What Is the Suboxone Lawsuit About?
The Suboxone lawsuit is a product liability claim against Indivior PLC (formerly part of Reckitt Benckiser Pharmaceuticals), the manufacturer of Suboxone sublingual film. Suboxone combines buprenorphine and naloxone and is a widely used, medically important treatment for opioid use disorder. The lawsuit does not challenge the medication's value in treating opioid dependence. It challenges the specific film formulation, which dissolves under the tongue, and the company's failure to warn that this method of delivery could severely damage teeth.
Plaintiffs allege that Suboxone film is acidic and that prolonged contact with the sublingual tissue and surrounding teeth breaks down enamel over time, leading to decay, cavities, gum disease, and in more severe cases, tooth loss.
In June 2022, the FDA required Indivior to add a warning about dental problems to Suboxone film's label, describing risks including tooth decay, cavities, oral infections, and tooth loss. Suboxone film had been on the market since 2010, and plaintiffs allege the company knew or should have known about these risks years before the label was updated.
If you currently take Suboxone or another buprenorphine-based medication, do not stop taking it without talking to your doctor first. This medication plays an important role in treating opioid use disorder, and stopping suddenly can increase the risk of relapse or overdose. Legal claims about dental injury and ongoing medical treatment for opioid use disorder are separate issues, and you can pursue one without affecting the other.
What Injuries Are Linked to Suboxone Film Use?
The dental injuries described in this litigation range from moderate to severe. They often develop gradually with continued use.
Severe Tooth Decay
Plaintiffs report significant tooth decay developing after using the product, even in teeth with no prior history of dental issues.
Cavities
Plaintiffs describe new, rapidly progressing cavities that formed despite having no previous history of tooth decay.
Enamel Erosion
The acidic nature of the dissolving film is alleged to wear away protective tooth enamel over time.
Dental Abscesses and Oral Infections
Advanced decay can lead to painful infections requiring urgent dental treatment.
Gum Disease
Some claims describe gum tissue damage and disease connected to prolonged film use.
Tooth Loss
In the most severe cases, patients have required tooth extractions, root canals, or other significant restorative dental work.
| Injury | FDA-Acknowledged Risk | Source |
|---|---|---|
| Tooth decay, cavities | Yes | FDA Drug Safety Communication, June 2022 |
| Oral infections, abscesses | Yes | FDA Drug Safety Communication, June 2022 |
| Tooth loss | Yes | FDA Drug Safety Communication, June 2022 |
The FDA's warning applies specifically to buprenorphine medicines that dissolve in the mouth. Not everyone who uses Suboxone film develops these complications.
Who Qualifies to File a Suboxone Claim?
Every case depends on how the medication was used and what specific dental injury developed.
Documented Suboxone Film Use
Claims are strongest when prescription and pharmacy records confirm regular use of the sublingual film, rather than other forms of buprenorphine treatment like tablets, which are not part of this specific litigation.
Diagnosed Dental Injury
Claims typically involve a dentist's diagnosis of significant decay, tooth loss, or related damage, ideally with dental records showing the progression over time.
Timing Consistent With Use
Claims are strongest when the dental damage developed or was diagnosed during a period of documented film use, particularly before the June 2022 label change.
No Significant Prior Dental History
While not required, claims are often stronger when the person had a reasonably healthy dental history before starting Suboxone film.
Every case depends on the specific facts, and you don't need every dental record gathered before reaching out. Contact our team for a free case evaluation to review your treatment history and dental injury.
What Is the Current Status of Suboxone Litigation?
Federal Suboxone dental injury lawsuits are consolidated in MDL No. 3092, In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, before Judge J. Philip Calabrese in the U.S. District Court for the Northern District of Ohio. The docket officially lists under 2,000 individual case filings, but because the court allows batch filings of up to 100 plaintiffs per complaint, attorneys estimate more than 11,000 people currently have claims in the litigation.
This litigation is still in the discovery phase, and progress has been slower than in some other mass torts. The court has worked through several rounds of narrowing a "Core Discovery Pool" of cases for more intensive review, a step toward eventually selecting a small group of bellwether trial cases. Under the current schedule, the court expects to select four final bellwether cases by mid-2027, with the first trial projected for March 2028. No settlements or verdicts have been reached in the dental injury litigation as of today. Separately, Indivior has resolved unrelated antitrust lawsuits brought by drug wholesalers and health plans, but those settlements have nothing to do with the dental injury claims covered here.
How Long Do You Have to File a Suboxone Lawsuit?
Deadlines for filing a Suboxone dental injury lawsuit vary by state. They typically range from two to three years. It depends on when your specific claim is considered to have started running under your state's law.
Most states apply a discovery rule for these types of claims, meaning the clock generally starts when you discover, or reasonably should have discovered, both your dental injury and its likely connection to Suboxone film, not necessarily when you first started the medication.
Because the FDA's warning wasn't added until June 2022, and dental damage can take time to fully diagnose, timing can be complicated to calculate on your own. Call to find out if your claim is still within the filing window.
What Compensation Can You Recover in a Suboxone Lawsuit?
Compensation in a Suboxone dental injury case depends on the severity of the damage and the dental treatment it required, but claims generally cover the following:
- Dental treatment costs, past and future, including fillings, root canals, extractions, and restorative work like crowns or implants
- Lost wages, for time missed due to dental procedures and recovery
- Pain and suffering
- Loss of enjoyment of life, in cases involving significant, permanent dental damage
No settlements or verdicts have been reached in this litigation as of today, since the MDL remains in the discovery phase and no bellwether trial has occurred. Every case is different, and past results do not guarantee future outcomes. Settlement values, if the litigation eventually reaches that stage, will likely depend heavily on the outcomes of future bellwether trials still years away under the current schedule.
Frequently Asked Questions About Suboxone Lawsuits
Talk to a Suboxone Lawsuit Attorney Today
More than 11,000 people currently have claims in the Suboxone dental injury litigation, and the FDA has formally acknowledged the link between sublingual film use and serious tooth decay. If you used Suboxone film and developed significant dental damage, you may be entitled to compensation.
We offer free, confidential case reviews with no upfront fees. You only pay if we recover compensation for you. Call 866-582-7177, or fill out our free case evaluation form to find out if you qualify.