Suboxone (buprenorphine/naloxone) sublingual film is widely prescribed for opioid use disorder treatment. In January 2022, the FDA issued a safety communication warning that the film causes severe dental problems including tooth decay, tooth fracture, and tooth loss — even in patients with no prior dental problems. Plaintiffs allege Indivior knew about the dental risks for years and failed to warn patients and prescribers. MDL 3092 is in active discovery with 3,000+ plaintiffs.
Suboxone film dissolves under the tongue with a highly acidic pH, directly eroding dental enamel over time. The buprenorphine also reduces saliva production, further accelerating decay. Indivior's internal studies allegedly showed dental risks before the product launched. The 2022 FDA warning is the causation anchor — an admission that the drug-dental injury link is real.
MDL formed 2023. Indivior is the primary defendant. Injury is severe dental erosion and tooth decay from sublingual buprenorphine/naloxone (Suboxone). FDA required black box dental warning in 2022. Discovery ongoing. Strong failure-to-warn theory.