Suboxone Tooth Decay Claims Surge Beyond MDL Count

While the multidistrict litigation (MDL) publicly lists roughly 1,800 filed lawsuits, early 2026 filings revealed a far larger pool of potential claims. A Schedule A census filed in the proceedings identified more than 5,700 active claims tied to alleged Suboxone dental damage.

That difference reflects another issue at the center of the litigation: the contrast between the relatively small number of cases initially identified by the U.S. Food and Drug Administration and later research suggesting the problem may have been far more widespread.

In January 2022, the FDA issued a drug safety communication warning that buprenorphine medicines dissolved in the mouth had been linked to serious dental problems. The agency said it had identified 305 reported cases associated with the medications, including 131 classified as serious.

Later that year, researchers published a study in the Journal of the American Medical Association finding substantially higher rates of dental adverse events among users of sublingual buprenorphine/naloxone compared to patients using other opioid-treatment medications. The study included 21,404 people taking sublingual buprenorphine (film strips that dissolve in your mouth), 5,385 transdermal buprenorphine, and 6,616 oral naltrexone. The results show adverse dental problems affect:

• 6 per 1,000 taking sublingual buprenorphine
• 2 per 1,000 taking transdermal buprenorphine
• 9 per 1,000 taking oral naltrexone

“Clinicians might consider drugs other than sublingual buprenorphine/naloxone in patients with previous dental problems,” the authors wrote.

For plaintiffs’ attorneys, the contrast between the FDA’s 305 reports and the broader findings in the JAMA study has become a recurring theme in the litigation. They argue the FDA’s adverse-event database likely captured only a fraction of actual cases because reporting is voluntary and often incomplete. The epidemiological research, they contend, points to a much larger population of patients who may have experienced tooth decay and other oral complications linked to dissolvable buprenorphine products.

That same concern is now emerging in the MDL proceedings themselves. Attorneys note that public docket totals often understate the size of mass tort litigation because many claimants first enter census registries before formally filing lawsuits.

In the Suboxone proceedings, the newly disclosed Schedule A census suggests the litigation may still be in an early expansion phase despite already ranking among the larger pharmaceutical MDLs in federal court.

As discovery continues, attention is expected to focus not only on the science surrounding Suboxone-related dental injuries, but also on whether public court filings significantly underrepresent the number of patients alleging harm.