Allegations Only · No Settlement Yet
This article describes ongoing mass-tort litigation. The injury claims described below are unproven allegations made by plaintiffs. Indivior, Indivior Solutions, and Aquestive Therapeutics have not been found liable, there is no settlement, and there is no claim form. This page is informational and is not legal or medical advice.
Thousands of people who say Suboxone's dissolvable film rotted their teeth now have a court-ordered path to trial — and after a key ruling let the core claims survive, the first bellwether case is scheduled to go before a jury in March 2028.
What Is the Suboxone Tooth Decay Lawsuit About?
Suboxone is a buprenorphine-and-naloxone medication used to treat opioid use disorder. The cases consolidated in this litigation focus on the sublingual film — the version placed under the tongue to dissolve. According to the complaints, the film is designed to be acidic to maximize how much buprenorphine the body absorbs, and plaintiffs allege that this acidity erodes tooth enamel and causes severe decay, cavities, and tooth loss with repeated daily use.The central allegation is a failure to warn. Plaintiffs allege that when the FDA first approved Suboxone film in 2010, the label carried no warning about dental risk at all, and that the manufacturers knew or should have known of mounting adverse-event reports for years before any warning appeared. The FDA did not require a dental-injury warning until June 17, 2022, after issuing a January 2022 drug safety communication that tooth decay, cavities, oral infections, and tooth loss had been reported with buprenorphine medicines dissolved in the mouth — even in patients with no history of dental problems. Plaintiffs who used the film before that label change say they were never warned.
The cases are consolidated as In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, before Judge J. Philip Calabrese in the U.S. District Court for the Northern District of Ohio. The defendants are Indivior Inc. (the company that holds the new drug application for Suboxone film), Indivior Solutions, and Aquestive Therapeutics (identified on the label as the manufacturer). All injury and liability questions remain to be decided.
The Core Legal Rulings: What Survived the Motion to Dismiss
On December 31, 2024, Judge Calabrese ruled on the defendants' motion to dismiss, granting it in part and denying it in part. The ruling is the backbone of the litigation because it defines which legal theories the plaintiffs can actually pursue. Here is what the court decided:• Pre-2022 failure to warn survives (against Indivior Inc.). The court allowed plaintiffs to pursue failure-to-warn claims covering the period between the film's 2010 launch and the FDA-mandated label change on June 17, 2022. The court noted the original label carried no warning about dental erosion, decay, or tooth loss. Because federal law makes the new-drug-application holder responsible for the label, this claim proceeds against Indivior Inc.
• Pre-approval design defect survives (against all three defendants). The court ruled that federal law does not preempt a design-defect claim based on the manufacturers' conduct before FDA approval. Plaintiffs pointed to a specific alternative — the injectable buprenorphine product Sublocade, approved in 2017 — to argue a safer design was feasible from the start. That claim may proceed against Indivior Inc., Indivior Solutions, and Aquestive Therapeutics.
• Post-2022 warning claims may continue. Even though the FDA added dental warnings in June 2022, the court ruled that later independent research — including a research letter published in the Journal of the American Medical Association in December 2022 — could qualify as "newly acquired information," allowing plaintiffs who used the film after 2022 to argue the updated warning was still inadequate.
• What the court dismissed. The court threw out post-approval design-defect claims, because a manufacturer cannot independently change an FDA-approved drug's formulation without prior FDA approval. The court also rejected any theory that the defendants should simply have stopped selling the drug.
The Official 2026–2028 Court Timeline
The pace of the case is set by the court's Second Amended Case Management Order No. 15 (the Bellwether Protocol) and its Exhibit A, entered March 27, 2026. Rather than try thousands of cases at once, the court is narrowing the pool down to a handful of representative "bellwether" trials. The key milestones:• April 20, 2026: Plaintiff Fact Sheets due for the Core Discovery Pool.
• May 20, 2026: Defendant Fact Sheets due.
• June 10, 2026: Computer-generated random selection of 20 cases.
• June 24, 2026: Each side selects 15 cases, building toward the full pool.
• July 2, 2026: Parties submit the Selection Order establishing the 50-case Core Discovery Pool.
• July 13, 2026 – January 15, 2027: Deposition period for the 50 Core Discovery cases (with a holiday recess from December 21, 2026 to January 3, 2027).
• January 29, 2027: Pool trimmed to the 15 Trial Pool cases.
• February 12, 2027: Individual complaints filed for Schedule A plaintiffs selected for the Trial Pool.
• June 4, 2027: Close of corporate fact discovery and non-expert discovery for the Trial Pool.
• June 11, 2027: Final bellwether selection — the field narrows to the final 4 single-plaintiff trial cases and their order.
• June 30 – October 11, 2027: Expert report exchange and expert depositions.
• November 8 – December 17, 2027: Briefing on summary judgment (Rule 56) and expert admissibility (Rule 702 / Daubert) motions.
• Week of January 10, 2028: Oral argument on pre-trial motions for Trial Case #1.
• March 2028: The first bellwether trial begins before Judge Calabrese.
Bellwether verdicts do not resolve every case, but they signal to both sides how juries are likely to react and often shape any later global settlement negotiations.
Is There a Suboxone Tooth Decay Settlement Amount Yet?
No. There is no settlement and no announced payout figure in the Suboxone tooth decay litigation. Unlike a class action settlement with a single fixed fund, a mass tort resolves case by case, and any value turns on the specific injuries proven in each case. The bellwether trials starting in March 2028 are designed to show how juries weigh the evidence, which is typically what shapes any later settlement discussions. No outcome or payment is guaranteed.Who Qualifies for the Suboxone Tooth Decay Lawsuit?
Because each plaintiff must prove their own injury, the court's records orders (Case Management Order No. 13 and the related collection orders) are strict about the documentation a claimant has to produce to stay in the litigation:• A five-year look-back. The standard authorization requires providers to release records starting five years before the patient's first Suboxone film prescription, running through the present.
• Broad medical and dental scope. Required records go well beyond basic charts — itemized bills, pharmacy and prescription logs, medication-assisted-treatment (MAT) clinic records, counseling notes relating to opioid use disorder, and all dental imaging, including dental X-rays, panorexes, and digital scans.
• Four categories of providers. Authorizations must reach (1) the clinician(s) who prescribed Suboxone film; (2) the dental professional(s) who treated the claimed injuries; (3) the pharmacies or MAT clinics where the film was dispensed; and (4) any primary care physician, addiction specialist, or counselor who treated the patient for opioid use disorder.
• Streamlined authorizations. Providers must accept the court-approved master authorization form — including electronic signatures such as DocuSign — and cannot demand their own proprietary release forms or stall the process. The court can issue an order to show cause against providers that refuse to comply.
In practice, these cases are documented with proof of Suboxone film use (prescription and pharmacy records) alongside dental records and imaging showing the decay, erosion, or tooth loss the plaintiff alleges.
Important: There Is No Claim Form — This Is a Mass Tort
This is the part patients most often get wrong. The Suboxone Tooth Decay litigation is a mass tort / personal-injury MDL, not a class action settlement. That means:• There is no settlement fund and no online claim form — not on OpenClassActions.com and not anywhere else. Any site advertising a quick Suboxone "claim form" payout does not reflect how this litigation actually works.
• Mass-tort cases are pursued as individual lawsuits within the MDL, typically filed by personal-injury attorneys rather than through any centralized claim portal.
• Personal-injury claims are governed by each state's statute of limitations — a filing time limit that varies from state to state.
This page is informational and is not legal advice.
For a broader view of how these drug-injury cases work, see our Mass Tort Lawsuits hub. The separate $30 million Suboxone antitrust settlement is an unrelated matter about drug pricing — not these dental-injury claims.
Frequently Asked Questions
What is the Suboxone tooth decay lawsuit about?
Plaintiffs allege that the acidic formulation of Suboxone sublingual film caused severe tooth decay, erosion, and tooth loss, and that the manufacturers failed to warn about that dental risk before the FDA required a label change in June 2022. These are unproven allegations; no defendant has been found liable.
Is there a Suboxone tooth decay settlement or claim form?
No. This is a mass-tort MDL (MDL 3092), not a class action settlement, so there is no settlement fund and no online claim form. Mass-tort cases are pursued as individual lawsuits within the MDL, typically filed through personal-injury attorneys.
Who qualifies for the Suboxone tooth decay lawsuit?
The litigation generally involves people who used Suboxone sublingual film and later experienced serious dental injuries such as tooth decay, erosion, cavities, or tooth loss. Eligibility in any individual case depends on records confirming film use and the dental injuries claimed.
How much is the Suboxone tooth decay lawsuit worth?
There is no settlement amount yet. A mass tort resolves case by case rather than through a single fund, and any value depends on the injuries proven. The first bellwether trial is set for March 2028, and no outcome or payment is guaranteed.
When is the first Suboxone trial?
Under the court's Second Amended Case Management Order No. 15 (Bellwether Protocol), the first bellwether trial is set to begin in March 2028 before Judge J. Philip Calabrese in the Northern District of Ohio.
What proof or records are required to join the Suboxone lawsuit?
Court orders require plaintiffs to produce medical, dental, and pharmacy records — including dental X-rays — generally dating from five years before the patient's first Suboxone film prescription to the present, along with records confirming Suboxone film use and the dental injuries claimed.
Sources
• FDA Drug Safety Communication — Dental Problems With Buprenorphine Medicines Dissolved in the Mouth (Jan. 2022)• In re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, U.S. District Court for the Northern District of Ohio — Opinion and Order on Motion to Dismiss (Dec. 31, 2024) and Second Amended Case Management Order No. 15 with Exhibit A (Mar. 27, 2026).
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