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Suboxone Lawsuit

Suboxone Tooth Decay Lawsuit – MDL 3092

Suboxone Tooth Rot Lawsuit

Approximately 1 in 500 adults with insurance have been prescribed a form of Suboxone, a drug intended to primarily treat opioid use disorder. In late 2023, attorneys began filing Suboxone lawsuits. The Suboxone attorneys have sued the manufacturer of the drug Suboxone, Indivior, claiming that the pharmaceutical company failed to properly warn that Suboxone film would rot a user’s teeth. In early 2024, due to the number of Suboxone lawsuits on file around the country, the Suboxone lawsuits were all consolidated into MDL 3092. Since the formation of the Suboxone MDL, approximately 500 Suboxone dental lawsuits have been filed. Our Suboxone attorneys expect that several thousand Suboxone lawsuits will be filed in the coming months. For a free Suboxone lawsuit case evaluation, call 202-792-7927.

Suboxone Usage and Side Effects

Suboxone, primarily used to treat opioid use disorder and pain management, combines buprenorphine and naloxone to manage withdrawal symptoms and reduce cravings. However, its administration, typically via a sublingual film, has been linked to various dental issues. These problems range from cavities and tooth decay to more severe conditions like tooth loss and oral infections. The sublingual method of administering Suboxone exposes the teeth and gums to acidic ingredients, which damage the teeth. 

Common and Serious Side Effects of Suboxone

While common side effects of Suboxone include headaches, nausea, and sweating, the medication can also lead to more grave health concerns that were not initially warned about on the Suboxone label. Dental complications, as noted, are among the serious side effects, with Suboxone’s acidity contributing to enamel erosion. Many injured by Suboxone have claimed that all of their teeth have had to be removed as a result of taking Suboxone film. Others have alleged that they have required hospitalization due to repeated oral infections due to Suboxone film. 

FDA Advises Preventative Measures for Suboxone Users

Recently, the FDA advised that it’s crucial for individuals on Suboxone treatment to inform their dentists about their Suboxone usage so that their dental care can be appropriately tailored. Moreover, the FDA has taken steps to address concerns about Suboxone by requiring new warnings on Suboxone’s label about potential dental problems. This FDA action came after hundreds of reports surfaced linking Suboxone film to significant oral health issues, highlighting the need for heightened awareness and preventive care among Suboxone users and healthcare professionals.

Allegations of Tooth Decay

Suboxone has been linked to severe dental issues, leading to multiple allegations and lawsuits. Individuals have reported a variety of dental problems, from cavities and tooth decay to more severe conditions such as tooth loss and oral infections. These issues allegedly stem from the acidity of buprenorphine, a key component of Suboxone, which can damage tooth enamel and overall dental health.

Reported Dental Injuries

     

      1. Cavities and tooth decay

      1. Cracked teeth and the need for crown or crown replacements

      1. Oral infections

      1. Loss of tooth enamel

      1. Necessity for root canal treatments

      1. Complete tooth loss

    These allegations have not only raised concerns among users but have also led to legal actions against Indivior, the manufacturer of Suboxone. Plaintiffs in these cases argue that Indivior failed to adequately warn medical providers and consumers about the potential risks associated with the drug. It is claimed that the company knew or should have known about the risks of dental problems linked to their product.

    Legal Actions and Claims

    Suboxone tooth decay lawsuits focus on the severe dental issues experienced by users. Plaintiffs are seeking compensation for their dental injuries, which they attribute directly to the use of Suboxone. The legal claims emphasize the lack of warnings provided to medical professionals and consumers, which could have mitigated or prevented the harm caused. These cases highlight the need for increased transparency and responsibility from pharmaceutical manufacturers regarding the side effects of their products.

    Scientific Evidence and Lawsuits

    Suboxone, primarily utilized for treating opioid use disorder, has been implicated in numerous legal battles concerning its alleged side effects on dental health. The core of these lawsuits is the claim that Suboxone can cause severe dental problems, such as tooth decay, which the plaintiffs argue result from the drug’s acidity and its interaction with dental enamel. Notably, several lawsuits have been consolidated into a multidistrict litigation (MDL) in the Northern District of Ohio, reflecting the scale and seriousness of these allegations.

    Legal Documentation and Claims

    The lawsuits assert that Indivior, the manufacturer of Suboxone, had prior knowledge—or reasonably should have had knowledge—of the potential risks associated with the drug but failed to provide adequate warnings to healthcare providers and consumers. For instance, the case filed by Plaintiff David Sorensen emphasizes that neither he nor his physician were alerted to the risks of dental erosion, a side effect that could have been mitigated with proper patient education and preventive dental care.

    Multidistrict Litigation and Court Proceedings

    The U.S. Judicial Panel on Multidistrict Litigation has played a pivotal role in the legal proceedings by consolidating the Suboxone claims. This consolidation within MDL-3092 aims to streamline the process, allowing for a more organized and efficient handling of the cases. The panel’s decision to centralize the lawsuits underscores the complexity and uniformity of the legal issues involved, which predominantly revolve around the alleged failure to warn and the resultant dental injuries.

    In these legal confrontations, plaintiffs’ attorneys have been vigorously advocating for the centralization of all federal Suboxone lawsuits, arguing that this would enhance the efficiency of the pretrial proceedings and factual questions. This legal strategy not only highlights the scale of the issue but also points to a systemic failure on the part of the pharmaceutical company to safeguard consumer health, despite clear indications of potential harm.

    Extracted rotten tooth with a big cavity being examined.

    The Science Behind Suboxone and Dental Issues

    Suboxone, a medication primarily used in opioid addiction treatment, is administered sublingually, meaning it dissolves under the tongue. This method, while effective for drug delivery, exposes the teeth and gums to the medication’s active ingredients, notably buprenorphine. The acidity of buprenorphine is a contributing factor to dental issues such as tooth decay, cavities, and even tooth loss. 

    Not all individuals taking Suboxone will experience dental problems; however, those who do should not only seek immediate dental intervention but also consider legal consultation. Legal professionals specializing in pharmaceutical litigation can provide guidance on potential compensation claims related to Suboxone-induced dental issues. As the legal landscape surrounding Suboxone continues to evolve, staying informed about both medical and legal developments is crucial for patients and healthcare practitioners alike.

    FDA Warnings and Manufacturer Responsibility

    In January 2022, the U.S. Food and Drug Administration (FDA) took significant action concerning the dental risks associated with buprenorphine-containing medications like Suboxone. The agency mandated the addition of a new warning to both the prescribing information and the patient medication guide, highlighting the potential for severe dental issues. These warnings were based on accumulated reports of adverse dental outcomes such as tooth decay, cavities, and tooth loss, particularly from medications that dissolve in the mouth to treat opioid use disorder and pain.

    The response from the manufacturer, Indivior, has also been under scrutiny. Indivior, having pleaded guilty to felony charges related to deceptive marketing practices in July 2019, agreed to pay over $600 million to resolve criminal and civil liabilities. This included misleading health providers and the public about the safety of Suboxone Film, contributing to an environment where the full extent of potential dental side effects may not have been adequately communicated. The settlements and legal actions reflect a broader accountability trend where pharmaceutical companies must uphold stringent transparency, especially concerning potential drug side effects.

    Furthermore, the FDA’s proactive stance includes encouraging healthcare professionals and patients to report any adverse events related to buprenorphine or other medications through the FDA MedWatch program. This initiative aims to gather comprehensive data to better understand and mitigate the risks associated with these treatments. The FDA also advises patients on the importance of maintaining excellent oral hygiene and regular dental check-ups to preemptively address any potential dental complications arising from the use of these medications. This comprehensive approach underscores the dual responsibility of both the regulatory bodies and pharmaceutical manufacturers in safeguarding public health while providing effective medical solutions.

    Legal Perspective

    In the unfolding legal landscape surrounding Suboxone, the U.S. Judicial Panel on Multidistrict Litigation has taken a pivotal step by consolidating 15 claims related to Suboxone tooth decay into a multidistrict litigation (MDL) in the Northern District of Ohio. This consolidation aims to streamline the legal process, providing a structured framework for handling these cases more efficiently. 

    Plaintiffs’ attorneys have been vigorously advocating for the centralization of all federal Suboxone lawsuits to address the shared factual questions and legal issues more effectively. This strategy not only facilitates a more systematic approach to litigation but also highlights the broader implications of pharmaceutical responsibility and patient safety. Indivior, the drug’s manufacturer, has faced significant legal challenges, not only with the MDL but also with an antitrust class-action lawsuit that settled for $60 million over claims that limited competition led to inflated prices for consumers.

    The legal ramifications for Indivior continue with various settlements and ongoing cases emphasizing the necessity for pharmaceutical companies to uphold high standards of transparency and safety. This series of legal actions reveals a pattern of accountability that could shape future regulatory and legal landscapes, ensuring better protection for consumers and fostering a more transparent drug market.

    Legal Options for Affected Patients

    Patients who have experienced severe dental issues following the use of Suboxone sublingual strips are advised to seek legal counsel to explore potential compensation claims. To qualify for a Suboxone lawsuit, individuals must demonstrate that they were prescribed Suboxone Sublingual Film for opioid addiction or pain management, used the medication for at least six months, and subsequently suffered from dental injuries such as cavities, tooth loss, or fractures. It is crucial to have dental records that substantiate these claims, and any diagnosis of dental problems should be within the timeframe that allows for legal action, considering the statute of limitations.

    Steps to Initiate a Suboxone Lawsuit

       

        1. Contact a Qualified Lawyer: If serious dental issues have occurred, contacting a lawyer immediately is essential. Law firms specializing in pharmaceutical litigation often offer free case evaluations and operate on a contingency fee basis, meaning they only collect fees if they secure a settlement or jury verdict.

        1. Gather Necessary Documentation: Patients should compile all relevant pharmaceutical and dental records. These documents are critical for substantiating the claim that Suboxone usage directly caused the dental issues.

        1. File a Lawsuit: Your lawyer will help file a lawsuit against the manufacturer, alleging that insufficient warnings were provided about the dental risks associated with Suboxone. The legal process may involve negotiation for a settlement or preparation for a jury trial.

      Affected individuals must act swiftly to avoid missing the opportunity to file their claims. The statute of limitations, which may vary by state, determines the timeframe one has to pursue a case. Engaging a lawyer early in the process enhances the chances of a favorable outcome and ensures that all procedural requirements are met within the appropriate timeline.

      Implications for Pharmaceutical Companies

      The recent developments in litigation and regulatory actions surrounding Suboxone have significant implications for pharmaceutical companies, particularly those involved in the production and distribution of opioid treatment medications. The Federal Trade Commission (FTC) has demonstrated a proactive stance in ensuring consumer protection and fair market practices by returning nearly $60 million to consumers affected by the alleged Suboxone film scheme. This action underscores the increasing scrutiny on pharmaceutical companies to maintain ethical marketing practices and transparent disclosure of drug side effects.

      Financial Impact and Market Dynamics

      Pharmaceutical companies are facing financial repercussions as evidenced by the substantial settlements in antitrust class-action lawsuits. These settlements not only involve hefty financial compensations but also highlight the broader economic impact on the market dynamics of pharmaceutical products. The lawsuit that claimed limited competition led to consumers overpaying for Suboxone has prompted a reevaluation of market strategies and pricing policies among drug manufacturers. This scenario stresses the importance of compliance with antitrust laws and the potential financial risks of non-compliance.

      Regulatory Compliance and Consumer Trust

      The FDA’s Overdose Prevention Framework and the actions taken by the FTC are critical components that pharmaceutical companies must consider in their operational and strategic planning. Ensuring compliance with these regulatory frameworks is essential not only for legal adherence but also for building and maintaining consumer trust. Companies are expected to engage in rigorous risk evaluation and mitigation strategies, especially for medications with significant side effects, to prevent medication errors and enhance drug safety. This comprehensive approach to drug safety can serve as a basis for strengthening the trust between consumers and pharmaceutical providers, which is crucial in the highly regulated pharmaceutical industry.

      Conclusion

      By examining Suboxone’s potential dental dangers and its enveloping legal battles, this article has spotlighted the complex nexus of medical necessity and unexpected side effects, complemented by a legal framework aiming to address patient grievances. The discussions herein have not only underscored the significance of being informed about the possible ramifications of sublingual Suboxone usage but also highlighted the proactive steps undertaken by regulatory bodies and health professionals to mitigate these risks. 

      As we conclude, the call to action for those affected by Suboxone’s unfavorable dental outcomes becomes clear. If you or someone you know has suffered from tooth decay or other dental issues potentially caused by Suboxone in the sublingual film, it’s crucial to recognize the value of expert legal representation in navigating these complex issues. Contact us today for a free consultation, and let our team at Nigh Goldenberg Raso & Vaughn assist you through every step of your legal journey. 

      FAQs

      1. What compensation can be expected from a Suboxone lawsuit?
      Suboxone lawsuits, particularly against the manufacturer Indivior, are based on claims that the drug has caused significant dental damage. The amount of compensation awarded to plaintiffs varies based on the extent of dental damage, the cost of dental treatments, and the emotional distress experienced. 

      2. What impact does Suboxone have on dental health?
      The FDA has issued warnings that sublingual medications containing buprenorphine, such as Suboxone, have been linked to various dental issues. Users of Suboxone have reported experiencing oral infections, significant tooth decay, cavities, and even tooth loss.

      3. Is there an ongoing lawsuit regarding the side effects of Suboxone?
      Yes, there is currently a lawsuit concerning the dental side effects of Suboxone. The lawsuit alleges that the manufacturers were aware of the risks of severe dental decay and other related injuries but failed to adequately inform both the prescribing physicians and the patients. The accusation is that the manufacturers prioritized their profits over the well-being of the users.

      4. What are the criteria for participating in the Suboxone lawsuit?
      To be eligible to participate in a Suboxone lawsuit, several key requirements must be met:

         

          • The individual must have been prescribed Suboxone in a sublingual film prior to June 2022.

          • The individual must have experienced dental complications as a result of using the Suboxone sublingual film.

          • The claim must be filed within the applicable statute of limitations, which varies by jurisdiction.

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