Suboxone Tooth Decay Lawsuit

This page explores Suboxone, its associated dental complications, and the subsequent Suboxone tooth decay lawsuits in 2024. Our lawyers are seeking settlement compensation for victims nationwide 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.

This page provides:

  1. Comprehensive news and updates on Suboxone tooth decay litigation,
  2. The story behind these Indivior lawsuits, where our Suboxone attorneys think this litigation is going
  3. When we believe a settlement is most likely, and
  4. Predicted average settlement amounts for a Suboxone tooth decay lawsuit.

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.


Suboxone Tooth Decay Lawsuit Updates

December 7, 2024 – New Suboxone Lawsuit

In a new lawsuit filed Thursday in the MDL, a plaintiff from Madison, Indiana, who was prescribed Suboxone in Michigan alleges that the pharmaceutical companies responsible for Suboxone film failed to warn users about the drug’s severe risk of dental damage.

The complaint highlights. of course, that the defendants, including Indivior and Aquestive Therapeutics, were aware of the drug’s risks for over a decade but delayed providing adequate warnings. The plaintiff cites a 2022 FDA Drug Safety Communication that confirmed significant dental issues associated with buprenorphine products dissolved in the mouth. Despite this, the plaintiff contends that the manufacturers failed to update patient medication guides adequately.

With an eye towards the statute of limitations battle to come, the complaint is clear that there is still not an adequate warning on the product in spite of the FDA safety communication.

December 4, 2024 – MDL Adds 38 New Cases

The Suboxone tooth decay MDL experienced a sharp uptick in filings with 38 new cases in November—a 850% increase over October’s 4 cases. However, filings remain far below the pace seen earlier this year. The total is now 716 cases.  Again, filed lawsuits are not the best marker of activity in this litigation because of the tolling agreement we discuss below.

December 2, 2024 – Suboxone Settlement Update

Suboxone-related dental injury victims are eager to know when settlement payouts might begin. So when do we expect a Suboxone settlement?

There is speculation that a settlement might come sooner than expected, potentially before critical legal milestones like a Daubert ruling. However, a more realistic timeline points to mid-2025, tied to the debated three-year statute of limitations. Defense attorneys for Indivior, the manufacturer of Suboxone, argue that this window expires around June 2025—a timeline likely to influence the company’s settlement strategy.

Indivior is unlikely to announce settlements before mid-2025 out of concern that doing so could spark a wave of new claims. By waiting closer to the statute of limitations cutoff, the company seeks to limit the influx of new plaintiffs and better control its overall liability.  So the talk of an early Suboxone settlement is, in our minds, just talk.

November 30, 2024: Motion to Dismiss Hearing

Judge Calabrese has scheduled oral arguments for the defendant’s motion to dismiss on December 16. In preparation, the court has directed the parties to submit a joint report by December 12, outlining any additional issues they believe should be addressed during the proceedings.

November 25, 2024: CMO #3 Modifications

Judge Calabrese modified Case Management Order No. 3 on Friday. This is the order that permits plaintiffs alleging dental injuries from Suboxone film to file actions directly in his court in Ohio.

The modification in the order focuses on service of process.  Defendants Indivior Inc., Indivior Solutions Inc., and Aquestive Therapeutics, Inc. have agreed to waive formal service of summons under Rule 4 for cases within the MDL.

November 23, 2024: Multiple Lawyers

Many Suboxone victims have hired more than one lawyer for their claim. One key takeaway from Thursday’s status conference was the need for attorneys to familiarize themselves with the Rubris Crosslink platform, mentioned in our November 15 update below, to begin addressing this issue. Duplicate representation can create conflicts and inefficiencies that slow down case progress and, if left unresolved, complicate settlement negotiations.

The Rubris Crosslink will help solve the problem of Suboxone victims hiring multiple lawyers by providing a centralized system to identify and manage overlapping legal representation. This is not a Suboxone specific problem—we see victims agreements with multiple law firms in every mass tort. Why?  Mostly, it is the result of misunderstandings, aggressive marketing, and people just wrongly thinking two bites of the apple is better than one.

The platform uses its database to track cases across participating firms, flagging instances where a client has retained more than one lawyer. This enables firms to resolve conflicts early, ensuring smoother case management and better outcomes for victims.

November 21, 2024: Unique Warning Case

A warnings case in the Suboxone litigation has a somewhat unique wrinkle. For patients who chose to continue to use the drug, proper warnings could have empowered them to take preventative dental measures and avoid or significantly reduce the harm caused by Suboxone.

Simple interventions—such as rinsing the mouth with water after taking the drug, increasing fluoride use, or scheduling more frequent dental checkups—could mitigate these harmful effects of the drug. Without adequate warnings, patients were left unaware of the risks and, therefore, unable to take steps to protect their oral health. This lack of information resulted in preventable harm, which is central to the claims of negligence against Suboxone’s manufacturers.

What makes this case unique is that it isn’t solely about whether patients would have chosen to avoid the drug entirely if properly warned—a common focus in failure-to-warn cases. Some patients likely would have continued using Suboxone to manage their opioid addiction even if properly advised of the risk.  In most tort cases, that would kill the failure to warn claim.

In these cases, another argument is the absence of warnings denied Suboxone patients the ability to take proactive steps to minimize dental damage.  By failing to issue timely and adequate warnings, Indivior exposed patients to unnecessary suffering that could have been avoided even if they remained on the medication.

November 18, 2024:  New Suboxone Lawsuit

In a new lawsuit filed last week, a Kentucky resident has alleged that the makers of Suboxone film. The plaintiff, who was prescribed Suboxone to manage opioid dependency, claims that prolonged use of the medication caused irreversible damage to their teeth, requiring extensive dental work.

The lawsuit names Indivior and related entities and and Aquestive Therapeutics as defendants, asserting that they were aware of the drug’s acidic formulation and its potential to cause tooth erosion, cavities, and other oral health problems.

Further, the plaintiff contends that the defendants prioritized profits over patient safety, delaying the introduction of a safer injectable alternative, Sublocade, to maintain their market dominance with Suboxone Film. The plaintiff seeks compensatory, statutory, and punitive damages, arguing that the defendants’ negligence and failure to act responsibly have caused significant harm.

You are not seeing many new Suboxone lawsuits these days because of the tolling agreement. One of the battles in cases like this is whether the statute of limitations has passed.

November 17, 2024: Is Indivior Miscalculating What It Will Take to Settle These Lawsuits?

Indivior may assume that juries will be less sympathetic to plaintiffs who are often in recovery from addiction. This could be a costly miscalculation if that logic takes them to a trial before a global Suboxone settlement.

From talking to clients in this litigation for over a year, it is hard not to be moved by the human stories that plaintiffs will ultimately bring to the courtroom. These people do not come across not as abstract figures. By and large, they come off as kind, credible, and deeply sympathetic people whose lives have been profoundly affected.

Jurors may find themselves moved by the tangible suffering caused by Suboxone’s severe dental damage. What might seem like an impersonal injury on paper becomes strikingly real when plaintiffs share their experiences—struggling with addiction, making strides in recovery, only to face a painful and permanent consequence they were never warned about.

If the company underestimates the emotional weight these stories carry, it may be surprised by the scale of the verdicts juries are willing to deliver.

November 15, 2024: Case Management Conference Agenda

The agenda for the upcoming status conference:

  1.  Status of amended CMO No. 3 (see the March 27 update)
  2. Update on Rubris Crosslink platform (specialized software or system used for managing case-related documents, facilitating communication, or conducting legal research and e-discovery)
  3. Dismissal of Indivior PLC, Reckitt Benckiser Healthcare (UK) Ltd. in one case
  4. Search terms and document production protocol
  5. Status of production of adverse-event information

Nothing too exciting.

November 11, 2024: Pill Versus Film

We get calls from people who took Suboxone pill and want to bring a claim. They get frustrated when we cannot help them.  I get that.  But the sublingual film really is the key to these claims.

The process of dissolving the medication in the mouth before it’s absorbed creates a prolonged exposure to the drug within the oral cavity. While it is in the mouth, the pH balance is be affected. Buprenorphine and the naloxone in the formulation lead to a decrease in the mouth’s natural pH, especially when left to dissolve over an extended period under the tongue.  So Suboxone lawyers argue both that the manufacturers failed to warn about these issues and the drug’s design was more harmful than prior forms of the drug.

November 5, 2024: New Case Management Order

In the latest Suboxone MDL order, plaintiffs with cases filed by October 7, 2024, are now required to submit detailed documentation verifying their claims. This Case Management Order will ultimately be good for plaintiffs who have strong cases and want to get to a Suboxone settlement sooner rather than later.

Why? Because in any large-scale litigation, plaintiffs without sufficient proof of harm can bog down the process, delaying critical settlement evaluations and holding back compensation for those who need it most. Defendants need to know how many real cases there are before they can begin to consider settlement.

To address this, the court has mandated each plaintiff to complete a Census Form, along with medical, dental, and pharmacy authorizations, and to provide proof of brand-name Suboxone film use and documented dental injuries.  All submissions are to be securely managed via the Rubris Crosslink system—a common, highly confidential data platform for MDLs—to ensure accuracy and transparency for all parties.

Deadlines are strict(ish). Plaintiffs have 270 days from the order to submit the required information, or risk dismissal. Importantly, the court will review cases where multiple law firms may represent the same plaintiff, requiring them to clarify representation and avoid potential conflicts.  This is another bit of craziness that has to be cleared up—victims who somehow have two lawyers who filed claims for them.

These steps are typical of complex MDLs and are essential for calculating fair settlements. They help to ensure that plaintiffs with documented harm from Suboxone are in position to get their cases settled while claimants that really do not have viable claims can be pushed aside.

November 3, 2024 – Ask Us About the Suboxone Lawsuits

We give brutally honest answers to your Suboxone lawsuit questions.

October 31, 2024:  Design Defect

There is no question the key issue in this litigation is failure to warn.  But there is also a strong design defect case that will be thoroughly explored.

Design defect claims in Suboxone litigation focus on the assertion that the medication’s formulation is inherently flawed, leading to severe dental injuries among users. Plaintiffs argue that the acidic properties of Suboxone, combined with its prolonged exposure to teeth during under the tongue administration, create a high risk for tooth decay, erosion, and even tooth loss.

Unlike many other medications, Suboxone is designed to dissolve slowly in the mouth. This prolongs direct exposure to its acidic components. The result is the drug weakens enamel and fostering an environment for decay. This somewhat unique feature of Suboxone’s design is central to these claims. Suboxone lawyers contend it results in more harm than necessary, especially given the already vulnerable health profile of many patients in addiction recovery.

In addition to its acidic properties, Suboxone’s formulation also lacks elements that could mitigate these harmful effects, such as pH buffers or additives to reduce acidity. Plaintiffs’ attorneys argue that reasonable, alternative designs could have prevented or significantly reduced the risk of dental injuries. By failing to include protective ingredients, Indivior prioritized the drug’s efficacy over patient safety.

Alternative delivery methods or non-acidic/less acidic formulations would also reduce prolonged contact with teeth. The absence of these protective measures forms the basis of design defect claims.

October 26, 2024 – How Does Indivior See This Litigation?

Who knows how the decision makers that matter at Indivior see this litigation?  But it might just be they anticipate juries will be unsympathetic to plaintiffs who are often recovering drug addicts.  Indivior is handicapped by the fact they are not hearing the stories of what some of these victims have been through and how those stories are articulated. The reality is that so many of these plaintiffs come across as kind, credible, and deeply sympathetic.

Jurors may very well find themselves moved by the very real suffering caused by the severe dental damage these people endured as a result of Suboxone. What might have seemed like an abstract injury gains emotional weight when personalized through real stories of suffering. The image of a struggling individual, recovering from addiction (or pain) and now facing irreversible tooth decay without warning…it could very possibly lead to bigger verdicts than even our lawyers expect.

October 20, 2024 – Flow of Suboxone Plaintiffs

What is amazing is that more than a year into this litigation our law firm is still getting more calls from Suboxone victims than any other type of litigation we handle.  The number of people impacted by Suboxone is far greater than anyone anticipated when this litigation began.  The injuries are also more significant than lawyers expected.

October 18, 2024 – Suboxone Overdose

The deeper we get into the Suboxone litigation and the more we talk to victims the more we learn about the drug. Our initial take was wondering whether there should be a Suboxone recall after we saw the carnage this drug took on the mouths of so many.

But there are a lot of benefits to Suboxone that we did not focus on when the litigation began.  For example, it is helpful that it is hard to overdose on Suboxone and using it for long periods can be manageable if you can control the side effects.

The point is we would not support a Suboxone recall.  Instead, we think there should be strong warning—there still is not a strong warning in 2024—that would allow people to both make an informed choice and to take steps to monitor and mitigate the risks of severe tooth decay.

October 4, 2024 – Status Conference

This weekend, there is a rare two-day status conference in the Suboxone MDL. The biggest thing on the agenda that matters to you if you have or are considering bringing a Suboxone lawsuit is putting together a plan for bellwether trials.

Bellwether trials are the first trials in mass tort litigation.  They are used to test the waters, previewing how juries may respond to the evidence and arguments presented by both plaintiffs and defendants.  These trials will focus on key issues shared by the majority of cases in the MDL, such as claims related to design defects, inadequate warnings, or misleading marketing practices associated with Suboxone. Because bellwether trial results often indicate how future cases might be decided, they play a crucial role in shaping the litigation strategy for both sides.

Bellwether trials are essential in the journey toward a global settlement in an MDL like Suboxone. The outcomes of these trials can significantly impact the direction of settlement negotiations because they give both parties a sense of the potential liability and exposure for the defendant.  But our lawyers think there is a real possibility that the defendants will want to settle these lawsuits before there is a bellwether trial because they fear what a jury will do. But you need trial dates to put pressure on defendants to settle.  So, getting a trial set sooner rather than later will expedite an eventual Suboxone Settlement.

October 1, 2024 – No New Cases Added to MDL in September

New case filings have stopped in the Suboxone class action MDL. No new cases were added to the MDL in September, leaving the total number of pending cases at 674. This is due to a coming final tolling agreement, allowing prospective plaintiffs to file claims rather than actual lawsuits in court.

September 30, 2024 – New Case to Defeat Motion to Dismiss

The Third Circuit recently addressed implied preemption of state failure-to-warn claims in the drug labeling context in In Re Fosamax (Sept. 20, 2024). The court vacated and remanded the district court’s decision, stating that it gave too little weight to the presumption against preemption and held that the plaintiffs’ state law claims were not preempted.
In our August 24 update below, we talk about the Suboxone defendants’ motion to dismiss for preemption.  Plaintiffs’ lawyers are confident we will win this motion even without this new case.  This should not be a close call. But this new opinion holds the door open just a little wider. It’s like bringing a parachute to a skydive when you’re already wearing a jetpack. Unnecessary, maybe, but who’s going to complain about an extra layer of safety?  Every small advantage counts when the stakes are this high. The entire litigation rides on winning this motion. Fosamax is the kind of precedent that nudges the argument even further in the right direction.

September 25, 2024: Dental Records

The Suboxone MDL docket has been quiet the last few weeks.  The big hustle right now is getting dental records for the plaintiffs. The victims who get the best Suboxone settlements will be those with a huge gap between their dental records from before and after using Suboxone.

September 23, 2024: Why Do Suboxone Lawyers Prefer Cases with Use Before June 2018?

The Suboxone lawsuits primarily target the use of brand-name Suboxone prior to June 2018. Before this time, Indivior, the company responsible for the design, testing, and production of Suboxone, controlled the vast majority of the market.

After June 2018, generic versions of Suboxone became more widely available and took over the majority of market share. The current wave of Suboxone tooth decay lawsuits is focused on the brand-name version of the drug, alleging that its defective design contributed to severe dental problems such as tooth decay, erosion, and tooth loss.

Why not sue the generic manufacturers? You can. But it is more difficult. This difficulty arises from the legal precedent set by the Supreme Court which effectively protects generic drug manufacturers from liability for failure-to-warn claims – the signature claim in this litigation.  Generic manufacturers are legally required to copy the brand-name drug’s labeling exactly, including warnings, as per FDA regulations. They cannot independently change or add warnings to the drug’s label, even if they become aware of potential risks.

Because generic manufacturers must follow the label of the original brand-name drug, the courts have consistently ruled that they cannot be held liable for failing to provide additional warnings beyond what the brand-name manufacturer has included. This means that for lawsuits like those related to Suboxone, plaintiffs are largely limited to targeting Indivior, the original manufacturer, even if they were harmed by the generic version of the drug.

September 13, 2024: Injuries in This Litigation

Today is less of an update and more of a comment.

I think the evidence at trial will show that Indivior knew Suboxone caused tooth decay and failed to put a warning on the product because they wanted to maximize profits and thought that a warning would be a disincentive for doctors to prescribe the medication.

But I think the severity of the injuries in this litigation in terms of the scope of the dental decay that victims have endured have surprised and will continue to surprise Indivior and Aquestive and probably also a lot of plaintiffs’ lawyers.  The injuries we are seeing from victims and the impact it has had on their lives is very real.  Your mouth was not built to withstand the steady, relentless onslaught of chemical compounds designed to break down one addiction, while surreptitiously handing you another problem – in this case, catastrophic dental decay.

September 10, 2024 – New Suboxone Lawsuit Filed

A Utah man has filed a new lawsuit in federal court, alleging that Indivior and Aquestive Therapeutics among others, are responsible for severe dental injuries caused by the prescription drug Suboxone film.
The plaintiff, who was prescribed the medication to treat opioid addiction, claims that the drug’s acidic formulation resulted in permanent dental damage, including tooth decay and erosion, despite the drug being marketed as safe.

The plaintiff argues that the defendants failed to adequately warn of the dental risks associated with Suboxone film, which combines buprenorphine and naloxone, and is designed to be absorbed through the mouth. The complaint highlights a January 2022 FDA warning about the potential for serious dental issues with buprenorphine-based medications, but claims that such warnings were not included in Suboxone’s medication guide until June 2022 (not to mention that those warnings are still inadequate).

The lawsuit seeks compensatory and punitive damages, alleging negligence, defective design, and failure to provide adequate warnings. The plaintiff also asserts that the defendants knowingly concealed the risks associated with the drug to maximize profits at the expense of patient safety.

September 9, 2024 – Talk of Bellwether Trials

At the recent status conference, the judge started discussions with the attorneys about developing a plan for bellwether trials. In the context of a Suboxone MDL, a bellwether trial acts as a test case, giving both parties insight into how future lawsuits may be decided and helping determine fair settlement amounts when negotiations are unsuccessful.

As we explain more fully below, progressing toward a bellwether trial is the most effective route to settling these claims sooner rather than later.

September 3, 2024 – 1 New Case Added to MDL

After dropping a few cases last month, the Suboxone class action MDL increased by just one case in August.  That brings the current number of pending cases up to 674.

Why are there so newly filed suits?  Lawyers expect a tolling agreement to be finalized soon that will allow plaintiffs to preserve their claims for the purposes of the statute of limitations without filing a lawsuit.

August 24, 2024 – Response to Motion to Dismiss

In our July 31st update, we talked about the motion to dismiss Indivior and Aquestive Therapeutics filed in the MDL.

The biggest issue in this litigation is the failure to warn claim. The defendants argue that these claims are preempted by federal law, specifically because they contend that the FDA’s approval of the Suboxone film label precludes any state-law claims about inadequate warnings. It is the same tired argument our attorneys see in every failure to warn case.

The plaintiffs counter by emphasizing that federal law does not prevent them from bringing claims based on the failure to update the label in light of newly acquired information. They argue that the defendants had a continuous duty to monitor and update the label with any new information that emerged after the initial FDA approval, and that their failure to do so is actionable under state law.

Next, the plaintiffs dispelled the defendants’ assertion that their design-defect claims are entirely preempted by federal law. The defendants argue that the plaintiffs cannot claim that Suboxone film should have been designed differently because the FDA approved the drug’s design.  But that is ridiculous  There was a safer alternative design existed before the launch of Suboxone film, in the form of Sublocade, an extended-release injectable version of buprenorphine. They argue that the existence of this FDA-approved alternative design undermines the defendants’ preemption argument. It shows that a safer design was not only feasible but available, and the defendants’ choice not to pursue it constitutes a design defect under state law.

Finally, the plaintiffs challenge the broader concept of implied preemption that the defendants rely on to dismiss all claims. The defendants suggest that federal regulations implicitly preempt any state-law claims, but the plaintiffs argue that this doctrine is an unconstitutional overreach that infringes on the states’ rights to protect their citizens through their own laws. The plaintiffs assert that state law plays a complementary role to federal regulations in ensuring the safety of pharmaceutical products and that the court should reject the defendants’ preemption defense to allow the claims to be adjudicated on their merits.

August 21, 2024 – New Video

We put out a new Suboxone video to summarize where we are in the litigation and some more thoughts on expected settlement amounts.

August 17, 2024 – New Appointments to Plaintiffs’ Committee

The Suboxone MDL Judge issued new Case Management Orders this week making additional appointments of lawyers to the Plaintiffs’ Leadership Development Committee (LDC). Appointment to the LDC is usually reserved for younger, less experienced lawyers who don’t qualify for a seat on the main steering committee or leadership committee (the body that actually makes decisions). The LDC is usually tasked with researching certain issues and other support work for the main leadership committee.

August 9, 2024 – Schedule A Tolling Agreement Update

Regarding the status of a potential agreed tolling agreement, the defense submitted a draft stipulation to the plaintiffs on July 25, 2024. The plaintiffs are currently reviewing it and anticipate providing revisions to the defense next week. The parties request to update the court on their ongoing progress at the next status conference.

August 2, 2024 – Case Count

The Suboxone (Buprenorphine/Naloxone) Film Products MDL-3092 experienced a slight decrease in active cases from July to August 2024. The number of active cases decreased by three from 677 to 673. You will see fewer filed lawsuits with a final tolling agreement near.

July 31, 2023 – Defendants File Motion to Dismiss

The Suboxone defendants have filed a motion seeking to dismiss all of the suboxone lawsuits against them based on the doctrine of federal preemption.

We see federal preemption asserted as an affirmative defense like this in most product liability cases involving prescription drugs. The defense argument is basically that tort plaintiffs can’t sue the manufacturers under state law for failure to warn when federal FDA regulations govern the content of warning labels for prescription drugs.

This argument is rarely successful in these specific types of cases, and we do not expect it to be any different here.

July 30, 2024 – All 50 States and D.C.

Starting in July 2024, our firm is reviewing new Suboxone suits in all 50 states, which means we will review claims in one and two-year statute of limitations jurisdictions where you can expect the defendants to argue that the statute of limitations has passed.

These are the states that generally have a three (or more) year statute of limitations where we are certainly accepting new lawsuits:

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. But again, we are no longer limiting other jurisdictions.

July 2, 2024 – Suboxone Settlement Rumors

These is some scattered talk of early settlement talks on the Suboxone MDL. Will this happen? I’m betting no. I don’t see Indivior getting serious about settlement until June 2025 at the earliest.

But who knows? I’m passing the rumor along to you for what it is worth.

June 24, 2024 – Court Rules Denies Defendant’s Motion

Good news today – plaintiffs won the general causation issue we have been talking about in numerous previous updates (start with the April 19th update).

The defendants requested that the parties focus on discovery with general causation issues and delay case-specific and marketing-related discovery. The plaintiffs opposed this, arguing it would prolong the litigation and misallocate resources. I think it would have added over a year to the timeline of this litigation.

After hearing arguments on June 3, 2024, the court denied the defendants’ motion. In the ruling, the MDL judge emphasized that separating general causation from other discovery would be inefficient and complex, given the intertwined nature of the evidence.

The court referenced similar MDL cases, noting that each is unique and must be managed accordingly.

Ultimately, the court decided that integrated discovery would better serve the progression of the Suboxone lawsuits. It is also a tea leaf that the judge believes these cases will get past any Daubert challenged and make it to a jury.

June 21, 2024 – Plaintiffs File Newly Amended Master Complaint

Yesterday, the plaintiffs filed a new amended master complaint to fine-tune their allegations in the Suboxone class action lawsuit.

June 19, 2024 – Plaintiffs File New Complaint

Plaintiffs have filed a new complaint with the two lists we discuss in the update below. There are nearly 10,000 new plaintiffs in the litigation.

Next year at this time will be the three year statute of limitations many lawyers are expecting will be applied to most cases with a three year deadline to file.  My take has always been it is hard to settle a mass torts until the three year statute has passed.

Defendants in a mass tort, such as those involving Suboxone, might prefer to wait until the statute of limitations has passed for most lawsuits before agreeing to a settlement to minimize their overall liability.

By doing so, they can avoid the risk of new claims being filed by knowing the cap on the total number of lawsuits they need they need to address.

Defendants also want to avoid motivating victims who are sitting on the sidelines who have not hired a lawyer who would be motivated by news of a settlement.

June 11, 2024 – Two Lists for Tolling Agreement

There are two lists for the tolling agreement. The main list is for plaintiffs from states other than New Jersey, Virginia, and Delaware. These plaintiffs have diversity jurisdiction, meaning they can file their cases in federal court and potentially be included in a multidistrict litigation based on diversity jurisdiction.

Diversity jurisdiction is a form of jurisdiction that allows cases to be heard in federal court where the parties are citizens of different states or countries and the amount in controversy.

This jurisdiction is intended to provide a neutral forum for parties from different states to resolve their disputes and to prevent potential bias in state courts.

So there is a separate list for plaintiffs residing in New Jersey, Delaware, and Virginia – where the defendant corporations reside. Since these plaintiffs share state citizenship with a defendant, they lack diversity jurisdiction and would typically need to file their cases in state court.

However, the tolling agreement allows these non-diverse plaintiffs to toll their claims, meaning they can delay filing their lawsuits without losing the right to do so later.)

May 25, 2024 – Plaintiffs Argue that MDL Judge Should Deny Indivior Request

Plaintiffs responded to the “general causation should go first in discovery” argument.  Victims’ lawyers argue that the MDL judge should deny Indivior request to bifurcate general and case-specific discovery because it presupposes that Indivior will win future motions under Rule 702 and 56, which is unlikely given existing scientific evidence linking Suboxone film to dental erosion.

The motion does a nice job of laying out the zillion MDL where the defendants tried to pull this garbage, and it did not work.

May 17, 2024 – Plaintiff Attorneys’ Request for Tolling Period Goes On

We have been talking in the last few updates about a tolling agreement that would allow plaintiffs to avoid filing a lawsuit but still give them the opportunity to keep their case safe on the statute of limitations.

No one is sure of what the statute of limitations is for certain, and there are also nuances of specific cases that could vary this deadline to file a Suboxone lawsuit.  But lawyers on both sides acknowledge that a potential bar date of June 17, 2024, exists for many plaintiffs in states with a two-year statute of limitations.

Plaintiffs wanted a tolling period for clients retained by the bar date, allowing time to investigate claims, such as obtaining medical or pharmacy records to substantiate Suboxone use.

Victims’ Suboxone lawyers have argued that without this period, a rush of complaints would result in filing Suboxone suits that seem viable but will not be after the medical records are collected.

The defendants insist on not waiving their time-bar defenses.  They want to make plaintiffs’ lawyers spend the time and money to file thousands of lawsuits, hoping some will drop out.

In a new ruling today, the judge decided to borrow a procedural innovation we saw in the Xarelto litigation to find a Goldilocks middle ground. By June 14, 2024, the plaintiffs’ lawyers will file a complaint on the master MDL docket, listing individual plaintiffs on a schedule. Defendants may file a motion to sever by July 1, 2024, with severed claims continuing as separate actions and amendments relating back to the original filing.

What does that mean?   I’m not 100% sure.  We will know more at the case management conference next month.  But I can tell you how I think this will work.

By June 14,  the plaintiffs’ lawyers in leadership must file a comprehensive complaint on the master MDL docket, including a schedule (Schedule A) listing individual plaintiffs. This schedule will contain specific information for each plaintiff, such as names, the firm representing them, their residency and citizenship, designated venue, and details regarding their case, such as where they were prescribed and used Suboxone film.

Then, Defendants will have until July 1, 2024, to file a motion to sever, requesting that the MDL judge separate individual plaintiffs’ claims from the master complaint. If the judge grants the motion to sever, the severed claims will continue as separate individual actions, ensuring that the claims remain active and linked to the original MDL filing.

Plaintiffs whose claims are severed would need to immediately file an amendment to their lawsuits in their new individual actions. These amendments will relate back to the original filing date in the MDL, preserving the plaintiffs’ original filing dates and any associated statute of limitations considerations.

This middle-ground approach allows for an organized and streamlined process to manage numerous claims without overwhelming the court system with simultaneous filings. It probably gives plaintiffs mostly what we need, but just adding in a bunch of additional hoops.

May 14, 2024 – Defense File Brief in Opposition to Proposed Tolling Agreement

Lawyers for the defense filed an opposition brief yesterday laying out why they will not agree to the tolling agreement proposed by the plaintiffs. The brief explains that the plaintiffs’ tolling agreement is simply not in the defendants’ best interests.

The brief rejects the argument set forth by the plaintiffs that without a tolling agreement, plaintiffs’ lawyers will be forced to “blind file” claims to avoid SOL expiration without being able to properly investigate those claims first. (See May 3, 2024 update just below on what a tolling agreement is.)

The reality is that it can take time to collect all the medical records in these cases. Dentists are generally slower than other healthcare providers in producing records. So without a tolling agreement, there will be lawsuits where the victim’s version does not align with the medical records. So Indivior has to defend a lawsuit that otherwise never would have been filed.

Why would Indivior take that risk? They are hoping that the statute of limitations will expire on enough Subxonne lawsuits because few lawyers will be willing to step up and put the cases into suit.

I’ve talked to Suboxone lawyers who thought Indivior would consent to a tolling agreement because they fear litigation in multiple jurisdictions, making these cases brutal to defend. A tolling agreement would push more cases out of state court and into the MDL. But I always assumed this was the path the defendant would take. Now we will wait to see what the court does.

April 26, 2024 – Maryland Man Alleges Suboxone Caused Tooth Decay

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

April 19, 2024 – Indivior Believes Focus Should Be on General Causation

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.  Suboxonein 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 – Georgia Woman Alleges Suboxone Caused Tooth Decay

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.

March 28, 2024 – Criteria for Suboxone Cases

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 (or something equally awful).

March 27, 2024 – MDL Judge Issues Case Management Order

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 – How Severe Do My Dental Injuries Need To Be? 

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.

February 28, 2024 – Ohio Man Alleges Suboxone Caused Dental Damage

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 5, 2024 – MDL Panel Ruling Creates MDL-3092

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.

The U.S. Judicial Panel on Multidistrict Litigation issued a transfer order on Friday to consolidate multiple lawsuits involving the marketing, sales practices, and product liability of Suboxone (Buprenorphine/Naloxone) film.

This decision comes after plaintiffs in eight separate actions petitioned for centralization in the Northern District of Ohio, arguing that the fifteen cases, currently spread across five different districts, share common factual questions.

The panel has also been informed of eleven related actions across nine districts, further complicating the legal landscape.

Every Suboxone lawsuit in this litigation centers on allegations that Suboxone film, a treatment for opiate addiction, causes dental erosion and decay due to its acidic composition—a stark departure from its previous tablet form.

One defendant, Reckitt, argued that centralization might lead to future unwarranted lawsuits.

However, the Panel found these objections without merit, emphasizing that centralization will facilitate more streamlined and efficient pretrial proceedings, including discovery, and help avoid inconsistent rulings.

The choice of the Northern District of Ohio as the venue was easy. Everyone agreed to it.

This consolidation represents a crucial step forward in the path to a global Suboxone settlement to compensate victims for their injuries.

Will there be a Suboxone settlement in 2024 now?  It is unlikely.  Our more realistic prediction is a settlement in 2025. Our Suboxone attorneys do not think we will see a single settlement payout in 2024, but many dynamics at play should lead to compensation in 2025.

The big thing for victims is that the clock is ticking.  Most likely, there are people with severe decay who would have had a claim that they have already lost the right to sue because the deadline to file a Suboxone lawsuit has passed.

But the issue is complicated, and the only way to figure it out is to call a lawyer today.

Call us, but if not, call anyone handling these claims.

February 4, 2024 – JPML Creates Suboxone MDL

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 – Statute of Limitations Issues in Suboxone Litigation

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. There is an argument that some are making that the deadline to file a Suboxone lawsuit has not even begun because the warning on the product is inadequate.

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

If you live in one of these states, the time to file a Suboxone lawsuit could be running out. Contact us today.  (This has since been updated and we are taking cases in all 50 states now.)

January 26, 2024 – Suboxone Hearing 

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 22, 2024 – New Suboxone Case Highlights Statute of Limitations Issue

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 6, 2024 – Federal Judges to Deliberate on Consolidating Suboxone Cases 

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 – Woman Alleges Suboxone Caused Permanent Tooth Damage

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 – Ohio Woman Files Suboxone Lawsuit

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 – Statute of Limitations

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 – JPML Holds Hearing Next Month for Potential MDL

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 five 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 – Defendant Response to Plaintiff Motion

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.

November 27, 2023 – How Can Suboxone Cases Become a Lawsuit

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 – Plaintiff Attorneys Ask for Consolidation

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.

October 25, 2023 – Indivior Agrees to Settle for $385 Million

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

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 2024. The plaintiffs’ lawyers in a Suboxone tooth decay lawsuit are not calling for a Suboxone recall.

What these attorneys are arguing, however that drugmakers like Indivior have a responsibility to fully disclose all known risks associated with their products. This transparency gives patients the ability to make informed decisions.  (It also gives them the opportunity, as we discuss above, to mitigate the harm of the side effects. Dental risks, unlike some side effects, can often be mitigated through preventive measures like rinsing the mouth after use, increasing fluoride intake, or scheduling more frequent dental checkups. )

By failing to provide adequate warnings about the risk of severe dental injuries, Suboxone manufacturers deprived patients of the ability to take proactive steps to protect their health. Without proper warnings, patients are left in the dark, unable to take these precautions and suffering avoidable harm as a result. The crux of these lawsuits is simple: patients deserve the information needed to make informed choices.

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

By 2012, a case report published by Harvard Medical School professors had already shed light on a troubling side effect associated with the long-term use of Suboxone, a combination of buprenorphine and naloxone prescribed to manage opioid dependence. The report detailed the case of a patient who, after 18 months of stable treatment with Suboxone tablets, experienced a rapid and severe decline in oral health. This individual, who had no significant history of dental issues, suddenly required extensive dental interventions to treat decay across multiple teeth.

The Harvard professors hypothesized that the chronic use of sublingual buprenorphine/naloxone may have played a pivotal role in the patient’s dental deterioration. They guessed at the obvious: Suboxone is administered under the tongue, and the sublingual route of delivery may expose the oral cavity to prolonged contact with the medication.

The case report prompted further discussions on the potential dental risks for patients using Suboxone long-term, suggesting that healthcare providers consider these risks and monitor the oral health of patients on such treatments.  But the defendants appeared to have done nothing but let the profits keep rolling in.

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 of 3.4 when dissolved in water, indicating a high level of acidity. The pH scale, which ranges from 0 to 14, is used to measure the acidity or alkalinity of a substance. A pH of 7 is considered neutral, while values below 7 indicate increasing acidity, and values above 7 indicate alkalinity. The mouth’s natural pH typically ranges between 6.2 and 7.0, which is slightly acidic but generally safe for maintaining tooth health.

Tooth enamel, the hard outer layer of teeth, begins to demineralize when exposed to an acidic environment, specifically when the pH drops below 5.5. At this point, the enamel starts to lose essential minerals such as calcium and phosphate.  It leads to weakening the tooth structure. This makes teeth more susceptible to cavities and decay. This is not complicated. When substances like Suboxone, with a significantly acidic pH, come into prolonged contact with teeth, they can accelerate this demineralization process.

Acidic environments can result from multiple sources, including certain foods, beverages, bacterial activity, and conditions like dry mouth. These factors lower the mouth’s pH and, over time, contribute to tooth erosion. Given Suboxone’s acidic pH, the drug creates a terribly persistent low pH in the mouth, weakening enamel and causes dental injuries.

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. It was obvious.

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 rinsing away food particles and bacteria, neutralizing oral acids, stabilizing the mouth’s pH balance, and ensuring the mouth remains moist and lubricated.

When saliva production is reduced, 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 Suboxone 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 Suboxone 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, Indivior 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.

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 those 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 that the manufacturers knew or should have known that Suboxone, when used as prescribed and intended, causes harmful damage to the teeth due to buprenorphine’s acidity.

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 warning 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 manufacturers’ liability appears to be clear and hard to defend.

Who Are the Defendants in the Suboxone Lawsuits?

The primary defendant in the Suboxone lawsuits is Indivior, Inc., the pharmaceutical company that makes and sells Suboxone. Indivior 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 Indivior and its rapidly expanding opioid addiction treatment business into a new, publicly traded company.

The Suboxone tooth decay lawsuits generally name Indivior, Reckitt, and their various U.S. operating entities as defendants. Primary liability for the Suboxone liabilities will ultimately fall on Indivior, a public company listed on the London Stock Exchange and well capitalized.

Indivior has a checkered 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 Indivior 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. For some cases, there will be statute of limitations issues that might make some cases worth less. But assuming these cases are successful and backed by strong evidence we are seeing linking Suboxone to dental damage, our Suboxone lawyers believe this estimate is a reasonable starting point.

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.

Above, we talk about when we expect there to be a Suboxone settlement.

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.

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