Problems With Suboxone Dental Injury Records Collection Continues in MDL

Suboxone manufacturers are calling for pharmacies and medical providers to face sanctions for failing to comply with court orders requiring production of records relevant to dental injury lawsuits being pursued by former users.

The drug manufacturer Indivior wants a federal judge to pursue contempt charges against a number of pharmacies and medical providers who have failed to turn over key medical records of individuals pursuing Suboxone dental injury lawsuits, despite numerous requests from the Court, plaintiffs and defendants.

Indivior currently faces thousands of Suboxone lawsuits filed by former users of the buprenorphine and naloxone film strips, which have been widely prescribed in recent years to treat opioid addiction. However, the users claim that they were left with devastating dental injuries and tooth decay, which the drug manufacturers failed to disclose as a potential side effect associated with the treatment.

The U.S. Food and Drug Administration (FDA) first approved Suboxone in pill form in 2002, which was designed to help users avoid withdrawal symptoms while undergoing therapy to help them break their addiction. However, the drug makers later introduced Suboxone film strips, which users place beneath their tongue until they dissolve.

Almost immediately following the design change, Indivior and the FDA began to receive Suboxone dental injury reports from patients, which ultimately led to a Suboxone dental side effects warning being added to the drug’s label in June 2022. However, users indicate this information should have been disclosed years earlier.

In February 2024, a Suboxone dental injury lawsuit MDL (multidistrict litigation) was established in the Northern District of Ohio, centralizing the claims before U.S. District Judge Philip Calabrese for coordinated discovery and pretrial proceedings.

Early in the litigation, Judge Calabrese announced a bellwether trial process would be followed to prepare representative cases for early trial dates to help gauge how juries may respond to evidence and testimony likely to be repeated throughout the litigation. He designated 500 cases as part of a Records Collection Pool, with the goal of having each plaintiff produce records so that the parties can then narrow that group down to 100 representative cases that will be eligible for the next phase of discovery.

However, lawyers are having trouble collecting patient records from a number of pharmacies and medical providers, who have refused to respond to direct requests from individual plaintiffs and Suboxone dental injury lawyers. Plaintiffs, defendants and the Court have made repeated requests and demands that the pharmacies turn over those patient records, but many have failed to do so.

Last February, the Court issued an order requiring Suboxone prescription records to be produced within 30 days after a pharmacy received a proper request. However, it has been nearly a year and some have still failed to do so. Last summer, plaintiffs warned the Court of the issues collecting the records and Judge Calabrese issued a show cause order in August, demanding compliance with the court’s requests or an explanation as to why the requests for patients’ prescription information have not yet been turned over.

Still having problems collecting the records, Indivior attorneys filed a motion for order to show cause (PDF) on January 23, giving the remaining non-compliant pharmacies another 30 days to turn over the records, calling for Judge Calabrese to hold those pharmacies who do not comply in contempt of court, or leveling sanctions against them. The motion includes a list of two dozen providers who are still not in compliance with the court’s discovery orders.

Once all of the data has been collected for the record pool lawsuits, it is expected that a final group of 15 Suboxone lawsuits will be prepared for the first bellwether trials.

While the outcome of these bellwether trials will not be binding on any remaining claims, the average payouts awarded by juries may have a significant impact on future Suboxone settlements. However, if no settlement or other resolution is achieved during the pretrial proceedings, Judge Calabrese is likely to remand the cases back to their originating federal districts for individual trial dates.

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