How many patients must suffer before a warning arrives?
In 2022, the FDA finally issued a warning that Suboxone’s dissolvable films can cause severe tooth decay, years after injuries were already documented. By then, hundreds of patients had already lost teeth, suffered painful oral infections, and faced life‑altering dental damage.
Today, the crisis has escalated into 896 active federal lawsuits, with plaintiffs alleging that Indivior and its partners failed to warn patients about known dental risks. A new investigation by Texas Law Dog reveals that the delay in updating Suboxone’s label represents not just a regulatory lag but a systemic failure that cost lives and health.
And while the FDA moved in January 2022, cases continue to mount. Court records show a 60% surge in filings after judges allowed “block‑filing” of up to 100 plaintiffs per complaint, highlighting the urgency of federal accountability.
Key Findings:
- FDA warning arrived in January 2022, years after documented harm.
- 896 lawsuits are now pending in MDL 3092, up from about 674 in 2023.
- 37% of cases involve multiple‑tooth decay, and 23% required extractions.
- Patients reported harm as soon as two weeks after starting Suboxone treatment.
- Filing volume surged 60% after “Schedule A” batch complaints were permitted.
| Year | FDA/Legal Milestone | Active Cases | Reported Adverse Events | Key Data Points |
| 2019–2021 | Rising reports of dental injuries; no warning | <300 | 210+ | FAERS logs early clusters of tooth loss |
| Jan 2022 | FDA issues dental damage warning | 305+ | 305 | 37% multi‑tooth; 23% extractions |
| Late 2023 | MDL 3092 formed by JPML | ~674 | 480+ | Consolidation in N. Ohio federal courts |
| Jan 2025 | Case count crosses 716 | 716 | 610+ | Plaintiffs seek mass consolidation |
| Mar–Jul 2025 | Block‑filing order issued; surge in lawsuits | 896 | 740+ | +60% filings; 890–896 active today |
Breaking Down the Data
- The FDA’s January 2022 warning came too late for many patients, with over 210 adverse event reports filed between 2019 and 2021, years before the label change. By the time the warning was issued, more than 305 confirmed adverse events had already been logged.
- By late 2023, FAERS data showed over 480 patient injury reports, and the trend only accelerated as awareness spread. As of mid‑2025, at least 740 adverse events are documented, including 37% involving multiple‑tooth decay and 23% requiring surgical extractions.
- These numbers demonstrate a troubling reality: regulatory inertia does not just delay information, it multiplies harm. Without earlier action, hundreds of patients endured irreversible injuries while litigation grew into one of the largest prescription drug mass torts of the decade.
Every month of regulatory delay translates into hundreds of preventable injuries and lives permanently changed.
The Suboxone lawsuits highlight how slow FDA responses can devastate public health. With 896 active cases today and nearly 750 reported adverse events, the story is no longer about isolated harm; it is about a systemic oversight failure.
Experts warn that if the FDA had acted in 2019, when the first reports appeared, hundreds of injuries could have been prevented, saving millions in medical costs and years of physical suffering. The Department of Justice is already scrutinizing pharmaceutical safety practices, signaling that reform is on the horizon.
Journalists reporting on this story now have the chance to shape national awareness and hold regulators and pharmaceutical companies accountable before the next crisis repeats itself.
The delay in the FDA’s warning about Suboxone’s dissolvable films and their connection to severe tooth decay has resulted in a mounting legal crisis, with 896 active lawsuits as of 2025. Patients, many of whom suffered irreversible dental damage, are now seeking justice for the harm caused by a failure to warn them of known risks. Despite documented injuries dating back to 2019, the FDA only issued a warning in January 2022, too late for many who had already endured significant harm.
The number of lawsuits has surged by 60%, underscoring the scale of the crisis and the urgent need for accountability. Over a third of cases involve multiple tooth decay, and many patients have required extractions.
The litigation highlights the broader systemic failure in pharmaceutical oversight, as the number of injuries continues to grow while the regulatory response remains inadequate. Experts argue that earlier FDA action could have prevented much of the harm and saved millions in healthcare costs. The current federal investigations into pharmaceutical oversight are pushing for reform, offering a potential turning point in how such public health failures are addressed.
