journal Article.
Journal of special operations medicine : a peer reviewed journal for SOF medical professionals • Deaton TG • PMID 42314209 • Journal Article.
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket filed in JPML: The plaintiffs are suing the manufacturers of Suboxone film, alleging that the drug was defectively designed and caused severe dental injuries such as erosion and decay. Despite being aware of the acidic properties of Suboxone film and its potential to harm dental health, the defendants reportedly f
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc.,, Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13814581. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092. Filed by Christina Anthony
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Solutions, Inc., Indivior, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13805155.. Filed by Michael Baggett. (Attachments: # 1 Civil Cover Sheet) (Nigh, Daniel) (Entered: 08/01/2026)
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Solutions, Inc., Indivior, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13805152.. Filed by Samantha Andrews. (Attachments: # 1 Civil Cover Sheet) (Nigh, Daniel) (Entered: 08/01/2026)
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc. f/k/a MonoSol RX, LLC, Indivior Inc., Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13805018. Plaintiff has indicated that case may be related to pending civil action 1:24-MD-03092. Filed by Andrew Betro. (Atta
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc. f/k/a MonoSol RX, LLC, Indivior Inc.,, Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13804995. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Clayton Farley
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13782104. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by David Whitney.
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13781824. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Anthony Boward
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13781525. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Mallissa Nelso
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand against Aquestive Therapeutics, Inc. f/k/a MonoSol RX, LLC, Indivior Inc., Indivior Solutions Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13778747.. Filed by Dean Morgan. (Kraft, Kristine) (Entered: 07/17/2026)
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LexGenius Ranking
92Score
Court, news, and regulatory activity are elevated
Monitoring
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monitoring
Last: Aug 12, 2026, 2:00 AM UTC
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Source Monitoring
PACER
PACER
Google News
FAERS
PubMed
Event feed
59
events detected
AI Brief
Suboxone Teeth remains active mdl with 59 current signals in the accepted feed.
Overview
MDL 3092 is in active bellwether preparation before Judge J. Philip Calabrese in the Northern District of Ohio. The court selected a 100-case Core Discovery Pool in February 2026 and is narrowing to 50 cases for depositions running July 2026 through January 2027. First bellwether trial is scheduled for March 2028.
Key developments
PACER court filing on Dec 31: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation. ‖ LawFold.com news on May 31: Suboxone Class Action Lawsuit: How Much Will I Get - LawFold.com. ‖ FAERS FDA alert on Jun 21: FAERS Filing 26907876: Dental caries. ‖ PubMed research on Jul 30: Flare Reaction Following Intra-articular Steroid Injection in Frozen Shoulder. A Retrospective Study..
Generated Aug 12, 2026, 2:00 AM UTC
Tracked MDLs
MDL 3092
N.D. Ohio
Suboxone (buprenorphine/naloxone) film products liability