More Than 9,600 Join Suboxone Lawsuit Over Tooth Decay in MDL Filing

Suboxone lawsuit bundled complaint filed just before two-year anniversary of FDA label warning linking the film strips to tooth decay risks.

In a mass filing submitted late Friday, thousands of new plaintiffs joined together in a Suboxone tooth decay lawsuit, which was filed just ahead of a potential deadline that may have impacted individuals living in many states, dramatically increasing the size and scope of the litigation being pursued against the makers of the opioid addiction drug for failing to warn about potential dental side effects.

Suboxone (buprenorphine and naloxone) is a prescription treatment that 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 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 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 Suboxone tooth decay warnings were added to the medication, after the FDA identified hundreds of complaints involving tooth loss. 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.

As the two year anniversary of this Suboxone warning label update approached, about 500 Suboxone lawsuits were filed throughout the federal court system. However, that number increased by a factor of nearly 20, when more than 9,600 individuals throughout the United States joined together in a bundled complaint authorized by the U.S. District Judge presiding over the litigation earlier this month.

Suboxone Lawsuit Bundled Complaint

Given similar questions of fact and law raised in separate complaints being pursued throughout the federal court system earlier this 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.

In early pretrial filings, the drug maker took the position that the two-year anniversary of the FDA label change triggered a filing deadline for individuals residing in many states with a two-year statute of limitations, arguing that claimants continuing to use the medication knew or should have known by that date that Suboxone was a potential cause of their tooth decay.

Since lawyers are continuing to investigate and vet large numbers of claims, multiple attempts were made 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, the drug make Indivior refused to agree to such an agreement.

With the Court facing the prospect that thousands of individual complaints may be filed in a very short period of time, Judge Calabrese issued a case management order late last month, which allowed plaintiffs to submit a bundled Suboxone lawsuit by June 14, 2024, which could allow an unlimited number of individuals to join together in one filing

The bundled complaint (PDF) was submitted late Friday afternoon, containing an attached list of more than 9,600 individuals, which identified where each plaintiff resided, where they were prescribed Suboxone and where they used the drug. However, all of the individuals adopted the same allegations against the drug maker.

June 2024 Suboxone Lawsuit Update

The filing greatly expands the scope of liability the Suboxone drug maker faces for failing to warn users and the medical community about the potential impact that the acidic sublingual film may have on tooth enamel, causing teeth to deteriorate, chip, break and fall out of the mouth over time.

The number of claims is expected to continue increasing in the coming years, as Suboxone injury lawyers continue to review and file claims for individuals from states that have longer statute of limitations periods, or so-called “discovery rules”, which indicate that the filing deadline is only triggered when a claimant actually learns about the cause of their injury.

As part of the coordinated management of the litigation, it is expected that Judge Calabrese will establish a “bellwether” process, where the parties will select a small group of representative claims in the coming months, which will need to go through case-specific discovery and work up for early trial dates.

To obtain additional information about each of the claimants on the bundled complaint, Judge Calabrese has indicated that the drug maker can file a motion to severe the case into individual lawsuits by July 1, 2024. Once that motion has been filed, he indicated the Court will issue a briefing schedule, after which plaintiffs may be required to file a more detailed individual complaints, which will more fully comply with the Court’s standard filing requirements.

While the outcome of any future bellwether trials scheduled in the MDL will not be binding on all claimants, the cases will be closely watched and the average Suboxone tooth decay lawsuit payouts awarded by juries may have a big impact on the amount of any settlement the drug maker may end up paying to avoid the need for each individual claim to go before juries in the future.