Ohio has been one of the states hardest hit by the opioid epidemic. And now, Ohioans who received Suboxone for opioid addiction treatment are facing a new risk: damage to their teeth.
Suboxone oral film, made to be dissolved in the mouth, has been linked to dental erosion and decay—side effects that some claim the companies behind the product did not warn about.
Hundreds of Suboxone tooth decay lawsuits have been filed across the country and consolidated in Ohio federal court. If you were prescribed Suboxone and developed dental issues such as tooth breakage, tooth loss, or tooth decay, you may be eligible to file a claim. Graham Law can help you find a lawyer for your case.
UPDATE: Ohio’s filing deadline for Suboxone tooth decay claims expired in June 2024 due to the state’s 2-year statute of limitations for personal injury claims; in states with a 3-year statute of limitations claims can still be filed until 2025.
What’s The Link Between Suboxone and Dental Problems?
The Food and Drug Administration (FDA) released a safety communication in 2022 warning that dental problems—including tooth decay, cavities, oral infections, and loss of teeth—were being reported with Suboxone and other medicines containing buprenorphine.
Suboxone, a combination of buprenorphine and naloxone, is a type of opioid drug approved by the FDA to manage withdrawal symptoms from opioid addiction. Originally sold in tablet form and now available as an oral dissolvable strip, it has become the preferred medication to treat opioid use disorder.
According to the FDA, Suboxone dental problems can begin within weeks of a patient starting treatment, and multiple teeth are often affected.
Suboxone manufacturer Reckitt Benckiser, which has since rebranded as Indivior, received FDA approval to sell Suboxone film in 2010. The film is placed under the tongue or inside the cheek, allowing the drug to be absorbed faster and more effectively than the pill version of the drug.
Most patients use Suboxone film one to three times daily and hold the strip in their mouth for 5 to 10 minutes. Because Suboxone is acidic, it can wear away tooth enamel and lead to dental problems.
The FDA safety communication notes that Suboxone dental problems sometimes begin within two weeks of a patient starting the drug and that multiple teeth are often affected. Common treatments required are tooth extraction, root canals, dental surgery, and crowns and implants, according to FDA.
Why Are Patients Filing Suboxone Dental Lawsuits?
FDA states that, despite the risk of Suboxone dental problems, the benefits of buprenorphine medications outweigh their risks.
Drug companies, however, have a legal duty to warn about the risks associated with their products. Dental problem warning labels were added to Suboxone and other buprenorphine products in 2022. A subset of Suboxone users claim in lawsuits that these warnings were too little, too late.
Plaintiffs in Suboxone tooth decay lawsuits allege that Indivior and its subsidiaries, multiple Reckitt Benckiser Group units, and Aquestive Therapeutics Inc., all of which are or were involved in the production and distribution of Suboxone, knew—but failed to warn—that the product causes tooth damage. To support their argument, plaintiffs point to FDA adverse event reports about Suboxone and tooth decay that go back a decade or more.
“Clients have been twice victimized by Big Pharma: first in hooking them on opioids and now by saddling them with devastating dental injuries from Suboxone film.”
Plaintiffs say that, prior to 2022, they were using the product without the benefit of a warning label that was only belatedly added—and then only in response to FDA reporting. As a result, for years, doctors who prescribed Suboxone film did not have enough information to help them make an informed decision about whether to use the product.
Plaintiffs are claiming financial harm from things like dental procedures, as well as emotional distress and physical pain from Suboxone tooth problems. They’re saying that they struggled to overcome opioid addiction and the stigma related to it, only to suffer damage to their teeth and self-esteem following Suboxone use. Some say they’ve had to pay tens of thousands of dollars in dental bills. Others say they can’t afford to fix their teeth.
An attorney representing Suboxone plaintiffs summed up the issue when she said, “Our clients have been twice victimized by Big Pharma: first in hooking them on opioids and now by saddling them with devastating dental injuries from Suboxone film.”
Is There a Suboxone Class Action Lawsuit?
Suboxone tooth decay lawsuits have been filed in several states, including Ohio, Florida, Georgia, Pennsylvania, Illinois, Texas, and New York. In February 2024, these lawsuits were consolidated and centralized in U.S. District Court for the Northern District of Ohio as part of what’s known as “multidistrict litigation,” or MDL.
Multidistrict litigation is not the same as a class action. MDLs make it easier to manage similar complex—and potentially high value—cases from different jurisdictions. A class action is meant to handle a high volume of cases, each of which deals with relatively low value claims that would not be feasible to litigate individually. Class action plaintiffs share lawyers and settlement funds. Plaintiffs who are part of an MDL retain their own individual case and lawyer.
Suboxone companies previously faced a class action lawsuit alleging that they violated certain state antitrust, consumer protection, and unjust enrichment laws. The lawsuit did not claim that Suboxone is harmful in any way. It ended in a class action settlement.
The FTC also sued the makers of Suboxone for allegedly preventing patients from choosing lower-priced generic equivalents. The companies agreed to pay $60 million to settle FTC’s charges.
Can I File a Suboxone Tooth Decay Lawsuit?
You may be able to file a lawsuit if you took Suboxone prior to 2022 and developed dental injuries such as tooth decay, cavities, gum disease, oral infections, tooth erosion, tooth sensitivity, tooth loss, tooth breakage, receding gums, or oral ulcers and lesions.
Anyone who started using Suboxone in 2022 or later, after the FDA published its safety communication and dental problem warning labels were added to Suboxone, is likely ineligible for legal action.
Graham Law is performing Suboxone tooth decay lawsuit reviews and referring those who might have a viable claim to law firms that can assist them. If you think you may qualify, please call or contact us.