Suboxone Film Tooth Decay Problems Could Have Been Avoided With Safer Alternative Design, Plaintiffs Argue

In response to a motion to dismiss filed by Indivior, plaintiffs indicate that the drug maker knew about the risk of tooth decay problems from Suboxone long before the FDA required an update to the label warning.

Plaintiffs pursuing Suboxone film tooth decay lawsuits have responded to a recent motion to dismiss filed by Indivior, indicating that their failure to warn and design defect claims are not preempted by federal law, since the drug maker had the opportunity to formulate a safer version of the opioid addiction treatment, but refused to do so.

Indivior Inc. faces about 11,000 product liability lawsuits currently pending in the federal court system, each raising similar claims that former users of the sublingual film version of Suboxone were left with devastating dental damage and tooth decay problems, since the drug maker failed to adequately disclose the risk that the medication may degrade tooth enamel, resulting in lost or broken teeth, and the need for substantial dental treatments.

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

It was not until June 17, 2022 that the U.S. Food and Drug Administration required a label update to warn about the Suboxone film tooth decay problems, after identifying hundreds of complaints involving damage 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.

Motion to Dismiss Suboxone Film Lawsuits

On July 26, Indivior filed a motion to dismiss Suboxone lawsuits before any cases could go to trial, 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 argued 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.

In a response to the motion to dismiss (PDF) submitted on August 23, plaintiffs note that scientific studies and adverse event reports have long established the risk of Suboxone film tooth decay problems well before the label update, which the manufacturer chose to ignore. In addition, they indicate that the claims should not be preempted by federal law since incidents of tooth decay were likely being underreported by the drug maker long before the FDA’s required warning label update.

Plaintiffs maintain that Indivior knew about the problems and could have submitted a request to the FDA to change the label and update the warnings, but chose not to do so.

At least 10 years before the FDA label update, Harvard researchers published a case report linking Suboxone use to dental injuries, the plaintiffs note. According to the response, scientific evidence over the years continued to point to tooth decay risks, but Indivior refused to change the formulation or acknowledge the problems.

Instead, the company ignored dozens of adverse event reports submitted to the FDA, despite knowing that those probably represented only a fraction of the actual incidents of Suboxone film tooth decay problems. The plaintiffs say that Indivior also knew, or should have known, that many dentists who saw the after effects of Suboxone use and treated severe cases of tooth decay may not have even known their patients were using the film strips, and thus would not have reported the potential connection.

Cases filed before the June 2022 label change fall “squarely within the framework of what Defendants had the power, ability, and obligation to do,” the response from plaintiffs said.

“[T]he Suboxone film label remains inadequate following the June 17, 2022 additions because the language does not adequately inform patients and physicians that permanent dental erosion and decay are associated with Suboxone film usage,” according to the response. “It merely states that ‘cases… have been reported.’ Nor does it inform physicians or patients that ‘indefinite’ use of the drug (which its prescribing information indicates may be the duration of maintenance treatment) increases that risk.”

Plaintiffs further argue that Indivior’s motion to dismiss based on federal preemption arguments fail because safer alternative delivery methods were available, which the FDA already approved, in the form of extended-release injectable buprenorphine (Sublocade), which does not cause the same tooth decay problems as Suboxone film.

September 2024 Suboxone Film Lawsuit Update

The motion to dismiss comes as the U.S. District Judge presiding over the litigation prepares the parties to select a small group of cases for early bellwether trials, to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

Since February 2024, all Suboxone film tooth decay lawsuits have been centralized in an MDL (Multidistrict Litigation), which is assigned to U.S. District Judge Philip Calabrese in the Northern District of Ohio for coordinated discovery and pretrial proceedings.

In July, 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.