Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL

The U.S. District Judge presiding over all Suboxone tooth decay lawsuits brought throughout the federal court system has ordered the parties to begin the process of exchanging information about each of the claims, in hopes of selecting a representative sample of cases for further discovery and eventual bellwether trials, which may drive settlement negotiations in the future.

There are currently about 11,000 Suboxone dental claims pending in a federal MDL (multidistrict litigation), which was established earlier this year to manage discovery and pretrial proceedings, since each of the lawsuits raises similar allegations that the makers of the opioid dependency drug failed to adequately disclose that the sublingual film version of the medication may degrade tooth enamel, leading to an increased risk of broken or lost teeth.

Although Suboxone (buprenorphine and naloxone) was first approved in a dissolvable tablet form in 2002, the drug maker subsequently introduced a sublingual film version of the drug about ten years later, which is placed under the tongue or inside the cheek. However, lawsuits allege that film version was only developed to delay competition from generic versions of the original drug, and failed to contain critical warnings for users that Suboxone film may cause tooth decay and permanent dental problems.

It was not until June 17, 2022 that the U.S. Food and Drug Administration required a warning label update about the Suboxone tooth decay side effects, after identifying hundreds of complaints involving problems experienced by users. However, plaintiffs maintain that they may have avoided permanent damage and costly dental treatments if earlier warnings and instructions had been provided.

Since February 2024, the Suboxone tooth decay lawsuit MDL has been centralized before U.S. District Judge Philip Calabrese in the Northern District of Ohio, where a status conference was held on Friday.

Identification of Representative Suboxone Dental Claims Ordered

Following his meeting with the parties, Judge Calabrese issued a court order (PDF) on July 19, calling on the lawyers to begin collecting and exchanging case-specific information from claimants in the litigation generally, which will lead to the selection of a smaller number of cases that may be prepared for a series of early bellwether trials, and help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

“The parties discussed their positions on how they should collect and exchange case-specific information,” Judge Calabrese wrote. “Based on these discussions, the Court directed the parties to negotiate a protocol for the exchange of information from claimants generally and leading to cases for further discovery or, ultimately, trial.”

Judge Calabrese called for the parties to separately submit proposals to the court by August 27, regarding the specific information about each Suboxone dental 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.

While the outcome of any early bellwether discovery or trial dates will not have any binding impact on remaining claims, the average Suboxone tooth decay 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.

The next status conference is scheduled for September 4. The parties are expected to submit a joint agenda for the status conference by August 29.