Allegations Only · No Settlement Yet
This article describes ongoing mass-tort litigation. The statements below are unproven allegations. No manufacturer has been found liable, there is no certified class, there is no settlement fund, and there is nothing to claim at this time. This page is informational and is not legal or medical advice — do not stop taking a prescribed medication without talking to your doctor.
The Suboxone MDL Is Moving Toward Trial
The federal litigation over dental injuries allegedly caused by Suboxone sublingual film has cleared its earliest hurdles and is now on a firm, court-ordered path toward its first trial. The cases are consolidated as multidistrict litigation (MDL 3092) in the U.S. District Court for the Northern District of Ohio before Judge J. Philip Calabrese, who has both defined which legal claims may proceed and set a detailed discovery calendar that ends with a first bellwether trial in March 2028.For patients who were prescribed Suboxone film and later suffered serious tooth decay, broken teeth, or tooth loss, this is a meaningful shift: the case is no longer at the "are attorneys investigating?" stage. It is an active product-liability litigation with deadlines, a defined discovery pool, and a trial date. This page is the evergreen overview — what the litigation alleges, who may qualify, what survived dismissal, and how to pursue a claim.
Latest update: For the full court-ordered 2026–2028 bellwether calendar and a detailed breakdown of the motion-to-dismiss rulings, read our news update: Suboxone Tooth Decay MDL 3092 Moves Toward a March 2028 Trial →
What Is the Suboxone Tooth Decay Lawsuit About?
Suboxone is a prescription medication used to treat opioid use disorder. It combines buprenorphine, a partial opioid agonist that reduces cravings and withdrawal, with naloxone, an opioid antagonist added to deter misuse. The medication at the center of this litigation is the sublingual film — a strip placed under the tongue or against the cheek, where it is held in the mouth to dissolve.The plaintiffs allege the film is acidic — with a pH of approximately 3.4 — and that holding an acidic strip in direct, repeated contact with the teeth and gums, often combined with the dry mouth (reduced saliva) that opioids can cause, contributed to enamel erosion, cavities, cracked teeth, dental infections, and tooth loss. Saliva normally helps neutralize acid and protect enamel, so reduced saliva can compound the risk.
Central to the case is the timing of the warning. When Suboxone film launched in 2010, the plaintiffs allege the label carried no warning at all about dental erosion, decay, or tooth loss. It was not until June 17, 2022 that the FDA required a dental-problems warning to be added to the labeling for buprenorphine medicines dissolved in the mouth. The lawsuits allege that for more than a decade — from launch through that 2022 label change — patients and prescribers were not warned of a risk the manufacturers allegedly knew or should have known about.
What Survived the Motion to Dismiss
Before a mass tort can advance, the court decides which legal theories are viable. In its motion-to-dismiss opinion, the court allowed the heart of the case to proceed: plaintiffs may pursue pre-2022 failure-to-warn claims (covering the 2010 launch through the FDA-mandated label change on June 17, 2022) and a pre-approval design-defect theory built on a viable safer alternative — the injectable buprenorphine product Sublocade, approved in 2017. Post-2022 label-adequacy claims also survived on a "newly acquired information" theory tied to later clinical research. The court dismissed post-approval design-defect claims, because a manufacturer cannot unilaterally reformulate an approved film without FDA sign-off.The defendants are split by claim type: failure-to-warn proceeds against the NDA sponsor, Indivior Inc., while design-defect claims may proceed against Indivior Inc., Indivior Solutions, and Aquestive Therapeutics. For a section-by-section breakdown of the ruling, see the MDL 3092 news update.
Where the Case Stands — Heading to a March 2028 Trial
The court has set a bellwether schedule that works a large pool of cases through discovery, trims it to a smaller trial pool, then narrows to a handful of representative cases tried first to guide the rest of the MDL. The key milestones:• Mid-2026 — fact sheets are exchanged and a 50-case Core Discovery pool is finalized.
• January 2027 — the pool is trimmed to 15 Trial-pool cases.
• June 2027 — the field is narrowed to 4 single-plaintiff bellwether cases.
• March 2028 — the first bellwether trial commences before Judge J. Philip Calabrese.
The full, date-by-date 2026–2028 calendar — including the deposition windows and the summary-judgment and Daubert briefing schedule — is laid out in our Suboxone MDL 3092 news update.
What Proof Is Required to Join the Lawsuit? (Doc #672)
Because these are individual product-liability claims, each claimant must document both their Suboxone use and their dental injuries. The court's records-collection order (Doc #672) sets out exactly what disclosures are required.• A five-year look-back window. Claimants must sign an Authorization for Disclosure requiring entities to hand over documentation starting five years before the patient's first Suboxone film prescription and running through the present. This establishes baseline dental health before the drug.
• A broad documentation scope. The required disclosures go well beyond basic charts. They include itemized bills, invoices, and statement history; insurance records; pharmacy logs; MAT (medication-assisted treatment) clinic records; counseling notes relating to opioid use disorder; and all digital imaging — including dental X-rays, panorexes, and digital scans.
• Records from four categories of providers. Authorizations must reach: the medical professional(s) who prescribed Suboxone film; the dental professional(s) who treated or extracted the claimed injuries; the pharmacies or clinics where the film was dispensed; and any primary care physician, addiction specialist, or counselor treating the patient for opioid use disorder.
• Streamlined, enforceable authorizations. Under Case Management Order No. 13, healthcare facilities may not delay the process by demanding their own proprietary release forms. They must accept the standard court-approved master authorization and honor electronic signatures (such as DocuSign). Non-compliance can result in a federal Order to Show Cause for contempt.
Important: There Is No Online Claim Form — This Is a Mass Tort
Important: the Suboxone tooth decay litigation is a mass tort made up of individual personal-injury lawsuits — it is not a class action with a settlement fund. That distinction matters for how you act on it.Because no settlement exists, there is no simple online claim form on OpenClassActions.com — or anywhere else — that lets you "sign up" and wait for a check. There is no settlement fund, no payout, and no class to join. Each claimant pursues their own lawsuit, which must be filed and litigated individually within the MDL by a qualified attorney. To participate, an injured patient must consult a private attorney, who will evaluate the case, gather the records described above, and file an individual complaint.
Deadlines also matter independently of the trial schedule: statutes of limitations vary by state, and waiting can forfeit a claim regardless of how the MDL progresses. Anyone who believes they were injured should speak with counsel as soon as possible. This page is informational only and is not legal or medical advice, and it does not create an attorney-client relationship.
Frequently Asked Questions
Is there a Suboxone settlement or claim form yet?
No. The cases are consolidated in MDL 3092 in the Northern District of Ohio and remain in active discovery, with a first bellwether trial set for March 2028. There is no settlement fund and no online claim form. These are individual mass-tort claims, not a class action, so a victim must retain a private attorney to file an individual lawsuit.
What claims survived the motion to dismiss?
Per Doc #173, pre-2022 failure-to-warn claims (2010 launch through the June 17, 2022 label change) and a pre-approval design-defect theory (based on the injectable alternative Sublocade) may proceed, and post-2022 label-adequacy claims survive on a "newly acquired information" theory. Post-approval design-defect claims were dismissed. Failure-to-warn proceeds against Indivior Inc.; design-defect proceeds against Indivior Inc., Indivior Solutions, and Aquestive Therapeutics.
When is the first Suboxone bellwether trial?
Under the court-ordered schedule (Doc #668, Exhibit A), the parties build a 50-case Core Discovery pool through mid-2026, trim it to a 15-case Trial pool in January 2027, and narrow to four bellwether cases by June 2027. The first bellwether trial is set to begin in March 2028 before Judge J. Philip Calabrese.
What records do I need to join the Suboxone lawsuit?
Per Doc #672, you must authorize disclosure of medical and dental records from five years before your first Suboxone film prescription to the present — including prescription and pharmacy logs, dental X-rays, panorexes and scans, itemized bills, insurance records, and MAT clinic and counseling records — from your prescriber, treating dentist, dispensing pharmacy or clinic, and any primary care or addiction provider.
Should I stop taking Suboxone?
No one should stop taking a prescribed medication without first talking to their doctor. This page is informational and is not medical advice. Suboxone is an important treatment for opioid use disorder, and stopping suddenly can be dangerous.
Sources
• Court records — In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092 (N.D. Ohio), Doc #173 (motion-to-dismiss opinion), Doc #668 Exhibit A (case-management schedule), and Doc #672 (records-collection order).• U.S. FDA — Dental problems with buprenorphine medicines dissolved in the mouth (June 2022 warning)
• U.S. FDA — Drugs
Important Disclosures
This page is for general informational purposes and does not constitute medical or legal advice. Do not stop taking any prescribed medication without consulting your physician. You should consult a qualified attorney about your individual situation. OpenClassActions.com is not a law firm and is not a claims administrator, and this page does not create an attorney-client relationship.Free settlement alerts
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