Lawsuit Alleges Permanent Dental Damage from Suboxone Dental Side Effects

An Ohio woman, Teresita Badalamenti, has filed a lawsuit alleging permanent damage to her teeth caused by the dental side effects of Suboxone. The complaint, filed in the U.S. District Court for the District of Northern Ohio, targets Suboxone’s manufacturers, including Indivior, Inc., Aquestive Therapeutics, MonoSol, RX, Inc., and Reckitt Benkiser, LLC. Badalamenti claims that critical warnings about Suboxone’s high acidity and the risk of tooth decay were withheld from users and the medical community.

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Suboxone and Its Dental Side Effects

Suboxone, a medication containing buprenorphine and naloxone, was initially approved in 2002 to assist individuals recovering from opioid addiction by alleviating withdrawal symptoms during therapy. In January 2022, the FDA issued a warning concerning the risk of dental side effects associated with Suboxone. Over 300 reports linked tooth decay and tooth loss to buprenorphine drugs, primarily affecting users in their 40s but also impacting individuals as young as 18. Some reported dental damage within just two weeks of starting Suboxone treatment.

Subsequently, the FDA ordered updates to the prescribing information for all buprenorphine products designed to dissolve in the mouth, including Suboxone films and tablets. However, Badalamenti and other former users are now pursuing Suboxone tooth decay lawsuits against Indivior, alleging that the company was aware of the dental side effects well before the FDA’s warnings.

Lack of Warning and Alleged Permanent Damage

Badalamenti’s lawsuit asserts that she was prescribed Suboxone after developing opioid addiction due to pain management medications. Neither she nor her doctors were warned about the potential for tooth decay and damage. Similar to other Suboxone tooth decay lawsuits, Badalamenti claims that she has experienced permanent tooth damage due to Suboxone side effects, necessitating extensive dental work to address the issues.

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The lawsuit points to numerous incident reports received by Indivior and studies and case reports published in medical literature, suggesting that the drug maker was aware of the risks associated with Suboxone dental damage. Badalamenti alleges that the company prioritised profits over consumer safety.

The lawsuit states, “Of the adverse events reported to FDA before the mandated label change, 40% were classified as serious. Over one-third reported the problem as affecting two or more teeth. Some of the adverse events were reported in patients with no prior history of dental issues.”

Deceptive Marketing Claims

The complaint also raises concerns about the introduction of Suboxone film versions in 2009, which are linked to a higher risk of dental side effects. Badalamenti claims that the introduction of Suboxone film was driven by a desire to avoid generic competition and extend patent protections, rather than to benefit patients.

Previously, the federal government and states accused the manufacturer of fraudulent actions related to Suboxone, including attempts to control supply and inflate pricing. In 2019, Reckitt Benckiser Pharmaceuticals settled for $700 million over Medicaid fraud allegations. Indivior reached a $600 million settlement with the Justice Department in 2020 and agreed to pay an additional $300 million in 2021 to settle similar claims filed by all 50 states and the District of Columbia, resolving allegations of aggressive and deceptive marketing.

This lawsuit highlights concerns over the alleged withholding of vital dental side effect information associated with Suboxone, raising questions about the prioritisation of profits over patient safety.

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