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Suboxone Tooth Lawsuit

Our legal team is actively involved in Suboxone litigation, specifically focusing on lawsuits related to tooth decay. Our attorneys are representing individuals affected by tooth decay, broken teeth, and other dental injuries caused by Suboxone.

Suboxone lawsuits are being pursued because the defendants were aware of the drug’s propensity to cause severe dental issues, yet failed to inform the public.

While a warning was eventually added in 2022, these Suboxone lawsuits seek justice for individuals who suffered dental injuries prior to this warning. These victims, unaware of the risks associated with Suboxone, experienced tooth decay and other dental problems without sufficient warning or justification.

This page is about when a Suboxone lawsuit will settle and what the expected Suboxone settlement payouts will be.

Our lawyers are actively reviewing and accepting new Suboxone tooth decay cases. We have already accepted thousands of qualified claims.  If you used Suboxone and experienced significant tooth decay, you may have a legal claim.

Contact us today at 800-322-3010 or contact us online for a free case evaluation. We are here to explore your legal options and fight for the justice you deserve.

Suboxone Dental Lawsuit News & Updates

The litigation surrounding Suboxone-related tooth decay claims continues to evolve.  Our lawyers are really high on these lawsuits and the prospects for quality settlements.

There continue to be significant developments that shape and reshape the direction of these lawsuits. Plaintiffs are actively filing new cases that argue that manufacturers failed to warn consumers of the risks despite having knowledge from medical literature and adverse event reports. The multidistrict class action is gaining momentum, with key rulings (that we discuss below in the updates) determining which claims can move forward, including those related to design defects and failure-to-warn allegations.

As the MDL grows, discovery is now underway. We are making progress.  The gist of it all is proving that Suboxone’s manufacturers knew about the drug’s potential for severe dental harm but failed to act. The judge’s recent rulings have helped define the scope of the litigation in a ay that helps us, with pre-approval design defect claims and post-2022 failure-to-warn claims remaining active.

Additionally, thousands of claims have been registered under tolling agreements, suggesting that the total number of cases will likely surge in the coming months. With court proceedings progressing and new lawsuits being filed, the fight for accountability in the Suboxone litigation is far from over.

If you or a loved one suffered dental damage from Suboxone, staying informed on these updates is critical as the legal landscape continues to develop. Here is the latest:

February 14, 2025: MDL Status Conference

A status conference was held in the Suboxone tooth decay MDL this week. The MDL Judge used the conference as an opportunity to address various housekeeping and procedural issues. First, the judge set forth a process for the withdraw of attorneys for the group of plaintiffs who were not required to file lawsuits to preserve their claims. Second, the judge instructed attorneys for both sides to work collaboratively on issues relating to discovery of electronically stored information. Finally, Indivior was ordered to produce the New Drug Application (NDA) for Sublocade, an alternative drug for the treatment of opioid addiction. This could have relevance to some of the claims in the Suboxone litigation.

February 6, 2025: Suboxone MDL Sees Spike in New Cases

January saw a sharp rise in Suboxone tooth decay lawsuits, with 142 new cases joining the MDL. This uptick pushes the total number of pending cases to 896. That said, given that many claims remain under the tolling agreement, the number of officially filed Suboxone does not necessarily reflect the full scope of legal activity in this litigation.

January 29, 2025: New Suboxone Lawsuit

In a newly filed lawsuit, the plaintiff alleges that Suboxone caused significant dental damage, including tooth decay, erosion, and loss, despite being used as prescribed. The plaintiff claims to have experienced a sudden and severe decline in oral health, necessitating extensive dental treatments such as root canals, fillings, and extractions. The complaint highlights that Suboxone’s acidic formulation, with a pH as low as 3.4, is a critical factor in the dental harm, as prolonged exposure to the dissolved medication in the mouth alters microbial activity and promotes decay. While Canadian labeling for Suboxone warned of potential dental issues, no similar warnings were provided in the United States. So plaintiff was obviously not advised of the risk by his doctor or the packaging.  The plaintiff contends that the manufacturers knew of these dangers through adverse event reports, medical literature, and internal communications but failed to take action to update U.S. labels or adequately warn patients, leading directly to the plaintiff’s injuries.

This looks like a strong case on causation. The plaintiff had no prior history of significant dental problems or changes in dental hygiene practices before initiating Suboxone treatment for opioid dependency. Despite diligent oral care and no increase in the consumption of sugary foods or beverages, the plaintiff began experiencing rapid and unexplained deterioration in dental health after starting Suboxone, including the need for multiple root canals, crown replacements, and tooth extractions.

The plaintiff did the right thing, following the prescribed instructions to a T, allowing the medication to dissolve in the mouth as directed to maximize absorption. Of course, this was the problem—prolonged exposure to its acidic formulation. This prolonged exposure contributed to a significant decline in the plaintiff’s oral health, causing physical pain, emotional distress, and substantial financial expenses for corrective dental treatments.

January 10, 2025: A (Mostly) Huge Win in the MDL

On December 31, 2024, Judge Calabrese issued a critical ruling in the MDL. The court decided that pre-approval design defect claims—alleging Suboxone was defectively designed before FDA approval—could proceed. The judge found no evidence that Congress intended to preempt these claims. However, post-approval design defect claims were dismissed because federal law preempts state-law demands to remove or redesign a drug after FDA approval.

The judge also allowed failure-to-warn claims for actions after the 2022 label change to move forward. Plaintiffs allege the manufacturer could have updated warnings earlier based on newly acquired safety information, including a 2022 study showing Suboxone’s risks of dental damage. Claims from before FDA approval and the period between 2010 and the 2022 label change were not addressed, as they weren’t part of the motion to dismiss.

This ruling is a mixed bag. While some claims survived, others were struck down, particularly those challenging Suboxone’s design after FDA approval. But on balance, this is a huge with for us.  The MDL will now continue with discovery and further arguments, offering plaintiffs the chance to prove what we think is obvious:  that Indivior failed to warn about risks and released an unsafe product. This decision keeps alive some of the most important claims, allowing us to push forward and hold the manufacturers accountable.

More Suboxone Litigation Updates

We have been doing these updates for quite some time. Click on the link to get more information on the update.

December 3, 2024: MDL Case Count Update
38 new cases were added to the Suboxone class action MDL during the month of November. That is a significant increase in the volume of new cases added per month compared to September and October. There are now 716 pending cases in the MDL, but there are thousands more Suboxone tooth decay claims that have been registered under the tolling agreement with Indivior in lieu of being filed in court.
November 28, 2024: Hearing Set on Motion to Dismiss
The MDL has set a hearing for oral arguments on the motion to dismiss filed by the defendants in the Suboxone MDL. The hearing will be held on December 16, and lawyers for both sides are being asked to submit a joint report to the judge shortly before the hearing outlining any additional issues that could potentially be addressed during the hearing.
October 20, 2024: Plaintiffs Now Required to Submit Documents
In a new Case Management Order issued by the Suboxone tooth decay MDL judge, all plaintiffs in the Suboxone MDL will now be required to submit more detailed information and documentation to support their claims. All plaintiffs must now complete and submit a Census Form along with signed authorizations for dental, medical, and pharmacy records that will be used to verify their alleged use of brand name Suboxone.
August 14, 2024: Defense Files Motion to Dismiss
Lawyers for the defendants have filed a motion to dismiss in the Suboxone MDL. The motion is based on the federal preemption defense, which is commonly asserted in these types of pharmaceutical cases. The defense is rarely successful in these cases, and we don’t expect anything different here.
January 30, 2023: MDL Number Assigned
The U.S. Judicial Panel on Multidistrict Litigation (JPML) convened in Santa Barbara, California, on January 25. The MDL number for this case, officially titled “In Re: Suboxone [Buprenorphine/Naloxone] Film Marketing, Sales Practices, and Products Liability Litigation,” will be MDL-3092.
January 2, 2023: Hearing Scheduled for New MDL Formation
The JPML is scheduled to hold a hearing to discuss the potential formation of a new MDL for Suboxone tooth decay lawsuits. Currently, at least 15 Suboxone lawsuits are pending in five U.S. District Courts, with more cases being enrolled or investigated nationwide.
December 13, 2023: Defendants Support MDL Consolidation
Responding to plaintiffs’ lawyers’ motion, defendants in the Suboxone lawsuits agree on the significant commonalities in these cases and support their consolidation into a class action before Judge J. Philip Calabrese in the Northern District of Ohio.
December 7, 2023: New Class Action Coming Soon
We believe there will be a Suboxone class action lawsuit soon, probably in Ohio. Our lawyers predict over 10,000 cases.
November 27, 2023: Motion for MDL Formation
Exploration of the critical elements in the motion for transfer, coordination, or consolidation for the formation of a Suboxone MDL class action lawsuit in the Northern District of Ohio, aimed at centralizing all current and future Suboxone-related lawsuits.

About Suboxone

Suboxone emerged as a ray of hope amidst the opioid crisis, offering an alternative for those grappling with opioid dependence when it was FDA-approved in 2002. Comprising buprenorphine and naloxone, Suboxone was designed to combat misuse while alleviating withdrawal symptoms.

Buprenorphine, a semi-synthetic opioid, gained attention in the 1960s for its unique qualities—it could alleviate pain and simultaneously counteract the effects of opioids like heroin and morphine. Distinct from Suboxone, buprenorphine serves as an opioid agonist for managing opioid dependence or moderate-to-severe pain.

Researchers began exploring buprenorphine’s potential for opioid use disorder (OUD) management in the 1970s, noting its advantages over medications like methadone due to a lower risk of overdose and a less appealing form for potential abuse, dissolving under the tongue.

In 1995, buprenorphine received FDA approval for pain relief, and in 2002, Suboxone, a blend of buprenorphine and naloxone, obtained FDA endorsement for managing opioid dependence.

While there’s no call for a Suboxone recall, lawsuits address the need for comprehensive warnings about associated risks. Plaintiffs contend that drugmakers should provide thorough information to patients, allowing them to make informed choices and take preventive measures, including dental precautions to avoid risks linked to the drug.

Suboxone Works Great… But

As most of you reading this know, Suboxone works. Well. Suboxone fairly acclaimed as the best-in-class treatment for opioid addiction.

It is also true that good drugs can have side effects. Suboxone can cause  nausea, vomiting, drug withdrawal syndrome, headache, sweating, numbness or tingling, swelling of the extremities, pain, and insomnia.

So what does the drug company do? It warns patients about these risks.

But sometimes, for whatever reason, drug companies do not tell doctors or users of the drug of the risks.  Our Suboxone lawyers believe that an earlier warning could have cost Indivior money in lost sales.

Suboxone Injuries Our Clients Are Reporting

Since our law firm begin taking Suboxone lawsuits, our phones have been ringing off the hook with victims who believe they have bene injured by Suboxone.  Here are the injuries they are reporting:

  • Dry Mouth: A notable side effect of Suboxone is reduced saliva production, which can intensify the risk of tooth decay due to decreased natural oral protection.
  • Tooth Erosion: There’s a potential for enamel erosion with Suboxone use, leaving teeth more susceptible to decay and sensitivity.
  • Severe Tooth Decay: A critical concern where users report cavities and extensive damage to their teeth.
  • Oral Infections: There’s an increased risk of developing infections in the mouth, which could lead to more serious dental complications if left untreated.
  • Brittle Teeth: Prolonged use of Suboxone might contribute to the weakening of teeth, making them more prone to cracks and fractures.
  • Gum Problems: The use of Suboxone might lead to an increased risk of gum-related diseases, adversely affecting overall dental health.

Suboxone Tooth Decay Lawsuits

An increasing number of nationwide lawsuits are being filed against Suboxone manufacturers, alleging wrongful and negligent conduct in various aspects of the drug’s development, design, testing, labeling, packaging, promotion, advertising, marketing, distribution, and sales.

These legal actions specifically claim that the manufacturers had prior knowledge or should have been aware that Suboxone, as prescribed, leads to harmful dental damage due to the acidic nature of buprenorphine. Despite this awareness, the lawsuit contends that the manufacturers initially marketed and sold Suboxone without providing warnings regarding the risks of tooth decay.

In January 2022, the FDA released a public safety announcement highlighting the risks of tooth decay linked to Suboxone. Only after this warning was issued did the Suboxone makers update the drug’s label to include information about the potential risk of tooth decay. This failure to warn adequately, despite prior knowledge, constitutes a clear example of negligence, making the manufacturers’ liability challenging to dispute.

Defendants in the Suboxone Lawsuits

The central defendant in the Suboxone legal cases is Indivior, Inc., a pharmaceutical firm responsible for manufacturing and marketing Suboxone. Indivior specializes in developing drugs for treating opioid dependency, with Suboxone being a prominent product in their portfolio. Initially, Indivior was a division of the British pharmaceutical company Reckitt Benckiser (Reckitt). However, in 2014, Reckitt separated Indivior, along with its rapidly expanding opioid addiction treatment segment, forming a new publicly traded company.

The Suboxone tooth decay lawsuits typically list Indivior, Reckitt, and their various U.S. operating entities as defendants. Indivior, being a publicly traded entity listed on the London Stock Exchange and well-financed, is expected to bear primary responsibility for the Suboxone-related liabilities. However, Indivior has faced legal issues in the past. In 2019, the company was indicted by the Department of Justice for false marketing claims and a scheme aimed at steering patients toward doctors likely to prescribe Suboxone.

Another significant defendant in the Suboxone lawsuits is Aquestive Therapeutics Inc., a pharmaceutical company headquartered in New Jersey. Aquestive collaborated with Indivior in the development of Suboxone.

When Will the Suboxone Settlement Be?

One of the most common questions we hear is: When will the Suboxone lawsuits settle, and when can victims expect to receive settlement checks? This is the right question because civil lawsuits are about money.  Compensation is the only justice you can get in this litigation.

The honest answer is that no one can say for sure when we will have a Suboxone settlement.  But based on the current status of the litigation and what we know about similar multidistrict litigations (MDLs), here’s what we can realistically expecct:

Will Suboxone Cases Settle in 2025?

There’s always a chance that Suboxone settlement checks could begin going out in 2025, but this is unlikely if we are being realistic. While there is some speculation about an earlier resolution, the timeline for a global settlement is tied to specific litigation milestones.

At this point, the MDL is still in its discovery phase, with plaintiffs gathering critical evidence from Indivior. Bellwether trials, which are essential for setting the tone for settlement negotiations, are expected to begin in late 2026. Historically, global settlements in MDLs typically occur shortly before the first bellwether trial or after initial trial verdicts provide guidance on potential jury awards.

When Will Indivior Get Serious About Settlements?

Indivior is unlikely to engage in meaningful settlement discussions before mid-to-late 2025. This timing aligns with the statute of limitations debates, a pivotal issue that could influence how many claims are ultimately filed. By waiting until this deadline approaches, Indivior minimizes the risk of encouraging a flood of new claims while still positioning itself for strategic negotiations.

Suboxone Lawsuit Timeline

Suboxone Lawsuit Pushes Foward

January 15, 2025

In a big win, the plaintiffs fend off a motion to dismiss many of the key claims in the Suboxone MDL.

Upcoming Status Conference in MDL

January 11, 2025

The next Suboxone MDL case management conference will address discovery disputes, deposition protocols, and preparations for bellwether trials.

MDL Judge Partially Denies Motion to Dismiss

January 3, 2025

The judge upholds failure-to-warn claims against Indivior but narrows post-approval design defect claims, allowing plaintiffs to proceed with lawsuits over inadequate warnings.

MDL Adds 38 New Cases

December 4, 2024

The Suboxone MDL reaches 716 pending cases as more plaintiffs allege the drug caused severe tooth decay and dental damage.

New Lawsuit Filed in Indiana

December 7, 2024

A plaintiff from Indiana alleges that Suboxone manufacturers failed to warn about dental damage risks, despite a 2022 FDA Drug Safety Communication confirming the issue.

FDA Issues New Suboxone Safety Warning

January 2022

The FDA warns that buprenorphine-based medications dissolved in the mouth, like Suboxone, can cause severe tooth decay, infections, and tooth loss.

Harvard Study Links Suboxone to Tooth Decay

2012

A study by Harvard Medical School finds that patients using Suboxone for opioid addiction treatment suffer rapid and severe dental deterioration due to the drug’s acidity.

Suboxone Film Introduced

2010

Indivior introduces Suboxone Film, a new dissolvable version of the drug. The company shifts marketing from tablets to film, despite potential long-term oral health risks.

FDA Approves Suboxone for Opioid Addiction Treatment

2002

Suboxone is approved by the **FDA** as a treatment for opioid dependence, containing buprenorphine and naloxone to reduce withdrawal symptoms.

Why Does It Take So Long to Receive a Suboxone Settlement Check?

Even after a global settlement is reached, victims should understand that it takes time to receive individual settlement checks. Here’s why:

  1. Global Settlement Agreement: Once the parties agree to a settlement, they must finalize the terms and framework for distributing the funds.
  2. How Gets What?:  A system needs to be developed. In a points-based settlement system for Suboxone litigation, each plaintiff’s claim would be evaluated based on specific criteria such as the severity of dental injuries, the extent of required treatments (e.g., root canals, extractions, or implants), and the duration of Suboxone use. Points would be assigned to these factors, with higher points leading to larger settlement payouts to try to give out settlement compensation reflects that the individual impact of the injuries.  This is a hard
  3. Claims Administration: A settlement fund administrator is typically appointed to oversee the process, ensuring that claims are verified, injuries are categorized, and compensation is distributed based on a tiered system.
  4. Proof of Injury Documentation: Plaintiffs must provide supporting documentation, such as dental and medical records, to substantiate their claims and determine their settlement tier.  This is real work for the lawyers to get these records in order and that work is happening every day right now.
  5. Distribution of Funds: The administrator reviews each claim, allocates settlement amounts, and processes payments to plaintiffs. This step alone can take months or longer, depending on the volume of claims.

What Does This Mean for Suboxone Plaintiffs?

The good news is that Suboxone cases have strong potential for favorable settlements due to compelling evidence of causation and Indivior’s failure to warn consumers. However, patience will be key. This litigation will likely result in significant settlements.  There are no guarantees.  But we believe this.  Still,  plaintiffs should prepare for the reality that the process will take time, even after a global settlement is reached.

Unfortunately, there is no way to speed up this timeline. Plaintiffs’ attorneys and court-appointed leadership are doing everything possible to move the litigation forward efficiently, but certain phases—such as discovery, bellwether trials, and settlement fund administration—are unavoidable steps in the process.

What Can Plaintiffs Do in the Meantime?

If you’ve suffered dental injuries from Suboxone, now is the time to:

  • Document Your Injuries: Ensure you have detailed records of your dental treatments and costs, both past and future.
  • Stay Updated: Follow litigation developments closely and maintain regular communication with your attorney to understand where your case stands. The court is going to require that your paperwork is complete.
  • Be Patient:  This is the hard part.  There is nothing you can do to speed up settlements.  No one is getting paid a Suboxone settlement right now. Trust (and verify) that your legal team is working diligently to secure the best possible outcome, even if it takes time.

Estimated Settlement Value of Suboxone Lawsuits

Our attorneys currently project the potential settlement range for Suboxone tooth decay lawsuits to fall between $50,000 and $150,000. However, this estimation is solely for settlement purposes. In the event these Suboxone cases proceed to trial, the potential payout from a verdict might significantly increase, potentially involving punitive damages. We believe that if Suboxone cases were to reach trial, the potential value could surpass $1 million.

This forecast is admittedly premature. The Suboxone tooth decay litigation is still in its nascent stages, making it challenging to predict definitive settlement amounts accurately. Describing this estimate as speculation wouldn’t be entirely unfair. Yet, if these tooth decay lawsuits demonstrate success, given the justifiability of a warning and substantial evidence supporting causation, we can reasonably gauge their potential payout value.

Get a Suboxone Lawyer

If you have suffered harm from Suboxone, call us today at 800-322-3010 or contact us online for a free case evaluation. We are here to explore your legal options and fight for the justice you deserve.

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