2 minute read
Introduction
Suboxone, a medication that combines buprenorphine and naloxone, has been instrumental in helping individuals recover from opioid addiction. However, recent concerns over its film formulation have highlighted serious health risks, particularly regarding dental decay and tooth loss. These risks, combined with allegations of design flaws and inadequate warnings, have led to growing scrutiny from both public health oAicials and the legal community. As litigation over Suboxone Film gains momentum, patients and healthcare providers are taking a closer look at the potential dangers of this widely used medication.
Background
The U.S. Food and Drug Administration (FDA) issued a warning in 2022, stating that buprenorphine-based medications, including Suboxone Film, were linked to severe dental problems, ranging from cavities to complete tooth loss. According to the FDA’s findings, the dissolvable nature of the film increases contact with teeth, potentially leading to prolonged exposure to substances that can damage enamel. Additionally, research published in Drug and Alcohol Dependence has highlighted the importance of proper post-use oral hygiene for patients using buprenorphine products, emphasizing that the drug’s formulation may contribute to dental erosion if precautions are not taken.
Lawsuits
In response to these issues, lawsuits have been filed alleging that Indivior, the manufacturer of Suboxone, failed to adequately warn patients and healthcare providers about the dental risks associated with the product. In February 2024, these lawsuits were consolidated into multidistrict litigation (MDL) under the U.S. District Court for the Northern District of Ohio. One of the key legal arguments is that the design of Suboxone Film was inherently flawed and that a safer alternative design could have been developed. A December 2024 court decision further allowed claims of failure to warn and design defects to proceed, noting that there was suAicient evidence to suggest the manufacturer may have had access to information warranting stronger warnings or design changes.
Conclusion
The Suboxone litigation highlights the need for greater accountability in the pharmaceutical industry. While the medication has been an important tool in the fight against opioid addiction, its potential side eAects cannot be overlooked. Studies in the Journal of the American Dental Association have underscored the long-term consequences of dental decay, which can impact overall health and quality of life. As these cases continue to unfold, the outcomes may set a precedent for improving patient safety in addiction treatments and ensuring more transparent communication about risks. For patients, staying informed and discussing alternative treatment options with healthcare providers is crucial for making the best decisions for their recovery journey.
How We Can Help
At the Michael Lynch Firm, we’re handling cases for people who’ve been harmed by Suboxone film. If you or someone you care about has been injured, let us fight for you. You may be entitled to compensation for your medical bills, pain, and other damages. call us at 888-585-5970 or email brandon@mblynchfirm.com for a free consultation.
Date: January 24, 2025
Editor-in-Chief: Brandon Salter
Editor: Sonya Coenen
Citations
https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines
https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder
https://www.drugwatch.com/news/2024/02/05/suboxone-tooth-decay-lawsuits-consolidated-in-ohio-mdl/
https://caselaw.findlaw.com/court/us-dis-crt-n-d-ohi-eas-div/116829507.html