Lawsuit Alleges That Levaquin Was Intentionally Mislabeled To Downplay Risks Of Side Effects

Lawsuit Alleges That Levaquin Was Intentionally Mislabeled To Downplay Risks Of Side EffectsA lawsuit against Johnson & Johnson and its affiliate, Janssen Pharmaceuticals, is asking for $120 million in compensation and $750 million in punitive damages for six plaintiffs who contend that the two companies and former FDA commissioner Margaret Hamburg conspired to hide the side effects of the antibiotic Levaquin.

The suit, filed in U.S. District Court in January, accuses J&J and Janssen of violating the federal Racketeer Influenced and Corrupt Organizations (RICO) Act. Although the RICO Act is typically used in criminal cases, its purpose is to prohibit individuals or companies from engaging in illegal, deceptive or harmful behavior.

The plaintiffs allege that J&J, Janssen and Hamburg conspired to conceal harmful side effects from the use of Levaquin, an antibiotic used to treat bacterial infections such as urinary tract infections, pneumonia and abdominal infections. Serious side effects from taking Levaquin can include muscle pain, permanent nerve damage or tendon ruptures.

Levaquin received FDA approval in 1998. Since then, more than 1,000 lawsuits have been filed against J&J and Janssen alleging that the manufacturers knew that Levaquin increased the incidence of peripheral neuropathy but hid that information.

In 2012, J&J settled more than 845 Levaquin lawsuits for an undisclosed sum and said that it was negotiating settlements in another 190 cases.

In 2013, the FDA issued an order from manufacturers of all fluoroquinolones — including Levaquin, Cipro, Avelox, Noroxin, Floxin and Factive — to add “black box” warnings to the labels of the drugs to include information about the potential harmful side effects. The FDA discovered that neuropathy symptoms appeared in some patients using fluoroquinolones and that those symptoms could begin at any time and even with short-term use.

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