Indivior to Provide Suboxone Tooth Decay Data in MDL

Indivior to Provide Suboxone Tooth Decay Data in MDL

Introduction

The U.S. District Judge overseeing the federal Suboxone tooth decay lawsuits has announced that Indivior, the drug’s manufacturer, will soon provide electronic data on adverse events related to its opioid treatment, Suboxone.

This data will be critical as both sides continue exchanging information, which will help guide the selection of cases for bellwether discovery in the ongoing multidistrict litigation (MDL).

Currently, over 11,000 product liability lawsuits have been filed against Indivior in federal courts, with plaintiffs alleging that Suboxone’s sublingual film version caused severe dental damage, including tooth decay and enamel erosion. These users claim Indivior failed to warn about the risks associated with the drug, only adding a warning about tooth decay to the label in June 2022 after the FDA had received numerous complaints.

The litigation centers around the claim that had Indivior disclosed the risk earlier, patients and the medical community could have taken preventive measures, potentially avoiding permanent tooth damage and tooth loss. However, for many plaintiffs, the warning came too late, leading to irreversible dental harm.

In response to these common allegations, all Suboxone injury claims have been consolidated into an MDL, with the U.S. District Judge presiding over the coordination of discovery. This includes gathering information on issues that affect all claims, which will eventually lead to bellwether trials. These early trials will help both sides gauge how juries might respond to the evidence presented and influence future settlements.

In July, the judge requested that the parties submit proposals on the specific information required for each Suboxone dental claim to help identify a representative sample of cases. This process is crucial for driving the litigation toward a resolution. A case management conference was held in early October, where the court outlined steps to move the litigation forward. The judge emphasized the importance of obtaining Indivior’s electronic data on Suboxone-related adverse event reports, which is expected to be produced by the next status conference in November.

This electronic data will provide key insights into when Indivior became aware of the dental damage caused by Suboxone and how widespread the issue is. The information gathered will likely play a central role in determining which injuries are most commonly reported and assist in selecting representative cases for the bellwether trials.

To facilitate this process, the judge has ordered all plaintiffs with claims filed by October 7 to complete a census form within 270 days. This form will require specific details about their use of Suboxone Film and the dental injuries they experienced. Plaintiffs will also need to authorize the release of dental and pharmacy records, which will be uploaded into a common database for both parties to review.

The census form will ask plaintiffs to provide information about when they were first prescribed Suboxone Film, any other versions of the drug they may have used, and the extent of their dental problems. For example, plaintiffs will need to disclose whether they had teeth extracted or replaced due to Suboxone-related decay. This process will not only help identify cases that should proceed but will also eliminate claims that lack sufficient evidence or involve products that are not part of the litigation.

The judge's recent order states that any plaintiff who cannot demonstrate that they suffered dental injury from Suboxone or used the brand-name film will have their claim dismissed with prejudice, meaning they cannot refile. However, if plaintiffs fail to complete their census form due to temporary circumstances, such as being transient, their claims will be dismissed without prejudice, allowing them to refile at a later date.

Once representative claims are selected, the MDL will proceed with case-specific discovery. This phase will involve exchanging expert reports and gathering evidence to demonstrate how Suboxone leads to dental injuries. A smaller group of cases will then be chosen for the first bellwether trials.

These early trials, though not binding on the remaining claims, are critical for shaping the litigation's outcome. The results of the bellwether trials will likely influence future settlement negotiations, as both sides will better understand how juries respond to the evidence. While the specific payout for each Suboxone dental injury lawsuit is uncertain, the average settlement amount from these bellwether trials will likely determine how much Indivior might be required to pay in future settlements. The company may opt to resolve many claims through settlement, rather than facing thousands of individual trials, depending on the outcome of these initial cases.

In summary, the Suboxone litigation is moving forward with coordinated efforts to gather key information and identify representative cases for bellwether trials. As Indivior prepares to produce data on adverse events, both sides will continue exchanging evidence to establish the extent of Suboxone’s role in causing dental injuries. The outcome of the upcoming trials will be crucial in determining how much Indivior may need to pay in settlements to resolve the remaining claims and bring the litigation to a close