Suboxone Lawsuit Filed Over Tooth Decay, Damage Caused By Opioid Addiction Drug

Lawsuit claims that the manufacturers knew about reports of Suboxone tooth decay long before the FDA required new label warnings in 2022.

The first of what could be many Suboxone tooth decay lawsuits to come was filed this week by an Ohio man, claiming that a version of the opioid addiction treatment designed to dissolve in the mouth causes tooth decay and permanent dental damage, due to its high acidity.

The complaint (PDF) was filed by David Sorensen this week in the U.S. District Court for the Northern District of Ohio, pursuing claims against Indivior, Inc., Aquestive Therapeutics, MonoSol Rx, Inc. and Beckitt Benckiser LLC as defendants.

Suboxone (buprenorphine and naloxone) is a drug first approved in 2002 to treat recovering opioid addicts; helping them avoid withdrawal symptoms while they undergo therapy to help them break their addiction.

In January 2022, the FDA warned there had been more than 300 cases of tooth decay and dental problems linked to Suboxone and buprenorphine drugs, most commonly involving users in their 40s. However, the tooth decay problems have also been seen among those as young as 18 years old, with some of the dental damage from Suboxone reported as soon as two weeks after beginning treatment.

Later that year, due to concerns about Suboxone and tooth decay side effects, the FDA mandated an update to the prescribing information for all buprenorphine products meant to dissolve in the mouth, including Suboxone films and tablets.

Suboxone Tooth Decay and Dental Damage

According to the Suboxone lawsuit, the manufacturer changed the prescribing information to add warnings about the risk of dental problem, but did not add it to the medication guide most commonly seen by patients.

Sorensen indicates he became addicted to opioids after using them for pain management treatment and was subsequently prescribed Suboxone to treat his addiction. As a result of his use of Suboxone, the lawsuit claims Sorensen now suffers from permanent tooth decay and has needed to undergo extensive dental work as a result.

The lawsuit indicates Indivior knew about the Suboxone tooth decay risks long before the FDA warning, but failed to adequately warn physicians or patients. By the end of 2010, the manufacturer had submitted at least 20 reports to the FDA of patients who suffered tooth decay after using Suboxone.

Case reports linking Suboxone tablets to dental health problems began to also be reported in medical literature in 2012. One case study by Harvard researchers identified 11 patients who suffered worsening dental health at Brigham and Women’s Hospital in Boston between just May and November 2012.

Patients reportedly suffered cracked teeth, an increased need for fillings, crown replacements, root canals and tooth extractions. Researchers blamed the decay on prolonged contact with Suboxone, which is acidic in nature and can damage tooth enamel.

As of June 2022, the manufacturers were aware of about 150 reports of Suboxone dental damage, but failed to add additional label warnings until required by the FDA, the lawsuit claims.

Suboxone Lawsuit Points to Deceptive Marketing Tactics

Originally designed as a dissolving pill, the drug manufacturer allegedly waited until its patent exclusivity expired, allowing generic versions of Suboxone to hit the market, before introducing a dissolving film version in 2009. The lawsuit claims the introduction of Suboxone film, which is placed under the tongue and rapidly introduced in the patient’s blood stream, was actually done to avoid generic competition and extend patent protections, not to benefit patients..

The FDA expressed concerns about the risk of pediatric exposure, however the agency approved the film version of Suboxone in August 2010. This gave the manufacturer another three years of exclusivity until August 2013. Just a month before that patent exclusivity expired, the manufacturer presented another version of the drug.

“Defendants executed a monopolistic strategy known as a product hop from sublingual Suboxone tablets to sublingual Suboxone film for the purpose of foreclosing generic competition,” Sorensen’s lawsuit states. “A product hop involves modest reformulations of a brand-name drug prior to expiration of its market exclusivity for the purpose of stymieing generic competition and preserving monopoly profits.”

But the lawsuit indicates the manufacturers did not stop there.

The states and federal government accused the manufacturer of submitting a fraudulent petition to the FDA in September 2012, which claimed the Suboxone Tablet had to be discontinued due to safety concerns. However, regulators determined that, in actuality, the manufacturer sought to control supply and improperly inflate Suboxone pricing, including what state Medicaid programs paid for it.

In 2019, Reckitt Benckiser Pharmaceuticals reached a $700 million settlement with the federal government and states over Suboxone Medicaid fraud allegations. Indivior spun off from the company shortly afterwards and reached a $600 million Suboxone settlement agreement with the Justice Department in 2020, to resolve claims of aggressive and deceptive marketing. Then, in 2021, the company agreed to pay another $300 million to settle similar claims filed by all 50 states and the District of Columbia.