In 2002, Indivior Incorporated received FDA approval for the buprenorphine medication Suboxone. The drug became a staple for medication-assisted treatment (MAT) of opioid use disorder (OUD).
However, a series of clinical studies and product liability lawsuits assert that Suboxone has the potential to cause serious dental complications, including tooth erosion and decay. Although extant medical literature advances several hypotheses for the mechanism by which oral buprenorphine damages teeth, the unnerving relationship between the two is clear.
The recent Suboxone tooth decay lawsuits allege that Indivior, the manufacturer, and its affiliates either knew or ought to have known of these risks but failed to warn users and endangered the public. The qualified Suboxone tooth decay lawyers at Dolman Law Group, PA have been closely following the groundswell of court filings in recent months and are preparing for a drastic increase in the near future.
If you were prescribed Suboxone before 2022 and subsequently developed severe dental complications, contact us for a free consultation at (727) 451-6900.
What Is Suboxone Buprenorphine?
The primary ingredient in Suboxone is buprenorphine, a semisynthetic opiate that binds to the brain’s opioid receptors and diminishes the symptoms of withdrawal while decreasing cravings. On account of the FDA’s “orphan drug” designation, Suboxone enjoyed exclusive market access until 2009.
After Indivior Inc. encountered growing competition for its buprenorphine tablet in the early 2010s, it invested in the development of alternative administration methods, including sublingual and buccal routes.
However, buprenorphine-naloxone displays low pH levels and can increase oral acidity. Over time and in the absence of sufficient precautions, the medication can result in the demineralization of tooth enamel and the reduction of salivary flow.
As a result, long-term users of oral Suboxone have experienced a variety of serious dental complications, including:
- Dental fillings
- Dental caries
- Cracked teeth
- Crown replacements
- Root canals
- Tooth extractions
Decade of Clinical Research Linking Oral Suboxone to Dental Disease
As Indivior was combatting market competitors through the production of novel Suboxone modalities, researchers were investigating an alarming rise in dental disease amongst buprenorphine users. The subsequent research studies sought to determine the exact cause of Suboxone tooth decay and erosion, identifying several possible origins.
The first hypothesis asserts that oral Suboxone use can radically alter acidity levels in the mouth, that contributes to demineralization and tooth decay. Another common explanation suggests that buprenorphine-naloxone can decrease salivary flow, further contributing to an oral chemical imbalance.
The third, and most recent, hypothesis postulates that the oral administration of Suboxone can increase the virulence of the naturally occurring oral bacteria, Streptococcus mutans. If left untreated, the proliferation of S. mutans can produce excess lactic acid which severely damages the teeth.
2013 Case Series Identifies Dental Complications in Buprenorphine Users
In 2013, The Primary Care Companion for CNS Disorders published a limited case series that followed the dental decline of oral buprenorphine users at Brigham and Women’s Hospital. The eleven participants were then receiving treatment for opioid use disorder (OUD) and displayed unusually sudden dental complications after relying on sublingual administration methods.
The study discovered that over 90% of participants suffered from low to moderate salivary buffering in sharp contrast to the general population. Although the study provided a useful foundation for further research, it nevertheless refrained from definitively linking oral buprenorphine use to dental issues on account of limitations in the design.
Analysis of Medicinal Dental Caries Discovers Suboxone Impact on Dental Health
Several years later, researchers relied upon the VigiBase database to investigate the connection between various medications and medicinally-induced dental caries. Amongst the 88 prescription drugs identified in the 2017 study, buprenorphine-naloxone (Suboxone) ranked highly for its potential to diminish salivary flow.
Many oral Suboxone users have reported developing the symptoms of dry mouth (xerostomia) after taking the medication. In more extreme cases, dry mouth can result in irreparable tooth damage as the regulating effects of saliva cause oral acidity levels to spike exponentially.
JAMA Study Detects High Rates of Dental Disease in Oral Buprenorphine Users
In early January 2022, the Food and Drug Administration published a warning about the dental adverse events associated with oral buprenorphine use. The development not only required Indivior to revise Suboxone’s warning label but also resulted in an uptick in medical interest.
The first major Suboxone research study in the aftermath of the FDA decision was the most extensive to date, relying upon readily available information through the PharMetrics database. Researchers established three cohorts of recovering opioid users who had received oral buprenorphine-naloxone, transdermal buprenorphine, and oral naltrexone prescriptions.
After following participants for one year, the researchers observed that sublingual Suboxone users displayed considerably higher rates of dental caries and tooth loss than the other cohorts. However, the study’s inability to account for compounding variables like dental hygiene and history or cigarette use and soda consumption discouraged researchers from definitively asserting a buprenorphine-tooth erosion link.
Nevertheless, the disproportionate rates of dental complications amongst oral Suboxone users in comparison to transdermal buprenorphine and oral naltrexone recipients confirmed earlier suspicions about the unique harmfulness of the medication and method of administration.
2023 Survey of Suboxone Adverse Event Reports from FDA
Aside from assessing and approving novel prescription medications, the FDA conducts postmarketing reviews to determine the long-term safety and efficacy of saleable drugs. One way in which the agency accomplishes this task is through the collection of adverse event reports (AERs) from prescribing physicians and users.
The voluntary and public submissions commonly influence the FDA’s decision making and inform prospective users. Beginning in 2007, the FDA received a litany of Suboxone AERs which outlined the drug’s risk to dental health.
In 2023, Current Drug Safety published a survey of the accessible oral buprenorphine incident reports from 2015 to 2021. Corroborating the observations of the 2022 JAMA study, researchers concluded that sublingual, buccal, and oral buprenorphine accounted for a “disproportionate reporting of dental disorders” in the available FDA records.
New Suboxone Tooth Decay Research Receives Federal Grant
In October 2023, UTHealth Houston School of Dentistry Professor Bin-Yan Wang received a $700,000 federal grant to conduct groundbreaking research on the role of oral buprenorphine administration and the virulence of Streptococcus mutans. Although researchers have hypothesized that oral buprenoprhine negatively impacts S. mutans levels, Professor Wang’s research represents the most targeted and extensive investigation of the link thus far.
Moreover, the study is poised to assume an important role in the current and prospective Suboxone tooth decay lawsuits, which will rely heavily on extant and ongoing research to prove that oral buprenorphine-naloxone can cause dental complications.
Who Is Liable in Suboxone Tooth Decay Lawsuits?
The recent Suboxone tooth decay lawsuits primarily target Indivior Incorporated. In defective drug litigation, the most common charge against irresponsible drug manufacturers addresses their “failure to warn” users of the risks their products pose.
Given the availability of the Suboxone AERs and various high-profile research studies, plaintiffs allege that Indivior Inc. either knew or should have known of the dental problems associated with sublingual and buccal forms of the drug. Unfortunately, the pharmaceutical company sought to avoid negative publicity and reputational damage in the midst of unrelated litigation.
Additional defendants in the buprenorphine product liability litigation include Aquestive Therapeutics Inc. and Reckitt Benckiser, Indivior’s former parent company. Aquestive played an important role in Suboxone’s development and the latter oversaw Indivior’s production and distribution strategies.
Common Damages in Suboxone Dental Decay Lawsuits
For many recovering opioid users, dental complications already pose considerable risks. Aside from the pain and discomfort tooth erosion and decay can cause, their treatment also requires enormous medical expenditures and liberal insurance coverage.
Fortunately, these injuries may be compensable. In product liability litigation, users of defective drugs reserve the right to seek financial assistance from reckless manufacturers in the form of economic and non-economic damages, including:
- Medical costs – past, present, and future
- Lost wages and income
- Out-of-pocket expenses
- Pain and suffering
- Decreased quality of life
- Emotional anguish
In order to determine the compensation to which you may be entitled and the statute of limitations for your claim, we advise speaking with a qualified Suboxone tooth decay lawyer as soon as possible.
Why Choose Dolman Law for Your Suboxone Tooth Decay Lawsuit
At Dolman Law Group, we maintain a steadfast commitment to defending consumer rights against the irresponsibility of massive pharmaceutical companies. As the body of clinical research and the number of Suboxone lawsuits grow, our qualified product liability lawyers are on standby to provide advice and counsel for eligible plaintiffs.
We possess over 120 combined years of personal injury law experience and have considerable familiarity with product liability litigation. From Zantac and Tylenol lawsuits to litigation against Tepezza, Ozempic, and Uloric, we know how to devise compelling defective drug lawsuits and work tirelessly to defend them.
For those recovering from opioid use disorder (OUD), pursuing time-intensive and extensive litigation may appear daunting. That is why we place a high emphasis on alleviating our clients of procedural and technical obstacles, enabling them to tend to their health while we safeguard their rights.
Contact Dolman Law Group for Help with Your Suboxone Tooth Decay Lawsuit
Indivior Incorporated was once hailed as a champion in the effort to combat the American opioid crisis. However, antitrust violations, illicit schemes, and unjustifiable deception have revealed the company’s willingness to manipulate markets and consumers to increase profits.
The recent Suboxone tooth decay lawsuits are only the latest illustration of Indivior’s unethical and illegal business practices, and we are determined to hold the pharmaceutical giant accountable for their negligence. In a free consultation, Dolman Law Group’s Suboxone tooth decay lawyers can assess the eligibility of your claim, the compensation to which you may be entitled, and the legal recourse at your disposal. Moreover, we work on a contingency-fee basis, which means you don’t pay unless we successfully resolve your case.