What’s the Future of Suboxone Tooth Decay Claims in Court?
The increasing number of legal actions against the manufacturer of Suboxone, Indivior, is gaining prominence within legal circles. Suboxone, a medication used to address opioid addiction, has become the subject of numerous lawsuits.
Individuals across the United States have claimed that the sublingual film form of Suboxone caused serious dental issues. These concerns mainly include tooth decay, erosion, and even tooth loss. The litigation commenced in late 2023 and has expanded to include over 11,000 claimants.
As the number of claims continues to rise, the statute of limitations has been surpassed in multiple states. The court’s subsequent actions could set a significant precedent for future pharmaceutical-related lawsuits. This blog post delves into the present status of the Suboxone lawsuits. It also discusses the pivotal legal issues at stake, and what can be anticipated as the litigation progresses.
How Did the Suboxone Tooth Decay Lawsuits Begin?
The combination of buprenorphine and naloxone, termed Suboxone, was first authorized in 2002 as a tablet. Nevertheless, ten years later, Indivior introduced a sublingual film version that dissolves beneath the tongue or inside the cheek. As per the Suboxone lawsuit, this sublingual formulation is highly acidic.
Despite its availability since 2013, the sublingual form of Suboxone did not warn of potential dental damage until June 2022. This change in labeling occurred after the FDA received numerous reports of tooth decay and tooth loss from Suboxone users.
Plaintiffs in the MDL argue that the delay in adding these warnings contributed to their dental injuries. This could have been prevented with earlier preventive advice or modifications to how the drug was administered.
Besides the harm caused by the drug, the lawsuit focused on Indivior’s perceived failure to adequately test the sublingual film. The U.S. Judicial Panel on Multidistrict Litigation noted the central issue involves the sublingual film’s acidic damage to teeth.
Specification of Suboxone’s Dental Side Effects
According to legal and scientific reviews, Suboxone’s sublingual film is found to have a highly acidic pH, comparable to vinegar. This can significantly lower the pH balance in the mouth when used. The acidity is likely responsible for various dental problems reported by users, including tooth decay and erosion.
Moreover, a study cited in legal documents found that patients using oral buprenorphine, an ingredient in Suboxone, experienced dental issues. A significant percentage of them suffer from compromised salivary buffering, which is crucial for maintaining dental health.
Suboxone Lawsuits Centralized for Efficiency
The Suboxone tooth decay lawsuits were officially consolidated into MDL 3092 in February 2024. This occurred in the Northern District of Ohio under U.S. District Judge J. Phillip Calabrese by the U.S. Judicial Panel on Multidistrict Litigation.
This consolidation, overseen by the U.S. Judicial Panel on Multidistrict Litigation, is intended to streamline the pretrial discovery process. It also aims to address the plaintiffs’ common factual issues.
Challenges and Controversies Surrounding the Tolling Agreement
One of the most pressing issues in this MDL concerns Indivior, the drug manufacturer. They have refused to agree to a tolling agreement that would extend the deadline for claimants to file lawsuits. Plaintiffs’ attorneys argue that Indivior’s refusal will lead to inefficiencies. This is because many complaints may be filed with incomplete information due to time constraints.
The Plaintiffs’ Steering Committee has expressed concerns about the manufacturer’s decision. They fear it could result in a flood of lawsuits in the coming weeks. Many of these may lack sufficient detail.
They suggest a limited tolling period to ensure thorough investigations and that only legitimate claims are filed. Despite these requests, Indivior has remained firm. Hence, it led the court to issue a case management order allowing bundled complaints to reduce the administrative burden.
The Path Forward to Resolution
The court recently rejected Indivior’s proposal for a phased discovery process to speed up the legal proceedings. Indivior initially wanted to prioritize general causation, which would have postponed addressing marketing and promotion issues. The plaintiffs argued that this approach would unnecessarily prolong the legal proceedings and inefficiently used resources.
Judge Calabrese agreed with the plaintiffs, stating that limiting evidence on general causation could hinder truth-seeking and slow the MDL’s progress. Consequently, discovery will proceed traditionally with a coordinated schedule.
Moreover, the Judge is anticipated to manage an influx of new claims as more plaintiffs join the MDL. From July 1 onwards, defendants have the option to request that bundled complaints be separated into individual lawsuits. This will enable each case to proceed based on its own merits while still being part of the larger MDL.
After the pretrial procedures in the MDL, individual lawsuits are likely to move forward. In this regard, TruLaw predicts a settlement timeline by the middle of 2025. Plaintiffs need to submit detailed complaints about their particular cases. Only then, settlements or court trials will ensue.
FAQs
What is a multidistrict litigation?
Multidistrict litigation (MDL) is a specialized legal process in the USA. It is designed to manage complex cases that involve multiple plaintiffs across different jurisdictions. MDL combines multiple lawsuits that share common factual questions to streamline pretrial procedures. This helps prevent repetitive discovery efforts and supports efficient resolution of the cases.
When were the warnings about tooth decay linked to Suboxone first mentioned?
The warnings about tooth decay were introduced to Suboxone in June 2022. It followed numerous complaints received by the FDA regarding dental issues caused by the drug’s sublingual film version. The warnings also highlighted problems like tooth decay, cavities, dental abscesses, erosion, and even tooth loss associated with buprenorphine medications.
What is expected to happen after the MDL proceedings?
After the pretrial procedures in the MDL, individual lawsuits are likely to move forward. Most notably, the MDL process focuses on streamlining the pretrial activities such as discovery, motions to dismiss, and evidentiary hearings. This often leads to a resolution before trial. Moreover, it could include settlements or summary judgments, depending on the findings during these initial stages.
The legal battle over Suboxone tooth decay is an assessment of pharmaceutical companies’ management of potential side effects and warnings. The plaintiffs are optimistic. They think that the judicial system will hold Indivior responsible for the damage caused by its sublingual film. Meanwhile, the manufacturer may argue that the delayed warning releases it from earlier liability.