Suboxone Tooth Decay Lawsuit

This page explores Suboxone, its associated dental complications, and the subsequent Suboxone tooth decay lawsuits in 2023-2024. 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 lawsuit is about what Suboxone does to your teeth. 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.

In 2024, our firm is reviewing new Suboxone suits in these states:

Arkansas	Connecticut	Florida*	Maryland
Massachusetts	Mississippi	Missouri	Montana
Nebraska	New Hampshire	Maine	New Mexico
New York	North Carolina	North Dakota	Rhode Island
South Carolina	South Dakota	Vermont	Virginia
Washington	Washington D.C.	Wisconsin	Wyoming

*Recently added – and we also need to add Michigan as well.

We explain why our Suboxone lawyers are focused on these jurisdictions below.

It is easy to join the Suboxone lawsuit. If you have a potential claim for tooth injury and would like to sign up to bring a claim, please call us today at 800-553-8082 or contact us online for a free consultation.

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Suboxone Tooth Decay Lawsuit Updates

April 26, 2024: A new Suboxone tooth decay lawsuit was filed yesterday.  A Prince George’s County, Maryland man was prescribed this drug for opioid addiction.  He ultimately developed severe tooth decay and seeks compensation for the harm that was caused to him.

His lawsuit focuses on the failure of Indivior to provide the readily available information on the risk tooth decay to him or his doctors, the core allegation that runs through every Suboxone suit in this class action.

April 19, 2024: Indivior is making noise that it believes this is the rare MDL in which the focus should be on general causation before we get to specific causation.

In the Suboxone tooth decay litigation, general causation involves proving that Suboxone can cause dental issues, such as tooth decay. This requires plaintiffs to gather scientific evidence and expert testimony to establish that Suboxone has the inherent potential to harm dental health.

Specific causation pertains to demonstrating that Suboxone directly caused dental problems in the specific plaintiff involved in the litigation. This requires personalized evidence, such as the plaintiff’s dental records and expert assessments of their particular dental condition, linking the individual’s tooth decay directly to their use of Suboxone.

Let’s be honest about one thing: in some of these cases, specific causation will be a challenge.  But proving general causation will be a walk in the park.  Suboxone, in its film form, is highly acidic and causes devastating dental harm with extended use. We all know this. Reports of serious dental problems associated with the use of Suboxone oral films began appearing in medical literature as early as 2012. These dental problems, including tooth decay, cavities, oral infections, and loss of teeth, are reported even in patients with no history of dental issues. As a result, the product now warns of this exact problem.

Yet Indivior says we should focus now on general causation because this is a special case where we do not know if Suboxone causes dental decay.  This notion is utterly insane. This is one of the more ridiculous arguments in mass tort history.

April 18, 2024: A Georgia woman filed a Suboxone lawsuit last week after suffering significant dental damage, including tooth decay, the need for multiple tooth extractions, and ongoing dental issues, as a direct consequence of using prescription Suboxone film. The medication was prescribed in 2016 to treat opioid use disorder stemming from an initial ACL injury and subsequent arthritis.

The crux of this case, like every Suboxone tooth decay lawsuit, is the failure to warn.  Despite continuous use of the medication from 2016 to 2021, neither the patient nor their physicians were informed of the risk of dental erosion and decay linked to the Suboxone film. As a result of these unanticipated side effects,  this woman now faces the necessity of further dental treatments, including root canals or additional extractions and potentially dentures, and is seeking damages for these injuries.

April 4, 2024: MonoSol, one defendant named in some Suboxone claims, was dismissed from the litigation today. MonoSol, who also got tangled up and dismissed from the antitrust claims involving Suboxone and product hopping, has no part in this litigation. Drilling down on the issues and defendants that matter is progress in the litigation.

April 1, 2024: As of April 1, 2024, the new Suboxone class action MDL has 44 pending cases. When it was created in February, it had 15 cases. This means that 30 new cases have been added in the first six weeks of the MDL.

March 28, 2024: We talked on Wednesday about raising the bar in terms of the severity of injury. Our law firm is now doing that.  We require three or more extractions or similar injuries for all new cases.

March 27, 2024:  The MDL judge issued a Case Management Order (CMO No. 3) today for the Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation MDL.  This order, agreed upon by all parties involved, outlines the process for directly filing and serving lawsuits related to Suboxone film within this multidistrict litigation (MDL).

The scope of this order includes cases transferred to the court by the Judicial Panel on Multidistrict Litigation, any related actions transferred or filed later, and cases initially filed in or moved to this court. It specifies that using the direct filing and service procedures does not waive any legal defenses that defendants may have.

Key points from the order include:

• Plaintiffs can file their Suboxone-related lawsuits directly in the Northern District of Ohio to be included in the MDL, aiming to streamline the process and improve efficiency.
• There’s no obligation for a lawsuit to be filed directly into the MDL, although there is no reason not to file directly.
• Attorneys from anywhere in the U.S. can represent clients in this litigation without needing to file a motion or pay a fee for appearing pro hac vice in federal court in Ohio.
• All complaints filed must include specific information and comply with designated formatting, including stating the chosen venue for the lawsuit—where the suit would have been filed if there had not been an MDL.
• The order facilitates easier service of process on defendants, with most agreeing to waive formal service requirements, streamlining the initiation of these cases.

March 26, 2024: The one question no one has really addressed is how severe the dental injuries need to be to support a claim.

First, let’s be clear. Anyone with an injury has the right to bring a claim. So what I’m really talking about is how serious does the injury need be for you to get a lawyer who will take your case… and not eventually drop you because your injuries are not severe enough.

This question is the natural evolution of mass tort litigation where the injuries vary in severity. At first, lawyers get excited. They want cases – as many as they can grab. Then practical reality sets it.  It takes work to get these files ready to go and the juice is not worth the squeeze on smaller injury lawsuits.

So Suboxone lawyers are now tightening their criteria.  Where the criteria ultimately settles will still vary from lawyer to lawyer.  But for our group, there needs to be at least one tooth extraction or comparable injury.  Just tooth decay or a root canal is not enough. That bar could get raised to two or three extractions or comparable injuries before all is said and done.

Yes, we want people to call and hire our lawyers. But we also want to make sure we are giving you real information here without the fluff. If you have opinions or questions – or hear with others have to say – you can always got the comments below this page.

March 19, 2o24: The MDL judge issued CMO #3 which lays out some of the ground rules for the MDL.  The most notable is that plaintiffs’ lawyers can now file a Suboxone lawsuit directly into the MDL.

In an MDL, direct filing enables plaintiffs to submit their cases straight into the central MDL court, eliminating the hassle of filing in your local federal district court and then wait for the case to be transferred.

March 12, 2024: Defendants filed their corporate disclosures in the MDL yesterday.  These are basic disclosures made as required by Federal Rule of Civil Procedure 7.1 and applicable local rules, such as Local Civil Rule 3.13(b) in this context.

These are relatively meaningless but it is good to see the litigation ball rolling.

March 7, 2004: Today was the Suboxone lawsuit initial status conference. Leadership counsel was appointed, and discussions on organization, procedures, and initial discovery were held.

The court reviewed the parties’ stances on the Plaintiffs’ subject matter jurisdiction and the personal jurisdiction over three international defendants.  This is not a critical issue in the litigation but one that needs to be address.

The next status conference is scheduled for April 16, 2024, at 2:00 p.m. The MDL judge also asked for agenda for this meeting by April 11, 2024.

March 6, 2024: Can you direct file a Suboxone tooth decay lawsuit in the MDL-3092?  Not yet. But the details to allow direct filing should be worked out shortly.

March 5, 2024: As of today, there are 51 total cases pending in the newly formed Suboxone tooth decay MDL. We are expecting this to be a fast-growing MDL so look for this number to increase substantially over the next few months.  I don’t think 100,000 lawsuits is out of the question.

February 28, 2024: In a new Suboxone lawsuit filed in the MDL, the plaintiff, an Ohio man, was prescribed and used Suboxone as directed by his healthcare provider. Despite adhering to the prescribed usage, he encountered significant dental damage attributed directly to the medication.

Throughout the relevant period, neither he nor his medical advisors were alerted to or aware of the grave risk of dental erosion and decay associated with Suboxone, specifically the absence of warnings about its potential to inflict permanent tooth damage. Consequently, he has suffered from irreversible dental harm and has had to undergo extensive dental treatments to mitigate the damage caused by Suboxone.

One key to these cases when tried individually is what the prescribing doctor will say about whether they knew of the risks when prescribing the drug.  The strongest Suboxone lawsuit will be cases where the prescribing physician says they were unaware of the risks of dental injuries with the drug.

February 23, 2024: the U.S. District Judge overseeing these cases has set a deadline of March 1 for attorneys representing plaintiffs to submit applications for leadership roles. These positions are intended to coordinate legal actions and strategies that will advantage all parties seeking compensation for dental erosion and tooth decay as a result of Suboxone use.

February 19, 2024: A resident of Mt. Sterling, Kentucky, has brought forward a new lawsuit after suffering significant dental damage, which they attribute to Suboxone film. The man was prescribed Suboxone in 2011 by a physician and was never warned of the the drug’s potential for causing tooth decay until late 2023.

The plaintiff, now facing permanent tooth damage and the aftermath of extensive dental work, argues that this negligence has directly resulted in substantial physical and emotional distress.

February 14, 2024:  There is a lot of confusion about the deadline to file Suboxone lawsuit for dental issues.  There is confusion because… it is confusing.  Statutes of limitations in product liability claims are complicated, and you often do not know the deadline to apply to a particular case until a judge rules.

This confusion is compounded by an antitrust Suboxone lawsuit unrelated to the dental injury litigation.  The deadline for this is February 17, 2024.  So our law firm is getting frantic calls that they need to file their case before the deadline.

If you have a possible dental injury case, you want to call a lawyer. Right now. Some people have likely already lost their rights to file a claim. We are only taking new Suboxone claims in 27 states now because of our interpretation – that could be wrong – about how a court will rule in most cases in states with a shorter statute of limitations.  (The statute we are taking cases in are listed below.)

Do not leave it to hope and chance. Contact a lawyer today.  I would rather it be us. But it is more important that you contact someone who can help you.

February 5, 2024: Let’s dig a little deeper into the MDL Panel ruling creating MDL-3092, a new Suboxone class action lawsuit.

I keep saying class action lawsuit because that is what people call it. But we’re actually dealing with a Multidistrict Litigation (MDL), which consolidates individual lawsuits from across the country into one court, allowing for streamlined pretrial processes without merging the cases into a single claim.

Unlike a class action, where plaintiffs are treated as a single entity, an MDL respects each plaintiff’s case as distinct, potentially leading to different outcomes for each party based on their specific circumstances. This distinction is crucial because, in an MDL, each claimant can receive a personalized resolution, whereas, in a class action, all members of the class are bound by a single verdict or settlement.

February 4, 2024: On Friday, the Judicial Panel on Multidistrict Litigation created an MDL Suboxone class action lawsuit, consolidating all federal lawsuits alleging that the manufacturers of Suboxone film did not adequately inform consumers that the medication for opioid use disorder includes components that could lead to dental decay.

The Panels moved the 15 Suboxone lawsuits, originally spread across five judicial districts, to the U.S. District Court in the Northern District of Ohio. Judge J. Philip Calabrese has been assigned to manage these proceedings.

The MDL is In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, case number 1:24-md-03092.

January 30, 2024:  The statute of limitations is potentially problematic for some in the Suboxone litigation. So if you cannot get a lawyer on the phone, it could be because you are in a state where the two-year statute of limitations gives lawyers cause for concern.

I used a lawyered-up word like cause for concern because the deadline to file is often not simple in mass tort lawsuits. For just one example, if your injuries showed up more recently, that may be a way around the statute of limitations.

Still, most Suboxone lawyers – including us are now only taking cases in these jurisdictions because of “concerns” about the statute of limitations. These are the states in which we are taking new cases: 

Texas	Florida	New York	North Carolina
Connecticut	New Jersey	Virginia	Washington
Massachusetts	Missouri	Maryland	Wisconsin
South Carolina	Connecticut	Utah	Arkansas
Mississippi	New Mexico	Nebraska	New Hampshire
Maine	Montana	Rhode Island	South Dakota
North Dakota	Washington D.C.	Vermont	Wyoming

In the last few weeks, our Suboxone attorneys have received many calls from Ohio, Kentucky, and California. Unfortunately, if your Suboxone use was in those states or any state not on this list, our lawyers are not taking your case. (We are also not taking Suboxone cases in Michigan, which is on the list, for other reasons.)

If you live in one of these states, the time to file a Suboxone lawsuit is running out. Contact us today.

January 26, 2024: Yesterday was the Suboxone hearing to determine whether to make this litigation an MDL class action lawsuit. The court should rule early next month. The prediction here is that the MDL Panel will consolidate all Suboxone lawsuits in federal court in Ohio.

January 24, 2024: We have opened the comments section below for you to ask questions, share your story, or hear others’ experiences on Suboxone.

January 22, 2024: A new Suboxone case was filed this week that will highlight the challenges of bringing Suboxone lawsuits that may be after the statute of limitations has passed.

The plaintiff in this case is a resident and citizen of Kentucky, residing in Mt. Sterling within Montgomery County. The plaintiff experienced tooth damage directly linked to the use of prescription Suboxone film by the defendants. In 2011, a physician prescribed Suboxone film to treat the plaintiff’s opioid use disorder. However, the plaintiff says he only discovered in the last few months of 2023 that the film had caused tooth decay.

That last allegation will be essential. Arguably, Kentucky’s draconian one-year statute of limitations has passed. But there is a way around it: the discovery rule. The plaintiff is saying he did not learn of his injuries until 2023 and filed his Suboxone tooth decay lawsuit within a year of the manifestation of his injury.

January 9, 2024: We give brutally honest answers to your Suboxone lawsuit questions.

January 8, 2024: As this litigation proceeds and we learn more about the mess that Indivior has made with Suboxone, our lawyers are amazed at the breadth and scope of litigation involving this drug. Indivior recently announced a legal victory as the High Court of Justice in England and Wales dismissed representative claims filed by a pension fund. The claim, filed in September 2022, accused Indivior of FSMA violations through misleading statements about an alleged fraudulent scheme involving its Suboxone products. A similar accusation was directed at Reckitt Benckiser.

I don’t fully understand how the British mass tort system works. But plaintiffs had also sought a representative proceedings approach. This method would have allowed a representative to pursue legal action on behalf of unnamed claimants without the need to demonstrate damages for each, a departure from standard multi-party proceedings that require evidence of both liability and damages. So apparently individual Suboxone lawsuits can proceed but not as a class action as they had hoped.

January 6, 2024: The big date on the horizon in this litigation is January 25, 2024. A team of federal judges on the JPML in California will deliberate on potentially unifying all federal court Suboxone teeth lawsuits related to tooth decay into a single MDL class action lawsuit. Suboxone lawyers know what will happen. The judges will agree to house these cases in federal court in Ohio. But that event will kickstart the litigation, which will hopefully be a big step towards a global settlement payout for victims who have bad teeth from Suboxone.

January 4, 2024: The last Suboxone lawsuit filed is one of our cases on behalf of a young woman who became addicted to opioids like so many Americans have. She was prescribed Suboxone film to treat her addiction and the chronic pain that caused the addiction in the first place.

Plaintiff and her physicians were not warned of the significant risks of dental erosion, tooth loss, oral pain, infections, and decay associated with using Suboxone film. Of course, there was a lack of information or warning that Suboxone film could cause permanent damage to teeth and gums.

As a result of using Suboxone film as prescribed, this woman has since experienced permanent tooth damage and has undergone extensive dental work to address the harm caused by the drug. Understandably, she is seeking compensation for the damages incurred due to these injuries and her pain and suffering.

January 1, 2024: A Cuyahoga County, Ohio woman filed a Suboxone lawsuit after damage to her teeth she says was directly caused by prescription Suboxone film.

Initially, the plaintiff became addicted to opioids prescribed by a physician for pain management. Subsequently, the plaintiff was prescribed Suboxone film by a physician to address opioid use disorder. During the relevant periods, neither the plaintiff nor their physicians were warned or aware of the significant risk of dental erosion and decay posed by the Suboxone film. There was no indication or warning about the potential for permanent tooth damage caused by the medication.

As a consequence of using Suboxone film as prescribed, the plaintiff alleges sustained permanent tooth damage. She has undergone extensive dental work to rectify the damage inflicted by the Suboxone film.

The plaintiff attributes these injuries to the Defendants’ actions and inactions and seeks damages for the harm suffered due to their prescription of Suboxone film.

December 22, 2023:  In a car accident case, it is easy to figure out the statute of limitations. It is more different to figure out the statute of limitations for a Suboxone lawsuit. Making it more complicated, two statutes with the exact same statute of limitations might apply the deadline to file differently.

So what do you do? If your question is whether you can still apply for a Suboxone lawsuit, call a lawyer. Call us, call someone. But do it now.

The two-year statute of limitations is arguably approaching in many jurisdictions, including:

Alabama	Arizona	California
Colorado	Connecticut	Delaware
Georgia	Hawaii	Idaho
Illinois	Indiana	Iowa
Kansas	Minnesota	Nevada
Ohio	Oklahoma	Oregon
Pennsylvania	W. Virginia

December 20, 2023: The JPML will hold a hearing next month on whether to create a new MDL for the Suboxone tooth decay lawsuits in federal courts. At least 15 Suboxone lawsuits are pending in 5 U.S. District Courts. There are also hundreds, possibly thousands, of additional Suboxone tooth decay cases that have already been signed up or are under active investigation by lawyers nationwide.

December 13, 2023:  The defendants in the Suboxone lawsuits – including Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc. – responded to the plaintiffs’ lawyers’ motion for a class action lawsuit for Suboxone.

Perhaps surprisingly, the defendants agree that all these cases have much in common so that a class action makes sense. They also believe it is a good idea to bring all the similar lawsuits together under one judge, J. Philip Calabrese, in the Northern District of Ohio. This would make things more efficient and consistent across cases.

December 7, 2023: We have a new Suboxone update video that explains all of the latest developments in the litigation, where we are on the path to an MDL class action lawsuit, and why specifically why our attorneys believe the Suboxone lawsuits are particularly strong claims.

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 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 two 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 to dismiss this case and ruled it could proceed.

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.

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.

2012 Study

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.

2013 Study

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 cases, recorded between May and November 2012, involved individuals with opioid dependence who exhibited deteriorating dental health following the start of buprenorphine treatment. The patients in the study suffered from various dental issues, including cavities, fillings, cracked teeth, crowns needing replacement, root canal treatments, and tooth extractions.

The researchers pointed out – remember, this was 11 years ago – that cavities and tooth erosion typically occur in environments where the pH level is low.

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.

Dry Mouth

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. Surprisingly, however, 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 not always well funded for detailed 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.

2022 Warning

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.

At the heart of every Suboxone lawsuit lies a “failure to warn” claim, which centers on the allegation that the manufacturers of Suboxone did not adequately inform consumers or healthcare providers about the potential risks and side effects associated with its use. A failure to warn claim is a legal argument used in product liability law, asserting that a product’s manufacturer or distributor did not sufficiently communicate the dangers or adverse effects of the product to those who purchased or used it.

This lack of proper warning can lead to consumers suffering injuries or adverse health effects that they might have avoided had they been fully informed about the product’s risks. In the context of Suboxone, these lawsuits contend that the manufacturer failed to provide comprehensive information about the drug’s potential to cause harm, leading to legal actions based on the premise that patients and doctors were not properly warned of the risks involved in its use.

Suboxone Lawsuits

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 Suboxone Lawsuit Settlement Amounts 

Our lawyers currently estimate that the settlement payout value of Suboxone tooth decay lawsuits will be somewhere around $50,000 to $150,000.  Very small cases will be lot less and you can expect settlement over this range, too.

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 compensation 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. It is nearly impossible to project the average Suboxone lawsuit payout per person with so little information.  Moreover, who will qualify is not yet set in concrete.  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.

Some victims are frustrated we do not have high Suboxone settlement projections because that is not enough compensation for everything they have gone through.  Our attorneys get that.  It would be easy for us to say the average settlement will be $500,000.  It would help us get more clients.  But we have an obligation to tell you what we think and that is what we are doing.

Suboxone Settlement and Criminal Charges

In 2016, 41 states, along with the District of Columbia, filed an antitrust lawsuit against Defendants for monopolistic practices in the opioid-addiction treatment market, specifically focusing on the drug Suboxone. The states were 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.

This case, heard in the Eastern District of Pennsylvania, was eventually settled in the summer of 2023, with Indivior agreeing to pay $102.5 million.

Further legal challenges emerged for Indivior. On April 9, 2019, a federal grand jury in Virginia indicted the company, accusing it of operating an illegal nationwide scheme to boost prescriptions of Suboxone film. The indictment claimed that Indivior’s “Here to Help” program, ostensibly a support resource for addiction patients, was actually used to connect patients with doctors known for prescribing Suboxone and other opioids beyond legal limits. Indivior was also accused of stopping the production of its tablet form of Suboxone to impede the FDA’s approval of generic versions.

To resolve these charges, Reckitt, the parent company, forfeited $647 million in proceeds from Indivior, paid $700 million in civil settlements to the federal government and six states, and paid an additional $50 million to the Federal Trade Commission. Reckitt’s settlement amounted to $1.4 billion, a figure more than double what Purdue Pharma paid in 2007 to settle a case with the Justice Department over its marketing of OxyContin.

Additionally, there were personal legal repercussions for Indivior’s executives. Shaun Thaxter, the former CEO, was sentenced to six months in federal prison, fined $100,000, and ordered to forfeit $500,000 after pleading guilty to misdemeanor misbranding of Suboxone film related to misleading statements about accidental pediatric exposure. Timothy Baxter, Indivior’s former medical director, also pleaded guilty to the same charge and received a sentence of six months of home detention, 100 hours of community service, and a $100,000 criminal fine.

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, patient safety, and doing the right thing.

Can I Still Apply for a Suboxone Lawsuit?

Our firm is only taking new Suboxone teeth lawsuits in 2024 in states with a three-year statute of limitations. In our December 22, 2023 update, we listed the two-year statute of limitations states. We are also no longer taking new cases in Louisiana, Tennessee, or Kentucky.

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. 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.