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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 10,500 Suboxone dental lawsuits have been filed. Our Suboxone attorneys expect that several thousand additional Suboxone lawsuits will be filed within the next year. For a free Suboxone lawsuit case evaluation, call 202-792-7927.

Suboxone Lawsuit MDL 3092 Timeline

June 2024 – Establishing Leadership Development Committee & Common Benefit

On June 14, 2024, the Suboxone plaintiff attorneys filed approximately 10,000 Suboxone lawsuits in a single day, which are listed in Schedule A per Suboxone case management order #4. The Suboxone judge allowed the mass filing of Suboxone lawsuits on Schedule A, in part because pharmacy records requests are still pending for these Suboxone plaintiffs. Only plaintiffs who took name-brand Suboxone will be eligible to maintain a Suboxone lawsuit. Many of the 10,000 Suboxone lawsuits that were filed on Schedule A will likely eventually be dismissed due to only taking generic Suboxone (The US Supreme Court has previously held that generic drug manufacturers are immune to liability from failing to adequately warn when their label matches the brand-name drug label). 

On June 11, 2024, the Court entered Suboxone case management order #8 – Protocol for common-benefit fees and expenses. The Court noted that “Common-Benefit Work” includes all work done and expenses incurred that are of value to the Suboxone lawsuits in MDL 3092. The 20 page order details exactly what can be billed as common benefit work for the Suboxone MDL.

On June 6, 2024, the Court entered Suboxone case management order #7, setting forth the procedure to appoint a Suboxone Plaintiffs’ Leadership Development Committee (LDC). The Court noted that the Suboxone LDC is intended to provide mentorship to attorneys committed to long-term involvement in MDL practice with the goal of developing future MDL leaders. Attorneys wishing to be part of the Suboxone Film Leadership Development Committee have until July 8, 2024, to submit their applications. 

May 2024 – Suboxone Document Production

The Suboxone court entered CMO 6 on May 21, 2024, which covered Evidence Rule 502(D) (Attorney-Client Privilege & Work Product) & other privileged materials. The Suboxone order notes that it will provide the maximum protection allowed under the Federal Rules of Evidence and shall be enforceable in all other State and federal proceedings. The Suboxone court order goes on to describe the process of claiming privilege and what must be included in a Suboxone privilege log.

On May 21, 2024, the Suboxone court also entered case management order #5, titled “Designation and Handling of Protected Information.” This court order governs the handling of Suboxone documents, depositions, deposition exhibits, interrogatory responses, responses to admissions, responses to request for production of documents, and all other Suboxone discovery obtained during the course of the Suboxone lawsuits. The lengthy court order also details how Suboxone documents can be classified as “Confidential Information” if the Suboxone documents contain:

  • Information protected from disclosure by any applicable state or federal statute or regulation;
  • Research, design, development, financial, technical, marketing, planning, regulatory, manufacturing, or commercial information that the Designating Party has maintained as confidential;
  • Trade secrets; or
  • any Protected Data.

The Suboxone court order then goes on the allow certain Suboxone documents to be labeled “Highly Confidential Information” if the information would create a substantial risk of competitive or business injury.

Who are allowed to view the confidential Suboxone documents that are produced in the Suboxone lawsuits?

  • The Court, including attorneys, employees, judges, magistrates, secretaries, special masters, stenographic reporters, staff, transcribers, and all other personnel necessary to assist the Court in its function, and the jury (and any appellate court or other court);
  • Mediators or other individuals engaged or consulted in Suboxone settlement negotiations on behalf of part of all of MDL 3092;
  • Court reporters, stenographers, and videographers retained to record testimony taken in MDL 3092
  • Suboxone attorneys and their employees who have responsibility for the preparation of Suboxone depositions and the Suboxone trial;
  • Suboxone experts, consultants, investigators, or expert consulting firms retained by the Suboxone lawyers;
  • Witnesses during their Suboxone depositions;
  • Suboxone mock jurors or professional jury or trial consultants

 

On May 16, 2024, the court entered Suboxone CMO 4 titled “Schedule A Complaint”. The order notes that the Suboxone Plaintiffs’ Leadership had requested a tolling agreement to afford counsel time to investigate their Suboxone claims by, for example, obtaining medical or pharmacy records to substantiate Suboxone use. The Suboxone Plaintiffs’ leadership was concerned that a flood of Suboxone lawsuits might be filed without adequate vetting to demonstrate that the plaintiff actually took name brand Suboxone in order to protect potential statutes of limitations triggered by a warning change to the Suboxone label in June of 2022. The Suboxone defendants refused to agree to tolling, so the judge ordered that the Suboxone plaintiffs could file a complaint on the master Suboxone MDL docket captioned “The Individuals Identified on Schedule A v. Individor, Inc. et al.” The following information must be included for each Suboxone lawsuit filed via Schedule A:

  • Suboxone Plaintiff’s first and last name;
  • First and Last name of any consortium Suboxone Plaintiff;
  • Law Firm representing each Suboxone Plaintiff;
  • Location where Suboxone Plaintiff is a resident and citizen;
  • Suboxone Plaintiff’s designated venue;
  • Location (city, State) where Suboxone Plaintiff currently resides;
  • Location(s) (city, State) where Suboxone Plaintiff claims, alleges, or represents they were prescribed Suboxone film; and
  • Location(s) (city, State) where Suboxone Plaintiff claims, alleges, or represents they used Suboxone film. 

 

Following the filing of Suboxone lawsuits via Schedule A, the Suboxone defendants will have until July 1, 2024, to file a motion to sever and the Court will then set a briefing schedule with the expectation that Suboxone lawsuits filed on Schedule A will then file separate individual actions, which will be a continuation of the original suit filed via Schedule A. 

March 2024 – Initial Suboxone Status Conference

As per case management order 1 of the Suboxone litigation, the first Suboxone case management conference was held on March 7, 2024. Following the first Suboxone case management conference, the judge appointed Plaintiffs’ leadership for the Suboxone lawsuits in the 2nd Suboxone case management order on March 8, 2024. A direct filing order allowing all Suboxone lawsuits nationwide to be filed into the Suboxone MDL 3092 was entered on March 18, 2024 and later amended on March 27, 2024.  Lawsuits filed into an MDL typically greatly increase once a direct filing order is entered.

Judge J. Philip Calabrese
Judge Calabrese

February 2024 – Suboxone MDL 3092 Created

On February 2, 2024, the Judicial Panel on MultiDistrict Litigation (JPML) issued a transfer order to centralize all Suboxone lawsuits into the Northern District of Ohio under Judge Philip Calabrese. At the time the JPML consolidated the Suboxone lawsuits, there were 15 Suboxone lawsuits on file in 5 different federal district courts. The JPML held that consolidating the Suboxone lawsuits “in the Northern District of Ohio will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” The Suboxone defendants had objected to consolidation and the JPML noted, “defendant’s objection is not taken well. Centralization allows for streamlined discovery, briefing, and rulings regarding personal jurisdiction of the Reckitt defendants before a single judge.” In regard to having Judge Philip Calabrese preside over the litigation, the JPML commented that they were able to “assign this litigation to a jurist who has not yet had the opportunity to preside over an MDL.” The JPML gave MDL 3092 the official title “In re: Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation.”

Suboxone Settlements & Judgments

October 2023 – $385 Million Suboxone Settlement

On October 23, 2023, a $385 million Suboxone settlement with direct purchasers of Suboxone was announced to resolve the Suboxone antitrust Multi-District Litigation (MDL), which was pending in the United States District Court for the Eastern District of Pennsylvania. It was noted that “the $385 million is expected to be made in November 2023 and funded from Indivior’s (Suboxone’s manufacturer) existing cash.” It was further noted that the Suboxone antitrust MDL had been litigated for a decade. 

April 2021 – $300 Million Suboxone Settlement 

In April of 2021, the makers of Suboxone agreed to a $300 million settlement for falsely and aggressively marketing and promoting Suboxone, resulting in improper expenditures of state Medicaid funds. The Attorney General of Maryland commented that the makers of Suboxone “misled the public about Suboxone’s risks, promoted its use to physicians, and defrauded state Medicaid programs out of hundreds of millions of dollars to increase its bottom line.” It was also noted that the Suboxone settlement resolved six whistleblower lawsuits pending in federal courts in Virginia and New Jersey.

Judge James Jones
Hon. James Jones

November 2020 – $289 Million Suboxone Criminal Penalty

On November 12, 2020, it was announced that the manufacturer of Suboxone would pay $289 million in criminal penalties in connection with a guilty plea for improperly marketing the Suboxone. U.S. District Judge James P. Jones of the Western District of Virginia entered the sentence against the maker of Suboxone pursuant to a plea agreement. The Acting Assistant Attorney General of the U.S. Justice Department’s Civil Division commented, “We will hold drug manufacturers accountable when they make representations that could affect consumer’s access to opioid addiction treatment.”

October 2020 – Suboxone CEO Sentenced to Jail

The CEOs of pharmaceutical companies are rarely held accountable for their company’s bad behavior. However, that wasn’t the case when it came to the CEO of the company that manufactures Suboxone. On October 22, 2022, Shaun Thaxter, the former CEO of the company (Indivior) that manufactures Suboxone, was sentenced to 6 months in federal prison and ordered to pay a $100,000 fine and forfeit $500,000. A United States Attorney noted, “Thaxter failed to prevent efforts to build profits through misleading safety claims, which led to millions of dollars in ill-gotten gains for Individor. As the Court recognized today, this sentence should serve as a deterrence to other pharmaceutical executives.” According to court documents, the Suboxone CEO had authority over the marketing and sales of Suboxone Film which, along with other Suboxone products, generated nearly all of the company’s revenue. Furthermore, in 2012, the CEO oversaw and encouraged Individor’s efforts to secure formulary coverage for Suboxone Film from the Massachusetts Medicaid agency called MassHealth. The CEO also asked employees to devise a strategy to win preferred drug status for Suboxone Film and counteract a non-opioid competitor MassHealth was considering for opioid addiction treatment. Some employees had even shared false and misleading information with MassHealth about Suboxone Film’s risk of accidental pediatric exposure. Just two months after receiving the false information, MassHealth announced it would approve Suboxone Film for Medicaid patients with children under the age of six. 

June 2020 – Suboxone Manufacturer CEO Pleads Guilty

On June 30, 2020, Shaun Thaxter, CEO of Indivior, pleaded guilty to causing the introduction of misbranded Suboxone Film into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act. Thaxter had been the CEO of the companies that manufactured Suboxone (Individor – formerly Reckitt Benckiser Pharma). The Suboxone Film was considered misbranded due to untruthful drug safety claims. The Suboxone CEO is scheduled to be sentenced in U.S. District Court in Abingdon in October of 2020. 

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.  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 Dental Measures for Suboxone Film 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.

Suboxone Film Dental Injuries

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.

      • Cavities and tooth decay

      • Cracked teeth and the need for crown or crown replacements

      • Oral infections

      • Loss of tooth enamel

      • Necessity for root canal treatments

      • Complete tooth loss

    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 Adds Tooth Decay Warning to Suboxone Instructions For Use (IFU)

    FDA Requires Suboxone Label To Warn of Dental Damage

    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 Options for  Patients Injured by Suboxone Film

    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

        • 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.

        • 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.

        • File a Suboxone 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.

      Suboxone FAQs

      Do you have to have taken name-brand Suboxone to qualify for a Suboxone lawsuit?

      Yes, only those who took name-brand Suboxone Film qualify for a Suboxone lawsuit. Those who took generic Suboxone Film (buprenorphine/naloxone) do not qualify for a Suboxone lawsuit.

      Why Does Only Name-Brand Suboxone Film Qualify for A Suboxone Lawsuit?

      The Suboxone lawsuits allege that the manufacturer of Suboxone Film failed to warn that Suboxone Film can cause dental damage. Per FDA regulations, a generic drug manufacturer must have the same warnings as the name-brand and the generic drug manufacturer is unable to change the label. Therefore, the generic drug manufacturer can not be sued for failure to warn. 

      What compensation can be expected from a Suboxone lawsuit?

      The Suboxone lawsuits are seeking to achieve financial compensation for those who used name-brand Suboxone Film and then suffered complications with their teeth. The amount of compensation through any Suboxone settlement will vary significantly based on the facts specific to each Suboxone users’ lawsuit.

      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.

      Is there an ongoing lawsuit regarding the side effects of Suboxone Film?

      Yes, there is currently a lawsuit concerning the dental side effects of Suboxone Film. 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.

      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:

          • Must have taken name-brand Suboxone film (Suboxone film went generic in June of 2018, so most users that started after June of 2018 will have taken generic Suboxone).

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

        Suboxone Lawyer

        If you or someone you know has suffered from tooth decay or other dental issues after taking Suboxone sublingual film, Contact us today for a free Suboxone lawsuit consultation. Let our Suboxone team at Nigh Goldenberg Raso & Vaughn assist you through every step of your legal journey. Call 202-792-7927 to talk to our Suboxone attorneys today.

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