A Zinbryta lawsuit may be an option for people who have experienced serious complications associated with the drug, including liver injury, inflammatory brain disorders and other immune-mediated disorders. Zinbryta is a prescription medication indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.
Since the drug’s approval in 2016, the safety profile of Zinbryta has been continuously monitored by the FDA due to serious risks associated with the medication, including a risk of liver injury and other immune-mediated disorders. In addition to those risks, the FDA is aware of a recall of Zinbryta announced by the EMA after the agency received a dozen reports of serious inflammatory brain disorders possibly linked to the use of the drug. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Zinbryta Lawsuit Commercial?
You may have seen a Zinbryta lawsuit commercial on television and wondered whether you or a loved one have been affected by it and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or distributor. The purpose of this article is to provide you with additional information about lawsuits and other litigation involving dangerous drugs so that you have a better understanding of your options.
What is Zinbryta?
Zinbryta (also known by its active ingredient, daclizumab) is a long-acting injection used to treat adults with relapsing forms of multiple sclerosis (MS), a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.
Zinbryta is self-administered by the patient monthly. Zinbryta was approved by the FDA in May 2016 and is manufactured by Biogen, Inc. of Cambridge, Massachusetts.
According to the FDA, Zinbryta should “generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions.” As a result of such risks, a boxed warning has been added to the drug’s label telling prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Zinbryta is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.
Zinbryta Side Effects
According to the drug’s prescription information, the most common side effects associated with Zinbryta include:
- Upper respiratory tract infection
- Pain or swelling of the nose, throat or mouth
- Abnormal liver function tests
- Eczema (dry, itchy, scaly or inflamed skin)
- Depression or depressed mood
- Enlargement of lymph nodes
Other Zinbryta Risks
According to boxed warnings, there are serious risks associated with the use of Zinbryta, including:
- Liver injury – According to the drug’s prescription information, “Zinbryta can cause severe liver injury including life-threatening events, liver failure, and autoimmune hepatitis. In clinical trials, 1 patient died due to autoimmune hepatitis.” Liver injury, including autoimmune hepatitis, can occur at any time during treatment with Zinbryta, with cases reported up to four months after the last dose of the medication.
- Inflammation of the colon (non-infectious colitis) – An increased occurrence of serious colitis (less than one percent) was reported in patients treated with Zinbryta compared with none for patients treated with another form of treatment or placebo.
- Skin reactions
- Enlargement of lymph nodes (lymphadenopathy)
- Hypersensitivity reactions (anaphylaxis or angioedema)
Additionally, the use of Zinbryta may increase the risk for infections, particularly upper respiratory tract infections, urinary tract infections and viral infections. Symptoms of depression and/or suicidal ideation occurred more often in patients taking Zinbryta than those who took another form of treatment or placebo.
FDA Warning Involving Zinbryta
As a result of a voluntary withdrawal of Zinbryta issued by Biogen and Abbvie, the FDA has begun working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States
Additionally, the agency is working with the manufacturers to ensure that health care professionals have the information they need to carefully transition patients who are using Zinbryta to another treatment.
According to a safety communication issued by the FDA in March 2018, the EMA announced a recall of Zinbryta following 12 reports of serious inflammatory brain disorders worldwide. The safety profile of the drug has been recognized by the FDA since the drug’s approval in March 2016 and has led the agency to continuously monitor any adverse events related to the use of Zinbryta, including the risk of liver injury and other immune-mediated disorders.
Zinbryta and Inflammatory Brain Disorders
In March 2018, the EMA issued a press release recommending “the immediate suspension and recall” of Zinbryta after the agency received twelve reports of serious inflammatory brain disorders worldwide.
Inflammatory brain disorders reportedly linked to the use of Zinbryta include:
- Encephalitis – An inflammation of the brain, often due to a bacterial or viral infection. Symptoms may or may not be present in mild cases; however, severe cases can be life-threatening. Serious symptoms requiring immediate medical attention may include confusion, hallucinations, seizures, weakness and loss of sensation.
- Meningoencephalitis – An inflammation of the brain and surrounding tissues, typically caused by a virus, bacterium, parasite or other microorganism. Examples of the condition include West Nile virus, mumps or tuberculosis. Symptoms may vary and can include fever, confusion, vomiting, seizures, or in some cases, death.
According to the EMA’s press release, Zinbryta may also be associated with other severe immune reactions affecting other organs in the body.
Has There Been a Zinbryta Recall or Voluntary Withdrawal?
On March 2, 2018, Biogen and Abbvie announced a voluntary withdrawal of Zinbryta worldwide. According to the manufacturer’s news release, executive vice president and chief medical officer Alfred Sandrock, M.D., Ph.D. stated that “the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients.”
The withdrawal announced by the drug’s manufacturers came after the EMA began reviewing Zinbryta following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain. Within a week of the EMA’s initial press release, the agency issued another, this time recommending “the immediate suspension and recall of the multiple sclerosis medicine Zinbryta (daclizumab beta) following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis.” According to the EMA, three cases were fatal.
Drug recalls may be conducted by the drug manufacturer, by FDA request, or by FDA order. The FDA plans to continue to investigate the issue and provide information as it becomes available. Potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result. Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There a Zinbryta Class Action Lawsuit?
At the time of this article’s publication, a Zinbryta class action lawsuit action has not been filed on behalf of patients who suffered serious complications. Zinbryta lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device.
Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by Zinbryta and similar drugs, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding.
MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by dangerous drugs.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments.
After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Lauren A. on May 16, 2016
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Have There Been Any Zinbryta Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any Zinbryta lawsuit settlements at this time.
Instead, it is expected that Zinbryta lawsuits will be consolidated in federal court through an MDL.
Zinbryta lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Zinbryta Lawsuit News
- March 2018FDA issues safety communication stating that the agency is working with manufacturers “to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients to another treatment.”
- March 2018EMA issues a press release recommending that Zinbryta be immediately suspended and recalled due to twelve reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis.
- March 2018EMA issues a press release stating that it had begun “an urgent review” of Zinbryta following seven cases of serious inflammatory brain disorders in Germany and Spain.
- may 2016FDA approves Zinbryta for the treatment of adults with relapsing forms of MS.
How a Zinbryta Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Zinbryta, or other similar drugs containing the active ingredient, may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.