Zinbryta Lawsuit | 2025 Latest Updates

Zinbryta Lawsuit Overview

The Zinbryta lawsuit involves legal claims against Biogen and AbbVie, Inc. for failing to adequately warn patients and doctors about serious side effects of their multiple sclerosis medication daclizumab.

The primary allegations center on the manufacturers’ failure to warn about risks of encephalitis, Stevens-Johnson Syndrome, and potentially fatal liver injury despite clinical evidence of these complications.

The FDA reported at least 3 cases of encephalitis or meningoencephalitis linked to Zinbryta, leading to worldwide withdrawal in March 2018.

The drug carried a black box warning for liver injury, with one clinical trial subject dying from autoimmune hepatitis.

Zinbryta lawsuit claims focus on the manufacturers’ alleged negligence in warning about severe brain disorders, liver damage, and other life-threatening side effects that can occur up to 4 months after discontinuing treatment.

Latest Zinbryta Lawsuit Updates

• March 2018 – AbbVie and Biogen issued a voluntary worldwide withdrawal of Zinbryta after numerous patients reported developing severe brain inflammation. The companies stated that characterizing the evolving benefit/risk profile would not be possible given the limited number of patients being treated and the complexity of adverse events [1].
• March 2018 – The European Medicines Agency (EMA) moved to place an immediate suspension on Zinbryta amid reports of deaths and brain inflammation. The EMA confirmed that Zinbryta posed a risk of potentially lethal immune reactions affecting the brain and liver, even several months after treatment cessation [2].
• 2018 – The FDA began reviewing all adverse events associated with Zinbryta after 3 cases of encephalitis or meningoencephalitis were reported. This type of brain inflammation can cause seizures, confusion, and death [3].

FDA Reports and Statistics

The FDA has documented significant safety concerns with Zinbryta through clinical trials and post-market surveillance.

In clinical trials comparing Zinbryta to Avonex, 1,841 participants were studied for 144 weeks, with an additional trial involving 412 participants treated for 52 weeks.

During these studies, one subject died due to autoimmune hepatitis linked to Zinbryta use.

The FDA confirmed at least 3 cases of encephalitis or meningoencephalitis associated with Zinbryta, prompting a comprehensive review of all adverse events. Immune-mediated disorders were observed in 5% of patients treated with Zinbryta during clinical trials.

The drug was only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program due to documented risks of severe liver injury and immune-mediated conditions.

Zinbryta Injuries & Side Effects

Zinbryta has been linked to severe and potentially life-threatening complications that can occur during treatment or up to 4 months after discontinuation, leading to the drug’s worldwide withdrawal.

• Liver Failure: Severe hepatic injury that can be fatal, including autoimmune hepatitis requiring immediate medical intervention
• Encephalitis: Life-threatening brain inflammation causing seizures, confusion, and potentially death
• Meningoencephalitis: Dangerous inflammation of the brain and surrounding membranes leading to neurological complications
• Stevens-Johnson Syndrome: Severe skin and mucous membrane reactions that can be life-threatening
• Immune-Mediated Disorders: Serious autoimmune conditions including lymphadenopathy, non-infectious colitis, and severe dermatologic reactions
• Death: Fatal complications from liver failure, brain inflammation, or severe immune reactions

What is Zinbryta?

Developed in a joint partnership between Biogen and Abbvie, Inc., Zinbryta (generic: daclizumab) is a humanized monoclonal antibody drug used to treat adults with relapsing forms of multiple sclerosis (MS).

The medicine works by binding to immune cells (lymphocytes or white blood cells) and reducing the activity of cells involved in the immune attack that causes damage associated with MS.

Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated – Biogen and Abbvie, Inc., said in a statement.
Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntary worldwide withdrawal.

What is Multiple Sclerosis?

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (the brain and spinal cord). MS occurs when the immune system attacks nerve fibers and myelin sheathing (a fatty substance that surrounds/insulates healthy nerve fibers) in the brain and spinal cord.

This attack causes inflammation, which destroys nerve cell processes and myelin–altering electrical messages in the brain.

MS is unpredictable and affects each patient differently – some individuals may be mildly affected, while others may lose their ability to write, speak, or walk.

Related Articles:

• MS Treatment Drug Lemtrada Lawsuit
• MS Treatment Drug Campath Lawsuit

Do You Qualify for a Zinbryta Lawsuit?

You may qualify for a Zinbryta lawsuit if:

• You took Zinbryta for multiple sclerosis treatment before its withdrawal in March 2018
• You experienced serious side effects including liver failure, encephalitis, meningoencephalitis, Stevens-Johnson Syndrome, or severe immune reactions
• The injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to Zinbryta use

Evidence Required for a Zinbryta Lawsuit

To pursue a successful Zinbryta lawsuit, you will need to gather comprehensive documentation and evidence:

• Medical Documentation: Complete medical records showing your multiple sclerosis diagnosis, Zinbryta prescription history, and treatment for complications
• Prescription Records: Documentation proving you were enrolled in the Zinbryta REMS program and received the medication through authorized channels
• Injury Documentation: Medical records detailing the onset and treatment of side effects, including liver function tests, brain imaging, and hospitalization records
• Expert Medical Testimony: Medical experts who can establish the causal connection between Zinbryta use and your specific injuries
• Treatment Timeline: Documentation showing when symptoms appeared in relation to Zinbryta use, including cases where symptoms developed up to 4 months after discontinuation

Damages You Can Recover

Successful Zinbryta lawsuits may result in compensation for:

• Medical Expenses: Past and future medical costs including emergency treatment, hospitalization, liver transplants, and ongoing neurological care
• Lost Wages: Income lost due to inability to work during recovery and long-term disability from complications
• Pain and Suffering: Compensation for physical pain, emotional distress, and reduced quality of life from severe complications
• Punitive Damages: Additional compensation intended to punish manufacturers for failing to adequately warn about known risks

Zinbryta Recall Information

Zinbryta was subject to a voluntary worldwide withdrawal in March 2018 initiated by manufacturers Biogen and AbbVie, Inc.

The withdrawal came after the European Medicines Agency moved to place an immediate suspension on the drug amid reports of deaths and brain inflammation.

The FDA had previously implemented a Risk Evaluation and Mitigation Strategy (REMS) program due to documented risks, requiring special certification for prescribers, patient enrollment, and pharmacy authorization.

The drug carried the FDA’s strongest black box warning about liver injury risks and immune-mediated disorders. The manufacturers stated that the drug’s potential risks outweighed its benefits, leading to the global market withdrawal.

Statute of Limitations for Zinbryta Lawsuits

The statute of limitations for filing a Zinbryta lawsuit varies by state, typically ranging from 2 to 3 years from the date of injury discovery or when you reasonably should have known about the connection between your injuries and Zinbryta use.

Because some Zinbryta complications can develop up to 4 months after discontinuing treatment, the discovery rule often applies, meaning the statute of limitations begins when you discovered or should have discovered your injuries were caused by the medication.

Given that Zinbryta was withdrawn from the market in March 2018, it’s crucial to consult with an experienced attorney immediately to ensure your rights are protected and to avoid missing critical filing deadlines.

FAQs

1. What should I do if I suspect Zinbryta is causing serious side effects?

Seek immediate medical attention if you experience severe side effects. Document your symptoms and treatments, then consult with a personal injury attorney to discuss your legal options.

2. Can a Zinbryta lawsuit lead to changes in the drug’s labeling or usage recommendations?

Yes, successful lawsuits can lead to changes in drug labeling, increased warnings, and updated prescribing practices. In Zinbryta’s case, the drug was completely withdrawn from the market.

3. Can family members of affected individuals also file claims?

In some cases, family members may be able to file claims for loss of consortium, emotional distress, or wrongful death. Consult with an attorney to explore potential claims for family members.

4. What is the difference between encephalitis and meningoencephalitis?

Encephalitis is inflammation of the brain tissue, while meningoencephalitis involves inflammation of both the brain and the surrounding protective membranes. Both conditions can be life-threatening and cause seizures, confusion, and death.

5. Was Zinbryta the only multiple sclerosis drug with these risks?

While other MS medications have risks, Zinbryta’s unique risk profile led to its worldwide withdrawal. The drug required special REMS program participation due to documented severe complications.

6. How long after stopping Zinbryta can complications develop?

Serious complications, including liver injury and brain inflammation, can occur up to 4 months after stopping Zinbryta, making ongoing monitoring essential.

7. What was the Zinbryta REMS program?

The REMS (Risk Evaluation and Mitigation Strategy) was a restricted distribution program that required certified prescribers, enrolled patients with ongoing monitoring, and certified pharmacies to dispense the drug.

8. Do I need to pay attorney fees upfront for a Zinbryta lawsuit?

Most pharmaceutical liability attorneys work on a contingency fee basis, meaning you pay no upfront costs and attorney fees are only collected if your case is successful.

9. Can I still file a lawsuit even though Zinbryta was withdrawn?

Yes, you can still file a lawsuit for injuries caused by Zinbryta before its withdrawal, as long as you file within your state’s statute of limitations.

10. What compensation have other patients received in similar pharmaceutical cases?

Compensation varies based on the severity of injuries, but settlements and verdicts in pharmaceutical cases can include substantial amounts for medical expenses, lost wages, pain and suffering, and punitive damages.

Get a Free Zinbryta Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action for Zinbryta injuries. With statute of limitations periods varying by state – typically only 2 to 3 years from the date of injury discovery – and Zinbryta’s withdrawal occurring in March 2018, it’s crucial to act quickly to protect your rights.

Schmidt & Clark offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – you pay nothing unless we win
• Payment only if we win your case through our contingency fee structure
• Experienced legal representation in pharmaceutical litigation and dangerous drug cases

Should you or someone close to you have suffered injuries due to being prescribed Zinbryta, it is imperative that you reach out to our legal team without delay.

You could be eligible for financial reparation through a lawsuit against the makers of the drug, and our attorneys are here to assist you.

References

1. https://investors.biogen.com/news-releases/news-release-details/biogen-and-abbvie-announce-voluntary-worldwide-withdrawal
2. https://multiplesclerosisnewstoday.com/2018/03/06/biogen-and-abbvie-withdraw-ms-therapy-zinbryta-marketing-authorizations/
3. https://www.fda.gov/drugs/drug-safety-and-availability/fda-working-manufacturers-withdraw-zinbryta-market-united-states