The story of Zinbryta follows a pattern that has become distressingly familiar. The drug was created to treat multiple sclerosis and aimed specifically at those who were not getting relief from other medications. This resulted in an excessively expensive drug being marketed to desperate patients, and an approval process that may have overlooked greater than usual risks on the basis that the drug was for those who were otherwise out of options.
Zinbryta and Multiple Sclerosis
Zinbryta is a synthetic drug that was developed to treat patients who suffer from multiple sclerosis. In patients with this disease, the immune system malfunctions and damages myelin, a membrane that covers nerve fibers. This disturbs communication between the brain and other parts of the body and may destroy or cause permanent damage to nerves. The majority of those afflicted with MS experience a steady progression of the disease over time. Complications can include epilepsy, paralysis of the legs, depression and bladder, bowel and sexual difficulties.
The Story Behind Zinbryta
At present, there is no cure for MS. Treatment is aimed at slowing its course and helping patients recover from its effects. The hope was that Zinbryta would reduce inflammation and help restore proper immune function. It was developed for patients who were unable to get relief from existing treatments and may have played a role in the pricing for the drug. In September of 2017, Congressman Elijah Cummings launched a probe into the reasons for its high price in the U.S. After an investigation by the Washington-based nonprofit Ecology International found that the annual cost to American patients, more than $96,000 per year, was three to four times higher than in other high-income countries.
Zinbryta and the FDA
Because Zinbryta was developed as a “last-resort” treatment, the FDA viewed the risk-benefit equation differently. If you begin with an assumption that a patient might be without hope in the absence of the treatment proposed, it can seem to be more reasonable to allow for the possibility of greater risk to the patient.
This is a slippery slope, however, and in the real world, this not work out well for the either the drug or the patients. In fact, it did not take long for it to become apparent that the prospect that this solution carried great danger to patients who used it.
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Liver Damage and Zinbryta
It was obvious from the outset that Zinbryta had the potential to cause serious liver damage and to cause further damage to the immune system. The product carried a “black box” warning, the most extreme warning required on certain drug labels. According to the FDA, this label is “designed to call attention to serious or life-threatening risks.”
Viewed from another perspective, a black box warning may be a final step before a drug is subject to recall. This is where Zinbryta started its life on the market and, unfortunately, in short order it became apparent that quite aside from its great expense to patients, its risks were both unacceptable and unjustified.
Zinbryta was approved by the FDA in May 2016, and by 2017 enough evidence had accumulated of serious liver damage that it was stipulated that it should only be used after the failure two prior therapies and by patients were unable to be helped with any other existing MS treatment.
By March 2018, suspension and recall of the drug in the European Union was ordered by the European Medicines Agency (EMA). This decision was based on 12 reports of life-threatening inflammatory brain disorders among patients using the drug, with three deaths resulting from these complications.
The EMA ordered that any patients taking the drug be monitored for six months following cessation of treatment, and noted symptoms of adverse reaction including the following:
- High temperature
- Severe headache
- Nausea, vomiting
- Yellowing of the skin or eyes
In March 2018, the makers of the drug, Biogen and AbbVie, announced a voluntary withdrawal of the drug from the global market, with a commitment to continue to make it available through April 2018.
Legal Representation for Victims
If you feel that you or a loved one have been harmed by this drug, the skilled Zinbryta lawyers in Miami at Goldberg & Rosen are a vital resource. Several factors come into play that may have the potential to significantly complicate a claim for compensation. For example, it could be stated that it was well understood that this is a dangerous substance, and the risks were communicated with diligence. Only a firm with deep experience in the nuances of the law and the customary and accepted practices of the pharmaceutical and regulatory sectors could truly identify the flaws in such an argument and put forward a compelling case in mediation or at trial.
Goldberg & Rosen: Zinbryta Attorney
If you are considering taking legal action to seek damages, a consultation with our experienced litigators can quickly help you clarify how to best move forward. Goldberg & Rosen in Miami have an extensive record of success, and our legal team has recognized as a top law firm for injury claims associated with dangerous drugs. We are available to discuss what happened to you or your loved one by phone or in a free online case evaluation.