Lawyers “Optimistic” Suboxone Tolling Agreement Will Be Reached For Tooth Decay Lawsuits

Lawyers involved in Suboxone tooth decay lawsuits indicate they are close to reaching a tolling agreement, which would extend the statute of limitations in certain claims to allow additional time for the parties to vet injuries before thousands of individual lawsuits may need to be filed in the federal court system.

The manufacturers of Suboxone already face more than 600 product liability lawsuits brought on behalf of former users of the opioid addiction treatment, each raising similar allegations that inadequate warnings were provided for years about the risk of permanent and disfiguring dental problems that may result from use of the sublingual film version of the drug.

However, about 10,000 additional claims were recently listed on a bundled Suboxone complaint that was filed last month, just before the two-year anniversary of a label change, which may have triggered the statute of limitations for individuals living in certain states.

In a recent court filing, the parties involved in the litigation indicate they are “optimistic” that an agreement can be reached to transfer those claims to a tolling agreement, avoiding the need for the court to be flooded with individual Suboxone lawsuits if the judge presiding over the litigation decides to severe the bundled complaint.

Suboxone Tooth Decay Problems

Suboxone (buprenorphine and naloxone) is a prescription treatment for individuals dealing with opioid addictions, which has been widely used over the past decade, as much of the United States faced an epidemic of opioid abuse and addiction. The drug is intended to help people stop using the powerful pain medications, by reducing cravings and helping manage withdrawal symptoms.

Although Suboxone 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 adequate warnings for users that Suboxone film causes tooth decay and permanent dental problems, resulting in disfiguring injuries and the need for expensive treatments.

It was not until June 17, 2022 that the U.S. Food and Drug Administration required Suboxone tooth decay warnings to be added to the medication, after identifying hundreds of complaints involving tooth loss, and plaitiffs maintain that they may have avoided permanent damage and costly dental treatments if earlier warnings and instructions had been provided.

In February 2024, the U.S. Judicial Panel on Multidistrict Litigation established a Suboxone tooth decay lawsuit MDL, since each of the complaints raise similar questions of fact and law. As a result, lawsuits brought throughout the federal court system have been transferred to U.S. District Judge Philip Calabrese in the Northern District of Ohio, for coordinated discovery and pretrial proceedings.

In early MDL filings, the drug maker took the position that the June 2022 FDA label change should trigger the start of the statute of limitations, leading to a rush of claims being filed over the past few months for individuals residing in states with two-year deadlines.

Since lawyers were continuing to investigate and vet large numbers of claims, multiple attempts were made prior to the two year anniversary of the warning label update to enter a tolling agreement with the drug maker, which would extend the filing deadline. However, the drug maker refused, leading Judge Calabrese to authorize the filing of a bundled complaint with a list of Suboxone claims still under investigation by June 14, indicating that the court would then consider briefing on whether each individual claimant would be severed and required to file an individual lawsuit.

Suboxone Lawsuit Tolling Agreement Close

In a joint status report (PDF) issued on July 1, the parties indicate that they have met and discussed terms of a potential tolling agreement for claims included in the bundled complaint, and are close to a resolution.

A separate tolling agreement has already been reached for claims involving plaintiffs residing in states where the drug makers are based, avoiding the need for those cases to be filed in the state court system. Since the drug maker and those plaintiffs are not from diverse jurisdictions, those claims could not be filed in the federal MDL, so the parties have agreed to extend the statute of limitations for those non-diverse plaintiffs until June 16, 2025.

Lawyers indicate they are optimistic that a similar agreement can be reached for the claims previously included on the bundled complaint, indicating that they will file another status report with Judge Calabrese by August 1, detailing the progress of these discussions and the status of any agreement.

As part of the coordinated pretrial proceedings in the Suboxone MDL, it is ultimately expected that Judge Calabrese will establish a “bellwether” process, where a small group of representative claims will be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.

While the outcome of those early trial dates will not be binding 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.