Suboxone Dental Erosion Problems Resulted in Permanent Damage to Teeth: Lawsuit

According to allegations raised in a recently filed product liability lawsuit, side effects of Suboxone film expose users of the opioid addiction treatment to a serious risk of dental erosion problems, including tooth damage, rot, decay and fractures, which was not adequately disclosed on the drug’s warning label for years.

Suboxone (buprenorphine and naloxone) was first introduced in 2002, as a dissolvable tablet used for treatment of recovering opioid addicts. However, the drug makers subsequently introduced a sublingual film version of Suboxone in 2013, which has been linked to a staggering number of reports involving permanent damage to teeth.

In a complaint (PDF) filed in the U.S. District Court for the District of Maine on December 29, Christine Edwards indicates that she could have avoided damage to her teeth if the drug makers had provided earlier warnings and instructions about steps that could be taken to avoid minimize Suboxone dental erosion problems while on the treatment.

Edwards, of Maine, indicates that she was prescribed Suboxone film for the treatment of opioid addiction, which she developed during treatment for chronic pain management. However, the lawsuit indicates neither she nor her doctor were given any warning of the risk that the highly acidic drug may break down natural enamel on teeth, causing tooth decay over time.

The lawsuit presents claims against the drug manufacturers and distributors, naming Indivior Inc., Aquestive Therapeutics, Inc., Monosol RX, and Reckitt Benckiser LLC as defendants.

“Defendants marketed Suboxone film as a maintenance drug, knowing that Suboxone film patients would use the product for extended time periods, yet failed to warn of the risk of extended use of Suboxone film posed to dental health,” Edwards’ lawsuit states. “Due to the absence of any warnings regarding extended use of Suboxone film, Plaintiff and Plaintiff’s healthcare providers were unaware of the increasing risk of dental injuries with extended use of the product.”

It was not until June 2022, that the drug makers provided updated warnings about Suboxone dental erosion problems, disclosing for the first time that use of the drug was associated with irreversible tooth damage, and instructing doctors to monitor dental health during treatments.

As a result of the drug makers’ failure to provide earlier warnings, Edwards indicates she suffered dental erosion and tooth decay, leading to permanent damage. She has had to undergo substantial dental work in response.

January 2024 Suboxone Tooth Erosion Lawsuit Update

Edwards’ complaint raises similar allegations to those being presented in dozens of Suboxone dental erosion lawsuits now being pursued throughout the federal court system, each indicating that the drug makers placed a desire for profits before the health and safety of consumers.

Given common questions of fact and law raised in the cases, 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.

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.

It is ultimately expected that hundreds of claims will be brought throughout the federal court system, if not thousands. After the JPML hearing, the panel 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.