Suboxone Lawsuit – December 2024 Update

Individuals are filing Suboxone lawsuits against Indivior, Inc. after suffering severe dental injuries from Suboxone sublingual films. These lawsuits have been consolidated into MDL 3092-Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation in federal court in the Northern District of Ohio. As of November 2024, there are 678 lawsuits pending in the federal Suboxone litigation. The presiding judge is J. Philip Calabrese. This lawsuit is in early stages, but several hundred individuals have filed cases. People are continuing to file Suboxone lawsuits today. However, the statute of limitations will keep some individuals from filing, so speaking with an attorney as soon as possible is crucial to filing a viable case.

Suboxone Lawsuit Timeline & News – December 2024

November 15, 2024: Case Management Conference Date Set in Suboxone MDL

Judge J. Philip Calabrese has set a case management conference for November 21, 2024. The joint agenda for the hearing includes an update on the Rubris Crosslink platform and formal dismissal of defendant Indivior PLC, Reckitt Benckiser Healthcare (UK) Ltd., and Reckitt Benckiser LLC in Cook v. Indivior, et al., Case No. 1:24-sf-65709.

November 4, 2024: Census Protocol Ordered for Suboxone MDL

Judge J. Philip Calabrese has ordered a census protocol in the Suboxone MDL out of the Northern District of Ohio. In accordance with this order, plaintiffs must complete a census form and provide records substantiating injury claims or risk dismissal from the lawsuit. Plaintiffs who have dual representation will have 21 days to resolve the issue.

November 1, 2024: Suboxone MDL Grows to 678 Cases

As of November 1, 2024, there are 678 pending cases in the Suboxone MDL. The litigation rests on the allegations that Suboxone sublingual film manufacturers knew or should have known of the risk of serious dental injuries the drug posed to users and failed to warn consumers. 

October 8, 2024: Status Conference Set in Suboxone Lawsuit

During an in-person status conference held on October 4 and 5, the court reviewed a number of issues in the litigation, including amending the language of a previous order in light of the dismissal of several defendants, protocols for document production, and the bellwether process.

October 1, 2024: Bellwether Process for Suboxone Lawsuit Expected to be Finalized in Coming Months

The process for bellwether trials in the Suboxone lawsuit is expected to be finalized in the coming months. Bellwether trials are used to determine how similar cases may be resolved.

What is the Suboxone Lawsuit About?

Individuals across the country are filing lawsuits against the makers of Suboxone, alleging the companies such as Indivior knew or should have known about the risk of severe tooth decay associated with the use of the drug. Plaintiffs report suffering irreparable damage to their teeth, including tooth decay, tooth loss, and oral infections. Despite a growing number of reports indicating a link between Suboxone sublingual strips and severe dental injuries, the manufacturer did not update the label to include dental issues as a side effect until 2022.

Suboxone Lawsuit Information
Lawsuit Name:	MDL 3092-Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation
Main Injuries:	Severe dental injuries
Defendants:	Indivior, Inc.
Mass tort or class action?	Mass tort
MDL Number:	3092
Pending Cases:	678
Court Name (Venue):	United States District Court–Northern District of Ohio
Have There Been Settlements?	Not yet
Active Lawsuit?	Yes

Why Are People Filing Suboxone Lawsuits?

Nationwide, Suboxone sublingual film patients are filing lawsuits alleging the manufacturer knew of the risk of dental issues associated with the use of the drug and failed to warn consumers. The popular opioid treatment drug has been prescribed for over 20 years in the United States. Despite receiving a growing number of reports of dental issues, the company did not update the medication’s label to reflect the possible side effects until 2022. Individuals who suffered dental problems after taking Suboxone sublingual strips may be entitled to compensation for their losses, including medical bills, lost income, pain and suffering, and any future care and treatment. 

In January 2022, the U.S. Food & Drug Administration issued a drug safety communication warning about the large number of dental problems reported with the use of dissolvable forms of Suboxone. These problems often result in substantial procedures and long-term harm, including root canals, crowns or crown replacement, and tooth extraction.

Suboxone Lawsuit Spotlight

King v. Indivior, Inc., et al. 1:23-cv-01924

According to the complaint, Keith King, from Geauga County, Ohio, was prescribed Suboxone to treat his opioid addiction. After 16 months of use, Mr. King alleges that he suffered severe and permanent tooth damage that required substantial dental work to repair. The case, filed in the Northern District of Ohio, was transferred to the MDL in February 2024. He accuses the manufacturer of Suboxone of defective design and failing to adequately warn consumers about the dental risks associated with the use of the drug. 

Sorensen v. Indivior, Inc., et al. 1:23−01855

David Sorensen, a resident and citizen of Cuyahoga County, Ohio, filed a lawsuit against Indivior, the manufacturer of Suboxone, alleging the high acidic content of the drug caused him permanent tooth decay. As a result of the damage, Mr. Sorenson required extensive dental repair, which resulted in economic and non-economic losses. The case, originally filed in the Northern District of Ohio, was consolidated into the MDL in February 2024. 

Delcastillo v. Indivior, Inc., et al. 2:24-cv-01111

Vincent Delcastillo, a resident and citizen of Suffolk County, New York, filed a lawsuit in the Eastern District of New York alleging Indivior was responsible for his tooth decay. According to legal documents, Delcastillo suffered serious dental problems after being prescribed Suboxone and was not warned about the potential for severe harm. Mr. Delcastillo required substantial dental work to repair the harm caused by the opioid treatment drug.

Whom Are People Filing Suboxone Lawsuits Against?

People are filing lawsuits against Indivior, who manufactured Suboxone sublingual strips starting in 2010. Legal documents reveal that Suboxone patients suffered severe tooth decay, frequently resulting in tooth loss and extraction. Patients allege that the company knew of the risks of dental harm and failed to warn consumers until the FDA required an update to the label in 2022. Other allegations include that the drug was defectively designed and that the company engaged in false advertising and was negligent. 

The defendant in the Suboxone lawsuit is:

• Indivior, Inc.

Suboxone Defendant: Indivior

Indivior, Inc. is a global pharmaceutical company responsible for manufacturing a number of drugs, including Suboxone. The company was established as a division of Reckitt Benckiser in 1994 but demerged in 2014. The companies are no longer affiliated. Indivior previously faced scrutiny for the fraudulent marketing of Suboxone. Multiple lawsuits allege the company engaged in a fraudulent scheme to increase prescriptions nationwide.

Allegations Against The Manufacturer

Allegations against the manufacturer include that the company knew or should have known about the risks of severe dental problems associated with the use of Suboxone sublingual strips. Legal documents also accuse the company, Indivior, of failing to warn patients about the potential for harm and accuse the pharmaceutical giant of engaging in false advertising and defective design. 

What Stage is the Suboxone Lawsuit In?

Suboxone lawsuits remain in their early stages. Hundreds of cases have been consolidated into multidistrict litigation out of the Northern District of Ohio. Due to the widespread use of the opioid treatment drug, it is expected that many more people may be eligible for a lawsuit.

• February 5, 2024: Initial transfer of cases to MDL #: 3092 – In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation 
• March 8, 2024: Establishing of Plaintiff’s Leadership
• September 10, 2024: Order dismissing defendants Indivior PLC, Reckitt Benckiser LLC, and Reckitt Benckiser Healthcare (UK) Ltd. with prejudice.
• November 21, 2024: Status conference hearing in Suboxone MDL.

What Is Suboxone And How Does It Work?

Suboxone, whose generic name is buprenorphine and naloxone, is a sublingual film used to treat opioid addiction. The prescription drug was originally FDA-approved in 2002 and marketed in tablet form. Lawsuits allege the manufacturer of Suboxone engaged in false and deceptive advertising in an effort to delay generic competition. The company promoted the use of its sublingual film as a safe alternative to the tablet form of its drug. 

Suboxone Sublingual Film’s Mechanism of Action

The sublingual film is placed under the tongue to dissolve. Buprenorphine, one of the active ingredients in Suboxone, is a partial opioid agonist. It blocks and partially activates the opioid receptors. The film is placed under the tongue or inside the cheek. The film has a high acidity, which may be one of the reasons it can cause serious tooth decay and damage.

Side Effects of Suboxone Sublingual Film

Suboxone has several known side effects. According to the FDA label, some of those side effects include chills, headache, fever, insomnia, and abdominal pain. In some instances, individuals experienced potentially permanent dental issues. Despite concerns, this potential side effect was not added to the label until 2022. 

Less-Common Side Effects of Suboxone Sublingual Films

Common Side Effects of Suboxone Sublingual Films

Serious Side Effects Associated with the Suboxone Sublingual Film Lawsuit

One of the serious side effects associated with the Suboxone sublingual film lawsuit is the risk for adverse dental effects. This risk was not added to the label until 2022, meaning countless patients took the drug for long periods of time without knowing the potential for harm. In some instances, the drug caused irreparable damage to the person’s teeth. 

Injuries Caused By Suboxone Sublingual Film

It is believed that the high acidity in Suboxone sublingual film and the amount of time it is required to dissolve increases a person’s risk for adverse dental effects. These effects include the potential for severe tooth decay, tooth loss and extraction, gum injuries, and oral infections. 

Severe Tooth Decay

A significant number of Suboxone patients report experiencing severe tooth decay after taking the prescription medication. As early as 2007, the manufacturer of Suboxone, then Reckitt Benckiser, began receiving reports of adverse dental effects after taking the drug. By 2021, prior to the label being updated, the manufacturer was aware of more than 100 reports of dental issues potentially associated with Suboxone use.

Outcomes for Severe Tooth Decay

In many cases, the tooth decay caused by Suboxone, including dental caries, required the removal of one or more teeth. Severe tooth decay can result in an abscess or infection. The pain can be nearly unbearable, affecting your ability to perform normal daily activities. 

Tooth Loss and Extraction

Suboxone is also known to result in tooth loss and extraction as a result of the sublingual film’s impact on the gums and teeth. One potential factor is the high acidity in the film and the amount of time it takes to dissolve in the mouth. 

Outcomes for People Who Lose Teeth

Tooth loss and extraction are painful and permanent issues. It can take six months to a year to properly extract and replace a tooth. In many cases, the person must wait for several months after the tooth is pulled before a replacement can be put in. The process is lengthy and expensive. If someone is unable to afford a replacement tooth, they are often left without a feasible solution. 

Gum Injuries and Oral Infections

Individuals taking Suboxone have also reported a wide range of gum injuries and oral infections. These issues include gingivitis, periodontal disease, gingival disorder, and abscesses.

Outcomes for Gum Injuries and Oral Infections

Dental problems, including gum injuries and oral infections, are often debilitating. These conditions can make it uncomfortable to eat, drink, or talk. Individuals experiencing gum injuries or oral infections often need reparative intervention or even surgery to restore the damage. In some cases, it may prove irreversible.  

Cracked Teeth

Another potential issue associated with taking Suboxone sublingual film is a higher rate of cracked teeth. The film’s high acidity may weaken tooth enamel, causing the tooth to decay and crack.

Outcomes for People With Cracked Teeth

If mild, a dentist may be able to repair the crack with the use of dental bonding. More serious cracks require a crown or root canal to replace. These procedures are expensive. Left untreated, however, the fracture can become worse, requiring extraction.

Studies Linking Sublingual Strips and Severe Dental Injuries

Scientific studies link Suboxone sublingual strips to severe dental injuries. These studies highlight the concern that patients and healthcare providers were not warned about the potential for these outcomes prior to 2022. 

Study Highlight: Sublingual Buprenorphine and Dental Problems: A Case Series

In October 2013, researchers published Sublingual Buprenorphine and Dental Problems: A Case Series in The Primary Care Companion for CNS Disorders. The letter reported findings on a link between individuals taking sublingual buprenorphine and worsening dental health. 

The study, which had 11 participants, found that over half the people taking the opioid treatment drug experienced tooth pain and low saliva buffering, which is linked with a higher risk of cavities. In addition, there were reports of 5 caries, four fillings, and two cracked teeth. In order to repair the harm, some patients needed surgical intervention, including a crown, root canal, or dental extraction. 

Overview: Sublingual Buprenorphine and Dental Problems: A Case Series
Description of Study:	The study was conducted to determine the phenomena of worsening dental health reported by those taking sublingual buprenorphine.
Published In:	The Primary Care Companion for CNS Disorders
Study Authors	Joji Suzuki, MD; Leena Mittal, MD; and Sook-Bin Woo, DMD, MMSc
# of Participants	11
Findings	Over half of those taking sublingual buprenorphine experienced tooth pain, and over 90% had low to moderate saliva buffering.

Research Letter Highlight: Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease

In December 2022, researchers published a letter highlighting the Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease. The research letter published in the Journal of the American Medical Association (JAMA) found that patients taking sublingual buprenorphine/naloxone had a higher incidence of dental problems compared to those taking transdermal buprenorphine and oral naltrexone. 

In fact, sublingual buprenorphine/naloxone had a 42% higher risk of developing dental issues compared to those taking transdermal buprenorphine and a 67% higher risk compared to those taking oral naltrexone.

Overview: Association Between Sublingual Buprenorphine-Naloxone Exposure and Dental Disease
Description of Study:	The pharmacoepidemiologic study looked at the risk of dental adverse events associated with sublingual buprenorphine/naloxone use.
Published In:	Journal of the American Medical Association (JAMA)
Study Authors	Mahyar Etminan, Ramin Rezaeianzadeh,  Abbas Kezouh, et al
# of Participants	21,404
Findings	The findings show that sublingual buprenorphine/naloxone users have a 42% higher risk of developing dental issues compared to those taking transdermal buprenorphine and a 67% higher risk compared to those taking oral naltrexone.

FDA/EPA Warnings About Suboxone Sublingual Film

After receiving more than 300 reports (131 classified as serious) of adverse dental health reports, the U.S. Food and Drug Administration issued a warning to consumers about the risk. According to the warning letter, adverse dental issues reported by sublingual buprenorphine users included tooth decay, cavities, oral infections, and tooth loss. 

Some issues were reported in patients who had no prior history of dental problems. As a result of these reports, the FDA required updated labeling to warn about these risks. 

Current/Past Suboxone Sublingual Film Information Labels

When Suboxone sublingual film was first on the market, the original warning label contained no mention of adverse dental effects. It was not until 2022, after more than 300 reports of dental issues were received, that the label was updated to include a warning of potential harm. 

What Damages Can People Sue Suboxone Manufacturers For?

Individuals who suffered adverse dental effects as a result of taking Suboxone may be entitled to damages. Damages can include both economic and non-economic losses, including compensation for medical and dental bills, lost wages, follow-up treatments, emotional distress, and pain and suffering. 

Potential Damages in a Suboxone lawsuit:

• Current and future medical expenses: Suboxone patients may be entitled to compensation for medical costs, dental treatments, surgical interventions, and procedures, as well as any expenses related to follow-up care and maintenance.
  
• Lost income and loss of future earning capacity: If the injuries required time off from work related to treatments and recovery or impacted future earning capacity, you may be able to secure damages related to lost wages.
  
• Pain and suffering: Depending on the circumstances of the case, Suboxone patients may be able to recover losses related to chronic physical pain and emotional distress. Emotional distress includes the psychological impacts and any impact or reduction to your quality of life.
  
• Permanent disability or disfigurement: If the injury resulted in a permanent disability or disfigurement, you may claim additional damages related to the impacts on your life.
  
• Punitive damages: In some instances, plaintiffs may be able to seek punitive damages. Punitive damages are designed to hold the manufacturer, Indivior, accountable for gross negligence or intentional misconduct. Allegations include the fact that the company knew of the risk of dental issues for years before updating the warning label.

Who Qualifies to File a Suboxone Lawsuit?

In order to file a Suboxone sublingual strip lawsuit, each person has to meet certain eligibility requirements. Our legal partners are focusing on the specific injuries listed below:

• Eligibility criteria
  
  • Proof of Prescription and Use: Patient must have received a prescription for Suboxone on or before June 2022 and used the drug for at least six months prior to incurring dental injuries.
    
  • Proof of Dental Injury: Medical or dental records must show a qualifying injury such as tooth erosion, gum disease, cavities, or oral infection.
    
  • Proof of Routine Dental Care: Patient must be able to establish routine dental care prior to taking Suboxone.
    
  • Proof of Failure to Warn: Patient must not have received a warning of the risk of dental injuries before taking the drug.
    
  • Non-use of Methamphetamines: Patient must not have used methamphetamines.

To qualify for a Suboxone lawsuit, you must be able to prove that you received a prescription for the drug before June 2022 and used it for at least six months prior to experiencing dental injuries. Qualifying dental injuries include tooth decay, tooth extraction or loss, gum issues, and oral infection. Claims must also be filed within the statute of limitations. Failure to file within the legal deadline may result in your case being denied or dismissed. 

What Proof Do You Need to File a Suboxone Lawsuit?

To file a Suboxone lawsuit, you must secure the documentation necessary to substantiate your claim. Evidence that can help support your case may include your prescription history, dental records, employment history, expert and witness statements, and studies linking the injury you sustained to Suboxone use. 

Evidence of Suboxone Use and Timeline of Use

• Proof of Prescription: Suboxone patients must be able to prove that they were prescribed the drug prior to 2022 and used it for at least six months before experiencing adverse dental effects. A prescription history, along with proof of purchase, can help to establish a clear timeline of events.

Evidence About Your Diagnosis and Treatments

• Proof of Diagnosis and Treatments: Medical and dental records can help to show what dental injuries you incurred as a result of Suboxone use. These records should include x-rays, hospitalizations, dentist notes, imaging, proof of crowns or tooth extraction, billings, and any evidence of treatment. 

Evidence Showing Your Losses

• Proof of Damages: Evidence is needed to show proof of economic and non-economic losses. This may include pay stubs as proof of missed work or time off, receipts showing out-of-pocket expenses, and notes from therapists indicating the impact the injuries had on your quality of life.

Testimony From You and Your Family

• Proof of Personal Impact: Personal and witness statements can also help to establish how the injuries impacted your daily life. Testimony from those closest to you, such as your friends, family, and coworkers, can help to establish how your Suboxone-related injuries adversely affected your personal and professional life.

7 Steps to File a Suboxone Lawsuit

There are several important steps to file a Suboxone lawsuit. It is essential to consult with a qualified attorney as early in the process as possible to ensure all legal requirements are met, and your lawsuit is filed timely. Due to encroaching statutes of limitations that may be applicable to Suboxone claims, lawsuits should be filed as soon as possible. 

These are the 7 steps for filing a Suboxone lawsuit:

1. Consult with a Qualified Suboxone Lawyer: The first step to file a Suboxone lawsuit is consulting with a qualified lawyer. A lawyer can help review your claim to determine whether you meet the qualifications necessary to file a claim and if your case falls within the applicable statute of limitations.
   
2. Ensure Eligibility for Filing a Claim: During your initial case review, the attorney you retain will help determine whether you meet the eligibility requirements necessary for filing a Suboxone lawsuit. These requirements include that you were prescribed the drug prior to 2022 and took it for at least six months before experiencing adverse dental effects. Your attorney will also review any legal deadlines to ensure you have not pissed the opportunity to file a case.
   
3. Collect Necessary Evidence: Once eligibility is determined, you can gather the necessary evidence to support your claim. This evidence may include your medical and dental records, proof of lost wages, and documentation of how your injuries impacted your quality of life.
   
4. File Claim in Appropriate Jurisdiction: With the appropriate evidence in hand, your attorney will then draft and file a complaint in the appropriate jurisdiction. In some cases, you may be able to join existing litigation.
   
5. Enter Discovery Phase and Begin Negotiations: After the case is filed, you will enter the discovery phase. During this phase, each party is able to gather and exchange information. Your attorney may also engage in negotiations to determine if a favorable settlement can be reached without the case going to trial.
   
6. Set Case for Trial: If a settlement cannot be reached, the matter may be set for trial. At trial, each party will present their case. A judge or jury will then determine the outcome of the case, including any award of damages.
   
7. Resolve Matter or Appeal Decision: If there is an award of damages, your attorney will provide guidance on when you will receive compensation. If the decision is not favorable, you may be able to appeal. 

What to Expect When Filing a Suboxone Lawsuit

The Suboxone lawyer you retain will provide guidance on the legal process to filing a lawsuit as well as what to expect throughout the litigation. However, it is important to know that the process can be lengthy, taking several months to a year or more to resolve. If one is offered, accepting a settlement may expedite the resolution of the case. 

Attorneys generally accept Suboxone lawsuits on a contingency fee basis, meaning there are no upfront fees. Compensation depends on a number of factors, including the severity of your injuries and whether the matter is resolved via a settlement or at trial.

What is the Deadline for Filing a Suboxone Lawsuit?

The deadline for filing a Suboxone lawsuit is state-specific. In most states, the statute of limitations for a product liability or personal injury case is between 1 and 3 years; however, some states allow up to six years to file. The timeline usually starts from the date of the injury or the date it is discovered that Suboxone caused the injury. It is imperative to remember that the legal timeline may be affected by the warnings issued by the FDA in 2022.

There are limited exceptions that may extend the statute of limitations that are known as tolling. For example, if the plaintiff was a minor or incapacitated at the time the injury occurred or was discovered, the statute of limitations may be extended. Due to the complexities of legal deadlines, early action is strongly recommended. An attorney can help ensure that any legal requirements are met and that your case is promptly filed.

Suboxone Settlements and Awards

Settlement amounts in Suboxone lawsuits are expected to range between $50,000 and $150,000. However, several factors may influence the potential value of a case, including provable medical expenses, lost wages, and the impact an injury has had on a plaintiff’s quality of life. 

In addition, if it can be proven that the manufacturer of Suboxone was grossly negligent or acted with intentional misconduct, a plaintiff may be entitled to punitive damages, which can substantially increase an award. An attorney can help determine the potential value of your case. 

In order to protect your Suboxone settlement, you will want to ensure you do not have any disqualifying factors. For example, it is important to practice good dental hygiene, follow all dental recommendations, address any concerns regarding your teeth or gums immediately, and engage in routine dental visits. 

Average Suboxone Settlement Amounts

Suboxone settlements are expected to range between $50,000 and $150,000, with amounts expected to vary depending on provable damages. The severity of the injury and the impact on the quality of a person’s life can increase or decrease the potential value of the case. 

Factors Affecting the Value of a Suboxone Lawsuit

There may be factors that can affect the value of a Suboxone lawsuit. To secure the largest possible recovery, it is important to provide evidence of your injuries. Evidence helps to substantiate your claim and prove your damages.  

Factors that may affect the value of a Suboxone lawsuit:

• Severity of the injury: Things that may increase the value of your case include past medical bills showing the cost of diagnosing and treating your tooth decay, estimations of ongoing or future treatment costs, verification of lost income, and proof of any impact on your ability to work in the future or diminished earning capacity.
  
• Impact on the Quality of Life: Evidence showing the impact on your quality of life, such as documentation showing chronic pain or emotional distress, proof of long-term or permanent disability, and evidence of disfigurement, may all increase the value of your case.
  
• Proof of Impact on Relationships: Proof that your personal relationships were affected by your tooth decay or other dental injuries may entitle you to compensation for loss of companionship, support, or intimacy.
  
• Proof of Gross Negligence or Misconduct: Proof that the manufacturer of Suboxone acted with gross negligence or intentional misconduct may entitle a plaintiff to punitive damages, substantially increasing the value of the case. 

Learn More About Suboxone Lawsuits From Our Legal Team

Individuals suffering dental injuries after taking Suboxone may be entitled to compensation. The time to take legal action, however, may be coming to a close. It is critical to act fast and consult with an experienced attorney before the legal deadline passes. If you suffered tooth decay, gum disease, cavities, tooth loss, or other adverse dental effects after taking Suboxone for at least six months, you may qualify.

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