Is There a Suboxone Lawsuit?
Yes. Individuals throughout the United States are pursuing Suboxone lawsuits after discovering that the drug can cause tooth decay and other serious dental complications.
A growing body of medical research and adverse events reported to the U.S. Food and Drug Administration (FDA) have identified a serious risk of Suboxone dental side effects, which has now left many suffering with decayed and damaged teeth.
According to allegations raised in Suboxone lawsuits being pursued against Indivior Inc. and its subsidiaries, the drug makers placed a desire for profits before consumer safety, and failed to adequately warn about the link between Suboxone use and tooth deterioration.
The product liability lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations for individuals who have suffered tooth decay and dental problems after using Suboxone.
Who Qualifies for a Suboxone Lawsuit?
Financial compensation may be available through a Suboxone lawsuit payout for individuals who used the sublingual films and developed any of the following dental problems;
- Severe tooth decay
- Tooth loss
- Broken teeth
- Tooth extractions
- Jaw bone deterioration
- Underwent oral surgery
- Required dental implants
- Other serious tooth issues
2023 Suboxone Lawsuit Update
Following recent studies and case reports linking Suboxone and dental problems, individuals are now pursuing Suboxone lawsuits over the manufacturer’s failure to warn about the side effects of the opioid and chronic pain management drug.
- November 2023 Update: As the number of Suboxone tooth decay lawsuits being filed continues to grow, each raising allegations that the manufacturer failed to disclose dental decay side effects caused by Suboxone sublingual films, a motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML), requesting all claims be transferred before one judge as part of a Suboxone tooth decay MDL.
- September 2023 Update: The first of what is expected to be thousands of Suboxone tooth decay lawsuits was filed in the U.S. District Court for the District of Louisiana.
- December 2022: A research letter was published in the prestigious medical journal JAMA warning that Suboxone sublingual films double the risk of severe dental problems, including major cavities and tooth loss.
- January 2022 Update: On January 12, 2022, the FDA issued a Suboxone warning label update to include tooth decay and dental complications following an increasing number of adverse events being reported by users.
Problems with Suboxone Sublingual Film
Suboxone (buprenorphine and naloxone) is a treatment for opioid dependence originally developed by Reckitt Benckiser’s pharmaceutical division, which later demerged and became Indivior Inc.
A tablet form of Suboxone was first approved by the U.S. Food and Drug Administration (FDA) in October 2002, amidst the escalating opioid epidemic largely caused by the over-prescribing of opioid pain relievers and the rampant use of illicit heroin street drugs.
As the original patent on the drug was set to expire in October 2009, which would have allowed generic versions of Suboxone to enter the market and drive prices down, Reckitt instructed its subsidiary company, Indivior Inc. to begin developing a new sublingual film version of Suboxone with the same ingredients in an effort to secure a new patent and remain the sole provider of this highly in-demand class of opioid treatment drugs.
Shortly after the sublingual film version of Suboxone received FDA approval in August 2010, Reckitt launched a campaign to remove the pill version of the drug from the market, telling officials that the pill version was unsafe, citing concerns of child safety.
Suboxone Settlement with The Department of Justice
However, the move was seen by federal officials as an attempt to persuade the FDA from approving future generic pill forms of the drug to limit Reckitt’s competition. The use of these alleged tactics led to the U.S. Department of Justice filing an antitrust lawsuit against the manufacturer, claiming Reckitt Benckiser Group PLC prevented a fair market for their own financial gain.
Ultimately, the Suboxone antitrust lawsuit settled for $1.4 billion in July 2019, when Reckitt Benckiser agreed to pay $1.4 billion to the federal government, several states, and the FTC to resolve its potential criminal and civil liability related to the federal investigation of the marketing of the opioid addiction treatment drug Suboxone.
The settlement included a forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million.
Suboxone Tooth Decay Reports Ignored
As Reckitt deployed its sublingual film version of Suboxone to keep exclusive market share of the Suboxone class of drugs, the manufacturer ignored a growing number of dental problems caused by Suboxone being reported by users to the FDA.
In addition to the manufacturers failure to warn about Suboxone side effects, lawsuits claim that the sublingual film version of the drug contains a dangerous design defect that blocks saliva production and introduces the highly acidic buprenorphine drug directly to the users teeth, both of which have been found to cause tooth decay and dental complications.
Does Suboxone Cause Tooth Decay?
Yes. Suboxone sublingual strips decrease saliva production and introduce highly acidic conditions in the mouth, both of which have been shown to negatively affect dental health by wearing down enamel and diminishing the protective saliva around the teeth.
Suboxone Promotes Tooth Decay
Suboxone sublingual films are notably acidic, which can contribute to tooth decay. When these films dissolve under the tongue, they introduce this acidity to the mouth. This acidic environment can weaken tooth enamel, the protective outer layer of teeth. When enamel erodes, the teeth’s inner layer, dentin, becomes more exposed and vulnerable to decay.
Suboxone Film Dental Risks Nearly 2x Greater than Other Versions
A research letter titled “Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease” was issued in the JAMA medical journal in December 2022, alerting healthcare professionals to the possible dental risks linked with prolonged use of sublingual or buccal buprenorphine medications.
Analyzing data from 21,404 individuals on buprenorphine and naloxone combo drugs, the study discovered that those using sublingual versions like Suboxone were nearly 2x more likely to suffer dental problems compared to the other user groups, finding;
Dental Problems per 1,000 Users:
- Under-the-tongue version: 21.6
- Patch users: 12.2
- Pill users: 10.9
When it came to severe dental problems, such as cavities or lost teeth, the rates were 8.2 for sublingual users, compared to 3.5 for patch users, and 3.8 for pill users out of 1,000.
Researchers concluded their study warning that;
“This study found an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine and oral naltrexone. Sublingual buprenorphine/naloxone is acidic in nature. Patients are instructed to hold the tablet under the tongue for 5 to 10 minutes to maximize absorption. Thus, prolonged acidic exposure of the drug in the mouth might lead to tooth damage.”
Suboxone Blocks Saliva Production
Suboxone films can cause dry mouth due to buprenorphine known risk of suppressing acetylcholine, which is a neurotransmitter that stimulates saliva production. This makes it harder for the body to produce saliva.
Case Study Warns Suboxone Inhibits Saliva Production
A research article published in The Primary Care Companion for CNS Disorders in October 2013, researchers investigated a select group of individuals who experienced deteriorating dental health after consuming buprenorphine medications.
The study revealed that a staggering 90% of participants on buprenorphine medications exhibited saliva levels significantly below average, with a decrease of about 50% compared to the national mean. Additionally, the research pointed out that buprenorphine/naloxone drugs, when dissolved in water, possess a notably acidic pH of 3.4.
The findings suggest that Suboxone’s hindrance of salivary secretion, paired with the extended contact of the acidic buprenorphine medication, can promote dental issues.
Suboxone Tooth Decay Side Effects
Suboxone side effect lawsuits claim that the acidic nature of Suboxone, combined with its propensity to induce dry mouth, is associated with dental decay and various dental complications that require painful oral procedures to relieve their pain and symptoms, including
- Enamel Erosion
- Dentin Exposure
- Gum Disease (Periodontitis)
- Root Decay
- Gum Recession
- Tooth Sensitivity and Pain
- Tooth Abscess
- Tooth Loss
- Bone Loss in the Jaw
- Tooth Fractures
- Oral Infections
Corrective Dental Procedures:
- Bone Reinforcement
- Dental Bridges
- Dental Crowns
- Dental Implants
- Dental Veneers
- Desensitization Therapies
- Gum Procedures
- Root Canals
- Scaling and Root Cleaning
- Tooth Extractions
- Tooth Fillings
Suboxone Tooth Decay Drug Warning Label Update
Prior to 2022, there was no indication or warning of tooth decay or dental issue risks outlined in the Suboxone Medication Guide or Prescribing Information.
However, in January 2022, the FDA issued a press release in January 2022, warning that Suboxone sublingual films and similar buprenorphine products that dissolve in the mouth have been associated with an increasing incidence of dental decay and severe dental complications.
At the time of the FDA warning, officials revealed that over 300 reports of dental complications caused by Suboxone were reported annually among patients consuming orally dissolvable buprenorphine products. Out of these, 131 were deemed severe. Many patients reported experiencing dental issues as early as two weeks into the treatment, while the average time for diagnosis was around 2 years after starting treatment.
Given the rising reports of dental side effects linked to Suboxone, the FDA mandated the inclusion of a new buprenorphine dental side effects warning in both the prescribing details and the patient Medication Guide for all similar class drugs that dissolve orally.
The FDA further instructed that prescriber and patient documentation incorporated recommendations for sustaining or enhancing oral health during Suboxone or other orally dissolvable buprenorphine treatments. This involved urging healthcare professionals to direct patients to dental professionals and to advise patients to undergo consistent dental check-ups while using these medicines.
Allegations Raised in Suboxone Lawsuits
Individuals throughout the United States are now pursuing Suboxone lawsuits against Indivior Inc. and its subsidiaries raising allegations that the manufacturer,
- Failed to adequately research the link between Suboxone and dental problems.
- Failed to warn about the increased risk of tooth decay side effects.
- Failed to recommend routine dental checkups or preventive dental plans.
- Falsely advertised the medications as a safe opioid addiction treatment.
- Placed profits over consumer safety by ignoring reports of Suboxone dental problems.
- Failed to issue a Suboxone recall to ensure consumers were aware of the health risks.
Are there any costs to hire a Suboxone lawyer?
There are absolutely no out-of-pocket costs to review your case or hire our attorneys. Suboxone lawsuits are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis.
Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their Suboxone lawsuit — regardless of their individual financial resources.
You pay nothing up front to hire our Suboxone lawyers, and we only receive an attorney fee or expenses out of the money that is obtained from the manufacturer. Our law firm receives nothing unless we win your case!
What are the steps in a Suboxone case evaluation?
Complete Our Case Evaluation Request Form. Providing contact information and some information about your Suboxone problems.
Get Contacted by Saiontz & Kirk, P.A. You will be contacted by our law firm to help determine if financial compensation may be available for you and your family.
You Decide If You Want to Move Forward. If our lawyers determine that we can help with your case then you decide whether to move forward and hire us to pursue compensation.