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After years of reports, government investigations, and legal actions arising from opioid manufacturers’ roles in creating the nation’s opioid crisis by misrepresenting or concealing the risks of addiction and abuse, the manufacturers of drugs used to treat opioid abuse disorder have allegedly also concealed risks of the damaging side effects their drugs cause.
In recent months, several patients have filed lawsuits alleging that the manufacturers and/or distributors of Suboxone, a tablet/film used to treat opioid abuse disorder, failed to disclose the risks of tooth decay and dental damage when using the drug. Many of these lawsuits have now been consolidated into a multidistrict litigation.
What is Suboxone?
Suboxone is a brand-name version of buprenorphine/naloxone in sublingual film form. Suboxone is one of the primary medications used to treat opioid use disorder. However, because of the highly acidic nature of the formulation, some patients who have been prescribed Suboxone have reported suffering from severe tooth decay and permanent dental damage.
These patients allege that Suboxone’s manufacturer, the pharmaceutical company Indivior, concealed the risks of tooth decay from Suboxone use from patients and their physicians. Indivior did not officially update Suboxone’s labeling to disclose the risks of tooth decay until 2022—20 years after the U.S. Food and Drug Administration first approved the medication. With the labeling update, company officials and the FDA recommended patients maintain post-administration dental hygiene efforts and keep up with regular dental checkups to reduce the risk of tooth decay from Suboxone use.
Timeline of the Suboxone MDL in the Northern District of Ohio
Over the past few years, several plaintiffs who suffered tooth decay and dental damage after using Suboxone filed product liability lawsuits against Indivior. There was an initial delay in the filing of many lawsuits because of questions about the medical link between Suboxone and tooth decay. However, those questions were put to bed when Indivior formally added its warning about tooth decay to Suboxone’s label in 2022.
Patients have sued Indivior and the company’s parent, Reckitt Benckiser, which spun off Indivior (formerly the company’s opioid treatment division) into a new publicly traded company in 2014. Some lawsuits have also named as a defendant Aquestive Therapeutics, a pharmaceutical company that developed Suboxone with Indivior.
The lawsuits generally allege the defendants knew about the potential risk of tooth decay and dental injuries from Suboxone tablets or films, yet failed to inform doctors and patients about this risk so that physicians could make appropriate prescribing decisions and give patients care instructions to reduce the possibility that they experience tooth decay. Some suits allege the defendants concealed these risks to maximize profits from Suboxone, concerned that physicians might prescribe the drug less frequently on account of patients’ risks of developing tooth decay.
Because of the similarities in facts and legal claims among the Suboxone lawsuits being filed across the country, the Judicial Panel on Multidistrict Litigation created a Suboxone MDL in February 2024 to consolidate lawsuits filed against the creators, manufacturers, and distributors of Suboxone in the U.S. The MDL, No. 3092, was sited in the Northern District of Ohio, with Judge J. Philip Calabrese presiding over it. The JPML ordered the consolidation of lawsuits asserting product liability, marketing, and sales practices claims against Suboxone.
In early March 2024, Judge Calabrese appointed leadership counsel for the MDL and held hearings on organization, filing procedures, and initial discovery in the case. Many patients who have suffered tooth decay after taking Suboxone, along with legal observers, have noted concerns that many patients may have already lost the right to file lawsuits in the Suboxone MDL because of shorter statutes of limitations in their home states.
Although the Suboxone MDL is still in the early stages, with only a few dozen cases currently consolidated within the MDL, we may see many more suits join them once Judge Calabrese establishes formal procedures for new cases to join the MDL and plaintiffs’ firms ramp up their marketing efforts to locate Suboxone patients who may have suffered harm from their use of the drug.
The success of these lawsuits may turn on what Indivior and its affiliated companies knew about the risks of Suboxone use and what information they conveyed to healthcare providers. Given that Indivior’s former CEO stepped down in June 2020 and was sentenced in October that year to six months in jail after pleading guilty to his role in a scheme to secure Medicaid formulary coverage for Suboxone Film by misleading government officials about the product’s dangers to children, there’s a good chance there may be more skeletons in Indivior’s Suboxone closet.
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