What the Lawsuits Allege
Suboxone is a medication used to treat opioid use disorder, combining buprenorphine and naloxone. The lawsuits focus on the dissolvable sublingual film version, made by Indivior. Plaintiffs allege the film is acidic and caused severe dental injuries, including tooth decay, enamel erosion, fractures, and tooth loss, and that the company failed to warn users and healthcare providers for years.
A central factual anchor is that the FDA required a warning about dental problems to be added in June 2022, after reports of these injuries. Plaintiffs allege Indivior and related companies knew or should have known about the risk long before then and that safer ways to deliver the medication were available. The defendants dispute the claims.
The MDL and a Key Ruling
The federal cases are consolidated as MDL 3092 in the Northern District of Ohio before Judge Philip Calabrese, with court-tracked filings using batched complaints that represent a much larger group of plaintiffs than the raw docket count suggests. The litigation is a multidistrict litigation, not a class action.
In an important early ruling, the court partially denied Indivior attempt to dismiss the cases, allowing design-defect and failure-to-warn claims to proceed. Indivior has raised a federal-preemption defense, arguing that prior FDA approval of the label limited what warnings it could add. That defense remains contested as the litigation develops.
Where Things Stand
The litigation is moving through discovery and the early stages of selecting bellwether cases, with depositions focused on what the company knew about the dental risk, when it knew it, and why a warning was not added sooner. No bellwether trials have taken place and no settlement has been reached.
Eligibility generally centers on having used the Suboxone film and suffered significant dental injury, with documentation. One nuance is the deadline: many users did not connect their dental problems to the medication until the 2022 warning, which can matter for the statute of limitations, so a prompt individual assessment is important.
How to Get Legal Help
If you or a family member fits the description here, a consultation with a lawyer who handles this specific litigation is the reliable next step. Deadlines vary by state and can be unforgiving, most of these firms offer a free review, and these cases are typically taken on contingency, so you pay nothing unless they recover for you.
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Suboxone Lawsuit: The Tooth Decay Claims Explained: Frequently Asked Questions
Answers to the most common questions about this case and your legal options.
What is the Suboxone lawsuit about?
It alleges that the dissolvable Suboxone film, used to treat opioid dependence, is acidic and caused severe dental injuries such as tooth decay, erosion, and tooth loss, and that the maker failed to warn until the FDA required a warning in June 2022. The defendants dispute this.
Who makes Suboxone?
The film version at the center of the litigation is made by Indivior, with related companies also named. The cases focus specifically on the sublingual film formulation.
Where are the cases handled?
Federal cases are consolidated as MDL 3092 in the Northern District of Ohio before Judge Philip Calabrese. It is a multidistrict litigation, not a class action, and batched filings represent a large group of plaintiffs.
Has a court ruled yet?
The court partially denied Indivior motion to dismiss, allowing design-defect and failure-to-warn claims to proceed. Indivior has raised a federal-preemption defense that remains contested. No bellwether trials have happened and no settlement has been reached.
Is there a filing deadline issue?
Yes. Many users did not connect their dental problems to Suboxone until the 2022 FDA warning, which can affect when the statute of limitations began. Because deadlines vary by state, a prompt individual assessment matters.