Neb. man sues Rituxan makers alleging drug made him susceptible to paralyzing infectionBy Timberly Ross, AP
Wednesday, August 11, 2010
Neb. man sues makers of Rituxan after infection
OMAHA, Neb. — An Omaha man who contracted an infection that rendered him a quadriplegic after taking the immunosuppressant Rituxan says the drug’s makers knew of the risk but didn’t warn users right away, according to a federal lawsuit filed Wednesday.
Jesse Peetz, 23, said in court documents that he began taking Rituxan in 2003 for treatment of an autoimmune disorder, but that he hadn’t known the drug would make him more susceptible to untreatable infections. In September 2005, he developed a near-fatal viral infection that cost him his motor function.
The lawsuit filed in U.S. District Court in Nebraska claims Genentech Inc. and Biogen Idec were negligent and failed to warn users of Rituxan’s dangers until 2007.
Caroline Pecquet, a spokeswoman for South San Francisco, Calif.-based Genentech Inc., said Wednesday that the company is “committed to ethical and legal promotional practices,” but declined to comment on the specifics of Peetz’s lawsuit.
Pecquet also said 2 million people worldwide have used Rituxan in the 12 years its been on the market.
A message left Wednesday with Cambridge, Mass.-based Biogen Idec wasn’t immediately returned.
Rituxan, according to the drug’s website, is approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Its risks include fatal reactions from infusion, kidney failure and serious brain infection.
Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz’ condition, meaning the Food and Drug Administration had not approved it for that use.
Peetz’s doctor first treated him with Rituxan in May 2003 when he was suffering from a serious episode of his autoimmune disorder. Peetz responded well to the drug, so the doctor decided to continue treatment to keep the disorder in remission, according to the lawsuit.
Peetz took Rituxan for two years before developing a near-fatal viral infection that left him “a ventilator-dependent flaccid quadriplegic,” the lawsuit said. Peetz’ court filing said the drug puts all users at risk, not just those taking it for off-label conditions.
In 2007, Genentech and Biogen Idec issued a warning that Rituxan could put users at risk for untreatable viral infections that can lead to “catastrophic injury and death” for up to one year after discontinuing its use, the lawsuit said.
“This case explores what happens when pharmaceutical companies dedicate more focus to marketing and sales than to safety,” said Peetz’ attorney, Maren Chaloupka. “Patients and doctors are forced to trust that pharmaceutical manufacturers will be honest about the risks involved with the drugs being marketed. If the pharmaceutical manufacturers conceal and deceive, the results to the patient can be absolutely devastating.”
Peetz has requested a jury trial. He’s seeking more than $75,000 in medical costs, plus compensation for pain and suffering and court costs.
In 2005, former Genentech employee Paul McDermott filed a whistleblower lawsuit in federal court in Maine over the marketing of Rituxan. In it, he said Genentech and Biogen Idec was promoting Rituxan as an off-label treatment for rheumatoid arthritis as part of a scheme to defraud Medicare and Medicaid. At the time, Rituxan wasn’t approved by the FDA to treat rheumatoid arthritis. Court documents show both sides agreed in 2008 to drop the case. It was unclear whether a settlement was reached. A message left Wednesday for McDermott’s attorney wasn’t immediately returned.
Biogen Idec: www.biogenidec.com
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