Suboxone Tooth Loss Lawsuit: MDL 3092 Status and Who Qualifies

Suboxone film combines buprenorphine and naloxone and is used to treat opioid use disorder. The FDA approved the film in 2010; before that, Suboxone was sold as a tablet. Patients dissolve the film under the tongue or in the cheek, often every day for years.

According to the court's description of the MDL, plaintiffs allege the defendants designed Suboxone film to be acidic, which they say leads to dental erosion and decay when the film dissolves in the mouth, and that the defendants knew but failed to warn. The complaints cite case reports from 2012 and 2013 linking the film's acidity to dental problems, and adverse event reports that continued for years. Plaintiffs also point to Sublocade, a monthly buprenorphine injection approved in 2017, as a safer alternative.

The defendants are Indivior Inc. and Indivior Solutions Inc., which market Suboxone film, and Aquestive Therapeutics, Inc., also named in the lead case. They deny the claims and argue federal law preempts them.

These are individual personal injury cases gathered into a mass tort. No court has found that Suboxone film caused anyone's dental injuries.

The Judicial Panel on Multidistrict Litigation centralized the federal cases on February 2, 2024 as In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092, Case No. 1:24-md-3092, before Judge J. Philip Calabrese in the Northern District of Ohio. The court describes common questions about general causation, the mechanism of injury, the adequacy of testing, and the sufficiency of warnings.

The bellwether plan, set out in Second Amended Case Management Order No. 15 filed March 27, 2026, started with a random pool of 500 plaintiffs for records collection, narrowed to 50 for core discovery, and will narrow again to 15 trial pool cases. The schedule sets the first bellwether trial for March 2028, more than four years after the MDL was formed.

Besides filed lawsuits, many claimants are listed on a court-approved "Schedule A," which let people preserve claims without each filing a separate complaint. The JPML count of 1,827 pending cases reflects filed actions, not everyone on that list.

The court reappointed the plaintiffs' leadership committee on July 2, 2026, and on July 16, 2026 entered Case Management Order No. 23 setting rules for deposing the doctors and dentists of core discovery plaintiffs. If your case is picked for core discovery, your treating dentist may be asked to sit for a deposition, and the court has warned that uncooperative providers risk delaying the whole MDL.

Attorneys generally look for:

• Use of the film, not the tablet. The claims are specific to Suboxone sublingual film. Generic buprenorphine films raise separate manufacturer questions.
• Serious dental injury after starting the film, such as multiple cavities, fractured teeth, abscesses, extractions, or complete tooth loss.
• Documented treatment by a dentist or oral surgeon.
• Timing. Use that began before June 17, 2022 fits the clearest failure to warn theory, because the label did not warn of dental injury until then.

You are less likely to qualify if your dental problems were already severe before you began the film, if you used only the tablet or the Sublocade injection, or if you started the film well after the June 2022 warning. Past drug use or dental hygiene do not automatically disqualify you, but the defense will raise them.

Family members sometimes ask whether they can pursue a claim for someone still in recovery. Generally the person who used the film brings the claim, but a guardian or estate may act in some situations. For more on how these cases differ from class settlements, see class action vs. individual lawsuit.

No Suboxone dental case has been tried or settled, so there is no average payout. If the litigation resolves, compensation in individual cases or a settlement program would likely reflect:

• the extent of dental damage and number of teeth affected;
• cost of past and future dental work, which can be high for implants or full-mouth restoration;
• pain, infections, and effects on eating, speech, and work;
• the strength of records linking the timeline to the film.

Dental restoration costs are a central part of these claims, so written estimates for future work matter as much as past bills. Mass tort attorneys usually work on contingency. For how these cases differ from class actions, see class action vs. mass tort.

Any recovery would also be reduced by fees and costs. In June 2026 the court entered an amended order setting up a common-benefit fund, which pays lawyers who do MDL-wide work out of a share of individual recoveries. That is standard in MDLs, but it is one reason to ask any attorney you speak with how fees and costs are calculated before you sign.

In January 2022, the FDA issued a drug safety communication warning that dental problems, including tooth decay, cavities, oral infections, and loss of teeth, had been reported with buprenorphine medicines dissolved in the mouth, even in patients with no history of dental issues. On June 17, 2022, the FDA required the makers to add information about dental problems to the Suboxone film label.

On December 31, 2024, Judge Calabrese ruled on the defendants' preemption-based motion to dismiss in the lead case. The court let the plaintiff proceed on pre-approval design defect claims against Indivior Inc., Indivior Solutions, and Aquestive, and on failure to warn against Indivior Inc., while dismissing other theories. The defendants had not sought dismissal of failure to warn claims for the period between the 2010 approval and the June 2022 label change.

The claims arise under state product liability law. Plaintiffs must still prove, through expert evidence, that the film can cause and did cause their dental injuries.

Every claim is subject to the statute of limitations for personal injury in the plaintiff's state, commonly two or three years, and many states use a discovery rule. Defendants are likely to argue that the January 2022 FDA communication or the June 17, 2022 label change started the clock, which would mean many two-year and three-year deadlines have already passed. Plaintiffs may argue the link was not reasonably knowable to them until later.

Whether any exception applies depends on your state and your facts, so do not assume it is too late, and do not wait.

Keep copies of any dental bills and records showing when damage was first diagnosed, since those dates are what an attorney will measure against your state's deadline.

Suboxone plaintiffs will not all get trial dates. The court is using a funnel to pick a handful of representative cases, and knowing the stages explains why the first trial is not until 2028.

The 500-plaintiff pool was chosen at random: 100 individually filed cases and 400 from Schedule A. Each side then picks five trial pool cases and five more are chosen at random, for 15, and the court will decide which case is tried first based on the parties' written arguments. Expert reports, Rule 702 challenges, and summary judgment motions for the first trial case are scheduled through late 2027, with oral argument the week of January 10, 2028.

What the lead case tells you about your own claim

The December 2024 ruling came in the case of Ryan Bennett, who filed suit on November 2, 2023 and alleged severe, permanent tooth damage and loss. Because he stopped using the film before the June 2022 label change, the court did not have to decide whether the new warning cuts off failure to warn claims for people who kept using the film afterward. That leaves an open question for anyone whose dental injury happened mainly after June 17, 2022.

The court also accepted, at the pleading stage, the plaintiff's use of Sublocade, a monthly buprenorphine injection approved in 2017, as a possible safer alternative design, and noted that injectable buprenorphine products were being developed as early as 2006. Those points support the design defect theory as the case moves to experts.

If you are on Schedule A

Being listed on Schedule A preserved a claim without a separate complaint, but it does not make the claim immune from deadlines or from being picked for the records pool. If your attorney tells you your case was selected, respond quickly to requests for records and authorizations.

1. Do not stop your treatment on your own. Talk to your prescriber about options and about protecting your teeth.
2. See a dentist and ask for copies of X-rays and records.
3. Request pharmacy records for every Suboxone film fill.
4. Collect bills and written estimates for past and future dental work.
5. Be careful with ads promising fixed payouts. No settlement exists.

In a case review, expect questions about when you started Suboxone film, whether you ever used tablets or another form, what your teeth were like before, when problems began, and what dental work you have had or need. Accurate answers about your dental history help an attorney judge the claim realistically; the defense will get those records anyway.

Independent attorneys who handle Suboxone cases can review your timeline and your state's deadline. A free case review takes about two minutes. See also our guide to what an MDL is, the Ozempic lawsuit, and the Chantix lawsuit.