Suboxone Lawsuit: Tooth Decay Claims, Updates and More

Indivior has filed a motion to dismiss over 11,000 lawsuits which allege that they knew or should have known that Suboxone could cause tooth decay but failed to warn about this risk. United States District Judge Philip Calabrese will hear oral arguments regarding this motion on December 16 in Ohio's Northern District.

The motion to dismiss argues that federal laws prevented Indivior from warning about the risk of tooth decay earlier than they did. Therefore, Indivior is arguing that failure to warn claims based on state laws should be preempted by federal laws, which would absolve Indivior of liability for users' dental injuries.

The motion has been opposed by plaintiffs, who argue that the company is always responsible for its labeling, arguing the company could have done more to alert doctors and users about dental damage risks. The plaintiffs also argue that alternative, safer designs existed which could have delivered the active ingredient in Suboxone in a way which didn't cause users to lose tooth enamel.

Our lawyers see Indivior's argument used in the majority of product liability cases which involve prescription medication. The argument is very rarely successful and we don't expect it to be successful regarding the Suboxone litigation.

38 cases were filed in the Suboxone MDL in November. This represent an 850 percent increase compared to the four cases filed in October. There are now 716 pending cases in the MDL.

A lawsuit was filed by a Kentucky man in Ohio on November 14, alleging that his use of Suboxone film strips led to permanent tooth damage.

The lawsuit alleges that Indivior and Aquestive Therapeutics failed to adequately warn doctors and patients about a high risk of tooth decay linked to Suboxone.

The lawsuit is now one of over 11,000 lawsuits which raise similar allegations that drug makers could have prevented serious tooth decay and erosion by providing earlier information.

The lawsuit notes that while it wasn't until 2022 that a safety communication was issued by the FDA regarding this issue, the FDA had started receiving reports of the drug causing tooth damage in February 2006, with the drug's manufacturers knowing of at least 13 instances of tooth decay prior to the film strips even being approved.

September saw no new cases added to the Suboxone MDL. There are 674 cases pending in the MDL. The reason for this is a final tolling agreement was reached which allows possible plaintiffs to simply file claims rather than file actual lawsuits.

A federal Suboxone lawsuit has been filed by Utah man. The lawsuit alleges that defendants including Indivior caused the man to suffer severe dental injuries.

The plaintiff was prescribed Suboxone for opioid addiction and claims the medication being acidic caused him to suffer permanent damage to his teeth, including erosion and tooth decay, even though the medication was marketed as being safe.

The lawsuit alleges that the defendants did not warn about the drug's dental risks adequately. The complaint points out that while the FDA warned in January 2022 about the dental issue associated with the drug, the drug's medication guide did not include warnings about tooth decay until June of 2022.

The lawsuit, which alleges that the defendants knowingly hid the risks of the drug from the public in order to profit, seeks compensatory damages and punitive damages.

As of September 3, 2024, there were 674 pending cases in the Suboxone MDL.

The judge presiding over the Suboxone MDL will meet with attorneys tomorrow. The parties are indicating they are going to seek guidance regarding an agenda for a meeting which is scheduled for October in order to prepare to discuss information necessary for the court to choose a representative sample of claims in order to go through discovery as well as preparation for the initial federal bellwether trials.

Over 11,000 claims are currently being pursued which alleges that Indivior's medication Suboxone caused users to develop tooth decay and dental damage because the manufacturer didn't adequately warn about the risk that the drug can damage tooth enamel.

Plaintiffs who are pursuing Suboxone lawsuits recently responded to Indivior's motion to dismiss, indicating that federal law does not preempt claims of defective design and failure to warn because the company had a chance to create a safer version of the drug but chose not to.

Indivior is facing around 11,000 lawsuits alleging that Suboxone users ended up experiencing tooth decay and dental damage because the company failed to warn about the risk of degraded tooth enamel associated with the medication.

Indivior, on July 26, had filed a motion to dismiss lawsuits in the MDL, arguing that federal law preempts failure to warn claims and design defect claims because it wasn't able to change the drug's label without the permission of the FDA.

The plaintiffs' response to the motion noted that the risk of tooth decay associated with the drug has long been established by adverse event reports and scientific studies which Indivior willfully ignored. The plaintiffs argued that federal law does not preempt the claims since tooth decay incidents were probably underreported far before the FDA required an update to the drug's warning label. The plaintiffs argued that the company knew about problems with tooth decay and had a chance to ask the FDA to update its warnings and change its label, but made the choice not to do this.

The plaintiffs noted that a case report that linked the drug to dental injuries was published by Harvard researchers at least 10 years prior to the FDA requiring a label change for the drug.

The Suboxone MDL saw a slight decrease regarding active cases in the month of July. The total number of cases which are active in the MDL decreased from 677 cases to 673.

Indivior Inc. is trying to convince a judge it should be considered immune to liability in lawsuits alleging that Suboxone caused plaintiffs to develop tooth decay, arguing that design defect and failure to warn claims in the lawsuits should be preempted by federal law.

The company faces around 11,000 lawsuits which allege the company did not adequately warn that Suboxone's sublingual film version can degrade the enamel of teeth, leading to an increased risk of broken or lost teeth.

A motion to dismiss was filed by Indivior on July 26. The motion argues the company was unable to change its warning label without the permission of the FDA.

Preemption motions such as this are usually struck down by courts when the courts find that drug manufacturers did not adequately disclose info which could have led the FDA to order an update to the drug's warning label.

The plaintiffs have yet to file a response to the motion.

The judge presiding over the Suboxone MDL has ordered parties involved to start the process of information exchange regarding each claim in the MDL, in order to eventually lead to the selection of representative cases for additional discovery and, eventually, bellwether trials which might drive future settlement negotiations.

Around 11,000 Suboxone claims are currently pending in the MDL. The lawsuits allege that the drug's manufacturers failed to adequately warn that the medication's sublingual film version might degrade the enamel of teeth, leading to a higher risk of lost or broken teeth.

A court order was issued on July 19 which called on attorneys to start gathering and exchanging information from the claimants. This will eventually lead to a small number of cases being selected which might be prepared for bellwether trials, helping to gauge how the juries might respond to certain testimony and evidence which will be presented through the litigation.

The judge called for the plaintiffs and defendants to submit proposals by August 27 regarding specific info about Suboxone claims they think will help to identify cases which are representative of others in the MDL, driving resolution of litigation.

A proposed order regarding electronic discovery has led to a dispute arising between defendants and plaintiffs about the handling and production of electronic documents during discovery.

Lawyers representing plaintiffs desire an efficient, streamlined process and are arguing that the defendants are causing the process to be overly burdensome and complicated. They are claiming the defendants are failing to provide specific reasons as to why certain requests for documents aren't feasible, and are attempting to saddle the plaintiffs with the burden of proof.

The defendants are arguing that requests by the plaintiffs are too demanding and some productions of documents aren't feasible. They desire each request for documents to receive an individual evaluation, and the PLC is arguing this would lead to unnecessary delays.

Battles like this are very common in mass tort litigation like the Suboxone MDL.

June saw 319 new cases added to the Suboxone MDL bringing the total number of cases up to 677.

Some rumors are going around about early settlement talks regarding the Suboxone MDL. It seems unlikely that Indivior will get serious regarding settlement until at least June 2025, but maybe there's some weight behind the rumors.

In other news, plaintiffs won the issue regarding general causation which has been talked about in our April 21 update. The defendants had requested that the focus of discovery should be general causation, delaying discovery relating to marketing and case-specific issues. Plaintiffs opposed the request, arguing this would prolong litigation and lead to misallocation of resources.

The defendants' motion was denied by the court, who ruled that it would be complex and inefficient to separate general causation discovery from other discovery, since the evidence has an intertwined nature.

A request by Suboxone's manufacturer to restrict early discovery in the Suboxone MDL has been denied by a United States District Judge. The judge found that the requested "phased" approach wouldn't simplify MDL proceedings or expedite litigation.

The judge found that the proposal from the defendants might limit scientific evidence regarding general causation to a body of knowledge which is artificially narrow, probably interfering with a search for truth regarding general causation or rendering such determinations unreliable or attenuated from science. The judge also found that the proposal failed to present an efficient or workable discovery sequencing, and would do little in order to advance progress in the MDL.

June 14 saw a mass filing being submitted in the Suboxone MDL. The filing included a list of over 9,600 plaintiffs, where they lived, where their Suboxone prescription was written and where Suboxone was used by them.

The mass filing came just before a possible deadline which might have impacted plaintiffs in various states, representing a dramatic increase in the scope and size of the Suboxone litigation which is seeking to hold the drug's manufacturers accountable for not warning about the drug's potential for causing severe tooth decay.

While the number of Suboxone lawsuits filed in federal court continues to grow, lawyers for plaintiffs are arguing the court should reject a proposal set forth by the drug's manufacturer which would see the litigation split into two different phases, limiting early discovery to info regarding how the drug causes tooth decay.

In April, the drug's manufacturer, Indivior, proposed that the court should split the litigation into two phases. This would require parties to address if enough scientific evidence exists establishing Suboxone causes dental erosion before any individual cases would be prepared for trial.

Plaintiffs, on May 24, urged the court to reject this proposal, stating little to no debate exists amongst experts regarding Suboxone causing tooth decay.

The plaintiffs argue the likelihood that the defendants would prevail through this strategy is "remote" because "decades" of scientific evidence supports the claim that Suboxone causes tooth decay. The plaintiffs argue that all phased discovery would do is unnecessarily prolong the litigation and waste resources.

Around 500 lawsuits are currently pending in federal court alleging that Suboxone caused patients to develop tooth decay.

In other news, it is currently being estimated that the majority of Suboxone cases may settle for $50,000 to $150,000, with some small cases possibly settling for slightly less and some large cases possibly settling for more. However, if cases end up going to trial, their value could greatly exceed $150,000, possibly exceeding $1 million when possible punitive damages are taken into account. Keep in mind these estimates are very preliminary, and it is difficult to predict final settlement amounts.

The judge overseeing the Suboxone MDL has issued two critical pretrial orders.

The first order ends up providing comprehensive guidelines regarding the handling of privileged materials as it relates to Federal Rule of Evidence 502(d).

The order is important since it applies to all privileged information in interrogatory responses, documents and deposition transcripts, as well as other materials which are produced during discovery.

The purpose of the order is to protect against the waiver of work-product protections or privilege, making sure inadvertent disclosures don't result in these protections being lost across state and federal proceedings. The judge clearly wants the production of documents to happen quickly without any debacles.

The second order ends up establishing guidelines for how protected information is handled during discovery. The order applies to any and all discovery materials, depositions and documents produced during the case, outlining how materials are designated "highly confidential" or "confidential."

With many Suboxone lawsuits likely to end up being filed in the near future ahead of a statute of limitations which may be triggers for numerous claimants, the judge overseeing the Suboxone MDL has authorized the filing of a bundled complaint by plaintiffs by June 14. This complaint might include thousands or tens of thousands of legal claims.

Plaintiffs will be allowed to file a complaint, to which can be attached a list of claims or spreadsheet which will be considered to have been filed by that date. This bundled complaint will only require attorneys to identify individual claimants, their places of residence, the location where they were prescribed the medication, and the location where they used the medication.

Lawsuits allege that Suboxone caused users to develop serious dental damage, and that the drug's manufacturers failed to adequately warn users about the risk of tooth decay associated with the drug.

At the start of April, 44 cases were pending in the Suboxone tooth decay MDL. In April, 161 cases were added to the MDL, bringing the total case number to 205.

A virtual interim status conference has been scheduled by the MDL court for May 14, and the court has ordered parties to submit some documents by May 7 which relate to tolling issues, procedural motions and protective orders.

A lawsuit was filed on April 25 involving a Maryland man who was prescribed Suboxone for opioid addiction. The lawsuit alleges the man ended up with severe tooth decay, seeking financial compensation for harm which he endured.

The focus of the lawsuit, like every lawsuit in the Suboxone litigation, is Invidior's failure to provide information to him and his doctors which was readily available regarding the risk of tooth decay.

Lawyers are expecting thousands of lawsuits to be filed in the next two months over Suboxone causing its former users to develop permanent tooth decay. The reason for the upcoming deluge of lawsuits is that in June 2024, it will be two years since the drug's label was changed to warn about tooth decay, meaning some cases may see the statute of limitations triggered in June.

Warnings about tooth decay were added to the drug's label on June 17, 2022 after over 300 dental damage cases were identified by the FDA. Therefore, some cases may see the statute of limitations expire on June 17, 2024.

However, in some states, the statute of limitations for dangerous drug injuries is a specific amount of time from the date the user became aware that their injuries were caused by the drug, not from the date of a label change. So, if you became aware that your dental injuries were caused by Suboxone less than two years before June 17, 2024, your case may not see the statute of limitations expire on that date.

If you have developed permanent dental damage after taking Suboxone, call us today for a free consultation. We can let you know if you are still eligible to file a claim or if the statute of limitations has expired regarding your case.

In other news, a lawsuit was filed last week by a Georgia woman who claims that the use of Suboxone caused her to suffer severe dental damage such as tooth decay, ongoing dental issues, and a need to have multiple teeth removed. The lawsuit claims she was prescribed Suboxone in 2016 for the treatment of opioid use disorder which stemmed from an injury to her ACL and resulting arthritis. The lawsuit claims the woman needs further dental treatment, including possibly dentures, extractions and root canals, and claims that the defendants failed to warn her about the risk of tooth damage associated with the drug.

In other news, Invidior, shockingly, is indicating it believes that the focus in this MDL should be on if Suboxone can cause tooth decay rather than if Suboxone caused tooth decay in specific plaintiffs. This is very questionable, since Suboxone's label now literally warns that it can cause tooth decay. Suboxone film is very acidic, and it reduces saliva production - saliva is our mouths' natural way of neutralizing acid. The drug has been reported to cause tooth damage due to its acidity since 2012. It is baffling that Invidior would question if Suboxone causes tooth decay when the drug's own label actually warns it can cause tooth decay.

A lawsuit filed on April 2 in Ohio alleges that a New York man suffered from permanent tooth decay after taking Suboxone. The lawsuit refers to Suboxone film strips as "unreasonably dangerous" and alleges the product did not contain adequate warnings regarding the risk of serious dental erosion associated with it. The lawsuit alleges that the defendants knowingly took advantage of an opioid epidemic in order to profit from an unsafe, dangerous product. The lawsuit claims the plaintiff required substantial dental work after suffering from permanent tooth damage, and that this may have been prevented had proper warnings on the product's label been present. The lawsuit alleges the defendants knew or should have known the product could cause serious tooth damage based on scientific knowledge, testing, post-marketing studies and published research.

New cases can now be filed directly in the Suboxone MDL in Ohio, regardless of the origination of the underlying claim. This means that new claims will not have to be filed in district courts around the country, meaning plaintiffs won't then have to wait for those claims to be moved into the MDL.

Defendants in the Suboxone MDL have filed corporate disclosures. These basic disclosures are required to be filed, and are somewhat meaningless. However, it is encouraging to see the ball rolling regarding litigation.

51 cases are pending so far in the just-formed Suboxone MDL. This number will likely increase greatly in the coming months, and could eventually reach as high as 100,000.

As anticipated, the number of new cases being filed in the Suboxone MDL is now rapidly increasing. May saw 153 new cases filed in the MDL, representing the second consecutive month in which over 100 cases were added. 358 cases are now pending in the MDL.

The judge presiding over the Suboxone MDL is going to hold the first status conference in the MDL next week. This conference will see discussion of the schedule and organizational structure for pretrial proceedings in the MDL. The schedule will likely involve preparation of representative cases for bellwether trials.

A Kentucky resident has filed a lawsuit alleging that Suboxone film caused significant dental damage.

The man was given a prescription for Suboxone in 2011, but claims he wasn't warned that the drug had the potential to cause tooth decay until 2023.

The man, now having undergone extensive dental work and facing permanent damage to his teeth, is alleging that negligence caused him to not be warned until 2023, and that this negligence has caused him substantial emotional and physical distress.

A lawsuit was filed in Ohio on February 7 by an Ohio man who alleges that taking Suboxone caused him to develop permanent damage to his teeth, resulting in the necessity of significant dental work. The lawsuit alleges this tooth damage was avoidable, and that the drug's manufacturers should have disclosed adequate information regarding the dental erosion risk on the medication's warning label. The lawsuit pursues claims of failure to warn against the defendants, alleging that wrongful conduct occurred in the process of Suboxone's marketing packaging, labeling, testing, design and development. The lawsuit alleges that the plaintiff and his doctors were never warned about the risk of dental decay and erosion posed by Suboxone, alleges that the drug wasn't adequately tested, and alleges that the defendants failed to tell healthcare providers how to safely identify and monitor signs of possibly severe dental complications associated with the use of the drug.

A Suboxone multidistrict litigation (MDL) has been created by the Judicial Panel on Multidistrict Litigation (JPML). The MDL consolidates all federal Suboxone lawsuits which allege that Suboxone's manufacturers failed to adequately warn consumers that the opioid addiction medication could cause dental decay.

The 15 Suboxone lawsuits which have already been filed, which were spread across a total of five judicial districts, have been moved to a district court in Ohio. Overseeing the MDL will be Judge J. Philip Calabrese.

A hearing occurred regarding if an MDL should be formed consolidating Suboxone product liability lawsuits into a single court.

A Suboxone lawsuit filed this week alleges that a Kentucky citizen was prescribed Suboxone in 2011 for the treatment of opioid dependence. While Kentucky's one-year long statute of limitations has long since passed, the plaintiff is claiming he did not discover until the end of 2023 that his tooth decay had been caused by Suboxone.

This case will be interesting regarding how courts interpret the discovery rule in terms of Suboxone lawsuits and various states' statutes of limitations.

A lawsuit has been filed by an Ohio woman alleging that she suffered permanent tooth damage from Suboxone, requiring extensive dental work as a result. The plaintiff alleges that she was prescribed prescription Suboxone film for opioid use disorder, and that neither she nor her physicians were aware or warned about the risk of dental decay and erosion connected with Suboxone, and that there was no warning or indication that the medication had the potential to cause permanent tooth damage.

Defendants in Suboxone lawsuits responded to a motion by plaintiffs' lawyers to consolidate Suboxone lawsuits into a multidistrict litigation, agreeing that all of the Suboxone lawsuits have a lot in common, so consolidation into an MDL makes sense.

Plaintiff's lawyers have requested the JPML to consolidate every federal Suboxone lawsuit into an MDL so the cases can be more efficiently managed.

14 Suboxone lawsuits have been filed in the past two weeks against Indivior.

Suboxone manufacturer Indivior is facing a lawsuit regarding the false claims act which accuses Indivior of committing fraud against the federal government. It is alleged by the lawsuit that the company took part in an illegal kick-back scheme along with a company known as Express Scripts, and that financial rewards were given for the promotion of the drug.

Suboxone manufacturer Indivior has agreed to a $385 million settlement in a lawsuit filed by drug wholesalers who claimed the company unlawfully suppressed competition from generic medications. The lawsuit claims that Indivior developed its Suboxone dissolving film solely to suppress competition in the form of generic Suboxone after the original patent expired.

An Ohio man has filed a lawsuit alleging that Suboxone caused him to suffer from serious tooth decay which eventually led to him permanently losing several teeth. The lawsuit alleges that the defendants negligently failed to warn the plaintiff, as well as the plaintiff's doctors, that Suboxone could cause tooth decay.