Suboxone Tooth Decay Lawsuit: Suboxone Lawsuits (January 2025)

As of November 2024, significant developments have occurred in the Suboxone tooth decay litigation:

Case Management and Census Protocol

On November 13, 2024, Judge J. Philip Calabrese, overseeing the Suboxone multidistrict litigation (MDL) in the Northern District of Ohio, issued a case management order establishing a census protocol. This protocol requires plaintiffs who filed claims by October 7, 2024, to submit proof of harm, including pharmacy records confirming Suboxone film usage and medical or dental records documenting injuries.

Status of Filed Cases

As of November 2024, the MDL comprises 678 active cases. This reflects a slight increase from previous months, indicating ongoing interest and participation in the litigation.

Allegations Against Indivior

Plaintiffs allege that Indivior, the manufacturer of Suboxone, failed to adequately warn users about the risk of severe dental problems, including tooth decay, erosion, and loss, associated with the medication. The lawsuits claim that the company prioritized profits over consumer safety by not providing sufficient warnings about these potential side effects.

Implications for Plaintiffs

Establishing the census protocol signifies a move toward organizing and streamlining the litigation process. Plaintiffs must now provide specific documentation to support their claims, which may influence the progression and outcomes of individual cases.

These developments highlight the ongoing legal challenges faced by Indivior and the affected individuals seeking compensation for their alleged injuries. The litigation continues to evolve, with further updates anticipated as the cases proceed through the legal system.

Virginia-based pharmaceutical company Indivior agreed to an $85 million settlement over allegations of healthcare fraud and antitrust violations in a major case before the Roanoke County Circuit Court. Plaintiffs—five health care benefit plans that paid for Suboxone—claimed Indivior engaged in a fraudulent “product hop” by switching the market from Suboxone tablets to a newer film version in 2010 to block generic competition. This scheme was initially flagged by a whistleblower within the company, sparking the legal action.

The plaintiffs filed suit in 2020 after opting out of the Suboxone multidistrict litigation (MDL). They argued that Indivior’s actions forced them to pay more for Suboxone than otherwise. In October 2023, a jury ruled in the plaintiffs' favor on a statute of limitations defense, affirming their claims were not time-barred. This $85 million settlement, reached just days before the case was set to go to a five-week trial, ranks among the largest opt-out pharmaceutical recovery settlements on record.

Earlier this month, the court held a status conference for the Suboxone tooth decay MDL. The main goal was to prepare for the upcoming bellwether trials, which are a big deal in mass tort cases like this. These trials help both sides predict how juries might respond to key issues—like whether the product had defects, lacked proper warnings, or was marketed misled. Most importantly, they will show how an average jury would rule if a Suboxone claim were taken to trial.

There’s a good chance the defendants could settle before the trials begin to avoid the risk of unfavorable jury verdicts. But locking in trial dates is essential to kickstart serious settlement talks. Once those trials are on the calendar, we could see a quicker, more complete resolution in the Suboxone case.

We’ll monitor the situation closely and share updates as we have them. Rest assured, we’re fully committed to seeing this through and pushing for a fair outcome every step of the way.

The recently issued Case Management Order No. 11 for the Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation lays the groundwork for how electronic discovery and document production will be handled in the ongoing lawsuits. This order emphasizes protocols to ensure that physical and digital documents, such as emails and spreadsheets, are preserved, processed, and shared between the parties to promote efficiency and fairness.

The order focuses on handling Electronically Stored Information (ESI), including rules for preserving relevant metadata (information about a document's history, such as who created it and when), organizing files, and ensuring that all parties have access to the necessary documents. It also sets out specific methods for dealing with complex electronic files, such as spreadsheets and databases, to ensure they are produced in a usable format.

Notably, the order encourages collaboration between parties in determining search methods and protocols, helping to reduce unnecessary court interventions. It also provides guidelines for how non-party documents, such as those obtained through subpoenas, should be managed, ensuring that the discovery process remains thorough yet efficient.

This order demonstrates the court's intent to streamline the discovery process while balancing the burden on the parties involved. It ensures that relevant information is shared without imposing undue technical burdens on any party.

We have a major update for you in the ongoing Suboxone litigation, which will likely strengthen the plaintiffs' position when it comes to the motion to dismiss under "implied preemption" filed by the defense. In response, the Plaintiff Leadership Committee (PLC) filed a "Notice of Supplemental Authority." A "Notice of Supplemental Authority" is just a fancy term for information that is relevant to an issue in the ongoing case but was not available when earlier briefs were submitted.

The PLC's response claimed that state law claims should not be dismissed based on this judicial doctrine without explicit preemption by Congress. A huge part of their argument to back this up is the Supreme Court's recent ruling in Loper Bright v. Raimondo, which challenged the validity of the implied preemption theory.

Additionally, a recent ruling by the U.S. Court of Appeals for the Third Circuit in the Fosamax case also supports the PLC's position. In that case, the court concluded that the district court erred in its analysis of preemption and instead favored the plaintiffs' right to bring state law claims. This ruling, along with the reasoning in Loper Bright, throws out the idea that FDA statements alone can preempt these types of state-based claims.

These recent rulings could have a major positive impact on the claims in the Suboxone MDL, particularly when it comes to failure-to-warn and design-defect allegations at the state level.

The PLC is hoping the court will consider this new authority and rule that the plaintiffs' state law claims can remain intact.

Stay tuned for more updates as this major part of the Suboxone case develops.

Judge Calabrese, who is overseeing the MDL against Suboxone for tooth decay, has dismissed some of the defendants' subsidiary organizations. In general, when a plaintiff files a lawsuit, they often name not just the main company but also its parent company and other related companies since they are often involved in the alleged harm.

In this order, the Judge has released:

• Indivior PLC
• Reckitt Benckiser LLC
• Reckitt Benckiser Healthcare (UK) Ltd.

However, other defendants, including Aquestive Therapeutics and two main Indivior units, remain in the MDL.

The Judge cited an August 22 formal request filed by plaintiff Ryan Bennett and agreed to by the defendants, asking the court to dismiss these defendants. During a status conference on September 4, the additional plaintiffs also agreed to release the plan.

The defendants were dismissed with prejudice in Bennett's case and without prejudice in the other cases.

The MDL was established in February, consolidating more than a dozen Suboxone-related suits from various states into the Northern District of Ohio. Since then, more claims have been transferred from other states, expanding the case.

Several law firms, including Dolman Law Group, represent the plaintiffs, while Sutter O'Connell Co. and Bowman & Brooke LLP represent the companies.

After Indivior filed a Motion to Dismiss, plaintiffs in the Suboxone MDL (Multi-District Litigation) swiftly filed their motion to counter Indivior's arguments for dismissal. Indivior's motion hinges on preemption claims, arguing that federal law shields them from state-level liability claims. They contended that certain aspects of the plaintiff's failure-to-warn and design-defect claims were preempted by federal regulations, particularly those governing the approval and labeling of Suboxone.

However, the plaintiffs' motion argued against this preemption defense. They emphasized that their claims were not preempted because they were based on newly acquired information that Indivior allegedly failed to incorporate into their product's labeling, as required by the FDA's Changes Being Effected (CBE) regulations. These regulations allow drug manufacturers to update labels with new warnings without prior FDA approval when new risks are identified. The plaintiffs maintained that Indivior had ample evidence of the risks associated with Suboxone's delivery system well before the FDA's June 2022 label change but failed to act, breaching their duty to warn.

Additionally, the plaintiffs challenged Indivior's arguments regarding the design-defect claims, pointing out that an alternative delivery system for buprenorphine, such as the FDA-approved injectable Sublocade, could have mitigated the risks posed by Suboxone film. They argued that this alternative design was feasible and should have been considered by Indivior before launching the Suboxone film.

In summary, the plaintiffs' motion sought to dismantle Indivior's preemption defense, arguing that the company had a continuous obligation to monitor and update its product labeling and design in light of new information, a responsibility they claim Indivior neglected. This filing marks a significant step in the ongoing litigation, highlighting the complex interplay between federal regulations and state law claims in pharmaceutical litigation.

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 preempt state law (federal law will rule). 

Indivior contends that Ryan Bennett's failure to warn claims are preempted because the label was approved. Thus, they allege that an approved label is legally adequate. Unfortunately for Indivior, they have relied on the assumption that plaintiffs cannot rely on newly acquired information that predates a change in label. 

Indivior's argument fails as a result of the case Wyeth v. Levine. Wyeth holds that manufacturers remain responsible for their label at all times. Thus, newly acquired information may consist of data previously submitted. In other words, the plaintiff may rely on data that predates the FDA's approval of the Suboxone film label to prove an element of his claim or evade preemption.

Further, Indivior also relies on the fact the FDA approved an updated label in 2022. However, Indivior remains responsible for the Suboxone film label at all times. Newly acquired information, in this case, when taken cumulatively with all existing information, should lead to a label change, which is at the heart of the plaintiff's argument. 

Indivior's design defect preemption argument is illogical. Mr. Bennett's pre-approval design defect argument relates to the buprenorphine delivery system. The defendant claims Mr. Bennett's pre-approval design defect claim is preempted as we would be speculating what action the FDA may take. 

In this case, the controlling question is whether the FDA would approve a buprenorphine delivery system that is a safer alternative to sublingual Suboxone. Fortunately, we do not need to speculate what the FDA may or may not do. The FDA has approved a safer Sublocade alternative (injectable buprenorphine). 

Defendants filed a motion to dismiss and challenge the plaintiff's claims under federal preemption in every conceivable mass tort claim. This was expected in the lawsuit, and we anticipate Judge Calabrese will deny Inidivior's motion to dismiss. The next step in Suboxone litigation will be discovering whether exposure to Suboxone film can result in tooth loss.

A research letter published six months after the June 2022 Suboxone film label change sheds light on how harmful this drug is to a user's dental health. The research letter, published in the Journal of the American Medical Association, illustrated a significantly increased risk for adverse dental events (dental injuries) in individuals using sublingual buprenorphine compared to those using transdermal buprenorphine or oral naltrexone. Many of the individuals who used sublingual buprenorphine suffered severe tooth decay.

This letter will be considered when the Court hears arguments regarding the sufficiency of the label on Suboxone film. This goes to the heart of the plaintiff's argument in the lawsuit. Plaintiffs contend that Indivior's warning label fails to adequately inform patients or physicians that the Suboxone film poses serious dental risks. 

We expect Judge Calabrese to take notice of the 10,000 lawsuits listed on Schedule A submitted to the Court back in June. Practically every last client whose claim is pending in federal court suffered severe tooth decay. 

We believe (along with several other law firms) that Indivior failed to warn users and physicians prescribing Suboxone that the product was inherently dangerous and posed a considerable risk to dental health.

We believe the paper insert added to the box of Suboxone film strips is the weakest form of warning. Drug manufacturers know full well that most people won't read it because it's too long and too complicated, and patients assume if the information is important, their doctor, pharmacist, or the package's label would warn them.

And I would venture to go one step forward and say that most people cannot read it. This is not because people taking Suboxone can't read, of course; it's 33 pages long and includes paragraphs like the following, which no regular person could understand.

The 4:1 combination of buprenorphine and naloxone was not mutagenic in a bacterial mutation assay (Ames test) using four strains of S. typhimurium and two strains of E. coli. The combination was not clastogenic in an in vitro cytogenetic assay in human lymphocytes or in an IV micronucleus test in the rat.

From SUBOXONE® "HIGHLIGHTS OF PRESCRIBING INFORMATION" Section 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

According to WordCounter.net, the document contains 18,025 words and would take a person with a college graduate reading level approximately 1 hour and 5 minutes to read.

If Indivor truly wanted to warn patients, they could have simply added the warning to the packaging's label like all other major warnings.

Additionally, Indivior never sent out "Dear Doctor" letters warning physicians who regularly prescribe Suboxone films about the likelihood of chronic tooth decay. Had doctors been warned, they could have passed this information on to their patients. Doctors do not just magically know every side effect caused by a medication. They rely on manufacturer patient reports and communications to acquire this information. Thus, this is the basis of Dolman Law Group's stand.

We have filed hundreds of Suboxone lawsuits and await the case to move forward. This will happen once the tolling agreement that will streamline the Suboxone litigation is finalized, likely only days away.

A joint status report was filed in the Suboxone lawsuit, indicating that both sides are very close to executing a tolling agreement. Indivior (defendant manufacturer) has provided plaintiffs with a proposed order to edit and provide feedback on proposed terms. Plaintiffs expect to provide their response within a week. 

The number of cases filed in the Suboxone MDL pending in federal court dropped from 677 to 673 in the past few weeks. We expect slower growth of lawsuits filed in the MDL as a result of the pending tolling agreement, which will give plaintiffs until sometime in 2025 to bring their lawsuits.

However, the number of potential Suboxone lawsuits continues to grow month over month. Law firms simply have more time to investigate their claims and perform their due diligence. For firms that believe the statute of limitation for the lawsuit began running as of June 2022, the next big rush to file claims will not be until next summer. 

At Dolman Russo, we have taken a position that the alleged warning label change in 2022 failed to provide notice. We believe the warning, which was listed in an insert and not on the bottle itself, did not adequately warn those prescribed Suboxone film of the potential dental problems they could face from exposure. The known danger of Suboxone dental injuries should have prompted a more thorough warning to inform patients and warn medical providers that exposure can result in dental decay.

The number of cases filed in the Suboxone MDL dropped from 677 to 673 in the past few weeks. We expect slower growth in this litigation as a result of the pending tolling agreement, which will give plaintiffs until sometime in 2025 to bring their lawsuits.

Indivor has filed for a partial dismissal of the Suboxone lawsuits primarily based on the doctrine of federal preemption. Here is what you need to know:

*Note: when you read "preempt" below, in this context, it means that whatever issue they are talking about is invalid for X reason. This will help make the following much more clear.

1. Design Defect Preemption: The defendants argue that federal law preempts the design defect claims. They assert that any change to Suboxone's design would have required FDA approval. Thus, it is impossible to comply with federal and state law. Since the FDA approved Suboxone's formulation, the defendants cannot be held liable under state law for not altering the design post-approval.
2. Failure to Warn Preemption: The defendants also claim that federal law preempts the failure-to-warn claims during two significant periods:
   • At the time of approval: The FDA approved Suboxone after determining its safety and efficacy. Because of this, the defendants argue that the plaintiffs' claims challenging the initial label are preempted because the FDA's approval process is the ultimate authority on a drug's safety based on the information available. Again, the defendants are claiming that because the FDA initially approved the label, that should shield them from claims that the label was faulty.
   • Post-approval after June 2022 label change: After the FDA-mandated label change in June 2022, the defendants argue that there has been no newly acquired information that would justify another label change under the FDA's "changes being effected" (CBE) regulation. Therefore, they claim that any assertions that the label remained inadequate are also preempted. This is the same argument as the "time of approval" argument—aka the FDA approved it and did not tell us that we needed to make any other changes; therefore, plaintiffs shouldn't be able to complain about the label because federal law overrides state law.
3. Claims Against Non-NDA Holders: The defendants argue that federal law bars non-NDA (New Drug Application) holders from modifying the drug label. And since only the NDA holder can make changes to the label, claims against anyone other than the NDA holder are preempted. Indivor claims it was not applying for a new drug, so they were not the NDA holder and, therefore, can't be sued.
4. Inadequate Allegations: Finally, the Indivor's attorneys argue that the plaintiff's allegations are insufficient for a lawsuit against certain defendants (Indivior PLC, Reckitt Benckiser Healthcare (UK) Ltd., and Reckitt Benckiser LLC) because there is no specific allegation that these entities manufactured, marketed, or sold Suboxone Film. Basically, this is corporations being shady, which is, unfortunately, just an accepted fact in America. Indivior is claiming that Indivior PLC and the other companies it lists cannot be sued because they don't make Subxone; they are just the parent company of Indivior Inc. and Indivior Solutions which actually makes and markets Suboxone. It's a load of bs and they know it.
5. Dismiss with Prejudice: The defendant's motion wants the Court to dismiss these claims with prejudice, meaning they cannot ever be refiled or attempted again in anyway.

We will keep you updated on what the Judge has to say about this motion.

Defendant Indivior has filed an answer to the plaintiff's first amended master complaint. Further, Indivior also filed a motion to dismiss for lack of personal jurisdiction. Without bogging our readers down in legalese, both pleadings are a mere formality and contain very little in the way of substance. Indivior will almost certainly lose on their personal jurisdiction argument. 

Although Indivior is a country domiciled in the United Kingdom and Wales, its products are prescribed and sold throughout the United States. This is nothing more than an attempt to waste the time of plaintiff lawyers, and the very lawyers who filed this pleading get to bill Indivior for their work.

Indivior's answer to the master complaint tells us very little. In fact, Indivior essentially denied each and every allegation raised by the plaintiffs—aside from the fact a lawsuit was filed and they are a defendant.

Again, this is typical in any mass tort or class action lawsuit. Defendant(s) have no incentive to admit any factual allegations at this point and will force plaintiffs to prove each and every count through the process of discovery.  The next status conference is set for September 4, 2024, and we expect a tolling agreement to be reached by all parties at such point.

Judge Calabrese has issued an order in the Suboxone tooth decay lawsuit MDL following the latest status conference on July 18, 2024. The Court has directed Indivior to turn over specific documents related to the antitrust litigation that was resolved in October 2023. We believe these documents will illustrate the egregious marketing tactics utilized by the defendant manufacturer. Keep in mind that Indivior paid $385 million to resolve the antitrust litigation, and this will shed light on what a bad actor this company is and continues to be. 

Further, Judge Calabrese ordered Indivior to turn over documents from its patent litigation. Forty-two (42) state attorneys general accused Indivior of pulling its oral tablet form of Suboxone to avoid generic competition. 

Indivior ultimately settled its patent litigation for $102.5 million. These documents will show how the tablets were replaced by sublingual film to avoid generic competition, as the patent on the tablet form was set to expire. Additionally, plaintiffs contend that Indivior failed to properly test Suboxone film and the dangers it poses to one's oral health, including tooth decay and tooth loss. 

Both plaintiffs and defendants were provided a deadline of August 16, 2024, to negotiate a protocol for exchanging information related to all claimants. This information will be used to determine whether individual claims are representative of other cases in the Suboxone tooth decay MDL and what information each party needs to resolve this lawsuit.

The next status conference has been set for September 4, 2024. We are hopeful that a tolling agreement will be reached by both plaintiffs and defendants by this date.

There are presently 692 Suboxone lawsuits consolidated in the United States District Court for the Northern District of Ohio. While the number of lawsuits being filed has slowed considerably, there is a good reason for that. On June 14th, the Plaintiffs submitted a list with the Court for all claims in states with a one or two-year statute of limitations. Thus, the next big rush of lawsuits will not be filed until next spring, prior to June of 2025, when states with a three-year statute of limitations will expire.

We are nowhere near a Suboxone settlement. This is a question I face regularly from our client base. However, I still remain steadfast in my confidence this will be a rather quick-moving mass tort, and I expect a Suboxone settlement by 2026. The science is simply very clear, and Indivior has proven to be a bad actor. 

Both parties signed off on a stipulated agenda for the upcoming case management conference in the Suboxone tooth decay lawsuit, which will take place July 18, 2024, in Cleveland. Plaintiff lawyers and lawyers for the defendant manufacturer (Indivior) continue working together to convert the Schedule A complaint (filed with the Court on June 14th) into a tolling agreement. 

ESI (electronically stored information) will be a contested issue in the upcoming hearing. Indivior has objected to specific RFP's (requests for production) of patent documents for Suboxone film or documents related to the antitrust MDL. Both sides will present oral arguments on all outstanding and disputed RFP's at this next hearing. There is also contention regarding the order of discovery and timing of a plaintiff's fact sheet. The plaintiffs believe it is way too early to subject their clients to burdensome and unnecessary discovery at this phase.

The lawyers for both the plaintiffs and defendant manufacturer (Indivior) have expressed confidence in reaching a tolling agreement in the near future. Further, they reached an agreement to inform Judge Calabrese by August 1, 2024, on the status of their continued talks. The aim is to execute a tolling agreement that will eliminate the need to file individual lawsuits to preserve a statute of limitations in the future. 

We believe Indivior has come to realize just how many plaintiffs there will be in the Suboxone lawsuit. The recent schedule submitted by the plaintiffs on June 14 contained over 10,000 names. We expect there will ultimately be close to 50,000 plaintiffs in the Suboxone class action lawsuit when all is said and done.

Judge Calabrese has now issued an order ruling against Indivior's motion for bifurcation. Indivior asked Judge Calabrese for phased discovery wherein the Court would conduct general causation discovery first and specific causation thereafter. 

Phased discovery would add at least a year to eighteen months to the Suboxone lawsuit. However, the Judge felt that organic and specific causation are heavily intertwined. Thus, separating or sequencing general and specific causation would not be pragmatic. Further, the Judge stated that most MDLs (multidistrict litigation) operate efficiently by running both general and specific causation in tandem and on parallel tracks. This is a huge victory for the plaintiffs, and we expect Suboxone litigation to take off.

Over the past ten days we have seen the expiration of the statute of limitations for individuals residing in a handful of states. While a tolling agreement has been rejected by Indivior (defendant-manufacturer), Judge Calabrese allowed for the plaintiffs to file a master complaint with two separate schedules of individuals. One schedule was for folks residing in states with a two year statute of limitations and one in which the defendant is not a resident of. The second list is of individuals residing in New Jersey, Virginia and Delaware, where the corporate defendants are domiciled.

The master complaint with a schedule of plaintiffs was submitted to the court on June 14th. The schedules contains over 10,000 plaintiffs that are now part of the lawsuit which has been consolidated in United States District Court for the Northern District of Ohio. The majority of law firms representing plaintiffs in Suboxone litigation only filed on behalf of residents of states with two year statute of limitations. However, a few firms added plaintiff names to the schedule for all of their clients regardless of state. This is a decision that makes little sense to those in leadership.

Plaintiff leadership filed a new amended master complaint in the United States District Court for the Northern District of Ohio. Keep in mind that the plaintiff steering committee is simply attempting to plead their claims with a greater level of specificity. This is just a process of fine-tuning the master complaint for those looking to file a lawsuit going forward.

This is a pivotal move for Suboxone lawyers as discovery will soon proceed, and a fine-tuned complaint is somewhat of a roadmap for how plaintiffs will build and illustrate their claims. We are simply waiting at this time for Judge Calabrese to submit an order on whether general causation and specific causation discovery will be bifurcated or not. Plaintiffs have asked Judge Calabrese to allow general and specific causation discovery to proceed forward in parallel tracks.

A master complaint has now been submitted to the Court, with over 10,000 plaintiffs listed on the schedule. While we anticipate the lawsuit's number of plaintiffs will grow substantially over the next year, many of the 10,000 plaintiffs submitted in Schedule A will eventually fall off. 

Many Suboxone lawyers had no choice but to file on behalf of plaintiffs to preserve their claims in anticipation of the statute of limitation expiring. However, these very Suboxone lawyers did not necessarily receive records proving proof of usage by the deadline. Thus, many plaintiffs filed without their lawyer having enough time to perform due diligence.

The irony is that in every mass tort, the defendant manufacturer complains that some of the claimants in a multidistrict litigation lawsuit have claims with little to no merit. Yet, in this case, Indivior rejected a stipulated tolling agreement. The benefit of a tolling agreement is that there would no longer be a deadline to file a lawsuit, regardless of what state one resides in. In this case, Indivior is creating the peril they will later complain of.

Keep in mind that you may not see a new lawsuit filed for quite some time, as lawyers no longer fear the expiration of a statute of limitations.

Based on a prior motion requesting the tolling (pausing) of certain plaintiffs' ability to file their lawsuits in the MDL or in state court, there are now two lists of Suboxone cases. The lists were formed due to the location of the defendants' business residences - Delaware, New Jersey, and Virginia.

The more extensive list includes lawsuits in every state except New Jersey, Delaware, and Virginia. These claims have jurisdictional diversity, so they can be filed in federal court and consolidated into an MDL. The second list is for plaintiffs who reside in New Jersey, Delaware, and Virginia. These plaintiffs lack diversity since they are in the same state as the defendants. Typically, the second list of plaintiffs must file their lawsuits in state court, but the tolling agreement gives them time to decide where to file without losing their rights with time.

On June 6th, Judge Calabrese held oral arguments, during which both sides argued about bifurcating or separating the causation issues involved in these cases. As explained in the May 30th update, Indivior asked Judge Calabrese to separate general and specific causation issues. Indivior wants discovery to take place in stages. 

At LLN, we believe bifurcation is a terrible idea. It creates inefficiency and adds considerable time due to unnecessary procedural hurdles. Most MDL Judges have ruled against bifurcation in other cases, and we expect Judge Calabrese to do the same.

General Causation Versus Specific Causation

General causation is the simple premise that exposure to "x" causes "y." So, in these cases, plaintiffs must prove that Suboxone causes dental problems. Specific causation relates to the evidence needed to prove that Suboxone caused harm to each plaintiff.

In this case, based on substantial evidence that prolonged use of sublingual Suboxone strips leads to dental erosion and tooth loss, general causation appears blatantly apparent. Additionally, the FDA unilaterally changed the warning label on sublingual Suboxone back in 2022 due to the number of adverse event reports. The FDA has already found a causal link between the use of the sublingual form of Suboxone and poor dental outcomes. 

The LLN team believes this is little more than a stall tactic used by Indivior to delay these claims and frustrate the plaintiffs. They hope the many victims of their negligent conduct will grow frustrated and give up. Further, Indivior understands the costs associated with Suboxone tooth decay litigation, and they know the longer these cases take, the more plaintiff law firms must pay to protect their client's rights. Indivior wants to deter other lawyers from pursuing these cases and limit the number of plaintiffs. The more plaintiffs, the greater the pressure is on the manufacturer to settle.

We hold firm that bifurcation should be denied. General and specific causation should run parallel tracks to encourage judicial economy and avoid wasting the Court's resources by handling protracted litigation that shouldn't have to face unnecessary procedural hurdles. 

As the number of Suboxone tooth decay lawsuits grows, plaintiffs' attorneys urge the court to reject a proposal from the drug manufacturer, Indivior, Inc., and Reckitt Benckiser LLC. The proposal suggests splitting the litigation into two phases and limiting early discovery to the link between Suboxone and dental erosion, which plaintiffs argue would unnecessarily delay the claims.

Currently, about 500 product liability lawsuits are pending against the manufacturers, all alleging inadequate warnings about the tooth decay risks associated with Suboxone, a treatment for opioid addiction. The FDA added tooth decay warnings to Suboxone in June 2022 after over 300 cases of dental damage were reported. Plaintiffs believe that earlier warnings could have prevented severe dental issues and costly treatments.

With the two-year anniversary of the warning label change approaching, thousands more lawsuits are anticipated from individuals suffering from significant tooth loss and disfigurement due to Suboxone.

In response to the growing litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized the lawsuits in February 2024 under U.S. District Judge Philip Calabrese in the Northern District of Ohio for coordinated pretrial proceedings and early bellwether trials. Judge Calabrese is currently working on establishing a pretrial schedule and selecting representative claims for early trials to gauge jury responses to key evidence and testimony.

Indivior's proposal to bifurcate discovery involves selecting three to five lawsuits for a general causation phase, deferring other case-specific discovery. Plaintiffs argue that this approach would only delay justice and is based on the presumption that the defendants will prevail, which is unlikely given extensive scientific evidence linking Suboxone to tooth decay.

In an opposition brief filed on May 24, plaintiffs highlighted that phased discovery would unnecessarily prolong the MDL and waste resources. They pointed out that most MDL courts avoid bifurcation due to its inefficiency. Judge Calabrese has ordered Indivior to respond by May 31, with oral arguments on the phased discovery proposal set for June 6.

Last week, the court issued two Case Management Orders pertaining to the handling of protected information and privileged materials. Here is a summary of each.

Case Management Order No. 5: Designation And Handling Of Protected Information

Case Management Order No. 5 addresses the handling of protected information. It defines and categorizes the types of protected information that will come up in the Suboxone MDL, including "Confidential Information," "Highly Confidential Information," and "Protected Data." It defines who can access different types of protected information and how these materials should be labeled and managed. It also includes steps for marking documents as confidential, handling mistakes, and protecting personal data, as well as what to do if there's a breach or if confidential info needs to be shared in court.

Case Management Order No. 6: Evidence Rule 502(D) And Privileged Materials

Case Management Order No. 6 addresses how privileged materials in the Suboxone Product Liability Litigation will be handled. It states that Rule 502(d) of the Federal Rules of Evidence is applicable to this case which ensures the maximum protection of privileged information.

Rule 502(d) of the Federal Rules of Evidence allows the Court to order that any protected information exchanged during a case doesn’t count as giving up its legally protected confidentiality. This rule enables the plaintiffs to share information with the defense without worrying about losing their legal protections, like attorney-client privilege. It applies to both federal and state cases, ensuring that mistakenly disclosed confidential information remains protected.

Both Orders No. 5 & 6 will remain in effect until modified or terminated by the Court.

On May 13, Suboxone's defense team officially declared their refusal to accept a tolling agreement in the Suboxone tooth decay MDL. This agreement would have allowed lawyers for injured plaintiffs to file lawsuits after the statute of limitations had expired, as long as the injuries occurred before the SOL expired. In short, it would have allowed plaintiff attorneys to vet the cases rather than filing them and vetting them later.

Since a tolling agreement would save the Court time and money and maintain the integrity of the MDL, we thought the Court might step in, and so it did.

Judge Calabrese announced that the plaintiff steering committee must file a master MDL list of all individual plaintiffs by June 14 (the generally agreed-upon date the SOL expires in states with 2-year deadlines).

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 before the statute of limitations expired. More details will be available at the next hearing.

We finally have an explanation for why Suboxone's lawyers rejected the tolling agreement in the Suboxone MDL. Today, Suboxone's defense lawyers filed an opposition brief countering the plaintiffs' request for a tolling agreement.

The plaintiffs requested the tolling agreement to prevent personal injury lawyers from being forced to file cases without thoroughly vetting them just to beat the statute of limitations deadline.

The defendant's rejection acknowledged the situation the plaintiffs are in but made clear that their is nothing in it for them.

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

The plaintiffs argued that a tolling agreement would be fair to Indivior’s consumers and would prevent Indivior from having to try cases across the country, given that every state has a different statute of limitations. Because of this, we initially thought Indivior would consent to the tolling agreement to avoid litigation across multiple jurisdictions and save themselves time and money. However, it's now clear that won't happen.

This decision will push many more cases toward state courts rather than the consolidated federal MDL, which defeats the whole point. It is possible that the Judge will intervene and make some sort of motion that satisfies the issue, though they cannot force the defendants into a full-fledged tolling agreement.

The plaintiff steering committee filed a brief with the Court, emphasizing the fairness and efficiency of tolling agreements, and requesting the defendant to respond to the complaints. In essence, plaintiffs argue that MDLs are designed to promote judicial efficiency, and tolling agreements enhance this by simplifying each lawsuit, ensuring equitable treatment for all parties involved. 

Remember, a statute of limitations can only be suspended if both parties agree. A tolling agreement would extend or extinguish the statute of limitations, and plaintiffs would no longer be forced to file a lawsuit on every last case. 

In turn, this takes pressure off the Clerk of Court and enables more substantive work to occur, as there will be less pressure on plaintiffs to file lawsuits. The goal is for factual and expert development to proceed. Forcing the plaintiffs to file every last lawsuit slows this process down considerably.

Recent MDLs such as 3M, Zantac, and CPAP set the precedent for using tolling agreements in MDLs. Presently, Indivior is facing plaintiffs to file their lawsuits. Thus, when a Suboxone lawyer is hired shortly before an expiring statute of limitations, the absence of a tolling agreement prevents the attorney from diligently investigating the merits of the plaintiff's claims. 

Without the benefit of a tolling agreement, many of these lawsuits, which are often based solely on the client's statement of having taken sublingual Suboxone, would be filtered out by the lawyer if they were given sufficient time. The absence of a tolling agreement allows non-meritorious claims to congest the MDL, creating a situation that we expect Indivior to complain about later. This is a clear example of the very problem we are trying to address. 

The plaintiffs, in an effort to streamline the MDL and reduce unnecessary costs, offered to submit proof of usage to defendants via pharmacy or medical records. However, on May 8, 2024, Indivior rejected the plaintiff's offer to enter into a tolling agreement. This unfortunate decision places a significant burden on the plaintiffs, leading to unnecessary costs and a waste of judicial resources. 

Additionally, the plaintiffs requested that if we are forced to file each and every Suboxone lawsuit, defendants must be forced to answer all lawsuits. This is the only equitable remedy in a situation where the defendant is gambling, and the plaintiffs lack the time or resources to file every claim. 

There are now 486 Suboxone lawsuits filed into the MDL consolidated in the U.S. District Court for the Northern District of Ohio before Judge Philip Calabrese. This MDL had grown quickly since the beginning of April when there were just under 40 lawsuits alleging tooth loss as a result of exposure to sublingual buprenorphine. We had previously predicted rapid growth of this MDL based on the upcoming deadline in June for individuals residing in states with a two-year statute of limitations.

In the latest status conference hearing, Judge Calabrese entertained arguments from both sides as to the structure of discovery. In our last update, we first discussed Indivior's desire to focus on general causation. More specifically, plaintiffs bear the burden to prove that regular exposure to sublingual form of Suboxone can cause serious dental problems such as tooth loss or tooth extractions.

This is a thinly veiled attempt by Indivior to simply drag this lawsuit out and frustrate plaintiffs who may cease pursuing their potential claim, having experienced worsening dental health since using sublingual Suboxone.

We believe general causation is extremely strong in the lawsuit. This is evidenced by the FDA unilaterally forcing Indivior to change its warning label on sublingual buprenorphine back in June of 2022. However, Indivior is seeking to extend this lawsuit by a year or two to prevent more lawyers from investing in this lawsuit.

Another issue that is beginning to receive attention is a potential tolling agreement. This would suspend the statute of limitations for a defined period. This allows plaintiffs to further investigate their cases without feeling the need to file a lawsuit to preserve the rights of their clients. Indivior's defense counsel would be less overwhelmed responding to every last lawsuit. We shall see how this one plays out.

Indivior, the manufacturer of Suboxone, has asked the MDL judge to focus only on the general issue of whether the drug can be linked to dental concerns before the court considers whether any specific plaintiff can establish a link between their Suboxone use and their unique dental problems. The LLN team believes this is an attempt to delay the litigation and wear down the plaintiffs over time, so they eventually give up and accept a lower settlement to resolve their claims.

Indivior relies on prior Multidistrict Litigation situations where the court required initial proof that the drug could harm a user. The big difference between those MDLs and the Suboxone lawsuits is that Indivior has already placed a warning about tooth decay on Suboxone without a fight.

Adding a warning about tooth decay to the Suboxone label supports general causation in these cases, and shows Suboxone's link to dental injuries. The warning should be considered an acknowledgment by Indivior and the FDA that there's a scientific link between Suboxone use and dental problems.

Adding a warning to a label implies that there have been enough user reports or scientific findings about these problems to warn users about dental injuries. So, there's no reason to waste time arguing about general causation and ignoring each plaintiff's specific causation except to drag out the litigation and further harm the injured claimants. Instead, the court should consider both causation issues simultaneously to keep the MDL moving toward trial or settlement.

Twelve new Suboxone lawsuits were filed into the MDL over the past week. Over thirty lawsuits have been filed for the month of April with a few days to go.

The second status conference occurred in the Northern District of Ohio. Here are a few highlights from the latest hearing:

• Judge Calabrese set a filing deadline for a joint submission on general causation for April 23rd. Any further submissions are due by May 24th, and responses to those submissions are due by May 31st. To resolve the general causation issues, a hearing is scheduled for June 6.
• The next status conference is scheduled for May 14th. 
• The parties are to submit a joint briefing schedule by May 7th.
• On May 14th, the court will discuss a potential tolling agreement for Suboxone lawsuits, which would pause the statute of limitations for specific states.

We believe proving general causation will not be difficult for the plaintiffs in this Suboxone MDL. 

Multiple studies illustrate a causal relationship between using the ingredients in Suboxone (sublingual buprenorphine) and a wide array of dental injuries and worsening dental health. Further, the FDA required Indivior to change its warning label for Suboxone film in June of 2022 due to the amount of adverse reports filed by users. 

Specific causation will be a much greater obstacle, as plaintiffs must establish that each Suboxone user's individual exposure is causally related to their injuries. Suboxone lawyers will likely establish this in the specific cases chosen as potential bellwether trials.

As we mentioned below, some States have two-year statutes of limitations (SOL) that will expire in less than two months. The FDA forced Indivior to change its warning label in June of 2022, so we are beginning to see a rush by plaintiff law firms to file their Suboxone tooth decay lawsuits for clients residing in a State with a two-year SOL. 

We have tightened our criteria at Lawsuit Legal News to ensure only strong Suboxone cases are filed into the MDL. We only sign claims wherein the individual has lost three or more teeth following exposure to Suboxone sublingual strips.

At this point, the typical Suboxone lawsuit filed into the MDL is from states with a two-year statute of limitations.

This MDL was only created in February. In the first six weeks, 44 plaintiffs have filed cases alleging Suboxone caused severe dental problems. According to an agreed-upon court order, new lawsuits may now be filed directly into the MDL in the Northern District of Ohio rather than being transferred from federal courts of different states.

New complaints must include certain information, including the location where the case would have been filed if there was no MDL. The defendants also agreed to waive formal service requirements, which will move these cases along more quickly.

The Lawsuit Legal News team made an internal decision to require three or more extractions (equivalent to losing three teeth, either from a procedure or from them falling out) as a result of using sublingual Suboxone strips. Our goal is in line with the overarching goal of only filing strong cases into the MDL. 

If you are seeking to file a lawsuit, our attorneys can walk you through the specific statute of limitations in your State.

CMO #3 allows for cases to be directly filed into the Suboxone MDL.  Direct filing is meant to avoid unnecessary delays associated with transferring each case and for judicial efficiency.  Plaintiffs alleging dental injuries as a result of using sublingual Suboxone may file their lawsuit in the Northern District of Ohio as a member case.  

We believe cases will inevitably be narrowed to complete tooth loss.  Most of our existing client base has at least one tooth extraction or tooth loss that came out independently after prolonged exposure to Suboxone sublingual strips.  The plaintiffs' steering committee is wary of filing lawsuits into the MDL with minimal injuries.  Indivior's defense counsel can target a weak case as a potential bellwether case that would not benefit most plaintiffs. 

As mentioned below, the statute of limitations will expire this June in states with a two-year deadline on product liability claims.  As of April 1, 2024, we will no longer accept claims from individuals residing in states with a two-year statute of limitations.  Keep in mind that Indivior changed the warning label on sublingual Suboxone back in June of 2022.  As a result, we expect a flurry of Suboxone lawsuits to be filed in the MDL over the next sixty days. 

Additionally, we expect advertising for Suboxone tooth decay claims to take off following the most significant mass tort conference in the country in Las Vegas in the first week of April.  Mass Torts Made Perfect is attended by both lawyers and vendors.  Many of these vendors will be pushing Suboxone tooth decay advertising campaigns as this is considered a safe project, considering the strong science and the market cap of  Reckitt Benckiser (parent company of Indivior). 

The initial status conference was held this Thursday (03/07/2024) before the honorable Judge Philip Calabrese in the United States District Court for the Southern District of Ohio. Both Matthew Dolman and Stanley Gipe were present at the status conference. Stanley Gipe of Dolman Law Group was named one of the eighteen members of the Plaintiff's Steering Committee appointed by Judge Calabrese.

We anticipate many lawsuits will be filed by June 1, 2024. The FDA changed the warning label for Suboxone sublingual film in late June of 2022. The new Suboxone warning label in 2022 referenced individuals using sublingual medications containing buprenorphine who have reported a myriad of serious dental injuries, including severe dental decay, oral infections, tooth loss, cavities, and other dental injuries. 

Several states have a 2-year statute of limitations on product liability/failure to warn claims. Many law firms are no longer taking on Suboxone tooth decay clients who reside in such states. However, we believe the MDL will expand rapidly with the sudden influx of lawsuits over the next eighty days. We will continue to update the public on the rapidly evolving Suboxone litigation.

As of June 2024, 305 cases of dental problems were reported to the FDA from individuals who used sublingual buprenorphine. A number of these individuals suffered tooth decay within an average time of two years following long-term exposure to sublingual Suboxone film.

It is also worth noting eight lawsuits were filed in the past week. 

A new lawsuit filed by an Ohio man illustrates the harm caused by prescription Suboxone film. A gentleman who used the sublingual form of Suboxone for sixteen consecutive months went from having excellent dental hygiene to losing eight teeth along with a host of other dental injuries. A physician prescribed Suboxone film to treat opioid addiction. Extensive tooth loss indicates this is not just another Suboxone tooth decay lawsuit. We have struggled with the term "tooth decay lawsuit," as the vast majority of our Suboxone clients to date have lost multiple teeth at a minimum.

Aside from issues with dental hygiene, many of our clients have lost vocational prospects as it is challenging to attain employment with missing teeth. Unfortunately, we are often judged by our appearances. Many of our clients have lost employment or face limited job prospects due to tooth loss. It is important to note that the vast majority of our clients have suffered severe dental injuries as opposed to a few cavities.

A Kentucky man filed a Suboxone lawsuit after suffering extensive dental problems related to using Suboxone since 2011. In his lawsuit, the man claims he was never warned about the potential harm he might experience until the end of 2023. Now, after extensive dental procedures, physical pain, and emotional suffering, he is facing permanent dental damage related to his use of Suboxone. He was prescribed Suboxone film to treat opioid use disorder. 

Also, a man from Ohio filed a lawsuit alleging his doctor prescribed Suboxone, and despite taking the medication as prescribed, the plaintiff suffered extensive tooth damage and other dental injuries. He also claims there was no warning about potential dental issues or the grave risk of decay and erosion that he experienced. He is seeking compensation for permanent dental damage and the medical expenses related to multiple procedures to treat the harm caused by Suboxone.

One of the most important factors in these Suboxone tooth decay lawsuits may be whether the prescribing doctors had information about the potential risks associated with the sublingual version of buprenorphine. If your doctor can testify they did not know about possible Suboxone risks, you will have a stronger case.

Six new Suboxone lawsuits were filed in the past week as litigation continues to pick up now that an MDL has been established.

[UPDATE! As of July 7, 2024, we now assume that Indivior failed to provide any legitimate warning to users of Suboxone film or the physicians prescribing such. We contend that the warning contained many pages into the insert is hardly a warning. An insert is the weakest form of a warning, unlike an actual black box warning found on a table for medication. Further, Indivior never provided a "Dear Doctor" letter placing medical professionals who routinely prescribe Suboxone on notice of the adverse effects of sublingual buprenorphine-naloxone exposure. WE ARE NOW TAKING CASES IN ALL 50 STATES.]

Many prospective clients have inquired about how the statute of limitations in their state will affect their right to bring a Lawsuit. The information is confusing and conflicting for people considering these cases. Many states have a two-year statute of limitations on product liability lawsuits based on a "failure to warn" theory.

Since Indivior, the maker of Suboxone, was forced to add tooth decay to its warning label in January 2022, the statute of limitations ran out in January 2024 for states with 2-year filing limits.

However, we are still taking Suboxone tooth decay claims in states that have a statute of limitations of three, four, and five years.

States that we are still accepting and potentially filing Suboxone tooth decay lawsuits include:

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

If you experienced serious dental issues (tooth loss, tooth fractures, tooth extractions, severe tooth decay, oral infections, or tooth erosion) while using Suboxone sublingual films and you reside in one of the above states, call us immediately. You may be entitled to compensation for the extensive dental treatments required to restore your oral health, and we can help you file a lawsuit to preserve your rights and seek damages.

Indivior is simply a bad actor who rushed the sublingual form of the drug to market when the patent on the pill form was set to expire. They simply did not want to face competition from generic Suboxone tablets. Ironically, Suboxone tablets did not cause long-term dental issues. Indivior created the very peril they now complain of.

The initial status conference in the Suboxone tooth decay MDL has been set by Judge Calabrese for March 7, 2024, in Cleveland, Ohio. This hearing aims to determine legal leadership for both plaintiffs and defendants. Then Judge Calabrese will likely establish a discovery calendar to streamline this lawsuit. 

Attorneys who are interested in a leadership position are required to attend in person. Further, applications for leadership must be submitted to the Court by March 1, 2024. 

Our Suboxone lawyers believe this will be a fast-moving mass tort due to the strength of the science establishing a link between sublingual buprenorphine and tooth decay along with a wide array of other dental injuries. We are representing many clients who have suffered severe tooth decay. In fact, due to so many adverse event reports received by the FDA, it unilaterally changed the warning label for Suboxone sublingual films.

We project that the plaintiffs will get past Daubert hearing requirements (a Daubert hearing is where the Court determines the admissibility of expert testimony and the methodology behind their scientific findings and conclusions.) 

While we will unlikely see a Suboxone settlement in 2024, this lawsuit could conceivably be resolved within the next two to three years at most. Thus, it will move more quickly than other mass tort lawsuits. 

In the past week, we have begun seeing heavy internet advertising for Suboxone lawsuits; especially on Facebook and Instagram. The Suboxone tooth decay lawsuit will be one of the most popular mass torts in 2024 as more folks become aware of the adverse impact sublingual buprenorphine has on their dental health. 

The Suboxone lawsuits share a similar legal theory of liability. Injured plaintiffs allege prescription Suboxone film causes tooth erosion and decay because it has an acidic ingredient that differs from the prior tablet form of this medication. 

In addition, plaintiffs claim the maker of Suboxone knew about this potential problem yet failed to warn patients using the drug. After these lawsuits began, Suboxone added a warning about potential dental issues.

Since the plaintiffs will need to provide a solid scientific basis to support these claims, the team at Lawsuit Legal News does not expect any settlement discussions or payments in the coming months while both sides sort out the related medical research. We anticipate Suboxone tooth decay litigation will take a few years to play out. 

In the meantime, filing deadlines are approaching or may have expired by now. To learn more about your specific right to join this MDL, reach out to the LLN team today.

Officially, the Federal Suboxone lawsuits have been consolidated into a Multi-District Litigation (MDL), which brings separate lawsuits from around the nation into one court. This helps organize and streamline discovery processes and motion hearings to ensure consistent court rulings while each case maintains a separate legal claim.

There was no need for oral arguments during the JPML hearing since both sides agreed to the MDL beforehand. Judge Phillip Calabrese will preside over the litigation in the Northern District of Ohio. Thus, all federal Suboxone lawsuits have been consolidated before Judge Calabrese in the Northern District of Ohio.

The Joint Panel on Multidistrict Litigation met today in Santa Barbara, California, to discuss consolidation of all Suboxone lawsuits filed in Federal Courts throughout the United States, known as an MDL.

We are projecting that all lawsuits concerning physician-prescribed Suboxone film will be consolidated into a single case in the Northern District of Ohio. This consolidation will move things along more quickly and could help clients receive compensation sooner. We expect an order from the JPML within the next week or two at most.

It is worth noting that both Reckitt-Benckiser and Indivior have previously filed responsive motions with the JPML and agree with consolidating the Suboxone lawsuit. Thus, this seems like a predictable outcome.

Some states are starting to reach their statute of limitations for product liability cases or defective drug cases. Since Indivior added a warning to the Suboxone films in January 2022, exactly 2 years ago, potential plaintiffs in a state with a 2-year statute of limitations will soon (or may already) not be able to file a lawsuit. Read our updated section on the Statute of Limitations for the Suboxone Lawsuit.

At this point the Suboxone class action lawsuit has not evolved into multidistrict litigation. However, the JPML will be meeting in the next ten days to discuss consolidating all federal lawsuits within the Suboxone class action lawsuit into multidistrict litigation before a single judge in a single jurisdiction.

On January 12th, another product liability lawsuit was filed against the manufacturers of the buprenorphine-naloxone medication Suboxone. The plaintiff is Lindsay Haddad, a woman who had used Suboxone to treat her opioid addiction. 

In her personal injury lawsuit filed with the U.S. District Court Western District of Pennslyvania, she describes the extensive tooth decay and dental issues she experienced as a result of using the defective drug. 

Haddad's provider prescribed her the sublingual film version of Suboxone in 2013, the same year it was made available. At that time, Suboxone was not labeled with any warnings concerning potential tooth decay.

Haddad argues that Indivior should be liable for her damages based on the flawed design of sublingual Suboxone, but also because the manufacturer failed to warn her or her providers that using Suboxone could cause irreparable damage to her teeth. Her Suboxone tooth decay lawsuit also alleges that the company failed to rigorously test the sublingual film form of the drug and used a defective design.

We expect the Suboxone class action lawsuit to continue to pick up momentum over the coming month.

While plaintiffs await the U.S. Judicial Panel on Multidistrict Litigation (JPML) hearing scheduled for January 25th to determine if their Suboxone lawsuits and claims will be consolidated, more and more people who have been prescribed Suboxone are continuing to find out that their dental problems might be linked to their medication.

This has caused a rise in product liability lawsuits against the manufacturer of the Buprenorphine medication Suboxone.

A new lawsuit filed by a New York resident this week shows the problems associated with long-term Suboxone use. Suboxone was prescribed to this individual to treat opioid addiction. In turn, the acidity of Suboxone caused significant tooth decay, resulting in the extraction of multiple teeth. Unfortunately, neither the plaintiff nor his physician knew the significant risks of Suboxone use.

The FDA's Adverse Event Reporting System (FAERS) already shows a disproportionately high rate of dental disorder claims associated with buprenorphine medications. We believe that physicians prescribing Suboxone film would be aware that the cure to opioid use disorder may be worse than the problem itself.

Another person has brought a claim against Suboxone—this time a woman in Ohio—who claims that taking Suboxone to treat her opioid addiction caused her severe dental injuries. In the lawsuit filed on her behalf, she claims that the manufacturer of Suboxone was aware of this dangerous side effect but chose not to include any warning about possible tooth decay on the drug's warning label or in the drug's medication pamphlet given to patients. Additionally, the lawsuit claims that the Ohio woman's physician was also not aware of the dangers of Suboxone when it comes to tooth decay and other dental problems.

In the lawsuit, the plaintiff explains that her addiction started when she was prescribed opioid pain medicine by a doctor. And, like so many who have suffered directly or indirectly from America's opioid crisis, she became addicted. As she was seeking help for her substance dependence issue, she was prescribed Suboxone.

Now, having conquered her addiction and the tribulations that go along with it, the plaintiff claims she had to undergo extensive dental work to repair the damage caused by Indivior's negligence and is seeking compensation for her present and future medical bills along with pain and suffering.

The Judicial Panel on Multidistrict Litigation (JPML) will be hearing arguments from plaintiffs and defense counsel on creating multidistrict litigation for Suboxone on January 25, 2024, in Santa Barbara, California. We project that all federal lawsuits that comprise the Suboxone class action lawsuit will be consolidated in the Northern District of Ohio. 

This would be a very favorable jurisdiction for bringing legal actions alleging dental damage caused by Suboxone. The purpose of consolidation is to streamline discovery and pretrial proceedings.  

A petition has been filed with the Judicial Panel on Multidistrict Litigation (JPML) by a group of lawyers acting on behalf of plaintiffs to consolidate all lawsuits filed in Federal Court into multidistrict litigation (MDL). As of today, most Suboxone lawsuits have been filed in the United States District Court for the Northern District of Ohio, which is the odds-on favorite to be selected as the jurisdiction for the forthcoming lawsuits.

We anticipate the Suboxone class action lawsuit will inevitably become an MDL (multidistrict litigation) soon. Once enough lawsuits have been filed in Federal Courts nationwide, the plaintiffs will petition the JPML (Judicial Panel on Multidistrict Litigation) to consolidate all lawsuits before one Judge in one (Federal Court) jurisdiction. 

There is a lot of potential for Suboxone tooth decay lawsuits to move forward. The manufacturer simply rushed the sublingual film version to market, fearing competition from generic tablets. To combat this, they quickly developed a film version, marketed it as "better," and got the word out to doctors as soon as possible.

Unfortunately, this decision has seemingly led to a large number of adverse event reports of serious dental issues and dental injuries, so many that it has become alarming. They all begin with the destruction of tooth enamel due to the acidity of sublingual Suboxone strips.

Our law firm began investigating Suboxone teeth lawsuits back in August of 2023. We were among the first law firms to investigate claims related to dental injuries from Suboxone sublingual exposure.

We are seeing a growing number of plaintiffs filing lawsuits in Federal Court alleging a wide array of dental injuries caused by the acidic Suboxone sublingual films used to wean individuals off of opiates. The acidic films destroy the protective outer layer of one's tooth enamel. Many of the Suboxone product liability lawsuits list oral infections, degradation of tooth enamel, tooth extractions, diminution of oral health, and other serious dental problems related to using this product. However, cavities and tooth loss appear to be the most common complaints with this chronic pain medication. 

Fourteen new Suboxone lawsuits were filed against Indivior in federal courts over the past ten (10) days. We believe that this mass tort will explode over the coming months. Indivior's patent on the tablet form of Suboxone was set to expire, which would allow for generic competition. Thus, the sublingual form was rushed to market, leading to a host of Suboxone side effects and terrible dental outcomes. 

The crisis and effects of opioids led to this prescription medication exploding in popularity, which makes for a potentially large plaintiff base.  We believe a Suboxone settlement is nowhere near the horizon as this lawsuit is just kicking off.

The pharmaceutical giant Indivior—who has been sued for monopoly violations, lying to the government, and so many more—got hit with another legal challenge recently for an illegal kickback scheme and false marketing claims. Indivior says they did nothing wrong and are fighting the potential class action lawsuit in court. However, with so many individuals experiencing dental problems while taking Suboxone, along with the scientific evidence, it's possible they could be found liable for negligence. Further, Indivior will deal with antitrust litigation relating to how their product has been marketed. Thus, Indivior will be fighting a multi-pronged legal battle in the future on multiple fronts. 

David Sorensen has filed a Suboxone lawsuit in the Northern District of Ohio, naming Indivior Inc. as the defendant. The lawsuit alleges the sublingual film form of Suboxone led to permanent tooth decay, and he incurred significant expenses in treating multiple medical providers for dental care.

The Suboxone lawsuit is the beginning of a litigation storm. Plaintiff lawyers will argue that Indivior was fearful their patent on Suboxone tablets was about to expire. In turn, the defendant manufacturer introduced the sublingual film version, which some will say was rushed to market. Indivior Inc. did everything to avoid dealing with generic versions of their medication designed to treat drug addicts during the opioid crisis.

The FDA has unilaterally changed the warning label on sublingual buprenorphine. The gold standard medication used to treat opioid addiction now has a warning label that warns of adverse dental events such as; severe tooth decay, dental infection or abscesses, tooth erosion, oral infections, partial and total tooth loss.

The leading opioid addiction medication was previously the subject of a drug safety communication issued by the FDA in early January 2022

The FDA issued a drug safety communication wherein they warned the public about dental injuries related to the use of sublingual Suboxone. The Federal Drug Administration lists severe dental health issues such as tooth decay, oral infections, significant amounts of cavities, and loss of teeth. The adverse event reports of severe dental injuries, even in individuals with no history of oral health issues, are alarming.

Keep in mind that this drug safety communication states that the benefits provided by Suboxone outweigh the harm. However, we believe this is only part of the story as Indivior has a history of being a bad actor. We believe that the risk of dental injuries such as severe tooth decay was significantly increased by the introduction of the sublingual version of Suboxone. 

We believe the sublingual version was rushed to market by Indivior to avoid generic competition, as the patent on the tablet form of the opioid addiction medication was about to expire. This argument will be at the heart of the forthcoming Suboxone tooth decay litigation. 

Furthermore, we anticipate Indivior's defense lawyers will argue that the benefits provided by Suboxone (best in class for opioid addiction treatment) far outweigh the potential nasty side effects. In turn, the volume of adverse event reports documented by the FDA, taken in conjunction with the growing class of plaintiffs alleging significant dental injuries, demonstrates the danger of this product. 

We strongly believe Indivior has victimized opioid addicts by introducing a medication that is incredibly harmful to one's oral health based on the acidity of the sublingual film version of Suboxone.