Another Influx of Suboxone Tooth Decay Lawsuits Expected in Coming Months

The U.S. District Judge presiding over all federal Suboxone tooth decay lawsuits indicates that plaintiffs and defendants have been unable to reach an agreement on tolling or how to handle an expected increase in the filing of new claims in advance of a potential deadline in June 2025, which may apply to individuals in states with a three-year statute of limitations.

There are already about 10,000 product liability lawsuits being pursued against the makers of Suboxone film, an opioid addiction treatment that has been linked to a risk of devastating dental problems for users, including tooth decay and erosion.

Although the sublingual film was first introduced in 2010, it was not until June 2022, following an FDA mandate, that the drug maker added information about Suboxone tooth damage side effects to the warning labels.

Former users now indicate that they could have avoided permanent and disfiguring tooth decay from Suboxone if earlier warnings and information had been provided to users and the medical community. In addition, plaintiffs maintain that a safer alternative design for delivery of the addiction treatment was available, but the drug maker placed a desire for profits before the health and safety of users.

Since nearly identical allegations were being raised in complaints brought throughout the federal court system, all Suboxone lawsuits were centralized as part of a federal multidistrict litigation (MDL) last year, with U.S. District Judge Philip Calabrese presiding over coordinated discovery and pretrial proceedings in the Northern District of Ohio.

Shortly after the Suboxone MDL was established, a potential deadline for individuals living in states with a two-year statute of limitations led to an influx of new claims that needed to be filed in June 2024. To avoid overwhelming the court, Judge Calabrese allowed the filing of one bundled Suboxone lawsuit, which included about 9,600 individuals from two year states who were still gathering documentation to support their claims.

States have different statutes of limitations, which require that any legal claim be filed within a certain amount of time after a cause of action arose, or when a plaintiff knew or should have known the cause of their injury. The makers of Suboxone have maintained that the addition of the new warnings in June 2022 triggers the start of clock on filing a claim for many individuals.

As the three year anniversary now approaches in the next few months, Judge Calabrese has suggested that the Court will not be authorizing another bundled complaint, since there is sufficient time for lawyers to investigate and vet potential claims. Therefore, the court is taking steps to prepare for an influx of individual Suboxone lawsuits, according to minutes (PDF) issued following a status conference last week.

“Counsel discussed the next potential limitations deadline (in June 2025), which might apply to plaintiffs in States with a three-year statute of limitations. Based on their discussions to date, counsel have no general agreement on tolling or on how to handle an expected increase in filings of new cases in advance of that deadline,” Judge Calabrese wrote. “After discussing potential options for processing those filings, the Court expressed its view that there is sufficient time for investigation between now and June 2025 that an alternative to filing a lawsuit pursuant to Second Amended Case Management Order No. 3 is not necessary. But the Court will investigate its capacity to process a large number of filings at the deadline.”

Following last summer’s mass filing, which involved a total of 9,559 claimants, plaintiffs have been required to submit additional documentation establishing a bare minimum of information to support their claims. According to the minutes from last week’s status conference, at least 927 cases have since been removed from the list, leaving 8,631 remaining on the bundled complaint. In addition, several thousand plaintiffs have filed Suboxone lawsuits individually.

As part of the coordinated management of the litigation, Judge Calabrese is working with the parties to gather information about each claim to select a representative group of lawsuits that will go through case-specific discovery and preparations for a series of early bellwether trials.

While the outcome of any early bellwether trial dates in the MDL will not have any binding impact on remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone tooth decay settlements the drug maker may offer to avoid the need for each individual lawsuit to go before a jury in the future.