• Have been prescribed Suboxone (dissolvable film) for opioid addiction or pain management
• Used prescription Suboxone for at least six months before suffering injuries
• Have one of more of the following injuries: Tooth loss, tooth fractures, tooth decay, oral surgeries, tongue injuries, gum injuries within the last 10 years
• Do not have a lawyer

A product liability lawsuit has been filed against the manufacturers of Suboxone®, alleging that the drug's acidity led to tooth decay and permanent dental damage.

The lawsuit was filed on September 25 in the U.S. District Court for the Northern District of Ohio against:

• Indivior
• Aquestive Therapeutics
• MonoSol Rx
• Beckitt Benckiser

Suboxone® is a medication used for treating opioid use disorder by managing withdrawal symptoms and reducing cravings. It is typically taken orally as a tablet or film, affecting salivary flow and oral pH due to its high acidity, which can have immunosuppressive effects.

The consumer who was prescribed Suboxone® claims to have suffered permanent tooth decay and required extensive dental work due to the medication. The consumer is seeking compensatory and punitive damages, along with attorney fees.

According to the lawsuit, the defendants were aware or should have been aware that Suboxone®, when used as directed, could harm teeth due to the acidity of buprenorphine.

The lawsuit asserts that Indivior knew about the risk of tooth decay associated with Suboxone® well before the FDA issued a warning in 2022. In 2010, the manufacturer reported nearly 20 cases of dental issues in patients using Suboxone® to the FDA.

Furthermore, in 2012, case reports were published linking dental problems to Suboxone® use. One of these reports identified 11 patients at Brigham and Women’s Hospital in Boston who experienced deteriorating dental health attributed to prolonged contact with Suboxone®. Their dental issues included:

• Cracked teeth
• Crown replacements
• Root canals
• Tooth extractions; and,
• Additional fillings.

In January 2022, the FDA issued a warning about over 300 cases of tooth decay, loss, and oral infections linked to the use of Suboxone® and buprenorphine medications, even in patients with no previous oral health problems.

More than 130 of these cases were considered severe. Later, the FDA mandated an update to the prescribing information for all buprenorphine products, including Suboxone® tablets and films, to address the risk of dental problems.

We believe all consumers who use Suboxone® before experiencing tooth injury, tooth damage, gum injuries, or oral surgery should receive justice and potential compensation for pain and suffering.