Lawsuit Alleges Suboxone Caused Dental Damage, Erosion and Tooth Decay

Suboxone manufacturers received complaints about dental damage from the film strips for years before adding label warnings about the risk of tooth decay and erosion, lawsuit claims.

A Kentucky man has filed a lawsuit against Suboxone manufacturers, indicating that use of the opioid treatment film strips caused him to suffer permanent damage to his teeth.

The complaint (PDF) was brought by Douglas Rebholz in the U.S. District Court for the Northern District of Ohio on November 14, indicating that Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics Inc. failed to provide adequate warnings to patients and the medical community about the high risk of dental erosion and damage linked to the drug addiction treatment.

Suboxone has been around for decades, originally approved by the U.S. Food and Drug Administration (FDA) in October 2002, with the film strip version gaining approval in 2010. However, while the active ingredient buprenorphine has long been linked to dental erosion and tooth decay, the manufacturers failed to add label warnings to alert users to the risk of Suboxone film strip tooth decay problems until June 2022.

Rebholz’ claim joins more than 11,000 other Suboxone lawsuits currently being pursued by former users of the sublingual film version of the drug, each raising similar allegations that serious tooth erosion and decay could have been avoided if the drug makers had provided earlier information and instructions on how to avoid the dental damage while using their product.

According to the lawsuit, Rebholz was prescribed Suboxone by his doctor for the treatment of opioid use disorder. However, because of the lack of warnings, he indicates he suffered permanent tooth decay, and has needed substantial dental work to repair the damage.

The complaint notes that the FDA began receiving reports of Suboxone tooth damage as early as February 2006, with the manufacturers aware of at least 13 cases of tooth decay before the film strips were approved. After they hit the market, the number of complaints filed with the agency accelerated dramatically.

“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 tablets or film, 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,” Rebholz’ complaint 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.”

The lawsuit suggests that if the manufacturers had not withheld information about Suboxone tooth damage risks from the public and medical community, Rebholz’ dental damage, and tooth decay suffered by thousands of other users, could have been avoided.

He presents claims for strict liability, failure to warn, negligent failure to warn, defective design, negligent design defect, and seeks both compensatory and punitive damages.

November 2024 Suboxone Lawsuit Update

Given common allegations raised in the litigation, Rebholz’ complaint was filed in the Northern District of Ohio, where thousands of similar claims have been consolidated before U.S. District Judge Philip Calabrese for coordinated pretrial proceedings, as part of a federal MDL or multidistrict litigation.

In July, Judge Calabrese called for the parties to separately submit proposals to the court outlining the specific information about each Suboxone dental damage claim that they believe will help identify cases that are a “representative sample” of others pending in the MDL, and “drive resolution” of the litigation.

Following the selection of a representative sample of claims, the parties will move forward with a lengthy case-specific discovery process in the MDL, including the exchange of expert reports and other evidence establishing how Suboxone causes dental injuries, before a smaller group is identified for the first trial dates.

While the outcome of these early bellwether trials will not have any binding impact on remaining claims, the average Suboxone dental injury lawsuit payout may impact the amount of money the drug maker will be required to pay to avoid the need for each individual lawsuit to go before a jury in the future.