Suboxone Tooth Decay Lawsuits

Suboxone Lawsuit Updates

Below you can find Suboxone lawsuit news and updates on the Suboxone MDL. As the judge, court, or parties make decisions, we will let you know with some extra perspective added in.

November 1, 2024 – Indivior Settles Healthcare Fraud Case for $85 Million

Indivior, the Virginia-based pharmaceutical company behind Suboxone, reached an $85 million settlement with five healthcare benefit plans, resolving allegations of healthcare fraud and antitrust violations. The plaintiffs accused Indivior of orchestrating a fraudulent “product hop” in 2010, transitioning from Suboxone tablets to film to block generic competition, inflating costs for healthcare plans.

This settlement follows the plaintiffs’ 2020 decision to opt out of a broader multidistrict litigation (MDL) to pursue independent claims. After a jury in October 2023 ruled that the statute of limitations did not time-bar their claims, the settlement was reached days before a scheduled five-week trial, marking one of the largest opt-out recoveries in pharmaceutical litigation history.

October 14, 2024 – Bellwether Trials for Suboxone MDL Near Following Status Conference

A status conference was held to prepare for bellwether trials in the Suboxone tooth decay MDL. These pivotal trials aim to test key legal and factual issues, including claims of product defects, insufficient warnings, and misleading marketing. The outcomes will provide insights into jury perspectives and may influence settlement negotiations.

While trial dates remain pending, their scheduling is expected to pressure defendants into negotiating settlements, potentially accelerating the resolution of the MDL.

October 1, 2024 – Court Issues Order on E-Discovery Protocols in Suboxone MDL

Case Management Order No. 11 detailed protocols for handling electronically stored information (ESI) in the Suboxone litigation. The order ensures fair and efficient discovery of digital records, including emails and spreadsheets, while safeguarding metadata and promoting collaboration between parties to avoid court intervention.

The guidelines also address third-party document production and set standards for dealing with complex files like databases. This order demonstrates the court’s effort to streamline discovery without imposing undue burdens.

September 27, 2024 – Key Court Rulings Bolster Plaintiffs’ Position Against Preemption Defense

Plaintiffs in the Suboxone litigation gained a significant advantage when the court acknowledged new precedents challenging the defense’s “implied preemption” argument. The Plaintiff Leadership Committee (PLC) submitted a “Notice of Supplemental Authority,” citing two major rulings:

• Loper Bright v. Raimondo: Questioned the validity of implied preemption without explicit Congressional authorization.
• Fosamax Ruling: Affirmed plaintiffs’ ability to pursue state law claims despite FDA regulatory approval.

These decisions could preserve failure-to-warn and design-defect claims, a critical win for plaintiffs challenging Indivior’s liability.

September 11, 2024 – Some Defendants Dismissed from MDL

Judge Calabrese dismissed subsidiaries Indivior PLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd. from the Suboxone MDL following agreements between plaintiffs and defendants. Other key defendants, including Aquestive Therapeutics and primary Indivior units, remain in the case. The MDL, centralized in Ohio since February 2024, now includes over a dozen consolidated cases, with more expected to join.

September 1, 2024 – Plaintiffs Counter Indivior’s Motion to Dismiss

Plaintiffs in the MDL filed strong counterarguments against Indivior’s motion to dismiss, which relied on federal preemption. They argued:

• Failure-to-Warn Claims: Based on “newly acquired information” under FDA regulations, allowing label updates without prior approval.
• Design-Defect Claims: Highlighted safer alternatives like injectable Sublocade, emphasizing that these options should have been pursued.

The plaintiffs accused Indivior of neglecting its duty to warn and failing to prioritize patient safety by opting for less risky designs.

August 23, 2024 – Indivior Files Motion to Dismiss on Preemption Grounds

Indivior sought dismissal of design-defect and failure-to-warn claims, citing federal preemption, which bars state law claims conflicting with federal regulations. Plaintiffs countered that the FDA’s 2022 label change failed to account for pre-existing data on Suboxone film’s risks. They argued that preemption does not absolve Indivior of its ongoing responsibility for product safety and warning updates.

August 18, 2024 – Research Links Suboxone Film to Severe Dental Risks

A research letter in the Journal of the American Medical Association highlighted the risks of severe tooth decay linked to Suboxone film. The findings, published post-FDA label updates in June 2022, revealed significantly higher rates of dental injuries among Suboxone users compared to alternative treatments like transdermal buprenorphine or oral naltrexone.

The evidence supports plaintiffs’ claims that Suboxone’s labeling failed to adequately warn of dental risks, affecting nearly all claimants in the MDL. Over 10,000 cases involving severe tooth decay were identified on a court-submitted schedule in June.

August 8, 2024 – Joint Status Report Indicates Tolling Agreement is Near in Suboxone Tooth Decay Lawsuit

A joint status report has been filed in the Suboxone lawsuit that indicates both parties are close to finalizing a tolling agreement. Indivior has shared a proposed order with the plaintiffs for them to review. We anticipate the plaintiffs will provide their response this week.

August 6, 2024 – Slight Decrease in Cases Due to Potential Tolling Agreement

Recently, the number of lawsuits in the Suboxone multidistrict litigation dropped from 677 to 673. This decline is likely due to the upcoming tolling agreement, which if passed, means that lawyers no longer need to rush to file their cases. If approved, this agreement will extend the deadline for plaintiffs to around 2025.

August 1, 2024 – Indivior Seeks Partial Dismissal in Suboxone Tooth Decay Lawsuit

Indivior has filed a motion for partial dismissal of the Suboxone lawsuits, citing federal preemption. Similar to our update on July 28, this motion is unlikely to be granted. However, here’s why Suboxone’s lawyers say the cases should be dismissed:

1. Design Defect Preemption: They argue that federal law overrides claims against Suboxone’s design because any changes require FDA approval and since the FDA approved the design, Indivior can’t be held liable under state law.
2. Failure to Warn Preemption: They claim that federal law preempts failure-to-warn claims since the FDA approved the label initially and after changes in June 2022. Therefore they argue that they shouldn’t be held accountable for any label issues.
3. Claims Against Non-NDA Holders: They assert that federal law prevents anyone other than a New Drug Application (NDA) holder from changing the drug label. Since Indivior was not an NDA holder, they argue they can’t be sued over label changes.
4. Inadequate Allegations: They contend that the lawsuits against the parent companies are unfounded because the parent companies themselves did not manufacture, market, or sell Suboxone films. (This is ridiculous because the parent companies are obviously responsible for the actions of their other companies, which they only divide for just this type of shady purpose.)

Indivior wants the court to dismiss the lawsuit with prejudice which will permanently bar anyone from ever filing a similar lawsuit again.

We’ll keep you posted on the judge’s decision.

July 28, 2024 – Indivior Responds to Plaintiff’s Complaint in Suboxone Tooth Decay Lawsuit

Indivior has responded to the plaintiff’s master complaint with a motion to dismiss for “lack of personal jurisdiction.” This is essentially a legal maneuver they know won’t be approved. However, it buys them time and increases the chances of plaintiffs settling for less.

Indivior’s argument about personal jurisdiction is weak because Suboxone is widely available in the US and is therefore subject to US laws.

July 20, 2024 – Judge Orders Indivior to Provide Antitrust and Patent Litigation Evidence

Just as we predicted, Indivior fought against the inclusion of the information from their past lawsuits over them pushing out generic competitors (settled for $385 million) and their questionable marketing tactics (settled for $102.5 million). However, Judge Calabrese has ordered them to provide the key documents from their settled antitrust case and patent litigation.

It will be interesting to see how this information impacts the ongoing lawsuit. The next conference is on September 4, 2024.

July 12, 2024 – Agenda Set for July 18 Case Management Conference in Suboxone Lawsuit

Both parties have agreed on the agenda for the upcoming Suboxone tooth decay lawsuit conference on July 18, which will hopefully resolve the tolling agreement issue.

The focus is likely to shift to the disagreement over the electronically stored information (ESI) since we anticipate that Indivior will contest any evidence requests related to Suboxone’s previously settled patent and antitrust lawsuits. We all know that they will fight to prevent this likely damning evidence from being included in the Suboxone tooth decay lawsuit.

June 26, 2024 – Judge Rejects Defense’s Bifurcation Request in Suboxone Lawsuit

Judge Calabrese has denied Indivior’s motion for bifurcation in the Suboxone lawsuit. Indivior wanted the discovery process to be broken down into two parts. Their request suggested that the cases start with general causation and then move to specific causation.

This approach would have added at least a year to the length of the lawsuit. And, I think we have made it clear—or rather Indivior has made it clear—how desperate they are to delay the litigation.

However, the judge ruled that separating them wouldn’t be practical and noted that all MDL cases handle both aspects concurrently.

This decision is a significant win for the plaintiffs, and we expect the Suboxone litigation to start gaining momentum.

June 24, 2024 – Recent Updates in the Suboxone Lawsuit

In the past ten days, the statute of limitations expired for individuals in several states. Although Indivior rejected a tolling agreement, Judge Calabrese allowed the plaintiffs to file a master complaint with two lists (or “schedules”) of individuals.

One schedule is for those in states with a two-year statute of limitations where the defendant is not a resident, and the other is for residents of New Jersey, Virginia, and Delaware, where the corporate defendants are based.

The master complaint includes over 10,000 plaintiffs and was submitted to the court on June 14th where the cases were consolidated in the U.S. District Court for the Northern District of Ohio. Most law firms representing plaintiffs only included residents from states with a two-year statute of limitations, although a few firms listed all their clients regardless of state, a move that has puzzled leadership.

June 14, 2023 – Suboxone Lawyers File Amended Complaint with List of Plaintiffs in States with a 2-Year Statute of Limitations

A master complaint has been filed with the court, listing over 10,000 plaintiffs. While we expect the number of plaintiffs in the Suboxone lawsuit to grow significantly over the next year, many of those listed in Schedule A are likely to eventually be removed.

Lawyers had to file quickly to protect their clients’ claims before the statute of limitations expired. This creates a negative situation for all involved because it forces lawyers to file lawsuits before they have even vetted their clients’ claims since it is best to be safe than sorry. You can always drop a lawsuit—you cannot file on if you miss the deadline.

This situation is ironic because in most mass tort cases, defendants complain about the merit of claims in MDL lawsuits. Here, Indivior’s rejection of a tolling agreement has created the very problem they will likely criticize later.

Now that there is no fear of the statute of limitations expiring, new Suboxone lawsuits may not be filed for some time.

June 11, 2024 – CMO #7 Creates Leadership Development Committee

This week, Case Management Order No. 7 was issued in the Suboxone MDL. It introduced a Leadership Development Committee (LDC), which serves as a mentorship program for attorneys who want the skills and experience they will need to be able to accept leadership roles in future multidistrict litigation cases.

Attorneys selected for the LDC will work on various projects related to the Suboxone case. In exchange for this experience, these attorneys are expected to offer their services at a reduced rate.

Any attorneys interested in joining the LDC must apply by July 8, 2024.

May 18, 2024 – Number of Suboxone Claims Filed into MDL Rises

On May 13, the defense for Suboxone officially stated that they would not agree to a tolling agreement, which would have allowed the plaintiffs to file lawsuits after the statute of limitations while preserving their right to sue. The aim was to prevent injury attorneys from around the country from filing every lawsuit they had ASAP before they really had time to gather all the proper evidence. This would have saved the Court time and money, prevented the defense from having to try cases across the US in state courts, and would have allowed more Suboxone patients to get the help they need.
However, Judge Calabrese took a play out of the Xarelto case and adopted a procedure to find a middle ground.
The general cut-off date for the statute of limitations in states with a two-year limit is June 14, 2024. So, the Judge has ruled that by that date, June 14, the plaintiffs’ lawyers must file a master MDL list of all individual plaintiffs.
Defendants will then have until July 1, 2024, to file a motion for severance which would remove the case from the MDL and allow them to amend their lawsuit in state courts while preserving the original filing dates which was before the statute of limitations.
This will help lessen the burden on the court from a massive amount of cases being filed at once and will provide the plaintiffs with a structured process for overcoming the SOL problem. We will learn more at the next hearing.

May 13, 2024 – Indivior Denies Tolling Agreement in Suboxone MDL

We finally have an answer from Suboxone’s lawyers about why they will not acquiesce to the tolling agreement.
Today, the defense lawyers for Suboxone filed an opposition brief countering the plaintiffs’ proposed tolling agreement. Their argument is simple: it’s not in their best interest. They rebutted the plaintiffs’ claim that without the agreement, personal injury lawyers would be forced to blind file to prevent the statute of limitations from expiring before they can properly investigate the claims they want to file. The brief admitted that gathering medical records, particularly from dentists, can take a long time, and that might cause lawsuits to be filed that do not have supporting evidence. However, Indivior wants the SOL to expire on as many cases as possible for obvious reasons.

In the brief, they state, “Defendants would get no benefit other than purported proof of use of Suboxone film, untethered to causation and purported damages.”

However, it was the plaintiffs’ stance that a tolling agreement would not only be fair to Indivior’s consumers, but it would also prevent Indivior from having to try cases all across the country, since every state as a different SOL.
We admit that we did think Indivior would consent to the tolling agreement to avoid litigation across multiple jurisdictions. But, it is now clear that won’t be happening.

This decision will push many, many more cases toward state courts rather than the consolidated federal MDL. What the Court decides or any steps it might take remains to be seen.

May 2, 2024 – Discovery Order and Potential Tolling Agreement are the Focus in Suboxone Lawsuit MDL

In the second status conference hearing for the Suboxone MDL, Judge Calabrese heard arguments from both sides about Indivior’s desire to focus on general causation, as we discussed in the previous update. However, the concept of a tolling agreement is also gaining attention in this case.

A tolling agreement is a legal arrangement— which both parties have to agree to—that temporarily suspends the statute of limitations for the issue at hand in order to allow plaintiffs to add cases with consideration and to prevent a storm of cases from being thrown at the defense and the Court all at once. So far, Indivior has shown no interest in agreeing to a tolling agreement in the Suboxone MDL.

April 21, 2024 – General Causation and Future Schedule

This week, Judge Calabrese held the second status conference for the Suboxone MDL. Here are some of the things we learned about the current status of the lawsuit.

Indivior’s legal team has been insistent on the need for a general causation phase of discovery. General causation is more or less what it sounds like, “in general, does Suboxone cause tooth decay?” It’s more or less the initial questions or basis of the lawsuit. Suboxone’s lawyers argue that proving general causation is crucial before moving on to address specific claims. This makes perfect sense; it would save resources, money, and time because if the plaintiffs can’t prove general causation, there is no reason to move forward with anything else.

However, it’s our position and the position of the plaintiff steering committee, that general causation is not necessary because Indivior basically admitted already that Suboxone can generally cause tooth decay.

Why do we think this? Well, we believe Indivior previously acknowledged potential dental risks associated with Suboxone when they updated their label. They would not have made this change and definitely would have contested the FDA’s decision if there was no data to support that Suboxone causes tooth decay. We will have to see if Judge Calabrese agrees.

The plaintiff steering committee has proposed that the Court address both general and specific causation simultaneously. This would improve efficiency, reduce any redundancy, and ensure that each case receives appropriate attention. However, this will only happen if the Judge agrees that general causation has already been established.

Judge Calabrese set a series of deadlines regarding the issue of general causation during the hearing. By April 23, 2024, both parties need to submit their arguments regarding whether Suboxone can generally cause harm, any follow-up documents are due by May 24, and any
replies are expected by May 31. There is a status conference scheduled for June 6, 2024 during which the Judge plans to resolve this issue.

The next interim status conference is scheduled for May 14, 2024, to discuss the potential suspension of statute of limitations deadlines through what is known as a tolling agreement.

April 28, 2024 – Expiring Statute of Limitations – States Where We Are Accepting Cases

We have received a lot of calls from people wondering how the statute of limitations in their state will affect their ability to file a Suboxone Lawsuit. Statute of limitations information can be confusing, and there is a lot of different information out there about who can file a suboxone lawsuit and who can’t.

Exactly half of states in America have a two-year statute of limitations on product liability lawsuits.

Since Indivior was forced by the FDA to add tooth decay and dental injury warnings to its label in January 2022, the statute of limitations ran out in January 2024 for any state with a 2-year filing limit.

However, we are still taking Suboxone lawsuits from states with three-, four-, and five-year statutes of limitations. The states we are accepting claims for the Suboxone lawsuit include:

• Arkansas
• Florida
• Maine
• Maryland
• Massachusetts
• Michigan
• Minnesota
• Missouri
• Montana
• New Hampshire
• New Mexico
• New York
• North Carolina
• North Dakota
• Rhode Island
• South Carolina
• South Dakota
• Vermont
• Washington
• Wisconsin
• Wyoming

March 28, 2024 – Potential Increase in Injury Severity Threshold

The lawyers for the injured victims of Suboxone (the plaintiffs) have been discussing with the defense the need to potentially raise the bar for the severity of dental injuries required for a person to qualify for the Suboxone lawsuit. There are two main reasons that we have been considering upping the requirements for the severity of the dental injuries: From the plaintiff’s point of view, if the threshold is raised, it could greatly help us to win the lawsuit or get a significant settlement by only focusing on plaintiffs with severe dental problems that can be demonstrably linked to Suboxone. This would streamline the lawsuit by excluding less severe cases and prevent the defense from being able to claim that the plaintiffs are throwing any case they can at the MDL, which the court, the public, and attorneys, in general, are not fond of.

From the defense’s point of view, this interest in upping the requirements for participating in the lawsuit could be a way to make it harder for some plaintiffs to participate and, therefore, decrease the number of people they may have to pay for their injuries. This is not news to us plaintiff attorneys, and we are weighing all possible sides of this issue to make sure that we make the best decision for the most people and for the people who need the help the most.

March 12, 2024 – Suboxone Lawsuit Defendants File Disclosures

Indivior, the manufacturer of Suboxone and defendant in the Suboxone Tooth Decay Lawsuit, has filed its corporate disclosures within the MDL. These disclosures are essentially documents containing relevant information about the defendant’s finances, practices, and potentially any internal communications related to prescribed Suboxone film and its dental risks. The disclosures could contain critical information. This update will likely have three significant implications. The first implication is that the plaintiffs’ lawyers will be able to use the information in these disclosures to build their case. The disclosures might reveal internal documents or communications acknowledging that Suboxone films can cause dental problems (and therefore, they were aware of it) or efforts to downplay the risks. The second major implication is that the financial information disclosed could influence potential settlement discussions. If the disclosures show that the defendant has significant financial resources, it might encourage them to consider a settlement to avoid a potentially costly trial.

Finally, the disclosures can offer insights into the arguments that the defense plans to use to make their case or rather, to defend themselves from the lawsuits being filed against them in the suboxone lawsuits MDL. This will allow the plaintiffs’ lawyers to prepare a more focused legal strategy to counter those arguments. We don’t have access to the specifics of these disclosures yet, but the fact that they’ve been filed shows progress in the lawsuit and provides opportunities for both sides of the lawsuit to strengthen their positions.

March 23, 2024 – New Case Management Order Issued in the Suboxone Tooth Decay Lawsuit

Case Management Oder (‘CMO”) #3 has been issued by Judge Calabrese. The latest order allows plaintiffs to simply file their Suboxone tooth decay lawsuit directly into the MDL which avoids delays waiting on transfer orders issued by the MDL Judge.

Plaintiffs who allege dental injuries following prolonged exposure to sublingual buprenorphine can file suboxone lawsuits directly into MDL 3092 in the Northern District of Ohio as a member case. This will greatly promote judicial efficiency.

As we are rapidly approaching the expiration of the statute of limitations in states with a two-year SOL, we will soon see a flurry of Suboxone product liability lawsuits filed into the MDL. However, plaintiffs must be careful when filing each new Suboxone lawsuit as a weak case will quickly be targeted by defense counsel as a potential bellwether case.

Further, we anticipate the plaintiff steering committee will soon commit to more stringent requirements or criteria to qualify for the Suboxone tooth decay lawsuit. Presently, the vast majority of tooth decay Suboxone lawsuits allege a wide array of dental injuries including severe tooth decay, dental caries, dental erosion of tooth enamel, tooth fractures and gum infections.

We expect plaintiff leadership to limit injuries for suboxone lawsuits to the actual loss of a tooth. Whether such loss is a result of a tooth extraction or the tooth naturally fell out as a result of exposure to buprenorphine drugs makes little difference.

March 9, 2024- Judge Calabrese Appoints Plaintiff Steering Committee at First Status Hearing over Suboxone Lawsuits

The initial status conference was held in the Suboxone lawsuit in United States District Court for the Northern District of Ohio. Judge Calabrese appointed eighteen (18) individuals to serve on the plaintiffs steering committee for IN RE SUBOXONE (BUPRENORPHINE/NALOXONE) FILM PRODUCTS LIABILITY LITIGATION – MDL 3092.

Judge Calabrese will be setting a discovery timeline and create a mechanism for plaintiffs to file their Suboxone tooth decay lawsuits directly into the MDL over the coming weeks. The next hearing (status conf) is set for April 16, 2024, at 2 p.m.

Plaintiff lawyers handling Suboxone lawsuits are beginning to scramble in anticipation of the statute of limitations in two-year states expiring in early June 2024. More specifically, the warning label on Suboxone sublingual strips was changed in June 2022.

Thus, the statute of limitations (hereinafter referred to as “SOL”) in states with two-year SOLs will soon expire. We anticipate a flurry of Suboxone lawsuits will be filed prior to June for the preservation of the client’s rights in these states.

February 18, 2024 – Hearing set on March 7th to Determine Leadership in the Suboxone Lawsuit

Judge Calabrese has set a hearing for the Suboxone lawsuits MDL on March 7, 2024, in Cleveland, Ohio. While this is considered an early status conference, Judge Calabrese will begin determining and assigning leadership positions for both the plaintiffs and defendants.

February 12, 2024 – Will There be a Settlement in the Suboxone in 2024?

While we believe the Suboxone lawsuits will be a fast-moving mass tort litigation, a settlement is unlikely this year. We now have over 20 federal Suboxone lawsuits in the MDL but we are likely eighteen months away from bellwether trials at the earliest. Our Suboxone lawyers project this lawsuit will take two to three years to reach the state of a settlement which still makes this a speedy mass tort. We believe the science is relatively clear, and the plaintiffs will succeed in the Daubert hearing for the Suboxone lawsuits.

A Daubert hearing is where the Court determines the admissibility of both the plaintiff’s and defense’s expert witnesses, the methodology behind their scientific conclusions, and how it relates to suboxone films causing tooth decay and the Suboxone lawsuits as a whole. The sheer number of adverse event reports filed by Suboxone users resulted in the FDA (Federal Drug Administration) unilaterally changing the warning label on Suboxone sublingual films in 2022. Keep checking this page for updates on the project which should be coming weekly.

February 6, 2024 – JPML Creates an MDL for Suboxone Tooth Decay Lawsuit

The U.S. Judicial Panel on Multidistrict Litigation consolidated 16 Suboxone lawsuits that had been previously filed in various U.S. Federal Courts. The Suboxone lawsuit will now be consolidated before Judge Philip Calabrese in the U.S. Federal Court for the Northern District of Ohio.

The Suboxone lawsuits allege that Indivior Inc. (the manufacturer of Suboxone) failed to warn users that the sublingual form of this prescription medication for opioid use disorder is tremendously acidic to the teeth. In turn, there are numerous adverse event reports of severe dental decay and other dental injuries, including broken teeth, tooth loss, tooth erosion, tooth fractures, and permanent tooth damage.

We already know the defendant manufacturer is a bad actor that rushed prescription Suboxone film to market when the patent on Suboxone tablets was close to expiring. In turn, what was considered the gold standard for opioid addiction treatment has become in the case of many of our clients, the cause for tooth extractions.

January 18, 2024 – Helpful Information While We Wait on January 25th

While we wait for the Suboxone lawsuit JPML hearing on the 25th, we have put together some helpful information for people who are actively taking Suboxone or were taking Suboxone and are worried about their dental hygiene. Scroll below to the section “How Can I Prevent Tooth Decay from Suboxone?”

January 9, 2024 – Suboxone Tooth Decay Lawsuit Appears Headed to Louisiana

It’s almost a surety that the Joint Panel on Multidistrict Litigation (JPML) will consolidate the Suboxone cases into an MDL which will move the cases to a single Federal Court, with a single judge, and in a single jurisdiction to manage pretrial proceedings, discovery, and motions, for all the cases involved.

January 4, 2024 – Suboxone Lawsuit Appears to be Gaining Traction

As more and more Suboxone tooth decay lawsuits are filed against the makers of a drug that has become the gold standard in opioid addiction treatment, hopes are high that the Suboxone lawsuit MDL will move forward at the end of this month. The Food and Drug Administration (FDA) has received a significant number of adverse event reports of oral health issues concerning the sublingual film version of Suboxone.

The opioid crisis led to the growth in popularity of Suboxone.  However, the original patent on Suboxone tablets was set to expire when the sublingual film version was introduced without much testing on the long-term use and overall dental outcomes.  Indivior Inc. was likely preoccupied with the thought of tamping generic competition, as a later felony conviction and violation of monopoly laws might show.

Adverse event reports of tooth loss, advanced tooth decay, and oral infections have been received by the FDA.  There is a growing body of anecdotal evidence that Indivior Inc. (originally a subsidiary of Reckitt Benckiser) knew the sublingual film form of Suboxone has a damaging effect on dental health including severe tooth decay.

We are seeing more Suboxone lawsuits filed in Federal Courts throughout the U.S. Thus, it is more likely than not the JPML will consolidate these lawsuits for a consistent and streamlined discovery.

Monopoly Allegations Against Suboxone May Reveal More About the Current Tooth Decay Litigation

In October 2023, the maker of Suboxone, Indivior, were facing a different kind of Suboxone lawsuit when they settled for a hefty $385 million in lawsuits related to Suboxone, but not because of failing to warn about tooth decay—though they might be related.

These lawsuits were brought by pharmaceutical wholesalers over accusations that Indivior created a monopoly by forcing a sublingual film version of Suboxone onto the market just as their patent for Suboxone tablets was running out.

Earlier in 2023, they settled two other lawsuits—one for $102.5 million to multiple US states and the other for $30 million to health insurers for affecting healthcare costs.

In the U.S. pharmaceutical patents last 20 years and are crucial for drug companies to protect their investments and profits. The idea is that the 20-year period gives the company time to recoup research and development costs and generate profits.

After that, generic manufacturers can produce and sell cheaper versions of the drug, which usually significantly reduces the original manufacturer’s profits but helps Americans with less expensive alternatives.

However, the three lawsuits accused Indivior of circumventing these regulations by rushing a sublingual film version of Suboxone onto the market. They then marketed it to doctors and patients as superior to its tablet counterpart, sidelining generic options by keeping the entire buprenorphine market in their pocket.

Amid these claims of monopolization, it’s possible that in their haste to get the films on pharmacy shelves, they overlooked concerns surrounding Suboxone films.

It’s possible that they either failed to discover that sublingual films cause tooth decay during their research or, worse, they knowingly withheld this information to avoid the FDA’s regulatory hurdles and the time it would have taken to research the problem further.

These monopoly allegations and settlements, and the accompanying tooth decay allegations, paint a complex picture of a pharmaceutical giant trying to navigate between maintaining its market share and ensuring patient safety.

As these events unfold, they will bring to light more than just the fact that Suboxone can cause tooth decay. They will reveal something about the dangers of pharmaceutical companies prioritizing profits over patient safety and the need for a stronger focus on patient safety in the American healthcare industry.

January 1, 2024 – Lawyers Confident Suboxone Tooth Decay Lawsuits Will Soon be Consolidated in Northern District of Ohio

Our lawyers feel confident the Suboxone class action lawsuit will be consolidated and centralized before a single Judge in one federal jurisdiction. In fact, we are confident Suboxone lawsuits will inevitably be consolidated in the Northern District of Ohio.

If you used sublingual film form, contact us immediately to determine whether you qualify to file a Suboxone lawsuit. Suboxone tooth decay litigation is going to expand significantly over the coming year. Your time to take action is now.

January 1, 2024 – Strength of Science in Suboxone Tooth Decay Litigation

What we really love about Suboxone lawsuits is the science. There is a clear link between use of Suboxone sublingual films and severe tooth decay. Unlike recent mass tort failures such as Tylenol,we are not discussing an over the counter drug. Prescription Suboxone film is commonly referred to individuals undergoing opioid addiction treatment.

The sheer number of folks who have complained of dental injuries in the past four years is alarming. This is why we can expect the Judicial Panel on Multidistrict Litigation to consolidate all Suboxone tooth decay lawsuits.

We now represent many individuals who were prescribed Suboxone (sublingual buprenorphine) and suffered severe dental injuries, tooth decay, tooth loss, oral infections requiring tooth extraction, tooth fractures, and other severe dental injuries. Our colleagues participating in the Suboxone class action lawsuit are telling us their clients are consistently dealing with serious dental injuries. We believe this is a lawsuit that will easily get past the Daubert standard in Federal Court.

December 15, 2023 – JPML Will Determine the Fate of Suboxone Lawsuits in January

The Joint Panel on Multidistrict Litigation (JPML) has announced that there will be a hearing session on January 25th, 2024, where they will hear oral arguments regarding the formation of a Suboxone tooth decay MDL. The hearing will take place in Santa Barbara, California.

After this hearing, it’s expected that an MDL for the Suboxone tooth decay lawsuits will be formed, which, if approved, will mark a significant win for the plaintiffs and simplify pretrial proceedings.

December 6, 2023 – Suboxone Lawsuit Defendants Support Plaintiffs’ Calls to Establish a Suboxone MDL

The defendants in the Suboxone lawsuits (Indivior Solutions, Indivior Inc., and Aquestive Therapeutics, who jointly developed Suboxone) have responded to the plaintiffs’ motion to form an MDL lawsuit for Suboxone.

This move is a bit surprising, but if the defendants saw the writing on the wall, it does make sense for them to agree to the motion so that all the similar Suboxone lawsuits can be brought together under one judge in one court to make things more efficient and consistent which will save everyone time and money.

November 14, 2023 – Plaintiffs in Suboxone Lawsuit Petition for Multidistrict Litigation

Several plaintiffs have begun the process to request the formation of a multidistrict litigation (MDL) for the Suboxone tooth decay lawsuits. Lawyers representing these plaintiffs filed a motion to transfer with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion calls for the establishment of an MDL in the U.S. District Court for the Northern District of Ohio to better handle the many lawsuits filed in different districts regarding Suboxone’s link to tooth decay.

November 1, 2023 – Suboxone Lawsuit Continues to Grow

Indivior now faces an additional 14 Suboxone tooth decay lawsuits with more expected in the coming months.

October 30, 2023 – Was Indivior Engaged in a Kickback Scheme?

In addition to the many lawsuits filed against Indivior regarding the link between Suboxone use and tooth decay, there are also ongoing lawsuits against the makers of Suboxone which allege they were involved in an illegal kickback scheme and that they illegally tried to suppress competition by blocking generic versions of Suboxone. These separate lawsuits help put pressure on the defense in the growing number of Suboxone tooth decay lawsuits.

September 25, 2023 – First Suboxone Tooth Decay Lawsuit Filed

The first lawsuit against Indivior and Reckitt Benckiser alleging a link between the branded drug suboxone and tooth decay is filed in the United States District Court for The Northern District of Ohio by plaintiff David Sorensen. We saw this lawsuit as inevitable. There have been far too many reports of adverse events related to dental injuries associated with sublingual Suboxone.

January 12, 2022 – FDA Changes Warning Label of Suboxone

The FDA officially announced that drugs like Suboxone can cause tooth decay, requiring new warning labels on the medicines. Numerous reports of dental damage, including broken teeth, severe tooth decay, and gum infections, prompted the FDA to at least list tooth decay for now as a potential health risk. There are a growing number of reports showing a link between Suboxone sublingual films and tooth decay along with other dental health issues. So far, there have not been any Suboxone lawsuits that we have heard of.