Legally Reviewed and Edited by: Terry Cochran

Published on: June 14, 2024

Suboxone, originally celebrated as a breakthrough in treating opioid addiction, is now linked to severe dental issues such as tooth decay, cavities, and tooth loss. These side effects have prompted many patients, who turned to Suboxone to escape addiction, to face new challenges of extensive dental damage.

Since 2023, a wave of lawsuits have been filed against Indivior, the pharmaceutical company behind Suboxone. If you’ve been affected, you may have questions about taking legal action for possible compensation.

Get answers to common Suboxone lawsuit FAQs so you know your rights and what to expect during the legal process. Work with our experienced product liability attorneys at Cochran, Kroll & Associates, P.C. to help you seek compensation for the physical and emotional impacts of Suboxone on your well-being.

What is Suboxone?

Suboxone is a medication primarily used in the treatment of opioid addiction. It is a combination of Buprenorphine and Naloxone, two active ingredients that work together to manage withdrawal symptoms and reduce the likelihood of misuse.

Buprenorphine acts as a partial opioid agonist, which means it provides some of the effects of opioids to ease withdrawal symptoms without delivering the full impact of opioid drugs. Naloxone is an opioid antagonist that blocks the effects of opioids and is included to deter misuse of the medication.

Suboxone is available in two primary forms: tablets and sublingual films. The sublingual film, designed to dissolve under the tongue, has been linked to numerous dental issues. The tablets are swallowed and do not have the same prolonged contact with the mouth, reducing the risk of dental problems.

Who is Indivior?

Indivior is a specialty pharmaceutical company that markets and manufactures Suboxone, a leading medication for opioid addiction treatment. Originally a division of Reckitt Benckiser, Indivior was spun out as an independent company in 2014.

Indivior is known for its focus on medications to treat serious health conditions like opioid use disorder, but it has faced significant legal challenges due to its marketing practices. In 2020, the FDA forced the company to pay $600 million for criminal and civil damages relating to false statement charges and sentenced the CEO to six months of incarceration.

The company collaborates with other firms, such as Aquestive Therapeutics, Inc., which manufactures films and oral soluble products on behalf of Indivior??.

If the Suboxone Tablet was Effective, Why Did Indivior Change it to a Sublingual Film?

Indivior claimed that its sublingual film was safer than tablets because children were less likely to mistake it for candy and accidentally ingest it. However, this claim turned out to be false, and Indivior pleaded guilty to a felony for misleading statements about its product’s safety, costing the company hundreds of millions.

It’s believed that financial interests primarily drove Indivior’s shift to sublingual film. The company aimed to extend its market exclusivity on the drug combination of naloxone and buprenorphine, effectively keeping generic competitors at bay even after their initial patent expired.

This move was eventually labeled an antitrust violation, leading to a lawsuit in which drug wholesalers won $385 million in damages from Indivior.

What are the Typical Injuries Associated with Suboxone Use?

Suboxone, particularly in its sublingual film form, has been linked to several dental issues, including:

• Cavities. Users may experience an increased rate of cavities due to the prolonged exposure of teeth to Buprenorphine.
• Tooth decay. The acidic nature of Buprenorphine and the reduced saliva production contribute to tooth decay.
• Oral infections. The breakdown of enamel and exposure to harmful bacteria can lead to oral infections.
• Tooth loss. Severe decay and infections can cause tooth loss, which can lead to the need for surgical interventions like dental implants or dentures.

These dental problems can lead to financial burdens for patients due to the high cost of dental treatments, including fillings, crowns, root canals, and surgical interventions such as implants or dentures.

The emotional and psychological impact of these dental issues is also a major concern, as tooth loss can lead to anxiety, depression, and a reduced quality of life.

How Does Suboxone Cause Dental Problems?

The main culprit behind Suboxone-related dental issues is Buprenorphine. When taken sublingually, the film remains in the mouth for about ten minutes, exposing teeth to the drug’s effects.

Buprenorphine reduces saliva production, leading to dry mouth, which is a factor in tooth decay. Saliva helps neutralize acids and combat harmful bacteria; its reduction can make tooth enamel more susceptible to erosion and decay.

What is a Suboxone Lawsuit?

One of the most common Suboxone lawsuit FAQs is what these cases are based on. In other words, what are they, and what are the grounds for filing? The legal controversies surrounding Suboxone primarily focus on its sublingual film version.

Indivior is facing numerous lawsuits alleging that it failed to adequately warn users about the risks of severe dental problems associated with the prolonged use of Suboxone sublingual films. Plaintiffs argue that the company should have known about and disclosed these risks, given its extensive experience producing Buprenorphine-based medications.

The lawsuits are typically based on these legal grounds:

• Failure to warn. Plaintiffs allege that Indivior failed to provide adequate warnings about the risks of severe dental problems associated with the use of Suboxone sublingual films.
• Product liability. Claims that Suboxone was defectively designed or manufactured, leading to unexpected harm.
• Negligence. Accusations that Indivior was negligent in its duty to ensure the safety of its product and adequately inform users of potential risks.
• Misrepresentation. Claims that Indivior made false or misleading statements about the safety and efficacy of Suboxone sublingual films.

Are Suboxone Lawsuits Individual or Class Action?

Although they began as individual legal actions, Suboxone lawsuits have transitioned to a more consolidated format called Multidistrict Litigation (MDL). This consolidation under MDL is designed to streamline pre-trial proceedings by bringing similar cases together in one district court. This process helps manage large numbers of lawsuits that share common issues, reducing the burden on the judiciary and increasing efficiency.

In an MDL, each plaintiff retains their own lawsuit, but pretrial activities like discovery and evidentiary motions are coordinated. The goal of an MDL is to handle complex cases more effectively, potentially leading to settlements or rulings that apply across many similar cases. This format can impact the speed and outcome of cases involving widespread claims against products like Suboxone.

What is the Role of the Judicial Panel in Multidistrict Litigation?

The Judicial Panel on Multidistrict Litigation (JPML) coordinates Suboxone lawsuits, particularly those filed in federal courts. The panel decides whether cases should be centralized in a specific district court to ensure consistent rulings and efficient case management. The Northern District of Ohio has been assigned to handle Suboxone-related litigation to streamline the judicial process.

What Responsibilities Do Pharmaceutical Companies Have Regarding Drug Safety?

Pharmaceutical companies have strict legal and ethical responsibilities to ensure the safety and efficacy of their products. These responsibilities are crucial for protecting public health and form the foundation for product liability lawsuits when failures occur.

Understanding these duties can help clarify the basis for legal actions against companies like Indivior in Suboxone-related litigation:

• Adequate warnings and instructions. Pharmaceutical companies must provide clear and adequate warnings about the potential risks and side effects associated with their drugs. This duty includes ensuring that healthcare providers and patients are fully informed about any dangers from the drug’s use. Warning labels, package inserts, and other informational materials must be comprehensive, accurate, and regularly updated as new information becomes available.
• Pre-market testing. Before a drug can be marketed, pharmaceutical companies must conduct extensive pre-market testing, including clinical trials, to ensure its safety and efficacy. These trials must adhere to rigorous standards set by regulatory bodies like the U.S. Food and Drug Administration (FDA). Testing helps identify potential side effects and assess the drug’s overall risk-benefit profile.
• Post-market surveillance. Even after a drug is approved, pharmaceutical companies are responsible for monitoring its safety through post-market surveillance. This involves tracking adverse events reported by healthcare providers and patients, conducting additional studies as necessary, and updating safety information based on new data.
• Regulatory compliance. Compliance with regulatory requirements is fundamental. This includes adhering to guidelines for manufacturing practices, reporting adverse events, and conducting recalls if necessary. Failure to comply with these regulations can result in legal action and penalties.
• Truthful advertising. Pharmaceutical companies must ensure that their marketing and promotional materials accurately represent the drug’s benefits and risks. Misleading advertising, which exaggerates benefits or downplays risks, can lead to serious consequences, including regulatory action and lawsuits.
• Patient safety first. Pharmaceutical companies’ primary ethical obligation is to prioritize patient safety over profits. This includes a commitment to transparency, rigorous testing, and honest communications about the drug’s potential effects.
• Corporate accountability. Pharmaceutical companies must be accountable for their products. This means taking swift action to address any safety concerns, including withdrawing the product from the market if necessary and compensating those harmed by the drug.

Do I Need Legal Representation for a Suboxone Lawsuit?

Given the complexity of Suboxone lawsuits, having experienced legal representation is crucial. A skilled Suboxone lawyer at Cochran, Kroll & Associates, P.C. can help you with the following:

• Evaluating claims. Our attorneys will thoroughly assess the merits of your case, considering the specific circumstances of your Suboxone use and the associated health damages. This includes evaluating medical evidence and legal precedents to determine your eligibility for compensation.
• Filing the lawsuit. We handle all aspects of filing the lawsuit, including drafting and submitting legal documents to the court. This process also involves articulating the grounds of your claim based on negligence, product liability, or other legal theories.
• Gathering evidence. Our attorneys collect evidence to build a strong case. This includes obtaining medical and dental records, securing expert testimony on the specific side effects of Suboxone, and gathering evidence of any misrepresentations by the manufacturer about the drug’s safety.
• Negotiating settlements. We negotiate with the defendant’s legal team to secure a fair settlement before trial. This often involves detailed discussions on the extent of harm and the compensation necessary for your recovery and rehabilitation.
• Representing at trial. If settlement negotiations do not result in a fair agreement, our attorneys will represent you at trial. We will present your case, advocate on your behalf, and work toward securing a verdict that provides the compensation you deserve.

What Steps Can I Take to Minimize the Risk of Dental Problems While Using Suboxone?

To minimize the risk of dental problems while using Suboxone, consider the following steps:

• Maintain good oral hygiene. Brush and floss regularly and use fluoride toothpaste.
• Stay hydrated. Drink plenty of water to combat dry mouth.
• Regular dental check-ups. Schedule regular visits to your dentist for professional cleanings and early detection of issues.
• Swish and swallow water. After the sublingual strip dissolves, swish and swallow water to help remove residual medication from your mouth. Wait at least an hour before brushing your teeth.
• Use saliva substitutes. Products like saliva substitutes or stimulants can help keep your mouth moist.

What Should I Do if I Have Already Experienced Dental Issues Due to Suboxone?

If you have already experienced dental issues due to Suboxone, it is crucial to document your dental problems and seek medical attention. Consult with a Suboxone lawyer at Cochran, Kroll & Associates, P.C. to explore your legal options and potentially file a lawsuit for compensation.

To prove that Suboxone caused your dental problems, you will need to provide evidence such as the following to demonstrate a direct link between Suboxone use and your dental problems:

• Medical records. Include detailed documentation of your Suboxone prescription, your medical history, and a usage timeline. Records should illustrate how long you’ve been taking Suboxone and any corresponding medical supervision.
• Dental records. Provide records that detail the onset and progression of your dental issues. These records should trace changes in your dental health before, during, and after Suboxone use.
• Expert testimony. Gather testimony from medical and dental experts to provide an authoritative link between your Suboxone use and dental problems based on their expertise and review of your health records.
• Pharmacological studies. Include studies or research that highlight the side effects of Suboxone, particularly if there is documented evidence of dental decay as a potential side effect, to strengthen your case.
• Prescribing information and manufacturer warnings. Collect all available prescribing information and any warnings provided by the manufacturer about Suboxone. Focus on any disclosures related to dental side effects to show whether the risks were communicated to you and your healthcare providers.
• Comparative dental evaluations. Secure reports from dental evaluations before starting Suboxone and after experiencing issues. These comparative analyses can clearly demonstrate the specific changes and impacts on your dental health attributed to the drug.

Who Can File a Suboxone Lawsuit?

To be eligible to file a Suboxone lawsuit, you must typically meet the following criteria:

• Usage. You used Suboxone sublingual film as prescribed for opioid dependence or recovery.
• Dental issues. You experienced significant tooth decay, cavities, or other dental problems beyond normal expectations.
• Damages. Your dental issues resulted in financial losses such as medical bills, pain and suffering, or lost wages.

Our attorneys at Cochran, Kroll, & Associates, P.C. can meet you during a free consultation to evaluate your eligibility. We’ll answer any Suboxone lawsuit questions you might have and determine if we have enough evidence to file a claim on your behalf for damages related to Suboxone use.

What’s the current Status of Suboxone Lawsuits?

As of May 2024, Suboxone tooth decay lawsuits against Indivior have continued to evolve since their onset. The initial case, Sorensen v. Indivior, filed in September 2023, marked the beginning of what has grown into a major legal challenge against the pharmaceutical manufacturer.

With additional cases rapidly accumulating, 358 claims had been filed by June 2024, reflecting an escalating concern over Suboxone’s side effects. Here are the latest updates:

• June 10, 2024 – causation debate. Oral arguments occurred regarding whether to bifurcate (divide into two branches) general and specific causation issues in the lawsuit. Indivior proposed separating these into stages, beginning with general causation—whether Suboxone can cause dental problems—followed by specific causation for individual claims. This approach has been criticized for potentially creating inefficiencies and delaying the resolution of claims, with most MDL judges historically opposing such bifurcation due to its tendency to complicate and prolong litigation unnecessarily.
• June 11, 2024 – diverse jurisdiction impact. The lawsuits have been divided into two categories based on jurisdictional diversity following a tolling motion that paused some plaintiffs’ abilities to file. The larger list includes lawsuits from states outside New Jersey, Delaware, and Virginia, all filed in federal court due to jurisdictional diversity and potentially consolidated into the MDL.
  Plaintiffs from New Jersey, Delaware, and Virginia form the second list. They lack jurisdictional diversity and are generally required to file in state court. However, a tolling agreement gives them additional time to decide on filing without losing rights as time progresses.

The legal landscape surrounding these cases continually changes as they progress in the MDL court. Our legal team at Cochran, Kroll, & Associates, P.C. can help you understand your current options, prepare your complaint, and stay updated on all Suboxone lawsuit litigation rulings.

How Does the FDA’s Updated Warning Impact Suboxone Lawsuits?

In January 2022, the FDA issued an updated warning label for Suboxone, highlighting the risk of dental problems. Suboxone units purchased after this date may be ineligible for claims based on failure to warn, as the updated label provides the necessary information about these risks. This update could impact the eligibility and strength of some Suboxone lawsuits.

However, you may still be eligible to file based on negligence or product liability. Consult with our attorneys at Cochran, Kroll, & Associates, P.C. so we can evaluate your case and give you an overview of your legal options.

What is the Statute of Limitations for Filing a Suboxone Lawsuit?

The statute of limitations for filing a Suboxone lawsuit varies by state. Michigan allows three years, but it is still recommended that you act as soon as possible to preserve your rights.

For instance, if you used Suboxone with the new warning labels (printed in June 2022), you only have until June 2025 to file in Michigan. Consult with a Suboxone lawyer at our law firm to understand the specific deadlines applicable to your case.

Will My Suboxone Lawsuit Go to Trial?

Not all Suboxone lawsuits will go to trial. Many cases are settled out of court through negotiations between the plaintiff’s and defendant’s legal teams. However, if a fair settlement cannot be reached, your case may proceed to trial, where a judge or jury will determine the outcome. Your lawyer will guide you through this process and help you understand the likelihood of your case going to trial.

What can Plaintiffs Expect in Terms of Compensation?

Settlement amounts in Suboxone lawsuits can vary widely and will reflect your damages. Factors influencing the settlement include the severity of dental injuries, the extent of financial losses (such as medical expenses and lost wages), and the impact on your quality of life. More severe cases involving extensive dental treatments and lifestyle disruptions will likely receive higher compensation.

For instance, if you experience tooth loss, you may require extensive dental procedures, including implants. Full-mouth dental implants can cost around $56,000, not including additional exams, X-rays, or mediations. We can help you win a settlement that covers all these expenses, plus pain and suffering damages for the emotional toll on your well-being.

How Can Affected Individuals Find the Right Lawyer for Their Case?

Choosing the right lawyer for a Suboxone lawsuit is a critical step in seeking justice and compensation for the harm caused by the medication. A competent lawyer can guide you through the complex legal process, help gather necessary evidence, and advocate on your behalf. Here are some tips to help you find the right Suboxone lawyer.

• Specialization in pharmaceutical litigation. Look for a lawyer or law firm specializing in pharmaceutical litigation and with a track record of handling similar cases. Cochran, Kroll & Associates, P.C. is skilled in this area, representing numerous clients in lawsuits against large pharmaceutical companies. Our experience with product liability, negligence, and failure-to-warn cases makes us a strong choice for Suboxone-related litigation.
• Medical expertise. Legal expertise combined with medical knowledge is invaluable in pharmaceutical lawsuits. Eileen Kroll, a leading attorney at Cochran, Kroll & Associates, P.C., brings a unique advantage with her background as a registered nurse. Her medical training provides insights into the healthcare aspects of these cases, enabling her to understand complex medical records and effectively communicate the extent of injuries and damages to the court.
• Successful case history. Review the firm’s past case outcomes. A history of successful settlements and verdicts in similar cases can indicate the lawyer’s capability. Cochran, Kroll & Associates, P.C. has a proven track record of securing favorable outcomes for our clients, including significant compensation in pharmaceutical and product liability cases.
• Contingency fees. Many personal injury lawyers, including those at Cochran, Kroll & Associates, P.C., work on a contingency fee basis. This means they only get paid if you win your case. This arrangement can make legal representation more accessible as you do not have to pay upfront fees.
• Personalized attention. Choose a lawyer who will give your case the personalized attention it deserves. Large firms might delegate your case to junior associates, but at Cochran, Kroll & Associates, P.C., clients benefit from the personalized attention that ensures your specific circumstances are fully understood and addressed.

Take Action Today: Seek Legal Help for Your Suboxone-Related Issues

If you or a loved one have suffered from severe dental problems due to Suboxone, it’s time to take action. Contact Cochran, Kroll & Associates, P.C. for a free consultation to explore your legal options and secure the compensation you deserve. Our experienced team can provide the support and advocacy you need, answer your Suboxone lawsuit FAQs, and protect your rights and health.

Our contingency fee basis means we only get paid if we win your case, so there is no financial risk to you to get started. Call our law firm today at 1-866-MICH-LAW  and schedule your no-obligation, free case evaluation.

Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.