Zinbryta Lawsuit | 2026 Latest Updates

Biogen and AbbVie face claims they failed to warn patients about serious immune-mediated risks from Zinbryta. The companies pulled the multiple sclerosis drug from the market worldwide in 2018. Lawsuits allege the risk was not adequately disclosed.

The alleged injuries include autoimmune hepatitis, encephalitis, meningoencephalitis, and other immune-mediated reactions reported during Zinbryta’s two years on the market. Some cases involved permanent harm or death, according to regulators who reviewed the reports.

Attorneys are now investigating individual product-liability claims against Biogen and AbbVie over Zinbryta. No class action or multidistrict litigation has been confirmed, and each case would proceed on its own.

Latest Zinbryta Lawsuit Updates

May 18, 2018: EMA Confirms Zinbryta’s Risks Outweigh Its Benefits

The PRAC’s conclusion was issued on May 18, 2018 [1]. It confirmed that Zinbryta‘s immune reactions could be serious and fatal, affecting the brain, liver, and other organs, and that the risk outweighed its benefits.

More than 10,000 patients worldwide had received Zinbryta by that point. This finding closed the European Commission’s Article 20 safety review of Zinbryta, first requested three months earlier.

April 30, 2018: US and Canadian Withdrawal Completed

The FDA confirmed that Zinbryta’s withdrawal from the United States market was completed that day [2]. Health Canada confirmed the Canadian withdrawal was completed the same day. Neither country’s patients could get a new prescription after that.

The withdrawal followed Biogen and AbbVie‘s announcement two months earlier that they would pull Zinbryta everywhere. It marked the final step in the drug’s exit from North America.

March 27, 2018: European Commission Withdraws EU Marketing Authorization

The European Commission withdrew Zinbryta’s marketing authorization across the European Union that day. Biogen Idec Ltd, the authorization holder, had requested the withdrawal itself.

This step made the earlier suspension permanent within the EU. It came about three weeks after the agency’s safety committee first recommended pulling Zinbryta from pharmacies and hospitals. That recommendation followed reports of serious brain inflammation.

March 16, 2018: Health Canada Announces Voluntary Withdrawal

Health Canada announced Zinbryta’s voluntary withdrawal from the Canadian market that day [3]. The agency said no cases of encephalitis or meningoencephalitis had been reported in Canada.

Biogen and AbbVie coordinated the Canadian action with the withdrawals already underway in the United States and Europe. Health Canada told patients to keep taking other prescribed medications unless a doctor said otherwise.

March 8, 2018: European Commission Suspends Zinbryta’s Marketing Authorization

The European Commission issued a legally binding decision that suspended Zinbryta’s marketing authorization throughout the European Union that same week. The decision followed the safety committee’s recommendation two days earlier.

Pharmacies and hospitals in EU countries could no longer dispense Zinbryta once the suspension took effect. Manufacturers had to pull existing stock from pharmacy shelves immediately under the same binding order.

March 6, 2018: EMA Recommends Immediate Suspension and Recall

The European Medicines Agency‘s safety committee recommended immediate suspension of Zinbryta’s marketing authorization [4]. It also called for an immediate recall from pharmacies and hospitals across Europe due to the risk.

The committee cited 12 worldwide reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis. Three of those cases were fatal. The recommendation came four days after Biogen and AbbVie’s own withdrawal announcement.

March 2, 2018: Biogen and AbbVie Announce Voluntary Worldwide Withdrawal

On March 2, 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of Zinbryta’s marketing authorizations [5]. The companies cited an evolving benefit-risk profile they said they could no longer characterize.

Only a limited number of patients were still being treated with Zinbryta by that point. The announcement came before any regulator had ordered a suspension or recall. It set off the string of withdrawals that followed.

February 26, 2018: European Commission Requests Formal Safety Review

The European Commission requested a formal safety review of Zinbryta under Article 20 of EU law that week. The request came after growing reports of serious brain inflammation linked to the drug.

The review gave the European Medicines Agency authority to recommend suspending or withdrawing Zinbryta across the bloc. It was the first official step in the chain of actions that followed over the next three months.

What Is Zinbryta?

Zinbryta, known generically as daclizumab, was an interleukin-2 receptor blocking antibody. The FDA approved it for adults with relapsing forms of multiple sclerosis, according to its label [6].

Doctors generally reserved it for patients who had already tried two or more other MS therapies without success. Biogen manufactured Zinbryta and co-marketed it with AbbVie from 2016 until the 2018 withdrawal described below.

Who May Be Affected?

People who took Zinbryta for relapsing multiple sclerosis between its 2016 approval and the March 2018 withdrawal are the group this page addresses.

This includes patients who had already tried other MS treatments without relief, since doctors generally reserved Zinbryta for that group.

Anyone who developed liver injury, autoimmune hepatitis, encephalitis, meningoencephalitis, or another serious immune-mediated reaction during Zinbryta treatment falls within this group.

This also includes a reaction that began up to five months after the last dose, the period in which the FDA label documents reported cases of liver injury.

A patient’s family also falls within this group and can raise the same circumstances if the patient died from one of these reactions.

Only an individual legal review of the medical records and treatment dates can confirm whether a specific case still qualifies for a claim today.

Reported Injuries or Damages

Reported injuries include hepatic injury and autoimmune hepatitis, some of them fatal. Patients also reported immune-mediated disorders affecting the brain, including encephalitis and meningoencephalitis, and serious skin reactions such as drug eruptions and erythema multiforme.

Across Zinbryta’s clinical trials, immune-mediated disorders occurred in 28% of treated patients overall, the FDA label states, including 32% of Zinbryta patients versus 12% of patients on Avonex in that trial.

That trial followed 919 Zinbryta patients and 922 Avonex patients for two to three years (median 27 months), and 5% of Zinbryta patients stopped for drug-related liver injury versus 4% on Avonex.

A second trial followed 417 Zinbryta patients, 208 at the approved dose, against 204 on placebo for up to 52 weeks. Serum transaminase elevations occurred during treatment and up to four months after the final dose, the same label states.

The EMA’s final review found patients could be at risk from the start of treatment through several months after the final dose, and that Zinbryta’s risks outweighed its benefits.

These are regulators’ safety findings, not court rulings on individual causation. The Judicial Panel on Multidistrict Litigation has not formed a Zinbryta multidistrict litigation, so each claim moves forward on its own [7].

Recall and Regulatory Background

The FDA, EMA, and Health Canada each confirmed Zinbryta was voluntarily withdrawn from every market where it had been sold. The withdrawal followed reports of serious immune-mediated reactions described above.

Zinbryta had been distributed only through a restricted program, ZINBRYTA REMS, meant to track patients and monitor for liver injury. That program ended when the manufacturers stopped marketing the drug.

A completed withdrawal does not by itself prove Biogen or AbbVie is liable for any patient’s injury. A lawyer would need to examine the medical and case facts to reach that determination.

Evidence to Preserve

People weighing a Zinbryta claim should gather and keep the following records now, before time passes and they become harder to find:

• Zinbryta prescription records and any paperwork from enrolling in the REMS monitoring program
• Medical records showing liver-function test results (ALT, AST, and bilirubin levels) and the date of any diagnosis
• Hospital or specialist records documenting a diagnosis of encephalitis, meningoencephalitis, or a serious skin reaction
• A dated record of every Zinbryta dose received, including when the last dose was given
• Correspondence from Biogen, AbbVie, or a pharmacy about the 2018 withdrawal
• Employment and income records, if lost wages are part of a claim

Keeping these records organized makes it easier for a lawyer to match a specific case against the drug’s known risks and the treatment timeline.

Filing Deadlines

Deadlines for a Zinbryta claim come from state law. There is no single nationwide deadline. Missing one can end a claim even when the medical facts are strong.

The exact deadline depends on where the patient lives and when the immune reaction, diagnosis, or death happened. Some states start the clock at diagnosis rather than the date of the last dose.

Anyone weighing a Zinbryta claim should talk to a lawyer promptly to find out which deadline applies to their state and situation.

Potential Compensation

A Zinbryta claim may cover certain categories of damages, depending on the facts of the case. These may include past and future medical expenses for liver injury or immune-related brain inflammation, lost income, and pain and suffering.

No public verdict or settlement has been reported for a Zinbryta claim so far, and no case has been identified where punitive damages were awarded.

Compensation amounts vary by case. Past results do not guarantee future outcomes. The categories above are only examples of potential compensation.

Frequently Asked Questions

Is There a Zinbryta Class Action Lawsuit?

There is no Zinbryta class action lawsuit or multidistrict litigation confirmed at this time. The JPML’s pending-docket report, dated September 1, 2026, lists no Zinbryta or daclizumab case. Any claim currently proceeds as an individual lawsuit.

What Is the Difference Between Encephalitis and Meningoencephalitis?

The difference between encephalitis and meningoencephalitis involves the membrane covering the brain. Encephalitis affects brain tissue alone, while meningoencephalitis also inflames that membrane. Regulators grouped both conditions among Zinbryta’s serious immune-mediated reactions, some of which proved fatal.

What Was the Zinbryta REMS Program?

The Zinbryta REMS program was the FDA’s Risk Evaluation and Mitigation Strategy restricting how the drug could be prescribed. Prescribers needed certification training, patients had to enroll and follow ongoing monitoring, and pharmacies needed certification before dispensing any dose.

How Common Were Immune Reactions in Zinbryta’s Placebo-Controlled Trial?

Immune reactions in Zinbryta’s placebo-controlled trial occurred in 13% of Zinbryta patients versus 7% of patients on placebo, the FDA label states. Serious immune-mediated disorders were reported in 0.5% of patients in each group during that same trial.

What Does the Research Say About Zinbryta and Brain Inflammation?

Research on Zinbryta and brain inflammation comes from the FDA’s approval trials. In the trial comparing Zinbryta to Avonex, serious immune-mediated disorders occurred in 4% of Zinbryta patients versus less than 1% of Avonex patients, the FDA-approved label states.

Can I Still File a Lawsuit Even Though Zinbryta Was Withdrawn?

Yes, a Zinbryta lawsuit can still be filed even though the drug left the market in 2018. The withdrawal itself does not start or end the filing deadline. That deadline runs from state law and the date of the injury or diagnosis, and a lawyer can confirm which one applies.

References

1. https://www.ema.europa.eu/en/news/ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits
2. https://www.fda.gov/drugs/drug-safety-and-availability/fda-working-manufacturers-withdraw-zinbryta-market-united-states
3. https://recalls-rappels.canada.ca/en/alert-recall/zinbryta-daclizumab-beta-voluntary-withdrawal-canada-due-risk-encephalitis
4. https://www.ema.europa.eu/en/documents/press-release/ema-recommends-immediate-suspension-and-recall-multiple-sclerosis-medicine-zinbryta_en.pdf
5. https://news.abbvie.com/2018-03-02-Biogen-and-AbbVie-Announce-the-Voluntary-Worldwide-Withdrawal-of-Marketing-Authorizations-for-ZINBRYTA-R-daclizumab-for-Relapsing-Multiple-Sclerosis
6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s007lbl.pdf
7. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-September-1-2026.pdf