Lawsuit Alleges Suboxone Film Caused Tooth Damage and Need for Substantial Dental Work

The Suboxone film lawsuit claims the manufacturer knew about the risk of tooth damage for years, but failed to warn patients or the medical community until the FDA forced new label warnings in 2022.

After suffering tooth damage from Suboxone film, which resulted in permanent tooth loss and required substantial dental work, an Ohio woman has filed a product liability lawsuit against the manufacturers of the opioid addiction treatment, alleging that they failed to adequately disclose the dental side effects users were experiencing.

The complaint (PDF) was filed by Ashley Fitzsimmons on December 21 in the U.S. District Court for the Northern District of Ohio, naming Indivior, Inc., Aquestive Therapeutics, Inc, MonoSol, Rx, Inc. and Reckitt Benckiser LLC as defendants.

Suboxone (buprenorphine and naloxone) was initially introduced as a dissolvable tablet in 2002, after approval by the U.S. Food and Drug Administration (FDA) for treatment of recovering opioid addicts. Amid the opioid abuse epidemic in the United States, the drug quickly grew to become a blockbuster treatment, helping users avoid withdrawal symptoms while undergoing therapy to help them break their addiction.

According to the complaint filed by Fitzsimmons, the drug makers designed and introduced a new Suboxone film version, which was approved in 2013, as part of an effort to stymie competition from generic versions of the tablet. However, the decision to place a desire for profits before consumer safety has left users with permanent tooth damage caused by Suboxone film, since the highly acidic drug breaks down natural enamel on teeth, causing tooth decay over time.

The drug makers did not add Suboxone film tooth damage warnings until mid-2022, after the FDA required an update to the prescribing information. However, Fitzsimmons now joins a growing number of individuals pursuing Suboxone tooth decay lawsuits against the manufacturers, alleging that they could have avoided permanent tooth damage and substantial dental work if earlier warnings had been provided for consumers and the medical community.

Fitzsimmons indicates in the lawsuit that the manufacturers knew 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.

“Defendants knowingly withheld and/or misrepresented information from consumers and physicians concerning the safety and efficacy of Suboxone film, including, but not limited to, raw data sets, documents, data analyses, and/or other information related to the risk of Suboxone film users suffering dental erosion and decay as a result of their Suboxone film use,” the lawsuit states. “Such information was material and relevant to the risk of patients, like Plaintiff, developing serious dental injuries as a result of using Suboxone film as prescribed.”

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.

Prior to individual users filing lawsuits against over Suboxone film tooth damage, the federal government and various states previously pursued claims against Suboxone manufacturers, claiming that the drug companies 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.

January 2024 Suboxone Tooth Damage Lawsuit Update

The U.S. Judicial Panel on Multidistrict Litigation (JPML) is scheduled to hear oral arguments over whether to centralize all Suboxone tooth damage lawsuits on January 25, 2024, at a hearing in Santa Barbara, California.

Given common questions of fact and law raised in complaints pending throughout the federal court system, but the drug maker and individual plaintiffs have indicated the litigation should be consolidated before one judge for coordinated discovery and pretrial proceedings.

In complex pharmaceutical litigation, where large numbers of claims are brought by users of the same medication or medical product, each experiencing the same or similar injuries, it is common for the U.S. JPML to centralize the litigation to reduce duplicative discovery into common issues that will arise in all claims, avoid conflicting pretrial rulings and to serve the convenience of certain witnesses and parties who will be required to testify in each of the lawsuits.

As Suboxone tooth decay lawyers continue to review and file claims for individuals who experienced dental erosion after receiving the opioid addiction treatment, it is ultimately expected that hundreds of claims will be brought throughout the federal court system.

After the hearing, the JPML will determine whether to transfer the claims to one court and confirm the judge appointed to preside over the proceedings. However, if Suboxone tooth damage settlements are not reached following coordinated pretrial proceedings in the MDL, each individual claim ma later be remanded back to the U.S. District Court where it was originally filed for separate trial dates.