Last Updated on January 11, 2025
In a significant development, U.S. District Judge J. Philip Calabrese has denied the majority of a motion to dismiss filed by Suboxone manufacturer Indivior Inc., allowing the failure to warn claims and a majority of the design defect claims to proceed.
This ruling, issued on December 31, 2024, advances the multidistrict litigation (MDL) concerning the alleged dental risks associated with Suboxone film. The decision addresses federal drug regulations with state law claims, providing an operational framework for the litigation to proceed.
Court’s Analysis of Design and Warning Claims
The court addressed two primary components of the case: failure to warn and design defects. According to the ruling, claims that the defendants should have designed a safer product before seeking FDA approval in 2010 can proceed against all defendants – Indivior Inc., Indivior Solutions, and Aquestive Therapeutics. However, design defect claims after FDA approval were dismissed because federal law prevents manufacturers from changing an approved drug’s formulation without agency permission.
The failure-to-warn claims were partially preserved. The court is allowing these claims to proceed, but limited them to Indivior Inc., as the holder of the FDA approval, for the period between 2010 and the June 2022 label change.
Under FDA regulations, drug manufacturers are responsible for updating safety information as new risks emerge. Without clear evidence that the FDA would have rejected updated warnings, plaintiffs’ claims remain viable.
Current Status of Pending Cases
As of early 2025, the Suboxone MDL includes 716 active cases filed in federal court, with hundreds of additional cases pending in state courts. The Suboxone cases focus on severe dental issues, such as tooth decay, fractures, and loss, allegedly caused by the acidic formulation of Suboxone film, which was designed to maximize absorption under the tongue.
Plaintiffs’ Core Arguments
The plaintiffs contend that Indivior knew or should have known about the dental risks associated with Suboxone film. The court found these arguments sufficient to allow the claims to proceed at this stage of litigation.
The court noted that potential alternative safer designs, specifically injectable forms of the drug, existed that might have prevented these dental injuries. Additionally, the Court found the FDA’s June 2022 requirement for Indivior to add warnings about dental risks supports the plaintiffs’ position.
Anticipated Litigation Timeline
With this ruling, the court will likely establish schedules for focused discovery regarding Indivior’s knowledge of dental risks prior to 2022 and the development process of Suboxone film before its 2010 approval.
Bellwether trials are anticipated to begin by late 2025. These initial cases will help evaluate the strength of the legal theories and may influence potential settlements.
Documentation Recommendations for Affected Patients
Individuals who have experienced dental injuries while using Suboxone film may wish to document:
- Usage timeline (particularly before the June 2022 label change)
- Dental problems experienced during and after use
- Communications with healthcare providers about Suboxone and dental issues
Looking Ahead
This ruling establishes parameters for plaintiffs seeking compensation for alleged Suboxone-related injuries, while recognizing federal drug regulations. While some claims have been limited, allegations about inadequate warnings and pre-approval design choices remain viable.
For additional information about this litigation or to discuss potential legal rights, individuals who have experienced dental injuries while using Suboxone may contact qualified product liability counsel for a confidential case evaluation. Time limitations may apply to potential claims.
Note: This article provides general information about ongoing litigation and should not be construed as legal advice. Consult qualified legal counsel regarding your specific situation. This update reflects case developments as of January 2025.