Tysabri Lawsuit Filed Over PML Brain Infection

Irvin Jackson

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The makers of the multiple sclerosis (MS) drug Tysabri face a number of product liability lawsuits brought over severe brain infections linked to the medication, known as progressive multifocal leukoencephalopathy (PML).

Tysabri (natalizumab) is an intravenous injection given every 28 days to treat multiple sclerosis (MS) and Crohn’s disease. Manufactured by Biogen Idec Inc. and marketed with Elan Corp PLC, Tysabri has been shown to prevent relapse, cognitive decline and vision loss associated with MS.

Shortly after Tysabri was introduced in 2004, it was recalled after cases of PML were identified, including at least two deaths. The medication was re-introduced in 2006, with stricter guidelines for usage and more prominent warnings about the possible PML risks associated with Tysabri.

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At least 395 cases of PML have been linked to Tysabri and 95 of those patients have died. A growing number of Tysabri lawsuits continue to be filed on behalf of patients and family members of individuals who died, alleging that the manufacturer has failed to adequately warn consumers or the medical community about the potential risk of PSL from Tysabri side effects.

One of the latest brain infection lawsuit over Tysabri was filed by Kimberly A. Yout, 45, earlier this month in Middlesex Superior Court in Massachusetts. According to a recent report by the Boston Globe, the complaint joins about half a dozen other lawsuits filed against the two companies.

Yout has fought MS since 1997, and was able to make a living as a banker and part-time model. However, she was diagnosed with PML a little more than a year ago, after taking Tysabri for six years. She now is blind in one eye, has cognitive brain problems, speech problems, walking problems and has had to move in with her mother.

Tysabri is used by about 118,000 patients worldwide and brought in $1.6 billion in revenue for Biogen Idec in 2012. Elan sold its share of the drug to Biogen earlier this year.

PML is a rare and deadly brain infection that is believed to be caused when some immunosuppressant drugs, like Tysabri, disable the immune system enough for the JC virus to take hold.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Biogen, Brain Infection, Elan, Multiple Sclerosis, Product Liability Lawsuit, Progressive Multifocal Leukoencephalopathy (PML), Tysabri

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1 Comments

Salvatore
Diagnosed RR MS 11 / 1991 Started using Tysabri 6 / 15 / 2007 Stopped using Tysabri 2 / 15 / 2011 Because of the Tysabri infusions, my white cell , Blood Count went Dangerously Low. As of today it remains the same. Very low and I am seeing an Infectious Disease Doctor. I am taking Antibiotics twice a day, every day. The Count won’t seem to come back up and I am concerned about getting the PML situation. As a result of the circumstances in this situation, I question if I have a case to peruse.

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