In one Massachusetts drug defect lawsuit, Kimberley A. Yout is suing Elan Pharmaceuticals and Biogen Idec Inc. for over $1 million in damages. Yout, 45, contends that taking Tysabri to regulate her multiple sclerosis caused her to develop progressive multifocal leukoencephalopath (PML), which is a rare brain infection. Yout, is not the only one claiming that the two companies did not warn patients about the risks involved with prolonged use of the medication. She took Tysabri for six years. Now, Yout says she can’t balance her checkbook, see out of an eye, use an ATM, or live independently.
Approved by the FDA in 2004, Elan and Biogen Idec took it off the market after there were reports of several cases of PML resulting in two fatalities. Despite the possible risks, Tysabri was brought back out again in 2006 with regulator approval and a “risk management” program supposed to train doctors on how to prescribe Tysabri and properly monitor patients.
Tysabri is a huge-selling drug. Last year, the medication was used by about 118,000 patients and brought in $1.6 billion of revenue. That said, Tysabri continues to be linked to incidents of PML. Per Biogen Idec data, there have been about 395 cases of PML linked to the medication, including 92 fatalities in the US.
Also according to the company’s studies, there are risk factors for MS patients that make them more vulnerable to developing PML: Previous use of immunosuppressant drugs, use of Tysabri for two years, or contraction of the JC virus are what can up a patient’s risk.
In her Massachusetts Tysabri injury case, Yout is claiming products liability, including fraudulent and negligent misrepresentation of the drug. Another woman also seeking drug defect compensation over Tysabri in this state is Marla Fair, a 40-year-old woman who took the drug for a couple of years before receiving her PML diagnosis.
Fair now needs a wheelchair and cane to walk and she gets 24-hour care. She and her husband believe the risks are associated with Tysabri far outweigh the benefits and that the medication should be taken off the market.
Progressive Multifocal Leukoencephalopath
This is a white matter of the brain disease caused by a virus infection. The JC Virus, also called Polyomavirus JC, is in a lot of people and doesn’t cause harm unless the immune defenses are lowered. Symptoms can include weakness, clumsiness, personality changes, speech problems, life threatening disabilities, and even death.
Drug manufacturers are supposed to warn of adverse risks, as well as make drugs that are safe for use. When drug defects or a drug that is inherently dangerous causes injury or death to the patient, the victim and his/her family may be able to sue for Boston products liability or wrongful death damages.
Biogen Idec, Elan facing suits over MS drug side effects, The Boston Globe, September 10, 2013
NINDS Progressive Multifocal Leukoencephalopathy Information Page, National Institute of Neurological Disorders and Stroke
More Blog Posts:
Johnson & Johnson Adds Red Warning Alert to Tylenol Caps Following Slew of Drug Injury Lawsuits, Massachusetts Drug Injury Lawyers Blog, August 31, 2013
GranuFlo Lawsuits Seek to Give Patients and Families Compensation Over Dangerous Drug Injuries, Massachusetts Drug Injury Lawyers Blog, August 13, 2013
Woburn, MA Compounding Pharmacy Recalls Drugs After Regulators Find “Foreign Matter” in Vials, Boston Injury Lawyer Blog, March 25, 2013