Suboxone Acidity Caused Permanent Tooth Damage, Lawsuit Claims

The manufacturers knew for years that Suboxone acidity could damage teeth, but lawsuit claims that a desire for profits was placed before patients’ dental health, by failing to provide any warnings.

An Ohio man has filed a lawsuit against Suboxone manufacturers, indicating that acidity of the opioid addiction drug left him with permanent tooth damage, and alleging that he may have avoided the problems if information about the Suboxone dental decay risk had been disclosed to patients and the medical community.

The complaint (PDF) was filed by Ryan Bennett on November 2, in the U.S. District Court for the Northern District of Ohio, presenting claims against Indivior, Inc., Aquestive Therapeutics, Inc., MonoSol, Rx, Inc. and Reckitt Benckiser Healthcare Ltd. as defendants.

Suboxone (buprenorphine and naloxone) was approved by the U.S. Food and Drug Administration (FDA) in 2002, for treatment of recovering opioid addicts; helping them avoid withdrawal symptoms while undergoing therapy to help them break their addiction. While originally sold as a tablet, the drug makers subsequently introduced Suboxone film, which users place beneath the tongue until it is dissolved.

However, Bennett indicates that the manufacturers knew, or should have known, about Suboxone toxicity, after receiving an influx of adverse event reports and published case studies describing the devastating tooth damage. It was not until early 2022 that Suboxone tooth damage warnings were added, after the FDA identified more than 300 cases of tooth decay and dental problems reported to the agency.

According to the complaint, Bennett became addicted to opioids that were prescribed for pain management, and he was prescribed Suboxone to treat his addiction. However, he had no idea that he would be left with long-term tooth damage from Suboxone.

“During the relevant time periods, Plaintiff and Plaintiff’s physicians were given no warning and had no knowledge of the serious risk of dental erosion and decay Suboxone film posed,” the lawsuit states. “Subsequently, and as a result of Plaintiff’s prescribed use of Suboxone film, Plaintiff now suffers from permanent tooth damage and/or had substantial dental work performed to repair the damage caused by Suboxone film.”

The lawsuit claims the manufacturers knew that the active ingredient, buprenorphine, could cause dental erosion. However, instead of warning the medical community, or federal regulators, they focused on generating and protecting the blockbuster profits the drug brought in as the country continues to fight the opioid addiction crisis.

Concerns over Suboxone acidity began as early as studies in 2012, and through the years, medical literature continued to pour in, as well as adverse event reports.

“Before the FDA released its Safety Communication on January 12, 2022, Defendants were aware of at least 136 reports of adverse dental events in patients taking Suboxone, but took no steps to alert patients or prescribers of the danger to oral health that Suboxone posed until after the FDA required them to do so,” the lawsuit states. “Of the adverse events reported to FDA before the mandated label change, 40% were classified as serious. Over one-third reported the problem as affecting two or more teeth. Some of the adverse events were reported in patients with no prior history of dental issues.”

Previous Suboxone Lawsuit Settlements

Originally designed as a dissolving pill, Indivior allegedly waited until its patent exclusivity was about to expire before introducing Suboxone film versions in 2009, which has been linked to the greatest risk of dental erosion side effects.

Bennett and other plaintiffs pursuing a Suboxone tooth damage lawsuit now claim the introduction of the film version of the drug was not done to benefit patients, but to help the drug maker avoid generic competition and extend patent protections.

The federal government and various states previously pursued a lawsuit against Suboxone manufacturers, claiming that it illegally sought to control supply and inflate prices for the critical opioid addiction drug, including what state Medicaid programs paid for it.

In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing. Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia.