Suboxone Lawsuit Filed Over Tooth Decay, Damage Caused by Opioid Addiction Drug
Suboxone, a medication used to treat opioid addiction, has been linked to severe tooth decay. Lawsuits filed by those who have used the medication allege that the manufacturers did not adequately warn patients or healthcare professionals about the medication’s risks.
Have you used Suboxone and struggled with tooth decay? Wallace Miller may be able to represent you. Call our office at 312-261-6193 to speak to a member of our legal team, or fill out our online questionnaire for a case assessment in minutes.
If you are struggling with opioid addiction, you are not alone. The Substance Abuse and Mental Health Services Administration’s National Helpline is available 24/7, 365 days a year, and provides services in English and Spanish. Call the helpline at 1-800-662-HELP (4357).
Photograph by Jr de Barbosa, CC BY-SA 3.0, via Wikimedia Commons.
March 2024 Update
We are proud to share that Wallace Miller attorney Jessica Wieczorkiewicz has been appointed to a leadership position as a member of the Plaintiffs’ Steering Committee in the Suboxone MDL. The attorneys chosen for the leadership committee play a crucial role throughout the litigation, from gathering evidence and working up the liability story to representing clients in the courtroom. A leadership appointment is a strong endorsement of an attorney’s experience, skill, and dedication to the litigation, and our firm has time and time again been appointed to leadership positions in numerous cases.
Throughout the lawsuit process, Leadership Counsel manages and administrates plaintiffs’ affairs and acts on behalf of the plaintiffs’ best interests. Over the next several months, they will continue to take the lead in gathering evidence, assembling witnesses, and working with experts regarding the science of the case. Following this discovery process, as in many MDLs, the parties will likely establish a bellwether protocol so certain “test” cases can be tried.
February 2024 Update
February 7, 2024 — Judge J. Philip Calabrese, who is overseeing the consolidated MDL in the Northern District of Ohio, has entered the first Case Management Order, scheduling an initial status conference for March 7, 2024, in Cleveland, Ohio.
Initial status conferences allow plaintiffs’ and defendants’ counsel to preview the case theories for the court and outline plans to move the litigation forward. Topics for discussion may include whether categories of cases raise different common issues of law or fact, the anticipated volume of cases to be filed, how discovery should be managed, and jurisdictional considerations.
Before the conference, plaintiffs’ and defendants’ attorneys will file a joint memorandum addressing these matters. Plaintiffs’ counsel will also file an additional memorandum proposing a leadership structure, leadership responsibilities and authority, and a potential common benefit fund.
Many attorneys participate in the case management conference by phone, while counsel seeking leadership positions in this MDL will attend in person.
February 2, 2024 — The Judicial Panel on Multidistrict Litigation (JPML), which determines whether multiple civil actions should be transferred to a single court under the multidistrict litigation (MDL) system, has officially consolidated the existing Suboxone film product liability lawsuits in the Northern District of Ohio. The consolidation was proposed by plaintiffs in December 2023 to address common questions across the lawsuits and ensure legal rulings are consistent. Judge J. Philip Calabrese will oversee the cases that have already been brought against the manufacturers of Suboxone as well as any additional cases filed in this MDL in the future.
December 2023 Update
In November, plaintiffs in the Suboxone litigation filed a motion to consolidate their cases in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio. The defendants filed their response to the motion on December 13 and agreed to transfer the relevant Suboxone cases to the district in front of Judge J. Philip Calabrese. While this means that this district is likely to be selected, the official move still depends on a transfer order from the Judicial Panel on Multidistrict Litigation.
Consolidation, or grouping multiple individual cases into one pretrial process, is common in situations like these. It helps to avoid duplicate work across many different litigations, prevent inconsistent court rulings, and preserve court resources. While the individual medical histories and circumstances of the plaintiffs vary, the allegations of wrongful conduct by the defendants and injuries caused by their product are similar. This allows for general liability discovery, or gathering information that applies to all cases on behalf of all plaintiffs.
The U.S. District Court for the Northern District of Ohio was proposed by plaintiffs and agreed to by defendants due to its central location, the multiple Suboxone cases already filed in the district, and Judge Calabrese’s background and experience. The multidistrict litigation will apply both to Suboxone lawsuits already filed and to “tag-along cases,” or cases filed in the future that deal with similar facts and claims.
Since the first lawsuit was brought in the Northern District of Ohio in September 2023, more than 15 Suboxone cases have been filed. Many more are expected to join the multidistrict litigation in the months ahead.
This content was reviewed by Jessica Wieczorkiewicz.
Suboxone: The basics
Suboxone is a prescription drug that is used to aid in the treatment of opioid use disorder. It is available as a film that can be placed sublingually (under the tongue) or buccally (between the cheek and the gums). The film contains a combination of naloxone, also known as Narcan, and buprenorphine, which are absorbed through the mouth. The mixture is designed to be acidic in order to maximize the absorption of buprenorphine and minimize the absorption of naloxone.
Buprenorphine is a synthetic opioid developed in the 1960s and first marketed in the U.S. in 1985. A schedule III narcotic analgesic, it is prescribed to treat pain and opioid use disorder. Buprenorphine can be administered in a variety of ways, including via tablets, films, implant, and injection. While there are other medications that fill a similar function, buprenorphine is the first of its kind that can be prescribed and dispensed in physician offices, rather than only in specific opioid treatment clinics. This makes it far more accessible to those who need it.
Naloxone is an opioid antagonist, which means that it can bind to the same receptors as opioids, blocking or reversing their effects. Administration of naloxone has been shown to reverse opioid overdose, and many medical and governmental organizations provide naloxone kits to civilians for use in emergencies (if you live in Illinois, this website can help you find a naloxone distribution center near you).
The opioid epidemic and the pharmaceutical industry
Opioids are a class of drugs made from the opium poppy plant or synthesized in a laboratory. Common opioids include oxycodone, hydrocodone, morphine, codeine, and fentanyl. Most commonly used to treat pain, they are highly addictive and widely misused.
The opioid epidemic began in the 1990s, when pharmaceutical companies including Purdue Pharma, the manufacturers of OxyContin, reassured doctors and medical providers that opioids did not pose a risk of addiction or dependence. In fact, these medications have been shown to be highly addictive, and as rates of prescription increased, so did rates of misuse.
Since 1999, nearly 800,000 people have died of drug overdose in the U.S. alone, and in 2020, almost 75 percent of all drug overdose deaths involved an opioid. It is estimated that more than 2.5 million Americans suffer from an opioid use disorder. In 2017, the opioid epidemic was declared a public health emergency by the U.S. Department of Health and Human Services.
A Naloxone kit used for reversing overdoses. Photograph by New Brunswick, public domain.
How do opioids affect the brain?
Opioids attach to and activate mu receptors—a class of receptors that help modulate physiological functions including stress, mood, and memory—in the brain, spinal cord, and other organs. By acting on these receptors, they block pain signals and release large amounts of dopamine, a brain chemical associated with pleasurable experiences and motivation. By altering the user’s brain chemistry, opioids strongly reinforce the act of taking the drug. Long-term use of opioids has been shown to change the frontal region of the brain and can lead to issues with memory, attention, and self-control.
Over time and use, the body comes to depend on these chemicals, and going without opioids results in withdrawal. Opioid withdrawal can be not only extremely unpleasant but potentially life-threatening. Its symptoms include muscle pain, diarrhea, nausea and vomiting, insomnia, rapid heart rate and breathing, and nervous system dysfunction. If severe and untreated, these symptoms can result in dehydration, high levels of blood sodium, and even heart failure.
Understanding opioid addiction treatment
Treatment for and recovery from opioid addiction is a difficult and complex process. Medications including buprenorphine and methadone can aid in recovery through a “whole patient” approach called Medication Assisted Treatment (MAT).
Safe, reliable medications that treat opioid dependence are a crucial component of treatment plans for many individuals. These medications don’t cause a high, but rather help manage withdrawal symptoms and repair brain circuits impacted by the addiction by only partially activating the mu receptors. This helps to reduce cravings and withdrawal symptoms.
The use of medications including buprenorphine has been proven to decrease opioid use, opioid overdose deaths, criminal activity, and disease transmission while increasing retention in treatment and overall social functioning.
There is an enormous amount of stigma around opioid addiction and the use of medications to help manage it. The bottom line, however, is that addiction is a disease and the current prevalence of opioid addiction is directly related to the actions of a handful of wealthy corporations. People suffering from opioid dependence deserve reliable resources to treat it.
Image by the National Institute on Drug Abuse.
How does Suboxone treat opioid addiction?
The combination of buprenorphine and naloxone in Suboxone helps treat opioid addiction by:
- Reducing withdrawal symptoms.
- Reducing the desire to use opioids.
- Blocking the effects of other opioids.
- Preventing the cycle of highs and lows of opioid misuse.
Suboxone and similar medications remain important components of MAT and opioid dependency treatment in general. As with any medication, the manufacturers have a responsibility to their consumers to warn them of any potential risks.
The opioid addiction industry
Medical treatment for opioid dependency is a crucial component of recovery. However, the same pharmaceutical companies that created the opioid crisis have used it as another opportunity to make money in what defendant Reckitt Benckiser called the “opioid dependence marketplace.”
These companies have prevented the widespread use of cheaper generic drugs and, in some cases, put drugs with dangerous side effects on the market without warning consumers. Those recovering from opioid addiction deserve safe, reliable treatment options. Instead, the pharmaceutical industry—which created the opioid public health emergency in the first place—once again let them down.
Quashing the competition
Suboxone proved to be a significant money-maker for its manufacturers. As a result, these companies used a strategy called “product hopping” to create a monopoly on the opioid treatment drug and avoid generic competition.
Under the U.S. healthcare system, new brand drugs may be shielded from competition from generic versions of those same drugs for a set period of time, to help their manufacturers recoup research and development costs. After that period expires, generic versions are allowed to enter the market, causing drug prices to drop and saving money for patients and the healthcare system.
Focused on profits, pharmaceutical companies have a vested interest in extending the time in which they are protected from competition for as long as possible through patent strategies, litigation, regulatory maneuvering, and other tactics.
In product hopping, the company shifts the drug from one form to another without meaningfully altering the drug’s composition. The alternate form of the drug will have longer monopoly rights as a “new” drug, and there will be no time for the generic version of the first form to hit the market. Companies may even pull the first form of the drug from the market entirely or pressure physicians to prescribe the new version. Product hopping costs patients and the healthcare system billions of dollars a year.
Image by Pixabay.
In 2009, the tablet form of Suboxone was making more than $700 million in U.S. sales. However, the drug’s exclusivity was set to expire, which would lead to drops in prices as generic versions entered the market. In order to prevent loss of profits, the manufacturers introduced an oral film version of Suboxone. There was no meaningful difference in the efficacy of the drug or even its administration, as both dissolved orally. The patent claim for the Suboxone film acknowledged that the new version was “essentially matching that of currently [] marketed tablets containing the same active.”
After patenting the film, Suboxone’s manufacturers pressured physicians to prescribe it, pushed false claims that the tablet form posed greater risk of accidental pediatric exposure, increased the tablet’s price, and finally announced the removal of the tablet form altogether.
The manufacturers were subsequently sued by the Department of Justice, the Federal Trade Commission, and a number of state attorneys general. In 2019, defendant Reckitt Benckiser agreed to a settlement to resolve the accusations of anticompetitive behavior. However, estimates hold that Suboxone’s product hop costs the healthcare system more than $403 million annually.
Tooth decay caused by Suboxone
Since its introduction, Suboxone use has been linked to permanent tooth decay. Individuals using the medication have reported dental problems including cavities, tooth loss, dental decay, tooth fracture, and oral infections.
In many cases, those who suffered tooth decay as a result of Suboxone use needed substantial, expensive dental work. This kind of procedure is generally not covered by Medicaid, saddling those who need treatment with expensive bills.
While opioid use can be associated with tooth damage, dental problems as a result of Suboxone use have been reported even in patients with no history of dental issues. Despite documentation of these issues over decades, no warning was included on Suboxone’s label until the FDA mandated it in 2022.
Acidity of buprenorphine medications
Patients using Suboxone are directed to place the film in their mouth three times a day. The film takes about nine minutes to dissolve, and the patients are instructed to hold the film and saliva in their mouth for the duration to maximize absorption.
Because Suboxone is highly acidic, the repeated exposure causes decay and damage to the teeth. The former medical director of Indivior, one of the defendants, established that Suboxone’s pH was 3.4 when dissolved in water. The pH scale measures how acidic or basic a substance is: 0 is very acidic, 7 is neutral, and 14 is very basic. Suboxone’s pH of 3.4 is close to that of vinegar; for reference, the pH of normal saliva is about 6.
Research and investigation: What’s really happening with Suboxone films?
The first official report on the link between Suboxone and tooth decay was published more than ten years ago. In 2012, Harvard Medical School professors affiliated with Boston’s Brigham and Women’s Hospital collaborated on a case report of a patient suffering from sudden oral health decline while using Suboxone tablets.
A year later, the lead author of the Harvard report and colleagues published a case series of 11 patients using Suboxone. The patients reported dental caries, fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The report urged further research with larger sample sizes, but Suboxone continued to be prescribed without a warning.
Finally, in 2022, the Journal of the American Medical Association published a research letter detailing the findings of a pharmacoepidemiologic study. The study, which included tens of thousands of patients taking Suboxone from 2006 to 2020, found “an increase in the risk of adverse dental outcomes associated with sublingual buprenorphine/naloxone compared with transdermal buprenorphine or oral naltrexone.” The incidence of tooth decay for those using Suboxone films specifically was more than twice as high than in those who used Suboxone patches or tablets.
Image by Pixabay.
Reports sent to the FDA
The reports on Suboxone’s harmful effects were not limited to academic studies. By 2022, more than 300 adverse events related to tooth decay and pain had been reported to the official database of the Food and Drug Administration (FDA), 40 percent of which were classified as serious under FDA criteria.
Many of these reports were sent in by medical professionals and sometimes involved most or all of a patient’s teeth. Procedures including tooth extraction, removal, root canal, and surgery were often required.
In some circumstances, even one adverse event report may qualify as a call for further research. However, the defendants made no moves to change the label until forced to do so by the FDA.
FDA warnings issued
In 2022, the FDA issued a Drug Safety Communication based on the adverse event reports. The communication alerted patients and health providers to the dental risks of Suboxone and required a warning of dental problems be added to the prescribing information and patient medication guide for all mouth-dissolved buprenorphine medicines. The warning was officially added to the prescribing information in June of 2022.
The FDA notes that the benefits of Suboxone clearly outweigh the risks. However, drug manufacturers have a duty to their consumers to warn them about all potential side effects, a duty that the defendants in the Suboxone tooth decay lawsuit neglected.
Who are the defendants?
The Suboxone tooth decay lawsuit involves a number of defendants, all of whom are involved in some aspect of manufacturing, developing, researching, designing, testing, licensing, marketing, distributing, and selling Suboxone film. These pharmaceutical companies include:
- Indivior, Inc, Indivior PLC, and Indivior Solutions, Inc.
- Aquestive Therapeutics, Inc.
- MonoSol Rx, Inc.
- Reckitt Benckiser LLC and Reckitt Benckiser Healthcare (UK) Ltd.
Suboxone lawsuits aim to hold defendants responsible
The plaintiffs in the Suboxone tooth decay lawsuit allege that the defendants failed to warn patients, prescribers, and the medical community about the link between Suboxone film and dental decay. Physicians who prescribed Suboxone were not warned about the risk and recommended the medication to their patients under the assumption that it was safe to use.
In addition, plaintiffs claim that the defendants failed to update the label when information came to light about the connection between Suboxone and tooth decay. The defendants had a duty to protect consumers, make sure their product had adequate warnings, and monitor the safety of their product. Instead, they withheld and misrepresented information on Suboxone and did not add a warning until forced to do so by the FDA. They claimed that Suboxone was safe and effective but failed to adequately test its safety and effectiveness. This amounts to reckless disregard for the safety and welfare of people exposed to Suboxone.
Wallace Miller is committed to fighting for the rights of those who have been harmed by the negligence of pharmaceutical corporations. If you have used Suboxone and believe you may have suffered tooth decay as a result, contact our office at 312-261-6193 or via our online questionnaire for a confidential and free consultation with our legal team.
Frequently asked questions
Am I eligible for a Suboxone lawsuit?
You may be eligible for the Suboxone tooth decay litigation if you:
- Have been prescribed the dissolvable film form of Suboxone for pain management or opioid addiction;
- Used Suboxone with a prescription for at least six months prior to dental issues;
- Suffered from dental injuries including cavities, tooth loss, tooth fractures, tooth decay, tongue injury, and/or gum injury; and
- Received some dental care before starting Suboxone.
Everyone’s injuries and medical history are different, and so is every potential case. Call our office at 312-261-6193 to discuss your circumstances and receive a free, confidential consultation, or fill out our online questionnaire for an assessment in minutes.
How much will my Suboxone lawsuit cost me?
There is no fee to file a Suboxone lawsuit with Wallace Miller unless we win your case. Our firm relies entirely on the settlement amounts of successful cases to pay our operation fees, so there are no out-of-pocket costs for our clients.
Photograph by Wallace Miller.
How much can I recover from a Suboxone tooth decay lawsuit?
In any litigation, there is no guarantee of a settlement or jury verdict in your favor. As the Suboxone trial process continues, plaintiff and defense counsel will evaluate a number of factors to assess the strengths and weaknesses of the case. Bellwether trials will test the merits of the cases in front of the jury and provide guidance on valuing potential settlements. From there, factors specific to the individual plaintiff’s case such as medical history, severity of tooth decay, and related conditions may influence the potential settlement or verdict.
Our lawyers are committed to fighting for the best possible outcome for all plaintiffs involved. We will work with you throughout the process to keep you informed about updates on your Suboxone case, including the likelihood of a settlement and your potential award amount.
What kind of compensation can I receive?
Compensation in cases like these can help cover bills associated with the injury and discourage future wrongdoing. Types of compensation that plaintiffs in the Suboxone tooth decay lawsuits may be eligible to receive include:
- Medical expenses (both in regards to purchasing Suboxone and treatment as a result of its use)
- Pain and suffering
- Mental anguish
- Physical impairment
- Loss of enjoyment of life
- Punitive damages
Should I stop using Suboxone?
Do not stop using Suboxone or any other opioid addiction treatment without talking to your doctor. Suddenly ceasing use of Suboxone or other buprenorphine medications can lead to withdrawal or opioid relapse.
While Suboxone use has been linked to tooth decay, medical professionals may still advise that the benefits of the medication may be acceptable to certain patients, depending on their circumstances. In the end, the patient must be given the information to make an informed choice on whether they are willing to accept the medication’s risks.
Before considering any change in medication, speak with your doctor about the dangers of using Suboxone, ways to mitigate harm to your teeth, and potential medication alternatives.
Resources are available for those struggling with drug dependence. The Substance Abuse and Mental Health Services Administration’s National Helpline is available 24/7, 365 days a year, and provides services in English and Spanish. Call the helpline at 1-800-662-HELP (4357).
What can I do to prevent tooth decay from Suboxone?
The FDA has advised that patients using Suboxone should take a few precautions to help protect their teeth:
- After the medication has completely dissolved, swish a large sip of water around your teeth and gums and swallow.
- Wait at least an hour after using Suboxone before brushing your teeth. This gives your mouth a chance to return to normal before abrasive brushing.
- If you are able to do so, schedule a dentist visit and inform your dentist that you are taking Suboxone so that you can develop a plan together to prevent tooth decay.
Continue to work with your doctor and dentist to monitor tooth health and develop a prevention plan. It is vital that any change in treatment is carefully considered with a doctor.
Left to right: Nicholas P. Kelly, Edward A. Wallace, Molly Condon Wells, Mark R. Miller, Jessica Wieczorkiewicz, Timothy E. Jackson.
Meet Wallace Miller: Committed to fighting for your rights
Wallace Miller is proud to fight for the rights of those who have been harmed by dangerous opioid treatment drugs. Our law firm is focused on protecting the victims of negligence and fraud through consumer protection, product liability, employment, environmental and toxic harm, and personal injury litigation.
What sets Wallace Miller apart from other firms is our commitment to our clients, our ability to handle complex high-stakes litigation, and our outstanding track record of success. We only take on cases that our firm has faith in—those that can make a difference in our clients’ lives.
If you have questions about your potential Suboxone tooth decay case, reach out to Wallace Miller at 312-467-7362 or fill out our online questionnaire.