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Johnson & Johnson faces $800 million racketeering lawsuit over its antibiotic, Levaquin.
Plus, an FDA panel said last year that there are serious side effects of the entire class of antibiotics that Levaquin is a part of. Levaquin is prescribed to treat bacterial infections of the skin, sinuses, kidneys, bladder or prostate.
In the lawsuit, 5 plaintiffs allege that J&J and its Janssen unit deliberately mislabeled and misbranded Levaquin, playing down the harmful side effects of the drug for its own financial gain. They also listed former FDA Commissoner Margaret Hamburg in the suit, under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act.
"These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs," according to the suit. The plaintiffs’ health problems have resulted in preventing them from obtaining work and they have accrued “enormous” medical expenses, according to the complaint.
The plaintiffs are asking to be awarded more than $120 million in compensatory damages and more than $750 million in punitive damages. The signficiant $800 million in damages stems from the fact that an estimated 60 million worth of Levaquin prescriptions were written during the time period in question.
In addition, J&J executives “unduly influenced” the FDA and Hamburg, the complaint states.
However, J&J defended its actions. "We … believe our actions regarding the medicine have been appropriate, responsible and in the best interests of patients," the company told FiercePharma in an email. "[W]e continually monitor the safety and efficacy of all our medicines and, in cooperation with the U.S. FDA and other health authorities, we update our product labels with new information so doctors and patients can make informed decisions."
Read more: FDA approves generic Levaquin