Suboxone Lawsuit: MD Man Claims Strips Caused Permanent Tooth Damage

A Maryland resident has initiated a product liability lawsuit against Indivior, the pharmaceutical company behind Suboxone, alleging that the opioid addiction medication caused him to suffer severe dental issues, including permanent tooth damage. This claim, filed in the U.S. District Court for the Northern District of Ohio on January 7, 2025, highlights growing concerns regarding the alleged side effects of Suboxone, particularly its potential impact on users’ dental health.

Overview of Suboxone and Its Uses

Suboxone is a widely prescribed opioid use disorder medication that combines two active ingredients: buprenorphine and naloxone. It is primarily used to treat opioid addiction by alleviating cravings and withdrawal symptoms. The drug is typically administered in the form of a sublingual film, meant to dissolve under the tongue, allowing for rapid absorption into the bloodstream.

While Suboxone has been effective for many individuals seeking recovery from opioid dependence, reports of serious side effects have emerged in recent years. One of the most alarming issues is the potential link between Suboxone use and dental problems, including tooth decay, cavities, and even tooth loss.

Allegations Raised in the Suboxone Lawsuit

Michael James Rolf, the plaintiff in this new Suboxone lawsuit, asserts that his use of Suboxone led to significant dental complications. According to the complaint, Rolf was not adequately warned about the potential risks associated with the medication, specifically its impact on dental health. He claims that both he and his physician were unaware that Suboxone could cause severe tooth damage, resulting in the need for extensive dental surgery.

The lawsuit alleges that Indivior and its affiliates, including Indivior Solutions and Aquestive Therapeutics, provided misleading information about the safety of Suboxone, prioritizing profits over consumer safety. Rolf contends that the manufacturers were aware of the dental risks associated with the medication but failed to properly disclose this information to patients and healthcare providers.

The Potential Link Between Suboxone and Dental Issues

Research has increasingly suggested a connection between the use of Suboxone and dental problems. Many patients have reported experiencing dry mouth, a condition known as xerostomia, which can significantly increase the risk of tooth decay. Saliva plays a crucial role in maintaining oral health by neutralizing acids and washing away food particles. A reduction in saliva production can create an environment conducive to the growth of harmful bacteria, leading to cavities and other dental issues.

Additionally, some studies have indicated that buprenorphine, one of the active ingredients in Suboxone, may have direct adverse effects on oral health. The medication’s interaction with salivary glands could further exacerbate the problem, contributing to the deterioration of dental health among users.

In January 2022, the FDA issued a drug safety communication warning patients about the potential risk of dental problems associated with buprenorphine medicines dissolved in the mouth. At that time, the agency indicated that “dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues.”

Growing Number of Suboxone Dental Damage Claims

Rolf’s lawsuit is part of a broader trend, with hundreds of similar claims currently being pursued by former Suboxone users. Many of these lawsuits share common allegations, including claims of severe tooth decay and erosion that plaintiffs say could have been prevented had the manufacturers provided adequate warnings and guidance for mitigating dental damage.

In February 2024, all federal Suboxone lawsuits related to tooth decay were centralized into a multidistrict litigation (MDL) in Ohio. This consolidation allows for coordinated pretrial proceedings and discovery, streamlining the legal process for affected individuals. As the legal proceedings unfold, the outcomes of early Suboxone bellwether trials may significantly influence future potential settlements offered by the drug manufacturer.

The Role of the FDA and Recent Developments

Suboxone received its initial approval from the FDA in October 2002, with the sublingual film version gaining approval in 2010. Despite the growing body of evidence linking Suboxone to a possible increased risk of dental issues, warnings regarding these risks were not included on the product label until June 2022, following an FDA mandate.

This delay in providing what many see as crucial safety information has raised concerns among healthcare professionals and patients alike. Many users of Suboxone, including Rolf, argue that they were not adequately informed about the potential risk of Suboxone side effects, leading to preventable health complications.

Seeking Compensation for Alleged Suboxone-Related Injuries

The lawsuit filed by Michael James Rolf serves as a stark reminder of the potential health risks associated with medications like Suboxone. Rolf’s legal claim seeks both compensatory and punitive damages, alleging that the manufacturers failed to warn patients about the known risks associated with Suboxone use. As more individuals come forward with similar Suboxone claims, the implications for the pharmaceutical industry and public health could be significant. It underscores the importance of transparency and comprehensive patient education regarding the risks and benefits of medications prescribed for opioid addiction treatment.