This page explores the history of Suboxone, the potential dental complications associated with it, and the Suboxone tooth decay lawsuits in 2023 that have followed. Our lawyers are seeking settlement compensation for victims who have suffered tooth decay, tooth loss, and tooth erosion from Suboxone.
What is the Suboxone lawsuit about? The core of every Suboxone lawsuit is that the defendants knew of the risk of severe tooth decay and other dental injuries. They did not convey that risk to prescribing doctors or patients because they chose profits over people.
If you have a potential Suboxone lawsuit, call us today at 800-553-8082 or contact us online for a free consultation.
Suboxone Tooth Decay Lawsuit Updates
November 27, 2023: Let’s take a deeper look at the critical points in the motion for transfer and coordination or consolidation – in layperson’s terms, create and Suboxone MDL class action lawsuit – in the Northern District of Ohio to house all current and future lawsuits related to Suboxone.
- Background on Suboxone: Suboxone film is a prescription drug used to treat opioid use disorder. It works by reducing withdrawal symptoms and opioid cravings without causing the highs and lows of opioid misuse. The drug contains buprenorphine, a synthetic opioid, which partially activates opiate receptors in the brain.
- Administration Forms and Dental Issues: Buprenorphine can be administered in various forms, including implants, injections, patches, tablets, and films. The acidic makeup of Suboxone film, in particular, has been linked to severe and permanent dental erosion and decay.
- Defendants’ Role: The defendants are responsible for developing, designing, testing, labeling, packaging, manufacturing, distributing, selling, and promoting Suboxone. The Suboxone tablet was initially approved by the FDA as an “Orphan Drug” in 2002. Its exclusivity expired in 2009.
- Transition to Film and Alleged Schemes: To avoid competition with generic versions of the tablet, the defendants developed Suboxone film, which the FDA approved in 2010. After this, the defendants allegedly schemed to increase film prescriptions and decrease tablet prescriptions, leading to antitrust violations and criminal convictions of senior executives.
- Awareness of Dental Issues: This is the key to every Suboxone lawsuit. As early as 2007, adverse event reports (AERs) and literature indicated a possible link between sublingual administration of Suboxone tablets and films and severe dental decay. Between 2007 and 2021, at least 136 adverse events related to oral health were reportedly associated with Suboxone use, indicating defendants’ awareness of the dental health issues.
The plaintiffs’ Suboxone lawyers argue that despite knowing about the potential for dental injuries from the acidic formulation of Suboxone tablets and films, the defendants did not take adequate action to prevent these issues. The motion suggests consolidating these cases would be efficient and just, as they involve similar facts and claims.
November 17, 2023: Plaintiffs’ lawyers have asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federal Suboxone lawsuits into a multidistrict litigation (MDL) for streamlined pretrial proceedings. The consolidation of these lawsuits would be a game-changer for sure. Right now, we have lawsuits spanning across multiple districts nationwide. A Suboxone class action lawsuit would efficiently manage these claims alleging the same core components.
November 1, 2023: In just the last 2 weeks, 14 new Suboxone tooth decay lawsuits have been filed against Indivior in federal courts. The Northern District of Ohio continues to be the venue with the most pending cases, but there are pending cases in over a dozen different federal districts.
October 30, 2023: In addition to the growing number of product liability lawsuits by individuals who suffered tooth decay, the maker of Suboxone is also facing a false claims act lawsuit accusing the company of defrauding the federal government. The lawsuit alleges that Indivior engaged in an illegal kick-back scheme with a company called Express Scripts, which gave them financial rewards for promoting Suboxone. Last week, a federal judge denied a motion seeking to dismiss this case and ruled that it could moved forward.
October 26, 2023: We have opened up the comments section below if you have a question or want to tell your story.
October 25, 2023: Indivior, the company that makes the drug Suboxone, has now agreed to settle a lawsuit by drug wholesalers alleging that Indivior unlawfully suppressed generic competition. Indivior will pay $385 million to resolve most of the claims which claim that the company’s dissolving film version of Suboxone was developed for the sole purpose of suppressing competition from generic Suboxone after the expiration of the original patent. Indivior has already paid $900 to settle similar claims brought by the government.
October 16, 2023: King v. Indivior, Inc, et al. 1:23-cv-01924 (N.D. Ohio) is one of the most recent Suboxone tooth loss lawsuits to get filed in federal court. The plaintiff in the case is a man from southern Ohio who was prescribed Suboxone to help treat his opioid addiction disorder. After taking the Suboxone sublingual films for just over a year, the plaintiff started to suffer severe tooth decay, which eventually resulted in the permanent loss of several teeth. The Complaint accuses the defendants of negligently failing to warn the plaintiff and his doctors about the risks of tooth decay from Suboxone.
Developed as a medication to combat opioid addiction, Suboxone emerged as a beacon of hope amid the opioid crisis. Approved by the FDA in 2002, Suboxone offered an alternative for individuals battling opioid dependence. Its primary active ingredients, buprenorphine, and naloxone, were carefully combined to mitigate misuse while easing withdrawal symptoms.
Suboxone’s development goes back to the 1960s, a time when the wonder drug buprenorphine first made its entrance. Buprenorphine, a semi-synthetic opioid, was a curious creation—it could numb pain and simultaneously block the effects of opioids like heroin and morphine.
But Buprenorphine and Suboxone are distinct medications. Suboxone is a combination drug designed specifically for managing opioid dependence, consisting of two active ingredients. Buprenorphine, on the other hand, is an opioid agonist used for addressing opioid dependence or for the management of moderate-to-severe pain.
As the 1970s dawned, researchers began poking around the potential of buprenorphine as a solution for managing opioid use disorder (OUD). They were drawn to it because it seemed to outshine other OUD medications like methadone. Why? For starters, it had a lower risk of overdose. Plus, it could be conveniently taken by dissolving under the tongue, making it seem less appealing for abuse.
Fast forward to 1995, and buprenorphine got the FDA’s approval for pain relief. In 2002, the FDA gave the nod to Suboxone, a combination medication that blended buprenorphine with naloxone, an opioid antagonist.
No Suboxone Recall But a Warning
No one is arguing that Suboxone has become an essential weapon in treating addiction in 2023. The plaintiffs’ lawyers in a Suboxone tooth decay lawsuit are not calling for a Suboxone recall. But what attorneys are saying through Suboxone lawsuits is that drugmakers must give patients a warning of all the risks associated with a drug they are selling so patients can make an informed choice, and so they can take precautions – as you can with dental injuries – to avoid the risk of the drug.
Suboxone Tooth Decay Lawsuits
The original labels for Suboxone tablets and film carried no warnings regarding the risk of tooth damage associated with their prescribed use. But Suboxone tooth decay lawsuits alleged the defendants had plenty of reason to know of the risk and put a tooth decay warning on the product.
A case report published by Harvard Medical School professors in 2012 – 11 years ago – highlighted a patient who experienced a sudden decline in oral health while using Suboxone tablets. This patient, who had been prescribed Suboxone for opioid dependence, required extensive dental treatment for decay in multiple teeth after 18 months of stable treatment. The authors suggested that chronic use of sublingual buprenorphine/naloxone may have affected the patient’s dental decline.
In 2013, the lead author of the 2012 case report and other Harvard colleagues published a case series featuring eleven patients who experienced worsening dental health after initiating buprenorphine treatment at Brigham and Women’s Hospital in Boston. These patients encountered dental caries, dental fillings, cracked teeth, crown replacements, root canals, and tooth extractions. The researchers noted that dental cavities and tooth erosion occur in environments with low pH levels.
The Ph of Suboxone
Suboxone has a low pH, with a value of 3.4 when dissolved in water. What does that mean?
The pH scale measures acidity or alkalinity, ranging from 0 to 14. A pH of 7 is neutral, while values below 7 indicate acidity and above 7 indicate alkalinity. The mouth naturally maintains a slightly acidic pH, usually between 6.2 and 7.0.
Tooth enamel, the protective outer layer of teeth, demineralizes (loses minerals) when exposed to acids. When the mouth’s pH becomes too acidic (below 5.5), it creates conditions where enamel starts to dissolve, a process called demineralization.
Acidic environments can result from acidic foods and beverages, bacterial activity, and dry mouth. Frequent exposure to acidic conditions weakens tooth enamel over time, making it more vulnerable to decay. So the makers of Suboxone did not even need these studies to be clued into the dental injuries that prolonged contact between tooth surfaces and Suboxone could beat down a patient’s teeth.
Xerostomia, commonly referred to as dry mouth, is a condition characterized by insufficient saliva production from the salivary glands. This insufficiency can result in various issues, including a decreased pH level within the oral cavity.
Saliva plays a crucial role in maintaining oral health by performing functions such as rinsing away food particles and bacteria, neutralizing oral acids, stabilizing the mouth’s pH balance, and ensuring the mouth remains moist and lubricated.
When there is a reduction in saliva production, the mouth’s pH level can decline, potentially leading to dental decay, cavities, oral infections, and even tooth loss.
Dry mouth can arise from various factors, including Soboxone use, medical conditions like diabetes, Sjögren’s syndrome, and HIV, the natural aging process, radiation therapy to the head and neck, chemotherapy, tobacco consumption, and alcohol consumption.
Suboxone in particular has the potential to induce dry mouth. When there is a shortage of saliva, the accumulation of bacteria can contribute to the development of tooth decay which will be a focus of why so many of these Soboxone users have cavities and severe tooth decay.
Still No Suboxone Warning
Yet despite the increasing evidence linking dental problems to Suboxone and the fact that the drug is acidic, the companies responsible (referred to as “Defendants”) should have taken steps to update the drug’s label. This update would have warned users about the potential risks to their dental health. An update would have avoided any suboxone class action lawsuit or personal injury claims.
But here we are. The defendants chose not to take any action. Suboxone lawsuits allege that the defendants ignored the growing body of research, adverse-event reports, and even their own knowledge about how acidic the drug is. They failed to fulfill their responsibility to address the possible harm Suboxone use could pose to patients’ dental health.
What’s even more concerning is that despite the mounting evidence connecting Suboxone to dental issues and the fact that the drug is acidic, the companies responsible for producing and promoting Suboxone (referred to as “Defendants”) should have taken steps to update the drug’s label. Such an update would have included a warning to users about the potential risks to their dental health while using Suboxone. However, surprisingly, they didn’t take any action in this regard.
And let’s face it, most recovering addicts spend a significant time without focusing on dental hygiene. This is a vulnerable population in the first place that is no always well funded for detail work that may not be covered by insurance. So we are left with people trying to rebuild their lives after battling opioid addiction who were prescribed Suboxone and believe it’s a safe and effective way to overcome addiction.
These people trusted that the drug would aid their recovery, and if there were risks associated with it, they would know about it. But the responsible for creating and promoting Suboxone didn’t inform patients about the potential risks to their dental health.
Do you need more proof that a Suboxone dental problem warning was necessary? There is a warning now. In January 2022, Suboxone added a warning about potential dental issues associated with Suboxone use. Specifically, the warning highlights that Suboxone can potentially lead to tooth decay, cavities, oral infections, and even tooth loss.
So, what does all this mean? It means that the people who were supposed to ensure your safety while using Suboxone failed to do so. They didn’t provide the necessary warnings, instructions, or information about the potential dental dangers. This negligence and lack of transparency jeopardized, for many of you reading this, your health and preventing you from making informed decisions about your treatment.
A growing number of Suboxone product liability lawsuits are being filed in courts nationwide. The lawsuit alleges that the manufacturers of Suboxone engaged in wrongful and negligent conduct in connection with the development, design, testing, labeling, packaging, promoting, advertising, marketing, distribution, and selling of Suboxone.
Specifically, the lawsuit alleges the manufacturers knew or should have known that Suboxone when used as prescribed and intended, causes harmful damage to the teeth due to the acidity of buprenorphine. Despite that knowledge, the plaintiffs in this lawsuit allege that the manufacturers initially sold and marketed Suboxone without warning about tooth decay risks.
In January 2022, the FDA issued a public drug safety communication that warned about the risks of tooth decay associated with Suboxone. Only after the FDA issued this public warning did the makers of Suboxone revise the warning label for the drug to include a warning about the risk of tooth decay. That is a classic example of negligent failure to warn, and the liability of the manufacturers appears to be clear and hard to defend.
Who Are the Defendants in the Suboxone Lawsuits?
The primary defendant in the Suboxone lawsuits is Indivor, Inc., the pharmaceutical company that makes and sells Suboxone. Indivor is a specialty pharmaceutical company that primarily focuses on developing and selling drugs, like Suboxone, which are used to treat opioid dependency. Indivor was formerly a division of the British pharmaceutical company Reckitt Benckiser (Reckitt). In 2014, however, Reckitt spun off Indivor and its rapidly expanding opioid addiction treatment business into a new, publicly traded company.
The Suboxone tooth decay lawsuits generally name Indivor, Reckitt, and their various U.S. operating entities as defendants. Primary liability for the Suboxone liabilities will ultimately fall on Indivor, a public company listed on the London Stock Exchange and well capitalized. Indivor has a checked past. In 2019, the Department of Justice indicted the company for false marketing claims and a scheme to direct patients to doctors who were likely to prescribe Suboxone.
One of the other primary defendants in the Suboxone lawsuits is Aquestive Therapeutics Inc., a pharmaceutical company based in New Jersey. Aquestive and Indivor developed Suboxone jointly.
Will There Be a Suboxone Class Action Lawsuit?
Given the number of Suboxone lawsuits our attorneys expect will be filed, we think there will be a (sort of) Suboxone class action lawsuit. We say sort of because, technically, it is not a class action but an MDL (Multi-District Litigation). An MDL class action is a legal procedure used in the federal court system to handle multiple civil cases that share common questions of fact, as we have with the Suboxone lawsuits. There are many plaintiffs with similar claims against these defendants. MDLs are not pure class action lawsuits but rather a consolidation of cases for pretrial proceedings to streamline the legal process and make it more efficient.
When numerous lawsuits with similar issues are filed in different federal courts nationwide, either party (plaintiff or defendant) can request the Judicial Panel on Multi-District Litigation to transfer the cases to a single federal district court. This court will then manage pretrial proceedings, including discovery and motions, for all the cases involved.
If this happens as our lawyers expect, Suboxone lawsuits in federal court will be grouped and assigned to a single judge for pretrial proceedings. This judge will handle common issues, such as determining the admissibility of evidence and pretrial motions, for all the Suboxone suits in the MDL.
This can be a good path for victims to get reasonable settlement amounts. What happens is a few representative Suboxone cases (known as bellwether cases) would be selected from the MDL for trial. These cases are chosen because they are considered to be representative of the broader group of cases. The outcomes of these trials – and the size of the jury payouts – can help attorneys on both sides come to the appropriate settlement compensation.
Potential Settlement Value of Suboxone Tooth Decay Lawsuits
Our lawyers currently estimate that the settlement payout value of Suboxone tooth decay lawsuits will be somewhere around $50,000 to $150,000. Keep in mind, however, that this is the settlement value of these cases. If Suboxone cases go to trial, the verdict payout could be significantly higher, including punitive damages. We think the potential value of Suboxone cases at trial could be more than $1 million.
Is this prediction premature? Absolutely. We are in the very early stages of the Suboxone tooth decay litigation, which makes it impossible to predict with any certainty what the ultimate Suboxone settlement amounts might be. If you want to call that pure speculation, that is not unfair. But if we assume these tooth decay lawsuits are successful – and it will be hard to argue that a warning was not justified, that these cases are successful and supported by adequate causation evidence, we can reasonably estimate their potential payout value.
Forty-two states announced a settlement against Indivior Inc., a global pharmaceutical company. The settlement resolves allegations of violations of state and federal antitrust laws related to market exclusivity for Suboxone, a prescription drug used in opioid addiction treatment.
The states are Alabama, Alaska, Arkansas, Colorado, District of Columbia, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin.
As part of the settlement, Indivior will pay $102.5 million to the states and is prohibited from engaging in future anticompetitive conduct. Suboxone, manufactured and marketed by Indivior, helps recovering opioid addicts manage withdrawal symptoms during treatment.
What does this have to do with dental injury lawsuits? Well, it underscores why lies within every Suboxone lawsuit: Invidior and the other defendants put profits ahead of the law and doing the right thing.
Contact Us About a Suboxone Tooth Decay Lawsuit
The national product liability lawyers at Miller & Zois are seeking and accepting new Suboxone tooth decay lawsuits in all 50 states. If you took Suboxone and subsequently suffered tooth decay, you may be eligible to file a case. Call us today at 800-553-8082 or contact us online for a free consultation.