Indivior Files Motion to Dismiss Suboxone Failure to Warn Lawsuits Based on Federal Preemption

Suboxone manufacturer attempts to argue that failure to warn and design defect claims over tooth decay risks should be preempted by federal law.

The makers of Suboxone are attempting to convince a federal judge that they should be immune from liability in tooth decay lawsuits being pursued by former users of the opioid addiction treatment, maintaining that federal law should preempt failure to warn and design defects that form the basis of the litigation.

Indivior Inc. faces about 11,000 Suboxone lawsuits currently pending in a federal multidistrict litigation (MDL), which was established earlier this year to manage pretrial proceedings in a growing number of complaints being pursued by individuals throughout the U.S.

Each of the lawsuits raises similar allegations, claiming that the company failed to adequately disclose that the sublingual film version of the medication may degrade tooth enamel, increasing the risk that users will experience lost or broken teeth, leaving them with disfiguring injuries and substantial dental bills.

Although Suboxone (buprenorphine and naloxone) was first approved in a dissolvable tablet form in 2002, the drug maker subsequently introduced a sublingual film version of the drug about ten years later, which is placed under the tongue or inside the cheek. However, lawsuits allege that film version was only developed to delay competition from generic versions of the original drug, and failed to contain critical warnings for users that Suboxone film may cause tooth decay and permanent dental problems.

It was not until June 17, 2022 that the U.S. Food and Drug Administration required a warning label update about the Suboxone tooth decay side effects, after identifying hundreds of complaints involving problems experienced by users. However, plaintiffs maintain that they may have avoided permanent damage and costly dental treatments if earlier warnings and instructions had been provided.

Since February 2024, the Suboxone tooth decay lawsuit MDL has been centralized before U.S. District Judge Philip Calabrese in the Northern District of Ohio, where it is expected that a small group of representative claims will soon be selected for a series of “bellwether” trials, to help gauge how juries may respond to evidence and testimony that will be repeated in hundreds of claims.

Suboxone Manufacturer Preemption Claim

On July 26, Indivior filed a motion to dismiss (PDF), arguing that design defect and failure to warn claims are preempted by federal laws, which dictated what Indivior could put on the Suboxone label warnings.

The company argues that it could not have changed the label, or the formulation, of Suboxone without permission from the U.S. Food and Drug Administration, and a lack of such an order means that the company cannot be held liable for violating state design defect and failure to warn laws, as federal law should take precedence.

“Plaintiff claims that the Suboxone Film label was inadequate at the time the FDA approved it because it did not address the claimed risk of adverse dental events,” the motion states. “Federal law preempts this claim.”

A response to the motion has not yet been filed by plaintiffs, who have argued that the drug maker placed it’s desire for profits before consumers safety by withholding critical safety information from the FDA and users for years. Such preemption motions are typically defeated when Courts find that the drug maker failed to adequately disclose information that may have led federal regulators to update the warning label.

While the pretrial motions are addressed, Judge Calabrese has ordered lawyers to begin collecting and exchanging case-specific information about the individual claimants in the litigation, which will lead to the selection of “bellwether” claims that will go through case-specific discovery and be prepared for early trial dates.

Earlier this month, Judge Calabrese called for the parties to separately submit proposals to the court by August 27, regarding the specific information about each Suboxone dental claim that they believe will help identify cases that are a “representative sample” of others pending in the MDL, and “drive resolution” of the litigation.

While the outcome of any early bellwether discovery or trial dates will not have any binding impact on remaining claims, the average Suboxone tooth decay lawsuit payout may impact the amount of money the drug maker will be required to pay to avoid the need for each individual lawsuit to go before a jury in the future.

The next status conference is scheduled for September 4. The parties are expected to submit a joint agenda for the status conference by August 29.