A Levaquin lawsuit was filed in a California federal court by a Kentucky woman who was diagnosed with peripheral neuropathy (nerve damage) after taking the popular antibiotic Levaquin (levofloxacin).

Plaintiff Geraldine B. alleges that Levaquin caused her to develop peripheral neuropathy after she took the medication as directed and that the drug label lacked proper warnings and directions as to the dangers associated with Levaquin use.

According to the Levaquin lawsuit, “The warning label for Levaquin during the period from September 2004 through August 2013 misled Plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Levaquin was ‘rare’ and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms.”

The Levaquin lawsuit further alleges that peripheral neuropathy cannot always be avoided by discontinuing Levaquin. In addition, information about this debilitating Levaquin side effect was “buried at the bottom of a long list of adverse reactions.”

What is Levaquin?

The antibiotic Levaquin (levofloxacin) is prescribed to treat bacterial infections, pneumonia, skin infections, and bubonic plague. It was created by the drug company Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and was approved by the U.S. Food and Drug Administration (FDA) in 1996. It has been available as a generic drug since 2011. Every year, over 6 million people are prescribed oral Levaquin, and over 1 million are given intravenous Levaquin in a hospital setting.

What is Peripheral Neuropathy (PN)?

Peripheral neuropathy (nerve damage) occurs when nerves between the brain and body are damaged, causing a condition called paresthesia in the arms and legs. There are over 100 different types of peripheral neuropathy, depending on which nerves are involved. Many people suffer from general numbness, muscle weakness, and problems with coordination, which can cause problems with walking, fastening buttons, or balancing. Some types of peripheral neuropathy can cause severe, chronic pain that is extremely difficult to treat. Symptoms of peripheral neuropathy generally include:

• Pain
• Burning
• Tingling
• Numbness
• Weakness
• Change in sensation to light touch, pain, or temperature
• Change in sense of body position
• Loss of reflexes
• Paresthesia
• Muscle wasting
• Paralysis

FDA Safety Warning

Although warnings about peripheral neuropathy were added to the label in 2004, dozens of case reports linking quinolone antibiotics with nerve damage were published throughout the 1990s. In 2001, a study of 45 cases found that most cases occurred within a week, 80 percent were “severe,” and over 60 percent persisted for at least one year.

It was not until August 2013 that the FDA published a Safety Communication to emphasize that nerve damage from Levaquin could occur rapidly and cause permanent complications. The FDA issued new warnings because the original warnings did not adequately describe the risk of rapid onset and permanent nerve damage.

According to the FDA: “In some patients the symptoms had been ongoing for more than a year despite discontinuation of the fluoroquinolone. Several patients were continued on the fluoroquinolone drug despite the occurrence of neuropathic symptoms.”

The prescribing information now warns that Levaquin should be discontinued if patients develop symptoms like pain, burning, tingling, numbness, muscle weakness, or changes in the senses.

Geraldine is seeking all general, economic, medical expenses, compensatory, punitive damages, and legal costs for Janssen’s alleged deception in marketing Levaquin and putting her and the public at risk of developing irreversible peripheral neuropathy. She has demanded a jury trial for this case.

The Levaquin Lawsuit is Case No. 3:14-cv-05246-VC, in the U.S. District Court for the Northern District of California, San Francisco Division.