Zinbryta Lawsuit | Brain Disorders, Debilitating Injuries & Fatalities
Zinbryta is a medication used to treat adults who have recurring multiple sclerosis. The drug is intended to block certain receptors that can contribute to relapses of the disease. However, the manufacturers withdrew this drug from the marketplace in 2018. The market withdrawal followed reports that there were cases of encephalitis in patients who took the drug. This has led to debilitating conditions and, in some instances, fatalities. Zinbryta side effects can be devastating. As a result, the manufacturers of these drugs face the possibility of numerous lawsuits. If you or a loved one has taken this medication and suffered harm, it is critical to contact a Zinbryta lawsuit attorney immediately. Many people are wondering ,”what is a daclizumab black box warning?” and what is “zinbryta prescribing information.”
What is Zinbryta?
Zinbryta was designed, manufactured and sold by the biotech giant Biogen and a spinoff of Abbott Laboratories. The medication was approved for use by the FDA as treatment for multiple sclerosis in 2016. This was approximately 20 years after the drug was first approved by the FDA. In the interim, it was used to treat various conditions such as preventing acute rejection of kidney transplants as well as asthma and other respiratory conditions. The drug took on the name Zinbryta after it began to be used for multiple sclerosis. Zinbryta is the trade name for Daclizumab.
Update-11/9/19- “A federal jury in Seattle awarded a former Biogen sales representative nearly $6 million after she claimed the drugmaker fired her for refusing to pursue off-label marketing, according to STAT. Danita Erickson filed a retaliation lawsuit against the drugmaker in July 2018, claiming she was pressured to ensure a multiple sclerosis drug, Zinbryta, was prescribed by a hematologist to a patient with aplastic anemia, which was not an FDA-approved use. Ms. Erickson didn’t want to pursue off-label marketing because Zinbryta had a black box warning on the product labeling, which is reserved for drugs with the most severe and potentially life-threatening side effects, the lawsuit noted.” Becker Hospital
5/5/2019- “A mom with multiple sclerosis says she lost her hair, became covered in lesions and even became suicidal — all because of a greedy doctor who was cashing in on her dubious medication, according to a Manhattan lawsuit.“I went to a very dark place,” Pamela Hill, 65, told The Post. “I just trusted [the doctor] and did not even question, which is something I’ll regret forever.’’The retired Realtor’s nightmare began in 2016 when her Long Island doctor, Stephen Newman, suggested that she switch from the MS drug Tecfidera to a new pharmaceutical, Zinbryta, her suit says.Hill, who was diagnosed with MS at age 29, said Tecfidera hadn’t been working for her anymore. Both it and Zinbryta are manufactured by Biogen. What Hill didn’t know was that Zinbryta had serious risks and was only approved by the FDA for “second-line use,” or when safer options don’t work, her suit says.” NY POST
3/14/18- “The US Food and Drug Administration (FDA) today announced it continues to work with manufacturers Biogen and AbbVie to manage withdrawal of the multiple sclerosis (MS) drug daclizumab (Zinbryta).
3/2/18- “First the news at hand: On March 2, drugmakers Biogen and AbbVie jointly announced the decision to voluntarily withdraw daclizumab (better known by its brand name Zinbryta) from all markets worldwide. In a statement released by both companies, who collaborated on the drug’s development, company officials acknowledged ongoing concerns regarding “the complex and evolving benefit/risk profile” of daclizumab, which is a member of the monoclonal antibody class of MS agents. Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, notes in the statement. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.” Everyday health
6/7/16-“The FDA has approved daclizumab (Zinbryta) as a treatment for adults with relapsing forms of multiple sclerosis. Zinbryta is a long-acting injection that is self-administered by the patient every month. The FDA’s approval was based on results from 2 clinical trials. In the first trial, Zinbryta was compared with Avonex in 1841 patients over the course of 144 weeks. Those who used Zinbryta had fewer clinical relapses. The second trial looked at Zinbryta vs placebo in 412 patients for 52 weeks. Again, patients experienced fewer relapses while taking Zinbryta when compared with the other group.” Pharmacy times
Zinbryta side effects
Zinbryta was a type of medication of last resort for those suffering from multiple sclerosis. Usually, Zinbryta was prescribed if patients have severe side effects from at least two different prior medications. Zinbryta worked by decreasing several cells that caused relapses of multiple sclerosis such as pro-inflammatory lymphoid tissue inducer cells and t-cells. At the same time, it increased cells that helped to regulate the immune system.
Daclizumab black box warning
The main advertised side effect was potential severe liver injury. That was known and was part of the black box warning. This was part of the reason why the drug was only prescribed to patients who had previously tried other drugs. In the wake of a safety review, the drug was only available under restrictive conditions and with regular monitoring given the effect that it had on the liver.
Side Effects of Zinbryta
However, other dangerous side effects of Zinbryta soon became apparent. Specifically, there were several reports in Europe of patients experiencing brain inflammation after taking the drug. Three of the patients who experienced this reaction died from the inflammation. Most of the patients who have received Zinbryta reside in Europe, although there were a number in the U.S. who received the drug. It is believed that nearly 10,000 patients received this drug in the time that it was available on the market.
Encephalitis can be fatal in a worst-case scenario. Even if a patient survives the condition, it can have lifelong consequences. These include memory loss, behavior changes, fatigue and epilepsy. Encephalitis is more likely than not to cause permanent damage and has the potential to lead to lasting brain damage. It may take months for the most acute symptoms to pass and for the patient to be out of jeopardy for death.
Risks of usage of this drug outweighed its benefits
In the wake of the reports of the brain inflammation, the European Commission requested a review of this medication as permitted by its regulations. The review concluded that the risks of usage of this drug outweighed its benefits. As a result of this finding, Biogen and AbbiVie withdrew the drug from the marketplace. This ceased all further regulatory reviews of the medication. At the time that the medication was withdrawn, the manufacturers urged doctors to stop prescribing the drug and transition existing patients to other medications. The FDA worked with the makers of the drug to make sure that it was withdrawn from the marketplace within two months of the time that the withdrawal was announced. At the time, the FDA acknowledged that the safety profile of the drug was consistently recognized since it received FDA approval to treat multiple sclerosis.
Culture that “celebrated” and rewarded off-label prescriptions
Currently, potential lawsuits against Biogen and AbbiVie are in the investigation phases. There is another lawsuit pending against Biogen by a former employees. The lawsuit claims that when this employee expressed concern and filed a complaint about off-label uses for the drug, that she was retaliated against by being fired. The lawsuit claims that there was a culture that “celebrated” and rewarded off-label prescriptions of the drugs for unapproved usages. When she reported this to an internal company hotline, she was allegedly fired.
- “Biogen and AbbVie have announced the voluntary withdrawal Zinbryta ™ (daclizumab) from the worldwide market.
- Zinbryta is an immune-modulating therapy that was approved in 2016 for people with relapsing MS and generally reserved for people who had an inadequate response to two or more MS therapies.
- According to a company press release, the European Medicines Agency had raised new safety concerns related to reports of inflammation of the brain or its surrounding tissues (inflammatory encephalitis and meningoencephalitis) among people taking Zinbryta.” Source
Possible Zinbryta Lawsuits
With regard to encephalitis, this was not a known side effect that was disclosed or warned about. Since lawsuits have yet to be filed, it is not yet known whether there is any evidence of the manufacturers knowing about these side effects, but Zinbryta lawsuit lawyers are actively investigating this possibility. Since some forms of the drug had been in use for over 20 years, there is the possibility that there is testing data that may address this.
Given that this drug was not widely prescribed, it is more likely that the Zinbryta lawsuits will proceed individually as opposed to as a class action. If you or a loved one have taken this medication and have been injured, you must file the Zibryta lawsuit before the statute of limitations has run.
Host of other possible side effects
In addition to brain inflammation, there are a host of other possible side effects that can be grounds for a lawsuit. There is the possibility of Stevens Johnson Syndrome or drug-induced hepatitis that could have resulted from this medication. While the brain injuries are the most publicized possible complication, given the short period for which this drug was prescribed, possible side effects are still being learned. If you have taken this drug, it is important that you are vigilant to monitor any change in your condition and consult a lawyer immediately if you notice any changes.
When you reach out to a Zinbryta side effects lawyer or Zinbryta law firm, you can receive a free case assessment regarding your injury and the attorney will discuss with you whether you have a viable legal claim. You would not have to pay a lawyer anything unless you are successful in achieving some sort of financial recovery in your case. It is vital that you consult a zinbryta side effects attorney who has a background in product liability law, especially in the area of defective drugs.