Plaintiffs Oppose Phased Discovery Over Suboxone Tooth Decay Risks in MDL

As a growing number of Suboxone tooth decay lawsuits continue to be filed in the federal court system, plaintiffs’ attorneys are urging the Court to reject a proposal by the drug manufacturer, which would split the litigation into two phases and limit early discovery to information about how the opioid addiction treatment actually causes dental erosion problems.

There are currently about 500 product liability lawsuits pending in the federal court system against Indivior, Inc. and Reckitt Benckiser LLC, each raising similar allegations that the drug makers failed to adequately warn users and the medical community about the tooth decay risks from Suboxone (buprenorphine and naloxone), which is a prescription treatment for individuals dealing with addiction to opioid pain medications.

The U.S. Food and Drug Administration (FDA) added Suboxone tooth decay warnings to the medication in June 2022, after identifying more than 300 cases of dental damage reported to the agency. However, plaintiffs maintain they may have avoided permanent dental problems if earlier warnings and instructions had been provided on how to avoid erosion enamel and tooth loss years before the FDA pushed for the new warnings.

Leading up to the two-year anniversary for this warning label change, it is widely expected that several thousand Suboxone lawsuits will be filed by individuals who have been left with devastating tooth loss, often resulting in the need for costly dental work and leaving them with disfiguring injuries.

Since each of the claims raise nearly identical allegations, the U.S. Judicial Panel on Multidistict Litigation (JPML) established coordinated pretrial proceedings in February 2024, centralizing lawsuits brought throughout the federal court system before U.S. District Judge Philip Calabrese in the Northern District of Ohio for discovery and a series of early bellwether trials.

As part of the management of the growing litigation, Judge Calabrese is currently working with the parties to establish a pretrial schedule for the exchange of information, and determining when the parties should select a group of representative claims for early “bellwether” cases, to test how juries may respond to certain evidence and testimony that could be repeated throughout the claims.

Bifurcated Discovery in Suboxone Lawsuits Will Delay Litigation

In early April, Indivior submitted a proposal to bifurcate the Suboxone discovery, indicating that Judge Calabrese should divide the litigation into two distinct phases, which would require the parties to first address whether there is enough scientific evidence to establish that Suboxone causes tooth decay, before preparing any individual cases for trial.

The drug maker has proposed that Judge Calabrese randomly select three to five lawsuits to be included in the general causation phased discovery, where those plaintiffs would produce all pharmacy, medical and dental records for expert review while developing their opinions about whether Suboxone film caused the tooth decay injuries. During that process, all other case-specific workup and discovery would be deferred, which plaintiffs indicate will unnecessarily delay claims for years.

In an opposition brief (PDF) submitted on May 24, plaintiffs urged Judge Calabrese to reject the defendants’ proposal, saying there is little to no dispute among experts and scientists over the existence of Suboxone tooth decay risks.

Plaintiffs point out that the drug maker’s proposal is only more efficient if the Court “presupposes” that the Defendant will prevail on early motions to dismiss the litigation. Otherwise, the phased discovery will add years to the litigation, by requiring the parties to restart the balance of general and case specific discovery after the court considers any motions to dismiss, which are extremely unlikely to be granted.

“[T]he likelihood of Defendant prevailing is remote given that decades of scientific publications support Plaintiffs’ allegations that the highly acidic substances like Suboxone film cause dental erosion and decay,” according to the brief, which points to decades of scientific studies leading up to the FDA decision to update the warning label. “The only thing phased discovery would accomplish is unnecessarily prolonging this MDL and wasting resources in direct contravention of growing complaints about the protracted nature of MDLs. It is for this reason that the vast majority of MDL courts decline to adopt bifurcation.”

The typical MDL bellwether approach already involves a pretrial evaluation of the causation evidence before the first trials are allowed to begin, and the full bellwether discovery process may act as a catalyst for driving Suboxone settlements that will avoid the need for thousands of individual cases to be set for trial in the future.

Judge Calabrese has ordered the drug manufacturer to reply by May 31, and the Court will hear oral arguments over the phased discovery proposal on June 6.