Suboxone Lawsuit for Tooth Decay

Our law firm is handling Suboxone lawsuits. Our lawyers are bringing these tooth decay lawsuits because the defendants knew their drug was causing severe tooth decay and other dental injuries and told no one.

Yes, they finally put a warning on in 2022. But every Suboxone lawsuit that is being filed is for victims of tooth decay, broken teeth, and other dental injuries that flow from Suboxone, who used the product before 2022 and were blindsided with this risk for no good reason.

Potential dental issues with Suboxone include:

• Tooth decay
• Tooth loss and extraction
• Infections
• Cracked teeth
• Cavities
• Root canal
• Dental caries (loss of enamel, dentine, etc.)
• Crown or crown replacement

If you are a victim, you may be eligible for compensation through a Suboxone lawsuit payout. Our lawyers believe that the defendants in these cases will be forced to pay reasonable settlement amounts to patients who used this product and suffered severe dental injuries.

Our Suboxone lawyers are actively investigating claims against the drug manufacturers for their failure to provide adequate warnings about the risks of severe tooth decay and other dental problems associated with Suboxone in 2024.

Our lawyers are reviewing cases in all 50 states, including those in which the statute of limitations has arguably passed. This page will provide news and updates on the Suboxone litigation and predictions about the potential settlement value of these cases.

Find out if you qualify for a Suboxone lawsuit payout by contacting our law firm online to schedule a case review. You can also reach out to our product liability attorneys at any time by calling 800-553-8082 or contacting us online.

No fees or expenses are involved – ever – unless we successfully secure a settlement amount or jury payout for you.

Suboxone Lawsuit News and Updates

Our lawyers are committed to keeping victims updated on the latest events in this litigation.

October 3, 2024:

Plaintiffs filed a Complaint with Jury Demand and attached a Schedule A list of plaintiffs on June 14, 2024 under the “sort of” tolling agreement that the MDL judge allowed.  Somehow, due to a technical issue with the Excel file used, some plaintiffs identified before the deadline were unintentionally left out of the original submission.  Plaintiffs corrected this on Tuesday.

October 1, 2024: No Cases Added to MDL

New case filings in the Suboxone class action MDL have essentially halted, with no new cases added in September. As a result, the total number of pending cases remains at 674. This slowdown is due to a new tolling agreement that permits prospective plaintiffs to file claims instead of formal civil lawsuits in court.

September 25, 2024:  Why Most of the Best Suboxone Lawsuits Will Have Pre-2018 Usage

The Suboxone lawsuits primarily target the brand-name version of the drug used before June 2018, when Indivior, the company behind its design, testing, and production, controlled the market.

What changed? After June 2018, generic versions of Suboxone became widely available and quickly dominated market share.  No one wanted to keep paying Indivior’s  ridiculous pricing that had made it a fortune. Yet the ongoing lawsuits focus on brand-name Suboxone, alleging that its defective design led to serious dental issues, including tooth decay, erosion, and even tooth loss.

But why not sue the generic manufacturers? While technically possible, it’s a legal uphill battle. This stems from a Supreme Court ruling that protects generic drug makers from liability for failure-to-warn claims—the cornerstone of these lawsuits. According to FDA regulations, generic manufacturers must mirror the brand-name drug’s label, warnings and all, without deviation. Even if they become aware of new risks, they are legally prohibited from adding or changing the warnings.

Because of this, courts have repeatedly found that generic manufacturers can’t be held liable for failing to provide additional warnings. In the case of Suboxone, this means plaintiffs are largely confined to suing Indivior, the original manufacturer, even if they were harmed by the generic version.

The irony, of course, is patients who only took generic Suboxone are left to bear the brunt of a system that shields the follower regardless of its inaction.  The law should point its finger at the original architect and the copyist that does not lift a finger to notify the FDA or the original manufacturer of the problem.  But it does not.

September 7, 2024: Suboxone Status Conference

There was a Suboxone status conference on Wednesday.  This litigation is starting to move along. This what came out of it:

Pending Motions to Dismiss

For lawsuits that are being voluntarily dismissed, the judge believes at this stage the best path is dismissal without prejudice, which means you have the option of refiling the lawsuit.

Discovery from Prior Litigation

Defendants are finalizing their review of deposition transcripts from prior antitrust and patent litigation, with plans to amend their discovery response by September 30, 2024. The relevance of most expert reports from prior litigation is being assessed, and further follow-up with counsel is expected.

Status of Discovery

A unified deadline of September 18, 2024, was set for defendants to provide a list of custodial and non-custodial sources of electronically stored information. Discovery prioritization was given to Indivior over Aquestive. Plaintiffs are to provide information on individuals listed on Schedule A, including records of dental injury and product identification, by September 30, 2024.  If you are a plaintiff on Schedule A, make sure you cooperate with your lawyer to get these records to the defendants.

Bellwether Protocol

Agreement was reached that all claimants must complete a census form. A draft census form, highlighting any disputes, is due by September 30, 2024. The Court plans to finalize the census form at the October status conference and discuss the scope of additional information needed from claimants for bellwether selection.

Next Status Conference

Scheduled for October 4, 2024, with continuation into October 5th.

September 3, 2024: MDL Adds 1 New Case in August

Following a decline in cases last month, the Suboxone class action MDL saw an increase of just 1 case in August, bringing the total number of pending cases to 674.

September 2, 2024:  Suboxone Lawsuits Filed in State Court

There are few Suboxone tooth decay lawsuits filed in state court because there are not many jurisdictions where the defendants can be sued in state court.  A Suboxone case can be removed from state court to federal court under diversity jurisdiction if the parties are from different states (complete diversity) and the amount in controversy is more than $75,000.  There are states where the defendants reside where there is clear state court jurisdiction – notably Virginia, Delaware, Ohio and New Jersey – but there is not diversity in most states.

Indivior recently removed a case that was filed by a Nevada man who is claiming dental injuries from the drug. His Suboxone lawyers for some reason filed the lawsuit in Clark County in Nevada but it will end up with the other cases in the MDL.

August 30, 2024: Arguments for Motion to Dismiss

August 25, 2024: Response to Motion to Dismiss

At the end of last month, we told you about a motion defendants filed that, if granted, would dismiss all of the plaintiff’s claims.

August 14, 2024: Plaintiff Leadership Appointments

This week, the judge overseeing the Suboxone MDL issued new Case Management Orders, appointing additional lawyers to the Plaintiffs’ Leadership Development Committee (LDC). The LDC typically includes younger, less experienced attorneys who may not yet qualify for a position on the main steering or leadership committee—the group responsible for making key decisions. The LDC is generally assigned to research specific issues and provide support to the primary leadership committee.

August 5, 2024: Case Count

The Suboxone class action actually dropped four cases from  677 to 673. This is phone number with so many cases – over 10,000 – protected by the “sort-of” tolling agreement that will be soon replaced by a real tolling agreement.

July 31, 2024: Motion to Dismiss Filed By Defendants

The defendants in the Suboxone litigation have filed a motion to dismiss all lawsuits against them, citing the doctrine of federal preemption. This defense is often used in product liability cases involving prescription drugs. The core of the argument is that plaintiffs cannot sue manufacturers under state law for failure to warn when federal FDA regulations govern the content of warning labels for these drugs. However, this argument rarely succeeds in such cases, and we don’t anticipate a different outcome here.

July 23, 2024: Defendants In Process Of Producing Critical Documents

Getting all the relevant documents from the Suboxone defendants – most notably, Indivior, will be critical to this litigation. The defendant say they are in the process of producing the IND and NDA for Suboxone film and tablets. Regarding antitrust and patent litigation, they will serve amended discovery responses by early next week and continue to supplement their document production.

The parties disagree on the discoverability of documents related to the buprenorphine drug Sublocade and its potential as an alternative design for Suboxone film. It would be really helpful if they discussed tooth decay so Suboxone lawyers really want these documents. The judge will revisit this issue at the next status conference.

July 3, 2024: Lawyers Discuss Converting Filing In Federal Court 

Suboxone lawyers are discussing converting filing in federal court based on diversity jurisdiction into a formal tolling agreement, which would pause the statute of limitations. They’ve had positive discussions and are hopeful about reaching an agreement. They need more time to finalize this and will provide an update by August 1, 2024.

The attorneys have already reached a tolling agreement for non-diverse plaintiffs in state court, which pauses the statute of limitations until June 16, 2025. Plaintiffs’ counsel has shared the names and details of these plaintiffs as part of the agreement.

Why is Indivior willing to agree now after all of it effort to take a tolling deal?  There is already a de facto order in place from the court. See the May 17 update below.

July 1, 2024:  Jurisdiction May Matter in this Litigation

From a statute of limitations standpoint, these states – and Florida and Michigan – are the best states right now for a Suboxone claim because they have a longer deadline to file:

June 24, 2024: MDL Judge Denies Defense’s Motion

The plaintiffs in the Suboxone MDL won a major early victory on the issue of whether to bifurcate discovery. The defense had filed a motion to put off any case-specific discovery and first focus only on the issue of general causation. After hearing oral arguments earlier this month, the MDL denied that motion. The judge explained that the defense proposal would have been inefficient and overly-complicated.

June 20, 2024: Suboxone Lawsuits Near 10,000

Nearly 10,000 people have been added to the Suboxone class action lawsuit. Our May 17th update below explains how this mass filing of plaintiffs looking to protect the statute of limitations were able to file their claim together.

June 11, 2024: Merck & Co. Only Revised Canadian Warning In March 2023

It was not until March 2023 that Merck & Co. revised its Canadian warnings to include reports of “dental caries” among Suboxone users, leading to cavities, decay, filling loss, and sometimes total tooth loss.

For context, the FDA issued a bulletin in January 2022 highlighting the severe dental risks associated with buprenorphine-containing medicines. Yet it took Merck over a year to revise its Canadian warnings.

June 5, 2024: Hearing On General Causation Bifurcation Argument Expected Tomorrow

Tomorrow is the hearing on the general causation bifurcation argument before the MDL judge we talked about in the April 17, 2024 update below. Plaintiffs argue that the Court should deny Indivior request to bifurcate general and case-specific discovery because it presupposes Indivior will prevail on future motions. As the plaintiffs’ response does a great job of explaining, this is unbelievably unlikely given the existing scientific evidence linking Suboxone film to dental erosion. The scientific evidence demonstrates that Suboxone film’s high acidity causes dental erosion, and xerostomia (dry mouth), a known side effect of buprenorphine, reduces saliva that would naturally neutralize acid, leaving teeth more vulnerable to damage. This evidence allows plaintiffs to prove general causation, making bifurcated discovery unnecessary.

June 3, 2024: 153 New Cases Added To MDL

As anticipated, the number of new cases in the Suboxone MDL is rapidly increasing. Last month, 153 new cases were added, marking the second consecutive month with over 100 new cases. The total number of pending cases now stands at 358.

May 30, 2024: Texas Resident Files New Suboxone Lawsuit 

A resident of Jasper, Texas has filed a new lawsuit alleging that the Suboxone film caused him severe dental erosion and decay due to its acidic formulation. The plaintiff asserts that the defendants, including Indivior and other related entities, failed to adequately warn or inform patients and healthcare providers of the significant dental risks. The plaintiff now suffers permanent dental damage and seeks compensatory and punitive damages, claiming the defendants’ negligence and failure to provide proper warnings and instructions regarding the use of Suboxone film.

May 17, 2024: Some Resolution On Tolling Issue 

We have some resolution on the tolling issue. By June 14, 2024, the plaintiffs’ lawyers file a complaint on the master MDL docket, listing individual plaintiffs on an attached schedule with specified details. This will alleviate the need for plaintiffs listed to file their own individual lawsuits.

Defendants may file a motion to sever by July 1, 2024. I’m not totally sure how that would work.  If severed, plaintiffs will file separate actions continuing from the original MDL suit and promptly amend their complaints, ensuring they relate back to the original filing date.

May 14, 2024: Defense Attorneys Submit Rebuttal Brief 

Yesterday, defense attorneys submitted a rebuttal brief, outlining their refusal to accept the tolling agreement suggested by the plaintiffs. They clarified that the plaintiffs’ proposed agreement does not align with the defendants’ best interests. Furthermore, the brief dismisses the plaintiffs’ assertion that without a tolling agreement, their attorneys would be compelled to file claims blindly to prevent expiration under the statute of limitations, without adequate opportunity for investigation.

May 1, 2024: 161 New Cases Added To MDL

In April, the number of cases in the newly established Suboxone tooth decay class action MDL surged more than threefold. Starting the month with only 44 pending cases in the Suboxone MDL, an additional 161 new cases have been added, elevating the total number of cases in the MDL to 205. This rapid early growth in litigation comes as no surprise, and we anticipate further acceleration.

April 18, 2024: New Suboxone Lawsuit Filed By New York Plaintiff

A new Suboxone lawsuit filed last week involves a Westchester County, New York, plaintiff who has experienced significant dental damage, attributed to the use of prescription Suboxone film. Initially prescribed the medication for opioid addiction, the plaintiff was not warned of the potential for serious dental erosion and decay. Despite adhering to medical advice, the plaintiff now faces permanent tooth damage and has undergone extensive dental work to address the harm caused by the medication. The lawsuit seeks compensation for the injuries and damages incurred as a result of using Suboxone film.

April 17, 2024: Indivior Pushes For Prioritization Of General Causation 

Indivior advocates for a discovery phase that prioritizes general causation due to its pivotal role in the litigation’s outcome.

Indivior’s legal team asserts that if general causation cannot be reliably established through scientific evidence, it would render other aspects of the cases unnecessary and inefficient. This strategic approach is designed to conserve resources by averting extensive discovery and litigation efforts that could potentially be futile if general causation is not proven.

Indivior is right that general causation must be proved, or the rest of the case is moot. Are there other personal injury MDLs where this is also true? Yes, every single one.

Indivior draws upon past legal precedents in which courts have ordered discovery to commence with general causation, citing this method as a way to streamline the process and avoid unnecessary legal expenses. Specifically, they cite four cases where this was kinda, sorta the path out of zillions of MDLs over the years.

One huge distinction between the Suboxone lawsuits and those isolated cases is that the manufacturer already has put a warning on the product and has not sought to have it removed.

The update to the Suboxone warning label to include tooth decay is indicative of general causation in the litigation concerning its link to dental injuries. This change in labeling is an acknowledgment by the manufacturer and regulatory authorities of a plausible link between Suboxone use and dental issues, based on observed data and reported cases.

It is a big deal that the warning on this product ultimately changed. A warning label change significantly impacts the arguments surrounding general causation. It is evidence that the manufacturer was aware of potential harms caused by their product, which clearly suggests that there is a scientifically reasonable basis for believing that the product can cause the injury claimed. The label change implies that there have been enough reports or findings to warrant caution to users about specific health risks, in this case, dental injuries.

What a delay would do for Indivior is give them a chance to delay the litigation. After we prove general causation, we would be nowhere on getting individual lawsuits ready for trial. Endless delays frustrate plaintiffs and would push them into being willing to accept lower Suboxone settlement amounts.

Adopting a dual-track discovery approach for both specific and general causation simultaneously can significantly enhance litigation efficiency by ensuring that individual claims are processed concurrently with broader causation issues. This method prevents the stalling of personal adjudications and alleviates the undue burden on plaintiffs, who otherwise might face prolonged delays and increased financial and emotional strain.  Such a plan allows for a more dynamic allocation of resources, potentially minimizing redundancy and ensuring that all aspects of each case receive timely and appropriate attention. By addressing individual specifics alongside general causation, the court can streamline proceedings, reduce bottlenecks, and facilitate a quicker resolution.

April 10, 2024: Attorneys Soon To Begin Dropping Unresponsive Clients

Is your Suboxone lawyer calling you? Please return the call. Many attorneys will soon begin dropping clients they cannot reach as they race to file claims in the MDL in states with a two-year statute of limitations.

April 1, 2024: 30 New Cases Added To MDL

Over the last month, 30 new cases have been added to the new Suboxone class action MDL, which now has 44 pending cases.

March 25, 2024: Four New Suboxone Lawsuits Transferred To MDL

Four new Suboxone suits were transferred to the MDL today.

March 19, 2024: Judge Calabrese Establishes Protocol For Direct Filing And Service Of Process

In Case Management Order No. 3, Judge Calabrese establishes protocols for the direct filing and service of process. Defendants have agreed to waive formal service of summons for cases in this MDL, except for Reckitt Benckiser Healthcare (UK) Ltd., which has agreed to abate the issue of service waiver. Defendants are required to establish an email address to accept service of complaints, facilitating an expedited process. However, this does not apply to Reckitt Benckiser, who clearly wants to be difficult.  So traditional service methods may still be required.

Importantly, the order allows for the direct filing of Suboxone lawsuits. Direct filing in an MDL allows plaintiffs to file their lawsuits directly into the centralized proceeding, bypassing the initial filing in their local jurisdiction and the subsequent transfer process.

The order also confirms that directly filing an action does not determine the applicable choice of law and does not require the application of Ohio’s choice of law rules. Instead, the choice of law will be determined as if the case were originally filed in the designated “Original Venue” and then transferred to the MDL. Upon completion of pretrial proceedings, cases will be presumptively transferred back to their original venues for trial, unless otherwise objected to or agreed upon by the parties.

March 11, 2024: New Video On Suboxone Lawsuit

We put up a pretty new and pretty comprehensive Suboxone lawsuit video today that explains where we are in the litigation and talks about expected settlement amounts.

March 8, 2024: First Suboxone Status Conference Held

Yesterday, the first Suboxone status conference was held. There is not much to report, but we should shortly have the ability to direct file in the MDL and hopefully graduate to a short-form complaint, which will make filing claims much easier.

Lawyers’ impression of the hearing is that Judge Calabrese will be eager to move this litigation forward. That is good news for everyone.

March 7, 2024: Defendants Propose Gradual Approach To Pretrial Discovery

The defendants are proposing a gradual approach to pretrial discovery in the Suboxone litigation. They want an initial phase focusing specifically on establishing general causation.

In other words, the Suboxone defendants want first to gather evidence to determine if there is a general link between the defendant’s actions or product and the alleged harm. On the other hand, the plaintiffs are against splitting the discovery process into different phases, particularly when it comes to investigating general causation.

Why?  Two reasons.  First, general causation is a lock in these cases. We have a warning on the subject of this litigation.  Second, bifurcated litigation slows down the path to getting trial dates which slows down the path to settlement.

March 5, 2024: Federal Judge Approves $385 Million Settlement

A federal judge in the US District Court of the Eastern District of Pennsylvania has approved a $385 million settlement between a group of direct purchasers and Indivior Inc., the maker of Suboxone, an opioid addiction treatment.

This is not a tooth decay class action lawsuit alleging personal injuries.  This is an entirely different Suboxone lawsuit. The settlement resolves claims that Indivior abused its monopoly over Suboxone.  The lawsuit initiated nearly a decade ago centered on Indivior’s decision to switch Suboxone from a tablet to a sublingual film in 2010, with plaintiffs alleging anticompetitive motives.  Indivior had previously settled with 42 states’ attorneys general for approximately $102.5 million and with a plaintiff class of end-payors for $30 million.

March 4, 2024: New Suboxone Lawsuit Filled On Behalf Of Pennsylvania Woman

A new Suboxone lawsuit was filed Friday on behalf of a Pennsylvania woman who was prescribed Suboxone film in 2016 to treat an opioid addiction that began after a wrist surgery nearly ten years before. She switched to Suboxone film in 2019.  Her tooth decay symptoms began in 2020.  Of course, neither she nor her doctors understood that her dental complications were from Suboxone because there was no warning on the product until 2022.

March 1, 2024: Currently 51 Pending Cases In MDL

The newly created Suboxone tooth decay class action MDL currently has a total of 51 pending cases. This is going to be a fast-growing MDL so look for this number to go up very quickly over the next few months.

February 19, 2024: New Suboxone Lawsuit Filed In Federal Court

A new Suboxone lawsuit was filed in federal court last week. A resident of Washington County, Pennsylvania, filed suit following severe dental damage attributed to the use of Suboxone film she used for opioid use disorder management.

As all of these suits do, this lawsuit emphasizes the absence of adequate warnings about the potential for dental erosion and decay associated with the medication, despite the FDA mandating a new warning label in June 2022 for all buprenorphine medications that dissolve in the mouth. This label change highlighted the risk of dental issues, a warning not deemed necessary for other buprenorphine formats like injectables or patches.

February 13, 2024: Case Management Order No. 1 Outlines Initial Steps

MDL No. 3092 is moving forward now.  Case Management Order No. 1 for the Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, as this litigation will be called, kicks off the litigation and outlines the initial steps for organizing and managing these consolidated lawsuits.

Nothing surprising in this order from Judge J. Philip Calabrese,   Here are the key points summarized:

1. Initial Status Conference: Scheduled for March 7, 2024, at the Carl B. Stokes U.S. Courthouse in Cleveland, Ohio. This is a preliminary conference, and parties are not required to submit a Rule 26(f) Report beforehand.
2. Attendance Requirements:
   • Counsel for all parties do not need to attend in person, and groups with similar interests are encouraged to appoint a single attorney to represent them collectively at the conference.
   • Attendance via phone is allowed, but notice must be given to the Court’s MDL Clerk by March 4, 2024.
   • Counsel seeking leadership roles should be present in person, as those not in attendance won’t have the opportunity to speak at this conference.
3. Participation of Other Counsel: Attorneys representing clients not currently part of the litigation but who may be joined later are invited to attend or participate.
4. Pre-Conference Submissions:
   • By March 1, 2024, parties must submit a joint memorandum discussing various issues, including case categorization, anticipated case numbers and types, document repository creation, discovery protocols, and more.
5. Leadership Structure:
   • The court plans to appoint leadership counsel for plaintiffs, considering criteria such as cooperation, commitment, experience, and resources.
   • Applications for leadership positions are due by March 1, 2024.
6. Plaintiffs’ Separate Submission: Also by March 1, 2024, plaintiffs’ counsel must submit a memorandum detailing the proposed leadership structure, responsibilities, and the management of a common benefit fee and expense fund.
7. Stays on Pleadings and Discovery: Deadlines for defendants to respond to complaints and all current disclosures, discovery, and motions to dismiss are stayed until the status conference, where further directions will be discussed.
8. Application to Later-Filed Cases: This order applies to all cases later filed in, transferred to, or removed to this court as part of the MDL.
9. Admission of Counsel: Attorneys of record in transferred actions may continue to represent their clients without the need for a pro hac vice motion, but must maintain an electronic filing account. This is a blessing.

This order sets the procedural groundwork for managing the litigation, including initial conference logistics, leadership structure, and preliminary case management protocols.

February 4, 2024: Suboxone Lawsuit Gains New Momentum

You will see more lawyers getting involved, and, more importantly, we are increasing our settlement payout estimates. The warning was changed for a reason—suboxone causes tooth decay. No one disagrees with this, an incredible luxury in proving any civil lawsuit.

January 30, 2024: New Study Suggests Pregnant Woman Should Consider Suboxone Over Methadone

All along we have told you we do not support a Suboxone recall. Instead, what our Suboxone lawyers are saying is that patients need to know the dental injury risks to make an informed choice and to engage in dental hygiene to control that risk.

The findings of a new study suggest that pregnant women are a group that should be talking to their doctor about possibly choosing Suboxone over methadone. Why? The study found that women seeking treatment for opioid addiction may face a higher risk of delivering a child with birth defects if they use methadone, compared to the use of Suboxone or other buprenorphine drugs.

January 26, 2024: JPML Panel Meets To Discuss Lawsuit Consolidation

Today, the JPML Panel met to discuss whether to consolidate the Suboxone lawsuits. Our lawyers believe the Panel will rule next month to consolidate these cases in a new Suboxone class action lawsuit.

January 23, 2024: Accepted States

In 2024, our lawyers are accepting new Suboxone lawsuits in these states (and now, in April 2024, Michigan).  UPDATE: We now take claims in all 50 states for reasons explained above.

January 16, 2024: New Suboxone Lawsuit Filed By Pennsylvania Resident

A new Suboxone lawsuit was filed on Friday. The plaintiff, a resident and citizen of  Pennsylvania, experienced dental damage directly caused by using the Suboxone film prescribed by the Defendants.

In 2013, a physician prescribed Suboxone film to Plaintiff for the treatment of opioid use disorder. Of course, neither Plaintiff nor Plaintiff’s physicians were informed of the significant risk of dental erosion and decay associated with Suboxone film. Plaintiff now suffers from permanent tooth damage and has undergone extensive dental procedures to address the damage caused by Suboxone film.

January 11, 2024: More Suboxone Lawsuits Expected In MDL By End Of Month

Our lawyers have not seen any new Suboxone lawsuits since the one filed by our legal team at the end of last year. More will be filed before the MDL hearing at the end of the month to show the MDL Panel that the volume of cases justifies a Suboxone class action lawsuit.

January 4, 2023: Suboxone Medication Guide Does Not Include Warnings Surrounding Tooth Decay

What is crazy is that the medication guide for Suboxone film does not include warnings about certain tooth decay risks as a potential side effect of this drug formulation. It is in the prescribing information, but Indivior apparently does not take it seriously enough – even with all of these Suboxone dental injury lawsuits – to put it in the medication guide. It is hard to understand what Indivior is thinking.

January 2, 2023: Thousands Of Suboxone Cases Under Active Investigation

As we head into the hearing later this month on forming a Suboxone class action MDL, there are at least 15 Suboxone tooth decay cases pending in 5 different federal districts nationwide. That may seem like a small number, but there are thousands more Suboxone cases under active investigation and soon to be filed by lawyers across the country.

December 13, 2023: Suboxone Defendants Agree With Motion To Create Class Action MDL

The defendants in the Suboxone tooth decay lawsuits recently filed a response to the request for class action MDL consolidation. In the response, the Suboxone defendants actually agreed with the motion to create a new Suboxone class action MDL. They request that the MDL be assigned to Judge Philip Calabrese in the Northern District of Ohio. The Suboxone MDL will likely be established next month.

December 7, 2023: New Video Provides Latest New In Efforts To Create Suboxone Class Action

We have a new video proving the latest news in the effort to create a Suboxone class action lawsuit and how an MDL will put real settlement pressure on Indivior. We also talk about the main reason our lawyers believe most victims bringing a Suboxone lawsuit will have a strong case.

November 27, 2023: Plaintiffs Petition To Consolidate All Federal Suboxone Lawsuits Into Single MDL

Legal representatives for the plaintiffs have petitioned the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal lawsuits related to Suboxone into a single multidistrict litigation (MDL).

So, this is the effort to form a class action lawsuit. Plaintiffs ask that every federal Suboxone lawsuit be transferred to a federal court in Ohio. What would this do? It would simplify and expedite pretrial processes and push Indivior to offer reasonable settlement amounts (down the road, anyway). Presently, these lawsuits are scattered across various federal districts. Forming an MDL class action lawsuit would provide a more efficient way to handle these cases, which all share similar foundational allegations.

November 3, 2023: 14 New Suboxone Lawsuits Filed In Federal Courts

In just the last two weeks, fourteen new Suboxone product liability lawsuits have been filed in federal courts against the manufacturer, Indivior. Eight of them were filed in the Northern District of Ohio, which has the most pending Suboxone cases of any district.

November 2, 2023: Ohio Man Files Suboxone Lawsuit

A man in Wood County, Ohio, filed a Suboxone lawsuit after suffering from dental injuries after using Suboxone film.

Like most of the victims who call our law firm, he developed an addiction to opioids. His doctor prescribed Suboxone to manage the addiction. As a result of the prescribed usage of Suboxone film, the plaintiff now alleges he suffers from permanent tooth damage.

His Suboxone tooth decay lawsuit seeks damages for the substantial dental procedures he has undergone and for the pain and suffering these injuries have caused him.

October 30, 2023: Suboxone Manufacturer To Fight Two-Front Litigation Battle

Indivior, the manufacturer of Suboxone, will be fighting a two-front litigation battle. While the number of tooth decay suboxone lawsuits continues to grow, Indivior will also defend a false claims act lawsuit accusing the company of an illegal kickback scheme. Last week, a federal judge rejected Indivior’s motion to dismiss that case and allowed it to proceed.

October 24, 2023: Indivior Agrees To $385 Million Settlement

The maker of Suboxone, Indivior, has now agreed to pay another $385 million to settle an antitrust lawsuit accusing the company of illegally suppressing generic competition.

The lawsuits claim that Indivior introduced the dissolving film tab version of Suboxone just as its patent on the original pill version was about to expire to block competition from generic Suboxone tablets. Indivior already paid $900 million to settle a similar lawsuit the states and the federal government brought.

October 16, 2023: Ohio Man Files Suboxone Lawsuit In Federal Court 

A man from Geauga County, Ohio, became the latest plaintiff to file a Suboxone tooth decay lawsuit in federal court King v. Indivior, Inc, et al. 1:23-cv-01924 (N.D. Ohio).

According to the Complaint, the plaintiff became addicted to opioids after being prescribed them by his doctor. The plaintiff was eventually prescribed Suboxone to treat his addiction. After just 16 months on Suboxone, the plaintiff began to suffer severe tooth decay and eventually had to have several teeth extracted permanently.

The Complaint alleges that neither the plaintiff nor his doctor knew Suboxone caused tooth decay.

Suboxone

Suboxone is a medication primarily used in the treatment of opioid addiction, and it has been an assistance to doctors trying to get patients off opioids.

Suboxone combines two active ingredients: buprenorphine and naloxone. Buprenorphine is a partial opioid agonist, which means it activates the same receptors in the brain as opioids but to a lesser degree, reducing withdrawal symptoms and cravings while preventing the intense high associated with full opioid agonists like heroin or prescription painkillers.

Naloxone, on the other hand, is an opioid antagonist that reverses the effects of opioids and can precipitate withdrawal symptoms if misused. Suboxone comes in the form of sublingual films or tablets, and it’s typically administered as part of a comprehensive treatment program that includes counseling and therapy.

While Suboxone has admittedly had some success in helping individuals manage opioid addiction and transition towards a drug-free life, it’s not without its risks and side effects. Common side effects may include nausea, headache, sweating, constipation, and sleep disturbances.

These side effects are generally manageable and are outweighed by the benefits of reducing opioid dependence. You can help manage them because… the companies that make and distribute the drug warn about these risks. So doctors and patients know of the risks and make an informed choice. So you would think…

Suboxone Converts from Pills to Film

The idea to convert Suboxone tablets into a film dosage form stemmed from the need for a more user-friendly and, frankly, potentially less abusable format. The film version was intended to replicate the pharmacokinetics of the tablet form, ensuring similar therapeutic effects.

The film comprises about 25% by weight of a polymeric carrier matrix, which is critical for structuring the film and controlling the release of the active ingredients. The pH of the product is really key and this is segue into the story of how these lawsuits came about.

The effectiveness of the Suboxone film largely depends on maintaining a specific acidity level in the presence of saliva—around a pH of 3 to 3.5. This acidic environment is crucial because it ensures that buprenorphine, the main active ingredient in Suboxone, stays in a form that the body can absorb more easily. When buprenorphine is in this slightly acidic setting, it stays mostly non-ionized, which is the state that allows it to be absorbed effectively through the mucous membranes in the  mouth.

The Problem is the pH in the Film

This is where the Suboxone lawsuits come into play. A pH level of 3 to 3.5 in the mouth is considered highly acidic.  For some context, your normal saliva typically has a neutral pH, ranging from about 6.5 to 7.5. When the pH level in the mouth drops below 5.5, it creates an environment where tooth enamel can begin to demineralize, leading to tooth decay.

At a pH of 3 to 3.5, the acidic environment is significantly more aggressive in terms of potential harm to the teeth. This level of acidity can rapidly erode tooth enamel and increase the risk of cavities and other forms of dental damage. Such acidic conditions are usually the result of consuming acidic foods and drinks, such as citrus fruits, sodas, and certain sports drinks.

Maintaining a more neutral oral pH is crucial for dental health, and frequent exposures to highly acidic environments should be minimized to protect teeth from decay and erosion.  That is a real key to this litigation that does not get enough attention.  If you are taking a drug, there are rarely precautions you can take to avoid serious risk.  Here, a warning would have done wonders for patients who could have taken much better care of their teeth than a normal person would to prevent unnecessary tooth decay.

Suboxone Lawsuits

Our law firm is handling Suboxone lawsuits. Our lawyers are bringing these tooth decay lawsuits because the defendants knew their drug was causing severe tooth decay and dental injuries and told no one.

Yes, they finally put a warning on in 2022. But every Suboxone lawsuit that is being filed is for victims of tooth decay, broken teeth, and other dental injuries that flow from Suboxone, who used the product before 2022 and who were blindsided with this risk for no good reason.

If you are a victim, you may be eligible for compensation through a Suboxone lawsuit payout. Our lawyers believe that the defendants in these cases will be forced to pay reasonable settlement amounts to patients who used this product and suffered severe dental injuries.

Again, our Suboxone lawyers are actively investigating claims against the drug manufacturers for their failure to provide adequate warnings about the risks of severe tooth decay and other dental problems associated with Suboxone. Our legal team began bringing Suboxone lawsuits in 2023, and our team will bring many more suits in 2024.

No fees or expenses are involved – ever – unless we successfully secure a settlement amount or jury payout for you.

The Risk of Dental Injuries

Studies have indicated that Suboxone sublingual films, which dissolve under the tongue, may lead to tooth decay and other dental problems due to their acidic nature.

Extended exposure to this acidic medication can weaken tooth enamel and contribute to dental issues such as cavities, gum disease, and even tooth loss. These dental problems can be painful and may necessitate corrective dental procedures like fillings, extractions, or implants.

If you started taking Suboxone in 2023, you likely learned about this risk through discussions with your doctor or reading the package insert.

To manage this risk, patients can take extra care of their teeth through regular brushing, flossing, and using fluoride toothpaste and mouthwash to strengthen tooth enamel. Dietary adjustments, like reducing sugary food and beverage consumption while ensuring a calcium and vitamin D-rich diet, can also help maintain strong teeth.

However, if you used the product before the 2022 warning, you probably did not know about this risk. If you suffered severe tooth decay or other dental injuries and were unaware of the risk, you are an ideal candidate for a Suboxone lawsuit.

The Core of Every Suboxone Lawsuit – Failure to Warn

If you are taking Suboxone in 2023, you likely know of this risk because you discussed it with your doctor or read it on the package insert. What can they do? They can be extra careful with their teeth. Patients could have paid extra attention to their oral hygiene practices. This includes regular brushing and flossing to maintain healthy teeth and gums. Using fluoride toothpaste and mouthwash can also help strengthen tooth enamel.

Patients can also adjust their dietary habits. This could involve reducing the consumption of sugary foods and beverages, which can contribute to tooth decay. A diet rich in calcium and vitamin D can help maintain strong teeth.

Patients can also, not for nothing, choose another drug than Suboxone to deal with withdrawal.

No Warning Before 2022

But if you took the product before the warning in 2022, you likely did not know of this risk. If you did not know of the risk and you suffered severe tooth decay or other dental injuries, you are a prime candidate for a Suboxone lawsuit.

In June 2022, the defendants finally updated the prescribing information for Suboxone film to include warnings about the risk of dental issues.

The Suboxone Study That Broke the Camel’s Back

A 2022 study confirmed what Suboxone lawyers had already known – Suboxone causes dental injuries. Researchers looked at three groups of people who used different medications: sublingual buprenorphine/naloxone, transdermal buprenorphine, and oral naltrexone. They found that the group using sublingual buprenorphine/naloxone had a higher risk of dental problems compared to the other two groups.

Specifically, they found that the group using sublingual buprenorphine/naloxone had more dental issues, such as cavities and tooth loss. The risk of dental problems was 1.42 times higher compared to those using transdermal buprenorphine and 1.67 times higher compared to those using oral naltrexone.

The incidence rates of dental caries or tooth loss were also significantly higher with sublingual buprenorphine/naloxone at 8.2 per 1000 person-years, compared to 3.5 for transdermal buprenorphine and 3.8 for oral naltrexone. That is a huge difference. For dental caries or tooth loss, the HRs were 1.57 for sublingual buprenorphine/naloxone versus transdermal buprenorphine and 1.71 versus oral naltrexone.

Why? Researchers think the acidic nature of sublingual buprenorphine/naloxone might be causing these dental problems. People taking this medication are instructed to hold it under their tongue for a few minutes, which could expose their teeth to acid for extended periods.

What our Suboxone lawyers have been able to gather from all of this is that Suboxone sublingual films are notably acidic. We have known forever that acidity can contribute to tooth decay. When these films dissolve under the tongue, they introduce acidity to the mouth, weakening tooth enamel—the protective outer layer of teeth. As enamel erodes, the inner layer, dentin, becomes more exposed and vulnerable to decay.

Who Qualifies for a Suboxone Lawsuit in 2024?

Victims who used these sublingual films and developed dental problems such as severe tooth decay or loss, tooth extractions, broken teeth, and jaw bone injuries are potential plaintiffs. Our lawyers expect that if there is a Suboxone class action lawsuit and a settlement, there will be higher settlement amounts if you require dental implants, oral surgeries, or other escalated dental treatment.

Primary Defendants in Suboxone Lawsuits

Indivior, Inc. and Aquestive Therapeutics Inc. are the pharmaceutical companies that developed Suboxone, and Indivor is the primary drug manufacturer. Both of these companies are named as primary defendants in the Suboxone lawsuits. Neither of these companies is a household name like Pfizer. That is because these are not your typical “big pharma” companies. Instead, they are specialty or “boutique” pharmaceutical companies that focus on a specific segment of the drug industry.

Indivior’s entire business is specifically focused on developing and manufacturing buprenorphine-based drugs that are utilized in the treatment of opioid dependency. Until fairly recently, Indivior was a division of Reckitt Benckiser (Reckitt), a larger pharma company based in the United Kingdom. When the market for opioid dependency drugs started to explode about eight years ago, Reckitt cashed in on the potential profitability and spun off Indivior as a new publicly traded company. Reckitt owns a significant percentage of shares in Indivor and is typically named as a defendant in the Suboxone lawsuits.

Although all of the various companies related to Suboxone are generally named in these lawsuits, Indivior will assume primary liability. One thing that stands out about Indivior is that it already has a “rap sheet” with U.S. authorities.

Estimated Settlement Payout Value for Suboxone Lawsuits

Our mass tort attorneys estimate that successful Suboxone lawsuits involving tooth decay could have a settlement payout value range of around $30,000 to $150,000.

Trial value is a different story. The estimated jury payout for a Suboxone lawsuit that goes to trial could be millions of dollars. In a case like this, what could inflate jury awards is the possibility of punitive damages, and it sounds like, based on what Suboxone lawyers already know before we even get into pretrial discovery,  there is fertile ground for punitive damages in these cases.

Even if punitive damages are not awarded, the trial value of these cases would be much higher than their settlement value. What would be a reasonable estimate of the average jury verdict for a Suboxone compensation claim even without punitive damages? That question takes the word speculative to a whole new level. But our attorneys think the potential jury payouts for a Suboxone lawsuit would be $500,000 to $1 million. A case with a sympathetic plaintiff and good facts could fetch an even larger Suboxone payout.

All of this – jury predictions and settlement payout estimates – are very speculative. The Suboxone tooth decay lawsuits are still very new. We have still in the discovery phase in any of the cases. So there is no question there are a ton of  variables could potentially impact the viability of these cases. Our settlement compensation payout estimates are based on the assumption that these cases will be viable and successful. It is all very new, but our Suboxone lawyers have high hopes for these lawsuits.

• More Suboxone lawsuit settlement amount predictions

Punitive Damages

Punitive damages may really drive Suboxone settlement amounts in this litigation. It is not a complex case to make here.

The defendants are alleged to have knowingly and consciously disregarded the safety of others. Specifically, it is claimed that they misled the medical community and the public with false or misleading information about Suboxone’s safety and effectiveness and did not provide adequate usage instructions or training. They allegedly downplayed, understated, or ignored the severe side effects and risks associated with Suboxone, particularly its potential to cause dental erosion and decay, despite being aware or should have been aware of these risks.

So plaintiffs will seek, in jurisdictions where the law allows, punitive damages by arguing that the defendants’ conduct was willful, intentional, and recklessly disregarded the rights and safety of consumers. The message to the jury: the defendants should be punished and deterred from similar conduct in the future.

If a jury accepts the ample evidence plaintiffs will present, it may award millions of dollars in jury compensation. Would verdicts like this drive Suboxone settlement payouts higher? Of course.

How to Join the Suboxone Tooth Decay Lawsuit

Our national mass tort lawyers are looking for Suboxone cases across the country. Call us today at 800-553-8082 or contact us online for a free consultation.