Johnson & Johnson and its Janssen Pharmaceutical unit have been named in a RICO lawsuit that accuses the companies of concealing side effects associated with Levaquin. The complaint seeks $800 million in compensatory and punitive damages.
The federal Racketeer Influenced and Corrupt Organizations (RICO) act is the law used to prosecute organized crime. The Levaquin lawsuit, which is now pending in the U.S. District Court, District of Columbia, charges that Johnson & Johnson and Janssen conspired with other defendants to mislabel and misbrand the antibiotic for financial gain. They are further accused of endeavoring to conceal the potential for Levaquin to cause serious complications, including peripheral neuropathy, musculoskeletal issue, cardiovascular and skin problems.
“These concerted efforts resulted in significant harm and/or death to consumers of Levaquin, including plaintiffs,” the complaint alleges.
Levaquin belongs to a class of antibiotics called fluoroquinolones. Other dugs in this class include Avelox, Cipro and a variety of generic brands. These powerful medications are known to be associated with a number of serious side effects. For example, the labeling for all fluoroquinolones currently includes a black box warning – the strongest possible safety alert – regarding a potential association with tendon injuries.
Peripheral neuropathy, a type of nerve damage, has also been known to occur with the use of Levaquin and other fluoroquinolones. Mention of this potentially debilitating problem was first included on the drugs’ labels in 2004. But in 2013, the U.S. Food & Drug Administration (FDA) ordered that the labels be modified to more accurately describe the rapid onset of nerve damage symptoms and the potential for permanent peripheral neuropathy.
This past November, a group of FDA advisors recommended that stronger warnings pertaining to the treatment of sinus infections, urinary-tract infections and bronchitis that worsens existing chronic obstructive pulmonary disease be included on all fluoroquinolone labels.
Hundreds of product liability lawsuits have been filed against the makers of Levaquin, Cipro and Avelox by individuals who allegedly developed peripheral neuropathy related to use of the drugs. The lawsuits claims, among other things, that Johnson & Johnson and other manufacturers were aware of the link between fluoroquinolone antibiotics and peripheral neuropathy as early as 2001, but concealed this risk from doctors and patients.