Suboxone Side Effects Caused Permanent Tooth Damage, Maryland Man’s Lawsuit Claims

A Maryland man has filed a Suboxone lawsuit against Indivior, indicating that use of the drug maker’s sublingual film strips to treat an opioid addiction led to permanent tooth damage and the need for extensive dental surgery.

The complaint (PDF) was brought by Michael James Rolf, of Dundalk, Maryland in the U.S. District Court for the Northern District of Ohio on January 7, naming Indivior, Inc., Indivior Solutions, Inc., and Aquestive Therapeutics, Inc. as defendants. The lawsuit claims that the drug maker provided false and misleading information about the dental risks associated with Suboxone for year, placing a desire for profits before consumer safety.

Suboxone was first approved by the U.S. Food and Drug Administration (FDA) in October 2002, with the sublingual film version receiving approval in 2010. Despite the known association between the formulation of Suboxone and dental issues such as tooth decay and erosion, the manufacturers did not include warnings about these potential Suboxone side effects on the initial product label.

It was not until June 2022, following an FDA mandate, that warnings about Suboxone tooth decay side effects were added to the labeling for the sublingual films.

Rolf’s claim joins more than 11,000 Suboxone lawsuits that are currently being pursued by former users of the sublingual film version of the drug, each raising similar allegations that severe tooth decay and erosion could have been prevented if the manufacturers had provided timely warnings and instructions to mitigate dental damage.

Rolf indicates he became addicted to opioids that were originally prescribed for pain management, and was then prescribed Suboxone film strips to treat the addiction.

However, he indicates that neither he, nor his physician, were given warning that Suboxone side effects could cause dental damage, which resulted in Rolf suffering permanent tooth damage and requiring “substantial dental work” to address.

The lawsuit indicates the manufacturers knew about the problem, but kept complaints and other warning signs under wraps to maintain their profits. They also failed to alert healthcare professionals and patients that they needed to be on the lookout for decay of tooth enamel, the complaint states.

“Defendants willfully, wantonly, and intentionally conspired, and acted in concert, to ignore relevant safety concerns and to deliberately not study the safety and efficacy of Suboxone film, particularly for long-term use as a maintenance drug,” Rolf’s lawsuit states. “Defendants failed to disclose a known risk and, instead, affirmatively misrepresented that Suboxone film was safe for its intended use indefinitely.”

Rolf presents claims of failure to warn, negligent failure to provide adequate warnings and instructions, defective design, negligent design defect, and seeks both compensatory and punitive damages.

January 2025 Suboxone Lawsuits Update

Since February 2024, all Suboxone lawsuits over the tooth decay risks have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge Philip Calabrese, for coordinated discovery and pretrial proceedings in the Northern District of Ohio, where Rolf’s complaint was also filed.

The judge has scheduled a series of status conferences over the first half of 2025, to review progress in the Suboxone litigation with lawyers involved in the claims, including the exchange of certain information and documents.

In mid-2025, it is expected that the parties will identify a small group of Suboxone failure to warn lawsuits that are representative of the litigation as a whole, to serve as bellwether test cases for early jury trials.

While the outcome of any early bellwether trial dates in the MDL will not have any binding impact on remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone tooth decay settlements the drug maker may offer to avoid the need for each individual lawsuit to go before a jury in the future.