Tysabri Lawsuit
A Tysabri lawsuit may be an option for people who have experienced serious complications associated with the drug, including progressive multifocal leukoenceopathy (PML). PML is a serious brain infection that may result in severe disability or even death. 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 Tysabri Lawsuit Commercial?
You may have seen a Tysabri 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 Tysabri?
Tysabri (natalizumab) is a prescription medication manufactured by Biogen Idec and the now defunct Elan Corporation. It is most commonly used to treat multiple sclerosis (MS), a disease that affects the body’s central nervous system and disrupts the flow of information within the brain, and between the brain and the body, and Crohn’s disease, a chronic inflammatory bowel disease that affects the lining of the digestive tract.
According to the drug’s prescription information, Tysabri is used as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate MS therapy.
Additionally, Tysabri is used to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies.
Tysabri was originally approved by the Food and Drug Administration (FDA) in 2004 for the treatment of MS, and in 2008, the FDA approved the drug for treatment of Crohn’s disease when other treatments, such as Remicade and Humira failed.
Tysabri belongs to a class of medications known as immunomodulators. According to the FDA, natalizumab, as well as similar drugs in its class, works by stopping certain cells of the immune system from reaching the brain and spinal cord and causing damage.
Tysabri Side Effects
Serious side effects associated with Tysabri may include:
- Unusual or serious infections
- Liver damage (symptoms may include yellowing of the skin and eyes, nausea, vomiting, unusual darkening of the urine, and feeling tired or weak)
Other side effects may include:
- Headache
- Urinary tract infection
- Lung infection
- Pain in the arm or legs
- Vaginitis
- Nose and throat infections
- Feeling tired
- Joint pain
- Depression
- Diarrhea
- Rash
- Stomach area pain
Additionally, patients treated with Tysabri may experience serious allergic reactions, such as hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin or low blood pressure.
Progressive Multifocal Leukoencephalopathy
Tysabri may increase a patient’s chance of getting a rare brain infection that usually causes death or severe disability, known as progressive multifocal leukoencephalopathy (PML). According to the National Institute of Neurological Disorders and Stroke, PML is a rare, sometimes fatal, disease of the white matter of the brain caused by a virus known as the JC virus.
The disease usually occurs in people with lowered immune defenses, particularly individuals with acquired immune deficiency syndrome (AIDS). Patients undergoing chronic corticosteroid or immunosuppressive therapy for organ transplant, individuals with certain types of cancer (such as Hodgkin’s disease or lymphoma), and individuals with autoimmune conditions such as multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosis are at risk for PML as well.
Prominent symptoms of PML include clumsiness; progressive weakness; and visual, speech, and sometimes personality changes. In many cases, the progression of the disease and its symptoms may lead to life-threatening disability and death.
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FDA Warnings
On February 5, 2010, the FDA issued a drug safety communication alerting the public “that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received.” This information was reportedly based on 31 confirmed cases of PML received by the FDA.
On April 22, 2011, the FDA issued a drug safety communication stating that the agency “continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn’s disease.” The alert is an update to the agency’s safety communication issued in February 2010.
On January 20, 2012, the FDA issued a drug safety communication informing the public that patients who test positive for anti-JC virus (JCV) may be at an increased risk of PML. According to the FDA’s alert, risk factors include presence of anti-JCV antibodies, longer duration of Tysabri treatment (more than two years), and prior treatment with an immunosuppressant medication.
Has There Been a Tysabri Recall?
In February 2005, drug manufacturers Biogen Idec and Elan Pharmaceuticals reportedly announced that they had asked doctors to stop treating patients with Tysabri.
According to an article published by Forbes, two patients developed PML after being treated with Tysabri and Avonex, another drug used to treat MS. One patient reportedly died.
Although the FDA has issued multiple drug safety communications since manufacturers briefly pulld the drug in 2005, the agency has not notified the public of an additional Tysabri recall. Lawsuits 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 Tysabri Class Action Lawsuit?
At the time of publication, no Tysabri class action lawsuit has been filed on behalf of patients who experienced serious complications associated with the drug. Likewise, Tysabri lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple lawsuits are filed against the drug makers alleging injuries and other damages caused by Tysabri and similar drugs, it is anticipated that these lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called a 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 pharmaceutical products.
Have There Been Any Tysabri Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any opioid lawsuit settlements at this time. Instead, it is expected that opioid lawsuits will be consolidated in federal court through an MDL. Opioid lawsuit attorneys note that the outcome of any case is never guaranteed and past results are not necessarily predictive of future outcomes.
Lauren A. on May 16, 2016
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Tysabri Lawsuit Claims
A lawsuit filed in 2016 alleges that the drug manufacturers knew of the risks associated with Tysabri as far back as 1992. Additionally, the lawsuit claims that the drug makers knew or should have known that prolonged use of the treatment increases the risk for PML and that they failed to adequately warn patients and health care providers of such as risk.
Additional lawsuits allege that the drug manufacturers failed to adequately warn patients of the risk of PML associated with the prolonged use of Tysabri, specifically in patients with MS. According to the Boston Globe, at least a half-dozen lawsuits pending in Massachusetts and three other states contain similar allegations linking Tysabri to the development of PML. Although the FDA continues to believe that the benefits of the drug outweigh the risks, plaintiffs claim that the drug makers failed to warn patients and fraudulently misrepresented the drug in product information.
Tysabri Lawsuit News
- September 2017After observing data from more than 37,000 patients, researchers indicated that prolonged use of Tysabri, particularly among patients who had previous immunosuppressant exposure, may lead to an increased risk of PML. This information was consistent with previously calculated estimates
- June 2016In a lawsuit filed in the United States District Court District of New Jersey, the plaintiff claims that he developed PML after receiving treatment with Tysabri.
- May 2012In an article published in the New England Journal of Medicine, researchers concluded that “[p]ositive status with respect to anti–JC virus antibodies, prior use of immunosuppressants, and increased duration of natalizumab treatment, alone or in combination, were associated with distinct levels of PML risk in natalizumab-treated patients with multiple sclerosis.”
- January 2012The FDA issued a drug safety communication informing the public that patients who test positive for anti-JC virus (JCV) may be at an increased risk of PML.
- February 2011The FDA issues a drug safety communication, stating that the agency continues to evaluate the potential risk of PML associated with the use of Tysabri to treat MS and Crohn’s disease.
- February 2010Based on 31 confirmed cases of PML received by the FDA, the agency issues a drug safety communication alerting the public that the risk of developing PML associated with the use of Tysabri increases with the number of Tysabri infusions received.
- February 2005According to Forbes, Biogen Idec and Elan Pharmaceuticals announced that they had asked doctors to stop treating patients with Tysabri after two patients reportedly developed PML (one patient later died).
How a Tysabri 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 Tysabri 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.
