Medical Records of Suboxone Tooth Decay Must Be Produced Under MDL Court Order

The order comes as the parties work to evaluate claims for tooth decay from Suboxone, and struggle to reach agreement on plans for selecting representative candidates for potential bellwether trials.

The U.S. District Judge presiding over all Suboxone tooth decay lawsuits, brought throughout the federal court system, has issued an order requiring pharmacies and other medical providers to produce records within 30 days after receiving a request from lawyers, to avoid delaying or obstructing progress in the litigation.

There are currently more than 11,000 product liability lawsuits being pursued by former users of the opioid addiction treatment, each raising similar allegations that they were left with devastating tooth decay from Suboxone film, which was introduced in 2010 and has been found to degrade tooth enamel, resulting in lost or broken teeth, as well as the need for substantial dental treatments.

The litigation took off after the U.S. Food and Drug Administration (FDA) required new Suboxone tooth decay warnings in June 2022, with each of the claims indicating that plaintiffs could have avoided permanent damage and costly dental treatments if earlier information and instructions had been provided by the manufacturers.

While the number of individuals coming forward to present claims has continued to increase dramatically, lawyers and the courts have faced numerous delays gathering dental records and prescription evidence needed to determine the most representative claims to select for early bellwether trials, which will help gauge how juries may respond to certain evidence and testimony likely to be repeated throughout the litigation.

Since February 2024, claims brought throughout the federal court system have been centralized as part of a Suboxone lawsuits MDL, or multidistrict litigation, where U.S. District Judge Philip Calabrese is overseeing coordinated discovery and pretrial proceedings in the Northern District of Ohio.

To promote potential Suboxone tooth decay settlements or another resolution for the litigation, Judge Calabrese has called on the parties to develop plans to help identify a small group of Suboxone dental injury claims that are representative of the litigation as a whole, to serve as bellwether test cases for early jury trials.

However, that process has been impacted by repeated issues gathering supporting documentation, as many pharmacies and other facilities have imposed different requirements regarding medical authorization forms that must be signed by plaintiffs, and some have routinely rejected authorizations signed electronically, even though they comply with federal laws regarding the production of medical information.

“The Court finds that the timely and complete production of medical and other records documenting a Plaintiff’s care and treatment is necessary to the efficient conduct of these proceedings,” Judge Calabrese states in an order (PDF) issued late last week. “Any lack of cooperation by medical providers and/or records custodians in timely providing records as requested or authorized by a Plaintiff runs the risk of delaying, obstructing, or frustrating this MDL’s progress.”

In response, the court order requires all holders of medical records to efficiently and quickly provide plaintiffs’ medical records. It orders the record holders to accept Plaintiffs’ ink or electronic signatures as authorization to turn over medical records, and requires that the facilities “unconditionally” accept court-approved authorizations and produce those records within 30 days after a request is submitted.

“Entities may not require additional documentation beyond a Plaintiff’s executed authorization, such as a copy of Plaintiff’s identification, before producing records,” the judge indicated. “Counsel for the Plaintiff is responsible for verifying that the individual executing the authorization is the Plaintiff.”

The order was issued after a Suboxone lawsuit status conference held on February 12, at which time the parties reported that they still have been unable to agree on a process for selecting bellwether cases. However, the parties are expected to meet again with Judge Calabrese on March 11, and the Court has indicated it expects another influx of Suboxone tooth decay lawsuits to be filed in advance of the three year anniversary of the label change in June 2025.