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
1,854 pending
Bellwether / Trial
No verdicts yet
Settlement Status
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Case overview
The Suboxone tooth decay MDL (No. 3092) pending in the Northern District of Ohio before Judge J. Philip Calabrese has grown to approximately 890–900 cases as of mid-2025, with bellwether trials approaching and no global settlement expected until 2026. Plaintiffs allege that Indivior and predecessor manufacturers knew the sublingual film's acidic formulation caused severe dental injuries—cavities, enamel erosion, tooth loss—but failed to warn for over a decade. Defendants argue risks were disclosed after the January 2022 FDA label change and assert federal preemption and causation defenses.
Causation Theory
The causation theory centers on the sublingual film's acidic pH and prolonged oral exposure: patients hold the film under the tongue for 5–10 minutes, three times daily, eroding enamel and causing xerostomia. A December 2022 JAMA study found 21.6 dental events per 1,000 person-years with sublingual buprenorphine versus 9.0 with oral naltrexone. The FDA's January 12, 2022 safety communication identified 305 reported dental cases, including 131 serious events, prompting a boxed warning addition. A May 2024 FAERS disproportionality analysis (Current Drug Safety) confirmed significantly elevated reporting for sublingual formulations (ROR 23.55; 95% CI 17.84–31.11).
Case Management Orders
Litigation status
MDL 3092 is in bellwether preparation phase before Judge J. Philip Calabrese in the Northern District of Ohio. The court ordered a 500-plaintiff record collection pool and randomly selected 100 plaintiffs for Core Discovery Pool/bellwether consideration in January 2026. A June 1, 2026 census deadline will function as a claims shakeout, with case management conferences scheduled for January 21 and March 6, 2026.
MDL Track
MDL 3092
N.D. Ohio
Suboxone (buprenorphine/naloxone) film products liability
1,849 pending
State Court Activity
Thousands of claims registered under tolling agreements pending MDL census deadline
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
Over 13,300 Suboxone dental problem reports received from all 50 states and D.C. between January 2023 and November 2025 per Drugwatch tracking data. JAMA study (Etminan et al., 2022) found 21.6 dental adverse events per 1,000 person-years with sublingual buprenorphine/naloxone, with hazard ratio of 1.67 versus oral naltrexone. FDA safety communication January 12, 2022 warned of dental risks with transmucosal buprenorphine formulations.
Highest rate of Suboxone dental problems reported at 10.04 per 100,000 population per Drugwatch data analysis (2024).
Second-highest per capita rate of dental problem reports; among top five states for Suboxone dental problem rates alongside Maine, New Mexico, Vermont, and Washington.
Fourth-highest dental problem rate per capita; also among highest buprenorphine dispensing rates nationally per CDC 2023 data.
Third-highest per capita dental problem rate.
Fifth-highest per capita rate; 504 individual dental problem reports filed—third-highest raw number nationally.
701 dental problem reports—highest raw volume nationally.
518 reports—second-highest raw volume.
399 reports—fourth-highest raw volume.
375 reports.
MDL No. 3092 (In Re: Suboxone Film Marketing, Sales Practices, and Products Liability Litigation) centralized before Judge J. Philip Calabrese. Approximately 1,882 cases pending as of November 2025; estimated 11,000+ individual plaintiffs when accounting for joint complaints.
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
FDA Mandates Dental Warning Label
FDA requires warning for dental risks on buprenorphine-containing products that dissolve in the mouth, including Suboxone sublingual films.
JPML Creates MDL 3092
U.S. Judicial Panel on Multidistrict Litigation consolidates Suboxone tooth decay litigation as MDL 3092 before Judge J. Philip Calabrese in the Northern District of Ohio.
Plaintiff Leadership Structure Approved
Judge Calabrese issues order establishing Plaintiffs' Leadership Development Committee procedures. Court records indicate 358 pending cases in MDL 3092.
Preemption Ruling on Design Defect Claims
Judge Calabrese rules that pre-approval design defect claims survive federal preemption challenge, allowing plaintiffs to proceed with claims regarding Suboxone film formulation.
MDL Exceeds 11,000 Registered Claims
Plaintiffs' Leadership Committee reports over 11,000 product liability lawsuits in federal system, with 8,611 Schedule A complaints being vetted. Status conference held March 11, 2025.
Block Filing Protocol Approved
Court authorizes bundled complaints of up to 100 plaintiffs per filing to manage influx of cases approaching statute of limitations deadlines.
Medical Records Compliance Orders
Judge Calabrese issues orders to treatment centers and physicians demanding compliance with medical records production. MDL 3092 active case count reaches 1,854.
MDL Case Count at 1,853
As of March 2, 2026, MDL 3092 reports 1,853 pending lawsuits. Bellwether trials anticipated to drive settlement negotiations.
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 56 current signals in the accepted feed.
Overview
MDL 3092 is in bellwether preparation phase before Judge J. Philip Calabrese in the Northern District of Ohio. The court ordered a 500-plaintiff record collection pool and randomly selected 100 plaintiffs for Core Discovery Pool/bellwether consideration in January 2026. A June 1, 2026 census deadline will function as a claims shakeout, with case management conferences scheduled for January 21 and March 6, 2026.
Key developments
Trajectory
Suboxone Teeth is moving on the court side on MDL 3092 — docket scheduling and case-management orders should lead the next editorial update.
Editorial intelligence
MDL 3092 should stay on the lead docket watch because it is the primary consolidation vehicle for Suboxone Teeth.
Generated Apr 28, 2026, 1:00 AM UTC
56 events detected
No recent news signals. Monitoring is active — this section updates automatically.
The International journal on drug policy • Bayoumi AM • PMID 42030790 • Journal Article.
Journal of the American Geriatrics Society • Gravenstein S • PMID 41992533 • Journal Article.
The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG • Kaushal G • PMID 41983014 • Journal Article.
Journal of controlled release : official journal of the Controlled Release Society • Goh CF • PMID 41935721 • Journal Article.
La Clinica terapeutica • Khalifa A • PMID 41773361 • Journal Article.
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-13639485. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092. Filed by David Joe Akers.
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint with jury demand Joinder against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions, Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13639464. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092. Filed by Dawn Aleshi
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-13621530. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Nathan Bjurstro
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-13621512. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Keith Chamberla
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13621396. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Brandon Blackmon. (Attachments:
Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
PACER docket entry from OHND: Complaint against Aquestive Therapeutics, Inc., F/K/A MonoSol Rx, LLC, Indivior Inc., Indivior Solutions Inc.. Filing fee paid $ 405, Receipt number AOHNDC-13621344. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Kyle Embree. (Attachments: # 1 C
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-13620580. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Leonard Harring
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-13619469. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Rosa Palacios.
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-13619423. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Jessie Roberts.
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-13619323. Plaintiff has indicated that case may be related to pending civil action 1:24-md-03092-JPC. Filed by Kim Pillsbury.
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LexGenius Ranking
92Score
Court, news, and regulatory activity are elevated
Monitoring
Live
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Last: Apr 28, 2026, 1:00 AM UTC
Next: 37:25
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PACER
PACER
Google News
FDA
PubMed
Event feed
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events detected
AI Brief
Suboxone Teeth remains active mdl with 56 current signals in the accepted feed.
Overview
MDL 3092 is in bellwether preparation phase before Judge J. Philip Calabrese in the Northern District of Ohio. The court ordered a 500-plaintiff record collection pool and randomly selected 100 plaintiffs for Core Discovery Pool/bellwether consideration in January 2026. A June 1, 2026 census deadline will function as a claims shakeout, with case management conferences scheduled for January 21 and March 6, 2026.
Key developments
PACER court filing on Apr 23: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation. ‖ FAERS FDA alert on Dec 29: FAERS Filing 26206242: Acute kidney injury. ‖ PubMed research on Apr 23: Effect of the COVID-19 pandemic on initiations of opioid agonist therapy in Ontario: A population-based interrupted time series analysis..
Generated Apr 28, 2026, 1:00 AM UTC
Tracked MDLs
MDL 3092
N.D. Ohio
Suboxone (buprenorphine/naloxone) film products liability