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A Baltimore woman is one of six plaintiffs in a lawsuit against pharmaceutical giant Johnson & Johnson. They say the company and others hid information about debilitating side effects of the antibiotic Levaquin, and that they did it for their own financial gain.
The lawsuit is unusual because the plaintiffs are alleging that the company engaged in racketeering and violated the Federal RICO act---a law normally used to prosecute organized crime.
Attorney Larry Klayman out of Washington, D.C. is arguing that Johnson & Johnson and other defendants worked together to mislabel and misbrand Levaquin, despite being aware of serious harmful side effects of the drug. Terry Aston of Baltimore is one of the plaintiffs. She sat down with In Focus in September to describe how taking Levaquin for a minor infection changed her life forever.
"I'm tired all the time," Aston said. "I have to really push to get anything done. I have pain everyday, all day throughout my body. I'm very, I can't lift things like I used to."
Levaquin and other fluoroquinolone drugs were the subject of an FDA hearing in November. Two FDA committees overwhelmingly voted that the existing labels do not fully explain the risks of taking the drugs.
In a statement, Jennifer Norton, a spokeswoman for Janssen Pharmaceuticals under Johnson & Johnson wrote in part:
"We continually monitor the safety and efficacy of all our medicines and, in cooperation with the US FDA and other health authorities, we update our product labels with new information so doctors and patients can make informed decisions. While we haven't been served the complaint you reference, we stand behind Levaquin® and believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients."
The suit also names Dr. Margaret Hamburg, former FDA commissioner, and her husband as defendants. The plaintiffs are seeking close to a billion dollars in damages. See the full complaint here.