Suboxone Film Lawsuits: What the Court Record Shows

Suboxone film is a form of buprenorphine, a medicine used to treat opioid use disorder, that is held under the tongue or against the inside of the cheek until it dissolves. Federal lawsuits alleging that the film damaged users’ teeth have been consolidated in In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, before Judge J. Philip Calabrese in the Northern District of Ohio. The Judicial Panel on Multidistrict Litigation reported 2,022 actions pending in the proceeding and 2,112 filed in total as of October 1, 2026. A separate line of antitrust proceedings brought by the Federal Trade Commission against the manufacturers in 2019 and 2020 is not part of the MDL. No court has found that Suboxone film caused any individual’s dental injury.

What the FDA has said about dental problems

In a Drug Safety Communication dated January 12, 2022, the FDA warned that dental problems, including tooth decay, cavities, oral infections and loss of teeth, had been reported with buprenorphine medicines dissolved in the mouth. The agency said the problems can be serious and have been reported even in patients with no history of dental issues. It required a new warning about the risk to be added to the prescribing information and the Medication Guide for those products.

The agency said its review of its adverse-event database and the medical literature through December 31, 2018, identified 305 cases of dental adverse events, 131 of them classified as serious. Twenty-six involved patients with no reported prior history of dental problems, and 113 mentioned two or more teeth affected; the most common treatment reported was tooth extraction or removal, in 71 cases. The agency also said the benefits of the medicines clearly outweigh the risks.

The products the FDA identified are tablets and films dissolved under the tongue or against the inside of the cheek, sold under brand names that include Suboxone, Subutex, Zubsolv, Bunavail, Cassipa and Belbuca, and as generics. The FDA said buprenorphine was approved in 2002 as a tablet for opioid use disorder, and a film placed inside the cheek was approved in 2015 for pain. The communication is a regulatory action about labeling, not a finding that the medicine caused any patient’s dental injury.

What is established vs. what is alleged

Established by the documents reviewed here: the FDA’s January 2022 safety communication and the labeling requirement it announced; the creation of MDL No. 3092 and its pending-case counts; the court’s December 31, 2024 ruling; and the Commission’s antitrust filings and the monetary terms on its case pages.

Alleged, and not decided: that Suboxone film causes dental erosion and decay; that the defendants designed the film to be acidic; and that they knew of the risk but failed to warn patients and prescribers. Those are the claims asserted in the complaints, as the Panel’s transfer order and the court’s opinion describe them.

Where the claims stand procedurally

The Panel created MDL No. 3092 by a transfer order docketed in the Northern District of Ohio on February 5, 2024. The order centralized 15 actions pending in five districts, alongside 13 actions already filed in the Northern District of Ohio, and renamed the proceeding In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation. The master docket number is 1:24-md-3092, and the presiding judge is J. Philip Calabrese.

On December 31, 2024, the court ruled on a motion to dismiss in one member case, granting it in part and denying it in part. The court allowed a pre-approval design-defect claim to proceed against Indivior Inc., Indivior Solutions and Aquestive Therapeutics, and a failure-to-warn claim to proceed against Indivior Inc. It dismissed the design-defect claim as preempted to the extent it concerned the period after the FDA approved Suboxone film, and it deferred the question whether a June 2022 label change preempts later warning claims to another member case. The court treated the underlying allegations as matters that remain to be proved.

On May 19, 2025, the court entered an amended case management order setting out a bellwether protocol. It provides for a record collection pool of 500 plaintiffs, from which a core discovery pool of 50 cases will be drawn, and from which 15 cases will be selected for a trial pool. The Panel’s report dated October 1, 2026 records 2,022 actions pending out of 2,112 filed. No trial date and no verdict appear in the documents reviewed here.

The antitrust cases are separate

The product-liability claims in the MDL are not the only Suboxone litigation. The Federal Trade Commission brought separate antitrust proceedings against the manufacturer and its former parent in the Western District of Virginia.

In a complaint filed July 11, 2019, the Commission alleged that Reckitt Benckiser Group plc and its former subsidiary, now Indivior, Inc., developed the dissolvable film version of Suboxone and worked to shift prescriptions to it as generic tablets became available, and that they misrepresented that the film was safer than the tablets because children were less likely to be accidentally exposed to it. The Commission’s case page records that Reckitt Benckiser agreed to pay $50 million to settle the charges and that Indivior agreed to pay an additional $10 million. On May 10, 2021, the Commission announced that it had sent nearly $60 million in payments to consumers.

The Commission filed a separate complaint against Indivior Inc. on July 24, 2020, under the same file number. Its case page records a joint motion for entry of a stipulated order for a permanent injunction and monetary relief, and lists the matter’s status as pending as of the page’s last update. These antitrust matters concern competition and pricing, and they are distinct from the MDL, which concerns personal-injury allegations about the film.

Key dates

• 2002: the FDA approves buprenorphine as a tablet dissolved under the tongue to treat opioid use disorder (FDA safety communication).
• July 11, 2019: the FTC files its antitrust complaint against Reckitt Benckiser Group plc (FTC case page).
• July 24, 2020: the FTC files its antitrust complaint against Indivior Inc. (FTC case page).
• January 12, 2022: the FDA issues a Drug Safety Communication on dental problems with buprenorphine medicines dissolved in the mouth and requires a new label warning (FDA safety communication).
• February 5, 2024: the Panel’s transfer order creating MDL No. 3092 is docketed in the Northern District of Ohio (transfer order).
• December 31, 2024: the court rules on a motion to dismiss, allowing pre-approval design-defect and failure-to-warn claims to proceed in part (opinion and order).
• May 19, 2025: the court enters the amended bellwether protocol order (case management order).
• October 1, 2026: the Panel reports 2,022 actions pending in MDL No. 3092 out of 2,112 filed (Panel statistics report).

What this does not establish

The documents reviewed here do not show a court finding that Suboxone film caused any individual’s dental injury. The December 31, 2024 ruling decided only whether certain claims could proceed past the pleading stage, and the court described the underlying matters as remaining to be proved. The case is in consolidated pretrial proceedings, and the documents record no trial verdict and no approved settlement in the MDL.

The FDA’s January 2022 communication is a regulatory action about labeling, not a determination that the medicine caused any patient’s injury. The FTC’s case pages record antitrust allegations and monetary settlements, which resolve competition claims and are not findings about the safety of the product.

Frequently asked questions

Is there a Suboxone settlement?

No settlement of the product-liability claims appears in the documents reviewed here. The FTC’s case pages record settlements of the Commission’s antitrust claims, and the Panel’s October 2026 report records thousands of actions still pending in the MDL. An MDL is a consolidated pretrial proceeding, and a settlement of the personal-injury claims would require court approval.

What injuries are alleged in the MDL?

The Panel’s transfer order describes the actions as sharing questions arising from the alleged propensity of Suboxone film to cause dental erosion and decay. The FDA’s 2022 communication documents the dental adverse events the agency reviewed. Those are allegations and a regulatory action, not court determinations of causation.

Does the FDA say that Suboxone film causes tooth decay?

The agency’s January 2022 communication warns that dental problems, including serious ones, have been reported with buprenorphine medicines dissolved in the mouth, and it required a new warning in the labeling. It also states that the benefits of the medicines clearly outweigh the risks. It does not conclude that the medicine caused any individual’s dental injury.

The pharmaceutical lawsuits hub collects the site’s coverage of drug litigation, including the Oxbryta withdrawal litigation, the GLP-1 litigation and the Depo-Provera meningioma litigation. A background guide explains how an MDL differs from a class action.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by District, October 1, 2026” (link, accessed 2026-10-13)
2. U.S. District Court for the Northern District of Ohio: “MDL 3092, Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation” (link, accessed 2026-10-13)
3. U.S. Judicial Panel on Multidistrict Litigation: “In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, Transfer Order” (link, accessed 2026-10-13)
4. U.S. District Court for the Northern District of Ohio: “Opinion and Order, In re Suboxone Film Products Liability Litigation, MDL No. 3092 (Doc. 173), December 31, 2024” (link, accessed 2026-10-13)
5. U.S. District Court for the Northern District of Ohio: “Amended Case Management Order No. 15 (Bellwether Protocol), MDL No. 3092 (Doc. 228), May 19, 2025” (link, accessed 2026-10-13)
6. U.S. Food and Drug Administration: “FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain” (link, accessed 2026-10-13)
7. Federal Trade Commission: “Reckitt Benckiser Group PLC, FTC Matter No. 131 0036” (link, accessed 2026-10-13)
8. Federal Trade Commission: “Indivior Inc., FTC Matter No. 131 0036” (link, accessed 2026-10-13)

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