If you or a loved one took Suboxone, a prescription drug used to treat opioid addiction, you may join a lawsuit against the drug's manufacturers. This blog will explain the Suboxone lawsuit and how you can get involved.
What is Suboxone?
Suboxone is a brand name for a drug that contains two active ingredients - buprenorphine and naloxone.
Buprenorphine is an opioid medication. It is used to treat opioid addiction by reducing cravings and withdrawal symptoms. Naloxone is added to discourage misuse of the drug. It causes withdrawal if Suboxone is injected.
Suboxone was approved by the FDA in 2002 as a safer alternative to methadone for treating opioid dependence. It quickly became a popular treatment option. Certified doctors could prescribe it in an office rather than through daily visits to a clinic like methadone treatment.
The warning label was changed in June 2022, so some potential plaintiffs may have lost the opportunity to file a lawsuit as of June 2024. However, the parties are discussing a tolling agreement that might extend the filing deadline into 2025. To learn if you can still bring a Suboxone lawsuit, reach out to the LLN team today.
The Allegations
Despite being marketed as a safer treatment option, Suboxone and its manufacturers (Indivior Inc., formerly Reckitt Benckiser Pharmaceuticals) are now facing numerous lawsuits.
The key allegations include:
- Anti-Competitive Behavior: Plaintiffs allege that Indivior waged a campaign to unfairly extend its monopoly on Suboxone after the drug's original patent expired in 2009. This allegedly included product hopping and filing patents for new formulations that provided no clinical benefit over the original to delay cheaper generic versions from coming to market.
- Improper Marketing: The lawsuits claim that Indivior marketed Suboxone for uses that went beyond its FDA-approved indications, such as promoting it as a drug to initiate treatment rather than just maintain treatment after detox from opioids.
- Failure to Warn: Plaintiffs state that Indivior failed to adequately warn about the potentially life-threatening consequences of abruptly discontinuing Suboxone after long periods of use. Some cases allege this led to hospitalization or death when patients struggled with severe withdrawal.
Don't wait any longer, call 866-535-9515 or submit your case for review today!
Who Is Eligible?
If you took Suboxone anytime from its FDA approval in 2002 to the present day, you may be eligible to file a claim or join a class action lawsuit against the manufacturers.
This includes:
People Who Struggled to Discontinue Suboxone
One group eligible to join the Suboxone lawsuits consists of individuals who became dependent on the medication during addiction treatment but then faced severe, potentially life-threatening withdrawal effects when trying to discontinue usage.
The drug's manufacturers stand accused of failing to provide adequate warnings about the risks and dangers of abruptly stopping Suboxone, particularly after an extended period of use. Court documents allege Indivior misrepresented or downplayed the risks of dependence and the difficulty of discontinuing the medication.
As a result, many patients who took Suboxone as prescribed for months or years struggled with:
- Intense cravings
- Anxiety
- Insomnia
- Vomiting
- Diarrhea
- Other harsh withdrawal symptoms when attempting to taper off the drug
Some cases describe hospitalizations due to:
- Dehydration
- Seizures
- Other complications from sudden discontinuation
These lawsuits seek compensation for the physical and mental distress plaintiffs endured from undisclosed discontinuation risks. Plaintiffs also seek damages for any medical costs of treatment or hospitalization needed to safely wean off Suboxone under proper medical supervision after failed self-attempts.
Relapse After Improper Initiation Instructions
Another category of plaintiffs consists of those who relapsed into opioid abuse after misleading marketing led to improper instructions for how to initiate Suboxone treatment.
According to the allegations, Indivior promoted Suboxone for uses beyond its FDA-approved purpose as a maintenance treatment for opioid dependence. This included encouraging the use of the drug to abruptly initiate detox from opioids like heroin without going through a full withdrawal process first.
However, Suboxone was only approved to be started once the body has been fully cleared of opioids to avoid triggering severe withdrawal symptoms. Those who began taking it without proper detox first often found the medication ineffective at actually preventing cravings and discontinuation effects.
As a result, many patients relapsed back into illicit opioid use due to a lack of relief. This setback required undergoing subsequent treatment programs, counseling, hospitalization, or other services to regain sobriety at additional financial and personal costs.
These lawsuits aim to compensate individuals for the expenses and impacts caused by relapsing from opioid addiction due to the alleged improper marketing and off-label promotion of how to initiate Suboxone.
Off-Label Usage for Unapproved Conditions
Eligibility to participate in the Suboxone litigation also extends to individuals who were prescribed the medication for uses beyond its FDA-approved purpose of treating opioid dependence - such as for pain management.
While doctors can prescribe drugs for off-label reasons based on their medical judgment, drug companies are prohibited from actively marketing medications for non-approved uses. However, the lawsuits accuse Indivior of aggressively and improperly promoting Suboxone for conditions like chronic pain.
As a result, patients may have taken Suboxone in situations where it lacked evidence of efficacy or safety. This may have subjected them to undisclosed side effects, tolerance, dependence, or withdrawal issues.
Anyone who was prescribed and took Suboxone for a condition beyond the treatment of opioid addiction may be able to seek compensation through these lawsuits.
Damages could account for:
- The financial costs of purchasing Suboxone
- Medical expenses from any complications
- Personal injury from inappropriate off-label usage
Overpayment for Brand Suboxone Due to Lack of Generics
Finally, a significant portion of the plaintiffs consists of anyone who paid inflated brand-name prices for Suboxone during the period when generic equivalents should have been available at lower costs.
Allegations claim that Indivior waged a deliberate, multi-year campaign of product reformulations and patent submissions without any therapeutic benefit. The true motivation, according to the lawsuits, was to unfairly extend the exclusivity period and block generic alternatives from entering the market through regulatory technicalities and roadblocks.
As a result, patients continued paying high out-of-pocket costs or insurance co-pays and premiums for the expensive branded version of Suboxone for years longer than should have been permitted based on the original patent expiration timeline.
Anyone who was prescribed and paid for branded Suboxone rather than a generic version during the period of delayed competition could be entitled to recoup monetary damages. This includes individual consumers. It also includes insurance providers who overpaid based on Indivior's alleged anti-competitive actions.
What Damages Do Plaintiffs Claim?
The lawsuits against Indivior seek compensation for economic damages caused by the drug makers' alleged misconduct.
This can include:
The Cost of Suboxone and Hospitalization
One of the main categories of damages being sought in the Suboxone litigation is reimbursement for the excessive costs paid by patients and health insurers for the medication itself. This also includes any hospitalization required due to severe withdrawal symptoms.
Plaintiffs allege that Indivior's misconduct, including delaying cheaper generic alternatives from entering the market, allowed the company to charge inflated prices for brand-name Suboxone for years longer than permitted.
This extended monopoly period forced patients to pay high out-of-pocket costs or premiums for the expensive brand drug.
The lawsuits seek to recover the amount overpaid for Suboxone Film or Suboxone Tablets during the time that generics were allegedly blocked through anti-competitive actions like product-hopping and sham patent filings on minor reformulations.
Additionally, compensation is being pursued for cases where patients were hospitalized with severe withdrawal symptoms, dehydration, or other complications after suddenly discontinuing Suboxone.
The drug's manufacturers are accused of improperly downplaying or failing to warn about the risks of abruptly stopping usage, particularly for those who had been taking Suboxone long-term.
Costly inpatient treatment may have been required to safely wean patients off Suboxone under medical supervision. The lawsuits aim to recoup these hospitalization expenses that could have been avoided with proper warnings.
Payment for Relapse Treatment
Another significant area of damage involves situations where improper marketing allegedly misled patients about how to use Suboxone, leading to relapses in abuse and a need for additional substance abuse treatment.
Court filings claim that Indivior promoted Suboxone for uses beyond its approved indications, such as initiating treatment for opioid addiction rather than just maintaining existing treatment. Some lawsuits contend that marketing materials downplayed the need to fully withdraw from opioids before starting Suboxone.
As a result, patients may have initiated Suboxone at the wrong point. They may have experienced diminished effectiveness in preventing cravings or withdrawal symptoms. This could have led to continued opioid abuse, overdoses, or a return to illicit drug use.
When relapses occurred due to ineffective Suboxone treatment stemming from improper marketing, those patients often required expensive follow-up care.
This could include:
- Additional medication-assisted therapy
- Inpatient rehab programs
- Counseling services
- Other addiction treatments
The goal of these lawsuits is to recover costs for this subsequent care that should not have been needed if Suboxone was properly marketed within its FDA-approved purpose and guidelines.
Recovery of Overcharges for Brand Suboxone
A key economic injury alleged in the Suboxone litigation is the extended period of high costs paid for the brand name medication due to the delayed market entry of generic equivalents. Plaintiffs state Indivior waged a series of product-hopping and sham patent maneuvers precisely to stave off competition from lower-cost generics.
By reformulating Suboxone into new versions like the sublingual film strip, the company obtained additional patent protection and shifted patients to these new formulations, all while withdrawing and suppressing the original tablet form that generics were prepared to target.
Court documents accuse Indivior of misleading promotion that pushed patients and doctors to switch to the new patent-protected products, even though they offered no improved clinical benefits over the existing Suboxone tablet.
The result forced patients and insurance companies to continue covering the high branded Suboxone costs for years longer than they should have if generic competitors had entered the market through normal patent expiration.
These lawsuits seek to recover the amount overcharged and overpaid for branded Suboxone versus what the costs would have been if affordable generics were available when expected based on the original patent timeline before Indivior's actions delayed them.
Some lawsuits also seek damages for personal injury from improper use or withdrawal complications.
How to Join the Lawsuit
If you believe you may have a valid claim related to Suboxone:
Gather Records
The first step in joining the Suboxone lawsuit is collecting all relevant documentation of your experience with the medication. This will establish your eligibility to participate in the litigation. It will also establish the potential damages you deserve.
Gather every medical record, doctor's note, hospital discharge summary, and any other paperwork that details your Suboxone prescription, usage, side effects experienced, attempts to discontinue the drug, and any relapses or treatments needed as a result.
You'll also want to locate proof of payment for Suboxone itself, such as pharmacy receipts and records from your health insurance company. If withdrawal complications hospitalized you, keep those medical bills and records, too.
Having thorough documentation makes it easier for lawyers to validate your eligibility and understand the full extent of financial costs or personal injuries you incurred related to Suboxone. Take time now to organize everything before seeking legal counsel.
Find a Lawyer
With your records prepared, the next step is to find a qualified law firm actively handling Suboxone cases. Check legal directories, advertisements, or online for firms that mention they are reviewing Suboxone claims.
Many law firms are offering free, confidential case evaluations to assess potential plaintiffs' eligibility for these lawsuits. They should request copies of your Suboxone records and details to review your situation.
The lawyers will analyze if you fit the criteria for claims like victims of improper marketing, failure to warn about withdrawal risks or financial injury from delayed generics due to anti-competitive practices. If they determine you likely have a valid case, they can guide you through the process of formally joining the litigation.
File a Claim
Should the law firm conclude you are eligible to participate, the next phase is to file your claim and become a plaintiff or join an existing class action lawsuit related to Suboxone and its manufacturers.
The lawyers will have you provide a detailed accounting of your experience with Suboxone, including:
- Dates you took the medication and for how long
- Any "off-label" uses or marketing claims made to you about Suboxone
- The process and effects of trying to discontinue usage
- Financial costs incurred for Suboxone, hospitalization, or relapse treatment
They will use this information to draft the formal legal pleadings and documents required to add your claim to the litigation. You'll likely be asked to verify the accuracy before attorneys file everything in court.
With your claim filed, you officially become a plaintiff seeking damages from the alleged misconduct around Suboxone.
Be Patient
After joining the lawsuit, there is typically a long waiting period as attorneys gather evidence, develop legal strategies, facilitate settlement negotiations, or prepare for a potential trial. Pharmaceutical cases tend to be very complex, given the technical and scientific factors involved.
The Suboxone litigation in particular is expected to be a lengthy process. Claims have been mounting over several years already. The litigation may continue for years more as each legal issue surrounding the drug's marketing and anti-competitive actions gets argued out.
Your law firm should keep you reasonably updated on major developments or milestones in the case. However, you'll need to brace yourself for a lot of waiting during this phase as the work behind the scenes slowly grinds forward.
The positive side is that by having your claim officially filed, your rights are preserved to receive your share of any settlement or jury award that is eventually reached with Indivior, no matter how long it takes. Remain patient, and let your lawyers diligently pursue the compensation you may deserve.
Stay Up-to-Date
As the Suboxone lawsuits progress, stay informed on any developments or major case updates. Check reputable legal news sources or the website of the law firm handling your claim.
You may also want to explore joining a claimant group or online forum for those involved in the same litigation. This can provide useful information and support during what could be a lengthy process.
Contact a Suboxone Lawyer
If you or someone you know took Suboxone for opioid addiction treatment, don't wait to ask a lawyer to evaluate your eligibility for these lawsuits. The statute of limitations limits the time window to file a claim.
Take the first step today by gathering your medical records and contacting a qualified law firm about your experience with Suboxone. You may be entitled to significant compensation.
A confidential case review is free, so getting started is not risky. If Suboxone or its manufacturer harmed you, don't miss your opportunity to hold its manufacturers accountable.