Suboxone MDL Judge Orders Pharmacies to Explain Record Delays

Suboxone MDL Judge Orders Pharmacies to Explain Record Delays

Introduction

The U.S. District Judge overseeing all Suboxone tooth decay lawsuits has ordered a number of pharmacies to “show cause” why they should not be held in contempt or face sanctions for failing to provide prescription records requested by plaintiffs. These records were required under a prior court order that directed pharmacies to turn them over within 30 days of receiving a valid medical authorization form.

Struggles with Nationwide Compliance

This latest order follows months of unsuccessful efforts to secure compliance from pharmacies across the country. Plaintiffs’ attorneys have argued that many pharmacies continue to ignore or delay requests for patient prescription histories, which are necessary to prove use of the brand-name Suboxone film strips at issue. With more than 11,000 lawsuits already pending, this failure to cooperate has slowed progress in the litigation.

Suboxone’s Development and Widespread Use

Suboxone, a combination of buprenorphine and naloxone, was first introduced in tablet form in 2002 to help patients manage withdrawal symptoms and reduce dependency on opioids. The medication quickly became a central part of opioid treatment programs. Indivior, the drug’s manufacturer and a subsidiary of Reckitt Benckiser, later introduced a dissolvable film strip version. Patients were instructed to place the strip under their tongue until it dissolved, offering a more convenient alternative to the tablets.

FDA Warnings About Dental Damage

Concerns about the safety of the Suboxone film strips emerged years later. In 2022, the U.S. Food and Drug Administration (FDA) issued updated safety warnings, acknowledging reports of severe tooth decay, enamel erosion, and other dental injuries linked to the use of the film. These warnings came after hundreds of complaints had been filed by patients. However, plaintiffs now allege that the manufacturer knew, or reasonably should have known, about these risks long before the FDA acted, and yet failed to properly inform doctors and patients.

Centralization of Federal Suboxone Lawsuits

As claims multiplied, the federal court system consolidated them into a multidistrict litigation (MDL) in February 2024. The MDL, established in the Northern District of Ohio, allows one judge to oversee pretrial proceedings and discovery, improving efficiency and avoiding conflicting rulings. The centralized litigation currently involves more than 11,000 lawsuits with similar allegations against Indivior and Reckitt Benckiser.

Bellwether Trials Planned to Test Claims

Judge Philip Calabrese, who is overseeing the MDL, has outlined plans for a bellwether process. Under this structure, a small group of representative lawsuits will proceed to early trial dates. The purpose is not to resolve all claims, but to test how juries respond to key pieces of evidence and witness testimony. These bellwether outcomes often help shape settlement discussions, since both plaintiffs and defendants gain a clearer sense of potential jury awards.

Records Collection Pool Established

To prepare for bellwether trials, the court previously created a “Records Collection Pool” of 500 lawsuits. Each plaintiff in this group must provide documentation verifying that they were prescribed Suboxone film strips prior to experiencing dental damage. Once records are collected, the parties plan to narrow the group down to 100 lawsuits for further discovery, and eventually select 15 cases for the first bellwether trials. However, the process has been slowed significantly by pharmacies’ reluctance to turn over records.

Court Orders Compliance from Pharmacies

In February 2025, Judge Calabrese issued a formal order requiring pharmacies to produce requested Suboxone prescription records within 30 days of receiving a valid request. Yet, despite this directive, several pharmacies failed to comply. On July 31, plaintiffs filed a motion documenting these problems and asking the court to intervene. In response, Judge Calabrese issued an amended “order to show cause” in early August, compelling non-compliant pharmacies to either produce the records or explain why they had not done so.

Hearing Scheduled for August 25

The judge’s latest order sets a show-cause hearing for August 25, requiring custodians of records from the identified pharmacies to appear in court. At the hearing, these representatives must explain their failures to comply with earlier orders and risk facing sanctions if their explanations are not satisfactory. At least one pharmacy, Albertsons Companies, has already filed a response, stating on August 4 that it had been unaware of the earlier motion but has since begun producing the necessary records.

Potential Outcomes of Bellwether Trials

Once the prescription data has been gathered and reviewed, the litigation will move forward with the selection of 15 lawsuits for the initial bellwether trials. While verdicts in these trials will not be binding on other lawsuits, they are expected to strongly influence potential settlement values. If juries award substantial damages, it could encourage Indivior and Reckitt Benckiser to negotiate a broader settlement. However, if no resolution is reached, Judge Calabrese is likely to remand the lawsuits back to their original courts for individual trial dates across the country.