Lawsuit Alleges Suboxone Tooth Decay Risks Were Not Adequately Disclosed By Drug Maker

An Ohio man indicates that he suffered severe damage to his teeth and had to undergo substantial dental work after taking Suboxone to treat his opioid addiction, indicating that the drug makers knew about the risk, but failed to adequately warn users and the medical community.

The complaint (PDF) was filed by Keith King in the U.S. District Court for the Northern District of Ohio on October 2, pursuing damages from Indivior, Inc. Aquestive Therapeutics, Inc., MonoSol Rx, Inc. and Reckitt Benckiser LLC as defendants, for failing to disclose the Suboxone tooth decay risks.

Suboxone (buprenorphine and naloxone) was first approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.

Amid the nationwide opioid abuse and addiction epidemic in the United States, which has ravaged communities nationwide, Suboxone became a blockbuster drug, generating billions in profits for the manufacturers. However, King indicates that the pharmaceutical industry placed it’s desire for profits before the dental health and safety of users.

Nearly a decade after Suboxone was introduced, the U.S. Food and Drug Administration (FDA) required a new Suboxone tooth decay side effects warning in early 2022, following hundreds of reports involving tooth decay and tooth loss linked to the medications. However, King and a growing number of other users are now pursuing lawsuits, alleging that users could have avoided severe and costly dental decay problems from Suboxone if earlier warnings and instructions had been provided.

According to the lawsuit, King became addicted to opioids after he was prescribed them for pain management. He was then prescribed Suboxone to treat his addiction, and indicates that the drug caused major and severe tooth damage, requiring significant dental work to repair the damage.

Suboxone involves a combination of buprenophine and naxoline, which is intended to be ingested through oral absorption either as a tablet or film. However, buprenorphine is known to be acidic, and the drug makers knew or should have known that inclusion of buprenorphine in a dissolvable form would lead to dental erosion and tooth decay.

King indicates the manufacturers received numerous complaints regarding Suboxone tooth decay during the years after it was introduced, and were aware of studies linking its use to tooth decay, but failed to provide adequate warning labels for patients or the medical community.

“Despite adverse-event reports from healthcare professionals and consumers, Defendants did not adequately warn of the risk of serious and irreversible dental injury associated with using Suboxone until the label change in June 2022,” King’s lawsuit states. “Defendants willfully, wantonly, and intentionally conspired, and acted in concert, to withhold information from Plaintiff, Plaintiff’s healthcare providers, and the general public concerning the known hazards associated with the use of Suboxone.”

Suboxone Deceptive Marketing Claims

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 have been linked to the greatest risk of dental side effects. Plaintiffs claim the introduction of Suboxone film, which is placed under the tongue and rapidly introduced in the patient’s blood stream, 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.

King and other former users are now pursuing Suboxone tooth decay settlements from the drug makers, seeking reimbursement for the dental damage caused by the drug, as well as pain and suffering, and punitive damages.