Data on Suboxone Tooth Decay Problems, Other Adverse Events to be Turned Over by Indivior Early in MDL Discovery

Suboxone tooth decay data will be produced as the parties work to exchange information needed to select a representative group of lawsuits for early bellwether trials.

The U.S. District Judge presiding over all federal Suboxone tooth decay lawsuits indicates that Indivior will turn over electronic data on adverse events linked to its popular opioid treatment within the next few weeks, as lawyers continue to work on exchanging information about thousands of claims, which will help guide the selection of a representative group of cases for bellwether discovery in the MDL.

There are currently more than 11,000 product liability claims being pursued against the drug maker throughout the federal court system, each raising similar allegations that former users of the sublingual film version of Suboxone were left with devastating dental damage and tooth decay problems, since Indivior failed to adequately disclose the risk that the medication may degrade tooth enamel.

Plaintiffs maintain that they may have avoided permanent tooth decay and tooth loss problems if Indivior had provided earlier instructions for users and the medical community. However, warnings about the Suboxone tooth decay problems were not added to the drug label until June 2022, after the FDA identified hundreds of complaints involving damage experienced by users.

Given common allegations raised in the litigation, all Suboxone injury cases have been centralized in an MDL before U.S. District Judge Philip Calabrese, who is presiding over coordinated discovery into issues that will impact all claims, and is expected to schedule a series of early bellwether trials, which will help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout the claims.

In July, Judge Calabrese called for the parties to separately submit proposals to the court outlining the specific information about each Suboxone dental claim that they believe will help identify cases that are a “representative sample” of others pending in the MDL, and “drive resolution” of the litigation.

Earlier this month, the court held a two-day case management conference with lawyers involved in the claims and issued a court order (PDF) on October 8, outlining the steps that will be taken over the coming weeks to help move the litigation forward.

Suboxone Tooth Decay Census and Adverse Event Reports

Judge Calabrese reports that Indivior will produce electronic data on all Suboxone adverse event reports by the next status conference, which is currently scheduled for November 21.

During that hearing, the parties and the Court will discuss any disagreements on the production, which is expected to provide critical evidence about when Indivior knew or should have known about the Suboxone tooth decay problems being experienced by users.

The data will also likely be key in determining what types of injuries are most commonly reported, helping in the selection of representative cases for potential bellwether trials.

To gather information about Suboxone lawsuits filed so far, Judge Calabrese indicates that each plaintiff with a claim filed by October 7 will be required to complete a census form within 270 days, providing specific details about their use of Suboxone Film and the dental injuries they experienced.

“Based on this discussion and the various options counsel presented, the Court determined that there will be a single census process, not one that collects additional information from a subset of claimants,” the order states. “Along with the census form, all claimants will complete authorizations for Defendants to request dental and pharmacy records. Defendants will upload any records received to a common database.”

According to the Suboxone Film Census Form approved by the Court, each plaintiff will submit their contact information, the approximate month and year when they were first prescribed Suboxone Film, as well as information about various other versions of the drug they used. The form will also gather information about the nature of tooth decay problems caused by Suboxone, including whether they had any teeth extracted or replaced, and other details on the damages they experienced.

This process will not only help the parties select representative claims for potential bellwether workup, but also help wean out claims that do not have sufficient substantiation of their injury or involve the use of products not at issue in the litigation.

According to the order issued last week, Judge Calabrese indicates that any claimants who cannot establish that they experienced a dental injury or use of brand name Suboxone film will have their claim dismissed with prejudice. However, if any claimants fail to timely complete their census form, due to transience or similar reason, they will have their claims dismissed without prejudice, allowing them to refile in the future.

Following the selection of a representative sample of claims, the parties will move forward with a lengthy case-specific discovery process in the MDL, including the exchange of expert reports and other evidence establishing how Suboxone causes dental injuries, before a smaller group is identified for the first trial dates.

While the outcome of these early bellwether trials will not have any binding impact on remaining claims, the average Suboxone dental injury lawsuit payout may impact the amount of money the drug maker will be required to pay to avoid the need for each individual lawsuit to go before a jury in the future.