Levaquin users slap J&J with $800M RICO suit, claiming pharma giant hid serious side effects

Johnson & Johnson ($JNJ) is facing yet another lawsuit over its antibiotic Levaquin from people who claim that the company hid serious side effects. The latest legal action comes a couple of months after an FDA panel flagged serious problems associated with the entire class of antibiotics and voted to change the meds' labels.

Five plaintiffs allege in a new suit that J&J and its Janssen unit deliberately mislabeled and misbranded Levaquin, playing down harmful side effects for its own financial gain. The plaintiffs sued J&J and others--including former FDA commissioner Margaret Hamburg--under the federal Racketeer Influenced and Corrupt Organizations (RICO) act, a law typically used to prosecute organized crime. "These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs," according to the suit.

The plaintiffs are seeking more than $120 million in compensatory damages and more than $750 million in punitive damages to drive home "the seriousness of their egregious conduct and to deter similar conduct in the future."

But J&J is standing by its med. "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."

The latest suit marks another chapter in J&J's Levaquin saga. The company has encountered thousands of lawsuits over the past several years from plaintiffs claiming that it did not adequately warn patients about the drug's dangers.

J&J has scored some court victories along the way, but was also handed one $1.8 million verdict in a Levaquin case. In 2012, the company resolved some of its legal woes over Levaquin, settling 845 legal actions for an undisclosed sum and announcing negotiations to settle another 190 cases.

But drama regarding the drug's alleged side effects is still playing out at the FDA. In 2008, the agency added a label warning about potential tendon damage to all fluoroquinolone antibiotics, including Levaquin. And in November, an FDA advisory committee voted that the entire class should have its labels changed to reflect other potentially serious side effects. Committee members flagged concerns about a "constellation of disabling adverse events" associated with Levaquin and other meds, including musculoskeletal issues, peripheral neuropathy, cardiovascular and skin problems.

- read the suit (PDF)
- here's ABC's take

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