Suboxone MDL Judge Issues Show Cause Order to Pharmacies Failing To Turn Over Records

Court will hold a hearing on August 25, at which time it will be determined whether pharmacies that have failed to comply with prior orders to produce Suboxone prescription records will face sanctions.

The U.S. District Judge presiding over all Suboxone tooth decay lawsuits has ordered a number of pharmacies to “show cause” why they should not be held in contempt or subjected to sanctions for failing to turn over plaintiffs’ prescription records, which have been requested pursuant to a prior Court order requiring that they be produced within 30 days of receipt of an executed medical authorization.

The orders come after months of efforts to get pharmacies nationwide to comply with information requests linked to more than 11,000 product liability lawsuits against Reckitt Benkiser and its subsidiary, Indivior, the makers of Suboxone sublingual film strip opioid addiction treatments. Each claim raises similar allegations that patients fighting opioid addictions were not warned that the strips side effects could erode tooth enamel, resulting in potentially severe dental damage.

Originally introduced in tablet form in 2002, Suboxone (buprenorphine and naloxone) is used to help users avoid opioid withdrawal symptoms while undergoing therapy to help them break their addiction. The product’s manufacturer, Indivior, later introduced a filmstrip version, which users place under their tongue until it dissolves.

The U.S. Food and Drug Administration (FDA) added new Suboxone tooth decay warnings for the film strips in 2022, following hundreds of complaints involving dental damage. Plaintiffs argue that the manufacturer knew, or should have known, about the risks much sooner, yet failed to adequately warn them about the potential risks of enamel erosion.

However, a critical first step in the litigation requires each plaintiff to produce records establishing that they received brand-name Suboxone film strips before their tooth decay.

Since so many similar claims were being brought throughout the federal court system, a Suboxone tooth decay lawsuit MDL (multidistrict litigation) was established in February 2024, centralizing the claims before U.S. District Judge Philip Calabrese in the Northern District of Ohio, for coordinated discovery and pretrial proceedings.

Early in the litigation, the Suboxone MDL judge indicated that a “bellwether” process will be followed to identify a representative group of claims that will be prepared for early trial dates, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the lawsuits.

Judge Calabrese previously designated 500 cases for 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, who have refused to respond to direct requests from Suboxone lawyers and individual plaintiffs.

To address the issue, in February 2025, the court issued an order requiring Suboxone prescription records to be produced within 30 days after a pharmacy received a proper request

After a number of plaintiffs filed a motion (PDF) on July 31, outlining issues they were having with several pharmacies, Judge Calabrese issued an amended order to show cause (PDF) late last week, 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.

Judge Calabrese’s order calls for the pharmacies to respond within 30 days as to why they should not be held in contempt of court or be targeted by additional court sanctions for noncompliance. Pharmacies affected by the order include:

The judge’s order schedules a show-cause hearing for August 25, indicating that custodians of those records from the affected pharmacies must attend to explain their failure to comply so far with court orders.

At least one pharmacy has already answered. On August 4, Albertsons Companies filed a response (PDF) with the court, alleging that it was unaware of the motion seeking plaintiff data and has begun producing the required records.

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 Suboxone trials will not have any binding impact on 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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