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.