Thousands of Suboxone Lawsuits Over Tooth Decay Likely To Be Filed Before June 2024 Anniversary of Label Change

Although plaintiffs’ lawyers have proposed a tolling agreement to avoid flooding the court with tooth decay lawsuits over the next two months, the drug maker has refused to extend any Suboxone statute of limitations deadlines.

Although the federal court system only recently established consolidated pretrial proceedings for all Suboxone lawsuits, lawyers expect “thousands” of claims will be filed over the next two months by former users of the opioid addiction film who were left with permanent tooth decay, as the two year anniversary of a label warning update approaches in June 2024, which may trigger the statute of limitations on some claims.

Suboxone (buprenorphine and naloxone) was first approved by the U.S. Food and Drug Administration (FDA) in 2002, as a dissolvable tablet prescribed to help individuals dealing addictions to opioid-based pain killers. However, the lawsuits allege that the drug maker introduced the new Suboxone film version about ten years later, which has been linked to an increased risk of serious dental problems, which were not adequately disclosed on the initial warning label.

Although the drug maker suggested at the time Suboxone film was introduced that it was safer, subsequent investigations have determined that the alternate version was really introduced to increase profits, by holding off competition from generic manufacturers. However, as a result of this decision to place profits before consumer safety, former users now indicate that they have been left with devastating tooth decay, often resulting in broken or extracted teeth, leaving them with massive dental bills and disfiguring injuries.

It was not until June 17, 2022 that Suboxone tooth decay warnings were added to the medication, after the FDA identified more than 300 cases of dental damage reported to the agency, and plaintiffs maintain that they may have avoided permanent tooth problems if earlier warnings and instructions had been provided about certain steps that can be taken to avoid erosion of enamel and tooth loss.

Given similar questions of fact and law raised in complaints filed in U.S. District Courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to centralize all Suboxone lawsuits before U.S. District Judge Philip Calabrese in the Northern District of Ohio in February 2024, as part of an MDL or multidistrict litigation.

Over the past two months, the size of the Suboxone MDL has increased from about 20 cases to more than 200. However, Suboxone tooth decay lawyers now indicate that a flood of new filings are expected over the next two months, since the manufacturer has refused to enter any tolling agreements that would extend a potential statute of limitations deadline that may apply to some claims.

Thousands More Suboxone Lawsuits Expected

June 17 will mark two years since the FDA’s required label update was finalized, which the manufacturer is expected to argue triggers the start of the statute of limitations period for some claims.

While additional time may be available under state-specific discovery rule provisions, or based on individual fact patterns for specific claims, it will likely be some time before the court weighs in on the impact of this potential June 17 Suboxone deadline, and determines which claims may be subject to dismissal if not filed. Therefore, it is expected that there will be a sharp rise in new Suboxone lawsuits filed over the next sixty days.

In a joint status report (PDF) submitted in advance of a Case Management Conference held today, the Plaintiffs’ Leadership Committee (PLC) informed the court that “thousands” of claims are likely to be filed within a very short period of time, since the drug manufacturer has refused to consider a tolling agreement, which would allow lawyers to informally register the claims without bringing an actual complaint.

“Given the number of cases, the PLC proposed to Defense Counsel that the Parties enter into a Tolling Agreement so as to allow Plaintiffs’ Counsel sufficient time to investigate their respective clients’ cases,” plaintiffs wrote in the report. “In addition, the PLC proposed that it would supply certain information to Defense Counsel so as to reduce the risk of improper cases being filed into this MDL. Defendants declined.”

Although both the judge presiding over the litigation, and clerks office may soon be overwhelmed with new case filings, the defendants have opposed any such agreement, maintaining that they intend to raise limitations defenses with respect to claims filed after June 17, 2024.

The plaintiffs lawyers indicated that they intend to discuss the issue further, as well as the possible ramifications of mass filing in a short period of time, at a Case Management Conference today, as they will be forced to quickly file large numbers of claims to protect against any potential statute of limitations date while continuing to fully investigate potential claims.