Suboxone Tooth Decay Lawsuit – Updated February 2025

Judge Calabrese just made things a bit easier for people looking to file Suboxone-related Big news for folks thinking about filing a Suboxone lawsuit: Judge Calabrese just signed off on an order that could make the process more affordable. Normally, each federal case costs $405 to file. But now, up to 100 plaintiffs can be included in a single complaint—with just one filing fee. That means major savings for individuals who were otherwise priced out of pursuing justice. 

On top of that, the judge is allowing electronic bulk-filing of cases, which will make it easier for attorneys to organize everything and track what kinds of injuries are being claimed. With tens of thousands of potential cases still out there, this update could open the door for many more people to take action.

Judge Calabrese recently signed an order that's going to make life a lot easier for attorneys handling Suboxone tooth decay lawsuits. Now, up to 100 plaintiffs can file their claims together in a single complaint, paying just one filing fee. This might sound like a small detail, but it speaks volumes about how massive this litigation really is.

We’re expecting yet another wave of new lawsuits this summer as the three-year statute of limitations deadline hits in several states. Right now, the drug makers behind Suboxone are already dealing with over 10,000 lawsuits alleging they failed to warn people about serious dental damage linked to their film strips. That's thousands of real people who've suffered broken teeth, tooth loss, and extensive dental work—and more claims are on the way.

Meanwhile, preparations for the first Suboxone bellwether trials are already underway. These early trials are a big deal because they'll give everyone involved a sense of how juries might react, and what type of compensation jurors think plaintiffs deserve. Ultimately, the bellwether outcomes will play a huge role in deciding how thousands of other claims get resolved.

Progress is picking up in the Suboxone litigation. Judge Calabrese has laid out the process for selecting bellwether cases—the handful of “test” trials that will help shape how the rest of the lawsuits are handled. The first step? Randomly choosing 500 cases and reviewing their records. From there, the court will go through a few rounds of narrowing down until a lead case is chosen to go to trial. 

Bellwether trials are important because they give both sides a preview of how juries might respond to the evidence. It’s a key step that often leads to serious settlement talks down the line.

One of the major hurdles in filing a Suboxone lawsuit—especially for people with dental injuries—has been getting access to dental records. Some dental offices have been dragging their feet or flat-out ignoring requests from patients and their attorneys. To move things along, Judge Calabrese issued an order clarifying what kind of authorization is needed for records to be released. He also made it clear that dental providers who don’t comply could face legal consequences, including contempt of court. 

These records are key evidence in tooth damage claims, and without them, it’s nearly impossible to move a case forward. This order is a strong push to make sure survivors aren’t being stalled by paperwork issues.

As the window to file Suboxone-related lawsuits starts to close, Judge Calabrese is encouraging Indivior—the company behind the drug—to agree to a tolling arrangement. What that means is pretty straightforward: it would pause the countdown on filing deadlines and give people more time to prepare their cases.

 Without it, lawyers may need to rush and file every potential case, even the ones that aren’t fully ready, just to meet the cut-off. A tolling deal would give more time for solid cases to come together and avoid clogging up the system. It’s a move that could benefit both sides in the long run.

Defendants in the Suboxne case have requested that the court bifurcate (or separate) the liability and damages stages of the upcoming trials.

If this request is granted, it would mean that juries would first need to decide whether Suboxone manufacturers are legally responsible (aka whether Suboxone is actually the cause of the tooth decay [psst...science says it is]) and the juries can hear separate evidence about individual damages if the initial causation stage is successful.

This strategy is old and tiring. The defense wants to separate the jury from the emotional elements of people being injured, suffering, and having their lives destroyed, while also delaying the procedures and potentially causing some plaintiffs to settle for less because they will get sick of waiting.

Almost ALL defense attorneys try this.

The judge’s decision on this request will be important, as it could impact the flow and strategy of future trials.

In an effort to encourage resolution, the judge has ordered mediation between plaintiffs and defendants before the first bellwether trials begin. This move suggests the court wants both sides to explore settlement options before fully committing to trial.

Mediation could lead to early resolutions/settlements for certain plaintiffs, but given the size and complications of this litigation, a global settlement is still uncertain.

If mediation proves unsuccessful, the trials will proceed as scheduled, providing more insight into how juries might respond to the allegations against the manufacturers. Either way, this order introduces a potential off-ramp for some litigants before the trials begin.

The FDA has contributed new evidence to the Suboxone MDL, supporting the claims that Suboxone can cause severe dental damage.

This data from the FDA includes additional reports of tooth decay, enamel erosion, and related oral health issues among patients prescribed the drug. The agency’s findings may strengthen the plaintiffs’ arguments, particularly when it comes to causation, and could influence the upcoming expert testimony. With this data as backup, plaintiffs might just find it easier to establish liability and increase settlement leverage.

Indivior is expected to challenge the FDA’s findings, possibly arguing alternative causes or questioning the methodology behind the data collection.

The court has tightened its standards for the plaintiff fact sheet (PFS) in the Suboxone case. This change is likely meant to streamline discovery and ensure consistency across cases.

Plaintiffs will now need to provide more detailed medical histories, more thorough proof of Suboxone usage, and evidence linking their dental injuries to the medication.

These changes are going to cause some delays and will definitely end up lowering the number of overall cases.

What is a Plaintiff Fact Sheet (PFS)?

Plaintiff Fact Sheet (PFS) is a standardized document used in MDL and mass tort cases to make the discovery process easy and uniform. Instead of traditional interrogations and requests for this and that, a PFS provides essential information about each plaintiff’s claims, and all the information is in the same order and answers the same questions.

The PFS helps both sides assess the merits of each case and determine whether to proceed with that case or not.

What's included in a Plaintiff Fact Sheet?

While the exact requirements vary depending on the case and the court's orders, a PFS typically includes:

• Personal Information – Name, contact details, date of birth, and Social Security number.
• Medical History – Health conditions, history of dental or other injuries, and relevant past treatments.
• Medication Usage Information – When and how the plaintiff used the medication (e.g., Suboxone), dosage, duration, and prescribing physician details.
• Injury Details – Specific allegations about how Suboxone or another product harmed the plaintiff, including symptoms, diagnoses, and impact on daily life.
• Economic Damages – Details and exact figures on the medical bills, lost wages, and other financial losses attributed to the injury.
• Alternative Causes – If the plaintiff has any pre-existing conditions or other risk factors that could have contributed to their injuries, it also must be listed.

The court has set a deadline for selecting the bellwether trials, which will be a big step in the Suboxone MDL.

These early test cases will help to give both the defense attorneys and the plaintiff attorneys an understanding of how juries might respond to the evidence and overall vibe of the case. This information is invaluable.

Whatever the juries decide during the bellwether trials will shape either settlement discussions or trial strategies, depending on the outcome.

Ideal Plaintiff Example: If the juries show a tendency to believe the Suboxone tooth decay science and seem to sympathize with these people who were trying to become better members of society, things could look for the plaintiffs. Once these bellwether juries come back with their final trial award decisions, and they are high, it will definitely push Indivior to settle rather than risk every other trial going the same way.

Ideal Defendant Example: If the bellwether juries don't seem to understand the laws and science involved in the Suboxone MDL—it's presented in a confusing way, and things don't make much sense—and they have more of an attitude that lacks empathy for people looking to recover from drugs than things could go well for the defense. This would likely give Indivior the edge when it comes to settlement negotiations, and they may decide to take the cases to trial anyway in the hope that they will get

Both plaintiffs and defendants will have a say in the selection process, with criteria mostly focusing on the severity of injuries, facts and patterns, and jurisdictional issues. Whatever the situation, this clearly shows signs that the Subxone MDL is moving into its more active stage, where things will move a little quicker.

On December 31, 2024, Judge Calabrese delivered a major win for plaintiffs in the Suboxone MDL. The Court denied the defendants’ motion to dismiss key claims, allowing 'pre-approval design defect' and 'post-label-change failure to warn' claims to move forward. The judge noted evidence that adverse event reporting continued even after the label update in June 2022.

While the Court dismissed 'post-approval design defect' claims, the ruling keeps the core of the plaintiffs’ case intact. Discovery will now focus on what the defendants knew about the risks of Suboxone film and when they knew it.

This is a big step toward holding Reckitt Benckiser and Indivior accountable for marketing Suboxone without adequate dental risk warnings. It’s another reminder that corporations cannot avoid responsibility for the harm their negligence causes.

The Court issued Case Management Order No. 11, outlining protocols for electronic discovery in the Suboxone MDL. This ensures the preservation, organization, and sharing of key documents, including emails and spreadsheets, between the parties.

The order emphasizes collaboration to streamline the process and prevent unnecessary court interventions. It also provides guidelines for managing non-party documents and complex files like databases.

This move underscores the Court’s intent to keep the MDL efficient while balancing the discovery burdens on all parties.

Judge Calabrese has dismissed several subsidiaries from the Suboxone MDL, including Indivior PLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd. However, key defendants like Aquestive Therapeutics and the main Indivior entities remain involved.

This decision narrows the case but ensures the focus remains on the companies most responsible for Suboxone’s design, marketing, and labeling.

Defendants filed a partial motion to dismiss against plaintiff Ryan Bennett, claiming the doctrine of federal preemption completely preempts his design defect claims. Indivior also claims parts of the plaintiff's failure to warn claim are also preempted. The doctrine of federal preemption states that when state law interferes or conflicts with federal law, federal law will supersede the state law.

Motion to Dismiss Based on Failure to Warn Claims 

Indivior contends that Ryan Bennett's failure to warn claims are preempted because the label was approved by the FDA, aka the U.S. Food and Drug Administration—clearly a federal body. Remember, the federal law overrules the state law concept? Thus, they allege that an approved label is legally adequate. 

Unfortunately for Indivior, their argument fails based on legal precedent, Wyeth v. Levine, which says that manufacturers remain responsible for their label at all times. This means Indivior, or any manufacturer, remains responsible for updating their own label at all times regardless of whether it was once approved by the FDA in the past. 

Motion to Dismiss Based on Design Defect

Indivior also filed a motion to dismiss for the design defect claim. Again, the reason is complicated, but basically, it comes down to the idea that Indivior believes the defective design of the Suboxone film strips is theoretical since, to prove the defect, one would need to guess whether the FDA would approve a safer alternative.

Fortunately, we do not need to speculate what the FDA may or may not do. The FDA has already approved a safer alternative to Suboxone film strips: Sublocade, an injectable version of buprenorphine, the same medicine in the film strips. 

Pharmaceutical Companies Always Try This

Do you know what is so frustrating about these cases? These giant pharmaceutical companies spend hundreds of millions on these beautiful advertisements you and I see everywhere, claiming how great their medicine is and how it will change your life. But if they are negligent, put profits over safety, or fail to warn consumers about serious side effects, they jump right to their playbook and do EVERYTHING they can to avoid being held responsible for their mistakes. 

They are literally following this format:

1. Find an illness hurting people. 
2. Convince them you have the perfect solution.
3. Sell them the solution at an astronomical price.
4. If the solution ends up causing more harm, they fight like hell to say that steps 1-3 were not their fault.

These drug manufacturers always file a motion to dismiss and use the federal preemption strategy in every single lawsuit against them. And this is just one page of their giant playbook on how to get out of being held accountable for their harmful actions. 

It’s really quite infuriating.

A recent study in The Journal of the American Medical Association underscores the serious dental harm caused by sublingual Suboxone compared to other buprenorphine formulations. Users experienced significantly higher rates of tooth decay and dental injuries.

This evidence bolsters plaintiffs' claims that Indivior’s label failed to adequately warn patients and doctors about Suboxone’s dental risks. It will be a critical focus as the MDL moves forward.

Indivior has filed a motion for partial dismissal, relying heavily on federal preemption arguments. They claim that FDA approval of Suboxone’s design and labeling protects them from liability.

Their primary arguments include:

1. Design Defect Preemption: They argue federal law overrides state claims because any design change would need FDA approval.
2. Failure to Warn: They assert that the FDA’s initial label approval and the lack of "newly acquired information" post-2022 protect them.
3. Non-NDA Holder Claims: They claim only the New Drug Application (NDA) holder can be held responsible, shielding certain entities.

Indivior’s motion seeks to dismiss these claims with prejudice, aiming to avoid future challenges. However, plaintiffs are confident these arguments won’t hold up under scrutiny.

Judge Calabrese has directed Indivior to turn over key documents from its antitrust litigation, which concluded in October 2023. These records are expected to shed light on the company’s marketing tactics and decision-making processes.

Indivior previously paid $385 million to settle antitrust claims, where it was accused of pulling Suboxone tablets from the market to avoid generic competition. Additional documents from patent litigation, which resulted in a $102.5 million settlement, will also be produced.

This order will help plaintiffs demonstrate how Indivior prioritized profits over patient safety by rushing Suboxone film to market without adequate testing of its dental risks. The next status conference is set for September 4, 2024, and we anticipate further developments then.

In a significant win for plaintiffs, Judge Calabrese has denied Indivior’s motion to bifurcate discovery. Indivior had sought to separate general and specific causation, a move that would have delayed the litigation by up to 18 months.

The judge recognized that general and specific causation are intertwined and should proceed concurrently. This decision keeps the MDL on track and demonstrates the Court’s commitment to judicial efficiency. With this ruling, the Suboxone litigation is poised to gain momentum.

Because the statute of limitations (deadline to file a claim) varies from state to state. There has been much confusion over two things:

1. Which states have an expired statute of limitations (SOL) and which are still within the deadline?
2. And how can the court prevent a situation in which thousands of attorneys file all their Suboxone claims before vetting them just to make sure they meet the deadline?

After much back and forth, here is a breakdown of the statute of limitations for the Suboxone MDL:

1. FDA Warning and Label Update: In June 2022, Suboxone's warning label was updated to reflect the dental health risks. This set the clock on failure-to-warn claims for states with a two-year SOL, making their deadline June 2024.
2. Tolling Agreements: To address the concerns about the upcoming SOL deadlines, the plaintiffs in the Suboxone MDL sought tolling agreements. A tolling agreement effectively pauses the SOL to allow more time for potential plaintiffs to file claims and vet existing claims. The defendants initially resisted, causing approximately 10,000 Suboxone lawsuits to be filed simultaneously on June 14, 2024.
3. State-Specific SOL Variations: Moving forward, you need to know the SOL deadline for your state; they range from one to four years for these types of product liability claims. For instance, states with a two-year SOL had a filing deadline of June 2024, while those with a three-year SOL have until June 2025, and those with a four-year SOL have until June 2026.
4. States with Three-Year SOL:
   • Arkansas
   • Maryland
   • Massachusetts
   • Michigan
   • Montana
   • New Hampshire
   • New Mexico
   • New York
   • Rhode Island
   • South Carolina
   • South Dakota
   • Vermont
   • Washington
   • Washington D.C.
   • Wisconsin
5. States with Four-Year SOL:
   • Florida
   • Nebraska
   • Utah
   • Wyoming

*It's important to note that the SOL can vary based on individual circumstances and specific state laws. So speak with a qualified mass tort attorney involved in the Suboxone MDL to ensure your case qualifies with applicable deadlines.

On June 6, 2024, Judge Calabrese heard oral arguments on whether to bifurcate general and specific causation issues in the Suboxone MDL. Indivior argued for staged discovery, claiming it would simplify the case.

Plaintiffs strongly opposed the motion, emphasizing that bifurcation would unnecessarily delay the process and burden plaintiffs with additional procedural hurdles. The LLN team believes this is a stalling tactic by Indivior to frustrate plaintiffs and discourage participation in the MDL.

General causation, or whether Suboxone causes dental injuries, is already supported by FDA findings and label changes in 2022. Plaintiffs argue this issue should not delay the simultaneous consideration of specific causation for individual claims.

With no agreement reached on tolling, Judge Calabrese has ordered the plaintiff steering committee to submit a master list of plaintiffs by June 14, 2024. This step ensures that all claims are preserved before the statute of limitations expires in states with a two-year deadline.

Defendants must respond by July 1, 2024, to determine if cases should remain in the MDL or proceed in state courts. While tolling agreements are typically used to streamline MDLs, Indivior’s refusal to cooperate has created additional challenges. Despite this, the Court’s intervention aims to prevent procedural delays and protect the rights of affected plaintiffs.

During the latest status conference, Judge Calabrese heard arguments on discovery protocols and the potential for a tolling agreement. Indivior is pushing for staged discovery focused solely on general causation, which plaintiffs argue is unnecessary given the strong evidence linking Suboxone to dental harm.

Tolling agreements, which could extend filing deadlines and reduce unnecessary lawsuits, remain a contentious issue. Plaintiffs have offered to provide proof of Suboxone use through pharmacy or medical records, but Indivior has rejected this proposal.

The absence of a tolling agreement risks overwhelming the MDL with unvetted claims, creating inefficiencies for both sides. The next steps in discovery will be critical in determining how this litigation progresses.

Indivior is asking the Court to prioritize general causation in the Suboxone MDL, a move many see as an attempt to stall the litigation. General causation addresses whether Suboxone causes dental injuries, an issue already supported by the FDA’s 2022 label change.

Plaintiffs argue that both general and specific causation should proceed together to avoid unnecessary delays. Indivior’s focus on general causation appears to be a tactic to wear down plaintiffs and limit the number of claims filed.

Despite these challenges, new Suboxone lawsuits continue to be added to the MDL, reflecting the growing awareness of the drug’s dental risks.

The Lawsuit Legal News team has revised its case intake criteria for the Suboxone MDL. Moving forward, cases must involve three or more tooth extractions or significant tooth loss directly linked to sublingual Suboxone use.

This decision ensures that only strong cases are filed into the MDL, aligning with the goal of maintaining the integrity of the litigation. Plaintiffs with qualifying cases should act promptly to understand the specific statute of limitations in their state.

Under Case Management Order No. 3, Judge Calabrese has permitted the direct filing of lawsuits into the Suboxone MDL. This move eliminates delays associated with transferring cases from other jurisdictions, improving efficiency for plaintiffs and the Court.

While plaintiffs’ leadership is cautious about filing cases with minimal injuries, the MDL is expected to grow rapidly as the statute of limitations deadline approaches for states with two-year filing windows. We anticipate a significant surge in claims over the next two months.

The first status conference for the Suboxone MDL took place on March 7, 2024, before Judge Philip Calabrese. At this hearing, Stanley Gipe of Dolman Law Group was appointed to the Plaintiff’s Steering Committee, which will help lead the litigation.

With the FDA’s 2022 label update linking sublingual Suboxone to severe dental injuries, this litigation has strong scientific backing. We expect rapid growth in the MDL as more plaintiffs come forward and the statute of limitations nears for states with shorter deadlines.

Judge Calabrese has scheduled the first status conference in the Suboxone MDL for March 7, 2024, in Cleveland, Ohio. The agenda includes appointing leadership for both plaintiffs and defendants and establishing a discovery calendar.

This litigation is expected to move quickly due to the strong scientific evidence linking Suboxone to severe dental issues. Attorneys seeking leadership positions must attend in person and submit applications by March 1, 2024.

Advertising for Suboxone lawsuits is ramping up across social media platforms, reflecting growing awareness of the litigation. This mass tort is poised to become one of the largest of 2024, driven by the mounting evidence of Suboxone’s dental risks and the sheer number of affected individuals.

The Judicial Panel on Multidistrict Litigation (JPML) has officially consolidated Suboxone lawsuits into a Multidistrict Litigation (MDL) before Judge Philip Calabrese in the Northern District of Ohio. This streamlines pretrial proceedings while allowing individual claims to retain their independence.

The agreement to consolidate reflects the strength of the cases and the growing number of plaintiffs alleging dental injuries caused by Suboxone film.

The JPML has scheduled a hearing for January 25, 2024, to decide on consolidating Suboxone lawsuits into an MDL. This would likely centralize the litigation in the Northern District of Ohio, a favorable venue for these cases.

Consolidation would streamline discovery and pretrial rulings, ensuring consistency across claims while reducing the burden on individual courts.

The first Suboxone lawsuit alleging dental injuries has been filed in the Northern District of Ohio by David Sorensen. The plaintiff claims that Suboxone’s sublingual film caused severe tooth decay, leading to significant medical expenses.

This case marks the beginning of what is expected to become a major mass tort, with plaintiffs accusing Indivior of rushing Suboxone film to market to avoid generic competition after its tablet patent expired.

The FDA has updated the warning label for sublingual Suboxone to include risks of severe dental injuries such as tooth decay, oral infections, and total tooth loss. This change followed a safety communication in January 2022 and reflects growing concerns about the drug’s impact on dental health.

This label update is a critical piece of evidence in the Suboxone litigation, as it directly links the drug to serious dental injuries.

The FDA issued a safety communication warning the public about severe dental injuries linked to sublingual Suboxone, including tooth decay, infections, and tooth loss. Despite acknowledging the risks, the FDA stated that Suboxone’s benefits for treating opioid addiction outweigh the harm.

Plaintiffs argue that these risks were not adequately communicated to patients or healthcare providers, setting the stage for future litigation against Indivior.