Suboxone Tooth Decay Lawsuit

Is There a Suboxone Tooth Decay Lawsuit?

Yes, Suboxone tooth decay lawsuits are now being investigated by lawyers. Lawsuits claim that Indivior Inc. and its affiliated businesses attempted to monopolize the market and block generic versions of Suboxone from entering the market by redeveloping Suboxone tablets in the form of sublingual films that dissolve in the individual’s mouth.

A growing body of medical research and adverse events have highlighted Suboxone dental side effects among users with no previous history of dental issues now experiencing tooth decay, cavities, oral infections, gum disease and loss of teeth, often requiring extensive dental care.

Lawsuits claim that the manufacturer placed its market position and profits above consumer safety, and failed to adequately research tooth decay and tooth loss side effects of the reformulated Suboxone strips.

Who is Eligible for a Suboxone Lawsuit?

Financial compensation may be available through a Suboxone lawsuit for individuals who used buprenorphine and naloxone sublingual films, and suffered any of the following complications:

• Severe tooth decay
• Tooth loss
• Broken teeth
• Tooth extractions
• Underwent oral surgery
• Required dental implants
• Other serious tooth issues

To determine if you or a loved one qualify for a Suboxone tooth decay lawsuit, submit information for review by a Suboxone lawyer, who will evaluate the circumstances of your potential claim.

Attorneys handle all Suboxone lawsuits on a contingency fee basis, which means that there are no fees or expenses paid unless a settlement or lawsuit payout is received.

2024 Suboxone Tooth Decay Lawsuit Updates

After recent research and case findings linking Suboxone with dental issues, people are now filing Suboxone lawsuits against the drug manufacturer for failing to warn about the adverse effects of the opioid-based pain management medication.

• April 24, 2024 Update: Indivior has proposed that the Court randomly choose three to five Suboxone lawsuits for inclusion in the general causation phased discovery. As part of this process, the selected plaintiffs would be required to submit all their pharmacy, medical, and dental records for expert examination to develop opinions on whether Suboxone film is linked to tooth decay. The Court is scheduled to hear oral arguments over the phased discovery proposal on June 6.
• April 23, 2024 Update: In a joint status report submitted on April 11, 2024 , the Plaintiffs’ Leadership Committee (PLC) informed the court that “thousands” of Suboxone lawsuits are likely to be filed within a very short period of time before June 17, which marks two years since the FDA required a Suboxone label update for tooth decay side effects.
• April 1, 2024 Update: As thousands of Suboxone tooth loss claims continue to be investigated by lawyers across the nation, the JPML reported in this months updated docket report that an additional 30 lawsuits have been filed in the Suboxone multidistrict litigation. A total of 44 Suboxone lawsuits are now pending in the MDL as of April 1, 2024.
• March 19, 2024 Update: Judge Calabrese issued a case management order on March 18, allowing new Suboxone tooth loss lawsuits to be filed directly in the MDL court, eliminating the need for filing in various U.S. District Courts and awaiting transfer to the Ohio MDL court. The Court is also expected to approve a Master Complaint and Short Form Complaint in the coming weeks which will allow plaintiffs to file their claims using a condensed form that incorporates specific allegations unique to each individual, such as injuries caused by Suboxone sublingual films.
• March 12, 2024 Update: The judge presiding over the Suboxone litigation issued a case management order appointing a group of 20 plaintiffs’ lawyers to serve in various leadership positions in the MDL. The attorneys will be tasked with coordinating status updates for the court, arguing certain pretrial motions, conducting discovery and depositions into common issues that impact all claims, and potentially negotiating a framework for Suboxone tooth decay settlements that may help resolve large numbers of claims.
• March 7, 2024 Update: At an case management conference on March 7, 2024, Judge Calabrese directed the parties to establish a process allowing plaintiffs to file claims directly with the MDL court. A deadline for implementing this direct filing order is March 15, 2024.
• February 21, 2024 Update: In a recent case management order, U.S. District Judge Philip Calabrese has set a deadline of March 1, 2024, for plaintiffs’ lawyers to apply for leadership roles in the new Suboxone multidistrict litigation.
• February 6, 2024 Update: The JPML issued a transfer order (PDF) on February 2, instructing that all Suboxone lawsuits over tooth decay problems filed in federal courts should be centralized under U.S. District Judge Philip Calabrese in the Northern District of Ohio for pretrial proceedings.
• January 4, 2024 Update: In a Notice of Hearing Session issued late last month, a panel of federal judges are scheduled to hear oral arguments over whether to centralize the growing number of Suboxone tooth decay lawsuits on January 25, at the U.S. Bankruptcy Court Federal Building in Santa Barbara, California.

Suboxone Overview

Suboxone is a prescription medication used to treat opioid addiction, combining buprenorphine, a partial opioid agonist, with naloxone, an opioid antagonist. The drug is often issued in conjunction with behavioral and mental health interventions to those battling opioid addiction.

Buprenorphine in Suboxone has a high binding affinity for opioid receptors in the brain, allowing it to attach to and occupy these receptors. Due to its high affinity, buprenorphine effectively displaces other opioids from these receptors and remains bound, which is meant to reduce withdrawal symptoms and prevent other opioids from exerting their effects.

Naloxone is added to Suboxone to deter misuse and potential abuse. While buprenorphine has opioid effects that can be abused if taken in large quantities or injected, naloxone is an opioid antagonist, which means it blocks the effects of opioids. If a person tries to inject or misuse Suboxone, the naloxone will counteract the opioid effects of buprenorphine and can precipitate withdrawal symptoms, making it an undesirable choice for illicit use.

How is Suboxone taken?

Suboxone sublingual films and tablets are designed to release their active ingredients (buprenorphine and naloxone) directly into the bloodstream through the mucous membranes in the mouth, specifically the area under the tongue. The drug has been offered in the following forms;

• Sublingual Film (current): Users place the thin strip beneath the tongue for 5 to 10 minutes to maximize absorption, allowing it to dissolve completely. It’s important not to chew or swallow the film because it’s designed to be absorbed through the mucous membranes in the mouth.
• Sublingual Tablets (though discontinued in 2012): Similarly, the tablet is placed under the tongue and allowed to dissolve fully without chewing or swallowing.

Users are advised to avoid eating or drinking until the film or tablet has completely dissolved, which typically takes several minutes. The exact dosage and frequency are determined by a healthcare provider and may be adjusted based on the individual’s response to the treatment and specific needs.

Suboxone Dosage

Suboxone sublingual film dosages are tailored to the specific needs of the individual patient. A common starting dose is often set at either

• 4mg/1mg ratios of buprenorphine to naloxone, or
• 8mg/2mg ratios of buprenorphine to naloxone

However, these initial dosages can vary based on the patient’s opioid dependence and other factors. As treatment progresses, this dose can be modified according to the patient’s response and requirements.

How long do I take Suboxone?

The duration of Suboxone sublingual film treatment is not standardized and varies based on individual needs and the nature of their opioid dependency. There are typically two approaches to Suboxone treatment plan durations which include;

• Short-Term Detox: Individuals may take Suboxone for a brief period, ranging from a week up to several weeks, as part of their detoxification regimen.
• Long-Term Maintenance: A significant number of patients use Suboxone over extended periods, from several months to years. Some even continue its usage indefinitely, based on their personal requirements and guided by their healthcare professional’s advice.

Does Suboxone Cause Tooth Decay and Tooth Loss?

Yes. Suboxone sublingual films can cause both acidity and dry mouth, each impacting dental health by eroding enamel and reducing saliva that normally protects teeth. Users are advised against brushing immediately after administration, allowing the acidic residue prolonged contact with teeth. Over time, this can accelerate decay and heighten the likelihood of tooth loss.

Suboxone is Acidic

Suboxone sublingual films have a confirmed acidic nature, which is a significant factor in their potential to contribute to tooth decay. Here’s a deeper explanation:

• Acidic Nature of Suboxone: The formulation of Suboxone sublingual films inherently contains acidic components. When these films are placed under the tongue to dissolve, they can introduce this acidity directly to the oral environment.
• Tooth Enamel Erosion: Our tooth enamel, the hard outer layer of our teeth, is vulnerable to acidic environments. Prolonged exposure to acidic substances, like that from Suboxone films, can erode this enamel. Once the enamel is compromised or thinned, the underlying dentin becomes more exposed, making teeth more susceptible to decay.
• Instructions on Dental Hygiene Post-Use: The instruction labels for Suboxone sublingual films advise users only to drink water after use, and to not brush their teeth immediately after using the product, warning this can lead to advanced tooth decay. However, it also means that the acidic residues of Suboxone can remain in contact with teeth for a more extended period, potentially allowing it to wear away at the enamel, making teeth more susceptible to decay.

Suboxone Causes Dry Mouth

Suboxone sublingual films, containing both buprenorphine and naloxone, have been confirmed to cause dry mouth (xerostomia) as a known side effect. The reason for this primarily lies in buprenorphine’s impact as a partial opioid agonist:

• Suboxone Inhibits Saliva Production: Buprenorphine, an active component in Suboxone, can exhibit anticholinergic properties. This means that it can suppress the action of acetylcholine, a neurotransmitter responsible for stimulating saliva production. When its activity is reduced by Suboxone, the result can be decreased salivary flow or dry mouth.
• Central Nervous System Impact: Buprenorphine, by virtue of its action on the central nervous system, can modify the normal functioning of several bodily systems. One of the outcomes of this action can be a reduction in saliva production, leading to a feeling of a dry mouth.

It has been found through medical research that individuals taking Suboxone may experience this side effect of dry mouth. This is particularly significant because a consistent dry mouth can elevate the risk of dental problems like tooth decay and gum disease. This happens because saliva is vital for oral health, aiding in food digestion, flushing out food particles, and neutralizing harmful acids.

Suboxone Tooth Decay Side Effects

Lawsuits claim the acidic composition of Suboxone coupled with its tendency to cause dry mouth has been linked to tooth decay and a wide range of dental side effects, including

• Cavities: Small holes in the teeth caused by decay.
• Enamel Erosion: Thinning and weakening of the outermost layer of the tooth.
• Dentin Exposure: Exposure of the inner layer of the tooth, leading to sensitivity.
• Gum Disease (Periodontitis): Decayed teeth can lead to gum infections, which, if untreated, can destroy the bone that supports the remaining teeth..
• Root Decay: Decay occurring on the tooth’s root, especially when gums recede.
• Gum Recession: Pulling away of gums from the teeth, exposing more of the tooth or its root.
• Tooth Sensitivity: Pain or discomfort when consuming hot, cold, sweet, or acidic foods and drinks.
• Tooth Abscess: Pus-filled pocket resulting from a bacterial infection in the tooth.
• Tooth Discoloration: Yellowing or browning of teeth due to decay and staining.
• Tooth Loss: Advanced decay leading to the loss of a tooth.
• Chewing Difficulties: Problems when eating due to damaged or painful teeth.
• Bone Loss in the Jaw: Decay and periodontal disease can lead to a loss of bone that supports teeth.
• Chronic Bad Breath: Persistent foul smell from the mouth due to decay and associated bacterial activity.
• Tooth Fractures: Weakened teeth can break or fracture more easily.
• Oral Infections: These can spread, leading to more severe health issues if not treated.

Dental Treatments Following Suboxone Tooth Decay

In Suboxone dental decay lawsuits and across social media platforms, individuals are claiming they have “lost all my teeth” and have been left to to use their own dental insurance or pay out of pocket for dental work, such as;

• Dental Fillings: To treat cavities and minor tooth decay.
• Root Canal Therapy: For decay that has reached the tooth’s inner pulp.
• Crowns: To cap and protect a damaged tooth after decay has been removed.
• Bridges: To replace one or more missing teeth by anchoring onto adjacent healthy teeth.
• Dentures: Custom-made replacements for missing teeth, either partial or full sets.
• Dental Implants: Surgical placement of a titanium post into the jawbone to replace the root of a missing tooth, followed by placing a crown on top.
• Veneers: Thin porcelain laminates bonded to the front of teeth to improve appearance.
• Tooth Extractions: Removal of severely decayed teeth that cannot be saved.
• Bone Grafting: To strengthen areas of the jawbone that have deteriorated, usually in preparation for implants.
• Fluoride Treatments: To strengthen enamel and prevent further decay.
• Scaling and Root Planing: A deep cleaning procedure to treat and prevent gum disease.
• Gum Surgery: To address advanced periodontal disease or receding gums.
• Desensitizing Treatments: For teeth that have become sensitive due to enamel erosion and exposed dentin.

How to Stop Tooth Decay While Taking Suboxone

While maintaining good oral hygiene may help prolong the onset of Suboxone tooth decay side effects, the U.S. Food and Drug Administration (FDA) issued an updated Suboxone warning in 2022, recommending that individuals establish a comprehensive dental care plan with a dentist.

However, this recommendation came far too late for many who have taken Suboxone for years and suffered severe dental complications as a result of the manufacturer’s defective design of the sublingual films, and failure to warn about dental side effects.

Suboxone’s Controversial Market Approval

Suboxone was originally developed by Reckitt Benckiser’s pharmaceutical division, which later demerged and became Indivior. The U.S. Food and Drug Administration (FDA) granted approval of Suboxone (buprenorphine and naloxone) tablets for the treatment of opioid dependence in October 2002.

As the opioid epidemic continued to spiral across the U.S. in the early 2000’s due to the over-prescribing of opioid pain relievers and the increased use of illicit heroin street drugs, Reckitt sought to extend the patent of its Suboxone drug, which was due to expire on October 8, 2009.

When the original patent for the Suboxone tablets was nearing its expiration, Reckitt used its subsidiary Indivior Inc. to develop a sublingual film format of Suboxone containing the same active ingredient, which allowed the company to secure a new patent and expand its exclusive rights to market the drug. This is often a controversial strategic move in the pharmaceutical industry that is referred to as “product hopping” or “evergreening”.

After the Suboxone sublingual films received FDA approval on August 30, 2010, the manufacturer started a process that removed the pill version of Suboxone from the market in favor of the film version, claiming the tablets were no longer safe citing concerns over child safety. However, lawsuits claim Reckitt removed the tablets to align with its business interests to delay generic competition. Reckitt Benckiser obtained a patent on the Suboxone sublingual film shortly after on July 2, 2013.

Suboxone Settlement with The Department of Justice

The U.S. Department of Justice (DOJ) filed an antitrust lawsuit against Reckitt Benckiser Group PLC, the former parent company of Indivior, in April 2019, claiming the manufacturer’s tactics prevented fair competition and kept prices high.

A Suboxone antitrust lawsuit settlement was ultimately reached in in July 2019, when Reckitt Benckiser agreed to pay $1.4 billion to the federal government, several states, and the FTC. Despite the willingness to settle the lawsuit, Reckitt denied any wrongdoing. However, these settlements did not provide any amount of compensation to individuals who used Suboxone that developed dental side effects.

Suboxone Tooth Decay Drug Warning Label Update

Up until 2022, no form of the Suboxone drugs contained any warning about tooth decay or dental problems. That was until the FDA issued a buprenorphine warning in January 2022, stating Suboxone sublingual films and other buprenorphine that dissolve in the mouth have been linked to a growing number of tooth decay and serious dental issues.

At the time, the FDA indicated there had been more than 300 cases of tooth decay and dental problems reported among patients using orally dissolvable buprenorphine medications on an annual basis. The agency indicated that 131 cases were classified as serious, with many individuals reporting the dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment.

As a result of the growing number of Suboxone side effects being reported, the FDA required a new warning about the risk of dental problems to be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth.

The prescribing and patient information also included strategies to maintain or improve oral health while undergoing treatment with Suboxone and other orally dissolvable buprenorphine medications, which included prescribers referring patients to dental care services and encouraging them to have regular checkups while taking these products.

Studies Linking Suboxone and Tooth Decay

Leading up to the FDA warning label update, and afterwards, a growing number of case reports and medical studies have outline the inherent risks of oral version of dissolvable Buprenorphine drugs having direct contact with the mouth and teeth.

Suboxone Film Dental Risks Nearly 2x Greater than Other Versions

Shortly after the updated label warning was released, a research letter titled Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease was published in the medical journal JAMA in December 2022, warning health professionals of the potential risk of dental adverse events associated with long-term use of sublingual or buccal formulations of buprenorphine drugs.

The study reviewed data on 21,404 people using forms of buprenorphine and naloxone combination drugs and found that sublingual forms such as Suboxone were 2 times more likely to suffer serious dental issues such as large cavities or lost teeth.

Specifically the study found that for every 1,000 people using the under-the-tongue version, about 21.6 had dental problems. For the patch users, about 12.2 out of 1,000 had dental issues. For the pill users, around 10.9 out of 1,000 faced dental problems.

For those who suffered serious dental issues like cavities or lost teeth, researchers recorded the following rates per type of buprenorphine use;

• 8.2 out of 1,000 for under-the-tongue users
• 3.5 out of 1,000 for patch users
• 3.8 out of 1,000 for pill users

Researchers stated in the research letter;

“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.”

Case Report Warns of Suboxone Film Dental Risks

In a study published in The Primary Care Companion for CNS Disorders in October 2013, researchers looked at a small population of individuals reporting worsened dental conditions after taking buprenorphine drugs.

Researchers identified that over 90% of the participants using buprenorphine drugs had a low levels of saliva, which averaged 50% lower than the nation average. The study further raised concerns that buprenorphine/naloxone drugs are acidic, with a pH of 3.4 when dissolved in water.

The study indicated that Suboxone’s blocking of saliva production to protect the teeth compounded with the prolonged exposure to highly acidic buprenorphine drug can promote dental complications.

Suboxone Tooth Decay Lawsuit Examples

Suboxone users are now filing lawsuits against the manufacturer, raising allegation that the manufacturer knew or should have known about the increased risk of severe dental injuries associated with the drug.

Suboxone Dental Side Effects Lawsuit: Keith King filed a Suboxone dental side effects lawsuit in the U.S. District Court for the Northern District of Ohio on October 2, 2023, claiming the drug manufacturer placed it’s desire for profits before the dental health and safety of users. King, who was prescribed Suboxone for opioid addiction stemming from pain medication, claims the drug led to substantial tooth damage requiring extensive dental repairs.

Suboxone Dental Decay Lawsuit: Teresita Badalamenti filed a Suboxone dental decay lawsuit in the U.S. District Court for the District of Northern Ohio on September 26, 2023, claiming that neither she nor her doctors were warned about possible dental side effect caused by Suboxone. Badalamenti claims that her teeth began to decay after starting Suboxone, which has resulted in permanent damage to her teeth and the need for substantial dental work.

Suboxone Tooth Decay Lawsuit: David Sorensen filed a Suboxone tooth decay lawsuit in the U.S. District Court for the Northern District of Ohio on September 25, 2023, claiming he now suffers from permanent tooth decay and has needed to undergo extensive dental work as a result as a result of taking Suboxone.

The lawsuit claims Indivior, Inc. knew about the Suboxone tooth decay risks long before the FDA warning, but failed to update the prescribing information to add warnings about the risk of dental problems.

Suboxone Lawsuit FAQs

Who is the Suboxone lawsuit against?

Suboxone lawsuits are being filed against the manufacturer and its subsidiaries, which include Indivior Inc., Aquestive Therapeutics, MonoSol Rx, Inc. and Reckitt Benckiser LLC.

Is there a Suboxone class action lawsuit over tooth decay?

There has not been a Suboxone class action lawsuit filed against the manufacturer(s) for tooth decay injuries. At this time, individuals are pursuing individual Suboxone tooth decay and tooth loss lawsuits to seek compensation for the damages sustained by their dental injuries.

How much is the Suboxone lawsuit payout worth?

The settlement amount for dental damage resulting from Suboxone use would depend on various factors and could vary from case to case. Here are some key considerations:

• Severity of Damage: The more severe the dental complications, the higher the potential settlement amount could be.
• Medical Costs: The claimant could be compensated for past, current, and future dental treatments related to the damage caused by Suboxone.
• Pain and Suffering: Compensation might be included for pain, emotional distress, or reduced quality of life due to dental complications.
• Loss of Income: If the dental complications led to missed work or reduced earning potential, the claimant could be compensated for those losses.

How to Join the Suboxone Tooth Decay Lawsuit

To join the Suboxone tooth decay lawsuit, submit information about your potential claim for review by a product liability lawyer to determine whether you qualify for a Suboxone tooth decay lawsuit payout.

Drug manufacturers have a responsibility to adequately research and test drugs to ensure they are safe and free of defective designs, and to warn the public about the potential side effects.

Suboxone lawyers provide free claim evaluations and consultations. There are no fees or expenses unless a recovery is obtained in your case.