A New York man has filed a product liability lawsuit against the makers of Suboxone sublingual film, claiming that the strips have caused him to suffer severe dental erosion and tooth decay. The product liability lawsuit, filed this week in the U.S. District Court for the Eastern District of New York, alleges that the manufacturers, Indivior Inc., Aquestive Therapeutics Inc., Monosol Rx Inc., and Reckitt Benckiser LLC, failed to adequately warn users and the medical community about the risks associated with Suboxone sublingual film. 

What is Suboxone?

Suboxone is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid addiction. It is a combination of two active ingredients: buprenorphine and naloxone. Buprenorphine works by binding to the same receptors in the brain as opioids, helping to alleviate withdrawal symptoms and reduce cravings. Naloxone is included in Suboxone to prevent misuse and abuse of the medication. When taken as prescribed, Suboxone can be an effective tool in helping individuals recover from opioid addiction.

The Introduction of Suboxone Strips

Originally, Suboxone was available in tablet form. However, the drug manufacturers later introduced Suboxone film strips, which are placed under the tongue and dissolve in the mouth. These strips were marketed as a more convenient and discreet alternative to the tablets. Unfortunately, thousands of users have reported experiencing severe dental decay and other dental problems as a result of using Suboxone film strips.

Dental Erosion and Tooth Decay Linked to Suboxone

There has been growing concern about the potential connection between Suboxone strips and dental erosion, tooth decay, and other dental injuries. This alleged link is thought to be due to the acidic formulation of Suboxone film, which may damage the teeth. This acidity can potentially lead to the erosion of enamel and the development of cavities, ultimately resulting in tooth decay and loss. 

In a case series published in October 2013, researchers looked at patients taking buprenorphine who reported worsening dental health after initiating treatment. They found that “The prolonged contact between tooth surfaces with buprenorphine/naloxone […] may be a contributing factor in the alteration of tooth surface microbial profile and/or the pH to promote dental caries, similar to what has been previously reported in patients who use methamphetamine.”

In January 2022, the FDA issued a Drug Safety Communication warning about the dental problems associated with medicines containing buprenorphine that are dissolved in the mouth, including Suboxone. The agency identified more than 300 cases of dental damage, 131 cases classified as serious, reported since buprenorphine was approved. Despite these reports, the drug manufacturers did not take action to warn patients about the dental risks until the FDA issued its warning.

Claims Raised in Vincent Delcastillo’s Lawsuit

In this latest Suboxone lawsuit, Vincent Delcastillo alleges that he became addicted to opioids after being prescribed them for pain management. To address his opioid use disorder, his physician prescribed Suboxone strips. Neither Delcastillo nor his physician was informed about the potential dental risks associated with Suboxone strips. As a result, Delcastillo experienced severe and permanent tooth damage, requiring extensive dental work.

Delcastillo’s lawsuit further claims that the manufacturers underreported adverse events to the FDA and targeted a vulnerable patient population. Individuals suffering from opioid use disorder often face barriers to follow-up care due to stigma, insurance limitations, and financial constraints. Delcastillo and others pursuing Suboxone lawsuits argue that they may have avoided permanent tooth damage if they had been properly informed about the risks and instructed on preventive measures.

Suboxone Lawsuits and Multidistrict Litigation

Delcastillo’s lawsuit joins a growing number of Suboxone tooth decay lawsuits being filed by former users of the drug. These lawsuits share similar allegations that the manufacturers knew or should have known about the dental risks associated with Suboxone use but failed to provide adequate warnings. As a result, individuals like Delcastillo have suffered significant dental damage and now seek compensation for their injuries.

In February 2024, the U.S. Judicial Panel on Multidistrict Litigation issued an order to consolidate Suboxone lawsuits into a multidistrict litigation (MDL) in the Northern District of Ohio. This consolidation allows for more efficient handling of similar claims, streamlining the discovery process and avoiding conflicting pretrial rulings. After coordinated discovery and potential bellwether trials, individual claims may be remanded back to their original filing districts for trial.