Suboxone Lawsuit

More than 2 million people in the United States rely on Suboxone as part of their journey to overcome opioid addiction. While the medication has been praised for its effectiveness in managing withdrawal symptoms, troubling reports of severe dental damage and other side effects have surfaced, leaving many patients grappling with unexpected health complications.

If you or a loved one has experienced harm from Suboxone, you may be entitled to pursue legal action against its manufacturer. Lawsuits against Indivior, the pharmaceutical company behind Suboxone, allege that the risks of the drug were downplayed, and patients were not adequately warned about its potential dangers.

Whether you’ve suffered unexpected dental decay, liver damage, or other complications, there is legal recourse available. At LitigationConnect, we are here to fight for the justice you deserve. 

Don’t wait to take the first step—contact us today at (833) 552-7274 for a free consultation to explore your options.

What is Suboxone?

Suboxone is a prescription medication designed to aid individuals in managing opioid dependency, combining the active ingredients buprenorphine and naloxone. Buprenorphine is a partial opioid agonist, meaning it interacts with the same brain receptors as opioids like heroin or oxycodone but produces a milder effect. This helps to reduce cravings and withdrawal symptoms without delivering the euphoric "high" that fuels addiction. Naloxone, on the other hand, acts as a deterrent. If someone attempts to misuse Suboxone by injecting it, naloxone triggers withdrawal symptoms, discouraging abuse.

Approved by the U.S. Food and Drug Administration (FDA) in 2002, Suboxone quickly became a cornerstone in Medication-Assisted Treatment (MAT) programs for opioid addiction. MAT, endorsed by organizations such as the Substance Abuse and Mental Health Services Administration (SAMHSA), combines medication with counseling and behavioral therapies. The goal is to support individuals in achieving long-term recovery while reducing the risk of overdose.

However, as Suboxone’s popularity grew, so did reports of unexpected side effects.

Reported Side Effects of Suboxone

These effects vary in severity, but certain issues have prompted legal action due to their impact and the lack of sufficient warning provided to patients.

Common Side Effects

Many individuals using Suboxone experience mild to moderate side effects that can usually be managed with adjustments to dosage or medical supervision. These include:

• Nausea and vomiting
• Headaches
• Constipation
• Insomnia or sleep disturbances
• Sweating and fatigue

Although these symptoms may seem manageable, they can persist or worsen, especially without proper medical guidance.

Severe and Long-Term Side Effects

More troubling are the reports of severe health complications linked to Suboxone, which have become the foundation of numerous lawsuits. These include:

1. Dental Damage
   • In 2022, the FDA issued a safety warning about the risk of serious dental issues, including tooth decay, cavities, and tooth loss, associated with buprenorphine-containing medicines like Suboxone that dissolve in the mouth.
   • Patients reported experiencing sudden and severe dental decay despite maintaining good oral hygiene.
2. Respiratory Depression
   • Buprenorphine’s opioid-like properties can slow breathing, particularly when combined with other sedatives. This can pose a life-threatening risk, particularly for individuals with pre-existing respiratory conditions.
3. Liver Damage
   • Suboxone use has been linked to cases of acute liver failure and liver inflammation. Individuals with a history of liver disease or those consuming alcohol while using Suboxone are at heightened risk.
4. Dependency or Misuse
   • Despite its intended use as an addiction treatment, Suboxone itself carries a risk of dependency, especially if not used strictly as prescribed.

What Makes These Risks Legally Significant?

Legal Basis for Suboxone Lawsuits

Suboxone lawsuits primarily focus on allegations that Indivior, the manufacturer, failed to provide adequate warnings about significant health risks associated with the medication. These cases leverage various legal principles under product liability law, which holds manufacturers accountable for harm caused by defective or unreasonably dangerous products.

Failure to Warn

A cornerstone of Suboxone lawsuits is the claim that Indivior failed to adequately warn users about the risk of severe dental problems associated with the drug’s sublingual (under-the-tongue) administration. This issue came into sharper focus following the FDA’s 2022 safety warning.

• Legal Implications:
  Manufacturers are obligated to provide clear warnings about foreseeable risks associated with their products. States like California enforce strict liability for failure to warn, meaning plaintiffs do not need to prove negligence—only that the warning was inadequate and the harm was linked to the product’s use.
• Preventable Harm:
  Plaintiffs assert that Indivior could have mitigated these risks by including instructions for minimizing harm, such as rinsing the mouth with water after use or regularly consulting a dentist.

Defective Design

Another prominent allegation is that Suboxone’s design—specifically its sublingual delivery method—was inherently flawed. Plaintiffs argue that the drug’s prolonged exposure to teeth and gums led to concentrated chemical damage, exacerbating dental decay.

• Design Alternatives:
  Plaintiffs suggest that alternative delivery methods, such as pills or transdermal patches, could have minimized or eliminated the risk of dental harm. These claims are bolstered by comparative studies showing that non-sublingual formulations of buprenorphine (a key ingredient in Suboxone) do not carry the same dental risks.
• Legal Framework:
  Under defective design claims, plaintiffs must demonstrate that a safer, feasible design existed and that the existing formulation posed unnecessary risks. Courts often assess whether the product’s benefits outweighed its risks—a standard that has not favored Indivior (based on prior rulings) if alternative methods were available.

Negligence

The lawsuits also allege that Indivior was negligent in its research and response to emerging safety concerns.

• Insufficient Safety Testing:
  Plaintiffs argue that the company failed to conduct adequate long-term safety studies on Suboxone’s effects, particularly regarding dental health. Reports of dental problems began surfacing years before the FDA’s 2022 warning, raising questions about whether Indivior ignored early red flags.
• Failure to Act:
  Lawsuits claim that Indivior failed to act on early patient complaints and healthcare provider reports. This inaction allegedly prolonged the period during which patients were unknowingly exposed to preventable harm.

Marketing Misconduct

Indivior has also been accused of misleading marketing practices, a claim echoed in both private lawsuits and regulatory actions.

• Exaggerated Safety Profile:
  Plaintiffs contend that Indivior downplayed Suboxone’s risks in its marketing materials, emphasizing its effectiveness in treating opioid addiction while failing to disclose the potential for severe dental damage, liver issues, and dependency.

Relevant Laws and Precedents

• State Product Liability Laws: Depending on the jurisdiction, plaintiffs may pursue claims under theories of strict liability, negligence, or breach of warranty. For instance, California’s strict liability law holds manufacturers strictly liable for harm caused by defective products, regardless of intent or negligence.
• Consumer Protection Statutes: Many states, such as Florida under the Florida Deceptive and Unfair Trade Practices Act (FDUTPA), provide legal remedies for consumers harmed by deceptive or unfair practices, including misleading drug advertisements.
• Federal Food, Drug, and Cosmetic Act (FDCA): This federal law governs the approval and labeling of medications. While violations of the FDCA do not directly create private rights of action, they can serve as evidence in state-level product liability lawsuits.

Multidistrict Litigation (MDL) and Class Actions

Given the widespread nature of Suboxone-related harm, many lawsuits have been consolidated into Multidistrict Litigation (MDL) in federal court. MDLs streamline pretrial proceedings for cases with common issues, such as those alleging dental damage and inadequate warnings.

Potential Compensation in Suboxone Lawsuits

Filing a Suboxone lawsuit offers individuals an opportunity to seek compensation for the physical, emotional, and financial toll caused by the medication’s harmful side effects. 

While every case is unique, successful plaintiffs may be entitled to various forms of damages, depending on the extent of their injuries and losses.

Types of Damages Available

• Economic Damages

1. These are quantifiable losses directly tied to the plaintiff’s injuries:
   • Medical Expenses: Reimbursement for past and future medical bills, including:
     • Dental treatments like fillings, root canals, implants, or dentures to address decay or tooth loss.
     • Liver function tests, imaging studies, and treatments for related conditions.
   • Lost Wages: Compensation for income lost due to missed work during recovery.
   • Loss of Earning Capacity: Damages for diminished ability to work if injuries prevent resuming a previous career or working full-time.
2. Non-Economic Damages
   • These address the subjective, non-monetary impact of Suboxone-related injuries:
     • Pain and Suffering: Compensation for physical pain, emotional distress, and reduced quality of life.
     • Loss of Consortium: Damages for the negative impact of injuries on a plaintiff’s relationship with their spouse or family.
3. Punitive Damages
   • In cases where the manufacturer’s conduct is deemed reckless or egregious, courts may award punitive damages. These serve as a financial penalty for the defendant and a deterrent against similar behavior.

Factors Influencing Settlement Amounts

• Severity of Injuries

1. Cases involving permanent harm, such as tooth loss or chronic liver damage, typically result in higher compensation.
2. Medical Documentation
   • Detailed records linking Suboxone to the injuries strengthen the case and can impact the settlement value.
3. Manufacturer Conduct
   • Evidence of gross negligence, such as suppressing safety data or misleading marketing, can lead to higher punitive damages.
4. Geographic Location
   • Jurisdictions with plaintiff-friendly product liability laws may result in more favorable outcomes. For example, states like California and New Jersey often see higher awards in product liability cases due to their legal frameworks.

Realistic Settlement Expectations

While large class action or MDL cases may result in settlements reaching millions collectively, individual compensation varies widely based on personal circumstances. Previous settlements, like Indivior’s $86 million agreement with U.S. states over deceptive practices, provide a benchmark but do not guarantee specific outcomes for individual plaintiffs.

Eligibility Criteria for Filing a Suboxone Lawsuit

If you’ve suffered harm from using Suboxone, you may be wondering whether you have grounds to pursue a legal claim. Determining eligibility for a lawsuit involves evaluating several factors, including the nature of your injuries, evidence linking them to Suboxone, and applicable statutes of limitations.

Key Factors to Assess Eligibility

• Documented Use of Suboxone

1. Plaintiffs must provide medical records, pharmacy receipts, or other documentation proving that they were prescribed and used Suboxone.
2. Evidence of Harm
   • Legal claims typically focus on specific injuries such as:
     • Dental Damage: Tooth decay, cavities, gum disease, or tooth loss that required medical intervention.
     • Liver Damage: Diagnosed liver conditions, such as inflammation or failure, that developed during or after Suboxone use.
     • Respiratory Issues: Breathing complications tied to Suboxone’s opioid properties.
   • Photos, medical records, and expert evaluations can help establish a causal link between the drug and these injuries.
3. Failure to Receive Adequate Warning
   • Plaintiffs must demonstrate that they were not informed about the risks associated with Suboxone or that these risks were insufficiently disclosed. This is central to failure-to-warn claims.
4. Timely Filing Under Statutes of Limitations
   • Each state has its own statute of limitations, typically ranging from 1 to 6 years, for filing product liability lawsuits. For example:
     • In California, the statute of limitations for personal injury claims is 2 years from the date of injury or discovery of harm.
     • In New York, plaintiffs have 3 years to file from the injury date.
   • A legal professional can assess when the clock began ticking based on the discovery rule, which allows filing after realizing the harm was connected to Suboxone.
5. Impact on Quality of Life
   • Compensation may be influenced by how the injury affects daily living, employment, or emotional well-being.

Steps to Determine Eligibility

• Seek Medical Evaluation:
  • Obtain a thorough assessment from a healthcare provider to confirm the nature and severity of your injuries.
• Compile Evidence:
  • Gather records, photographs, prescriptions, and correspondence with healthcare providers related to Suboxone use and the resulting injuries.
• Consult Legal Representation:
  • Your attorney will review your case, determine eligibility, and ensure you meet filing deadlines.

Protect Your Health and Rights with LitigationConnect

Every story of harm caused by Suboxone deserves to be heard, and every individual impacted by its side effects deserves justice. 

LitigationConnect, is here to bridge the gap between you and the legal assistance you need. Our team of experienced attorneys is ready to help you pursue compensation for the pain and losses Suboxone has caused. From initial consultation to case resolution, you’ll have guidance every step of the way.

Don’t wait to take action. Contact LitigationConnect today at (833) 552-7274 for a free case evaluation and take the first step toward securing the justice and compensation you deserve.