Blank Label Pill Bottle

A lawsuit was filed in the U.S. District Court for the District of New Jersey on December 6, 2016 by a California man left with a debilitating form of nerve damage called peripheral neuropathy after using the popular antibiotic Levaquin in 2013.

Levaquin is part of a class of antibiotics, known as fluoroquinolones, which also includes Avelox and Cipro. Use of the antibiotics has been curtailed in the past year as more information about the risk of peripheral neuropathy and other health problems has surfaced. Peripheral neuropathy involves damage to the nerves, causing persistent pain, burning, tingling, numbness, weakness and sensitivity to light touch, with impaired movement.

FDA Required Stronger Warnings for Levaquin and Other Fluoroquinolones in 2013

An FDA advisory panel looked at the safety of this class of antibiotics, used to treat sinus infections, urinary tract infections, and chronic obstructive pulmonary disease (COPD) worsened by bronchitis, and voted in 2013 to recommend that the FDA strengthen the drug’s warning labels for treatment of sinusitis, urinary tract infections, and bronchitis.

In 2013, the FDA used a drug safety communication to announce that it was requiring manufacturers of Levaquin and other fluoroquinolones to provide label warnings that symptoms of nerve damage may continue for months or even years after taking the drug. Johnson & Johnson ignored this requirement.

Johnson & Johnson for Years Concealed from Medical Community Levaquin’s Risk

The December 2016 lawsuit states that the global drug maker Johnson & Johnson and its Janssen Pharmaceuticals’ subsidiary knew about the link between Levaquin and nerve damage for years, and ignoring the FDA’s requirement, failed to warn the medical community or users of their antibiotic that they may be left with irreversible peripheral neuropathy.

The 2013 warnings provided gave false and misleading information for consumers and the medical community, suggesting that reports of nerve damage were rare and temporary. “The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible,” the lawsuit states.  The language regarding the “rare” risk of peripheral neuropathy was buried at the bottom of a long list of adverse reactions included on the Levaquin label.

October 2016 Lawsuit Also Revealed Concealment of Peripheral Neuropathy Risk

Earlier, in October 2016, a group of 48 plaintiffs filed a joint lawsuit naming Bayer Healthcare, Merck & Co., and Johnson & Johnson and its Janssen subsidiary as defendants, indicating they developed peripheral neuropathy after Levaquin, Avelox and Cipro antibiotic treatments, with some of the plaintiffs experiencing fatal injuries. That case joined hundreds of other Levaquin lawsuits, Avelox lawsuits and Cipro lawsuits, each with allegations that the drug makers failed to provide users and the medical community adequate warnings of the risks.

Research Indicated Other Risks to Levaquin and Avelox Use

Research in 2015 also concluded that fluoroquinolones may cause severe collagen degradation that impacts the aorta, resulting in a risk of aortic aneurysms and aortic dissection. The result has been a growing number of aortic aneurysms lawsuits and aortic dissection lawsuits from Levaquin and Avelox use, conditions that would have been avoided if proper warnings had been provided to users of the antibiotics.