Suboxone (Buprenorphine/Naloxone) Film
Centralized before Judge J. Philip Calabrese in the Northern District of Ohio in February 2024, the Suboxone (Buprenorphine/Naloxone) Film litigation consolidates federal claims alleging that Indivior failed to adequately warn patients and prescribers that the sublingual film formulation of Suboxone could cause severe tooth decay and dental injury through prolonged direct contact with teeth — a warning the company did not add to the product label until 2022, more than a decade after the film's introduction. With 1,827 actions pending, the docket is a substantial pharmaceutical mass tort still in its case-organization phase.
The structural development driving this docket's near-term trajectory is the court-ordered census process: plaintiffs have 270 days to complete census forms covering both individually filed and bundled tooth-decay claims, with the resulting data set intended to help the court identify a representative sample of cases for initial bellwether trials, and with claims filed after October 7, 2024 excluded from this first round. A comprehensive census of this kind is a common tool in high-volume pharmaceutical MDLs for converting an undifferentiated claim pool into an organized inventory the court can actually manage toward bellwether selection.
Once the census concludes, the sequence that typically follows — case-specific discovery, expert-report exchanges, and selection of a representative bellwether sample — will determine how long this docket takes to produce its first trial-tested read on the tooth-decay causation theory and the adequacy of Indivior's original warning label. Criterica Intelligence's platform tracks census and case-identification processes like this across every active MDL as a leading indicator of how a docket is likely to sequence toward bellwether trials, without predicting the outcome of any future causation determination.
Plaintiffs allege that Indivior failed to warn that the Suboxone film's prolonged direct contact with teeth could cause severe dental injury, a warning not added to the label until 2022, more than a decade after the film launched.
A census is a structured data-collection process requiring plaintiffs to document their claims within a set period. It converts a large, undifferentiated claim pool into an organized inventory the court can manage toward bellwether selection.
The docket is expected to proceed to case-specific discovery, expert-report exchanges, and identification of a representative sample of cases for initial bellwether trials.
Courts commonly set a cutoff date to create a manageable, defined pool for the first round of case organization and bellwether selection, with later-filed claims addressed in a subsequent phase.
Statistics shown reflect historical or illustrative model outputs derived from real case data. They are not predictions or guarantees of any individual outcome. Litigation results depend on facts, jurisdiction, judge, and counsel, and vary case by case. Model accuracy is subject to selection effects and changing legal dynamics.