Court Allows Suboxone Tooth Decay Lawsuits To Be Filed in Bundled Complaint by June 14, 2024

With a large influx of Suboxone tooth decay lawsuits likely to be filed in the coming weeks, ahead of the two-year anniversary for a label change that may trigger the statute of limitations for many claimants, the U.S. District Judge presiding over the federal litigation has authorized plaintiffs to file a bundled complaint by June 14, 2024, which may include thousands or even tens of thousands of claims.

Suboxone (buprenorphine and naloxone) is a prescription treatment for individuals dealing with addictions to opioid-base pain killers, which has been widely used by individuals throughout the United States over the past decade.

Although the drug 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 users were not adequately warned that Suboxone film causes tooth decay and permanent dental problems for users.

It was not until June 17, 2022 that Suboxone tooth decay warnings were added to the medication, after the FDA identified hundreds of complaints involving tooth loss, and plaintiffs maintain that they may have avoided permanent damage and costly dental treatments if earlier warnings and instructions had been provided about certain steps that can be taken to avoid erosion of enamel and tooth loss while using Suboxone film.

Thousands of Suboxone Film Lawsuits Expected Before June 2024 Deadline

Given similar questions of fact and law raised in complaints filed throughout the federal court system over the past year, the U.S. Judicial Panel on Multidistrict Litigation established a Suboxone tooth decay lawsuit MDL in February 2024, centralizing all claims before U.S. District Judge Philip Calabrese in the Northern District of Ohio, for coordinated discovery and pretrial proceedings.

Nearly 500 product liability lawsuits over the Suboxone film have already been filed against the drug maker Indivior, but the pace of new claims is expected to increase dramatically over the next 30 days, leading up to the two year anniversary for the lable change, which the drug maker has argued establishes a Suboxone lawsuit deadline for many claimants.

Since lawyers are continuing to investigate and vet large numbers of claims, plaintiffs have made multiple attempts to enter a tolling agreement with the drug maker, which would extend the filing deadline for certain claimants who already retained a lawyer, and impose other limitations on the litigation. However, Indivior has refused to agree to such an agreement, and the courts are starting to be flooded with new complaints.

In a brief (PDF) filed on May 10, the Plaintiffs’ Steering Committee highlighted concerns for the court about the impact of the drug maker’s refusal to enter a tolling agreement, indicating that it will result in many cases being filed with incomplete information, which will lead to inefficiencies throughout the litigation. In addition, plaintiffs indicated that if the manufacturer forces large numbers of claims to be filed in the next 30 days, the Court should require defendants to file an answer to each complaint.

“Since November 2023, Plaintiffs worked to persuade Defendants of the benefits of a tolling agreement to ensure this MDL is administered efficiently. The PLC proposes a tolling agreement where every potential claimant would supply proof of use from pharmacy or medical records to guarantee that this MDL includes only people who used Suboxone film,” the brief states. “On May 8, Defendants advised that they will not consider tolling at this time.”

Bundled Suboxone Lawsuits Authorized

To address the issue, Judge Calabrese issued a case management order (PDF) on May 16, allowing plaintiffs to file a bundled complaint by June 14, 2024, where they can attach a spreadsheet or list of claims that will all be considered as filed as of that date. The bundled complaint only requires lawyers to identify the individual claimants, where they reside, where they were prescribed Suboxone, and where they used the drug.

“Instead of a blanket or generally applicable tolling period of, say, 60 or 90 days, the Plaintiffs’ Leadership Committee proposed a brief tolling period for clients retained by the bar date to afford counsel time to investigate their claims by, for example, obtaining medical or pharmacy records to substantiate Suboxone use,” Judge Calabrese wrote. “As outlined in the PLC’s brief on the issue, the alternative is a rush of complaints filed in a compressed period of time with vetting that might be reasonable under the circumstances but not of a sufficient quality that would ordinarily meet the standards of federal practice or even an MDL.”

The order indicates that after July 1, defendants will have the right to file a motion to sever the bundled complaint into individual lawsuit. Once that motion is filed, Judge Calabrese indicates the Court will issue a briefing schedule, giving plaintiffs the ability to file separate individual actions, which will be a continuation of the original lawsuit. Plaintiffs will be allowed to file a more detailed amendment to the original complaint that will comply with the court’s filing requirements.