Lawsuits allege the Suboxone sublingual film — designed to dissolve under the tongue — caused severe tooth decay, erosion, and tooth loss, and that patients were never warned of the dental risk before a 2022 FDA-mandated label change.
Suboxone (buprenorphine/naloxone) sublingual film is prescribed to treat opioid dependence. The film is acidic and is held under the tongue or inside the cheek until fully dissolved — a delivery method lawsuits allege repeatedly bathed teeth in acid, causing decay, erosion, fractures, and tooth loss even in patients with previously healthy teeth.
In June 2022, the FDA required a warning about dental problems — including tooth decay, cavities, oral infections, and tooth loss — to be added to the drug's prescribing information and medication guide. Lawsuits allege the manufacturer knew or should have known of the risk years earlier, and that patients and prescribers were left without the warning needed to protect their dental health.
Federal claims have been consolidated into a multidistrict litigation in the Northern District of Ohio (MDL 3092), where thousands of cases are pending. The litigation is moving through coordinated pretrial proceedings, with early case-management and bellwether selection underway.
Federal claims are consolidated in MDL 3092 in the Northern District of Ohio, where thousands of cases are pending. The litigation is in coordinated pretrial proceedings — no global settlement has been announced, and new claims continue to be filed.
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