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In a significant development for individuals affected by Suboxone-related dental injuries, U.S. District Judge J. Philip Calabrese has permitted crucial claims to advance in the multidistrict litigation (MDL) concerning Suboxone film. This ruling, issued on December 31, 2024, addresses allegations that the medication's acidic formulation leads to severe dental issues, including tooth decay and gum problems.
Background on Suboxone and Dental Injuries
Suboxone, a medication combining buprenorphine and naloxone, is commonly prescribed to treat opioid dependence. It is often administered as a sublingual film placed under the tongue. Recent claims suggest that the film's acidic nature may erode dental enamel, resulting in significant dental health problems for users.
Court's Analysis of Design and Warning Claims
The court's decision focused on two primary allegations: design defects and failure to warn.
- Design Defect Claims: The judge allowed claims that the defendants should have designed a safer product before seeking FDA approval in 2010 to proceed against all defendants—Indivior Inc., Indivior Solutions, and Aquestive Therapeutics. However, design defect claims concerning post-approval design changes were dismissed, as federal law requires manufacturers to obtain FDA permission before altering an approved drug's formulation.
 - Failure-to-Warn Claims: The court permitted these claims to proceed but limited them to Indivior Inc., 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.
Implications for Affected Individuals
This ruling signifies a substantial progression in the legal proceedings for individuals alleging dental injuries due to Suboxone. By allowing key claims to move forward, the court acknowledges the potential validity of these allegations, enabling plaintiffs to pursue compensation for their injuries.
Legal Support and Next Steps
If you or a loved one has experienced dental issues potentially linked to Suboxone use, it's crucial to seek legal counsel to understand your rights and options. The progression of this litigation underscores the importance of holding pharmaceutical companies accountable for the safety of their products.
At Kershaw Talley Barlow, we are committed to advocating for individuals harmed by defective drugs. Our experienced attorneys are closely monitoring the developments in the Suboxone litigation and are prepared to provide the support and representation you need.
For more information or to discuss your case, please contact us for a confidential consultation.