aibioIndivior discloses Suboxone dental injury MDL of about 22,098 plaintiffs; no bellwether before 2028
Tickers INDV
Indivior Pharmaceuticals, Inc. is the named defendant in the Northern District of Ohio MDL. Canadian class actions name subsidiaries, and a qui tam case names Indivior Inc.
Key facts
- Company
- Indivior Pharmaceuticals, Inc. (NASDAQ: INDV)
- News type
- Legal
- Primary source
- Indivior Pharmaceuticals 10-Q for the quarter ended September 30, 2026 (SEC EDGAR)
Indivior Pharmaceuticals, Inc. (Nasdaq: INDV) said in its 10-Q filed October 29, 2026 that, as of October 23, 2026, approximately 1,925 cases naming approximately 22,098 plaintiffs sit in a federal multi-district litigation over dental injuries allegedly caused by SUBOXONE Film. The case is In Re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, in the U.S. District Court for the Northern District of Ohio. The 10-Q does not name individual plaintiffs.
The filing says Indivior "has been named as a defendant" in numerous such lawsuits. It does not list other defendants in the MDL. Proposed class actions filed in Quebec and British Columbia in April 2024 name various Indivior subsidiaries "among other defendants", also without naming them.
The case
The plaintiffs allege that SUBOXONE Film was defectively designed and caused dental injury, and that Indivior failed to warn of the risks. They generally seek compensatory damages, punitive damages and attorneys' fees and costs. The suits follow a June 2022 revision to the Prescribing Information and Patient Medication Guide, which the FDA required of all manufacturers of buprenorphine medicines dissolved in the mouth to treat opioid use disorder.
One complaint filed in the MDL on June 14, 2024 attached a schedule of nearly 10,000 plaintiffs, called the Schedule A Plaintiffs. The parties agreed to toll their claims so counsel could investigate, including whether an Indivior product was used. Plaintiffs have been dismissing Schedule A claimants, and about 4,813 remained as of October 23, 2026.
Outside the MDL, one complaint has been filed in New Jersey state court. The parties also agreed to toll the claims of no less than 1,043 other individuals in Delaware, New Jersey and Virginia. No complaints have been filed for them yet. The Canadian actions cover SUBOXONE Tablets as well as Film.
Defendants
The only defendant the 10-Q names for the dental claims is Indivior Pharmaceuticals, Inc. The Canadian defendants are described only as various subsidiaries and others. The filings do not name the others.
Where it stands
The 10-Q says the MDL cases are at a preliminary stage and that no bellwether trial would occur before the end of the first quarter of 2028 at the earliest. The 10-K filed February 26, 2026 had put the earliest bellwether trials in the fourth quarter of 2027.
Indivior says it has begun evaluating the claims, believes it has meritorious defenses and intends to defend itself vigorously. Given the preliminary stage, it says no estimate of possible loss can be made.
Why it matters to shareholders
The 10-Q says the company records accruals for loss contingencies only when a liability is probable and the amount can be reasonably estimated, and that adverse outcomes in litigation "could have a material impact to the Company." It makes no estimate for the dental claims.
The 10-K reported that Indivior's primary insurance carrier had said defense costs for the dental MDL should be reimbursed now that the company's self-insurance retention is exhausted. It also said the primary and secondary carriers issued a reservation of rights against payment of any liability costs. The 10-Q does not repeat that discussion.
Related matters
The same note describes other disclosed cases. In August 2018 a federal court in the Western District of Virginia unsealed a declined qui tam complaint under the federal and state False Claims Acts, United States ex rel. Miller v. Reckitt Benckiser Group PLC et al., Case No. 1:15-cv-00017. The relator's sixth amended complaint, filed December 7, 2023, names only Indivior Inc. Discovery is stayed pending resolution of certain discovery disputes.
In the United Kingdom, certain shareholders issued claims on September 21, 2022 against Indivior PLC, now known as Indivior Limited. The court directed a split trial, and the first trial is to be scheduled for the fourth quarter of 2028.
Indivior also reports settlements of civil opioid litigation with government subdivisions in 49 states, the District of Columbia, territories and tribal nations, plus a separate Maryland settlement with a $1.9 million provision at September 30, 2026.