Suboxone Lawsuit

Suboxone is a drug approved by the FDA to help treat Opioid Use Disorder (OUD). It is made up of two medications, buprenorphine and naloxone. Buprenorphine works by blocking the opioid receptors in the brain, which can reduce withdrawal symptoms and cravings for opioids when used under medical supervision. 

Naloxone (Narcan) is included in Suboxone to help reverse the dangerous symptoms of an opioid overdose and make it harder for the medication to be abused.

Suboxone is also available in generic forms. 

Suboxone comes in the form of sublingual films or tablets, which are administered as part of a comprehensive treatment program that includes counseling and therapy. The method of taking Suboxone is through oral administration. Suboxone is available in three forms:

1. Sublingual Suboxone Tablets (most commonly round, orange, uncoated): These tablets are placed underneath the tongue.

2. Sublingual Suboxone Film Strips (most commonly paper thin, orange rectangle or square): These film strips are also placed underneath the tongue.

3. Buccal Suboxone Film Strips (most commonly paper thin, orange rectangle or square): These film strips are placed between the gums and teeth.

Suboxone is most commonly offered in four different dosages:

- 2 mg buprenorphine and 0.5 mg naloxone

- 4 mg buprenorphine and 1 mg naloxone

- 8 mg buprenorphine and 2 mg naloxone

- 12 mg buprenorphine and 3 mg naloxone

Belbuca contains the same active ingredient as Suboxone (buprenorphine) but does not include naloxone (Narcan). Belbuca is not approved for OUD; it is instead prescribed to patients with chronic pain. There are no generic versions of Belbuca.

Belbuca is available in many dosages as a square yellow dissolvable film:

• 75 mcg
• 150 mcg
• 300 mcg
• 450 mcg
• 600 mcg
• 750 mcg
• 900 mcg

Like Belbuca, Subutex contains only buprenorphine. Reckitt Benckiser (now Indivior) discontinued Subutex in the U.S. in 2011 after developing new formulations that were less likely to be abused. Subutex is still available in generic forms, but practitioners most often prescribe Suboxone instead.

Yes, according to the medical literature. In December of 2022, a research letter published in the Journal of the American Medical Association reported dental adverse events associated with buprenorphine medications like Suboxone. The study, which examined thousands of patients from 2006–2020, found “an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone…”

While this study is the most robust to date in terms of patient cohort and duration, it is not the only research confirming a link between Suboxone and problems with teeth. In 2012, Harvard Medical School professors affiliated with Brigham and Women’s Hospital in Boston published a case report on a patient with sudden dental problems while using Suboxone tablets. The authors concluded that the “patient’s experience of a sudden decline in her oral health without any changes in her dental hygiene practices or sugary food/beverage consumption raises the possibility that chronic use of sublingual buprenorphine/naloxone may have played a role.” 

A year later, the lead author from the 2012 study worked with Harvard colleagues to publish a case series of eleven patients at Brigham and Women’s Hospital. The study patients experienced dental caries, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The authors noted that cavities and tooth erosion “occur when teeth are exposed to an environment that has low pH.” 

pH is a scale running between 0 and 14 measuring the acidity or basicity of an aqueous solution. It inversely indicates the activity of hydrogen ions in the solution. A pH of 7 indicates neutral. A pH of less than 7 indicates acidity and a pH of greater than 7 indicates a base. 

A Suboxone tablet measures acidic at 3.4 pH. Patients are specifically instructed to keep the Suboxone tablet and the accumulating saliva in their oral cavity to maximize absorption. Based on the average ingestion of Suboxone tablets three times daily for an average span of nine minutes to dissolve, the authors of the 2013 and 2012 studies concluded that “prolonged contact between tooth surfaces with buprenorphine/naloxone, therefore, may be a contributing factor in the alteration of the tooth microbial profile and/or the pH to promote dental caries, similar to what has been previously reported in patients who use methamphetamine.”

Suboxone is acidic to maximize buprenorphine absorption while minimizing absorption of the naloxone. This acidic formulation leads to dental erosion and decay. 

Suboxone teeth problems include:

• Tooth decay
• Tooth loss
• Extraction
• Oral infections
• Cracked teeth
• Cavities
• Root canal
• Dental caries (loss of enamel)
• Crown or crown replacement
• Gingivitis and other gum disease

One thing to remember is that these dental issues are not limited to Suboxone; the FDA also warned about Subutex and Belbuca teeth issues.  

Yes, you can pursue compensation in a Suboxone lawsuit if you meet certain requirements (more on this below). Even if you had problems with your teeth before using Suboxone, Belbuca or Subutex, lawsuits allege the medication increased your risk of tooth decay and other dental issues.

We are not aware of large-scale lawsuits involving methadone and tooth decay. That said, studies have shown that methadone can cause dental decay. That’s because methadone can cause xerostomia (dry mouth), which can make teeth produce more plaque, potentially leading to tooth decay. Methadone is also acidic, which can lead to dental erosion. 

The only way to know for certain if you qualify for a Suboxone lawsuit is to fill out a case evaluation form. A Suboxone lawyer will review your case and determine if you are eligible.          
Potential plaintiffs in Suboxone lawsuits are individuals who used Suboxone for at least six months prior to 2022 and later experienced severe tooth decay or loss, necessitating corrective dental procedures such as fillings, extractions, or implants. 

Please keep in mind that the criteria to qualify for a Suboxone lawsuit may change over time due to court rulings, scientific findings, and other variables.

Indivior, Inc. and Aquestive Therapeutics Inc. are the pharmaceutical companies named as defendants in the Suboxone lawsuits. Indivior, specifically, is the primary manufacturer of the drug, but both companies play a significant role in the production and marketing of Suboxone. 

Indivior was originally a division of Reckitt Benckiser, a larger pharmaceutical company based in the United Kingdom. When the market for opioid dependency drugs expanded, Reckitt spun off Indivior as a separate publicly traded company. Indivior's close relationship with Reckitt, which continues to own a significant percentage of shares, adds weight to their involvement in lawsuits against Suboxone.

Suboxone tooth decay lawsuits are filed for individuals; they are not part of a class action. While these lawsuits make similar allegations against the same defendants, the plaintiffs have differing claims for damages. 

How do the courts handle these types of cases? Through the creation of a multidistrict litigation (MDL). Although not classified as a typical class action lawsuit, an MDL consolidates all federal cases for efficient pretrial proceedings. This allows plaintiffs with similar allegations against the defendants to collaborate and present a stronger collective argument.

In February 2024, the Judicial Panel on Multidistrict Litigation (JPML) issued an order to consolidate Suboxone teeth decay lawsuits into an MDL. The order consolidates claims filed in several federal courts before the Hon. Judge J. Philip Calabrese for the U.S. District Court in the Northern District of Ohio.

No, there has not been a Suboxone settlement. With the formation of the Suboxone MDL, we anticipate litigation to continue well into 2025.. In mass torts, settlement negotiations could begin at any time, but typically, they do not progress until bellwether trials are due to begin, and we are several months away from trial dates. 

It should be noted that Indivior has paid Suboxone settlements stemming from its activities in marketing and selling Suboxone. 

In October of 2023, Indivior paid a $385 million settlement resolving lawsuits brought by drug wholesalers alleging the company illegally suppressed generic competition for Suboxone.  

In August of 2023, Indivior paid a similar settlement of $30 million to resolve a class action lawsuit brought by health care plans.

The Department of Justice indicted Indivior in June of 2023 for participating in an illegal scheme that funneled patients to specific doctors prescribing Suboxone. To resolve the matter, the company agreed to pay a settlement of $102 million to 41 states and Washington D.C. 

In 2021, the Federal Trade Commission announced a $60 million settlement with Indivior over deceptive marketing allegations. Nearly 52,000 people received a payout as part of the settlement.  

Wisner Baum offers free case evaluations for those who may have suffered Suboxone teeth problems. Please fill out our case evaluation form or give us a call at 855-948-5098