Indivior Seeks To Prioritize Link Between Suboxone and Tooth Decay in Early Discovery

Under the drug maker’s proposal, plaintiffs would have to first establish that Suboxone film strips cause tooth decay and dental erosion, before any case-specific discovery begins in the recently established Suboxone MDL.

With a rapidly growing number of Suboxone tooth decay lawsuits being filed in the federal court system, the drug maker Indivior is calling for the MDL judge to establish a “phased” discovery approach, where issues related to general causation would be addressed by the court before litigation moves forward into case-specific details or any bellwether test trials are scheduled.

Although the U.S. Judicial Panel on Mutltidistrict litigation (JPML) just recently established consolidated pretrial proceedings for lawsuits filed against Indivior over failure to warn about the tooth decay risks associated with the widely used opioid addiction drug, it is widely expected that several thousand Suboxone lawsuits will be filed in the next few months.

As the parties debate the organizational structure for the consolidated pretrial proceedings, the drug maker has proposed that the MDL judge delay moving forward with traditional discovery, until after plaintiffs have established that they can prove a link between Suboxone and tooth decay, which plaintiffs are expected to oppose, since it would likely substantially delay any settlements or resolution for the claims.

Lawsuits Claim Tooth Decay Caused by Suboxone Film

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 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, a federal decided to Suboxone lawsuit MDL was established before U.S. District Judge Philip Calabrese in February 2024, transferring claims filed throughout the federal court system to the Northern District of Ohio for coordinated discovery and pretrial proceedings.

Indivior Calls for Phased Discovery of Suboxone Lawsuits

On April 16, Judge Calabrese held a status conference (PDF) on Suboxone litigation, during which parties met to discuss several issues that need to be resolved before the litigation can move forward. One of those issues was an April 11 proposal (PDF), filed by Indivior, Inc, which seeks to have the court require that plaintiffs prove general causation before other discovery takes place.

“If Plaintiffs cannot prove general causation – that Suboxone film is capable of causing the dental injuries alleged – all of their claims and all of their cases fail,” defendants argued. “As many courts have recognized, there is no point in undertaking the time and expense of developing and litigating other aspects of these cases if general causation cannot be established through scientifically reliable evidence.”

In a supplement (PDF) filed on April 23, Indivior suggested that the Court should randomly select three to five lawsuits to be included in the general causation phased discovery, where those plaintiffs would produce all pharmacy, medical and dental records for expert review while developing their opinions about whether Suboxone film caused the tooth decay. During that process, all other case-specific workup and discovery would be deferred.

Plaintiffs have indicated they oppose the phased discovery plan, since such bifurcated approaches typically result in substantial delays preparing cases for trial, preventing the first cases from going before juries for several years. In addition, the typical MDL bellwether approach does involve a pretrial evaluation of the causation evidence before the first trials are allowed to begin, and the full bellwether discovery process is often the catalyst for driving Suboxone settlements that will avoid the need for thousands of individual cases to be set for trial in the future.

Judge Calabrese has established a briefing schedule, which requires plaintiffs to file their official response by May 24, with a reply from the drug manufacturer due by May 31. The Court will hear oral arguments over the phased discovery proposal on June 6.