The Suboxone lawsuit MDL was centralized on February 2, 2024, in the Northern District of Ohio and now proceeds against Indivior Inc., the Indivior affiliate defendant, and Aquestive Therapeutics, Inc. Like the parallel MDL, the docket uses early documentary proof to test case viability before bellwether trials.
Plaintiffs allege that Suboxone sublingual film caused tooth decay, enamel erosion, gum disease, and tooth loss, and that its manufacturers added no dental warning until the FDA required one in June 2022. This analysis tracks the factual record, preemption rulings, records protocol, defendant posture, industry implications, and trial schedule.
How the Suboxone Tooth Decay Claims Became MDL 3092
The JPML's transfer order centralized In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, Case No. 1:24-md-3092 (N.D. Ohio 2024), before Judge J. Philip Calabrese. Fifteen actions from five districts, plus eleven related actions in nine districts, moved to a judge the panel called "a jurist who has not yet had the opportunity to preside over an MDL." JPML statistics counted 1,832 pending actions by July 1, 2026, up from roughly 51 in March 2024.
Defendants sought FDA approval for the film on October 20, 2008, obtained approval in August 2010, and ceased distributing the tablet in March 2013. The film composition patent targets a local pH of about 2 to 4 to improve buprenorphine absorption while limiting naloxone uptake.
The FDA's Drug Safety Communication warned on January 12, 2022, that "tooth decay, cavities, oral infections, and loss of teeth" had been reported with transmucosal buprenorphine medicines. Its FAERS review identified:
- 305 total cases of dental problems, 131 classified as serious
- 71 cases requiring tooth extraction or removal
- 26 patients with no prior dental history; average age 41.8
The court's September 2024 order dismissed Indivior PLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd. without prejudice from all MDL cases, and with prejudice in the Bennett bellwether case. The court found they did not manufacture, distribute, or sell the film. That leaves Indivior Inc., the NDA holder; the Indivior affiliate; and Aquestive Therapeutics, Inc., the film's exclusive global manufacturer.
Which Claims Survived the December 2024 Preemption Ruling?
Judge Calabrese's December 2024 ruling split both theories along two dates: the 2010 FDA approval and the June 17, 2022 label change. Four holdings now frame the pleading-stage rulings:
- The post-approval design-defect claim was preempted. "Federal law preempts Plaintiff's design-defect claim to the extent that claim relates to the period after FDA's approval of Suboxone film in 2010," under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), impossibility logic.
- The pre-approval design-defect claim survived against Indivior Inc., the Indivior affiliate, and Aquestive, anchored in Ohio Rev. Code § 2307.75(A)'s "at the time it left the control of its manufacturer" language, with Sublocade, the monthly injection approved in 2017, pleaded as the alternative design.
- The 2010-through-June 17, 2022 failure-to-warn claim was unchallenged and proceeds against Indivior Inc.
- The post-June 17, 2022 warning claim also survived because plaintiffs cited a JAMA research letter, which reported adjusted hazard ratios ranging from 1.42 to 1.71 across dental adverse event and tooth-loss endpoints, as potential newly acquired information. Because only the NDA holder may strengthen a label through the Changes Being Effected regulation under Wyeth v. Levine, 555 U.S. 555 (2009), Aquestive and the Indivior affiliate exited the failure-to-warn theory entirely.
Two questions remain open: whether pre-approval design defect survives renewed preemption scrutiny at summary judgment, and whether the post-June-2022 warning claim survives a merits ruling the court could not reach because the bellwether plaintiff stopped using the film before the label changed.
From a 500-Case Records Pool to a 15-Case Trial Pool
CMO No. 12 required each plaintiff filed on or before October 7, 2024 to serve, within 270 days, a completed census form, executed medical, dental, and pharmacy authorizations, and records proving brand-name Suboxone film use and a later dental injury. CMO No. 15 then built a four-tier pipeline.
The Record Collection Pool contained 500 cases: 100 individually filed and 400 Schedule A cases. Records were "substantially complete" when defendants held records for 425 of the 500. The Core Discovery Candidate Pool drew 100 cases from substantially complete files, though two dismissals cut it to 98 by February 2026.
The Core Discovery Pool then narrowed the docket to 50 cases: 20 random selections plus 15 chosen by each side. The Trial Pool will contain 15 cases, five per side plus five random, with plaintiffs' selections due to defendants by January 29, 2027. Only substantially complete files fed the candidate pool, and selection rules barred later cures. The July 2026 MDL docket shows provider depositions underway under CMO No. 23.
Why Records Compliance Became the Litigation's Chokepoint
Dismissal practice has been the docket's most visible case-resolution activity, including records-related show-cause dismissals and the September 2024 dismissal of several corporate defendants. The MDL docket reports no verdict or settlement. CMO No. 12 put teeth in the census: plaintiffs who cannot substantiate injury or product identification face dismissal with prejudice, and those who fail to serve census materials face dismissal without prejudice.
The first enforcement cycle ran through fall 2025. The court issued a show-cause order on September 9, 2025 (ECF No. 328) and a companion order (ECF No. 329). After reviewing 297 submissions, the court's October 2025 order rejected as insufficient good cause "issues regarding email or phone service, failure to inform counsel of a change in contact information, lack of communication with counsel, lack of understanding of deadlines and obligations, miscommunications or misunderstandings, demanding work hours, and vague or unspecified personal or health issues."
The second cycle turned on providers. CMO No. 13 requires any entity receiving an executed authorization and a copy of the order to produce records within 30 days; entities may not demand proprietary forms and must accept court-approved electronic signatures. An April 9, 2026 amended show-cause order, triggered by three successive non-compliance reports, warned that entities failing to produce and appear face contempt motions under Rule 45(g). On April 24, 2026, the court dismissed plaintiff Keith King with prejudice for failing to respond to a show-cause order.
Which Defense Positions Remain Live for Indivior and Aquestive?
With preemption partially resolved, two defense lines remain open through 2027 motion practice. Limitations comes first. Defendants argued claims accrued no later than June 17, 2022, when the label change put the dental risk on notice.
The putative bar date in two-year states was June 17, 2024, addressed by the bundled Schedule A complaint filed June 14, 2024 under CMO No. 4. In three-year states, the putative bar date was June 17, 2025.
Amended CMO No. 3 protects home-state law: direct filing in Ohio "will not determine the applicable choice of law," including for limitations and repose. On causation, the court's June 2024 denial rejected defendants' bid to sequence general-causation discovery ahead of merits work, so alternative-cause arguments about opioid use, xerostomia, and dental hygiene will run through expert discovery and Rule 702 motions.
An Emerging Gatekeeping Template for Pharmaceutical MDLs
MDL 3092's architecture, front-loaded documentary proof, mandatory authorizations, a centralized records workflow, and dismissal with prejudice for non-compliance, is more demanding than a standard plaintiff fact sheet but less formal than a Lone Pine order. The same design appeared almost simultaneously in the Depo-Provera litigation, where Pretrial Order 17 required "initial documentary proof of use for each named Defendant's product, and initial documentary proof of their alleged meningioma injury," and draft Rule 16.1 would make prima facie evidence orders and fact sheets explicit topics for early MDL planning.
Indivior discloses no reserve for the dental MDL: "Given the status and preliminary stage of litigation, no estimate of possible loss can be made at this time." Its 2025 annual filing treats the company's opioid-litigation settlement provision and its concluded $600 million DOJ resolution as separate matters from the dental claims. The dental exposure is still expanding through the roughly 10,000 Schedule A plaintiffs whose claims the parties agreed to toll while counsel investigate product use before filing individual complaints.
Benchmarks cut both ways: the Vioxx settlement was $4.85 billion, the CPAP benchmark paid $1.075 billion in March 2025, and Zostavax ended with the Third Circuit affirming dismissal of 1,189 cases after adverse expert rulings, with no settlement at all.
Intake, Preservation, and Diligence Lessons from MDL 3092
The court's enforcement record turns preservation duties into a practical playbook. Records collection became the dividing line between viable and dismissed cases well before the court reached the merits. The lessons differ by side of the caption.
For Plaintiff Counsel
- Collect intake records. Tennessee and Colorado require only seven years' retention and North Carolina eleven, so a client who used the film from 2015–2017 may face lawful destruction of proving records before suit is filed.
- Treat provider follow-up as a docketed deadline. CMO No. 13's 30-day production window matches HIPAA's 30-day response period, subject to one 30-day extension; document escalation on day 31.
- Keep contemporaneous, dated diligence records. The October 2025 good-cause standard demanded "sufficient supporting details, as opposed to a general unsupported or conclusory statement."
- Maintain current client contact information; the court refused to excuse communication lapses.
For Defense Counsel
Census enforcement did the winnowing that early dispositive motions usually attempt, at lower briefing cost. The preserved post-June-2022 preemption and limitations defenses are queued for Trial Pool Rule 12 motions; arguments rejected in the December 2024 ruling may not be repeated, but unresolved ones are not foreclosed.
The Trial Track Between Now and a March 2028 First Trial
The Second Amended CMO No. 15 fixes the path forward, with any bellwether trial not expected before the first quarter of 2028. Remaining milestones are set across 2027 and early 2028.
Trial Pool fact discovery concludes June 4, 2027. Rule 702 motions are due November 8, 2027, with replies due December 17, 2027. Daubert oral argument is set for the week of January 10, 2028, and the projected first bellwether trial remains March 2028. The parties were directed to identify anticipated expert topics by March 9, 2026, though not to name individuals.
Records Discipline Now Determines Trial Posture
MDL 3092 rewards firms that treated records collection as threshold proof of viability rather than a later-stage chore. For plaintiff counsel, the census regime makes early retrieval and preserved diligence records the difference between a surviving claim and a dismissal that arrives before any merits ruling. For defense counsel, census enforcement has done the winnowing that early dispositive motions usually attempt, while the preserved preemption and limitations defenses wait for 2027 motion practice.
Firms entering the next pharmaceutical mass tort should expect this front-loaded architecture from the outset rather than treating it as a Suboxone-specific quirk. For a comparable look at how documentary-proof requirements shape an active products MDL, see the analysis of the Bard PowerPort litigation.
