A woman from Hanover, Massachusetts claims that after taking Tysabri for six years to control her multiple sclerosis (MS), her life has never been the same.
Kimberley A. Yout has been living with MS since 1997. Yout states that last year she was diagnosed with a rare brain infection, which she believes is a side effect of Tysabri. She complains of slurred speech and an unsteady gait.
Once a successful businesswoman who worked as a manager of a bank, as well as a model, Yout’s quality of life has greatly diminished. “Today, I can’t even balance a checkbook, I can’t use an ATM, I can’t see out of one eye. I had to move back in with my mother. I’ve lost my independence. I’ve lost everything,” said Yout.
According to the Boston Globe, “the lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states.” In each of these suits, families are asking for more than $1 million in punitive damages. Taking Tysabri caused a rare brain infection in these patients called progressive multifocal leukoencephalopathy (PML). The disease causes an infection in the white matter of the brain, which can lead to severe disability and even death.
Many doctors still prescribe Tysabri, claiming it is effective for adults with MS when other drugs no longer work, despite the potential risks. They say it is considered effective in slowing the progression of relapsing MS.
Tysabri was approved by the U.S. Food and Drug Administration (FDA) in 2004 but removed from the market just one year later after the death of two patients who were diagnosed with PML. Tysabri was put back on the market in 2006, accompanied by a “risk management” program.
Biogen Idec and Elan are facing complaints in Middlesex Superior Court in Woburn. The suit claims that the companies did not appropriately warn patients of the serious risks associated with long-term use of the drug.
FDA spokeswoman Stephanie Yao said, “Based on the available information to date, the FDA continues to believe that the benefits of taking Tysabri outweigh the potential risks.” In August there were 395 confirmed cases of Tysabri-related PML. Ninety-two of those patients died.
Yout’s lawsuit alleges that the two companies did not warn patients of the actual risks, and that they fraudulently misrepresented the drug in product information. The complaint states, “Tysabri was unaccompanied by adequate warnings of the risk of PML, either known or reasonably scientifically knowable at the time of distribution.”
If you or a loved one suffered adverse side effects from taking Tysabri, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).