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Raptiva Pulled from Market Due to Concerns About Side Effects

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San Antonio, TXIt has been more than three years since Raptiva was voluntarily withdrawn from the market due to concerns about serious Raptiva side effects. Specifically, the drug was pulled after reports surfaced of a reported increased risk of Raptiva PML (progressive multifocal leukoencephalopathy), a rare progressive neurologic disease that is often fatal. Even though Raptiva was pulled from the market three years ago, lawsuits were scheduled to go to court in 2012.

On February 19, 2009, the US Food and Drug Administration (FDA) issued an alert that it received four reports of PML either fully or potentially linked to the use of Raptiva. Of those four incidents, three patients died. All four of the patients had taken Raptiva for more than three years and none of the patients took any other medications that could suppress the immune system. Just two months after the FDA's alert was issued, Genentech, manufacturer of Raptiva, voluntarily withdrew it from the market.

According to Bloomberg (1/13/12), approximately 100 Raptiva lawsuits were consolidated in state court in Oakland, CA as of January 13, 2012. More lawsuits were reportedly pending in Texas and Massachusetts, alleging Genentech??"which was bought by Roche Holdings AG one month before Raptiva was recalled??"downplayed the risks associated with Raptiva.

At least one Raptiva lawsuit was scheduled for court in 2012. That lawsuit was filed by the family of Stephen Johnson and alleges the businessman died of PML after taking Raptiva for approximately five years to treat psoriasis, Bloomberg (1/26/12) reports. The family sought $15 million in compensatory damages.

In January 2012 the plaintiff's legal team announced they had reached a settlement in the lawsuit, which Roche denied. The plaintiff's team later retracted the statement and the lawsuit, which was set for court January 30, 2012, was then delayed until June 4, 2012.

Progressive multifocal leukoencephalopathy is a rare brain infection that attacks the patient's central nervous system. When the FDA announced the voluntary recall of Raptiva, it noted that the risk of developing PML was rare and associated with long-term use. "Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death," the FDA stated. "There is no known effective treatment for PML," (4/8/09). Symptoms include weakness, impaired speech, vision loss and cognitive deterioration. When it was on the market, Raptiva was given as a once-weekly shot to treat psoriasis, an inflammation of the skin.

The lawsuit is Johnson v. Genentech Inc., RG 10-494957.

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READER COMMENTS

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I was amazed after reading that 'Raptivia' manufactured by GENETECH, might possibly be creating an illness called PML; termed as a 'rare nuerological untreatable condition' that eats 'the brain'.
No, not exactly. It isn't the chemical but the manufacturers of said same, that are, as best as I can tell you, are the #1 leading cause of PML, I have ever truly identified. THEIR DRUGS have a tendancy to cause this in multi-patients with a variety of conditions that their meds seem to find their way to treating them. My sister at 42; with whom they informed us that they had cured her stage 3 non-hodgkins lymphoma and she wouldnt even require her last chemo treatment (9/21/07); would die by October 8, 2007. Diagnosis? PML, a virus that comes on as a result of the use of the chemo drug Rituxan, mfgd. by GENETECH. It eats the outter gray matter of the brain. FDA took it off the warning list in June 2007, citing that the drug hadn't killed anybody. Connie became #25 in the world that year who would die of it! How many since? Of course it hadnt at that point as nobody was using it!! It appears that GENETECH has taken this golden formula combination and spilled out into other areas of treatment. We never got to sue GENETECH, but if theres still an opportunity we'd like to discuss it.

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