Cleveland, OH On September 10, 2024, the Northern District of Ohio dismissed claims against Indivior PLC and two Reckitt Benckiser entities in Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation in the multidistrict litigation centralized in the Northern District of Ohio. The court’s decision is a significant setback for individuals who suffered serious Suboxone side effects and dental damage from using the sublingual film form of the drug. They allege that Indivior and other defendants failed to adequately warn about the potential for dental erosion and decay associated with the film's acidic properties.
Pain, suffering, tooth loss, social isolation and cost
Indivior produced buprenorphine-based products to treat opioid use disorder. An opioid, itself, Suboxone was thought to be an appropriate treatment alternative because it was less addictive than other opioids.
The FDA approved Suboxone sublingual film on August 30, 2010, and Indivior removed the tablet version from the market that same year. The film was thought to be less likely to be abused than the tablet form, but the chemical composition of the drug is highly acidic. Patients are encouraged to hold the film in their mouths to maximize absorption. This is now linked to a variety of dental injuries, including:
Severe tooth decay;
Cavities and tooth loss;
Oral infections;
Gum injuries;
Tongue injuries; and
Other dental issues.
The personal injury lawsuits consolidated in the MDL allege that Indivior knew or should have known of the risk of dental problems with the under-the-tongue method of administration. Nonetheless, the company failed to warn patients of the potential harm for over a decade.
The court's decision to dismiss claims against Indivior and the two Reckitt -Benckiser entities with prejudice (meaning that they cannot be re-filed) leaves only Aquestive Therapeutics Inc. and two other Indivior units as defendants. Although specific details have not been disclosed, the decision was based on a stipulation of dismissal filed by the parties, and is likely the result of a settlement agreement.
Impact on Suboxone patients
As a general rule, plaintiffs’ attorneys try to name as many defendants as possible in an effort to maximize the potential for financial recovery. The dismissal of Indivior PLC and the Reckitt Benckiser units represents a significant setback for the plaintiffs in the Suboxone side effect lawsuit. It means that these specific defendants will no longer be liable for the damages allegedly suffered by the plaintiffs. The dismissal of some of the defendants is a blow.
However, it is important to note that this does not necessarily affect the claims against other defendants in the litigation. Plaintiffs may still pursue claims against other entities involved in the manufacturing, marketing, and distribution of the medication.
Potential avenues to continue the lawsuit
Despite the dismissal, plaintiffs may still have options to pursue compensation for their injuries. Some potential avenues include:
Plaintiffs can continue to pursue claims against any remaining defendants in the litigation, such as manufacturers, distributors, or pharmacies.
Plaintiffs may choose to file individual lawsuits against the defendants, particularly if they believe that their specific circumstances warrant individual attention.
Some states have their own legal systems for product liability claims, and plaintiffs may be able to pursue claims in state courts; and
If a class action lawsuit is certified, plaintiffs may be able to pool their resources and legal efforts to pursue a larger settlement or judgment.
The wider litigation picture – antitrust, fraud and criminal indictments
In 2019, pharmaceutical companies and Medicare brought a different MDL antitrust lawsuit against Indivior and Reckitt Benckiser, Inc. That antitrust lawsuit focused on the 2010 corporate decision to pull Suboxone tablets off the market in connection with the introduction of the sublingual film.
In 2019, RB Group settled with the FTC and agreed to pay $50 million to consumers. In 2020, Indivior also settled and agreed to pay $10 million to consumers. In June 2023, Indivior paid a settlement to a group of states and then in August, paid $30 million in a class action brought by health plans. In November 2023, Indivior settled an antitrust suit, paying $385 million to 70 drug wholesalers.
Indivior and RB Group faced criminal and civil charges for allegedly engaging in deceptive marketing efforts. Charges were brought by the US Department of Justice (DOJ) and several states. Indivior and RB Group separately resolved the charges against them in 2019. Indivior agreed to pay $600 million, while RB Group agreed to pay $2.1 billion in resolution of DOJ and state charges.
As of November 1, Indivior agreed to settle a fraud case brought in Roanoke County (Virginia) Circuit Court ahead of a pending trial. Indivior will pay $85 million.
More to come
The Suboxone MDL is still in its early stages. For those plaintiffs who continue with their claims against the remaining defendants, discovery and pretrial motions are expected to continue into 2025. Depending on how the bellwether trials unfold, the litigation could result in either a series of jury verdicts or a global settlement for those who were injured.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Suboxone Tooth Decay claim at no cost or obligation.