The FDA has been informed by Biogen Idec Inc. that a fifth person has developed a rare brain disease known as progressive multifocal leukoencephalopathy (PML) after being treated with its multiple sclerosis drug Tysabri.
Biogen and its development partner, Elan Corp. PLC of Ireland, had hoped to return the drug to the market despite three previously confirmed cases of PML (with two deaths) as well as a fourth unconfirmed case. Sales of the drug were suspended on February 28 of this year.
Only last week, Biogen was hinting at a strategy for bringing the drug back to the market that included testing all patients for the virus that causes PML and stop treatment with Tysabi in time to allow the patients to recover. Experts, however, are not sure at what point additional cases of PML may prove to be an insurmountable obstacle to that plan.
Each time one of these cases is announced Elanâ€™s stock tumbles in value.
Newsinferno.com contacted Jerrold S. Parker, a partner in the New York personal injury law firm of Parker & Waichman, for his thoughts since his firm represents the estate of one of the patients who died from a confirmed case of PML while taking Tysabri. He stated: “This is just another example of a pharmaceutical company placing profits above the publicâ€™s safety.
Rather than lose the money it took to bring a questionable drug to market, Biogen and Elan will do anything they can to recover their investment and more. The real question is; at what point will Tysabri become unmarketable and fall by the wayside with all of the other drugs that have proven to be too dangerous to continue selling to a trusting public?”
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